ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00853229
Conditions: Vulvodynia Vulvar Vestibulitis
Keywords: vulvodynia vulvar vestibulitis chronic vulvar pain generalized vulvodynia localized vulvodynia
Sponsor: The Cleveland Clinic
Start date: 2009-02-01; Completion date: 2013-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

Detailed description:
Vulvodynia is a condition exclusive to women and involves mostly burning, rawness, and itching of the external genitourinary tract that often results in painful intercourse. Vulvodynia rarely results in severe morbidity or mortality; rather it causes symptoms of the lower genital, urinary, and gastrointestinal tracts that can impact a woman's daily activities and negatively affect her quality of life.

Despite the fact that chronic vulvovaginal symptoms are one of the most common reasons for visits to a gynecology clinic, epidemiologic studies of the incidence and prevalence of these conditions are rare and available population-based studies are limited. Approximately 16% of women will experience chronic vulvar pain at some point in their lifetime; with 5% experiencing this condition before age 25.

Treatment approaches include behavioral changes, medical management, and surgery, specifically vulvar vestibulectomy. Prior to considering surgical intervention, all medical treatment options should be exhausted. Although vulvodynia is quite prevalent and can be a debilitating disease, there are few studies that critically evaluate the medical management of vulvodynia. Pregabalin is an anticonvulsant that has proven efficacy in the treatment of diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Anecdotal data and one case report provide hope that this medication may also be effective in the treatment of vulvodynia.

Arms: arm 1: pregabalin and placebo given using a cross-over design arm 2: placebo and pregabalin given using a cross-over design
Interventions: intervention 1: pregabalin
Intervention descriptions: intervention 1: pregabalin 150mg twice daily for 4 weeks

Protocol documents:
Clinical trial NCT00863746
Conditions: Carcinoma Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer (NSCLC) Sorafenib
Sponsor: Bayer
Start date: 2009-04-01; Completion date: 2013-04-01
Enrollment: 703 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Detailed description:
Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST).

Arms: arm 1: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID) arm 2: Participants received 2 tablets of placebo orally twice daily (BID)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily (BID) intervention 2: Placebo - 2 tablets twice daily (BID)

Protocol documents:
Clinical trial NCT00867503
Conditions: Ovarian Cancer
Keywords: ovarian cancer bendamustine
Sponsor: University of Arizona
Start date: 2009-02-01; Completion date: 2013-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study design is a non-randomized, open label, single center Phase II trial. Eligible patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease.

Patients will be treated with bendamustine Hydrochloride 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2. 20 patients will be enrolled in the study.

OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine hydrochloride, in women with platinum and taxane refractory ovarian cancer.

Detailed description:
Bendamustine, a non-cross resistant cytotoxic, has potential to offer a new regimen for the treatment of ovarian cancer in women who are refractory to standard drug regimens. Non-cross resistance to platinum is critical for the development of effective salvage regimens in this platinum resistant population. In addition bendamustine's cytotoxic effects are thought to occur via several mechanistic pathways, apoptosis, DNA repair, DNA replication, DNA transcription. The study seeks to determine the efficacy and safety of bendamustine in women with advanced ovarian cancer.

Arms: arm 1: bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
Interventions: intervention 1: Bendamustine HCL
Intervention descriptions: intervention 1: bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.

Protocol documents:
Clinical trial NCT00873457
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: B-Cell Chronic Lymphocytic Leukemia Leukemia
Sponsor: Daphne Friedman
Start date: 2009-08-01; Completion date: 2013-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Perifosine inhibits the AKT pathway (a way cells communicate with each other). This pathway is felt to be important in the development of several types of cancers including chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is thought perifosine may be able to block this pathway and lead to an improvement in the CLL or SLL. The purpose of this trial is to see if perifosine is an effective treatment for relapsed or refractory CLL or SLL. Another purpose of this study is to look at the effect perifosine has on cells.

Detailed description:
Chronic lymphocytic leukemia and small B-cell lymphocytic lymphoma represent different manifestations of the same disease. CLL/SLL (hereafter denoted by CLL) is a clonal disorder of small B lymphocytes expressing a characteristic morphology and immunophenotype. The B cells express CD19, dim CD 20, dim CD 5, CD 23, CD 43, CD 79a, and weakly express surface immunoglobin. CLL can present asymptomatically in 25% of patients when diagnosed on a complete blood count. It also can present with diffuse painless lymphadenopathy and, in a smaller number of patients, B symptoms.

CLL is characterized by accumulation of circulating B cells predominantly in the G0 phase of the cell cycle. These cells are resistant to apoptosis. CLL has been found to have aberrant signaling in several pathways including NF-kB, Akt/PI3K, and JNK/STAT pathways. Akt is important in promoting CLL survival and viability, as seen in in vitro experiments where blocking its activity results in apoptosis. Thus an AKT inhibitor may lead to increased apoptosis and may have a role in the treatment of this disease.

Treatment options for CLL range from a watch and wait approach to high dose chemotherapy with stem cell support. Currently, there is no consensus on the best treatment regimen, since no treatment has been shown to improve survival in randomized prospective clinical trials. New approaches to treatment, especially those with lower toxicity rates, are needed.

Perifosine has been shown to inhibit or otherwise modify signaling through a number of different signal transduction pathways, including Akt, MAPK, and JNK. These pathways are involved in the development of cancers and resistance to chemotherapy. Perifosine is of particular interest, especially due to the difficulty in discovery of drugs that inhibit these pathways with minimal toxicity. The effect of perifosine on CLL cells has been tested in the laboratory and has been shown to be an active agent against primary CLL cells in vitro.

Arms: arm 1: Perifosine 50 mg twice a day for a total of six 28-day cycles.
Interventions: intervention 1: perifosine
Intervention descriptions: intervention 1: Perifosine 50 mg will be taken orally twice a day for a maximum of six 28-day cycles

Protocol documents:
Clinical trial NCT00902668
Conditions: Breast Cancer Radiation Toxicity
Keywords: radiation toxicity stage IA breast cancer stage IB breast cancer stage II breast cancer breast cancer in situ
Sponsor: Virginia Commonwealth University
Start date: 2009-04-01; Completion date: 2013-04-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of radiation therapy.

PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects after radiation therapy in women with breast cancer.

Detailed description:
OBJECTIVES:

* To determine the incidence of good/excellent cosmetic outcome, as defined by the Harvard Scale, after radiotherapy in women treated with lovastatin, as compared to historical controls.

OUTLINE: Patients undergo standard external beam whole-breast irradiation and/or accelerated partial breast irradiation. Patients receive oral lovastatin once daily beginning on the first day of radiotherapy and continuing for 12 months in the absence of disease progression or unacceptable toxicity.

Patients complete a questionnaire, the Breast Cancer Treatment Outcome Scale, at baseline and then at 6 months, 12 months, and 3 years after completion of radiotherapy to assess cosmetic and functional outcomes.

After completion of radiotherapy, patients are followed periodically for up to 5 years.

Arms: arm 1: Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lovastatin intervention 2: questionnaire administration intervention 3: adjuvant therapy intervention 4: accelerated partial breast irradiation intervention 5: external beam radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00913744
Conditions: Exudative Age-Related Macular Degeneration Focal Vitreomacular Adhesion
Keywords: AMD
Sponsor: ThromboGenics
Start date: 2010-01-01; Completion date: 2013-04-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ocriplasmin intervention 2: Sham injection
Intervention descriptions: intervention 1: ocriplasmin intravitreal injection (125 µg) intervention 2: Sham injection

Protocol documents:
Clinical trial NCT00920140
Conditions: Cancer
Keywords: Oncology, GSK1120212, MEK inhibitor, hematological malignancies, AML CMML MDS
Sponsor: GlaxoSmithKline
Start date: 2011-05-01; Completion date: 2013-04-01
Enrollment: 97 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose escalations will continue based on predefined parameters until a maximum tolerated dose is established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or refractory leukaemias (AML, MDS or CMML) will be determined.

Detailed description:

Arms: arm 1: The proposed treatment schedule of GSK1120212 is continuous daily dosing. At the initiation of dosing, a loading dose will be given prior to starting continuous dosing (maintenance dose).

Alterations to the dose and schedule will be based on emerging PK, PD, and tolerability data. The goal will be to define a regimen that is well tolerated and provides adequate PK and PD. This will be the recommended Phase II schedule. arm 2: A dose determined by Phase I to further evaulate the safety profile, PK, PD, and clinical activity of GSK1120212.
Interventions: intervention 1: GSK1120212 intervention 2: GSK1120212
Intervention descriptions: intervention 1: Starting dose based on GSK protocol MEK111054 and then dose escalation based on Dose Limiting Toxicities per protocol. intervention 2: Dose will be maximum tolerated dose based on Phase I results.

Protocol documents:
Clinical trial NCT00935818
Conditions: Smoking
Keywords: smoking nicotine tobacco dependence cessation abstinence
Sponsor: Mayo Clinic
Start date: 2009-09-01; Completion date: 2013-04-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.

Detailed description:
Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States and accounts for 30% of U.S. cancer deaths. Varenicline and bupropion SR (sustained-release) are non nicotine pharmacotherapies FDA-indicated for the treatment of tobacco dependence in cigarette smokers. Although varenicline has proven greater efficacy than bupropion SR, both medications are associated with high end-of-treatment smoking abstinence rates. However, almost two-thirds of smokers treated with varenicline report smoking at 6 months. Because varenicline and bupropion SR have different mechanisms of action and different neuropharmacologic targets, combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy. In our recent pilot study of combination therapy with varenicline and bupropion SR, we observed treatment to be well-tolerated with 7-day point prevalence smoking abstinence rates of 71% (95% CI: 54-85%) at 3 months and 58% (95% CI: 41-74%) at 6 months. Determining the efficacy of combination therapy compared to single-agent therapy has immediate and important clinical implications. In this study, we will conduct a randomized, multicenter, controlled clinical trial evaluating the efficacy of combination therapy with varenicline and bupropion SR compared to varenicline and placebo in 506 cigarette smokers at the Mayo Clinic in Rochester, MN, and the University of Minnesota in Minneapolis, MN.

Arms: arm 1: Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year. arm 2: Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
Interventions: intervention 1: Varenicline intervention 2: placebo intervention 3: bupropion SR
Intervention descriptions: intervention 1: varenicline - 1 mg bid for 12 weeks intervention 2: placebo for 12 weeks intervention 3: bupropion sr - 150 mg bid for 12 weeks

Protocol documents:
Clinical trial NCT00939991
Conditions: Brain Tumor Glioblastoma
Keywords: GBM
Sponsor: Katy Peters
Start date: 2009-10-01; Completion date: 2013-04-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients. Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken orally once every day. Vorinostat will be taken orally on days 1-7 and 15-21 of each 28-day cycle. In the phase I portion of this study, the dose of Vorinostat will be escalated in successive cohorts of patients to determine the maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs). In the phase II portion of this study, the dose of Vorinostat will be the MTD determined in the phase I portion. The primary endpoint of the phase II study is 6-month progression-free survival (PFS) for recurrent GBM (Glioblastoma) patients. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at Duke.

Detailed description:

Arms: arm 1: Phase I- Bevacizumab will be administered intravenously every other week. Temozolomide will be administered on a continuous daily dosing schedule. Vorinostat will be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat will be escalated in successive cohorts of patients to determine the MTD of this regimen.
Interventions: intervention 1: Vorinostst/Bevacizumab/Temozolomide
Intervention descriptions: intervention 1: Bevacizumab will be administered intravenously at the dose 10 mg/kg every other week. Temozolomide will be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat will be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat will be escalated in successive cohorts of patients to determine the MTD of this regimen. Bevacizumab doses may be given by the local oncologists under the direction of the Duke investigators.

Protocol documents:
Clinical trial NCT00946296
Conditions: Graves Disease Hyperthyroidism
Keywords: Graves Disease
Sponsor: University of Massachusetts, Worcester
Start date: 2005-04-01; Completion date: 2013-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.

Detailed description:
Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss.

The outcomes to be measured in this surgery are operative time, operative complications and blood loss.

Arms: arm 1: 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. arm 2: The experimental group receives no treatment.
Interventions: intervention 1: Potassium Iodide
Intervention descriptions: intervention 1: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.

Protocol documents:
Clinical trial NCT00947427
Conditions: Type 1 Diabetes Preservation of Insulin Secretion Newly Diagnosed Type 1 Diabetes Canakinumab in Type 1 Diabetes
Keywords: type 1 diabetes newly diagnosed T1D T1D canakinumab anti IL-1
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2010-10-01; Completion date: 2013-04-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine.

The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management.

Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year.

All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.

Detailed description:

Arms: arm 1: Placebo solution given by subcutaneous injection on monthly basis for 12 months arm 2: Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months
Interventions: intervention 1: canakinumab (anti IL-1beta) intervention 2: Placebo
Intervention descriptions: intervention 1: canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months intervention 2: Placebo subcutaneous injections

Protocol documents: