ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00484874
Conditions: Hodgkin's Disease
Keywords: Hodgkin's lymphoma Radioimmunotherapy Bexxar I-131 Tositumomab Safety Efficacy Nuclear Medicine Monoclonal antibody Radiolabeled
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2007-06-01; Completion date: 2015-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.

Detailed description:
One third of patients with Hodgkin's lymphoma (HL) do not respond to or have their disease come back after their first therapy. These patients often then receive high-dose chemotherapy and blood or marrow transplant. Despite high response rates after transplant, a significant number, 26-65%, of these patients have their disease come back again. After transplant, therapy options are limited and alternative therapies for patients with HL who have relapsed post-transplant or who are ineligible for transplant are needed. Based on recent studies about how HL develops and good results of patient studies evaluating the use of the unlabeled anti-CD20 antibody Rituximab in HL, we think that radioimmunotherapy (RIT) with I-131 Tositumomab(Bexxar®) will be an effective alternative therapy in patients with relapsed/refractory HL who are post or ineligible for transplant.

The rationale for the use of RIT in cancer is that radiolabeled monoclonal antibodies will specifically target and irradiate tumor cells but not normal tissues. The specific tumor targeting of RIT theoretically allows higher doses of radiation to be delivered to tumor as compared to external beam radiation because the effects of the radiation on normal tissues is less with RIT. Iodine-131 Tositumomab (Bexxar®) was approved by the FDA for another type of lymphoma in 2003. The antibody (Tositumomab) recognizes and attaches to a protein on lymphoma cells and can kill these cells. The radioisotope (I-131) can help the antibody kill cells better.

Iodine-131 Tositumomab (Bexxar®) is given through a vein in the arm. Iodine-131 Tositumomab (Bexxar®) is given in an outpatient setting.

Arms: arm 1: I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
Interventions: intervention 1: I-131 Tositumomab therapeutic regimen
Intervention descriptions: intervention 1: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.

Protocol documents:
Clinical trial NCT00623935
Conditions: Acute Myelogenous Leukemia
Keywords: AML
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-03-01; Completion date: 2015-11-01
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates \< 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals \> 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.

Detailed description:

Arms: arm 1: Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2). arm 2: Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
Interventions: intervention 1: Fludarabine intervention 2: Busulfan intervention 3: Total Body Irradiation intervention 4: Stem Cell Transplant
Intervention descriptions: intervention 1: Fludarabine (40 mg/m2/day x 4 days) intervention 2: Busulfan (3.2 mg/m2/day x 2 days or x 4 days). intervention 3: Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant. intervention 4: Allogeneic stem cell transplant from related or unrelated donor

Protocol documents:
Clinical trial NCT00634179
Conditions: Lymphoma, B-Cell Follicular Lymphoma
Keywords: Lymphoma
Sponsor: Emory University
Start date: 2008-02-01; Completion date: 2015-11-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).

Detailed description:
This study will assess whether adding bortezomib (Velcade) to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment.

Patients who are eligible to take part in the study will receive VR-CHOP at the doses of Velcade and vincristine established in phase 1. Patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects. All patients will go on to receive maintenance therapy after completion of their initial treatment as designed by the protocol.

Arms: arm 1: INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.

MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bortezomib intervention 2: Rituximab intervention 3: Doxorubicin intervention 4: Cyclophosphamide intervention 5: Vincristine intervention 6: Prednisone
Intervention descriptions: intervention 1: Bortezomib 1.6 mg/m² given on days 1 and 8 intervention 2: Rituximab 375 mg/m² intervention 3: Doxorubicin 50 mg/m² intervention 4: Cyclophosphamide 750 mg/m² intervention 5: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1 intervention 6: Prednisone 100 mg/day given orally on days 1-5

Protocol documents:
Clinical trial NCT00722865
Conditions: Hodgkin Lymphoma
Keywords: Avastin bevacizumab ABVD angiogenesis antiangiogenic Hodgkin
Sponsor: Massachusetts General Hospital
Start date: 2008-09-01; Completion date: 2015-11-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the effectiveness and safety of Avastin when combined with standard chemotherapy for Hodgkin lymphoma. Avastin works differently than standard chemotherapy drugs. It is a type of protein called an antibody which binds to a substance called VEGF(Vascular Endothelial Growth Factor). VEGF stimulates the growth of the blood vessels that feed tumors and encourages tumor cell growth. VEGF is produced in excess by Hodgkin lymphoma cells, and is associated with a poorer outcome in patients with Hodgkin lymphoma. When the activity of VEGF is interrupted in multiple other cancer types, the blood vessels around the tumor cells die resulting in less nutrient delivery and death to the tumor. Blocking of VEGF has also been shown to improve delivery of chemotherapy to cancer cells, making standard chemotherapy work better. This trial uses Avastin in combination with standard chemotherapy with the goal of improving the cure rate over chemotherapy alone.

Detailed description:
Participants will be given Avastin as well as ABVD (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) intravenously on days 1 and 15 of a 28 day cycle. Participants will receive up to a total of 6 cycles of therapy.

Arms: arm 1: single-arm, open-label
Interventions: intervention 1: Avastin
Intervention descriptions: intervention 1: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles.

Protocol documents:
Clinical trial NCT00790400
Conditions: Tuberous Sclerosis Complex (TSC) Lymphangioleiomyomatosis (LAM)
Keywords: Angiomyolipoma AML Tuberous Sclerosis Complex TSC mTOR RAD001 Mammalian Target of Rapamycin Everolimus Afinitor SEGA Subependymal Giant Cell Astrocytoma Seizures Tuberous sclerosis complex (TSC) Tuberous sclerosis benign tumors of brain kidney heart eyes lungs skinTSC1 TSC2 hamaratin tuberin, tumor growth suppressors gyri tubers Sporadic Lymphangioleiomyomatosis. Lymphangioleiomyomatosis (LAM) rare lung disease
Sponsor: Novartis Pharmaceuticals
Start date: 2009-04-01; Completion date: 2015-11-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.

Detailed description:

Arms: arm 1: Study drug was given by continuous oral daily dosing of two 5 mg tablets. arm 2: Placebo was given by continuous oral daily dosing of two 5 mg tablets.
Interventions: intervention 1: Everolimus (RAD001) intervention 2: Everolimus Placebo
Intervention descriptions: intervention 1: Everolimus is used in 5 mg strength tablets, blister-packed under aluminum foil in units of ten tablets and dosed on a daily basis. 10mg daily dosing throughout the trial. intervention 2: Matching placebo was provided as a matching tablet and was also blister-packed under aluminum foil in units of ten.

Protocol documents:
Clinical trial NCT00934440
Conditions: Renal Cell Carcinoma
Keywords: kidney cancer renal cell
Sponsor: University of Kansas Medical Center
Start date: 2009-06-01; Completion date: 2015-11-01
Enrollment: 11 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab.

Detailed description:
In this study, the investigator will assess progression-free and overall survival of patients with advanced renal cell carcinoma treated with 5-azacitidine in combination with bevacizumab. Patients will continue on treatment until either disease progression or development of other criteria for withdrawal.

Arms: arm 1: A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.
Interventions: intervention 1: Bevacizumab intervention 2: Azacitidine
Intervention descriptions: intervention 1: * First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes.
* Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes.
* Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles). intervention 2: * Dose level 1: 35 mg/m2/day for 7 days.
* Dose level 2: 55 mg/m2/day for 7 days.
* Dose level 3: 75 mg/m2/day for 7 days.

  * mg/m2/day = dose based on height and weight

Protocol documents:
Clinical trial NCT01052480
Conditions: Influenza A Influenza B
Keywords: Antiviral Anti-Influenza Immune Plasma Emerging Infectious Disease Swine Flu
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2010-12-01; Completion date: 2015-11-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.

Detailed description:
Morbidity and mortality occur despite treatment with current antivirals. Circulating influenza H1N1 and H3N2 isolates are highly resistant to amantadine and rimantadine, whereas previous seasonal H1N1 isolates were highly resistant to oseltamivir. So there is concern that circulating influenza A/H1N1 2009 virus may also acquire oseltamivir resistance.

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza. Hospitalized subjects with influenza at risk for severe disease (as defined in the inclusion criteria) will be eligible for study participation. This study will enroll adults, children and pregnant women.

Up to 40 sites in the United States will participate in this protocol. One hundred eligible subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric equivalent) of anti-influenza immune plasma on Study Day 0 in addition to standard care or standard care alone (50 subjects receiving standard care alone; 50 subjects receiving anti-influenza immune plasma and standard care).

Subjects will be assessed on Study Day 0 (pre-dose), 30 minutes post-dose (plasma arm only), and on Study Days 1, 2, 4, 7, 14, and 28. All subjects will undergo a series of efficacy, safety, and PK (HAI) assessments during the study. Blood samples will be collected at each time point (except Day 1). Nasal and oropharyngeal swabs for influenza PCR will be obtained on Days 0,1,2,4 and 7.

Arms: arm 1: Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies (Anti-Influenza Immune Plasma) in addition to standard care. arm 2: Participants will receive standard care.
Interventions: intervention 1: Anti-Influenza Immune Plasma intervention 2: Standard Care
Intervention descriptions: intervention 1: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline intervention 2: All subjects will receive an anti-influenza antiviral (e.g., oseltamivir or zanamivir), but may include treatment with licensed antivirals in patient populations or at doses not covered in the package insert, or with medications available under a EUA. Standard care may also include antibiotics and other medications.

Protocol documents:
Clinical trial NCT01198132
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing-Remitting Relapsing Multiple Sclerosis (RMS) Rebif Vitamin D3 Cholecalciferol
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-11-01; Completion date: 2015-11-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this multicentre, randomised, double-blind, placebo-controlled study is to evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.) interferon beta-1a 44 microgram (mcg) \[Rebif\] 3 times weekly. The subjects will be divided into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the other group will be on placebo along with Rebif treatment. A total of 200 subjects will be recruited in 20-30 centres in France.

Detailed description:

Arms: arm 1: Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 3 times a week. arm 2: Subjects receive matching placebo to Cholecalciferol once every two weeks along with subcutaneous injection of Rebif 3 times weekly.
Interventions: intervention 1: Cholecalciferol (Vitamin D3) intervention 2: Placebo intervention 3: Rebif
Intervention descriptions: intervention 1: Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week. intervention 2: Subjects receive matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly. intervention 3: Subjects receive subcutaneous injection of Rebif 44 mcg 3 times weekly.

Protocol documents:
Clinical trial NCT01257802
Conditions: Lupus Erythematosus, Systemic Systemic Vasculitis Isolated Angiitis of Central Nervous System Lung Disease With Systemic Sclerosis Lung Disease Interstitial Diffuse
Sponsor: Joseph Mccune
Start date: 2011-05-01; Completion date: 2015-11-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.

Detailed description:
Patients will be women ages 18-40 with either a severe rheumatic disease requiring cyclophosphamide or interstitial lung disease requiring cyclophosphamide to be administered either daily orally; monthly intravenously; or intravenously every 2 weeks for 6 doses. Because cyclophosphamide treatment may be required urgently for some indications, study entry may occur before either the first or second dose of cyclophosphamide for patients receiving cyclophosphamide intravenously.

Of 16 participants who were screened, only 14 were randomized and only 7 participants actually completed the study. Due to this low number, follicle stimulating hormone (FSH) levels were not obtained.

Secondary outcome measures that are not available include presence of menses and FSH.

Arms: arm 1: Monthly depot leuprolide acetate 3.75 mg injection during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses arm 2: Monthly placebo injection during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses.
Interventions: intervention 1: depot leuprolide acetate 3.75 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses intervention 2: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses

Protocol documents:
Clinical trial NCT01267422
Conditions: Leber Hereditary Optic Neuropathy
Keywords: Leber's Hereditary Optic Neuropathy,11778 LHON mutation, rAAV2-ND4,triamcinolone acetonide
Sponsor: Bin Li
Start date: 2011-04-01; Completion date: 2015-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber hereditary optic neuropathy with 11778 LHON mutation.

Detailed description:
Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production.

Material and Method Seven patients with 11778 LHON mutation were randomly treated with a Single IVT Injection of recombinant Adeno-Associated Virus-NADH dehydrogenase, subunit 4 (complex I)（rAAV2-ND4)（0.05ml).The dose was 5 × 10\^9 vg/0.05 mL for patients younger than 12 years old, and 1 × 10\^10 vg/0.05 mL for patients older than 12 years old. The visual acuity, visual evoked potential （VEP）,optical coherence tomography（ OCT）, computerized visual field, electroretinograms(ERG), retinal nerve fiber layer(RNFL)and Liver and kidney function in plasma were compared before and after treatment at 1,3,and 6, months interval.

Arms: arm 1: injection
Interventions: intervention 1: rAAV2-ND4
Intervention descriptions: intervention 1: injection

Protocol documents: