ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00193492
Conditions: Lymphoma, Follicular
Keywords: Lymphoma Bevacizumab Rituximab
Sponsor: SCRI Development Innovations, LLC
Start date: 2005-09-01; Completion date: 2013-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.

Detailed description:
Upon determination of eligibility, patients will randomly be assigned to one of two treatment arms:

* Rituximab
* Rituximab + bevacizumab

For every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1 patient will receive treatment number 2 (rituximab + bevacizumab). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Arms: arm 1: All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9. arm 2: All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
Interventions: intervention 1: Bevacizumab intervention 2: Rituximab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00211887
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Clinical trial treatment trial autoimmune disease Relapsing Remitting MS Treatment interferon beta-1a glatiramer acetate
Sponsor: Fred Lublin
Start date: 2005-01-01; Completion date: 2013-03-01
Enrollment: 1008 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS).

Detailed description:
This is a multicenter, double blind, randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized. All patients will remain on therapy until the last patient completes the study. All patients will then be transitioned, based on the findings, to open label of combination with continued follow-up or some recommendation about single agent therapy. While the study design benefits from having two arms of single agent therapy to examine the important question of whether there are differences between the single agents, the primary interest is in combination therapy. Therefore, a two-group combination versus single agent concept was used - splitting the population into single agent and combination therapy equally. The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN intramuscularly (IM) and GA subcutaneously (SC) (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients).

Arms: arm 1: Active Interferon B1a Weekly vs. Placebo Glatiramer Acetate

Interferon b-1a (IFN) intramuscularly weekly arm 2: Placebo Interferon B1a Weekly vs. Active Glatiramer Acetate

Glatiramer acetate 20mg daily arm 3: Active Interferon B1a Weekly and Active Glatiramer Acetate
Interventions: intervention 1: Interferon beta 1-a intervention 2: glatiramer acetate intervention 3: placebo
Intervention descriptions: intervention 1: The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients). intervention 2: The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN IM and GA SC (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients). intervention 3: an inactive substance

Protocol documents:
Clinical trial NCT00290654
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ breast cancer in situ
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2002-12-01; Completion date: 2013-03-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

Detailed description:
OBJECTIVES:

Primary

* Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite\^® Radiation Therapy System.

Secondary

* Determine the early and late complication rates and cosmetic outcome in these patients after treatment.

OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins\* (no ink on tumor) undergo placement of the MammoSite\^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery.

NOTE: \*If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met.

Beginning 2-5 days after placement of the MammoSite\^®, patients undergo brachytherapy through the MammoSite\^® twice daily for 5 days (a total of 10 fractions).

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

Arms: arm 1: Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
Interventions: intervention 1: Tamoxifen intervention 2: Lumpectomy intervention 3: brachytherapy
Intervention descriptions: intervention 1: Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient intervention 2: A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS. intervention 3: Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.

Protocol documents:
Clinical trial NCT00332839
Conditions: Renal Transplantation
Keywords: enteric-coated mycophenolate sodium, everolimus, CNI-free regimen
Sponsor: Novartis Pharmaceuticals
Start date: 2005-11-01; Completion date: 2013-03-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.

Detailed description:

Arms: arm 1: Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids. arm 2: Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
Interventions: intervention 1: Everolimus intervention 2: Cyclosporin A (CsA) intervention 3: Tacrolimus intervention 4: Enteric Coated - Mycophenolate Sodium (EC-MPS) intervention 5: Corticosteroids
Intervention descriptions: intervention 1: Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). intervention 2: The dose was based on the participants' blood level of C0h (80-150 ng/ml). intervention 3: The dose was based on the participants' blood level of C0h (5-10 ng/ml). intervention 4: The dose was ≥ 720 mg/day. intervention 5: Corticosteroids were given according to local standard and/or the Investigators' discretion.

Protocol documents:
Clinical trial NCT00347438
Conditions: Breast Cancer
Keywords: breast cancer neoadjuvant locally advanced
Sponsor: University of Chicago
Start date: 2006-09-01; Completion date: 2013-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery.

The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.

Detailed description:

Arms: arm 1: Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
Interventions: intervention 1: Capecitabine
Intervention descriptions: intervention 1: Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).

Protocol documents:
Clinical trial NCT00355199
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: DLBCL R-HDS R-CHOP14
Sponsor: Gruppo Italiano Terapie Innovative nei Linfomi
Start date: 2005-05-01; Completion date: 2013-03-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk patients with DLBCL Non-Hodgkin's lymphomas.

Detailed description:
Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic survival curve with patients in complete remission (which can be considered cured) and patients that relapse. This last group of subjects have only 25%-33% chance of long free disease survival if treated with a second line therapy with high dose chemotherapy plus autologous transplant of PBPC.

Therefore in order to achieve an improvement of the overall survival in patient with DLBCL, it is necessary to increase the number of complete remission after first line therapy.

The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis.

Arms: arm 1: R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting. arm 2: Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).
Interventions: intervention 1: Rituximab-HDS intervention 2: Rituximab-CHOP
Intervention descriptions: intervention 1: Rituximab-HDS intervention 2: Rituximab-CHOP

Protocol documents:
Clinical trial NCT00361374
Conditions: Major Depressive Disorder
Keywords: Depression Omega-3 Boston
Sponsor: Massachusetts General Hospital
Start date: 2006-07-01; Completion date: 2013-03-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines the difference in the effectiveness of two natural compounds, eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the development of major depression.

Detailed description:
The study lasts for eight weeks and involves four visits after the screen and baseline visits (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will take a placebo. This study is double-blind, which means that neither the participant, nor the doctor, nor the research staff will know which group each person is in. At the end of the study the participant will be offered three months of follow-up care at the Depression Clinical and Research Program.

Arms: arm 1: Eicosapentaenoic acid (EPA) Omega-3, 1g/day arm 2: Docosahexaenoic acid (DHA) Omega-3, 1g/day arm 3: Placebo capsule (980mg soybean oil)
Interventions: intervention 1: eicosapentaenoic acid intervention 2: docosahexaenoic acid intervention 3: Placebo
Intervention descriptions: intervention 1: 1 gram/day intervention 2: 1 gram/day intervention 3: 980 milligram/day

Protocol documents:
Clinical trial NCT00422383
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2013-03-01
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: rituximab [MabThera/Rituxan] intervention 3: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 500mg iv in days 1 and 15, and 500mg iv on days 168 and 182 intervention 2: 500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182 intervention 3: 1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182

Protocol documents:
Clinical trial NCT00422422
Conditions: Epilepsy
Keywords: Brivaracetam Epilepsy Child Pharmacokinetics Adolescents
Sponsor: UCB Pharma
Start date: 2011-07-01; Completion date: 2013-03-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Brivaracetam
Intervention descriptions: intervention 1: Oral solution

Evaluation period (3 weeks up-titration):

For subjects ≥8 years:

* \~0.4 mg/kg bid for Week 1
* \~0.8 mg/kg bid for Week 2
* \~1.6 mg/kg bid for Week 3

For subjects \<8 years:

* \~0.5 mg/kg bid for Week 1
* \~1.0 mg/kg bid for Week 2
* \~2.0 mg/kg bid for Week 3

Down-titration period (up to 2 weeks):

For subjects ≥8 years:

* \~0.8 mg/kg bid for Week 4
* \~0.4 mg/kg bid for Week 5

For subjects \<8 years:

* \~1.0 mg/kg bid for Week 4
* \~0.5 mg/kg bid for Week 5

Protocol documents:
Clinical trial NCT00438854
Conditions: Chronic Lymphocytic Leukemia
Keywords: dasatinib BMS-354825 CLL SLL LYN kinase
Sponsor: Massachusetts General Hospital
Start date: 2006-12-01; Completion date: 2013-03-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.

Detailed description:
* After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures.
* Dasatinib is given orally once daily. Each participant will have a pill diary to record doses and any missed doses. All necessary drug refills will be given during clinic appointments, at which time the pill diary and any unused study drug will be returned.
* During the first month of study treatment the participant will come to the clinic at the following intervals: Day 1: An EKG will be performed two hours after the first dose of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4: A physical examination, EKG and blood samples will be drawn once a week.
* Beginning with the second month of study treatment, participants will come to the clinic monthly for up to two years. The following tests and procedures will be done; physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG (monthly for 6 months, then when medically indicated), CT of the neck, chest and abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2, additional blood will be drawn for research testing.
* Participants can continue to take the study drug for up to two years as long as their disease does not progress and they are not experiencing any serious side effects.

Arms: arm 1: All patients were treated with dasatinib pills by mouth as treatment.
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.

Protocol documents:
Clinical trial NCT00484939
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-07-01; Completion date: 2013-03-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.

No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.

Detailed description:

Arms: arm 1: Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle. arm 2: Participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Interventions: intervention 1: Bevacizumab intervention 2: Capecitabine
Intervention descriptions: intervention 1: Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials. intervention 2: Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.

Protocol documents:
Clinical trial NCT00485953
Conditions: Bone Loss Osteoporosis Breast Cancer
Keywords: Osteoporosis breast cancer aromatase inhibitors bone loss bone mineral density
Sponsor: Susan L. Greenspan
Start date: 2007-09-01; Completion date: 2013-03-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1) prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease bone turnover.

Detailed description:
This double-blind, placebo-controlled, randomized clinical trial will test the hypothesis that risedronate 35 mg once weekly, a potent antiresorptive agent, will prevent bone loss or improve bone mass and decrease bone turnover in elderly, osteopenic, postmenopausal women (ages 55 and older) with breast cancer on aromatase inhibitor therapy. 110 subjects will be randomized to receive either oral risedronate 35 mg once weekly or placebo for two years. Our primary outcome variable will be change in PA spine bone mineral density (BMD). Secondary endpoints will be BMD at the total hip, femoral neck, trochanter, lateral spine, forearm, and total body, and markers of bone turnover. We will also assess if the improvements in BMD are greater at sites of trabecular bone (spine) versus cortical bone (wrist). BMD will be measured at six month intervals. Biochemical markers of bone turnover will be measured at baseline, 6 months, 12 months, and 24 months.

Arms: arm 1: risedronate 35 mg weekly arm 2: Placebo
Interventions: intervention 1: risedronate
Intervention descriptions: intervention 1: risedronate 35 mg per week

Protocol documents: