ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01022398
Conditions: HMG-CoA Reductase Inhibitors-related Myalgias
Keywords: Vitamin D3 HMG-CoA reductase inhibitors (statin)-related myalgias
Sponsor: Creighton University
Start date: 2010-02-01; Completion date: 2011-06-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this project is to determine if Vitamin D supplementation \[10,000 international units of cholecalciferol (vitamin D3) by mouth weekly\] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.

Detailed description:

Arms: arm 1: Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly arm 2: Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
Interventions: intervention 1: cholecalciferol/placebo
Intervention descriptions: intervention 1: 10,000 IU by mouth weekly for 6 months

Protocol documents:
Clinical trial NCT01026194
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-12-01; Completion date: 2011-06-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo / Teneli (Teneligliptin) + pio (pioglitazone) intervention 2: Teneli / Teneli + pio
Intervention descriptions: intervention 1: Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. intervention 2: Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.

Protocol documents:
Clinical trial NCT01031628
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST Gastrointestinal stromal tumors Exon 9 Gleevec Imatinib blood levels
Sponsor: Sarcoma Alliance for Research through Collaboration
Start date: 2010-01-01; Completion date: 2011-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.

Detailed description:

Arms: arm 1: Patients with blood level less than 1100 will continue imatinib 400 mg daily arm 2: Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL arm 3: Patients with blood level ≥1100 will continue imatinib 400 mg daily arm 4: Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Interventions: intervention 1: Imatinib mesylate intervention 2: Imatinib mesylate intervention 3: Imatinib mesylate
Intervention descriptions: intervention 1: 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops intervention 2: 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops intervention 3: 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops

Protocol documents:
Clinical trial NCT01032915
Conditions: Non-infectious Uveitis
Keywords: Quiescent uveitis intermediate uveitis panuveitis posterior uveitis uveitis
Sponsor: Novartis Pharmaceuticals
Start date: 2010-02-01; Completion date: 2011-06-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

Detailed description:

Arms: arm 1: AIN457 300mg s.c weekly for 3 weeks then every 2 weeks arm 2: AIN457 300mg s.c at baseline and Week 2 then every 4 weeks arm 3: AIN457 150mg s.c at baseline and Week 2 then every 4 weeks arm 4: Placebo s.c weekly for 3 weeks then every 2 weeks
Interventions: intervention 1: AIN457 intervention 2: AIN457 intervention 3: AIN457 intervention 4: Placebo
Intervention descriptions: intervention 1: AIN457 300mg s.c weekly for 3 weeks then every 2 weeks intervention 2: AIN457 300mg s.c at baseline and Week 2 then every 4 weeks intervention 3: AIN457 150mg s.c at baseline and Week 2 then every 4 weeks intervention 4: Placebo s.c weekly for 3 weeks then every 2 weeks

Protocol documents:
Clinical trial NCT01042145
Conditions: Croup
Keywords: Primary Care Treatment Croup Corticosteroids Prednisone Dexamethasone Randomized trial
Sponsor: Washington University School of Medicine
Start date: 2009-10-01; Completion date: 2011-06-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. It was conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. Our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.

Detailed description:

Arms: arm 1: Prednisone, 2mg/kg for 3 days arm 2: Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Interventions: intervention 1: Prednisone intervention 2: Dexamethasone
Intervention descriptions: intervention 1: 2 mgs/kg for 3 days intervention 2: 0.6 mgs for one day, then placebo for 2 days

Protocol documents:
Clinical trial NCT01044771
Conditions: HIV Infections Proteinuria
Keywords: HIV Human immunodeficiency virus tenofovir viread truvada proteinuria
Sponsor: Metropolis Medical
Start date: 2010-01-01; Completion date: 2011-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated.

Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure

Detailed description:
As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir

Arms: arm 1: Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients
Interventions: intervention 1: change from tenofovir to raltegravir
Intervention descriptions: intervention 1: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID

Protocol documents:
Clinical trial NCT01045161
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2009-03-01; Completion date: 2011-06-01
Enrollment: 544 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.

Detailed description:

Arms: arm 1: Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks arm 2: Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks arm 3: Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
Interventions: intervention 1: Aclidinium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment. intervention 2: Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment

Protocol documents:
Clinical trial NCT01051440
Conditions: Bipolar Depression
Keywords: lisdexamfetamine vyvanse bipolar disorder depression stimulant magnetic resonance spectroscopy functional magnetic resonance imaging neuropsychological testing
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Start date: 2010-02-01; Completion date: 2011-06-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There have been reports that stimulants may be effective for bipolar depression without triggering mania. This study will examine whether lisdexamfetamine can improve depressive symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the study drug or placebo in addition to a mood stabilizer. The study includes functional magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the medication alters the response to affective stimuli or glutamate, glutamine, or gamma aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine whether the study drug improves memory and attention in this population. The primary hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary hypothesis is that it will result in an increased response to affective stimuli and altered neurotransmitter levels in the anterior cingulate cortex.

Detailed description:

Arms: arm 1: Subjects will receive placebo for lisdexamfetamine. arm 2: Subjects will start with 20 mg per day of lisdexamfetamine and may increase to a maximum of 40 mg.
Interventions: intervention 1: Lisdexamfetamine intervention 2: Placebo
Intervention descriptions: intervention 1: Start at 20 mg daily. Increased to a maximum of 40 mg daily. Can be decreased in 10 mg increments. intervention 2: Subjects will receive placebo matched to lisdexamfetamine.

Protocol documents:
Clinical trial NCT01057277
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer Advanced Inoperable Head & Neck Cancer
Sponsor: howard safran
Start date: 2009-12-01; Completion date: 2011-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if RAD001, to a maximum dose of 10 mg/day, can be safely administered with cisplatin, and concurrent radiotherapy, for patients with locally advanced, inoperable, squamous cell carcinoma of the head and neck.

Detailed description:
To perform a phase I study of RAD001, to a maximum dose of 10 mg/day, with cisplatin, and concurrent radiotherapy, for patients with locally advanced, inoperable, squamous cell carcinoma of the head and neck

Arms: arm 1: Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47
Interventions: intervention 1: RAD001(Afinitor)
Intervention descriptions: intervention 1: Rad001 in combination withCisplatin and Concurrent RT

Protocol documents:
Clinical trial NCT01065558
Conditions: Lesch-Nyhan Disease
Keywords: Ecopipam Lesch-Nyhan Disease Safety Self-Injurious Behavior
Sponsor: Psyadon Pharma
Start date: 2010-02-01; Completion date: 2011-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effects of ecopipam in patients with Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the brain that helps nerves talk to one another; ecopipam does this by stopping the chemical (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam causes in LND patients, and whether ecopipam may be able to relieve the self-injurious behaviors seen in these patients.

Detailed description:

Arms: arm 1: Patients were administered ecopipam on an escalated dosing schedule over 11 days starting at 12.5 mg/day and increasing to the maximal tolerated dose or to 200 mg/day.
Interventions: intervention 1: Ecopipam
Intervention descriptions: intervention 1: Tablets, once daily, for two weeks up to 200 mg/day

Protocol documents:
Clinical trial NCT01084005
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-03-01; Completion date: 2011-06-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control

Detailed description:

Arms: arm 1: patients receive linagliptin 5 mg tablets once daily arm 2: patients receive placebo tablets matching linagliptin 5 mg once daily
Interventions: intervention 1: linagliptin intervention 2: placebo
Intervention descriptions: intervention 1: patients receive linagliptin 5 mg tablets once daily intervention 2: patients receive placebo matching linagliptin 5 mg once daily

Protocol documents:
Clinical trial NCT01088295
Conditions: HIV Infection
Keywords: Metabolic HIV Fat accumulation AIDS Metabolic abnormalities in HIV infection HIV Infections
Sponsor: University of California, Los Angeles
Start date: 2010-05-01; Completion date: 2011-06-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. The investigators will be looking at how the amount of fat in the body changes when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is a medication used to treat blood pressure, but has been shown to decrease fat in the organs in people both with and without high blood pressure. The study involves 8 visits over a period of about 24 weeks.

Detailed description:

Arms: arm 1: Telmisartan 40mg po daily for 24 weeks
Interventions: intervention 1: Telmisartan
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01105975
Conditions: Dyslipidemia
Keywords: Dyslipidemias Mixed dyslipidemia Hypercholesterolemia Atherosclerosis Atorvastatin Simvastatin Rosuvastatin Metabolic Diseases Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Cholesteryl Ester Transfer Protein Inhibitors Cholesteryl Ester Lipid Metabolism Disorders
Sponsor: Eli Lilly and Company
Start date: 2010-04-01; Completion date: 2011-06-01
Enrollment: 398 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of your participation in this study is to help answer the following research question(s)

* Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
* Whether LY2484595 alone improves blood fats profile compared to sugar pills.
* Whether LY2484595 interferes with break down or functioning of statins.
* Whether LY2484595 has any side effects that would not support testing it in future studies.

Detailed description:
Patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (\<45 or greater than or equal to 45 mg/dL for men; \<50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None
Interventions: intervention 1: LY2484595 intervention 2: Atorvastatin intervention 3: Simvastatin intervention 4: Rosuvastatin intervention 5: Placebo for LY2484595 intervention 6: Placebo for Statins
Intervention descriptions: intervention 1: Administered daily by mouth for 12 weeks intervention 2: Administered daily by mouth for 12 weeks intervention 3: Administered daily by mouth for 12 weeks intervention 4: Administered daily by mouth for 12 weeks intervention 5: Administered daily by mouth for 12 weeks intervention 6: Administered daily by mouth for 12 weeks

Protocol documents:
Clinical trial NCT01110499
Conditions: Ocular Hypertension Primary Open-Angle Glaucoma
Sponsor: Allergan
Start date: 2010-06-01; Completion date: 2011-06-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Detailed description:

Arms: arm 1: AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 2: AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 3: AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 4: AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 5: AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 6: AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 7: AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. arm 8: bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
Interventions: intervention 1: AGN-210961 Formulation 1 intervention 2: AGN-210961 Formulation 2 intervention 3: AGN-210961 Formulation 3 intervention 4: AGN-210961 Formulation 4 intervention 5: AGN-210961 Formulation 5 intervention 6: AGN-210961 Formulation 6 intervention 7: AGN-210961 Formulation 7 intervention 8: bimatoprost ophthalmic solution 0.03%
Intervention descriptions: intervention 1: AGN-210961 Formulation 1 in one eye once daily for 7 days. intervention 2: AGN-210961 Formulation 2 in one eye once daily for 7 days. intervention 3: AGN-210961 Formulation 3 in one eye once daily for 7 days. intervention 4: AGN-210961 Formulation 4 in one eye once daily for 7 days. intervention 5: AGN-210961 Formulation 5 in one eye once daily for 7 days. intervention 6: AGN-210961 Formulation 6 in one eye once daily for 7 days. intervention 7: AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. intervention 8: bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Protocol documents:
Clinical trial NCT01117857
Conditions: Depression Menopause Vasomotor Symptoms
Sponsor: Massachusetts General Hospital
Start date: 2009-08-01; Completion date: 2011-06-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausal women. The secondary aim of the study is to examine if an eight-week intervention with duloxetine significantly reduces vasomotor symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in vasomotor symptoms in menopausal women.

Detailed description:

Arms: arm 1: After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.

Protocol documents:
Clinical trial NCT01119768
Conditions: Non Erosive Reflux Disease Chronic Gastritis
Keywords: GI Nexium Phase IV Co-diagnosed NERD
Sponsor: AstraZeneca
Start date: 2010-04-01; Completion date: 2011-06-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.

Detailed description:
A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.

Arms: arm 1: 20 mg q.d. (quaque die) once a day dosing for 8 weeks arm 2: 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Interventions: intervention 1: Esomeprazole intervention 2: Esomeprazole
Intervention descriptions: intervention 1: 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment intervention 2: 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up

Protocol documents: