ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01697332
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Brigham and Women's Hospital
Start date: 2013-01-01; Completion date: 2016-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease and its progression in COPD. We hypothesize that measurement of alveolar surface area, septal thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate better with quality of life measures in COPD subjects than traditional diagnostic measures such as spirometry and Computed Tomography.

Detailed description:

Arms: arm 1: All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.
Interventions: intervention 1: Hyperpolarized 129Xe gas
Intervention descriptions: intervention 1: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.

Protocol documents:
Clinical trial NCT01710709
Conditions: Bipolar I
Keywords: Aripiprazole, Intramuscular (IM) Depot, Bipolar
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-11-01; Completion date: 2016-12-01
Enrollment: 748 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

Detailed description:
This will be an open-label, uncontrolled study which will enroll subjects completing Study 31-08-250 and new subjects. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e 31-08-250).

This open-label study will be comprised of phases similar to the pivotal double-blind study (i.e. Study 250): a screening phase (if applicable), a conversion phase (Phase A, if applicable), an oral stabilization phase (Phase B, if applicable), and an IM depot open-label maintenance phase (Phase C). Phase C will be a minimum of 28 weeks up to a 52-week treatment period with a 4 week follow up period.

During Phase C (the open-label maintenance phase) rescue medication will be allowed for subjects who do not meet stability criteria. This analysis focuses on Phase C due to ClinicalTrials.gov system limitations.

Arms: arm 1: Aripiprazole, Intramuscular (IM) Depot
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: 400mg or 300mg, intramuscular injections every 4 weeks.

Protocol documents:
Clinical trial NCT01743001
Conditions: Pulmonary Arterial Hypertension
Keywords: exercise capacity Eisenmenger Syndrome
Sponsor: Actelion
Start date: 2013-05-21; Completion date: 2016-12-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

Detailed description:

Arms: arm 1: Subjects receive macitentan 10 mg oral tablet once daily arm 2: Subjects receive macitentan-matching placebo oral tablet once daily
Interventions: intervention 1: Macitentan 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Macitentan 10 mg oral tablet once daily intervention 2: Macitentan-matching placebo oral tablet once daily

Protocol documents:
Clinical trial NCT01748994
Conditions: Obesity Metabolic Syndrome
Keywords: Obesity Fat distribution Adipogenesis Adipocyte Preadipocyte Ectopic fat
Sponsor: Pennington Biomedical Research Center
Start date: 2011-02-01; Completion date: 2016-12-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The body shape of obese women varies between having the majority of fat either above the waist ("apple" shape) or below the waist ("pear" shape). The study will investigate what restricts: apple"-shaped women from being "pear"-shaped at the cellular level. Since "pear" shaped women tend to have better health, this study will open the door to future research in regulating body shape and thus improving health.

Detailed description:
Adipose tissue expandability and the distribution of stored fat in the body are stronger predictors of health risk. A better understanding of the factors that determine regional fat mass growth may lead to developing new strategies for prevention or treatment of metabolic complications of obesity. The objective of this proposal is to study the responsiveness of different fat depots to adipogenic stimulation in upper-body and lower-body obese women.

Arms: arm 1: Administration of placebo to upper- and lower-body obese women arm 2: Administration of pioglitazone to upper- and lower-body obese women
Interventions: intervention 1: Pioglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: 30mg per day for four months intervention 2: None

Protocol documents:
Clinical trial NCT01805895
Conditions: Intracerebral Hemorrhage
Keywords: Stroke Acute Intracerebral Hemorrhage Intracerebral Hemorrhage Hemorrhagic stroke Hemorrhage Minocycline
Sponsor: Augusta University
Start date: 2013-02-01; Completion date: 2016-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.

Detailed description:
MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.

Arms: arm 1: This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. arm 2: This arm will not receive any minocycline. This arm will receive standard of care treatment.
Interventions: intervention 1: Minocycline
Intervention descriptions: intervention 1: This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.

Protocol documents:
Clinical trial NCT01813149
Conditions: Complex Regional Pain Syndrome (CRPS)
Keywords: Complex Regional Pain Syndrome (CRPS)
Sponsor: The Cleveland Clinic
Start date: 2012-08-01; Completion date: 2016-12-01
Enrollment: 128 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
40 CRPS patients will be recruited over a three-year period (target of 160 patients at all sites). Assessment of exclusion criteria will be undertaken during initial recruitment. Exclusion criteria are: \<18 years; a second chronic pain syndrome that would interfere with pain rating; psychiatric comorbidity; pain in both hands or feet; pregnancy or breastfeeding; sympathectomy in the affected limb; use of topical medication; known sensitivity to alpha 1- adrenoceptor agonists or other contraindications. Patients will maintain their regular oral medications throughout the study period.

Assessment of sympathetically maintained pain (SMP) will require an intradermal dose of Phenylephrine to rekindle SMP and mechanical hyperalgesia. Clonidine will be used to control for affects of algometer fiction and may inhibit SMP by inhibiting the release of more norepinephrine from sympathetic nerve terminals. Skin biopsies will be obtained under sterile conditions from a site of mechanical or thermal hyperalgesia using a 3mm diameter skin biopsy punch under local anesthesia. Samples from a mirror image site on the contralateral body side will also be taken.

Detailed description:
Patients diagnosed with CRPS and control subjects will be enrolled in the study. The CRPS participants will be administered with phenylephrine (day 1) and clonidine (day 2). The control participants will not receive any intervention.

The aim of this study is to determine if expression of α1-adrenoceptors (α1-AR) altered in the skin of a subgroup of patients whose pain is associated with increased adrenergic sensitivity after nerve trauma. Increased adrenergic sensitivity will be determined by assessing pain in patients after administration of phenylephrine on day 1. Expression of α1-AR will be determined by taking skin biopsies on day 2 after administration of clonidine. Then, we will compare the expression of α1-AR in patients who were classified as having increased adrenergic sensitivity versus those who were not.

Arms: arm 1: Subjects will be injected with phenylephrine and clonidine at affected and unaffected sites.
Interventions: intervention 1: phenylephrine and clonidine intervention 2: punch biopsy
Intervention descriptions: intervention 1: Subjects will be injected with phenylephrine and clonidine at both affected and unaffected sites. intervention 2: None

Protocol documents:
Clinical trial NCT01827943
Conditions: Relapsed Bladder Cancer
Keywords: Relapsed bladder cancer
Sponsor: Institut Bergonié
Start date: 2009-06-01; Completion date: 2016-12-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.

Detailed description:
In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival. This study will also search for genes involved in the response to treatment.

Arms: arm 1: Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
Interventions: intervention 1: Temsirolimus
Intervention descriptions: intervention 1: Temsirolimus

Protocol documents:
Clinical trial NCT01841632
Conditions: Liver Transplantation
Keywords: Liver transplantation Allogeneic liver transplantation Solid organ transplantation
Sponsor: Prof. Dr. Marc-H. Dahlke, Ph. D.
Start date: 2013-04-01; Completion date: 2016-12-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
MultiStem ® is a new biological product, manufactured from human stem cells obtained from adult bone marrow. Factors expressed by MultiStem cells are believed to regulate immune system function and augment tissue repair.

Standard of care pharmacological immunosuppression after liver transplantation can achieve reasonable survival of liver grafts and patients. The side effects of this treatment, however, are clinically significant and diminish the overall success of organ transplantation as a curative therapy. It is therefore the objective of this study to implement cellular immunomodulation therapy with MultiStem as an adjunct to standard pharmacological immunosuppression with the ultimate goal of significantly reducing drug-based immunosuppression.

As this is the first study with MultiStem in this subject population it has been designed as a safety and feasibility trial. However, first evidence of a potential benefit for this patient population will be explored cautiously.

Detailed description:

Arms: arm 1: Dose escalation

Cohort 1

Drug: MultiStem, Dose 1 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Cohort 2

Drug: MultiStem, Dose 2 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Cohort 3

Drug: MultiStem, Dose 3 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)

Cohort 4

Drug: MultiStem, Dose 4 of MultiStem; Route and time: Two infusions; First: intra portal at liver transplantation (day 1), second: intra venous (day 3)
Interventions: intervention 1: MultiStem
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01869634
Conditions: Human Immunodeficiency Virus Infection
Keywords: HIV cardiovascular risk systemic immune activation
Sponsor: University of California, Davis
Start date: 2013-06-01; Completion date: 2016-12-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.

Detailed description:
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.

Arms: arm 1: HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. arm 2: HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months.
Interventions: intervention 1: darunavir with ritonavir and fixed-dose viread+emtricitabine daily
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01904526
Conditions: Smoking
Keywords: Guanfacine PK/PD Smokers
Sponsor: Yale University
Start date: 2013-07-01; Completion date: 2016-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.

Detailed description:

Arms: arm 1: Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release
Interventions: intervention 1: Guanfacine
Intervention descriptions: intervention 1: 3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.

Protocol documents:
Clinical trial NCT01940900
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD choroidal neovascularization Fovista® E10030 Lucentis®
Sponsor: Ophthotech Corporation
Start date: 2013-08-01; Completion date: 2016-12-01
Enrollment: 627 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Detailed description:
Subjects will be randomized in a 1:1 ratio to the following dose groups:

* Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
* Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Arms: arm 1: E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection arm 2: E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Interventions: intervention 1: E10030 intervention 2: ranibizumab intervention 3: E10030 sham intravitreal injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Pressure on the eye with a syringe with no needle

Protocol documents:
Clinical trial NCT01944839
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD choroidal neovascularization Fovista® E10030 Lucentis®
Sponsor: Ophthotech Corporation
Start date: 2013-08-01; Completion date: 2016-12-01
Enrollment: 619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Detailed description:
Subjects will be randomized in a 1:1 ratio to the following dose groups:

* Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
* Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Arms: arm 1: E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection arm 2: E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Interventions: intervention 1: E10030 intervention 2: ranibizumab intervention 3: E10030 sham intravitreal injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Pressure on the eye with a syringe with no needle

Protocol documents:
Clinical trial NCT02045212
Conditions: Non-arteritic Ischemic Optic Neuropathy Optic Nerve Injuries
Keywords: Ischemic Optic Neuropathy Traumatic Neuropathy Non Arteritic Ischemic Neuropathy (NAION)
Sponsor: Regenera Pharma Ltd
Start date: 2014-02-01; Completion date: 2016-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.

Detailed description:

Arms: arm 1: 3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 arm 2: 3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo
Interventions: intervention 1: RPh201 intervention 2: Placebo
Intervention descriptions: intervention 1: SC injection twice a week during 13/26 weeks intervention 2: SC injection twice a week during 13/26 weeks

Protocol documents:
Clinical trial NCT02051686
Conditions: Acetabulum Fractures
Keywords: Acetabulum Fractures Pelvic Ring Injuries Tranexamic Acid
Sponsor: University of Missouri-Columbia
Start date: 2013-06-01; Completion date: 2016-12-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain.

The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Detailed description:
Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

Arms: arm 1: Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. arm 2: The control group will receive a similar volume load of normal saline and maintenance doses.
Interventions: intervention 1: Tranexamic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. intervention 2: The control group will receive a similar volume load of normal saline and maintenance doses.

Protocol documents:
Clinical trial NCT02051764
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2014-05-01; Completion date: 2016-12-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Flortaucipir F18 intervention 2: Florbetapir F 18 intervention 3: Brain PET Scan
Intervention descriptions: intervention 1: 370 megabecquerel (MBq) IV single-dose intervention 2: 370 megabecquerel (MBq) IV single-dose intervention 3: positron emission tomography (PET) scan of the brain

Protocol documents: