ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02547428
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: centanafadine sustained-release Attention-Deficit Hyperactivity Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2015-08-03; Completion date: 2016-06-04
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a Phase 2b, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover study to evaluate safety and efficacy of CTN SR compared with placebo in adults with ADHD. Efficacy was also evaluated in the subgroup of adults with ADHD treated with a target CTN SR dose of 400 mg/day.

Detailed description:

Arms: arm 1: Participants received CTN SR tablets starting at a dose of 100 or 200 milligrams (mg) on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 1. The dose was decreased based on safety and tolerability based on Investigator's discretion, followed by a washout Period of 1 week followed by matching-placebo for up to 3 weeks in Period 2. The most common total daily dose (TDD) was 400 mg/day. arm 2: Participants received matching-placebo for up to 3 weeks in Period 1, followed by a washout Period of 1 week, followed by CTN SR tablets starting at a dose of 100 or 200 mg on Day 1. Dose was up titrated up to 800 mg daily dose for up to 3 weeks in Period 2. The dose was decreased based on safety and tolerability based on Investigator's discretion. The most common TDD was 400 mg/day.
Interventions: intervention 1: CTN SR intervention 2: Matching placebo
Intervention descriptions: intervention 1: CTN SR tablets, daily, Orally. intervention 2: Matching-placebo tablets daily, orally.

Protocol documents:
Clinical trial NCT01715831
Conditions: Arthritis, Rheumatoid
Sponsor: Hoffmann-La Roche
Start date: 2013-01-15; Completion date: 2016-06-06
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could benefit from the study drug, according to the opinion of the investigator, will receive 8 milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The anticipated time on study treatment is 104 weeks.

Detailed description:

Arms: arm 1: Participants will receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant will be of 800 mg of tocilizumab. Participants may also receive disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
Interventions: intervention 1: DMARDs intervention 2: Tocilizumab
Intervention descriptions: intervention 1: DMARDs may be added to the tocilizumab treatment in any visit, at the discretion of the investigator, according to the local prescription information and participant's tolerance. Study protocol does not specify any particular DMARD. intervention 2: Tocilizumab will be administered at 8 mg/kg IV dose every 4 weeks for 104 weeks

Protocol documents:
Clinical trial NCT02036515
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-03-12; Completion date: 2016-06-06
Enrollment: 464 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

Detailed description:
The duration of the trial will be approximately 69 weeks. This will include a 1-week Screening Period, an up to 12-week wash-off/titration /dose-stabilization period, a 2-week single-blind, placebo run-in period, a 52-week double-blind, placebo-controlled treatment period (including a 26-week Phase A and 26-week Phase B), and a post-treatment telephone contact 14 days after the last dose of blinded investigational product.

Arms: arm 1: Ertugliflozin, 5 mg, oral, once daily for 52 weeks arm 2: Ertugliflozin, 15 mg, oral, once daily for 52 weeks arm 3: Matching placebo to ertuglifozin, oral, once daily for 52 weeks
Interventions: intervention 1: Ertugliflozin 5 mg intervention 2: Ertugliflozin 15 mg intervention 3: Placebo for ertugliflozin 5 mg intervention 4: Metformin intervention 5: Sitagliptin intervention 6: Glimepiride intervention 7: Insulin intervention 8: Placebo for ertugliflozin 10 mg
Intervention descriptions: intervention 1: Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks intervention 2: Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks intervention 3: Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks intervention 4: Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. intervention 5: Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period. intervention 6: Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion intervention 7: Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country. intervention 8: Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks

Protocol documents:
Clinical trial NCT04525157
Conditions: Vitiligo
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2014-06-06; Completion date: 2016-06-06
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet B (NB-UVB) phototherapy, in patients with nonsegmental vitiligo. Afamelanotide is expected to increase the rate of the repigmentation induced by NB-UVB, leading to a reduced frequency and dose of NB-UVB.

Detailed description:
Vitiligo is the most common depigmentation disorder. A commonly used treatment is phototherapy with narrow-band ultraviolet B irradiation (NB-UVB). Further therapeutic approaches are desired and currently being evaluated. The investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-MSH). Afamelanotide activates melanin in skin, with the controlled-release injectable implant formulation having an affect across the total body surface area (pandermally). Earlier studies in vitiligo patients showed afamelanotide, in combination with NB-UVB, could induce faster and deeper repigmentation in patients compared to NB-UVB alone.

Arms: arm 1: Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0). arm 2: Participants received Placebo implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0). arm 3: The study design was modified into a single-arm, open label study with only one treatment group receiving afamelanotide implants plus NB-UVB light.

Participants received Afamelanotide implants (Days 28, 56, 112, 140, and 168) and NB-UVB light (twice weekly for 7 months from Day 0).
Interventions: intervention 1: Afamelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01794845
Conditions: Squamous Cell Carcinoma Head and Neck Cancer Recurrent Disease
Keywords: SCCHN Head and Neck Cancer Squamous Cell Carcinoma Recurrent
Sponsor: University of Miami
Start date: 2013-06-03; Completion date: 2016-06-07
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

Detailed description:
The investigator's approach is based on the following reasons:

* Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.
* LDFRT will render enhanced bax activation mediated mode of cell death.
* Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.
* The toxicity profile is expected to be minimal.

Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.

Arms: arm 1: Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
Interventions: intervention 1: Erbitux intervention 2: Taxotere intervention 3: Low Dose Fractionated Radiation Therapy
Intervention descriptions: intervention 1: Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. intervention 2: Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. intervention 3: Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.

Protocol documents:
Clinical trial NCT02516410
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2015-08-01; Completion date: 2016-06-07
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).

Detailed description:

Arms: arm 1: VX-661 100 milligram (mg) plus IVA 150 mg fixed dose combination (FDC) tablet administered orally in the morning and IVA 150 mg film-coated tablet administered orally in the evening up to Week 12. arm 2: Placebo matched to VX-661 plus IVA FDC tablet administered orally in the morning and placebo matched to IVA film-coated tablet administered orally in the evening up to Week 12.
Interventions: intervention 1: VX-661 plus ivacaftor combination intervention 2: Ivacaftor intervention 3: Placebo (matched to VX-661 plus ivacaftor combination) intervention 4: Placebo (matched to ivacaftor)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02234180
Conditions: Adenocarcinoma of the Gastroesophageal Junction Stage IIB Esophageal Adenocarcinoma Stage IIIA Esophageal Adenocarcinoma Stage IIIB Esophageal Adenocarcinoma Stage IIIC Esophageal Adenocarcinoma
Sponsor: Academic and Community Cancer Research United
Start date: 2014-09-01; Completion date: 2016-06-08
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well regorafenib works in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes and have completed chemoradiation therapy and surgery. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the disease-free survival (DFS) for patients with resected esophageal and gastroesophageal (GE) junction adenocarcinoma treated with regorafenib vs. placebo in the adjuvant setting.

SECONDARY OBJECTIVES:

I. To compare the safety profile of adjuvant regorafenib vs. placebo in patients with locally advanced resectable esophageal and GE junction adenocarcinoma.

II. To compare the overall survival (OS) for patients with resected esophageal and GE junction adenocarcinoma treated with regorafenib vs. placebo in the adjuvant setting.

III. To compare the DFS in those patients that receive at least 1 cycle of therapy.

IV. To collect tumor samples for future genomic analysis to explore the biology of locally advanced esophageal and GE junction adenocarcinoma.

V. DFS will be compared between the arms from the time of surgery as well.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Within 6-12 weeks after surgery, patients receive regorafenib orally (PO) once daily (QD) on days 1-21.

ARM II: Within 6-12 weeks after surgery, patients receive placebo PO QD on days 1-21.

In both arms, courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, and every 6 months for up to 5 years.

Arms: arm 1: Within 6-12 weeks after surgery, patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. arm 2: Within 6-12 weeks after surgery, patients receive placebo PO QD on days 1-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Placebo intervention 2: Regorafenib
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT02357420
Conditions: Diabetes Mellitus Diabetes Mellitus Complications Gastroparesis
Keywords: Diabetes Mellitus Delayed Gastric Emptying Vomiting Gastroparesis Gastrointestinal Motility Disorder
Sponsor: Allergan
Start date: 2015-01-29; Completion date: 2016-06-09
Enrollment: 393 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of multiple dose regimens of relamorelin on vomiting episodes, gastric emptying and gastroparesis symptoms in participants with Type 1 and Type 2 diabetes mellitus and gastroparesis. Study drug (relamorelin and placebo) will be administered subcutaneously in a blinded fashion.

Detailed description:

Arms: arm 1: Relamorelin 10 microgram (μg) was administered subcutaneously (SC) by injection twice daily (BID) for 12 weeks. arm 2: Relamorelin 30 μg was administered SC by injection BID for 12 weeks. arm 3: Relamorelin 100 μg was administered SC by injection BID for 12 weeks. arm 4: Placebo-matching relamorelin was administered SC by injection BID for 12 weeks.
Interventions: intervention 1: Relamorelin intervention 2: Placebo
Intervention descriptions: intervention 1: Double blind relamorelin was given subcutaneously BID for 12 weeks. intervention 2: Placebo given subcutaneously for 12 weeks.

Protocol documents:
Clinical trial NCT01141478
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular Proton Beam Radiotherapy Sorafenib
Sponsor: Loma Linda University
Start date: 2010-09-08; Completion date: 2016-06-10
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.

Detailed description:

Arms: arm 1: A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. arm 2: Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
Interventions: intervention 1: Proton Beam Radiotherapy intervention 2: Sorafenib
Intervention descriptions: intervention 1: Fifteen consecutive sessions intervention 2: 400 mg po bid

Protocol documents:
Clinical trial NCT02196324
Conditions: Prurigo Nodularis
Keywords: Prurigo Nodularis Atopic Dermatitis Lichen-simplex chronicus
Sponsor: Vyne Therapeutics Inc.
Start date: 2014-07-09; Completion date: 2016-06-10
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor antagonist is safe and effective for treatment of prurigo nodularis versus placebo.

Detailed description:
The sensation of itch is transmitted to the brain through the nervous system. Several chemicals are involved in transmitting this signal.This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal. This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial. The trial will involve once daily pills for 8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period. Patients will also be monitored for safety and will have blood taken for testing and several points during the trial. Overall participation will last about 14 weeks

Arms: arm 1: serlopitant 5 mg tablets arm 2: Placebo tablets
Interventions: intervention 1: serlopitant intervention 2: Placebo
Intervention descriptions: intervention 1: NK1 receptor antagonist intervention 2: Placebo

Protocol documents:
Clinical trial NCT02281318
Conditions: Asthma
Keywords: Asthma control Lung function Health-related quality of life Mepolizumab Severe Eosinophilic asthma
Sponsor: GlaxoSmithKline
Start date: 2014-12-11; Completion date: 2016-06-10
Enrollment: 556 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function.

Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

Detailed description:

Arms: arm 1: Participants will receive Mepolizumab 100 mg subcutaneously (SC) into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses) along with their respective standard care of treatment arm 2: Participants will receive placebo (0.9% sodium chloride) subcutaneously into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses) along with their respective standard care of treatment
Interventions: intervention 1: Mepolizumab intervention 2: Placebo intervention 3: SOC
Intervention descriptions: intervention 1: Humanised Immunoglobulin G (IgG) antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with sterile water for injection, just prior to use intervention 2: Sterile 0.9% sodium chloride solution intervention 3: Standard of Care (SOC) will differ by participants, however it will include high dose ICS with at least one other controller, e.g. LABA, with or without maintenance OCS

Protocol documents:
Clinical trial NCT02710630
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-03-22; Completion date: 2016-06-10
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate.

The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Dabigatran etexilate tablet E1 intervention 2: Dabigatran etexilate tablet D1 intervention 3: Dabigatran etexilate tablet C1 intervention 4: Dabigatran etexilate tablet B1 intervention 5: Dabigatran etexilate tablet A1 intervention 6: Dabigatran etexilate capsule
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02179671
Conditions: Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
Keywords: Lung cancer; NSCLC
Sponsor: AstraZeneca
Start date: 2014-07-25; Completion date: 2016-06-11
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .

Detailed description:
This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A; tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B; MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled concurrently into multiple cohorts.

Arms: arm 1: Gefitinib once daily followed by MEDI4736 arm 2: AZD9291 once daily followed by MEDI4736 arm 3: Selumetinib twice daily + docetaxel, followed by MEDI4736 arm 4: Tremelimumab every 4 weeks followed by MEDI4736
Interventions: intervention 1: Gefitinib intervention 2: AZD9291 intervention 3: Selumetinib+Docetaxel intervention 4: Tremelimumab
Intervention descriptions: intervention 1: Gefitinib once daily followed by MEDI4736 intervention 2: AZD9291 once daily followed by MEDI4736 intervention 3: Selumetinib twice daily + docetaxel, followed by MEDI4736 intervention 4: Tremelimumab every 4 weeks followed by MEDI4736

Protocol documents: