Kornimate/medical-research-clean huggingface dataset:
prediction of ovarian malignancy in the presence of sonographic pelvic mass

Conditions: Ovarian Neoplasm

Summary: the objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. the investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).

patients that arrive to the sonographic unit of the gynecological department with a diagnosis of ovarian mass will have a sonographic examination that include: trans-vaginal +- trans-abdominal ultrasound with doppler and three dimensional sonographic exam. anamnestic data will be collected and serum test for ca 125, he4 and cea. the management of the specific patient will be according to the department protocol, regardless the study data. the investigators will collect data about operation outcome and histological results of women that will be operated. women that won't be operated on will be followed up every 6 months by the study team. at the end of the study a statistical analysis will be made to create a sensitive and specific test for the prediction of malignancy in sonographic diagnosed ovarian mass.

Eligibility criteria:
inclusion criteria: * patients referred with sonographic diagnosis of pelvic mass exclusion criteria: * pregnant women * known gynecologic malignancy

Keywords: pelvic mass ovarian mass ultrasound serum markers ovarian malignancy
trial of a vaccination with tumor antigen-loaded dendritic cell-derived exosomes

Conditions: Non Small Cell Lung Cancer

Summary: lung cancer is the worldwide leading cause of cancer death. in france, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. the 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in france. in advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. the median progression-free survival (pfs) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. gustave roussy and curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mctx) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (dex). mctx inhibits treg functions restoring t and nk cell effector functions and dex are able to activate the innate and adaptive immunity. phase i trials showed the safety and feasibility of dex vaccines but no induction of t cells could be monitored in patients. since 2007, we validated a new process for isolation of second generation dex with improved immune stimulatory capacities. we propose a maintenance immunotherapy in 47 advanced unresectable nsclc patients responding or stabilized after induction chemotherapy with dex-based treatment to improve pfs rate at 4 months in these patients.


Eligibility criteria:
inclusion criteria: * advanced unresectable non small cell lung cancer * responding or stabilizer after induction chemotherapy

Keywords: advanced unresectable non small cell lung cancer responding or stabilized after induction chemotherapy
impact of bariatric surgery in obese patients with and without obstructive sleep apnea syndrome

Conditions: Obesity; Bariatric Surgery Candidate; Apnea, Obstructive

Summary: it has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (osa) syndrome. given the strong associations between osa and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in osas patients.

it has been shown to date that obesity is associated with increased mortality and that weight loss significantly improves cardiovascular risk factors. bariatric surgery is now the most effective intervention for the long-term treatment of obesity and its complications. among patients receiving bariatric surgery, 30-90% have moderate to severe obstructive sleep apnea (osa) syndrome. the progressive loss of weight contributes to the regression of the symptoms related to osa. observational studies have shown that bariatric surgery can rapidly improve glycemic control and cardiovascular risk factors with a significantly higher remission rate of hypertension and dyslipidemias than in the non-surgical group. given the strong associations between osa and cardiometabolic comorbidities, this project is based on the hypothesis of a lower improvement of cardiovascular risk factors and a higher number of post-surgical complications in osas patients.

Eligibility criteria:
inclusion criteria: * patient, male or female, aged over 18 * patient in preparation for bariatric surgery (ring, sleeve gastrectomy or bypass) in the center celiobe. * patient affiliated with social security or beneficiary of such a scheme * patient having signed the free and informed consent exclusion criteria: * patient who has already had bariatric surgery (ring, sleeve gastrectomy or bypass). * patient already receiving cpap treatment for sleep apnea syndrome. * patients with pathology indicating the use of cpap in self-guided mode (heart failure with altered ejection fraction) for patients diagnosed with osas * patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study * patient suffering from mental pathology does not make possible the collection of a consent. * protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant, lactating or parturient woman * patient hospitalized without consent

Keywords: obesity bariatric surgery obstructive sleep apnea
rtms-induced cumulative pattern of sbdnf in chronic schizophrenia

Conditions: Schizophrenia

Summary: this study aims at investigating the neuroplastic potential and the possible factors affecting rehabilitation in chronic schizophrenia patients on stable medication, by investigating the cumulative pattern of serum bdnf representing the neuroplasticity in the brain, through quantitative stimulus such as rtms.

subjects who have been enrolled for this study will take baseline evaluation for sociodemographic data and serum level of bdnf, plasma prolaction, and magnesium, etc. and then, weekday regular stimulation through rtms will be applied on dlpfc of brain. after the completion of stimulation for 2 weeks, the change or response of serum bdnf will be analyzed and compared.

Eligibility criteria:
inclusion criteria: * duration of illness over 10 years * on stable medication, antipsychotics * no change on medication within at least 2 weeks * diagnosis of schizophrenia according to dsm-iv-tr exclusion criteria: * left or both-handedness * anticonvulsant use * lorazepam equivalent over 3 mg

Keywords: rtms-induced cumulative pattern of sbdnf
new biomarkers and therapeutic targets in osteoporosis via omics technologies

Conditions: Osteoporosis, Postmenopausal; Osteoporosis Fracture; Osteoporosis, Severe

Summary: this study aims to discover novel biomarkers and therapeutic targets for osteoporosis through the use of advanced omics technologies, including proteomics and metabolomics. by analyzing bone and plasma samples from patients with osteoporosis, the research seeks to understand the underlying mechanisms of the disease and identify potential diagnostic and therapeutic biomarkers.

study objectives: 1. to investigate the proteomic profile of bone and plasma in clinical osteoporosis compared to patients with osteoarthritis. 2. to study the metabolomic profile of serum in clinical osteoporosis compared to patients with osteoarthriti. 3. to identify and validate potential biomarkers for osteoporosis diagnosis and treatment. 4. to elucidate the pathophysiological mechanisms involved in osteoporosis. methodology: clinical osteoporosis: patient recruitment: 60 postmenopausal women will be divided into two groups: those with osteoporotic hip fractures and a control group with osteoarthritis undergoing total hip replacement. sample collection: bone samples: collected from the femoral neck during surgery, cleaned, and divided into four parts. one part will be used for bone density analysis (pqct or dxa), and the other parts will be stored for proteomic analysis. blood samples: fasting morning blood samples will be collected for general biochemical tests, bone turnover markers, and stored for metabolomic and proteomic analyses. technologies and analysis: proteomics: utilizes mass spectrometry to identify and quantify proteins in bone and plasma. key pathways and protein networks involved in osteoporosis will be identified using bioinformatics tools. metabolomics: analyzes small molecules in serum to uncover metabolic changes associated with osteoporosis. both targeted and non-targeted approaches will be used to identify significant biomarkers. expected outcomes: 1. identification of specific proteins and metabolites as biomarkers for osteoporosis. 2. enhanced understanding of the molecular mechanisms driving bone loss. 3. validation of therapeutic targets for potential treatment strategies. significance: this integrative approach combining proteomics and metabolomics aims to provide a comprehensive understanding of osteoporosis, facilitating the development of more accurate diagnostic tools and effective treatments for this widespread bone disease.

Eligibility criteria:
inclusion criteria: * postmenopausal female patients with osteoporotic subcapital femoral neck fracture (arm 1) * postmenopausal female patients with hip osteoarthritis that will undergo total hip replacement (arm 2) exclusion criteria: * patients that have undergone before osteoporotic fractures * patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions

Keywords: osteoporosis osteoarthritis hip fracture postmenopausal osteoporosis proteomics metabolomics osteoporotic hip fracture
implementation of a rapid recovery program in gynecologic oncology surgery: a pilot study

Conditions: Cervical Cancer; Uterine Endometrial Cancer; Ovarian Cancer

Summary: over 600,000 hysterectomies are performed annually in the united states. despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. rapid recovery protocols (rrp) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.

subjects will be randomly assigned to one of two groups: rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (nsaids) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).

Eligibility criteria:
inclusion criteria: * women who are being seen at the women's health center by the gynecologic oncology group at the university of minnesota if planned surgery includes an exploratory laparotomy exclusion criteria: * \< 19 years old * pregnant * undergoing a procedure other than laparotomy * scheduled to be discharged the same day of surgery * chronic narcotic pain medication user * american society of anesthesiologists (asa) score of \> or = 3 * any condition that would exclude women from undergoing regional anesthesia

Keywords: laparotomy hysterectomy
effects of forest bathing in vancouver, b.c. parks

Conditions: Nature, Human; Mental Health Wellness 1; Stress, Psychological; Blood Pressure; Environmental Exposure; Anxiety

Summary: this study aims to investigate environmental factors that influence people's responses to the japanese practice of forest bathing in vancouver, b.c. parks.

the primary research aim is to investigate the relationship between biotic and abiotic factors in a sample of vancouver, b.c. forested parks and specific health-related outcomes after forest bathing interventions. forest bathing programs are a promising therapeutic method for enhancing heart rate and blood pressure functions and an effective psychological relaxation strategy. this study will investigate changes in autonomic nervous system activity and mood states after a 60-90 minute forest bathing program in four vancouver, b.c. parks. approximately 100 adult participants will be recruited for the study and participate in four sessions over one year. physiological responses, pulse rate, systolic and diastolic blood pressure, and psychological indices will be measured before and after each session. the health effects of forest-based interventions will vary due to environmental factors such as weather, temperature, humidity, light, and participants' psychological and physiological states. we are taking measurements pre- and post-treatment to detect any change in response during each session and seasonally. primary endpoint is to determine if the guided walk provides greater enhanced heart rate and blood pressure functions and an effective psychological relaxation strategy over the self-guided walk. secondary endpoints: 1) to determine if participants living in neighborhoods with below average street trees receive greater benefits than participants that live in neighborhoods with average or above average street trees, 2) assess changes within the same individuals over time 3) if there are different outcomes seasonally 4) if there are different outcomes between study sites.

Eligibility criteria:
inclusion criteria: * adults (19+) that are residents of vancouver, b.c. * spend time on a trail in a vancouver park for at least 60 minutes per month * willing to refrain from tobacco products, alcohol, caffeine, marijuana, and psilocybin for at least two hours prior to arriving at the study site and during the forest bathing sessions exclusion criteria: * must be able to move along a barrier-free trail independently * non-residents (e.g. tourists) * children (under 19 years of age) * participants with pets

Keywords: forest bathing shinrin-yoku forest therapy forest-based intervention forest immersion nature therapy
comparison of losartan associated with indapamide versus hyzaar® in the hypertension treatment

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the clinical efficacy of indapamide 1.5mg / losartan 50mg and indapamide 1.5mg / losartan 100mg on reduction of blood pressure.

* open label,randomized, multicenter * experiment duration: 12 weeks. * 05 visits (day 0 - randomization), (day 1 - 2 weeks pos-randomization), (day 2 - 4 weeks pos-randomization), (day 3 - 8 weeks pos-randomization) and (day 4 - 12 weeks pos-randomization). * evaluate the efficacy of a medication associated with two antihypertensive agents in two fixed doses compared to the hyzaar® in patients with hypertension * adverse events evaluation

Eligibility criteria:
inclusion criteria: * adults male or female aged ≥ 18 years old; * patients with a diagnosis of hypertension (defined by the medical investigator) treated with monotherapy or at least two blood pressure measurements ≥ 140/90, in a sitting position with a 5' interval between measurements, * patients with normal lab tests results in the last six months or that the investigator consider not clinically significant, * patient who accept the discontinuation of previous hypertension therapy. exclusion criteria: * patients with blood pressure ≥ 180/100 mmhg; * patients with uncontrolled hypertension (≥ 140/90 mmhg) treated with thiazide diuretics; * presence of concomitant coronary artery disease, congestive heart failure, diabetes and renal failure (creatinine\> 1.5 mg / dl); * patients with hypo or hyperkalemia (serum potassium outside normal range); * patients with alt greater than 2.5 the upper limit of normal or active liver disease; * pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period; * patients on drug or alcohol abuse in the last two years; * patients with secondary hypertension (renovascular disease, pheochromocytoma, cushing's syndrome); * patients with allergic reactions or hypersensitivity to ace inhibitors, diuretics or medications containing sulfa and / or any excipients of formulation; * refusal or inability to provide the informed consent term.; * refusal to discontinue the anti-hypertensive medication. * patients at the discretion of the investigator does not have indication for discontinuing the current medications;
lung tissue research consortium

Conditions: Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease

Summary: the ltrc will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the ltrc. collections of specimens will be linked to individual clinical data appropriate to the particular disease. the primary goal of the ltrc is to identify participants with suspected lung cancer or metastatic disease who are willing to provide informed consent for research use of their specimens and data. secondarily, the ltrc investigators intend to collect clinical data, limited exposure data, physiologic studies, and radiographic studies from these participants.


Eligibility criteria:
inclusion criteria: * adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases. exclusion criteria: * diagnosis of cystic fibrosis or pulmonary hypertension. * any other condition that, in the judgment of the investigator, precludes participation. * failure to obtain written consent.
young goalkeeper's fracture: radiographic findings

Conditions: Radius Fractures

Summary: the aim of this project is to evaluate retrospectively goalkeeper's fractures in children using the children fracture classification and to evaluate the distal radius tilt angle of the growth plate on plain radiographs of the forearm. patients positive for goalkeeper's fracture will prospectively answer a questionnaire concerning risk factors and circumstances during the injury.

distal forearm or radius fractures in young goalkeepers have been named "the young goalkeeper's fracture" in the literature. while catching the soccer ball the child suffers a distal forearm fracture due to axial forces to the immature bone of the child. these goalkeeper's fractures on radiographs may be subtle or difficult to discriminate from normal radiographs. retrospective study for the evaluation of radiographs of the forearm from 2005 - 2016 of children with history of catching a ball. two radiologist are blinded for history, age, name and findings on final reports. first reading without measurement of distal tilt angle, second reading with measurement of distal tilt angle and after consensus meeting. questionnaire: prospectively all patients with goalkeeper's fracture will answer a questionnaire concerning circumstances and risks during the accident.

Eligibility criteria:
inclusion criteria: * children 1-16 years of age with distal radius fracture and the clinical history: "child catches a ball", between 1/2005 - 7/2016. * control group (1-16 years) with normal distal radius and no history to catch a ball and no fracture. evaluation of the normal distal tilt angle of the radius. exclusion criteria: * pathological fractures * other history of trauma than to catch a ball * patients older than 16 years

Keywords: goalkeeper's fracture
a randomised cross-over study with two 1-piece urostomy bags.

Conditions: Urostomy

Summary: background urostomy is a surgical procedure that detours or diverts urine away form a diseased or defective bladder. the bladder can be removed and the urine is passed out of the body through an opening (stoma) in the stomach. people with urostomy will not be able to start and stop urine coming out through the stoma, so a urostomy bag will be fitted to collect the urine as it comes out. a urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a bag connected to the adhesive to collect the urine. it is very important the standard is high on these products; otherwise the user (urostomy-patient) will experience lots of problems with the skin around the stoma.

in this trial we are comparing two types of urostomy bags - the sensura 1-piece and hollisters moderma flex. both products are ce-marked, meaning that they are safe and approved in use for people with an urostomy. population 30 urostomy operated people from uk will participate in the trial. only participants who normally use a flat 1-piece urostomy bag can participate. it is very important that the participants keep their normal use- and change pattern. furthermore they need to be over 18 years old, have had the urostomy for more than 3 months, the size of the urostomy shall be between 15-55 mm, otherwise the bag will not fit them and then they should be able to handle the bags themselves and be willing to use the two products tested in the trial.

Eligibility criteria:
inclusion criteria: in order to be enrolled in the clinical investigation, the subject must: * be at least 18 years old, * be mentally and physically capable of signing the written consent form * be able to fill in the case report form (questionnaire) * have an urostomy with a size between 15-55 mm. * have had the urostomy for 3 months or more, * use a 1-piece bag normally. * be able to handle the bag themselves (application and removal) * be willing to use coloplast sensura 1-piece bag * be willing to use hollisters moderma flex, 1-piece bag exclusion criteria: in order to be enrolled in the clinical investigation, the subjects must not: * be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma forward) * need to use an ostomy belt * be currently suffering from any dermatologiacal problems, needing special treatment, in the peristomal area (investigator will evaluate skin according to a newly developed ostomy skin tool from coloplast a/s) * being treated with chemo- or radiation therapy, * be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or * be pregnant or breast-feeding.

Keywords: urostomy, 1-piece, cross-over, randomised, preference