ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02197130
Conditions: Huntington's Disease
Keywords: Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms
Sponsor: Pfizer
Start date: 2014-09-01; Completion date: 2016-10-01
Enrollment: 272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5 mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.

Detailed description:

Arms: arm 1: 20 mg PF-02545920 BID arm 2: 5 mg PF-02545920 BID arm 3: Matching placebo
Interventions: intervention 1: PF-02545920 intervention 2: PF-02545920 intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards. intervention 2: 5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards. intervention 3: Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.

Protocol documents:
Clinical trial NCT02218008
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder (MDD) depression Alkermes ALKS 5461 samidorphan
Sponsor: Alkermes, Inc.
Start date: 2014-07-01; Completion date: 2016-10-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ALKS 5461.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ALKS 5461 intervention 2: Placebo
Intervention descriptions: intervention 1: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) intervention 2: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Protocol documents:
Clinical trial NCT02227329
Conditions: Catheter-related Bloodstream Infection (CRBSI) Nos Bloodstream Infection Due to Central Venous Catheter Bloodstream Infection Due to Hickman Catheter
Keywords: Home Parenteral Nutrition Infection Prevention CRBSI Ethanol Lock Therapy
Sponsor: Mayo Clinic
Start date: 2014-07-01; Completion date: 2016-10-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (HPN). Central catheter related blood stream infection is a major complication in patients on HPN. The investigators hypothesize that the prophylactic use of ELT will decrease the number of catheter related blood stream infections compared to the control group. The investigators further hypothesize that with the introduction of prophylactic ELT, the number of infections will decrease.

Detailed description:
Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs may also result in the need for central venous catheter (CVC) removal and replacement. Current literature supports the use of antibiotics locks in patients with repeated CRBSI. There is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. Compared with antibiotic and other solution locks, which have limitations, ELT has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. There is a lack of a randomized controlled study to characterize the role of ELT in adult patients on HPN.

Arms: arm 1: All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush. arm 2: All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
Interventions: intervention 1: Ethanol intervention 2: Heparin Lock intervention 3: Normal Saline
Intervention descriptions: intervention 1: Prophylactic ELT will be administered at the time when the HPN is not being infused. intervention 2: 3 mL of 100 U/ml heparin intervention 3: None

Protocol documents:
Clinical trial NCT02249585
Conditions: Cardiac Index
Sponsor: Seoul National University Hospital
Start date: 2014-09-01; Completion date: 2016-10-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.

Detailed description:

Arms: arm 1: Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure. arm 2: Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure. arm 3: Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
Interventions: intervention 1: Standard abdominal pressure intervention 2: Low abdominal pressure intervention 3: Conventional neuromuscular blockade intervention 4: Deep neuromuscular blockade
Intervention descriptions: intervention 1: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery intervention 2: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery intervention 3: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch intervention 4: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch

Protocol documents:
Clinical trial NCT02255565
Conditions: ADHD Autism
Keywords: Quillivant
Sponsor: Seattle Children's Hospital
Start date: 2014-09-01; Completion date: 2016-10-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).

Detailed description:
To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in children with ASD and ADHD. The investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with ASD have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without ASD.

Arms: arm 1: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. arm 2: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. arm 3: Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Interventions: intervention 1: Very Low Dose Quillivant XR intervention 2: Low Dose Quillivant XR intervention 3: Moderate Dose Quillivant XR
Intervention descriptions: intervention 1: Oral suspension dose once a day increasing to a 10mg dose intervention 2: Oral suspension dose once a day increasing to a 20mg dose intervention 3: Oral suspension dose once a day increasing to a 40mg dose

Protocol documents:
Clinical trial NCT02260986
Conditions: Atopic Dermatitis
Sponsor: Regeneron Pharmaceuticals
Start date: 2014-09-01; Completion date: 2016-10-01
Enrollment: 740 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection weekly (qw) from Week 1 to Week 51. arm 2: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 51. During weeks in which Dupilumab was not administered, participants received placebo. arm 3: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 51.
Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab) intervention 3: Topical Corticosteroid (TCS)
Intervention descriptions: intervention 1: Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs intervention 2: Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs intervention 3: All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.

Protocol documents:
Clinical trial NCT02261805
Conditions: Cancer Small Cell Lung Cancer
Sponsor: Georgetown University
Start date: 2014-10-01; Completion date: 2016-10-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase I/safety dose expansion study of the combination of the drug ganetespib and doxorubicin in patients with advanced solid tumors. The purpose of the Phase I part of the study is to determine the recommended phase II dose of ganetespib when given in combination with doxorubicin. The recommended Phase II dose determined at the end of the dose escalation phase will be used to conduct a safety dose expansion phase in relapsed/refractory small cell lung cancer to determine if there is a signal of efficacy in this population.

Detailed description:
The dose escalation phase of the study will follow a standard 3+ 3 dose escalation scheme with two dose levels of ganetespib (1-- mg/m2 and 150 mg/m2) administered weekly on Days 1 and 8 of a 21-day cycle, in combination with a fixed dose of doxorubicin at 50 mg/m2 administered on Day 1 alone. After 4-6 cycles of combination therapy, continuation of single agent ganetespib will be permitted for subjects who are deriving clinical benefit.

Pharmacokinetic samples for plasma drug levels of ganetespib will be collected pre-dose and 4 hours after completion of treatment on Day 1 and Day 8 of cycle 1 only in subjects in the dose escalation phase.

The recommended Phase II dose determined at the end of the dose escalation phase will be used to conduct a safety dose expansion phase in relapsed/ refractory small cell lung cancer to determine if there is a signal of efficacy in this population.

Arms: arm 1: Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle arm 2: Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle arm 3: Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
Interventions: intervention 1: Ganetespib intervention 2: Doxorubicin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02271217
Conditions: Post-Ischemic Stroke
Keywords: Post stroke Ischemic stroke
Sponsor: Acorda Therapeutics
Start date: 2014-12-01; Completion date: 2016-10-01
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

Detailed description:
This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Arms: arm 1: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart. arm 2: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart. arm 3: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Interventions: intervention 1: Placebo intervention 2: dalfampridine-ER 7.5mg intervention 3: dalfampridine-ER 10mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02291549
Conditions: Chronic Sinusitis Nasal Polyposis
Keywords: endoscopic sinus surgery corticosteroid chronic rhinosinusitis mometasone furoate polyposis
Sponsor: Intersect ENT
Start date: 2014-12-01; Completion date: 2016-10-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Detailed description:
The RESOLVE II Study is a randomized, sham-controlled, double-blind, parallel arm multicenter trial conducted in up to 45 clinical centers (academic and private) across the United States in 300 adults with chronic sinusitis, who are indicated for revision surgery because of recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis.

Arms: arm 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200mcg) once daily arm 2: In-office bilateral sham procedure

Mometasone furoate nasal spray (200mcg) once daily
Interventions: intervention 1: S8 Sinus Implant intervention 2: Mometasone furoate nasal spray intervention 3: Sham
Intervention descriptions: intervention 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses intervention 2: Mometasone furoate nasal spray (200mcg) once daily intervention 3: In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.

Protocol documents:
Clinical trial NCT02373124
Conditions: Cocaine Use Disorders
Sponsor: New York State Psychiatric Institute
Start date: 2014-12-01; Completion date: 2016-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the feasibility of a treatment paradigm that involves naturalistic cocaine use opportunities in the context of psychotherapy aimed at utilizing these opportunities therapeutically.

Detailed description:

Arms: arm 1: 52 minute infusion of NMDA antagonist
Interventions: intervention 1: infusion of NMDA antagonist
Intervention descriptions: intervention 1: 52 minute infusion

Protocol documents:
Clinical trial NCT02389829
Conditions: Migraine
Sponsor: Montefiore Medical Center
Start date: 2015-03-01; Completion date: 2016-10-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.

Detailed description:

Arms: arm 1: Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. arm 2: Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.

Patients can receive second 10mg dose at 1 hour.
Interventions: intervention 1: Hydromorphone intervention 2: Prochlorperazine intervention 3: Diphenhydramine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02390219
Conditions: Cystic Fibrosis Advanced Lung Disease
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2015-03-01; Completion date: 2016-10-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation

Detailed description:

Arms: arm 1: Lumacaftor 400 milligram (mg) and ivacaftor 250 mg combination tablet orally twice daily for 24 weeks.
Interventions: intervention 1: Lumacaftor intervention 2: Ivacaftor
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02404805
Conditions: HIV Hepatitis C
Keywords: dolutegravir simeprevir HIV HCV
Sponsor: University of Colorado, Denver
Start date: 2016-02-01; Completion date: 2016-10-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.

Detailed description:
To investigate the potential for drug interactions between simeprevir and dolutegravir, participants will receive each drug alone and the drugs in combination for 7 days. The pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be compared.

Arms: arm 1: Sequence 1,2,3: simeprevir only, then dolutegravir only, then both simeprevir and dolutegravir. arm 2: Sequence 1,3,2: simeprevir only, then both simeprevir and dolutegravir, then dolutegravir only. arm 3: Sequence 2,1,3: dolutegravir only, then simeprevir only, then both simeprevir and dolutegravir. arm 4: Sequence 2,3,1: dolutegravir only, then both simeprevir and dolutegravir, then simeprevir only. arm 5: Sequence 3,1,2: both simeprevir and dolutegravir, then simeprevir only, then dolutegravir only. arm 6: Sequence 3,2,1: Both simeprevir and dolutegravir, then dolutegravir only, then simeprevir only.
Interventions: intervention 1: dolutegravir intervention 2: simeprevir
Intervention descriptions: intervention 1: dolutegravir tablets 50mg, once daily x 7 days. intervention 2: simeprevir tablets 150mg, once daily x 7 days.

Protocol documents:
Clinical trial NCT02418819
Conditions: Schizophrenia
Sponsor: Pfizer
Start date: 2015-04-01; Completion date: 2016-10-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.

Detailed description:
B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of 3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100 psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with schizophrenia are on background treatment with SOC antipsychotics and other psychotropic medications.

All doses will be administered twice daily, with approximately 12 hours between each dose.

Arms: arm 1: PF-06412562 3mg BID arm 2: PF-06412562 9mg BID arm 3: PF-06412562 45mg BID arm 4: Placebo BID
Interventions: intervention 1: PF-06412562 3mg BID intervention 2: PF-06412562 9mg BID intervention 3: PF-06412562 45mg BID intervention 4: Placebo
Intervention descriptions: intervention 1: PF-06412562 intervention 2: PF-06412562 intervention 3: PF-06412562 intervention 4: Placebo

Protocol documents:
Clinical trial NCT02421120
Conditions: Cystic Fibrosis Cystic Fibrosis Pulmonary Exacerbation Pseudomonas Aeruginosa Infection
Sponsor: Joseph L. Kuti, PharmD
Start date: 2015-09-01; Completion date: 2016-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly approved broad spectrum intravenous antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day study.

Detailed description:
Participants will receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours, in addition to standard intravenous antibiotic therapy selected by the site. Just prior and then after the final dose, a total of six blood samples will be collected to measure ceftolozane and tazobactam concentrations. Data will be fit to a population pharmacokinetic model. The final model will be utilized in a Monte Carlo simulation to determine the probability of several different dosing regimens retaining concentrations above the minimum inhibitory concentration (MIC) for at least 39% of the dosing interval. These data will be utilized to determine an optimized dosing regimen for adults with CF.

Arms: arm 1: Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Interventions: intervention 1: Ceftolozane/Tazobactam
Intervention descriptions: intervention 1: 1 hour intravenous infusion

Protocol documents: