Kornimate/medical-research-clean huggingface dataset:
lifestyle intervention to improve insulin sensitivity and markers of cardiovascular risk in prostate cancer survivors

Conditions: Prostate Cancer

Summary: the purpose of this study is to discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes and other cardiovascular disease, in men receiving gnrh hormone therapy for prostate cancer.

* in this study, participants will be divided into two groups. one group will undergo intensive lifestyle changes (lifestyle intervention group) designed by the diabetes prevention group, and the other (control group) will follow the guidelines for healthy living established by the food guide pyramid and the national cholesterol education program. * all visits will take place at the general clinical research center at the massachusetts general hospital. * at the initial visit, the following will be performed: bionutrition evaluation; oral glucose tolerance test (ogtt); additional blood work and; dual energy x-ray absorptiometry (dxa) scan. * after the initial visit, visits will be scheduled at 3, 6 and 12 months after and the above procedures will be repeated. * participants will be randomized into one of the two study groups. lifestyle intervention group: the goal for participants assigned to this group are to achieve and maintain a weight loss of at least 7% of initial body weight through a healthy low calorie, low fat diet and to engage in physical activity of moderate intensity. control group: participants in this group will receive standard nutrition and exercise recommendations from the food guide pyramid and the national cholesterol education program step 1 diet to reduce body weight and increase physical activity.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer * current hormone therapy with gnrh agonist of 3 months or longer * overweight or obese (body mass index of 25kg/m2 or greater) * no other conditions that prevent intensive lifestyle intervention exclusion criteria: * history of diabetes mellitus requiring drug therapy * hemoglobin aic of 7% or greater * symptomatic metastatic disease * myocardial infarction within 6 months * treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels * disease progression according to psa working group criteria

Keywords: insulin sensitivity diabetes prevention program lifestyle intervention
bispectral index: a comparison of bifrontal montage agreement

Conditions: Surgery; Bispectral Index

Summary: the researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead.

bispectral index (bis) monitors are fda approved to gauge depth of sedation by analyzing segments of electroencephalogram (eeg) waves. the bis monitor utilizes a proprietary algorithm to process the eeg information second by second, and outputs a number (0-100) that corresponds with a patient's level of consciousness. a level of 0 indicates no eeg activity; a level of 100 indicates awake eeg activity. several studies demonstrated that bis monitors may not be useful in paralyzed patients, as patients who were paralyzed and not sedated unexpectedly showed a large decrease in their bis values following administration paralytic medications. vivien et al found bis values dropped an average of 24 points in already sedated patients when the patients were given paralytics. in the same year, messner and colleagues paralyzed non-sedated volunteers and found a dramatic drop in bis values until paralysis wore off or was reversed. schuller et al repeated the messner experiment and found similar results with 18 of 20 non-sedated volunteer's bis values dropping to levels expected of patients who were sedated. these results suggest that bis monitors are integrating electromyography (emg) data into its algorithm to derive a bis value. our hypothesis is that a bis monitor commenced after paralysis, thereby lacking exposure to any "awake" emg activity, will result in a cleaner data set and more accurate representation of a patient's level of sedation. studying in this manner will require the subject to wear two bis sensors in a frontal montage. the manufacturer of the sensors gives no guidance as to which side of the forehead an individual sensor is placed, and no studies demonstrate bis validity with the use of concurrent sensors. the purpose of the present investigation is to assess the measurement difference and variability associated with use of concurrent bifrontal bis sensors. the data obtained will be used as a framework for a future study related to the use of paralytics and bis monitoring.

Eligibility criteria:
inclusion criteria: 1. adult patient having elective cardiac surgery exclusion criteria: 1. patient refusal. 2. pediatric patients. 3. emergency procedure. 4. patients with known or suspected carotid or cerebrovascular disease. 5. patients with prior stroke. 6. skin condition or anatomy preventing proper sensor placement.

Keywords: bis bispectral index paralysis
a phase 2 study with enzastaurin plus chemotherapy or placebo plus chemotherapy for prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.


Eligibility criteria:
inclusion criteria: * you are at least 18 years old. * you live close enough to the doctor's office to attend all of your required visits. * you have not been treated with chemotherapy for your prostate cancer. * your organs must be functioning properly. exclusion criteria: * you are unable to swallow pills. * you have another serious illness besides your prostate cancer. * you have taken another experimental drug within the last 30 days. * you have a serious heart condition. * you are receiving another anti-cancer therapy.
the effect of patient's position after intra-tympanic injection

Conditions: Sudden Hearing Loss

Summary: the effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. the patients will be seated after one of the intra tympanic injections that are routonely performed due to sudden sensorineural hearin loss (snhl). the patients will be asked if they taste the steroids in their throats.


Eligibility criteria:
inclusion criteria: * patients diagnosed with sudden sensorineural hearing loss, treated using intra-tympanic injection of steroids * patients who signed an informed consent form exclusion criteria: * dysgeusia * inner or middle ear malfomation * eustachian tube dysfunction
intramedullary nailing of tibia fractures

Conditions: Tibial Fractures; Malleolar Fractures

Summary: currently, the treatment of choice for tibial fracture is intramedullary nailing. this procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. in concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. in this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.


Eligibility criteria:
inclusion criteria: * all patients, 18+ years of age, that have been treated at the university of utah over the past five years for tibial fracture combined with medial or posterior malleolar fracture. exclusion criteria: * none

Keywords: tibia fractures medial fractures posterior malleolar fractures
antibacterial prophylaxis vs no prophylaxis for hematological malignancies patients before allo-hsct

Conditions: Antibacterial Prophylaxis; Hematological Malignancies; Allogenetic Hematopoietic Stem Cell Transplantation; Imipenem

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) is a potentially curative treatment for a variety of hematologic malignancies. bacterial infections remain a common complication of allo-hsct, especially in the pre-engraftment phase. pre-engraftment neutropenia typically lasts for up to 2 weeks in autologous hsct but is considerably longer in allogeneic hsct recipients who receive myeloablative conditioning regimens. this is a prospective, randomized, controlled, phase ii/iii clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with hematological malignancies before allo-hsct. all patients aged above 14 years, diagnosed with hematological malignancies and ready to undergo allo-hsct, no active infection within 3 weeks before allo-hsct, with a normal ct scan-chest before entering the transplantation cabin and willing to participate in the trial will be enrolled.


Eligibility criteria:
inclusion criteria: * aged above 14 years; * diagnosis with hematological malignancies and be ready to undergo allo-hsct; * no active infection within 3 weeks before allo-hsct; * with a normal ct scan-chest before entering the transplantation cabin. exclusion criteria: * age \< 14 years; * active and documented infection at admission; * with a abnormal ct scan-chest before entering the transplantation cabin; * with any conditions not suitable for the trial; * unwilling to participate in the trial.
fall detection and prevention for memory care through real-time artificial intelligence applied to video

Conditions: Alzheimer's Disease and Related Dementia; Fall Injury

Summary: the purpose of the research is to study a new safety monitoring system developed by safelyyou to help care for a loved one with dementia. the goal is to provide better support for unwitnessed falls. the safelyyou system is based on ai-enabled cameras which detect fall related events and upload video only when these events are detected. the addition of a human in the loop (hil) will alert the facility staff when an event is detected by the system.

this process enables staff to know about falls without requiring residents wear a device and to see how falls occur for residents that cannot advocate for themselves while still protecting resident privacy by only uploading video when safety critical events are detected. seeing how the resident went to the ground (1) prevents the need for emergency room visits when residents intentionally moved to the ground without risk and (2) allows the care team to determine what caused an event like a fall and what changes can be made to reduce risk. preliminary evidence. the proposed study follows a series of pilots. in pilot 1, we showed the technical feasibility of detecting falls from video with 200 falls acted out by healthy subjects. in pilot 2, in a 40-resident facility, we demonstrated the acceptance of privacy-safety tradeoffs and showed a reduction of total facility falls by 80% by providing the system for 10 repeat fallers. in pilot 3, we addressed repeatability of fall reduction in a cohort of 87 residents with adrd in 11 facilities of three partner networks. in pilot 4 (nih sbir phase i), we demonstrated that falls can be detected reliably in real-time within the partner facilities. we detected 93% of the falls; reduced the time on the ground by 42%; showed that when video was available, the likelihood of ems visit was reduced by 50%; and reduced total facility falls by 38%.

Eligibility criteria:
the study population includes residents of care facilities that are a high fall risk with a particular focus on care facilities with high populations of individuals with alzheimer's disease and related dementias. there are no gender, race, ethnicity, language or literacy requirements for participation and all residents are eligible. inclusion criteria - living at a participating skilled nursing facility or equivalent, ccrc, exclusion criteria - 18 years old or younger
cardioverter defibriilator placement for primary prevention of sudden cardiac death in patients older than 70 years

Conditions: Heart Failure; Primary Prevention of Sudden Cardiac Death; Implantable Cardioverter Defibrillator

Summary: the primary objective of dilemma study is to assess whether the "heart failure optimal therapy alone (hfot)" strategy is non inferior to the "hfot+icd" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an icd indication for primary prevention of scd whether there is an indication for cardiac resynchronization therapy or not.

rationale although not recognized by guidelines, there is no available data demonstrating the benefit of implantable cardioverter defibrillator (icd) for primary prevention strategy of sudden cardiac death (scd) in elderly. nevertheless, icd are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs. main objective the primary objective of dilemma study is to assess whether the "heart failure optimal therapy alone (hfot)" strategy is non inferior to the "hfot+icd" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an icd indication for primary prevention of scd whether there is an indication for cardiac resynchronization therapy or not. design this is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. follow up will last 4 years.

Eligibility criteria:
inclusion criteria: * ≥70 years old, * left ventricular ejection fraction ≤ 35% * nyha class ii or iii * heart failure hfot ≥ 3 months * providing informed consent * affiliated to a french health insurance system. exclusion criteria: * enrolled in or planning to enroll in a conflicting interventional trial * prior unstable sustained ventricular arrhythmia requiring external cardioversion * myocardial infarction within the 40 days * coronary artery intervention (catheter or surgical) within 90 days * history of syncope in the previous 6 months * advanced cerebrovascular disease * cognitive impairment leading to the incapacity of consent * any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year. * patient under tutorship, curatorship, or legal safeguard * persons deprived of their liberty by judicial or administrative decision (prisoner)

Keywords: heart failure prevention strategy of sudden cardiac death implantable cardioverter defibrillator heart failure optimal therapy mortality
cardiac allograft vasculopathy and dobutamine stress echocardiography / brain natriuretic peptide coupling

Conditions: Vasculopathy; Allograft

Summary: primary purpose :to early detect cardiac allograft vasculopathy and to identify patients with high risk of cardiac events, by coupling the analysis of the kinetics of the brain natriuretic peptide ( bnp) with that of the left ventricle (lv) during a dobutamine stress echocardiography. hypothesis : plasma bnp elevation and abnormalities of lv kinetic during the esd, will be associated with the presence of allograft vasculopathy and the arisen of cardiovascular events.


Eligibility criteria:
inclusion criteria: * heart transplant recipients exclusion criteria: * no respect of inclusion criteria * pregnancy * severe renal failure (creatinin clearance \< or equal to 30 ml/min) * dobutamine stress echocardiography contraindication

Keywords: -heart transplant, allograft vasculopathy, dobutamine stress echocardiography, brain natriuretic peptide vasculopathy
vte prevention following total hip and knee arthroplasty

Conditions: Venous Thromboembolism

Summary: consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.

aspirin and rivaroxaban prevent venous thromboembolism (vte) via different mechanisms. aspirin is significantly cheaper than rivaroxaban. aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (epcatii) when compared to rivaroxaban alone. this study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.

Eligibility criteria:
inclusion criteria: 1. patients undergoing elective tha/tka at the participating institutions will be potentially eligible for this study 2. written informed consent in accordance with federal, local and institutional guidelines exclusion criteria: 1. previous documented vte (proximal dvt or any pe) 2. hip or lower limb fracture in the previous three months, not related to present surgery 3. metastatic cancer 4. life expectancy less than 6 months 5. history of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis 6. history of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin 7. history of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban 8. creatinine clearance less than 15 ml per minute 9. pre-operative platelet count less than 100 x 109 /l 10. need for long-term anticoagulation due to a pre-existing co-morbid condition or due to the development of vte following surgery but prior to randomization 11. received anticoagulation post operatively 12. bilateral tha/tka or simultaneous hip and knee arthroplasty 13. major surgical procedure within the previous 3 months 14. requirement for major surgery post arthroplasty within a 90 day period 15. chronic daily aspirin use with dose greater than 100 mg a day 16. women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period 17. unwilling or unable to give consent 18. previous participation in the epcat iii study 19. under 18 years of age 20. concomitant use of drugs that are strong inhibitors of p-gp and cyp3a4 (e.g., systemic treatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of p-gp and cyp3a4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, st. john's wort) 21. known allergy to food dye

Keywords: total hip and knee arthroplasty
follow up treatment of children with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the purpose of the study is to examine how well two types of treatment follow up work compared to one another: 1. standard community follow up 2. medication monitoring plus tailored case management follow up. a child's participation will involve 3 months of treatment consisting of medication and psychological, behavioural, and academic interventions tailored to their individual needs. following this treatment, the child will be randomly assigned to receive two years of either community follow up or medication monitoring plus tailored case management follow up delivered by the study team. during both types of follow up, at 6 month intervals, the parent and child will be asked to complete interviews with our study personnel and comprehensive assessments pertaining to adhd symptoms and various other areas of functioning. parents will also be asked to obtain information from the child's teacher regarding the child's functioning at 6 month intervals during the school year.


Eligibility criteria:
inclusion criteria: * age 6 to 12 years * dsm-iv adhd diagnosis by a specialist i.e. child psychiatrist or developmental paediatrician (dsm 5 adhd criteria do not differ dramatically from dsm iv criteria for children) * intelligence quotient (iq) \> 80 as per the wechsler intelligence scale for children (wisc-iv) * proficiency in english or french exclusion criteria: * history of autism spectrum disorder (asd) or psychosis * significant brain traumas (encephalitis, head injury requiring hospitalization, etc.) * major medical conditions or impairments that would interfere with the ability of the child to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities.

Keywords: treatment of adhd long-term treatment follow-up
effect of lubricating gel for pain relief during speculum examination in gynecologic oncology patients

Conditions: Pain

Summary: pelvic examination, an important part of gynecologic oncology patients to help detect cancers recurrence or infections.despite its importance, many women are reluctant and anxious about the procedure because of fear, as well as discomfort and pain. the objective of this study is to estimate whether using lubricating gel decreases patient pain during speculum insertion compared with using water in gynecologic oncology patients


Eligibility criteria:
inclusion criteria: \*female patients who came for surveillance for malignant gynecologic disease such as uterine cancer, cervix cancer, and ovarian cancer with or without radiotherapy and chemotherapy exclusion criteria * women were undergoing vulvectomy or vaginectomy * women with narrow vagina for standard medium size of speculum for examination * women who underwent fertility sparing surgery. * women had vaginitis
deciphering mechanisms underlying cancer immunogenicity

Conditions: Head and Neck Cancer; Ovarian Cancer; Cervical Cancer; Cervical Intraepithelial Neoplasia 3; Glioblastoma Multiforme of Brain Stem; Non Small Cell Lung Cancer; Anal Cancer

Summary: this trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the pd-1 (programmed death) expression in t cells (t lymphocytes) in different solid tumors. the study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial. patients with any of the following tumor types may be enrolled in the trial: * head and neck cancer, * ovarian cancer, * cervical cancer, * pre-invasive cin iii cervical cancer (cervical intra-epithelial neoplasia iii cervical cancer), * other solid tumor types (including glioblastoma, nsclc (non-small cell lung cancer), anal cancer) each tumor type will be considered as an independent cohort. for each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected. study participation of each patient will be 5 years.


Eligibility criteria:
inclusion criteria: 1. patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, nsclc and anal cancer) or patients with pre-invasive cervical high grade dysplasia (cin ii or iii) 2. age ≥ 18 years at the time of study entry 3. patient followed within a standard of care procedure or clinical trial 4. ecog performance status 0-2 5. patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 6. patient affiliated to a social health insurance in france 7. patient may participate to other clinical trials exclusion criteria: 1. known history of positive test for hepatitis b virus or hepatitis c virus or immunodeficiency virus (hiv) or hanta virus 2. any condition contraindicated with blood sampling procedures required by the protocol (including hemoglobin \< 8g/dl) 3. patient pregnant, or breast-feeding 4. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 5. patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship

Keywords: head and neck cancer ovarian cancer cervical cancer cervical intraepithelial neoplasia 3 glioblastoma multiforme of brain stem non small cell lung cancer anal cancer