ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01146613
Conditions: Alcoholism
Keywords: Alcohol Alcohol abuse Alcoholism Alcohol Dependence Varenicline Drinking
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date: 2011-02-01; Completion date: 2012-07-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).

Detailed description:

Arms: arm 1: Varenicline Tartrate arm 2: None
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5mg capsules x 2, 2x a day for 12 weeks intervention 2: identical matched placebo x 2, 2xday, 13 weeks

Protocol documents:
Clinical trial NCT01151761
Conditions: Cholangiocarcinoma Hepatobiliary Neoplasm Liver Cancer Bile Duct Cancer Cancer of Gallbladder
Sponsor: Stanford University
Start date: 2011-01-01; Completion date: 2012-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA).

Detailed description:
Investigators hope to learn more about neoadjuvant SBRT and chemotherapy for unresectable CCA, and if SBRT followed by chemotherapy can lead to successful liver transplantation. This knowledge is important for this patient group as this disease is a highly lethal malignancy that often presents as unresectable, however surgery or transplantation are the only curative options.

Arms: arm 1: The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
Interventions: intervention 1: Stereotactic Body Radiotherapy intervention 2: Gemcitabine intervention 3: Cisplatin intervention 4: Carboplatin intervention 5: Capecitabine intervention 6: 5FU intervention 7: Liver transplantation
Intervention descriptions: intervention 1: Standard of care intervention 2: 100 mg/m2, IV intervention 3: 25 mg/m2, IV intervention 4: AUC 2, based on Calvert formula, IV intervention 5: 1000 mg/m2, PO intervention 6: 200 mg/m2 intervention 7: None

Protocol documents:
Clinical trial NCT01152190
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2010-09-01; Completion date: 2012-07-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally, once daily for 8 weeks intervention 2: Administered orally, once daily for 8 weeks

Protocol documents:
Clinical trial NCT01164501
Conditions: Diabetes Mellitus, Type 2 Renal Insufficiency
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2012-07-01
Enrollment: 741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.

Detailed description:

Arms: arm 1: BI 10773 tablets once daily arm 2: BI 10773 tablets once daily arm 3: Placebo tablets matching BI 10773
Interventions: intervention 1: BI 10773 intervention 2: Placebo intervention 3: Placebo intervention 4: BI 10773 intervention 5: Placebo intervention 6: Placebo
Intervention descriptions: intervention 1: BI 10773 tablets once daily intervention 2: Placebo tablets identical to BI 10773 low dose intervention 3: Placebo tablets identical to BI 10773 high dose intervention 4: BI 10773 tablets once daily intervention 5: Placebo tablets identical to BI 10773 low dose intervention 6: Placebo tablets identical to BI 10773 high dose

Protocol documents:
Clinical trial NCT01184456
Conditions: HIV Infection Gastrointestinal Symptoms
Keywords: AIDS Acquired Immunodeficiency Syndrome HIV Human Immunodeficiency Virus
Sponsor: AIDS Healthcare Foundation
Start date: 2010-08-01; Completion date: 2012-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Improvement in the rate of bacterial translocation may lead to a decrease in a chronic inflammatory response thereby decreasing CD4 destruction and HIV proliferation.

By the addition of probiotics we hope to show a reduction in LPS leading to a decrease in chronic inflammation and therefore an improvement in immune markers.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GanedenBC30, GBI-30, PTA-6086 intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days. intervention 2: 1 capsule per day for 90 days.

Protocol documents:
Clinical trial NCT01189461
Conditions: Anti- VGF Inhibitor Diabetic Macular Edema Diabetic Retinopathy
Keywords: pegaptanib sodium diabetic macular edema
Sponsor: Pfizer
Start date: 2011-01-01; Completion date: 2012-07-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic macular edema.

Detailed description:

Arms: arm 1: all patients will receive pegaptanib sodium
Interventions: intervention 1: pegaptanib sodium
Intervention descriptions: intervention 1: Upon enrollment, all subjects will be treated in the study eye with pegaptanib sodium 0.3 mg at the investigators' discretion based on visual acuity assessment up to a maximum of 48 weeks. The minimum dosing interval between injections will be at least 6 weeks.

Protocol documents:
Clinical trial NCT01227655
Conditions: Parkinson's Disease
Keywords: Parkinson PD Wearing-off Levodopa/DDCI
Sponsor: Bial - Portela C S.A.
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 427 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

Detailed description:
This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.

DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa

Arms: arm 1: BIA 9-1067, OPC, Opicapone 25 mg once daily (QD). arm 2: BIA 9-1067, OPC, Opicapone 50 mg once daily (QD). arm 3: PLC, Placebo
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Levodopa intervention 4: Carbidopa intervention 5: Benserazide
Intervention descriptions: intervention 1: Capsules will be used. intervention 2: comparator intervention 3: None intervention 4: DOPA decarboxylase inhibitor (DDCI) intervention 5: DOPA decarboxylase inhibitor

Protocol documents:
Clinical trial NCT01246713
Conditions: Acetaminophen Metabolism Acetaminophen Poisoning Drug Metabolism by Excipients
Keywords: acetaminophen excipients
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2010-12-01; Completion date: 2012-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether excipients in the liquid formulation of acetaminophen prevent the formation of the toxic metabolites of acetaminophen.

Detailed description:
Acetaminophen (APAP) poisoning is the most frequent cause of acute hepatic failure in the United States. Toxicity requires cytochrome P-450 bioactivation of APAP. Children are less susceptible to APAP toxicity; the current theory is that they have different metabolism than adults. However, children's liquid preparations of APAP contain excipients which have been shown to inhibit APAP bioactivation in vitro and in rodents. Children tend to ingest liquid preparations, which could potentially explain their decreased susceptibility instead of an intrinsically different metabolism. Further, our review of Poison Center epidemiologic data shows that liquid preparations are less toxic in adults. Our hypothesis is that excipients in liquid preparations inhibit the bioactivation of APAP. The design is a pharmacokinetic cross-over study in humans. Healthy adult subjects will be recruited for administration of therapeutic doses of APAP in capsule and liquid formulations. Plasma via a heplock will be collected at serial time points up to 8 hours and assayed for APAP and its metabolites. After a washout period, subjects will receive the same dose of APAP in the alternate preparation. The pattern of metabolites, indicating the activity of the bioactivating enzymes, will be compared. A significant difference in P-450 metabolites will support the hypothesis and provide preliminary data for studies in patients who have ingested potentially toxic doses of APAP. Ultimately, this work could support development of novel antidotal therapy for APAP overdose.

Arms: arm 1: Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. arm 2: Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation.
Interventions: intervention 1: Acetaminophen liquid formulation intervention 2: Acetaminophen solid formulation
Intervention descriptions: intervention 1: Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. intervention 2: Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.

Protocol documents:
Clinical trial NCT01250925
Conditions: Myopia Refractive Error
Keywords: Contact lens Lens care
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2010-08-01; Completion date: 2012-07-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

Detailed description:
An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.

Arms: arm 1: 33 participants will be assigned to use this lens care regimen during the six-week assessment period arm 2: 33 participants will be assigned to use this lens care regimen during the six-week assessment period arm 3: 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Interventions: intervention 1: ReNu MultiPlus® MultiPurpose Solution intervention 2: OPTI-FREE® RepleniSH® intervention 3: Clear Care®
Intervention descriptions: intervention 1: Contact lens care regimen intervention 2: Contact Lens care regimen intervention 3: Contact lens care regimen

Protocol documents:
Clinical trial NCT01254305
Conditions: Major Depressive Disorder
Keywords: Depression Fatigue Major Depressive Disorder
Sponsor: Forest Laboratories
Start date: 2011-04-01; Completion date: 2012-07-01
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Detailed description:

Arms: arm 1: 40 -120 mg/day Levomilnacipran ER capsules, oral administration arm 2: Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing arm 3: Matching placebo capsules, oral administration
Interventions: intervention 1: Levomilnacipran ER intervention 2: Paroxetine, Sertraline, Citalopram or Fluoxetine. intervention 3: Placebo
Intervention descriptions: intervention 1: Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks intervention 2: Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks intervention 3: Matching placebo capsules, oral administration, once daily dosing

Protocol documents:
Clinical trial NCT01256658
Conditions: Malaria
Keywords: P. falciparum malaria asymptomatic carriers bed-nets ITN-insecticide-treated net idiopathic trigeminal neuralgia RDT-Rapid diagnostic test
Sponsor: Novartis
Start date: 2010-11-01; Completion date: 2012-07-01
Enrollment: 14075 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a number of clinical malaria cases in children less than 5 years of age and the improvement of hemoglobin levels in the overall population.

Detailed description:

Arms: arm 1: Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. arm 2: Participants received COA566 treatment for symptomatic malaria episodes only.
Interventions: intervention 1: COA566
Intervention descriptions: intervention 1: COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.

Protocol documents:
Clinical trial NCT01270542
Conditions: Retinal Detachment Diabetic Retinopathy
Keywords: Traction Retinal Detachment (PDR) Proliferative Diabetic Retinopathy (PDR)
Sponsor: University of Southern California
Start date: 2009-06-01; Completion date: 2012-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Detailed description:
Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Arms: arm 1: Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. arm 2: Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
Interventions: intervention 1: Avastin (bevacizumab) intervention 2: Sham injection
Intervention descriptions: intervention 1: single 0.05 mL intravitreal injection of bevacizumab 1.25 mg intervention 2: Subject's eyes will be anesthetized but no injection will be performed.

Protocol documents:
Clinical trial NCT01292005
Conditions: Acute Pancreatitis
Keywords: pancreatitis pancreatic necrosis severe acute pancreatitis (SAP) Alcoholic pancreatitis gallstone pancreatitis
Sponsor: Mayo Clinic
Start date: 2009-04-01; Completion date: 2012-07-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.

Detailed description:
Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in.

You will be put into either the treatment group or the control group.

* The treatment group will receive a drug called pentoxifylline
* The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours).

When subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.

Arms: arm 1: Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. arm 2: Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Interventions: intervention 1: Pentoxifylline intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. intervention 2: 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.

Protocol documents:
Clinical trial NCT01292187
Conditions: Osteopenia
Keywords: Osteoporosis Osteopenia Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Salmon calcitonin Calcitonin
Sponsor: Tarsa Therapeutics, Inc.
Start date: 2011-01-01; Completion date: 2012-07-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.

Detailed description:
This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US. The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits. Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability. After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo. All subjects took 600 mg calcium citrate and 1000 IU vitamin D once daily with breakfast beginning with the run-in phase. The duration of treatment including the run-in phase was 54 weeks. Bone mineral density (BMD) and C-terminal telopeptide of type 1 collagen (CTx-1) were determined at Baseline and Weeks 28 and 54 after randomization. The % change from baseline in lumbar spine BMD was calculated and compared: active to placebo. The change from baseline in plasma CTx-1 was also calculated and compared likewise.

To confirm that there is no effect of meal timing on this product, subjects in both arms were further randomized to take the active or placebo on an empty stomach at bedtime or with the meal at dinnertime.

Arms: arm 1: Intervention: Oral calcitonin at dinnertime or oral calcitonin at bedtime. Postmenopausal subjects with osteopenia were treated for one year (also with vitamin D and calcium supplements) to determine if oral calcitonin tablets would prevent the loss of bone mineral density compared with placebo. Randomization to active or placebo was done 2:1. After randomization, further randomization was done to divide each arm into two groups, one in which dosing was at dinnertime and the other in which dosing was at bedtime to determine if food affected efficacy or safety. arm 2: Intervention: oral placebo at dinnertime or oral placebo at bedtime
Interventions: intervention 1: Oral calcitonin at dinnertime intervention 2: Oral placebo at dinnertime intervention 3: Oral calcitonin at bedtime intervention 4: Oral placebo at bedtime
Intervention descriptions: intervention 1: Oral calcitonin at dinnertime. intervention 2: Oral placebo at dinnertime. intervention 3: Oral calcitonin at bedtime intervention 4: Oral placebo at bedtime

Protocol documents:
Clinical trial NCT01294462
Conditions: Acute Coronary Syndrome Percutaneous Coronary Intervention
Keywords: acute coronary syndrome coronary disease coronary artery disease
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2012-07-01
Enrollment: 801 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: Ticagrelor (AZD6140) arm 2: Clopidogrel
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel intervention 3: Acetylsalicylic acid ASA
Intervention descriptions: intervention 1: 90 mg, oral dose twice daily intervention 2: 75 mg, oral dose once daily intervention 3: Low Dose ASA

Protocol documents: