ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03168022
Conditions: Healthy Adults
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2015-12-16; Completion date: 2016-01-26
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial drug product. This bioequivalence study will confirm (1) the drug product manufactured from these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.

Detailed description:
This will be a single centre, bioequivalence, open-label, randomized, single-dose, 2-period, 2 sequence, crossover study under fasting conditions.

Potential subjects will be screened by medical and psychiatric history, and laboratory and physical examinations 2 to 30 days prior to drug administration. All eligible subjects will be admitted to the study unit on Day -1, the day prior to dose administration. Baseline values will be considered the last value obtained before dosing for each assessment. On Day 1, the morning after admission, after all pre-dose assessments have been completed and subjects who remain eligible have agreed to continue, subjects will be randomly assigned to study medication and will receive the assigned test drug. Subjects will be required to fast for at least 10 hours prior to dosing until at least 4 hours post-dose.

For each period, subjects will be confined to the study site from at least 10 hours before dosing until after the 24-hour post-dose blood draw. Subjects will come back for all subsequent blood draws. Subjects will be reassessed for eligibility prior to each dosing period.

Arms: arm 1: 1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved. arm 2: 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
Interventions: intervention 1: Treatment A intervention 2: Treatment B
Intervention descriptions: intervention 1: 1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved. intervention 2: 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.

Protocol documents:
Clinical trial NCT00796445
Conditions: Melanoma
Keywords: DERMA Tumor antigen Immunotherapeutic Adjuvant cancer therapy Melanoma ASCI
Sponsor: GlaxoSmithKline
Start date: 2008-12-01; Completion date: 2016-01-27
Enrollment: 1351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

Detailed description:

Arms: arm 1: Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals. arm 2: Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
Interventions: intervention 1: GSK 2132231A intervention 2: Placebo
Intervention descriptions: intervention 1: IM solution, a course of 13 injections administered over 27 months intervention 2: IM solution, a course of 13 injections administered over 27 months

Protocol documents:
Clinical trial NCT02404389
Conditions: Actinic Keratosis
Keywords: Actinic keratosis, patients, topical, lesion count, clearance rate
Sponsor: Novartis Pharmaceuticals
Start date: 2015-03-05; Completion date: 2016-01-27
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.

Detailed description:

Arms: arm 1: LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications arm 2: LFX453 0.15% liquid crystal cream (LCC) Twice daily applications arm 3: Vehicle to nanomedicinal cream (NMC) Twice daily applications arm 4: Vehicle to liquid crystal cream (LCC) Twice daily applications arm 5: Aldara cream 3 applications per week
Interventions: intervention 1: Investigational Treatment intervention 2: Active comparator
Intervention descriptions: intervention 1: Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up. intervention 2: Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Protocol documents:
Clinical trial NCT02421211
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic Simeprevir Ledipasvir Sofosbuvir
Sponsor: Janssen Sciences Ireland UC
Start date: 2015-05-19; Completion date: 2016-01-27
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Detailed description:
This is an open-label (all people know the identity of the intervention), 2-panel, Phase 2, randomized (study medication assigned to participants by chance) study. The study will consist of 3 study phases: Screening Phase (5 weeks), an Open-label Treatment Phase (70 days for Panel 1 and 56 days for Panel 2), a Post-treatment Follow-up Phase (12 weeks after the actual end of treatment). Participants will receive a combination of the following treatments: Treatment A: SMV 150 milligram (mg) once daily; Treatment B: LDV 90 mg along with SOF 400 mg once daily; Treatment C: SOF 400 mg once daily. Participants will be randomly assigned to Panel 1 (Treatment AC followed by Treatment AB) and Panel 2 (Treatment B followed by Treatment AB). The total study duration will be approximately 27 weeks for participants in Panel 1 and 25 weeks for participants in Panel 2. Participants will be primarily accessed for pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Arms: arm 1: Participants will receive Simeprevir (SMV) 150 milligram (mg) capsule (Treatment A) along with Sofosbuvir (SOF) 400 mg tablet, orally, once daily (Treatment C) from Day 1 until Day 14 followed by SMV 150 mg capsule (Treatment A) along with fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF (Treatment B), orally, once daily from Day 15 until Day 70. arm 2: Participants will receive FDC tablet of 90 mg LDV/400 mg SOF (Treatment B), orally, once daily from Day 1 until Day 14 followed by SMV 150 mg capsule (Treatment A) along with FDC tablet of 90 mg LDV/400 mg SOF (Treatment B), orally, once daily from Day 15 until Day 56.
Interventions: intervention 1: Simeprevir (SMV) intervention 2: Ledipasvir (LDV) intervention 3: Sofosbuvir (SOF)
Intervention descriptions: intervention 1: Participants will receive 150 milligram (mg) of SMV (Treatment A) once daily in Panel 1 and Panel 2. intervention 2: Participants will receive 90 mg of LDV once daily as FDC tablet with SOF (Treatment B) in Panel 1 and Panel 2. intervention 3: Participants will receive 400 mg of SOF alone (Treatment C) in Panel 1 and as FDC tablet with LDV (Treatment B) once daily in Panel 2.

Protocol documents:
Clinical trial NCT02096705
Conditions: Diabetes
Sponsor: AstraZeneca
Start date: 2014-03-31; Completion date: 2016-01-28
Enrollment: 477 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin arm 2: Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT02171260
Conditions: Pediatrics Solid Tumors
Keywords: Tumors Lymphomas Solid Tumors Pediatric
Sponsor: Eisai Inc.
Start date: 2014-07-31; Completion date: 2016-01-28
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of this regimen in Part A1 (participants greater than or equal to \[\>=\] 12 months and less than \[\<\] 18 years). Part A2 will enroll infants (greater than \[\>\] 6 months and \<12 months) one dose level behind the dose level at which participants in Part A1 are enrolling, in order to maximize safety for infant participants. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.

Detailed description:

Arms: arm 1: Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle. A cycle of therapy is considered to be 21 days. The starting dose for eribulin mesylate will be at 1.1 milligram per square meter (mg/m\^2) (Dose Level 1), which is approximately 80% of the adult MTD, and will be escalated up to no more than 2.2 mg/m\^2.
Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle.

Protocol documents:
Clinical trial NCT01611194
Conditions: Traumatic Brain Injury With Brief Loss of Consciousness Post-Concussion Syndrome
Keywords: HBO2 HBOT mTBI Brain injury PCS PTSD hyperbaric oxygen
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2012-09-11; Completion date: 2016-01-29
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brain injury

Detailed description:
Active duty military personnel and Veterans received for 60-minute daily chamber sessions in which they received HBO2, 1.5 atmospheres absolute (ATA), or sham intervention (1.2 ATA, room air) for post concussion syndrome (PCS).

The study is to provide a rationale for the selection of outcome assessments to serve as primary and secondary endpoints for a pivotal randomized clinical trial of hyperbaric oxygen for the treatment of PCS. The participants will undergo a comprehensive battery of symptom and quality of life assessments. The distribution of response, change in response over time, homogeneity of variance across subgroups, and relationships between outcome measures will be compared by treatment assignment with a cohort from a study of similar design among a normal study population.

Arms: arm 1: Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. arm 2: Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
Interventions: intervention 1: Hyperbaric oxygen (HBO2) at 1.5 atms intervention 2: Sham control 1.2 atms
Intervention descriptions: intervention 1: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week. intervention 2: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Protocol documents:
Clinical trial NCT02413229
Conditions: Plaque Psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2015-04-01; Completion date: 2016-01-29
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Detailed description:
This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Arms: arm 1: DSXS applied once a day for a total of 28 days. arm 2: Placebo (vehicle) applied once a day for a total of 28 days.
Interventions: intervention 1: DSXS1411 intervention 2: Placebo
Intervention descriptions: intervention 1: DSXS (Taro Pharmaceuticals Inc.) intervention 2: Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Protocol documents:
Clinical trial NCT02448368
Conditions: Healthy
Sponsor: Ardea Biosciences, Inc.
Start date: 2015-05-01; Completion date: 2016-01-29
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.

Detailed description:

Arms: arm 1: RDEA3170, 5 mg (FN24), administered in the fasted state. arm 2: RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal). arm 3: RDEA3170, 10 mg (FN25), administered in the fasted state. arm 4: RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal). arm 5: RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. arm 6: RDEA3170, 10 mg (FN26), administered in the fasted state. arm 7: RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal). arm 8: RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
Interventions: intervention 1: RDEA3170,10 mg intervention 2: RDEA3170, 2.5 mg intervention 3: RDEA3170, 5 mg intervention 4: RDEA3170, 10 mg intervention 5: RDEA3170, 2.5 mg
Intervention descriptions: intervention 1: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. intervention 2: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. intervention 3: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. intervention 4: Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9. intervention 5: Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Protocol documents:
Clinical trial NCT02439970
Conditions: Cytomegalovirus Disease
Keywords: kidney transplant allograft recipients
Sponsor: Chimerix
Start date: 2015-09-01; Completion date: 2016-01-30
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor

Detailed description:
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral BCV versus vGCV for the prevention of CMV disease in high-risk kidney transplant allograft recipients, defined as CMV-seronegative recipients (R-) receiving a CMV-seropositive graft (D+). The study comprised a screening evaluation period (up to 14 days posttransplant), a treatment period (up to 28 weeks posttransplant), and a posttreatment follow-up period (24 weeks, through Week 52 posttransplant).

Arms: arm 1: 100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily. arm 2: 900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
Interventions: intervention 1: Brincidofovir intervention 2: Valganciclovir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02143843
Conditions: Primary Open-Angle Glaucoma Ocular Hypertension
Sponsor: ForSight Vision5, Inc.
Start date: 2014-06-05; Completion date: 2016-01-31
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.

Detailed description:

Arms: arm 1: 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.
Interventions: intervention 1: Bimatoprost
Intervention descriptions: intervention 1: Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.

Protocol documents:
Clinical trial NCT02277769
Conditions: Dermatitis, Atopic
Sponsor: Regeneron Pharmaceuticals
Start date: 2014-11-30; Completion date: 2016-01-31
Enrollment: 708 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15. arm 3: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab)
Intervention descriptions: intervention 1: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms. intervention 2: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.

Protocol documents:
Clinical trial NCT02540668
Conditions: Healthy
Sponsor: AstraZeneca
Start date: 2015-09-30; Completion date: 2016-01-31
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with lanabecestat by measuring international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average. Information about any side effects that may occur will also be collected. The study will last about 5 weeks from the first dose to follow-up for each participant.

Detailed description:

Arms: arm 1: Single oral dose of 15 mg warfarin on Day 1. arm 2: Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
Interventions: intervention 1: Lanabecestat intervention 2: Warfarin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02568397
Conditions: Healthy
Sponsor: AstraZeneca
Start date: 2015-10-31; Completion date: 2016-01-31
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.

Detailed description:

Arms: arm 1: Single dose of dabigatran etexilate administered orally. arm 2: Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.
Interventions: intervention 1: Lanabecestat intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents: