Kornimate/medical-research-clean huggingface dataset:
effects of exercise in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. the investigators designed the effect study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage iv) on cancer-related physical fatigue, health-related quality of life (hrqol), and other disease and treatment-related side effects at six months (primary endpoint).

the effect study is a multicentre, randomised controlled trial. the intervention group will participate in a 9-month exercise intervention. the exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. the multimodal exercise program comprises aerobic-, resistance- and balance components. after completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine. unsupervised exercises will be supported by an activity tracker (fitbit) and an exercise app specifically designed for the effect trial. patients randomized to the control group will also receive an activity tracker (like the intervention group). the investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer stage iv * ecog (eastern cooperative oncology group scale) performance status ≤ 2 * able and willing to perform the exercise program and wear the activity tracker exclusion criteria: * a potential subject who meets any of the following criteria is not eligible for enrolment into this study: * unstable bone metastases inducing skeletal fragility as determined by the treating clinician * untreated symptomatic known brain metastasis * estimated life expectancy \< 6 months as determined by the treating clinician * serious active infection * too physically active (i.e. \>210 minutes/week of moderate-to-vigorous intentional exercise * severe neurologic or cardiac impairment according acsm criteria * uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise * uncontrolled severe pain * any other contraindications for exercise as determined by the treating physician * any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician * pregnancy

Keywords: exercise cancer-related fatigue quality of life
effect of limicol on (ldl)-cholesterol levels in moderate hypercholesterolaemia

Conditions: Delivery of Health Care

Summary: the purpose of this study is to validate the effectiveness of food supplement limicol on reducing ldl-cholesterol in moderate hypercholesterolemic volunteers.

cardiovascular disease (cvd), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in france. these diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies.the dydlipidémies have a role in the formation of cvd in participating in the genesis of atherosclerosis. the cholesterol and ldl-cholesterol in particular is subject to oxidation process in plasma. the molecules of oxidized ldl-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. following a succession of different processes including inflammation, atherosclerotic plaque is formed. the result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. given this pathophysiology, reduce blood lipids, including ldl-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids. the objective of this study is to validate the effectiveness of limicol, formulated with proven scientific data on the reduction of ldl-cholesterol in volunteers with moderate hypercholesterolaemia (ldl-cholesterol).

Eligibility criteria:
inclusion criteria: * about 18 to 65 years (inclusive). * subject has a stable weight for at least three months before the start of the study. * subject able and willing to comply with the protocol and agreeing to give their consent in writing. * subject affiliated with a social security scheme. * subject willing to be included in the national register of volunteers who lend themselves to biomedical research.

Keywords: cholesterol ldl-cholesterol coronary artery disease red yeast rice plants extract cholesterol excess.
effect of walnuts on sperm parameters and male fertility

Conditions: Oligozoospermia; Asthenozoospermia; Teratozoospermia; Fertility

Summary: the investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men seeking care for infertility will beneficially affect sperm parameters and fertility. the investigators will compare the walnut intervention to the commonly suggested recommendation of adding an otc multivitamin supplement to the diet.

purpose: the investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men with oligo- astheno- or teratospermia will beneficially affect sperm parameters. the investigators found in a previous study (robbins et al. 2012, biology of reproduction 87(4):101, 1-8.) that walnuts added to a western diet improved sperm parameters in healthy, young men of unknown fertility and the most improvement occurred in participants with poor sperm parameters at baseline. the investigators now test the walnut dietary intervention in a fertility clinic population known to have poor sperm parameters. the investigators will compare the walnut intervention to the usual care suggestion of adding an otc multivitamin supplement to the diet. neither walnuts nor the otc multivitamin have been tested for efficacy in this fertility clinic population previously. methods: a randomized, parallel two-group, dietary intervention trial with single-blind masking of outcome assessors will be conducted with up to 140 men who present for fertility work-up with semen parameters below the 25th centile for count, and 10th centile for motility and/or morphology according to the who 5th edition, laboratory manual for the processing and examining of human semen, 2010. repeated measures at baseline and 12 weeks include: semen analyses (primary outcome), blood fatty acid/ nutrient profiles (secondary outcomes); ipaq physical activity questionnaire and iief index of erectile function (potential modifiers or confounders). dietary intake will be assessed throughout using 24-hour asa dietary recall x 5 and fertility assessed by questionnaire at one year post enrollment.

Eligibility criteria:
inclusion criteria: * age 21 years or older * sperm concentration \< or = to 41 million per ml * sperm motility \< or = to 40% * normal sperm morphology forms \< or = to 5.5% * patients of howard h. kim, md seen at the male reproductive medicine and microsurgery clinic, cedars-sinai medical center, los angeles, california * have eaten walnuts throughout life without adverse reaction exclusion criteria: * allergy to walnuts or tree nuts * food allergy * known genetic cause of infertility * known anatomical cause of infertility * history of seizure disorder

Keywords: randomized controlled trial spermatozoa sperm male infertility walnuts nutrition male reproduction
footbaths with ginger, mustard & warm water only in female adolescents with & without anorexia nervosa

Conditions: Anorexia Nervosa

Summary: a randomized, controlled, three-arm study to investigate the effects of footbaths with ginger, mustard or warm water alone in female, adolescent patients with anorexia nervosa and in healthy, female adolescents on psychophysiological parameters.

in a cross-over study design, the subjects (21 female patients with anorexia nervosa, 20 healthy, female controls) receive footbaths with either ginger, mustard or warm water alone in a randomized order with a wash-out period of at least 1-3 days. the effects of each intervention on the objective warmth generation are measured by infrared thermography, whereas the subjective warmth perception is determined by the 'herdecke warmth perception questionnaire'. all parameters are determined at specified times (t1 = right before, t2 = right after and t3 = 10 minutes following the footbath), which enables an evaluation based on pre-post-comparisons. the statistical analysis comprises analyses of variances based on linear mixed effects models (after checking for carry-over effects).

Eligibility criteria:
inclusion criteria: * signed informed consent of the parents * age 12-18 years exclusion criteria: * infectious disease with body temperature above 38 °c * skin damages at the lower legs/feet * known intolerance/ anaphylaxis to mustard or ginger preparations * cardiac arrhythmia * pregnancy * insufficient knowledge of the german language * bmi percentile \< 10% (for control group)
effect of suture for mesh fixation in lichtenstein hernia repair

Conditions: Inguinal Hernia

Summary: the investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for lichtenstein hernia repair. effect parameters include chronic pain.

pain is a frequent problem after open inguinal hernia repair. the most frequent operative technique for inguinal hernia repair in adults is the lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. we therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.

Eligibility criteria:
inclusion criteria: * healthy males 18-80 years * primary inguinal unilateral hernia exclusion criteria: * recurrent hernia * bilateral, scrotal or femoral hernia * bmi above 35

Keywords: pain
head-to-head comparison of hepatocellular cancer (hcc) screening strategies: a prospective population-based cohort study in zhongshan city

Conditions: Hepatocellular Cancer (HCC)

Summary: based on the preliminary retrospective validation of the efficacy of five hcc screening strategies(including conventional afp combined with ultrasound-based general screening strategy, reach-b, aged, amapand amap 3.0 risk score) in xiaolan town, a head-to-head comparison for hcc screening is conducted in zhongshan city, guangdong province. the study is a prospective, single-center, head-to-head trial aiming to enroll 4,500 hbsag-positive individuals. it adopts a two-phase design of "hbv screening first, followed by hcc surveillance":phase i: recruitment of age-eligible populations at study sites for hbsag screening to establish a high-risk cohort positive for hepatitis b surface antigen.phase ii: implementation of uniform hcc surveillance (afp combined with liver ultrasound every six months) for hbsag-positive individuals, with concurrent application of different risk stratification models to evaluate risk levels and screening efficacy for each participant during follow-up.furthurmore, based on baseline biological information and follow-up data, the study also aims to explore the development of a more effective risk prediction model for hcc.


Eligibility criteria:
inclusion criteria: * voluntarily sign the informed consent form. * household registration in zhongshan city, guangdong province. * aged 35 and above. * positive screening result for hepatitis b surface antigen (hbsag). exclusion criteria: * previous history of liver cancer or liver transplantation. * pregnant women. * severe comorbidities (e.g., end-stage cardiopulmonary diseases, advanced malignancies). * individuals lacking legal capacity or unable to provide informed consent.

Keywords: screening hepatocellular cancer amap
retrospective study of surgical complications in patients with defunctioning stoma after low anterior resection (lar)

Conditions: Rectal Cancer

Summary: this study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after larfor rectal cancer. the data from this retrospective study will be analyzed by the study sponsor to aid in designing a prospective clinical trial for a new technology that offers a treatment alternative to standard of care defunctioning stoma in patients undergoing lar for rectal cancer.


Eligibility criteria:
inclusion criteria: 1. adults, 18 years of age or older at the time the lar surgery was performed. 2. having an open or minimally invasive colorectal resection with diverting loop ileostomy surgical procedure performed between january 15, 2015 and january 15, 2019 for treatment of a known or suspected malignant condition. 3. availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the lar surgery. exclusion criteria: 1. planned surgical procedure is a hartmann's procedure (surgical resection of the rectosigmoid colon with closure of the anorectal stump and formation of an end colostomy). 2. having a documented medical history of inflammatory bowel disease prior to the lar surgery. 3. having a concomitant major surgical procedure performed in combination with the lar surgery (e.g., colorectal resection with hepatectomy).

Keywords: low anterior resection
cv disease in adolescents with type 2 diabetes

Conditions: Cardiovascular Diseases; Diabetes Mellitus; Heart Diseases; Obesity

Summary: to study cardiac and vascular structure and function in a population of adolescents with type 2 diabetes mellitus (t2dm) compared to a similar group with obesity alone and a similar non-obese group.

background: the prevalence of type 2 diabetes mellitus has increased dramatically in adolescents. this appears to be a direct result of the increase in prevalence and severity of obesity in the pediatric population. in adults with type 2 diabetes, it is well known that the risk for cardiovascular disease (cvd) is quite high. this has led to current clinical recommendation that adults with diabetes be considered equivalent in risk to those adults who already have existing coronary artery disease. it is not known if adolescents with type 2 diabetes have an equivalent high level of risk of cvd as the adult population. if they do then it would be expected that they would develop clinical cvd in their late 20's or 30's. this would have important clinical implications and would suggest the need for very aggressive management of cvd risk factors and diabetes. design narrative: the study is a cross-sectional evaluation of cardiac and vascular structure and function in a population of adolescents with type 2 diabetes compared to a group with similar age, sex, race and bmi with obesity alone and a non obese group with similar age, sex and race. 300 subjects with type 2 diabetes, 300 subjects with obesity and 300 non obese subjects will be studied. assessment of cvd development will be accomplished using novel non invasive imaging methods for subclinical atherosclerosis including echocardiographic measurement of cardiac structure and function, ultrasound evaluation of carotid intimal medial thickness, and evaluation of endothelial function by brachial artery reactivity. the primary hypothesis is that adolescents with type 2 diabetes will have greater abnormality in cardiac and vascular structure and function compared to controls with obesity. subjects with obesity alone will have greater abnormality in cardiac and vascular structure and function compared to controls who are not obese. correlates of cardiac and vascular abnormalities including markers of inflammation, adiponectin, diet and physical activity will also be evaluated.

Eligibility criteria:
an estimated 300 subjects, ages 10 to 23, with type 2 diabetes, 300 subjects with obesity and 300 non-obese subjects will be studied. inclusion criteria: * diabetes, type 2 * obese exclusion criteria: * diabetes, type 1
study of olomorasib (ly3537982) in combination with standard of care in participants with resected or unresectable kras g12c-mutant non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part a in participants with resected kras g12c-mutant nsclc and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part b in participants with unresectable kras g12c-mutant non-small cell lung cancer. the study may last up to 3 years for each participant.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of nsclc. * part a 1. clinical stage ii-iiib (n2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. patients with a pathologic complete response are not eligible. 2. pathologic stage ii-iiib (n2) nsclc treated with initial upfront resection. * part b - clinical stage iii, unresectable nsclc, without progression on concurrent platinum-based chemoradiotherapy. * must have disease with evidence of kras g12c mutation. * must have known programmed death-ligand 1 (pd-l1) expression * must have an ecog performance status of 0 or 1. * able to swallow oral medication. * must have adequate laboratory parameters. * contraceptive use should be consistent with local regulations for those participating in clinical studies. * women of childbearing potential must * have a negative pregnancy test. * not be breastfeeding during treatment exclusion criteria: * have known changes in the egfr or alk genes. * have another type of cancer that is progressing or required active treatment within the past 3 years before screening. * have an active autoimmune disease that required systemic treatment in the past 2 years. endocrine replacement therapy is allowed. * had any immune-related side effect or allergic reaction (grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than grade 1 that has not resolved. this does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
teleconsultation in type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to compare the effects on glycemic control of teleconsultation versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.

the growing incidence of diabetes and the need to contain health care costs empower the necessity to identify new models to cope with regular periodic follow up of patients affected by diabetes mellitus. telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. this study wants to verify the feasibility and the efficacy of teleconsultation in patients with type 1 diabetes mellitus. in particular by a randomized controlled approach the effects on glycemic control of patients followed by teleconsultation or traditionally in standard visit in the outpatient clinic. the patients in the teleconsultation group will arrange their bookings on a website (http://www.telediabete-fid.it/) in this website they could also access to web educational courses (mainly nutrition, insulin management, glucose monitoring auto-control) or to nutritional and psychological counselling.

Eligibility criteria:
inclusion criteria: * patients affected by type 1 diabetes mellitus, 5-50 years old under multi injection insulin therapy or under continuous subcutaneous insulin infusion * with a feasible web access exclusion criteria: * without a feasible web access * that need a periodic physical examination

Keywords: teleconsultation insulin therapy hba1c
nonsteroidal antiinflammatory drugs in women with postpartum pre-eclampsia

Conditions: Hypertension

Summary: hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. the available data in the medical literature have primarily focused on antenatal and peripartum management. there are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension. the purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.

our objective is evaluate ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. we include only women with vaginal delivery.

Eligibility criteria:
inclusion criteria: vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia exclusion criteria: sensitivities to ibuprofen cesarean delivery
post-operative rehabilitation of knee osteochondral defect: a case series

Conditions: Osteochondral Defect; Osteochondritis Dissecans

Summary: a case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at california state university, northridge (csun). all subjects received surgical intervention to treat the defect. the surgeries performed were either an osteoarticular transfer system (oats) procedure and/or a microfracturing procedure. subjects were treated post-operatively by the csun team physical therapist and/or athletic trainers at csun. this paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.


Eligibility criteria:
inclusion criteria: * student athlete at csun * diagnosed with osteochondral dissecans (ocd) * underwent surgical procedure to treat ocd * treated postoperatively by the team physical therapist and/or athletic trainers at csun. exclusion criteria: - no concurrent ligamentous injures to the knee during the time of subject participation in the study
the prevelance rate of human cytomegalovirus (hcmv), epstein-barr virus (ebv) and human herpes virus (hhv-6) in a saliva of the patient with periodantitis

Conditions: Cytomegalovirus; Epstein-Barr Virus Infections; Herpesvirus Infection

Summary: the purpose of this study is to study the prevalence of ebv, hcmv, hhv-6 in saliva and on the toothbrush patient with periodontitis.

human cytomegalovirus (hcmv), epstein-barr virus (ebv) human herpes virus6 (hhv-6)

Eligibility criteria:
inclusion criteria: * patient with peridontitis exclusion criteria: * previous periodontal treatment in last 3 month * toothbrushing disability