ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00620282
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-02-01; Completion date: 2010-05-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone.

Detailed description:

Arms: arm 1: Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) arm 2: Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12) arm 3: Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: glimepiride
Intervention descriptions: intervention 1: Stepwise dose increase, s.c. (under the skin) injection, once daily intervention 2: Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily intervention 3: Tablets, 1 - 4 mg daily

Protocol documents:
Clinical trial NCT00627926
Conditions: Hepatitis C
Keywords: Genotype 1
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2008-03-01; Completion date: 2010-05-01
Enrollment: 1095 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Detailed description:

Arms: arm 1: Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. arm 2: Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. arm 3: Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Interventions: intervention 1: Pegylated Interferon Alfa 2a intervention 2: Telaprevir intervention 3: Ribavirin intervention 4: Placebo
Intervention descriptions: intervention 1: subcutaneous injection, 180 micrograms once per week intervention 2: 375 mg tablets administered orally every 8 hours at a dose of 750 mg intervention 3: 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg intervention 4: Telaprevir matching placebo

Protocol documents:
Clinical trial NCT00631475
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Actelion Idiopathic Pulmonary Fibrosis bosentan Tracleer Interstitial Lung Disease BUILD 3 (NCT00391443)
Sponsor: Actelion
Start date: 2008-04-01; Completion date: 2010-05-01
Enrollment: 128 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

Detailed description:

Arms: arm 1: For patients who were administered bosentan during BUILD 3 (NCT00391443):

Same dose will continue

For patients who were administered placebo during BUILD 3 (NCT00391443):

Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg
Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: For patients who were administered Bosentan during BUILD 3 (NCT00391443):

continue on same dose

For patients who were administered placebo during BUILD 3 (NCT00391443):

Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs \< 90 lbs.)

Protocol documents:
Clinical trial NCT00636792
Conditions: Follicular Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2008-02-01; Completion date: 2010-05-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Detailed description:

Arms: arm 1: This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.
Interventions: intervention 1: VELCADE intervention 2: Bendamustine intervention 3: Rituximab
Intervention descriptions: intervention 1: VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle. intervention 2: Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle intervention 3: Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5

Protocol documents:
Clinical trial NCT00642694
Conditions: Major Depressive Disorder Insomnia
Keywords: MDD Major Depressive Disorder Depression Initial Insomnia sleep difficulty sleeping down sad Major Depressive Disorder(MDD) and initial insomnia
Sponsor: University of Texas Southwestern Medical Center
Start date: 2007-05-01; Completion date: 2010-05-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo group.

Detailed description:
The primary objective of the study is to assess the time to remission in depression with initial insomnia using the SSRI antidepressant escitalopram combined with ramelteon or placebo. Patients will be assessed at each visit for depressive symptoms and insomnia, using the 30-item Inventory of Depressive Symptoms, Clinician-Rated version (IDS-C30; Rush et al 1986; Rush et al., 1996) as the primary outcome measure. The IDS self-report version will be used to assess self-reported changes in symptom severity. The 17 item Hamilton Rating Scale for Depression, (HRSD17; Hamilton, 1960) will also be administered, as it is the most commonly utilized depression symptom severity measure at this time.

Arms: arm 1: Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Ramelteon (One 8 mg capsule at night) arm 2: Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Matching Placebo (One capsule at night)
Interventions: intervention 1: Escitalopram intervention 2: Ramelteon intervention 3: Placebo
Intervention descriptions: intervention 1: Escitalopram 10 or 20mg qd based on symptoms at patient visit intervention 2: Ramelteon 8 mg qd intervention 3: Matching placebo qd

Protocol documents:
Clinical trial NCT00655538
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Start date: 2008-02-01; Completion date: 2010-05-01
Enrollment: 476 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: dalcetrapib
Intervention descriptions: intervention 1: po daily for 36 weeks intervention 2: 600mg po daily for 36 weeks

Protocol documents:
Clinical trial NCT00662545
Conditions: HIV Infections Hepatitis B
Keywords: HIV Hepatitis B treatment experienced
Sponsor: University of California, San Francisco
Start date: 2008-04-01; Completion date: 2010-05-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24 weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After 24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.

Detailed description:
Design: This is a randomized, controlled pilot study of open-label entecavir for the treatment of persistent HBV viremia in HIV-HBV coinfected individuals who have failed to suppress HBV replication after 48 weeks on tenofovir containing therapy.

Primary Objective: To evaluate the mean log reduction of HBV DNA with entecavir(ETV) intensification in comparison to continued standard therapy with tenofovir and lamivudine/emtricitabine at 24 weeks of therapy

Study Population: HIV-HBV co-infected individuals with detectable HBV DNA after 48 weeks of therapy with tenofovir and lamivudine/emtricitabine whose HIV viremia is well controlled ( \< 75 copies at time of enrollment)

Treatment: Subjects will be randomized to continue with standard therapy or to receive intensification with 1 mg daily of open label entecavir for the 24 week duration of the study.

Sample Size: 24 subjects will be enrolled.

Duration 24 weeks of treatment

Primary Endpoint: Mean log10 reduction of HBV DNA at 24 weeks of standard therapy vs. entecavir intensification.

Arms: arm 1: Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine arm 2: continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Interventions: intervention 1: Entecavir with continued standard of care antiretroviral therapy intervention 2: continued standard of care with tenofovir in addition to emtricitabine or lamivudine
Intervention descriptions: intervention 1: 1 mg by mouth daily intervention 2: continued standard of care with tenofovir in addition to emtricitabine or lamivudine

Protocol documents:
Clinical trial NCT00671528
Conditions: Dermatitis, Atopic Eczema, Atopic Skin Diseases, Eczematous
Keywords: Impetiginous
Sponsor: Organon and Co
Start date: 2009-07-01; Completion date: 2010-05-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema:

* Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
* Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream
* Arm C: Betamethasone diproprionate cream

At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile.

Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed.

Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.

Detailed description:

Arms: arm 1: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) arm 2: Combination of betamethasone diproprionate cream and gentamicin sulfate cream arm 3: Betamethasone diproprionate cream
Interventions: intervention 1: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) intervention 2: Cream (betamethasone diproprionate and gentamicin) intervention 3: Cream (betamethasone diproprionate)
Intervention descriptions: intervention 1: Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. intervention 2: Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. intervention 3: Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.

Protocol documents:
Clinical trial NCT00682357
Conditions: Osteoarthritis
Keywords: Osteoarthritis, intra articular steroids
Sponsor: University of Kansas Medical Center
Start date: 2008-05-01; Completion date: 2010-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis.

Detailed description:
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis. The purpose of the study is to determine if intra-articular steroids suppress markers of bone formation or resorption in osteoarthritis patients and whether these markers may be modified by Vitamin D or Dual-energy X-ray absorptiometry (DEXA) bone density status

Arms: arm 1: Methylprednisone 80 mg and Lidocaine 20 mg arm 2: Methylprednisolone 16 mg and Lidocaine 20 mg arm 3: Placebo and Lidocaine 20 mg
Interventions: intervention 1: Methylprednisolone and Lidocaine intervention 2: Methylprednisolone and Lidocaine intervention 3: Placebo and Lidocaine
Intervention descriptions: intervention 1: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg intervention 2: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg intervention 3: Placebo and lidocaine 20 mg

Protocol documents:
Clinical trial NCT00686335
Conditions: Asthma
Keywords: asthma nocturnal asthma glucocorticoid dependent persistent asthma signs and symptoms lung function prednisone
Sponsor: Amgen
Start date: 2008-06-01; Completion date: 2010-05-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms: arm 1: After the 4 week run-in period with immediate release prednisone (Cortancyl), patients were switched to the identical dose of modified release prednisone tablets (Lodotra). Study medication for the Lodotra treatment period consisted of Lodotra in 2 dose strengths (5 mg and 1 mg prednisone per tablet). Patients were to take their tablets with or after the evening meal (at 10 pm +/- 30 minutes) for 4 weeks. arm 2: During the 4 week run-in period, patients remained on their respective pre-study dose of prednisone or equivalent. However, patients were standardized to 5 mg and 1 mg tablets of immediate release prednisone (Cortancyl). Patients were to take their tablets with or after the morning meal (at 8am +/- 30 minutes) for 4 weeks.
Interventions: intervention 1: Lodotra intervention 2: Cortancyl
Intervention descriptions: intervention 1: Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period. intervention 2: Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl).

Protocol documents:
Clinical trial NCT00689338
Conditions: Invasive Candidiasis
Keywords: Candida Candidemia Systemic Candidiasis ICU Intensive Care Unit Critical Care Unit Anidulafungin Ecalta Eraxis Fluconazole Voriconazole
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2010-05-01
Enrollment: 216 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Detailed description:

Arms: arm 1: Option to treat with oral azole therapy following treatment with anidulafungin
Interventions: intervention 1: Anidulafungin intervention 2: Fluconazole intervention 3: Voriconazole
Intervention descriptions: intervention 1: Anidulafungin Intravenous Administration intervention 2: Oral Administration of Fluconazole intervention 3: Oral Administration of Voriconazole

Protocol documents:
Clinical trial NCT00689728
Conditions: Arthritis, Rheumatoid
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2010-05-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).

Detailed description:

Arms: arm 1: Double-blind Treatment: 30 mg LY2127399 administered as a single intravenous (IV) infusion over 30 minutes at 0, 3, and 6 weeks.

Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24.

Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery. arm 2: Double-blind Treatment: 80 mg LY2127399 administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks.

Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints, could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on initial randomized treatment up to Week 24.

Follow-up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery. arm 3: Double-blind Treatment: Placebo comparator administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks.

Rescue: At Week 16 primary endpoint, participants without at least 20% improvement in either tender or swollen joint counts based on 28 joints could receive an additional (unblinded) 30 minute infusion of LY2127399 80 mg or remain on same initial randomized treatment up to Week 24.

Follow-Up: Optional visits beyond Week 24, if needed, to assess safety including B cell count recovery.
Interventions: intervention 1: LY2127399 intervention 2: Placebo
Intervention descriptions: intervention 1: LY2127399 will be administered as a single IV infusion over 30 minutes. intervention 2: Placebo will be administered as a single IV infusion over 30 minutes.

Protocol documents:
Clinical trial NCT00695955
Conditions: Hypertension
Keywords: Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy
Sponsor: Takeda
Start date: 2007-06-01; Completion date: 2010-05-01
Enrollment: 669 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Detailed description:
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.

Takeda Global Research and Development is developing TAK-491 (azilsartan medoxomil) for the treatment of essential hypertension. This study is being conducted to demonstrate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Study participation is anticipated to be approximately 1 year and 1.5 months, and participants will be required to return to the clinic for 10 study visits.

Arms: arm 1: None
Interventions: intervention 1: Azilsartan medoxomil with or without add-on chlorthalidone intervention 2: Azilsartan medoxomil with or without add-on hydrochlorothiazide
Intervention descriptions: intervention 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved. intervention 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.

Protocol documents: