ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01699178
Conditions: Male Hypogonadism
Sponsor: Clarus Therapeutics, Inc.
Start date: 2012-08-01; Completion date: 2014-04-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.

Detailed description:
This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an open-label study. This study contained an arm to evaluate the oral TU formulation as well as a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was included in the Phase III study and in this extension study to allow a general evaluation of comparative safety. Subjects randomized to oral TU in the Phase III study were continued on oral TU in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel therapy. This 2-year period of therapy and assessments was to provide a long-term view of the safety of oral TU and the stability of the T replacement.

Arms: arm 1: Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months. arm 2: Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
Interventions: intervention 1: Oral testosterone undecanoate intervention 2: Transdermal testosterone gel (AndroGel)
Intervention descriptions: intervention 1: Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID intervention 2: Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Protocol documents:
Clinical trial NCT01701401
Conditions: Chronic Hepatitis C Virus
Keywords: HCV genotype 1 (GT-1) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Additional relevant MeSH terms: Hepatitis Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action
Sponsor: Gilead Sciences
Start date: 2012-09-01; Completion date: 2014-04-01
Enrollment: 870 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Detailed description:

Arms: arm 1: LDV/SOF administered for 12 weeks arm 2: LDV/SOF+RBV administered for 12 weeks. arm 3: LDV/SOF administered for 24 weeks arm 4: LDV/SOF+RBV administered for 24 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: LDV/SOF 90/400 mg FDC tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01708902
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2014-04-01
Enrollment: 876 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Detailed description:

Arms: arm 1: patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID arm 2: patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID arm 3: patient to receive a tablet containing metformin 500mg BID arm 4: patient to receive a tablet containing metformin 1000mg BID arm 5: patient to receive a tablet containing linagliptin 5mg once daily
Interventions: intervention 1: linagliptin2.5mg/metformin1000mg intervention 2: linagliptin2.5mg/metformin1000mg intervention 3: linagliptin 5mg intervention 4: Metformin 500mg intervention 5: linagliptin2.5mg/metformin500mg intervention 6: linagliptin2.5mg/metformin500mg intervention 7: linagliptin 5mg intervention 8: Metformin 1000mg
Intervention descriptions: intervention 1: linagliptin2.5mg/metformin1000mg BID intervention 2: linagliptin2.5mg/metformin1000mg BID intervention 3: linagliptin 5mg once daily intervention 4: Metformin 500mg BID intervention 5: linagliptin2.5mg/metformin500mg BID intervention 6: linagliptin2.5mg/metformin500mg BID intervention 7: linagliptin 5mg once daily intervention 8: Metformin 1000mg BID

Protocol documents:
Clinical trial NCT01711918
Conditions: Patients With Gastroparesis Who Have Failed Standard Therapy
Keywords: gastroparesis domperidone nausea vomiting
Sponsor: Ron Schey
Start date: 2012-07-01; Completion date: 2014-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To provide oral domperidone to patients between the ages of 18 and 60 years of age, according to the investigator's judgment, a prokinetic effect is needed for the relief of severe gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal pain. We will recruit patients for two years and the patients will be given domperidone for up to two years.

Detailed description:

Arms: arm 1: Participants will received domperidone at a dose of 10mg given up to three times per day
Interventions: intervention 1: Domperidone
Intervention descriptions: intervention 1: oral tablet; dose is 10mg per tablet given up to 3 times daily.

Protocol documents:
Clinical trial NCT01719757
Conditions: Cancer
Keywords: Targin, Cancer Pain
Sponsor: Mundipharma Korea Ltd
Start date: 2012-07-01; Completion date: 2014-04-01
Enrollment: 359 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.

Detailed description:
An open-label, multi-center, nonrandomized, prospective, non-interventional, observational phase IV trial.

At the first visit, a detailed medical history is taken, including previous analgesics and concomitant treatment. After inclusion, patients enter a 4-week observation period during which they will receive bid of TARGIN 10/5mg and/or 20/10mg. The dose adjustments of TARGIN as well as of analgesic co-medication, rescue-medication and other treatments (e.g. laxatives) can be performed at any time-point during the observation period by the physician in dependence of medical demand. The asymmetric dose is allowed during the observation period by the physician's judgment. (e.g. 10/5 mg in the morning and 20/10 mg in the evening).

Data are gathered using interview-administered questionnaires at baseline (visit 1) and study end (visit 2).

During the observation period, unscheduled visits are allowed after the first visit due to inadequate pain control or occurrence of adverse events.

Arms: arm 1: Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Interventions: intervention 1: Oxycodone/Naloxone
Intervention descriptions: intervention 1: Twice daily

Protocol documents:
Clinical trial NCT01752023
Conditions: Non-small Cell Lung Cancer Metastatic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2013-03-01; Completion date: 2014-04-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Response rates.

Changes in tumor blood flow.

Detailed description:
To determine the objective response rates of cisplatin and gemcitabine with or without SUBATM-itraconazole in patients with chemotherapy-naïve metastatic squamous non-small cell lung cancer.

To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.

Arms: arm 1: SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone. arm 2: Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.
Interventions: intervention 1: Cisplatin + Gemcitabine with SUBATM-itraconazole intervention 2: Cisplatin + Gemcitabine
Intervention descriptions: intervention 1: Experimental Arm intervention 2: Active Comparator

Protocol documents:
Clinical trial NCT01765296
Conditions: Localized Primary Osteoarthritis of Hip Localized Primary Osteoarthritis of Knee
Keywords: COX-1 COX-2 carbonic anhydrase anti-inflammatory Cyclooxygenase Inhibitors Polmacoxib
Sponsor: CrystalGenomics, Inc.
Start date: 2013-03-01; Completion date: 2014-04-01
Enrollment: 362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* 6-week Efficacy Study The objective of this study is to prove the safety and non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The primary efficacy parameter is the difference from Baseline to Week 6 in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale.
* Extended Safety Study The objective of the Extended Safety Study is to collect a total of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data, and an additional 18 weeks of safety data for those subjects who agree on the consent form to continue into the Extended Safety Study. Subjects will be administered CG100649 2 mg only during 18 weeks of Extended Safety Study.

Detailed description:
1. Number of Subjects: 350 (2:2:1 ratio of experimental vs. active comparator vs. placebo comparator)
2. Adverse Events will be coded to preferred term and body system using the Medical Dictionary for Regulatory Activities (MedDRA)

Arms: arm 1: Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase) arm 2: Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase) arm 3: CG100649 2 mg capsule by mouth, once a day for 6 weeks (Treatment Phase); CG100649 2 mg capsule by mouth, once a day for 18 weeks (Safety Phase)
Interventions: intervention 1: CG100649 intervention 2: Celecoxib intervention 3: Placebo
Intervention descriptions: intervention 1: 2 mg capsule intervention 2: 200 mg capsule intervention 3: Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule

Protocol documents:
Clinical trial NCT01767103
Conditions: Hepatic Impairment
Keywords: Hepatic Impairment Liver Impairment Liver Disease Ferriprox® LI DFP Deferiprone
Sponsor: ApoPharma
Start date: 2013-01-01; Completion date: 2014-04-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Detailed description:
Post-marketing study to evaluate the effect of impaired hepatic function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild and moderate hepatic impairment as compared to healthy volunteers.

Arms: arm 1: Healthy volunteers with normal hepatic function received a single 33 mg/kg dose of Ferriprox®. arm 2: Subjects with mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points received a single 33 mg/kg dose of Ferriprox®. arm 3: Subjects with moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points received a single 33 mg/kg dose of Ferriprox®.
Interventions: intervention 1: Ferriprox®
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01767987
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome ACS Percutaneous Coronary Intervention PCI Ranolazine Coronary Angiogram Cardioprotectant
Sponsor: Harvey Hahn
Start date: 2012-11-01; Completion date: 2014-04-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).

Detailed description:
Ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. Furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (PCI).

We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above (i.e. precondition the myocardium). We plan to screen all patients scheduled for an elective coronary angiogram. Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI.

Arms: arm 1: Oral treatment Intervention: Drug: Ranolazine 1000 mg arm 2: Oral treatment Intervention: Drug: Placebo
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI intervention 2: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI

Protocol documents:
Clinical trial NCT01784666
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder Depression Lithium Valproate Isradipine
Sponsor: Massachusetts General Hospital
Start date: 2013-02-01; Completion date: 2014-04-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an "add-on" to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.

Detailed description:
Primary Aim: To estimate the antidepressant efficacy of isradipine versus placebo as an adjunct to lithium, valproate, and/or other atypical antipsychotics among individuals with bipolar I disorder in a nonpsychotic major depressive episode.

Hypothesis: Isradipine will be superior to placebo in improvement of depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).

Arms: arm 1: Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks) arm 2: Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks arm 3: Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks
Interventions: intervention 1: Isradipine intervention 2: Placebo
Intervention descriptions: intervention 1: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. intervention 2: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Protocol documents:
Clinical trial NCT01786902
Conditions: Idiopathic Short Stature
Keywords: growth hormone
Sponsor: Dong-A ST Co., Ltd.
Start date: 2012-02-01; Completion date: 2014-04-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.

Detailed description:

Arms: arm 1: 1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week) arm 2: Height be measured with no treatment
Interventions: intervention 1: DA-3002
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01807923
Conditions: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2013-05-01; Completion date: 2014-04-01
Enrollment: 559 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Detailed description:
This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter study of orally administered lumacaftor in combination with ivacaftor in participants aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.

The study included a Screening Period (Day -28 through Day -1), a Treatment Period (Day 1 \[first dose of study drug\] to Week 24 ± 5 days), and a Safety Follow-up Visit (4 weeks ± 7 days after the Week 24 Visit).

Arms: arm 1: Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24. arm 2: LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24. arm 3: LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
Interventions: intervention 1: Lumacaftor Plus Ivacaftor Combination intervention 2: Ivacaftor intervention 3: Placebo
Intervention descriptions: intervention 1: Fixed dose combination tablet intervention 2: Film-coated tablet intervention 3: Matching placebo tablet

Protocol documents:
Clinical trial NCT01807949
Conditions: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2013-04-01; Completion date: 2014-04-01
Enrollment: 563 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Detailed description:
This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter study of orally administered lumacaftor in combination with ivacaftor in participants aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.

The study included a Screening Period (Day -28 through Day -1), a Treatment Period (Day 1 \[first dose of study drug\] to Week 24 ± 5 days), and a Safety Follow-up Visit (4 weeks ± 7 days after the Week 24 Visit).

Arms: arm 1: Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24. arm 2: LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24. arm 3: LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
Interventions: intervention 1: Placebo intervention 2: Lumacaftor Plus Ivacaftor Combination intervention 3: Ivacaftor
Intervention descriptions: intervention 1: Matching placebo tablet intervention 2: Fixed dose combination tablet intervention 3: Film-coated tablet

Protocol documents:
Clinical trial NCT01828515
Conditions: Memory Impairment
Sponsor: University of Texas Southwestern Medical Center
Start date: 2012-12-01; Completion date: 2014-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine whether vilazodone attenuates the memory and mood effects of corticosteroids on the human hippocampus in 24 healthy controls.

Detailed description:
In animals and humans, stress and corticosteroid excess are associated with changes in hippocampal structure and functioning. These findings have important implications to the millions of patients taking prescription corticosteroids and to patients with major depressive disorder or bipolar disorder who have elevated cortisol levels and memory impairment. The investigators believe that vilazodone may be a medication that can block the effects of hydrocortisone on the human hippocampus. The investigators propose to examine whether vilazodone attenuates the effects of corticosteroids in a randomized, double-blind, placebo-controlled pilot study using a within-subject crossover design.

Arms: arm 1: Vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days) and hydrocortisone 160 mg x 4 days (days 16-19) following vilazodone pre-treatment. After a 23 day medication washout the procedure will be repeated using placebo daily for 19 days and hydrocortisone 160 mg x 4 days (days 16-19) following placebo pre-treatment. arm 2: Placebo daily for 19 days and hydrocortisone 160 mg x 4 days (days 16-19) following placebo pre-treatment. After a 23 day medication washout the procedure will be repeated using Vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days) and hydrocortisone 160 mg x 4 days (days 16-19) following vilazodone pre-treatment.
Interventions: intervention 1: Vilazodone intervention 2: Placebo intervention 3: Hydrocortisone
Intervention descriptions: intervention 1: Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days. intervention 2: None intervention 3: Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment

Protocol documents: