ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00888628
Conditions: Diabetes Mellitus, Type I
Keywords: Type I diabetes Islet after Kidney Transplant Islet transplantation
Sponsor: Massachusetts General Hospital
Start date: 2009-05-01; Completion date: 2016-08-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.

The primary objectives of the study are:

\- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works

The Secondary objective of the study is:

* To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes

Detailed description:
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.

All patients will receive Etanercept to promote engraftment.

Arms: arm 1: Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.

For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.

Induction therapy for subsequent transplants will be 2 doses of basiliximab.

All patients will receive Etanercept to promote engraftment.
Interventions: intervention 1: Purified Pancreatic Islets intervention 2: Etanercept
Intervention descriptions: intervention 1: Islet after kidney transplant in patients with type I diabetes. intervention 2: Given as induction for islet cell transplant

Protocol documents:
Clinical trial NCT01113632
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Ofatumumab
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-07-01; Completion date: 2016-08-01
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The risk of immunosuppression deters many patients from receiving fludarabine, while combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that rituximab is safe and well tolerated when used as a single agent in patients with CLL. In addition, maintenance therapy with rituximab was well tolerated by CLL patients, with probable prolongation of progression-free survival (Hainsworth et al. 2003). Based on pre clinical and clinical studies indicating possible increased efficacy of ofatumumab in patients with CLL, we wish to develop an antibody-only regimen for older patients and patients who refuse fludarabine-based regimens.

Detailed description:

Arms: arm 1: Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks arm 2: Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks
Interventions: intervention 1: Ofatumumab
Intervention descriptions: intervention 1: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Protocol documents:
Clinical trial NCT01168973
Conditions: Non-Small Cell Lung Cancer
Keywords: second line non small cell lung cancer NSCLC phase 3 ramucirumab lung cancer docetaxel taxotere
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2016-08-01
Enrollment: 1253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ramucirumab intervention 2: Placebo (for Ramucirumab) intervention 3: Docetaxel
Intervention descriptions: intervention 1: 10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met intervention 2: Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met intervention 3: 75 milligrams per square meter (mg/m\^2) (60 mg/m\^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Protocol documents:
Clinical trial NCT01225055
Conditions: Spinal Cord Injury Bone Loss Osteoporosis
Sponsor: Thomas J. Schnitzer
Start date: 2010-10-01; Completion date: 2016-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

Detailed description:
The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Arms: arm 1: Teriparatide alone with sham vibration arm 2: Vibration alone with placebo-teriparatide arm 3: Teriparatide with vibration applied in conjuction
Interventions: intervention 1: Teriparatide intervention 2: vibration
Intervention descriptions: intervention 1: 20 ug daily over 12 months intervention 2: 10 min/day for 12 months

Protocol documents:
Clinical trial NCT01257087
Conditions: Type 2 Diabetes Mellitus Obesity
Keywords: Type 2 Diabetes Mellitus Obesity Bariatric Surgery Glycaemic control Microvascular complications Intensive Conservative
Sponsor: Imperial College London
Start date: 2010-12-01; Completion date: 2016-08-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.

Detailed description:
Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery. Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.

Arms: arm 1: Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group. arm 2: Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Interventions: intervention 1: Insulin
Intervention descriptions: intervention 1: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.

Protocol documents:
Clinical trial NCT01293539
Conditions: Retinoblastoma
Keywords: Retinoblastoma intra-arterial chemotherapy angiography
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2011-03-01; Completion date: 2016-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to show that chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye.

Detailed description:
Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.

Arms: arm 1: Single group assignment of patients with intraocular retinoblastoma, unilateral or bilateral.
Interventions: intervention 1: Melphalan hydrochloride
Intervention descriptions: intervention 1: Drug administered intra-arterially (injection in the artery).

Standard dose:

2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (\>3 years old)

Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.

Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.

Dose not to exceed 0.5mg/kg, per treatment cycle.

Protocol documents:
Clinical trial NCT01362959
Conditions: Delirium Psychomotor Agitation Substance Withdrawal Syndrome Nicotine Replacement Therapy
Keywords: Delirium Psychomotor Agitation Substance Withdrawal Syndrome Nicotine replacement therapy
Sponsor: Gelderse Vallei Hospital
Start date: 2012-06-01; Completion date: 2016-08-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether transdermal nicotine replacement therapy is safe and effective for treating nicotine withdrawal symptoms in the critically ill smoking patient.

Detailed description:
Cigarette smoking remains the leading cause of preventable disease and premature death worldwide. There are about 1.2 billion smokers in the world, half of whom will die from diseases caused by smoking. Smoking causes 5 million deaths per year, and if present trends continue, 10 million smokers per year are projected to die by 2025.

Furthermore, abstinence from the highly addictive tobacco products can lead to withdrawal symptoms. Although these symptoms are non-life threatening in healthy and hospitalized adults they are not well described in the mechanically ventilated active smoking patient.

Retrospective studies found a higher, lower or equal mortality in critically ill patients receiving nicotine replacement therapy compared to patients receiving no nicotine replacement.

Because of these conflicting results and the absence of a randomized controlled trial studying the efficacy and safety of transdermal nicotine replacement therapy in the critically ill smoking patient a clinical study will be conducted.

Arms: arm 1: None arm 2: The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.
Interventions: intervention 1: Transdermal nicotine patch intervention 2: Cutaneous patch, containing no active substances
Intervention descriptions: intervention 1: The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applicated daily. intervention 2: During the study period of thirty (30) days, the control product will be applicated daily.

Protocol documents:
Clinical trial NCT01381718
Conditions: Brain and Central Nervous System Tumors Cognitive/Functional Effects Fatigue Neurotoxicity Psychosocial Effects of Cancer and Its Treatment
Keywords: childhood brain tumor neurotoxicity fatigue cognitive/functional effects psychosocial effects of cancer and its treatment
Sponsor: University of South Florida
Start date: 2011-08-01; Completion date: 2016-08-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment.

PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.

Detailed description:
OBJECTIVES:

Primary

* Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by direct assessment of attention in children with cognitive impairment after treatment for a primary brain tumor.

Secondary

* Determine whether modafinil, compared to placebo, is associated with improved executive function, as assessed using the BRIEF executive function and hippocampal learning and executive function tasks from the CogState battery. Determine whether modafinil, compared to placebo, is associated with improved attention, as assessed by the Conners' (3rd Edition) 3 Parent Rating Scale (CPRS-3) - Short Form.
* Determine whether modafinil, compared to placebo, is associated with reduced fatigue as assessed using the PedsQL Multidimensional Fatigue Scale.
* Evaluate the safety of modafinil in this population.

OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.

* Arm I: Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
* Arm II: Participants receive placebo PO QD on days 1-42. Participants complete a semi-automated, computerized cognitive-testing system (CogState) designed to assess psychomotor, attention/vigilance, memory, and other components of executive function by presenting different tasks, each with its own set of rules, at baseline and after completion of study therapy. Participants also complete the PedsQL Multidimensional Fatigue Scale (Peds QL-MFS).

Parents or legal guardians complete the PedsQL-MFS, the Conners Parent Reported Scale (CPR-3), and the Behavior Rating Inventory of Executive Function (BRIEF) at baseline and after completion of study therapy.

Clinical and/or research staff administer the Systematic Assessment for Treatment Emergency Events (SAFTEE), a semi-structured interview designed to elicit adverse events, at baseline and periodically during study.

After completion of study therapy, participants are followed up for 30 days.

Arms: arm 1: Participants receive modafinil orally (PO) once daily (QD) on days 1-42. arm 2: Participants receive placebo PO QD on days 1-42.
Interventions: intervention 1: modafinil intervention 2: placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT01394627
Conditions: Hypoglycemia
Sponsor: Brigham and Women's Hospital
Start date: 2011-01-01; Completion date: 2016-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to look at whether blockade of the mineralocorticoid receptor will result in changes in the cardiovascular and inflammatory response to hypoglycemia.

Detailed description:
The effect of ongoing hypoglycemia on cardiovascular autonomic function is unclear and the focus of this protocol. In our preliminary studies, the investigators demonstrated that baroreflex sensitivity is impaired during hypoglycemia in healthy individuals. Treatment with eplerenone (200mg total administered in two doses in the 15 hours prior to the hypoglycemic clamp) prevented this impairment.

The study is based on the overarching hypothesis that hypoglycemia leads to increases in aldosterone/mineralocorticoid receptor (MR) activity and increased cardiovascular injury.

This study will address the following Specific Aims:

To test the hypothesis that MR blockade will reduce the adverse effects of hypoglycemia on inflammation and on autonomic control of cardiovascular function.

The investigators will determine the effects of hypoglycemia (50 mg/dl for 2.0 hours) on the blood inflammatory factor interleukin-6 levels, and on cardiovascular autonomic function (baroreflex sensitivity) in each subject under two conditions - pretreatment with MR blockade (eplerenone) and pretreatment with placebo.

Arms: arm 1: hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) arm 2: hypoglycemia of 50 mg/dl plus placebo
Interventions: intervention 1: Eplerenone intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg x 2 intervention 2: None

Protocol documents:
Clinical trial NCT01395758
Conditions: Metastatic Non-Small Cell Lung Cancer
Keywords: KRAS mutation metastatic NSCLC
Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Start date: 2011-07-01; Completion date: 2016-08-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

Detailed description:
This is a randomized, open-label Phase 2 study designed to compare treatment with erlotinib plus tivantinib (ARQ 197) versus single agent chemotherapy in subjects with previously treated KRAS mutation positive NSCLC. Eligible subjects are randomly assigned to receive erlotinib plus tivantinib or one of three (based on Investigator's choice) single-agent chemotherapy agents including pemetrexed, docetaxel, or gemcitabine.

Arms: arm 1: Eligible subjects will be randomly assigned to receive erlotinib plus tivantinib (ARQ 197).

Treatment will be open-label and continue until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. arm 2: Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy can be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.
Interventions: intervention 1: ARQ 197 plus erlotinib intervention 2: Pemetrexed, docetaxel or gemcitabine
Intervention descriptions: intervention 1: Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197. intervention 2: Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label.

Protocol documents:
Clinical trial NCT01431573
Conditions: Major Depressive Disorder Bipolar Disorder
Keywords: Depression
Sponsor: New York State Psychiatric Institute
Start date: 2011-07-01; Completion date: 2016-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study seeks to replicate previous findings that sleep deprivation results in marked improvement in depression symptoms, as well as to test whether concurrent treatment with Light Therapy and Lithium are successful in locking in and maintaining therapeutic effects in both bipolar and unipolar depressed subjects.

Detailed description:
Both refractory depression and bipolar depression are difficult to treat. A night of complete sleep deprivation has been shown to result in marked improvement in 60% of depressed patients, although maintenance of therapeutic effects have not been sustained with wake therapy alone. This pilot study will assess the effectiveness of wake therapy in treating both bipolar depression (5 participants)and major depression (5 participants), as well as the effectiveness of concomitant light therapy and lithium in maintaining the therapeutic effects. Participants will undergo direct observation in the hospital for one week during initial treatment with alternating nights of sleep deprivation, light therapy and lithium treatment, and then will be seen weekly as outpatients for 6 weeks.

Arms: arm 1: * Bipolar patients must take lithium; others do not take lithium
* all patients are hospitalized for a week during which they do not sleep on alternating nights
* for six weeks, including the week in the hospital all patients sit in front of bright lights at specified times and for specified durations
Interventions: intervention 1: Wake Therapy intervention 2: light box intervention 3: Lithium
Intervention descriptions: intervention 1: Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day. intervention 2: use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire intervention 3: For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)

Protocol documents: