ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00357370
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2006-10-01; Completion date: 2008-03-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: 20 mg arm 2: 10 mg arm 3: 20 mg arm 4: None
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, once daily, up to 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, up to 12 weeks

Protocol documents:
Clinical trial NCT00360555
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2006-07-01; Completion date: 2008-03-01
Enrollment: 1584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria.

Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Detailed description:

Arms: arm 1: flibanserin 25 mg b.i.d arm 2: flibanserin 50mg qhs/b.i.d arm 3: flibanserin 50mg b.i.d./100mg qhs arm 4: placebo comparator
Interventions: intervention 1: flibanserin intervention 2: flibanserin 50mg intervention 3: flibanserin 100mg intervention 4: placebo
Intervention descriptions: intervention 1: flibanserin 25 mg b.i.d intervention 2: flibanserin 50mg qhs/b.i.d. intervention 3: flibanserin 50 mg b.i.d/100mg qhs intervention 4: placebo comparator

Protocol documents:
Clinical trial NCT00362414
Conditions: Acute Stroke
Keywords: Stroke
Sponsor: University of California, Irvine
Start date: 2006-08-01; Completion date: 2008-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.

Detailed description:
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.

Arms: arm 1: All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.
Interventions: intervention 1: Dual Growth Factor
Intervention descriptions: intervention 1: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation

30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation

Protocol documents:
Clinical trial NCT00363298
Conditions: Obsessive-Compulsive Disorder
Keywords: D-amphetamine, dextro-amphetamine, stimulant drug
Sponsor: Stanford University
Start date: 2006-08-01; Completion date: 2008-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks.

Detailed description:
The study will investigate whether dextro-amphetamine (d-amphetamine) is safe and effective compared to caffeine as an active placebo when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and whether tolerance (loss of therapeutic effect) to the medication will develop over a period of several weeks

D-amphetamine is approved by the U.S. Food and Drug Administration to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Because of the effects that d-amphetamine has on the brain, Dr. Koran believes it may be helpful in treating OCD. A positive finding in this study may stimulate research aimed at improving OCD treatment and understanding of the neurochemistry involved.

This research study will enroll 24 people who are taking medication for their OCD but are not receiving sufficient benefit. The research will be performed only at Stanford University.

Arms: arm 1: dextro-amphetamine capsules, 15 mg per capsule, in Bottles A and B, dose: one from Bottle A each morning and 1 from Bottle B each morning arm 2: caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules, dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning
Interventions: intervention 1: dextro-amphetamine intervention 2: Sham Comparison
Intervention descriptions: intervention 1: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks. intervention 2: caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg caffeine in Bottle A and 100 mg caffeine in Bottle B. Frequency: once daily. Duration: 5 weeks

Protocol documents:
Clinical trial NCT00367237
Conditions: Arthritis, Psoriatic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-05-01; Completion date: 2008-03-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.

Detailed description:

Arms: arm 1: Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week arm 2: Oral methotrexate (MTX) 15 mg/week
Interventions: intervention 1: Infliximab + methotrexate (IFX + MTX) intervention 2: Methotrexate (MTX)
Intervention descriptions: intervention 1: Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6. intervention 2: Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.

Protocol documents:
Clinical trial NCT00367991
Conditions: Myocardial Infarction
Keywords: Platelet function tests Erythropoietin Myocardial infarction
Sponsor: Yale University
Start date: 2006-11-01; Completion date: 2008-03-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Patients with heart attacks are treated with medicines to reduce the clotting action of platelets. This study is trying to determine whether erythropoietin alters the clotting action of platelets in patients receiving anti-platelet medicines. It is important to understand the effects of erythropoietin on platelets since preliminary studies in animals suggest that erythropoietin may protect the heart from damage during a heart attack.

Detailed description:
Anti-apoptotic effects of erythropoietin in experimental myocardial infarction (MI) and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of recombinant human erythropoietin (rHuEpo) in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of rHuEpo (at a dose previously shown not to inhibit the anti-platelet effects of aspirin and clopidogrel in healthy subjects) on platelet function and other safety measures and measure of infarct size in patients with acute coronary syndromes receiving clinically-indicated standard anti-platelet therapy with aspirin, clopidogrel and glycoprotein Iib-IIIa inhibitors.

Specific Aim 1: To determine the effects of intravenous rHuEpo 400 U/kg daily for 3 days vs. placebo on in vivo and in vitro platelet function in patients with acute MI undergoing percutaneous revascularization.

Specific Aim 2: To obtain pilot data to estimate the effects of administration of rHuEpo 400 U/kg daily for 3 days vs. placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute MI undergoing percutaneous revascularization

Arms: arm 1: recombinant human erythropoietin 200 U/kg IV daily for 3 days arm 2: Normal saline volume to match active treatment IV daily for 3 days
Interventions: intervention 1: Recombinant human erythropoietin alfa (drug) intervention 2: Placebo
Intervention descriptions: intervention 1: 200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days intervention 2: Normal saline to match active drug (rHuEpo)

Protocol documents:
Clinical trial NCT00380874
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Keywords: Pain chemotherapy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-01-01; Completion date: 2008-03-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

Detailed description:
This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.

Arms: arm 1: flexible dosing arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: 150- 600 mg/day (double blind in divided doses) intervention 2: Placebo

Protocol documents:
Clinical trial NCT00390013
Conditions: Vulvar Pain Symptoms Vulvodynia (Chronic Vulvar Pain)
Keywords: Vulvar Pain
Sponsor: Colleen Stockdale
Start date: 2007-01-01; Completion date: 2008-03-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.

Detailed description:
There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.

Arms: arm 1: Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) arm 2: Placebo titration and dosing for total of 8 weeks (Cross over)
Interventions: intervention 1: Gabapentin intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: 300 mg. capsules

Dosage schedule for weeks 1 and 2 and weeks 12 and 13:

1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
8. at completion of study treatment you will titrate off study drug over a weeks time. intervention 2: Placebo capsules

Dosage schedule for weeks 1 and 2 and weeks 12 and 13:

1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
8. at completion of study treatment you will titrate off study drug over a weeks time.

Protocol documents:
Clinical trial NCT00390559
Conditions: Drug Addiction Smoking Cessation
Keywords: Nicotine Replacement Therapy Tobacco Smoking Smoking stimuli Gender
Sponsor: Virginia Commonwealth University
Start date: 2005-10-01; Completion date: 2008-03-01
Enrollment: 80 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.

Detailed description:
Currently,about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, suc has the taste, sight, or smell of cigarette smoke. Tailoring treatments to the separate needs of smoker subgroups , such as men and women, my produce better cessation outcomes. The purpose of this study is to assess whether men and women differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related stimuli.

Participants in this double-blind, dose-comparison study will complete separate sessions in random order.

Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.

Arms: arm 1: 21 mg patch/Nicotine-containing cigarette arm 2: 0 mg patch/nicotine-containing cigarette arm 3: 21 mg patch/no nicotine cigarette arm 4: 0 mg patch/no nicotine cigarette
Interventions: intervention 1: nicotine transdermal system intervention 2: Nicotine transdermal system intervention 3: Nicotine containing cigarette intervention 4: Placebo cigarette
Intervention descriptions: intervention 1: 21 mg nicotine transdermal system intervention 2: Placebo nicotine patch intervention 3: Nicotine containing cigarette intervention 4: Non nicotine containing cigarette

Protocol documents:
Clinical trial NCT00390689
Conditions: Idiopathic Restless Legs Syndrome
Sponsor: Boehringer Ingelheim
Start date: 2006-10-01; Completion date: 2008-03-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.

Detailed description:

Arms: arm 1: Pramipexole 0.25 mg given once daily arm 2: Pramipexole 0.5 mg given once daily arm 3: Pramipexole 0.75 mg given once daily
Interventions: intervention 1: Pramipexole 0.125 mg tablet intervention 2: Pramipexole 0.5 mg tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00394771
Conditions: Breakthrough Bleeding
Keywords: oral contraceptives breakthrough bleeding spotting
Sponsor: Duramed Research
Start date: 2006-10-01; Completion date: 2008-03-01
Enrollment: 567 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary

Detailed description:
This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Arms: arm 1: 42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. arm 2: 21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. arm 3: 21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. arm 4: 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Interventions: intervention 1: DR-1031 intervention 2: Seasonale® intervention 3: Portia®
Intervention descriptions: intervention 1: Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm. intervention 2: 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles. intervention 3: Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.

Protocol documents:
Clinical trial NCT00395863
Conditions: Brain Tumor
Sponsor: Bracco Diagnostics, Inc
Start date: 2006-11-01; Completion date: 2008-03-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Compare the efficacy of MultiHance and Magnevist

Detailed description:
The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.

Arms: arm 1: 0.5 M MultiHance at a single injection arm 2: 0.5 M Magnevist at a single injection
Interventions: intervention 1: Multihance intervention 2: Arm 2 - Magnevist
Intervention descriptions: intervention 1: 0.5 M at a single injection intervention 2: 0.5 M Magnevist at a single dose injection

Protocol documents:
Clinical trial NCT00401544
Conditions: Anemia Non-Myeloid Malignancies
Keywords: anemia chemotherapy induced anemia darbepoetin alfa cancer
Sponsor: Amgen
Start date: 2006-12-01; Completion date: 2008-03-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

Detailed description:

Arms: arm 1: Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 2: Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 3: Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). arm 4: Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Interventions: intervention 1: darbepoetin alfa intervention 2: IV iron dextran
Intervention descriptions: intervention 1: Darbepoetin alfa administered by subcutaneous injection. intervention 2: Administered by intravenous (IV) injection.

Protocol documents:
Clinical trial NCT00409708
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder, ADHD Cytogenetic abnormalities, extended-release methylphenidate,
Sponsor: Novartis
Start date: 2006-11-01; Completion date: 2008-03-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD) treated for 3 months with either extended release methylphenidate or behavioral therapy.

Detailed description:
This study will determine whether the administration of extended-release methylphenidate in treatment-naïve children with Attention Deficit Hyperactivity Disorder (ADHD) affects the frequency of chromosomal abnormalities.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy intervention 2: Behavior Therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: