ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00556673
Conditions: Asthma
Keywords: Asthma, QMF149, fixed combination of indacaterol and mometasone furoate
Sponsor: Novartis
Start date: 2007-10-01; Completion date: 2008-04-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

Detailed description:

Arms: arm 1: In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. arm 2: In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
Interventions: intervention 1: indacaterol maleate/mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate intervention 3: fluticasone proprionate / salmeterol xinafoate
Intervention descriptions: intervention 1: Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. intervention 3: Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.

Protocol documents:
Clinical trial NCT00558571
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2008-04-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: BI 10773 low dose intervention 2: placebo to BI 10773 intervention 3: BI 10773 medium dose intervention 4: BI 10773 high dose
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00560937
Conditions: Schizophrenia
Keywords: Schizophrenia Pregnenolone Cognition Negative Symptoms
Sponsor: Durham VA Medical Center
Start date: 2005-06-01; Completion date: 2008-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.

Detailed description:
See brief summary

Arms: arm 1: Pregnenolone arm 2: Placebo
Interventions: intervention 1: Pregnenolone intervention 2: Placebo
Intervention descriptions: intervention 1: Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks intervention 2: Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks

Protocol documents:
Clinical trial NCT00561795
Conditions: Primary Peritoneal Carcinoma Tumor Epithelial Ovarian Cancer Uterine Disease Cervix Diseases Neoplasms, Ovarian Cancer
Keywords: AGO Advanced, Gynaecologic cancer(s), Genetics GW786034, Pazopanib,
Sponsor: GlaxoSmithKline
Start date: 2007-09-01; Completion date: 2008-04-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

Detailed description:

Arms: arm 1: Oral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles arm 2: Oral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m\^2 IV over three hours day one q 3 weeks for six cycles
Interventions: intervention 1: pazopanib (GW786034) intervention 2: carboplatin intervention 3: paclitaxel
Intervention descriptions: intervention 1: 800 mg orally once a day for 6 cycles intervention 2: IV over one hour every 3 weeks of 6 cycles intervention 3: IV 175 mg/m\^2 given over 3 hours on day one of a 21 day cycle for six cycles

Protocol documents:
Clinical trial NCT00567112
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-11-01; Completion date: 2008-04-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: 10 mg MK-0941 DFC (fasted) intervention 2: 10 mg MK-0941 OCT (after meal) intervention 3: 10 mg MK-0941 OCT (before meal) intervention 4: 10 mg MK-0941 OCT (fasted)
Intervention descriptions: intervention 1: single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state intervention 2: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal intervention 3: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast intervention 4: single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state

Protocol documents:
Clinical trial NCT00569660
Conditions: Myelofibrosis
Keywords: Myelofibrosis MF Leukemia Azacitidine Vidaza
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-06-01; Completion date: 2008-04-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if azacitidine can help to control MF. The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied.

Detailed description:
Azacitidine is a drug that is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.

If you are found to be eligible to take part in this study, you will be able to begin treatment with azacitidine. You will receive azacitidine as an injection under the skin once a day for 7 days in a row. This will be repeated every 4 weeks (4 weeks equals 1 cycle). The first cycle of azacitidine will be given at M. D. Anderson, in an outpatient setting. Later cycles of treatment courses may be given at M. D. Anderson or by a cancer doctor in your community.

You may receive up to 12 cycles of treatment if you are responding well to treatment. You will be taken off study if your disease gets worse or intolerable side effects occur. Once you go off study, you will receive follow-up as is standard of care for your disease.

This is an investigational study. Azacitidine is FDA approved for the treatment of myelodysplastic syndrome. Its use in this study is experimental. A total of up to 34 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: 75 mg/m\^2 Subcutaneous Daily for 7 days every 4 weeks
Interventions: intervention 1: Azacitidine
Intervention descriptions: intervention 1: 75 mg/m\^2 subcutaneous daily for 7 days (every 4 week cycle)

Protocol documents:
Clinical trial NCT00590226
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes inpatient hyperglycemia SQ insulin Hospitalized patients with type 2 diabetes
Sponsor: Emory University
Start date: 2006-12-01; Completion date: 2008-04-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA.

This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.

Detailed description:

Arms: arm 1: Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously arm 2: NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously
Interventions: intervention 1: Detemir + aspart insulin before meals intervention 2: NPH insulin + regular insulin
Intervention descriptions: intervention 1: Detemir insulin SQ once daily + aspart insulin SQ before meals intervention 2: NPH insulin SQ + regular insulin SQ before breakfast and dinner

Protocol documents:
Clinical trial NCT00605306
Conditions: Asthma
Keywords: Asthma spirometry lung function serum cortisol serum potassium plasma glucose
Sponsor: Novartis
Start date: 2008-01-01; Completion date: 2008-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.

Detailed description:

Arms: arm 1: Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. arm 2: Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
Interventions: intervention 1: indacaterol maleate / mometasone furoate intervention 2: placebo to indacaterol maleate/mometasone furoate
Intervention descriptions: intervention 1: Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device. intervention 2: Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

Protocol documents:
Clinical trial NCT00610740
Conditions: Cervical Cancer Endometrial Cancer Ovarian Cancer
Keywords: recurrent cervical cancer cervical cancer endometrial carcinoma ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent endometrial carcinoma
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-07-01; Completion date: 2008-04-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be an effective way to kill more tumor cells.

PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical cancer, or ovarian epithelial cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix

Secondary

* To document any side effects directly attributed to local administration of gemcitabine hydrochloride.

OUTLINE: Patients undergo application of topical gemcitabine hydrochloride directly to the cervix using the CerviPrep™ drug delivery device during routine hysterectomy.

Uterine vein and peripheral blood samples are obtained periodically to measure local and peripheral gemcitabine hydrochloride concentration levels in the blood. Local gemcitabine hydrochloride concentration levels are also measured in uterine tissue samples obtained from the surgical specimen after hysterectomy.

Patients complete a self-reported symptom diary for the first 7 days after surgery for assessment of local and systemic side effects associated with topical administration of gemcitabine hydrochloride.

After completion of study therapy, patients are followed at 2-4 weeks.

Arms: arm 1: CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
Interventions: intervention 1: topical gemcitabine hydrochloride intervention 2: therapeutic conventional surgery
Intervention descriptions: intervention 1: Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device. intervention 2: hysterectomy

Protocol documents:
Clinical trial NCT00619307
Conditions: Relapsing Multiple Sclerosis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2007-07-01; Completion date: 2008-04-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rebif New Formulation + prophylactic Ibuprofen intervention 2: Rebif New Formulation + ibuprofen PRN
Intervention descriptions: intervention 1: Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected intervention 2: Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.

Protocol documents:
Clinical trial NCT00620854
Conditions: Osteoporosis
Sponsor: Tarsa Therapeutics, Inc.
Start date: 2008-02-01; Completion date: 2008-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).

Detailed description:

Arms: arm 1: Oral Tablet arm 2: Oral Tablet arm 3: Nasal Spray
Interventions: intervention 1: Recombinant Salmon Calcitonin (rsCT) intervention 2: Oral Tablet intervention 3: Oral Tablet intervention 4: Nasal Spray
Intervention descriptions: intervention 1: Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4. intervention 2: 0.15 mgs recombinant salmon calcitonin, single oral dose intervention 3: 0.2mgs recombinant salmon calcitonin, single oral tablet intervention 4: 200 IU recombinant salmon calcitonin, single intranasal spray

Protocol documents:
Clinical trial NCT00646958
Conditions: Infectious Skin Diseases Bacterial Skin Diseases Staphylococcal Skin Infections Streptococcal Infections Abscess
Sponsor: Melinta Therapeutics, Inc.
Start date: 2007-12-01; Completion date: 2008-04-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections

Detailed description:

Arms: arm 1: Radezolid 450 mg PO QD arm 2: Radezolid 450 mg PO BID arm 3: Linezolid 600 mg PO BID
Interventions: intervention 1: Radezolid intervention 2: Radezolid intervention 3: Linezolid
Intervention descriptions: intervention 1: 450mg PO QD intervention 2: 450mg PO BID intervention 3: 600mg PO BID

Protocol documents:
Clinical trial NCT00660829
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2007-12-01; Completion date: 2008-04-01
Enrollment: 536 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.

Detailed description:

Arms: arm 1: Placebo arm 2: 0.15% Azelastine Hydrochloride
Interventions: intervention 1: Placebo intervention 2: 0.15% Azelastine Hydrochloride
Intervention descriptions: intervention 1: Placebo intervention 2: 0.15% Azelastine Hydrochloride 822 mcg

Protocol documents:
Clinical trial NCT00708123
Conditions: Healthy Subjects Partial Denture Wearers Caries
Keywords: remineralization enamel fluoride caries in situ
Sponsor: GlaxoSmithKline
Start date: 2007-11-01; Completion date: 2008-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.

Detailed description:
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources \[sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)\] using an in situ caries model.

Arms: arm 1: Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 2: Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 3: Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 4: Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 5: Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
Interventions: intervention 1: Sodium fluoride toothpaste intervention 2: Placebo toothpaste
Intervention descriptions: intervention 1: Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F intervention 2: Fluoride free toothpaste (0 ppm F)

Protocol documents:
Clinical trial NCT00733954
Conditions: Plaque Psoriasis
Sponsor: Galderma R&D
Start date: 2007-08-01; Completion date: 2008-04-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

Detailed description:
Same as above.

Arms: arm 1: clobetasol propionate spray 0.05% arm 2: clobetasol propionate ointment 0.05%
Interventions: intervention 1: clobetasol propionate spray intervention 2: clobetasol propionate ointment
Intervention descriptions: intervention 1: Apply twice daily intervention 2: Apply twice daily

Protocol documents: