ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00233363
Conditions: Xerostomia Sjogren's Syndrome
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2005-04-15; Completion date: 2006-01-27
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

Detailed description:

Interventions: intervention 1: Rebamipide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00207714
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis CNTO 148 Methotrexate Joint pain Arthritis
Sponsor: Centocor, Inc.
Start date: 2003-11-01; Completion date: 2006-02-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Detailed description:
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Golimumab intervention 2: MTX intervention 3: Placebo intervention 4: Infliximab
Intervention descriptions: intervention 1: Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous. intervention 2: Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous intervention 3: Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous intervention 4: Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Protocol documents:
Clinical trial NCT00215553
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Windtree Therapeutics
Start date: 2001-05-01; Completion date: 2006-02-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).

Detailed description:
This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.

Arms: arm 1: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. arm 2: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 3: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 4: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. arm 5: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 6: 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. arm 7: Received standard ARDS management and ICU care (Standard of Care \[SOC\]). Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
Interventions: intervention 1: A.1 Lucinactant intervention 2: B.3 SoC intervention 3: A.2 Lucinactant intervention 4: A.3 Lucinactant intervention 5: A.4 Lucinactant intervention 6: B.1 Lucinactant intervention 7: B.2 Lucinactant
Intervention descriptions: intervention 1: 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL intervention 2: Standard ARDS management and ICU care intervention 3: 3 30 mL aliquots at a concentration of 10 mg/mL each intervention 4: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 5: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed intervention 6: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 7: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed

Protocol documents:
Clinical trial NCT00276016
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: Organon and Co
Start date: 2006-01-01; Completion date: 2006-02-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.

Detailed description:

Arms: arm 1: Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Placebo: Placebo capsules. arm 2: Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Placebo: Placebo capsules.

Phenylephrine: Immediate-release 12 mg capsules for oral administration. arm 3: Placebo: Placebo capsules.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration. arm 4: Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Placebo: Placebo capsules.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration. arm 5: Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Placebo: Placebo capsules. arm 6: Placebo: Placebo capsules.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Interventions: intervention 1: phenylephrine intervention 2: pseudoephedrine intervention 3: placebo
Intervention descriptions: intervention 1: immediate-release 12 mg capsules for oral administration intervention 2: 60 mg immediate-release tablets for oral administration intervention 3: placebo capsules

Protocol documents:
Clinical trial NCT00396292
Conditions: Anemia
Keywords: Anemia postpartum Postpartum anemia
Sponsor: American Regent, Inc.
Start date: 2005-02-01; Completion date: 2006-02-01
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Detailed description:
This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Arms: arm 1: A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered arm 2: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
Interventions: intervention 1: Oral iron tablets intervention 2: VIT-45
Intervention descriptions: intervention 1: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 intervention 2: A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

Protocol documents:
Clinical trial NCT00530075
Conditions: Wegener's Granulomatosis
Keywords: Wegener Granulomatosis Vasculitis Gusperimus Immunosuppression
Sponsor: Nippon Kayaku Co., Ltd.
Start date: 2003-12-01; Completion date: 2006-02-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. The efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. A prospective, international, nulti-centre, single limb, open label study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity Score (BVAS) \>=4 and previous therapy with cyclophosphamide or methotrexate. Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped early for white blood count \< 4,000/mm3. The primary endpoint was complete remission (BVAS=0 for at least 2 months) or partial remission (BVAS\<50% of entry score). After the sixth cycle azathioprine was commenced and follow-up continued for a further six months.

Detailed description:

Arms: arm 1: Gusperimus
Interventions: intervention 1: Gusperimus
Intervention descriptions: intervention 1: SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles

Protocol documents:
Clinical trial NCT00895453
Conditions: Vulvovaginal Candidiasis
Keywords: recurrent vulvovaginal candidiasis itraconazole classic homeopathy
Sponsor: Medical University of Vienna
Start date: 2000-05-01; Completion date: 2006-02-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.

Detailed description:
Objective:

Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.

Design:

Single-centre, prospective, randomized.

Sample:

One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.

Methods:

Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.

Arms: arm 1: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). arm 2: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days. arm 3: CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.
Interventions: intervention 1: itraconazole intervention 2: lactobacillus gasseri intervention 3: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
Intervention descriptions: intervention 1: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid) intervention 2: Lactobacillus vaginal tablets monthly given through 6 days intervention 3: CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.

Protocol documents:
Clinical trial NCT02281526
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2005-05-01; Completion date: 2006-02-01
Enrollment: 17 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety assessments were performed.

Detailed description:
The screening visit was performed 2 to 21 days before the first administration of study medication, the treatment phase consisted of 12 days (of which study medication was administered during the first 8 days), and the follow-up visit was performed 15 to 19 days after the first administration of study medication.

Arms: arm 1: This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls arm 2: This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00117325
Conditions: Rhinitis, Vasomotor
Keywords: Vasomotor Rhinitis VMR nonallergic rhinitis GW685698X
Sponsor: GlaxoSmithKline
Start date: 2005-07-11; Completion date: 2006-02-09
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Detailed description:

Arms: arm 1: GW685698X
Interventions: intervention 1: GW685698X
Intervention descriptions: intervention 1: Aqueous Nasal Spray 100mcg

Protocol documents:
Clinical trial NCT00118703
Conditions: Vasomotor Rhinitis Rhinitis, Vasomotor
Keywords: nonallergic rhinitis GW685698X VMR vasomotor rhinitis
Sponsor: GlaxoSmithKline
Start date: 2005-07-01; Completion date: 2006-02-09
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Detailed description:

Interventions: intervention 1: GW685698X
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00105508
Conditions: Parkinson's Disease Dyskinesia
Keywords: Parkinson's Disease Dyskinesia Dyskinesia associated with dopaminergic treatment
Sponsor: EMD Serono
Start date: 2004-09-30; Completion date: 2006-02-28
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sarizotan intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks. intervention 2: Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.

Protocol documents:
Clinical trial NCT00077636
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-12-01; Completion date: 2006-03-01
Enrollment: 1469 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Copegus intervention 2: Copegus intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 400mg po bid for 16 weeks intervention 2: 400mg po bid for 24 weeks intervention 3: 180 micrograms sc weekly for 16 weeks intervention 4: 180 micrograms sc weekly for 24 weeks

Protocol documents:
Clinical trial NCT00078767
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD Depression Anxiety
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Start date: 2001-04-01; Completion date: 2006-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).

Detailed description:
Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.

Arms: arm 1: Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day arm 2: Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
Interventions: intervention 1: Trauma-Focused Cognitive Behavioral Therapy intervention 2: Sertraline Pill intervention 3: Placebo Oral Tablet
Intervention descriptions: intervention 1: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent intervention 2: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT intervention 3: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Protocol documents:
Clinical trial NCT00087568
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-01-01; Completion date: 2006-03-01
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.

Detailed description:

Arms: arm 1: Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks. arm 2: Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (\< or \>=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Interventions: intervention 1: Ribavirin intervention 2: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 1000/1200mg po bid for 36 or 60 weeks intervention 2: 180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)

Protocol documents:
Clinical trial NCT00160563
Conditions: Asthma
Keywords: Pediatry EPAAC atopic Children prevention of asthma Levocetirizine Xyzal
Sponsor: UCB Pharma
Start date: 2004-06-01; Completion date: 2006-03-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).

36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

Detailed description:

Arms: arm 1: Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) arm 2: Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) arm 3: Placebo after having been randomized to Placebo in the preceding A00309 trial - NCT00152464 (PLC-PLC)
Interventions: intervention 1: LEVOCETIRIZINE intervention 2: Placebo
Intervention descriptions: intervention 1: 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months intervention 2: Oral drops, bid for 18 months

Protocol documents: