ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01913470
Conditions: NAFLD
Keywords: NAFLD Non-alcoholic Fatty Liver Disease Obesity Pediatrics Children Losartan Cozaar
Sponsor: Miriam Vos, MD
Start date: 2013-07-01; Completion date: 2015-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of mortality and natural history studies of adults show that NAFLD is an independent risk factor for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health standpoint, as it represents an early and possibly more aggressive form of the disease. Currently there is no effective treatment for pediatric NAFLD.

Losartan is an orally-administered angiotensin II receptor antagonist which is currently on the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has been shown to be important in many disease states including renal disease, cardiovascular disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed as a novel treatment of NAFLD in part because they would treat both the factors increasing cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic inflammation.

This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others. Safety will be assessed by the recording of adverse events, clinical laboratory parameters, vital signs and physical examinations.

Detailed description:

Arms: arm 1: 0.4mg/kg/day (max 25mg) for one week and then increase to 0.8mg/kg/day (max 50mg) for 7 additional weeks then placebo pill for 8 weeks arm 2: placebo pill taken for 8 weeks then 0.4mg/kg/day (max 25mg) for one week and then increase to 0.8mg/kg/day (max 50mg) for 7 additional weeks
Interventions: intervention 1: Losartan
Intervention descriptions: intervention 1: Oral tablet to be taken once daily at 0.4mg/kg/day (max 25mg) for one week and then increased to 0.8mg/kg/day (max 50mg) for 7 additional weeks.

Protocol documents:
Clinical trial NCT01919723
Conditions: Acute Coronary Syndrome
Keywords: PCI Ticagrelor Eptifibatide
Sponsor: University of Alabama at Birmingham
Start date: 2014-02-01; Completion date: 2015-12-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.

Detailed description:
In this study, 70 patients with Acute Coronary Syndrome who are undergoing non-emergent percutaneous coronary intervention (PCI) will be randomized to ticagrelor loading dose and eptifibatide bolus-only versus ticagrelor loading dose and eptifibatide bolus plus 2 hour infusion administrated after cardiac catheterization, but before PCI. Platelet function testing will be performed at baseline and follow-up.

Arms: arm 1: Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart) arm 2: Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
Interventions: intervention 1: Ticagrelor intervention 2: Eptifibatide
Intervention descriptions: intervention 1: Ticagrelor loading dose intervention 2: i.v. infusion

Protocol documents:
Clinical trial NCT01921257
Conditions: Rhinoconjunctivitis
Keywords: Cat Allergy Rhinoconjunctivitis
Sponsor: Circassia Limited
Start date: 2013-08-01; Completion date: 2015-12-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

Detailed description:

Arms: arm 1: Cat-PAD and Placebo
Interventions: intervention 1: Cat-PAD intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01937871
Conditions: Benign Prostate Hyperplasia Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2013-09-01; Completion date: 2015-12-01
Enrollment: 909 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Detailed description:

Arms: arm 1: Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks. arm 2: Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.

Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period arm 3: Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.

Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period
Interventions: intervention 1: 5 mg Tadalafil intervention 2: Placebo intervention 3: 0.2 mg Tamsulosin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01939977
Conditions: Secondary Hyperparathyroidism Due to Renal Causes
Keywords: Hyperparathyroidism Hyperparathyroidism Secondary Paricalcitol Calcifediol Parathyroid hormone Renal transplantation
Sponsor: Fundación Senefro
Start date: 2014-01-01; Completion date: 2015-12-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

Detailed description:
The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

Arms: arm 1: Paricalcitol oral capsules. arm 2: Calcifediol oral drops.
Interventions: intervention 1: Paricalcitol intervention 2: Calcifediol
Intervention descriptions: intervention 1: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours. intervention 2: 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.

Protocol documents:
Clinical trial NCT01946412
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2013-12-01; Completion date: 2015-12-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy of long-term ivacaftor treatment in this population of patients with CF.

Detailed description:

Arms: arm 1: None arm 2: Ivacaftor will be administered every 12 hours (q12h) from Day 1 through the Week 84 Visit. The ivacaftor dose will be:

* 50 mg q12h for subjects 2 to \<6 years of age and \<14 kg,
* 75 mg q12h for subjects 2 to \<6 years of age and ≥ 14 kg, or
* 150 mg q12h for subjects ≥ 6 years of age.
Interventions: intervention 1: Ivacaftor
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01951066
Conditions: Diabetic Macular Edema
Sponsor: Johns Hopkins University
Start date: 2013-10-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

Detailed description:
Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

Arms: arm 1: Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16. arm 2: Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.
Interventions: intervention 1: Dexamethasone Implant intervention 2: Anti-VEGF injection
Intervention descriptions: intervention 1: Patients will receive a single injection of a dexmethasone implant intervention 2: Patients will receive PRN injections of an anti-VEGF agent

Protocol documents:
Clinical trial NCT01954628
Conditions: COPD
Keywords: Exacerbation of COPD Unstable COPD
Sponsor: Aquinox Pharmaceuticals (Canada) Inc.
Start date: 2013-10-01; Completion date: 2015-12-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo in subjects following exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology 2-containing Inositol-5'-Phosphatase 1) pathway.

Detailed description:
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide. Acute exacerbations of COPD are usually treated with steroids and/or antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts and suppression of the immune system (from the steroids) and increasing bacterial resistance and other side effects from the use of antibiotics. During an acute exacerbation of COPD, the inflammation in the airways increases.

AQX-1125 represents a new type drug that based current data is thought decrease the inflammatory process and therefore may provide a therapeutic benefit in the treatment of COPD.

Arms: arm 1: 1 x AQX-1125 capsule daily arm 2: 1 x Placebo capsule daily
Interventions: intervention 1: AQX-1125 intervention 2: Placebo
Intervention descriptions: intervention 1: Synthetic SHIP1 activator intervention 2: Placebo control

Protocol documents:
Clinical trial NCT01986751
Conditions: Pain
Keywords: nerve block motor blockade lower extremity pain nerve block
Sponsor: University of Alabama at Birmingham
Start date: 2014-01-01; Completion date: 2015-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.

Detailed description:

Arms: arm 1: A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). arm 2: Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine
Interventions: intervention 1: Clonidine intervention 2: ropivacaine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01995045
Conditions: Retinal Detachment Proliferative Vitreoretinopathy Retinoschisis
Keywords: Retina Vitreoretinal Surgery
Sponsor: Emory University
Start date: 2012-07-01; Completion date: 2015-12-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

Detailed description:
Currently, patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital receive a injection of local anesthesia behind the eye (retrobulbar) at the start of surgery to minimize discomfort felt during the surgery. At the end of surgery all patients receive a periocular antibiotic and steroid injection. Some patients also receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of surgery in order to decrease postoperative pain and discomfort.

It has been our observation that when the local anesthesia is combined with a steroid (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients tend to be pain free for longer intervals then when local anesthesia is used alone. The objective of this study is to evaluate if patients receiving triamcinolone acetonide combined with local anesthesia and antibiotic compared to those receiving local anesthesia and antibiotic alone do better with postoperative pain control.

All eligible patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital will be offered enrollment. About 60 patients will be invited to participate in this study. Patients will undergo standard of care surgery. At the conclusion of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of care. Half of the patients will receive this mixture plus steroid and the other half will receive this mixture plus saline. On postoperative day 1, patients will be given a questionnaire to assess pain. Pain levels in the two groups will be compared.

Arms: arm 1: Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide arm 2: Retrobulbar anesthesia with Bupivicaine Hydrochloride
Interventions: intervention 1: Triamcinolone intervention 2: Bupivicaine Hydrochloride
Intervention descriptions: intervention 1: Retrobulbar anesthesia intervention 2: Retrobulbar anesthesia

Protocol documents:
Clinical trial NCT01998399
Conditions: Community Acquired Pneumonia, Severe
Keywords: CAP Pneumonia Intensive Care Unit Mechanical Ventilation
Sponsor: Gordon Bernard
Start date: 2014-08-01; Completion date: 2015-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the drug ticagrelor will be an effective treatment for patients with severe community acquired pneumonia. The primary objective is to reduce all-cause mortality in the ticagrelor group compared to the placebo group.

Detailed description:

Arms: arm 1: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days arm 2: Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
Interventions: intervention 1: Ticagrelor intervention 2: Placebo
Intervention descriptions: intervention 1: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days intervention 2: Placebo 180 mg loading dose followed by 90 mg BID for 90 days.

Protocol documents:
Clinical trial NCT02001987
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2014-01-01; Completion date: 2015-12-01
Enrollment: 139 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic drugs (csDMARDs) in participants with moderate to severe active rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic csDMARDs and/or biologic therapy.

Detailed description:

Arms: arm 1: Participants will receive tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week administered as monotherapy or in combination with methotrexate or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who complete the core study period will be allowed to enter a long-term-extension (LTE) period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC tocilizumab, whichever occurs first.
Interventions: intervention 1: Tocilizumab intervention 2: Methotrexate intervention 3: csDMARDs
Intervention descriptions: intervention 1: Tocilizumab will be administered at a dose of 162 mg as SC injection once a week. intervention 2: Methotrexate will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion. intervention 3: csDMARDs (at investigator's discretion) will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.

Protocol documents:
Clinical trial NCT02023918
Conditions: Diabetes Metabolic Syndrome Insulin Resistance
Keywords: Growth hormone antagonism
Sponsor: University of California, San Francisco
Start date: 2014-01-01; Completion date: 2015-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.

Detailed description:

Arms: arm 1: Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
Interventions: intervention 1: pegvisomant
Intervention descriptions: intervention 1: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.

Protocol documents:
Clinical trial NCT02061085
Conditions: Breast Neoplasm Metastasis
Keywords: Breast Neoplasm Metastasis Receptor,HER-2 Eribulin Furans, ketones Antimitotic agent
Sponsor: MedSIR
Start date: 2013-07-01; Completion date: 2015-12-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma (MBC) previously exposed to taxanes for early stage.

The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.

Detailed description:

Arms: arm 1: Eribulin Dosage: 1.4 mg/m2 Route of administration: IV bolus Schedule of cycle: D1 and D8 every 21 days
Interventions: intervention 1: Eribulin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02062658
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Sponsor: New York State Psychiatric Institute
Start date: 2013-12-01; Completion date: 2015-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.

Detailed description:

Arms: arm 1: 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Interventions: intervention 1: Ketamine intervention 2: Exposure and Response Prevention
Intervention descriptions: intervention 1: 0.5mg/kg IV intervention 2: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.

Protocol documents: