ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02076178
Conditions: Infection, Human Immunodeficiency Virus
Keywords: Pre-Exposure Prophylaxis HIV integrase Intramuscular Injection GSK1265744
Sponsor: ViiV Healthcare
Start date: 2014-03-27; Completion date: 2016-02-23
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744 (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed by a one week washout period. Following safety lab assessments from the Oral Phase, participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744 LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg of 744 or a matching control

Detailed description:

Arms: arm 1: Participants will receive daily oral 744 (30 mg tablets) for 4 weeks, followed by a one week washout period followed by intra-muscular (IM) injections of 800 mg of 744 LA at three time points at 12 week intervals as: Week 5, Week 17, and Week 29 arm 2: Participants will receive daily oral matching placebo for 4 weeks, followed by a one week washout period followed by intra-muscular (IM) injections of saline at three time points at 12 week intervals as: Week 5, Week 17, and Week 29
Interventions: intervention 1: 744 Tablet intervention 2: 744 LA Injection intervention 3: Placebo Tablet intervention 4: Placebo Injection
Intervention descriptions: intervention 1: White to almost white oval shaped film coated 30 mg tablets for oral administration intervention 2: Sterile white to slightly coloured suspension containing 200 mg/mL of 744 as free acid for administration by intramuscular (IM) injection intervention 3: Microcrystalline cellulose, Opadry film-coating, white OY-S-28876 intervention 4: Sterile saline 0.9% Sodium Chloride Injection

Protocol documents:
Clinical trial NCT02226003
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-09-23; Completion date: 2016-02-23
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo.

Detailed description:
Each participant will be in the study for approximately 39 weeks including: a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a 2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.

Arms: arm 1: Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks. arm 2: Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. arm 3: Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
Interventions: intervention 1: Ertugliflozin intervention 2: Sitagliptin intervention 3: Placebo to Ertugliflozin intervention 4: Placebo to Sitagliptin intervention 5: Glimepiride
Intervention descriptions: intervention 1: Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks. intervention 2: Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. intervention 3: Matching placebo to ertugliflozin administered orally, once daily for 26 weeks. intervention 4: Matching placebo to sitagliptin administered orally, once daily for 26 weeks. intervention 5: Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.

Protocol documents:
Clinical trial NCT02125877
Conditions: Chronic Iron Overload Due to Transfusion-dependant Anemias
Keywords: Iron overload Chelation Thalassemia Myelodysplastic syndrome (MDS) Transfusional hemisiderosis Deferasirox ICL670 Dispersible tablet Film-coated tablet
Sponsor: Novartis Pharmaceuticals
Start date: 2014-07-08; Completion date: 2016-02-24
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

Detailed description:

Arms: arm 1: Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose. arm 2: Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
Interventions: intervention 1: Deferasirox dispersible tablet intervention 2: Defearisox film-coated tablet
Intervention descriptions: intervention 1: Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use. intervention 2: Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Protocol documents:
Clinical trial NCT01307397
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2016-02-24
Enrollment: 3219 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer \[AJCC\]) metastatic melanoma.

Detailed description:

Arms: arm 1: Participants will receive vemurafenib at a dose of 960 milligrams (mg) twice daily (bid) until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.
Interventions: intervention 1: Vemurafenib
Intervention descriptions: intervention 1: Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

Protocol documents:
Clinical trial NCT02563899
Conditions: Hyperhidrosis
Keywords: Primary Axillary Hyperhidrosis GSK573719 Hyperhidrosis Disease Severity Scale (HDSS) Topical PRO Hyperhidrosis Symptom Severity Measure (HSSM) Umeclidinium
Sponsor: GlaxoSmithKline
Start date: 2015-11-23; Completion date: 2016-02-25
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical effect of topically applied umeclidinium following once daily topical administration to axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine whether topically applied umeclidinium can decrease hyperhidrosis without systemic anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at the highest possible concentration.

Subjects will be dosed by site staff each night immediately before bedtime for 14 days. Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS) measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24 subjects.

Detailed description:

Arms: arm 1: Subjects will receive umeclidinium once daily before bedtime for 14 days. arm 2: Subjects will receive vehicle once daily before bedtime for 14 days.
Interventions: intervention 1: Umeclidinium intervention 2: Vehicle
Intervention descriptions: intervention 1: Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be available at a concentration of 18.5 milligrams (mg) umeclidinium parent per gram. 2 mg of this formulation will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of formulation applied daily to both axillae is expected to range between approximately 204 and 680 mg. Total daily dosage of the active pharmaceutical ingredient (umeclidinium parent) to both axillae will range between approximately 3.8 and 12.6 mg. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects. This lower strength formulation will contain 11.5 mg parent per gram. intervention 2: The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. 2 mg of the vehicle will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of vehicle applied daily to both axillae is expected to range between approximately 204 and 680 mg.

Protocol documents:
Clinical trial NCT02483533
Conditions: Central Abdominal Bulging
Sponsor: Evofem Inc.
Start date: 2015-06-01; Completion date: 2016-02-26
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.

Detailed description:

Arms: arm 1: Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study. arm 2: Subjects received either LIPO-202 or Placebo for LIPO-202 in the parent study (LIPO-202-CL-18 or LIPO-202-CL-19). Subjects will not receive any additional treatment in this follow-on study.
Interventions: intervention 1: LIPO-202 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02207374
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-08-04; Completion date: 2016-02-27
Enrollment: 601 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy.

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.
Interventions: intervention 1: semaglutide intervention 2: DPP-4 inhibitor
Intervention descriptions: intervention 1: Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks. intervention 2: Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

Protocol documents:
Clinical trial NCT02641353
Conditions: Healthy Volunteers
Keywords: Apremilast Healthy volunteers Bioavailability Food effect Pharmacokinetic
Sponsor: Amgen
Start date: 2016-01-05; Completion date: 2016-02-27
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the safety and tolerability of apremilast will be obtained.

Detailed description:
This is a phase 1, open-label, randomized, three-period, six-sequence crossover study in healthy subjects. The study will consist of a screening phase, baseline (Day -1), three study periods, and a follow-up phone call. Each study period will be four days in duration (Day 1 through Day 4) followed by a five-day washout between doses.

Eligible participants will be admitted into the study center on Day -1 of study Period 1 for baseline measurements. During each study period, participants will receive a single 30 mg oral dose of apremilast on Day 1 according to the assigned treatment sequence. Participants will be confined at the study center from Day 1 of study Period 1 through Day 4 of study Period 3, including the 5 day washout between doses. All participants will be discharged from the study center on Day 4 of study Period 3 following completion of required study procedures. A follow-up phone call will occur approximately four days after the discharge from the study center.

The study will be conducted in compliance with International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).

Arms: arm 1: A single oral dose of 30 mg apremilast tablet after an overnight fast. arm 2: A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after an overnight fast. arm 3: A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after a high-fat meal.
Interventions: intervention 1: Apremilast Tablet intervention 2: Apremilast Oral Suspension
Intervention descriptions: intervention 1: 30 mg tablet intervention 2: 30 mg oral suspension

Protocol documents:
Clinical trial NCT01193257
Conditions: Prostate Cancer
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-11-15; Completion date: 2016-02-29
Enrollment: 1099 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Orteronel intervention 2: Prednisone intervention 3: Orteronel Placebo
Intervention descriptions: intervention 1: Orteronel tablets intervention 2: Prednisone tablets intervention 3: Orteronel placebo-matching tablets

Protocol documents:
Clinical trial NCT01214421
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords: Kidney Disease ADPKD Autosomal Dominant Polycystic Kidney Disease Adult Polycystic Kidney Disease
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-05-26; Completion date: 2016-02-29
Enrollment: 1083 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

Detailed description:

Arms: arm 1: Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 milligrams (mg) in the morning \[AM\]/15 mg in the evening \[PM\] titrated to 60 mg \[AM\]/30 mg \[PM\], then 90 mg \[AM\]/30 mg \[PM\] based on tolerability were given orally twice daily until the last participant originating from prior studies (either 156-04-251 or 156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290) who was eligible for efficacy analysis completed the Month 24.
Interventions: intervention 1: Tolvaptan
Intervention descriptions: intervention 1: Tablets of 15 or 30 mg

Protocol documents:
Clinical trial NCT01766817
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: IPF
Sponsor: Bristol-Myers Squibb
Start date: 2013-01-31; Completion date: 2016-02-29
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).

Detailed description:

Arms: arm 1: BMS-986020, 600 mg tablets, by mouth, once daily, 26 weeks arm 2: BMS-986020, 600 mg tablets, by mouth, twice daily, 26 weeks arm 3: Placebo, 0 mg tablets, by mouth, twice daily, 26 weeks
Interventions: intervention 1: BMS-986020 intervention 2: Placebo matching with BMS-986020
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01791244
Conditions: Multiple Sclerosis Relapsing-Remitting
Keywords: Multiple Sclerosis Relapsing-Remitting Rebif RebiSmart Patient support program
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2013-02-28; Completion date: 2016-02-29
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.

Detailed description:

Arms: arm 1: Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with technical support for RebiSmart. arm 2: Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
Interventions: intervention 1: Rebif®
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02319668
Conditions: Dental Prophylaxis and Implant Surgery
Sponsor: GlaxoSmithKline
Start date: 2015-02-01; Completion date: 2016-02-29
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute. Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital

Detailed description:

Arms: arm 1: Mouthwash containing 0.2% w/v Chlorhexidine digluconate arm 2: Sodium fluoride toothpaste (Aquafresh Mild \& Minty)
Interventions: intervention 1: 0.2% w/v Chlorhexidine digluconate intervention 2: Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Intervention descriptions: intervention 1: Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse. intervention 2: Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing

Protocol documents:
Clinical trial NCT02336555
Conditions: Postherpetic Neuralgia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-03-12; Completion date: 2016-02-29
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia.

The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.

Detailed description:

Arms: arm 1: In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days) arm 2: In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
Interventions: intervention 1: MK-8291 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-8291 oral tablets intervention 2: Placebo oral tablets

Protocol documents: