ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00189488
Conditions: Graft Versus Host Disease Hematologic Malignancies
Keywords: Hematological Malignancies Graft-versus-host-disease Oral Mucositis Allogeneic Transplantation
Sponsor: Swedish Orphan Biovitrum
Start date: 2005-12-01; Completion date: 2013-08-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the effect of palifermin versus placebo in the reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.

Detailed description:

Arms: arm 1: Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively. arm 2: Placebo to palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to palifermin 180 μg/kg once prior to transplant and at least 96 hours from previous placebo to palifermin 60 μg/kg dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively.
Interventions: intervention 1: Palifermin intervention 2: Placebo intervention 3: Conditioning Regimen intervention 4: Allogeneic stem cell transplant intervention 5: Methotrexate
Intervention descriptions: intervention 1: Administered as an intravenous (IV) bolus. intervention 2: Administered as an intravenous (IV) bolus. intervention 3: Each participant received 1 of the following conditioning regimens:

* Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16)
* TBI/VP-16
* Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie \> 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible)
* Busulfan (Bu)/Cy
* Bu/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\])
* Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\]) intervention 4: Allogeneic marrow/peripheral blood progenitor cell transplantation intervention 5: None

Protocol documents:
Clinical trial NCT00323297
Conditions: Pulmonary Arterial Hypertension
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-09-01; Completion date: 2013-08-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bosentan intervention 2: Placebo intervention 3: Bosentan intervention 4: Sildenafil Citrate
Intervention descriptions: intervention 1: Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil) intervention 2: Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil) intervention 3: Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase intervention 4: Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase

Protocol documents:
Clinical trial NCT00390234
Conditions: Fallopian Tube Cancer Female Reproductive Cancer Ovarian Carcinosarcoma Ovarian Sarcoma Recurrent Ovarian Epithelial Cancer Recurrent Uterine Sarcoma Stage III Ovarian Epithelial Cancer Stage III Uterine Sarcoma Stage IV Ovarian Epithelial Cancer Stage IV Uterine Sarcoma Uterine Carcinosarcoma Uterine Leiomyosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-09-01; Completion date: 2013-08-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap (ziv-aflibercept).

II. To assess the incidence of disease stabilization, as measured by 6-month progression-free survival, in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap.

SECONDARY OBJECTIVES:

I. To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap.

\* As of 24 October 2012, overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up, who has been off protocol therapy for at least 3 years. Time to progression and median survival times have been based on the currently available data.

II. To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma.

III. To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to histology (uterine leiomyosarcoma vs malignant mixed mullerian tumor/carcinosarcoma). Patients receive ziv-aflibercept over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline, every 8 weeks during treatment, and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay (ELISA).

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ziv-aflibercept
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00461851
Conditions: Bladder Cancer
Keywords: Advanced/Metastatic Bladder Carcinoma
Sponsor: Yale University
Start date: 2007-03-01; Completion date: 2013-08-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.

Detailed description:

Arms: arm 1: Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8. intervention 2: Carboplatin will be given on day 1 to an AUC of 5. intervention 3: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid

Protocol documents:
Clinical trial NCT00509587
Conditions: Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-06-01; Completion date: 2013-08-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving pazopanib works in treating patients with recurrent or metastatic invasive breast cancer. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVE:

I. To determine the antitumor activity of pazopanib, in terms of objective response rate (partial and complete response), in patients with recurrent or metastatic invasive breast cancer.

SECONDARY OBJECTIVES:

I. To determine the duration of objective response, rate and duration of stable disease.

II. To determine 6-month progression-free and median and overall survival rates in patients treated with this drug.

III. To document the safety and tolerability of this drug in these patients.

OUTLINE: This is a multicenter, open label study.

Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and at 1, 4, and 8 weeks for correlative laboratory studies. Blood samples are evaluated for the following tumor markers by ELISA: VEGF, bFGF, sFLT-1, sTIE-2, sE-Selectin, VCAM-1, PDGF-AA, PDGF-AB and PDGF-BB. TSP-1 in plasma is measured by Accucyte™ competitive immunoassay.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: pazopanib hydrochloride intervention 2: pharmacological study intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00520481
Conditions: Adenocarcinoma of the Prostate
Keywords: prostate cancer
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2013-08-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment.

Detailed description:
Thirty-one chemotherapy-naїve participants with asymptomatic metastatic androgen-independent prostate cancer will be enrolled and treated with intravenous (i.v.) IMC-A12 (Cixutumumab) at 10 milligrams per kilogram (mg/kg) administered over 1 hour every 2 weeks. An additional 10 participants will be enrolled and treated with IMC-A12 at a dose of 20 mg/kg every three weeks. Treatment will continue until evidence of disease progression or intolerable toxicity. Radiographic evaluation of response will be performed every 8 weeks for the participants treated with i.v. IMC-A12 at 20 mg/kg.

Arms: arm 1: Thirty-one participants will receive IMC-A12 at 10 milligrams per kilogram (mg/kg) administered over 1 hour every other week (every 14 days). An additional 10 participants will receive IMC-A12 at a dose of 20 mg/kg every three weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Radiographic evaluation of response will be performed every 8 weeks for the participants treated with intravenous (i.v.) IMC-A12 at 10 mg/kg and every 9 weeks for the participants treated with i.v. IMC-A12 at 20 mg/kg.
Interventions: intervention 1: IMC-A12 (Cixutumumab)
Intervention descriptions: intervention 1: 10 mg/kg i.v. infusion over 1 hour every 2 weeks or 20 mg/kg i.v. infusion over 1 hour every 3 weeks.

Protocol documents:
Clinical trial NCT00623012
Conditions: Graft Versus Host Disease
Sponsor: Yale University
Start date: 2008-02-01; Completion date: 2013-08-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant.

Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Rapamycin intervention 2: Tacrolimus
Intervention descriptions: intervention 1: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week. intervention 2: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks.

Protocol documents:
Clinical trial NCT00662129
Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-11-01; Completion date: 2013-08-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab.

Secondary

* To determine the overall survival of patients treated with this regimen.
* To determine the progression-free survival of patients treated with this regimen.
* To determine the confirmed response rate in patients treated with this regimen.
* To determine the duration of response in patients treated with this regimen.
* To determine the time to treatment failure in patients treated with this regimen.
* To determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.

Arms: arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.
Interventions: intervention 1: bevacizumab intervention 2: gemcitabine hydrochloride intervention 3: paclitaxel albumin-stabilized nanoparticle formulation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00674154
Conditions: Vitamin D Deficiency Primary Hyperparathyroidism Hypercalcemia
Keywords: Vitamin D Primary hyperparathyroidism hypercalcemia
Sponsor: University of Aarhus
Start date: 2008-05-01; Completion date: 2013-08-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

Detailed description:
The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Arms: arm 1: Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks arm 2: Placebo, two tablets daily in 52 weeks.
Interventions: intervention 1: Cholecalciferol
Intervention descriptions: intervention 1: 2800 IE daily in 52 weeks

Protocol documents:
Clinical trial NCT00705939
Conditions: Gaucher Disease
Keywords: Gaucher Disease Enzyme replacement therapy
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2013-08-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is an extension trial to Study NCT00376168 and NCT00712348.

Detailed description:
This will be a multi-center, double-blind, parallel group, extension trial to assess the safety and efficacy of prGCD in patients completing NCT00376168. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the extension study will be fifteen months. There will be two treatment groups: 30 units/kg every 2 weeks or 60 units/kg every 2 weeks.

Arms: arm 1: Continue taliglucerase alfa treatment from PB-06-001 (NCT00376168) arm 2: Continue taliglucerase alfa treatment from PB-06-001 (NCT00376168) arm 3: Continue taliglucerase alfa treatment from PB-06-002 (NCT00712348)
Interventions: intervention 1: Taliglucerase alfa
Intervention descriptions: intervention 1: Intravenous infusion every 2 weeks

Protocol documents:
Clinical trial NCT00755716
Conditions: Tobacco Dependence
Keywords: nicotine patch smoking topiramate
Sponsor: UConn Health
Start date: 2006-04-01; Completion date: 2013-08-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Specific aims:

1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of treatment with topiramate or placebo or topiramate plus nicotine patch for smoking cessation.
2. To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking satisfaction, and adverse effects during smoking cessation.
3. To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.

Detailed description:
This is a 10-week, randomized, double-blind, single-site study of treatment with either: topiramate, or placebo, or topiramate plus nicotine patch. Approximately, 90 subjects ages 18-65 who smoke at least 10 cigarettes per day will be screened for study participation, with the intention of 60 subjects being eligible for randomized treatment (20 per arm).

Arms: arm 1: Person receives an inactive placebo arm 2: Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day for a total time of 10 weeks. arm 3: Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Interventions: intervention 1: Placebo (sugar pill) intervention 2: Topiramate intervention 3: Nicotine patch
Intervention descriptions: intervention 1: patients receive intervention 2: 25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper intervention 3: On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.

Protocol documents:
Clinical trial NCT00805467
Conditions: Rheumatoid Arthritis
Keywords: RA
Sponsor: AstraZeneca
Start date: 2008-08-01; Completion date: 2013-08-01
Enrollment: 624 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

Detailed description:

Arms: arm 1: R935788 50 mg tablet, orally, twice-a-day arm 2: R935788 100 mg tablet, orally, twice-a-day arm 3: R935788 100 mg tablet, orally, once-a-day arm 4: R935788 150 mg tablet, orally, once-a-day
Interventions: intervention 1: Fostamatinib Disodium (R935788)
Intervention descriptions: intervention 1: 50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD

Protocol documents: