ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02056171
Conditions: Delirium
Keywords: delirium pediatrics critical care quetiapine
Sponsor: Weill Medical College of Cornell University
Start date: 2015-03-01; Completion date: 2016-12-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.

Detailed description:
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an "off label" use as the FDA has not approved quetiapine for this indication.

Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.

Arms: arm 1: A randomized group will receive quetiapine as treatment for delirium. arm 2: A randomized group will receive placebo, and not quetiapine.
Interventions: intervention 1: quetiapine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. intervention 2: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.

Protocol documents:
Clinical trial NCT02081963
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: Nebulized amikacin; Non-Cystic Fibrosis Bronchiectasis; Bacterial clearance rate of sputum； Acute exacerbation.
Sponsor: Qilu Hospital of Shandong University
Start date: 2014-03-01; Completion date: 2016-12-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

Detailed description:
Objective: To assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.

Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.

Arms: arm 1: Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. arm 2: Participants received nebulized normal saline BID for 14 days in combination with standard treatment.
Interventions: intervention 1: Amikacin intervention 2: Normal saline
Intervention descriptions: intervention 1: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. intervention 2: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.

Protocol documents:
Clinical trial NCT02119676
Conditions: CRC (Colorectal Cancer)
Keywords: Metastatic Colorectal Cancer Colon Cancer Ruxolitinib adenocarcinoma regorafenib Jakavi ® Jakafi ® Stivarga ®
Sponsor: Incyte Corporation
Start date: 2014-03-01; Completion date: 2016-12-01
Enrollment: 396 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

Detailed description:
The study consisted of an open-label, Part 1 safety run-in (consisting of 1 to 3 cohorts of 9 subjects each), to confirm the safety of the regorafenib/ruxolitinib combination in subjects with relapsed or refractory metastatic colorectal cancer (CRC). If determined to be tolerable, Part 2 was to proceed as a randomized, double-blind study evaluating ruxolitinib or placebo in combination with regorafenib in subjects with relapsed or refractory metastatic CRC previously treated with fluoropyrimidine, oxaliplatin, and/or irinotecan based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy and if Kirsten rat sarcoma (KRAS) wild type an anti-epidermal growth factor receptor (EGFR) therapy.

Subjects in the safety run-in received open-label ruxolitinib and regorafenib; for the randomized, double-blind portion of the study all subjects received regorafenib and either ruxolitinib or placebo in a 1:1 blinded manner. Treatment for all subjects consisted of repeating 28-day cycles. Regorafenib was self-administered for the first 21 days of each cycle, and ruxolitinib/placebo was self-administered during the entire 28-day cycle. Treatment cycles continued as long as the regimen is tolerated, and the subject does not meet the discontinuation criteria. When subjects discontinued regorafenib, ruxolitinib or placebo they remained in the study and were followed for subsequent treatment regimens which were initiated and survival.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ruxolitinib intervention 2: Regorafenib intervention 3: Placebo
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth

Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.) intervention 2: Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.) intervention 3: 5 mg matching placebo tablets to be administered by mouth

Protocol documents:
Clinical trial NCT02129725
Conditions: Metabolic Syndrome
Sponsor: Vanderbilt University Medical Center
Start date: 2014-04-01; Completion date: 2016-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our research proposal will determine if PDE-5 inhibition exerts a favorable effect on insulin signaling pathways in skeletal muscle of subjects with impaired fasting glucose and/or impaired glucose tolerance.

Detailed description:
Participants enrolled in the study titled " Renin-angiotensin and fibrinolysis interaction in humans: effect of long-term PDE5 inhibition on glucose Homeostasis, (Specific aim 2)" will be offered the opportunity to participate in this sub-study.

We will obtain skeletal muscle biopsies from 16 subjects who are enrolled in specific aim 2. Eight subjects will be in the sildenafil group and 8 subjects will be in the placebo group.

Arms: arm 1: In the parent study, subjects are randomized to sildenafil 25 mg tid. arm 2: In the parent study, subjects are randomized to matching placebo
Interventions: intervention 1: Sildenafil citrate intervention 2: Placebo Oral Capsule
Intervention descriptions: intervention 1: Sildenafil citrate 25 mg, 1 capsule three times a day for 3 months intervention 2: placebo capsules, 1 capsule po three times a day for 3 months

Protocol documents:
Clinical trial NCT02136420
Conditions: Vestibular
Sponsor: Faisal_Karmali@MEEI.HARVARD.EDU
Start date: 2014-06-01; Completion date: 2016-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators will study adaptation of motion perception and manual control in altered gravity, including the effects of a drug (promethazine). The investigators will also study whether promethazine affects motion perceptual thresholds.

Detailed description:
Adaptation to altered gravity has been of concern from the earliest reports of space motion sickness, through the Apollo exploration era, and into current planning of exploration missions. The proposed research program takes a new approach which could lead to an effective, practical and acceptable protocol for preadapting astronauts to space flight. By using the gravito-inertial alterations possible with centrifugation in different body orientations the investigators will quantify an individual's sensory adaptation capability and use it to predict and to minimize the consequences of movement in any other gravity environment - eventually including weightlessness. The investigators will also study whether a drug (promethazine) affects motion perception and motion sickness.

Arms: arm 1: placebo arm 2: subject does test with no hypergravity training and placebo drug only arm 3: promethazine 25 mg, one time 120 minutes prior to experiment arm 4: promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training arm 5: placebo arm 6: subject does test with no hyper gravity training and placebo drug only arm 7: promethazine 25 mg, one time 120 minutes prior to experiment arm 8: promethazine 25 mg, one time 120 minutes prior to experiment arm 9: Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by \>4 days.

This arm corresponds to results published in Diaz-Artiles et al 2017. arm 10: Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by \>4 days.

This arm corresponds to results published in Diaz-Artiles et al 2017.
Interventions: intervention 1: Promethazine intervention 2: Hyper gravity training intervention 3: Placebo intervention 4: No hypergravity training
Intervention descriptions: intervention 1: Subject receives promethazine intervention 2: Subject receives hypergravity training before testing intervention 3: Placebo intervention 4: Subjects do not receive normal Earth gravity

Protocol documents:
Clinical trial NCT02157623
Conditions: Basal Cell Nevus Syndrome
Keywords: Basal Cell Nevus Syndrome Gorlin's Syndrome
Sponsor: Edward Maytin, MD, PhD
Start date: 2016-02-01; Completion date: 2016-12-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.

Detailed description:
This is a pilot intra-patient comparative study to evaluate the ability of cyclic Photodynamic Therapy (PDT) using Red (635 nm) or Blue (400 nm) light with 5-Aminolevulinic acid, to eliminate BCC skin cancers that occur in patients with Basal Cell Nevus Syndrome (Gorlin-Goltz Syndrome).

Patients will receive 3 cycles of Red light and Blue light PDT treatments, for a total of 6 treatments, over a 4 month period. Cycles will be spaced 2 months apart. Each cycle consists of a double course of PDT treatment with treatments spaced one week apart. Every subject will be treated with two light sources, blue and red, according to randomized assignments made to left side or right side of the body. There will be a final assessment visit at month 6.

Arms: arm 1: The tumor clearance with one side treated with Levulan and Red light PDT, and the contralateral side treated with Blue light PDT.
Interventions: intervention 1: Levulan intervention 2: Red Light PDT intervention 3: Blue Light PDT
Intervention descriptions: intervention 1: Levulan application followed by Red or Blue light PDT intervention 2: Aktilite™ (red lamp) after Levulan application on lesions intervention 3: Blu-U® (blue lamp) after Levulan application on lesions

Protocol documents:
Clinical trial NCT02187055
Conditions: Rhematoid Arthritis
Sponsor: Pfizer
Start date: 2014-08-01; Completion date: 2016-12-01
Enrollment: 1152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tofacitinib with methotrexate intervention 2: Tofacitinib without methotrexate intervention 3: Adalimumab with methotrexate
Intervention descriptions: intervention 1: Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months intervention 2: Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months intervention 3: Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months

Protocol documents:
Clinical trial NCT02213081
Conditions: Endometriosis
Keywords: Endometriosis chronic pelvic pain dysmenorrhea dyschezia bleeding ulipristal progesterone
Sponsor: Northwestern University
Start date: 2015-02-01; Completion date: 2016-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.

Detailed description:
This study will assess the use of a medication to improve symptoms of chronic, endometriosis-related pelvic pain among women who did no achieve relief with prior surgical and medical treatments.

Arms: arm 1: 1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.
Interventions: intervention 1: Ulipristal
Intervention descriptions: intervention 1: Patient will take 15mg every other day, or every 4 days per week.

Protocol documents:
Clinical trial NCT02214628
Conditions: Age-related Macular Degeneration
Keywords: Wet AMD Choroidal neovascularization Fovista® E10030 Avastin® Eylea®
Sponsor: Ophthotech Corporation
Start date: 2014-07-01; Completion date: 2016-12-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Detailed description:
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Arms: arm 1: Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration. arm 2: Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
Interventions: intervention 1: Fovista® (anti-PDGF BB) plus anti-VEGF
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02234141
Conditions: Pulmonary Arterial Hypertension
Sponsor: Gilead Sciences
Start date: 2014-11-01; Completion date: 2016-12-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.

Detailed description:

Arms: arm 1: Participants will receive selonsertib 2 milligrams (mg) for 24 weeks and may continue on this dose during the long-term treatment phase. arm 2: Participants will receive selonsertib 6 mg for 24 weeks and may continue on this dose during the long-term treatment phase. arm 3: Participants will receive selonsertib 18 mg for 24 weeks and may continue on this dose during the long-term treatment phase. arm 4: Participants will receive selonsertib placebo for 24 weeks, and may then be rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase.
Interventions: intervention 1: Placebo intervention 2: Selonsertib
Intervention descriptions: intervention 1: Tablet administered orally once daily intervention 2: Tablets administered orally once daily

Protocol documents:
Clinical trial NCT02240030
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease Motor fluctuations levodopa inhaled drugs OFF episodes
Sponsor: Acorda Therapeutics
Start date: 2014-11-01; Completion date: 2016-12-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Detailed description:

Arms: arm 1: Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration arm 2: Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration arm 3: Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Interventions: intervention 1: CVT-301 Low Dose intervention 2: CVT-301 High Dose intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02246764
Conditions: Ocular Hypertension Glaucoma
Keywords: Ocular hypertension. Glaucoma
Sponsor: Aerie Pharmaceuticals
Start date: 2014-09-01; Completion date: 2016-12-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.

Detailed description:

Arms: arm 1: 1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU) arm 2: 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) arm 3: 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Interventions: intervention 1: AR-13324 Ophthalmic Solution 0.02% intervention 2: AR-13324 Ophthalmic Solution 0.02% BID intervention 3: Timolol maleate Ophthalmic Solution 0.5% BID intervention 4: Placebo
Intervention descriptions: intervention 1: 1 drop once daily (QD), PM, OU intervention 2: 1 drop BID, AM/PM, OU intervention 3: 1 drop BID, AM/PM, OU intervention 4: 1 drop QD, AM, OU

Protocol documents:
Clinical trial NCT02258217
Conditions: Relapsing Remitting Multiple Sclerosis
Sponsor: OhioHealth
Start date: 2014-06-01; Completion date: 2016-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

Detailed description:
We propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses. Potential subjects will be identified during routine clinical evaluations. If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study. After consent is obtained, the patient will complete the first page of the ARMS survey. If prior steroid use was deemed tolerable then only the first page of the ARMS will be collected and analyzed and these patients will complete their participation in the trial. Their data from the ARMS will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. However, if patients self-report prior steroid intolerability, then they will advance into the Acthar treatment arm of the trial.

Arms: arm 1: Acthar 80 units subcutaneously for five consecutive days.
Interventions: intervention 1: Acthar
Intervention descriptions: intervention 1: Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.

Protocol documents: