ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00586157
Conditions: ADHD Attention Deficit Hyperactivity Disorder
Keywords: ADHD Attention Deficit Hyperactivity Disorder Daytrana MTS Patch Methylphenidate Transdermal System
Sponsor: Massachusetts General Hospital
Start date: 2006-09-01; Completion date: 2008-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Methylphenidate Transdermal System intervention 2: Placebo
Intervention descriptions: intervention 1: Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses) intervention 2: Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses)

Protocol documents:
Clinical trial NCT00588965
Conditions: Long QT Syndrome Cardiac Repolarization
Keywords: QT interval beta-blocker exercise electrocardiogram repolarizaton
Sponsor: MetroHealth Medical Center
Start date: 2007-08-01; Completion date: 2008-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy. In addition, LQT1 associated with a normal resting QT interval can be unmasked by the abnormal QT response to exercise testing (failure of the QT interval to shorten normally). Preliminary data from our laboratory show that the exercise QT intervals of patients with LQT1 are partially normalized by beta-blocker therapy. It is still currently not known if beta-blockers modify the QT/heart rate relationship (a primary effect on repolarization) or if the "normalizing" effect is due to the inability of subjects on beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for prolongation to occur. Moreover, the physiologic response of the exercise QT interval to beta-blockers in healthy control subjects is not known.

Objective. The objective of this study is to define the impact of beta-blocker therapy on the QT response to exercise and recovery in normal subjects.

Methods. Approximately 36 healthy adult subjects age-matched to previously studied LQT1 subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an exercise test, and 3) two weeks of placebo therapy ending in an exercise test. Beta blocker and placebo will be given in random order in a double-blind fashion. The QT response to exercise and recovery will be compared between drug-free and beta-blocker-treated states. These data will be compared to those previously collected for LQT1 subjects.

Implications. These results will provide new information about the effect of beta-blocker therapy on repolarization parameters in normal subjects, and will provide a context in which to interpret the previous findings that beta-blocker administration modifies the QT response to exercise in LQT1 subjects.

Detailed description:

Arms: arm 1: Subjects are assigned to placebo. arm 2: Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
Interventions: intervention 1: Placebo intervention 2: Propranolol LA
Intervention descriptions: intervention 1: Placebo will be given 1 pill daily for a week, then 2 pills daily, followed by the exercise test. intervention 2: Subjects will receive propranolol LA 80 mg one pill daily for 1 week then 2 pills daily for 1 week followed by exercise test.

Protocol documents:
Clinical trial NCT00598078
Conditions: Essential Tremor
Sponsor: Jazz Pharmaceuticals
Start date: 2007-12-01; Completion date: 2008-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Sodium Oxybate intervention 2: Sodium Oxybate intervention 3: Placebo
Intervention descriptions: intervention 1: Dose 1 intervention 2: Dose 2 intervention 3: Dose 3

Protocol documents:
Clinical trial NCT00599196
Conditions: Early Stage Parkinson's Disease
Keywords: Rotigotine Neupro®
Sponsor: UCB Pharma
Start date: 2002-08-01; Completion date: 2008-12-01
Enrollment: 381 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

Detailed description:
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Arms: arm 1: Rotigotine
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine trans-dermal patches, once daily:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);

Optimal dosing:

During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.

After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.

Protocol documents:
Clinical trial NCT00599521
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Adapalene
Sponsor: Galderma R&D
Start date: 2007-11-01; Completion date: 2008-12-01
Enrollment: 1067 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Detailed description:
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle
Intervention descriptions: intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Vehicle will be applied topically to the face, once a day, for 12 weeks

Protocol documents:
Clinical trial NCT00603018
Conditions: Anorexia Nervosa
Keywords: eating disorders anorexia nervosa anorexia PET brain imaging serotonin fMRI Prozac fluoxetine
Sponsor: University of Pittsburgh
Start date: 2007-06-01; Completion date: 2008-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.

Detailed description:

Arms: arm 1: Participants recovered from anorexia nervosa before and after administration of fluoxetine
Interventions: intervention 1: Fluoxetine
Intervention descriptions: intervention 1: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.

Protocol documents:
Clinical trial NCT00606307
Conditions: Myeloproliferative Diseases
Keywords: polycythemia vera (PV) essential thrombocythemia (ET) myelofibrosis (MF)
Sponsor: Italfarmaco
Start date: 2007-12-01; Completion date: 2008-12-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To evaluate efficacy and safety of ITF2357 in the treatment of patients with JAK2V617F positive myeloproliferative diseases \[Polycythemia Vera (PV), Essential Thrombocytosis (ET), Myelofibrosis (MF)\]. Efficacy was evaluated by ad hoc haematological and clinical criteria for PV and ET, and by internationally established response criteria (EUMNET criteria) for MF. Safety was evaluated by number of subjects experiencing an Adverse Event (AE), type, frequency, severity, timing and relatedness of AEs, including changes in vital signs and clinical laboratory results.

Secondary Objective:

To evaluate the JAK2 mutated allele burden by quantitative Real-Time Polymerase Chain Reaction (qRTPCR).

Detailed description:
This is a non-randomized, open-label, Phase IIA pilot study testing efficacy and safety of ITF2357 in a population of patients with JAK2V617F positive myeloproliferative diseases. All recruited patients received an initial dose of 50 mg b.i.d. of ITF2357 that was subsequently escalated to 50 mg t.i.d. in case of lack of significant toxicity. Treatment lasted up to a maximum of 24 cumulative weeks of drug administration. The study was carried out in Italy. Enrolled patients were subjects of both genders, with an established diagnosis of polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF) according to the revised WHO criteria.

Arms: arm 1: Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
Interventions: intervention 1: ITF2357
Intervention descriptions: intervention 1: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.

Protocol documents:
Clinical trial NCT00610883
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 1990-05-01; Completion date: 2008-12-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts:

* Induction ends on day 19
* Consolidation ends on day 38 or 42
* Maintenance may include up to 6 cycles

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
Intervention descriptions: intervention 1: LSA4 intervention includes three phases: induction, consolidation and maintenance

Protocol documents:
Clinical trial NCT00611715
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2003-11-01; Completion date: 2008-12-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the rate of clinical benefit (complete response \[CR\], partial response \[PR\], and stable disease \[SD\] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride.

Secondary

* To determine the time to progression (TTP) in patients treated with this regimen.
* To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen in these patients.
* To evaluate the safety of this regimen in these patients.
* To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP from the combination compared to tumors that do not express or overexpress these molecules.

OUTLINE: This is a multicenter study. Patients are stratified according to prior hormone therapy (hormone-therapy naive/first-line therapy vs prior hormonal therapy with either tamoxifen or an aromatase inhibitor in the adjuvant or metastatic setting/second-line therapy)

Patients receive oral letrozole and oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: erlotinib hydrochloride intervention 2: letrozole intervention 3: fluorescence in situ hybridization intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: OSI-774 150 mg/day intervention 2: Letrozole 2.5 mg/day intervention 3: To determine HER2 gene amplification or excess copies of the HER2 gene intervention 4: to measure the epidermal growth factor receptors (EGFR) intervention 5: To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

Protocol documents:
Clinical trial NCT00612573
Conditions: Acne Vulgaris
Sponsor: Warner Chilcott
Start date: 2008-02-01; Completion date: 2008-12-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Detailed description:

Arms: arm 1: Doxycycline dosed at 40 mg/day to subjects of appropriate weights arm 2: Doxycycline dosed at 80 mg/day to subjects of appropriate weights arm 3: Doxycycline dosed at 160 mg/day to subjects of appropriate weights arm 4: None
Interventions: intervention 1: Doxycycline 0.6 mg/kg/day intervention 2: Doxycycline 1.2 mg/kg/day intervention 3: Doxycycline 2.4 mg/kg/day intervention 4: Placebo
Intervention descriptions: intervention 1: doxycycline 40 mg/day, oral, 12 weeks intervention 2: doxycycline 80 mg/day, 12 weeks intervention 3: doxycycline 160 mg/day, 12 weeks intervention 4: Placebo, 12 weeks

Protocol documents:
Clinical trial NCT00616655
Conditions: Generalized Anxiety Disorder
Keywords: Anxiety
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-01-01; Completion date: 2008-12-01
Enrollment: 456 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

Detailed description:
This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg arm 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg arm 3: Placebo total daily dose 0.9 mg
Interventions: intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo
Intervention descriptions: intervention 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg intervention 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg intervention 3: Placebo total daily dose 0.9 mg

Protocol documents:
Clinical trial NCT00618618
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2008-04-01; Completion date: 2008-12-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).

Detailed description:

Arms: arm 1: Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 3: Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 4: Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 5: Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 6: Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
Interventions: intervention 1: Deoxycholic Acid Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. intervention 2: None

Protocol documents:
Clinical trial NCT00623467
Conditions: Central Nervous System Diseases
Keywords: Central Nervous System Imaging Diagnostic Imaging
Sponsor: Bayer
Start date: 2007-12-01; Completion date: 2008-12-01
Enrollment: 343 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. 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 will be compared to the results of images taken without Gadavist.

Detailed description:
Issues on safety will be addressed in Adverse Events section.

Arms: arm 1: Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

Protocol documents:
Clinical trial NCT00625989
Conditions: Asthma
Keywords: asthma atopy allergen challenge sputum myeloid and plasmacytoid dendritic cells
Sponsor: Hamilton Health Sciences Corporation
Start date: 2008-02-01; Completion date: 2008-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Summary:

A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen.

Hypothesis:

Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.

Objective:

The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.

Detailed description:
Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing will be preformed to assess airway hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced before challenge (0 hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7 hours following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.

Before the next study period begins, there will be a washout period of 2-4 weeks. On the first visit of the second study period, a methacholine challenge will be performed to ensure the return of PC20 to within one doubling dose of baseline values. Also, sputum will be induced before challenge (0hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7hrs following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.

Arms: arm 1: Inhalation challenge preformed with diluent. arm 2: Inhalation challenge preformed with allergen.
Interventions: intervention 1: Aeroallergen
Intervention descriptions: intervention 1: None

Protocol documents: