ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01857232
Conditions: CINV
Sponsor: Acacia Pharma Ltd
Start date: 2013-10-01; Completion date: 2015-02-01
Enrollment: 342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy

Detailed description:

Arms: arm 1: OND + DEX + FOS followed by oral DEX arm 2: OND + APD403 followed by oral PLACEBO arm 3: OND + APD403 followed by oral APD403 low dose arm 4: OND + APD403 followed by oral APD403 mid dose arm 5: OND + APD403 followed by oral APD403 high dose
Interventions: intervention 1: Ondansetron intervention 2: Placebo intervention 3: Dexamethasone intervention 4: Fosaprepitant intervention 5: APD403 IV intervention 6: APD403 oral
Intervention descriptions: intervention 1: 5HT3-antagonist intervention 2: Comparator intervention 3: Corticosteroid intervention 4: NK1 antagonist intervention 5: Amisulpride IV 20 mg intervention 6: Amisulpride oral 10, 20 or 40 mg

Protocol documents:
Clinical trial NCT01871558
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: type 2 diabetes basal insulin vildagliptin
Sponsor: Novartis Pharmaceuticals
Start date: 2013-06-01; Completion date: 2015-02-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

Detailed description:
This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.

Arms: arm 1: Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG arm 2: Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Interventions: intervention 1: Vildagliptin intervention 2: Metformin intervention 3: sulfonylurea (SU) intervention 4: Basal Insulin
Intervention descriptions: intervention 1: 50 mg b.i.d intervention 2: metformin is to be kept unchanged intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01888367
Conditions: Surgical Site Infections
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2013-10-01; Completion date: 2015-02-01
Enrollment: 445 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery. patients will be randomized to active or placebo gel in a double-blind manner. The gel will be applied a single time in the incision during closure at the end of surgery. A cohort of patients will also be randomized to standard of care, saline irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability of the active gel will be assessed compared to the control group (combined placebo gel and standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel: standard of care in a 4:1:1 ratio.

Detailed description:

Arms: arm 1: Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. arm 2: Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. arm 3: Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Interventions: intervention 1: DFA-02 Antibiotic Gel intervention 2: DFA-02 Placebo Gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01894776
Conditions: HIV Infection HIV-1 Infection Mycobacterium Avium Complex (MAC)
Keywords: healthy volunteers
Sponsor: Ottawa Hospital Research Institute
Start date: 2013-06-01; Completion date: 2015-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.

Detailed description:

Arms: arm 1: Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin

Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily

Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily
Interventions: intervention 1: Rifabutin intervention 2: Maraviroc
Intervention descriptions: intervention 1: Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days intervention 2: Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days

Protocol documents:
Clinical trial NCT01897792
Conditions: Coagulopathy Nosocomial Pneumonia
Sponsor: University of Alabama at Birmingham
Start date: 2013-05-01; Completion date: 2015-02-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.

Detailed description:

Arms: arm 1: Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first. arm 2: 100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Interventions: intervention 1: Vitamin C intervention 2: Vitamin E intervention 3: Saline (for Vitamin C) intervention 4: Placebo (for Vitamin E)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: 0.9% saline administered to mimic Vitamin C intervention 4: Sugar pill administered to mimic Vitamin E

Protocol documents:
Clinical trial NCT01927055
Conditions: Symptomatic Neurogenic Orthostatic Hypotension Parkinson's Disease Multiple Systems Atrophy Pure Autonomic Failure Dopamine Beta Hydroxylase Deficiency
Keywords: NOH OH PD MSA PAF DBH
Sponsor: Chelsea Therapeutics
Start date: 2013-11-01; Completion date: 2015-02-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

Detailed description:
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose.

Arms: arm 1: Droxidopa 100 mg, 200 mg, 300 mg arm 2: Placebo
Interventions: intervention 1: Droxidopa intervention 2: Placebo
Intervention descriptions: intervention 1: Droxidopa at 100 mg, 200 mg, 300 mg intervention 2: Placebo to match droxidopa capsules and strength designations

Protocol documents:
Clinical trial NCT01929044
Conditions: Intestinal Diseases
Sponsor: Boehringer Ingelheim
Start date: 2013-08-01; Completion date: 2015-02-01
Enrollment: 299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.

Detailed description:

Arms: arm 1: 1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection arm 2: 1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection
Interventions: intervention 1: 654-II (anisodamine) intervention 2: Buscopan® (hyoscine butylbromide)
Intervention descriptions: intervention 1: 10mg injection intervention 2: 20mg injection

Protocol documents:
Clinical trial NCT01937130
Conditions: Acute on Chronic Hepatic Failure Acute Liver Failure Liver Cirrhosis Acute Alcoholic Hepatitis
Keywords: Liver Failure Cirrhosis Alcoholic Hepatitis
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2013-09-01; Completion date: 2015-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.

Detailed description:

Arms: arm 1: Dosed twice daily arm 2: Dosed twice daily arm 3: Dosed twice daily arm 4: Dosed twice daily
Interventions: intervention 1: IDN-6556 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01945034
Conditions: Ankle Injuries
Keywords: topical ibuprofen ankle sprain
Sponsor: Pfizer
Start date: 2013-11-01; Completion date: 2015-02-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Topical IBU twice daily intervention 2: Placebo twice daily intervention 3: Topical IBU three times daily intervention 4: Placebo three times daily
Intervention descriptions: intervention 1: Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days intervention 2: Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days intervention 3: Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days intervention 4: Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days

Protocol documents:
Clinical trial NCT01955564
Conditions: Schizophrenia
Sponsor: Newron Pharmaceuticals SPA
Start date: 2013-06-01; Completion date: 2015-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.

Detailed description:
Doses from 1 to 30 mg were tested

Arms: arm 1: NW-3509a - 1mg or placebo arm 2: NW-3509a 2mg or placebo arm 3: NW-3509a 5mg or placebo arm 4: NW-3509a 10 mg or placebo arm 5: NW-3509a 20 mg or placebo arm 6: NW-3509a 30 mg or placebo
Interventions: intervention 1: NW-3509a
Intervention descriptions: intervention 1: single dose

Protocol documents:
Clinical trial NCT01965600
Conditions: Healthy
Keywords: Endotoxin challenge
Sponsor: Pfizer
Start date: 2014-03-01; Completion date: 2015-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
An endotoxin challenge will be administered to healthy subjects to induce production of inflammatory markers. An investigational drug or placebo will be administered prior to the endotoxin challenge to assess the effect of the investigational drug on the markers of inflammation. Safety and tolerability will also be assessed.

Detailed description:
The trial was terminated on 25 March 2015 due to safety concerns regarding the administration of endotoxin and because of the uncertain availability of future endotoxin lots.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-06282999 intervention 2: Placebo intervention 3: LPS intervention 4: PF-06282999 intervention 5: Placebo intervention 6: LPS
Intervention descriptions: intervention 1: Tablet, 125 mg, TID, 3 days, 1 of 2 periods intervention 2: Tablet, 0 mg, TID, 3 days, 1 of 2 periods intervention 3: IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods intervention 4: Tablet, 500 mg, BID, 3 days, 1 of 2 periods intervention 5: Tablet, 0 mg, BID, 3 days, 1 of 2 periods intervention 6: IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Protocol documents:
Clinical trial NCT01969721
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2013-10-01; Completion date: 2015-02-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.

Detailed description:

Arms: arm 1: Low dose arm 2: High dose arm 3: Low dose arm 4: High dose
Interventions: intervention 1: fluticasone propionate intervention 2: salmeterol intervention 3: placebo intervention 4: placebo intervention 5: tiotropium intervention 6: olodaterol intervention 7: olodaterol intervention 8: placebo intervention 9: placebo intervention 10: tiotropium intervention 11: fluticasone propionate intervention 12: salmeterol
Intervention descriptions: intervention 1: low dose intervention 2: None intervention 3: placebo/dummy for blinding purposes intervention 4: placebo/dummy for blinding purposes intervention 5: tiotropium high dose intervention 6: None intervention 7: None intervention 8: placebo/dummy for blinding purposes intervention 9: placebo/dummy for blinding purposes intervention 10: tiotropium low dose intervention 11: low dose intervention 12: None

Protocol documents:
Clinical trial NCT01977352
Conditions: Shoulder Pain Rotator Cuff Tear
Keywords: Exparel Liposomal Bupivacaine Arthroscopic Shoulder Surgery
Sponsor: St. Luke's-Roosevelt Hospital Center
Start date: 2014-01-01; Completion date: 2015-02-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Detailed description:

Arms: arm 1: 20 cc of bupivacaine 0.25% arm 2: liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Bupivacaine 0.25%
Intervention descriptions: intervention 1: liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) intervention 2: 20 cc of bupivacaine 0.25%

Protocol documents:
Clinical trial NCT01982643
Conditions: Methamphetamine Use Disorder
Sponsor: Walter Ling
Start date: 2013-11-01; Completion date: 2015-02-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a combination of extended-release depot naltrexone plus extended-release bupropion as a potential pharmacotherapy for methamphetamine (MA) use disorder.

Detailed description:
Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type) enrolled across three study sites. Following a maximum 30-day screening period to establish eligibility, participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks. Take-home oral study medication (BRP) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visit during Week 9. If Stage 1 data document success (see criteria below) in at least 3 "responder" study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of "responder" success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.

Arms: arm 1: extended-release depot naltrexone (XR-NTX; as Vivitrol®)plus extended-release bupropion tablets (BRP; as Wellbutrin XL®)
Interventions: intervention 1: naltrexone plus bupropion
Intervention descriptions: intervention 1: Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks.

Protocol documents:
Clinical trial NCT01996319
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2014-04-01; Completion date: 2015-02-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to assess the effect of QVA149 (110/50 ug q.d.) versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: QVA149 once a day during 21 days cross-over to placebo once a day for up to 21 days arm 2: Placebo once a day during 21 days cross-over to QVA149 once a day for 21 days
Interventions: intervention 1: QVA149 intervention 2: Placebo
Intervention descriptions: intervention 1: QVA149 (110/50 µg) once a day via Breezhaler® device intervention 2: Placebo once a day via Breezhaler® device

Protocol documents:
Clinical trial NCT02002221
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Diabetes Mellitus (DM) , diabetes, noninsulin-dependent diabetes mellitus (NIDDM), adult-onset diabetes, high blood sugar, T2DM
Sponsor: Novartis Pharmaceuticals
Start date: 2013-12-01; Completion date: 2015-02-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

Detailed description:

Arms: arm 1: Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study arm 2: In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Interventions: intervention 1: Vildagliptin (LAF237) intervention 2: Placebo intervention 3: Insulin intervention 4: Metformin
Intervention descriptions: intervention 1: Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily intervention 2: Matching placebo of vildagliptin 50 mg twice daily intervention 3: Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.

The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion. intervention 4: Patients continued their prescribed metformin dose, if applicable.

Protocol documents:
Clinical trial NCT02013388
Conditions: Healthy
Keywords: N91115 GSNORi SNO Cavosonstat
Sponsor: Nivalis Therapeutics, Inc.
Start date: 2014-02-01; Completion date: 2015-02-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.

Detailed description:
This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.

Arms: arm 1: single oral daily dose of 10 mg N91115 for 14 days arm 2: single oral daily dose of placebo for 14 days arm 3: single oral daily dose of 50 mg N91115 for 14 days arm 4: single oral dose of 50 mg N91115 arm 5: single oral daily dose of 250 mg N91115 for 14 days (fasted) arm 6: single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) arm 7: single oral daily dose of 500 mg N91115 for 14 days arm 8: Single oral dose of placebo (Day 1 only)
Interventions: intervention 1: N91115 intervention 2: Placebo intervention 3: N91115 intervention 4: Placebo-Day 1 only
Intervention descriptions: intervention 1: Given PO daily for 14 days intervention 2: Given PO daily for 14 days intervention 3: Given PO only on Day 1 intervention 4: Given PO- only on Day 1 (single dosed to match single dose treatments)

Protocol documents:
Clinical trial NCT02013544
Conditions: Vaginal Atrophy
Keywords: Vulvovaginal atrophy (VVA) Vaginal atrophy Atrophic vaginitis prasterone DHEA Intrarosa
Sponsor: EndoCeutics Inc.
Start date: 2014-02-01; Completion date: 2015-02-01
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Detailed description:

Arms: arm 1: Placebo vaginal ovule daily for 12 weeks arm 2: Prasterone (DHEA) vaginal ovule daily for 12 weeks
Interventions: intervention 1: Placebo intervention 2: Prasterone (DHEA)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: