ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00320541
Conditions: Breast Cancer
Keywords: Breast Cancer Cancer of Breast Cancer of the breast Breast Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2006-05-01; Completion date: 2012-08-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Detailed description:

Arms: arm 1: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days arm 2: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Interventions: intervention 1: gemcitabine intervention 2: paclitaxel intervention 3: bevacizumab
Intervention descriptions: intervention 1: 1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity intervention 2: 90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity intervention 3: 10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00343785
Conditions: Aplastic Anemia
Sponsor: Fred Hutchinson Cancer Center
Start date: 2006-02-01; Completion date: 2012-08-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host disease (GVHD) in patients with severe aplastic anemia undergoing donor bone marrow transplant. Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before and methotrexate and cyclosporine after transplant may stop this from happening

Detailed description:
PRIMARY OBJECTIVES:

I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 2.0-2.5 x 10\^8 nucleated cells/kg.

SECONDARY OBJECTIVES:

I. Engraftment and overall survival.

OUTLINE:

CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2.

TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or orally (PO) twice daily on days -1 to 50, followed by a taper until 6 months after grafting.

After completion of study treatment, patients are followed up at on day 180, 1 year, 1.5 years, 2 years, 3 years, and yearly thereafter.

Arms: arm 1: Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
Interventions: intervention 1: cyclophosphamide intervention 2: anti-thymocyte globulin intervention 3: cyclosporine intervention 4: allogeneic bone marrow transplantation intervention 5: methotrexate intervention 6: DNA analysis intervention 7: flow cytometry intervention 8: polymorphism analysis intervention 9: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV or PO intervention 4: Undergo allogeneic bone marrow transplantation intervention 5: Given IV intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies intervention 9: Correlative studies

Protocol documents:
Clinical trial NCT00361231
Conditions: Biliary Tract Cancer Gallbladder Adenocarcinoma
Keywords: Avastin GEMOX
Sponsor: Massachusetts General Hospital
Start date: 2006-05-01; Completion date: 2012-08-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.

Detailed description:
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* The following tests and procedures will be performed on day 1 and day 15 or each cycle: physical examination; medical history; blood work; and urine test. A PET scan will be repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.

Arms: arm 1: * The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Interventions: intervention 1: Bevacizumab intervention 2: Gemcitabine intervention 3: Oxaliplatin
Intervention descriptions: intervention 1: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects. intervention 2: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects. intervention 3: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.

Protocol documents:
Clinical trial NCT00365599
Conditions: Breast Cancer
Keywords: Breast cancer Suberoylanilide hydroxamic acid (SAHA) Vorinostat Tamoxifen Anti-hormonal therapy Estrogen receptor positive Progesterone receptor positive Metastatic disease Aromatase inhibitors (Ais) Histone deacetylase (HDAC) inhibitors Selective estrogen receptor modulators(SERMS)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-02-01; Completion date: 2012-08-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.

Detailed description:
Phase II trial to explore the efficacy of vorinostat and tamoxifen combined. Tamoxifen will be given once daily, continuously. Vorinostat will be given daily for 3 out of 4 weeks (a cycle). Responses will be assessed (restaged) after 2 cycles and toxicities will be captured continuously. Eligible patients will receive treatment in consecutive 4-week cycles, until progression of disease or unacceptable toxicity. Patients will be followed for evaluation of safety for at least 30 days after the last dose of the study drug.

Tests will be obtained pre-and post vorinostat treatment and correlated with plasma levels of vorinostat at the time of tumor biopsy and vorinostat doses; the tests will consist of:

* Patient history
* Physical exam (including height and weight)
* Toxicity assessment
* Pharmacokinetic (PK) sample
* Tumor fine needle aspirate (FNA)
* Peripheral Blood Mononuclear Cells (PBMC)
* Standard labs and Chemistry Profile
* Carcinoembryonic antigen (CEA), cancer antigen (Ca) 15-3, Ca 125 (If clinically indicated)
* Pregnancy Test
* Computed tomography (CT) scans, and magnetic resonance imaging (MRI)

Documentation of response and progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).

Arms: arm 1: As outlined in Intervention descriptions
Interventions: intervention 1: suberoylanilide hydroxamic acid (SAHA, Vorinostat) intervention 2: tamoxifen citrate (Tamoxifen)
Intervention descriptions: intervention 1: Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days). intervention 2: Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).

Protocol documents:
Clinical trial NCT00379587
Conditions: Hematological Malignancies
Keywords: Rituximab Chronic GVHD
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-09-01; Completion date: 2012-08-01
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted form one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to "reject" the body. Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them.

Detailed description:
Study Design: The study is designed as a Phase II, open label trial of Rituximab as chronic GVHD prophylaxis after HLA-matched, related or unrelated peripheral blood stem cell transplantation after ablative or non-ablative conditioning.

Primary Objective: To determine the incidence of clinically extensive chronic GVHD at one and two years after allogeneic stem cell transplantation after a single dose of Rituximab administered at 100 days, 6 months, 9 months and 1 year from transplantation as chronic GVHD prophylaxis.

Secondary Objectives: To determine the incidence of adverse hematological events, the incidence of infectious complications, the rate of malignant relapse, and the effects on donor hematopoietic chimerism after Rituximab administration.

Eligibility Criteria: Eligible patients will be 18 years of age or greater and will have undergone a non-myeloablative or fully ablative transplantation from an HLA-matched (6/6 loci) or single antigen/allele mismatched (5/6) donor approximately 100 days ago. Adequate performance status and organ function will be confirmed prior to enrollment. No ongoing infection or acute GVHD will be present at the time of enrollment. Evidence of sustained donor chimerism will be confirmed prior to study entry.

Treatment Description: Chronic GVHD prophylaxis will consist of Rituximab 375 mg/m2 administered 100 days, 6, 9 and 12 months after transplantation.

Accrual Objective: 68 patients will be accrued over 12 months.

Study Duration: Patients will be evaluated for two years after the time of transplantation for evaluation of the primary and secondary endpoints. Subjects will be followed longitudinally after completion of the study period for determination of clinical status.

Interventions: intervention 1: Rituximab intervention 2: 375 mg/m2 RRituximab
Intervention descriptions: intervention 1: Rituximab at months 3, 6, 9 and 12 post-transplant intervention 2: Rituximab 375 mg/m2 q3months

Protocol documents:
Clinical trial NCT00388362
Conditions: Graft vs Host Disease
Keywords: GVHD
Sponsor: Stanford University
Start date: 2005-11-01; Completion date: 2012-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To study the effectiveness of an immunosuppressive drug sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone.

Detailed description:
The purpose of this trial is to study the effectiveness of an immunosuppressive drug, sirolimus, in the treatment of chronic graft versus host disease in combination with prednisone. Graft versus host disease (GVHD) is a common complication in patients who have received blood or marrow transplantation from a related or unrelated donor. Chronic GVHD occurs approximately 100 days after transplantation and is the result of the donor immune system recognizing the patient's tissues as foreign and creating harmful effects on the patient's organs. We hope the use of sirolimus will decrease the significant disabling effects and deaths caused by chronic GVHD.

Arms: arm 1: Administration of Sirolimus and Prednisone
Interventions: intervention 1: Sirolimus intervention 2: Prednisone
Intervention descriptions: intervention 1: Patients will receive sirolimus at 2 mg/day orally with monitoring of trough drug levels weekly for 2 weeks to achieve trough drug levels 7-12 ng/ml. Along with prednisone therapy. intervention 2: Prednisone therapy will remain at the dose the patient received at the time sirolimus was begun. Withdrawal of prednisone will began after first evidence of improvement of chronic GVHD.

Protocol documents:
Clinical trial NCT00396097
Conditions: Idiopathic Short Stature
Keywords: ISS human growth hormone
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2012-08-01
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Detailed description:

Arms: arm 1: Standard daily HGH treatment arm 2: Formula-based dose regimen
Interventions: intervention 1: Genotropin intervention 2: Genotropin
Intervention descriptions: intervention 1: Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period. intervention 2: Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Protocol documents:
Clinical trial NCT00405548
Conditions: Left Ventricular Diastolic Dysfunction
Sponsor: Mayo Clinic
Start date: 2008-03-01; Completion date: 2012-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood in response to an intravenous salt solution.

Detailed description:
Prior to initiation of the study, subjects will be stabilized for at least one week on a no added salt diet (120 milliequivalent (mEq) Na/Day) which will be maintained during the study. Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot). The participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks. The study requires a screening visit to determine eligibility and discuss the study. At this visit a blood draw for heart and liver function and a six minute walk will be done. There will also be two other outpatient visits and two inpatient stays, for 48 hours, in the Clinical Research Unit at St. Marys Hospital. During the two overnight stays, blood and urine samples will be done to get heart and kidney function as well as a research echocardiogram. An acute saline load (0.9% normal saline 1.25 ml/kg/min for 1 hour) will be given and blood and urine samples collected After enrollment, the study lasts for twelve weeks. It is planned to treat 2 subjects with active drug per each placebo subject to improved the precision of between group comparison.

Arms: arm 1: BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks arm 2: Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Interventions: intervention 1: BNP (nesiritide) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00417612
Conditions: Hypophosphatemia, Familial Hyperparathyroidism
Keywords: Rickets, Hypophosphatemia Rickets, Vitamin D-Resistant Rickets, X-linked hypophosphatemic
Sponsor: Yale University
Start date: 2007-01-01; Completion date: 2012-08-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of paricalcitol, a form of synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease symptoms in children and adults with X-linked hypophosphatemic (XLH) rickets.

Detailed description:
XLH rickets is a rare inherited disorder in which the bones become painfully soft and bend easily because of a phosphate deficiency. This genetic defect causes the kidneys to allow excretion of an inappropriately high amount of phosphate into the urine. The kidneys are also unable to convert vitamin D into a form usable by the body, resulting in inadequate amounts of active vitamin D. Because vitamin D is needed to absorb calcium and phosphate from the intestine, this deficiency further reduces phosphate levels. Without the sufficient phosphate needed for normal bone growth, individuals with XLH rickets typically develop skeletal malformations, bone pain, and abnormally bowed legs. Hyperparathyroidism, a condition in which the parathyroid glands excrete excess amounts of PTH, also occurs frequently in individuals with XLH rickets, and may play a significant role in the skeletal complications associated with XLH rickets. The purpose of this study is to determine the effectiveness of paricalcitol in lowering PTH levels and reducing disease symptoms in individuals with XLH rickets.

This study will last 12 months. Participants will be randomly assigned to receive either paricalcitol or placebo, taken in the form of two pills daily for the duration of the study. During a baseline 3-day inpatient hospital stay, participants will undergo a physical exam, a cardiac ultrasound, a bone scan, blood collection, and a radiographic skeletal survey. The skeletal survey will include x-rays of various body parts. Participants who are 18 years or younger will not undergo the radiographic skeletal survey. Study visits for all participants will occur every 2 months until the end of the study. These visits will include a physical exam, review of disease symptoms, blood and urine collection, and a check of medication compliance.

Arms: arm 1: Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level arm 2: Participants given placebo capsule to match for comparison
Interventions: intervention 1: Paricalcitol intervention 2: Placebo
Intervention descriptions: intervention 1: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits. intervention 2: Placebo sugar pill

Protocol documents:
Clinical trial NCT00494221
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal cancer Recentin Metastatic Cancer FOLFOX
Sponsor: AstraZeneca
Start date: 2007-06-01; Completion date: 2012-08-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.

Detailed description:

Arms: arm 1: FOLFOX + Cediranib 20 mg arm 2: FOLFOX + Cediranib 30 mg arm 3: FOLFOX + Placebo Cediranib
Interventions: intervention 1: AZD2171 intervention 2: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intervention 3: Placebo Cediranib
Intervention descriptions: intervention 1: oral tablet intervention 2: intravenous infusion intervention 3: oral tablet

Protocol documents: