ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01582243
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, type 2 vildagliptin
Sponsor: Novartis Pharmaceuticals
Start date: 2013-04-01; Completion date: 2015-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment

Detailed description:

Arms: arm 1: Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Interventions: intervention 1: Vildagliptin
Intervention descriptions: intervention 1: Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Protocol documents:
Clinical trial NCT01588561
Conditions: Nicotine Dependence
Sponsor: Mclean Hospital
Start date: 2005-10-01; Completion date: 2015-09-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study, we sought to explore brain activity in nicotine-dependent men in response to acute intravenous nicotine using pharmacological magnetic resonance imaging (phMRI).

Detailed description:
phMRI was used to evaluate brain activity in response to 1.5 mg/70 kg intravenous nicotine or saline. The nicotine and saline were administered on different visits. The time courses of individual subjects' nicotine levels were used as regressors to assess neural activity relating to the infusions. The influence of Smoking history and physiological measures on the response to nicotine were also investigated.

Arms: arm 1: Participants are given a siingle infusion of nicotine (1.5 mg/70 kg), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans arm 2: Participants are given physiological saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans
Interventions: intervention 1: Intravenous Nicotine intervention 2: Saline - placebo
Intervention descriptions: intervention 1: Subjects received a single infusion of nicotine, 1.5 mg/70kg (New England Compounding Center, Framingham, MA), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans. intervention 2: Subjects received a single infusion of saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.

Protocol documents:
Clinical trial NCT01608295
Conditions: Major Depressive Disorder
Keywords: depressed geriatric older adults antidepressants depression anxious major depressive disorder MDD
Sponsor: University of California, Los Angeles
Start date: 2012-07-01; Completion date: 2015-09-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.

Detailed description:
This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We hope to detect difference in response in primary outcomes (depressed mood) and secondary outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of age or older) with major depression with anticipated 60 completers. This proposed trial will serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and use this project for dose-finding in this population.

Arms: arm 1: After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety. arm 2: After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Interventions: intervention 1: Vilazodone; Viibryd intervention 2: Paroxetine; Paxil
Intervention descriptions: intervention 1: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety. intervention 2: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.

Protocol documents:
Clinical trial NCT01633853
Conditions: Vitamin D Deficiency
Keywords: chronic kidney disease mineral and bone disorder vitamin D2 parathyroid hormone
Sponsor: Dongliang Zhang, MD
Start date: 2012-07-01; Completion date: 2015-09-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.

Detailed description:
This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.

Arms: arm 1: Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. arm 2: Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
Interventions: intervention 1: Vitamin D2 intervention 2: 1,25(OH)2 Vit D3
Intervention descriptions: intervention 1: Treatment with Vit D2. intervention 2: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

Protocol documents:
Clinical trial NCT01645787
Conditions: Spinal Muscular Atrophy
Keywords: Spinal Muscular Atrophy 4-aminopyridine dalfampridine Ampyra
Sponsor: Columbia University
Start date: 2012-06-01; Completion date: 2015-09-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3 compared to placebo and whether the duration of treatment affects outcome.

Detailed description:
Spinal muscular atrophy (SMA) is a genetically determined neuromuscular disorder that results in muscle weakness and impaired functional mobility. Fatigue is a common symptom in SMA with a resultant impact on physical function and quality of life however the precise mechanisms are unknown. At present there is no treatment for SMA. There is evidence that 4-AP improves function in SMA animal models. In patients with multiple sclerosis, 4-AP was found to improve walking ability and diminish fatigue. The purpose of the study is to determine whether treatment with 4-AP is associated with an increase in walking speed and endurance compared to placebo and whether the duration of treatment affects outcome. The study comprises a short term treatment trial in which participants are treated for 2 weeks with 4-AP and placebo in random sequence followed by a long treatment trial of 6 weeks in which patients are also treated with placebo and 4 AP. The primary outcome measure of the clinical study will be the six minute walk test (6MWT), which has been documented to be a valid and sensitive instrument to identify fatigue among ambulatory SMA patients. We will also assess the effect of 4-AP on muscle and nerve electrical function via electromyography (EMG) during the short term trial. Results of this study may provide support for larger clinical trials.

Arms: arm 1: 10 mg tab/ 1 tab twice daily arm 2: Placebo 1 tab /twice daily
Interventions: intervention 1: 4-aminopyridine intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg/twice daily intervention 2: Crossover study involving one trial with sugar pill (placebo)

Protocol documents:
Clinical trial NCT01647711
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2012-07-01; Completion date: 2015-09-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M mutations to a dose of intermittent afatinib established in Part A.

The secondary objective is to explore tumor response and tumor-derived biological markers of response to afatinib, as well as pharmacokinetic parameters of afatinib.

Detailed description:

Arms: arm 1: Establish the Maximal Tolerated Dose of a pulsatile, high-dose regimen of afatinib in patients with advanced solid tumors followed by treatment at that dose or a lower dose in patients with stage IV non-small cell lung cancer harboring EGFR T790M mutations who have progressed on therapy with a reversible tyrosine kinase inhibitor
Interventions: intervention 1: Dose escalation followed by treatment with MTD
Intervention descriptions: intervention 1: Fixed 3+3 dose escalation; expansion of MTD cohort

Protocol documents:
Clinical trial NCT01674062
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-05-01; Completion date: 2015-09-01
Enrollment: 95 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.

Detailed description:

Arms: arm 1: Females with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer will receive dual-agent treatment with pertuzumab and trastuzumab. Trastuzumab will be administered IV as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab will be administered IV at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications will be administered on Day 1 of each 3-week cycle. Treatment will continue for a minimum of 8 cycles and may be extended until disease progression, intolerable toxicity, or death. arm 2: Females with HER2-positive metastatic breast cancer will receive single-agent treatment with pertuzumab. Pertuzumab will be administered IV at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression may have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
Interventions: intervention 1: Pertuzumab intervention 2: Trastuzumab
Intervention descriptions: intervention 1: Loading dose 840 mg IV on Day 2 of Cycle 1, followed by 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity. intervention 2: 2 mg/kg IV once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1 and on Day 1 of each 3-week cycle thereafter until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT01678924
Conditions: Neuralgia, Postherpetic
Sponsor: Allergan
Start date: 2013-01-01; Completion date: 2015-09-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).

Detailed description:

Arms: arm 1: AGN-214868 Dose 1 given as injections into the area of pain on Day 1. arm 2: AGN-214868 Dose 2 given as injections into the area of pain on Day 1. arm 3: AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1. arm 4: AGN-214868 Dose 3 given as injections into the area of pain on Day 1.
Interventions: intervention 1: AGN-214868 intervention 2: AGN-214868 Placebo (Vehicle)
Intervention descriptions: intervention 1: AGN-214868 given as injections into the area of pain on Day 1. intervention 2: AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.

Protocol documents:
Clinical trial NCT01712074
Conditions: Alzheimer's Disease
Keywords: Randomized Double Blind Safety and Efficacy
Sponsor: Pfizer
Start date: 2012-11-01; Completion date: 2015-09-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-05212377 (SAM-760) intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg QD of PF-05212377 (SAM-760) intervention 2: Placebo QD

Protocol documents:
Clinical trial NCT01722045
Conditions: Age - Related Macular Degeneration (AMD)
Keywords: AMD
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-11-01; Completion date: 2015-09-01
Enrollment: 154 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Intravitreal Aflibercept Injection (IAI)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01733680
Conditions: ADHD
Keywords: ADHD executive function emotional self-regulation
Sponsor: State University of New York - Upstate Medical University
Start date: 2012-09-01; Completion date: 2015-09-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are proposing to test a medication derived from our prior studies of the gene SLC9A9. This one gene makes NHE proteins that control how we learn and remember items, which is impaired in ADHD and may cause an inability to plan, prioritize, self-monitor,inhibit, initiate, self-correct, or control one's behavior. The investigators now propose to investigate the therapeutic utility of an NHE inhibitor, amiloride hydrochloride, for the treatment of attention deficit hyperactivity disorder (ADHD) in medication-naïve adults with ADHD.

Detailed description:
Our specific aims and hypotheses are as follows:

Primary Aim: Assess the efficacy and adverse effects of amiloride in medication naive ADHD adults in a placebo controlled study. Hypothesis 1: Amiloride will reduce scores on our primary outcome measure, the Adult Attention-Deficit/Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) and on our secondary outcome, the ADHD specific Clinical Global Impressions (CGI) improvement scale. Hypothesis 2: Amiloride will be well tolerated and will have few side effects in adults with ADHD.

Exploratory Aim 2: Assess effects of amiloride on ADHD-associated clinical features. We will also assess, in an exploratory manner, the effect of amiloride on two clinical features that are not well treated by current ADHD medications: deficits in emotional self-regulation (DESR) and executive function deficit (EFD). Hypothesis 3 predicts that amiloride treatment will reduce symptoms of DESR and of EFD.

We will recruit 40 adults who are diagnosed with ADHD in a double blind placebo controlled study. 20 subjects will receive amiloride hydrochloride and 20 subjects will receive placebo for 8 weeks. Participation in the study requires subjects to meet with the physician for a screening visit, baseline visit and 8 additional weekly visits.

Arms: arm 1: Drug: Subjects will take 5mg qd Amiloride for 2 weeks, 10mg qd Amiloride for 3 weeks, 15 mg qd Amiloride for 3 weeks.

Behavioral: Each week subjects will complete the AISRS, BRIEF-A, and CGI. arm 2: Drug: Subjects will take placebo for 8 weeks Behavioral: Each week subjects will complete questionnaires: AISRS, BRIEF-A, and CGI
Interventions: intervention 1: amiloride intervention 2: Behavioral
Intervention descriptions: intervention 1: Subjects will take either amiloride hydrochloride or placebo for 8 weeks. intervention 2: Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement

Protocol documents:
Clinical trial NCT01734993
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-10-01; Completion date: 2015-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label, single arm, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in disease activity score based on 28-joint count \[DAS28\] of greater than \[\>\] 1.2 points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever occurs first.

Detailed description:

Arms: arm 1: Moderate to severe rheumatoid arthritis participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in DAS28 of \>1.2 points) will continue tocilizumab treatment within this local LTE study for a maximum of 156 weeks, or until SC TCZ becomes commercially available, whichever occurs first.
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: Participants will receive TCZ 162 milligrams (mg) SC injection once a week.

Protocol documents:
Clinical trial NCT01740817
Conditions: Diabetes Obesity
Keywords: diabetes obesity inflammation
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2008-01-01; Completion date: 2015-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether a lipid infusion can up-regulate toll-like receptor 4 (TLR4) signaling in human subjects

Detailed description:
The investigators plan to examine the effect of a lipid infusion on TLR4 expression and insulin sensitivity. A group of 30 subjects aged 18-60 years old, lean (BMI \< 26 kg/m2) normal glucose tolerant subjects without a family history of type 2 diabetes will receive a lipid or saline infusion. The subjects will be randomly assigned to first receive either a 48 hour long lipid or saline infusion. Approximately 4-6 weeks later subjects will return to undergo another study (if, in the first study they received lipid, on the second study they will receive saline, and vice versa). A near-equal number of women and men will be included in each group.

Arms: arm 1: Participants first received lipid infusion of 30ml/h x48h. After a washout period of 4-6 weeks, they then received saline infusion of 30ml/h x48h. arm 2: Participants first received saline infusion of 30ml/h x48h. After a washout period of 4-6 weeks, they then received lipid infusion of 30ml/h x48h.
Interventions: intervention 1: Intralipid 20% intervention 2: Saline
Intervention descriptions: intervention 1: 30 ml/h for 48 h intervention 2: 30 ml/h for 48 h

Protocol documents: