ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00808132
Conditions: Menopause Osteoporosis
Keywords: Postmenopausal Women Bazedoxifene/Conjugated Estrogens
Sponsor: Pfizer
Start date: 2009-01-01; Completion date: 2011-02-01
Enrollment: 1886 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Detailed description:

Arms: arm 1: bazedoxifene 20 mg/conjugated estrogens 0.45 mg arm 2: bazedoxifene 20 mg/conjugated estrogens 0.625 mg arm 3: bazedoxifene 20 mg arm 4: Prempro arm 5: Placebo
Interventions: intervention 1: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg intervention 2: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg intervention 3: bazedoxifene 20 mg intervention 4: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg intervention 5: Placebo
Intervention descriptions: intervention 1: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year. intervention 2: One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year. intervention 3: One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year. intervention 4: One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year. intervention 5: One capsule, placebo (over-encapsulated), once a day for one year.

Protocol documents:
Clinical trial NCT00809094
Conditions: Cystic Fibrosis
Sponsor: Stanford University
Start date: 2008-11-01; Completion date: 2011-02-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIB proof-of-concept study would examine the effects of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. We hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in the lungs of patients who have CF.

Detailed description:

Arms: arm 1: Placebo was administered oral tablet TID for 24 weeks. arm 2: Participants received 900 mg of oral N-acetylcysteine TID for 24 weeks.
Interventions: intervention 1: N-acetylcysteine (NAC) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00812812
Conditions: Depressive Disorder
Keywords: paroxetine selective serotonin reuptake inhibitor CDRS-R children and adolescents
Sponsor: GlaxoSmithKline
Start date: 2009-03-01; Completion date: 2011-02-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.

Detailed description:

Arms: arm 1: paroxetine 10-40mg/day arm 2: matched placebo to paroxetine
Interventions: intervention 1: paroxetine 10mg tablet intervention 2: paroxetine 20mg tablet intervention 3: matched placebo to paroxetine 10mg intervention 4: matched placebo to paroxetine 20mg
Intervention descriptions: intervention 1: 1 or 2 tablet(s) once a day intervention 2: 1 tablet once a day intervention 3: 2 tablets once a day intervention 4: 1 tablet once a day

Protocol documents:
Clinical trial NCT00813800
Conditions: Smoking Bipolar Disorder Depression
Keywords: Smoking Bipolar Disorder Depression
Sponsor: Mark Frye
Start date: 2009-01-01; Completion date: 2011-02-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with bipolar disorder have one of the highest rates of nicotine dependence and one of the lowest quit rates. Varenicline has been shown in previous trials to be effective for smoking cessation, but has not been studied in subjects with bipolar disorder. This 12-week open label trial will be conducted to assess the feasibility, acceptability, and safety of varenicline in bipolar depressed smokers, given in addition to the subject's primary treatment for bipolar disorder. The primary study hypothesis was that the abstinence rate for bipolar depressed patients will be 50%.

Detailed description:
Varenicline, a nicotinic acetylcholine receptor partial agonist, has been shown in two placebo-controlled trials to be efficacious for smoking cessation. Given the high prevalence of nicotine dependence in bipolar disorder and the high prevalence of sub-syndromal and syndromal depressive symptoms in bipolar disorder, this 12-week adjunctive varenicline open label trial will be conducted to assess the feasibility, acceptability, and safety of varenicline in bipolar depressed smokers. All subjects will receive individual behavioral counseling.

Primary hypothesis: the abstinence rate for bipolar depressed patients will be 50%. Secondary hypothesis: At final visit, bipolar depressed patients who have achieved remission, defined as a Montgomery Asberg Depression Rating Scale (MADRS) \<8, will have a higher rate of tobacco abstinence than depressed patients who did not achieve remission (MADRS \>/= 8).

Arms: arm 1: Open-label; subjects will receive a behavioral intervention in addition to Varenicline.
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.

Protocol documents:
Clinical trial NCT00814632
Conditions: Vulvodynia
Keywords: vulvodynia pelvic pain vulvar pain
Sponsor: Kenneth Peters, MD
Start date: 2008-12-01; Completion date: 2011-02-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of these factors may include altered immune response, infections, altered vaginal acid-base balance, allergic reactions and psychosexual disorders. Women are generally treated with medications such as anti-histamines, anti-depressants and anti-inflammatories, or with physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is utilized as a last resort.

Detailed description:
CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect on inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions.

This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female subjects aged 18 or older meeting criteria for diagnosis of vulvodynia or vulvar vestibulitis (vestibulodynia) will be treated with CC-10004 at 20mg orally twice a day for 12 weeks.The patient will be seen for a total of ten visits by the study coordinator.

Arms: arm 1: Study drug CC-10004 20mg taken orally twice a day.
Interventions: intervention 1: CC-10004
Intervention descriptions: intervention 1: CC-10004 20 mg. twice a day for 12 weeks

Protocol documents:
Clinical trial NCT00817206
Conditions: Renal Failure
Keywords: kidney transplantation renal transplantation maintenance immunosuppression tacrolimus Prevention of acute allograft rejection
Sponsor: Veloxis Pharmaceuticals
Start date: 2008-12-01; Completion date: 2011-02-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus, LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf® will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study will be treated with assigned study drug and followed for one year for patient survival and the incidence of graft rejection or graft loss.

Detailed description:
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP-Tacro tablets (tacrolimus, LifeCycle Pharma A/S, Horsholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult make and female kidney transplant patients. Recipients of kidney transplant 3 months to 5 years before Screening and on a stable dose of Prograf will be randomly assigned to be converted from Prograf twice daily to LCP-Tacro once daily or to remain on maintenance therapy with Prograf twice daily. There will be 11 study visits in the Treatment period.

Arms: arm 1: LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK) arm 2: Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Interventions: intervention 1: LCP-Tacro intervention 2: Prograf
Intervention descriptions: intervention 1: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets. intervention 2: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.

Protocol documents:
Clinical trial NCT00817531
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Baylor Breast Care Center
Start date: 2008-12-01; Completion date: 2011-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope that we can learn more about what makes triple negative breast cancers grow. We believe this information will help us to predict which patients will benefit from taking this drug or other drugs like it.

This study is a "neoadjuvant study", which means that it is only open to women who have not had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look at how the cells in your cancer change after taking the study medication. This will help us to understand whether or not dasatinib is an effective treatment for breast cancer. It will also help us to learn more about triple negative breast cancer and how to treat it.

Detailed description:
Women who have been recently diagnosed with a type of breast cancer called "triple negative", and have not yet received any type of treatment (surgery, radiation therapy, etc.) for breast cancer are among the patient population this study will seek. "Triple negative" means breast cancer is not estrogen receptor positive (ER+), progesterone receptor positive (PgR+) or human epidermal growth factor receptor positive (HER2+). Some types of breast cancers "overexpress" one or more of these receptors. "Overexpress" means that the cancer cells have too many of these receptors. ER and PgR are hormone receptors that are located on some types of breast cancer cells. When these receptors are present, the hormones estrogen and progesterone are able to tell cancer cells to grow and divide.

This kind of breast cancer does not have an over-production (overexpression) of these three receptors, and that is why we call it "triple-negative" breast cancer.

We are trying to find new and better treatments for women with triple negative breast cancer. We do not know what causes triple negative breast cancers to grow. Other research studies have shown that "triple negative" breast cancers overexpress different types of receptors. These receptors might help the cancer to grow.

We will be testing a drug called dasatinib. Dasatinib is a drug that is made by Bristol-Myers Squibb. It is sold under the name of Sprycel. It was first used to treat patients with leukemia, a type of blood cancer.

Dasatinib interferes with the growth of some cancers. Dasatinib attaches to the cancer cell and slows down or stops the cancer cell from growing. It is approved by the Food and Drug Administration (FDA), but not for the kind of cancer that you have been diagnosed with.

Arms: arm 1: Dasatinib / Sprycel 100 mg
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: pill form, 100 mg daily

Protocol documents:
Clinical trial NCT00827567
Conditions: Breast Cancer
Keywords: Breast cancer metastatic breast triple negative ER/PR negative Her2 Neu negative
Sponsor: Milton S. Hershey Medical Center
Start date: 2009-04-01; Completion date: 2011-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis of this clinical research study is to discover if the study drug RAD001 can shrink or slow the growth of Estrogen Receptor/Progesterone Receptor (ER/PR) negative or Human Epidermal growth factor Receptor 2 (Her2 Neu) negative breast cancer. The safety of RAD001 will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective.

Detailed description:
RAD001 is an orally administered cell cycle inhibitor with antitumor activity. RAD001, like Rapamycin, binds with high affinity to an intracellular immunophilin, FKBP12 and this complex specifically interacts with the mammalian target of rapamycin (mTOR) protein kinase, inhibiting downstream events such as the initiation of mRNA translation. RAD001 inhibits the growth of a wide range of histologically diverse tumor cells. RAD001 is being developed as a cytostatic agent to delay the time to tumor recurrence/progression or to increase survival in patients with various malignancies. The compound has good tolerability, a partially discovered mechanism of action. RAD001 has the ability to arrest cells in the G1 phase, and the ability to induce apoptosis. RAD001 is being investigated as an anticancer agent based on its potential to act directly on the tumor cells by inhibiting tumor cell growth and proliferation through possible inhibition of the PI3/AKT/MTOR pathway.

RAD001 was shown to have activity in human tumor cell lines originating from lung, breast, prostate, colon, kidney, melanoma and glioblastoma. RAD001 was also shown to have activity in human pancreatic neuroendocrine cells, where induction of apoptosis was reported, as well as in acute myeloid leukemia cells, adult T-cell leukemia cells, diffuse large B cell lymphoma cells, pancreatic tumor cells, ovarian cancer cells, and hepatocellular carcinoma cells.

Arms: arm 1: RAD001-10 mg by mouth once everyday
Interventions: intervention 1: RAD 001
Intervention descriptions: intervention 1: RAD 001-10 mg by mouth once everyday

Protocol documents:
Clinical trial NCT00828113
Conditions: Smoking
Keywords: smoking relapse withdrawal
Sponsor: University of Wisconsin, Madison
Start date: 2009-01-01; Completion date: 2011-02-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.

Detailed description:

Arms: arm 1: 52-week varenicline therapy + individual smoking cessation counseling arm 2: 13 weeks of varenicline therapy + individual smoking cessation counseling
Interventions: intervention 1: varenicline intervention 2: varenicline intervention 3: Individual smoking cessation counseling
Intervention descriptions: intervention 1: Extension of 1 mg twice daily treatment to 52 weeks intervention 2: Double-blind switch to placebo after 12 weeks of open-label therapy intervention 3: Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits

Protocol documents:
Clinical trial NCT00828178
Conditions: Systemic Lupus Erythematosus
Keywords: SLE atherosclerosis omega-3
Sponsor: Michelle Petri M.D.,MPH
Start date: 2009-02-01; Completion date: 2011-02-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE) patients.

Detailed description:
Patients with SLE have a fifty-fold increased risk of myocardial infarction. This risk is not totally explained by traditional cardiovascular risk factors. In a previous double-blind study of atorvastatin in SLE, there was no reduction in surrogate measures of coronary artery disease (coronary calcium, coronary IMT, carotid plaque) and no effect on inflammatory markers such as ICAM, VCAM, IL-6 and CRP. We need to find novel approaches to reduce coronary artery disease in SLE. In a preliminary study, omega-3 was shown to improve flow mediated dilation of the brachial artery, oxidative stress and disease activity in lupus patients. In this study we will determine if omega-3 improves brachial artery flow dilation, disease activity and other vascular inflammatory markers (IL-6, s-VCAM-1, s-ICAM-1) in SLE, in a double-blind placebo-controlled trial.

Arms: arm 1: 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters); flow-mediated dilation of the brachial artery arm 2: corn starch; flow-mediated dilation of the brachial artery
Interventions: intervention 1: Omega-3 intervention 2: flow-mediated dilation of the brachial artery intervention 3: corn starch
Intervention descriptions: intervention 1: Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks intervention 2: flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks intervention 3: 3 capsules qd for 12weeks

Protocol documents:
Clinical trial NCT00828750
Conditions: Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic
Keywords: eltrombopag thrombopoietin receptor agonist ITP blood platelet
Sponsor: GlaxoSmithKline
Start date: 2008-05-01; Completion date: 2011-02-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).

Detailed description:

Arms: arm 1: Eltrombopag oral tablets once daily
Interventions: intervention 1: Eltrombopag oral tablets
Intervention descriptions: intervention 1: Eltrombopag oral tablets once daily

Protocol documents:
Clinical trial NCT00830128
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-07-01; Completion date: 2011-02-01
Enrollment: 106 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pregabalin (Lyrica)
Intervention descriptions: intervention 1: Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks

Protocol documents: