ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00587860
Conditions: Irritable Bowel Syndrome
Sponsor: Mayo Clinic
Start date: 2006-02-01; Completion date: 2008-03-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see if St. John's wort helps people with irritable bowel syndrome, otherwise known as "IBS". St. John's wort is a herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes.

Detailed description:
Eligibility criteria:

1. Established diagnosis of IBS
2. 18-70 years of age

4\) U.S. resident 5) English-speaking (able to provide consent and complete questionnaires) 6) Able to participate in all aspects of the study

You will be asked to do the following:

* Undergo a screening interview and physical examination
* Take a urine pregnancy test (if applicable)
* Take a study pill twice daily for 12 weeks(3 months)
* Complete daily symptom diaries and bi-weekly questionnaires for 12 weeks.
* Complete a questionnaire at 6 months after the active phase of the study is over.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: St. John's wort intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day intervention 2: Dosage form: Tablet (450 mg) Dose: 450 mg twice a day, placebo twice a day

Protocol documents:
Clinical trial NCT00609765
Conditions: Pancreatic Cancer
Keywords: advanced unresectable metastatic endocrine tumors
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2007-08-01; Completion date: 2008-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.

Detailed description:
Patients will need to come for 24 study visits in all. Most study visits will take about 2 hours. At some of these study visits, the doctor

* Will do a physical exam
* Will take blood for routine lab tests
* Will do a urinalysis
* Will administer study medication Some study visits may be longer because patient will have a CT scan or an MRI.

At patient's last visit, they will have a CT scan or MRI.

After treatment starts, patient will:

* Have their blood pressure monitored with every dose of Avastin® (about every 2 weeks).
* Have a history and physical with every chemotherapy cycle (about every 4 weeks).
* Have their blood taken for routine blood tests with every chemotherapy cycle (about every 4 weeks).
* Have a CT scan or MRI during every other cycle (about every 8 weeks).
* Have a MUGA scan during every 4 cycles (about 16 weeks).
* Have blood taken for tumor markers during every cycle only if their markers were high at baseline.
* Patients will receive study medication to treat their cancer:
* Fluorouracil on days 1 through 5 of each cycle through cycle 12
* Doxorubicin on day 1 of each cycle through cycle 8
* Streptozocin on days 1 through 5 of each cycle through cycle 12
* Avastin® on days 1 and 15 of each cycle through cycle 12

Arms: arm 1: Protocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin.

Premedications: Dexamethasone, Ondansetron
Interventions: intervention 1: Avastin intervention 2: Fluorouracil intervention 3: Doxorubicin intervention 4: Streptozocin intervention 5: Dexamethasone intervention 6: Ondansetron
Intervention descriptions: intervention 1: Every 28 Days: Avastin 5mg/kg iv days 1 and 15 intervention 2: Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5 intervention 3: Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1 intervention 4: Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5 intervention 5: Premedication: Dexamethasone 20mg intravenously days 1-5 intervention 6: Premedication: Ondansetron 16mg intravenously days 1-5

Protocol documents:
Clinical trial NCT00619827
Conditions: Seasonal Allergic Rhinitis
Keywords: Sublingual immunotherapy Rhinitis Conjunctivitis Allergen challenge Allergen exposition chamber Grass pollen tablet Allergic rhinoconjunctivitis
Sponsor: Stallergenes Greer
Start date: 2007-09-01; Completion date: 2008-03-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

Detailed description:
The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Arms: arm 1: 300 IR grass pollen allergen extract tablet arm 2: Placebo tablet
Interventions: intervention 1: 300 IR grass pollen allergen extract tablet intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 300 IR grass pollen allergen extract tablet once daily during four months intervention 2: Placebo tablet once daily during four months

Protocol documents:
Clinical trial NCT00620776
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Cognitive Behavioral Therapy Psychotherapy plus medication Combined treatment
Sponsor: University of Pennsylvania
Start date: 2006-10-01; Completion date: 2008-03-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

Detailed description:
The specific aims of this study are to collect preliminary data relevant to the following hypotheses:

1. Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
2. Secondary Hypotheses: Combined CBT plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of GAD (worry), depressive symptoms, functional impairment, and quality of life.
3. Additional Exploratory Aim: We will explore the comparative relapse rates for the combined CBT plus medication treatment and the medication alone treatment condition at 6-month follow-up.

Arms: arm 1: Patients who receive combined cognitive behavioral therapy (CBT) plus medication (venlafaxine XR, flexibly dosed between 75-225 mg/day) treatment for GAD. CBT was once/week sessions for 12 weeks. Medication continued for the full 6 months. arm 2: These patients receive only medication treatment for GAD. Patients take venlafaxine (flexibly dosed from 75-225 mg/day) as part of NCT00183274 and are assessed over a 6 month period. Medication continued for the full 6 months.
Interventions: intervention 1: Cognitive Behavioral Therapy intervention 2: Venlafaxine XR
Intervention descriptions: intervention 1: This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks. intervention 2: Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).

Protocol documents:
Clinical trial NCT00654069
Conditions: Pain
Keywords: Pain
Sponsor: Acura Pharmaceuticals Inc.
Start date: 2007-09-01; Completion date: 2008-03-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

Detailed description:
This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.

Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.

Arms: arm 1: Tablet arm 2: Oxycodone HCl 5mg/Niacin 30mg tablet arm 3: Oxycodone HCl 7.5mg/Niacin 30mg tablet
Interventions: intervention 1: Placebo intervention 2: Acurox 5/30 mg intervention 3: Acurox 7.5/30
Intervention descriptions: intervention 1: 2 tablets every 6 hours for 48 hours intervention 2: 2 tablets every 6 hours for 48 hours intervention 3: 2 tablets every 6 hours for 48 hours

Protocol documents:
Clinical trial NCT00687102
Conditions: Cognition Aging
Keywords: breast cancer Tamoxifen Raloxifene hormone therapy
Sponsor: Wake Forest University
Start date: 2001-10-01; Completion date: 2008-03-01
Enrollment: 1498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.

Detailed description:
Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on cognitive aging. The two most commonly prescribed SERMs are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. In the face of potential widespread use of SERMs in healthy women, information on the effects of these agents on memory and other cognitive functions is essential.

The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene

* on age-associated declines in measures of verbal and nonverbal memory in women over age 65
* other cognitive abilities and mood
* with those resulting from more common forms of HT, specifically ET (conjugated equine estrogen) and ET plus progesterone

Co-STAR results will be compared to results from the Women's Health Initiative Study of Cognitive Aging (WHISCA), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (Premarin or Premarin plus medroxyprogesterone acetate) or placebo. A comparison of the Co-STAR treatment groups with the group of WHISCA participants receiving placebo will provide insights into the effects of SERMs relative to no treatment. A comparison of the Co-STAR treatment groups with WHISCA treatment groups receiving ET or ET plus progesterone will provide insights into the effects of SERMs relative to common HT treatments.

Co-STAR participants will be recruited from The National Cancer Institute's (NCI) Study of Tamoxifen and Raloxifene (STAR) NCT00003906, a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.

Arms: arm 1: Participants in the parent study, STAR assigned to Tamoxifen who were 65 or older at time of enrollment. arm 2: Participants in the parent study, STAR assigned to Raloxifene who were 65 or older at time of enrollment.
Interventions: intervention 1: tamoxifen intervention 2: raloxifene
Intervention descriptions: intervention 1: oral tamoxifen plus placebo daily for 5 years intervention 2: oral raloxifene plus placebo daily for 5 years

Protocol documents:
Clinical trial NCT00741013
Conditions: Lung Inflammation
Keywords: randomized positron emission tomography lung inflammation lovastatin recombinant human activated protein C endotoxin fluorodeoxyglucose
Sponsor: Washington University School of Medicine
Start date: 2007-03-01; Completion date: 2008-03-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this randomized, double-blind, placebo controlled trial we used positron emission tomography to determine if lovastatin or recombinant human activated protein C exhibit anti-inflammatory effects in humans following intrabronchial installation of lipopolysaccharide (LPS or endotoxin).

Detailed description:
Quantitative, noninvasive biomarkers for lung-specific inflammation have yet to be developed but can potentially contribute significantly to the development of therapies to treat lung inflammation. The purpose of this study was to demonstrate that positron emission tomographic (PET) imaging with \[18F}fluorodeoxyglucose (FDG-PET) can be used to quantify the change in lung inflammation in healthy volunteers.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: placebo pill and placebo IV intervention 2: Lovastatin pill and placebo IV intervention 3: placebo pill and recombinant human activated protein C IV intervention 4: Endotoxin
Intervention descriptions: intervention 1: Placebo pill every four hours, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS

Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS intervention 2: lovastatin pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS

Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS intervention 3: placebo pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS

recombinant human activated protein C IV 24 micrograms per kg per hour starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS intervention 4: Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.

Protocol documents:
Clinical trial NCT00745849
Conditions: Vasomotor Rhinitis
Keywords: non-allergic rhinitis, laryngopharyngeal reflux
Sponsor: University of Texas Southwestern Medical Center
Start date: 2005-06-01; Completion date: 2008-03-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis

Detailed description:

Arms: arm 1: esomeprazole 40mg po bid arm 2: None
Interventions: intervention 1: esomeprazole intervention 2: placebo
Intervention descriptions: intervention 1: 40mg by mouth twice daily intervention 2: None

Protocol documents:
Clinical trial NCT00758342
Conditions: Intraocular Pressure
Keywords: IOP lowering efficacy and safety of Azopt plus Travatan
Sponsor: Alcon Research
Start date: 2006-05-01; Completion date: 2008-03-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.

Detailed description:

Arms: arm 1: Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) arm 2: Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Interventions: intervention 1: Travoprost 0.004% + Brinzolamide 1.0% intervention 2: Travoprost 0.004% + Tears Natural
Intervention descriptions: intervention 1: Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily) intervention 2: Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Protocol documents:
Clinical trial NCT00759031
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2008-02-01; Completion date: 2008-03-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sodium Monofluorophosphate intervention 2: Triclosan/Fluoride/Copolymer
Intervention descriptions: intervention 1: Brush teeth and evaluate plaque score after one use of the study toothpaste intervention 2: Brush teeth and evaluate plaque score after one use of the study toothpaste

Protocol documents:
Clinical trial NCT00759161
Conditions: Psoriasis
Keywords: Plaque Type Psoriasis Topical
Sponsor: Pfizer
Start date: 2007-11-01; Completion date: 2008-03-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.

Detailed description:
This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.

Arms: arm 1: AN2728 Ointment, 5% arm 2: AN2728 Ointment Vehicle
Interventions: intervention 1: AN2728 intervention 2: AN2728 Ointment Vehicle
Intervention descriptions: intervention 1: AN2728 Ointment, 5%, twice daily for 4 weeks intervention 2: AN2728 Ointment Vehicle, twice daily for 4 weeks.

Protocol documents:
Clinical trial NCT00780975
Conditions: Prostate Cancer
Keywords: Aplidin Plitidepsin Prostate Cancer
Sponsor: PharmaMar
Start date: 2005-02-01; Completion date: 2008-03-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study to test the safety and efficacy of an investigational chemotherapy agent in patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the investigator conducting the study.

Detailed description:
Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United States. The majority of deaths occur in men with androgen-independent prostate cancer \[AIPC\]. Although 80% of men with advanced cancer will initially respond to androgen ablation with disease regression or stabilization, their malignancies become resistant to such therapy.

Arms: arm 1: Aplidin (Plitidepsin)
Interventions: intervention 1: Aplidin (plitidepsin)
Intervention descriptions: intervention 1: Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.

Protocol documents:
Clinical trial NCT00844376
Conditions: Hypercholesterolemia
Keywords: Cardiovascular Diseases
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-02-01; Completion date: 2008-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.

Detailed description:
Estimation of Relative Bioavailability

Arms: arm 1: Extemporaneous preparation suspension Atorvastatin prototype formulation arm 2: Commercial atorvastatin tablet (Lipitor®)
Interventions: intervention 1: Atorvastatin suspension intervention 2: Lipitor
Intervention descriptions: intervention 1: A single dose of 80 mg Atorvastatin suspension intervention 2: A single dose of 80 mg Lipitor tablet

Protocol documents:
Clinical trial NCT00944671
Conditions: Heartburn
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Start date: 2008-02-01; Completion date: 2008-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.

Detailed description:

Arms: arm 1: Famotidine/antacid combination tablet with water arm 2: Famotidine/Antacid EZ Chew tablet without water arm 3: Famotidine/Antacid EZ Chew tablet with water
Interventions: intervention 1: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet intervention 2: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water intervention 3: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Intervention descriptions: intervention 1: A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods intervention 2: A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods intervention 3: A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods

Protocol documents: