ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01011218
Conditions: Insomnia Fatigue
Sponsor: Stanford University
Start date: 2011-01-01; Completion date: 2016-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

Participants will be randomized into 4 groups:

* Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
* Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
* Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
* Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Detailed description:
The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.

Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.

Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.

Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Arms: arm 1: Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.

Armodafinil 150 mg/day by mouth. arm 2: Control behavioral intervention is a sleep hygiene handout completed by participant.

Armodafinil 150 mg/day by mouth. arm 3: Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.

No pharmaceutical intervention. arm 4: Control behavioral intervention is a sleep hygiene handout completed by participant.

No pharmaceutical intervention.
Interventions: intervention 1: BBT-I intervention 2: Control intervention 3: Armodafinil
Intervention descriptions: intervention 1: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone intervention 2: Control behavioral intervention is a sleep hygiene handout completed by participant. intervention 3: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.

Protocol documents:
Clinical trial NCT01029730
Conditions: Lymphoma
Keywords: Low grade lymphoma Previously untreated lymphoma Lymphoma first line bendamustine Treanda bortezomib Velcade rituximab Rituxan
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-03-01; Completion date: 2016-07-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.

Detailed description:

Arms: arm 1: Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Interventions: intervention 1: Bendamustine intervention 2: Bortezomib intervention 3: Rituximab
Intervention descriptions: intervention 1: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles intervention 2: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles intervention 3: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1

Protocol documents:
Clinical trial NCT01067144
Conditions: Pain Breast Cancer Lung Cancer
Sponsor: Stanford University
Start date: 2010-05-01; Completion date: 2016-07-01
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine whether administering Gabapentin prior to surgery affects duration of pain and opioid use post-surgery. The investigators aim to compare gabapentin to placebo in a prospective, randomized clinical trial in which patients will be followed post-surgery until pain resolves and opioid use ceases.

Detailed description:
Gabapentin was originally developed as an anti-convulsant, but was quickly recognized as a medication with significant analgesic activity in patients with neuropathic pain. More recently it has begun to be appreciated that it may have some benefits in the peri-operative period. Pre-operative Gabapentin reduces preoperative anxiety, early post-operative pain severity, post-operative opioid use and post-operative delirium (presumably through reduced opioid consumption). These same attributes are shared by medications such as NSAIDS and tylenol and the use of peri-operative gabapentin has not permeated the standard of care. Early post-operative pain severity and preoperative anxiety have been implicated in our own research as risk factors for prolonged time to pain resolution and prolonged time to opioid cessation. Since these endpoints are generally synonymous with time to recovery, interventions reducing these times would be seen not just to increase comfort but to actually speed recovery.

Arms: arm 1: Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively arm 2: 1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.
Interventions: intervention 1: Gabapentin intervention 2: Lorazepam (active control) intervention 3: Placebo (inactive)
Intervention descriptions: intervention 1: 1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period. intervention 2: 0.5 mg Lorazepam (active control) given pre-operatively in a single dose. intervention 3: 2 capsules of inactive placebo given 3-times a day post-operatively for the 72-hour post-surgical period.

Protocol documents:
Clinical trial NCT01102374
Conditions: Respiratory Infection
Keywords: Vitamin D Deficiency Respiratory Infection Nursing Home Residents Geriatrics Immunosenescence Prevention
Sponsor: University of Colorado, Denver
Start date: 2010-05-01; Completion date: 2016-07-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.

Detailed description:
This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.

Arms: arm 1: 100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day. arm 2: 12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Interventions: intervention 1: High Dose Vitamin D intervention 2: Standard Dose Vitamin D intervention 3: Placebo intervention 4: Usual Care
Intervention descriptions: intervention 1: Vitamin D3 100,000 IU monthly intervention 2: Vitamin D 12,000 IU monthly intervention 3: Placebo monthly intervention 4: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Protocol documents:
Clinical trial NCT01111825
Conditions: Breast Cancer
Keywords: HKI-272 (NERATINIB) TEMSIROLIMUS (CCI-779) HER2-Amplified Triple-negative invasive adenocarcinoma 10-005 Nerlynx PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2010-04-01; Completion date: 2016-07-01
Enrollment: 99 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease.

Detailed description:
Phase I Design A standard, 3+3, dose escalation schedule to determine the MTD of temsirolimus in combination with neratinib with no intrapatient dose escalation and a starting dose of temsirolimus 8 mg administered intravenously (IV) weekly (dose level 1) and three patients enrolled in each cohort.

Phase II Design The phase II portion of this trial is comprised of three cohorts. Two of the cohorts utilized a Simon two-stage design to determine the sample size to assess the efficacy of temsirolimus when administered in combination with neratinib: HER2-amplified and triple negative breast cancer. The third cohort was a single stage design with HER2-amplified patients and dose escalation.

Arms: arm 1: This is an open-label, single arm, dose-escalation phase I-II study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma. Patients with trastuzumab-refractory HER2-amplified disease or triple negative disease will be enrolled in both phases of this clinical trial.
Interventions: intervention 1: Temsirolimus intervention 2: Neratinib
Intervention descriptions: intervention 1: 28 day treatment cycle Phase 1

* Weekly intravenously (IV) on days 1, 8, 15, and 22
* Starting dose 8 mg IV weekly (dose level 1). Three patients initially enrolled in each cohort

Phase 2

* Dose escalation cohort - 8 mg IV weekly on Days 1, 8, 15, and 22, and then 15 mg IV weekly starting on Day 29
* HER2-amplified and Triple negative - 8 mg IV weekly on Days 1, 8, 15, and 22 intervention 2: 28 day treatment cycle

• 240 mg orally daily

Protocol documents:
Clinical trial NCT01133158
Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular non-Hodgkin's lymphoma relapse refractory
Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Start date: 2009-07-01; Completion date: 2016-07-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.

Detailed description:
Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.

Arms: arm 1: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years
Interventions: intervention 1: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Intervention descriptions: intervention 1: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Protocol documents:
Clinical trial NCT01136772
Conditions: Schizophrenia Schizoaffective Disorder
Sponsor: New York State Psychiatric Institute
Start date: 2011-03-01; Completion date: 2016-07-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

Detailed description:
The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule.

This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.

Arms: arm 1: Intramuscular injections of paliperidone palmitate 39-234 mg every month arm 2: Intramuscular injections of haloperidol decanoate 25-200 mg every month
Interventions: intervention 1: haloperidol decanoate intervention 2: paliperidone palmitate
Intervention descriptions: intervention 1: haloperidol decanoate injections, 25-200 mg once a month intervention 2: Paliperidone palmitate injections, 39 mg - 234 mg once a month

Protocol documents:
Clinical trial NCT01231399
Conditions: Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Esophageal Cancer Recurrent Gastric Cancer Stage IV Esophageal Cancer Stage IV Gastric Cancer
Sponsor: City of Hope Medical Center
Start date: 2012-02-01; Completion date: 2016-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with combination chemotherapy in treating patients with metastatic stomach or esophageal cancer that has spread to other places in the body.

Detailed description:
OBJECTIVES:

I. To determine the maximum tolerated dose of everolimus to use in combination with mFOLFOX6 \[oxaliplatin, leucovorin (leucovorin calcium), 5-FU (fluorouracil)\].

II. To better describe the toxicities associated with the combination of everolimus with mFOLFOX6.

III. To assess response rate and progression-free survival in this patient population.

IV. To assess overall survival in patients with metastatic gastric, esophageal and gastroesophageal junction (GEJ) adenocarcinoma treated with the combination of mFOLFOX6 + everolimus.

OUTLINE: This is a dose-escalation study of everolimus. Patients receive fluorouracil intravenously (IV) continuously over 46 hours, leucovorin calcium IV over 2 hours, and oxaliplatin IV over 2 hours on day 1. Patients also receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 1 year.

Arms: arm 1: Patients receive fluorouracil IV continuously over 46 hours, leucovorin calcium IV over 2 hours, and oxaliplatin IV over 2 hours on day 1. Patients also receive oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: fluorouracil intervention 2: leucovorin calcium intervention 3: oxaliplatin intervention 4: everolimus intervention 5: laboratory biomarker analysis intervention 6: immunohistochemistry staining method intervention 7: microarray analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given orally intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies

Protocol documents:
Clinical trial NCT01341457
Conditions: Solid Tumors
Sponsor: Eli Lilly and Company
Start date: 2011-05-01; Completion date: 2016-07-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of LY2603618 in combination with the standard dose of gemcitabine up to the global recommended dose of LY2603618 in Japanese participants with solid advanced or metastatic tumors.

Detailed description:

Arms: arm 1: Gemcitabine 1000 milligrams per meter squared (mg/m\^2) administered intravenously on days 1, 8 and 15 of at least one 28-day cycle. 170 or 230 mg LY2603618 administered intravenously on days 2, 9 and 16 of at least one 28-day cycle.

Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
Interventions: intervention 1: LY2603618 intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously

Protocol documents:
Clinical trial NCT01438411
Conditions: Bile Acid Synthesis Defect
Keywords: Cholic Acid Inborn Error Bile Acid Metabolism Inborn Error of Bile Acid Synthesis
Sponsor: Mirum Pharmaceuticals, Inc.
Start date: 2010-01-01; Completion date: 2016-07-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic acid in subjects with identified inborn errors of bile acid synthesis.

Detailed description:
This is a Phase 3, open-label, single center, nonrandomized study. This continuation protocol will consist of eligible subjects who have previously received cholic acid through the Cincinnati Children's Hospital Medical Center (CCHMC) Compassionate Use (91-10-10), CAC-001-01 study protocols and newly diagnosed subjects.

New subjects will be infants, children, adolescents identified from urine samples obtained from the clinical services of programs across the U.S., Canada, South America, Europe, and Asia. Subject or their legal representative will receive information regarding the study, and the principle investigator (PI) or designee will obtain informed consent. Serum and urine samples will be collected and sent to CCHMC to measure complete bile acid profile analysis. Clinical records including medical history, physical exams, vital signs, and laboratory assessments performed as standard of care will be reviewed to ensure subject eligibility and determine baseline values.

Subjects who have participated in Protocols conducted under IND 45,470 will be consented to continue to receive cholic acid capsules under this continuation protocol. Subjects will serve as their own controls and no placebo will be utilized.

Arms: arm 1: Active drug
Interventions: intervention 1: Cholic Acid
Intervention descriptions: intervention 1: 10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules

Protocol documents:
Clinical trial NCT01441765
Conditions: Renal Cell Carcinoma
Keywords: Kidney Metastatic Stage IV
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2011-11-01; Completion date: 2016-07-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug that are known to target specific cells (in this case, cells in the immune system) The DC RCC Vaccine is agent that tries to help the immune system to recognize and fight against cancer cells.

The purpose of this research study is to determine the safety of CT-011 alone, and in combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators are also trying to find out what effect the combination has on the disease, and on your immune system.

Detailed description:
This study is divided into 2 groups. The first 22 subjects will be in Group 1 and will receive CT-011 only. The next 22 subjects will be in Group 2 and will receive CT-011 and the DC RCC vaccine.

Group 1: Subjects in this cohort are not required to have tumor resection (nephrectomy) to participate in this study. For subjects who are undergoing nephrectomy and for subjects undergoing resection for another metastasis, infusions of CT-011 will begin 21 to 35 days post-surgery. Subjects will receive 4 cycles of CT-011 therapy. Each cycle consists of a dose of CT-011 given on days 1, 14, and 28 intravenously.

For subjects who are not undergoing nephrectomy for standard of care therapy, infusions of CT-011 will begin 21 to 28 days following registration on the study. Subjects will receive a total of four cycles of CT-011 therapy. Each cycle consists of a dose of CT-011 given on days 1, 14, and 28 intravenously.

Group 2: Subjects in this cohort will have chosen to undergo a "debulking nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells in your body) as a standard treatment for kidney cancer or have tumor lesions that are accessible (may be removed without major surgery) and are being removed to treat or diagnose their cancer. All subjects in this group will receive infusions of CT-011 21 to 35 days following tumor resection.

Subjects will receive a total of 4 cycles of CT-011 therapy. Each cycle consists of a dose of CT-011 given on days 1, 14, and 28. In addition they will receive a vaccination of the DC RCC vaccine on day 8 of each cycle.

Arms: arm 1: CT-011 3 mg/kg for 4 cycles of 6 weeks arm 2: CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion
Interventions: intervention 1: CT-011 intervention 2: DC/RCC fusion vaccine
Intervention descriptions: intervention 1: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks intervention 2: Vaccination once per cycle on Day 8 of treatment cycles 2-4

Protocol documents: