ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02577016
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-11-05; Completion date: 2016-11-18
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.

Detailed description:

Arms: arm 1: Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise. arm 2: Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
Interventions: intervention 1: Sitagliptin intervention 2: Placebo intervention 3: Ipragliflozin
Intervention descriptions: intervention 1: 50 mg tablet administered orally intervention 2: Placebo to sitagliptin administered orally intervention 3: 50 mg tablet administered orally as background medication

Protocol documents:
Clinical trial NCT03326726
Conditions: Skin Coverage
Sponsor: Medline Industries
Start date: 2016-11-16; Completion date: 2016-11-18
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.

Detailed description:

Arms: arm 1: 2% CHG
Interventions: intervention 1: 2% CHG
Intervention descriptions: intervention 1: Chlorhexidine Gluconate

Protocol documents:
Clinical trial NCT02854527
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-08-22; Completion date: 2016-11-19
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Main objective is to investigate mutual pharmacokinetic drug-drug interactions of digoxin, furosemide, metformin, and rosuvastatin when given all together as a cocktail

Detailed description:

Arms: arm 1: 1 tablet (0.25 mg) digoxin as single dose arm 2: 0.1 mL (1 mg) furosemide oral solution as single dose arm 3: 0.1 mL (10 mg) metformin oral solution as single dose arm 4: 1 tablet (10 mg) rosuvastatin as single dose arm 5: 1 tablet (0.25 mg) digoxin, 0.1 mL (1 mg) furosemide oral solution, 0.1 mL (10 mg) metformin oral solution, and 1 tablet (10 mg) rosuvastatin, all together as a single dose ('cocktail')
Interventions: intervention 1: Digoxin intervention 2: Furosemide intervention 3: Metformin intervention 4: Rosuvastatin intervention 5: Digoxin intervention 6: Furosemide intervention 7: Metformin hydrochloride intervention 8: Rosuvastatin
Intervention descriptions: intervention 1: single dose intervention 2: single dose intervention 3: single dose intervention 4: single dose intervention 5: 0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point) intervention 6: 1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point) intervention 7: 10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point) intervention 8: 10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)

Protocol documents:
Clinical trial NCT03121820
Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
Sponsor: Geropharm
Start date: 2016-10-11; Completion date: 2016-11-19
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects

Detailed description:
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg

Arms: arm 1: Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) arm 2: Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference)
Interventions: intervention 1: Memantinol tablets, 20 mg intervention 2: Akatinol Memantine® tablets, 20 mg
Intervention descriptions: intervention 1: Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition intervention 2: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition

Protocol documents:
Clinical trial NCT02137772
Conditions: Prevention of CMV Infection or Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-06-06; Completion date: 2016-11-21
Enrollment: 570 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT). The hypothesis being tested was that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through Week 24 post-transplant.

Detailed description:

Arms: arm 1: Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets. arm 2: Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
Interventions: intervention 1: Letermovir intervention 2: Placebo
Intervention descriptions: intervention 1: Letermovir 240 mg / 480 mg tablets, or 240 mg / 480 mg intravenous solution in 250 mL to be infused over 60 minutes. intervention 2: Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.

Protocol documents:
Clinical trial NCT02176642
Conditions: Urinary Urge Incontinence
Keywords: Urinary Urge Incontinence Posterior Tibial Nerve Stimulation PTNS Neuromodulation Oxybutynin Anticholinergic Medication
Sponsor: Duke University
Start date: 2014-08-01; Completion date: 2016-11-21
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in women undergoing treatment of urgency urinary incontinence (UUI).

The investigators hypothesize that combination therapy with PTNS and anticholinergic medication will result in a significant incremental improvement in UUI symptoms over that achieved with PTNS alone. In addition, the investigators hypothesize that the addition of anticholinergics to PTNS will result in a greater improvement in patients' perception of treatment response, symptom distress, and quality of life than PTNS alone.

Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI.

Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo.

Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire Short Form (OABq-SF).

An interim analysis will be conducted by an independent entity after 50 participants have completed the study protocol. A Data Safety Monitoring Board is not utilized because the study utilizes FDA approved treatments for urgency urinary incontinence.

Detailed description:

Arms: arm 1: Oxybutynin extended release (blinded tablet) 5mg by mouth daily for 6 weeks, Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks. arm 2: Placebo (blinded tablet) taken daily for 6 weeks. Posterior Tibial Nerve Stimulation utilizing the Urgent PC neuromodulation system administered weekly in the office setting for a total of 6 weeks.
Interventions: intervention 1: Oxybutynin extended release intervention 2: Posterior Tibial Nerve Stimulation intervention 3: Placebo
Intervention descriptions: intervention 1: 5mg tablet taken by mouth daily for 6 weeks intervention 2: In office therapy administered for 30 minutes once every week for a total of 6 weeks intervention 3: Tablet taken by mouth daily for 6 weeks

Protocol documents:
Clinical trial NCT02193074
Conditions: Spinal Muscular Atrophy
Keywords: Spinal Muscular Atrophy SMA SMN SMNRx ISIS-SMNRx ISIS-SMN Rx ISIS 396443 IONIS-SMNRx IONIS-SMN Rx Spinraza ENDEAR
Sponsor: Biogen
Start date: 2014-08-19; Completion date: 2016-11-21
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.

Detailed description:
This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc..

In August 2016, sponsorship of the trial was transferred to Biogen.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: nusinersen intervention 2: Sham procedure
Intervention descriptions: intervention 1: Administered by intrathecal (IT) injection as specified in the treatment arm. intervention 2: Small needle prick on the lower back at the location where the IT injection is normally made

Protocol documents:
Clinical trial NCT02584868
Conditions: Cardiac Surgery Cardiopulmonary Bypass
Sponsor: Queen Fabiola Children's University Hospital
Start date: 2013-02-15; Completion date: 2016-11-21
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.

Detailed description:

Arms: arm 1: Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®) arm 2: Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)
Interventions: intervention 1: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution intervention 2: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Intervention descriptions: intervention 1: Peri-operative fluid replacement therapy (max 40ml/kg/day) intervention 2: Peri-operative fluid replacement therapy (max 40ml/kg/day)

Protocol documents:
Clinical trial NCT01194219
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Sponsor: Amgen
Start date: 2010-09-09; Completion date: 2016-11-22
Enrollment: 844 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the effects of an called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study was to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study was able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Detailed description:

Arms: arm 1: Subjects initially randomized to apremilast 30 mg twice a day, and who demonstrate a PASI 75 response at Week 32 will be randomized (1 to 1) to either continue to receive apremilast 30 mg ) BID or to receive placebo (until effect is lost). At the time effect is lost, subjects will be treated with apremilast 30 mg twice a day for the duration of their participation in the study. arm 2: Subjects initially randomized to placebo, are assigned to apremilast 30 mg twice a day beginning at Week 16 for the duration of the subject's participation in the study. arm 3: Apremilast 30 mg by mouth (PO) twice a day (BID). Participants initially randomized to apremilast 30 mg BID, and who were able to demonstrate a Psoriasis Area Severity Index (PASI) -75 response at week 32 were randomized (1 to 1) to either apremilast 30 mg BID or oral placebo (until effect is lost). At relapse/loss of response to therapy prior to Week 52 (the time at which 75% improvement in PASI score compared to baseline was lost) or at Week 52, participants were re-treated with apremilast 30 mg BID for the duration of their participation in the study. Non-responders or partial responders (PASI response \<75) received additional topical therapies or phototherapy beginning at Week 32.
Interventions: intervention 1: Apremilast intervention 2: Placebo intervention 3: Topical treatments or phototherapy
Intervention descriptions: intervention 1: None intervention 2: Identical matching placebo intervention 3: At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.

Protocol documents:
Clinical trial NCT01688336
Conditions: Pancreatic Cancer
Keywords: Pancreatic Phase II FOLFIRINOX Unresectable Regimen First-line Resectable Borderline Oxaliplatin Leucovorin Irinotecan 5FU Lineberger University of North Carolina
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2012-01-01; Completion date: 2016-11-22
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, multi-center phase II clinical trial will assess the safety and efficacy of FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and borderline resectable (BR) pancreatic cancer.

Detailed description:
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard in the treatment of metastatic pancreatic cancer for selected patients. With improved overall survival (OS) and response rates (RR) in the metastatic setting, we hypothesize that in patients with less tumor burden, this regimen will be safe and well tolerated, improve OS, progression free survival (PFS), and RR, and improve resectability rates, as compared to historical data from standard single agent gemcitabine therapy for unresectable locally advanced (ULA) patients and standard radiation with concurrent 5 fluorouracil (5FU) chemotherapy for borderline resectable (BR) patients. While both ULA and BR patients will be eligible for the present study, our primary objective concerns ULA patients, and we plan to enroll 45 patients in this group.

Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2 weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI) every 2 cycles and reassessed for resectability of the tumor. All patients that are not able to undergo surgical resection, due to insufficient down-staging or patient preference, will continue on protocol-based therapy until disease progression, unacceptable toxicity, study withdrawal, or death.

Arms: arm 1: FOLFIRINOX given to all subjects
Interventions: intervention 1: FOLFIRINOX
Intervention descriptions: intervention 1: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours

Protocol documents:
Clinical trial NCT02145182
Conditions: Delayed Graft Function
Keywords: DGF Dialysis Kidney Kidney Transplantation eGFR Complement Eculizumab
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2014-08-21; Completion date: 2016-11-22
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.

Detailed description:

Arms: arm 1: Eculizumab was administered by intravenous (IV) infusion over 25-45 minutes (min) for 2 doses (on the day of transplant then 18-24 hours \[h\] later). arm 2: Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).
Interventions: intervention 1: Eculizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Eculizumab is a complement component 5 inhibitor. intervention 2: 0.9% sodium chloride

Protocol documents:
Clinical trial NCT02425826
Conditions: Parapsoriasis
Keywords: Parapsoriasis Plaque Psoriasis CC-10004 Apremilast Moderate Plaque Psoriasis Safety
Sponsor: Amgen
Start date: 2015-04-20; Completion date: 2016-11-22
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Detailed description:
This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast in subjects with moderate plaque psoriasis. 221 participants were randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the United States. Those randomized to the apremilast treatment group received apremilast 30 mg tablets orally twice daily for 52 weeks. Those randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily (BID) for 16 weeks. Beginning Week 16, those initially randomized to placebo were switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total).

Study enrolled adult patients with stable moderate plaque psoriasis, who are naïve to systemic psoriasis treatments.

Arms: arm 1: Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52. arm 2: Placebo tablets BID during Weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 36 weeks (from week 16 to week 52)
Interventions: intervention 1: Apremilast intervention 2: Placebo intervention 3: Placebo-Apremilast
Intervention descriptions: intervention 1: Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52. intervention 2: Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16. intervention 3: At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)

Protocol documents:
Clinical trial NCT02855086
Conditions: Brain Neoplasm Malignant Glioma
Sponsor: Eben Rosenthal
Start date: 2016-10-01; Completion date: 2016-11-22
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.

Detailed description:
This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

COHORT II: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

All patients undergo standard of care surgical resection of tumor on days 2-5.

After completion of study, patients are followed up at days 10 and 30.

PRIMARY OBJECTIVE:

Determine the efficacy of cetuximab-IRDye 800CW (cetuximab IRDye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio.

SECONDARY OBJECTIVE:

Determine the tolerability of the cetuximab IRDye800 as an imaging agent in subjects undergoing resection of malignant glioma.

Arms: arm 1: Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

All patients undergo standard of care surgical resection of tumor on days 2 to 5. arm 2: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Interventions: intervention 1: Cetuximab intervention 2: Cetuximab-IRDye 800CW intervention 3: Tumor resection
Intervention descriptions: intervention 1: Administered intravenously (IV) intervention 2: Administered intravenously (IV) intervention 3: Standard of care treatment

Protocol documents: