ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00982930
Conditions: Pseudomonas Aeruginosa Cystic Fibrosis
Keywords: Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents
Sponsor: Novartis Pharmaceuticals
Start date: 2009-08-12; Completion date: 2011-10-06
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.

Detailed description:

Arms: arm 1: Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, twice a day (b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.
Interventions: intervention 1: Tobramycin inhalation powder
Intervention descriptions: intervention 1: Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.

Protocol documents:
Clinical trial NCT01150890
Conditions: Crohn's Disease
Keywords: Ileal Crohn's Disease Ileo-colonic Crohn's Disease Colonic Chron's Disease
Sponsor: Amgen
Start date: 2010-11-09; Completion date: 2011-10-15
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Detailed description:

Arms: arm 1: Participants received placebo intravenously at baseline and week 4. arm 2: Participants received 210 mg brodalumab intravenously at baseline and week 4. arm 3: Participants received 350 mg brodalumab intravenously at baseline and week 4. arm 4: Participants received 700 mg brodalumab intravenously at baseline and week 4.
Interventions: intervention 1: Brodalumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as as an intravenous (IV) infusion over at least 30 minutes. intervention 2: Administered as as an intravenous (IV) infusion over at least 30 minutes.

Protocol documents:
Clinical trial NCT03633487
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser LLC
Start date: 2011-10-11; Completion date: 2011-10-15
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet

Detailed description:
A Phase I, Open-Label, Single-Dose, Single Period Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects

Arms: arm 1: Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet (single dose)
Interventions: intervention 1: Mucinex®
Intervention descriptions: intervention 1: Mucinex® 1200 mg ER Bi-Layer tablet

Protocol documents:
Clinical trial NCT01017952
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Safety COPD FEV1 Efficacy
Sponsor: GlaxoSmithKline
Start date: 2009-09-25; Completion date: 2011-10-17
Enrollment: 1635 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Detailed description:

Arms: arm 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 3: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 4: Long Acting Beta Agonist(LABA)
Interventions: intervention 1: FF/GW642444 Inhalation Powder intervention 2: GW642444 Inhalation Powder
Intervention descriptions: intervention 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD intervention 2: Long Acting Beta Agonist(LABA) Inhalation Powder

Protocol documents:
Clinical trial NCT01173848
Conditions: Chronic Kidney Disease Stage 3 and 4
Keywords: CKD Vitamin D
Sponsor: The Cleveland Clinic
Start date: 2010-07-01; Completion date: 2011-10-18
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.

Detailed description:
Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group.

The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.

Arms: arm 1: Patients randomized to take vitamin D2 arm 2: Patient's randomized to take Vitamin D3
Interventions: intervention 1: Ergocalciferol intervention 2: Cholecalciferol
Intervention descriptions: intervention 1: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months intervention 2: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months

Protocol documents:
Clinical trial NCT01165138
Conditions: Asthma
Keywords: GW642444 Vilanterol Asthma Fluticasone Furoate
Sponsor: GlaxoSmithKline
Start date: 2010-08-20; Completion date: 2011-10-19
Enrollment: 612 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.

Detailed description:

Arms: arm 1: Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks arm 2: Fluticasone furoate inhalation powder once daily for 12 weeks arm 3: Placebo inhalation powder once daily for 12 weeks
Interventions: intervention 1: Fluticasone furoate/Vilanterol Inhalation Powder intervention 2: Fluticasone Furoate Inhalation Powder intervention 3: Placebo Inhaltion Powder
Intervention descriptions: intervention 1: Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks intervention 2: Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks intervention 3: Placebo Inhaltion Powder inhaled orally once daily for 12 weeks

Protocol documents:
Clinical trial NCT01342913
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2011-02-01; Completion date: 2011-10-19
Enrollment: 528 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

Detailed description:
This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week Treatment period. There will be a 7-day Follow-up period after the treatment period.

Arms: arm 1: Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA) arm 2: Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Interventions: intervention 1: Fluticasone Furoate 100mcg/Vilanterol 25mcg intervention 2: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Intervention descriptions: intervention 1: Inhalation Powder intervention 2: Inhalation Powder

Protocol documents:
Clinical trial NCT00784654
Conditions: ADHD
Sponsor: Shire
Start date: 2009-01-27; Completion date: 2011-10-26
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after administered to children and adolescents aged 6-17 with ADHD for at least 6 months

Detailed description:

Arms: arm 1: Open-label 30, 50, or 70mg arm 2: None
Interventions: intervention 1: Lisdexamfetamine dimesylate (LDX) intervention 2: Placebo
Intervention descriptions: intervention 1: LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods) intervention 2: Placebo capsule once per day (double-blind period)

Protocol documents:
Clinical trial NCT01023035
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-12-07; Completion date: 2011-10-26
Enrollment: 687 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV) therapy and to assess its relationship to efficacy. All participants in this trial will be treated with the triple combination of boceprevir plus PEG2b/RBV. If a participant becomes anemic during treatment, the participant will be randomized to one of two therapeutic strategies for management of anemia (erythropoietin use versus RBV dose reduction).

Detailed description:

Arms: arm 1: Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period. arm 2: After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies. arm 3: After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
Interventions: intervention 1: Boceprevir intervention 2: Peginterferon alfa-2b (PEG2b) intervention 3: Ribavirin (RBV) intervention 4: Erythropoietin
Intervention descriptions: intervention 1: 800 mg given three times a day (TID), orally (PO) intervention 2: 1.5 µg/kg/week given subcutaneously (SC) intervention 3: Ribavirin weight-based dosing (WBD), 600 to 1400 mg/day given twice daily (BID), orally (PO) intervention 4: Initial dose of 40,000 Units given subcutaneously (SC) once weekly (QW), with dose adjustment as necessary to achieve and maintain serum hemoglobin levels of 10-12 g/dL

Protocol documents:
Clinical trial NCT02573350
Conditions: Tuberculosis, Multidrug-Resistant
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2009-03-26; Completion date: 2011-10-27
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible. The trial was performed globally at 14 sites qualified to treat MDR-TB. All 434 participants who completed Trial 242-07-204 were eligible for this trial if there was still potential clinical benefit to them and all inclusion criteria and no exclusion criteria were met.

Detailed description:

Arms: arm 1: Participants received Delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) along with at least 4 additional anti-TB medications per optimized background regimen (OBR) from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. arm 2: Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study.
Interventions: intervention 1: Delamanid intervention 2: OBR
Intervention descriptions: intervention 1: Delamanid was administered orally twice daily as 50-mg tablets under fed conditions in the morning and evening. intervention 2: Selection and administration of the treatment medications (i.e. OBRs) was based on World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study investigators could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.

Protocol documents:
Clinical trial NCT01372410
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Long acting muscarinic antagonist Tiotropium Chronic Bronchitis Emphysema Chronic Obstructive Pulmonary Disease
Sponsor: GlaxoSmithKline
Start date: 2011-07-01; Completion date: 2011-10-27
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.

Detailed description:
Inhaled bronchodilators, such as beta 2 agonists and anticholinergics, and inhaled corticosteroids are the mainstays of therapy in patients diagnosed with COPD. Anticholinergic bronchodilators or long acting muscarinic receptor antagonists function by blocking endogenous airway smooth muscle cholinergic tone. Treatment with anticholinergics has been shown to significantly improve forced expiratory volume in 1 second (FEV1), resting and dynamic lung hyperinflation, symptoms, and exercise capacity in patients with COPD. Currently tiotropium is the only approved long acting muscarinic antagonist available for treatment of COPD.

This is a multicenter, randomized, double-blind, placebo controlled, three way crossover, incomplete block study to evaluate 4 doses of GSK573719 inhaled once daily and 2 doses of GSK573719 inhaled twice daily over 7 days in patients with COPD. Tiotropium will be included as an open label active comparator. A placebo treatment will be included to evaluate treatment effect of each GSK573719 dose. Pharmacokinetic profiles of GSK573719 will also be determined. Each eligible subject will receive a sequence of 3 of 8 potential treatments for a total of 3 treatment periods per subject. There will be 7 clinic visits, during three of which 24 hour serial spirometry will be performed. The total duration of subject participation is approximately 9 weeks.

Arms: arm 1: 18 mcg, inhaled long acting muscarinic antagonist arm 2: inhaled medication arm 3: inactive/excipients only
Interventions: intervention 1: GSK573719 intervention 2: GSK573719 intervention 3: GSK573719 intervention 4: GSK573719 intervention 5: GSK573719 intervention 6: GSK573719 intervention 7: Tiotropium intervention 8: Placebo
Intervention descriptions: intervention 1: 125 mcg once daily intervention 2: 62.5 mcg once daily intervention 3: 31.25 mcg once daily intervention 4: 15.6 mcg once daily intervention 5: 31.25 mcg twice daily intervention 6: 15.6 mcg twice daily intervention 7: 18 mcg once daily intervention 8: once or twice daily

Protocol documents:
Clinical trial NCT00319020
Conditions: Pulmonary Arterial Hypertension
Keywords: bosentan pulmonary arterial hypertension children FUTURE 1
Sponsor: Actelion
Start date: 2005-08-23; Completion date: 2011-10-28
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.

Detailed description:

Arms: arm 1: Bosentan was administered at 4 mg/kg twice daily (b.i.d.) until the end of the study. It could be down-titrated to 2 mg/kg b.i.d. if not well tolerated.
Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: 32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally

Protocol documents:
Clinical trial NCT01009463
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD Safety FEV1 Efficacy
Sponsor: GlaxoSmithKline
Start date: 2009-09-25; Completion date: 2011-10-31
Enrollment: 1626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Detailed description:

Arms: arm 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 3: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 4: Long Acting Beta Agonist(LABA)
Interventions: intervention 1: FF/GW642444 Inhalation Powder intervention 2: GW642444 Inhalation Powder
Intervention descriptions: intervention 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) delivered within one dry powder inhaler (DPI) device for COPD intervention 2: Long Acting Beta Agonist(LABA) Inhalation Powder via DPI

Protocol documents:
Clinical trial NCT00095173
Conditions: Juvenile Rheumatoid Arthritis
Keywords: Juvenile Idiopathic Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2003-12-01; Completion date: 2011-11-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Detailed description:

Arms: arm 1: Double Blind Period arm 2: Double Blind Period arm 3: None
Interventions: intervention 1: Abatacept intervention 2: Placebo intervention 3: Abatacept
Intervention descriptions: intervention 1: IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier). intervention 2: IV infusions, IV, N/A, every 4 weeks, 6 months. intervention 3: Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing \< 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing \> 100 kg, monthly

Protocol documents:
Clinical trial NCT00561925
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2007-11-01; Completion date: 2011-11-01
Enrollment: 1068 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

Detailed description:

Arms: arm 1: 400 mg QD arm 2: 200 mg BID
Interventions: intervention 1: nevirapine IR intervention 2: nevirapine XR
Intervention descriptions: intervention 1: 200 mg BID intervention 2: 400 mg QD

Protocol documents:
Clinical trial NCT00891228
Conditions: Contraception
Keywords: Contraception Male Contraception Suppression of Sperm Production
Sponsor: Health Decisions
Start date: 2009-05-01; Completion date: 2011-11-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the number of men who have suppression of sperm production when using a daily regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.

Detailed description:

Arms: arm 1: Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head. arm 2: Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head. arm 3: Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Interventions: intervention 1: Testosterone intervention 2: Nestorone® intervention 3: Nestorone® intervention 4: Nestorone®
Intervention descriptions: intervention 1: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily. intervention 2: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head. intervention 3: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head. intervention 4: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.

Protocol documents: