ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00761137
Conditions: Sialorrhea Secondary to Parkinson's Disease
Keywords: sialorrhea drooling excessive salivation parkinson's disease
Sponsor: NeuroHealing Pharmaceuticals Inc.
Start date: 2008-03-01; Completion date: 2010-06-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.

Detailed description:
NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.

A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.

Arms: arm 1: subject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide arm 2: subject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide arm 3: subject received (blinded) each of the 4 drug doses at different visits - 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide arm 4: subject received (blinded) each of the 4 drug doses at different visits - 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide
Interventions: intervention 1: 0.3 mg tropicamide intervention 2: 1 mg tropicamide intervention 3: 3 mg tropicamide intervention 4: 0 mg tropicamide
Intervention descriptions: intervention 1: 0.3 mg tropicamide in intra-oral thin film intervention 2: 1 mg tropicamide in intra-oral thin film intervention 3: 3 mg tropicamide in intra-oral thin film intervention 4: 0 mg tropicamide (placebo) in intra-oral thin film

Protocol documents:
Clinical trial NCT00767000
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-01; Completion date: 2010-06-01
Enrollment: 813 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.

Detailed description:
This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: MK-0941 intervention 2: Comparator: Placebo intervention 3: Lantus intervention 4: Metformin
Intervention descriptions: intervention 1: MK-0941 tablets three times daily intervention 2: Matching placebo to MK-0941 three times daily intervention 3: Lantus injection once daily intervention 4: Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

Protocol documents:
Clinical trial NCT00770133
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-02-01; Completion date: 2010-06-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Detailed description:

Arms: arm 1: Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 2: Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 3: Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 4: Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Interventions: intervention 1: Ketotifen/naphazoline intervention 2: Naphazoline intervention 3: Ketotifen intervention 4: Vehicle
Intervention descriptions: intervention 1: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. intervention 2: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. intervention 3: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. intervention 4: One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Protocol documents:
Clinical trial NCT00770367
Conditions: Diabetes
Keywords: Cardiovascular risk biological markers
Sponsor: Medical University of South Carolina
Start date: 2008-10-01; Completion date: 2010-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
SPECIFIC AIMS

1. To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes.
2. To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment.
3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).

Detailed description:
The primary purpose of this study is to determine whether treatment with pioglitazone can reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes. Recent research has found that elevated serum ADMA is associated with increased cardiovascular events and mortality, particularly in people with diabetes (Boger 2005, Zoccali 2006, Ueda 2007). ADMA, by mediating nitric oxide (NO) availability, may trigger pro-atherogenic effects. High plasma concentration of this substance has been associated with intima-media thickening, left ventricular hypertrophy and all-cause and cardiovascular mortality in patients with end-stage renal disease, and associated with increased cardiovascular events in patients with diabetes (Kryzazanowska 2007). The result of higher levels of ADMA and reduced output of NO increases vasoconstriction, increases inflammation, and interferes with endothelial function. Preliminary studies indicate that pioglitazone may reduce ADMA levels, and thus lower cardiovascular risk.Thus, this protocol will test whether pioglitazone can reduce ADMA levels in adult patients with diabetes.

Arms: arm 1: 18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study. arm 2: 18 (other half of participants) volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take the placebo for the first 12 week period of the study and then take the Pioglitazone for the final 12 weeks of the study.
Interventions: intervention 1: Pioglitazone then Placebo intervention 2: Placebo then Pioglitazone
Intervention descriptions: intervention 1: Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo. intervention 2: Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.

Protocol documents:
Clinical trial NCT00783614
Conditions: HIV Infection
Keywords: HIV Cardiovascular Disease Endothelial Dysfunction
Sponsor: Hennepin Healthcare Research Institute
Start date: 2008-10-01; Completion date: 2010-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.

Detailed description:
Cardiovascular disease is now a major health concern among persons with HIV infection. Our general hypothesis is that HIV-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. HIV drug treatment (antiretroviral therapy; ART) may reduce inflammation and vessel injury via suppression of HIV replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. In this context, additional anti-inflammatory and anti-thrombotic medications are needed. Acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with HIV infection. The goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting ART and aspirin among persons with HIV infection.

Arms: arm 1: Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily arm 2: Start antiretroviral therapy (ART) immediately and initiate placebo pill daily arm 3: Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily arm 4: Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily
Interventions: intervention 1: Aspirin 325mg intervention 2: Antiretroviral therapy (ART)
Intervention descriptions: intervention 1: Patients randomized to Aspirin 325mg po daily versus placebo pill daily intervention 2: Patients randomized to start ART immediately or defer use for 1 month

Protocol documents:
Clinical trial NCT00785577
Conditions: Diabetic Neuropathy, Painful
Sponsor: Eli Lilly and Company
Start date: 2008-11-01; Completion date: 2010-06-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether a new treatment will be safe and effective in treating pain. Patients with diabetic peripheral neuropathy will be included.

Detailed description:

Arms: arm 1: LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules thrice daily (TID) po for 6 weeks arm 2: Pregabalin thrice daily (TID) oral for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks arm 3: LY545694 21 milligrams (mg) BID po for 1 week

Pregabalin placebo TID po for 6 weeks arm 4: LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.

Pregabalin placebo TID po for 6 weeks arm 5: LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.

Pregabalin placebo TID po for 6 weeks
Interventions: intervention 1: Placebo intervention 2: Pregabalin intervention 3: LY545694 21 mg intervention 4: LY545694 49 mg intervention 5: LY545694 105 mg
Intervention descriptions: intervention 1: LY545694 placebo BID po for 5 weeks

Pregabalin placebo capsules TID po for 6 weeks intervention 2: Pregabalin TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6

LY545694 placebo BID po for 5 weeks intervention 3: LY545694 21 mg BID po for 1 week

Pregabalin placebo TID po for 6 weeks intervention 4: LY545694 escalated to 49 mg BID po for 1 week during Week 2.

Pregabalin placebo TID po for 6 weeks. intervention 5: LY545694 105 mg BID po for 5 weeks

Pregabalin placebo TID po for 6 weeks

Protocol documents:
Clinical trial NCT00787787
Conditions: Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer
Sponsor: University of Washington
Start date: 2008-09-01; Completion date: 2010-06-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving sunitinib malate together with capecitabine works in treating patients with unresectable or metastatic liver cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor cells

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the progression-free survival of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with sunitinib and capecitabine.

SECONDARY OBJECTIVES:

I. To determine the overall survival, response rate by Response Evaluation Criteria in Solid Tumors (RESIST) criteria, alpha fetoprotein (AFP) response, survival at one year, and safety and tolerability.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21 and capecitabine PO twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Arms: arm 1: Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate intervention 2: capecitabine
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT00790062
Conditions: Uterine Atony Postpartum Hemorrhage
Keywords: Uterine atony Postpartum hemorrhage clinical trial Prophylactic oxytocin
Sponsor: University of Alabama at Birmingham
Start date: 2008-11-01; Completion date: 2010-06-01
Enrollment: 1798 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.

Detailed description:
Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.

Arms: arm 1: 1 dose only for prophylaxis given over 1 hour arm 2: One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010. arm 3: 1 dose only given over 1 hour
Interventions: intervention 1: Oxytocin
Intervention descriptions: intervention 1: See arms

Protocol documents:
Clinical trial NCT00791076
Conditions: Diabetes Mellitus, Type 1
Keywords: Insulin pump therapy Type 1 diabetic Chronic pancreatitis Pancreatic resection Pancreatic polypeptide
Sponsor: Johns Hopkins University
Start date: 2007-10-01; Completion date: 2010-06-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this research is to see if pancreatic polypeptide (PP), a hormone that is naturally produced by the pancreas and that works to control the amount of glucose that the liver makes, will reduce the amount of insulin required for people who must take insulin to maintain their normal blood glucose level.

Detailed description:
The pancreas is a large gland located behind the stomach. One of the functions of the pancreas is to produce two hormones: insulin and pancreatic polypeptide. Insulin helps the cells to take in glucose. The liver makes glucose and insulin normally acts to decrease or shut off the liver's production of glucose. However, in patients whose pancreas no longer makes insulin or makes low levels of pancreatic polypeptide the liver cannot perform these duties as well. Studies have shown that these important functions of the liver are improved for these patients when pancreatic polypeptide is given together with their insulin. Because PP increases the liver's sensitivity to insulin and thereby reduces the amount of glucose produced by the liver, this will result in fewer swings in blood sugar levels both in the upper and lower range. With fewer swings in blood glucose, a patient should decrease the amount of insulin used. One of the main benefits of lowering total insulin requirement is a reduction in the development of dangerous low blood sugar levels.

Arms: arm 1: Saline arm 2: Pancreatic Polypeptide
Interventions: intervention 1: Placebo intervention 2: Pancreatic Polypeptide (PP)
Intervention descriptions: intervention 1: 2pmol/kg-1/min-1 placebo infused continuously over 72 hours. intervention 2: 2pmol/kg-1/min-1 PP infused continuously over 72 hours.

Protocol documents:
Clinical trial NCT00793546
Conditions: Advanced Breast Cancer
Keywords: Bosutinib Exemestane postmenopausal breast cancer
Sponsor: Pfizer
Start date: 2009-02-01; Completion date: 2010-06-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

Detailed description:
This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. Even if the safety profile of the combination of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Arms: arm 1: combination of bosutinib and exemestane arm 2: exemestane
Interventions: intervention 1: Bosutinib intervention 2: exemestane intervention 3: Exemestane
Intervention descriptions: intervention 1: 300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs intervention 2: 25 mg tablet once daily intervention 3: 25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

Protocol documents:
Clinical trial NCT00794313
Conditions: Parkinson's Disease
Keywords: Parkinsons disease dyskinesia amantadine efficacy
Sponsor: Oregon Health and Science University
Start date: 2009-09-01; Completion date: 2010-06-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias. A drug called amantadine can reduce these movements. To date, there are no objective measures of these movements. The purpose of this study is to measure the reduction of the movements by amantadine and/or topiramate using an objective measure.

Detailed description:
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Currently, one of the very few treatments for these unwanted and involuntary movements is Amantadine. New options to treat dyskinesia would be clinically very valuable. In a previous study, we developed an objective measuring device to quantify dyskinesia.

All PD participants will receive all three of the drug treatment intervention (placebo, Amantadine 300 mg, Amantadine 300 mg plus Topiramate 150 mg). After 2 weeks of one drug treatment, the participants will complete an overnight visit at the OCTRI Inpatient unit. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100. The subjects will be split into 'high' and 'low' dose groups. Those who take \<50 mg/hour of oral levodopa or levodopa equivalents will be considered 'low' dose subjects and will receive 1 mg/kg/hr of IV Levodopa during the study visits (1, 2, and 3). Those who administer \> 50 mg/hr of oral levodopa to themselves normally will be considered 'high' dose subjects and will received 1.5 mg/kg/hr levodopa. Both groups will receive the infusion for two hours from 0900 - 1100. The study drug will be taken orally at 0800.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Amantadine 300 mg intervention 2: Topiramate intervention 3: Sugar Pill
Intervention descriptions: intervention 1: Amantadine, 300 mg, capsule, three times a day, two weeks intervention 2: Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week intervention 3: sugar pill, capsule, three times a day, 2 weeks

Protocol documents: