ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00686634
Conditions: Type 2 Diabetes Mellitus
Keywords: sitagliptin type 2 diabetes combination therapy
Sponsor: Charles Drew University of Medicine and Science
Start date: 2008-01-01; Completion date: 2010-03-01
Enrollment: 108 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.

Detailed description:
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.

Arms: arm 1: Sitagliptin 100 mg once daily
Interventions: intervention 1: Sitagliptin
Intervention descriptions: intervention 1: Sitagliptin 100 mg by mouth once daily

Protocol documents:
Clinical trial NCT00700375
Conditions: Emergent Coronary Procedure
Keywords: Patients undergoing an emergent coronary procedure
Sponsor: Osaka General Medical Center
Start date: 2008-07-01; Completion date: 2010-03-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.

Detailed description:
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sodium bicarbonate intervention 2: Sodium Chloride
Intervention descriptions: intervention 1: 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure intervention 2: 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure

Protocol documents:
Clinical trial NCT00703092
Conditions: PCOS
Sponsor: Virginia Commonwealth University
Start date: 2008-02-01; Completion date: 2010-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

Detailed description:
We hypothesize that 6 months of fiber supplementation will improve ovulation in women with PCOS by improving insulin sensitivity independent of weight loss. In this pilot study, we will determine the feasibility of conducting a larger double-blind, randomized trial in women with PCOS to test this hypothesis. We will evaluate 15 women over a 10-month period, starting with a 4-month intervention-free observation period to determine the effect on ovulation of adding up to 22g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary fiber intake, could feasibly be translated into clinical practice.

Arms: arm 1: 2 tablespoons daily
Interventions: intervention 1: Fiber-Stat
Intervention descriptions: intervention 1: Liquid fiber supplement, 2 tablespoons twice daily.

Protocol documents:
Clinical trial NCT00720369
Conditions: Bipolar Depression
Keywords: Bipolar depression elderly Coenzyme Q10 Magnetic resonance spectroscopy
Sponsor: Mclean Hospital
Start date: 2008-07-01; Completion date: 2010-03-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We propose to study and compare measures of brain energy metabolism in geriatric bipolar individuals and healthy older adults. We would also like to investigate changes in brain energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10 administration in older bipolar individuals.

Detailed description:
Hypotheses

1. At baseline, the forward rate constant (kfor) of CK enzymatic activity in the frontal lobe of older subjects with bipolar depression will be significantly decreased relative to that of age-matched healthy controls.
2. After 8 weeks of treatment, bipolar depression subjects will demonstrate an increase in the kfor of CK after 8 weeks of CoQ 10 treatment.
3. Increases in the CK forward rate constant (kfor) will correlate with improvement in subjects' mood state as assessed by the Montgomery Asberg Depression Rating Scale (MADRS).
4. Baseline measures of executive functioning and information processing speed (measured by performance on the Wisconsin Card Sorting Test (WCST), Trails A and B and Stroop tests) will be impaired in subjects with geriatric bipolar depression compared with healthy controls. These measures will improve with successful treatment with CoQ10 and correlate with increases in the CK forward rate constant (kfor).

Summary:

A review of literature suggests a distinct pattern of bioenergetic changes, possibly related to mitochondrial dysfunction and abnormal CK function, in older adults and in individuals with bipolar disorder. As opposed to rudimentary measurements of static metabolite concentrations, the novel use of MT-MRS in such individuals will offer insight into the enzyme kinetics of CK, specifically examining the rate at which ATP is formed from PCr. From previous investigations it would seem that the dietary-supplement, CoQ10, is able to improve the efficiency of mitochondrial function in subjects with altered bioenergetics. We propose to measure CK activity and PCr turnover rate before and after CoQ10 treatment, with the overall aim of understanding metabolic relationships between brain bioenergetic alterations and treatment with CoQ10 in geriatric bipolar depression.

Arms: arm 1: Open Label Study arm 2: Healthy controls completed all study procedures completed by the CoQ10 group but did not receive any study medication.
Interventions: intervention 1: CoEnzyme Q10
Intervention descriptions: intervention 1: CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day

Protocol documents:
Clinical trial NCT00720434
Conditions: Hepatitis C
Sponsor: Pfizer
Start date: 2008-08-01; Completion date: 2010-03-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).

Detailed description:

Arms: arm 1: 500 mg BID arm 2: 300 mg BID arm 3: 200 mg BID arm 4: Placebo
Interventions: intervention 1: PF-00868554 intervention 2: PF-00868554 intervention 3: PF-00868554 intervention 4: Placebo
Intervention descriptions: intervention 1: 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks. intervention 2: 300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks intervention 3: 200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks intervention 4: Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks

Protocol documents:
Clinical trial NCT00747344
Conditions: Psoriasis
Keywords: Psoriasis Psoriatic Arthritis Ustekinumab CNTO 1275
Sponsor: Centocor, Inc.
Start date: 2008-12-01; Completion date: 2010-03-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.

Detailed description:
This is phase 3, multicenter, randomized, placebo-controlled double-blind, parallel study of subcutaneous injection of placebo and ustekinumab 45mg in Taiwanese and Korean patients with moderate to severe plaque psoriasis. Ustekinumab is an experimental medicine that is being tested to see if it may be useful in treating moderate to severe psoriasis. The patients will receive either ustekinumab or placebo at week 0 or week 4, and will be followed up through week 36. Patients who randomized (study drug assigned by chance) to placebo will cross over to ustekinumab 45mg group at week 12 and week 16 .The effectiveness of ustekinumab will be compared with placebo treated patients at week 12. Safety information will be collected through week 36. Patients randomized to ustekinumab will receive placebo at week 12 to maintain the blind and additional dose of 45mg at week 16. This study will be conducted in approximately 13 sites in South Korea and Taiwan and will include approximately 120 patients with approximately 60 patients in each country. This study is "blinded." This means that neither you nor your study doctor will know in which group you are placed. However, in case of medical emergency, your study doctor can quickly find out which treatment group you are in. You may get either ustekinumab or placebo (which looks like the medicine being studied but has no active ingredients) at the start of the study. All patients in the study will eventually receive Ustekinumab after week 12. Patients assigned to the ustekinumab will receive 45 mg subcutaneously at weeks 0, 4 and 16; and placebo at week 12. Patiens assigned to placebo will receive subcutaneous injections of placebo at weeks 0 and 4; then crossover to 45 mg of ustekinumab at weeks 12 and 16. Duration of study participation up to 36 weeks.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo - Controlled Period (CP) intervention 2: Ustekinumab 45 mg - CP intervention 3: Placebo to ustekinumab 45 mg - after CP intervention 4: Ustekinumab 45 mg - after CP
Intervention descriptions: intervention 1: Placebo, Weeks 0-12 intervention 2: Ustekinumab 45 mg, Weeks 0-12 intervention 3: Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16 intervention 4: Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16

Protocol documents:
Clinical trial NCT00758680
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-08-01; Completion date: 2010-03-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.

Detailed description:

Arms: arm 1: After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU). arm 2: After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. arm 3: After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. arm 4: After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. arm 5: After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. arm 6: After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. arm 7: After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU. arm 8: After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients. arm 9: After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients. arm 10: After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
Interventions: intervention 1: MK-1006 intervention 2: Comparator: Placebo comparator
Intervention descriptions: intervention 1: MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period. intervention 2: Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.

Protocol documents:
Clinical trial NCT00759148
Conditions: Bacterial Conjunctivitis
Keywords: pink eye conjunctivitis moxifloxacin fluoroquinolone
Sponsor: Alcon Research
Start date: 2008-10-01; Completion date: 2010-03-01
Enrollment: 1179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.

Detailed description:

Arms: arm 1: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days arm 2: Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Interventions: intervention 1: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% intervention 2: Moxifloxacin AF Vehicle
Intervention descriptions: intervention 1: Eye drops intervention 2: Inactive ingredients used as a placebo for masking purposes

Protocol documents:
Clinical trial NCT00759564
Conditions: Pneumonia
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2010-03-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate what effect renal dysfunction has on a drug that has an intravenous (CP-70,429) and an oral form (PF-03709270).

Detailed description:
To evaluate the pharmacokinetics and safety.

Arms: arm 1: None
Interventions: intervention 1: CP-70,429 and PF-03709270
Intervention descriptions: intervention 1: Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg).

Protocol documents:
Clinical trial NCT00765102
Conditions: Multiple Myeloma
Keywords: Multiple Myelonoma Romidepsin Bortezomib
Sponsor: Celgene
Start date: 2008-09-01; Completion date: 2010-03-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.

Detailed description:

Arms: arm 1: Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.

Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
Interventions: intervention 1: Bortezomib intervention 2: Romidepsin
Intervention descriptions: intervention 1: Bortezomib was administered at a dose of 1.0 mg/m\^2 as an intravenous (IV) push over 3 to 5 seconds twice weekly for 2 consecutive weeks (Days 1, 4, 8 and 11) of each 28-day cycle. On days that bortezomib and romidepsin were administered together, bortezomib was administered prior to the romidepsin infusion.

Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles. intervention 2: Romidepsin initially was administered at a dose of 10 mg/m\^2 as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle. Based on the occurrence of Grade 3 thrombocytopenia at this dose level, the dose was reduced by protocol amendment to 8 mg/m\^2.

Protocol documents:
Clinical trial NCT00770913
Conditions: Refractory Reflux Esophagitis
Keywords: reflux esophagitis rabeprazole GERD Japan
Sponsor: Eisai Co., Ltd.
Start date: 2008-10-01; Completion date: 2010-03-01
Enrollment: 337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

Detailed description:
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: E3810 intervention 2: E3810 intervention 3: E3810
Intervention descriptions: intervention 1: 20 mg taken orally, once a day for 8 weeks. intervention 2: 10 mg, taken orally, twice a day for 8 weeks. intervention 3: 20 mg taken orally, twice a day for 8 weeks.

Protocol documents:
Clinical trial NCT00773968
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-09-01; Completion date: 2010-03-01
Enrollment: 140 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Detailed description:

Arms: arm 1: Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.
Interventions: intervention 1: Methoxy Polyethylene Glycol-Epoetin Beta
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.

Protocol documents:
Clinical trial NCT00774787
Conditions: Actinic Keratoses
Keywords: Combination treatment Imiquimod Cryotherapy
Sponsor: Rigel Dermatology
Start date: 2008-10-01; Completion date: 2010-03-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.

Detailed description:
Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in the United States is with cryotherapy, which uses intense cold to freeze and destroy the lesions. Efficacy appears to be related to how long one freezes the lesion, but increasing the freeze time may result in increased pain and/or skin pigment changes after treatment.

Cryotherapy is a provider-administered "focal" treatment that only treats the lesions that are frozen. There may be early actinic keratoses in the skin surrounding treated lesions that are not easily seen; these may progress over time to visible lesions. There several patient-administered topical treatments for actinic keratoses that are applied to a treatment area or "field" rather than to specific lesions. Imiquimod 5% cream is one such treatment, and is approved in the United States for the treatment of AKs with a dosing regimen of 1 packet applied 2 times per week to a 25 cm2 area 2x/week for 16 weeks.

The study will use a split-face design (one side of face treated and the other side untreated) to explore whether a 4-week course of topical imiquimod 5% cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) in the treatment area at follow-up.

Arms: arm 1: Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp arm 2: No treatment of treatment area on the other half of the face and/or balding scalp
Interventions: intervention 1: imiquimod 5% cream
Intervention descriptions: intervention 1: 1 packet (250 mg cream) 3 times per week for 4 weeks

Protocol documents:
Clinical trial NCT00777335
Conditions: Breast Cancer
Sponsor: Translational Research in Oncology
Start date: 2009-02-01; Completion date: 2010-03-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the benefit of panobinostat monotherapy given either orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Panobinostat - LBH589 intervention 2: Panobinostat - LBH589
Intervention descriptions: intervention 1: Solution for infusion - 25mg/5ml intervention 2: Hard gelatine capsules - 5mg and 20 mg

Protocol documents:
Clinical trial NCT00781599
Conditions: Smokers
Keywords: African american smokers smoking cessation African American smokers
Sponsor: Nikki Nollen, PhD, MA
Start date: 2008-10-01; Completion date: 2010-03-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3

Detailed description:

Arms: arm 1: Chantix for 3 months and Standard Counseling arm 2: Chantix for 3 months and Adherence Counseling
Interventions: intervention 1: Chantix intervention 2: Adherence Counseling intervention 3: Standard Counseling
Intervention descriptions: intervention 1: Chantix 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7, and 1 mg twice daily on day 8 through end of treatment at month 3 intervention 2: Induction Support counseling on days 8, 12, 20 and months 1 and 2. Adherence counseling based on the Information-Motivation-Behavioral Skills model of adherence behavioral change. intervention 3: Visit with counselor on Day 8 to develop a plan to quit smoking. Discuss strategies to quit, risks of continued smoking and discuss strategies for coping with withdrawal and craving.

Protocol documents: