ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00453362
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC Tarceva Positron emission technology PET Computerized tomography CT
Sponsor: Genentech, Inc.
Start date: 2006-12-01; Completion date: 2010-04-23
Enrollment: 88 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.

Detailed description:

Arms: arm 1: Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.

After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET and FLT-PET scans.
Interventions: intervention 1: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) intervention 2: 3'-deoxy-3'-[18F]fluorothymidine (FLT) intervention 3: erlotinib HCl
Intervention descriptions: intervention 1: FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie). intervention 2: FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection. intervention 3: Tablets taken orally 150 mg/day.

Protocol documents:
Clinical trial NCT00725725
Conditions: Panic Disorder
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-07-23; Completion date: 2010-04-23
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder. It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total score over 3 weeks of therapy.

Detailed description:

Arms: arm 1: Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. arm 2: Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. arm 3: Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Interventions: intervention 1: Cognitive-behavioral therapy intervention 2: Org 25935 intervention 3: Org 25935 intervention 4: Placebo
Intervention descriptions: intervention 1: Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration). intervention 2: 4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period. intervention 3: 12 mg Org 25935 is given in tablet form, a single dose two hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a two-week period. intervention 4: Placebo is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.

Protocol documents:
Clinical trial NCT00068419
Conditions: Desmoid Tumor
Sponsor: Children's Oncology Group
Start date: 2004-02-01; Completion date: 2010-04-26
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor (DT) and primary DT that is not readily amenable to surgery or radiation therapy.

SECONDARY OBJECTIVES:

I. Determine the tumor response rate in patients treated with this regimen.

II. Correlate changes in Magnetic Resonance Imaging (MRI) signal features of the tumor with clinical outcome in patients treated with this regimen.

III. Correlate pathological studies of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression in the tumor with clinical outcome in patients treated with this regimen.

IV. Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment.

V. Determine whether short-term endocrine toxicity is associated with treatment with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sulindac and oral tamoxifen twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.

After completion of study treatment, patients are followed for 5 years.

Arms: arm 1: Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
Interventions: intervention 1: tamoxifen citrate intervention 2: sulindac intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00575328
Conditions: Sexual Dysfunction Bipolar Disorder
Keywords: Sexual Dysfunction Bipolar Disorder
Sponsor: Massachusetts General Hospital
Start date: 2008-02-26; Completion date: 2010-04-26
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by the treatment for bipolar disorder. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes. We suspect that Maca Root will result in a significant reduction in sexual dysfunction when compared to a placebo group.

Detailed description:
The study seeks to enroll 80 patients with sexual dysfunction associated with their bipolar medication regimen over 24 months. Subjects were outpatient females between 18 and 80 years old with no significant symptoms of mania (Young Mania Rating Scale score\<10), and who have been on a steady regimen of medications to treat bipolar disorder for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects will be randomly assigned in a double blind manner to receive 3000 mg/day of maca root or identical placebo for 12 weeks to determine whether maca root is more effective than placebo for the treatment of sexual dysfunction associated with treatment regimens for bipolar disorder.

Arms: arm 1: Subjects in this arm will be given 3g/day of Maca Root. arm 2: Subjects in this arm will receive inactive placebo.
Interventions: intervention 1: Maca Root intervention 2: Placebo
Intervention descriptions: intervention 1: 3g/day of Maca Root for 12 weeks. intervention 2: Placebo provided by research pharmacy daily for 12 weeks.

Protocol documents:
Clinical trial NCT00590135
Conditions: Aortic Valve Stenosis
Keywords: calcific aortic valve stenosis echocardiography, transthoracic
Sponsor: The Cleveland Clinic
Start date: 2000-08-01; Completion date: 2010-04-26
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.

Detailed description:
This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS cohorts will be used, employing the accepted rate of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for comparison, we will prospectively study a registry of AS patients who meet our entry criteria but are either currently already being treated with or refuse to take an HMG-CoA reductase inhibitor (referred to as the "standard care" group).

All patient visits, laboratory studies, and echocardiograms will be performed at the Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT measurement which may be done at the patient's local doctor's office and the results faxed to Imaging Research. The 12-week follow-up assessment may be completed over the phone to establish any change in patient status since baseline, study medication compliance, concomitant medication use and to ascertain whether or not the appropriate laboratory test was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and 24 months.

Arms: arm 1: Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis
Interventions: intervention 1: atorvastatin (Lipitor)
Intervention descriptions: intervention 1: atorvastatin 40 mg by mouth once daily

Protocol documents:
Clinical trial NCT00711269
Conditions: Schizophrenia
Sponsor: Sumitomo Pharma Co., Ltd.
Start date: 2008-06-27; Completion date: 2010-04-27
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Detailed description:

Arms: arm 1: SM-13496 40 mg was administered orally once daily. arm 2: SM-13496 80mg was administered orally once daily. arm 3: Placebo was administered orally twice daily. arm 4: Risperidone was administered orally twice daily.
Interventions: intervention 1: SM-13496 (lurasidone HCl) intervention 2: SM-13496 (lurasidone HCl) intervention 3: Placebo intervention 4: Risperidone
Intervention descriptions: intervention 1: Lurasidone HCl: 40 mg/day intervention 2: Lurasidone HCl: 80 mg/day intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00912964
Conditions: Urinary Bladder, Overactive
Keywords: Urgency YM178 Urinary incontinence Mirabegron Micturition Frequency Urinary urgency incontinence Overactive Bladder
Sponsor: Astellas Pharma Inc
Start date: 2009-04-28; Completion date: 2010-04-27
Enrollment: 2030 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.

Detailed description:

Arms: arm 1: Participants received matching mirabegron placebo tablets orally once a day for 12 weeks. arm 2: Participants received mirabegron 25 mg tablets orally once a day for 12 weeks. arm 3: Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
Interventions: intervention 1: Mirabegron intervention 2: Placebo
Intervention descriptions: intervention 1: Mirabegron tablets intervention 2: Matching mirabegron placebo tablets.

Protocol documents:
Clinical trial NCT00704132
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-14; Completion date: 2010-04-28
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Detailed description:

Arms: arm 1: Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks. arm 2: Participants randomized to this arm will be administered matching placebo, daily for six weeks.
Interventions: intervention 1: Comparator: sitagliptin phosphate intervention 2: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: Sitagliptin tablet 100 mg, administered once daily before the morning meal. intervention 2: Matching placebo tablet, administered once daily before the morning meal.

Protocol documents:
Clinical trial NCT00807365
Conditions: Elderly
Keywords: Growth Hormone-Releasing Hormone Growth Hormone Insufficiency Aging Growth Hormone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones
Sponsor: Johns Hopkins University
Start date: 2007-12-17; Completion date: 2010-04-29
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the tests is to measure how the body handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.

Detailed description:
Growth hormone (GH) is a major anabolic hormone that exerts important stimulatory effects on protein synthesis. Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor I (IGF-I), produced systemically by the liver or locally in tissues in response to GH stimulation. IGF-I in turn regulates GH secretion by negative feedback mechanisms at the pituitary gland. Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-I levels. GH levels decline by 14% for each decade after puberty, and, in healthy 59-98 year old men, IGF-I levels below the 2.5 percentile of younger men are present in 85%. Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone, decrease in hypothalamic GHRH output, and diminished response to GHRH. The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass (LBM) and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes. It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition.

Arms: arm 1: Growth Hormone-Releasing Hormone
Interventions: intervention 1: GHRH
Intervention descriptions: intervention 1: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, \& 5:00 AM for 6 months.

Protocol documents:
Clinical trial NCT00355238
Conditions: Hepatocellular Carcinoma (HCC)
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-31; Completion date: 2010-04-30
Enrollment: 137 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: no comparator to brivanib
Interventions: intervention 1: brivanib (active)
Intervention descriptions: intervention 1: Tablet, Oral, Brivanib 800 mg, once daily, until progression

Protocol documents:
Clinical trial NCT00874731
Conditions: Metastatic or Locally Advanced Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-28; Completion date: 2010-04-30
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the electrical activity of the heart) in participants with advanced cancer. This study will be done in 2 parts. Part 1 (Pt 1) will evaluate the effect of a single 100 mg dose of ridaforolimus on QT interval in participants with advanced cancer. Fridericias's correction (QTcF) will be used. In Part 2 (Pt 2), participants will receive ridaforolimus at the current therapeutic dose (40 mg x 5 days).

Detailed description:

Arms: arm 1: \[Pt 1, Day 1\]: Participants received a single dose of placebo (10 oral tablets) on Day 1 of Part 1. \[Pt 1, Day 2\]: Following completion of Part 1 / Day 1, participants received a single dose of ridaforolimus 100 mg (10 x 10 mg oral tablets) on Day 2 of Part 1. Following completion of Part 1 / Day 2, participants entered a washout period of ≥5 days before the first dose Part 2. \[Pt 2\]: Following completion of Part 1, participants received ridaforolimus 40 mg (4 x 10 mg oral tablets) given once daily (QD) for 5 consecutive days followed by 2 days off-drug.
Interventions: intervention 1: Ridaforolimus 100 mg intervention 2: Ridaforolimus 40 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Part 1: A single oral dose of 100 mg ridaforolimus (10 x 10 mg tablets) was given on Day 2. intervention 2: Part 2 (optional): Ridaforolimus 40 mg (4 x 10 mg tablets) was received on a regimen of daily oral doses for 5 consecutive days followed by 2 days off-drug. intervention 3: Part 1: A single oral dose of placebo (10 x placebo tablets) was given on Day 1.

Protocol documents:
Clinical trial NCT00420199
Conditions: Active Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2007-05-01; Completion date: 2010-05-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The only trial in participants who are methotrexate-inadequate responders and have active Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism-of-action information on how Abatacept exerts its effects (including on bone) through new techniques.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abatacept intervention 2: Placebo
Intervention descriptions: intervention 1: Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment intervention 2: Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment

Protocol documents:
Clinical trial NCT00568776
Conditions: Alzheimer Disease
Sponsor: OPKO Health, Inc.
Start date: 2007-12-01; Completion date: 2010-05-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD).

Detailed description:
ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD patients.

This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo Control intervention 2: ELND005 intervention 3: ELND005 intervention 4: ELND005
Intervention descriptions: intervention 1: ELND005 matched placebo capsules for oral administration, bid for 78 weeks intervention 2: ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks intervention 3: ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks intervention 4: ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks

Protocol documents:
Clinical trial NCT00680745
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin efficacy safety sulphonylurea Type 2 diabetes
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2010-05-01
Enrollment: 597 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Detailed description:

Arms: arm 1: dapagliflozin 2.5mg + Glimepiride arm 2: dapagliflozin 5mg + Glimepiride arm 3: dapagliflozin 10mg + Glimepiride arm 4: Placebo + Glimepiride
Interventions: intervention 1: dapagliflozin intervention 2: Glimepiride intervention 3: metformin hydrochloride intervention 4: pioglitazone hydrochloride intervention 5: Rosiglitazone
Intervention descriptions: intervention 1: tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks intervention 2: tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks intervention 3: rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice intervention 4: rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice intervention 5: rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Protocol documents:
Clinical trial NCT00683800
Conditions: Vasomotor Symptoms
Keywords: Menopause Hot Flush Hot Flash Desvenlafaxine succinate Sustained Release
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2010-05-01
Enrollment: 2186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.

Detailed description:

Arms: arm 1: desvenlafaxine succinate (DVS) SR arm 2: Placebo
Interventions: intervention 1: desvenlafaxine succinate (DVS) SR intervention 2: Placebo
Intervention descriptions: intervention 1: Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days. intervention 2: Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.

Protocol documents: