ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01206517
Conditions: Schizophrenia Bipolar I Disorder
Keywords: asenapine pediatric schizophrenia bipolar I disorder
Sponsor: Organon and Co
Start date: 2010-07-18; Completion date: 2011-08-04
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a) participants with other conditions treatable with chronic antipsychotic medication can also be enrolled. Participants will receive a single sublingual placebo dose on Day -1, followed by multiple sublingual doses of asenapine twice daily (b.i.d.) for 6 days (Cohorts 1 and 2), 7 days (Cohort 3b-d), or 11 days (Cohort 3a), and a final once daily administration on Day 7 (Cohorts 1 and 2), Day 8 (Cohort 3b-d) or Day 12 (Cohort 3a).

Detailed description:

Arms: arm 1: Participants 10 or 11 years of age arm 2: Participants 10 or 11 years of age arm 3: Cohort 3a: Participants 10 or 11 years of age

Cohort 3b: Participants 12 or 13 years of age

Cohort 3c: Participants 14 or 15 years of age

Cohort 3d: Participants 16 or 17 years of age
Interventions: intervention 1: Asenapine 2.5 mg intervention 2: Asenapine 5 mg intervention 3: Asenapine 10 mg
Intervention descriptions: intervention 1: Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7. intervention 2: Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7. intervention 3: Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose on final day). For Cohorts 3b, 3c and 3d, rising dose schedule begins with asenapine 5 mg b.i.d. on Day 1 and dosing occurs through Day 8. For Cohort 3a, rising dose schedule begins with asenapine 2.5 mg b.i.d. on Day 1 and dosing occurs through Day 12.

Protocol documents:
Clinical trial NCT01103349
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-04-20; Completion date: 2011-08-09
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

Detailed description:

Arms: arm 1: Patients receive BI 671800 capsules twice daily arm 2: Patients receive Montelukast encapsulated tablets once daily arm 3: Patients receive placebo capsules and/or encapsulated placebo tablets
Interventions: intervention 1: BI 671800 intervention 2: Placebo intervention 3: Montelukast
Intervention descriptions: intervention 1: Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma intervention 2: Patients receive placebo capsules and/or encapsulated tablets intervention 3: Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma

Protocol documents:
Clinical trial NCT01009060
Conditions: Schizophrenia
Keywords: H3 Antagonist Schizophrenia double blind Histamine randomised placebo controlled Cognition
Sponsor: GlaxoSmithKline
Start date: 2009-12-01; Completion date: 2011-08-10
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia

Detailed description:
This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with schizophrenia who are stabilised on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or placebo for 7 weeks. They will undergo weekly review of safety, tolerability and cognitive performance measures.

Arms: arm 1: Repeat dose. arm 2: Repeat dose. Placebo to match GSK239512
Interventions: intervention 1: GSK239512 intervention 2: Placebo
Intervention descriptions: intervention 1: Histamine H3 Antagonist intervention 2: Placebo to match GSK239512

Protocol documents:
Clinical trial NCT01300455
Conditions: Sleep Apnea
Keywords: Insomnia obstructive sleep apnea orexin receptor antagonist
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-19; Completion date: 2011-08-11
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is that multiple doses of MK-4305 do not produce a clinically significant increase in Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.

Detailed description:

Arms: arm 1: In Period 1, suvorexant (40 mg tablets) administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening. arm 2: In Period 1, placebo administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered once daily for 4 consecutive days in the evening.
Interventions: intervention 1: Suvorexant intervention 2: Matching Placebo
Intervention descriptions: intervention 1: 40 mg tablets, orally once daily for 4 consecutive days in the evening intervention 2: Placebo tablets, orally once daily for 4 consecutive days in the evening

Protocol documents:
Clinical trial NCT00722046
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease antibody amyloid
Sponsor: Pfizer
Start date: 2008-12-05; Completion date: 2011-08-16
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: PF-04360365 0.1 mg/kg intervention 2: PF-04360365 0.5 mg/kg intervention 3: PF-04360365 1 mg/kg intervention 4: Placebo intervention 5: PF-04360365 3 mg/kg intervention 6: PF-04360365 8.5 mg/kg
Intervention descriptions: intervention 1: 0.1 mg/kg every 60 days (10 doses total) intervention 2: 0.5 mg/kg every 60 days (10 doses total) intervention 3: 1 mg/kg every 60 days (10 doses total) intervention 4: Placebo every 60 days (10 doses total) intervention 5: 3 mg/kg every 60 days (10 doses total) intervention 6: 8.5 mg/kg every 60 days (10 doses total)

Protocol documents:
Clinical trial NCT00682929
Conditions: Multiple Sclerosis
Keywords: cannabis marijuana Multiple Sclerosis spasticity
Sponsor: University of California, Davis
Start date: 2004-04-14; Completion date: 2011-08-17
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.

Detailed description:
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.

Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.

Comparisons: Three treatment arms will be compared:

1. inhaled cannabis and oral placebo
2. inhaled placebo and oral THC
3. inhaled placebo and oral placebo

The effects of these agents analyzed at 3 weeks and 7 weeks.

Arms: arm 1: Inhaled cannabis is compared to oral placebo. arm 2: Inhaled placebo is compared to oral THC. arm 3: Inhaled placebo is compared to oral placebo.
Interventions: intervention 1: Inhaled Cannabis intervention 2: Oral THC intervention 3: Oral Placebo intervention 4: Inhaled placebo
Intervention descriptions: intervention 1: Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks. intervention 2: Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks. intervention 3: Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks. intervention 4: Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.

Protocol documents:
Clinical trial NCT01358981
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-05-24; Completion date: 2011-08-17
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be the first study in which LY2881835 is given to humans in order to evaluate the safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the body and its effect on blood sugar levels.

The study consists of two parts. In part A, healthy subjects will participate and in part B, patients with type 2 Diabetes Mellitus (T2DM) will participate.

Detailed description:

Arms: arm 1: One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A).

There is a washout period of at least 5 days between periods (doses). arm 2: One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B.

There is a washout period of at least 5 days between periods (doses).
Interventions: intervention 1: LY2881835 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT00945191
Conditions: Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV
Keywords: Ovarian Cancer Stage IIIC Ovarian Cancer Stage IV CS-1008 Paclitaxel Carboplatin
Sponsor: Daiichi Sankyo
Start date: 2009-10-06; Completion date: 2011-08-23
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.

Detailed description:
This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patients was assessed by complete response rate.

Arms: arm 1: CS-1008 will be administered with paclitaxel and carboplatin.
Interventions: intervention 1: CS-1008 intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6 intervention 2: Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles intervention 3: Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles

Protocol documents:
Clinical trial NCT01262638
Conditions: Dyslipidemia
Sponsor: Esperion Therapeutics, Inc.
Start date: 2010-12-01; Completion date: 2011-08-23
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.

Detailed description:

Arms: arm 1: Subjects with hypercholesterolemia and normal triglycerides arm 2: Subjects with hypercholesterolemia and normal triglycerides arm 3: Subjects with hypercholesterolemia and normal triglycerides arm 4: Subjects with hypercholesterolemia and normal triglycerides arm 5: Subjects with hypercholesterolemia and elevated triglycerides arm 6: Subjects with hypercholesterolemia and elevated triglycerides arm 7: Subjects with hypercholesterolemia and elevated triglycerides arm 8: Subjects with hypercholesterolemia and elevated triglycerides
Interventions: intervention 1: ETC-1002 intervention 2: Placebo
Intervention descriptions: intervention 1: ETC-1002 daily for 12 weeks intervention 2: Placebo daily for 12 weeks

Protocol documents:
Clinical trial NCT01254565
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Parathyroid hormone
Sponsor: KAI Pharmaceuticals
Start date: 2011-02-20; Completion date: 2011-08-24
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).

Detailed description:

Arms: arm 1: Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort. arm 2: Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
Interventions: intervention 1: Etelcalcetide intervention 2: Placebo
Intervention descriptions: intervention 1: Administered intravenously (IV) at the end of hemodialysis intervention 2: Administered intravenously at the end of hemodialysis

Protocol documents:
Clinical trial NCT01181895
Conditions: Asthma
Keywords: asthma
Sponsor: GlaxoSmithKline
Start date: 2010-09-01; Completion date: 2011-08-26
Enrollment: 348 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

Detailed description:

Arms: arm 1: Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks arm 2: Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks arm 3: Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Interventions: intervention 1: Vilanterol intervention 2: Salmeterol Inhalation Powder intervention 3: Placebo Inhalation Powder NDPI intervention 4: Placebo Inhalation Powder Diskus
Intervention descriptions: intervention 1: Vilanterol inhalation powder inhaled orally once daily for 12 weeks intervention 2: Salmeterol inhalation powder inhaled orally twice daily for 12 weeks intervention 3: Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler intervention 4: Placebo inhalation powder inhaled orally twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00931762
Conditions: Primary Myelofibrosis Post-Polycythemia Vera Post-Essential Thrombocytopenia
Keywords: Bone marrow Myelofibrosis JAK2mutation Post-Polycythemia Vera Post-Essential Thrombocytopenia
Sponsor: Novartis Pharmaceuticals
Start date: 2009-08-31; Completion date: 2011-08-29
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the safety and efficacy of Panobinostat as a single agent in the treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential Thrombocythemia. There were two cohorts - participants with JAK2 mutation and participants without JAK2 mutation.

Detailed description:

Arms: arm 1: Participants received panobinostat 40 mg, capsules, orally, with or without food, three times a week on Monday, Wednesday, and Friday for up to 6 treatment cycles (each cycle of 28-days) with dose adjustments possible.
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: Panobinostat oral capsules

Protocol documents:
Clinical trial NCT00947193
Conditions: Hemophilia A Hemophilia B
Keywords: Hemophilia A Hemophilia B Factor VIII Factor IX FVIII FIX Nonsense mutation Premature stop codon HA HB PTC124 Ataluren
Sponsor: PTC Therapeutics
Start date: 2009-10-14; Completion date: 2011-08-30
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30% of participants with hemophilia and results in severe manifestations. Ataluren (PTC124) is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional FVIII/FIX. This study is a Phase 2a trial evaluating the safety and efficacy of ataluren in participants with HA or HB due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase FVIII/FIX activity levels.

Detailed description:
In this study, participants with hemophilia A or hemophilia B due to a nonsense mutation were treated with an investigational drug called ataluren (PTC124). Evaluation procedures to determine if a participant qualifies for the study was performed within 14 days prior to the start of treatment. Eligible participants who elected to enroll in the study then participated in a 28-day treatment period. Within the 28-day period, ataluren (PTC124) treatment was to be taken for 2 cycles of 14 days each 3 times per day with meals at a dose level of 5, 5, 10 milligrams/kilograms (mg/kg) in the first cycle and a dose level of 20, 20, 40 mg/kg in the second cycle. After the first 14-day cycle, study doses were changed to 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening) and the doses were administered for 1 cycle only. Then, there was an interval of approximately 14 days without treatment. During the study, ataluren (PTC124) efficacy, safety, and pharmacokinetics were evaluated periodically with measurement of FVIII/FIX activity and inhibitor levels, other blood tests, and urinalysis.

Arms: arm 1: Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 mg/kg in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening or 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
Interventions: intervention 1: Ataluren
Intervention descriptions: intervention 1: Oral powder

Protocol documents:
Clinical trial NCT01402947
Conditions: Healthy
Sponsor: Shire
Start date: 2011-07-25; Completion date: 2011-08-30
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone \& in combination with MMX Mesalazine/mesalamine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ciprofloxacin XR + MMX Placebo intervention 2: MMX Mesalazine/mesalamine + Ciprofloxacin XR
Intervention descriptions: intervention 1: MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 intervention 2: MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4

Protocol documents:
Clinical trial NCT00534417
Conditions: Metastatic Breast Cancer
Keywords: Hormone Receptor Positive Metastatic Breast Cancer
Sponsor: Accelerated Community Oncology Research Network
Start date: 2007-10-01; Completion date: 2011-09-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the combination of continuous daily capecitabine with fulvestrant on a loading dose schedule will delay disease progression in metastatic breast cancer (MBC) patients.

Detailed description:

Arms: arm 1: Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight \< 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.

Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days.
Interventions: intervention 1: capecitabine intervention 2: fulvestrant
Intervention descriptions: intervention 1: Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight \< 80 Kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 Kg. intervention 2: Fulvestrant will be given at 500mg on Day 1 followed by 250 mg on Days 15 and 29, then 250mg every 28 days(Q28d).

Protocol documents: