ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00887588
Conditions: Chronic Heart Failure
Keywords: Chronic heart failure preserved ejection fraction cardiovascular disease NT-proBNP biomarkers Heart failure with preserved left-ventricular ejection fraction
Sponsor: Novartis Pharmaceuticals
Start date: 2009-11-01; Completion date: 2011-12-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.

Detailed description:

Arms: arm 1: During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid. arm 2: During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
Interventions: intervention 1: LCZ696 intervention 2: Valsartan intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg, 100 mg and 200 mg tablets intervention 2: 40 mg, 80 mg and 160 mg tablets intervention 3: matching placebo to LCZ696 and Valsartan

Protocol documents:
Clinical trial NCT00920855
Conditions: Multiple Myeloma
Sponsor: Cephalon
Start date: 2009-06-01; Completion date: 2011-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).

Detailed description:

Arms: arm 1: Bendamustine in escalating doses of 50, 70 or 90 mg/m\^2 as combination therapy with bortezomib at 1.0 mg/m\^2/dose administered for up to eight 28 day cycles.
Interventions: intervention 1: bendamustine intervention 2: bortezomib
Intervention descriptions: intervention 1: Bendamustine was administered to 3 cohorts of patients at escalating doses of 50 (cohort 1), 70 (cohort 2) and 90 mg/m\^2/dose (cohort 3). Doses were administered by intravenous (iv) infusion once daily on days 1 and 4 of each 28-day cycle. Each iv was administered over 60 minutes and followed the injection of bortezomib.

Bortezomib will be administered to patients at a dose of 1.0 mg/m2/dose as an iv push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered to patients on days 1, 4, 8 and 11 of the 28-day cycle. intervention 2: Bortezomib was administered at a dose of 1.0 mg/m\^2/dose as an intravenous (iv) push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered on days 1, 4, 8 and 11 of each 28-day cycle.

Protocol documents:
Clinical trial NCT00932022
Conditions: Obesity Overactive Bladder Incontinence
Sponsor: Allergan
Start date: 2009-07-01; Completion date: 2011-12-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.

Detailed description:

Arms: arm 1: Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. arm 2: Placebo capsule taken orally once daily for 14 weeks.
Interventions: intervention 1: Trospium Chloride, Extended Release (XR) intervention 2: placebo
Intervention descriptions: intervention 1: Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks. intervention 2: Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Protocol documents:
Clinical trial NCT00932126
Conditions: Advanced Solid Tumors
Keywords: Phase 1 dose escalation dose finding pharmacokinetic and pharmacodynamic study
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2011-12-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.

Detailed description:
The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that contributed to the study termination.

Arms: arm 1: None
Interventions: intervention 1: PF-03758309
Intervention descriptions: intervention 1: Oral PF-03758309 will be administered in capsules (once or twice daily) until toxicity, progressive disease, or patient refusal to continue on therapy. The starting dose is 1 mg once daily.

Protocol documents:
Clinical trial NCT00940485
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2009-04-01; Completion date: 2011-12-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks. arm 2: Participants received entecavir 0.5 mg orally once daily for 48 weeks.
Interventions: intervention 1: entecavir intervention 2: entecavir intervention 3: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 0.5mg po daily for 8 weeks intervention 2: 0.5mg po daily for 48 weeks intervention 3: 180 micrograms sc/week for 48 weeks

Protocol documents:
Clinical trial NCT00942149
Conditions: Sepsis
Keywords: Infants Daptomycin
Sponsor: Duke University
Start date: 2010-01-01; Completion date: 2011-12-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC \<740 mch\*hr/mL.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: single dose of 6 mg/kg of daptomycin

Protocol documents:
Clinical trial NCT00945529
Conditions: Congenital Heart Defect
Keywords: Fontan
Sponsor: Ellen Spurrier
Start date: 2008-02-01; Completion date: 2011-12-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.

Detailed description:

Arms: arm 1: historical controls group of patients who did not receive iNO. arm 2: Prospective group who received iNO.
Interventions: intervention 1: inhaled nitric oxide (iNO)
Intervention descriptions: intervention 1: Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.

Protocol documents:
Clinical trial NCT00961298
Conditions: Irritable Bowel Syndrome Generalized Anxiety Disorder
Keywords: IBS Irritable Bowel Syndrome GAD Generalized Anxiety Disorder
Sponsor: West Penn Allegheny Health System
Start date: 2009-09-01; Completion date: 2011-12-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators propose to evaluate the effectiveness of duloxetine in treating subjects with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The investigators hypothesize that duloxetine as a single therapeutic agent will effectively target pain and other core symptoms of IBS as well as GAD in this patient population with both conditions.

Detailed description:
Generalized Anxiety Disorder (GAD) is commonly associated with Irritable Bowel Syndrome(IBS). The etiology of IBS remains unknown and it is often refractory to treatment. Duloxetine has demonstrated efficacy in the treatment of GAD as well as other pain disorders including fibromyalgia and diabetic neuropathy.

We plan to study 30 subjects with diagnoses of IBS and GAD between the ages of 18 and 65 years. There will be a single-blind placebo-run-in for the first 2 weeks, followed by open-label duloxetine for 12 weeks flexibly titrated to 120 mg/day. Subjects will be informed that they will receive placebo for 2 weeks during the trial. All study visits will be at Allegheny General Hospital Department of Psychiatry. The study consists of a total of nine office visits.

Arms: arm 1: Two weeks of placebo run in followed by 12 weeks of Duloxetine.
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.

Protocol documents:
Clinical trial NCT00967018
Conditions: Prostate Cancer
Keywords: Safety parameters ECG, blood and urine samples general health state
Sponsor: Ferring Pharmaceuticals
Start date: 2009-08-01; Completion date: 2011-12-01
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Detailed description:

Arms: arm 1: The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Interventions: intervention 1: Degarelix
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00974922
Conditions: Vitamin D Deficiency Hypertension
Keywords: Vitamin D Hypertension
Sponsor: UConn Health
Start date: 2009-08-01; Completion date: 2011-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.

Detailed description:
This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.

Arms: arm 1: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Aliskiren 150 mg to 300 mg once daily for 6 weeks arm 2: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks arm 3: Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks
Interventions: intervention 1: Aliskiren intervention 2: Cholecalciferol intervention 3: Placebo
Intervention descriptions: intervention 1: 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks intervention 2: 3000 I.U. once daily for 6 weeks intervention 3: Placebo for two weeks

Protocol documents:
Clinical trial NCT00982033
Conditions: Heart Failure
Keywords: Heart failure with normal ejection fraction Elderly
Sponsor: Wake Forest University Health Sciences
Start date: 2009-07-01; Completion date: 2011-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether treatment with aliskiren (300 mg) compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients with heart failure and normal ejection fraction (HFNEF).

Detailed description:
Heart Failure with Normal Ejection Fraction (HFNEF) is the most common form of heart failure, particularly in older persons. However, the optimal therapy for this disorder has not been defined. The primary chronic symptom in HFNEF is exercise intolerance, manifested by shortness of breath and fatigue with exercise. This is the major determinant of quality of life, can be measured objectively and reproducibly and is modifiable.

Arms: arm 1: 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo. arm 2: 50% of subjects will be randomized to placebo.
Interventions: intervention 1: aliskiren intervention 2: placebo
Intervention descriptions: intervention 1: aliskiren 300mg qd versus placebo for 24 weeks. intervention 2: placebo qd for 24 weeks

Protocol documents:
Clinical trial NCT00986479
Conditions: Treatment Resistant Major Depressive Disorder
Keywords: Patients
Sponsor: AstraZeneca
Start date: 2009-12-01; Completion date: 2011-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.

Detailed description:

Arms: arm 1: Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period. arm 2: Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
Interventions: intervention 1: AZD6765 intervention 2: Placebo to AZD6765
Intervention descriptions: intervention 1: Single IV infusion of 150 mg AZD6765. intervention 2: Single IV infusion of Placebo to AZD6765

Protocol documents:
Clinical trial NCT00994448
Conditions: Adolescent Methamphetamine Abuse
Keywords: Adolescents Methamphetamine abuse Bupropion Addiction Pharmacotherapy Cognitive Behavioral Therapy Contingency Management Teens
Sponsor: University of California, Los Angeles
Start date: 2009-10-01; Completion date: 2011-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dr Keith Heinzerling, who is a doctor at UCLA, is doing a research study with Behavioral Health Services in the Lincoln Heights neighborhood of Los Angeles to find out if a medication called bupropion can help adolescents (age 14-21) reduce or stop using methamphetamine. Bupropion is a drug that is already on the market, which means it has been approved by the FDA, but it has not been approved to treat methamphetamine abuse. What the study is trying to find out is if bupropion helps people to stop using methamphetamine. The study lasts up to 14 weeks and involves visits to the BHS clinic in Lincoln Heights twice a week. The first two weeks involve completion of questionnaires and assessments, including a physical exam, a blood test, EKG (a test that checks for problems with the electrical activity of a person's heart), and a psychological interview, to see if you are eligible for the study. If you are eligible, then you will be assigned by chance to take either the bupropion pills or placebo pills, which are pills that look the same, but contain no medication. This type of study is called a "double blind study" because neither you nor any of the study staff will know which medication you are taking. During the 8 weeks of taking the pills, you'll visit the clinic to complete additional questionnaires and assessments, to provide urine samples for testing for methamphetamine, and for once a week drug abuse counseling. At the end of your treatment, you'll have another physical exam including blood tests and the same test on your heart and then we'll ask you to come to the clinic once a week for four weeks for follow-up assessments. You'll be compensated for time spent doing research activities and for returning empty medication packages. The total compensation possible is $332 in gift cards for places such as Target, iTunes, groceries, and gas.

Your participation in the study is voluntary and deciding not to participate or deciding to stop participating at any time during the study is okay.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bupropion SR 150mg tabs intervention 2: Placebo tablets
Intervention descriptions: intervention 1: Bupropion SR 150mg tabs (Zyban) twice daily intervention 2: One placebo tablet twice daily

Protocol documents:
Clinical trial NCT00998582
Conditions: HIV Infections
Keywords: Cardiovascular Disease HIV Infection Abacavir Artery Elasticity Treatment experienced
Sponsor: Hennepin Healthcare Research Institute
Start date: 2009-10-01; Completion date: 2011-12-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent research as suggested that use of the HIV medication abacavir (Ziagen, or co-formulated with lamivudine as Epzicom) may increase risk for heart disease, though findings from multiple studies have been inconsistent. This pilot study will examine vascular function, a marker of heart disease risk, among patients taking abacavir as part of their HIV medications and are then randomized to: 1) switch to tenofovir, another HIV medication, or 2) continue to take abacavir.

Detailed description:

Arms: arm 1: Participants randomized to this arm will continue abacavir and their other HIV medications with no changes arm 2: Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
Interventions: intervention 1: Tenofovir disoproxil
Intervention descriptions: intervention 1: Participants taking an abacavir-based HIV treatment regimen will be randomized to switch to a tenofovir-based regimen or continue taking abacavir.

Protocol documents:
Clinical trial NCT01003184
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta insulin detemir Levemir Amylin Lilly
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2011-12-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide once weekly intervention 2: insulin detemir
Intervention descriptions: intervention 1: subcutaneous injection, 2mg, once a week intervention 2: subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day

Protocol documents:
Clinical trial NCT01006018
Conditions: Prediabetic State
Keywords: Prediabetic State
Sponsor: Emory University
Start date: 2011-07-01; Completion date: 2011-12-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.

Detailed description:

Arms: arm 1: Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth

\+ pioglitazone PLACEBO daily by mouth arm 2: Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth

\+ pioglitazone (TZD) 15 mg daily by mouth arm 3: Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

\+ pioglitazone (TZD) PLACEBO daily by mouth
Interventions: intervention 1: Sitagliptin + Pioglitazone PLACEBO intervention 2: Sitagliptin + Pioglitazone intervention 3: PLACEBO
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily intervention 2: Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily intervention 3: Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily

Protocol documents: