ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00655811
Conditions: Healthy
Keywords: Healthy volunteers
Sponsor: Wake Forest University
Start date: 2008-02-01; Completion date: 2009-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to study how people respond differently to capsaicin in different racial groups and the effect it has on your pain levels. Capsaicin is a natural product made from hot chili peppers that is useful for treating the itch symptoms of skin disease.

Detailed description:
To comprehensively evaluate the ethnic differences in response to topical capsaicin and its effect on thermal sensory thresholds.

Arms: arm 1: Capsaicin 0.1% cream application to the volar side of forearm. arm 2: Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.) to the opposite forearm.
Interventions: intervention 1: Capsaicin intervention 2: Placebo moisturizing cream
Intervention descriptions: intervention 1: Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A intervention 2: Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)

Protocol documents:
Clinical trial NCT00663117
Conditions: Inflammation Crohn's Disease
Keywords: naltrexone LDN IBD Inflammatory bowel disease
Sponsor: Milton S. Hershey Medical Center
Start date: 2006-09-01; Completion date: 2009-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed:

1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys;
2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response;
3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and
4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy.

Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.

Detailed description:
Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.

Arms: arm 1: placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months arm 2: Subjects are treated in a blinded fashion for 3 months with naltrexone 4.5 mg po for active Crohn's disease followed an open-labelled study where naltrexone is given an additional 3 months at 4.5 mg po; hence the total treatment interval in this arm is 6 months. The response to the intervention administered is measured in the activity index and mucosal healing by colonoscopy.
Interventions: intervention 1: Naltrexone-HCl intervention 2: Placebo
Intervention descriptions: intervention 1: naltrexone 4.5 mg intervention 2: Placebo

Protocol documents:
Clinical trial NCT00663169
Conditions: Arthritis, Gouty
Keywords: Arthritis Gouty ACZ885 IL1B protein Pain
Sponsor: Novartis
Start date: 2008-04-01; Completion date: 2009-10-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Detailed description:

Arms: arm 1: Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. arm 2: Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Interventions: intervention 1: canakinumab intervention 2: dexamethasone intervention 3: placebo matching canakinumab intervention 4: placebo matching dexamethasone
Intervention descriptions: intervention 1: 10 mg/kg intravenous infusion 250 mL over 2 hours. intervention 2: 12 mg intravenous infusion 50 mL over 30 minutes. intervention 3: 5% glucose in water intravenous infusion. intervention 4: Placebo intravenous infusion.

Protocol documents:
Clinical trial NCT00673387
Conditions: Overweight Obesity
Keywords: overweight obesity pramlintide metreleptin Amylin
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2009-10-01
Enrollment: 636 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.

Detailed description:

Arms: arm 1: Placebo matched to pramlintide BID plus placebo matched to metreleptin BID arm 2: 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID arm 3: Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID arm 4: Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID arm 5: Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID arm 6: Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID arm 7: Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID arm 8: Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID
Interventions: intervention 1: pramlintide acetate intervention 2: metreleptin intervention 3: placebo-P intervention 4: placebo-M
Intervention descriptions: intervention 1: subcutaneous injection, twice a day intervention 2: subcutaneous injection, twice a day intervention 3: subcutaneous injection, twice a day intervention 4: subcutaneous injection, twice a day

Protocol documents:
Clinical trial NCT00674206
Conditions: Breast Cancer
Keywords: Metastatic breast cancer
Sponsor: Emory University
Start date: 2008-10-01; Completion date: 2009-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin is effective for triple negative breast cancer.

Detailed description:
In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been in use for a long time. Gemcitabine is a treatment that is an effective therapy currently available to patients with this type and stage of breast cancer. Frequently, in cancer therapy, combinations of drugs prove more effective as treatment than the same drugs used alone. The combination of gemcitabine and oxaliplatin has not been tested in patients with triple negative breast cancer. It is hoped that the addition of oxaliplatin may cause your tumor to stop growing or possible your tumor may shrink. This assessment will be basd on measuring changes in the size of your tumor.

Arms: arm 1: All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m\^2 on Day 1 and Oxaliplatin 100 mg/m\^2 intravenously over 2 hours on Day 2.
Interventions: intervention 1: Gemcitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Gemcitabine 1000mg/m\^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal intervention 2: Oxaliplatin 100mg/m\^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal

Protocol documents:
Clinical trial NCT00678587
Conditions: Non-alcoholic Steatohepatitis Chronic Liver Disease HCV NASH - Nonalcoholic Steatohepatitis HIV Infection Thrombocytopenia Hepatitis C Virus HBV Human Immunodeficiency Virus Liver Diseases Hepatitis B Virus
Keywords: elective invasive procedure. platelet transfusion chronic liver disease-related thrombocytopenia platelets thrombopoietin
Sponsor: GlaxoSmithKline
Start date: 2008-06-01; Completion date: 2009-10-01
Enrollment: 292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

Detailed description:

Arms: arm 1: placebo, once daily, oral arm 2: 75 mg, once daily, oral
Interventions: intervention 1: Eltrombopag intervention 2: Placebo
Intervention descriptions: intervention 1: 75 mg, once daily, oral intervention 2: placebo, once daily, oral

Protocol documents:
Clinical trial NCT00681863
Conditions: Tourette Syndrome
Sponsor: Boehringer Ingelheim
Start date: 2008-05-01; Completion date: 2009-10-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).

Detailed description:

Arms: arm 1: all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) arm 2: patients to receive one tablet of pramipexole 0.0625 mg QD arm 3: patients to receive one tablet of pramipexole 0.125 mg BID arm 4: patients to receive one tablet of pramipexole 0.125 mg TID arm 5: patients to receive one tablet of pramipexole 0.25 mg BID
Interventions: intervention 1: pramipexole 0.125 mg BID intervention 2: pramipexole 0.0625 mg QD intervention 3: pramipexole 0.125 mg TID intervention 4: pramipexole 0.25 mg BID intervention 5: pramipexole 0.0625 mg BID
Intervention descriptions: intervention 1: titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose intervention 2: dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing intervention 3: titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose intervention 4: titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose intervention 5: 0.0625 mg BID given for first 4 wks of treatment

Protocol documents:
Clinical trial NCT00684177
Conditions: Skin Infections, Bacterial
Keywords: infection retapamulin secondarily-infected traumatic lesions placebo
Sponsor: GlaxoSmithKline
Start date: 2008-05-01; Completion date: 2009-10-01
Enrollment: 508 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.

Detailed description:
This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects \<18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion.

There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.

Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential.

Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Retapamulin Ointment, 1% intervention 2: Placebo ointment
Intervention descriptions: intervention 1: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. intervention 2: Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Protocol documents:
Clinical trial NCT00698932
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors HBA1c Incretins
Sponsor: AstraZeneca
Start date: 2008-06-01; Completion date: 2009-10-01
Enrollment: 568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 5mg, oral tablet, once daily for 24 weeks intervention 2: oral tablet, once daily for 24 weeks

Protocol documents:
Clinical trial NCT00705406
Conditions: Acute, Uncomplicated Human Influenza
Sponsor: BioCryst Pharmaceuticals
Start date: 2008-07-01; Completion date: 2009-10-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.

Detailed description:

Arms: arm 1: 600 mg peramivir administered as bilateral 2-mL intramuscular injection. arm 2: Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Interventions: intervention 1: Peramivir intervention 2: Placebo
Intervention descriptions: intervention 1: 600 mg peramivir administered as bilateral 2-mL intramuscular injection intervention 2: Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.

Protocol documents:
Clinical trial NCT00711516
Conditions: Excessive Sleepiness
Sponsor: Cephalon
Start date: 2008-09-01; Completion date: 2009-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.

Detailed description:

Arms: arm 1: Armodafinil treatment (200 mg/day) - Study drug was supplied as 50 mg tablets and the dose was titrated from a starting dose of 50 mg taken once daily in the morning (before 0800), increasing to 100 mg/day on Day 2, 150 mg/day on day 5, and then 200 mg/day beginning Day 8 and continuing through the end of the two week double-blind treatment period. arm 2: Placebo comparator - Placebo tablets matching the armodafinil 50 mg tablets drug were supplied and the dose was titrated from a starting dose of one tablet taken once daily in the morning (before 0800), increasing to two tablets/day on Day 2, three tablets/day on day 5, and then four tablets/day beginning Day 8 and continuing through the end of the two week double-blind treatment period.
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14. intervention 2: Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.

Protocol documents:
Clinical trial NCT00720096
Conditions: Ovarian Cancer
Keywords: Persistent Ovarian Cancer Genomic directed salvage chemotherapy Genomic Microarray
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2008-07-01; Completion date: 2009-10-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot study will help us to determine the success of using a special technique called microarray technology to examine cancer genes in order to predict how individual women will respond to one of two therapies, liposomal doxorubicin or topotecan, and which will be more effective in treating ovarian cancer that has returned (recurrent ovarian cancer). We believe that this study may lead to a means by which microarray technology can predict the most effective treatment decision, based on the genetic characteristics of her tumor tissue, for a woman with recurrent ovarian cancer.

Another purpose of this study is to determine how quickly a woman with recurrent ovarian cancer will respond to treatment (treatment response rate) and to evaluate the accuracy of the genomic predictions.

Recent data suggest that microarray technology can predict a patient's response to chemotherapy; this has not yet been proven in a forward-looking study which is why we are conducting this research.

Detailed description:
Patients who take part in the study will have an initial visit and undergo a CT guided core biopsy. Using tissue from a CT guided core biopsy, microarray analysis will be performed to help predict which of the two drugs appears to be better suited to individual genomic factors. The results will result in being assigned to treatment with either liposomal doxorubicin or topotecan.

Patients who receive liposomal doxorubicin - IV chemotherapeutic treatment will occur 3 times, 28 days apart, weeks 1,5,and 9. At each of these visits patients will be evaluated and have blood work to check their liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor.

Patients who receive topotecan - IV chemotherapeutic treatment will occur 4 times, 21 days apart, weeks 1,4,7, and 10. At each of these visits patients will be evaluated and have blood work to check levels of liver tests and electrolytes. Every 8 weeks patients will have a radiologic evaluation of their tumor.

Arms: arm 1: Liposomal Doxorubicin - Chemotherapy single agent systemic. arm 2: Topotecan - Chemotherapy single agent systemic.
Interventions: intervention 1: Liposomal Doxorubicin intervention 2: Topotecan
Intervention descriptions: intervention 1: Liposomal Doxorubicin 40 mg/m2 q 28 days intervention 2: 1. Topotecan (daily x 5 days of a 21 day cycle)
2. Per amendment #15: Topotecan (days 1, 8, 15 of a 28 day cycle)

Protocol documents:
Clinical trial NCT00729326
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide sitagliptin Amylin Lilly metformin thiazolidinedione
Sponsor: AstraZeneca
Start date: 2008-08-01; Completion date: 2009-10-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide intervention 2: sitagliptin intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: subcutaneous injection (5mcg or 10mcg), twice a day intervention 2: oral administration (100mg), once a day in the morning intervention 3: subcutaneous injection (5mcg or 10mcg), twice a day intervention 4: oral administration (100mg), once a day in the morning

Protocol documents:
Clinical trial NCT00730015
Conditions: Chronic Constipation
Sponsor: Ironwood Pharmaceuticals, Inc.
Start date: 2008-08-01; Completion date: 2009-10-01
Enrollment: 643 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Matching Placebo intervention 2: Linaclotide
Intervention descriptions: intervention 1: Oral, once daily intervention 2: Oral, once daily

Protocol documents:
Clinical trial NCT00730964
Conditions: Echocardiography
Keywords: Surveillance Optison Perflutren Echocardiography Subjects receive Optison during enhanced echocardiography
Sponsor: GE Healthcare
Start date: 2008-05-01; Completion date: 2009-10-01
Enrollment: 1039 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Detailed description:

Arms: arm 1: Open Label
Interventions: intervention 1: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
Intervention descriptions: intervention 1: The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed.

The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) .

The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.

Protocol documents: