Kornimate/medical-research-clean huggingface dataset:
bevacizumab, temozolomide and hypofractionated radiotherapy for patients with newly diagnosed malignant glioma

Conditions: Brain Cancer; Malignant Glioma

Summary: the purpose of this study is to test the safety of a new plan for treating glioblastoma. the usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. in this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. this study will look at what effects, good or bad, this approach has on the patient and the tumor.


Eligibility criteria:
inclusion criteria: * pathologic diagnosis of glioblastoma or grade iv glioma. * tumor volume should be less than 60 cc (approximately 5cm maximum diameter). * age \> or = to 18 * kps ≥70 * granulocyte count \>1.5 x 10 9/l * platelet count \>99 x 10 9/l * sgot \< 2.5x upper limit of normal (uln) * serum creatinine \< 2x uln * bilirubin \< 2x uln * all patients must sign written informed consent exclusion criteria: * any prior chemotherapy, radiotherapy and biologic therapy for glioma. * any prior experimental therapy for glioma. * multicentric glioma * other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin). * serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment. * pregnant or breast feeding women. * refusal to use effective contraception * inadequately controlled hypertension (defined as systolic blood pressure \>150 mmhg and/or diastolic blood pressure \> 100 mmhg) * prior history of hypertensive crisis or hypertensive encephalopathy * new york heart association (nyha) grade ii or greater congestive heart failure * history of myocardial infarction or unstable angina within 12 months prior to day 1 * history of stroke or transient ischemic attack * significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1 * history of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1 * evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of treatment or anticipation of need for major surgical procedure during the course of the study * core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to day 1 * history of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1 * serious, non-healing wound, active ulcer, or untreated bone fracture * proteinuria as demonstrated by a upc ratio ≥ 1.0 at screening * known hypersensitivity to any component of bevacizumab

Keywords: radiation bevacizumab avastin temozolomide newly diagnosed glioblastoma gbm malignant glioma radiotherapy 08-126
diagnostic contribution, prognosis and physiopathological aspects in arrhythmogenic cardiomyopathy. (acore)

Conditions: Arrhythmogenic Cardiomyopathy

Summary: this study aims to identify novel inflammatory biomarkers in ac, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.

the treatment of ac remains based on palliative measures aimed at treating the consequences of the disease: antiarrhythmic treatments, defibrillator, treatments for heart failure. the identification of new biomarkers, in particular circulating ones, would make it possible to open pathophysiology avenues which, in the long term, could lead to therapies targeted to autoimmunity or inflammation. many scientific and medical questions remain unanswered and require precise databases on the diagnostic and prognostic evaluation of this pathology. the objective of this study is to identify novel inflammatory biomarkers in patients with ac by studying the autoimmunity, inflammatory, and immunological profiles through blood samples and myocardial biopsies.

Eligibility criteria:
inclusion criteria: 1. adult patient (age ≥ 18 years old) 2. patient with a probable or confirmed diagnosis of cardiomyopathy according to the diagnostic criteria of the international task force 3. patient carrying a pathogenic mutation responsible for cardiomyopathy 4. patient informed individually of the research exclusion criteria: 1. patients under curatorship/guardianship 2. pregnant women 3. patients who expressed their opposition to participate in the study

Keywords: arrhythmogenic cardiomyopathy inflammatory biomarkers autoantibodies
study of tumor metabolism by isotopic tagging in patients with high-grade glioma (carbonomic)

Conditions: High-grade Glioma

Summary: the purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

the project aims to study protein turnover in glioblastoma using mass spectrometry after 13c-valine incorporation. this will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients with high-grade glioma.

Eligibility criteria:
inclusion criteria: * more or equal than 18 years old * patient affiliated to social security or similarly regime * informed consent form signed * high-grade glioma tumor suspicion * resective surgery indication * hematological assessment : * neutrophils \> 1500/mm3 * platelet \> 150 000 * blood creatinin normal * alkaline phosphatases and transaminases no more than two times normal * bilirubin \< 1.5 times normal exclusion criteria: * pregnant women and lactating mothers * ward of court or under guardianship * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalized without their consent * person under legal protection * precedent complete macroscopic tumor resective surgery * no valid inclusion criteria * intratumoral hemorrhage mri detected * treatment anticoagulant or antisludge treatments * active infections and non controled or medical affection or psychiatric intercurrent non treated * evolutive cerebral oedema without corticoid response * non controled epilepsy without antiepileptics response * karnofsky score \< 40% * weight \> 100 kg * no possibility of resective surgery
uk post-market waterjet ablation therapy for endoscopic resection of prostate tissue

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the water study (nct02505919) - which was a prospective multi-centre randomized blinded study comparing aquablation of the prostate with the aquabeam robotic system with standard transurethral resection of the prostate (turp) for the treatment of lower urinary tract symptoms (luts).

the study is a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the water study (nct02505919) - which was a prospective multi-centre randomized blinded study comparing aquablation of the prostate with the aquabeam robotic system with standard transurethral resection of the prostate (turp) for the treatment of lower urinary tract symptoms (luts). in post water, up to 46 water study subjects in the united kingdom who were active on the study at 36 months will be invited to participate, across 3 clinical study sites in england and wales. the study will consist of one follow-up time-point at 60 months (5 years) from the time of initial water study treatment date.

Eligibility criteria:
inclusion criteria: 1. subject was randomized and received treatment in the water study. 2. subject is mentally capable and willing to sign a study-specific informed consent form 3. subject is willing and able to comply with all study requirements exclusion criteria: dementia or psychiatric condition that prevents the participant from completing required follow up 2. participating in another investigational study that could affect responses to the study assessments
transvaginal radiofrequency ablation for overactive bladder

Conditions: Overactive Bladder

Summary: to assess the effectiveness of transvaginal radiofrequency oblation by the morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .


Eligibility criteria:
inclusion criteria: * age 18-85 years old * urinary incontinence for ≥ 3 months * reporting at least "moderate bother" on item 2 on the urinary distress inventor questioner, "do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork) * if mixed urinary incontinence, urge is reported predominant symptom on mesa score. * \>10 micturition per 24 hours and \>3 urgency episodes on 3-ay bladder diary * \> 1 uui episode on 3-day bladder diary * not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2-week wash-out period) exclusion criteria: * non-english speakers * severely impaired mobility or cognition * spinal cord injury or advanced/severe neurologic condition including multiple sclerosis, parkinson's disease * repair of pelvic organ prolapse in the previous 6 months * received intravesical botulinum injection within the previous 12 months * history of implanted nerve stimulator for incontinence * history of prior sling or vaginal mesh placement, unless onset of uui was completely unrelated to placement and severity was unaffected by mesh placement. * previous diagnosis of interstitial cystitis * active pelvic organ malignancy * history of pelvic radiation * urethral obstruction * urinary retention or prolonged catheter use * less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months * untreated symptomatic urinary tract infection * unevaluated hematuria * medical instability * allergy to anesthetics used in the study * not available for follow-up in 6 months * participation in other research trials that could influence results of this study
hyperthermia combined brachytherapy in ccu

Conditions: Cervical Cancer

Summary: the aim of this randomised trial was to investigate whether hyperthermia (ht) combined with interstitial brachytherapy (isbt) has any influence on local control (lc), disease-free survival (dfs), or acute and late side effects in patients with advanced cervical cancer. vaginal symptoms were assessed by soma score, bladder and rectum symptoms by eortc/rtog score. following the completion of radiochemotherapy, consecutive patients with cervical cancer (figo stage ii - iii) were randomly assigned to two treatment groups, either isbt alone or isbt combined with interstitial hyperthermia (isht). a total of 205 patients were included in the statistical analysis. once a week, ht, at a temperature above 42.5°c, was administered for 45 minutes before and during the hdr bt. follow-up examinations were scheduled at 6 weeks after the completion of bt, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. if relapse was suspected, biopsies were obtained from these patients.


Eligibility criteria:
inclusion criteria: * patients with locally advanced cervical cancer figo stage ii - iii * signed informed consent for participation in the study exclusion criteria: * patients with figo stage i and iv * patients with poor performance status with contraindications for radical treatments

Keywords: brachytherapy interstitial hyperthermia cervical cancer side effects locally advanced cervical cancer patients
efficacy of low-dose dexmedetomidine to prevent delirium in liver transplant patients

Conditions: Liver Transplantation

Summary: to test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative delirium in liver transplant patients in the icu. single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery. outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.


Eligibility criteria:
inclusion criteria: * adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation exclusion criteria: * pediatric patients (under 18 years) pregnancy patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine

Keywords: delirium incidence dexmedetomidine
improving diabetes control through peer counseling and incentives

Conditions: Diabetes Mellitus

Summary: the specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (dm) control: 1. peer counseling is an effective means of reducing hba1c (a measure of glucose control). 2. financial incentives are an effective means of reducing hba1c. this is a randomized controlled pilot study. there will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve dm control in low income and minority patients who are at high risk for premature morbidity and mortality.


Eligibility criteria:
inclusion criteria: * african american veteran * 50-70 years old * icd-9cm diagnosis code consistent with dm (any icd-9cm code starting with 250) * for patients: last two hba1c greater than 8% with at least one measure being within 3 months of enrollment * for peer counselors: hba1c of greater than 8% in the past 3 years and an hba1c less than or equal to 7.5% within 3 months of enrollment exclusion criteria: * unstable medical condition that would likely prevent the subject from completing the study * patients enrolled in telehealth will be excluded as such enrollment does not constitute usual care

Keywords: diabetes diabetes mellitus hba1c
epigenetic and microbiota modifications

Conditions: Diabetes type2; Obesity

Summary: in order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a lactobacillus fermentum d3 in pills daily; 2) fmt arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. after 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.


Eligibility criteria:
inclusion criteria: * type2 diabetes in treatment with metformin * 30 kg/m2≤imc≤40 kg/m2 * 30-70 years old * homa-ir \>6 * informed consent exclusion criteria: * psychopathologic alterations that do not permit the adherence to the trial. * diabetes medication different from metformin. * history of cholecystectomy. * use of probiotics, and/or antibiotics in the last 3 months

Keywords: diabetes type2 fmt probiotics microbiota
effect of emotional freedom technique and diaphragmatic breathing on post traumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic

Summary: a great many soldiers are returning from iraq and afghanistan with symptoms of post traumatic stress disorder (ptsd). clinical experience with many people has shown the effectiveness of the techniques of energy psychology for rapidly alleviating ptsd symptoms. the study proposes to determine whether a very brief course of treatment (3 sessions) with a common form of energy psychology called emotional freedom techniques (eft) has an effect on the stress biochemistry of subjects, by measuring their levels of stress hormones (cortisol, dhea) before and after treatment.

the purpose of the research: the purpose of this study is to test the effectiveness of emotional freedom technique (eft) versus diaphragmatic breathing in reducing post traumatic stress disorders. the scientific or scholarly rationale: clinical experience and anecdotal reports have demonstrated eft to be effective for a wide range of behavioral disorders, including ptsd. however with the exception of several studies demonstrating the efficacy of eft for the treatment of simple phobias, there have been no formal research studies in this area. it is the intention of this study to extend the phobia studies to the area of ptsd, and to determine what other conditions eft might be effective in treating. another intention of this study is to see whether, and to what degree, changes in psychological functioning (as measure by the pai and tsi) are reflected in physiological markers such as hrv (heart rate variability) and levels of cortisol and dhea. the procedures to be performed: approximately 8 to 10 subjects would be randomly designated to either the experimental or diaphragmatic breathing control groups. there will be 4-5 subjects in the eft experimental group and 4-5 subjects in the control diaphragmatic breathing group.

Eligibility criteria:
inclusion criteria: * ptsd * recent service in afghanistan or iraq * good health history exclusion criteria: * illegal drug use * recent physical trauma * head injuries, concussions, amputees * mental health issues prior to entering military service

Keywords: post-traumatic stress syndrome (ptsd)
epidemiology and determinants of outcomes of hospital acquired blood stream infections in the intensive care in turkey

Conditions: Bacteremia; Sepsis; Hospital Acquired Condition

Summary: in this observational study, it is aimed to investigate the mortality and morbidity rates of hospital-acquired blood stream infections that are treated in intensive care units (icu). the effects of properties of the micro-organism such as type and antimicrobial resistance on the infection and its outcomes will be mainly explored. in addition, the impact of antibiotic options and other treatment modalities on survival of patients will be investigated. twenty-seven different icus from turkey will be included in this study.

blood stream infection (bsi) is defined as the identification of a culprit pathogen in the blood culture sample of a participant. as such, and once contaminants are excluded, bsi is the only cause of sepsis where the presence of an infection and the pathogen are known with certainty. this makes bsi the perfect model of infection to study the effects of the micro-organism on the participant, and the effects of the antibiotics and other treatments on survival. there is an increasing trend in antimicrobial resistance rates among microorganisms that are associated with nosocomial infections treated in icu. however, infectious diseases physicians from turkey do not know contemporary epidemiological data of hospital-acquired bsi treated in icu in turkey. this study 'epidemiology and determinants of outcomes of hospital-acquired blood stream infections in the intensive care in turkey' is a multi-center prospective observational cohort study that will include patients with hospital-acquired blood stream infections (ha-bsi) treated in icus in turkey. this study will present unknown current epidemiology of ha-bsi in turkey. furthermore, it will provide very important data about 28-day mortality rates of ha-bsi treated in icu. the primary outcomes of this study can be accounted as following: (i)determinants of outcomes of ha-bsi, (ii) the effects of the source of infection on outcomes, (iii) the effects of microorganism on these outcomes, (iv) the effects of antimicrobial therapy and of source control on investigated outcomes. in this study, participant specific and organizational factors will be explored and the determinants of management of ha-bsi in icus will be described. there will be no intervention in this study. the data of participants will be obtained from hospital database and recorded into electronic case report forms anonymously.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * hospital acquired bloodstream infection (ha-bsi). * treated in the icu. * icu acquired or hospital acquired prior to icu admission exclusion criteria: * patients that had a positive blood culture in the hospital and transferred to icu for a different reason than specific treatment of the causes or consequences of ha-bsi. * previous inclusion in the study. * ha-bsi is defined as a positive blood culture (bc) sampled after 48 hours following hospital admission.

Keywords: bacteremia antimicrobial resistance mortality hospital acquired infections
relapse prevention study of pimavanserin in dementia-related psychosis

Conditions: Dementia-related Psychosis

Summary: the purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.


Eligibility criteria:
inclusion criteria: 1. meets criteria for all-cause dementia according to nia-aa guidelines 2. meets clinical criteria for one of the following disorders: dementia associated with parkinson's disease, dementia with lewy bodies, possible or probable alzheimer's disease, frontotemporal degeneration spectrum disorders, vascular dementia 3. has an mmse score ≥6 and ≤24 4. has had psychotic symptoms for at least 2 months 5. must be on a stable does of cholinesterase inhibitor or memantine, if applicable 6. if the subject is female, she must not be pregnant or breastfeeding. she must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception for the duration of the study exclusion criteria: 1. has psychotic symptoms that are primarily attributable to a condition other than dementia 2. has had a recent major depressive episode 3. has experienced suicidal ideation or behavior within 3 months prior to study enrollment 4. has evidence of a non-neurologic medical comorbidity or medication use that could substantially impair cognition 5. has a history of ischemic stroke within the last 12 months or any evidence of hemorrhagic stroke 6. has a known history of cerebral amyloid angiopathy (caa), epilepsy, cns neoplasm, or unexplained syncope 7. has any of the following: greater than new york heart association (nyha) class 2 congestive heart failure, grade 2 or greater angina pectoris, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an arrhythmia, an implantable cardiac defibrillator 8. had a myocardial infarction within the last 6 months 9. has a known personal or family history or symptoms of long qt syndrome 10. has a significant unstable medical condition that could interfere with subject's ability to complete the study or comply with study procedures 11. requires treatment with a medication or other substance that is prohibited by the protocol additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Keywords: dementia dementia-related psychosis dementia associated with parkinson's disease dementia with lewy bodies alzheimer's disease behavioral variant frontotemporal dementia progressive supranuclear palsy corticobasal degeneration vascular dementia hallucinations delusions psychosis