Kornimate/medical-research-clean huggingface dataset:
the impact of dietary intervention on oxidative/antioxidant markers and gut microbiota in athletes

Conditions: Non Communicable Diseases

Summary: during intense physical exercise, there is an overproduction of reactive oxygen species, which leads to oxidative stress and reduced training and sports performance, as well as the development of chronic diseases. eating foods with a high content of bioactive ingredients and high antioxidant potential can alleviate the negative effects caused by reactive oxygen species and improve the state of intestinal microflora. the aim of these interventional studies was to determine whether daily consumption of foods with high antioxidant potential, including fruit and nut bars, for a period of 1 month would reduce oxidative stress in athletes during competition and positively change the intestinal microflora.

the study concerns a 4-week dietary intervention. the intervention consisted of daily consumption of 1 bar weighing 50 g, containing nuts and dried fruits with high antioxidant potential. the study included a group of 50 women and men, healthy athletes (cyclists, long-distance runners and triathletes). a 3-day, 24-hour dietary interview was conducted before and after the dietary intervention. then, using the dieta 6.0 computer program, the energy and nutrient contents in the diet were estimated. in addition, adherence to the dietary intervention was assessed using a survey questionnaire. before and after the dietary intervention, oxidative-antioxidant markers were determined in the blood of the subjects (oxidative stress, antioxidant potential, concentration of antioxidant enzymes: glutathione peroxidase, superoxide dismutase, catalase) using ready-made kits. moreover, changes in the intestinal microbiome were assessed in feces before and after the dietary intervention. additionally, height and weight were measured before and after the intervention to calculate body mass index (bmi). the study will help answer the question of whether dietary intervention using foods with high antioxidant potential can influence changes in oxidative-antioxidant markers in the blood, intestinal microbiome and body weight of study participants.

Eligibility criteria:
inclusion criteria: * healthy men and women with high physical activity (triathletes, cyclists, long-distance runners), not taking medications for chronic diseases, age 20-50 years, men and women. exclusion criteria: * occurence of chronic diseases (e.g. hypertension, diabetes, cancer, thyroid diseases, neurodegenerative diseases), taking medications for chronic diseases, age\ 50 years, low physical activity

Keywords: sport cardiovascular disease antioxidant stress
study comparing lymphoseek® vs. albumin nanocolloid in head and neck, melanoma and breast cancer

Conditions: Head Cancer; Neck Cancer; Melanoma; Breast Cancer

Summary: comparison of the concordance of albumin nanocolloid and lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams


Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan. * at least 18 years of age at the time of consent. * the subject is clinically node negative (cn0) at the time of screening. * in melanoma patients * diagnosis of primary melanoma with sentinel node indication ( \>0.8 mm breslow thickness; clinically negative lymph nodes) * in breast cancer patients * t1-t2 n0 breast cancer. * patients with pure ductal carcinoma in situ (dcis) if lymph node biopsy is part of the surgical plan. * in oral cavity tumors patients * t1-t2 n0 oral cavity squamous cell carcinoma exclusion criteria: * pregnancy or lactation * clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes * patients that have had preoperative chemotherapy, immunotherapy or radiation therapy * patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor * patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).
rtms and body shape perception

Conditions: Anorexia Nervosa

Summary: anorexia nervosa (an) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. body weight and shape dissatisfaction is linked to the development, maintenance and relapse of an. neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with an compared with healthy subjects. repetitive transcranial magnetic stimulation (rtms) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rtms. the aim of this study was to investigate the effect of "excitatory" high-frequency rtms over the "hypoactive" inferior parietal cortex of 54 patients with an. this randomized, double-blind, placebo-controlled study will compare effective rtms (2000 ten-hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rtms. assessments will be performed before rtms and after the last rtms session (immediately after, at 15 days and three months). the principal criteria for judgement is a body image satisfaction scale (boby shape questionnaire, bsq-34). the secondary criteria for judgement are eating behaviour scales (eating attitude test, eat-40; bulimia test, bulit and eating disorders inventory, edi-2), the hamilton depression rating scale and hamilton anxiety rating scale, a quality of life scale (short-form health survey, sf-36), a body composition analysis using a dual-energy x-ray absorptiometry and the alpha-msh autoantibodies levels (biomarker for eating disorders recently described). inferior parietal cortex rtms could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. also positive results could have direct therapeutic implications with the possibility to complete regular rtms sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.


Eligibility criteria:
inclusion criteria: * female * age above 18 * restrictive anorexia nervosa with a disease duration more than one year and less than three years. * body mass index below 16 * patient receiving or having received optimal treatment for anorexia nervosa * right-handed * normal blood ionogramme * previous stable antidepressor treatment for one month and no expected modification in the three following months * patients arriving by car with someone else or by public transportation exclusion criteria: * pregnancy * contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc. * history of epileptic seizure * cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.) * history of previous rtms
triathlon® partial knee replacement (pkr) outcomes study

Conditions: Arthroplasty, Replacement, Knee

Summary: the purpose of this study is to compare the 10-year knee society score (kss) functional results of the triathlon pkr unicondylar knee to the 10-year knee society score (kss) functional results of the triathlon cruciate retaining (cr) total knee.


Eligibility criteria:
inclusion criteria: * the subject is a male or non-pregnant female 21-75 years of age at the time of enrollment. * the subject requires a primary cemented unicompartmental knee replacement. * the subject has a diagnosis of osteoarthritis (oa) or posttraumatic arthritis (ta). * the subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present. * the subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion. * the subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus. * the subject has signed the institutional review board (irb) approved study specific informed patient consent form. * the subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. exclusion criteria: * the subject has inflammatory arthritis or avascular necrosis(avn). * the subject is obese, bmi \> 35. * the subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint. * the subject has a history of anterior cruciate ligament (acl) reconstruction. * the subject has had a high distal femoral, or proximal tibial osteotomy. * the subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device. * the subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study. * the subject is immunologically suppressed, or is receiving chronic steroids (\>30 days duration). * the subject has a known sensitivity to device materials. * the subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis. * the subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * the subject has an active or suspected latent infection in or about the knee joint. * the subject is a prisoner.

Keywords: osteoarthritis, post-traumatic arthritis
a study to evaluate the safety and pharmacokinetics of bms-986177 in participants with end-stage renal dysfunction on chronic stable hemodialysis treatment

Conditions: Thrombosis; Factor XI; Renal Impairment; ESRD (End-Stage Renal Disease)

Summary: an oral dose of bms-986177 administered in end-stage renal dysfunction (esrd) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.


Eligibility criteria:
inclusion criteria: * classified at screening as having esrd requiring hemodialysis at least 3 times per week for 3 months. * clinical, ecg, and laboratory findings consistent with renal dysfunction * bmi of 18.0 to 38.0 kg/m2 inclusive * subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose) * women not of child bearing potential (wnocbp). sexually active fertile men with partners who are wocbp must use non-hormonal highly effective birth control exclusion criteria: * history of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening * evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising * current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug * any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis) * need for aspirin or need for p2y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor) * other protocol defined exclusion criteria could apply
the state of nebulizer therapy in russian federation

Conditions: Survey; Respiratory Failure; Respiratory Disease

Summary: it is known that the inhalation (nebulizer) use of drugs is of great importance in the intensive care of patients with acute and chronic respiratory failure of various origins. searching pubmed data for the last 5 years (2017-2022) for the keywords "nebulizer therapy" revealed 533 publications, and "mesh nebulizer therapy" - only 25 sources. during the same period, the national database (e-library) has 75 publications for the keywords "nebulizer therapy", and 4 sources for "mesh nebulizer therapy". it should be noted that almost all publications are devoted to the use of nebulizers for specific diseases and pathological syndromes. there are no works evaluating the adherence of specialists, systemic indications and actually used methods. the aim of trial is to study the current state of the use of nebulizer therapy in medical organizations and identify ways to improve its effectiveness this study is planned to be carried out using a questionnaire using a database based on the internet electronic survey form.

we intend to involve at least 3 medical organizations in the subjects of the russian federation with a population of up to 1 million people; at least 5 medical organizations in the constituent entities of the russian federation with a population level of 1 to 3 million people, at least 7 organizations with a population level of more than 3 million people. in cities of the russian federation with a population of 1 million people or more - at least 5 medical organizations, and in the cities of moscow and st. petersburg - at least 10 medical organizations.

Eligibility criteria:
inclusion criteria: * medical physicians exclusion criteria: * lack of experience in conducting nebulizer therapy. lack of technical capability for nebulizer therapy in a medical organization.
novel quantitative magnetic resonance imaging (mri) measures in the assessment and follow-up of patients with pulmonary hypertension (ph)

Conditions: Pulmonary Hypertension

Summary: a prospective study of the use of two novel mri techniques (oxygen-enhanced and fourier decomposition mri) in the initial diagnosis and follow-up of patients with pulmonary hypertension. the investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring. the reserach mri is in addition to standard of care and will not affect treatment decisions.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pulmonary hypertension. * age 18 and over. exclusion criteria: * standard contra-indications to mri (as per nhs mri safety questionnaire). * not medically fit for transfer to mri. * patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.

Keywords: mri oxygen enhanced fourier decomposition
prevalence of mullerian anomalies in infertile women

Conditions: Mullerian Anomaly of Uterus

Summary: * mullerian anomalies are congenital structural anomalies in the uterus . * its prevalence is not uncommon .

* pco is very common in gynecological practice * women with mullerian anomalies should be properly evaluated for other gynecological and urological problems

Eligibility criteria:
inclusion criteria: * females with age between 20-42 years with primary infertility exclusion criteria: * females with age above 42 years or below 20 years females with secondary infertility
non-interventional study to assess the frequency of cachexia in patients with non-small cell lung cancer.

Conditions: Non-small Cell Lung Cancer; Cachexia

Summary: the purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (nsclc).

this is a cross-sectional, non-interventional, european (france and belgium), multicentric prevalence study, conducted on a representative population of 500 patients with nsclc, to assess the frequency and the management of cachexia and associated symptoms. the study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the adelf (the association of french-speaking epidemiologists) and in accordance with the strobe recommendations for the drafting of reports and publications related to the study. the information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. the physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. the patient information form in france or a specific consent form in belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician). this study does not require any additional specific data. data will come from the medical file and from the routine disease management. furthermore, the following self-completion questionnaires will be proposed to patients: visual analogue scale for dietary intake (dietary intake vas), assessment of the concerns associated with the anorexia/cachexia (anorexia-cachexia module of the functional assessment of anorexia/cachexia therapy \[faact\] questionnaire), quality of life (eortc qlq-c30), and assessment of physical activity (ipaq, international physical activity questionnaire). abdominal ct-scan, if available, will be collected for assessment of skeletal muscle mass index at l3.

Eligibility criteria:
inclusion criteria: * patient 18 years of age and older * patient with nsclc * patient who has been informed of the study and who has signed a patient information leaflet for france or an informed consent for belgium * patient able to complete a self-assessment questionnaire exclusion criteria: * patient unable to consent and/or unable to sign the patient information form in france or an informed consent in belgium * patient with a complete resection of an early stage nsclc * history of head and neck cancer

Keywords: cachexia non-small cell lung cancer anorexia malnutrition
effect of baduanjin exercise on chronic periodontal disease in elderly

Conditions: Chronic Periodontal Disease

Summary: the metabolic syndrome (mets) is a spectrum of conditions that increase the risk of cardiovascular disease and diabetes mellitus. the components of mets include dysglycemia, visceral obesity, atherogenic dyslipidemia (elevated triglycerides and low levels of high-density lipoprotein) and hypertension. an association of periodontal disease and mets has been suggested. this association is believed to be the result of systemic oxidative stress and an exuberant inflammatory response. physical activity is associated as a potential tool for reduction of periodontal disease prevalence. the frequency of physical activity is directly related to a low occurrence of periodontitis.

for 6 months, mets elderly (25 elderly) with chronic periodontal disease will be involved in sixty-minute baduanjin physical training (5 session weekly). also, for 6 months, another mets elderly (25 elderly) with chronic periodontal disease will serve as a control non-trained group.

Eligibility criteria:
inclusion criteria: * fifty elderly with metabolic syndrome and chronic periodontal disease will be included * both sexes will be included exclusion criteria: * smokers * elderly engaged in physical activity programs * any cardiovascular/respiratory diseases that obstacle the conduction of baduanjin * elderly on drug therapies for chronic periodontal disease
the effect of mucogyne® ovule on wound healing (origyne)

Conditions: Cervicovaginitis

Summary: this clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the mucogyne® ovule medical device in promoting the process of wound healing, when used in accordance with its approved labelling, in the context of local cervicovaginal surgery.


Eligibility criteria:
inclusion criteria: 1. adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (leep) conization) for cervical or vaginal dysplasia, 2. is able to understand the study related information and to give a written informed consent, 3. has signed the informed consent form before beginning any study procedure, 4. has no condition that may interfere with the study assessments, 5. agrees not to use other vaginal products than those planned in the study protocol, during participation in the study, 6. is able to comply with protocol requirements and respect the conditions of the study, 7. affiliated to the social security system. exclusion criteria: 1. previous vaginal surgery within the year preceding the inclusion in the study, 2. known hypersensitivity to any of the medical device ingredients, 3. patient with local infectious lesions in the area to be repaired. 4. patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study, 5. patient who had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immunedeficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level \< 9 g/dl) and hemophilia), 6. immunosuppressive treatment, 7. heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records), 8. patients under judicial protection or under guardianship and patients deprived of freedom, 9. has any other severe chronic or acute medical or psychiatric condition that in the judgment of the investigator, could interfere with the study assessments.
rhomboid intercostal block versus serratus anterior plane block

Conditions: Postoperative Pain

Summary: evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

* to assess and compare quality of post- operative analgesia in each group. * time of performance of block in both groups. * to assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.

Eligibility criteria:
inclusion criteria: * adult patients aged between 21 to 60 years * undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -general anesthesia * informed consents * asa i \& ii * body mass index 25-30 kg/m2. exclusion criteria: * patients on anti-platelet, anticoagulant or b blocker drugs * patients with acute decompensated heart failure, hypertension, heart block, coronary disease, asthma, bleeding disorders, compromised renal or hepatic function * history of allergy to local anesthesia or opioid analgesia, * pregnancy.

Keywords: rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap
compliance and usability study evaluating rhinix™ nasal filters

Conditions: Seasonal Allergic Rhinitis

Summary: this study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in denmark.


Eligibility criteria:
inclusion criteria: * motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by astma-allergi danmark) * indicates having seasonal allergic rhinitis to grass via online questionnaire * informed consent (by email acceptance after having received information on the trial) * assess to internet and email exclusion criteria: * improper fit of the rhinix™ device