ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00885534
Conditions: Melanoma Skin Cancer
Keywords: skin cancer CISPLATIN TEMOZOLOMIDE VINBLASTINE 09-017
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-04-01; Completion date: 2013-10-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.

Detailed description:

Arms: arm 1: This is a single institution phase II trial in stage III or IV melanoma patients with measurable disease but no prior cytotoxic chemotherapy and not thought to be curable by surgery.Before starting the chemotherapy, you may need to have a fresh biopsy of your tumor. If you have already had a tumor biopsy that we can use, you may not need another biopsy. Your study doctor will review with you the biopsies you have had. We will try to obtain biopsy material that already exists but if we cannot, you will need another biopsy.
Interventions: intervention 1: Cisplatin, Vinblastine, Temozolomide
Intervention descriptions: intervention 1: Patients will receive CVT chemotherapy which consists of the following:

Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.

Protocol documents:
Clinical trial NCT00906399
Conditions: Relapsing Multiple Sclerosis
Keywords: interferon injectable MS SC PEGylated Interferon beta-1a relapsing PEG multiple sclerosis subcutaneous
Sponsor: Biogen
Start date: 2009-06-01; Completion date: 2013-10-01
Enrollment: 1516 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

Detailed description:
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.

Arms: arm 1: Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks. arm 2: 125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks. arm 3: 125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Interventions: intervention 1: BIIB017 (peginterferon beta-1a) intervention 2: Placebo
Intervention descriptions: intervention 1: Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection. intervention 2: Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.

Protocol documents:
Clinical trial NCT00919035
Conditions: Prostate Cancer
Keywords: prostate cancer androgen-independent prostate cancer (AIPC) Prostate Cancer
Sponsor: Oncology Specialists, S.C.
Start date: 2009-06-01; Completion date: 2013-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Torisel® 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.

Detailed description:
This is an open label phase II study conducted in patients who have androgen-independent and castration-resistant prostate cancer but who have not received systemic chemotherapy. Investigational therapy such as vaccines, immunotherapy, and some oral targeted agents are NOT considered chemotherapy. Prior use of steroids is not an exclusion criterion.

Patients who meet the inclusion criteria will be allowed to participate. Enrolled patients will receive single agent Torisel® at 25 mg weekly. Every 4 weeks of therapy will constitute one cycle of treatment. Patients will continue on therapy until voluntary withdrawal, toxicity, progression, or the investigator's discretion. Patients will be followed for 3 years after discontinuation of Torisel®.

Patients are allowed to receive intravenous or oral bisphosphonates for their bone metastases and are advised to continue androgen blockade while on study.

Arms: arm 1: Single Agent Temsirolimus (Torisel®)
Interventions: intervention 1: torisel
Intervention descriptions: intervention 1: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion

Protocol documents:
Clinical trial NCT00950742
Conditions: Breast Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-08-01; Completion date: 2013-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®

Detailed description:

Arms: arm 1: Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.
Interventions: intervention 1: Trastuzumab intervention 2: BIBW 2992
Intervention descriptions: intervention 1: Load: 4mg/kg-maintain:2mg/kg/week intervention 2: Increased dose cohorts from low dose to MTD

Protocol documents:
Clinical trial NCT00958776
Conditions: Cough Sore Throat Nasal Congestion Headache Fever Seasonal Influenza
Keywords: Influenza Hospitalized Antiviral Flu
Sponsor: BioCryst Pharmaceuticals
Start date: 2009-11-01; Completion date: 2013-10-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

Detailed description:

Arms: arm 1: * Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
* Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. arm 2: Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Interventions: intervention 1: Peramivir+SOC intervention 2: Placebo+SOC
Intervention descriptions: intervention 1: * Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
* Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care. intervention 2: Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Protocol documents:
Clinical trial NCT00995722
Conditions: Ocular Myasthenia Gravis
Keywords: Ocular myasthenia gravis Prednisone Steroids
Sponsor: Michael Benatar
Start date: 2011-12-01; Completion date: 2013-10-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and tolerability of prednisone in patients diagnosed with ocular myasthenia.

Funding Source - FDA OOPD

Detailed description:
The purpose of this study is to learn two things about prednisone in patients with ocular myasthenia. The first thing we aim to learn is whether or not prednisone is effective in improving the symptoms of double vision and drooping eyes that are experienced by patients with ocular myasthenia. The second thing we aim to learn is whether we can find a dose of prednisone that is well tolerated and safe. The overall goal is to find out whether a dose of prednisone that is safe and well tolerated is also effective in improving the symptoms of ocular myasthenia.

After completing screening assessments to confirm eligibility, all participants will receive treatment with pyridostigmine. If a participant's symptoms do not resolve within the first month while being treated with pyridostigmine, they will be randomized to receive prednisone or placebo. The amount of study medication a participant receives will depend on how their symptoms respond to the medication and if they experience any side effects.

After four months, participants that continue to have symptoms of ocular myasthenia and do not have side effects will receive open label high dose prednisone. Participants that no longer have symptoms will taper their dose of study drug in a double-blind fashion.

Arms: arm 1: Corticosteroid arm 2: Matched, inactive substance
Interventions: intervention 1: Prednisone intervention 2: Placebo
Intervention descriptions: intervention 1: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone. intervention 2: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.

Protocol documents:
Clinical trial NCT01025427
Conditions: HIV HIV Infections
Keywords: HIV HIV persistence HIV reservoirs
Sponsor: University of California, San Francisco
Start date: 2009-12-01; Completion date: 2013-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it does not to completely restore health. Patients doing well on otherwise effective HAART remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other "non-AIDS-defining" events. While complete eradication may never be feasible, a "functional cure" in which patients are able to maintain undetectable viral loads indefinitely without therapy may be possible. The best evidence for this are the so-called "elite" controllers, whom we define as individuals who are HIV-seropositive, with plasma HIV RNA levels below the level of conventional detection without treatment. Controllers may be conceptualized as a naturally occurring model of a functional cure (or "HIV remission"), and are ideal patients in which to study HIV persistence and the possibility of eradication.

We propose to conduct a pilot study to better characterize the reservoirs that lead to viral persistence in a group of well-characterized controllers. We propose two specific aims: 1) to characterize the dynamics of viral production in blood and gut-associated lymphoid tissue (GALT) in controllers; and 2) to prospectively treat 10 controllers with raltegravir, tenofovir/emtricitabine for 24 weeks and study the effects of HAART on viral dynamics and host inflammatory responses.

Our primary hypotheses are: 1) viral replication is ongoing in untreated controllers, 2) HAART will reduce viral replication in blood and GALT and decrease immune activation, and 3) higher levels of immune activation are associated with greater measures of microbial translocation and distribution of virus to more differentiated T cell subsets.

Detailed description:

Arms: arm 1: Sixteen controllers will be treated with open-label raltegravir/tenofovir/emtricitabine for 24 weeks.
Interventions: intervention 1: Raltegravir, tenofovir/emtricitabine
Intervention descriptions: intervention 1: 16 controllers will be treated with open-label raltegravir/tenofovir/emtricitabine for 24 weeks.

Protocol documents:
Clinical trial NCT01037309
Conditions: Duchenne Muscular Dystrophy
Sponsor: BioMarin Pharmaceutical
Start date: 2009-12-01; Completion date: 2013-10-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see whether PRO044 is safe and effective to use as medication for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.

Detailed description:
To assess the effect of PRO044 at different dose levels in subjects with Duchenne muscular dystrophy To assess the safety and tolerability of PRO044 at different dose levels in subjects with Duchenne muscular dystrophy To determine the pharmacokinetics of PRO044 at different dose levels after subcutaneous and intravenous administration in subjects with Duchenne muscular dystrophy.

Arms: arm 1: Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29. arm 2: Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29. arm 3: Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29. arm 4: Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29. arm 5: Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29 arm 6: Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29 arm 7: Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29 arm 8: Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29 arm 9: Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29
Interventions: intervention 1: PRO044 SC intervention 2: PRO044 IV
Intervention descriptions: intervention 1: Subcutaneous injection, once a week, for five weeks intervention 2: Intravenous injection, once a week, for five weeks

Protocol documents:
Clinical trial NCT01061528
Conditions: Nicotine Dependence
Keywords: cigarette smoking smoking cessation nicotine dependence
Sponsor: Butler Hospital
Start date: 2009-09-01; Completion date: 2013-10-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.

Detailed description:
1. 18-65 years of age,
2. a regular smoker for at least one year,
3. currently smoking 10 or more cigarettes per day,
4. report motivation to quit smoking in the next month.

Arms: arm 1: * One 60-minute individual session
* Seven 2-hour group sessions
* Two individual brief telephone contacts over an eight-week period.
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. arm 2: * One 60-minute individual session
* Seven 2-hour group sessions
* Two individual brief telephone contacts over an eight-week period.
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Interventions: intervention 1: Transdermal Nicotine
Intervention descriptions: intervention 1: Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.

Protocol documents:
Clinical trial NCT01063764
Conditions: Epilepsy Partial Seizures
Keywords: Keppra Levetiracetam Children Epilepsy Partial Seizures
Sponsor: UCB Japan Co. Ltd.
Start date: 2010-01-01; Completion date: 2013-10-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Detailed description:
Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Arms: arm 1: Open-label, single-arm
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.

Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.

Protocol documents:
Clinical trial NCT01098305
Conditions: Tobacco Use Disorder
Keywords: nicotine smokeless tobacco chewing tobacco varenicline
Sponsor: University of Pennsylvania
Start date: 2011-04-01; Completion date: 2013-10-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.

Detailed description:
The prevalence of smokeless tobacco use in the United States is low vs. cigarette smoking, yet rates have remained constant over the past few years. In contrast, the rate of smokeless tobacco use in India is 20%. Smokeless tobacco is a carcinogenic and responsible for \~10,000 deaths/year from oral cancer in India. Unfortunately, there have been remarkably few intervention trials in India for smokeless tobacco users. To date, no trial has evaluated the new FDA approved medication, varenicline, for smokeless tobacco use. We will conduct a randomized placebo-controlled trial of varenicline for smokeless tobacco dependence at the National Drug Dependence Treatment Center (NDDTC) at the All India Institute of Medicine (AIIMS) in New Delhi with 237 smokeless tobacco users. The primary aims of this trial are to: 1) enhance research capacity at the NDDTC (i.e., train AIIMS staff to implement the behavioral counseling protocol with pharmacotherapy, data collection and management procedures); 2) assess the efficacy of varenicline for increasing biochemically confirmed 7-day point prevalence smokeless tobacco quit rates at the end-of treatment; and 3) assess longitudinal patterns of relapse and recovery following treatment with varenicline. The results of this trial may guide future investments to evaluate the efficacy of varenicline for smokeless tobacco dependence in the US, which is critical since smokeless tobacco use in the US may increase in the coming years and no approved pharmacotherapy for this drug dependence exists in the US or around the globe.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline intervention 2: Counseling
Intervention descriptions: intervention 1: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily). intervention 2: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.

Protocol documents:
Clinical trial NCT01162005
Conditions: Nephrotic Syndrome
Keywords: Primary Nephrotic syndrome
Sponsor: Seoul National University Hospital
Start date: 2010-07-01; Completion date: 2013-10-01
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the investigators designed this prospective study. The investigators will enroll 100 children with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents.

Follow-up is every second week for the first 4 weeks, then monthly. After initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.

Detailed description:
Subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. Urine was analyzed for proteinuria at each visit. Serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.

Arms: arm 1: Tacrobell
Interventions: intervention 1: Tacrolimus
Intervention descriptions: intervention 1: dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year

Protocol documents: