ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00083915
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma DTPACE Tandem Transplant Cisplatin Cyclophosphamide Dexamethasone Doxorubicin Etoposide Sargramostim Thalidomide Melphalan
Sponsor: University of Arkansas
Start date: 2001-06-01; Completion date: 2010-06-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if transplant with a new regimen of chemotherapy called DT PACE-Melphalan is better than transplant with Melphalan alone. DT-PACE refers to a chemotherapy regimen for multiple myeloma consisting of Dexamethasone, Thalidomide, Cisplatin or Platinol, Adriamycin or doxorubicin, Cyclophosphamide, and Etoposide. Another purpose of this study is to find out if there will be fewer side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone.

Detailed description:
To evaluate, in a randomized phase III clinical trial in previously treated multiple myeloma patients, whether angio-chemotherapy with D.T. PACE followed by tandem transplant with MEL-DTPACE Hybrid may be equivalent or superior to tandem transplant with high dose melphalan in terms of complete remission (CR)/near CR/very good partial remission (VGPR) rate and event-free and overall survival.

Arms: arm 1: Autologous transplant with High Dose Melphalan alone arm 2: Melphalan plus Dexamethasone, Thalidomide, CisPlatinum, Adriamycin, Cyclophosphamide, and Etoposide
Interventions: intervention 1: Cisplatin intervention 2: Cyclophosphamide intervention 3: Adriamycin intervention 4: Etoposide intervention 5: Melphalan intervention 6: Thalidomide intervention 7: Dexamethasone
Intervention descriptions: intervention 1: 20mg/m2 continuous infusion days -3 and -2. intervention 2: 800 mg/m2 continuous infusion days -3 and -2. intervention 3: 20mg/m2 continuous infusion -3 and -2. intervention 4: 80mg/m2 continuous infusion -3 and -2. intervention 5: 200 mg/m2 IV over \<20 minutes on -1 on Arm 1. 50mg/m2 IV over 20 minutes days -3 and -2 on Arm 2. intervention 6: 200mg PO Continuing to Day +5, then hold until platelets \>50 thousand (K). intervention 7: 40 mg po days 1 - 4 (4 days)

Protocol documents:
Clinical trial NCT00098865
Conditions: Central Nervous System Tumor, Pediatric Neuroblastoma
Sponsor: Dana-Farber Cancer Institute
Start date: 2002-09-01; Completion date: 2010-06-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.

Secondary

* Determine preliminarily evidence of biologic activity of this regimen in these patients.
* Determine the toxic effects of this regimen in these patients.

STATISTICAL DESIGN: The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population. With a target accrual of 20 patients the 90% confidence for the true feasibility rate will be no wider than 40%.

Arms: arm 1: Thalidomide:

Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.

Temozolomide:

Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.

Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
Interventions: intervention 1: temozolomide intervention 2: thalidomide
Intervention descriptions: intervention 1: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation. intervention 2: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.

Protocol documents:
Clinical trial NCT00098956
Conditions: Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-01-01; Completion date: 2010-06-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also increase the effectiveness of topotecan by making tumor cells more sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the anti tumour activity of UCN-01 in combination with topotecan in patients with SCLC who relapsed or progressed \>= 3 months after completing first-line platinum-based chemotherapy (patient with sensitive disease) using objective response rates (complete and partial).

SECONDARY OBJECTIVES:

I. To determine the anti tumour activity of UCN-01 in combination with topotecan with regards to stable disease rate, median and overall survival rates as well as to determine the safety and tolerability of this combination.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.

Patients are followed for survival.

Arms: arm 1: Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.
Interventions: intervention 1: topotecan hydrochloride intervention 2: 7-hydroxystaurosporine
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00133705
Conditions: Leiomyoma
Keywords: A benign tumor derived from smooth uterine muscle tissue.
Sponsor: University of Rochester
Start date: 2003-07-01; Completion date: 2010-06-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.

Detailed description:
This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.

Arms: arm 1: Mifepristone 5 MG capsule taken once daily by mouth arm 2: Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth
Interventions: intervention 1: Mifepristone intervention 2: Inert Capsule
Intervention descriptions: intervention 1: Mifepristone 5mg/day by mouth for 6 months intervention 2: sugar pill

Protocol documents:
Clinical trial NCT00167245
Conditions: Alcoholism Cocaine Dependence
Keywords: Topiramate alcoholism cocaine dependence
Sponsor: Kyle Kampman
Start date: 2004-09-01; Completion date: 2010-06-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Detailed description:
The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3 months after completing medications).

Arms: arm 1: topiramate capsules dose titrated up to 300 mg daily arm 2: placebo capsules identical in appearance to the topiramate capsules
Interventions: intervention 1: Topiramate intervention 2: placebo
Intervention descriptions: intervention 1: 300mg/day for 13 weeks intervention 2: placebo pills

Protocol documents:
Clinical trial NCT00172042
Conditions: Non-Small-Cell Lung Cancer
Keywords: Non-Small-Cell Lung Cancer Bisphosphonates Zoledronic acid Bone metastases Prevention of bone metastases
Sponsor: Novartis Pharmaceuticals
Start date: 2005-03-01; Completion date: 2010-06-01
Enrollment: 437 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment. arm 2: No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
Interventions: intervention 1: Zoledronic acid 4 mg
Intervention descriptions: intervention 1: Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).

Protocol documents:
Clinical trial NCT00176904
Conditions: Adrenoleukodystrophy Metachromatic Leukodystrophy Globoid Cell Leukodystrophy Gaucher's Disease Fucosidosis Wolman Disease Niemann-Pick Disease Batten Disease GM1 Gangliosidosis Tay Sachs Disease Sandhoff Disease
Keywords: Inborn errors Storage disease errors of metabolism stem cell transplant
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 1995-01-01; Completion date: 2010-06-01
Enrollment: 135 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and engraftment of donor hematopoietic cells using this conditioning regimen in patients undergoing a hematopoietic (blood forming) cell transplant for an inherited metabolic storage disease.

Detailed description:
Prior to transplantation, subjects will receive Busulfan intravenously (IV) via the Hickman line four times daily for 4 days, Cyclophosphamide intravenously via the Hickman line once a day for 4 days, and Anti-Thymocyte Globulin (ATG) intravenously (IV) via the Hickman line twice daily for three days before the transplant. These three drugs are being given to subjects to help the new marrow "take" and grow.

On the day of transplantation, the donor's hematopoietic cells will be transfused via central venous catheter.

After hematopoietic cell transplant, subjects will then receive two drugs, cyclosporin and either methylprednisolone or Mycophenolate Mofetil (MMF). Cyclosporin and methylprednisolone or MMF are given to help prevent the complication of graft-versus-host disease and to decrease the chance that the new donor cells will be rejected.

Arms: arm 1: All patients treated with protocol regimen (chemotherapy and surgery).
Interventions: intervention 1: Stem Cell Transplant intervention 2: Busulfan, Cyclophosphamide, Antithymocyte Globulin
Intervention descriptions: intervention 1: The purpose of hematopoietic cell transplantation is to introduce hematopoietic cells from a normal donor that contains an enzyme able to get rid of the substances that have accumulated in the body of patients with storage diseases. Hematopoietic cells can come from bone marrow, peripheral blood (i.e., the blood circulating in our body's blood vessels) or umbilical cord blood (i.e., blood taken from the umbilical cord after a baby is born and umbilical cord is cut). intervention 2: Subjects will receive BUSULFAN intravenously (IV)- patients \< or= 12 kg 1.1 mg/kd/dose IV every 6 hours for 16 doses; patients \> 12kg 0.8 mg/kg/dose IV every 6 hours for 16 doses - via the Hickman line four times daily for 4 days, CYCLOPHOSPHAMIDE intravenously (50 mg/kg/day IV over 2 hours) via the Hickman line once a day for 4 days, and ANTI-THYMOCYTE GLOBULIN IV (15 mg/kg/day over 2 hours) via the Hickman line twice daily for three days before the transplant. These three drugs are being given to help the new marrow "take" and grow. METHYLPREDNISOLONE will be given as a pre-medication for the ATG.

Protocol documents:
Clinical trial NCT00177866
Conditions: Crohn's Disease
Sponsor: University of Pittsburgh
Start date: 2003-12-01; Completion date: 2010-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators will select 60 people who are 18-70 years of age with Crohn's disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigators will monitor the participants for 18 weeks after they start the medication and observe their Crohn's disease activity, assessing for flare-ups or exacerbations in the disease and other possible side effects of celecoxib. Based on these observations, a determination will be made by the investigators as to the safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a medication that they can prescribe for people who have Crohn's disease and experience chronic pain from arthritis and arthralgia.

Detailed description:
Please refer to brief summary (above).

Arms: arm 1: either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks arm 2: either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks
Interventions: intervention 1: Celebrex intervention 2: placebo
Intervention descriptions: intervention 1: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks. intervention 2: placebo PO BID for either the first eight weeks or the last eight weeks of the study.

Protocol documents:
Clinical trial NCT00181961
Conditions: Depression Sexual Dysfunction
Keywords: antidepressant-induced sexual dysfunction
Sponsor: Massachusetts General Hospital
Start date: 2007-12-01; Completion date: 2010-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the dose of Maca Root effective for the treatment of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive Disorder. We propose to carry out a dose-finding pilot study to determine the minimum effective dose of Maca Root. We hypothesize that patients who receive Maca Root will experience alleviation of their sexual dysfunction, and this effect will be more pronounced in those who receive higher doses of maca root.

Detailed description:
The purpose of this study is to determine whether Maca Root is effective for the treatment of antidepressant-induced sexual dysfunction, and to further determine whether higher doses of Maca Root powder would be more effective than lower doses in reducing the symptoms of antidepressant-induced sexual dysfunction. An additional aim of the study is to document the safety and tolerability of Maca Root, which could be particularly helpful in treating antidepressant-induced sexual dysfunction in elderly and cardiac-impaired populations taking oral nitrates who may not be eligible for treatment with the current oral phosphodiesterase inhibitors.

Subjects will be randomized into two arms of 10 for this 12-week study. The study will be double blind with regard to doses received. Ten subjects will receive 1500mg/day of maca for the 12-week period and the other 10 subjects will receive 3000mg/day of maca per day for the 12-week study period. Patients will be seen every other week. There is no placebo arm.

At the final study visit, week 12, subjects will be evaluated to see if their sexual function has returned.

After careful review of the literature we have found that there are very few studies that have evaluated Maca Root in humans. However the one very relevant study completed by Gonzalez and colleagues looked at doses of 1500 and 3000mg in men and found there were increased sexual interests on both doses. Thus, since this is a dose-finding study we believe this dose is an appropriate place to begin.

Hypotheses A:

The response rate will be higher for the high-dose maca group compared to the low-dose group; and this response will be comparable to the 50-85% reported with sildenafil.

Hypothesis B:

There will be a statistically significant difference in the magnitude of response between the two testing conditions, as measured by a decrease in baseline sexual dysfunction scores. The reduction in sexual dysfunction scores will be greater in the high-dose maca group than in the low-dose maca group.

Arms: arm 1: Patients receiving 1500mg of maca root arm 2: Patients receiving 3000mg of maca root
Interventions: intervention 1: Maca Root
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00203424
Conditions: Prostate Cancer
Sponsor: Translational Oncology Research International
Start date: 2006-01-01; Completion date: 2010-06-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus erlotinib following radical prostatectomy.

Detailed description:
This study explores the anti-tumor activity of adjuvant bevacizumab plus erlotinib in a select group of prostate cancer patients deemed at high risk for early relapse following radical prostatectomy.

Arms: arm 1: Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
Interventions: intervention 1: Erlotinib + Bevacizumab
Intervention descriptions: intervention 1: Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses

Protocol documents:
Clinical trial NCT00237770
Conditions: Hypotension Spinal Cord Injury
Keywords: Blood Pressure Cardiovascular Autonomic Control Nitric Oxide NOS Inhibitor Orthostatic Hypotension Spinal Cord Injury Tetraplegia
Sponsor: US Department of Veterans Affairs
Start date: 2003-06-01; Completion date: 2010-06-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.

Detailed description:
Despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. It must be appreciated however, that orthostatic hypotension may occur unpredictably in persons with chronic tetraplegia. This may result in a range of symptoms due to cerebral hypoperfusion from mild reduction in mental acuity to loss of consciousness. Nitric oxide (NO) is the most potent endogenous vasodilator which is synthesized by the enzyme NO synthase (NOS) and may be largely responsible for orthostatic hypotension in individuals with immobilizing conditions. Recent evidence suggests an up-regulation of inducible nitric oxide synthases (NOS) activity with prolonged exposure to hind limb suspension. The effects of NOS inhibition during orthostasis on blood pressure regulation in those with chronic tetraplegia may provide insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic changes. Treatment with a NOS inhibitor may facilitate the process of mobilization in those with acute higher cord lesions.

Arms: arm 1: Placebo control (normal saline) is employed on a separate visit during procedure.
Interventions: intervention 1: N-Nitro L-arginine-methylester (L-NAME) intervention 2: Head-up Tilt maneuver
Intervention descriptions: intervention 1: A non-specific inhibitor of the nitric oxide synthase enzyme. intervention 2: Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.

Protocol documents: