ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01753557
Conditions: Chronic Hepatitis C (CHC)
Keywords: Pegasys
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-12-01; Completion date: 2014-11-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MP-424 intervention 2: RBV intervention 3: PEG-IFN alfa-2a
Intervention descriptions: intervention 1: MP-424: 750mg every 8 hours (q8h) for 12 weeks intervention 2: RBV: 600 - 1000 mg/day based on body weight for 24 weeks intervention 3: PEG-IFN alfa-2a: 180mcg/week for 24 weeks

Protocol documents:
Clinical trial NCT01755546
Conditions: Low Back Pain Osteoarthritis Neuropathic Pain
Keywords: Chronic Pain CLBP Chronic Low Back Pain Back Pain Osteoarthritis OA Neuropathic Pain Nerve pain Painful neuropathy
Sponsor: BioDelivery Sciences International
Start date: 2012-12-01; Completion date: 2014-11-01
Enrollment: 304 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

Detailed description:

Arms: arm 1: Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
Interventions: intervention 1: EN3409
Intervention descriptions: intervention 1: Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily

Protocol documents:
Clinical trial NCT01763645
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC bevacizumab pharmacokinetics
Sponsor: Biocad
Start date: 2012-10-01; Completion date: 2014-11-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
BCD-021-02 is a double-blind randomized clinical trial comparing efficacy of BCD-021 (INN: bevacizumab) and paclitaxel + carboplatin to Avastin and paclitaxel + carboplatin in inoperable or advanced non-squamous NSCLC patients with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Avastin. Also study includes pharmacokinetics assessment.

Detailed description:

Arms: arm 1: BCD-021 is a product code for bevacizumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1. arm 2: In this arm patients will receive 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
Interventions: intervention 1: Bevacizumab intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle). intervention 2: Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally) intervention 3: Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).

Protocol documents:
Clinical trial NCT01775137
Conditions: Long-term Safety of TIP
Keywords: CF, Open-label, TIP, phase IV, extension study
Sponsor: Novartis Pharmaceuticals
Start date: 2013-02-01; Completion date: 2014-11-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.

Detailed description:

Arms: arm 1: TIP 112 mg/b.i.d
Interventions: intervention 1: TBM100
Intervention descriptions: intervention 1: Tobramycin inhalation powder (TIP) 112mg/b.i.d

Protocol documents:
Clinical trial NCT01785095
Conditions: Oocyte Donation
Sponsor: IBSA Institut Biochimique SA
Start date: 2013-03-01; Completion date: 2014-11-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.

Detailed description:

Arms: arm 1: FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.
Interventions: intervention 1: FSH (Follicle Stimulating Hormone)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01785524
Conditions: Peripheral Arterial Disease Type II Diabetes Mellitus
Keywords: Cardiovascular Diseases Vascular Diseases Arterial Occlusive Diseases Diabetes Exercise Functional Capacity
Sponsor: Duke University
Start date: 2013-02-01; Completion date: 2014-11-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in claudication onset time \[COT\] and peak walking time \[PWT\] relative to a group with the same exercise training but supplemented with placebo .This study is essentially exploratory in nature and designed to provide us with information to adequately develop power and execute a larger study. We have previously seen benefits from nitrate supplementation on function in PAD.

Detailed description:

Arms: arm 1: Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention. arm 2: Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention.
Interventions: intervention 1: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training intervention 2: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Intervention descriptions: intervention 1: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training. intervention 2: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.

Protocol documents:
Clinical trial NCT01785602
Conditions: Atopic Dermatitis
Keywords: Atopic eczema Skin Diseases
Sponsor: Novartis Pharmaceuticals
Start date: 2013-06-01; Completion date: 2014-11-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Participants received QAW039 450 mg daily by mouth. arm 2: Participants received matching placebo to QAW039.
Interventions: intervention 1: QAW039 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules intervention 2: Capsules

Protocol documents:
Clinical trial NCT01808326
Conditions: Leukaemia, Lymphoblastic
Sponsor: GlaxoSmithKline
Start date: 2013-04-01; Completion date: 2014-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open-label, single arm, phase II study of chlorambucil in subjects with previously untreated CLL.

The primary objective is to evaluate the response to chlorambucil in Japanese subjects with previously untreated CLL.

Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil in Japanese subjects.

Detailed description:
This study is an open-label, single arm, phase II study of chlorambucil in subjects with previously untreated CLL.

The primary objective is to evaluate the response to chlorambucil in Japanese subjects with previously untreated CLL.

Secondary objectives are to evaluate efficacy, safety and pharmacokinetics of chlorambucil in Japanese subjects.

Chlorambucil is an effective and well-tolerated chemotherapeutic agent currently approved for treatment of chronic lymphocytic leukemia (CLL) in the United States of America (US), European Union (EU) and other countries globally but not in Japan. Other more aggressive treatment options such as a combination of fludarabine (F) and cyclophosphamide are available, but are associated with significantly greater toxicities. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited additional toxicity.

Study OMB110911 has been conducted mainly in the US and EU to evaluate progression-free survival (PFS) and overall response (OR) in subjects with previously untreated CLL with ofatumumab in combination with chlorambucil versus (vs.) chlorambucil monotherapy.

The objective of this study is to evaluate overall response of chlorambucil in Japanese subjects with previously untreated CLL.

Arms: arm 1: chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles
Interventions: intervention 1: chlorambucil, tablets
Intervention descriptions: intervention 1: 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles

Protocol documents:
Clinical trial NCT01808534
Conditions: Adult Central Nervous System Germ Cell Tumor Adult Teratoma Malignant Extragonadal Germ Cell Tumor Malignant Extragonadal Non-Seminomatous Germ Cell Tumor Extragonadal Seminoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Ovarian Germ Cell Tumor Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor Stage IV Extragonadal Seminoma Stage IV Ovarian Germ Cell Tumor
Sponsor: Indiana University School of Medicine
Start date: 2013-02-01; Completion date: 2014-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate (complete response \[CR\]+partial response \[PR\]) of single agent palifosfamide in patients with refractory germ cell tumors.

SECONDARY OBJECTIVES:

I. To determine the duration of remission. II. To determine progression free and overall survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ cell tumors.

OUTLINE:

Patients receive palifosfamide intravenously (IV) over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Arms: arm 1: Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: palifosfamide
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT01813019
Conditions: Patient Diagnosed With OCD and Resistant to SSRI Treatment Failed SSRI Over 12 Weeks at Appropriate Doses
Keywords: Obsessive compulsive disorder (OCD), obsessive fears, obsessions, compulsions, OCD SSRI resistant
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-01; Completion date: 2014-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at appropriate doses).

Detailed description:
This was a randomized, double-blind, parallel group, placebo-controlled, 12-weeks 200 mg b.i.d oral dose treatment of AFQ056 (following a 4 week up-titration period and followed by a 3 week down-titration period) or matched placebo in patients diagnosed with OCD and on background SSRI treatment for at least 12 weeks. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective.

Arms: arm 1: Following baseline, approximately 60 patients who are considered eligible will be randomized to AFQ056 arm and will receive the dosing regimen of 4 weeks AFQ056 b.i.d up-titration period of 50 mg,100 mg, 150 mg and 200 mg , followed by 12 weeks AFQ056 200 mg fixed dose\* and then a 3 week down-titration of 100 mg, 50 mg and 25 mg AFQ056 b.i.d)

\*patients that do not tolerate 200 mg b.i.d may be down-titrated to 150 mg b.i.d. arm 2: Following baseline, approximately 60 patients who are considered eligible will be randomized to Placebo arm and will receive the dosing regimen of 4 weeks Placebo b.i.d up-titration period of 50 mg,100 mg, 150 mg and 200 mg , followed by 12 weeks Placebo 200 mg fixed dose\* and then a 3 week down-titration of 100 mg, 50 mg and 25 mg Placebo b.i.d) \*patients that do not tolerate 200 matching placebo AFQ056 mg b.i.d may be down-titrated to 150 mg b.i.d.
Interventions: intervention 1: AFQ056 intervention 2: Placebo
Intervention descriptions: intervention 1: mGluR5 antagonist intervention 2: Matched placebo

Protocol documents:
Clinical trial NCT01829516
Conditions: AOD Use, Abuse, and Dependence
Sponsor: University of California, San Francisco
Start date: 2013-05-01; Completion date: 2014-11-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.

Detailed description:
Impaired social functioning is an important feature of substance use disorders. Social deficits are a risk factor for developing substance use disorders as well as a consequence of substance abuse. Improved social functioning is also a key goal of effective substance abuse treatments. While treatment of disrupted social networks is a mainstay of psychosocial substance abuse treatments, there are currently no pharmacological interventions aimed at improving social functioning in individuals with substance use disorders. Oxytocin administration may shift preference from substance related cues to social cues and may decrease subjective craving for alcohol.

The specific aims are:

1. To examine the effects of intranasal oxytocin administration on social cognition in moderate to heavy social alcohol drinkers.
2. To examine the effects of intranasal oxytocin administration on alcohol craving.
3. To examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in moderate to heavy social alcohol drinkers.

Arms: arm 1: 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin. arm 2: 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.

NOTE: This is a cross-over design and subjects will participate in both arms.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Intranasal oxytocin intervention 2: Intranasal placebo

Protocol documents:
Clinical trial NCT01835015
Conditions: Age-related Macular Degeneration
Keywords: First in human Safety Tolerability Serum PK Intravitreal (IVT) Age-related macular degeneration AMD Geographic Atrophy Choroidal neovascularization
Sponsor: Alcon Research
Start date: 2013-05-01; Completion date: 2014-11-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).

Detailed description:
Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest. All subjects received active CLG561. Progress from one cohort to the next was time-lagged to allow for safety review. Dosing was also time-lagged within each cohort. Only one eye (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular examination occurred immediately after the IVT injection and continued throughout the outpatient visits at pre-determined timepoints. Collection of post-injection blood samples began after the IVT injection at pre-determined timepoints. Subjects were followed for up to 84 days.

Arms: arm 1: Single 50 μL intravitreal injection of CLG561, Dose Level A arm 2: Single 50 μL intravitreal injection of CLG561, Dose Level B arm 3: Single 50 μL intravitreal injection of CLG561, Dose Level C arm 4: Single 50 μL intravitreal injection of CLG561, Dose Level D arm 5: Single 100 μL intravitreal injection of CLG561, Dose Level E
Interventions: intervention 1: CLG561
Intervention descriptions: intervention 1: Administered by intravitreal injection, Day 1

Protocol documents:
Clinical trial NCT01841619
Conditions: Cutaneous Lupus Erythematosus
Keywords: skin, lupus, intravenous immunoglobulin, ivig
Sponsor: University of California, Irvine
Start date: 2013-03-01; Completion date: 2014-11-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to show that non-steroidal treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients.

Detailed description:
The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients. This project has relevant clinical implications due to the severe side effects of and lack of response to current therapies.

From the review of literature, it can be postulated that:

1. the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks;
2. clinical improvement should last several weeks after the last infusion; and
3. remission may be prolonged by maintenance IVIg therapy.

Although this is only a non-controlled study, the investigator expects that IVIg will improve CLE, including those resistant to standard treatments. It is anticipated that treatment with IVIg will facilitate healing of extensive cutaneous lesions and achieve rapid remission. Maintenance therapy with repeated monthly pulses of IVIg is expected to keep the disease in remission during the treatment-free follow up observational period. The results will provide the basis a multicenter randomized controlled study to identify which CLE subsets will benefit the most and which protocol will provide the optimal clinical outcome.

Arms: arm 1: IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
Interventions: intervention 1: IVIg
Intervention descriptions: intervention 1: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in \<25% subjects, the subjects will be re-treated by the standard protocol.

Protocol documents:
Clinical trial NCT01848899
Conditions: Coronary Artery Disease
Keywords: Coronary angiography Percutaneous coronary intervention Contrast media Platelet activity Thrombin generation Fibrinolysis
Sponsor: NYU Langone Health
Start date: 2013-02-01; Completion date: 2014-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iodixanol intervention 2: Ioxaglate intervention 3: Bivalirudin
Intervention descriptions: intervention 1: contrast media used during coronary angiography intervention 2: contrast media used during coronary angiography intervention 3: A direct thrombin inhibitor

Protocol documents: