ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00987948
Conditions: HIV Infections
Keywords: HIV dementia High HIV DNA within CD14+ PBMCs treatment experienced
Sponsor: University of Hawaii
Start date: 2010-01-01; Completion date: 2013-08-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
High levels of HIV infection within blood monocyte/macrophages (a type of white cells in the bloodstream) increases risk of dementia in HIV-infected individuals. Maraviroc (Selzentry) is a HIV medication that works by blocking the entry of HIV in cells including monocytes/macrophages that use a receptor called CCR5. The study hypothesis is that the addition of Maraviroc to a HIV antiretroviral regimen in HIV-infected individuals with high levels of HIV-infected monocyte/macrophages will lead to a decrease in the levels of infected monocyte/macrophages and to decrease in brain inflammation as studied by magnetic resonance spectroscopy (MRS, a form of MRI study).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: maraviroc (Selzentry)
Intervention descriptions: intervention 1: dosage varies with other medications being taken; will follow package insert guidelines

Protocol documents:
Clinical trial NCT00996866
Conditions: Vitamin D Deficiency
Sponsor: Winthrop University Hospital
Start date: 2008-12-01; Completion date: 2013-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies were done with non-obese subjects. This study looks at vitamin D supplementation requirements in obese patients as compared to non-obese subjects. This study also looks at changes in vitamin D level in obese patients undergoing medical weight loss. It is thought that obese patients have vitamin D deficiency through storage of vitamin D in the fat compartment not readily available for blood measurement. The investigators' hypothesis is that with medical weight loss vitamin D levels will increase in obese subjects.

Detailed description:
We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.

To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.

Arms: arm 1: Half of subjects will be randomized to the placebo group. arm 2: This is the study group that receives Vitamin D supplementation.
Interventions: intervention 1: Vitamin D3 intervention 2: placebo
Intervention descriptions: intervention 1: Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day. intervention 2: The placebo group will receive sugar pills appearing similar to the vitamin D capsules.

Protocol documents:
Clinical trial NCT01002820
Conditions: Epilepsy, Complex Partial
Keywords: Epileptic Seizures Seizure Disorder Seizures Convulsions Anticonvulsant Anticonvulsive Antiepileptic Ganaxolone
Sponsor: Marinus Pharmaceuticals
Start date: 2009-10-01; Completion date: 2013-08-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.

Detailed description:

Arms: arm 1: all subjects participating in 0602 are receiving ganaxolone for seizure control
Interventions: intervention 1: ganaxolone
Intervention descriptions: intervention 1: liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year

Protocol documents:
Clinical trial NCT01014351
Conditions: Metastatic Melanoma
Keywords: Metastatic Melanoma Everolimus Paclitaxel Carboplatin
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-02-01; Completion date: 2013-08-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.

Detailed description:

Arms: arm 1: Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle
Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: Everolimus
Intervention descriptions: intervention 1: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle intervention 2: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle intervention 3: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle

Protocol documents:
Clinical trial NCT01065506
Conditions: Smoking
Sponsor: Southern Methodist University
Start date: 2009-09-01; Completion date: 2013-08-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cognitive Behavioral Treatment intervention 2: Nicotine Patch intervention 3: Wellness Program intervention 4: Aerobic Exercise
Intervention descriptions: intervention 1: Cognitive Behavioral Treatment intervention 2: Nicotine Patch intervention 3: Wellness Program intervention 4: Aerobic Exercise

Protocol documents:
Clinical trial NCT01087970
Conditions: Head and Neck Neoplasms
Keywords: Pharynx Larynx Nose Parathyroid
Sponsor: Eli Lilly and Company
Start date: 2010-08-01; Completion date: 2013-08-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck.

Detailed description:

Arms: arm 1: Cycle 1:

Week 1 - Cetuximab 400 milligrams/square meter (mg/m²) on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin area under curve (AUC) 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Cycle 2-6:

Week 1 - Cetuximab 250 mg/m² on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin AUC 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Following Cycle 6, Cetuximab Monotherapy: 250 mg/m² intravenously weekly on Day 1
Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab intervention 3: Carboplatin intervention 4: Cisplatin
Intervention descriptions: intervention 1: Administered intravenously, for maximum of 6 cycles. intervention 2: Administered intravenously in combination therapy, for a maximum of 6 cycles.

After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression. intervention 3: Administered intravenously, for a maximum of 6 cycles intervention 4: Administered intravenously, for a maximum of 6 cycles

Protocol documents:
Clinical trial NCT01108757
Conditions: Catheter-Associated Urinary Tract Infection
Keywords: catheter urinary tract infection
Sponsor: The Cleveland Clinic
Start date: 2010-04-01; Completion date: 2013-08-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bactrim intervention 2: Placebo
Intervention descriptions: intervention 1: Bactrim DS BID for 3 days intervention 2: Corn starch capsules

Protocol documents:
Clinical trial NCT01125748
Conditions: Allergic Asthma
Sponsor: Genentech, Inc.
Start date: 2010-05-01; Completion date: 2013-08-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatment with Xolair were allowed to enter the study.

Detailed description:
The treatment designation for participants who reached the primary efficacy endpoint (1 protocol-defined severe asthma exacerbation) was unblinded to allow appropriate clinical intervention. Participants who had their treatment designation unblinded remained in the study for ongoing evaluation of safety and were allowed to continue on study drug known to be Xolair (or to start study drug known to be Xolair if they were in the placebo group).

Arms: arm 1: Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks. arm 2: Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
Interventions: intervention 1: Omalizumab intervention 2: Placebo intervention 3: Asthma therapies
Intervention descriptions: intervention 1: Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection. intervention 2: Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab. intervention 3: Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.

Protocol documents:
Clinical trial NCT01151540
Conditions: Lennox-Gastaut Syndrome
Keywords: Epilepsy Seizures
Sponsor: Eisai Co., Ltd.
Start date: 2010-11-01; Completion date: 2013-08-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.

Detailed description:

Arms: arm 1: Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period.
Interventions: intervention 1: Rufinamide
Intervention descriptions: intervention 1: The target dosage is approximately 45 mg/kg/day, taken orally twice a day.

Protocol documents:
Clinical trial NCT01191450
Conditions: Arterial Hypertension
Keywords: chlortalidone amiloride arterial hypertension
Sponsor: Eurofarma Laboratorios S.A.
Start date: 2011-08-01; Completion date: 2013-08-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.

Detailed description:
To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form.

Some eligibility criteria:

perform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram

Arms: arm 1: Chlorthalidone 25mg - one oral tablet a day in the morning arm 2: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning
Interventions: intervention 1: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg intervention 2: Higroton® Laboratório Novartis
Intervention descriptions: intervention 1: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks intervention 2: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks

Protocol documents:
Clinical trial NCT01200394
Conditions: Diabetic Nephropathies
Keywords: Diabetic nephropathy chronic kidney disease PF-00489791 phosphodiesterase PDE5
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2013-08-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-00489791 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, 20 mg once daily for 12 weeks intervention 2: Tablet, placebo once daily for 12 weeks

Protocol documents:
Clinical trial NCT01200433
Conditions: Intracranial Neurosurgery
Keywords: dexmedetomidine propofol cerebral blood flow brain oxygenation
Sponsor: The Cleveland Clinic
Start date: 2010-10-01; Completion date: 2013-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.

Detailed description:

Arms: arm 1: Subjects will be sedated with propofol. arm 2: Subjects will be sedated with dexmedetomidine.
Interventions: intervention 1: dexmedetomidine intervention 2: propofol
Intervention descriptions: intervention 1: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure. intervention 2: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response

Protocol documents:
Clinical trial NCT01203774
Conditions: Diabetes
Keywords: Diabetes
Sponsor: University of Colorado, Denver
Start date: 2010-09-01; Completion date: 2013-08-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.

Detailed description:

Arms: arm 1: SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin arm 2: Syringe-administered Glargine insulin and then pen-administered Glargine insulin
Interventions: intervention 1: Glargine insulin
Intervention descriptions: intervention 1: 20-180 units per day

Protocol documents:
Clinical trial NCT01260662
Conditions: Procedural Sedation
Keywords: Deep Procedural Sedation Propofol Ketamine Emergency Department Monitoring Capnography Procedural Sedation in the Emergency Department
Sponsor: Hennepin Healthcare Research Institute
Start date: 2010-11-01; Completion date: 2013-08-01
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided.

In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.

Detailed description:

Arms: arm 1: Deep sedation using propofol arm 2: Propofol and ketamine mixed 1:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation arm 3: Propofol and ketamine mixed 4:1, given at 0.1 cc/kg as initial bolus, followed by 1/2 that dose every 3 minutes as need for sedation
Interventions: intervention 1: Propofol intervention 2: 1:1 Propofol/Ketamine intervention 3: 4:1 Propofol/Ketamine
Intervention descriptions: intervention 1: 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation intervention 2: Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation intervention 3: Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation

Protocol documents:
Clinical trial NCT01264770
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis OSKIRA fostamatinib
Sponsor: AstraZeneca
Start date: 2011-01-01; Completion date: 2013-08-01
Enrollment: 644 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months

Detailed description:
Sub-study:

Full title: Optional Genetic Research

Date: 10 September 2010

Version: 1

Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA

The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013

Sub-study:

Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study

Date: 21 March 2011

Version: 1

Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by:

* Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.

Arms: arm 1: Oral treatment and subcutaneous injection arm 2: Oral treatment and subcutaneous injection arm 3: Oral treatment and subcutaneous injection arm 4: Oral treatment and subcutaneous injection arm 5: Oral treatment and subcutaneous injection
Interventions: intervention 1: Fostamatinib and placebo injections intervention 2: Fostamatinib and placebo injections intervention 3: Fostamatinib and placebo injections intervention 4: Adalimumab and placebo of fostamatinib intervention 5: Placebo of fostamatinib, fostamatinib, and placebo injections
Intervention descriptions: intervention 1: Fostamatinib 100mg twice daily and placebo injection once every two weeks intervention 2: Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks intervention 3: Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks. intervention 4: Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily. intervention 5: Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).

Protocol documents: