ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01560819
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: ulcerative colitis, gut microbial transplantation
Sponsor: Spectrum Health Hospitals
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC.

This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up.

Healthy donors \>18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.

Detailed description:

Arms: arm 1: Participants did not receive any bowel preparation before Gut Microbial Transplantation (GMT). Audio-visual aids were used to help reduce participants' anxiety about GMT.
Interventions: intervention 1: Gut Microbial Transplantation
Intervention descriptions: intervention 1: Each participant received Gut Microbial Transplantation (GMT) as retention enema over a period of 1 hour (60mL enema every 15 minutes) daily for 5 days. Although 240mL of GMT solution was prepared for each participant, the final administered dose was dependent on the subject's comfort and willingness to proceed with the next enema, which was assessed after each enema infusion. Subjects were monitored for 30 minutes after GMT for any immediate adverse events and discharged.

Protocol documents:
Clinical trial NCT01561833
Conditions: T Cell Lymphoma
Keywords: relapsed or refractory T cell lymphoma
Sponsor: Yale University
Start date: 2009-10-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other transformed T-cell lymphomas with the primary objective of studying the biological effects of the multikinase inhibitor, sorafenib.

Detailed description:
Primary objectives:

• To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein kinase (MAPK) pathway, specifically the inhibition of extracellular signal-regulated kinases (ERK) phosphorylation, and to correlate with clinical activity in patients with T-cell lymphoma.

Secondary objectives:

* To observe the clinical activity of sorafenib 400mg BID by determining response rate, and progression free survival in patients with T-cell lymphoma. Duration of response and duration of stable disease will also be measured.
* To determine the tolerability of sorafenib in patients with T-cell lymphoma.

Exploratory objectives:

* To observe the effects of sorafenib on T-cell subsets (CD4/CD8 ratio, and Tregs), and the effects of sorafenib on the monocytoid population.
* To observe the effects of sorafenib on the serum cytokine profile.
* To observe the effects of sorafenib on the T-cell receptor pathway, i.e. Lck, ZAP-70, and Syk.
* To observe changes in lymph node or skin morphology including tumor cell infiltrate, vasculature, and the tumor microenvironment in patients treated with sorafenib by performing serial biopsies of lymph nodes or skin.

Arms: arm 1: Sorafenib, 400 mg PO twice daily
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met.

Protocol documents:
Clinical trial NCT01563536
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C,Genotype 1
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2012-02-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.

Detailed description:
An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The study included post-treatment follow-up for 48 weeks.

Arms: arm 1: ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks arm 2: ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Interventions: intervention 1: ABT-267 intervention 2: ABT-450 intervention 3: ABT-333 intervention 4: Ritonavir intervention 5: Ribavirin
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Tablet intervention 4: Capsule intervention 5: Tablet

Protocol documents:
Clinical trial NCT01566604
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD) NVA237
Sponsor: Novartis Pharmaceuticals
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks treatment.

Detailed description:

Arms: arm 1: NVA237 50 µg once daily delivered via a single dose dry powder inhaler arm 2: Placebo once daily delivered via a single dose dry powder inhaler
Interventions: intervention 1: NVA237 intervention 2: Placebo
Intervention descriptions: intervention 1: Delivered via a single dose dry powder inhaler intervention 2: Delivered via a single dose dry powder inhaler

Protocol documents:
Clinical trial NCT01570829
Conditions: Obesity
Sponsor: Materia Medica Holding
Start date: 2011-12-01; Completion date: 2013-06-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2).
* To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).

Detailed description:
In general, patients will be observed during 24 weeks of trial.

Arms: arm 1: Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks. arm 2: Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Interventions: intervention 1: Dietressa intervention 2: Placebo
Intervention descriptions: intervention 1: Oral administration. intervention 2: Oral administration.

Protocol documents:
Clinical trial NCT01584518
Conditions: Fluid Over-load
Sponsor: Creighton University
Start date: 2012-07-01; Completion date: 2013-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The long-range goal of this proposal is to decrease morbidity and mortality related to pulmonary edema and congestive heart failure (CHF) in post-operative patients. The short-range goal is to determine a mechanistic endpoint when therapy for impending heart failure can be initiated and terminated based on B-type natriuretic peptide (BNP) levels. The investigators propose to utilize changing levels of BNP as a surrogate marker for CHF.

Detailed description:
Creighton University Medical Center is 334-bed Level I Trauma Center that hosts a wide variety of surgical and trauma patients. Many of these patients, including and especially those with pre-existing cardiac morbidities, develop symptoms of congestive heart failure (CHF) following trauma or surgical intervention because of a combination of physiological factors including third spacing followed by self-diuresis, and decreased contractility post injury. Normally, following the onset of CHF, surgeons begin treatment based on their clinical judgment of hemodynamic parameters and radiographic findings. CHF is known to increase morbidity, mortality, hospital length of stay and overall expenditure to the health care system and preventative measures and directed treatment modalities have potential to improve patient care and healthcare economics.

BNP, also known as beta-natriuretic protein or CHF peptide, is a cardiac neuro-hormone synthesized by the cardiac myocytes. It is released as a preproBNP peptide of 134 amino acids and is cleaved into proBNP (108 amino acids) and a signal peptide of 26 amino acids. ProBNP is subsequently cleaved into BNP (32 amino acids) and the inactive N-terminal proBNP peptide (NBNP; 76 amino acids). The effects of BNP are vasodilation, natriuresis and diuresis1.

Left ventricular end-diastolic wall stress (EDWS) measurement and ejection fraction are well established surrogates to predict the onset of CHF but require the invasive procedure of cardiac catheterization.

The mainstay of the treatment of CHF is diuretic drugs to try to remove excess fluid from the patient. In this project we plan to identify patients at risk for CHF and divide them into two groups. In one group BNP will be used to guide diuretic dosage and in the other conventional clinical parameters will be used.

Arms: arm 1: Diuresis based on CHF-P arm 2: Diuresis based on clinical judgement without data for CHF-P
Interventions: intervention 1: Furosemide
Intervention descriptions: intervention 1: Based on clinical standard per clinician

Protocol documents:
Clinical trial NCT01603394
Conditions: Postherpetic Neuralgia
Sponsor: Pfizer
Start date: 2012-10-01; Completion date: 2013-06-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.

Detailed description:
The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.

Arms: arm 1: None
Interventions: intervention 1: pregabalin
Intervention descriptions: intervention 1: Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.

Protocol documents:
Clinical trial NCT01616173
Conditions: Fracture of Ankle
Keywords: Nerve Block Anesthesia Recovery Period
Sponsor: Northwestern University
Start date: 2012-06-01; Completion date: 2013-06-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.

Detailed description:
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.

Arms: arm 1: Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL, and 50mL IV normal saline infusion arm 2: Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion arm 3: Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion
Interventions: intervention 1: Dexamethasone intervention 2: Dexamethasone intervention 3: Saline
Intervention descriptions: intervention 1: IV dexamethsone 8mg in 50mL (diluted in NS) intervention 2: 8mg/2mL intervention 3: 2mL

Protocol documents:
Clinical trial NCT01630109
Conditions: Pill Capsule Endoscopy Completion Rates
Sponsor: Ascension Health
Start date: 2012-12-01; Completion date: 2013-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam. This is a randomized, double-blind, placebo-controlled design. The outcomes to be assessed are capsule study completion rates, gastric transit time, small bowel transit time, and the effect of diabetes on pill capsule completion rates. The purpose of the study is to assess if metoclopramide given prior to pill capsule endoscopy has any effect on pill capsule completion rate, gastric transit time, small bowel transit time, and pill capsule completion rates in diabetes.

Detailed description:
Pill Capsule Endoscopy allows Gastroenterologists to visualize the mucosa of the small bowel beyond the reach of any endoscope and to an extent never before possible. It involves the ingestion of a small pill camera approximately the size of a large vitamin. 8 hours of images are transmitted to a sensor worn around the patient's waist. At the conclusion of the test, these images are downloaded to a computer for physician review. Meanwhile, the PillCam™ passes naturally through the digestive system and does not require retrieval.

Many of these pill capsule studies are incomplete due to failure of the pill capsule to reach the colon. Metoclopramide (brand name Reglan) is an anti-emetic that also has known pro-motility effects in the GI tract. The thought behind this study is that metoclopramide will increase the rate of passage of the pill capsule through the GI tract allowing a higher completion rate of the pill capsule studies.

Patients scheduled for pill capsule endoscopy will be approached on the morning of their procedure to inform them of the research study. After proper consent is obtained the patient will receive either 5 mg Metoclopramide, 10 mg Metoclopramide, or a placebo pill 30 minutes prior to their pill capsule study. The pill capsule camera records 8 hours worth of data. The patient will return at the conclusion of their study to turn in their recorder. The ordering gastroenterologist will then read the study. Information regarding pill capsule completion (pill capsule goes through the ileocecal valve), gastric transit time, and small bowel transit time will then be recorded and analyzed.

Arms: arm 1: Pro-motility agent arm 2: Pro-motility agent arm 3: Placebo to be used as the control group
Interventions: intervention 1: Metoclopramide intervention 2: Placebo
Intervention descriptions: intervention 1: A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy. intervention 2: A placebo capsule made to look like the metoclopramide capsule.

Protocol documents:
Clinical trial NCT01641159
Conditions: Cocaine Dependence
Keywords: Cocaine Crack Buspirone Relapse Prevention
Sponsor: University of Cincinnati
Start date: 2012-08-01; Completion date: 2013-06-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether or not buspirone is effective in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge.

Detailed description:
The primary objective is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment.

Arms: arm 1: Buspirone titrated to 60 mg/day for the 15-week active study arm 2: Placebo taken daily for the 15-week active study
Interventions: intervention 1: Buspirone intervention 2: Placebo
Intervention descriptions: intervention 1: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated. intervention 2: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.

Protocol documents:
Clinical trial NCT01645098
Conditions: Duchenne Muscular Dystrophy
Sponsor: Nationwide Children's Hospital
Start date: 2011-08-01; Completion date: 2013-06-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.

Detailed description:

Arms: arm 1: Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. arm 2: Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.
Interventions: intervention 1: Ketamine intervention 2: Dexmedetomidine
Intervention descriptions: intervention 1: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed intervention 2: 0.5 mcg/kg/hr IV

Protocol documents:
Clinical trial NCT01646814
Conditions: Gastroduodenal Ulceration
Keywords: Healthy volunteer comparison of incidence of treatment groups.
Sponsor: PLx Pharma
Start date: 2012-09-01; Completion date: 2013-06-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.

Detailed description:
Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Arms: arm 1: Investigational product, PL2200 arm 2: Active comparator, 325 mg aspirin tablets
Interventions: intervention 1: PL2200 intervention 2: Aspirin tablets
Intervention descriptions: intervention 1: PL2200, containing 325 mg aspirin active ingredient intervention 2: 325 mg aspirin tablets (USP)

Protocol documents:
Clinical trial NCT01657877
Conditions: Caries
Sponsor: GlaxoSmithKline
Start date: 2012-05-01; Completion date: 2013-06-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.

Detailed description:

Arms: arm 1: Dentifrice containing high fluoride content as SMFP and CSP arm 2: Dentifrice containing high fluoride content as SMFP and no CSP arm 3: Dentifrice containing low fluoride content as SMFP and no CSP arm 4: Dentifrice containing CSP but no fluoride arm 5: Dentifrice containing no CSP and no fluoride
Interventions: intervention 1: Calcium sodium phosphosilicate intervention 2: Sodium monoflurophosphate intervention 3: Placebo
Intervention descriptions: intervention 1: CSP high percentage weight by weight intervention 2: 500 to 1500 parts per million (ppm) of fluoride intervention 3: No CSP and no fluoride

Protocol documents:
Clinical trial NCT01696071
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2012-09-01; Completion date: 2013-06-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg tiotropium administered twice daily (morning and evening). In addition compare the 24 hours pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium administered twice daily in pharmacokinetic sub-investigation.

Detailed description:

Arms: arm 1: 2 puffs of daily dose (5 mcg) in the evening and 2 puffs of matching placebo in the morning via Respimat inhaler arm 2: 2 puffs of half daily dose (2.5 mcg) twice daily, in the evening and in the morning via Respimat inhaler
Interventions: intervention 1: Tiotropium 5 mcg qd intervention 2: Tiotropium 2.5 mcg bid
Intervention descriptions: intervention 1: 2 puffs (2.5 mcg each) in the evening 5 mcg in total and 2 puffs of matching placebo in the morning intervention 2: 2 puffs (1.25 mcg each) twice daily, in the evening and in the morning, 5 mcg in total

Protocol documents: