ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00681044
Conditions: Multiple Myeloma
Keywords: monoclonal immunoglobulin deposition disease light chain deposition disease
Sponsor: Boston Medical Center
Start date: 2006-10-01; Completion date: 2016-01-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy 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 the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.

Detailed description:
OBJECTIVES:

* To assess the tolerability of high-dose melphalan and autologous stem cell transplantation in patients with immunoglobulin deposition disease or light-chain deposition disease.
* To determine the hematologic response rate in patients treated with this regimen.
* To determine the predictability of early free light-chain response for heme response in patients treated with this regimen.
* To determine organ or clinical response in patients treated with this regimen.
* To determine overall survival of these patients.

OUTLINE:

* Stem cell mobilization: Patients undergo blood stem cell mobilization comprising filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before the last stem cell collection).
* Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells until the target number of stem cells (at least 2 x 10\^6 cluster of differentiation-34-positive cells) is reached.
* Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2.
* Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day 0.

After completion of study therapy, patients are followed at 3, 6, and 12 months and then annually thereafter.

Arms: arm 1: Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion
Interventions: intervention 1: filgrastim intervention 2: melphalan intervention 3: Stem Cell Infusion
Intervention descriptions: intervention 1: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC intervention 2: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2 intervention 3: infusion of previously collected stem cells on Day 0

Protocol documents:
Clinical trial NCT00727415
Conditions: Chronic Lymphocytic Leukemia
Keywords: advanced or progressive chronic lymphocytic leukemia Lenalidomide Fludarabine
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date: 2008-02-01; Completion date: 2016-01-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL).

Detailed description:
OBJECTIVES:

Primary

* To define the maximum tolerated dose (MTD) of Lenalidomide given in combination with FC.(Phase I)
* To evaluate the complete remission (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL). (Phase II)

Secondary

* To define the toxicity and the infection rate of patients treated with FCL and the median number of delivered courses of FCL, overall response rate and the progression-free survival and the relationship between the response and the baseline biologic factors (IgVH, FISH, ZAP-70, CD38).
* To evaluate the overall response rate (complete and partial responses).
* To evaluate the progression-free survival.

OUTLINE: This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL).

All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).

After completion of study treatment, patients are followed periodically for up to 18 months.

Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine phosphate intervention 3: Lenalidomide
Intervention descriptions: intervention 1: All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). intervention 2: All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). intervention 3: All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).

In the first phase of the study, the dose of Lenalidomide given with FC will be gradually escalated to reach the MTD. In the second phase of the study, FC will be given in combination with the Lenalidomide escalated to the MTD or the maximum planned dose.

Protocol documents:
Clinical trial NCT00744965
Conditions: Mild Gestational Diabetes
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-09-16; Completion date: 2016-01-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.

Detailed description:

Arms: arm 1: Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. arm 2: Women with mild gestational diabetes will be started ADA diet and placebo.
Interventions: intervention 1: Glyburide intervention 2: Placebo
Intervention descriptions: intervention 1: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control. intervention 2: Sham dose adjustments of the placebo will be made.

Protocol documents:
Clinical trial NCT00784134
Conditions: Intraventricular Hemorrhage
Keywords: intraventricular hemorrhage thrombolysis
Sponsor: Johns Hopkins University
Start date: 2009-07-01; Completion date: 2016-01-01
Enrollment: 500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).

Detailed description:

Arms: arm 1: administration of alteplase via the intraventricular catheter arm 2: 1 ml of normal saline administered via the intraventricular catheter
Interventions: intervention 1: Alteplase intervention 2: Normal saline
Intervention descriptions: intervention 1: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses intervention 2: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Protocol documents:
Clinical trial NCT00804908
Conditions: Melanoma Metastatic Melanoma Skin Cancer
Keywords: Temozolomide Skin cancer Melanoma Metastatic Melanoma ABT-888 MM
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-02-01; Completion date: 2016-01-01
Enrollment: 346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.

Detailed description:

Arms: arm 1: Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. arm 2: ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. arm 3: ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
Interventions: intervention 1: temozolomide intervention 2: ABT-888 intervention 3: Placebo
Intervention descriptions: intervention 1: temozolomide capsule administered orally once daily for 5 days every 28 days intervention 2: ABT-888 capsule administered orally twice daily for 7 days every 28 days intervention 3: Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days

Protocol documents:
Clinical trial NCT00814788
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer adenocarcinoma of the prostate recurrent prostate cancer
Sponsor: University of California, Davis
Start date: 2008-12-01; Completion date: 2016-01-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer.

Detailed description:
OBJECTIVES:

* To compare the PSA response rate in patients with hormone-independent recurrent or metastatic adenocarcinoma of the prostate treated with bicalutamide and everolimus after first-line androgen deprivation therapy.
* To evaluate the time to treatment failure and overall survival of these patients.
* To assess the toxicity of bicalutamide and everolimus in these patients.

OUTLINE: Patients are stratified according to disease status (metastatic disease vs biochemical recurrence without measurable disease).

Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28-42 days and then every 3 months thereafter.

Arms: arm 1: Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bicalutamide intervention 2: Everolimus
Intervention descriptions: intervention 1: 50 mg oral tablet daily intervention 2: 10 mg oral capsule daily

Protocol documents:
Clinical trial NCT00844480
Conditions: Bone Loss
Keywords: spinal cord injury osteoporosis bone loss zoledronic acid bisphosphonate
Sponsor: Thomas J. Schnitzer
Start date: 2010-03-01; Completion date: 2016-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be administered intravenously to people who have suffered an acute spinal cord fracture. The goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this population. Outcome measures will include bone density determinations over a one year period.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: zoledronic acid intervention 2: placebo
Intervention descriptions: intervention 1: zoledronic acid, 5mg, iv intervention 2: iv

Protocol documents:
Clinical trial NCT00859040
Conditions: Meningioma
Keywords: recurrent intracranial meningioma(s) progressive intracranial meningioma(s)
Sponsor: Patrick Y. Wen, MD
Start date: 2009-03-01; Completion date: 2016-01-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. This drug has been used in treatment of other tumors, and information from those other research studies suggests that SOM230C may help to stop the growth of meningiomas.

Detailed description:
* To enroll in the study, a sample of the participant's tumor tissue, stored from an earlier study, must be sent to a lab at the Dana-Farber/Harvard Cancer Center for diagnosis and special testing.
* Prior to starting the study medication, participants will undergo a Octreotide scan. This is a special type of scan used to obtain information about certain tumors.
* Participants will receive the study medication, SOM230C, via an injection into the buttocks every 28 days. Therefore, each treatment cycle lasts 28 days.
* The following tests and procedures will be done prior to the first, second and third treatment cycles, and every three treatment cycles thereafter: Complete physical examination including neurological exam; vital signs; current medication and symptom review; blood samples and a pregnancy test (for women of child-bearing potential).
* About 2/3 through the first treatment cycle (around day 22), participants will visit the research doctor for a complete physical examination including a neurological exam and blood work.
* Participants will have ECGs done prior to their first treatment cycle, about 2/3 through the first and third treatment cycles (around day 22), prior to their sixth treatment cycle, and every three treatment cycles thereafter.

Arms: arm 1: Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
Interventions: intervention 1: SOM230C
Intervention descriptions: intervention 1: Injection in the buttocks every 28 days

Protocol documents:
Clinical trial NCT00909844
Conditions: Precocious Puberty
Sponsor: Ipsen
Start date: 2008-04-01; Completion date: 2016-01-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Triptorelin (I.N.N.)
Intervention descriptions: intervention 1: Decapeptyl® SR 11.25mg

Protocol documents:
Clinical trial NCT00932893
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung Neoplasms ALK gene crizotinib
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2016-01-01
Enrollment: 347 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Detailed description:

Arms: arm 1: None arm 2: Investigator selection of either pemetrexed or docetaxel as the active comparator
Interventions: intervention 1: PF-02341066 intervention 2: Pemetrexed intervention 3: Docetaxel
Intervention descriptions: intervention 1: PF-02341066, 250 mg BID will be administered orally on a continuous schedule intervention 2: Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle intervention 3: Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

Protocol documents:
Clinical trial NCT00962390
Conditions: Benign Prostatic Hyperplasia
Sponsor: Ausio Pharmaceuticals, LLC
Start date: 2009-06-01; Completion date: 2016-01-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.

Detailed description:
The study is a phase 2a, randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of S-equol to placebo in patients with benign prostatic hyperplasia. The study objective is to examine a dose response of 3 dose levels of S equol versus placebo on prostate specific antigen concentrations in patients with benign prostatic hyperplasia. The safety of S-equol will be evaluated during the study.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: S-equol intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg S-equol 50mg S-equol, \& 150mg S-equol intervention 2: Placebo

Protocol documents:
Clinical trial NCT00976989
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-11-01; Completion date: 2016-01-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m\^2 iv, increased to 100 mg/m\^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.

Detailed description:

Arms: arm 1: 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab (T) and pertuzumab (P) every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. arm 2: FEC every three weeks for three cycles, followed by docetaxel, trastuzumab (T) and pertuzumab (P) every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. arm 3: Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab (P) every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Interventions: intervention 1: Pertuzumab intervention 2: Trastuzumab intervention 3: FEC intervention 4: Docetaxel intervention 5: TCH
Intervention descriptions: intervention 1: 840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly. intervention 2: 8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks. intervention 3: 5-fluorouracil 500 mg/m\^2, epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2. intervention 4: 75 mg/m\^2 for the first dose; 100 mg/m\^2 if no dose limiting toxicity occurs. intervention 5: Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m\^2. All treatments were given every three weeks by the IV route.

Protocol documents:
Clinical trial NCT00987935
Conditions: Carcinoma, Hepatocellular
Sponsor: Boehringer Ingelheim
Start date: 2009-10-01; Completion date: 2016-01-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients

Detailed description:

Arms: arm 1: Phase I dose escalation and phase II using dose determined in phase I arm 2: Twice daily dosing in phase II
Interventions: intervention 1: Sorafenib intervention 2: BIBF 1120
Intervention descriptions: intervention 1: 400 mg twice daily intervention 2: Twice daily

Protocol documents:
Clinical trial NCT00997386
Conditions: Hematologic Neoplasms Multiple Myeloma Anemia, Aplastic Hemoglobinuria, Paroxysmal Myelofibrosis
Keywords: Hematologic malignancies lymphoma, leukemia, MDS (myelodysplastic syndrome) reduced-intensity preparative regimen allogeneic peripheral blood stem cell transplant myelofibrosis or other myeloproliferative syndromes
Sponsor: University of Arizona
Start date: 2009-09-01; Completion date: 2016-01-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.

Detailed description:
Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.

Arms: arm 1: Three drug regimen using busulfan, and melphalan, and alemtuzumab.
Interventions: intervention 1: busulfan, and melphalan, and alemtuzumab
Intervention descriptions: intervention 1: intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT).

intravenous melphalan 100 mg/m2 on day -3.

intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.

Protocol documents: