ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02331277
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-09-01; Completion date: 2016-05-25
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

Detailed description:

Arms: arm 1: Subjects received BI 655064 240 milligram (mg) via subcutaneous injection every week, until 4 weeks. arm 2: Subjects received placebo matching to BI 655064 via subcutaneous injection every week, until 4 weeks.
Interventions: intervention 1: BI 655064 intervention 2: Placebo
Intervention descriptions: intervention 1: subcutaneous injection intervention 2: Placebo

Protocol documents:
Clinical trial NCT02452970
Conditions: Cholangiocarcinoma
Sponsor: EpicentRx, Inc.
Start date: 2015-07-16; Completion date: 2016-05-25
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label study, which means that patients will know what treatments they are receiving, is EPIC, a hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and Cholangiocarcinoma.

The study treatment is divided into two stages. During the first stage, patients will receive RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred.

The primary objective of this clinical trial is to evaluate the progression-free survival (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.

Detailed description:

Arms: arm 1: Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
Interventions: intervention 1: RRx-001 intervention 2: Gemcitabine and cisplatin
Intervention descriptions: intervention 1: RRx-001 (10 mg/m2) intravenously twice weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 30 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression intervention 2: RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression

Protocol documents:
Clinical trial NCT02641067
Conditions: Renal Impairment
Sponsor: Merck Sharp & Dohme LLC
Start date: 2016-01-26; Completion date: 2016-05-25
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.

Detailed description:

Arms: arm 1: Participants with severe renal impairment receive a single oral dose of 100 mg doravirine arm 2: Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine
Interventions: intervention 1: Doravirine
Intervention descriptions: intervention 1: Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally

Protocol documents:
Clinical trial NCT02099110
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-04-22; Completion date: 2016-05-26
Enrollment: 1233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin given together or alone along with metformin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.

Detailed description:
This study will include a 1-week screening period; an up to 12-week metformin titration/dose stabilization period; a 2-week single-blind placebo run-in period; a 52-week (26-week Phase A and 26-week Phase B) double-blind treatment period and a post-treatment telephone contact 14 days after the last dose of study medication.

Arms: arm 1: Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks arm 2: Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks arm 3: Ertugliflozin 5 mg, oral, once daily for 52 weeks arm 4: Ertugliflozin, oral, once daily for 52 weeks arm 5: Sitagliptin 100 mg, oral, once daily for 52 weeks
Interventions: intervention 1: Matching Placebo to Ertugliflozin 5 mg intervention 2: Matching Placebo to Ertugliflozin 10 mg intervention 3: Matching Placebo to sitagliptin 100 mg intervention 4: Ertugliflozin 5 mg intervention 5: Ertugliflozin 10 mg intervention 6: Sitagliptin 100 mg intervention 7: Metformin >= 1500 mg/day intervention 8: Insulin Glargine Rescue Medication intervention 9: Glimepiride Rescue Medication
Intervention descriptions: intervention 1: Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 2: Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 3: Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 4: Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 5: Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 6: Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 7: Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period intervention 8: Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion intervention 9: Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion

Protocol documents:
Clinical trial NCT01987479
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2014-01-30; Completion date: 2016-05-26
Enrollment: 150 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs.

Detailed description:

Arms: arm 1: Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.
Interventions: intervention 1: Non-Biologic DMARDs intervention 2: Tocilizumab intervention 3: Methotrexate
Intervention descriptions: intervention 1: Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study and is at the investigator's discretion. intervention 2: Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks. intervention 3: Methotrexate will be administered per investigator's discretion.

Protocol documents:
Clinical trial NCT02354976
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD Hypertriglyceridemia
Keywords: omega-3 carboxylic acid
Sponsor: AstraZeneca
Start date: 2015-09-01; Completion date: 2016-05-26
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with over-weight and hypertriglyceridemia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Omega-3 carboxylic acid intervention 3: Fenofibrate 200mg intervention 4: Placebo
Intervention descriptions: intervention 1: Placebo matching to Omega-3 carboxylic acids (olive oil) intervention 2: 4 g administered as 4 x 1 g capsules intervention 3: 200mg capsule administered once daily intervention 4: Placebo matching to fenofibrate 200mg

Protocol documents:
Clinical trial NCT02421679
Conditions: PTSD
Keywords: PTSD Military-related PTSD and other related conditions open-label extension
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2015-04-14; Completion date: 2016-05-26
Enrollment: 159 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study) \[NCT02277704\]. Patients will not be made aware of the therapy they received during the double-blind study.

Detailed description:
The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.

Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.

Arms: arm 1: TNX-102 SL taken daily at bedtime for 12 weeks
Interventions: intervention 1: TNX-102 SL
Intervention descriptions: intervention 1: 1x 2.8mg TNX-102 SL Sublingual tablet

Protocol documents:
Clinical trial NCT02470429
Conditions: Dry Eye
Sponsor: Alcon Research
Start date: 2015-07-17; Completion date: 2016-05-26
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Detailed description:
Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Arms: arm 1: SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days arm 2: Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Interventions: intervention 1: SYSTANE HYDRATION lubricant eye drops intervention 2: Hyabak 0.15% eye drops intervention 3: 0.9% saline eye drops
Intervention descriptions: intervention 1: Preserved with POLYQUAD (polidronium chloride) 0.001% intervention 2: Preservative-free intervention 3: Preservative-free, one drop 4 times a day in each eye (run-in period)

Protocol documents:
Clinical trial NCT02070744
Conditions: Cystic Fibrosis
Keywords: CF
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2014-03-01; Completion date: 2016-05-27
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Detailed description:

Arms: arm 1: Participants received VX-661 50 milligram (mg) tablet plus Ivacaftor (IVA) 150 mg tablet every 12 hours (q12h) for 12 weeks. arm 2: Participants received placebo matched to VX-661 tablet plus placebo matched to IVA tablet q12h for 12 weeks. arm 3: Participants received two VX-661 50 mg tablets once daily (qd) plus IVA 150 mg tablet q12h for 12 weeks. arm 4: Participants received two placebo matched to VX-661 tablets qd plus placebo matched to IVA tablet q12h for 12 weeks. arm 5: Participants who completed 12 week PC phase underwent a washout period of at least 4 weeks before entering the OLE phase and received two VX-661 50 mg tablets qd plus IVA 150 mg tablet q12h for 48 weeks in OLE phase.
Interventions: intervention 1: VX-661 intervention 2: Ivacaftor intervention 3: Placebo matched to VX-661 intervention 4: Placebo matched to Ivacaftor
Intervention descriptions: intervention 1: Tablet, oral use intervention 2: Film coated tablet, oral use intervention 3: Tablet, oral use intervention 4: Film coated tablet, oral use

Protocol documents:
Clinical trial NCT02525679
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-09-14; Completion date: 2016-05-27
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BI 655130 (spesolimab) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02550288
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2015-09-29; Completion date: 2016-05-30
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe \[EZ\] 10 mg/Atorvastatin \[Atora\] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.

Detailed description:

Arms: arm 1: 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. arm 2: 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. arm 3: 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. arm 4: 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks arm 5: 1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
Interventions: intervention 1: Ezetimibe 10 mg intervention 2: Atorvastatin 10 mg intervention 3: Placebo for Ezetimibe 10 mg tablet intervention 4: Placebo for Atorvastatin 10 mg capsule intervention 5: Diet control/Daily Exercise
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Protocol documents:
Clinical trial NCT00326872
Conditions: Neurofibromatosis Type 1 Plexiform Neurofibroma Spinal Cord Neurofibroma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-05-01; Completion date: 2016-05-31
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AZD2171 works in treating patients with neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess the efficacy of AZD2171, in terms of volume change in target tumors by 3-dimensional magnetic resonance imaging (3D MRI).

II. Describe and define the toxicities of AZD2171 in these patients.

SECONDARY OBJECTIVES:

I. Assess the value of 3D MRI data analysis in evaluating plexiform or paraspinal neurofibromas compared to conventional 2-dimensional MRI data analysis.

II. Assess the value of delayed contrast-enhanced MRI (DCE-MRI) in determining changes in vascularity of neurofibromas before and during treatment. III. Assess the quality of life of patients treated with AZD2171. IV. Evaluate the effect of AZD2171 on biological changes of human neurofibroma by comparing pre- and post-treatment specimens from patients involved in this trial or, alternatively, by evaluating the effect of AZD2171 on human tumor grafts in experimental animals.

V. Evaluate relevant pharmacodynamic markers (circulating endothelial cells \[CECs\] and vascular endothelial growth factor-2 \[VEGF2\] levels) and pharmacogenetics analyses (variation in kdr/flk-1 and other genes) in response to AZD2171.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor location (peripheral vs paraspinal plexiform neurofibroma). Patients receive oral AZD2171 once daily on days 1-28.

Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to course 2, prior to course 4, and every 6 courses thereafter.

Arms: arm 1: Patients receive oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to course 2, prior to course 4, and every 6 courses thereafter.
Interventions: intervention 1: Cediranib Maleate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01631331
Conditions: Basal Cell Carcinoma of the Skin Recurrent Skin Cancer
Sponsor: Stanford University
Start date: 2012-06-01; Completion date: 2016-05-31
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell carcinoma (BCCs) prior to surgical removal.

Detailed description:
PRIMARY OBJECTIVES:

I. The percent reduction in surgical defect area/size surrounding BCC tumor pre and post-vismodegib.

SECONDARY OBJECTIVES:

I. Recurrence rate post treatment II. Safety, tolerability and percent drop-out after 3 vs. 6 months of vismodegib in otherwise healthy patients.

OUTLINE:

Patients receive vismodegib orally (PO) once daily (QD) for up to 3 months if the initial BCC size is \< 2 cm and superficial or for up to 6 months if the initial BCC size is \>= 2 cm or non-superficial. After completion of vismodegib treatment, patients undergo Mohs surgery.

After completion of study treatment, patients are followed up for an average of 24 months.

Arms: arm 1: Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.
Interventions: intervention 1: vismodegib intervention 2: Mohs surgery
Intervention descriptions: intervention 1: Given PO intervention 2: Undergo Mohs surgery

Protocol documents:
Clinical trial NCT02482428
Conditions: External Genital Warts
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease
Sponsor: Novartis Pharmaceuticals
Start date: 2015-05-12; Completion date: 2016-05-31
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%.

During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.

Detailed description:

Arms: arm 1: LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks arm 2: LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks arm 3: Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks arm 4: Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks arm 5: Aldara 5% cream 3 applications per week for a maximum of 16 weeks
Interventions: intervention 1: Investigational Treatment intervention 2: Aldara
Intervention descriptions: intervention 1: Applied twice daily for up to 12 weeks intervention 2: Applied 3 times a week for 16 weeks

Protocol documents:
Clinical trial NCT01864174
Conditions: Type 2 Diabetes Mellitus
Sponsor: Bristol-Myers Squibb
Start date: 2013-06-20; Completion date: 2016-06-01
Enrollment: 1736 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy

Detailed description:

Arms: arm 1: Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks

Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks arm 2: Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks

Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks
Interventions: intervention 1: Metformin XR intervention 2: Metformin IR intervention 3: Placebo matching with Metformin XR intervention 4: Placebo matching with Metformin IR
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: