ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00463606
Conditions: Hypercholesterolemia Dyslipidemia
Sponsor: AstraZeneca
Start date: 2007-04-01; Completion date: 2008-02-01
Enrollment: 760 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Detailed description:
There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

Arms: arm 1: ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks arm 2: ABT-335 135mg monotherapy administered orally, once daily for 12 weeks arm 3: Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks
Interventions: intervention 1: ABT-335 and rosuvastatin calcium intervention 2: ABT-335 intervention 3: rosuvastatin calcium
Intervention descriptions: intervention 1: ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks intervention 2: ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks intervention 3: Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks

Protocol documents:
Clinical trial NCT00475306
Conditions: Nausea Extrapyramidal Symptoms
Keywords: Metoclopramide Nausea Akathisia Emergency department
Sponsor: Montefiore Medical Center
Start date: 2007-05-01; Completion date: 2008-02-01
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

Detailed description:
The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.

In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.

Arms: arm 1: Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes arm 2: Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes arm 3: Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes arm 4: Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes
Interventions: intervention 1: metoclopramide 10 mg intervention 2: Diphenhydramine 25 mg intervention 3: Placebo intervention 4: Metoclopramide 20 mg
Intervention descriptions: intervention 1: an anti-emetic medication intervention 2: used for prophylaxis against akathisia intervention 3: placebo intervention 4: Metoclopramide 20 mg

Protocol documents:
Clinical trial NCT00477490
Conditions: Nocturia
Sponsor: Ferring Pharmaceuticals
Start date: 2007-05-01; Completion date: 2008-02-01
Enrollment: 799 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Detailed description:

Arms: arm 1: Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded). arm 2: Participants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded). arm 3: Participants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded). arm 4: Participants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded). arm 5: Participants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Interventions: intervention 1: desmopressin acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg intervention 2: Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.

Protocol documents:
Clinical trial NCT00497289
Conditions: Preterm Infants Parenteral Nutrition n-3 Fatty Acids
Keywords: n-3 Polyunsaturated Fatty Acids (PUFA) parenteral nutrition preterm infant
Sponsor: B. Braun Melsungen AG
Start date: 2006-01-01; Completion date: 2008-02-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters.

Detailed description:

Arms: arm 1: Lipidem 20 % arm 2: Lipofundin MCT/LCT 20%
Interventions: intervention 1: Lipofundin MCT/LCT 20 % intervention 2: Lipidem 20%
Intervention descriptions: intervention 1: daily i.v. infusion for up to 5 days intervention 2: daily i.v. infusion for up to 5 days

Protocol documents:
Clinical trial NCT00500370
Conditions: Obesity
Keywords: exenatide obesity diabetes Amylin Lilly
Sponsor: AstraZeneca
Start date: 2007-06-01; Completion date: 2008-02-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide intervention 2: placebo
Intervention descriptions: intervention 1: subcutaneous injection (5mcg or 10mcg), twice a day intervention 2: subcutaneous injection (equivalent volume to active dose), twice a day

Protocol documents:
Clinical trial NCT00530790
Conditions: Restless Legs Syndrome
Keywords: Restless Legs Syndrome
Sponsor: GlaxoSmithKline
Start date: 2007-08-23; Completion date: 2008-02-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.

Detailed description:

Arms: arm 1: Subjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose will be increased at intervals of at least one week until sufficient efficacy is obtained (use "much improved" as a guide) without safety problem. Dose escalation will start at the initial dose 0.5 mg/day to 1 mg/day; after 1 mg/day, the dose will be increased by 1 mg/day to the maximum 6 mg/day.
Interventions: intervention 1: ropinirole controlled release (CR)-RLS
Intervention descriptions: intervention 1: White film-coated round-shaped tablet

Protocol documents:
Clinical trial NCT00536913
Conditions: Asthma
Keywords: Symbicort pMDI spacer children
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2008-02-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Detailed description:

Arms: arm 1: Budesonide/formoterol pMDI 40/2.25ug + spacer arm 2: Budesonide/formoterol pMDI 40/2.25 ug
Interventions: intervention 1: Budesonide/formoterol pMDI 40/2.25ug + spacer intervention 2: Budesonide/formoterol pMDI 40/2.25 ug
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00552110
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2007-07-01; Completion date: 2008-02-01
Enrollment: 707 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.

Detailed description:

Arms: arm 1: Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily arm 2: MFNS with OXY 3 sprays once daily arm 3: MFNS once daily arm 4: OXY twice daily arm 5: Placebo nasal spray
Interventions: intervention 1: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) intervention 2: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) intervention 3: mometasone furoate nasal spray (MFNS) once daily intervention 4: oxymetazoline nasal spray (OXY) twice daily intervention 5: Placebo
Intervention descriptions: intervention 1: MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM). intervention 2: MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening. intervention 3: MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening. intervention 4: OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning. intervention 5: Matching placebo to MFNS given every morning and every evening x 2 weeks.

Protocol documents:
Clinical trial NCT00579982
Conditions: Mood Disorders
Keywords: Mood disorder
Sponsor: GlaxoSmithKline
Start date: 2008-01-01; Completion date: 2008-02-01
Enrollment: 97 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3 weeks to determine convenience and satisfaction.

Detailed description:

Arms: arm 1: Lamictal orally disintegrating tablet (ODT)
Interventions: intervention 1: Lamotrigine
Intervention descriptions: intervention 1: Experimental formulation

Protocol documents:
Clinical trial NCT00587431
Conditions: Prostate Cancer
Keywords: Prostate Cancer Docetaxel 03-076
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2003-07-01; Completion date: 2008-02-01
Enrollment: 102 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GnRh (Leuprolide) intervention 2: Testosterone Gel intervention 3: Docetaxel
Intervention descriptions: intervention 1: Leuprolide LUPRON intervention 2: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p) intervention 3: 70 mg/m2 given on day o1 of each 3 week cycle

Protocol documents:
Clinical trial NCT00603187
Conditions: Healthy
Keywords: Male Contraception Acyline
Sponsor: University of Washington
Start date: 2008-01-01; Completion date: 2008-02-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We propose oral dosing of gastrointestinal permeation enhancement technology \[GIPET\] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.

Detailed description:
The purpose of this study is to test how the body responds to a new oral form of acyline given for seven days and to also look at the safety of oral acyline.

Acyline temporarily blocks the production of the hormone testosterone in healthy men. It has been tested in over 100 men in an injection form. This study will be testing acyline in a pill form for seven days.

This study may help develop an oral form of testosterone-blocker which may be useful in the treatment of diseases such as prostate cancer, premature puberty and possibly in a male contraceptive.

This study will evaluate a single dose of oral acyline given once a day for seven days and subsequent effects on Testosterone, FSH and LH blood serum concentrations.

Interventions: intervention 1: Acyline
Intervention descriptions: intervention 1: 20 mg GIPET enhanced oral dose, daily for 7-days

Protocol documents:
Clinical trial NCT00630539
Conditions: Atrophy Vaginal Diseases
Keywords: Menopausal symptoms Urogenital atrophy Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy
Sponsor: Shionogi
Start date: 2007-08-01; Completion date: 2008-02-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Detailed description:

Arms: arm 1: Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks arm 2: Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks arm 3: Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks arm 4: Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
Interventions: intervention 1: Placebo intervention 2: Ospemifene 5 mg intervention 3: Ospemifene 15 mg intervention 4: Ospemifene 30 mg
Intervention descriptions: intervention 1: 1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12). intervention 2: 1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12). intervention 3: 1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12). intervention 4: 1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Protocol documents:
Clinical trial NCT00633256
Conditions: Smoking
Sponsor: Yale University
Start date: 2006-12-01; Completion date: 2008-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several physiological and subjective outcome measures (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions lasting approximately thirty minutes. Our aims are:

1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity in overnight abstinent smokers. Reactivity to smoking cues will be captured with self-report smoking urges and physiological measures (heart rate, blood pressure, and skin conductance).

   We hypothesize that cycloserine, relative to placebo, will facilitate extinction of smoking cue reactivity.
2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking behavior will be measured with self-report smoking and saliva cotinine levels.
3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine dependent smokers. Memory performance will be measured with verbal learning, recognition and recall tasks.

4\) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.

Detailed description:

Arms: arm 1: 50 mg cycloserine arm 2: Matched placebo
Interventions: intervention 1: Cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg Cycloserine given in two separate experimental sessions separated by approximately one week. intervention 2: Matched placebo for subjects randomized to placebo arm. Given in two experimental sessions separated by approximately one week.

Protocol documents:
Clinical trial NCT00644917
Conditions: Healthy
Keywords: wound healing phototoxicity Healthy Subjects
Sponsor: Healthpoint
Start date: 2008-02-01; Completion date: 2008-02-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The product is being tested to see if exposure to light causes toxic reactions on the skin.

Detailed description:

Arms: arm 1: Drug arm 2: Placebo comparator arm 3: Subjects serve as own controls.
Interventions: intervention 1: Xenaderm intervention 2: Placebo
Intervention descriptions: intervention 1: 20mg under Finn chambers intervention 2: 20mg under Finn chambers

Protocol documents:
Clinical trial NCT00657020
Conditions: Smoking
Keywords: nicotine therapy fMRI/EEG replacement
Sponsor: GlaxoSmithKline
Start date: 2007-09-01; Completion date: 2008-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A single center, double blind, randomized, placebo controlled, two-treatments, two-period crossover study conducted in adult smokers.

Detailed description:
The main objective of this study is to use blood oxygen level-dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) in abstinent smokers to directly evaluate the effect of the 4 milligrams (mg) nicotine lozenge on brain activation associated with visual attention. The experimental task featured 3 conditions: 1. a highly demanding cognitive/attention task, 2. a simple cognitive/attention task, and 3. simply look at a '+' symbol. During the experiment these conditions are each presented a number of times in an alternating manner while acquiring images.

Arms: arm 1: Nicotine lozenge containing 4 mg of nicotine to be placed in mouth and suck to dissolution. arm 2: Placebo lozenge to be placed in mouth and suck to dissolution.
Interventions: intervention 1: Nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: Nicotine lozenge containing 4 mg of nicotine intervention 2: Placebo lozenge

Protocol documents:
Clinical trial NCT00666029
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome Volunteers recruited from the community
Sponsor: University Hospital Southampton NHS Foundation Trust
Start date: 2006-02-01; Completion date: 2008-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial to determine whether treatment with a statin improves muscle microvascular blood flow.

Detailed description:
To characterise features of the metabolic syndrome, including body fat, insulin sensitivity, and liver fat together with muscle micorvascular blood flow.

To undertake a randomised controlled trial of atorvastatin 40 mg. o.d for 6 months to determine whether any of the above measures change with treatment.

Arms: arm 1: Active arm atorvastatin 40 mg. o.d. arm 2: Placebo arm dummy pill
Interventions: intervention 1: atorvastatin intervention 2: placebo
Intervention descriptions: intervention 1: 40 m.g. o.d. tablets for 6 months intervention 2: Placebo

Protocol documents: