ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00621985
Conditions: Adrenal Hyperplasia, Congenital
Sponsor: Boston Children's Hospital
Start date: 2008-04-01; Completion date: 2009-06-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone and one on nocturnal dexamethasone.

Detailed description:
This is a Phase II clinical trial, intended to estimate the effect of instituting Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own baseline data. There is no control group. Patients with CAH who meet inclusion criteria will be admitted to the clinical research center for two 24 hour hospitalizations. Adrenal hormone profiles will be measured during each hospitalization. The patient will take his or her baseline hydrocortisone regimen during one hospitalization and a new regimen consisting of a single daily nocturnal dose of Dexamethasone during the second hospitalization.

Arms: arm 1: Experimental therapy with nocturnal dexamethasone.
Interventions: intervention 1: dexamethasone intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days. intervention 2: Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.

Protocol documents:
Clinical trial NCT00624052
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2008-03-01; Completion date: 2009-06-01
Enrollment: 838 participants; Allocation: ; Intervention model: 

Brief summary:
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

Detailed description:

Interventions: intervention 1: fixed-dose combination of telmisartan 40mg+amlodipine 10mg intervention 2: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00626795
Conditions: Impetigo Secondarily Infected Traumatic Lesions
Sponsor: LEO Pharma
Start date: 2008-02-01; Completion date: 2009-06-01
Enrollment: 773 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TD1414 2% cream intervention 2: TD1414 2% cream intervention 3: Bactroban® (mupirocin) 2% cream
Intervention descriptions: intervention 1: BID 7 days intervention 2: TID 7 days intervention 3: BID 7 days

Protocol documents:
Clinical trial NCT00631319
Conditions: Chronic Pain
Keywords: OA Chronic Pain Osteoarthritis OA Pain Osteoarthritis Pain Pain Hip Pain Knee Pain Joint Pain
Sponsor: Mallinckrodt
Start date: 2008-02-01; Completion date: 2009-06-01
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

Detailed description:

Arms: arm 1: OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg arm 2: Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
Interventions: intervention 1: OROS hydromorphone intervention 2: Placebo
Intervention descriptions: intervention 1: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets intervention 2: Placebo

Protocol documents:
Clinical trial NCT00632424
Conditions: Advanced Solid Tumors
Sponsor: R-Pharm
Start date: 2008-05-01; Completion date: 2009-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ixabepilone (oral formulation)
Intervention descriptions: intervention 1: Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00635882
Conditions: Asthma Airway Inflammation
Keywords: mometasone formoterol
Sponsor: Organon and Co
Start date: 2008-02-01; Completion date: 2009-06-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.

Detailed description:
This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period.

A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003.

Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: mometasone furoate/formoterol 100/10 mcg intervention 2: mometasone furoate/formoterol 200/10 mcg intervention 3: mometasone furoate/formoterol 400/10 mcg intervention 4: MF DPI 200 mcg intervention 5: MF MDI 200 mcg intervention 6: Placebo
Intervention descriptions: intervention 1: mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days intervention 2: mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days intervention 3: mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days intervention 4: MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days intervention 5: MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days intervention 6: MF/F MDI placebo twice daily (BID) (2 inhalations)

Protocol documents:
Clinical trial NCT00641043
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-03-01; Completion date: 2009-06-01
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: BI 1356 5mg in initial combination therapy with pioglitazone 30 mg arm 2: Placebo in initial combination therapy with pioglitazone 30 mg
Interventions: intervention 1: placebo + pioglitazone (30 mg) intervention 2: Linagliptin + pioglitazone (30 mg)
Intervention descriptions: intervention 1: placebo + overcapsulated 30 mg tablet, once daily intervention 2: 5 mg tablet + overcapsulated 30 mg tablet, once daily

Protocol documents:
Clinical trial NCT00649220
Conditions: Alzheimer's Disease
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2008-07-01; Completion date: 2009-06-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: memantine tablets, twice a day (bid), for 20 weeks

Protocol documents:
Clinical trial NCT00653523
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2007-12-01; Completion date: 2009-06-01
Enrollment: 151 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.

Detailed description:

Arms: arm 1: Ezetimibe 10 mg + Simvastatin 20 mg
Interventions: intervention 1: Ezetimibe intervention 2: Simvastatin
Intervention descriptions: intervention 1: Ezetimibe 10 mg once daily intervention 2: Simvastatin 20 mg daily

Protocol documents:
Clinical trial NCT00654095
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2007-12-01; Completion date: 2009-06-01
Enrollment: 146 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

Detailed description:

Arms: arm 1: Ezetimibe 10 mg + Atorvastatin 20 mg
Interventions: intervention 1: Ezetimibe intervention 2: atorvastatin
Intervention descriptions: intervention 1: Ezetimibe 10 mg once daily intervention 2: atorvastatin 20 mg once daily

Protocol documents:
Clinical trial NCT00654498
Conditions: Restless Legs Syndrome
Sponsor: Boehringer Ingelheim
Start date: 2008-04-01; Completion date: 2009-06-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

Detailed description:

Arms: arm 1: 4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily arm 2: 4 weeks of individual dose titration as for the investigational product, once daily
Interventions: intervention 1: Pramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00654745
Conditions: Type 2 Diabetes Hypertension
Keywords: blood pressure reduction
Sponsor: Daiichi Sankyo
Start date: 2008-05-01; Completion date: 2009-06-01
Enrollment: 207 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Detailed description:
This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Arms: arm 1: amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
Interventions: intervention 1: Amlodipine intervention 2: amlodipine / olmesartan medoxomil combination intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: Amlodipine 5 mg tablets , Daily for 3 weeks; intervention 2: amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg intervention 3: hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Protocol documents:
Clinical trial NCT00663208
Conditions: Chronic Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2008-05-01; Completion date: 2009-06-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

Detailed description:

Arms: arm 1: Daclatasvir (1 mg), once daily

or

Matching Placebo, once daily arm 2: Daclatasvir (10 mg), once daily

or

Matching Placebo, once daily arm 3: Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily arm 4: Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily arm 5: Group 5: Active Comparator

Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily arm 6: Group 6: Active Comparator

Daclatasvir (1-100 mg), once or twice daily

or

Matching Placebo, once or twice daily
Interventions: intervention 1: Daclatasvir intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, Oral, Approximately 182 days from initial dosing intervention 2: Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel

Protocol documents:
Clinical trial NCT00663793
Conditions: Contraception Hypogonadism
Keywords: Male Contraception Hypogonadism Testosterone
Sponsor: University of Washington
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

Detailed description:
This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Arms: arm 1: (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. arm 2: (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Interventions: intervention 1: Acyline intervention 2: Testosterone intervention 3: Finasteride
Intervention descriptions: intervention 1: 300 mcg/kg intervention 2: 24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. intervention 3: 1 mg PO once daily \[day -2 to day 12) 14 days total

Protocol documents:
Clinical trial NCT00664430
Conditions: Secondary Hyperparathyroidism Dialysis
Keywords: Dialysis Calcitriol Resistant Secondary Hyperparathyroidism
Sponsor: Abbott
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with calcitriol.

Detailed description:
This is a multi-center, prospective, open label, one arm, phase IV study designed to demonstrate paricalcitol efficacy and safety in the treatment of moderate to severe secondary hyperparathyroidism in calcitriol resistant participants on dialysis.

Following screening, participants began an 8-week controlled calcitriol therapy period. Participants whose parathyroid hormone (PTH) levels decreased were to be discontinued from the study. Those whose PTH levels did not decrease began paricalcitol therapy using a dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol was administered intravenously at anytime during the subjects' dialysis. The paricalcitol dose was to be titrated every 2 weeks until iPTH was reduced or up to 4 months, after which it was to be adjusted monthly for 1 year based on serum PTH, calcium, phosphorus, and albumin measurements.

Arms: arm 1: Participants began a controlled calcitriol therapy period (calcitriol challenge) to confirm calcitriol resistance. After this period, those who failed to reduce PTH (according to parameters in protocol) initiated paricalcitol therapy.
Interventions: intervention 1: Calcitriol intervention 2: Paricalcitol
Intervention descriptions: intervention 1: Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals. intervention 2: Dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol will be administered intravenously after the participants' dialysis. The paricalcitol dose will be titrated every 2 weeks until iPTH presents a reduction or up to 4 months, after which it will be adjusted monthly based on serum PTH, calcium, phosphorus and albumin measurements. Dosing may be modified by 2-4 mcg increments at 2- to 4-week intervals.

Protocol documents:
Clinical trial NCT00665626
Conditions: Rheumatoid Arthritis
Sponsor: Rigel Pharmaceuticals
Start date: 2008-05-01; Completion date: 2009-06-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.

Detailed description:

Arms: arm 1: Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day arm 2: Placebo, orally, twice-a-day
Interventions: intervention 1: Fostamatinib disodium (R935788) intervention 2: Placebo
Intervention descriptions: intervention 1: R935788 100 mg tablet, orally, twice-a-day intervention 2: Placebo, orally, twice-a-day

Protocol documents:
Clinical trial NCT00665925
Conditions: Rheumatoid Arthritis
Sponsor: Rigel Pharmaceuticals
Start date: 2008-05-01; Completion date: 2009-06-01
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Detailed description:

Arms: arm 1: R788, 100 mg tablet, orally, twice-a-day arm 2: R788, 150 mg tablet, orally, once a day arm 3: Placebo, orally, either once a day, or twice a day
Interventions: intervention 1: Fostamatinib disodium (R935788) intervention 2: Fostamatinib disodium (R935788) intervention 3: Placebo
Intervention descriptions: intervention 1: 100 mg tablet, orally, twice-a-day intervention 2: 150 mg tablet, orally, once a day intervention 3: Placebo, orally, either once a day, or twice a day

Protocol documents: