ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01955733
Conditions: Arthritis, Rheumatoid
Sponsor: Boehringer Ingelheim
Start date: 2013-05-31; Completion date: 2016-11-07
Enrollment: 91 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult patients with moderately to severely active rheumatoid arthritis (RA) who have successfully completed treatment in Trial 1301.1.

Detailed description:

Arms: arm 1: BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
Interventions: intervention 1: BI 695500
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02043860
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma High Risk Intermediate Risk Symptomatic
Sponsor: University of Illinois at Chicago
Start date: 2014-01-10; Completion date: 2016-11-07
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.

Detailed description:
To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant.

Arms: arm 1: Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
Interventions: intervention 1: Total Marrow Irradiation intervention 2: Autologous Transplant intervention 3: Melphalan intervention 4: Filgrastim (G-CSF)
Intervention descriptions: intervention 1: Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy. intervention 2: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue. intervention 3: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant. intervention 4: Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days.

Protocol documents:
Clinical trial NCT01912274
Conditions: Acute Myeloid Leukemia
Keywords: AML open label nonrandomized single arm elderly patients HMA newly diagnosed
Sponsor: Helsinn Healthcare SA
Start date: 2013-12-24; Completion date: 2016-11-08
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and effectiveness of pracinostat when combined with azacitadine for patients who are 65 years of age or older and have Acute Myelogenous Leukemia (AML)

Detailed description:

Arms: arm 1: 60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable
Interventions: intervention 1: Pracinostat intervention 2: Azacitidine
Intervention descriptions: intervention 1: Elderly newly diagnosed patients will all receive pracinostat intervention 2: Elderly newly diagnosed patients will all receive azacitadine

Protocol documents:
Clinical trial NCT02085252
Conditions: Prostate Cancer
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2013-06-03; Completion date: 2016-11-08
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.

Detailed description:
The drug being tested in this study is called leuprorelin. Leuprorelin is being tested to treat people who have prostate cancer. Study assessments will include adverse events, prostatic-specific antigen (PSA) levels, and prostate biopsies.

The study will enroll approximately 120 patients. Participants will be randomly assigned (by chance, like flipping a coin) to a treatment group that will receive leuprorelin 11.25 mg (as one injection) or to an untreated observation group. Patients in the leuprorelin group will also receive bicalutamide 50 mg, a non-steroidal antiandrogen, once daily for 15 days to prevent a flare-up.

This multi-center trial will be conducted in France. The overall time to participate in this study is 12 months. After the screening visit, participants will make 6 visits to the clinic.

Arms: arm 1: Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days. arm 2: Active surveillance is close medical monitoring of prostate cancer for any changes.
Interventions: intervention 1: Leuprorelin intervention 2: Bicalutamide
Intervention descriptions: intervention 1: Solution for injection intervention 2: Bicalutamide tablets

Protocol documents:
Clinical trial NCT01615120
Conditions: Prostate Cancer
Sponsor: GTx
Start date: 2012-08-14; Completion date: 2016-11-09
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy. This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.

Detailed description:

Arms: arm 1: one GTx-758 tablet orally administered daily arm 2: two GTx-758 tablets orally administered daily
Interventions: intervention 1: GTx-758 125 mg intervention 2: GTx-758 250 mg
Intervention descriptions: intervention 1: One 125 mg tablet once a day intervention 2: two 125 mg tablets once daily

Protocol documents:
Clinical trial NCT02267382
Conditions: Recurrent Vulvovaginal Candidiasis
Sponsor: Viamet
Start date: 2015-02-10; Completion date: 2016-11-09
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.

Detailed description:

Arms: arm 1: 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks arm 2: 1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks arm 3: 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks arm 4: 2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks arm 5: 2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
Interventions: intervention 1: VT-1161 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02377362
Conditions: Diabetes Mellitus, Type 2
Sponsor: GLWL Research Inc.
Start date: 2015-03-01; Completion date: 2016-11-09
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).

Detailed description:

Arms: arm 1: Escalating dose in at least 2 of 3 periods, starting at 10 milligrams (mg) arm 2: Escalating dose of placebo to match GLWL-01, in 1 period arm 3: Multiple ascending daily doses of GLWL-01 at up to six dose levels, based on Part A arm 4: Multiple daily doses of placebo to match GLWL-01 arm 5: Multiple daily doses of GLWL-01 at level based upon Part B arm 6: Multiple daily doses of placebo to match GLWL-01
Interventions: intervention 1: GLWL-01, Part A intervention 2: Placebo, Part A intervention 3: GLWL-01, Part B intervention 4: Placebo, Part B intervention 5: GLWL-01, Part C intervention 6: Placebo, Part C
Intervention descriptions: intervention 1: Capsules administered orally, in 2 out of 3 periods intervention 2: Capsules administered orally in 1 out of 3 periods intervention 3: Capsules administered orally either once or twice daily for 27 days, with a single dose on Day 28 intervention 4: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28 intervention 5: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28 intervention 6: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28

Protocol documents:
Clinical trial NCT02427607
Conditions: Epilepsy
Keywords: Epilepsy Perampanel
Sponsor: Eisai Co., Ltd.
Start date: 2015-05-12; Completion date: 2016-11-09
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.

Detailed description:

Arms: arm 1: Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) \[NCT02307578\]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day.
Interventions: intervention 1: Perampanel
Intervention descriptions: intervention 1: Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day.

Protocol documents:
Clinical trial NCT02906813
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2016-09-12; Completion date: 2016-11-09
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

Detailed description:
The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:

* TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)
* TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)
* TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)

Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period.

This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.

Arms: arm 1: TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 3. arm 2: TAK-935 300 mg, tablets, orally under fasted state on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg tablets, orally, 30 minutes after high-fat meal on Day 1 of Intervention Period 3. arm 3: TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 1, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 2, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 3.
Interventions: intervention 1: TAK-935 Tablets intervention 2: TAK-935 Oral Solution
Intervention descriptions: intervention 1: Tablets intervention 2: Oral solution

Protocol documents:
Clinical trial NCT01727726
Conditions: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders
Keywords: OPC-34712 brexpiprazole Major Depressive Disorder Adjunctive Treatment
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-12-01; Completion date: 2016-11-10
Enrollment: 2182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.

Detailed description:
This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial.

Arms: arm 1: Matching Placebo and assigned ADT arm 2: Brexpiprazole, flexible dose and assigned ADT arm 3: Seroquel XR, flexible dose and assigned ADT
Interventions: intervention 1: Brexpiprazole intervention 2: Seroquel XR intervention 3: Placebo
Intervention descriptions: intervention 1: tablet/capsule intervention 2: tablet/capsule intervention 3: tablet/capsule

Protocol documents:
Clinical trial NCT01890434
Conditions: Coronary Artery Disease
Keywords: Myocardial Perfusion Imaging
Sponsor: Bayer
Start date: 2013-08-26; Completion date: 2016-11-10
Enrollment: 478 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).

Detailed description:

Arms: arm 1: Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.

Protocol documents:
Clinical trial NCT01764633
Conditions: Dyslipidemia
Keywords: High cholesterol Treatment for high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia
Sponsor: Amgen
Start date: 2013-02-08; Completion date: 2016-11-11
Enrollment: 27564 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. arm 2: Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.
Interventions: intervention 1: Evolocumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. intervention 2: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Protocol documents:
Clinical trial NCT02207634
Conditions: Dyslipidemia
Keywords: High cholesterol Treatment for high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia
Sponsor: Amgen
Start date: 2014-09-10; Completion date: 2016-11-11
Enrollment: 1974 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

Detailed description:
Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in select countries (selected based on study start-up timelines) were invited to participate in this cognitive function study, 20130385. There was no separate randomization for Study 20130385; data were analyzed according to Study 20110118 randomized treatment arm.

Arms: arm 1: Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study. arm 2: Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.
Interventions: intervention 1: Evolocumab intervention 2: Placebo intervention 3: Background Statin Therapy
Intervention descriptions: intervention 1: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. intervention 2: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. intervention 3: Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.

Protocol documents:
Clinical trial NCT01200238
Conditions: Ocular Melanoma
Keywords: STA9090 STA-9090 HSP90
Sponsor: Dana-Farber Cancer Institute
Start date: 2010-09-17; Completion date: 2016-11-11
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
STA-9090, a synthetic small molecule, demonstrates significant activity for down-regulating Heat Shock Protein 90 or Hsp90 levels. Hsp90 belongs to a class of molecular chaperone proteins known to be critical regulators of cancer cell proliferation and survival. Preclinical laboratory experiments have shown STA-9090, an Hsp90 inhibitor, could inhibit ocular melanoma cell lines. The primary objective of this trial is to obtain evaluations of STA-9090 efficacy to metastatic ocular melanoma.

Detailed description:
Patients with metastatic ocular melanoma have a poor prognosis and very limited standard therapeutic options. The recent discoveries of GNAQ and GNA11 mutations leading to MAPK pathway activation and the over-expression of c-Met generate the hypothesis that inhibition of hsp90 client proteins will provide clinical benefit. This study tests the feasibility and efficacy of hsp90 inhibition in patients with metastatic ocular melanoma. Multiple components of the MAPK pathway (B-Raf, C-Raf, cdk4) in addition to c-Met are client proteins of hsp90 and dependent of active hsp90 for stability. Inhibition of hsp90 should lead to decreased expression of these client proteins.

Arms: arm 1: Cohort A participants received STA-9090 200 mg/m2 given intravenously (IV) over 1 hour once weekly (d1, 8, 15 of a 28 day cycle).

Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal. arm 2: Cohort B participants received STA-9090 150 mg/m2 given intravenously over 1 hour (IV) twice weekly (d1, 4, 8, 11, 15, 18 of a 28 day cycle).

Participants were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
Interventions: intervention 1: STA-9090
Intervention descriptions: intervention 1: None

Protocol documents: