ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00626340
Conditions: Menopause Depression
Keywords: menopause women major depressive disorder Magnetic Resonance Spectroscopy
Sponsor: University of Pennsylvania
Start date: 1999-07-01; Completion date: 2008-07-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects before and after estrogen replacement, and after fourteen days of medroxyprogesterone administration; and 2) in depressed menopausal subjects before and after treatment of their depression with antidepressant alone, estrogen alone or antidepressant plus estrogen. Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels. Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and pregnenolone sulfate.

Detailed description:

Arms: arm 1: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone. arm 2: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone. arm 3: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined. arm 4: Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.
Interventions: intervention 1: MDD diagnosis and Estrogen treatment intervention 2: MDD diagnosis and Fluoxetine treatment intervention 3: MDD diagnosis with both Estrogen and Fluoxetine treatment intervention 4: No depression and estrogen treatment
Intervention descriptions: intervention 1: Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause. intervention 2: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone. intervention 3: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined. intervention 4: Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.

Protocol documents:
Clinical trial NCT00633152
Conditions: Bacterial Infection
Keywords: complicated skin and skin structure infections linezolid ceftaroline clinical response microbiological response Cellulitis Abscess Wound infection Deeper soft tissue Significant surgical intervention Gram-positive bacterial infection Gram-negative bacterial infection bacterial infection cephalosporin broad-spectrum activity
Sponsor: Forest Laboratories
Start date: 2008-02-01; Completion date: 2008-07-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

Detailed description:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Arms: arm 1: Intramuscular every 12 hours arm 2: Intravenous every 12 hours
Interventions: intervention 1: ceftaroline intervention 2: linezolid intervention 3: Aztreonam
Intervention descriptions: intervention 1: 600 mg injected every 12 hours for at least 5 but not more than 14 days intervention 2: 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days intervention 3: 1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.

Protocol documents:
Clinical trial NCT00642434
Conditions: Diabetes
Keywords: diabetes blood pressure oxidative stress
Sponsor: University of New Mexico
Start date: 2004-01-01; Completion date: 2008-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation.

Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler

Detailed description:
The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation.

Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler. Baseline visit will be done when subjects are off all antihypertension medications except ACEI/ARB. Following the baseline study subjects will be randomized to study drug. The dose will be titrated until goal blood pressure is reached. Add on medication will be used if needed.

Subjects will then undergo a second study. The third study will take place after 5 months on treatment. Stud drug will then be stoppped and subjects will be restudied 2 weeks later

Arms: arm 1: study drug- carvedilol arm 2: study drug metorprolol
Interventions: intervention 1: carvedilol intervention 2: metoprolol
Intervention descriptions: intervention 1: variable intervention 2: variable

Protocol documents:
Clinical trial NCT00651118
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2008-03-01; Completion date: 2008-07-01
Enrollment: 832 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Detailed description:
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.

Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: azelastine Hcl intervention 3: azelastineHcl / fluticasone propionate intervention 4: fluticasone propionate
Intervention descriptions: intervention 1: placebo intervention 2: azelastine Hcl 548 mcg intervention 3: azelastine Hcl 548 mcg / fluticasone propionate 200 mcg intervention 4: fluticasone propionate 200 mcg

Protocol documents:
Clinical trial NCT00653224
Conditions: Seasonal Allergic Rhinitis
Keywords: levocetirizine Xyzal Seasonal Allergic Rhinitis total symptom score quality of life
Sponsor: UCB Pharma
Start date: 2008-04-01; Completion date: 2008-07-01
Enrollment: 580 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.

Detailed description:

Arms: arm 1: Matched placebo tablets arm 2: 5 mg tablet
Interventions: intervention 1: levocetirizine dihydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: 5 mg daily (oral tablet) for 14 days intervention 2: 0 mg daily (matching oral tablet) for 14 days

Protocol documents:
Clinical trial NCT00660660
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD Esophageal Reflux Gastro-Esophageal Reflux Regurgitation Gastric
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2008-07-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).

Detailed description:

Arms: arm 1: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate arm 2: None
Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate intervention 2: once daily

Protocol documents:
Clinical trial NCT00671723
Conditions: Atelectasis
Keywords: Atelectasis
Sponsor: University of Oklahoma
Start date: 2006-10-01; Completion date: 2008-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis.

We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.

Detailed description:

Arms: arm 1: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). arm 2: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). arm 3: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).
Interventions: intervention 1: Normal saline: intervention 2: Hypertonic Saline intervention 3: Dornase alpha
Intervention descriptions: intervention 1: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). intervention 2: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). intervention 3: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

Protocol documents:
Clinical trial NCT00684255
Conditions: Systemic Lupus Erythematosus Systemic Sclerosis
Keywords: Autoimmune Disease Reduced Intensity Transplant
Sponsor: New York Medical College
Start date: 2007-08-01; Completion date: 2008-07-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

Detailed description:
This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Arms: arm 1: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE). arm 2: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
Interventions: intervention 1: Reduced Intensity Allogeneic Transplant intervention 2: Fludarabine intervention 3: Busulfan intervention 4: Campath
Intervention descriptions: intervention 1: Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc). intervention 2: Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2 intervention 3: Busulfan 3.2 mg/kg Days \_8, -7, -6, -5 intervention 4: Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Protocol documents:
Clinical trial NCT00686803
Conditions: Hypertension
Keywords: hypertension controlled hypertension hypertensives
Sponsor: Palatin Technologies, Inc
Start date: 2008-04-01; Completion date: 2008-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.

Detailed description:
Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

Arms: arm 1: PL3994 Dose A arm 2: PL3994 Dose B arm 3: PL3994 Dose C arm 4: PL3994 Dose D arm 5: PL3994 Dose E arm 6: Placebo
Interventions: intervention 1: PL3994 intervention 2: Placebo
Intervention descriptions: intervention 1: Study drug intervention 2: Placebo

Protocol documents:
Clinical trial NCT00708097
Conditions: Caries
Keywords: fluoride in situ remineralization enamel caries
Sponsor: GlaxoSmithKline
Start date: 2008-04-01; Completion date: 2008-07-01
Enrollment: 57 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:
In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).

Arms: arm 1: Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. arm 2: Study toothpaste containing 1400 ppm F as NaF arm 3: Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF arm 4: Study toothpaste containing 675 ppm F as NaF arm 5: Fluoride free placebo toothpaste (0 ppm F)
Interventions: intervention 1: NaF intervention 2: Placebo intervention 3: NaMFP
Intervention descriptions: intervention 1: Fluoride intervention 2: Placebo intervention 3: Fluoride

Protocol documents:
Clinical trial NCT00720382
Conditions: Perennial Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2007-03-01; Completion date: 2008-07-01
Enrollment: 703 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Detailed description:

Arms: arm 1: 0.15% azelastine hydrochloride 1644 mcg arm 2: Mometasone furoate 200 mcg
Interventions: intervention 1: 0.15% azelastine hydrochloride intervention 2: Mometasone furoate
Intervention descriptions: intervention 1: 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM intervention 2: 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

Protocol documents:
Clinical trial NCT00731042
Conditions: Healthy
Keywords: Skin health
Sponsor: Solventum US LLC
Start date: 2008-03-01; Completion date: 2008-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Detailed description:

Arms: arm 1: 3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers arm 2: Purell Surgical Scrub with Moisturizers
Interventions: intervention 1: Avagard intervention 2: Purell Surgical Scrub
Intervention descriptions: intervention 1: Topical solution, 6 mL, 6 applications/day for 14 days. intervention 2: Topical solution, 4 mL, 6 applications/day for 14 days.

Protocol documents:
Clinical trial NCT00759330
Conditions: Chronic Low Back Pain
Keywords: Flurbiprofen, low back pain, chronic low back pain
Sponsor: Teikoku Pharma USA, Inc.
Start date: 2007-10-01; Completion date: 2008-07-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).

Detailed description:
This study is a multi-center, randomized, double-blind, placebo-controlled study in patients with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration. Patients also had an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase. The study began with a 14-day washout period of previously used pain medications. At the end of the 14-day baseline phase, patients were randomized to 1 of 4 treatments: Flurbiprofen tape applied once daily for 12 hours, Flurbiprofen tape applied once daily for 24 hours, placebo tape applied once daily for 12 hours, or placebo tape applied once daily for 24 hours. During the 7-day treatment phase, patients applied 2 treatment tapes once daily for 7 days. The tapes remained on for 12 or 24 hours of continuous treatment, depending on the treatment to which they were randomized. Patients were provided with rescue medication. After 7 days of tape treatment, patients returned to the clinic for a study exit visit.

Arms: arm 1: Placebo tape remained on for 12 hours of continuous treatment per day. arm 2: Flurbiprofen tape remained on for 12 hours of continuous treatment per day. arm 3: Placebo tape remained on for 24 hours of continuous treatment per day. arm 4: Flurbiprofen tape remained on for 24 hours of continuous treatment per day.
Interventions: intervention 1: Placebo Tape (Arm 1) intervention 2: Flurbiprofen Tape (Arm 2) intervention 3: Placebo Tape (Arm 3) intervention 4: Flurbiprofen Tape (Arm 4)
Intervention descriptions: intervention 1: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 2: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. intervention 3: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 4: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.

Protocol documents: