Datasets:

alicemkyn
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ivbench

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NCT00106691	binary	oncology	PHASE3	INDUSTRY	GTx	RANDOMIZED	TRIPLE	PREVENTION	2,023	test	Preneoplastic Conditions\|Prostatic Intraepithelial Neoplasia	Precancerous Conditions\|Prostatic Intraepithelial Neoplasia\|Neoplasms	Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)	To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)	The outcome measurement time is up to 36 months	% of participants cancer-free 36 months	NUMBER	Inclusion Criteria: * Give voluntary signed informed consent in accordance with institutional policies * Be male, aged ≥ 30 years * Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist * Have had a prostate biopsy in the last...	The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).	30 Years	null	MALE	Toremifene 20mg	Placebo	null	Placebo	null	The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.	null	The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days	Toremifene 20mg group	Placebo group	false	true	null	inert_control	709	717	0.595	0.549	0.046	1	64.4	0	0.747141	0.745636	EXPERIMENTAL	EXPERIMENTAL	rematched	released	inert_control	kept	null	null	null	c0000	c0000	PARALLEL
NCT00210132	binary	oncology	PHASE2	OTHER	Institut Bergonié	RANDOMIZED	TRIPLE	TREATMENT	2,025	test	Postoperative Pain\|Cancer	Pain, Postoperative\|Neoplasms	Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy	Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have major pain if VAS score is \>= 70.	Between surgery and up to 48 hours	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Thoracotomy for oncology thoracic surgery * Secondary or primary cancer * American Society of Anesthesiology (ASA) class 1 or 2 Exclusion Criteria: * Ropivacaine hypersensibility * Psychiatric disorders * Incapacity of using visual analog scale	Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain. There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Although thoracic epidural remains the gold standard, it is not without complications, which are rare ...	18 Years	null	ALL	Ropivacaine Arm	Reference Arm	Ropivacaine	Reference	ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.	ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.	ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropiva...	8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.	true	true	DRUG	inert_control	41	39	0.097561	0.076923	0.020638	1	56.1	0.431818	0.977778	0.911111	EXPERIMENTAL	SHAM_COMPARATOR	released	released	inert_control	kept	null	null	null	c0001	c0001	PARALLEL
NCT00210210	binary	oncology	PHASE3	OTHER	Institut Bergonié	RANDOMIZED	DOUBLE	TREATMENT	2,025	test	Postoperative Pain\|Breast Cancer	Pain, Postoperative\|Breast Neoplasms\|Agnosia	Morphine Consumption (First 48 Post-operative Hours)	Number of participants with at least one consumption of morphine within 48 hours following surgery.	within 48 hours following surgery	Participants	COUNT_OF_PARTICIPANTS	Inclusion criteria: * Patients 18 years older * ASA class 1 or 2 * with surgery of breast cancer (mastectomy or tumorectomy) Exclusion criteria: .Kétamine hypersensitivity * Major psychiatric disorders * Major cardio-vascular disorders * Major neurologic disorders * Major ocular disorders * Morphine in pre-operativ...	The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( k...	18 Years	100 Years	FEMALE	Ketamine Arm	Reference Arm	Ketamine	Saline solution	null	null	Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol".	Induction and anesthetic maintenance without ketamine (reference arm / saline solution)	Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol". Ketamine	Induction and anesthetic maintenance without ketamine (reference arm / saline solution) Saline solution	true	true	DRUG	inert_control	109	104	0.724771	0.740385	-0.015614	1	57.4	1	0.947826	0.904348	EXPERIMENTAL	SHAM_COMPARATOR	released	released	inert_control	kept	null	null	null	c0002	c0002	PARALLEL
NCT00217737	binary	oncology	PHASE3	NIH	National Cancer Institute (NCI)	RANDOMIZED	NONE	TREATMENT	2,025	test	Colon Adenocarcinoma\|Stage IIA Colon Cancer AJCC v7\|Stage IIB Colon Cancer AJCC v7\|Stage IIC Colon Cancer AJCC v7	Colonic Neoplasms	Disease-free Survival Rate at 5 Years	Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.	Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization	Proportion of participants	NUMBER	Inclusion Criteria: * STEP 1: INITIAL REGISTRATION * The distal extent of the tumor must be \>= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be \>= 12 cm from the anal verge as determined by surgical examination; colon...	This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluor...	18 Years	null	ALL	Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)	Arm C (Observation)	Bevacizumab\|Fluorouracil\|Leucovorin\|Oxaliplatin	null	Given IV ; Given IV ; Given IV ; Given IV	null	Patients receive oxaliplatin, leucovorin, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of diseas...	Patients undergo observation.	Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence o...	Patients undergo observation.	true	true	BIOLOGICAL\|DRUG	inert_control	435	998	0.00833	0.00816	0.00017	1	59	0.50655	1	1	EXPERIMENTAL	NO_INTERVENTION	released	released	inert_control	kept	null	null	null	c0003	c0003	PARALLEL
NCT00278408	binary	oncology	PHASE3	OTHER	German High-Grade Non-Hodgkin's Lymphoma Study Group	RANDOMIZED	NONE	TREATMENT	2,025	test	Lymphoma	Lymphoma\|Lymphoma, Follicular\|Lymphoma, Large B-Cell, Diffuse\|Lymphoma, Non-Hodgkin\|Lymphoma, B-Cell, Marginal Zone\|Lymphoma, Large-Cell, Anaplastic\|Lymphoma, Large-Cell, Immunoblastic\|Burkitt Lymphoma\|Lymphoma, Mantle-Cell	3 Years Event-free Survival	Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from...	Each patient will be observed for 3 years starting from completion of treatment.	Participants	COUNT_OF_PARTICIPANTS	DISEASE CHARACTERISTICS: * Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes: * Grade 3 follicular lymphoma * Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants: * Centroblastic * Immunoblastic * Plasmablastic ...	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydroch...	18 Years	60 Years	ALL	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication	null	null	null	null	null	null	Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable ...	Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable t...	false	false	null	active_comparator	155	150	0.812903	0.82	-0.007097	1	46	0.445161	0.858065	0.9	null	ACTIVE_COMPARATOR	unmatched	rematched	active_comparator	repaired	same_treatment_new_comparator	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication	null	c21_0001	PARALLEL
NCT00304239	binary	other	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	DOUBLE	TREATMENT	2,023	test	Actinic Keratosis	Keratosis, Actinic	Participant Complete Response Rate (CRR)	Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.	At Week 13	Percentage of participants	NUMBER	Inclusion Criteria: * Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate. * Males or females above 18 years of age. * Written ...	The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scal...	18 Years	null	ALL	Metvix-PDT	Vehicle-PDT	Metvix-PDT	Vehicle-PDT	Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.	Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.	Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.	Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.	Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.	Participants received Vehicle-PDT on face and/or scalp for 3 hours on Day 0 and Day 7.	true	true	COMBINATION_PRODUCT	inert_control	57	58	0.684	0.069	0.615	1	70	0.178082	0.767123	1	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0007	c0007	PARALLEL
NCT00422240	binary	other	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	DOUBLE	TREATMENT	2,024	test	Acne Vulgaris	Acne Vulgaris	Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)	Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with a...	At Week 12	percentage of participants	NUMBER	Inclusion Criteria: * A clinical diagnosis of acne vulgaris with facial involvement. * A minimum of 20 but not more than 50 inflammatory lesions * A minimum of 30 but not more than 100 noninflammatory lesions * A score of 3 (Moderate) on the Investigator's Global Assessment Scale	This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and ap...	12 Years	null	ALL	Adapalene Gel, 0.1%	Gel Vehicle	Adapalene Gel, 0.1%	Gel Vehicle	0.1% of adapalene gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	true	true	DRUG	inert_control	420	417	0.198	0.113	0.085	1	17.9	0.516667	0.864286	0.830144	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0010	c0010	PARALLEL
NCT00422240	binary	other	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	DOUBLE	TREATMENT	2,024	test	Acne Vulgaris	Acne Vulgaris	Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)	Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with a...	At Week 12	percentage of participants	NUMBER	Inclusion Criteria: * A clinical diagnosis of acne vulgaris with facial involvement. * A minimum of 20 but not more than 50 inflammatory lesions * A minimum of 30 but not more than 100 noninflammatory lesions * A score of 3 (Moderate) on the Investigator's Global Assessment Scale	This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and ap...	12 Years	null	ALL	Adapalene/Benzoyl Peroxide Gel	Gel Vehicle	Adapalene/Benzoyl Peroxide	Gel Vehicle	Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Participants were treated with adapalene 0.1 % \[weight by weight (W/W))\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	true	true	DRUG	inert_control	415	417	0.301	0.113	0.188	1	18.7	0.506024	0.836145	0.830144	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0011	c0011	PARALLEL
NCT00422240	binary	other	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	DOUBLE	TREATMENT	2,024	test	Acne Vulgaris	Acne Vulgaris	Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)	Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with a...	At Week 12	percentage of participants	NUMBER	Inclusion Criteria: * A clinical diagnosis of acne vulgaris with facial involvement. * A minimum of 20 but not more than 50 inflammatory lesions * A minimum of 30 but not more than 100 noninflammatory lesions * A score of 3 (Moderate) on the Investigator's Global Assessment Scale	This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and ap...	12 Years	null	ALL	Benzoyl Peroxide Gel 2.5%	Gel Vehicle	Benzoyl Peroxide Gel 2.5%	Gel Vehicle	2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.	true	true	DRUG	inert_control	415	417	0.222	0.113	0.109	1	18.4	0.498795	0.896386	0.830144	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0012	c0012	PARALLEL
NCT00469417	binary	oncology	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	NONE	TREATMENT	2,024	test	Superficial Basal Cell Carcinoma	null	Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle	Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.	3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months	percentage of participants	NUMBER	Inclusion Criteria: A participant with superficial BCC lesion(s) suitable for entry was defined as a participant with: * histologically confirmed diagnosis of primary superficial BCC lesion(s) * BCC lesions suitable for cryotherapy * males or females above 18 years of age * written informed consent. In accordance wit...	The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC). Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these partic...	18 Years	null	ALL	Metvix® PDT	Cryotherapy	Metvix® cream	Hand held liquid nitrogen spray cryotherapy	null	null	Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwat...	Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the free...	Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwat...	Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the free...	true	true	DRUG	active_comparator	60	58	0.92	0.9	0.02	1	63	0.333333	0.516129	0.706897	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0013	c0013	PARALLEL
NCT00472043	binary	oncology	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	DOUBLE	TREATMENT	2,024	test	Basal Cell Carcinoma	Carcinoma, Basal Cell	Percentage of Participants With Histologically Confirmed Complete Response (CR)	Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal...	up to 6 months	percentage of participants	NUMBER	Inclusion Criteria: A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with * Clinically diagnosed primary nodular BCC lesion(s). * Histologically confirmed diagnosis of BCC. * BCC lesions suitable for simple excision surgery. * Males or females above 18 years of age. * W...	Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been ...	18 Years	null	ALL	Metvix® Cream 160 Milligram Per Gram	Placebo	PDT with Metvix 160 mg/g cream	Placebo	null	null	Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesio...	Participants with primary nodular basal cell carcinoma received Metvix® matching placebo cream. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at...	Methyl aminolevulinate hydrochloride 160 milligram (mg)/gram (g) cream were received by participants with primary nodular basal cell carcinoma. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesio...	Participants with primary nodular basal cell carcinoma received Metvix® matching placebo cream. A thick layer of study cream was applied directly on the lesion and on 5 mm of the surrounding tissue. An approximately 1 mm thick layer of cream was applied to cover the lesion completely. The study cream was applied for at...	true	true	DRUG	inert_control	33	33	0.67	0.18	0.49	1	70	0.333333	0.939394	1	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0014	c0014	PARALLEL
NCT00472108	binary	oncology	PHASE3	INDUSTRY	Galderma R&D	RANDOMIZED	DOUBLE	TREATMENT	2,024	test	Basal Cell Carcinoma	Carcinoma, Basal Cell	Number of Participants With Histologically Confirmed Complete Response	The histological complete response was defined as 100 percent (%) of the lesions within the participant having negative findings in the histological examination. Histological examination included evaluation of all the microscopical slides from the excised tissue for presence of malignant basal cells. Complete response ...	up to 9 months	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with * Clinically diagnosed primary nodular BCC lesion(s). * Histologically confirmed diagnosis of BCC. * BCC lesions suitable for simple excision surgery. * Males or females above 18 years of age. * W...	Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination. For skin diseases, there had been ...	18 Years	null	ALL	Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g)	Photodynamic Therapy (PDT) With Placebo Cream	Photodynamic Therapy (PDT)\|Metvix cream	null	null	null	Participants with BCC lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\2) up to 14 weeks...	null	Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (m...	Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\2) up to 14 weeks. All participants ...	true	false	DRUG\|RADIATION	inert_control	33	32	0.757576	0.34375	0.413826	1	62	0.242424	1	0.96875	EXPERIMENTAL	PLACEBO_COMPARATOR	released	rematched	inert_control	kept	null	null	null	c0015	c0015	PARALLEL
NCT00493870	binary	oncology	PHASE3	INDUSTRY	US Oncology Research	RANDOMIZED	NONE	TREATMENT	2,023	test	Breast Cancer	Breast Neoplasms	3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients	The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among analyzed ITT patients. ITT patients are all patients who were randomized, whether or not they followed protocol. IDFS, defined as the...	3 years from randomization into study	percentage of participants	NUMBER	Inclusion Criteria: A woman will be eligible for inclusion in this study if she meets all of the following criteria: * Age \>18 to \<70 years old. * Has known ER and PR status * Has HER2 nonamplified disease, confirmed by FISH * Has known menopausal status (see Section 7.3 for criteria) * Has operable, histologically...	The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.	18 Years	70 Years	FEMALE	TC Arm	TAC Arm	Docetaxel\|Cyclophosphamide	Docetaxel\|Doxorubicin\|Cyclophosphamide	Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide ; 600 mg/m2 IV over 15-30 minutes on Day 1.	Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide ; • Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrast...	docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2	doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2	docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 Docetaxel: Docetaxel 75 mg/m2 IV over 1 hour on Day 1 plus Cyclophosphamide 600 mg/m2 IV over 15-30 minutes on Day 1 Q 21 day cycles X 6.	doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2 Docetaxel: Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide Doxorubicin: • Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, plus cyclophosphamide 500 mg/m2 IV over 15-30 minutes...	true	true	DRUG	active_comparator	969	965	0.911	0.932	-0.021	1	53.4	1	0.987768	0.984694	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0016	c0016	PARALLEL
NCT00566345	binary	infectious	PHASE3	INDUSTRY	Alachua Government Services, Inc.	RANDOMIZED	DOUBLE	PREVENTION	2,023	test	Influenza	Influenza, Human	Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens	null	21 days to 180 days after the date of vaccination	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: Male and female subjects who * are 18 to 49 years of age, inclusive, on the day of screening * have an understanding of the study, agree to its provisions and give written informed consent prior to study entry * If female and capable of bearing children - have a negative urine pregnancy test resul...	The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5...	18 Years	49 Years	ALL	Influenza Vaccine	Placebo	Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)	Phosphate buffered saline	Trivalent, non-adjuvanted vaccine; dose: 0.5 ml	Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml	Vero-cell derived influenza vaccine	Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)	Vero-cell derived influenza vaccine Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml	Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine) Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml	true	true	BIOLOGICAL	inert_control	1,792	1,817	0.019531	0.034122	-0.014591	1	null	0.566976	0.905413	0.920152	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0017	c0017	PARALLEL
NCT00618098	binary	other	PHASE3	INDUSTRY	Octapharma	RANDOMIZED	NONE	TREATMENT	2,023	test	Reversal of Anticoagulant Treatment	Hemophilia B	INR Response	Number of patients who had an INR response, defined as the correction of patient's INR to \<1.5, 15 minutes after the end of first infusion with study medication	15 minutes after the end of first infusion of OCTAPLEX or FFP	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Male or female patients at least 18 years of age. * Patients receiving oral anticoagulation with coumadin or warfarin derived agents. * Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where ora...	The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).	18 Years	null	ALL	Octaplex (Human Prothrombin Complex Concentrate)	Fresh Frozen Plasma	Octaplex (human prothrombin complex concentrate)	Fresh frozen plasma	INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was \< 1.5. Octaplex (500...	INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of \< 3 and 15 mL/kg for a participant with an initial INR of ≥ 3. If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was \< 1.5. Fr...	Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was \< 1.5.	Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was \< 1.5.	Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was \< 1.5. Octaplex (human prothrombin complex concentrate): INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum d...	Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was \< 1.5. Fresh frozen plasma: INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of \< 3 and 15 mL/kg for a parti...	true	true	BIOLOGICAL	active_comparator	97	103	0.762887	0.300971	0.461916	1	65.5	0.319588	0.680412	0.669903	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0018	c0018	PARALLEL
NCT00687882	binary	other	PHASE3	OTHER	Johns Hopkins All Children's Hospital	RANDOMIZED	SINGLE	TREATMENT	2,025	test	Venous Thrombosis	Venous Thrombosis\|Venous Thromboembolism\|Postthrombotic Syndrome	Efficacy Outcome - Occurrence of Symptomatic Recurrent Venous Thromboembolism	Occurrence of symptomatic recurrent venous thromboembolism. Primary safety endpoint is occurrence of clinically-relevant bleeding (major + clinically-relevant non-major) bleeding.	1 Year	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: 1. Children (birth to \<21 years of age) with radiologically-confirmed acute deep venous thrombosis in the past 30 days 2. In the opinion of the investigator, the venous thrombosis was a provoked (i.e., non-spontaneous) event (e.g.: hospitalization; Central venous catheterization; infection; dehydr...	The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasi...	null	20 Years	ALL	Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)	Parallel Cohort: Persistent Occlusive Thrombosis	null	No Intervention	null	Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.	null	Patients with completely occlusive thrombosis at 6 weeks.	Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks. Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.	Patients with completely occlusive thrombosis at 6 weeks. No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.	false	true	null	inert_control	154	76	0.006494	0.026316	-0.019822	1	8.7	0.468599	0.845411	1	EXPERIMENTAL	OTHER	rematched	released	inert_control	kept	null	null	null	c0019	c0019	PARALLEL
NCT00712881	binary	oncology	PHASE2	INDUSTRY	Cephalon, Inc.	RANDOMIZED	NONE	TREATMENT	2,024	test	Breast Cancer	Breast Neoplasms	Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast	The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue .	At the end of Cycle 8 (each cycle length = 21 days)	percentage of participants	NUMBER	Main Inclusion Criteria: * Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2. * Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria. * The p...	To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 ...	18 Years	70 Years	FEMALE	Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH)	Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH)	Liposomal doxorubicin hydrochloride\|Cyclophosphamide\|Trastuzumab\|Docetaxel	Cyclophosphamide\|Trastuzumab\|Free doxorubicin hydrochloride\|Docetaxel	Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. ; Cyclophosphamide will be administered per dose and schedule specified in the arm description. ; Trastuzumab will be administered per dose and schedule specified in the arm description. ; Docetaxel will be ...	Cyclophosphamide will be administered per dose and schedule specified in the arm description. ; Trastuzumab will be administered per dose and schedule specified in the arm description. ; Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description. ; Docetaxel will be admin...	Participants will receive MCH (liposomal doxorubicin hydrochloride \[60 milligrams {mg}/square meter {m\^2}\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of tr...	Participants will receive AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzu...	Participants received MCH (liposomal doxorubicin hydrochloride \[60 mg/m\^2\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kg), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining...	Participants received AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[8 or 6...	true	true	DRUG	active_comparator	63	63	0.413	0.54	-0.127	1	48.8	1	0.84127	0.888889	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0021	c0021	PARALLEL
NCT00841789	binary	other	PHASE2	OTHER	Michael Portman	RANDOMIZED	QUADRUPLE	TREATMENT	2,023	test	Mucocutaneous Lymph Node Syndrome\|Kawasaki Disease	Mucocutaneous Lymph Node Syndrome	IVIG Refractory	The primary outcome is the proportion of subjects who become refractory to IVIG. Subjects requiring 1 dose of IVIG are classified as responders and subjects requiring more than 1 dose are classified as IVIG refractory.	42 days after initial dose	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age * Provision of Parental Consent * Kawasaki Disease Presentation Exclusion Criteria: * Laboratory Criteria: Any laboratory toxicity, at the time of the screening visit or at any time during the study that in the opinion ...	The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD	2 Months	20 Years	ALL	Arm 1 -Etanercept	ARM 2 Placebo	Etanercept	null	etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.	null	Drug - Treatment with Etanercept as adjunct to standard treatment with IVIG and aspirin	null	Drug - Treatment with Etanercept as adjunct to standard treatment with IVIG and aspirin Etanercept: etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.	Placebo Placebo: Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.	true	false	DRUG	inert_control	100	101	0.13	0.217822	-0.087822	1	3.77	0.34	0.951456	null	EXPERIMENTAL	PLACEBO_COMPARATOR	released	rematched	inert_control	kept	null	null	null	c0023	c0023	PARALLEL
NCT01084876	binary	oncology	PHASE3	INDUSTRY	Celltrion	RANDOMIZED	TRIPLE	TREATMENT	2,025	test	Metastatic Breast Cancer	Breast Neoplasms	Objective Response Rate	Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the n...	6 months (up to 24 weeks)	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Are females * Have Her 2 over-expression * Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: * Current clinical or radiographic evidence central nervous system (CNS) metastases * Current Known infection * Pregnant or nursing mother	The purpose of the study is to demonstrate equivalence	18 Years	null	FEMALE	CT-P6	Herceptin	CT-P6\|Paclitaxel	Herceptin\|Paclitaxel	Administered every 3 weeks ; Administered every 3 weeks	Administered every 3 weeks ; Administered every 3 weeks	CT-P6 was administered at a loading dose of 8 mg/kg body weight by intravenous (IV) infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous ...	Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death or discontinuation. Paclitaxel was administered at a dose of 175 mg/m2 BSA as a continuous 3-hour IV infusion on the day ...	The ORR results for CT-P6 treatment group based on BOR during the Main Study Treatment Period (up to Cycle 8; 6 months) from the ITRC are presented below.	The ORR results for Herceptin treatment group based on BOR during the Main Study Treatment Period from the ITRC are presented below.	true	true	DRUG	active_comparator	244	231	0.565574	0.619048	-0.053474	1	53.8	1	0.758197	0.831169	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0024	c0024	PARALLEL
NCT01107496	binary	neuro_psych	PHASE1\|PHASE2	INDUSTRY	Supernus Pharmaceuticals, Inc.	RANDOMIZED	QUADRUPLE	OTHER	2,024	test	Attention-Deficit/Hyperactivity Disorder (ADHD)	Attention Deficit Disorder with Hyperactivity	Incidence of Adverse Events During 6 Weeks of Treatment	The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" a...	Weeks 1-6	percentage of subjects	NUMBER	Inclusion criteria: 1. Able to provide informed consent prior to any study procedure being conducted. 2. Capable and willing to comply with study procedures. 3. Male or female aged 18 to 64, inclusive. 4. Subjects with a current diagnosis of ADHD as confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV ...	This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD.	18 Years	64 Years	ALL	IR Viloxazine	Placebo	IR Viloxazine	Placebo	One 50mg immediate-release viloxazine capsule administered orally 3 times a day (150mg total daily dose) for Week 1. Two 50mg immediate-release viloxazine capsules administered orally 3 times a day (300mg total daily dose) for Weeks 2 to 6.	Placebo capsules administered orally 3 times a day	Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day	Treatment B: Placebo capsules administered orally 3 times a day	Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day	Treatment B: Placebo administered orally 3 times a day	true	true	DRUG	inert_control	26	25	0.885	0.72	0.165	1	37.7	0.538462	0.923077	0.923077	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0025	c0025	PARALLEL
NCT01120249	binary	oncology	PHASE3	NETWORK	SWOG Cancer Research Network	RANDOMIZED	TRIPLE	TREATMENT	2,024	test	Kidney Cancer	Kidney Neoplasms\|Carcinoma, Renal Cell	5-year Recurrence-free Survival (RFS)	To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any ca...	5 years from registration	percentage of paticipants	NUMBER	DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma * Clear cell or non-clear cell allowed * No disease of the collecting duct or medullary carcinoma * Considered pathologically either intermediate high-risk or very high-risk disease * No history of distant metastases ...	RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.	18 Years	120 Years	ALL	Everolimus	Placebo	null	null	null	null	null	null	Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	false	false	null	inert_control	755	744	0.67	0.63	0.04	1	58	0.311258	0.454305	0.688172	EXPERIMENTAL	PLACEBO_COMPARATOR	rematched	rematched	inert_control	kept	null	null	null	c0026	c0026	PARALLEL
NCT01182766	binary	other	PHASE2\|PHASE3	OTHER	University of Virginia	RANDOMIZED	QUADRUPLE	TREATMENT	2,025	test	Alcohol Dependence\|Nicotine Dependence	Alcoholism\|Tobacco Use Disorder	Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	No smoking in the last 4 weeks of the 18-week treatment with an expired carbon monoxide level of \<10 ppm as the biochemical verification. We used the intent-to-treat assumption, where missing smoking data were considered as smoking.	Week 15 - 18 of the 18-week medication treatment	participants	NUMBER	Inclusion Criteria: * Males and females who have given written informed consent * Subjects must be above the age of 18 * Good physical health * Diagnostic and Statistical Manual (DSM)-IV diagnosis of mild to severe alcohol use disorder * Smoking ≥ 5 cigarettes/day * Currently drinking at least 8 standard drink units (...	This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking pl...	18 Years	null	ALL	High-Dose Topiramate	Placebo	High-Dose Topiramate	Placebo	High-dose topiramate (up to 250 mg/day) with brief behavioral enhancement therapy	Placebo with brief behavioral enhancement therapy	High-dose topiramate (250 mg) with brief behavioral enhancement therapy	Placebo with brief behavioral enhancement therapy	High-dose Topiramate (up to 250 mg/day) with brief behavioral enhancement therapy	Placebo with brief behavioral enhancement therapy	true	true	DRUG	inert_control	77	84	0.077922	0.02381	0.054113	1	48.77	0.324675	0.532468	0.428571	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0027	c0027	PARALLEL
NCT01182766	binary	other	PHASE2\|PHASE3	OTHER	University of Virginia	RANDOMIZED	QUADRUPLE	TREATMENT	2,025	test	Alcohol Dependence\|Nicotine Dependence	Alcoholism\|Tobacco Use Disorder	Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	No smoking in the last 4 weeks of the 18-week treatment with an expired carbon monoxide level of \<10 ppm as the biochemical verification. We used the intent-to-treat assumption, where missing smoking data were considered as smoking.	Week 15 - 18 of the 18-week medication treatment	participants	NUMBER	Inclusion Criteria: * Males and females who have given written informed consent * Subjects must be above the age of 18 * Good physical health * Diagnostic and Statistical Manual (DSM)-IV diagnosis of mild to severe alcohol use disorder * Smoking ≥ 5 cigarettes/day * Currently drinking at least 8 standard drink units (...	This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking pl...	18 Years	null	ALL	Low-Dose Topiramate	Placebo	Low-Dose Topiramate	Placebo	Low-dose topiramate (up to 125 mg/day) with brief behavioral enhancement therapy	Placebo with brief behavioral enhancement therapy	Low-dose topiramate (125 mg) with brief behavioral enhancement therapy	Placebo with brief behavioral enhancement therapy	Low-dose Topiramate (up to 125 mg/day) with brief behavioral enhancement therapy	Placebo with brief behavioral enhancement therapy	true	true	DRUG	inert_control	75	84	0.066667	0.02381	0.042857	1	48.07	0.306667	0.466667	0.428571	EXPERIMENTAL	PLACEBO_COMPARATOR	released	released	inert_control	kept	null	null	null	c0028	c0028	PARALLEL
NCT01350817	binary	oncology	PHASE2	OTHER	University Hospital, Limoges	RANDOMIZED	NONE	TREATMENT	2,026	test	Non Small Cell Lung Cancer	Carcinoma, Non-Small-Cell Lung	Progression Free Survival at 15 Weeks.	null	at 15 weeks	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Histologically proven NSCLC ( * Mutational status of EGFR : wild type or unknown * Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radi...	This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 ev...	18 Years	null	ALL	Erlotinib	Docetaxel	Erlotinib + docetaxel	Docetaxel	docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16	docetaxel :75 mg/m² IV day 1 every 3 weeks.	null	null	Erlotinib + docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16	Docetaxel: docetaxel :75 mg/m² IV day 1 every 3 weeks.	true	true	DRUG	active_comparator	73	74	0.246575	0.22973	0.016846	1	59.1	0.191781	0.973333	0.973684	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0029	c0029	PARALLEL
NCT01499953	binary	other	PHASE3	OTHER	GWT-TUD GmbH	RANDOMIZED	NONE	TREATMENT	2,023	test	Superficial Vein Thrombosis	Thrombosis	Rate of Objectively Confirmed VTE Complications	The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension to...	45 +/- 5 days	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * acute symptomatic supragenual superficial vein thrombosis of the leg * at least one of the following major risk factor for VTE: * age \> 65 years or * male sex or * history of DVT/PE/SVT or * history of cancer or active cancer or * autoimmune disease or * SVT of a non-varicose vein * thrombus ext...	The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).	18 Years	null	ALL	Rivaroxaban	Fondaparinux	Rivaroxaban	Fondaparinux	Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral	Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous	Rivaroxaban for 45 days oral dose: 10 mg OD	Fondaparinux for 45 days subcutaneous application: 2,5 mg OD	Rivaroxaban for 45 days oral dose: 10 mg OD Rivaroxaban: Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral	Fondaparinux for 45 days subcutaneous application: 2,5 mg OD Fondaparinux: Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous	true	true	DRUG	active_comparator	211	224	0.033175	0.017857	0.015318	1	60.7	0.576271	0.940678	0.957627	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0031	c0031	PARALLEL
NCT01501513	binary	other	PHASE3	INDUSTRY	Braintree Laboratories	RANDOMIZED	SINGLE	TREATMENT	2,024	test	Colonoscopy\|Bowel Preparation\|Endoscopy	null	Percentage of Subjects With Successful Bowel Preparation	Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).	Day of colonoscopy	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. * At least 18 years of age * If female, and of child-bearing potential, is using an acceptable form of birth control * Negative urine pregnancy test at screening, if applicable * In the Investigator's j...	The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.	18 Years	null	ALL	BLI800 Approved Preparation Regimen	PEG-3350 Based Bowel Preparation	BLI800 approved preparation regimen	PEG-3350 based bowel preparation	solution for oral administration prior to colonoscopy	solution for oral administration prior to colonoscopy	BLI800 approved preparation regimen	PEG-3350 based bowel preparation	BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy	true	true	DRUG	active_comparator	183	177	0.956284	0.774011	0.182273	1	56.8	0.548913	0.913043	0.926554	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0032	c0032	PARALLEL
NCT01501513	binary	other	PHASE3	INDUSTRY	Braintree Laboratories	RANDOMIZED	SINGLE	TREATMENT	2,024	test	Colonoscopy\|Bowel Preparation\|Endoscopy	null	Percentage of Subjects With Successful Bowel Preparation	Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).	Day of colonoscopy	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. * At least 18 years of age * If female, and of child-bearing potential, is using an acceptable form of birth control * Negative urine pregnancy test at screening, if applicable * In the Investigator's j...	The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.	18 Years	null	ALL	BLI800 Investigational Preparation Regimen	PEG-3350 Based Bowel Preparation	BLI800 investigational preparation regimen	PEG-3350 based bowel preparation	solution for oral administration prior to colonoscopy	solution for oral administration prior to colonoscopy	BLI800 investigational preparation regimen	PEG-3350 based bowel preparation	BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy	PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy	true	true	DRUG	active_comparator	179	177	0.73743	0.774011	-0.036581	1	57.6	0.594444	0.916667	0.926554	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0033	c0033	PARALLEL
NCT01520701	binary	oncology	PHASE3	OTHER	Centre Francois Baclesse	RANDOMIZED	NONE	SUPPORTIVE_CARE	2,026	test	Head and Neck Cancer	Head and Neck Neoplasms\|Radiodermatitis	Impact of Applying a Bandage Hydrogel Skin on Head and Neck Pains	Assessing the impact of applying a bandage hydrogel skin on head and neck pains in patients with cancer of head and neck treated with concomitant radiotherapy by evaluating the proportion of patients with a deterioration in three or more points to their score algia EVA rating scale at the end of treatment compared to t...	end of radiotherapy (2 months after inclusion)	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Patient aged 18 years old * Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door * Patient treated by one of the following diagrams * radiotherapy alone * postoperative radiotherapy + / - sensitized platinum (cisplatin or carboplatin) * ar chemoradiation 5-FU and platin...	The investigators hope to get by reduced and delayed acute radiodermatitis following the application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and improved quality of life of patients with head and neck cancer treated with concomitant radiotherapy.	18 Years	null	ALL	Bandage Skin Hydrosorb	Ialuset® Application	bandage skin Hydrotac®	Ialuset®	Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrotac®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy).	Patients randomized to receive reference of the application of cervical Ialuset® on skin throughout the treatment period (the first day to last day of radiotherapy).	Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy	Arm with application to the skin Ialuset ® cervical during radiotherapy	Arm bandage skin hydrogel (Hydrotac®) on the skin cervical during radiotherapy	Arm with application to the skin Ialuset ® cervical during radiotherapy	true	true	DEVICE	active_comparator	40	37	0.25	0.162162	0.087838	1	60	0.136364	0.6875	0.575758	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0034	c0034	PARALLEL
NCT01546987	binary	oncology	PHASE3	NETWORK	Radiation Therapy Oncology Group	RANDOMIZED	NONE	TREATMENT	2,023	test	Prostate Cancer	Prostatic Neoplasms	Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)	Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage andro...	From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.	percentage of participants	NUMBER	Inclusion Criteria: 1. Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations: * Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage * GS ≥ 8, PSA \< 20 ng/mL, T stage ≥ T2 * GS...	RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prost...	18 Years	null	MALE	TAK-700 + ADT + RT	ADT + RT	GnRH agonist\|Anti-androgen\|TAK-700\|Radiation therapy	GnRH agonist\|Anti-androgen\|Radiation therapy	LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable). ; Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flut...	LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable). ; Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flut...	TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.	Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT.	TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.	Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT.	true	true	DRUG\|RADIATION	active_comparator	116	115	0.128	0.173	-0.045	1	null	0	0.966667	0.974576	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0035	c0035	PARALLEL
NCT01582711	binary	infectious	PHASE3	FED	Centers for Disease Control and Prevention	RANDOMIZED	NONE	PREVENTION	2,025	test	Latent Tuberculosis Infection	Latent Tuberculosis	Treatment Completion Rate.	To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.	Up to 16 weeks from start of treatment.	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Males and non-pregnant, non-nursing females * Age \> 18 years * Weight \> 45kg and considered appropriate to receive RPT 900mg and INH 900mg once weekly by the local site investigator * Willingness to provide signed informed consent. * Clinical indication for LTBI treatment such as: 1) persons wi...	The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a t...	18 Years	null	ALL	3HP SAT With SMS Reminders	3HP Directly Observed Therapy (DOT)	Self Administered Therapy (SAT)\|SMS reminders\|isoniazid and rifapentine	isoniazid and rifapentine	Self Administered Therapy (SAT) ; Short Message Service (SMS) text reminders ; rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)	rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly. Self Administered Therapy (SAT): Self Administered Therapy (SAT) SMS reminders: Short Message Servic...	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT) isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)	true	true	BEHAVIORAL\|DRUG	active_comparator	326	337	0.766871	0.872404	-0.105532	1	38	0.512195	1	1	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0036	c0036	PARALLEL
NCT01582711	binary	infectious	PHASE3	FED	Centers for Disease Control and Prevention	RANDOMIZED	NONE	PREVENTION	2,025	test	Latent Tuberculosis Infection	Latent Tuberculosis	Treatment Completion Rate.	To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.	Up to 16 weeks from start of treatment.	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria: * Males and non-pregnant, non-nursing females * Age \> 18 years * Weight \> 45kg and considered appropriate to receive RPT 900mg and INH 900mg once weekly by the local site investigator * Willingness to provide signed informed consent. * Clinical indication for LTBI treatment such as: 1) persons wi...	The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a t...	18 Years	null	ALL	3HP Self Administered Therapy (SAT)	3HP Directly Observed Therapy (DOT)	Self Administered Therapy (SAT)\|isoniazid and rifapentine	isoniazid and rifapentine	Self Administered Therapy (SAT) ; rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)	rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT) Self Administered Therapy (SAT): Self Administered Therapy (SAT) isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 ...	900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT) isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)	true	true	BEHAVIORAL\|DRUG	active_comparator	335	337	0.740299	0.872404	-0.132105	1	36	0.477745	1	1	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0037	c0037	PARALLEL
NCT01614964	binary	infectious	PHASE2	OTHER	Tulane University	RANDOMIZED	SINGLE	TREATMENT	2,024	test	Malaria	Malaria\|Malaria, Falciparum	Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.	Cure rate is defined as a lack of recrudescence within 42 days PCR-corrected (correcting for new infections due to treatment failures). The investigators were looking for no evidence of recurrent infection with the same parasite genotype after reduction of the asexual parasitemia to less than 25% of the admission value...	Subjects are followed for 42 days after beginning treatment with either AQ-13 or Coartem..	Participants	COUNT_OF_PARTICIPANTS	Inclusion Criteria 1. Adult Malian males ≥ 18 years of age, 2. Uncomplicated malaria with ≥ 2,000 asexual P. falciparum parasites per ul, and 3. Informed consent obtained and signed. Exclusion Criteria 1. Severe or complicated malaria (including temperature ≥ 40o C), 2. ≥ 100,000 asexual parasites per ul of blood, 3...	This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1...	18 Years	99 Years	MALE	AQ-13	Coartem Treatment	AQ-13 Treatment	Coartem Treatment	Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg)...	Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'Coartem Treatment' Participants randomized to the Coartem arm will receive six doses of Coa...	Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg)...	Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention: Active Comparator: Coartem. Participants randomized to the Coartem arm will be treated with...	Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg)...	Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention: Active Comparator: Coartem. Participants randomized to the Coartem arm will be treated with...	true	true	DRUG	active_comparator	33	33	0.848485	0.939394	-0.090909	1	30.3	null	0.848485	1	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0038	c0038	PARALLEL
NCT01666808	binary	oncology	PHASE2\|PHASE3	OTHER	Emory University	RANDOMIZED	NONE	TREATMENT	2,023	test	Prostate Cancer	Prostatic Neoplasms	Failure-free Survival	Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.	3-Year post-intervention	Percentage of participants	NUMBER	Inclusion Criteria: * Adenocarcinoma of the prostate, post radical-prostatectomy Detectable PSA * ECOG/Zubrod Performance Status of 0-2 * Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis * CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic disease outside of the...	Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy ...	18 Years	95 Years	MALE	FACBC PET Scan	Conventional-Only Imaging	FACBC	Radiation therapy	FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings	External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.	A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.	A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.	A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes. FACBC: FACBC is given intravenously prior to PET scan	A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.	true	true	DRUG	active_comparator	76	81	0.755	0.63	0.125	1	61	0	0.807229	0.804878	EXPERIMENTAL	ACTIVE_COMPARATOR	released	released	active_comparator	kept	null	null	null	c0039	c0039	SINGLE_GROUP

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ivbench (v2.1)

Intervention-blind benchmark of real within-trial contrasts for measuring interventional skill of clinical-trial simulators.

Paper: Does Your Trial Simulator Know What the Drug Does? An Intervention-Blind Test of Interventional Validity on 7,207 Registered Trials · HF Papers

Code / full release: github.com/alicemkyn/ivbench (tag v2.1.0)
Archived Zenodo release: doi:10.5281/zenodo.23521618

File	Description
`data/benchmark_contrasts_v2.1_final.csv.gz`	Primary table: 9,996 audited within-trial contrasts (treatment − comparator on the primary endpoint) from 7,207 trials
`data/benchmark_arms_v2.1.csv.gz`	Arm-level records used to build contrasts (40,450 rows)
`data/datacard_v2.1.json`	Construction / cohort datacard for the released contrast table. The `pre_finalize` object keeps the build_v21.py counts (10,004 contrasts, 7,210 trials)

Code is MIT; these data tables and result tables in the GitHub release are CC BY 4.0. Records are derived from ClinicalTrials.gov (public domain); please cite ClinicalTrials.gov as the primary source alongside this benchmark.

Load

contrasts is the default config. Each config is one file, so the two schemas are not concatenated. The Hub split is named train and holds the whole file. The benchmark temporal split is the column split_time (contrasts: train 7,789 / test 2,207).

from datasets import load_dataset

contrasts = load_dataset("alicemkyn/ivbench")
arms = load_dataset("alicemkyn/ivbench", "arms")

The same files can be selected explicitly:

contrasts = load_dataset(
    "alicemkyn/ivbench",
    data_files="data/benchmark_contrasts_v2.1_final.csv.gz",
    split="train",
)

arms = load_dataset(
    "alicemkyn/ivbench",
    data_files="data/benchmark_arms_v2.1.csv.gz",
    split="train",
)

Or with pandas:

import pandas as pd
contrasts = pd.read_csv(
    "hf://datasets/alicemkyn/ivbench/data/benchmark_contrasts_v2.1_final.csv.gz"
)

Splits and fields (summary)

Temporal split on results-posting year: train = posted before 2023, test = 2023+.
Released contrasts: 7,789 temporal-train rows and 2,207 temporal-test rows; 4,014 binary and 5,982 continuous.
Binary endpoints → risk difference; continuous → standardised mean difference.
Key columns include nct_id, family, split_time, delta, intervention / endpoint text fields, and v2.1 pairing metadata (ctrl_kind, v21_status, …). See the paper appendix and datacard_v2.1.json.

Citation

@inproceedings{koyun2026ivbench,
  title={Does Your Trial Simulator Know What the Drug Does? An Intervention-Blind Test of Interventional Validity on 7,207 Registered Trials},
  author={Koyun, Alicem},
  booktitle={NeurIPS 2026 Workshop on World Models for High-Stakes Health (WMHS)},
  year={2026},
  url={https://arxiv.org/abs/2611.05907}
}

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Paper for alicemkyn/ivbench

Does Your Trial Simulator Know What the Drug Does? An Intervention-Blind Test of Interventional Validity on 7,207 Registered Trials

Paper • 2611.05907 • Published 9 days ago

ivbench (v2.1)

Contents

Load

Splits and fields (summary)

Citation

Paper for alicemkyn/ivbench