ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01082640
Conditions: Renal Impairment
Keywords: Gout physiology Hyperuricemia Uric Acid Drug Therapy
Sponsor: Takeda
Start date: 2010-04-01; Completion date: 2012-05-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

Detailed description:
Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form in the body and settle in joints and other organs.

Approximately 40-60% of patients with hyperuricemia and gout have some degree of renal impairment. Hyperuricemia has long been associated with renal disease, and chronic hyperuricemia as seen in gout can lead to deposition of urate crystals resulting in diminished renal function.

This study will evaluate the effect of febuxostat on the renal function of patients with hyperuricemia and gout and moderate to severe renal impairment.

All participants must have an average sitting blood pressure measurement less than 160 mmHg systolic and less than 95 mmHg diastolic. All participants must meet the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). Participants are expected to return to the site for approximately 10 visits.

Arms: arm 1: Placebo-matching capsules, orally, twice daily for up to 12 months. arm 2: Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months. arm 3: Participants initially received febuxostat 40 mg, capsules, once daily (QD) and one placebo-matching capsule QD and remained on this dose for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg, capsule, QD, and one placebo-matching capsule QD at the Month 1 visit, and for the remainder of the study.
Interventions: intervention 1: Febuxostat intervention 2: Placebo
Intervention descriptions: intervention 1: Febuxostat capsules intervention 2: Febuxostat placebo-matching capsules

Protocol documents:
Clinical trial NCT01087502
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-03-01; Completion date: 2012-05-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

Detailed description:

Arms: arm 1: 52 weeks treatment arm 2: First 12 weeks of treatment arm 3: Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Interventions: intervention 1: Glimepiride intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: Linagliptin
Intervention descriptions: intervention 1: 1-4 mg daily after 12 weeks intervention 2: Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily intervention 3: Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment intervention 4: Placebo mach to 5 mg linagliptin once daily after 12 weeks intervention 5: 5 mg once daily

Protocol documents:
Clinical trial NCT01110187
Conditions: Traumatic Brain Injury
Keywords: Lacosamide Fosphenytoin traumatic brain injury Glasgow coma scale Disability Rating Scale Resource Utilization Questionnaire Continuous EEG seizures
Sponsor: University of Alabama at Birmingham
Start date: 2010-05-01; Completion date: 2012-05-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.

Detailed description:
The goals are to compare IV LCM and IV fPHT for seizure prophylaxis in the neuro-critical care setting in terms of the following outcome measures:

1. The short- and long-term incidence of adverse events related to the anticonvulsant medication
2. The frequency of clinically-evident and sub-clinical seizures, as demonstrated by continuous EEG monitoring for the first three days and by clinical assessment for up to 6 months after initial admission.
3. Intermediate and long-term outcomes as measured by standard outcome measures including Extended Glasgow Outcome Scale, Disability Rating Scale, and Resource Utilization Questionnaire

Arms: arm 1: Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide. arm 2: Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin
Interventions: intervention 1: lacosamide intervention 2: Fosphenytoin
Intervention descriptions: intervention 1: 200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose. intervention 2: 20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days

Protocol documents:
Clinical trial NCT01110434
Conditions: Cannabis Abuse Cannabis Dependence
Sponsor: Brown University
Start date: 2009-12-01; Completion date: 2012-05-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.

Detailed description:

Arms: arm 1: Topiramate (200 mg daily) arm 2: None
Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Topiramate (200 mg daily) intervention 2: Placebo (daily)

Protocol documents:
Clinical trial NCT01139762
Conditions: Benign Prostatic Hyperplasia Enlarged Prostate
Keywords: Benign Prostatic Hyperplasia (BPH) Enlarged Prostate
Sponsor: Eli Lilly and Company
Start date: 2010-09-01; Completion date: 2012-05-01
Enrollment: 696 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tadalafil intervention 2: Placebo intervention 3: Finasteride
Intervention descriptions: intervention 1: 5 milligrams (mg) administered orally, once daily for 26 weeks intervention 2: Administered orally, once daily for 26 weeks intervention 3: 5mg administered orally, once daily for 26 weeks

Protocol documents:
Clinical trial NCT01145417
Conditions: HIV-1 Infection Neuropathic Pain
Keywords: peripheral neuropathic pain pregabalin safety
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-07-01; Completion date: 2012-05-01
Enrollment: 217 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.

Detailed description:
The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Arms: arm 1: None
Interventions: intervention 1: pregabalin (Lyrica)
Intervention descriptions: intervention 1: 150 mg-600 mg/day (twice daily)

Protocol documents:
Clinical trial NCT01145560
Conditions: Severe Sepsis Septic Shock
Keywords: severe sepsis TNF neutralisation septic shock patients
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2012-05-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

Detailed description:

Arms: arm 1: AZD9773 250/50 units/kg arm 2: AZD9773 500/100 units/kg arm 3: None
Interventions: intervention 1: AZD9773 intervention 2: Placebo
Intervention descriptions: intervention 1: A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days intervention 2: Placebo

Protocol documents:
Clinical trial NCT01158820
Conditions: Sedation
Keywords: bronchoscopy
Sponsor: University of Pennsylvania
Start date: 2010-06-01; Completion date: 2012-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.

Detailed description:
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.

Arms: arm 1: midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand arm 2: dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Interventions: intervention 1: Dexmedetomidine load intervention 2: Ketamine load intervention 3: Midazolam load intervention 4: Fentanyl load intervention 5: Dexmedetomidine maintenance intervention 6: Ketamine maintenance intervention 7: Midazolam demand intervention 8: Fentanyl demand intervention 9: Benadryl demand
Intervention descriptions: intervention 1: Dexmedetomidine 1 µg/kg prior to bronchoscopy intervention 2: Ketamine 30 mg bolus prior to bronchoscopy intervention 3: 2 mg bolus prior to bronchoscopy intervention 4: 50 µg bolus prior to bronchoscopy intervention 5: 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average) intervention 6: 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average) intervention 7: 0.5 mg demand bolus at discretion of pulmonologist intervention 8: 12.5 µg demand bolus at discretion of pulmonologist intervention 9: 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus

Protocol documents:
Clinical trial NCT01165840
Conditions: Obesity Leprosy Tuberculosis
Keywords: Obesity Pharmacokinetics Dapsone Leprosy Tuberculosis
Sponsor: Texas Tech University Health Sciences Center
Start date: 2010-07-01; Completion date: 2012-05-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.

Detailed description:

Arms: arm 1: Dapsone 100 mg PO x 1 dose
Interventions: intervention 1: Dapsone
Intervention descriptions: intervention 1: 100 mg PO x 1 dose

Protocol documents:
Clinical trial NCT01167452
Conditions: Obesity Pharmacokinetics MRSA Tuberculosis PCP
Keywords: Obesity Pharmacokinetics MRSA Tuberculosis PCP
Sponsor: Texas Tech University Health Sciences Center
Start date: 2010-07-01; Completion date: 2012-05-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will find how weight affects the dosing of a drug called sulfamethoxazole and trimethoprim. Currently, the amount of sulfamethoxazole and trimethoprim a patient receives is the same regardless of the patient's weight. The entire cohort was analyzed for the study outcomes. BMI groups were for recruitment purposes only and were not used for ordinal data analysis.

All sulfamethoxazole and trimethoprim (Trade name is Bactrim or Septra) medication that you will receive in this study will be referred to as study medication within this informed consent form. This drug is a combination of two antibiotics, sulfamethoxazole and trimethoprim, which belongs to a class of medication known as "sulfones" and is approved by the US Food and Drug Administration (FDA) for the treatment of a wide variety of bacterial infections such as ear infections, urinary tract infections, bronchitis, traveler's diarrhea, and Pneumocystis carinii pneumonia. Sulfamethoxazole and trimethoprim is given orally.

Detailed description:
This study is designed to measure drug concentrations in the blood of volunteers administered a single oral dose of sulfamethoxazole and trimethoprim. The volunteers to be enrolled will not have ear infections, urinary tract infections, bronchitis, traveler's diarrhea, Pneumocystis carinii pneumonia, or any other bacterial infection. This is a single center study. A total of 36 adult volunteers will be consented for the study at the Clinical and Translational Research Center (CTRC). Volunteers will be recruited using IRB approved fliers. Volunteers will be admitted to the CTRC for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, twelve will have a BMI 25-40 kg/m2, and twelve will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. All volunteers will receive a single oral dose of sulfamethoxazole and trimethoprim of 1600 mg/320 mg. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 2, 4, 8, 12, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer is discharged from the study.

Arms: arm 1: 2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)
Interventions: intervention 1: Sulfamethoxazole/trimethoprim
Intervention descriptions: intervention 1: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose

Protocol documents:
Clinical trial NCT01168596
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease Fatigue
Sponsor: University of Florida
Start date: 2009-12-01; Completion date: 2012-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with Parkinson's disease (PD).

Detailed description:
Despite the fact that fatigue affects 40-50% of all patients with PD and is a leading cause of disability, we currently do not have any effective treatments for this symptom. Rasagiline is a well-tolerated and effective treatment for the motor symptoms of PD. Rasagiline is a MAO-B inhibitor that may decrease the breakdown of dopamine. Many patients report an improvement in their energy levels when on this medication. A proven treatment for PD fatigue would significantly improve the quality of life for numerous patients and their caregivers.

Arms: arm 1: Placebo tablet, 1 per day, duration is approximately 12 weeks. arm 2: Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.
Interventions: intervention 1: Rasagiline intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of Rasagiline versus placebo.

Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks. intervention 2: Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.

Protocol documents:
Clinical trial NCT01188772
Conditions: Hepatitis C Virus
Keywords: Hepatitis C Virus HCV hepatitis Genotype 1 Genotype 2 Genotype 3
Sponsor: Gilead Sciences
Start date: 2010-08-01; Completion date: 2012-05-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.

Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.

Detailed description:

Arms: arm 1: Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. arm 2: Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. arm 3: Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. arm 4: Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: Placebo to match sofosbuvir intervention 3: PEG intervention 4: RBV
Intervention descriptions: intervention 1: Sofosbuvir tablets were administered orally once daily. intervention 2: Placebo tablets to match sofosbuvir were administered orally once daily. intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection. intervention 4: Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).

Protocol documents:
Clinical trial NCT01201759
Conditions: Spinal Cord Injury
Keywords: cardiovascular risk
Sponsor: University of Miami
Start date: 2009-07-01; Completion date: 2012-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall study objectives are to examine whether:

1. Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

Detailed description:
To test Study Objective 1, 'overweight' and 'non-overweight' persons with SCI will be compared at baseline for fasting and postprandial responses. For Study Objective 2, all persons tested for Study Objective 1 will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. The last month will test effects of drug-placebo not examined in month 2. Fasting and postprandial responses will be tested at each time point. Intention-to-treat clinical standards ("…as randomized, so analyzed…") and 'last observation carried forward' clinical methods will be adopted.

Participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in CVD, CVD risks, and obesity.

Arms: arm 1: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. arm 2: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.
Interventions: intervention 1: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days intervention 2: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Intervention descriptions: intervention 1: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2 intervention 2: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.

Protocol documents: