ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00265330
Conditions: Bipolar Disorder
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-03-01; Completion date: 2008-01-01
Enrollment: 169 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ziprasidone oral capsules
Intervention descriptions: intervention 1: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Protocol documents:
Clinical trial NCT00578331
Conditions: Perennial Allergic Rhinitis
Keywords: rhinitis perennial allergic rhinitis allergic rhinitis
Sponsor: Alcon Research
Start date: 2006-12-01; Completion date: 2008-01-01
Enrollment: 890 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.

Detailed description:

Arms: arm 1: 2 sprays each nostril twice daily arm 2: 2 sprays each nostril twice daily
Interventions: intervention 1: Olopatadine 0.6% nasal spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: 2 sprays each nostril twice daily intervention 2: 2 sprays each nostril twice daily

Protocol documents:
Clinical trial NCT00065065
Conditions: Ulcerative Colitis Inflammatory Bowel Disease
Keywords: Rosiglitazone Ulcerative Colitis
Sponsor: James Lewis
Start date: 2002-09-01; Completion date: 2008-01-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.

Detailed description:
Ulcerative colitis is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) of all or a portion of the large intestine. There is presently no medical cure for ulcerative colitis, although surgical removal of the colon would cure the disease. Ulcerative colitis is generally treated with medications against diarrhea and infection, medications which suppress the immune system (the body system that protects a person against foreign substances) or with surgery.

It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body. Rosiglitazone has been shown to inhibit the production of some of these chemicals. The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis. The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo.

This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy. Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks. Disease activity will be measured using the Disease Activity Index (DAI) at visits 3 through 8. Additional outcomes measured will include histological disease activity (visits 3 and 7) and quality of life using the IBDQ (visits 3 through 8). The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response. Additionally, the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques.

Arms: arm 1: 4 mg of rosiglitazone taken twice daily for 12 weeks. arm 2: Identical in appearance to study drug taken twice daily for 12 weeks.
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: 4mg orally twice daily for 12 weeks intervention 2: pill that looks identical to rosiglitazone

Protocol documents:
Clinical trial NCT00101400
Conditions: Breast Neoplasms Breast Cancer
Keywords: Cancer
Sponsor: Bayer
Start date: 2004-02-01; Completion date: 2008-01-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.

Detailed description:

Arms: arm 1: Sorafenib 400 mg administered twice daily (b.i.d.)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: Sorafenib 400 mg administered twice daily (b.i.d.)

Protocol documents:
Clinical trial NCT00103402
Conditions: Prostatitis
Keywords: Prostatitis Non-bacterial Prostatitis Prostatodynia Alfuzosin Alpha-adrenergic blocker
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2005-02-01; Completion date: 2008-01-01
Enrollment: 272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Detailed description:
The two primary objectives of this study are:

* To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
* To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization.

There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected: visit 1 involves screening, visit 2 involves collection of baseline data and randomization, visit 3 is the 6-week evaluation, and visit 4 is the 12-week evaluation of the primary end point.

Arms: arm 1: 10 mg of alfuzosin once daily for 12 weeks arm 2: 10 mg of an identical-looking placebo once daily for 12 weeks
Interventions: intervention 1: Alfuzosin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00117507
Conditions: Myelodysplastic Syndromes Iron Overload
Keywords: MDS Myelodysplastic Syndrome ICL-670 ICL-670 and Myelodysplastic Syndrome
Sponsor: Novartis Pharmaceuticals
Start date: 2005-09-01; Completion date: 2008-01-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox.

Deferasirox were administered orally once per day for 12 months.

Detailed description:
Patients were screened for eligibility to determine if they meet all inclusion/exclusion criteria. The screening period were up to 4 weeks. Patient's baseline LIC will be determined non-invasively by means of MRI R2 analysis. In addition, blood and urine samples will be taken for the determination of baseline safety data.

Arms: arm 1: Participants received deferasirox 20mg/kg/day OD for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00129441
Conditions: Schizophrenia
Keywords: schizophrenia
Sponsor: University of Pittsburgh
Start date: 2005-08-01; Completion date: 2008-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.

Detailed description:
The goal of this study is to determine whether the short-term (4 week), double-blind administration of Merck L-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. This initial, small sample size study (n=9 on L-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Merck L-830982 intervention 2: Placebo
Intervention descriptions: intervention 1: The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy. intervention 2: Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Protocol documents:
Clinical trial NCT00132002
Conditions: Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2008-01-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response rate in patients receiving SAHA for stage IV breast cancer.

SECONDARY OBJECTIVES:

I. Time to progression. II. Overall survival. III. Toxicity profile. IV. Assessment of potential biological correlates.

OUTLINE: This is a multicenter study.

Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 8 weeks.

Arms: arm 1: Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00141115
Conditions: Alcoholism Generalized Anxiety Disorder Panic Disorder Social Phobia Anxiety Disorders
Keywords: Substance-induced anxiety disorder
Sponsor: New York State Psychiatric Institute
Start date: 2004-03-01; Completion date: 2008-01-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in alcohol use.

Detailed description:
Alcohol dependence is frequently associated with anxiety disorders. Treatment studies of individuals suffering from both alcohol dependence and anxiety have been limited. Anti-seizure medications have been used for the treatment of alcohol withdrawal for three decades. More recently, anti-seizure medications have been shown to reduce drinking and promote abstinence, and reduce drinking in abstinent alcoholics. Levetiracetam is a newer anti-seizure medication, with a structure different than that of other anti-seizure medications, that is safe and generally well tolerated. The Food and Drug Administration (FDA) has approved levetiracetam for use with other anti-seizure medications in the treatment of epilepsy in adults. The metabolism of levetiracetam is less complicated than older anti-seizure medications, which makes it easier to use and better tolerated, and it is not likely to interact with other medicines. Levetiracetam has been shown to prevent anxiety during sedative withdrawal, which is similar to alcohol withdrawal, in a laboratory study using mice. Levetiracetam also had anti-anxiety effects in laboratory study using mice. Given that other anti-seizure medications have been shown to be helpful in treating alcohol dependence, that levetiracetam is not likely to have interactions with other medications, and that in animals levetiracetam appeared to be helpful for treating a condition similar to alcohol dependence and anxiety, we believe it should be studied for the treatment of alcohol dependent patients with anxiety disorders.

Arms: arm 1: Levetiracetam 1500 mg BID
Interventions: intervention 1: levetiracetam
Intervention descriptions: intervention 1: Levetiracetam 1500 mg BID

Protocol documents:
Clinical trial NCT00147745
Conditions: Type 2 Diabetes
Keywords: Mechanism of action insulin sensitivity
Sponsor: Daiichi Sankyo
Start date: 2005-06-01; Completion date: 2008-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

Detailed description:

Arms: arm 1: colesevelam 3.8g administered daily for 12 weeks arm 2: Colesevelam matching placebo for 12 weeks arm 3: open-label Insulin Glargine for 12 weeks
Interventions: intervention 1: Colesevelam intervention 2: Colesevelam matching placebo intervention 3: Insulin glargine (Lantus)
Intervention descriptions: intervention 1: Colesevelam 3.8g for 12 weeks intervention 2: Colesevelam matching placebo for 12 weeks intervention 3: Insulin glargine for 12 weeks

Protocol documents:
Clinical trial NCT00176202
Conditions: Bipolar Disorder
Sponsor: University of Illinois at Chicago
Start date: 2003-04-01; Completion date: 2008-01-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

Detailed description:
Pediatric Bipolar Disorder (PBD) severely impairs a child's emotional development, and is associated with alarming rates of suicide, school failure, aggression, risk taking behaviors and substance abuse (Geller et al, 1998; 2001; Carlson et al, 1998). At present, very little is known about the pathophysiology or optimal treatment of PBD. The long range goals of this proposal are threefold: to investigate a range of pharmacotherapeutic agents that are safe and efficacious for PBD, to use fMRI techniques to examine abnormalities in brain function in this disorder, as well as any change in brain function after treatment.

In contrast to the adult literature, we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample. In one, lithium was found to be moderately effective in PBD with comorbid substance abuse (Geller et al, 1998). In the other, divalproex sodium, lithium and carbamazepine produced a maximum of 50% symptom reduction (Kowatch et al, 2000). Subsequently, Kafantaris et al (2001) observed a potentiation of lithium's antimanic effect when combined with risperidone. Further, a prospective, open trial of olanzapine for PBD reported a 70% symptom reduction (Frazier et al, 2001) with a retention rate of 96% compared to only 7% with classic mood stabilizers (Kowatch et al, 2000).

Thus, parallelling adult studies (Sachs et al, 2000), novel antipsychotics are a promising treatment in this population. Further, up to 60% of acute PBD episodes present with psychotic features (Geller et al, in press). Finally, the time to full effect with mood stabilizers is often 4 weeks in children (Kowatch et al, 2000; Geller et al, 1998; Kafantaris et al, 2001), whereas antipsychotics usually have a more rapid response onset (Pavuluri et al, in press). Given the potential efficacy of novel antipsychotics for PBD, the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer:

Arms: arm 1: Risperidone is an antimanic medication and is a second generation antipsychotic arm 2: Divalproex sodium is an antiepileptic medication and is a mood stabilizer
Interventions: intervention 1: Divalproex Sodium intervention 2: risperidone
Intervention descriptions: intervention 1: Divalproex sodium is a mood stabilizer intervention 2: Risperidone is a second generation antipsychotic and antimanic drug

Protocol documents:
Clinical trial NCT00182000
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Sponsor: Massachusetts General Hospital
Start date: 2003-11-01; Completion date: 2008-01-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).

Detailed description:
We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: seromycin intervention 2: Behavior Therapy
Intervention descriptions: intervention 1: 100mg tablet administered 1 hour prior to each therapy session intervention 2: 10 weekly hour-long behavior therapy sessions

Protocol documents:
Clinical trial NCT00203476
Conditions: Hyperlipidemia Hypercholesterolemia
Keywords: ezetimibe niacin colestipol hyperlipidemia adjunct therapy zetia
Sponsor: Tuscaloosa Research & Education Advancement Corporation
Start date: 2005-05-01; Completion date: 2008-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.

Detailed description:
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.

Arms: arm 1: Niacin dose range of 500-1500mg (average 888mg) arm 2: Colestipol dose range 5-15gm (average 9.5gm) arm 3: Ezitimibe 10mg (average 10mg)
Interventions: intervention 1: Niacin intervention 2: Colestipol intervention 3: Ezetimibe
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: