ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00665366
Conditions: Bipolar Disorder Mania
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2008-06-01; Completion date: 2011-10-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

Detailed description:

Arms: arm 1: Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. arm 2: Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
Interventions: intervention 1: Aripiprazole intervention 2: Placebo intervention 3: Lithium intervention 4: Valproate
Intervention descriptions: intervention 1: 5-, 10-, or 15-mg oral tablets in titrated doses for 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 12 weeks intervention 3: Participant's ongoing dose intervention 4: Participant's ongoing dose

Protocol documents:
Clinical trial NCT00849901
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2011-10-01
Enrollment: 337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: duloxetine intervention 2: Placebo intervention 3: fluoxetine
Intervention descriptions: intervention 1: 30-120 mg, PO, QD, for up to 38 weeks intervention 2: Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks intervention 3: 10-40 milligram (mg), PO, QD, for up to 38 weeks

Protocol documents:
Clinical trial NCT00064753
Conditions: Chronic Kidney Disease Cardiovascular Disease Death
Keywords: homocysteine multi-vitamin cardiovascular disease renal transplant recipients
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2002-05-01; Completion date: 2011-10-01
Enrollment: 4110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.

Detailed description:
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients

Arms: arm 1: Multivitamin with increased folic acid, vitamin B6 and vitamin B12 arm 2: Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12
Interventions: intervention 1: High Dose Multivitamin intervention 2: Low Dose Multivitamin
Intervention descriptions: intervention 1: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg intervention 2: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg

Protocol documents:
Clinical trial NCT00075608
Conditions: Multiple Myeloma Plasma Cell Neoplasm
Keywords: primary systemic amyloidosis
Sponsor: Boston Medical Center
Start date: 2001-08-01; Completion date: 2011-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.

PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.

Detailed description:
OBJECTIVES:

* Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis.
* Determine the response rate and durability of response in patients treated with this regimen.
* Determine immune reconstitution in patients treated with this regimen.

OUTLINE:

* Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection.
* Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2.
* Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0.

Patients are followed at 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.

Arms: arm 1: Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion
Interventions: intervention 1: filgrastim intervention 2: melphalan intervention 3: autologous stem cell transplantation intervention 4: stem cell infusion
Intervention descriptions: intervention 1: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection intervention 2: 140-200 mcg/kg IV over two days intervention 3: infusion of previously collected stem cells on Day 0 intervention 4: infusion of previously collected stem cells on Day 0

Protocol documents:
Clinical trial NCT00116584
Conditions: Bronchiolitis
Keywords: heliox bronchiolitis racemic epinephrine
Sponsor: University of Louisville
Start date: 2004-12-01; Completion date: 2011-10-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.

Detailed description:

Arms: arm 1: heliox-driven nebulizations for children with moderate to severe bronchiolitis arm 2: oxygen-driven nebulizations for children with moderate to severe bronchiolitis
Interventions: intervention 1: heliox intervention 2: oxygen
Intervention descriptions: intervention 1: continuous heliox therapy intervention 2: continuous oxygen therapy

Protocol documents:
Clinical trial NCT00163215
Conditions: Endocrine System Diseases
Sponsor: Pfizer
Start date: 2005-01-01; Completion date: 2011-10-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Somatropin
Intervention descriptions: intervention 1: Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years

Protocol documents:
Clinical trial NCT00174291
Conditions: Endocrine System Diseases
Sponsor: Pfizer
Start date: 2002-03-01; Completion date: 2011-10-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
* To evaluate the effect of increasing the growth hormone dose on the statural response
* To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis

Detailed description:
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Arms: arm 1: None
Interventions: intervention 1: Somatropin
Intervention descriptions: intervention 1: Liquid, daily to final height Maximum Dosage: 50 µg/kg/day

Protocol documents:
Clinical trial NCT00230282
Conditions: Leukemia B-cell Leukemia Chronic Leukemia Chronic Lymphocytic Leukemia (CLL)
Sponsor: Steven E. Coutre
Start date: 2004-07-01; Completion date: 2011-10-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.

Detailed description:
This single-arm study evaluated the safety and efficacy of the combination of fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC in previously untreated CLL patients. Participants received fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles, followed by a no-treatment rest period (observation) for 3 to 12 weeks.

Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive Campath stating at 3 mg/day with the dose adjusted to the maximum tolerated dose.

Arms: arm 1: Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.
Interventions: intervention 1: Alemtuzumab intervention 2: Fludarabine intervention 3: Cytoxan
Intervention descriptions: intervention 1: 3 to 30 mg, IV intervention 2: \[(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl\]methoxyphosphonic acid intervention 3: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide

Protocol documents:
Clinical trial NCT00245128
Conditions: Chronic Myeloproliferative Disorders
Keywords: chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia
Sponsor: OHSU Knight Cancer Institute
Start date: 2005-08-01; Completion date: 2011-10-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
* Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.

Secondary

* Determine reduction in marrow fibrosis in patients treated with this drug.
* Determine decrease in spleen size in patients treated with this drug.

OUTLINE: This is a multicenter, open-label, nonrandomized, pilot study.

Patients receive oral imatinib mesylate once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not experience a minor erythroid response or a 50% reduction in spleen size after 6 months of treatment are removed from the study. Patients experiencing clinical benefit (e.g., ongoing erythroid response) after 1 year of treatment may continue treatment with imatinib mesylate as above at the discretion of the principal investigator.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Interventions: intervention 1: imatinib mesylate
Intervention descriptions: intervention 1: Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.

Protocol documents:
Clinical trial NCT00256295
Conditions: Cancer of the Head and Neck
Keywords: Cancer of the Head and Neck
Sponsor: Sai-Hong Ignatius Ou
Start date: 2005-04-01; Completion date: 2011-10-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia.

Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen.

Detailed description:

Arms: arm 1: Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.
Interventions: intervention 1: Gemcitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: 1000 mg/m2 IV over 100 minutes Every 21 days intervention 2: 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days

Protocol documents:
Clinical trial NCT00281918
Conditions: Leukemia
Keywords: B-cell chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia
Sponsor: Hoffmann-La Roche
Start date: 2003-07-01; Completion date: 2011-10-01
Enrollment: 817 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Fludarabine Phosphate
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00289120
Conditions: Kidney Stone
Keywords: urolithiasis, cola
Sponsor: Emory University
Start date: 2003-11-01; Completion date: 2011-10-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Examine the effects of cola on risks of kidney stones

Detailed description:
Prospective crossover study examining the risks of cola on stone risk factors.

Arms: arm 1: Subjects will be given 500cc of Cola twice daily. arm 2: Subjects will be given 500cc of deionized water.
Interventions: intervention 1: Cola beverage intervention 2: Deionized water
Intervention descriptions: intervention 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm. intervention 2: Subjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm

Protocol documents:
Clinical trial NCT00300391
Conditions: Delirium
Keywords: Delirium Mechanical ventilation Intensive care Haloperidol
Sponsor: University of Pittsburgh
Start date: 2006-03-01; Completion date: 2011-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

Detailed description:
Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.

Arms: arm 1: Once diagnosed as delirious, randomized to haloperidol 5 mg IV arm 2: once diagnosed as delirious, received 5 mg saline placebo
Interventions: intervention 1: haloperidol intervention 2: Saline placebo
Intervention descriptions: intervention 1: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay. intervention 2: control arem

Protocol documents:
Clinical trial NCT00330759
Conditions: Bone Metastases
Keywords: Bone metastases lytic bone lesions advanced cancer multiple myeloma lymphoma solid tumors skeletal related events skeletal fractures spinal cord compressions, radiation to bone surgery to bone, bisphosphonates denosumab
Sponsor: Amgen
Start date: 2006-06-01; Completion date: 2011-10-01
Enrollment: 1779 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Detailed description:

Arms: arm 1: denosumab placebo with active zoledronic acid arm 2: active denosumab with zoledronic acid placebo
Interventions: intervention 1: Denosumab intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: 120 milligrams by subcutaneous injection every 4 weeks intervention 2: 4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks

Protocol documents:
Clinical trial NCT00357994
Conditions: Advanced Parkinson's Disease
Keywords: carbidopa levodopa-carbidopa levodopa levodopa/carbidopa suspension dyskinesia Duodopa levodopa-carbidopa intestinal gel Severe Motor Fluctuations DUOPA
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-01-01; Completion date: 2011-10-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.

Detailed description:
Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387) were 2 identically designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group, multicenter studies recruiting subjects from distinct sites. These studies evaluated the efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (LCIG) in the treatment of levodopa-responsive subjects with advanced PD who had persistent severe motor fluctuations, despite optimized treatment with oral levodopa-carbidopa, concomitant with other available antiparkinsonian medications. Participants were randomized to either LCIG active gel + placebo capsules or levodopa-carbidopa immediate release (IR) active capsules + placebo gel. Both treatment arms received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration, active LCIG or placebo gel. Data from these 2 studies were combined for analysis. The decision to combine the study data for analysis was made before enrollment was completed for both studies.

Arms: arm 1: Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. arm 2: Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
Interventions: intervention 1: Levodopa carbidopa intestinal gel (LCIG) intervention 2: Placebo gel intervention 3: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets intervention 4: Placebo (PBO) oral capsules intervention 5: CADD-Legacy® 1400 ambulatory infusion pump intervention 6: PEG tube intervention 7: J-tube
Intervention descriptions: intervention 1: infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa per/hour) intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: percutaneous endoscopic gastrostomy tube intervention 7: jejunal tube

Protocol documents: