Kornimate/medical-research-clean huggingface dataset:
discontinuation study of imatinib in adult cp cml patients who have a complete molecular response to imatinib

Conditions: Chronic Myeloid Leukemia; Imatinib; Complete Molecular Response

Summary: this prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript

imatinib (im) treatment has been the standard of care for chronic phase (cp) chronic myeloid leukemia (cml) and approximately 50% of cp cml patients who received im treatment achieve complete molecular response (cmr) at 6-7 years.(hochhaus a et al. leukemia 2009;23:1054-1061, hughes et al. blood 2008;112:334) the recent data from a study aimed to assess whether im can be discontinued in patients with a cmr lasting at least 2 years showed the probability of persistent cmr at 12 months was 41%, and suggested im can be safely discontinued, at least in some patients with sustained cmr. (mahon et al. lancet oncol 2010;11:1029-1035) however, to define whether discontinuation of im treatment can be safely employed, further validation and much longer follow-up are needed. aims this prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript. primary objective: * to evaluate the probability of persistent undetectable molecular residual disease (umrd) and mr4.5 at 12 months after discontinuation * to measure the duration of persistent umrd and mr4.5 after discontinuation * to identify contributing factors for sustained undetectable transcript secondary objective: * to evaluate the probability of major molecular response (mmr) loss * to evaluate the time taken to lose mmr at 12 months after discontinuation * in patients with loss of mmr, the probability of re-achieving mmr/mr4.5 * to measure the time taken to re-achieve mmr/mr4.5 after im resumption * to identify contributing factors for sustained re-achieve mmr/mr4.5 trial design this is a prospective, multicenter, non-randomised im discontinuation study. response evaluation after discontinuation, molecular response was monitored using rq-pcr assay every month up to 6 month follow-up, every 2 months up to 12 month follow-up, and every 3 months thereafter. the loss of mmr, mr4.5, and umrd were defined on 2 consecutive assessments. if loss of mmr occurred, im treatment was re-introduced. written informed consents were obtained for all patients

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years-old) ph+ cp cml patients who were treated with im for more than 3 years in sustained mr4.5 or undetectable transcript for at least 2 years are enrolled. mr4.5 or undetectable transcript must be sustained by 2 consecutive rq-pcr assay within 6 months exclusion criteria: * patients were diagnosed with ap or bp cml * ph+ all * received cytotoxic chemotherapy or any other tkis except imatinib * any evidence of on-going graft versus-host disease (gvhd) * relapsed patients after allogeneic stem cell transplantation
treatment of binge eating disorder

Conditions: Bulimia; Obesity

Summary: this is a multicenter (2 sites) randomized trial evaluating three group treatment models for subjects with binge eating disorder. one model is a cognitive behavior treatment (cbt) group, one is partial self help, and one is self help only.


Eligibility criteria:
* meet binge eating disorder (bed) criteria * not psychotic * not in other treatment

Keywords: binge eating obesity cognitive behavior
ranibizumab versus pdt for presumed ocular histoplasmosis

Conditions: Presumed Ocular Histoplasmosis (POHS)

Summary: the purpose of this study is to evaluate the change in visual activity of ranibizumab to photodynamic therapy (pdt)in patients with choroidal neovascularization (cnv) secondary to presumed ocular histoplasmosis


Eligibility criteria:
inclusion criteria: * subfoveal cnv due to presumed ocular histoplasmosis of less than 1 year duration * ability to provide written informed consent and comply with study assessments for the full duration of the study * age greater than or equal to 21 years of age * cnv lesion of than \< 5400 microns in diameter * best corrected visual acuity of 20/40-20/320 * birth control therapy for females of child-bearing potential exclusion criteria: * subfoveal ncv due tp presumed ocular histoplasmosis for \> 1 year * pregnancy or lactation premenopausal women not using adequate contraception * prior enrollment in the study * any other condition that the investigator believes would pose a significant hazard to the subject * participation in another simultaneous medical investigation or trial * participation in another trial or previous trial of ranibizumab or avastin * any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 snellen equivalent lines of bcva over the 12-month study period * previous panretinal photocoagulation * previous steroids or pdt in 3 months * previous participation in any studies of investigational drugs within 30 days preceding day 0 * prior participation in a genentech ranibizumab clinical trial * previous treatment with intravitreally (in either eye) or intravenously administered avastin within 3 months * previous use of macugen in the study eye within 3 months * prior submacular surgery

Keywords: histoplasmosis
efficacy and safety of aliskiren and atenolol in adults (>18) with mild to moderate hypertension

Conditions: Hypertension

Summary: this is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. each patient will be in the study for 12 weeks.


Eligibility criteria:
inclusion criteria: 1. outpatients 18 years of age and older. 2. patients with essential hypertension. exclusion criteria: severe hypertension, current diagnosis of heart failure, history or evidence of a secondary form of hypertension, participation in any investigational drug study within one month of planned participation, other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, aliskiren, atenolol, blood pressure
a phase ii study of dasatinib in children and adolescents with newly diagnosed chronic phase chronic myelogenous leukemia (cml) or with ph+ leukemias resistant or intolerant to imatinib

Conditions: Leukemia

Summary: the purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (cml), or in children with ph+ acute lymphoblastic leukemia (all), accelerated or blast phases cml who relapse after imatinib or who are resistant or intolerant to imatinib. the side effects of this oral investigational drug in children and adolescents will be evaluated


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * cp-cml who prove resistant or intolerant to imatinib (cohort 1) * ph+ all, ap-cml, or bp-cml who are resistant or intolerant to or who relapse after imatinib therapy (cohort 2) * newly diagnosed, treatment naive cp-cml (cohort 3) * lansky or karnofsky scale \>50 * life expectancy ≥12 weeks * adequate hepatic and renal function * written informed consent * target population for the pk substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation * target population for the pk substudy subjects must have cp-cml and be taking daily dasatinib (tablets or pfos) either as part of cohort 1 or cohort 3 of this protocol. patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this pk substudy * target population for the pk substudy subjects with cp-cml who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib pfos dose of at least 72 mg/m2 * target population for the pk substudy prior exposure to imatinib or other tki therapy is permissible * target population for the pk substudy subjects must meet relevant inclusion criteria exclusion criteria: * eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation * symptomatic cns involvement (other than signs and symptoms caused by leptomeningeal disease) * isolated extramedullary disease * prior therapy with dasatinib * target population for the pk substudy subjects participating in the pk substudy must comply with the relevant exclusion criteria * target population for the pk substudy subjects are not allowed to use proton pump inhibitors, h2 antagonists, cyp3a4 inhibitors and inducers when entering the pk substudy other inclusion/exclusion criteria may apply

Keywords: leukemia, pediatric
icu-vr prior to icu admission

Conditions: Post Intensive Care Syndrome (PICS); PTSD - Post Traumatic Stress Disorder

Summary: rationale: a substantial proportion of the intensive care unit (icu) survivors develop psychological impairments due to their icu admission. several interventions to mitigate these impairments have been explored but lack a proper effect. intensive care unit-specific virtual reality has proven to be potentially effective in treating ptsd and depression-related sequelae in icu-survivors. objective: to evaluate the contribution in terms of information provision and patients' perspectives of icu-vr to prepare lung transplant patients for their future icu admission study design: a monocentre randomized controlled study study population: lung transplant patients who are on the waiting list and understand the dutch language. due to the criteria for lung transplantation, these are 18-71 years of age. participants need to have signed the informed consent formular. intervention: the icu-vr intervention is designed by an interdisciplinary team of intensivists, icu nurses, a psychiatrist, a psychologist, and a former icu patient, to expose patients to the icu environment while offering treatment- and department-related information. during the 12-minute lasting intervention, patients experience different facets of icu treatment and receive information on the icu environment, treatment, and workflow. the intervention group will receive this treatment during the appointment with the lung transplantation nurse. the control group will receive the regular hospital preparation care. primary endpoints: the primary endpoint will be the difference in information provision of the icu care of lung transplant patients on the waiting list.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: * be on the waiting list for lung transplantation * age 18-71 years (maximum age for lung transplantation is 71 years) * understand the dutch language * signed informed consent exclusion criteria: while patients on the waiting list for lung transplantation are intensively monitored and only placed on the waiting list under strict conditions, no additional exclusion criteria above these are identified to exclude specific patients.

Keywords: virtual reality extended reality intensive care intensive care unit intensive care units critical care lung transplantation icu-vr
selegiline in outpatient treatment for cocaine dependence - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the efficacy and clinical safety of selegiline in the treatment of cocaine dependence and to assess neurotoxicity (magnetic resonance imaging, mri) post-hoc as a possible variable for future stratification in clinical trials.


Eligibility criteria:
inclusion criteria: m/f ages 21-50. meets dsm-iv criteria for cocaine. agreeable to conditions of study and signed informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative/hypnotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: cocaine dependence
electronic medical record review in monitoring the effects of adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors receiving temozolomide and radiation therapy

Conditions: Brain Tumor

Summary: this research trial studies electronic medical record review in monitoring the effects of adherence on myelosuppression and morbidity in patients with newly diagnosed brain tumors receiving temozolomide and radiation therapy. myelosuppression is a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets and is a side effect of some cancer treatments. morbidity is a term that refers to having a symptom of disease or medical problems caused by a treatment. monitoring patients' electronic medical records to compare side effects, such as myelosuppression and morbidity, with treatment adherence may be a way to enhance patient care by organizing data for medical staff.

primary objectives: i. retrospectively measure the frequency of nonadherence with established monitoring guidelines in the target patient population. ii. retrospectively assess the impact of nonadherence events on myelosuppression severity and patient morbidity. iii. prospectively measure the effect of an automated notification program on adherence rates. secondary objectives: i. quantify any time savings realized by patient care staff through the use of such a program. ii. quantify the number of patient care interventions that directly result from this automated monitoring and notification program. outline: patients' electronic medical records are reviewed for adherence, severe myelosuppression, and patient morbidity retrospectively and prospectively.

Eligibility criteria:
inclusion criteria: * retrospective: all patients seen in dr. lesser's clinic who received concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas from 01/01/07 through 03/31/2010 will be analyzed * prospective: all patients seen in dr. lesser's clinic who receive concurrent temozolomide and radiation therapy followed by adjuvant temozolomide for newly diagnosed malignant gliomas during and after the construction of the system until the end of the study exclusion criteria: * patients participating in clinical trials or other deviations from non-standard therapies that engender similar monitoring risk will be evaluated for this study on a case by case basis
biological markers predicting exercise capacity in cf-lvad patients.

Conditions: Heart Failure

Summary: establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.

the aim of this study is to investigate if specific biological markers can predict exercise capacity in advanced heart failure patients supported with continuous-flow left ventricular assist device patients.

Eligibility criteria:
inclusion criteria: * stable cf-lvad patients. exclusion criteria: * unstable cf-lvad patients.

Keywords: exercise
efficacy and safety of alogliptin vs. acarbose in chinese type 2 diabetes mellitus (t2dm) patients with high cv risk or chd treated with aspirin and inadequately controlled with metformin monotherapy or drug naive

Conditions: Type 2 Diabetes Mellitus

Summary: primary objectives: * to assess efficacy in terms of change from baseline in hemoglobin a1c (hba1c) at the end of study between the two drugs. * to assess tolerability in terms of overall gastrointestinal (gi) tolerability for alogliptin compared with acarbose during the whole treatment period. secondary objectives: * to assess efficacy in terms of the percentage of patients achieving hba1c\<7%. * to assess efficacy in terms of percentage of patients achieving hba1c\<7% without gi effects. * to assess change from baseline in fasting plasma glucose (fpg), 2-h post plasma glucose (2-h ppg), β-cell function (homa-β), lipids and body weight. * to assess safety in terms of occurrence of hypoglycemia events. * to assess safety in terms of other adverse events. * to assess patient adherence and tolerability.

the duration of the study for each patient will be approximately 17 weeks consisting of about 1 week screening period and 16-week treatment period.

Eligibility criteria:
inclusion criteria : * type 2 diabetes mellitus patients (age ≥18yr) drug naive or treated with metformin monotherapy (≥1500 mg/day or individually maximally tolerated dose) for at least 12 weeks with a hemoglobin a1c between ≥ 7.5% and ≤ 11.0% at screening. * fasting plasma glucose ≤13.3mmol/l(≤240mg/dl) at screening. * patients with documented history of coronary heart disease (chd) or high cardiovascular(cv) risk. * history of chd, defined as previous myocardial infarction or unstable/stable angina. * high cv risk, defined as male or female (age\> 50 yr), combined with at least one of these risk factors as below: family history of cardiovascular disease, history of hypertension, smoking, dyslipidemia, or protein urine. * already treated with aspirin or should start aspirin treatment at physician's discretion. exclusion criteria: * diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes. * previous treatment with any dipeptidyl peptidase -4 inhibitor or glucagon-like peptide-1 (glp-1) receptor agonists within 1 year of screening; * any contraindication of aspirin, dipeptidyl peptidase- 4 inhibitor and alpha-glucosidase inhibitor. * clinically apparent liver disease or moderate /severe renal impairment or end-stage renal disease * unstable cv disorder including heart failure (new york heart association class iii or iv), refractory angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180 mmhg, or diastolic blood pressure ≥105 mmhg). * acute coronary syndrome event within 6 month before randomization the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cardiac aggressive risk mitigation in thoracic radiotherapy (carma) trial

Conditions: Cancer

Summary: the purpose of this study is to examine adherence to cardio-oncology consultation.

the purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. in addition, the study will evaluate use of wearable devices such as a fitbit, and remote ekg (omron evolv) and blood pressure monitoring (alivecor kardiamobile) devices to monitor participant's health. blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism. study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.

Eligibility criteria:
inclusion criteria: * any stage (i-iv) malignancy being treated with high dose (≥30 gy) radiotherapy where the heart is in the treatment field. * have eastern cooperative oncology group (ecog) performance status (ps) of 0-2. * planning to receive standard of care radiotherapy treatments. * access to a smart device that has the capability to sync to the devices. * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * ability to read, write and understand english. exclusion criteria: * known allergy to surgical steel or elastomer/rubber. * heart attack within 6 months prior to study enrollment. * severe and/or active scleroderma or systemic lupus erythematosus.

Keywords: radiation therapy cardio-oncology cardiology cardiac toxicity lung cancer esophageal cancer breast cancer thoracic radiotherapy
physical exercise as a sustainability tool in men with dysmetabolic hypogonadism

Conditions: Hypogonadism, Male; Metabolic Syndrome; Autonomic Imbalance; Life Style, Healthy; Physical Inactivity

Summary: aim of this project is to delineate sustainable physical exercise programs and to assess the effects of such programs mainly on endocrine-metabolic and neurovegetative outcomes in a cohort of men with metabolic syndrome-related late-onset central hypogonadism. participants will undergo a personalised exercise program. after 6 months they will be subdivided into two groups, according to the weekly physical activity volume actually performed (above or below 600 met·minutes/week). changes in endocrine-metabolic and neurovegetative outcomes will be compared between the two groups.


Eligibility criteria:
inclusion criteria: * diagnosis of late-onset central hypogonadism: total t levels \< 8 nmol/l (or \< 12 nmol/l in the presence of calculated free t \< 225 pmol/l) combined with sexual symptoms (erectile dysfunction, low libido and loss of waking erections) \[12\]; * diagnosis of metabolic syndrome, defined as association of waist circumference (wc) \> 94 cm and at least two among the following criteria: triglycerides ≥ 150 mg/dl, hdl-c \ 100 mg/dl, blood pressure (bp) ≥ 130/85 mmhg \[33\]; * ability to give informed consent, in accordance with good clinical practice rules and applicable national laws. exclusion criteria: * history of hypothalamus-pituitary organic disorders and/or testicular diseases; * impossibility to assess cardiac autonomic regulation due to arrhythmias and/or current treatment for heart rate (hr) control (e.g., beta-blockers, antiarrhythmics); * impossibility to undergo clinical assessment; * impossibility or contraindications to perform exercise program (for instance, psychiatric disorders, severe musculoskeletal diseases, arrhythmias); * inability to give informed consent or unwillingness to be enrolled in the study.