ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01040871
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-01-01; Completion date: 2012-08-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Detailed description:

Arms: arm 1: VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles. arm 2: R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
Interventions: intervention 1: VELCADE intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Doxorubicin intervention 5: Prednisone intervention 6: Vincristine
Intervention descriptions: intervention 1: VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles. intervention 2: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles intervention 3: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles intervention 4: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles intervention 5: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles intervention 6: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Protocol documents:
Clinical trial NCT01053221
Conditions: Kidney Transplantation
Keywords: mycophenolate living donor
Sponsor: University of Wisconsin, Madison
Start date: 2006-03-01; Completion date: 2012-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.

Detailed description:
The objective of the study is to safely move HLA-identical renal transplant recipients from 2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid monotherapy. Safety will be assessed by monitoring renal function in subjects in the withdrawal group compared to those who remain on the standard 2-drug immunosuppression protocol. Results of immunological monitors such as DTH regulation in response to donor minor antigens and development of anti-donor antibodies will be correlated with successful withdrawal.

Arms: arm 1: Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy arm 2: Subjects will continue with their current immunosuppressive regimen of MPA (mycophenolate mofetil or mycophenolate sodium) and calcineurin inhibitor (cyclosporine or tacrolimus)
Interventions: intervention 1: Mycophenolic Acid intervention 2: Standard of Care: CNI and MPA
Intervention descriptions: intervention 1: Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months intervention 2: Tacrolimus or cyclosporine: dosed according to trough levels per standard of care Mycophenolate mofetil 750mg po bid or mycophenolate sodium 540mg po bid x 36 months

Protocol documents:
Clinical trial NCT01055171
Conditions: Alcohol Dependence PTSD
Keywords: alcohol dependence PTSD propanolol craving beta-block cue exposure addiction memory trauma addictive behavior
Sponsor: Medical University of South Carolina
Start date: 2010-01-01; Completion date: 2012-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of propranolol versus placebo on craving, distress and cue reactivity to trauma and alcohol cues.

Detailed description:
Summary and Synthesis: Epidemiological studies have established the occurrence of high rates of AD in persons with PTSD. Likewise, studies of alcohol/drug abuse treatment seekers have documented high rates of trauma exposure and PTSD. The high prevalence of PTSD/AD comorbidity is the cause of enormous human suffering, most of which either goes untreated or is resistant to treatment efforts. Both theory and research concerning the interface between these two disorders suggests that PTSD is associated with the initiation of excessive alcohol use and/or the development of AD by way of an escape/avoidance behavioral mechanism wherein escalating alcohol use is reinforced by its ability to dampen the negative emotions and arousal associated with PTSD. If PTSD is often a primary cause of the initiation and maintenance of AD, then clinical interventions that primarily impact PTSD should lead to significant improvements in craving for, and use of, alcohol. The findings of two recent treatment studies offer especially compelling support for this expectation. Drawing on both basic neuroscience research and a developing body of suggestive clinical/applied research, we were led to consider if the putative memory modulating properties of the adrenergic antagonist propranolol might have therapeutic benefits for PTSD/AD comorbid individuals. Thus, the proposed study will test the hypothesis that the strategic administration of propranolol coupled with the elicitation/retrieval of trauma-related memories will dampen emotional distress, alcohol craving and cue reactivity during subsequent exposure to trauma- and alcohol-related cues. A two-week follow-up laboratory session and clinical assessment will permit us to evaluate whether treatment benefits are maintained over time and if there are any changes in alcohol use and PTSD symptomatology.

Arms: arm 1: Patients will receive Propranolol in this condition. arm 2: Patient to receive placebo in this condition.
Interventions: intervention 1: Propranolol intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg; Single Administration. intervention 2: 40 mg; Single Dose.

Protocol documents:
Clinical trial NCT01074307
Conditions: Heart Failure, Congestive
Keywords: Systolic heart failure Bisoprolol Concor Echocardiogram
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2009-10-01; Completion date: 2012-08-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, open-labeled, multi-centric trial to evaluate the effect of bisoprolol (between low dose and high dose) on surrogate markers of heart failure in Korea.

Detailed description:
Subjects with systolic congestive heart failure (CHF) will be enrolled in this study after proper evaluation of NT-proBNP, global assessment of CHF, 6-minute walking test and improvement score of New York Heart Association (NYHA) and echocardiogram (left ventricular chamber size and ejection fraction \[LVEF\]). Each subject will be orally administered bisoprolol for 6 months starting at 1.25 mg at the Week 0 and titrated up to 10 mg during the 6 month period if the persistent standing systolic blood pressure (SBP) is greater than (\>) 90 millimeter of mercury (mm Hg) and there is no symptom of hypotension at the current dose medication (syncope, loss of consciousness, dizziness when standing up).

OBJECTIVES

Primary objective:

• To evaluate the effect of bisoprolol (between low dose and high dose) on surrogate markers of heart failure in Korea

Secondary objectives:

* To evaluate bisoprolol for the effects on clinical improvement of heart failure in Korea:

  1. New York Heart Association (NYHA),
  2. 6-minutes walking test
  3. Echocardiogram (left ventricular chamber size and LVEF)
* Hospitalization due to heart failure
* To evaluate the safety and tolerability of bisoprolol
* Global assessment of CHF

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Low Dose Bisoprolol intervention 2: High Dose Bisoprolol
Intervention descriptions: intervention 1: Bisoprolol tablet (Concor) will be administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose will be further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks. intervention 2: Bisoprolol tablet (Concor) will be administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose will be subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.

Protocol documents:
Clinical trial NCT01075087
Conditions: Pain Obesity Surgery
Keywords: TAP Block Pain Obesity Surgery Laparoscopic Banding
Sponsor: Northwestern University
Start date: 2010-03-01; Completion date: 2012-08-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of preoperative TAP block in laparoscopic bariatric surgery can improve the postoperative pain and quality of recovery in patients undergoing these procedures.

Detailed description:

Arms: arm 1: (control group) will receive sterile normal saline in the block arm 2: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Interventions: intervention 1: Placebo intervention 2: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
Intervention descriptions: intervention 1: Bilateral TAP block using sterile normal saline. intervention 2: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.

Protocol documents:
Clinical trial NCT01100307
Conditions: Macular Edema Diabetic Mellitus Retinal Disease
Keywords: diabetic macular edema Macugen sham-controlled study
Sponsor: Pfizer
Start date: 2010-05-01; Completion date: 2012-08-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

Detailed description:
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pegaptanib sodium intervention 2: sham injection
Intervention descriptions: intervention 1: Intravitreal injection of 0.3 mg every 6 weeks intervention 2: sham injection every 6 weeks

Protocol documents:
Clinical trial NCT01129336
Conditions: First or Second Line HER2-negative Breast Cancer Metastatic Disease Without Bone Metastasis
Keywords: HER2-negative HER2 Metastatic breast cancer First Line breast cancer Second Line breast cancer Breast cancer Metastatic Stage IV breast cancer Progression free survival PFS Circulating Tumor Cells CTCs Zoledronic acid HER2-negative metastatic breast cancer patients without bone metastasis
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2012-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.

Detailed description:

Arms: arm 1: Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18. arm 2: Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
Interventions: intervention 1: Zoledronic acid intervention 2: Standard Therapy
Intervention descriptions: intervention 1: Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18. intervention 2: Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.

Protocol documents:
Clinical trial NCT01133665
Conditions: Squamous Cell Carcinoma
Keywords: Head and Neck, Squamous Cell Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy
Sponsor: University of Chicago
Start date: 2010-02-01; Completion date: 2012-08-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide.

Detailed description:
To study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide. There is evidence with cetuximab in CRC, trastuzumab in breast cancer and rituximab with follicular lymphoma, that FcRIIIa polymorphisms correlate with clinical response to antibody therapy and clinical outcome. It is our hypothesis that patients with SCCHN will have clinical outcomes to cetuximab and lenalidomide that correlate with patient FcRIIIa genotype.

Secondary:

To evaluate the safety and toxicity profile of the combination of cetuximab and lenalidomide given to treat subjects with SCCHN.

To study FcRIIIa polymorphisms and the correlation with the ability of NK cells to mediate ADCC against SCCHN. It is our hypothesis that NK cells from patients with advanced SCCHN can mediate ADCC against SCCHN cell lines in the presence of cetuximab and lenalidomide and that the efficiency of ADCC correlates with FcRIIIa polymorphisms.

To evaluate the ability of NK cells to induce ADCC expression of specific activation markers on the NK cell surface. It is our hypothesis that NK cells that induce ADCC will express specific activation markers that are predictive of efficiency of ADCC.

Arms: arm 1: All Subjects Enrolled in the Trial
Interventions: intervention 1: Cetuximab and Lenalidomide
Intervention descriptions: intervention 1: The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide

Protocol documents:
Clinical trial NCT01143259
Conditions: Ileus
Keywords: Ileus Post operative ileus
Sponsor: Intermountain Health Care, Inc.
Start date: 2010-05-01; Completion date: 2012-08-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.

Detailed description:
Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus).

The Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model.

This trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Alvimopam intervention 2: 300 mg Polyethylene
Intervention descriptions: intervention 1: The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days. intervention 2: The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.

Protocol documents:
Clinical trial NCT01158404
Conditions: Advanced Cancer
Keywords: Metastatic Cancer Solid Tumors
Sponsor: Eli Lilly and Company
Start date: 2010-07-01; Completion date: 2012-08-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in participants with advanced cancer. This study includes dose escalation and dose confirmation components.

Detailed description:

Arms: arm 1: Dose escalation phase: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Dose confirmation phase: 30 mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.
Interventions: intervention 1: LY900009 - Dose Escalation Phase (Part A) intervention 2: LY900009 - Dose Confirmation Phase (Part B)
Intervention descriptions: intervention 1: 2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met. intervention 2: 30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.

Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.

Protocol documents:
Clinical trial NCT01184014
Conditions: Hyperglycemia
Keywords: corticosteroid hyperglycemia hospital corticosteroid induced hyperglycemia in the hospital
Sponsor: HealthPartners Institute
Start date: 2010-08-01; Completion date: 2012-08-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.

Detailed description:
The overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. This study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (BG) \>180 mg/dL): 1) a study-specific steroid NPH dosing algorithm plus standard recommended care (Experimental group) vs. 2) the standard recommended care (Methodist Hospital Complete Insulin Orders (Control group).

Arms: arm 1: a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO). arm 2: the standard recommended care (Methodist Hospital Complete Insulin Orders)
Interventions: intervention 1: NPH insulin plus Complete Insulin Orders intervention 2: Complete Insulin Orders
Intervention descriptions: intervention 1: NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor. intervention 2: 3-part insulin which includes background, meal-time and correction factor

Protocol documents:
Clinical trial NCT01191190
Conditions: CLL
Keywords: Leukemia Chronic leukemia Chronic Lymphocytic Leukemia Relapsed Refractory
Sponsor: Januario Castro, M.D.
Start date: 2010-08-01; Completion date: 2012-08-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis.

Detailed description:
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint is to determine the complete response (CR) to therapy and the secondary endpoints will assess the safety and tolerability of the regimen, the impact of the treatment on progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab. Cycles 1-3 will be administered without scheduled interruption every 28 days for a total of 12 weeks of therapy. Patients will receive allopurinol for tumor-lysis prophylaxis and antimicrobial prophylaxis. Blood glucose levels will be monitored immediately after HDMP infusion by finger stick glucometry. Two months following completion of treatment a response assessment will occur per iwCLL guidelines. The treatment will be administered as outpatient, and each cycle will be four weeks in duration.

Arms: arm 1: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.

Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.

Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.
Interventions: intervention 1: Ofatumumab/HDMP
Intervention descriptions: intervention 1: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.

Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.

Each patient will receive a maximum of 3 cycles (one cycle is 28 days)

Protocol documents: