ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00754767
Conditions: Breast Cancer Chemotherapeutic Agent Toxicity Neurotoxicity
Keywords: neurotoxicity chemotherapeutic agent toxicity stage IV breast cancer recurrent breast cancer
Sponsor: HealthPartners Institute
Start date: 2007-01-02; Completion date: 2008-05-02
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.

Detailed description:
OBJECTIVES:

* To evaluate the tolerability and usefulness of the dietary supplement, L-carnitine L-tartrate, in the prevention of chemotherapy-induced peripheral neuropathy in women with metastatic breast cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
* Arm II: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. arm 2: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
Interventions: intervention 1: L-carnitine L-tartrate intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00283959
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Galafold Migalastat Substrate
Sponsor: Amicus Therapeutics
Start date: 2006-06-27; Completion date: 2008-05-08
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) and how migalastat works in participants with Fabry disease.

Detailed description:
This was a Phase 2, open-label study in male participants with Fabry disease. The study consisted of a 4-week screening period during which participants' genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat via an in vitro assay. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 12-week treatment period, followed by an optional 36-week extension period. Participants received migalastat 150 milligrams (mg) once every other day (QOD) for 12 weeks during the treatment period. Participants could then opt to participate in the extension period.

Arms: arm 1: Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week extension period.
Interventions: intervention 1: migalastat HCl
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00304512
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Galafold Migalastat Substrate
Sponsor: Amicus Therapeutics
Start date: 2006-09-07; Completion date: 2008-05-09
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

Detailed description:
This was a Phase 2, open-label study in female participants with Fabry disease. The study consisted of a 4-week screening period, during which participants' galactosidase (GLA) genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 12-week treatment period, followed by an optional 36-week extension period. Participants received migalastat once every other day (QOD) for 12 weeks during the treatment period and the optional 36-week extension period for a total treatment duration of up to 48 weeks. Participants were stratified by α-Gal A enzyme activity (high \>40%, and low ≤40%) then randomly assigned to receive migalastat at 1 of 3 specified dose levels (50, 150, or 250 milligrams \[mg\]).

Arms: arm 1: Migalastat 50 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period. arm 2: Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period. arm 3: Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
Interventions: intervention 1: migalastat HCl
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00571519
Conditions: Type 2 Diabetes Mellitus
Sponsor: Daiichi Sankyo
Start date: 2007-11-14; Completion date: 2008-05-23
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

Detailed description:

Arms: arm 1: rivoglitazone HCl 0.5mg arm 2: rivoglitazone HCl 1.0 mg arm 3: rivoglitazone HCl 1.5 mg arm 4: placebo matching rivoglitazone HCl tablets arm 5: pioglitazone HCl 15 mg arm 6: pioglitazone HCl 30 mg arm 7: pioglitazone HCl 45 mg arm 8: matching placebo for pioglitazone
Interventions: intervention 1: Rivoglitazone HCl intervention 2: rivoglitazone HCl intervention 3: rivoglitazone HCl intervention 4: placebo intervention 5: pioglitazone HCl intervention 6: pioglitazone HCl intervention 7: pioglitazone HCl 45 mg intervention 8: placebo intervention 9: metformin
Intervention descriptions: intervention 1: 0.5 mg tablets administered orally, once daily intervention 2: 1.0 mg tablets administered orally, once daily intervention 3: 1.5 mg tablets administered orally, once daily intervention 4: placebo tablets matching rivoglitazone tablets administered orally, once daily intervention 5: 15 mg capsules administered orally, once daily intervention 6: 30 mg capsules administered orally, once daily intervention 7: 45 mg capsules administered orally, once daily intervention 8: placebo capsules for pioglitazone administered orally, once daily intervention 9: Oral tablets. Rescue medication.

Protocol documents:
Clinical trial NCT04495712
Conditions: Ventricular Arrhythmias
Keywords: Anti-Arrhythmia Agents Ventricular Fibrillation Ventricular Tachycardia Defibrillators, Implantable
Sponsor: VA Office of Research and Development
Start date: 2004-07-28; Completion date: 2008-05-28
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Neither the patients or their providers will know if they are getting spironolactone or placebo.

Detailed description:
Objectives: This study is designed to determine whether spironolactone at a dose of 25 mg per day in patients with implanted cardioverter defibrillators (ICD) will 1) Reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), 2) Improve health related quality of life, 3) Reduce the need for hospitalization, and 4) Change ventricular refractoriness.

Plan: The study was a randomized double blind placebo controlled multi-center trial. Patients were randomized to either 25 mg per day of spironolactone or placebo and followed for 2 years each. The primary endpoint is time to the first episode of VT/VF. Secondary endpoints will include changes in health related quality of life, frequency of hospitalization, and in a subset of patients the effect of spironolactone on the ventricular effective refractory period measured through the ICD 3 months after starting the study medication. All data analyses will be conducted on intent to treat basis.

Methods: Patients were recruited at the Portland VA ICD clinics, the Seattle VA ICD clinics, Oregon Health and Sciences University ICD clinics and the Little Rock, Arkansas VA ICD clinics. Randomization and drug preparation were done by the Portland VA Medical Center research pharmacy. For safety purposes serum potassium will be measured at 1, 2, 3, 6, 12, 18, and 24 months. Patients will undergo ICD interrogation to document the occurrence of ICD therapy for VT or VF and will be screened for potential drug side effects every 3 months during the study. Health related quality of life will be measured at baseline, 3, 6, 12, 18, and 24 months using Short Form Health Survey adapted for veterans (SF36V) Veterans Health Study Version, the Patients Concerns Assessment, and the Kansas City Cardiomyopathy Questionnaire. Hospitalizations will be tracked throughout the study. In the subset of patient enrolled at the Portland VA the ventricular effective refractory period will be measured via single extra stimuli pacing through the ICD at 3 months after randomization.

Arms: arm 1: Patients randomized to active therapy with spironolactone arm 2: patients randomized to placebo
Interventions: intervention 1: spironolactone intervention 2: placebo
Intervention descriptions: intervention 1: aldosterone blocker intervention 2: identical in appearance to spironolactone study drug

Protocol documents:
Clinical trial NCT00056472
Conditions: Major Depressive Disorder With Psychotic Features
Keywords: Major depressive disorder with psychotic features Delusional Depression Randomized Trial Combination Treatment SSRI Atypical Antipsychotic
Sponsor: Weill Medical College of Cornell University
Start date: 2003-01-01; Completion date: 2008-06-01
Enrollment: 259 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Detailed description:
Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.

This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Arms: arm 1: sertraline plus olanzapine arm 2: olanzapine (5 - 20mg/day) plus placebo
Interventions: intervention 1: Olanzapine intervention 2: Sertraline intervention 3: placebo
Intervention descriptions: intervention 1: 10-20mg/day intervention 2: 150-200mg/day intervention 3: tablet that ressembles sertraline but contains no medication

Protocol documents:
Clinical trial NCT00153101
Conditions: Cardiovascular Diseases
Sponsor: Boehringer Ingelheim
Start date: 2001-11-01; Completion date: 2008-06-01
Enrollment: 31546 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint.

Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.

Detailed description:

Interventions: intervention 1: Telmisartan intervention 2: Combination of Telmisartan and Ramipril intervention 3: Ramipril
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00154297
Conditions: Renal Transplantation
Keywords: Renal transplantation everolimus immunosuppressants wound-healing
Sponsor: Novartis Pharmaceuticals
Start date: 2005-06-01; Completion date: 2008-06-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

Detailed description:

Arms: arm 1: Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. arm 2: Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00358436
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Lung function Exacerbations Quality of Life
Sponsor: AstraZeneca
Start date: 2006-08-01; Completion date: 2008-06-01
Enrollment: 804 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Detailed description:

Arms: arm 1: Aclidinium bromide 200 μg once-daily by inhalation arm 2: Placebo by inhalation
Interventions: intervention 1: Aclidinium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks intervention 2: Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Protocol documents:
Clinical trial NCT00382148
Conditions: Peanut Hypersensitivity
Keywords: TOPS Peanut allergy Peanut-induced allergy Allergy
Sponsor: Genentech, Inc.
Start date: 2006-11-01; Completion date: 2008-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: omalizumab
Intervention descriptions: intervention 1: SC repeating dose

Protocol documents:
Clinical trial NCT00504556
Conditions: Atrial Fibrillation Thromboembolism
Keywords: Anti-coagulant Non-valvular Venous Thromboembolism Prevention of Blood Clots Atrial Fibrillation Non-valvular atrial fibrillation
Sponsor: Daiichi Sankyo
Start date: 2007-06-01; Completion date: 2008-06-01
Enrollment: 1146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

Detailed description:

Arms: arm 1: DU-176b 30mg tablet once daily arm 2: DU-176b 60mg once daily arm 3: DU-176b 30mg b.i.d. arm 4: DU-176b 60mg tablets two times a day arm 5: warfarin tablets
Interventions: intervention 1: Edoxaban (DU-176b) intervention 2: Edoxaban (DU-176b) intervention 3: Edoxaban (DU-176b) intervention 4: Edoxaban (DU-176b) intervention 5: warfarin
Intervention descriptions: intervention 1: 30mg tablet once daily intervention 2: 60mg tablet once daily intervention 3: 30mg tablet two times a day intervention 4: 60mg tablet two times a day intervention 5: warfarin tablets

Protocol documents:
Clinical trial NCT00059202
Conditions: Primary Sclerosing Cholangitis
Keywords: Urso PSC
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2002-07-01; Completion date: 2008-06-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.

Detailed description:

Arms: arm 1: Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet. arm 2: Ursodeoxycholic acid 28-30 mg/kg/day
Interventions: intervention 1: Ursodeoxycholic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses intervention 2: Placebo for Urso

Protocol documents:
Clinical trial NCT00074711
Conditions: Osteoporosis Osteopenia
Keywords: Bone Mineral Density Calcium
Sponsor: Creighton University
Start date: 2004-08-01; Completion date: 2008-06-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.

Detailed description:
Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density (BMD) during the course of the study than the group not receiving phosphate.

All participants will receive teriparatide and vitamin D during the course of the 12-month study. Participants will be randomly assigned to one of two groups. One group will receive calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine and hip at baseline and at 3, 6, and 12 months of treatment.

Arms: arm 1: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. arm 2: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Interventions: intervention 1: Calcium carbonate intervention 2: Calcium Phosphate
Intervention descriptions: intervention 1: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. intervention 2: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.

Protocol documents:
Clinical trial NCT00100932
Conditions: Non-Small-Cell Lung Carcinoma
Sponsor: Eisai Inc.
Start date: 2004-12-01; Completion date: 2008-06-01
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy.

Detailed description:

Arms: arm 1: E7389 28 day cycle arm 2: E7389 21 day cycle
Interventions: intervention 1: E7389 28 Day Cycle intervention 2: E7389 21 Day Cycle
Intervention descriptions: intervention 1: E7389 1.4 mg/m\^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle. intervention 2: E7389 1.4 mg/m\^2 IV bolus on Days 1 and 8 of a 21 day cycle.

Protocol documents: