Kornimate/medical-research-clean huggingface dataset:
medico-ecological monitoring ((csm, mctq, spaq, psqi, hrv, spirometry; anthropometry, bp) of the different population groups (students, schoolchildren, volunteers) in north caucasus

Conditions: Conditionally Healthy Persons; Persons With a High Body Mass Index

Summary: observational clinical trial of the chronotype, sleep quality, seasonal pattern, behavioral time preferences, the functional state of the body's regulatory systems and respiratory systems in individuals of different age groups and metabolic status. in the process of medico-ecological monitoring, including all of the above, an assessment of the psycho-physiological status and the state of the regulatory and respiratory systems of the subjects' body, living in north ossetia-alania, will be made.

modern methods of medicine are aimed at maintaining homeostasis in a situation when, under the influence of factors of the external or internal environment, acute, chronical and extreme (in covid-19 isolation) physiological stress, is formed, which the body is no longer able to compensate, and which forms the main group of human diseases - adaptation diseases, primarily cardiovascular, including cardiometabolic syndrome. against the background of the covid-19 pandemic, in conditions of limited physical activity, disruption of the daily routine and high psychophysiological load, various health disorders of both functional and organic nature may occur and existing pathologies may worsen. the aim of the study - screening of health of different age categories of the population, based on research of chronotype, sleep quality, seasonal pattern, behavioral time preferences and functional state of body's regulatory and respiratory systems in individuals from the different age groups. methods: testing of psycho-physiological functions using composite scale of morningness (csm), munich chronotype questionnaire (mctq), seasonal pattern assessment questionnaire (spaq), pittsburgh sleep quality index (psqi); heart rate variability (hrv); spirometry; anthropometry (measurement of height, weight, waist circumference), blood pressure measurement (bp). statistical analyses planned to perform frequency, correlation, factorial and variance analyzes using statistica 10,0 software ("statsoft, inc"). data investigate by mean value (m) and standard deviation (sd) in case of normal data distribution or nonparametric method with determination of median (me) and interquantile ranges (25th and 75th percentile) in the case of a distribution other than normal. anova, manova analysis. statistically significant differences in all statistical tests set to p\<0.05

Eligibility criteria:
inclusion criteria: conditionally healthy persons, persons with metabolic disorders in the presence of basic criterion ms - abdominal obesity. exclusion criteria: chronic somatic diseases; infectious diseases; malignant neoplasms of various organs and systems; viral infections; autoimmune diseases; mental illness; pregnancy and lactation in women

Keywords: public health metabolic syndrome chronotype sleep quality seasonal pattern regulatory systems physiological stress
effect of vitamin d supplement in induction of ovulation in overweight women with polycystic ovary syndrome

Conditions: Ovulation Induction

Summary: the aim of this work is to evaluate the effect of vitamin d supplementation in overweight infertile women with pcos undergoing induction of ovulation.

the study will include overweight infertile women with pcos seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups: group a (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin d and calcium supplement group b (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement

Eligibility criteria:
inclusion criteria: * polycystic ovarian syndrome diagnosis made according to eshre/asrm criteria. * infertility is the cause for seeking treatment. * overweight females with bmi more than 25 but less than 30. exclusion criteria: * causes of infertility other than pcos. * causes of anovulation other than pcos. * current or in last six months use of hormonal treatment. * contraindication to any drug used in the study.
intra- and inter-operator reliability of isometric back and abdominal muscle strength testing in healthy controls and persons with nonspecific chronic low back pain.

Conditions: Chronic Low Back Pain

Summary: low back pain (lbp) is currently the most common cause of functional impairment with regard to the musculoskeletal system1. lbp occurs in men and women in all age groups and has a peak incidence between 30 and 65 years. although 10% of the persons with lrp can be diagnosed with a specific underlying pathology (e.g., disc herniation, canal stenosis, spondylolysis, ...), 90% have symptoms with an unclear origin. 23% of the latter group will eventually develop chronic nonspecific low back pain (cnslbp)2. exercise therapy is seen as an important component in the rehabilitation of persons with cnsplbp3. because previous research showed reduced muscle strength of the back muscles4, exercise therapy that improves / recovers muscle strength is being investigated. however, there is still a lack of clarity concerning the effect that reduced muscle strength has on the development and further development of back pain5-6. the objective testing of back muscle strength remains a recurring issue. up to now, back muscle strength has been mainly tested by a battery of clinical tests (eg sorensen test) or the use of "iso machines"7. these iso machines contain a dynamometer that can very specifically reflect the isometric or isokinetic force on an axis of rotation. different types of these iso machines (eg cybex, biodex) have already been developed, each with specific designs (eg differences in the hip angle, differences in the stabilization of the participant). however, to date no standardized protocols are available for evaluating both abdominal and back muscle strength. furthermore, it is also essential that before such systems can be used in clinical intervention studies, the reliability of such systems is investigated and that reference data from healthy subjects are collected with which data from patients can be compared. the aim of the current research is therefore to investigate the intra- and inter-operator reliability of a standardized protocol drawn up according to the latest scientific evidence. a second goal is to set standard values for healthy persons for the developed protocol using the biodex 3 dynamometer system.


Eligibility criteria:
inclusion criteria: 1. medically diagnosed with non-specific chronic low back pain, 2. between 25-60 years old, 3. able to understand dutch (spoken and written). exclusion criteria: 1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed), 2. radiculopathy (uni- or bilateral), 3. co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, pregnancy, 4. ongoing compensation claims and/or (work)disability \> 6 months, 5. rehabilitation/exercise therapy program for lbp in the past 6 months.
a single-session intervention for families on waitlists for child anxiety treatment

Conditions: Anxiety Disorders

Summary: lengthy wait times to access treatment for youth anxiety disorders is a critical issue. to help address this issue, investigators will pursue the following aims in n = 65 families on waitlists for outpatient youth anxiety psychosocial treatment. aim 1 pilot phase: develop and pilot a single session intervention (ssi) tailored for families on waitlists for outpatient psychosocial treatment for youth anxiety disorders. investigators will pilot the single session intervention (ssi) with n = 5 families and use cognitive response interviewing to obtain data from parents and children, ensuring the content is understandable and accessible. the ssi will include psychoeducation on the cognitive behavioral conceptualization of anxiety, introduction to self-regulation strategies to manage physiological manifestations of anxiety, and cognitive restructuring of anxiogenic thoughts. the ssi will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts. investigators will refine the ssi based on these data. following the pilot phase, investigators will enroll an additional n = 60 families and randomize them to either the ssi (n = 30) or waitlist control (n = 30). aim 2 test phase acceptability, and satisfaction: examine acceptability of the refined ssi, as well as satisfaction with the ssi. investigators hypothesize that users will find the module to be acceptable and will report high satisfaction. aim 3 test phase anxiety outcomes: demonstrate reductions in youth anxiety symptom severity. investigators hypothesize that anxiety symptom severity and impairment will be significantly lower among youth who receive the refined ssi relative to youth on waitlist control. the main risk or discomfort from this research is that participants might feel uncomfortable answering questions about their behavior and feelings. another possible risk is breach of confidentiality that could identify a participant as having elevated levels of anxiety. the benefits of this ssi would include increasing accessibility and scalability of treatment for youth anxiety disorders. overall, this study will provide critically needed data to advance resource efficient treatment options for youth anxiety disorders.


Eligibility criteria:
inclusion criteria: * be between ages 7 and 17 years * endorse clinically elevated anxiety symptoms on either parent or youth report, as indicated by a score \> 25 on the screen for child anxiety and related emotional disorders-child or parent versions (scared-c/p). exclusion criteria: * parent report of past diagnosis of autism spectrum disorder, intellectual disability, bipolar disorder, tourette's disorder, psychotic disorders, or substance use disorders * show high likelihood of hurting themselves or others * not having access/connectivity needed for telehealth video conferencing to complete the module.
endocrine function during deferasirox therapy

Conditions: Iron Overload; Transfusion-dependent Thalassemia; Endocrine; Complications

Summary: a national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.


Eligibility criteria:
inclusion criteria: * adult and pediatric patients with transfusion---dependent thalassemia; * chelation with deferasirox as assigned chelation therapy; * available medical history including relevant clinical data (age at start of transfusion regimen, age at start of chelation therapy, prior chelation therapy, concomitant diseases and concomitant treatments, including hormonal replacement treatments if appropriate) and laboratory data (e.g tsh, ft3 and ft4, fasting serum glucose, ogtt serum glucose, bone mineral density z---score, t---score, g/cm2, pth, fsh, lh, testosterone and estradiol, serum ferritin, liver function tests,renal function tests, mri t2\* value) at baseline and at the end of study exclusion criteria: * non transfusion- dependent patients; * other chelation therapy than deferasirox or combination with other chelators during the observation; * absence of complete medical history as above specified
us guided eoi block versus espb for postoperative analgesia in laparoscopic cholecystectomy

Conditions: Postoperative Pain

Summary: to compare the efficacy of usg-guided bilateral external oblique intercostal (eoi) block with erector spinae plane block (espb) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both external oblique intercostal fascial plane block and erector spinae plane block are effective in providing post-operative analgesia.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years with a body mass index (bmi) of 18-35 kg/m2, * patients with the american society of anesthesiologists (asa) physical status i/ii, * patients scheduled for elective laparoscopic cholecystectomy. exclusion criteria: * allergy to local anaesthetics, * infection at the site of injection, * coagulopathy, * chronic pain syndromes, * prolonged opioid medication, * patients who received any analgesic 24 h before surgery.

Keywords: cholecystectomy eoi block esp block
effect of alnd with vein branches reservation on postoperative upper limb edema and dysfunction in breast cancer

Conditions: Breast Cancer Lymphedema

Summary: the purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after alnd.


Eligibility criteria:
inclusion criteria: * age 18-69 years old, * regardless of gender, * breast masses were diagnosed by histology and pathology, stage ii -iii. * clinical palpation of axillary lymph nodes is positive, or * axillary lymph node puncture pathology is positive, or * the multidisciplinary treatment cooperation group (mdt) recommends axillary lymph node dissection, * good physical state score (0-2), * no severe organ complications, * no congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs, * informed consent, understanding and compliance with research requirements. exclusion criteria: * pregnancy or lactation, * inflammatory breast cancer, * clinical findings of metastatic lesions, * sentinel lymph node biopsy was negative, * history of upper limb or shoulder, chest, back trauma or surgery, * previous history of local radiotherapy, * history of other tumors, * vascular embolic disease, * those who are unable to comply with the clinical trial requirements for any reason.

Keywords: breast cancer axillary lymph node dissection post-mastectomy lymphedema upper limb dysfunction axillary vein branches reservation
social network interventions in rural honduras

Conditions: Malnutrition; Dysentery; Social Transmission of Health Behaviors

Summary: this project will examine the spread of health interventions with a randomized control trial design by introducing public health interventions in 32 villages in the honduran department of lempira. based on identified public health needs in the region, namely improved drinking water and diet, this study will provide training on the use of chlorine (sodium hypochlorite) for water purification and multivitamins for nutritional supplementation. in some villages, individuals selected for their social connectedness will be trained and given coupons that can be redeemed for either chlorine bleach or multivitamins, and these persons will be asked to spread this information and distribute coupons to four people of their choosing. in other villages, individuals selected at random will receive the same training, materials, and instructions. a second wave of coupon distribution will provide coupons to those who received a coupon from the original "seed" groups so that they may disperse these coupons further out in the social networks. over the following months, study investigators will look at how knowledge of these health practices, and uptake or and adherence to the practices, spreads throughout the villages. more specifically, the investigators will examine the speed and extent of spreading of these new health practices after introducing them to three different initial "seed" groups: (1) people chosen on the basis of being named as a friend by many people in their village, (2) people chosen based on being named as a friend by a randomly chosen individual, and (3) a group of randomly chosen individuals. it is hypothesized that spread will occur faster and/or to a greater extent when the intervention is started in groups 1 and 2 versus group 3 (control group).


Eligibility criteria:
inclusion criteria: * residents of targeted communities, ages 15 and up exclusion criteria: * children younger than age 15

Keywords: social networks nutrition vitamins chlorine
impact of adapted physical activity on cognitive functions in breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most frequent cancer in women in western countries. the improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. but several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. to limit these damages, non therapeutic approaches such as adapted physical activity (apa) have been developped. the goal of this study is to evaluate the benefit of apa program on cognitive functions in patients with locally advanced breast cancer.

patient with cognitive complaint will be randomized in two groups : * experimental group : immediate apa program (after randomization) * standard group : delayed apa program (3 months after randomization) apa program contains 10 sessions of apa within five weeks (twice a week). each session is composed of 5 exercises (each made of 3 serial of 7 repetitions in slow speed). a cognitive and quality of life assessments will occur in two groups at 3 and 6 months after randomization. the primary objective of the study is to evaluate the impact of apa program on the improvement of cognitive functions in patients with breast cancer who have been treated by adjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * women * more than 18 years old * locally advanced breast cancer * patient who undergone surgery * cognitive complaint (fact-cog inferior or equal to 8/16) * no metastasis at the inclusion * patient who received adjuvant therapy by chemotherapy * patient with a social protection * barbizet scale superior or equal to 3 * no neurological history * no medical contraindication to apa * inform consent signed exclusion criteria: * metastatic breast cancer * history of other cancer (in 5 years before inclusion) * current chemotherapy or radiotherapy * chemotherapy or radiotherapy ended for more than 6 months * current apa program * blood transfusion for less than 6 mois * minimal mental score inferior to normal * patient no able to respond to the cognitive test * patient no able to realize apa program * drug use * alcohol abuse * patient under guardianship or curatorship or deprived of liberty

Keywords: adapted physical activity, cognitive functions
comparing efficiency of mirogabalin and pregabalin in primary tka

Conditions: Pain Postoperative; Osteoarthritis; Total Knee Arthroplasty

Summary: the goal of this rct is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty. the main question\[s\] it aims to answer are: • does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty. participants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after tka. researchers will compare to pregabalin group to see pain and functional outcomes after tka.

after surgery is complete, you will be randomly assigned to receive painkillers mirogabalin or pregabalin along with other standard medications. surgery by mirogabalin group: participants received 5 mg of mirogabalin, taken as half a tablet, every day. twice a day, after breakfast and dinner, for 6 weeks. in the pregabalin group: participants received 50 mg of pregabalin, one tablet taken daily. twice a day, after breakfast and dinner, for 6 weeks

Eligibility criteria:
inclusion criteria: 1. age 50-85 years old 2. unilateral primary osteoarthritis undergoing primary tka 3. asa i-iii exclusion criteria: 1. gfr \&lt;60 2. allergy to drug in this study 3. cannot underwent spinal anesthesia and adductor canal block 4. taking gabapentinoid within 3 months before surgery 5. history of previous knee surgery 6. severe liver disease

Keywords: mirogabalin pregabalin pain postoperative tka
her2-predict: translational study of tumor samples from patients treated with trastuzumab deruxtecan (t-dxd; ds-8201a)

Conditions: Metastatic Cancer

Summary: her2-predict is a multi-center, observational study using biological samples from patients treated with ds-8201a in the metastatic setting. patients will provide a baseline ffpe tumor sample and additionally, blood sample for ctdna determination will be collected.


Eligibility criteria:
a. inclusion criteria 1. women and men ≥18 years old that has been included in a trial using trastuzumab deruxtecan (t-dxd; ds-8201a). 2. the participant (or legally acceptable representative if applicable) provides written informed consent for the study. it is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart. 3. patients who are starting, are receiving or have received treatment with trastuzumab deruxtecan as a treatment for metastatic/advanced cancer. 4. submission of a formalin-fixed, paraffin-embedded tumor (ffpe) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. if a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). the tumor tissue should be of good quality and quantity based on total and viable tumor content. 1. acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases. 2. fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable. 5. patients included before starting experimental treatment must be able and willing to provide blood sample(s). b. exclusion criteria 6. not having participated or not willing to participate in a trial using trastuzumab deruxtecan. 7. inability to comply with study and follow-up procedures
"react-fm" real-world evidence from smartphone-based acceptance and commitment therapy in fibromyalgia

Conditions: Fibromyalgia

Summary: the objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. study participants receive 12 weeks of digital acceptance and commitment therapy (act) in addition to their standard care for fibromyalgia. the primary endpoint is the patient global impression of change (pgic) at week 12. this is a virtual, single-arm, pragmatic, non-significant risk study.


Eligibility criteria:
key inclusion criteria: 1. participant is 22 years of age or older 2. participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 acr criteria for fibromyalgia diagnosis 3. participant is capable of reading and understanding english and has provided written informed consent to participate (signed electronically). key exclusion criteria: 1. participant is not a resident of the united states 2. in the opinion of the investigator or sponsor, the participant suffers from a severe psychiatric condition 3. participant has a diagnosis of, or is being treated for any type of dementia (parkinson's disease, alzheimer's disease, huntington's disease, lewy body dementia, creuztfeldt-jacob disease, frontotemporal dementia, korsakoff syndrome, vascular dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)