ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00086515
Conditions: Diabetes Mellitus, Type II
Keywords: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-06-30; Completion date: 2007-02-02
Enrollment: 701 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo. arm 2: The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.
Interventions: intervention 1: Sitagliptin (MK0431) intervention 2: Placebo/Glipizide 5 mg intervention 3: Metformin intervention 4: Pioglitazone
Intervention descriptions: intervention 1: Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104 intervention 2: Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104) intervention 3: Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104) intervention 4: Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)

Protocol documents:
Clinical trial NCT02004886
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Metformin
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-08-11; Completion date: 2007-02-07
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.

Detailed description:

Arms: arm 1: MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893. arm 2: MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893 arm 3: Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893. arm 4: Placebo tablets matching the MK-0893 and placebo tablets matching metformin.
Interventions: intervention 1: MK-0893 intervention 2: Metformin intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: 10 mg and 100 mg tablets intervention 2: 500 mg metformin tablets intervention 3: Placebo tablets matching MK-0893 intervention 4: Placebo tablets matching metformin

Protocol documents:
Clinical trial NCT00423488
Conditions: Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease
Sponsor: Organon and Co
Start date: 2005-07-12; Completion date: 2007-02-16
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling the dose of simvastatin to 40 mg alone in reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the National Cholesterol Expert Panel (NCEP) III LDL-C target goal of \<2.6 mmol/L (\<100 mg/dL) for subjects with diabetes mellitus and coronary heart disease.

Detailed description:

Arms: arm 1: Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet. arm 2: Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet.
Interventions: intervention 1: Ezetimibe 10 mg intervention 2: Simvastatin 20 mg intervention 3: Ezetimibe Placebo intervention 4: Simvastatin 20 mg intervention 5: Simvastatin Placebo
Intervention descriptions: intervention 1: 1 x 10-mg tablet, provided as blinded study treatment intervention 2: 1 x 20-mg tablet, provided as open-label study treatment intervention 3: 1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment intervention 4: 1 x 20-mg tablet, provided as blinded study treatment intervention 5: 1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment

Protocol documents:
Clinical trial NCT00328653
Conditions: Conjunctivitis, Vernal
Keywords: vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin
Sponsor: Santen SAS
Start date: 2006-05-01; Completion date: 2007-02-22
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is:

* To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.

The secondary objectives of this study are:

* To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
* To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
* To assess the decrease in frequency of concomitant artificial tears use.

Detailed description:

Arms: arm 1: four times daily arm 2: four times daily arm 3: administered four times daily
Interventions: intervention 1: Cyclosporine NOVA22007 0.05% intervention 2: Cyclosporine NOVA22007 0.1% intervention 3: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00262080
Conditions: Hereditary Angioedema (HAE)
Sponsor: Shire
Start date: 2005-12-31; Completion date: 2007-02-28
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.

Detailed description:

Arms: arm 1: DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections. arm 2: Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
Interventions: intervention 1: ecallantide intervention 2: Phosphate Buffer Saline (PBS),
Intervention descriptions: intervention 1: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections. intervention 2: given as three 1mL subcutaneous injections.

Protocol documents:
Clinical trial NCT00435461
Conditions: Rhinitis, Allergic, Seasonal
Keywords: once daily mountain cedar fexofenadine allergic rhinitis fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2006-12-20; Completion date: 2007-02-28
Enrollment: 1000 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine

Detailed description:

Interventions: intervention 1: Fluticasone furoate and fexofenadine
Intervention descriptions: intervention 1: Fluticasone furoate and fexofenadine

Protocol documents:
Clinical trial NCT00541775
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-06-01; Completion date: 2007-03-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: sitagliptin 100 mg arm 2: rosiglitazone 8 mg arm 3: placebo
Interventions: intervention 1: Sitagliptin intervention 2: Comparator: Rosiglitazone intervention 3: Comparator: Placebo intervention 4: Comparator: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks. intervention 2: Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks. intervention 3: placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks. intervention 4: Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.

Protocol documents:
Clinical trial NCT00057551
Conditions: Depression Depressive Disorder
Sponsor: Weill Medical College of Cornell University
Start date: 2003-04-01; Completion date: 2007-03-01
Enrollment: 491 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

Detailed description:
Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.

Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.

Arms: arm 1: Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) arm 2: Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) arm 3: Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
Interventions: intervention 1: Brief Supportive Psychotherapy intervention 2: CBASP intervention 3: Medication Only
Intervention descriptions: intervention 1: brief supportive psychotherapy intervention 2: psychotherapy developed for chronic depression intervention 3: antidepressant medication

Protocol documents:
Clinical trial NCT00085839
Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva NSCLC EGFR ECOG Performance Status 2 erlotinib Non-Small Cell Lung Cancer OSI-774
Sponsor: OSI Pharmaceuticals
Start date: 2004-02-01; Completion date: 2007-03-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Detailed description:

Arms: arm 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy arm 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
Interventions: intervention 1: Tarceva (Trademark) (erlotinib HCl, OSI-774) intervention 2: Combination carboplatin and paclitaxel
Intervention descriptions: intervention 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy intervention 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Protocol documents:
Clinical trial NCT00178841
Conditions: Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome
Keywords: Cutaneous T-cell Lymphoma CTCL Mycosis Fungoides Sezary Syndrome Bexarotene Targretin Rosiglitazone Avandia
Sponsor: Vanderbilt University
Start date: 2005-06-01; Completion date: 2007-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.

Detailed description:
Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lymph nodes or visceral sites can be palliated but rarely cured, even with the most aggressive regimens of systemic chemotherapy. Unfortunately, current treatment options at this stage only provide a short term response. Thus, it is important that additional therapies are investigated to manage this malignancy.

Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL).Bexarotene binds the RXR(Retinoid X Receptor)inside the cell, a receptor that forms heterodimers with a multitude of other nuclear receptors. One of these is the PPARγ (Peroxisome Proliferator Activator Receptor Gamma), a nuclear receptor that binds Rosiglitazone.Rosiglitazone is an FDA approved antidiabetic agent of the Thiazolidinedione class. Rosiglitazone increases insulin sensitivity and is useful in the treatment of type 2 diabetes. In vitro data suggest that rosiglitazone and bexarotene may act synergistically to induce apoptosis in cell lines derived from patients with cutaneous T cell lymphoma (CTCL). This pilot study will investigate this possible synergism in a small cohort of patients with stable or progressive CTCL already being treated with bexarotene.

Interventions: intervention 1: Rosiglitazone and Bexarotene
Intervention descriptions: intervention 1: rosiglitazone added to bexarotene capsules

Protocol documents:
Clinical trial NCT00234078
Conditions: Dry Eye Syndromes
Keywords: OPC-12759 Dry eye syndromes
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2005-01-01; Completion date: 2007-03-01
Enrollment: 290 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.

Detailed description:

Arms: arm 1: 0.5% OPC-12759 (rebamipide) ophthalmic suspension arm 2: 1% OPC-12759 (rebamipide) ophthalmic suspension arm 3: 2% OPC-12759 (rebamipide) ophthalmic suspension arm 4: placebo of OPC-12759 (rebamipide) ophthalmic suspension
Interventions: intervention 1: 0.5% OPC-12759 intervention 2: 1% OPC-12759 intervention 3: 2% OPC-12759 intervention 4: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00289848
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-03-01; Completion date: 2007-03-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: sitagliptin 100 mg arm 2: placebo
Interventions: intervention 1: sitagliptin phosphate intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks. intervention 2: placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks

Protocol documents:
Clinical trial NCT00289887
Conditions: Hypertension
Sponsor: Organon and Co
Start date: 2006-02-01; Completion date: 2007-03-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Detailed description:

Arms: arm 1: Losartan arm 2: Placebo
Interventions: intervention 1: Comparator: losartan +/- HCTZ intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks. intervention 2: Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.

Protocol documents:
Clinical trial NCT00301366
Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema
Sponsor: Grifols Therapeutics LLC
Start date: 2006-06-01; Completion date: 2007-03-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

Detailed description:
The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.

Arms: arm 1: Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects.
Interventions: intervention 1: alpha-1 proteinase inhibitor (human)
Intervention descriptions: intervention 1: 60 mg/kg weekly for 20 weeks

Protocol documents:
Clinical trial NCT00405353
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis testosterone
Sponsor: University of California, Los Angeles
Start date: 2002-04-01; Completion date: 2007-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12 month treatment period with Androgel.

Detailed description:
Background: Men are less susceptible to many autoimmune diseases including multiple sclerosis (MS). Possible causes for this include sex hormones and/or sex chromosome effects. Testosterone treatment ameliorates experimental allergic encephalomyelitis (EAE), an animal model of MS, but the effect of testosterone supplementation on men with MS is not known.

Design, Setting and Participants: Ten men with relapsing remitting MS were studied using a crossover design whereby each patient served as his own control. There was a six-month pretreatment period followed by a twelve month period of daily treatment with 100mg of testosterone gel.

Main Outcome Measures: Brain atrophy and Cognitive testing

Arms: arm 1: 6 months pretreatment, 12 months treatment intervention with Androgel 10 grams of gel containing 100mg of testosterone
Interventions: intervention 1: Androgel 10 grams of gel containing 100 mg of testosterone
Intervention descriptions: intervention 1: testosterone gel

Protocol documents:
Clinical trial NCT00862459
Conditions: Brain Diseases Spinal Cord Diseases
Keywords: Contrast Agents
Sponsor: Bayer
Start date: 2005-08-01; Completion date: 2007-03-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Detailed description:
Safety issues are addressed in the Adverse Events section

Arms: arm 1: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. arm 2: Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. arm 3: Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Interventions: intervention 1: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 3: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 4: OptiMARK~0.1 mmol/kg BW
Intervention descriptions: intervention 1: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 2: Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 3: Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 4: Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Protocol documents: