ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00699907
Conditions: Ovarian Cancer
Keywords: Ovarian epithelial cancer High risk Biomarkers
Sponsor: University of Arizona
Start date: 2005-01-01; Completion date: 2014-11-01
Enrollment: 127 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Studying samples of blood and tissue in the laboratory from patients with a high risk of developing ovarian cancer may help doctors identify and learn more about biomarkers related to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.

Detailed description:
OBJECTIVE: Compare the biomarkers of patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are interested in taking flutamide vs patients at high risk for ovarian cancer who are undergoing prophylactic oophorectomy and are not interested in taking flutamide (control) vs patients who are undergoing oophorectomy for a medical indication (control).

OUTLINE: Patients who elected not to receive flutamide received prophylactic oophorectomy or oophorectomy for a medical indication. Patients who elected to receive flutamide received 125mg once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent prophylactic oophorectomy. All patients underwent blood and ovarian tissue sample collection at the time of surgery for biomarker laboratory studies. Proteomic, microarray, and polymorphism analysis were performed on the blood and tissue samples.

Arms: arm 1: Patients received oral flutamide (125 MG) once daily for 6 weeks in the absence of unacceptable toxicity. Patients then underwent risk-reducing salpingo-oophorectomy. arm 2: High risk patients underwent risk-reducing salpingo-oophorectomy. arm 3: Low risk patients underwent salpingo-oophorectomy for a medical indication.
Interventions: intervention 1: flutamide
Intervention descriptions: intervention 1: Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.

Protocol documents:
Clinical trial NCT00718523
Conditions: Ovarian Neoplasms
Sponsor: Translational Research in Oncology
Start date: 2009-01-01; Completion date: 2014-11-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (\<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

Detailed description:

Arms: arm 1: Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle. arm 2: AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
Interventions: intervention 1: AMG 479 intervention 2: AMG 479 Placebo
Intervention descriptions: intervention 1: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle intervention 2: Matching placebo administered Day 1 of each 21 day cycle.

Protocol documents:
Clinical trial NCT00790647
Conditions: Multiple Myeloma
Keywords: primary systemic amyloidosis
Sponsor: Boston Medical Center
Start date: 2008-06-01; Completion date: 2014-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.

Detailed description:
OBJECTIVES:

* To determine if hematologic responses to high-dose melphalan and autologous stem cell transplantation increase with addition of bortezomib in the conditioning regimen in patients with primary systemic amyloidosis.

OUTLINE:

* Autologous stem cell mobilization and collection: Patients receive filgrastim to mobilize stem cells, which are then collected.
* Conditioning regimen: Patients receive bortezomib intravenously on days -6, -3, 1, and 4 and oral high-dose melphalan on days -2 and -1.
* Stem cell transplantation: Patients undergo autologous stem cell transplantation on day 0.

After completion of study therapy, patients are followed every 6 months for 1 year and annually thereafter.

Arms: arm 1: Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
Interventions: intervention 1: filgrastim intervention 2: bortezomib intervention 3: melphalan intervention 4: Stem Cell Infusion
Intervention descriptions: intervention 1: 16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection intervention 2: 1.0 mg/m2/dose D -6, D-3, D +1, D + 4 intervention 3: 100 mg/m2/dose D -2, D -1 intervention 4: infusion of previously collected autologous stem cells

Protocol documents:
Clinical trial NCT00830037
Conditions: Chronic Kidney Disease Iron-deficiency Anemia
Keywords: anemia iron kidney disease progression glomerular filtration rate
Sponsor: Indiana University
Start date: 2008-08-01; Completion date: 2014-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The long-term goal is to assess the fall in kidney function measured by glomerular filtration rate (GFR) when patients with chronic kidney disease (CKD) are exposed to intravenous iron (IVIR). We hypothesize that in subjects with mild to moderate CKD, infusion of intravenous iron (IVIR), will generate oxidative stress and cause an inflammatory response that will be associated with a more rapid decline in glomerular filtration rate (GFR) compared to oral iron.

Detailed description:
Intravenous iron is commonly utilized and is likely a mechanism of renal injury in patients with CKD. This proposal will provide translational data on the role of intravenous iron to progression of kidney disease in patients with CKD. Comparison of IV iron with oral iron will allow testing the hypothesis that IVIR will generate an inflammatory response and albuminuria in the short-term, that will directly lead to a greater rate of fall in GFR, in the long-term, compared to oral iron. We hypothesize that after administration of one gram of IV iron over a course of 8 weeks, renal injury as documented by albuminuria (and fall in GFR) will be increased with IV iron sucrose therapy compared to those randomized to oral iron therapy. A randomized, parallel group, controlled trial will be performed. GFR will be measures every 6 months for two years in 200 participants by iothalamate clearances.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IV Iron intervention 2: Ferrous Sulfate
Intervention descriptions: intervention 1: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores. intervention 2: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.

Protocol documents:
Clinical trial NCT00887809
Conditions: Sarcoma Leiomyosarcoma Malignant Fibrous Histiocytoma Angiosarcoma
Keywords: Bevacizumab (avastin) Gemcitabine Taxotere (docetaxel) 09-015 Soft tissue
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-04-01; Completion date: 2014-11-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test whether an experimental drug called bevacizumab given together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can help sarcoma patients. This trial will examine what effects, good and/or bad the combination of gemcitabine, docetaxel and bevacizumab has on sarcoma.

Detailed description:

Arms: arm 1: Patients will receive bevacizumab at 15 mg/kg on day 1 of each 21-day cycle intravenously over 30 minutes followed by a one hour (+30/-15 min) break. For cycles 1 through 6, gemcitabine will be administered at 900 mg/m2 over 90 minutes on day 1 and 8 of a 21-day cycle. Docetaxel will be administered at 75 mg/m2, over 60 minutes, on day 8. This will be followed by either 5 days of filgrastim or a single injection of pegfilgrastim. For cycles 7 and beyond, gemcitabine will be given at 800 mg/m2 over 30 minutes on day 1 and 8; docetaxel will be given at 35 mg/m2 over 30 minutes, also on days 1 and 8.
Interventions: intervention 1: gemcitabine intervention 2: docetaxel intervention 3: bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00896298
Conditions: Hypoleptinemia Generalized Lipodystrophy Partial Lipodystrophy Insulin Resistance
Keywords: Lipodystrophy Insulin secretory response
Sponsor: University of Texas Southwestern Medical Center
Start date: 2006-04-01; Completion date: 2014-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.

Detailed description:
The mechanism by which leptin improves glucose and lipid control is not clear. We will examine the possible mechanisms of leptin action by studying the effects of leptin administration on food intake, insulin resistance, insulin secretory response, hepatic and intramuscular triglyceride stores in a large sample of patients with lipodystrophy.

Hypothesis: Leptin replacement in patients with generalized and partial lipodystrophy and hypoleptinemia will be safe and efficacious in improving the metabolic abnormalities associated with insulin resistance.

Arms: arm 1: Active Comparator for 4 months, then for 8 months. arm 2: Placebo for 4 months, then active comparator for 8 months.
Interventions: intervention 1: Leptin intervention 2: Placebo
Intervention descriptions: intervention 1: Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo. intervention 2: Sugar pill

Protocol documents:
Clinical trial NCT00927082
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2009-04-01; Completion date: 2014-11-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received Pegasys (Pegylated interferon alfa-2a \[PEG-IFN\]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430. arm 2: Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430. arm 3: Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430. arm 4: Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
Interventions: intervention 1: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

Protocol documents:
Clinical trial NCT00936221
Conditions: Melanoma
Keywords: BRAF mutation positive advanced melanoma Advanced cutaneous melanoma Unknown primary melanoma
Sponsor: AstraZeneca
Start date: 2009-07-01; Completion date: 2014-11-01
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Detailed description:

Arms: arm 1: AZD6244 in combination with dacarbazine arm 2: Placebo in combination with dacarbazine
Interventions: intervention 1: AZD6244 intervention 2: Dacarbazine intervention 3: Placebo
Intervention descriptions: intervention 1: oral capsules, 75mg twice daily intervention 2: 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle intervention 3: Placebo

Protocol documents:
Clinical trial NCT00988858
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-11-01; Completion date: 2014-11-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LY2603618 intervention 2: Pemetrexed
Intervention descriptions: intervention 1: 150 milligram per square meter (mg/m\^2) intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression intervention 2: 500 mg/m\^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression

Protocol documents:
Clinical trial NCT01022996
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin's Lymphoma Hodgkin Lymphoma Hodgkin's Disease Hodgkin Disease Lymphoma Lymphoproliferative Disorders Neoplasms by Histological type Lymphatic Diseases Hemic and Lymphatic Diseases Recurrent Lymphoma Refractory Lymphoma Relapsed Lymphoma Classical Hodgkin Lymphoma Classical Hodgkin's Disease Nodular sclerosing Hodgkin Lymphoma Mixed-cellularity Hodgkin Lymphoma Lymphocyte-rich Hodgkin Lymphoma Lymphocyte depleted Hodgkin Lymphoma
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2014-11-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.

Detailed description:

Arms: arm 1: Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. All patients were assigned to a daily dose of everolimus 10 mg (two 5-mg tablets), selfadministered orally and continuously from Cycle 1 Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death, or discontinuation from the study for any other reason.

A treatment cycle consisted of 28 days.
Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.

Protocol documents:
Clinical trial NCT01034553
Conditions: Refractory Multiple Myeloma
Sponsor: Mayo Clinic
Start date: 2010-02-01; Completion date: 2014-11-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the maximum tolerated doses (MTD) with the combination of MLN8237 and bortezomib. (Phase I) II. To describe the toxicities associated with the combination of MLN8237 and bortezomib. (Phase I) III. To evaluate the overall response rate to the combination of MLN8237 and bortezomib in patients with relapsed or refractory multiple myeloma. (Phase II)

SECONDARY OBJECTIVE:

I. To assess progression-free survival in patients treated with this combination. (Phase II)

II. To assess overall survival in patients treated with this combination.(Phase II)

OUTLINE: This is a phase I dose escalation study followed by a phase II study. Patients receive oral aurora kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment all patients are followed every 2 months for 1 year and then every 3 months for 1 year.

Arms: arm 1: Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11.
Interventions: intervention 1: Aurora A kinase inhibitor MLN8237 intervention 2: bortezomib
Intervention descriptions: intervention 1: Given orally intervention 2: Given IV

Protocol documents:
Clinical trial NCT01055886
Conditions: Smoking Cessation
Keywords: PTSD smoking cessation nicotine patch
Sponsor: Duke University
Start date: 2009-11-01; Completion date: 2014-11-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to evaluate the relationship between PTSD, mood, craving and withdrawal symptoms and factors associated with relapse in the context of a randomized clinical smoking cessation trial. The use of supplemental nicotine administration (SNA) during a "pre-treatment" phase before a targeted quit date is an innovative development in smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation.

Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date. The study is designed to address the following aims:

Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal through electronic diary assessment.

Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.

Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior.

Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal symptoms following the quit-date.

Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD.

Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood, anxiety sensitivity, distress tolerance, and self-efficacy.

Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect, increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each will independently be associated with shorter abstinence from smoking.

Detailed description:

Arms: arm 1: Nicotine patch given pre-quit attempt at weeks 4 through 6 arm 2: placebo patch given pre-quit from weeks 4 through 6
Interventions: intervention 1: nicotine patch intervention 2: placebo patch
Intervention descriptions: intervention 1: Nicotine patch, 7-21 mg. intervention 2: placebo patch used from weeks 4-6

Protocol documents: