ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00865969
Conditions: Peripheral T-cell Lymphoma
Keywords: Belinostat Peripheral T-cell lymphoma PXD101 PTCL HDAC inhibitor Histone deacetylase inhibitor
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2008-12-15; Completion date: 2014-10-27
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

Detailed description:
This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m\^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.

Arms: arm 1: Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Interventions: intervention 1: Belinostat
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02077465
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, chronic obstructive pulmonary disease; Safety, Pharmacokinetics
Sponsor: Gilead Sciences
Start date: 2014-03-11; Completion date: 2014-10-27
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.

Detailed description:

Arms: arm 1: Participants will receive andecaliximab every 2 weeks for a total of 3 infusions. arm 2: Participants will receive placebo to match andecaliximab every 2 weeks for a total of 3 infusions.
Interventions: intervention 1: Andecaliximab intervention 2: Placebo to match Andecaliximab
Intervention descriptions: intervention 1: 400 mg andecaliximab administered intravenously intervention 2: Placebo to match andecaliximab administered intravenously

Protocol documents:
Clinical trial NCT01137604
Conditions: Glioma
Sponsor: Eisai Inc.
Start date: 2010-11-09; Completion date: 2014-10-28
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An open-label phase 2, multicenter study in participants with recurrent malignant glioma.

Detailed description:

Arms: arm 1: Cohort 1 assessed participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \[GBM\]) who were bevacizumab-naive. Participants were planned to be accrued in Cohort 1 and randomized in a 1:1 ratio to receive lenvatinib (experimental) or bevacizumab (active comparator).

Cohort 1 - Bevacizumab

Cohort 1 - Lenvatinib arm 2: Cohort 2 assessed participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive. Participants in Cohort 2 were planned to be treated with lenvatinib. arm 3: Cohort 3 assessed participants with recurrent GBM who had disease progression following prior bevacizumab treatment. Participants in Cohort 3 were planned to be treated with lenvatinib.
Interventions: intervention 1: Lenvatinib intervention 2: Bevacizumab
Intervention descriptions: intervention 1: 24 mg lenvatinib capsules orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent. intervention 2: Bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.

Protocol documents:
Clinical trial NCT01114529
Conditions: Kidney Transplantation
Keywords: de novo renal allograft recipients renal allograft function CNI-free regimen
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-09; Completion date: 2014-10-30
Enrollment: 828 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

Detailed description:
This was a 24-month, multi-center, randomized, open-label trial with two parallel arms in adult de novo renal allograft recipients. The study consisted of a run-in period from transplantation to Randomization and a treatment period from Randomization until Month 24. At baseline visit, patients were transplanted and entered the run-in period from transplantation (Baseline) to Randomization (week 10-14 post-transplantation). At Week 10-14, eligible patients were randomized into one of the 2 treatment arms: standard CNIs and Myfortic versus everolimus and Myfortic and entered the treatment period of the study from Randomization to Month 24. Patients in both arms received steroids as per center practice and in any caseat least 5 mg/Day. At Randomization, patients were stratified according to their renal allograft function and previous cardiovascular events. The main analysis was performed at Month 12 and the follow-up analysis was performed at Month 24.

Arms: arm 1: Conversion from CNI to everolimus in combination with Myfortic and steroids arm 2: Control arm: CNI continuation, either Prograf or Neoral in combination with Myfortic and steroids
Interventions: intervention 1: Everolimus intervention 2: Prograf or Neoral
Intervention descriptions: intervention 1: Early CNI to everolimus conversion intervention 2: Active CNI-based control (Prograf or Neoral)

Protocol documents:
Clinical trial NCT01642212
Conditions: Eosinophilic Esophagitis (EoE)
Keywords: EoE
Sponsor: Shire
Start date: 2012-07-23; Completion date: 2014-10-30
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Detailed description:
Eosinophilic Esophagitis (EoE) is an inflammatory disorder of the esophagus and is a recognized clinical entity. Symptoms include feeding problems, heartburn, regurgitation, vomiting, abdominal pain and food impaction. The symptoms of EoE may be similar to gastroesophageal reflux disease (GERD) but do not resolve with gastric acid suppression. EoE is defined histologically as the presence of \> 15 intraepithelial eosinophils per high power fields on one or more esophageal biopsy specimens.

This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS induces a histologic response and a symptom response using a Dysphagia Symptom Questionnaire over a 16 week course of therapy.

Arms: arm 1: Taken once or twice daily for up to 40 weeks arm 2: Taken once or twice daily for 20 weeks
Interventions: intervention 1: Oral Budesonide Suspension (MB-9) intervention 2: Placebo
Intervention descriptions: intervention 1: OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period intervention 2: None

Protocol documents:
Clinical trial NCT01832506
Conditions: Solid Tumors
Keywords: Solid Tumors MSC2156119J c-Met inhibitor Japanese Phase 1
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2013-04-30; Completion date: 2014-10-31
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MSC2156119J
Intervention descriptions: intervention 1: Subjects will be administered with MSC2156119J 215 mg, 300 mg and 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT02222168
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-09-04; Completion date: 2014-10-31
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.

Detailed description:

Arms: arm 1: Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition. arm 2: Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition. arm 3: Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time.
Interventions: intervention 1: BI 409306
Intervention descriptions: intervention 1: film-coated tablet

Protocol documents:
Clinical trial NCT01161524
Conditions: Epilepsy
Sponsor: Eisai Inc.
Start date: 2010-09-01; Completion date: 2014-11-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

Detailed description:
This study consisted of the Core Study and the Extension Part A and B. The Core Study consisted of 2 phases: Prerandomization and Randomization. The Prerandomization Phase lasted up to 1 week, during which participants were assessed for their eligibility to participate in the study. The Randomization Phase consisted of 3 periods: Titration (6 weeks), Maintenance (13 weeks), and Follow-up (4 weeks; only for those participants not rolling over into the Extension Phase). During the Core Study Titration and Maintenance Periods, participants were randomized into perampanel (2 to 12 mg per day) or placebo treatment groups in a 2:1 ratio within each of the age-matched categories (ie, greater than or equal to 12 to less than 15 and greater than or equal to 15 to less than 18).

The extension phase consisted of part A (Conversion Period - 6 weeks and Maintenance period - 25 weeks) and Part B (Optional Extension Phase -52 weeks). The maximum duration for participation in Part B was 52 weeks.

Arms: arm 1: Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day. arm 2: Participants received matching placebo tablets once a day (6 tablets of placebo). arm 3: During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.
Interventions: intervention 1: Perampanel intervention 2: Placebo
Intervention descriptions: intervention 1: 2 mg titrated up to 8-12 mg maximum; taken once daily. intervention 2: Matching Placebo taken once daily.

Protocol documents:
Clinical trial NCT01363440
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema Diabetic Retinopathy
Sponsor: Regeneron Pharmaceuticals
Start date: 2011-05-01; Completion date: 2014-11-01
Enrollment: 466 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.

Detailed description:

Arms: arm 1: Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks. arm 2: Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks. arm 3: Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Interventions: intervention 1: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) intervention 2: Macular Laser Photocoagulation
Intervention descriptions: intervention 1: None intervention 2: Laser therapy

Protocol documents:
Clinical trial NCT01440946
Conditions: Hemophilia B
Sponsor: Bioverativ Therapeutics Inc.
Start date: 2012-06-01; Completion date: 2014-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes

Detailed description:
At the Baseline visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FIX over 10 (±5) minutes in the clinic under medical supervision at a dose of 50 IU/kg. A washout period with no FIX treatment is required prior to administration of prestudy FIX and prior to rFIXFc. A PK assessment is done with prestudy FIX and also done with rFIXFc on Day 1. After completing the PK assessments, participants begin weekly prophylactic treatment with rFIXFc for approximately 50 weeks, to obtain 50 EDs. One ED is defined as a 24-hour period in which a participant received 1 or more doses of rFIXFc, with the time of the first injection of rFIXFc defined as the start of the ED.

Arms: arm 1: At Baseline and at Day 1, participants receive a single intravenous (IV) injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg will be administered in clinic as an IV injection.

Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated.
Interventions: intervention 1: rFIXFc intervention 2: FIX
Intervention descriptions: intervention 1: Vials of rFIXFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose. intervention 2: Vials of prestudy FIX (provided by the participants) were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.

Protocol documents:
Clinical trial NCT01507831
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2012-01-01; Completion date: 2014-11-01
Enrollment: 2341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

* To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
* To evaluate the effects of alirocumab on other lipid parameters.

Detailed description:
The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.

Arms: arm 1: Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks. arm 2: Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.
Interventions: intervention 1: Placebo (for alirocumab) intervention 2: Alirocumab intervention 3: Lipid-Modifying Therapy (LMT)
Intervention descriptions: intervention 1: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe. intervention 2: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe. intervention 3: Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Protocol documents:
Clinical trial NCT01964352
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2013-11-01; Completion date: 2014-11-01
Enrollment: 813 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

Detailed description:

Arms: arm 1: Once daily 2 puffs solution for inhalation Respimat arm 2: Once daily 2 puffs solution for inhalation Respimat arm 3: Once daily 2 puffs solution for inhalation Respimat arm 4: Once daily 2 puffs solution for inhalation Respimat
Interventions: intervention 1: tiotropium intervention 2: placebo intervention 3: olodaterol intervention 4: tiotropium intervention 5: tiotropium intervention 6: olodaterol
Intervention descriptions: intervention 1: fixed dose combination intervention 2: None intervention 3: fixed dose combination intervention 4: fixed dose combination intervention 5: None intervention 6: fixed dose combination

Protocol documents:
Clinical trial NCT00074035
Conditions: Graft Versus Host Disease
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2003-12-01; Completion date: 2014-11-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.

PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.

Secondary

* Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the infection rate in patients treated with this drug.
* Determine the pharmacokinetics of this drug in these patients.
* Determine the changes in lymphocyte populations in patients treated with this drug.
* Determine the survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.

Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Arms: arm 1: treatment of pts with refractory graft vs host disease
Interventions: intervention 1: pentostatin
Intervention descriptions: intervention 1: 4 mg/sq m IV infusion over 20-30 min q 2 weeks

Protocol documents:
Clinical trial NCT00125528
Conditions: Low Back Pain Pain
Keywords: chronic pain low back pain D-cycloserine
Sponsor: Thomas J. Schnitzer
Start date: 2012-07-01; Completion date: 2014-11-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management of chronic neuropathic pain. This pilot study will attempt to determine the effect of D-cycloserine in the treatment of chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of chronic low back pain and to determine which pain measurement scales are best at measuring the efficacy of treatment.

Detailed description:
Human brain imaging studies indicate that the medial prefrontal cortex activity can predict more than 80% of the variance of chronic back pain intensity. Therefore, the investigators have hypothesized that modulation of brain activity at this site should result in analgesia. D-cycloserine has been shown to potentiate conditioned fear extinction. Based on this the investigators hypothesize that chronic neuropathic pain (back pain with radiculopathy) is partially mediated or potentiated by decreased ability to extinguish the pain memory, which the investigators hypothesize to be mediated through reward/aversion brain circuitry, and specifically through medial prefrontal cortex. They have tested this idea in pre-clinical studies and demonstrated that rats with neuropathic pain show analgesia over the long-term when treated with D-cycloserine. In humans with chronic back pain, the investigators hypothesize that D-cycloserine will enhance extinction of back pain which in turn should result in reduced emotional relevance of the pain, that is reduced suffering. It is quite possible that the overall intensity of the back pain will be unaffected, however, the associated suffering will be significantly attenuated.

This will be a double-blind, randomized, parallel group escalating dose study comparing D-cycloserine twice a day (bid) with placebo bid in patients with chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 12 weeks with study drug: 50 mg bid DCS or matching placebo for the first 4 weeks, then 100mg bid DCS or matching placebo for 4 weeks and finally 200mg bid DCS or matching placebo for 4 weeks. Assessments of efficacy and safety will be undertaken every 2 weeks using standard, validated instruments to evaluate change in pain, function, quality of life and adverse events.

Arms: arm 1: D-cycloserine 50mg bid/100mg bid/200 mg bid arm 2: placebo
Interventions: intervention 1: D-cycloserine intervention 2: placebo
Intervention descriptions: intervention 1: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid intervention 2: placebo bid

Protocol documents: