ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01923428
Conditions: Constipation Predominant Irritable Bowel Syndrome
Sponsor: Ardelyx
Start date: 2013-08-01; Completion date: 2014-10-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.

Detailed description:

Arms: arm 1: AZD1722 arm 2: AZD1722 arm 3: AZD1722 arm 4: None
Interventions: intervention 1: AZD1722 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01926626
Conditions: Nicotine Dependence
Keywords: Nicotine addiction Smoking Cessation Quit Smoking moclobemide Nicotine Patch
Sponsor: Jed E. Rose
Start date: 2013-09-01; Completion date: 2014-10-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.

Detailed description:

Arms: arm 1: After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Interventions: intervention 1: Nicotine Patch intervention 2: Moclobemide
Intervention descriptions: intervention 1: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)

Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks) intervention 2: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)

Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)

Protocol documents:
Clinical trial NCT01932606
Conditions: Heart Disease Heart Failure With Preserved Ejection Fraction Exercise Intolerance Pulmonary Hypertension
Sponsor: Barry Borlaug
Start date: 2013-08-01; Completion date: 2014-10-01
Enrollment: 28 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 assessed the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF.

Detailed description:
Subjects were studied on their long-term medications in the post-absorptive state and supine position. Right heart catheterization was performed with simultaneous expired gas analysis at rest and during supine exercise at a 20 Watts workload for 5 minutes. After the first exercise phase (before any drug administration) and after return to steady-state baseline hemodynamic values, subjects were randomized. Study drug or placebo was infused for 5 minutes. After a 10 minute observation period, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20 Watts workload for 5 minutes, identical to the study's first phase. Arterial and venous blood samples and hemodynamic and expired gas data were acquired during each stage of the protocol.

Arms: arm 1: Study drug (NaNO\_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. arm 2: Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
Interventions: intervention 1: Nitrite intervention 2: Saline Placebo for Nitrite
Intervention descriptions: intervention 1: Study drug (NaNO\_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. intervention 2: Normal saline placebo will be infused for 5 minutes during the cardiac catheterization procedure. Hemodynamics will then be measured at baseline after study drug infusion and again during low level exercise (20 Watts).

Protocol documents:
Clinical trial NCT01936389
Conditions: Exfoliation Syndrome Ocular Hypertension Open Angle Glaucoma
Sponsor: Robert Ritch, MD, LLC.
Start date: 2013-09-01; Completion date: 2014-10-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glaucoma is the world's the second leading cause of irreversible blindness. The World Health Organization (WHO) estimated the incidence of blindness due to glaucoma to be 4.4 million people worldwide in 2002. Intraocular pressure (IOP) is the sole proven modifiable risk factor for the development and progression of glaucomatous optic neuropathy. Medical therapy is aimed at lowering IOP in order to prevent or slow progression.

Exfoliation syndrome (XFS) is the most common identifiable cause of open-angle glaucoma, affecting an estimated 60 to 70 million people worldwide. Approximately two-thirds of patients have disease in only one eye on clinical examination; however, XFS is detectable in the other eye with conjunctival biopsy. XFS is also a systemic disease, with effects on the cardiovascular and cerebrovascular systems.

Patients with XFS are twice as likely to convert from ocular hypertension to glaucoma. Glaucoma in XFS is more severe than primary open angle glaucoma. There is greater diurnal IOP fluctuation, greater visual field loss and optic nerve head damage at the time of diagnosis, poorer response to medications, more rapid visual field progression and more frequent need for surgery.

Because you meet eligibility criteria for our study, we ask for your consent to participate in the study described below. In brief, you will be taking an investigational drug (AR-12286, rho-kinase Inhibitor) at either 0.5% or 0.7% once a day for 6 months. This drug is currently being tested in patients with primary open-angle glaucoma, but not yet in glaucoma in exfoliation syndrome. Because of the mechanism of glaucoma in XFS and the mechanism of action of rho-kinase inhibitors, there is reason to think it would be more effective in eyes with XFS and glaucoma than in primary open-angle glaucoma (ordinary glaucoma). There will be a baseline and study day 1 visit, week 1 visit, month 1 and 3 visit, week 13 visit, month 6 visit and a week 25 visit; for a total of 7 office visits.

Detailed description:

Arms: arm 1: 0.5% Rho-Kinase Inhibitor arm 2: 0.7% Rho-Kinase Inhibitor
Interventions: intervention 1: AR-12286
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01939548
Conditions: Schizophrenia
Keywords: PF-02545920 schizophrenia outpatient safety efficacy suboptimal response
Sponsor: Pfizer
Start date: 2013-10-01; Completion date: 2014-10-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 from baseline compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PF-02545920 intervention 2: Placebo intervention 3: PF-02545920
Intervention descriptions: intervention 1: PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit intervention 2: Placebo BID until the Week 12 visit intervention 3: PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit

Protocol documents:
Clinical trial NCT01953081
Conditions: Enteral Feeding Intolerance
Keywords: Enteral feeding
Sponsor: Takeda
Start date: 2014-01-01; Completion date: 2014-10-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.

Detailed description:

Arms: arm 1: TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours arm 2: Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
Interventions: intervention 1: TD-8954 intervention 2: Metoclopramide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01958645
Conditions: Healthy Subjects
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic
Sponsor: AstraZeneca
Start date: 2013-11-01; Completion date: 2014-10-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

Detailed description:
A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses in healthy male subjects.

Arms: arm 1: MEDI8111 arm 2: Placebo for MEDI8111
Interventions: intervention 1: MEDI8111 intervention 2: Placebo
Intervention descriptions: intervention 1: MEDI8111 lyophilisate for solution for infusion intervention 2: Placebo for MEDI8111 saline solution for infusion

Protocol documents:
Clinical trial NCT01959516
Conditions: COPD
Keywords: COPD, early morning symptoms
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-01; Completion date: 2014-10-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform daily activities by the patient.

Detailed description:
Randomized, multicenter, blinded, two-period cross-over design. Each treatment will last 28 days. All patients will receive both treatments in a cross-over design, with a wash-out period of 14-19 days in between. The total duration of the study for each patient is approximately 70 days (from randomization) plus 30 days of safety follow-up.

Arms: arm 1: Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days. arm 2: Participants will receive sequence B= tiotropium + placebo to glycopyrronium during 28 days, followed by a 14 day washout period, then sequence A= glycopyrronium + placebo to tiotropium for 28 days.
Interventions: intervention 1: Glycopyrronium intervention 2: Tiotropium intervention 3: Placebo to glycopyrronium intervention 4: Placebo to tiotropium
Intervention descriptions: intervention 1: Glycopyrronium capsule for inhalation once per day via SDDPI intervention 2: Tiotropium capsule for inhalation once per day via HandiHaler® device intervention 3: Placebo to glycopyrronium capsule for inhalation once per day via SDDPI intervention 4: Placebo to tiotropium capsule for inhalation once per day via HandiHaler® device

Protocol documents:
Clinical trial NCT01965327
Conditions: Friedreich Ataxia
Keywords: Friedreich ataxia Interferon gamma-1b FRDA
Sponsor: Children's Hospital of Philadelphia
Start date: 2013-08-01; Completion date: 2014-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults for which there is presently no therapy. Recently, a study reported that interferon gamma (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of children with FRDA.

Detailed description:
Study Objectives:

Primary:

• To assess the effect of Interferon Gamma-1b (IFN-g) on increasing frataxin expression and protein in children with FRDA.

Secondary:

* To assess the effect of IFN-g on neurological outcomes (FARS, performance measures, and hearing) in subjects with FRDA.
* To assess the effectiveness of IFN-g on quality of life in subjects with FRDA.
* To assess the safety and tolerability of IFN-g at the currently approved dose in the FRDA population.

Study Phases:

Screening - During screening, subjects will be assessed for inclusion and exclusion criteria.

Intervention - Subjects will begin treatment at baseline visit and the dose of study medication will be increased to the maximum dose over four weeks. The subjects will be maintained at the maximum dose for 8 weeks. After 12 weeks, treatment will stop. Study medication will be administered via subcutaneous injections three times per week for 12 weeks.

Follow-up - Follow-up visits will occur at 7 and 28 days after the subject has completed the 12 weeks of active treatment.

Arms: arm 1: All individuals in this study will be given active medication (interferon gamma-1b) for 12 weeks. This will be administered according to a dose-escalation schedule.
Interventions: intervention 1: Interferon Gamma-1b
Intervention descriptions: intervention 1: Subjects will begin by taking 10 mcg/m2 of IFN-g-1b for the first two weeks of the study. Dose will be escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study. Finally, the dose will be escalated to 50 mcg/m2 of IFN-g-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.

All doses will be administered via subcutaneous injection.

Protocol documents:
Clinical trial NCT01969565
Conditions: Multiple Myeloma
Sponsor: Emory University
Start date: 2013-08-01; Completion date: 2014-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of increasing doses of carfilzomib in combination with dexamethasone

Detailed description:

Arms: arm 1: Carfilzomib will be administered at a dose of 20 mg/m², with a dose escalation to 36 mg/m² after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m², with a dose escalation to 45 mg/m² after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.
Interventions: intervention 1: Carfilzomib intervention 2: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02006888
Conditions: Inflammation Cataracts
Keywords: Inflammation cataract surgery
Sponsor: ICON Bioscience Inc
Start date: 2014-01-01; Completion date: 2014-10-01
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.

Detailed description:
A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)

Arms: arm 1: IBI-10090 low dose arm 2: IBI-10090 med dose arm 3: Placebo
Interventions: intervention 1: IBI-10090 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo

Protocol documents:
Clinical trial NCT02007096
Conditions: Ventral Hernia Umbilical Hernia Incisional Hernia Postoperative Complications Pain, Postoperative
Keywords: Transabdominal plane block ventral hernia umbilical hernia incisional hernia hernia repair
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2012-08-01; Completion date: 2014-10-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

Detailed description:
Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.

Arms: arm 1: Receiving Transabdominal Plane Block with 0.25% bupivacaine arm 2: Receiving placebo saline injection
Interventions: intervention 1: Transabdominal Plane Block intervention 2: Non Transabdominal Plane Block
Intervention descriptions: intervention 1: 0.25% bupivacaine injection in 6 different locations in abdomen. Weight \<100kg: 50ml total; weight \>100kg: 60ml total intervention 2: Saline injection in 6 different locations in abdomen. Weight \<100kg: 50ml; weight \>100kg: 60ml

Protocol documents:
Clinical trial NCT02009384
Conditions: Metastatic Melanoma
Sponsor: University of Louisville
Start date: 2012-01-01; Completion date: 2014-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.

Detailed description:
This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.

Arms: arm 1: IV ipilimumab
Interventions: intervention 1: Ipilimumab
Intervention descriptions: intervention 1: administration of IV ipilimumab for up to 4 cycles

Protocol documents:
Clinical trial NCT02012218
Conditions: Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder, Depression
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-11-01; Completion date: 2014-10-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding adjunctive drug therapy.

Detailed description:

Arms: arm 1: ADT and Brexpiprazole
Interventions: intervention 1: ADT intervention 2: Brexpiprazole
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02013609
Conditions: MDD
Keywords: schizophrenia Major depressive disorder Anxiety Symptoms School, Work environment Mental Disorders Psychotic Disorders antipsychotic
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-11-01; Completion date: 2014-10-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response in a school or work environment.

Detailed description:

Arms: arm 1: Up to 3mg/day, once daily dose, tablets, orally
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally

Protocol documents:
Clinical trial NCT02013622
Conditions: Schizophrenia
Keywords: schizophrenia Mental Disorders Psychotic Disorders social avoidance emotional withdrawal passive/apathetic social withdrawal antipsychotic
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-11-01; Completion date: 2014-10-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.

Detailed description:

Arms: arm 1: Up to 4 mg/day, once daily dose, tablets, orally
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally

Protocol documents:
Clinical trial NCT02070965
Conditions: Plaque Psoriasis
Sponsor: Primus Pharmaceuticals
Start date: 2014-01-01; Completion date: 2014-10-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.

Detailed description:

Arms: arm 1: DFD01 Spray, bid, 28 days arm 2: Comp01 Lotion, bid, 14 days arm 3: DFD01 Spray, bid, 14 days
Interventions: intervention 1: DFD01 Spray intervention 2: Comp01 Lotion
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02073448
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2014-03-01; Completion date: 2014-10-01
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.

Detailed description:

Arms: arm 1: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide arm 2: Adapalene 01% Gel arm 3: Benzoyl Peroxide 2.5% Gel
Interventions: intervention 1: GK530G intervention 2: CD0271 intervention 3: CD1579
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: