ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01604343
Conditions: Arthritis, Rheumatoid
Keywords: Active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy Sirukumab Human Anti-IL-6 monoclonal antibody
Sponsor: Janssen Research & Development, LLC
Start date: 2012-08-15; Completion date: 2016-12-06
Enrollment: 1670 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) and inhibition of radiographic progression in patients with active RA who are unresponsive to treatment with disease-modifying antirheumatic drugs (DMARD).

Detailed description:
Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 120 weeks, which includes 104 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long-term safety and efficacy study, if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 52, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: Sirukumab intervention 4: Sirukumab intervention 5: Sirukumab
Intervention descriptions: intervention 1: Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 50. intervention 2: Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 104. intervention 3: Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 52 through Week 104. intervention 4: Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 104. intervention 5: Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 104.

Protocol documents:
Clinical trial NCT01755949
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation catheter ablation colchicine c reactive protein CRP
Sponsor: Mayo Clinic
Start date: 2013-03-01; Completion date: 2016-12-06
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Detailed description:
Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:

1. Paroxysmal atrial fibrillation, pre-ablation
2. Persistent atrial fibrillation, pre-ablation
3. Chronic persistent atrial fibrillation

Arms: arm 1: Colchicine 0.6 mg PO BID. Subjects not undergoing ablation. arm 2: Matching placebo. Subjects not undergoing ablation. arm 3: Colchicine 0.6 mg PO BID. Subjects undergoing ablation. arm 4: Matching placebo. Subjects undergoing ablation. arm 5: Colchicine 0.6 mg PO BID. Subjects undergoing ablation. arm 6: Matching placebo. Subjects undergoing ablation.
Interventions: intervention 1: Colchicine, 0.6 mg PO BID intervention 2: Matching placebo
Intervention descriptions: intervention 1: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo intervention 2: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug

Protocol documents:
Clinical trial NCT01791491
Conditions: Kidney Transplant
Sponsor: Bristol-Myers Squibb
Start date: 2013-05-09; Completion date: 2016-12-06
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Belatacept
Intervention descriptions: intervention 1: Single intravenous infusion of belatacept, 7.5 mg/kg

Protocol documents:
Clinical trial NCT02207088
Conditions: Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis Severe Renal Impairment End-stage Renal Disease
Keywords: Chronic Hepatitis C Hepatitis C End-stage renal disease Hepatitis C Genotype 1 Severe Renal Impairment renal disease Compensated Cirrhosis Renal impairment dialysis Hepatitis C Virus cirrhosis
Sponsor: AbbVie
Start date: 2014-09-23; Completion date: 2016-12-06
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.

Detailed description:

Arms: arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: tablet

Protocol documents:
Clinical trial NCT02268526
Conditions: HCMV
Keywords: Safety, efficacy, pharmacokinetics, CSJ148, HCMV, HCMV viral load, immunogenicity
Sponsor: Novartis Pharmaceuticals
Start date: 2015-06-02; Completion date: 2016-12-07
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to test if CSJ148 can prevent HCMV replication after stem cell transplantation.

Detailed description:
This study is randomized, double-blinded, and placebo-controlled. 80 Patients will be enrolled and randomized to CSJ148 and placebo in a ratio of 3:1. Patients undergoing stem cell transplantation will be enrolled into the study. The study will consist of a screening period, a baseline visit, approximately 3-month treatment exposure period, an end-of-therapy visit, a follow-up period, and a study completion evaluation approximately 3.5 months after the last dose of study drug is administered.

Arms: arm 1: Cohort 1: CSJ148 IV q 4weeks arm 2: Cohort 2: CSJ148 IV q 4weeks arm 3: Cohort 2: Placebo IV q 4weeks
Interventions: intervention 1: CSJ148 intervention 2: Placebo
Intervention descriptions: intervention 1: CSJ148 IV q 4weeks intervention 2: Placebo IV q 4weeks

Protocol documents:
Clinical trial NCT02796651
Conditions: Chronic Obstructive Pulmonary Disease - COPD
Keywords: Perforomist Pressair COPD Cigarette smoking Formoterol fumarate long-acting β2-adrenergic agonists (LABA) long-acting muscarinic antagonists (LAMA)
Sponsor: AstraZeneca
Start date: 2016-06-30; Completion date: 2016-12-07
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).

Detailed description:
This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.

Arms: arm 1: Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID). arm 2: Participants received formoterol fumarate 12 μg administered via Pressair BID. arm 3: Participants received formoterol fumarate 24 μg administered via Pressair BID. arm 4: Participants received placebo to formoterol fumarate administered via Pressair BID. arm 5: Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days. arm 6: Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration.
Interventions: intervention 1: Formoterol fumarate (6 μg) intervention 2: Formoterol furmarate (20 μg) intervention 3: Placebo for formoterol fumarate intervention 4: Formoterol fumarate (12 μg) intervention 5: Formoterol fumarate (40 μg)
Intervention descriptions: intervention 1: Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) intervention 2: Oral Inhalation (via a standard jet nebulizer connected to an air compressor. intervention 3: Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) intervention 4: Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) intervention 5: Oral Inhalation (via a standard jet nebulizer connected to an air compressor.

Protocol documents:
Clinical trial NCT02621047
Conditions: Hepatic Impairment
Keywords: Healthy volunteer Alectinib Hepatic impairment
Sponsor: Hoffmann-La Roche
Start date: 2015-12-04; Completion date: 2016-12-08
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

Detailed description:

Arms: arm 1: Participants with moderate hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 milligrams (mg) on Day 1. arm 2: Participants with severe hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 mg on Day 1. arm 3: Participants with normal hepatic function will receive alectinib at a single oral dose of 300 mg on Day 1.
Interventions: intervention 1: Alectinib
Intervention descriptions: intervention 1: Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Protocol documents:
Clinical trial NCT02673619
Conditions: Hyperhidrosis
Keywords: Topical Palmar Hyperhidrosis Umeclidinium
Sponsor: Stiefel, a GSK Company
Start date: 2016-03-07; Completion date: 2016-12-08
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is anticipated that topical administration of UMEC will block stimulation of muscarinic receptors, thereby reducing the overproduction of sweat in subjects who suffer from hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and tolerability of topically applied UMEC following once daily topical administration, for 28 days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also investigate if topically applied UMEC, at the highest possible concentration, will decrease palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or below that observed with inhaled administration. This is a double blind (Sponsor unblind), repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55 subjects.

Detailed description:

Arms: arm 1: Subjects will apply UMEC topically once daily (2microliter \[µL\]/centimeter \[cm\]\^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Randomization will be 4:1 (UMEC 1.85%: vehicle) arm 2: subjects will apply vehicle topical once daily (2µL/cm\^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Interventions: intervention 1: Umeclidinium intervention 2: Vehicle
Intervention descriptions: intervention 1: Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colourless solution, free from visible particulates, for topical application. Each subject total daily dose will be calculated as per study reference manual (SRM) using subject's hand area. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm\^2. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects. intervention 2: The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application.This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm\^2

Protocol documents:
Clinical trial NCT01177397
Conditions: Multiple Myeloma Diffuse Large B-Cell Lymphoma Glioblastoma Multiforme Hepatocellular Carcinoma Non-Small Cell Lung Cancer Neuroendocrine Tumors of Non-Pancreatic Origin Hormone Receptor-Positive Breast Cancer
Keywords: Advanced solid malignant neoplasms,Non-Hodgkin Lymphoma, Multiple Myeloma
Sponsor: Celgene
Start date: 2010-07-20; Completion date: 2016-12-09
Enrollment: 226 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

Detailed description:
Initially, patients will be treated with oral CC-223 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.

Arms: arm 1: All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.
Interventions: intervention 1: CC-223
Intervention descriptions: intervention 1: Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.

Protocol documents:
Clinical trial NCT00712933
Conditions: Systemic Lupus Erythematosus
Keywords: SLE Belimumab Antibodies Systemic Lupus Erythematosus Lupus Autoimmune Diseases
Sponsor: Human Genome Sciences Inc., a GSK Company
Start date: 2008-05-30; Completion date: 2016-12-09
Enrollment: 738 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a long-term continuation study to provide continuing treatment to subjects with SLE.

Detailed description:
This trial is a long-term continuation study to provide continuing treatment to subjects with System Lupus Erythematosus (SLE).

Arms: arm 1: 1 mg/kg dose of belimumab given IV every 28 days. arm 2: 10 mg/kg dose of belimumab given IV every 28 days.
Interventions: intervention 1: belimumab
Intervention descriptions: intervention 1: Recombinant, fully human, monoclonal antibody

Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.

Protocol documents:
Clinical trial NCT02603952
Conditions: Influenza
Keywords: Influenza Influenza A Flu Flu A
Sponsor: MedImmune LLC
Start date: 2015-12-07; Completion date: 2016-12-09
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.

Detailed description:
The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by Type A strains. Enrollment is planned in the United States, South Africa, and Australia.

Arms: arm 1: Participants will receive a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. arm 2: Participants will receive a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. arm 3: Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. arm 4: Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.
Interventions: intervention 1: Oseltamivir intervention 2: MEDI8852 intervention 3: Placebo
Intervention descriptions: intervention 1: 75 mg capsules orally BID from Day 1 to Day 5. intervention 2: MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. intervention 3: Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.

Protocol documents:
Clinical trial NCT02652416
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-09-16; Completion date: 2016-12-09
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)

Detailed description:

Arms: arm 1: Chinese, Japanese both arm 2: Chinese, Japanese both arm 3: Chinese, Japanese both arm 4: Chinese, Japanese both arm 5: placebo arm 6: placebo
Interventions: intervention 1: BI 1026706 intervention 2: Placebo
Intervention descriptions: intervention 1: oral administration intervention 2: placebo

Protocol documents:
Clinical trial NCT00815035
Conditions: Peanut Hypersensitivity
Keywords: Peanut Allergy
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-04-01; Completion date: 2016-12-12
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).

Detailed description:
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.

Arms: arm 1: Subjects randomized to receive active treatment with peanut protein flour. arm 2: Subjects randomized to receive placebo in the form of oat flour.
Interventions: intervention 1: Peanut OIT intervention 2: Placebo
Intervention descriptions: intervention 1: Peanut flour that is orally ingested in a graded fashion. intervention 2: Oat flour used as a placebo that is orally ingested a graded fashion

Protocol documents:
Clinical trial NCT01585298
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis MS Fingolimod Gilenya ECG Bradyarrythmia conduction abnormalities first dose observation
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-29; Completion date: 2016-12-12
Enrollment: 6998 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.

Detailed description:

Arms: arm 1: Fingolimod 0.5 mg by mouth once daily for 7 days.
Interventions: intervention 1: FTY720
Intervention descriptions: intervention 1: None

Protocol documents: