ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01037088
Conditions: Neuropathic Pain Reflex Sympathetic Dystrophy Peripheral Neuropathy Post-herpetic Neuralgia Spinal Cord Injury Multiple Sclerosis
Keywords: cannabis marijuana neuropathy antinociception mood cognition neuropathic pain
Sponsor: University of California, Davis
Start date: 2009-12-01; Completion date: 2012-11-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Detailed description:
We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.

Arms: arm 1: 3.53% THC by weight arm 2: 1.29% THC by weight arm 3: placebo marijuana
Interventions: intervention 1: Mild dose cannabis intervention 2: Low dose cannabis intervention 3: Cannabis
Intervention descriptions: intervention 1: 3.53% THC by weight intervention 2: 1.29% THC by weight intervention 3: 0.00% THC by weight

Protocol documents:
Clinical trial NCT01053507
Conditions: Post-Traumatic Headache
Keywords: Headache Post-traumatic headache Brain injury Cognitive impairment
Sponsor: Cady, Roger, M.D.
Start date: 2010-05-01; Completion date: 2012-11-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.

Detailed description:
Subjects will be enrolled at 3 investigative sites. At Visit 1, a medical, headache, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An ECG will be completed if one has not been completed in the previous 6 months. Subjects will be administered a series of psychological tests to help the study doctor decide whether or not a subject is eligible. The Headache Impact Test-6 and Migraine Specific Quality of Life Questionnaire will be completed at each visit. During a 30-day Baseline Period, subjects will treat with their usual medication and complete a daily Diary documenting headache symptoms and treatment. At Visits 2 and 3 subjects will complete the Mental Efficiency Workload Test and Migraine Early Warning Tool. Following randomization at Visit 2, subjects will treat daily for 30 days with Treximet or a matching placebo. Subjects will be provided with Treximet for rescue of any persisting or recurring headache. During the Treatment Period, subjects will complete a daily Diary reporting headache symptoms and response to treatment. After the 30-day Treatment Period, subjects will exit the study at Visit 3 .

Arms: arm 1: In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. arm 2: In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.
Interventions: intervention 1: sumatriptan/naproxen sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period. intervention 2: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Protocol documents:
Clinical trial NCT01072877
Conditions: Varicose Veins
Keywords: Varicose Veins
Sponsor: Boston Scientific Corporation
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Detailed description:

Arms: arm 1: Polidocanol injectable foam 0.125% arm 2: Polidocanol injectable foam 0.5% arm 3: Polidocanol injectable foam 1.0% arm 4: Polidocanol injectable foam 2.0% arm 5: Injection of vehicle comparator
Interventions: intervention 1: Polidocanol injectable foam (PEM) intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: Injection of Polidocanol injectable foam intervention 2: Placebo vehicle

Protocol documents:
Clinical trial NCT01091662
Conditions: Epilepsy
Keywords: Seizures Epilepsy Anticonvulsant Monotherapy Historical control
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2010-06-01; Completion date: 2012-11-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.

Detailed description:
This is an 18-week, double-blind, randomized, historical control, multicenter study with gradual conversion to monotherapy in subjects with partial onset seizures who are not well controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week titration period, 6-week taper or conversion period, and a 10-week monotherapy period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg QD(Day 0) to 1200 mg once a day(Week 2) to 1600 mg QD (Weeks 3-18) and may taper down from 1600 mg to 800 mg QD 3 days after the Week 18 visit. arm 2: Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg QD (Day0) to 800 mg QDweek2) to 1200 mg QD(weeks 3-18) and may taper down from 1200 mg to 600 mg QD 3 days after the Week 18 visit.

Subjects may continue in an open-label extension study with a starting dose of 1200 mg QD, or taper off their previous antiepileptic drugs during weeks 2-8.
Interventions: intervention 1: Eslicarbazepine acetate 1600 mg intervention 2: Eslicarbazepine acetate 1200 mg
Intervention descriptions: intervention 1: 1600 mg once per day intervention 2: 1200 once per day

Protocol documents:
Clinical trial NCT01096771
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS Parenteral Pharmaconutrition
Sponsor: Methodist Research Institute, Indianapolis
Start date: 2010-06-01; Completion date: 2012-11-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of nutritional supplementation with omega-9 "olive-oil" and omega-6 "soybean oil" based lipid emulsions in the Acute Respiratory Distress Syndrome (ARDS). The investigators hypothesize that these specific lipids in combination will immunomodulate the inflammatory reaction that occurs in the lungs of ARDS subjects. This concept is known as "Pharmaconutrition." These lipids will be given intravenously so as to assure administration and only as a supplement to enteral nutrition which all subjects will also receive. The omega-9 will be compared to the omega-6 formulation which is the only FDA approved formulation of use in the United States since its development in 1961 by Fresenius-Kabi, Bad Homburg, Germany. The investigators plan to perform a bronchoscopy with lavage within 24 hours of enrollment, begin the lipid administration and continue it for 96 hours after which time the investigators will repeat bronchoscopy with lavage to assess changes. The lipid administration will cease following the second bronchoscopy. The fluid obtained from lavage combined with serum samples obtained at the time of bronchoscopy will be analyzed for inflammatory mediators and cell counts. Clinical data tracing will include but not be limited to: ventilator days, nutritional status, ICU time, oxygenation and lung compliance, and 30-day mortality.

Detailed description:

Arms: arm 1: 96 hour continuous infusion. arm 2: 96 hour continuous infusion.
Interventions: intervention 1: ClinOleic 20% intervention 2: Intralipid 20%
Intervention descriptions: intervention 1: 96 hour continuous infusion. intervention 2: 96 hour continuous infusion.

Protocol documents:
Clinical trial NCT01098539
Conditions: Diabetes Mellitus, Type 2
Keywords: sitagliptin albiglutide renal impairment
Sponsor: GlaxoSmithKline
Start date: 2010-05-01; Completion date: 2012-11-01
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Detailed description:
This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Arms: arm 1: albiglutide weekly subcutaneous injection + sitagliptin matching placebo arm 2: albiglutide matching placebo + sitagliptin
Interventions: intervention 1: albiglutide intervention 2: sitagliptin
Intervention descriptions: intervention 1: albiglutide weekly subcutaneous injection + sitagliptin matching placebo intervention 2: albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

Protocol documents:
Clinical trial NCT01112059
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Sponsor: University of Alabama at Birmingham
Start date: 2008-11-01; Completion date: 2012-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.

Detailed description:
One molecule that is inhibited by doxycycline is matrix metalloprotease-9, which is emerging as an important mediator of lung inflammation and damage in cystic fibrosis. We hypothesize that the addition of treatment with doxycycline in CF inpatients will reduce MMP-9 activity and inflammatory markers in the sputum of cystic fibrosis patients compared to CF patients not treated with doxycycline.

Arms: arm 1: Patients given placebo twice a day for 8 days at beginning of inpatient CF exacerbation arm 2: Patients given doxycycline 100 mg tablet twice a day for 8 days at the beginning of inpatient CF exacerbation
Interventions: intervention 1: Doxycycline intervention 2: placebo
Intervention descriptions: intervention 1: 100 mg twice a day for 8 days intervention 2: placebo

Protocol documents:
Clinical trial NCT01126268
Conditions: Impetigo Folliculitis Secondarily Infected Eczema Minor Soft Tissue Infections
Keywords: Eczema Atopic dermatitis Infection Impetigo Folliculitis
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2010-04-01; Completion date: 2012-11-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Retapamulin (Altabax)
Intervention descriptions: intervention 1: Retapamulin ointment, applied topically twice daily for five days

Protocol documents:
Clinical trial NCT01131078
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-06-01; Completion date: 2012-11-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. arm 2: Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal. arm 3: Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
Interventions: intervention 1: Bevacizumab [Avastin] intervention 2: Capecitabine intervention 3: Irinotecan
Intervention descriptions: intervention 1: Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. intervention 2: Capecitabine was administered orally at a doses of 1000 or 1250, mg/m\^2 twice daily (Day 2 to 15) or as 650 mg/m\^2 twice daily on Days 1 to 21. intervention 3: Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.

Protocol documents:
Clinical trial NCT01135186
Conditions: Gastroparesis
Sponsor: Stanford University
Start date: 2010-05-01; Completion date: 2012-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)

Detailed description:
Patients are invited to participate in a research study of Kuvan® (sapropterin dihydrochloride). We hope to learn whether treatment with Kuvan® is safe and effective in improving the ability of the stomach to relax after eating and improving the symptoms of diabetic gastroparesis. Women are selected as a possible participant in this study because they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).

Arms: arm 1: open label study of sapropterin dihydrochloride
Interventions: intervention 1: sapropterin dihydrochloride
Intervention descriptions: intervention 1: sapropterin dihydrochloride: 10mg/kg/day

Protocol documents:
Clinical trial NCT01136876
Conditions: Coronary Artery Stenosis
Sponsor: Bracco Diagnostics, Inc
Start date: 2010-11-01; Completion date: 2012-11-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Detailed description:
This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.

Arms: arm 1: Non-ionic low-osmolar iodinated contrast media arm 2: Non-ionic iso-osmolar iodinated contrast media comparator
Interventions: intervention 1: Iopamidol intervention 2: Iodixanol-320
Intervention descriptions: intervention 1: Iopamidol 370, one time administration for percutaneous coronary intervention intervention 2: Iodixanol-320 single administration for percutaneous coronary intervention procedure

Protocol documents:
Clinical trial NCT01136915
Conditions: Coronary Artery Stenosis
Sponsor: Bracco Diagnostics, Inc
Start date: 2010-11-01; Completion date: 2012-11-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration \[eGFR\] \< 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iopamidol 370 intervention 2: Iodixanol 320
Intervention descriptions: intervention 1: one time administration for PCI intervention 2: Iodixanol 320 single injection for percutaneous coronary injection

Protocol documents:
Clinical trial NCT01140646
Conditions: Healthy, no Evidence of Disease Hot Flashes
Keywords: Hot flashes, dietary supplements, symptom management
Sponsor: Mayo Clinic
Start date: 2010-10-01; Completion date: 2012-11-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin.

PURPOSE: This phase II trial is studying the side effects and how well s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.

Detailed description:
OBJECTIVES:

I. To evaluate the impact of SAMe on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.

II. To evaluate the toxicity of SAMe in this study population. III. To evaluate the effect of SAMe using quality-of-life (QOL) measures.

OUTLINE:

During the first week, participants will complete a daily, prospective hot flash diary and complete baseline questionnaires and will not be taking any study medication. After this baseline week, participants will receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.

Arms: arm 1: The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
Interventions: intervention 1: S-adenosyl-L-methionine disulfate p-toluene-sulfonate intervention 2: questionnaire administration intervention 3: quality-of-life assessment
Intervention descriptions: intervention 1: Given orally intervention 2: Ancillary studies intervention 3: Ancillary studies

Protocol documents: