ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00609128
Conditions: Allergic Conjunctivitis
Keywords: tears conjunctival epithelial cells olopatadine eosinophils
Sponsor: University of Wisconsin, Madison
Start date: 2000-09-01; Completion date: 2009-11-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the research is to determine which inflammatory substances are involved in causing allergic symptoms in the eye. Allergic conjunctivitis is a common problem with symptoms of temporary redness, itching, tearing, and swelling of the eyes. Substances released by cells in the affected tissues cause allergic reactions in the eye and elsewhere in the body.

Detailed description:
Ocular allergies are extremely common, affecting up to 80 million people in the USA. Our research question is:

Are there differences in inflammatory mediators and cell surface activation markers in patients undergoing seasonal allergic conjunctivitis compared to those with sight threatening disease such as Atopic Keratoconjunctivitis (AKC) and will the use of the anti-allergy eye drop, PATANOL® (olopatadine hydrochloride) affect these parameters?

Experimental Design:

Ocular surface cells (by impression cytology) and tears (via capillary tube) are collected from allergic, non-allergic, and AKC subjects undergoing an reaction induced either by seasonal allergen or topical allergen provocation (specificity and dose determined via skin testing). Ocular surface cells are evaluated for surface activation markers. Tears are evaluated for mediator content. Tears are also incubated with peripheral blood eosinophils and lymphocytes to see effects on adhesion to conjunctival epithelial cells.

Arms: arm 1: one drop in one eye only two times per day at an interval of 6 to 8 hours for 1 week
Interventions: intervention 1: olopatadine
Intervention descriptions: intervention 1: olopatadine one drop in one eye for one week

Protocol documents:
Clinical trial NCT00609362
Conditions: Change in Bone Mineral Density Change in Bone Marrow Fat Content
Keywords: BMD Rosiglitazone Bone marrow fat
Sponsor: University of Aarhus
Start date: 2008-01-01; Completion date: 2009-11-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby decreasing bone strength. In a single study healthy volunteers were treated with rosiglitazone for 14 weeks and had a decrease in bone mineral density.

In the present study we wish to investigate the effect of this treatment on bone and fat tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks and compared with 25 women receiving placebo.

The effect will be evaluated as follows:

1. The effect on bone marrow density will be examined by a bone scan prior to and after treatment and again after 6 and 9 months.
2. The effect on bone turnover will be measured in blood- and urine samples at the same times.
3. The effect on fat distribution will be evaluated by an MRI scan after treatment.
4. The effect on bone marrow cells will be investigated bone marrow sampling immediately after treatment
5. The direct effect on fat will be examined by a biopsy immediately after treatment The study hypothesis is that rosiglitazone treatment decreases bone mineral density and increases bone marrow fat content. The causal molecular mechanisms will be investigated from the bone marrow and fat samples

Detailed description:

Arms: arm 1: 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day arm 2: 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo pill
Intervention descriptions: intervention 1: one tablet of rosiglitazone 8 milligrams per day for 14 weeks intervention 2: One encapsulated placebo pill a day for 14 weeks

Protocol documents:
Clinical trial NCT00622739
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder Children Adolescents Treatment
Sponsor: Baylor College of Medicine
Start date: 2007-02-01; Completion date: 2009-11-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators hypothesize that slower titration of ziprasidone will result in lesser side effects which will assist in medication compliance as measured by patient report and pill count.

Detailed description:
This study will enroll approximately 60 children and adolescents aged 10-17 years who have been diagnosed with bipolar disorder. Their participation will last about 8 weeks (2 weeks of screening and 6 weeks of medication management) and enrollment will last for two years. After the screening period, all subjects who meet inclusion/exclusion criteria will be randomized to either rapid or slow dose titration of ziprasidone. Subjects in the rapid titration group will reach their maximum dose of study drug over 2 weeks, subjects in the slow titration group over 4 weeks. The study doctor may deviate from the dosing schedule if clinically indicated. The primary data analysis of this pilot study will examine the effect of rapid- versus slow-dose titration of ziprasidone on manic symptoms.

Arms: arm 1: Rapid Dose Titration Group arm 2: Slow Dose Titration Group
Interventions: intervention 1: Ziprasidone intervention 2: Ziprasidone
Intervention descriptions: intervention 1: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects. intervention 2: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.

Protocol documents:
Clinical trial NCT00641056
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide exenatide once weekly metformin sulfonylurea insulin glargine Amylin Lilly
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2009-11-01
Enrollment: 467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Exenatide Once Weekly intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: subcutaneous injection, 2.0mcg, once weekly intervention 2: subcutaneous injection, variable dose, QD

Protocol documents:
Clinical trial NCT00661895
Conditions: Hypertension
Keywords: African American
Sponsor: Creighton University
Start date: 2005-08-01; Completion date: 2009-11-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when both control and intervention groups are given free antihypertensive medications and are involved in usual versus intensive intervention strategies. Because of this, it has not yet been determined whether the method of prescribing antihypertensive medications according to JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive medications and providing intensive behavioral and clinical interventions. Knowledge in this area of HTN treatment should better able medical and health practitioners to help their AA subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control by proposing a program that will evaluate the difference in HTN control among subjects receiving usual care and free medications and subjects also receiving free medications, but additionally being treated in a clinic that operates in a more intensive manner in relationship to patient behavior modification, patient-clinician interactions, and physical and social environments. At the conclusion of the study, the BEAT Hypertension Clinic investigators will report findings and help to answer the question of whether medication alone or medication combined with intensive behavioral and clinical treatment is more effective in HTN control in the AA population.

Detailed description:

Arms: arm 1: Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs). arm 2: No intervention
Interventions: intervention 1: Hydrochlorothiazide intervention 2: Lisinopril intervention 3: Lisinopril and Hydrochlorothiazide intervention 4: Nifedipine XL intervention 5: Metoprolol tartrate intervention 6: Atenolol intervention 7: Valsartan intervention 8: Doxazosin intervention 9: Clonidine intervention 10: Hydralazine intervention 11: Metoprolol succinate intervention 12: Amlodipine
Intervention descriptions: intervention 1: Hydrochlorothiazide 25 mg tablets intervention 2: Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet intervention 3: L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets intervention 4: 30 mg extended release tablets, 60 mg extended release tablets intervention 5: 50 mg tablets \& 100 mg tablets intervention 6: 50 mg tablet intervention 7: 80 mg tablets \& 160 mg tablet intervention 8: 4 mg tablets intervention 9: 0.2 mg tablets intervention 10: 50 mg tablets intervention 11: 50 mg tablet \& 100 mg tablet intervention 12: 5 mg tablets \& 10 mg tablets

Protocol documents:
Clinical trial NCT00669383
Conditions: Respiratory Compliance Functional Residual Capacity Pulmonary Function Testing
Keywords: premature delivery respiratory distress syndrome
Sponsor: Oregon Health and Science University
Start date: 2001-06-01; Completion date: 2009-11-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.

Detailed description:
The primary purpose of this randomized, blinded placebo controlled trial is to quantify and compare measurements of pulmonary function (including respiratory compliance and lung volumes/functional residual capacity) of hospitalized preterm infants whose mothers received an initial course of antenatal corticosteroids, remained undelivered after 14 days and at \< 34 weeks of gestation, and were then randomized to either a rescue course of antenatal corticosteroids or to a rescue course of placebo. In addition, follow-up pulmonary function tests, clinical outcomes, growth parameters, and the neurodevelopmental outcome of these infants will be followed.

Arms: arm 1: Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses arm 2: Placebo dose intramuscular q 24 hours x 2 doses
Interventions: intervention 1: betamethasone intervention 2: placebo
Intervention descriptions: intervention 1: 12 mg IM q 24 hours x 2 doses intervention 2: Placebo IM q 24 hours x 2 doses

Protocol documents:
Clinical trial NCT00670228
Conditions: AMI
Sponsor: Sanofi
Start date: 2008-04-01; Completion date: 2009-11-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC).

Secondary objectives:

To demonstrate that tight glycemic control using insulin glulisine and insulin glargine reduces markers of inflammation and improves Left Ventricular (LV) function and Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI undergoing Percutaneous Coronary Intervention (PCI).

Detailed description:

Arms: arm 1: In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL. arm 2: In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Interventions: intervention 1: Insulin Glargine (LANTUS) intervention 2: Insulin Glulisine (Apidra) intervention 3: Standard Therapy
Intervention descriptions: intervention 1: Subcutaneous insulin glargine was initiated 90 prior to the insulin glulisine infusion discontinuation (i.e. 48 hours after randomization) and titrated as per physician preference to maintain the plasma glucose between 90-130 mg/dL intervention 2: Prior PCI, subjects received a single IV bolus of insulin glulisine. The dose was 0.025 U/kg based upon patient reported weight.

Then IV insulin glulisine infusion was started within one hour of the IV insulin glulisine bolus and administered at a minimum rate of 2 U/h for 48 hours. The infusion was titrated in order to achieve and maintain the plasma glucose between 90 and 130 mg/dL. intervention 3: Standard insulin therapy titrated to blood sugar control

Protocol documents:
Clinical trial NCT00678379
Conditions: Postoperative Pain
Keywords: Tonsillectomy Postoperative Pain Clonidine Anesthetics, Local
Sponsor: Vanderbilt University Medical Center
Start date: 2008-04-01; Completion date: 2009-11-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Detailed description:
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsillar fossa prior to removal. While these studies have shown great promise, no large randomized trial of the most promising medications has been conducted. Because of this, many otolaryngologists do not administer intra-operative medications aimed at reducing post-operative pain. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Arms: arm 1: 1.5 ml injection of Normal Saline into each tonsillar fossa pre-tonsillectomy arm 2: Submucosal injection of 1.5 mL Lidocaine (1%) + Bupivacaine 0.5% into the tonsillar fossa, pre-tonsillectomy arm 3: Submucosal injection of 1.5 mL Lidocaine 1% + Bupivacaine 0.5% + Clondine 25mcg into the tonsillar fossa, pre-tonsillectomy
Interventions: intervention 1: lidocaine (1%) + bupivacaine (0.5%) intervention 2: Normal saline intervention 3: Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Intervention descriptions: intervention 1: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

B - lidocaine (1%) + bupivacaine (0.5%) intervention 2: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

A - normal saline intervention 3: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.

C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)

Protocol documents:
Clinical trial NCT00687830
Conditions: Colon Cancer
Keywords: Afternoon colonoscopy Morning Evening Bowel Preparation Efficacy Satisfaction
Sponsor: Cleveland Clinic Florida
Start date: 2008-02-01; Completion date: 2009-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.

Detailed description:
Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.

Arms: arm 1: Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy.

'Polyethylene Glycol afternoon' arm 2: Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy.

'Polyethylene Glycol morning'
Interventions: intervention 1: Polyethylene Glycol afternoon intervention 2: Polyethylene Glycol morning
Intervention descriptions: intervention 1: Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM intervention 2: Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM

Protocol documents:
Clinical trial NCT00690833
Conditions: Atopic Dermatitis
Sponsor: Wake Forest University
Start date: 2007-08-01; Completion date: 2009-11-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.

Detailed description:
To assess the efficacy of a desonide hydrogel 0.05% in both young children (age \<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis

Arms: arm 1: Approximately 40 male and female subjects (about 20 age 3 months to \<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD
Interventions: intervention 1: topical desonide hydrogel 0.05%
Intervention descriptions: intervention 1: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions

Protocol documents:
Clinical trial NCT00716859
Conditions: Glaucoma
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-07-01; Completion date: 2009-11-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Timolol intervention 2: latanoprost
Intervention descriptions: intervention 1: Timolol 0.5% dosed twice-daily intervention 2: Latanoprost 0.005% ophthalmic solution dosed once-daily

Protocol documents:
Clinical trial NCT00730522
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine Dependency Addiction vigabatrin
Sponsor: Catalyst Pharmaceuticals, Inc.
Start date: 2008-07-01; Completion date: 2009-11-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).

Detailed description:
This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during Screening/Baseline Phase, lasting up to 4 weeks.

At the conclusion of the Screening/Baseline Phase, subjects meeting all inclusion/exclusion criteria will be randomized to one of two treatment groups: vigabatrin or placebo. Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period. Subjects will be scheduled for clinic visits 3 times per week for efficacy and/or safety assessments during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects will return for follow up visits at Weeks 13, 16, 20 and 24.

Arms: arm 1: CPP-109 vigabatrin tablets arm 2: Matching Placebo Tablets
Interventions: intervention 1: CPP-109 vigabatrin intervention 2: Matching Placebo
Intervention descriptions: intervention 1: tablets, bid for 12 weeks intervention 2: tablets, bid, 12 weeks

Protocol documents: