ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00783263
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2008-11-01; Completion date: 2010-05-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Detailed description:

Arms: arm 1: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. arm 2: Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. arm 3: Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. arm 4: Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
Interventions: intervention 1: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg intervention 2: Comparator: rosuvastatin 10 mg intervention 3: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg intervention 4: Comparator: rosuvastatin 20 mg
Intervention descriptions: intervention 1: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks. intervention 2: Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks. intervention 3: Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks. intervention 4: Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

Protocol documents:
Clinical trial NCT00787137
Conditions: Arthritis, Psoriatic
Sponsor: PanGenetics UK Limited
Start date: 2008-12-01; Completion date: 2010-05-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.

Detailed description:

Arms: arm 1: Lowest dose PG102 arm 2: Second dose PG102 arm 3: Control
Interventions: intervention 1: PG102 intervention 2: Placebo comparator
Intervention descriptions: intervention 1: A single intravenous infusion intervention 2: Phosphate-buffered saline

Protocol documents:
Clinical trial NCT00788073
Conditions: Fragile X Syndrome
Keywords: fragile X syndrome irritability behavior problems
Sponsor: Seaside Therapeutics, Inc.
Start date: 2008-11-01; Completion date: 2010-05-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.

Detailed description:

Arms: arm 1: STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks arm 2: variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Interventions: intervention 1: STX209 intervention 2: Placebo
Intervention descriptions: intervention 1: Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks intervention 2: variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks

Protocol documents:
Clinical trial NCT00791973
Conditions: Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2008-11-01; Completion date: 2010-05-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

Detailed description:

Arms: arm 1: fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week arm 2: placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week
Interventions: intervention 1: fluticasone furoate intervention 2: Placebo
Intervention descriptions: intervention 1: 2 puffs in each nostril once daily for 1 week intervention 2: 2 puffs in each nostril once daily for 1 week

Protocol documents:
Clinical trial NCT00795704
Conditions: Type 2 Diabetes
Keywords: Herbal Supplement Type 2 Diabetes Mulberry Hemoglobin A1C
Sponsor: University of Mississippi Medical Center
Start date: 2008-04-01; Completion date: 2010-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. We also want to look at the safety of mulberry leaf extract in these patients.

Detailed description:
The methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. Evaluations of hemoglobin A1C (A1C) -- A measurement of blood glucose over the past 3 months -- will be done at baseline \[before placebo run-in period\] and 3 months. Evaluations of safety laboratories and adverse effect questionnaire will be done at 4 weeks and at 3 months following the randomization visit. Subjects will undergo a 2-week placebo run-in phase, and then will be divided into two groups: (1) mulberry leaf extract and (2) matching placebo. The subjects will ingest 1000 mg (#2 500 mg capsules) of standardized mulberry leaf extract (Nature-Gen, San Diego, CA) or matching placebo three times daily with meals for 3 months. Patients will be asked to monitor fasting morning blood glucose and 2-hour postprandial dinner blood glucose daily during the 2-week placebo run-in. To ensure compliance, only subjects compliant with both medication and monitoring instructions will be issued a 30-day supply of study medication at enrollment and the remainder at the 4-week safety visit. Each visit will consist of clinical examination, completed questionnaires, evaluation of self-monitoring blood glucose (SMBG), and donated blood for clinical laboratory tests. Standard recommendations for therapeutic lifestyle intervention will be given to both groups. All the clinical laboratory tests will be performed at the University of Mississippi Medical Center. All patients will receive identical 2-week placebo phase capsules, and then be randomized to each group using similar lookin

Arms: arm 1: Control Group arm 2: None
Interventions: intervention 1: Mulberry Leaf Extract intervention 2: Placebo
Intervention descriptions: intervention 1: Mulberry Leaf Extract 1000 mg by mouth three times daily for 3 months intervention 2: Placebo 500 mg #2 capsules by mouth three times daily

Protocol documents:
Clinical trial NCT00798161
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-12-01; Completion date: 2010-05-01
Enrollment: 857 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Detailed description:

Arms: arm 1: BI 1356 low dose + metformin 500 mg, twice daily arm 2: matching placebo arm 3: BI 1356 low dose + metformin 1000 mg, twice daily arm 4: Metformin 500 mg, twice daily arm 5: Metformin 1000 mg, twice daily arm 6: BI 1356 high dose, once daily
Interventions: intervention 1: BI 1356 intervention 2: BI 1356 + metformin intervention 3: Bi 1356 + metformin intervention 4: Metformin intervention 5: metformin intervention 6: matching placebo
Intervention descriptions: intervention 1: BI 1356 high dose tablet, once daily intervention 2: BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily intervention 3: BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily intervention 4: Metformin 500 mg tablet, twice daily intervention 5: metformin 1000 mg tablet, twice daily intervention 6: matching placebo

Protocol documents:
Clinical trial NCT00811928
Conditions: Leukopenia
Keywords: high-risk leukopenic patients
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-01; Completion date: 2010-05-01
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection

Detailed description:

Arms: arm 1: Posaconazole oral suspension 200 mg three times a day (TID) arm 2: Fluconazole 400 mg once daily (QD)
Interventions: intervention 1: Posaconazole intervention 2: Fluconazole
Intervention descriptions: intervention 1: 40 mg/mL; 200 mg (5 mL) TID

Treatment was continued with each cycle of chemotherapy until:

* The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
* 3 chemotherapy cycles or
* Total treatment duration up to 12 weeks (84 days) intervention 2: 50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules);

400 mg QD

Treatment was continued with each cycle of chemotherapy until:

* The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
* 3 chemotherapy cycles or
* Total treatment duration up to 12 weeks (84 days)

Protocol documents:
Clinical trial NCT00818519
Conditions: Acne Vulgaris
Keywords: Moderate Acne Vulgaris Oral contraceptive Female
Sponsor: Bayer
Start date: 2008-12-01; Completion date: 2010-05-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.

Detailed description:

Arms: arm 1: In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol). arm 2: The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Interventions: intervention 1: EE20/Drospirenone (YAZ, BAY86-5300) intervention 2: Placebo
Intervention descriptions: intervention 1: 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd intervention 2: Inert tablet

Protocol documents:
Clinical trial NCT00824616
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-01-01; Completion date: 2010-05-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Detailed description:

Arms: arm 1: Participants receiving placebo tablets three times daily plus insulin injection once daily arm 2: Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
Interventions: intervention 1: MK-0941 intervention 2: Placebo intervention 3: Insulin
Intervention descriptions: intervention 1: MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose. intervention 2: Placebo tablets, taken 3 times daily. intervention 3: Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Protocol documents:
Clinical trial NCT00825266
Conditions: Hypertension, Pulmonary
Keywords: pulmonary hypertension & insulin resistance
Sponsor: Stanford University
Start date: 2008-09-01; Completion date: 2010-05-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate 1) the incidence of insulin resistance (a pre-diabetic state) in patients with pulmonary hypertension, and 2) test the utility of a validated PH therapy (Tracleer) versus Pioglitazone in the treatment of those patients found to have insulin resistance.

Detailed description:
The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension ,is a study evaluating the incidence of insulin resistance in patients with pulmonary hypertension and testing the utility of a validated PH therapy(Tracleer) versus Pioglitazone in the treatment of those patients found to have insulin resistance.Patients with PAH must be stable on therapy for at least 3 months are considered for enrollment in this study.With the exception of PAH, subjects must be free of major medical illnesses, including diabetes mellitus ,malignancy or significant hepatic or renal disease.

Arms: arm 1: Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily. arm 2: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Interventions: intervention 1: bosentan intervention 2: Pioglitazone
Intervention descriptions: intervention 1: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study. intervention 2: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.

Protocol documents:
Clinical trial NCT00839540
Conditions: Candidemia
Keywords: candidemia echinocandin micafungin caspofungin
Sponsor: Gary E. Stein, Pharm.D.
Start date: 2008-12-01; Completion date: 2010-05-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:

To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities.

This investigation will provide clinicians information supporting the use of caspofungin and micafungin in situations where Candida strains may be a cause of infection.

Detailed description:
Methods:

Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia (\<500) APACHE II scores \> 20, or significant liver disease will be excluded. All will give written informed consent (Pappas et al. CID. Oct 1, 2007).

Drugs - Patients will receive either CFG: 70 mg loading dose (LD) followed by 50 mg once daily (qd) (8 patients), MFG: 100 mg qd (8 patients) or MFG: 200 mg qd (8 patients). All agents will be given by slow IV infusion (MFG will be supplied by Astellas).

Sera - Blood samples will be collected at the end of the infusion (peak) and at 12 h and 24 h (trough) after the beginning of an infusion (day 3-4).

Each patients sera will be tested (MIC and cidal activity) against their own Candida isolate (if isolated). In addition, recent clinical isolates of C. glabrata will also be tested against patient sera (time-kill) to verify previous in vitro and animal PD studies (Cota. AAC. Nov. 2006; Wiederhold. AAC. May 2007).

Results:

* Patient outcome, including Candida eradication, will be documented for each patient by repeat culture.
* Serum concentrations (lab to be determined) and PK analysis of each echinocandin will be determined for each patient.
* Serum cidal titers will be measured against each of the Candida isolates for each agent at each time period. Median and geometric mean Peak and duration of cidal activity will then be determined and compared.

Arms: arm 1: Patients receive Micafungin 100 mg qd arm 2: Patients receive 200 mg Micafungin qd arm 3: Patients receive caspofungin 70 mg LD followed by 50 mg qd
Interventions: intervention 1: micafungin intervention 2: Micafungin intervention 3: Caspofungin
Intervention descriptions: intervention 1: 100 mg qd by slow IV infusion for 24 h intervention 2: 200 mg qd by slow IV infusion for 24 h intervention 3: 70 mg LD followed by 50 mg qd by slow IV infusion for 24 h

Protocol documents:
Clinical trial NCT00852631
Conditions: Schizophrenia
Keywords: Quetiapine efficacy in schizophrenia
Sponsor: AstraZeneca
Start date: 2009-02-01; Completion date: 2010-05-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.

Detailed description:

Interventions: intervention 1: Quetiapine fumarate (Seroquel)
Intervention descriptions: intervention 1: 600mg Extended release tablet, oral, once daily

Protocol documents:
Clinical trial NCT00853151
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2009-02-01; Completion date: 2010-05-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Test the safety, tolerability and improvement of blood sugar control with combination therapy in individuals with Type 2 Diabetes.

Detailed description:

Arms: arm 1: Weekly LY2428757 plus 3 milligrams (mg) daily TT223 arm 2: Weekly LY2428757 plus 2 mg daily TT223 arm 3: Weekly LY2428757 plus daily TT223 placebo arm 4: Weekly LY2428757 placebo plus daily TT223 placebo
Interventions: intervention 1: LY2428757 intervention 2: TT223 intervention 3: Placebo for LY2428757 intervention 4: Placebo for TT223
Intervention descriptions: intervention 1: 14 mg subcutaneous injection 1 time a week for 5 weeks intervention 2: subcutaneous injection once a day for 4 weeks intervention 3: subcutaneous injection 1 time a week for 5 weeks intervention 4: subcutaneous injection once a day for 4 weeks

Protocol documents:
Clinical trial NCT00871351
Conditions: Primary Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2009-02-01; Completion date: 2010-05-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Detailed description:

Arms: arm 1: Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg arm 2: Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg arm 3: Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Interventions: intervention 1: Ezetimibe intervention 2: Atorvastatin intervention 3: Atorvastatin intervention 4: Rosuvastatin
Intervention descriptions: intervention 1: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) intervention 2: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) intervention 3: 2 tablets of 10 mg daily for 12 weeks (Weeks 5-16) intervention 4: 1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Protocol documents:
Clinical trial NCT00877929
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2009-02-01; Completion date: 2010-05-01
Enrollment: 706 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Detailed description:

Arms: arm 1: Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination arm 2: Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
Interventions: intervention 1: Telmisartan 80 intervention 2: Amlodipine 10 intervention 3: Amlodipine 10
Intervention descriptions: intervention 1: Telmisartan 80 mg intervention 2: Amlodipine 5 for two weeks, then forced titration to Amlodipine 10 intervention 3: Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Protocol documents:
Clinical trial NCT00885365
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis P. aeruginosa tobramycin
Sponsor: Chiesi Farmaceutici S.p.A.
Start date: 2009-04-01; Completion date: 2010-05-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.

Detailed description:

Arms: arm 1: tobramycin / Bramitob administered 300mg twice a day for 4 weeks arm 2: tobramycin / TOBI administered 300mg twice a day for 4 weeks
Interventions: intervention 1: tobramycin / Bramitob intervention 2: tobramycin / TOBI
Intervention descriptions: intervention 1: 300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen intervention 2: 300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen

Protocol documents:
Clinical trial NCT00888290
Conditions: Chronic Kidney Disease
Keywords: metabolic acidosis chronic kidney disease Estimated GFR 15-45
Sponsor: Albert Einstein College of Medicine
Start date: 2009-03-01; Completion date: 2010-05-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.

Detailed description:
This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.

Arms: arm 1: Sequential design. Participants will be getting different doses of sodium bicarbonate during the study. arm 2: Sequential design. Participants will be getting either placebo of different doses during the study.
Interventions: intervention 1: Sodium bicarbonate intervention 2: Placebos
Intervention descriptions: intervention 1: Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight intervention 2: Placebo at 3 different doses to match Sodium bicarbonate dosing

Protocol documents: