ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02234011
Conditions: Obsessive-Compulsive Disorder
Sponsor: Mclean Hospital
Start date: 2014-09-01; Completion date: 2016-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being done to learn whether administration of intranasal (inhaled through the nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to reduce pain during surgery and other procedures) but ketamine has not been approved by the FDA as a treatment for OCD.

The investigators believe that ketamine may be effective in reducing symptoms of OCD due to its ability to decrease the activity of a specific brain chemical called glutamate. Previous studies have shown that people with OCD can have abnormal levels of glutamate in their brains. This is the first time that intranasal ketamine is being studied in people with OCD. However, studies have been done in the past using intravenous (IV; through a needle into a vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in people with other psychiatric conditions.

This research study will compare ketamine to placebo. The placebo looks exactly like ketamine, but contains no ketamine. At some time during the study, the investigators will give you ketamine. At another time, the investigators will give you placebo. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.

Detailed description:

Arms: arm 1: Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later. arm 2: Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.
Interventions: intervention 1: Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02238925
Conditions: Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL) Myelodysplastic Syndrome (MDS)
Keywords: Newly Diagnosed AML Secondary AML Relapsed/Refractory AML Relapsed/Refractory ALL MDS
Sponsor: Jazz Pharmaceuticals
Start date: 2014-07-01; Completion date: 2016-01-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.

Efficacy and Safety will be assessed in all patients enrolled to the study.

Detailed description:
This study is an open-label, single-arm, Phase II, PK and pharmacodynamic (PD) trial of CPX-351 in patients with documented acute leukemia (AML or ALL) or MDS (IPSS score ≥ 1.5) and suitable for treatment with intensive chemotherapy. Each patient will be screened for hepatic impairment. Hepatic impairment will be assessed using the Child-Pugh system and only patients with a Child-Pugh score \<7 points will be eligible for this study. Patients will receive up to two inductions and four consolidation courses. Patients will be monitored for safety (early deaths, adverse events, metabolic changes, etc.) and efficacy (response for AML, ALL, and MDS) while on the study.

Arms: arm 1: Single Arm Study (Patients may receive up to 2 Inductions and 4 Consolidations):

Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.

Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.

Consolidations 1-4: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
Interventions: intervention 1: CPX-351
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02250612
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: SYL040012 bamosiran siRNA RNAi Glaucoma Ocular hypertension
Sponsor: Sylentis, S.A.
Start date: 2014-10-01; Completion date: 2016-01-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.

Detailed description:

Arms: arm 1: 1 drop in each eye once daily for 28 consecutive days arm 2: 1 drop in each eye once daily for 28 consecutive days arm 3: 1 drop in each eye once daily for 28 consecutive days arm 4: 1 drop in each eye once daily for 28 consecutive days arm 5: 1 drop in each eye twice daily for 28 consecutive days
Interventions: intervention 1: 1 drop of 0.375% SYL040012 (bamosiran) intervention 2: 1 drop of 0.750% SYL040012 (bamosiran) intervention 3: 1 drop of 1.125% SYL040012 (bamosiran) intervention 4: 1 drop of 1.5% SYL040012 (bamosiran) intervention 5: 1 drop of 0.5 % timolol maleate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02255032
Conditions: Uveitis Macular Edema Uveitis, Posterior Uveitis, Anterior Panuveitis Uveitis, Intermediate
Keywords: uveitis macular edema UME posterior uveitis anterior uveitis panuveitis intermediate uveitis noninfectious uveitis triamcinolone acetonide suprachoroidal space injection microneedle intravitreal injection corticosteroid CME choroid retina microinjection SCS
Sponsor: Clearside Biomedical, Inc.
Start date: 2014-10-01; Completion date: 2016-01-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Detailed description:
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.

The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.

Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.

Arms: arm 1: Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA arm 2: Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
Interventions: intervention 1: 4 mg CLS-TA intervention 2: 0.8 mg CLS-TA
Intervention descriptions: intervention 1: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) intervention 2: 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Protocol documents:
Clinical trial NCT02257684
Conditions: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma
Keywords: ALL LBL
Sponsor: Jazz Pharmaceuticals
Start date: 2014-09-01; Completion date: 2016-01-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL).

Detailed description:
The purpose of the study was to assess the response rate in children and young adults with ALL/LBL and hypersensitivity to pegaspargase defined as the proportion of subjects having a serum asparaginase activity (SAA) level of ≥ 0.1 IU/mL 14 days following the first IV pegcrisantaspase dose in Course 1. Also, to assess the safety of IV pegcrisantaspase therapy in children and young adults with ALL/LBL with hypersensitivity to pegaspargase.

Arms: arm 1: None
Interventions: intervention 1: pegcrisantaspase
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02268994
Conditions: Anemia of Chronic Kidney Disease
Keywords: ferric citrate Chronic kidney disease Anemia
Sponsor: Keryx Biopharmaceuticals
Start date: 2014-10-01; Completion date: 2016-01-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

Detailed description:
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline

Arms: arm 1: 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron arm 2: Matching Placebo
Interventions: intervention 1: ferric citrate intervention 2: Placebo
Intervention descriptions: intervention 1: 1 g ferric citrate containing approximately 210 mg of ferric iron intervention 2: Matching placebo

Protocol documents:
Clinical trial NCT02287350
Conditions: Pain
Keywords: pain moderate pain mild pain acute pain mild acute pain moderate acute pain mild or moderate acute pain NSAID nonsteroidal anti-inflammatory drug
Sponsor: Depomed
Start date: 2014-09-01; Completion date: 2016-01-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.

Detailed description:
This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.

Arms: arm 1: 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
Interventions: intervention 1: diclofenac potassium oral solution
Intervention descriptions: intervention 1: Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.

Protocol documents:
Clinical trial NCT02321098
Conditions: Foot Dermatoses
Keywords: Onychomycosis antifungal
Sponsor: Galderma R&D
Start date: 2014-02-01; Completion date: 2016-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.

The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.

Detailed description:
Study center:

A total of 50 subjects were to be included in 1 site in Iceland.

Methodology:

* Group Loceryl Nail Lacquer+ Cosmetic Varnish:

  * Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
  * Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.
* Group Loceryl Nail Lacquer alone:

  \- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails.
* All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).

Arms: arm 1: Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails arm 2: Loceryl NL once/week for 12 weeks on right or left foot toenails
Interventions: intervention 1: Loceryl NL + Cosmetic varnish intervention 2: Loceryl NL 12 weeks intervention 3: Loceryl NL 15 months
Intervention descriptions: intervention 1: Loceryl NL + Cosmetic varnish once/week for 12 weeks intervention 2: Loceryl NL once/week for 12 weeks intervention 3: Loceryl once/week for additional 15 months

Protocol documents:
Clinical trial NCT02343627
Conditions: Onychomycosis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2014-12-01; Completion date: 2016-01-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Detailed description:
This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Arms: arm 1: NVXT Solution once daily for 60 days arm 2: Vehicle of test product, once daily for 60 days
Interventions: intervention 1: NVXT Solution intervention 2: Vehicle of test product
Intervention descriptions: intervention 1: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. intervention 2: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.

Protocol documents:
Clinical trial NCT02354235
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412 MP-513 TA-7284 Teneligliptin Canagliflozin
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2015-01-01; Completion date: 2016-01-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.

Detailed description:

Arms: arm 1: Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin. arm 2: Patients receive placebo for 24 weeks in combination with Teneligliptin.
Interventions: intervention 1: Teneligliptin intervention 2: Canagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02357459
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2015-01-01; Completion date: 2016-01-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.

Detailed description:
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

* 32 mg FX006,
* normal saline (placebo), or
* 40 mg TCA IR.

Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7.

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[baseline\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

Arms: arm 1: Single 5 mL intra-articular (IA) injection Extended-release Formulation arm 2: Single 5 mL intra-articular (IA) injection arm 3: Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation
Interventions: intervention 1: FX006 intervention 2: Placebo intervention 3: TCA IR 40
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 5 mL IA injection intervention 3: Single 1 mL IA injection

Protocol documents:
Clinical trial NCT02357940
Conditions: Atopic Dermatitis (AD)
Keywords: Eczema Skin Irritation
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Start date: 2015-01-01; Completion date: 2016-01-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Detailed description:
At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Arms: arm 1: Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin arm 2: Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin
Interventions: intervention 1: Experimental Product
Intervention descriptions: intervention 1: 1% Colloidal Oatmeal Balm

Protocol documents:
Clinical trial NCT02413593
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral GS-7977 GS-5885 Ribavirin Sofosbuvir Ledipasvir Hepatitis C Hepatitis C, Chronic
Sponsor: Gilead Sciences
Start date: 2015-04-01; Completion date: 2016-01-01
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: LDV/SOF FDC plus RBV for 12 weeks
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02424149
Conditions: Cystoscopy
Sponsor: Hartford Hospital
Start date: 2015-04-01; Completion date: 2016-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.

Detailed description:

Arms: arm 1: No preoperative phenazopyridine arm 2: Preoperative phenazopyridine
Interventions: intervention 1: Phenazopyridine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02428231
Conditions: Multiple Sclerosis
Sponsor: Biogen
Start date: 2015-04-01; Completion date: 2016-01-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.

Detailed description:

Arms: arm 1: 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks arm 2: 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF twice daily for 6 weeks
Interventions: intervention 1: dimethyl fumarate
Intervention descriptions: intervention 1: Participants will be dosed twice daily for 12 weeks.

Protocol documents:
Clinical trial NCT02430532
Conditions: Multiple Sclerosis, Secondary Progressive
Keywords: INSPIRE SPMS Tecfidera BG00012
Sponsor: Biogen
Start date: 2015-05-01; Completion date: 2016-01-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

Detailed description:

Arms: arm 1: BG00012 120 mg (1 BG00012 120 mg capsule + 1 matching placebo capsule) orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID thereafter. arm 2: BG00012 120 mg capsule orally once a day supplemented with matching placebo capsules for the first 4 weeks of treatment, as an additional blinding measure. Matched placebo capsules only thereafter.
Interventions: intervention 1: dimethyl fumarate intervention 2: Placebo
Intervention descriptions: intervention 1: capsule intervention 2: matched placebo capsule

Protocol documents: