ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02251990
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-01-28; Completion date: 2017-04-10
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination \[FDC\]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%.

Detailed description:

Arms: arm 1: Participants receive a grazoprevir/elbasvir FDC tablet once daily (q.d.) by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and are followed-up for 24 weeks to Week 36. arm 2: Participants receive a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants receive open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants are then followed-up for 24 weeks to Week 52.
Interventions: intervention 1: Grazoprevir/Elbasvir intervention 2: Placebo
Intervention descriptions: intervention 1: FDC tablet containing 100 mg of grazoprevir and 50 mg of elbasvir taken q.d. by mouth for 12 weeks. intervention 2: Placebo tablet matching grazoprevir/elbasvir FDC tablet taken q.d. by mouth for 12 weeks.

Protocol documents:
Clinical trial NCT01645930
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2012-12-17; Completion date: 2017-04-11
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase 1 study is to characterize the pharmacokinetic (PK) and tolerability of oral ixazomib (MLN9708) when administered in combination with lenalidomide and dexamethasone in adult Asian participants with relapsed and/or refractory multiple myeloma.

Detailed description:
The drug being tested in this study was ixazomib. Ixazomib was tested to treat adult Asian people who had relapsed and/or refractory multiple myeloma.

The study enrolled 43 patients. Participants were enrolled to receive:

* Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg.

All participants were asked to take ixazomib capsules orally on Days 1, 8, and 15; lenalidomide capsules, orally, on Days 1 through 21; and dexamethasone tablets, orally, on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles).

This multi-center trial was conducted in Singapore, Hong Kong and South Korea. The overall time to participate in this study was up to 577 days. Participants made multiple visits to the clinic, and were contacted 30 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
Interventions: intervention 1: Ixazomib intervention 2: Lenalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Ixazomib capsules intervention 2: Lenalidomide capsules intervention 3: Dexamethasone tablets

Protocol documents:
Clinical trial NCT01641445
Conditions: Alcohol Drinking
Sponsor: Brown University
Start date: 2012-07-01; Completion date: 2017-04-12
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will help to determine whether the medication, topiramate, reduces alcohol use among adolescents with alcohol dependence. It will also help answer the question, "How does topiramate reduce drinking in teenagers?" Understanding how topiramate may reduce drinking in adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and help to identify additional medications that may hold promise for improving treatment outcomes for youth.

Detailed description:
Adolescent alcohol use is associated with myriad adverse legal, health, and educational consequences and contributes to the leading causes of mortality among youth. Yet despite the magnitude of this public health problem, treatment initiatives for youth remain inadequate. Given these data, the National Institute on Alcohol Abuse and Alcoholism identified the critical need for medications development research for youth with the goal of identifying promising agents for which large-scale clinical trials are justified. The long-term goal of this research program is to improve pharmacotherapy for alcoholism. The major objective of this project is to address the urgent need for empirical data on medications that may benefit youth. For the past 10 years our research program has successfully paired human laboratory paradigms with ecological momentary assessment (EMA), whereby research participants use handheld electronic diaries to monitor their drinking, craving, and sensitivity to alcohol in real time in their natural environment. Using this approach, we identified mechanisms by which medications act and patient characteristics that moderate these effects. The proposed study will test if and how topiramate (TPM), an anticonvulsant shown to be efficacious for treating adults, reduces drinking in youth. To this end, we will randomize adolescent problem drinkers to TPM or placebo for 8 weeks, in combination with biweekly motivational enhancement therapy sessions, using a two-group, double-blind design. While at the target dose (200 mg/day) youth will complete EMA in their natural environment. In addition, youth will complete alcohol cue reactivity assessments in the laboratory to test the effects of TPM on cue-elicited craving and physiological reactivity in a controlled environment. Youth will complete 6- and 12-month follow-up assessments to determine whether any benefits are sustained. This study will provide much needed data on the tolerability and efficacy of TPM with adolescents, while adding important new information about the biobehavioral mechanisms of TPM action in youth.

Arms: arm 1: Topiramate (200 mg) taken orally daily arm 2: Placebo ("sugar pill") taken orally daily
Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Topiramate (200 mg daily) intervention 2: Matching placebo capusules ("sugar pills"

Protocol documents:
Clinical trial NCT01934790
Conditions: Prostatic Neoplasms
Sponsor: Bayer
Start date: 2013-12-22; Completion date: 2017-04-12
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks.

The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride.

After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride.

After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death.

Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals.

An interim analysis of the safety data will be conducted during the study.

Detailed description:

Arms: arm 1: Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
Interventions: intervention 1: Radium-223 dichloride (Xofigo, BAY88-8223)
Intervention descriptions: intervention 1: Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.

Protocol documents:
Clinical trial NCT02494076
Conditions: Asthma
Sponsor: University of Colorado, Denver
Start date: 2014-10-01; Completion date: 2017-04-12
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Asthma is a leading cause of emergency department (ED) visits for children. A novel way of treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. PEP is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This study plans to learn more about the use of PEP therapy in the treatment of asthma exacerbations in children in the emergency department. Specifically, the study aims to evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. This study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to 18 years presenting to the ED with moderate to severe asthma exacerbations will be included in the study. Reduction in clinical asthma severity will be measured by change in the Pulmonary Asthma Score (the respiratory severity score used at the investigators institution). The need for additional therapies and hospitalization will also be evaluated.

Detailed description:

Arms: arm 1: Patients randomized to the EzPAP arm will receive first-line therapies and PEP therapy via EzPAP. All patients will receive 4 cycles with 12 breaths per cycle. 4 cycles is considered one time administration. arm 2: Patients randomized to the control arm will receive first-line therapies and standard therapy.
Interventions: intervention 1: EzPAP intervention 2: Standard Care
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01980992
Conditions: Wheat Allergy
Keywords: Food Allergy Wheat Allergy Oral Immunotherapy
Sponsor: Hugh A Sampson, MD
Start date: 2013-10-01; Completion date: 2017-04-13
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.

Detailed description:
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

Arms: arm 1: Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol. arm 2: Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.
Interventions: intervention 1: Wheat OIT
Intervention descriptions: intervention 1: Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Protocol documents:
Clinical trial NCT02058589
Conditions: Herpes Zoster
Keywords: Immunocompromised Safety ≥ 18 years of age Renal transplant Adults Immunosuppressed Immunogenicity Herpes zoster
Sponsor: GlaxoSmithKline
Start date: 2014-03-20; Completion date: 2017-04-13
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.

Detailed description:

Arms: arm 1: Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. arm 2: Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
Interventions: intervention 1: Herpes Zoster vaccine GSK1437173A intervention 2: Placebo
Intervention descriptions: intervention 1: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm. intervention 2: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Protocol documents:
Clinical trial NCT02582242
Conditions: Diabetes Type 2 Diabetes Mellitus
Sponsor: Novo Nordisk A/S
Start date: 2015-10-19; Completion date: 2017-04-18
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with type 2 diabetes inadequately controlled with basal insulin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: biphasic insulin aspart 30
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) thrice daily or twice daily. Subjects will continue with metformin all throughout the trial.

Protocol documents:
Prot_SAP_000.pdf: 
&RYHU3DJHIRU3URWRFRO
 
Sponsor name: 
Novo Nordisk A/S 
NCT number 
NCT02582242 
Sponsor trial ID: 
BIAsp-4200 
Official title of study: 
A 24-week, Multinational, Multicentre, Randomised, Open 
Label, Parallel-group Treat-to-target Trial to Compare Efficacy 
and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 
(Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes 
Inadequately Controlled With Basal Insulin 
Document date: 
13 September 2017 
 




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Clinical trial NCT00098345
Conditions: Thyroid Cancer
Keywords: Caprelsa (vandetanib) ZD6474
Sponsor: Genzyme, a Sanofi Company
Start date: 2004-11-01; Completion date: 2017-04-19
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.

Detailed description:

Arms: arm 1: Daily oral dose of Caprelsa (vandetanib) 300mg
Interventions: intervention 1: ZD6474 (vandetanib)
Intervention descriptions: intervention 1: oral once daily tablet

Protocol documents:
Clinical trial NCT01994993
Conditions: Complicated Intra Abdominal Infections
Keywords: Antibiotics ampicillin metronidazole clindamycin piperacillin-tazobactam Safety Infants Intra abdominal infections
Sponsor: Michael Cohen-Wolkowiez
Start date: 2013-12-01; Completion date: 2017-04-20
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

Detailed description:
The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.

Arms: arm 1: Ampicillin and gentamycin and metronidazole arm 2: ampicillin and gentamicin and clindamycin arm 3: piperacillin-tazobactam and gentamicin arm 4: Per standard of care antibiotics, and Metronidazole arm 5: metronidazole, clindamycin, or piperacillin-tazobactam
Interventions: intervention 1: ampicillin and metronidazole and gentamicin intervention 2: ampicillin and gentamicin and clindamycin intervention 3: gentamicin and Piperacillin- tazobactam intervention 4: standard of care antibiotics and metronidazole intervention 5: metronidazole, clindamycin, or piperacillin-tazobactam
Intervention descriptions: intervention 1: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 2: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 3: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 4: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA) intervention 5: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Protocol documents:
Clinical trial NCT01478048
Conditions: Multiple Myeloma
Keywords: Relapsed/Refractory Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Start date: 2011-11-30; Completion date: 2017-04-21
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].

Detailed description:

Arms: arm 1: On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered arm 2: None
Interventions: intervention 1: Elotuzumab intervention 2: Bortezomib intervention 3: Dexamethasone intervention 4: Dexamethasone intervention 5: Dexamethasone intervention 6: Dexamethasone
Intervention descriptions: intervention 1: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until subject meets criteria for discontinuation of study drug intervention 2: Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug intervention 3: Tablets; Oral; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug intervention 4: Tablets; Oral; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug intervention 5: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug intervention 6: Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug

Protocol documents: