ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02040298
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: University of California, San Francisco
Start date: 2014-01-01; Completion date: 2016-04-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to assess clemastine as a remyelinating agent in patients with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with multiple sclerosis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. The study will also assess the robustness and stability of this clinical effect in patients taking clemastine for up to 3 months. Patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.

Detailed description:

Arms: arm 1: 4mg clemastine twice daily for first 3 months -- crossover -- equivalent quantity/frequency of placebo for last 2 months arm 2: Placebo for first 3 months -- crossover -- 4mg clemastine twice daily for last 2 months.
Interventions: intervention 1: Clemastine intervention 2: Placebo
Intervention descriptions: intervention 1: 4mg tablet twice daily intervention 2: Placebo tablet twice daily

Protocol documents:
Clinical trial NCT02067611
Conditions: Osteoarthritis of the Knee
Keywords: Phase 2, Efficacy, Safety, Osteoarthritis
Sponsor: Lina Xu
Start date: 2014-02-01; Completion date: 2016-04-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.

Objectives of the study:

1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee;
2. To assess the safety and tolerability of multiple doses of X0002 when administered as a topical spray.

Detailed description:
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.

After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo):

Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ; Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID (approximately every 12 hours; n=25) .

Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.

Arms: arm 1: low dose, BID;middle dose, BID, or high dose, BID. arm 2: low dose, BID; middle dose, BID, or high dose, BID.
Interventions: intervention 1: X0002 intervention 2: Placebo
Intervention descriptions: intervention 1: Parallel Assignment intervention 2: Parallel Assignment

Protocol documents:
Clinical trial NCT02079805
Conditions: Essential Hypertension Complicated by Type 2 Diabetes Mellitus
Sponsor: Takeda
Start date: 2014-06-01; Completion date: 2016-04-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus

Detailed description:
The primary objective of the present study is to explore the effects of azilsartan 20 mg, compared with telmisartan 40 mg, once daily orally for 12 weeks on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus.

Arms: arm 1: Participants will receive azilsartan 20 mg once daily in the morning before or after breakfast. arm 2: Participants will receive telmisartan 40 mg once daily in the morning before or after breakfast.
Interventions: intervention 1: Azilsartan intervention 2: Telmisartan
Intervention descriptions: intervention 1: Azilsartan tablets intervention 2: Telmisartan tablets

Protocol documents:
Clinical trial NCT02091986
Conditions: Asthma
Keywords: asthma, children, budesonide pMDI
Sponsor: AstraZeneca
Start date: 2014-04-01; Completion date: 2016-04-01
Enrollment: 882 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.

Detailed description:
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma

Arms: arm 1: Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily arm 2: Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily arm 3: Budesonide pMDI 80µg, 2 acuations twice daily
Interventions: intervention 1: Symbicort pMDI intervention 2: Symbicort pMDI intervention 3: Budesonide pMDI
Intervention descriptions: intervention 1: Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily intervention 2: Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily intervention 3: Budesonide pMDI 80µg, 2 acuations twice daily

Protocol documents:
Clinical trial NCT02100007
Conditions: Solid Tumors
Keywords: solid tumors relapsed advanced metastatic small cell lung cancer ovarian cancer refractory
Sponsor: MEI Pharma, Inc.
Start date: 2014-04-01; Completion date: 2016-04-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors

Detailed description:

Arms: arm 1: ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle
Interventions: intervention 1: ME-344 intervention 2: Topotecan
Intervention descriptions: intervention 1: Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.

Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. intervention 2: Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.

Protocol documents:
Clinical trial NCT02115828
Conditions: Prostate Cancer
Keywords: Vismodegib Metastatic Castration-Resistant Prostate Cancer Accessible Metastatic Lesions for Tumor Biopsy
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2014-04-01; Completion date: 2016-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm pharmacodynamic study with mandatory metastatic tumor biopsies in men with castration-resistant prostate cancer.

The trial will evaluate the effect of vismodegib on tumor tissue in men with metastatic CRPC by obtaining tumor biopsies at baseline and after 4 weeks of treatment with vismodegib.

Detailed description:
The study will enroll 10 evaluable patients. Patients will receive a 30-day supply of 150 mg of vismodegib on day one of each cycle daily by mouth, beginning on Day 1, and continuously until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib or withdrawal from the study.

Tumor biopsies (nodal or visceral), skin biopsies, and CTCs will be obtained at baseline and after 4 weeks of treatment. PSA evaluations will be conducted every 4 weeks, imaging assessments (CT and Bone scan) will be conducted every 12 weeks and routine labs (blood counts and chemistry panel) will be conducted every 4 weeks.

The investigator's intent is to examine the fold change in GLI1 expression in each man following exposure to drug (comparing pre-treatment and on-treatment core biopsy samples). As secondary endpoints, the investigator will also explore clinical response (PSA responses, progression-free survival \[PFS\], radiographic responses), safety, and will examine changes from baseline in Gli2, PTCH1, and AKT1 mRNA levels by qRT-PCR, in situ GLI1 expression in tissue sections by mRNA in situ hybridization, and GLI1 expression in isolated circulating tumor cells (CTCs).

Arms: arm 1: Vismodegib Treatment arm will receive Vismodegib by mouth 150 mg daily up to 1 year.
Interventions: intervention 1: Vismodegib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02141620
Conditions: Cocaine Abuse Cocaine Dependence
Sponsor: University of Kentucky
Start date: 2014-05-01; Completion date: 2016-04-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and n-acetylcysteine.

Detailed description:

Arms: arm 1: Subjects will be maintained on oral placebo. arm 2: Subjects will be maintained on oral n-acetylcysteine.
Interventions: intervention 1: Cocaine intervention 2: n-Acetylcysteine intervention 3: Placebo
Intervention descriptions: intervention 1: The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine. intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02146833
Conditions: Prostate Cancer
Keywords: castrate-resistant prostate cancer prostate cancer Karyopharm KPT-330 selinexor
Sponsor: Karyopharm Therapeutics Inc
Start date: 2014-05-01; Completion date: 2016-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, Phase 2 clinical study of the oral Selective Inhibitor of Nuclear Export (SINE) selinexor (KPT-330) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description:
This is a Phase 2, open-label study to explore the effect of selinexor (KPT-330) therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Approximately 50 patients are planned for enrollment. Patients will receive an oral dose of selinexor on one of three dosing schedules.

Arms: arm 1: 80 mg twice weekly for 4 weeks (8 doses per 28-day cycle) arm 2: 80 mg once weekly for 4 weeks (4 doses per 28-day cycle) arm 3: 60 mg twice weekly for 2 weeks, then 1 week off (4 doses per 21-day cycle)
Interventions: intervention 1: Selinexor
Intervention descriptions: intervention 1: Comparison of different dosages and dosing schedules of drug.

Protocol documents:
Clinical trial NCT02153398
Conditions: Gastric Ulcer (GU) Duodenal Ulcer (DU) Anastomotic Ulcer (AU) Non-erosive Reflux Esophagitis Disease (NERD) Reflux Esophagitis (RE) Zollinger-Ellison Syndrome
Keywords: Gastric ulcer (GU) Duodenal ulcer (DU) Anastomotic ulcer (AU) Non-erosive reflux esophagitis disease (NERD) Reflux esophagitis (RE) Zollinger-Ellison syndrome
Sponsor: AstraZeneca
Start date: 2014-06-01; Completion date: 2016-04-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.

Detailed description:

Arms: arm 1: Age: ≥1 year Weight: \<20 kg arm 2: Age: ≥1 year to 11years Weight: ≥20 kg arm 3: Age: ≥1 year to 11years Weight: ≥20 kg arm 4: Age: 12 to 14 years Weight: ≥20 kg arm 5: Age: 12 to 14 years Weight: ≥20 kg
Interventions: intervention 1: D961H sachet 10 mg intervention 2: D961H capsule 10mg intervention 3: D961H capsule 20 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02158273
Conditions: Alcoholism
Keywords: Alcohol Relapse
Sponsor: The Scripps Research Institute
Start date: 2014-05-01; Completion date: 2016-04-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypotheses under test are that alcohol dependent subjects treated with fenofibrate will report decreased craving for alcohol following cue-exposure in the laboratory and report less drinking post treatment relative to placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sugar Pill intervention 2: TRICOR (fenofibrate)
Intervention descriptions: intervention 1: 145 mg/day, oral pill, 9 days intervention 2: 145 mg/day, oral pill, 9 days

Protocol documents:
Clinical trial NCT02159859
Conditions: End Stage Renal Disease
Keywords: ertapenem pharmacokinetic pharmacodynamics hemodialysis requires hemodialysis three times a week
Sponsor: William Beaumont Hospitals
Start date: 2014-12-01; Completion date: 2016-04-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

Detailed description:
After a hemodialysis session, subject will be administered ertapenem and the amount of ertapenem in the blood will be measured at seven time periods before the initiation of the next hemodialysis session.

Arms: arm 1: Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session
Interventions: intervention 1: Ertapenem
Intervention descriptions: intervention 1: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn

Protocol documents:
Clinical trial NCT02159976
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Sponsor: Seoul National University Bundang Hospital
Start date: 2014-07-01; Completion date: 2016-04-01
Enrollment: 390 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Detailed description:
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.

In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.

Arms: arm 1: pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) arm 2: pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Interventions: intervention 1: Pantoprazole intervention 2: Amoxicillin intervention 3: Clarithromycin intervention 4: Metronidazole intervention 5: Tetracycline intervention 6: Bismuth
Intervention descriptions: intervention 1: Pantoprazole 40mg bid intervention 2: Amoxicillin 1000mg bid intervention 3: Clarithromycin 500mg bid intervention 4: Metronidazole 500mg tid intervention 5: Tetracycline 1000mg bid intervention 6: Bismuth 600mg bid

Protocol documents:
Clinical trial NCT02162758
Conditions: Barrett's Esophagus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-07-01; Completion date: 2016-04-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).

Detailed description:
The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) with RFA. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Dexlansoprazole 60 mg once a day and placebo (this is a capsule that looks like the study drug but has no active ingredient) once a day
* Dexlansoprazole 60 mg twice a day.

All participants will be asked to take one capsule twice a day at the same time each day throughout the study.

This randomized, double-blind, multi-center, parallel group trial will be conducted in North America. The overall time to participate in this study is up to 13 months. Participants will make 5 visits to the clinic, and will undergo a safety follow-up assessment 30 days after the last dose of study drug.

Arms: arm 1: Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months. arm 2: Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months.
Interventions: intervention 1: Dexlansoprazole intervention 2: Dexlansoprazole Placebo
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release capsules intervention 2: Dexlansoprazole placebo-matching capsules

Protocol documents:
Clinical trial NCT02194933
Conditions: Schizophrenia With Impulsivity
Keywords: Schizophrenia Mental Disorders, Antipsychotic, Psychotic disorder, Impulsivity
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2015-02-01; Completion date: 2016-04-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by impulsive behavior.

Detailed description:

Arms: arm 1: Brexpiprazole 2 mg/day, once daily dose, tablet, orally arm 2: Brexpiprazole 4 mg/day, once daily dose, tablet, orally
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks

Protocol documents:
Clinical trial NCT02208310
Conditions: Crohn's Disease Vitamin D Deficiency
Keywords: Crohn's disease Vitamin D deficiency
Sponsor: University of Michigan
Start date: 2015-04-01; Completion date: 2016-04-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels are less likely to undergo surgeries and have better control of their disease. We intend to study the effects of high dose vitamin D supplementation in patients with vitamin D deficiency and Crohn's disease. We hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.

Detailed description:
Subjects are randomized to low or high dose vitamin D, and outcomes including steroid prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified Harvey-Bradshaw Index are measured.

Arms: arm 1: Patients will be given 400 IU cholecalciferol once daily for 30 days. \<-THIS IS THE Active Comparator Intervention. To maintain the blind, a random few will be given another round at the 30 day mark. For patients who enroll in the summer, a random few will again receive 400 IU cholecalciferol in March. arm 2: Patients will be given cholecalciferol 10,000 IU daily for 30 days. \<-THIS IS THE INTERVENTION. At that point, if their vitamin D levels remain below 50 ng/ml, the 30 day course will be repeated. For patients who enroll in the summer, levels will be rechecked in March and if \<50 ng/ml, a 30 day course will be administered.
Interventions: intervention 1: Cholecalciferol 10,000 IU intervention 2: Cholecalciferol 400 IU
Intervention descriptions: intervention 1: Cholecalciferol 10,000 IU po daily intervention 2: Cholecalciferol 400 IU po daily

Protocol documents: