Kornimate/medical-research-clean huggingface dataset:
role of menopause in thermoregulation

Conditions: Menopause; Aging

Summary: the frequency and severity of heat waves has increased in the last decades. older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. however, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. in this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

premenopausal and postmenopausal women will be recruited and different interventions will be given to each group. to mimic a postmenopausal hormone profile, premenopausal women will be given a gnrh antagonist, which acutely reduces estrogen concentrations. this induces a temporary post-menopausal state without compounding aging effects. postmenopausal women will be given a transdermal estradiol patch to acutely raise estrogen concentrations. supplementing estrogen in postmenopausal women allows for the effect of menopausal low estrogen concentration to be removed from the physiological effects of aging. subjects sign an informed consent form and undergo a medical screening prior to participation. the screening includes a physical exam, anthropometry, chemical and lipid profiles. each subject will complete 6 (3 for each treatment) experimental trials. for each intervention, participants will complete one passive heating experiment first, followed by two active heating experiments.

Eligibility criteria:
inclusion criteria: * women ages 42-64 exclusion criteria: * chron's disease, diverticulitis, or similar gastrointestinal disease * abnormal resting exercise electrocardiogram (ecg) * tobacco use * high-risk determined by the atherosclerotic cardiovascular disease (cvd) risk factor * assessment * using hormone therapy * using hormonal contraceptives

Keywords: thermoregulation heat stress
a biologic joint replacement strategy to treat patients with severe knee trauma and post-traumatic knee osteoarthritis

Conditions: Post-traumatic Osteoarthritis

Summary: with irb approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee oa and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. primary criteria for inclusion will be grade iv changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint as determined by physical examination, diagnostic imaging and knee arthroscopy by the pi. exclusion criteria include grade iii or iv changes in any other compartment of the knee, acute injury to any other part of the affected lower extremity, or inability to comply with the protocol. after enrollment, patients will undergo standardized knee radiography, and complete assessments (described below). size-matched (standard clinical methodology) proximal tibia with meniscus and distal femur allografts from the same donor will be obtained from a tissue bank (musculoskeletal transplant foundation, edison, nj) who has licensed the mops technology. the medial or lateral femoral condyle will be replaced using our novel instrumentation and technique described above. tibial plateau-meniscus grafts will be trimmed and used to replace the entire medial or lateral tibial condyle while sparing the attachments of acl, pcl and respective collateral ligament. the tibial plateau graft will be fixated using commercial available implants used for bone fixation. in the event that the meniscus has been detached from the tibial plateau during graft harvest, the periphery of the meniscus will be sutured to the capsule following standard meniscus transplant procedure. patients will undergo controlled post-operative rehabilitation according to standard protocols for osteochondral with concurrent meniscus allografts. range of motion, vas pain score, sf-12, tegner score, international knee documentation committee (ikdc) subjective and objective scores, promis bank v1.2 - physical function-mobility, promis v1.1 - global health, promis bank v1.1- pain interference, promis bank v1.2 - physical function and marx score as well as complete radiographs of the affected knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis.


Eligibility criteria:
inclusion criteria: 1. patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty 2. the subject is able and willing to consent to participate in the study exclusion criteria: 1. acute injury to any other part of the affected lower extremity 2. the subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence 3. bmi \> 40 4. age \> 50 at the time of enrollment 5. the subject is either pregnant, or a prisoner 6. currently involved in a workers' compensation case at the time of enrollment
investigation of urinary biomarkers for the detection of prostate cancer

Conditions: Prostate Cancer; Urine; Liquid Biopsy

Summary: the aim of this study is to investigate and possibly validate urinary biomarkers for prostate cancer. during this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, ctc or blood derived cfdna. proteins will be explored in urine as well. this is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with prostate cancer. the participants will be asked to provide a urine sample collected with the collipee® device and fill out an online questionnaire to collect usability data. thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.


Eligibility criteria:
inclusion criteria: * being at least 18 years old * being able to understand and read dutch * for cancer patients: being diagnosed with prostate cancer * for healthy volunteers: being male exclusion criteria: * for cancer patients: suffering from a blood cancer * for healthy volunteers: diagnosed with cancer

Keywords: first-void urine liquid biopsy oncology biomarker colli-pee
lung volume recruitment for lung function and cough impairment in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. this pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.


Eligibility criteria:
inclusion criteria: * history of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 mcdonald criteria exclusion criteria: * concomitant parenchymal pulmonary disease or pleural disease * symptomatic cardiomyopathy * unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction * contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month * known susceptibility to pneumothorax or pneumomediastinum * not competent to provide informed consent

Keywords: multiple sclerosis lung volume recruitment pulmonary function impairment cough impairment
comparison of different doses of oestrogen therapy for preventing intrauterine adhesion

Conditions: Asherman Syndrome

Summary: this single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.


Eligibility criteria:
inclusion criteria: 1. moderate and severe iua according to the afs iu adhesion scoring system (afs 1988 version) (19) showed in table1 (afs score≥5); 2. scheduled for hysteroscopic adhesiolysis; 3. agreed to have two follow-up hysteroscopy; and 4. written, informed consent obtained. exclusion criteria: 1. received estrogen therapy within 3 months of enrollment; 2. suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (pcos); 3. history of genital tuberculosis; and 4. contraindication for estrogen therapy.

Keywords: intrauterine adhesion oestrogen artificial periodic therapy
rasburicase for treatment of hyperuricemia in children and adolescence patients with tumor lysis syndrome

Conditions: Hyperuricemia

Summary: to provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia


Eligibility criteria:
inclusion criteria: * acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dl ) * with a minimum life expectancy of 3 months * having previously signed a written informed consent. exclusion criteria: * hypersensitivity to uricase or any of the excipients. * known history of g6pd deficiency. * previous treatment with rasburicase or uricozyme. * treatment with any investigational drug within 30 days before planned first rasburicase administration. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of balanced saline solution and albumin on volume expansion in shock patients

Conditions: Shock

Summary: to compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients

ci/svi increase amplitude and maintenance time

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, gender unlimited 2. shock requires volume resuscitation: insufficient tissue perfusion: wet and cold skin, decreased urine volume (\ 2.0mmol/l or vasoactive drugs are required to maintain map\>65mmhg 3. presence of volume reactivity: (under controlled ventilation) ppv ≥ 15% or passive leg raising test (+) or (under controlled ventilation) ivc variability ≥ 18% or the presence of volume reactivity as judged by clinicians 4. the patient has no obvious restlessness, rass ≤ 0 5. the legal representative of the subject signs the informed consent form- exclusion criteria: 1. pregnant and lactating women 2. end stage patients 3. bmi ≤ 15 or bmi ≥ 50 4. contraindication of indwelling central vein catheter and invasive arterial catheter 5. patients in ecmo and / or iabp therapy 6. hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour 7. myocardial infarction, nyha grade iv 8. patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism 9. allergic to compound sodium acetate ringer injection or albumin or with known side effects 10. other factors that may affect the monitoring and evaluation of relevant indicators

Keywords: shock sodium acetate ringer albumin
phase ii single vs hypofractionated irradiation for timely access to partial breast radiotherapy

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary: partial breast irradiation (pbi) is a targeted radiation approach commonly administered post-lumpectomy, specifically targeting the tumour bed. this targeted therapy reduces the exposure to other nearby tissues such as lungs, heart, and chest wall. however, traditional pbi treatment involves lengthy multiple fraction courses which presents a burden to patients from rural and remote communities, who must travel long distances to receive high quality cancer care. the purpose of this study is to compare single fraction (sf) pbi vs. multiple fraction (mf) pbi.

radiation can be delivered in multiple fractions, or doses, and can take up to several weeks or months of treatment depending on the type of cancer. radiation can also be offered in a single fraction. both techniques have evidence for use in clinical care. multiple fraction is offered to reduce the amount of radiation given at a single time that could reduce late toxicities. however, single fraction radiotherapy is more cost-effective and saves patient time. with this trial, we will compare single fraction vs. multiple fraction pbi in regards to their impact on quality of life, rates of provider and participant reported toxicities, and local control.

Eligibility criteria:
inclusion criteria: * female participants age 40 or older * able to provide informed consent * ptis-2 pn0 cm0 breast cancer less than 3 cm in maximum size * able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver/family/friend/research staff * eastern cooperative oncology group (ecog) performance status 0 - 2 * a history and physical examination, including ecog performance status, performed within 8 weeks prior to enrollment. * participant is judged able to: * maintain a stable position during therapy * tolerate immobilization device(s) that may be required to deliver pbi safely * negative pregnancy test for people of child-bearing potential (pocbp) within 4 weeks of rt start date exclusion criteria: * history of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years. * seroma not visible * ipsilateral implanted cardiac device * prior radiotherapy requiring summation for planning. * requirement for a radiation boost (as determined by the treating investigator) * positive lymph nodes \> 3 cm * positive surgical margins * surgical cavities lacking clear delineation * known germline brca1/2 mutation. * serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma) * pregnant or breastfeeding
social cognition training in individuals with huntington's disease

Conditions: Huntington&#39;s Disease (HD)

Summary: individuals with huntington's disease have impaired social cognition, which is the domain of cognition that allows individuals to understand others' perspectives so that they can navigate interpersonal actions successfully (e.g., understanding someone may be sad based of their facial emotion or tone of voice and then responding in a sympathetic manner). impaired social cognition is associated with impaired social functioning, poor psychological wellbeing and increased caregiver burden, which is known to be significant among those who care for individuals with huntington's disease. computerized social cognition training has been shown to improve social cognition in individuals with schizophrenia, who, like individuals with huntington's disease, have cognitive impairments. the investigators propose a pilot study of computerized social cognition training in individuals with huntington's disease. this will be a feasibility study that aims to show that social cognition training in hd can be studied in preparation for a larger randomized controlled trial. the investigators hypothesize that social cognition training can improve social cognition, social functioning, and quality of life in individuals with huntington's disease and decrease caregiver burden among those who care for individuals with huntington's disease.


Eligibility criteria:
inclusion criteria for individual with huntington's disease * diagnosed with huntington's disease based on genetic testing * must be between 18 and 65 years of age * native english speaker who is literate in english * stable psychotropic medication regimen for 4 weeks * must have a score of "somewhat easily" on all items in the cpq-12 * moca \>18 * completed 12 years of schooling * access to laptop or mobile device * willingness to come in person 6-12 weeks after first visit inclusion criteria for caregiver of individual with huntington's disease * lives with patient * must be between 18 and 65 years of age * native english speaker who is literate in english * moca \>26 * willingness to come in person within 6-12 weeks after first visit exclusion criteria for individual with huntington's disease * any known neurological condition (other than huntington's disease). * history of learning and/or intellectual disabilities * currently actively involved in any other interventional trial (i.e. have begun the intervention) or within 4 weeks of completing the final assessments of an interventional trial. * currently regularly completing a computerized cognitive training intervention. * active suicidal ideation with some intent exclusion criteria for caregiver of individual with huntington's disease * inability to provide informed consent * active suicidal ideation with some intent

Keywords: huntington&amp;#39;s disease social cognition caregiver burden
flavopiridol in treating patients with metastatic malignant melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of flavopiridol in treating patients who have metastatic malignant melanoma.

objectives: * assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma. * assess the toxicity of this treatment in these patients. * assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen. outline: this is a multicenter study. patients receive flavopiridol iv over 1 hour on days 1-3. treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks, and then every 3 months until disease progression or death. projected accrual: a total of 15-30 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic malignant melanoma not amenable to standard curative therapies * no prior regional or systemic therapy for metastatic disease * measurable disease * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * bone lesions not considered measurable * no known cns metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 hepatic: * bilirubin no greater than upper limit of normal (uln) * ast no greater than 2.5 times uln renal: * creatinine no greater than uln cardiovascular: * if history of cardiac disease, ejection fraction greater than 50% * no clinically significant cardiac symptomology pulmonary: * if history of pulmonary disease, fev1, fvc, and tlc greater than 60% predicted and dlco greater than 50% predicted * no clinically significant pulmonary symptomology other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other concurrent serious disease prior concurrent therapy: biologic therapy: * at least 4 weeks since prior adjuvant immunotherapy allowed * no prior immunotherapy for metastatic disease chemotherapy: * no prior chemotherapy for metastatic disease * no other concurrent chemotherapy endocrine therapy: * at least 4 weeks since prior adjuvant hormonal therapy radiotherapy: * at least 4 weeks since prior radiotherapy and recovered * must have measurable disease outside irradiated area or * evidence of progression or new lesions in irradiated area * no more than 25% of functioning bone marrow irradiated * no concurrent radiotherapy to sole site of measurable disease surgery: * at least 4 weeks since prior major surgery other: * no other concurrent anticancer therapy or investigational anticancer agents

Keywords: stage iv melanoma
antenatal micronutrient supplementation and birth weight

Conditions: Low Birth Weight; Infant Mortality; Pregnancy; Nutritional Status

Summary: the purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of nepal.

maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. and yet, the efficacy of such supplementation strategies has not been well established. specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination. comparisons: pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin a compared to a control group that received only vitamin a.

Eligibility criteria:
inclusion criteria: * married women of reproductive age identified as a new pregnancy using a urine test exclusion criteria: * menopausal or sterilized woman or currently already pregnant or breastfeeding an infant \<9 months of age

Keywords: micronutrients supplementation pregnancy birth weight infant mortality
effect of green tea in obese pre-hypertensive women

Conditions: Obese; Hypertension

Summary: the purpose of this study is to evaluate the effects of green tea on body weight, waist circumference, metabolic profile, inflammation, blood pressure and endothelial function in obese pre-hypertensive women.

crossover randomized controlled double-blinded trial. twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (gte) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments. endothelial function was evaluated by peripheral arterial tonometry method, using endo-pat 2000®.

Eligibility criteria:
inclusion criteria: pre-hypertensive women obese adult exclusion criteria: pregnant smoker elderly