ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01487499
Conditions: Small Cell Lung Cancer
Sponsor: University of Florida
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:

1. to implement a prospective clinical trial to test the feasibility and efficacy of intralesional chemotherapy as consolidative therapy immediately following standard systemic chemotherapy and radiation therapy for patients with limited stage SCLC by comparing tumor growth and survival rates of the treatment group and compare the outcomes to historical controls
2. to implement a prospective clinical trial to test the feasibility and efficacy as measured by tumor growth and survival rates of intralesional chemotherapy for patients with recurrent SCLC after standard treatment.

Detailed description:
Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome measurements of tumor growth and survival will be compared to subjects receiving standard of care treatment only.

Arms: arm 1: Subjects with limited stage SCLC treated sequentially with cisplatin. arm 2: No intervention
Interventions: intervention 1: Cisplatin
Intervention descriptions: intervention 1: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies

Protocol documents:
Clinical trial NCT01488487
Conditions: Advanced Adult Hepatocellular Carcinoma
Keywords: HCC Advanced Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma Liver Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to estimate the time to disease progression when everolimus and pasireotide are given together in patients with advanced or metastatic HCC who have not had any prior systemic therapy.

Detailed description:
This open label, single-arm Phase II study will assess time to progression (TTP) and safety of everolimus and pasireotide in patients with advanced or metastatic hepatocellular carcinoma (HCC) and limited prior systemic therapy. Should this regimen demonstrate efficacy, this will support a Phase III randomized clinical trial of this combination therapy. At least 30 patients will be enrolled into this Phase II study. Additionally, given the potential importance of the RAS/RAF/MEK/ERK and RAS/pAKT pathways, we propose to correlate outcomes with baseline pAKT, p-S6, somatostatin receptor tumor expression, and serum VEGF expression. We anticipate these exploratory analyses will increase understanding of the molecular pathways and their inhibition in this disease. The study will be performed as a University of North Carolina-coordinated, multicenter study.

Arms: arm 1: Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide Long Acting Release (LAR) 60 mg administered by intramuscular injection once per 28 day cycle on day 1.
Interventions: intervention 1: Everolimus intervention 2: Pasireotide
Intervention descriptions: intervention 1: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity. intervention 2: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT01509079
Conditions: Muscle Pain Joint Pain
Sponsor: HealthPartners Institute
Start date: 2012-03-01; Completion date: 2015-03-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.

Detailed description:
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vitamin D3 intervention 2: Vitamin D3
Intervention descriptions: intervention 1: Cholecalciferol capsule, 4000IU, daily for 6 months intervention 2: cholecalciferol capsule, 600 IU, daily for 6 months

Protocol documents:
Clinical trial NCT01522703
Conditions: Allergic Rhinitis Asthma Allergy
Keywords: asthma allergic rhinitis dietary interventions mouse allergy
Sponsor: Johns Hopkins University
Start date: 2012-03-01; Completion date: 2015-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization.

The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.

Detailed description:

Arms: arm 1: Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days arm 2: Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days
Interventions: intervention 1: Broccoli Sprouts intervention 2: Placebo
Intervention descriptions: intervention 1: 100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form. intervention 2: Alfalfa Sprouts

Protocol documents:
Clinical trial NCT01526408
Conditions: Meniere's Disease
Keywords: Meniere's Disease Vertigo Hearing loss Tinnitus Anti-viral Famciclovir
Sponsor: House Research Institute
Start date: 2011-12-01; Completion date: 2015-03-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.

Detailed description:

Arms: arm 1: Treatment with 3 months of placebo arm 2: Treatment with 3 months of active drug
Interventions: intervention 1: Famciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug). intervention 2: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months).

Protocol documents:
Clinical trial NCT01535261
Conditions: Macular Edema Central Retinal Vein Occlusion
Keywords: Ophthalmology Ranibizumab Central Retinal Vein Occlusion
Sponsor: Novartis Pharmaceuticals
Start date: 2012-02-01; Completion date: 2015-03-01
Enrollment: 357 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

Detailed description:

Arms: arm 1: Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
Interventions: intervention 1: Ranibizumab 0.5 mg/0.05 ml
Intervention descriptions: intervention 1: Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.

Protocol documents:
Clinical trial NCT01563185
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA ibuprofen famotidine pediatrics for > 1 month
Sponsor: Amgen
Start date: 2012-04-01; Completion date: 2015-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks.

The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.

Detailed description:
Approximately 30 JIA patients who meet all eligibility criteria and who are expected to require daily administration of an NSAID for up to 24 weeks will be enrolled. A subset of approximately 6 patients will participate in a single dose PK study at Day 0 with an abbreviated PK profile performed at Week 4 if possible. Multiple dose PK sampling will occur in all enrolled patients.

Study with completed results acquired from Horizon in 2024

Arms: arm 1: 800 mg ibuprofen/26.6 mg famotidine
Interventions: intervention 1: 800 mg ibuprofen/26.6 mg famotidine
Intervention descriptions: intervention 1: Oral tablet taken three time per day

Protocol documents:
Clinical trial NCT01571232
Conditions: Diabetic Macular Edema Non-proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy
Keywords: Macular Edema DME PDR NPDR Ozurdex Dexamethasone Avastin Bevacizumab
Sponsor: Retina Macula Institute
Start date: 2012-04-01; Completion date: 2015-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.

Detailed description:
This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

Arms: arm 1: Patients in this group receive Ozurdex at initial visit and at month 4 arm 2: Patients in this group receive Avastin Q1 month for 5 months.
Interventions: intervention 1: dexamethasone intravitreal implant intervention 2: intravitreal bevacizumab
Intervention descriptions: intervention 1: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5) intervention 2: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Protocol documents:
Clinical trial NCT01578850
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis etanercept methotrexate DMARDs
Sponsor: Pfizer
Start date: 2012-07-01; Completion date: 2015-03-01
Enrollment: 491 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Etanercept intervention 2: placebo
Intervention descriptions: intervention 1: etanercept 50mg once weekly + methotrexate with or without other DMARDs intervention 2: etanercept placebo once weekly + methotrexate with or without other DMARDs

Protocol documents:
Clinical trial NCT01580670
Conditions: Pediatric Crohn's Disease
Keywords: Infliximab REMICADE TA-650 pediatric Crohn's disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-03-01; Completion date: 2015-03-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.

Detailed description:
This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

Arms: arm 1: Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30.

Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg.

1. PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10
2. PCDAI score on the evaluation day exceeds 30
Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

Protocol documents:
Clinical trial NCT01585207
Conditions: Tourette's Disorder
Keywords: Tourette's Disorder vigabatrin
Sponsor: Barbara J. Coffey
Start date: 2012-07-01; Completion date: 2015-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if vigabatrin, an unusual anti-seizure medication, will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted into adulthood and have not responded to usual treatment.

Detailed description:
The aims of this study are to 1) explore proof of concept that CPP-109 will reduce tics, and 2) to obtain systematic data regarding dosing, safety and tolerability of CPP-109 in adults with treatment refractory TD. We will obtain preliminary data on estimate of effect size for tics using Cohen's d, calculating the difference between the two means (baseline and endpoint scores on the YGTSS), divided by the standard deviation of the difference.

Arms: arm 1: 3 tablets, bid for 8 weeks
Interventions: intervention 1: vigabatrin
Intervention descriptions: intervention 1: 3 tablets, bid for 8 weeks

Protocol documents:
Clinical trial NCT01623323
Conditions: Chronic Sinusitis With or Without Nasal Polyps
Sponsor: Optinose US Inc.
Start date: 2013-09-01; Completion date: 2015-03-01
Enrollment: 705 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Fluticasone Propionate
Intervention descriptions: intervention 1: Fluticasone Propionate 400 μg

Protocol documents:
Clinical trial NCT01625897
Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Mental Disorder Psychotropic Drugs Dopamine Agents Risperidone Central Nervous System Agents
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-05-01; Completion date: 2015-03-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with chronic phase or elderly schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MP-214 intervention 2: Risperidone
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214 intervention 2: Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone

Protocol documents:
Clinical trial NCT01631994
Conditions: Gastric Transit Time
Keywords: metoclopramide video capsule endoscopy gastric transit time
Sponsor: Winthrop University Hospital
Start date: 2011-09-01; Completion date: 2015-03-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Summary:

This study investigates the use of oral dissolving metoclopramide during standard video capsule endoscopy. Metoclopramide is a pro -motility agent, that is, this medication helps with movement through the stomach and small bowel. This study will help us determine the effectiveness of oral dissolving metoclopramide on transit time through the stomach and small bowel of the video capsule that is ingested. This study may help with better diagnoses of pathology in the small bowel. Each patient enrolled in the study will either be assigned to a group that only ingests the capsule or the group that receives the oral dissolving metoclopramide plus capsule. Each patient will undergo the same standard procedures and precaution used during standard video capsule endoscopy. The patients that will qualify for the study are patients that are in need of video capsule endoscopy for further imaging of the small bowel. The patients must meet the inclusion criteria provided in the protocol and must not meet any of the exclusion criteria in the protocol. The hypothesis is that the patients that ingest the metoclopramide will have better capsule images and transit time and will allow for enhanced diagnosis of small bowel pathology.

Detailed description:

Arms: arm 1: Patient's in this arm will receive the oral dissolving metoclopramide along with the capsule during capsule endoscopy. arm 2: This is the control group that will only ingest the capsule during video capsule endoscopy.
Interventions: intervention 1: metoclopramide
Intervention descriptions: intervention 1: 1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.

Protocol documents:
Clinical trial NCT01654276
Conditions: Gout
Sponsor: University of Texas Southwestern Medical Center
Start date: 2012-05-01; Completion date: 2015-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to evaluate whether the medication, febuxostat, can improve the degree of insulin resistance and other features of the metabolic syndrome (high blood pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol) by lowering uric acid levels in the blood.

Detailed description:
The metabolic syndrome (MS) is characterized by a constellation of metabolic features including dyslipidemia, hyperglycemia, hypertension, obesity, and insulin resistance. This cluster of features is strongly associated with type 2 diabetes, atherosclerotic cardiovascular disease, and increased cardiovascular and all-cause mortality. Hyperuricemia (elevated serum uric acid) is associated with insulin resistance and features of the MS in cross-sectional epidemiological studies. However, it remains unclear whether this association is causal or simply coincidental. If hyperuricemia CAUSES insulin resistance, then lowering serum uric acid by pharmacological means may result in improved insulin sensitivity and reversal of features of the metabolic syndrome. In some recent small studies, lowering serum uric acid with allopurinol was associated with improvement in some of the features and/or complications of the MS: Allopurinol use resulted in reduction in blood pressure in adolescents and improvement in exercise capacity in patients with chronic stable angina. A low urine pH is strongly associated with insulin resistance, and individual features of the metabolic syndrome. Similarly, a low fractional excretion of uric acid is also associated with metabolic syndrome feature. We therefore would like to examine the effect on febuxostat on these two parameters which have been linked with the metabolic syndrome.

The goal of this study is to evaluate whether pharmacological lowering of serum uric acid with the medication febuxostat is associated with improvement in the degree of insulin resistance and various features of the metabolic syndrome.

Arms: arm 1: Adult patients (age \> 21 years) with gout and hyperuricemia (serum uric acid \> 7.0 mg/dl in men and \>6.0 mg/dl in women) requiring uric acid lowering therapy.
Interventions: intervention 1: Febuxostat
Intervention descriptions: intervention 1: One 40 mg tablet once a day for 6 months

Protocol documents: