ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02158546
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Alkermes ALKS 5461 Samidorphan
Sponsor: Alkermes, Inc.
Start date: 2014-05-01; Completion date: 2015-12-01
Enrollment: 447 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ALKS 5461.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALKS 5461 intervention 2: Placebo
Intervention descriptions: intervention 1: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) intervention 2: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Protocol documents:
Clinical trial NCT02159729
Conditions: Submental Fat Healthy
Sponsor: Kythera Biopharmaceuticals
Start date: 2009-02-01; Completion date: 2015-12-01
Enrollment: 205 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Detailed description:
No study medication was administered in this study.

Arms: arm 1: Participants treated with placebo in previous ATX-101 studies arm 2: Participants treated with ATX-101 (1 mg/cm\^2) in previous phase 2 studies arm 3: Participants treated with ATX-101 (2 mg/cm\^2) in previous phase 2 studies arm 4: Participants treated with ATX-101 (4 mg/cm\^2) in previous phase 2 studies
Interventions: intervention 1: Placebo intervention 2: ATX-101 (1 mg/cm^2) intervention 3: ATX-101 (2 mg/cm^2) intervention 4: ATX-101 (4 mg/cm^2)
Intervention descriptions: intervention 1: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events intervention 2: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events intervention 3: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events intervention 4: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

Protocol documents:
Clinical trial NCT02168803
Conditions: Dyslipidemia
Keywords: abnormal cholesterol
Sponsor: Eli Lilly and Company
Start date: 2014-05-01; Completion date: 2015-12-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.

This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.

Detailed description:

Arms: arm 1: Single oral dose of evacetrapib on Day 1 arm 2: Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks arm 3: Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks arm 4: Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
Interventions: intervention 1: Evacetrapib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02181504
Conditions: Macular Degeneration
Sponsor: Allergan
Start date: 2014-09-01; Completion date: 2015-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Detailed description:

Arms: arm 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. arm 2: Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. arm 3: Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Interventions: intervention 1: abicipar pegol intervention 2: ranibizumab intervention 3: sham procedure
Intervention descriptions: intervention 1: Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8. intervention 2: Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. intervention 3: Sham procedure to the study eye at weeks 12 and 16.

Protocol documents:
Clinical trial NCT02199964
Conditions: Dry Eye
Keywords: Dry eye environmental stress artificial tears cyclosporin Restasis
Sponsor: Baylor College of Medicine
Start date: 2014-03-01; Completion date: 2015-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test that hypothesis that topical administration of the FDA approved immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface disease that results from a short term low humidity environmental stress

Detailed description:
This is a pilot study designed to evaluate the effect of two conventional dry eye therapies, artificial tears to hydrate and cyclosporine A as an anti-inflammatory, on the irritation symptoms and ocular surface disease of dry eye patients who will be exposed to a low humidity environment for 90 minutes. Patients with dry eye will be enrolled in this study and complete a validated symptom questionnaire and then undergo a complete ocular surface and tear examination to characterize their disease. Enrolled subjects will be exposed to a low humidity environment at the initial evaluation prior to any treatment and will be exposed to a low humidity environment for a second time. They will be randomized to receive either artificial tears or 0.05% cyclosporine A emulsion drop four times a day for 6 weeks.

Arms: arm 1: used in the eye 4 times a day arm 2: Over the Counter artificial tears used in the eye 4 times a day
Interventions: intervention 1: Cyclosporin 0.05% emulsion intervention 2: Endura, Refresh artificial tears
Intervention descriptions: intervention 1: Topical therapy for dry eye intervention 2: Over the counter therapy for dry eye, used 4 times a day

Protocol documents:
Clinical trial NCT02213900
Conditions: Delirium Cognitive Impairment Post-traumatic Stress Disorder Depression Anxiety
Keywords: delirium confusion surgery cognitive Impairment post-traumatic Stress disorder depression anxiety
Sponsor: Indiana University
Start date: 2013-09-01; Completion date: 2015-12-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effectiveness of a preventative low-dose of Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or thoracotomy.

Delirium is state of severe confusion and some symptoms include:

* Cannot think clearly
* Have trouble paying attention
* Have a hard time understanding what is going on around them
* May see or hear things that are not there. These things seem very real to them.

Detailed description:
50% of patients who undergo esophageal and/or lung resection suffer from acute brain dysfunction or delirium postoperatively. Delirium is a state of brain failure characterized by disturbance of consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. Presence of delirium in the post-operative phase is associated with a longer length of both intensive care unit and hospital stay, increased health-care costs, long-term functional and cognitive decline, and an increased risk of in-hospital and post-discharge mortality.

Haloperidol primarily acts by blocking dopamine (D2) receptors. This dopamine blockade in the cerebral cortex improves cognition and reduces delirium. Along with the dopamine blockade, haloperidol has anti-inflammatory properties. It inhibits production of lipopolysaccharide induced pro-inflammatory cytokines, interleukin (IL-1) and tumor necrosis factor alpha (TNF-α). Haloperidol also increases levels of Interleukin -1 receptor antagonist (IL-1RA), an anti-inflammatory cytokine that blocks the action of other pro-inflammatory cytokines. If unchecked, the inflammatory cytokines cause impaired concentration, sleep disturbances, and agitation the cardinal symptoms of delirium; and induce a reduction in cholinergic activity. Given the inhibitory effect of acetylcholine on certain cytokines such as interleukin-6, a repetitive cycle of inadequate regulation of inflammation due to cholinergic depletion ensues. Haloperidol with its anti-inflammatory properties seeks to mitigate this repetitive vicious cycle.

Arms: arm 1: Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days. arm 2: Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.
Interventions: intervention 1: Haloperidol intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days intervention 2: None

Protocol documents:
Clinical trial NCT02216422
Conditions: Chronic Hepatitis C Virus (HCV) Infection
Keywords: Chronic Hepatitis C Hepatitis C Hepatitis C Virus Hepatitis C Genotype 1b Interferon-Free
Sponsor: AbbVie
Start date: 2014-09-01; Completion date: 2015-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

Detailed description:
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.

Arms: arm 1: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
Interventions: intervention 1: Ombitasvir/Paritaprevir/Ritonavir intervention 2: Dasabuvir intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir intervention 2: Tablet intervention 3: Tablet

Protocol documents:
Clinical trial NCT02227875
Conditions: Type 2 Diabetes
Sponsor: Mylan Inc.
Start date: 2014-08-01; Completion date: 2015-12-01
Enrollment: 560 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks

Detailed description:
This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.

Arms: arm 1: receive Mylan's insulin Glargine arm 2: receive Lantus®
Interventions: intervention 1: Mylan's insulin glargine intervention 2: Lantus®
Intervention descriptions: intervention 1: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential. intervention 2: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Protocol documents:
Clinical trial NCT02233647
Conditions: Cocaine Use Disorder
Keywords: cocaine phendimetrazine pharmacotherapy
Sponsor: William Stoops
Start date: 2014-09-01; Completion date: 2015-12-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.

Detailed description:

Arms: arm 1: Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. arm 2: Subjects will be maintained on the low phendimetrazine dose. Cocaine will be administered acutely during low dose phendimetrazine maintenance.

Placebo will be administered acutely during low dose phendimetrazine maintenance. arm 3: Subjects will be maintained on the intermediate phendimetrazine dose. Cocaine will be administered acutely during intermediate dose phendimetrazine maintenance.

Placebo will be administered acutely during intermediate dose phendimetrazine maintenance. arm 4: Subjects will be maintained on the high phendimetrazine dose. Cocaine will be administered acutely during high dose phendimetrazine maintenance.

Placebo will be administered acutely during high dose phendimetrazine maintenance.
Interventions: intervention 1: Cocaine intervention 2: Placebo
Intervention descriptions: intervention 1: The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine. intervention 2: The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.

Protocol documents:
Clinical trial NCT02238379
Conditions: Social Perception
Keywords: Intranasal oxytocin Social perception EEG/ERP
Sponsor: Yale University
Start date: 2014-09-01; Completion date: 2015-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed. In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses. Brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).

Detailed description:

Arms: arm 1: Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. arm 2: Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: 24 International Units of Oxytocin in a Nasal Spray intervention 2: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.

Protocol documents:
Clinical trial NCT02250807
Conditions: Chronic Hepatitis C Genotype 4 Chronic Hepatitis C
Keywords: Chronic hepatitis C Genotype 4 chronic hepatitis C Simeprevir Sofosbuvir
Sponsor: Janssen R&D Ireland
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.

Detailed description:
This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period (until 24 weeks after end of treatment). The duration of the subjects' participation will be approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at Week 12 after the end of treatment. Subjects' safety will be monitored throughout the study.

Arms: arm 1: Subjects will receive oral capsule of Simeprevir 150 milligram (mg) along with oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.
Interventions: intervention 1: Simeprevir intervention 2: Sofosbuvir
Intervention descriptions: intervention 1: Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12. intervention 2: Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.

Protocol documents:
Clinical trial NCT02260635
Conditions: Hypercholesterolemia
Sponsor: Eli Lilly and Company
Start date: 2014-11-01; Completion date: 2015-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind treatment period will last for 12 weeks and the open-label extension period will last for an additional 40 weeks.

Detailed description:

Arms: arm 1: 130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12. arm 2: Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Interventions: intervention 1: Evacetrapib intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02262078
Conditions: Heart Failure
Keywords: Preserved Ejection Fraction
Sponsor: Mayo Clinic
Start date: 2014-10-01; Completion date: 2015-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.

Detailed description:
Patients referred to the cardiac catheterization laboratory for invasive exercise stress testing will be prospectively recruited. Standard right heart catheterization using high fidelity micromanometers (Millar Instruments) will be performed at rest and during supine exercise with simultaneous expired gas analysis (Medgraphics) as is the investigator's current practice. The protocol is rest-passive leg elevation--20 Watts exercise x 5 minutes, and then graded workload increases in 10Watt increments (3 minute stages) to exhaustion. Hemodynamic, arterial and mixed venous blood gas and expired gas data are acquired at rest, during each exercise stage and at peak exercise. Venous blood samples will be obtained at rest and at peak exercise. Perceived symptoms of dyspnea and fatigue will be quantified using the Borg dyspnea and effort scores at each stage of exercise.

After the initial exercise study and hemodynamics have returned to baseline, previously prepared study drug (normal saline placebo or Sodium Nitrite Inhalation Solution (AIR001) 90mg placed into the medication chamber) will be nebulized utilizing the Aerogen Solo-Idehaler over 10-15 minutes. After a 15 minute observation period post completion of nebulization, resting hemodynamic and expired gas data will be acquired exactly as in the initial run. Subjects will then repeat the leg elevation-20 Watt x 5 minutes exercise phase. Blood samples will be again obtained at rest and with exercise. Subjects will repeat exercise only at the 20 Watt stage, rather repeating the entire study. This is done to increase the feasibility and shorten the time of the case. The investigators have previously observed that the vast majority (\>85%) of the elevation in cardiac filling pressures and reduction in venous oxygen content in people with HFpEF occurs at the low 20 Watt workload, so repeating exercise hemodynamic assessment at this load should be sufficient to detect any clinically meaningful treatment effect.

Arms: arm 1: Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer arm 2: Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer
Interventions: intervention 1: Sodium Nitrite Inhalation Solution intervention 2: Placebo
Intervention descriptions: intervention 1: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise. intervention 2: Normal saline will be administered (by inhalation) to participants prior to exercise.

Protocol documents: