ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00090103
Conditions: Prostatic Hyperplasia
Keywords: Combination Therapy dutasteride BPH
Sponsor: GlaxoSmithKline
Start date: 2003-11-01; Completion date: 2009-04-01
Enrollment: 4844 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Detailed description:
A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

Arms: arm 1: dutasteride 0.5mg once daily arm 2: Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily arm 3: tamsulosin 0.4mg once daily
Interventions: intervention 1: dutasteride 0.5mg once daily for 4 years intervention 2: tamsulosin 0.4mg once daily for 4 years
Intervention descriptions: intervention 1: combination or single agent intervention 2: combination agent or single agent

Protocol documents:
Clinical trial NCT00179647
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma MM Revlimid CC5013 celgene cc-5013 relapsed/refractory lenalidomide dexamethasone Decadron
Sponsor: Celgene Corporation
Start date: 2005-09-01; Completion date: 2009-04-01
Enrollment: 1913 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma.

Detailed description:
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.

Subjects had the following options for dexamethasone treatment at the discretion of the treating physician:

Option A: No dexamethasone.

Option B: Oral pulse dexamethasone administered at a dose of 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle.

Option C: Oral pulse dexamethasone administered at a dose of 20 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle.

Option D: Oral dexamethasone administered at a dose of 40 mg weekly on Days 1, 8, 15, and 22 for each 28-day cycle for all cycles. Treatment was to be continued as tolerated until disease progression developed.

Doses of lenalidomide were allowed to be reduced first from 25 mg to 15 mg and then in 5-mg decrements due to lenalidomide toxicity. Subjects who could not tolerate a daily dose of 5 mg for 21 days every 28 days were discontinued from treatment. At the discretion of the investigator, doses of dexamethasone were modified due to dexamethasone toxicity. Dose reduction and discontinuation schemes for dexamethasone varied according to the treatment option administered.

Study visits occurred every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression was documented, study drug was discontinued for another reason, or lenalidomide became commercially available for this indication.

Arms: arm 1: single-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone
Interventions: intervention 1: lenalidomide intervention 2: dexamethasone
Intervention descriptions: intervention 1: Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone intervention 2: Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens

Protocol documents:
Clinical trial NCT00191789
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2003-02-01; Completion date: 2009-04-01
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

Detailed description:

Arms: arm 1: Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).

Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
Interventions: intervention 1: gemcitabine intervention 2: doxorubicin intervention 3: cisplatin intervention 4: surgery
Intervention descriptions: intervention 1: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8) intervention 2: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4) intervention 3: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8) intervention 4: Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Protocol documents:
Clinical trial NCT00251927
Conditions: Gastroesophageal Reflux
Keywords: Acid reflux disease Gastroesophageal Reflux Disease
Sponsor: AstraZeneca
Start date: 2001-10-01; Completion date: 2009-04-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.

Detailed description:

Arms: arm 1: Surgery arm 2: Esomeprazole (NEXIUM) therapy
Interventions: intervention 1: esomeprazole intervention 2: Laparoscopic fundoplication (surgery)
Intervention descriptions: intervention 1: 40 mg oral tablet administered daily intervention 2: Surgery

Protocol documents:
Clinical trial NCT00262600
Conditions: Atrial Fibrillation Stroke
Sponsor: Boehringer Ingelheim
Start date: 2005-12-01; Completion date: 2009-04-01
Enrollment: 18113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

Detailed description:

Arms: arm 1: twice a day arm 2: once a day arm 3: twice a day
Interventions: intervention 1: warfarin intervention 2: Dabigatran dose 1 intervention 3: Dabigatran dose 2
Intervention descriptions: intervention 1: once a day intervention 2: twice daily intervention 3: twice a day

Protocol documents:
Clinical trial NCT00353418
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2006-06-01; Completion date: 2009-04-01
Enrollment: 415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin intervention 3: Ribavirin
Intervention descriptions: intervention 1: 180 µg subcutaneously weekly for 48 weeks intervention 2: 800 mg orally daily for 48 weeks intervention 3: 1000 mg or 1200 mg (based on patient weight of \< 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks

Protocol documents:
Clinical trial NCT00394277
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2007-02-01; Completion date: 2009-04-01
Enrollment: 1175 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: peginterferon alfa-2a intervention 2: Ribavirin intervention 3: peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: 180 µg sc weekly for 48 weeks intervention 2: 1200 mg po daily for 48 weeks intervention 3: 360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks intervention 4: 1400-1600 mg po daily for 48 weeks

Protocol documents:
Clinical trial NCT00443703
Conditions: HIV Infection
Keywords: treatment experienced
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-05-01; Completion date: 2009-04-01
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.

Detailed description:

Arms: arm 1: Arm 1: MK0518 (raltegravir) + placebo to KALETRA™ (lopinavir (+) ritonavir ) arm 2: Arm 2: KALETRA™ (lopinavir (+) ritonavir) + placebo to MK0518 (raltegravir)
Interventions: intervention 1: MK0518 (raltegravir) intervention 2: Comparator: KALETRA™ (lopinavir (+) ritonavir ) intervention 3: Comparator: placebo intervention 4: Comparator: placebo
Intervention descriptions: intervention 1: MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment intervention 2: KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment. intervention 3: MK0518 (raltegravir) 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment intervention 4: KALETRA™ (lopinavir (+) ritonavir ) 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment.

Protocol documents:
Clinical trial NCT00600119
Conditions: Opioid Induced Constipation (OIC)
Keywords: NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
Sponsor: AstraZeneca
Start date: 2007-12-01; Completion date: 2009-04-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.

Detailed description:

Arms: arm 1: Placebo arm 2: NKTR-118
Interventions: intervention 1: placebo intervention 2: NKTR-118
Intervention descriptions: intervention 1: placebo, oral, once daily (QD) intervention 2: 5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)

Protocol documents:
Clinical trial NCT00949910
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2004-11-01; Completion date: 2009-04-01
Enrollment: 6586 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

Detailed description:

Arms: arm 1: Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.

Protocol documents:
Clinical trial NCT00015457
Conditions: Focal Dystonia
Keywords: Writer's Cramp Calcium Channel Antagonists Torticollis Chemodenervation
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Start date: 2001-04-01; Completion date: 2009-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.

Study Population: 20 patients with cervical dystonia

Design: Double-bind, placebo-controlled clinical trail.

Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.

Detailed description:
Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.

Study Population: 20 patients with cervical dystonia

Design: Double-bind, placebo-controlled clinical trail.

Outcome measures: dystonia rating scales (TWISTRS)

Arms: arm 1: cervical dsytonia patinets
Interventions: intervention 1: Amlodipine plus Botulinum toxin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00066677
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer
Sponsor: Fox Chase Cancer Center
Start date: 2003-10-01; Completion date: 2009-04-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.

Detailed description:
OBJECTIVES:

* Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
* Determine the objective response rate and overall survival of patients treated with these regimens.
* Determine the incidence of thromboembolic events in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15.
* Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.

Arms: arm 1: bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference. arm 2: rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle. Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
Interventions: intervention 1: rhuMAB-VEGF intervention 2: docetaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00100698
Conditions: AIDS HIV Infections
Keywords: HIV lipodystrophy growth hormone visceral fat IGF-I Treatment Experienced
Sponsor: Massachusetts General Hospital
Start date: 2004-01-01; Completion date: 2009-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

Detailed description:
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.

Arms: arm 1: recombinant human growth hormone subcutaneously once a day arm 2: placebo subcutaneously once a day
Interventions: intervention 1: recombinant human growth hormone intervention 2: placebo
Intervention descriptions: intervention 1: growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months intervention 2: placebo subcutaneously once a day, 18 months

Protocol documents:
Clinical trial NCT00114504
Conditions: Atherosclerosis
Keywords: atherosclerosis inflammation statins PET carotid ultrasonography
Sponsor: Kurume University
Start date: 2004-09-01; Completion date: 2009-04-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated.

Detailed description:
There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients.

Originally, we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and patients with FDG-positive plaque receiving diet management therapy. However, because patient number enrolled in the study was too small, the comparison was performed between FDG-positive patients with and without any statin therapy.

Arms: arm 1: Patients with FDG-positive plaque who received simvastatin and diet therapy arm 2: Patients FDG-positive plaque who received diet therapy alone
Interventions: intervention 1: simvastatin
Intervention descriptions: intervention 1: simvastatin 5-10 mg/day

Protocol documents:
Clinical trial NCT00115349
Conditions: Cardiovascular Diseases Heart Diseases Beta-Thalassemia
Sponsor: Carelon Research
Start date: 2005-06-01; Completion date: 2009-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether left ventricular function improves more rapidly with deferoxamine (DFO) and deferiprone (L1) combination therapy than with DFO monotherapy in patients with thalassemia and decreased ejection fractions. Secondary aims include evaluating changes in myocardial iron burden using T2\* and estimating the relative incidence and severity of chelator-induced toxicity.

Detailed description:
DESIGN NARRATIVE:

Participants will be randomized to 1 year of treatment with L1/DFO combination therapy or DFO monotherapy. At baseline, 6 months, and 1 year on therapy, cardiac function will be assessed by MRI measurement of left ventricular ejection fraction (LVEF), T2\*, Holter monitoring, and electrocardiography. Additional monitoring for safety includes weekly blood testing, monthly visits, and periodic eye and ear exams.

Arms: arm 1: Deferoxamine (DFO) and deferiprone (L1) combination therapy arm 2: Deferoxamine (DFO) monotherapy
Interventions: intervention 1: Deferoxamine intervention 2: Deferiprone (L1)
Intervention descriptions: intervention 1: Deferoxamine will be given daily for 12-24h/day 7 days a week either subcutaneous or intravenous at up to 50-60 mg/kg/day. intervention 2: The dose of L1, 75mg/kg in three divided oral doses, is the maximum dose at which toxicity has been tested in prospective trials

Protocol documents: