ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01823146
Conditions: Aging
Keywords: oxytocin socioemotional functioning trust amygdala aging
Sponsor: University of Florida
Start date: 2013-07-01; Completion date: 2014-09-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the body and the brain and has been shown to be relevant for many behaviors, particularly in social situations. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.

Detailed description:
In order to demonstrate oxytocin as a causal mechanism in socioemotional aging, the investigators propose to temporarily elevate oxytocin levels and then measure activity in the brain while participants engage in socially relevant tasks. Participants in this study will be randomly assigned (much like flipping a coin) to receive either a single administration of oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active drug). Neither participants nor the investigator will know to which condition each participant is assigned. Prior to being enrolled into the study a screening to determine eligibility will be conducted. Once the screening visit is completed and it has been determined that subjects can be randomized into the study, an appointment will be scheduled for the full study visit.

The purpose of the screening is to determine whether the individual is eligible for participation in the study and will consist of a series of questions about demographics and health history, two saliva samples, two short tasks, blood test, and brief meeting with a licensed clinician to ensure that it is safe for the individual to take part in the magnetic resonance imaging (MRI) and drug administration.

The study visit will comprise two collections of saliva for laboratory tests prior to and following the oxytocin administration in order to measure levels of the hormone in the body at baseline and after the spray. Saliva samples will also allow for an examination of how oxytocin-related genes may impact cognition and behavior during study tasks. Participants will work on various social tasks while in the MRI scanner, and response accuracy, response time, and brain activity will be recorded. After the scan, participants will complete a series of brief questionnaires on paper and on the computer.

Arms: arm 1: single dose of 24 IU oxytocin, self-administered intranasally (IN) arm 2: single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)
Interventions: intervention 1: Oxytocin spray intervention 2: Placebo spray
Intervention descriptions: intervention 1: single dose of 24 IU oxytocin, self-administered intranasally (IN) intervention 2: single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)

Protocol documents:
Clinical trial NCT01831466
Conditions: Psoriasis Vulgaris Psoriasis
Keywords: plaque psoriasis vulgaris topical treatment skin diseases papulosquamous Tofacitinib CP-690550 Xeljanz psoriasis moderate severe itch nail psoriasis
Sponsor: Pfizer
Start date: 2013-05-01; Completion date: 2014-09-01
Enrollment: 476 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: tofacitinib ointment 20 mg/g intervention 2: tofacitinib ointment 10 mg/g intervention 3: placebo ointment (vehicle) intervention 4: tofacitinib ointment 20 mg/g intervention 5: tofacitinib ointment 10 mg/g intervention 6: placebo ointment (vehicle)
Intervention descriptions: intervention 1: tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks intervention 2: tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks intervention 3: placebo ointment (vehicle) BID (twice daily) for 12 weeks intervention 4: tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks intervention 5: tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks intervention 6: placebo ointment (vehicle) QD (once daily) for 12 weeks

Protocol documents:
Clinical trial NCT01833130
Conditions: Chronic Migraine
Sponsor: Allergan
Start date: 2013-04-01; Completion date: 2014-09-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

Detailed description:

Arms: arm 1: OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. arm 2: Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Interventions: intervention 1: OnabotulinumtoxinA intervention 2: Normal saline (placebo)
Intervention descriptions: intervention 1: OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12. intervention 2: Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.

Protocol documents:
Clinical trial NCT01833533
Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Hepatitis C Virus Hepatitis C Genotype 1a Hepatitis C Treatment-Naïve Interferon-Free Paritaprevir Ombitasvir Dasabuvir Ribavirin Viekira PAK
Sponsor: AbbVie
Start date: 2013-03-01; Completion date: 2014-09-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.

Detailed description:
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection.

Arms: arm 1: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks arm 2: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Placebo for Ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Capsule intervention 3: Capsule

Protocol documents:
Clinical trial NCT01859988
Conditions: Atopic Dermatitis
Keywords: Eczema
Sponsor: Regeneron Pharmaceuticals
Start date: 2013-05-01; Completion date: 2014-09-01
Enrollment: 380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15. arm 3: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15. arm 4: Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. arm 5: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15. arm 6: Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
Interventions: intervention 1: Dupilumab intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01879735
Conditions: Cholestasis Primary Sclerosing Cholangitis Primary Biliary Cirrhosis
Sponsor: University of Aarhus
Start date: 2013-06-01; Completion date: 2014-09-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.

Detailed description:
The purpose of the study is the development of PET/CT protocols using 11C-CSar for human use. PET/CT methods developed in the pig studies are translated to studies in healthy humans and patients with cholestatic disorders. Dynamic PET/CT scans of the liver and biliary system are combined with measurements of tracer concentrations in a radial artery and a liver vein and measurements of hepatic blood flow by intravenous infusion of indocyanine green (ICG)/Ficks principle. Kinetic parameters from PET/CT measurements and invasive measurements are compared for validation of the PET estimated parameters and refinement of the PET modeling, if required.

Arms: arm 1: Examine the effect of ICG on the kinetics of the hepatic transport of 11C-CSar. If no effect is seen on the kinetics, ICG will be used during the "infusion method" experiments. arm 2: Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. If ICG does not affect the kinetics of 11C-CSar it will be used during these experiments to calculate hepatic blood flow.
Interventions: intervention 1: 11C-CSar intervention 2: ICG
Intervention descriptions: intervention 1: PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids. intervention 2: Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.

Protocol documents:
Clinical trial NCT01889251
Conditions: Symptomatic Vitreomacular Adhesion
Keywords: Vitreomacular Adhesion Vitreomacular Traction Vitreomacular Traction Syndrome Vitrectomy Central Visual Field Defect Blind Spot Intravitreal Injection Macula Retina Decreased Visual Acuity Visual Complaint SD-OCT Macular Hole
Sponsor: Alcon Research
Start date: 2013-07-01; Completion date: 2014-09-01
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.

Detailed description:

Arms: arm 1: Ocriplasmin administered as a single intravitreal injection to the study eye at baseline arm 2: Single sham injection to the study eye at baseline
Interventions: intervention 1: Ocriplasmin intervention 2: Sham injection
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01903265
Conditions: Primary Fibromyalgia
Keywords: pain sleep
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2013-09-01; Completion date: 2014-09-01
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Detailed description:

Arms: arm 1: Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. arm 2: Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
Interventions: intervention 1: TNX-102 SL 2.8mg intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. intervention 2: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Protocol documents:
Clinical trial NCT01910441
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Glycemic variability
Sponsor: Novartis Pharmaceuticals
Start date: 2013-07-01; Completion date: 2014-09-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

Detailed description:

Arms: arm 1: Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). arm 2: Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).
Interventions: intervention 1: Vildagliptin intervention 2: Glimepiride intervention 3: Metformin
Intervention descriptions: intervention 1: Vildagliptin 50 mg twice daily intervention 2: Glimepiride 1-6 mg once daily intervention 3: Metformin (1000-1500 mg daily)

Protocol documents:
Clinical trial NCT01911845
Conditions: Chronic Hepatitis C Infection Chronic Hepatitis C
Keywords: HCV Genotype 1 Hepatitis Genotype 1 Interferon Free methadone HCV Buprenorphine Hepatitis C Viekira Pak paritaprevir Viekira ombitasvir dasabuvir
Sponsor: AbbVie
Start date: 2013-04-01; Completion date: 2014-09-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.

Detailed description:
This study consisted of 2 periods: a 12-week treatment period and a 48-week post-treatment period (for all participants who received study drugs). All participants who received at least 1 dose of study drug were to be followed for 48 weeks post-treatment to monitor for safety, HCV RNA, the emergence and/or persistence of resistant viral variants, and assessment of patient-reported outcome (PRO) instruments.

Arms: arm 1: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Interventions: intervention 1: ABT-450/r/ABT-267 intervention 2: ABT-333 intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267 intervention 2: Tablet intervention 3: Tablet

Protocol documents:
Clinical trial NCT01919229
Conditions: Early Breast Cancer
Keywords: HR-positive HER2-negative Breast cancer LEE011 Letrozole CDK CDK4 CDK6 CDK4/6 Pharmacodynamics Pre-surgical Postmenopausal
Sponsor: Novartis Pharmaceuticals
Start date: 2013-10-01; Completion date: 2014-09-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.

Detailed description:
This randomized pre-surgical pharmacodynamics study will assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer.

Arms: arm 1: Letrozole 2.5 mg alone once daily arm 2: Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily. arm 3: Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
Interventions: intervention 1: LEE011 (ribociclib) intervention 2: letrozole
Intervention descriptions: intervention 1: Ribociclib was supplied in 200 mg hard gelatin capsules for oral use. intervention 2: Letrozole was supplied in 2.5mg tablets for oral use.

Protocol documents:
Clinical trial NCT01920802
Conditions: Healthy
Sponsor: New York State Psychiatric Institute
Start date: 2012-11-01; Completion date: 2014-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot randomized clinical trial is to begin to delineate the pathophysiological changes associated with antipsychotic associated metabolic side effects. The study will be performed in 36 healthy people between the ages of 18 and 30, who have never taken an antipsychotic, will undergo baseline laboratory tests before being randomized to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The primary outcome measure will be a correlation of early changes in leptin with weight gain. We will also record changes in food intake, resting metabolic rate, oral glucose tolerance and fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be followed closely to monitor for safety throughout the 4-week study and will be discontinued if there is a medically significant change in metabolic status or other antipsychotic side effects. Metabolic assessments will be performed again at the time of discontinuation or at the end of an 4-week period, and change from baseline in the two treatment groups will be compared.

Detailed description:
Study hypotheses:

1. Early changes (baseline vs day 3) in leptin will correlate with later changes in weight (at study termination.)

   1. Olanzapine will cause the greatest increase in calorie consumption from baseline on the multi-item meal compared with iloperidone or placebo.
   2. Olanzapine subjects will report the greatest frequency/quantity of eating in food diaries, and report increased preference for calorically dense foods (ie, higher fat content) compared to iloperidone or placebo.
   3. Early markers of endocrine changes caused by olanzapine will be greater than those caused by iloperidone or placebo, and these early changes will correlate with weight gain.
2. Olanzapine will have greater effects on glucose homeostasis than iloperidone or placebo, and these effects will be separate from effects on body weight and composition.

   1. Early signs of metabolic disturbance, including glucose intolerance (greater excursion on OGTT) and insulin resistance (higher plasma insulin) will precede any significant weight gain.
   2. Early evidence of glucose intolerance and/or insulin resistance will predict greater metabolic derangements with further dosing of olanzapine, as evidenced by exacerbated glucose intolerance on OGTT or higher plasma glucose/insulin levels. These effects may not necessarily parallel weight gain.
   3. Olanzapine will be associated with greater markers of inflammation than iloperidone or placebo.

Arms: arm 1: 5mg BID olanzapine for up to 4 weeks arm 2: 6mg BID iloperidone up to 4 weeks arm 3: BID placebo up to 4 weeks
Interventions: intervention 1: olanzapine intervention 2: iloperidone intervention 3: Placebo
Intervention descriptions: intervention 1: 5mg BID up to 4 weeks intervention 2: 6 mg BID up to 4 weeks intervention 3: BID up to 4 weeks

Protocol documents:
Clinical trial NCT01933334
Conditions: Systemic Sclerosis
Keywords: pirfenidone SSc-ILD scleroderma systemic sclerosis interstitial lung disease
Sponsor: Genentech, Inc.
Start date: 2013-10-01; Completion date: 2014-09-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PSSc-001 (LOTUSS)

This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).

Detailed description:

Arms: arm 1: Participants will receive one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day \[mg/day\]) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks maintenance period). arm 2: Participants will receive one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
Interventions: intervention 1: Pirfenidone
Intervention descriptions: intervention 1: Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).

Protocol documents:
Clinical trial NCT01944098
Conditions: Bariatric Surgical Pain
Sponsor: University of South Florida
Start date: 2013-08-01; Completion date: 2014-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.

Detailed description:

Arms: arm 1: Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr arm 2: Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: