Kornimate/medical-research-clean huggingface dataset:
the impact of exercise methods on human body functions and metabolism

Conditions: Metabolic Syndrome

Summary: the objective of this study is to compare the effects of 8 months of yoga and walking exercise training on weight-related body fat and metabolic biomarkers in women. participants will be randomly assigned to either a yoga group or a walking group. the yoga group will undergo 90-minute sessions, 3 times per week, while the walking group will engage in one-hour sessions, 6 times per week. physical and metabolic markers will be measured at baseline and after 8 months of intervention.

this randomized controlled trial aims to investigate the differential impacts of yoga and walking exercise training on weight-related body fat and metabolic biomarkers in women over an 8-month period. the study will recruit women aged 18-65 years, who will be randomly assigned to either a yoga group or a walking group. yoga group: participants in the yoga group will attend 90-minute yoga sessions, 3 times per week. walking group: participants in the walking group will engage in one-hour fast-paced walking sessions, 6 times per week. outcome measures: physical and metabolic markers will be assessed at baseline and after 8 months of exercise intervention. the primary outcomes will include changes in body weight, bmi, visceral fat, and basal metabolism. metabolic biomarkers such as serum leptin, glucose, total cholesterol (tc), apolipoprotein a (apoa), and apolipoprotein b (apob) will also be measured. participants will be monitored for adherence to the exercise protocol and any adverse events throughout the study. data will be collected during the intervention, and analyzed to determine the differential effects of yoga and walking on the measured outcomes. the study aims to provide insights into the relative benefits of yoga and walking exercise regimens on women's health, particularly in terms of body composition and metabolic health, thereby informing future exercise recommendations and health interventions.

Eligibility criteria:
inclusion criteria: female participants aged 18-65 years； willing and able to participate in an 8-month exercise program； generally healthy with no contraindications to physical activity； ability to provide informed consent exclusion criteria: current participation in a structured exercise program； known cardiovascular, respiratory, or metabolic disorders that contraindicate exercise； pregnancy or planning to become pregnant during the study period； use of medications affecting metabolism or physical activity levels； any other condition that, in the opinion of the investigators, would make participation unsafe or not feasible

Keywords: yoga, walking, exercise, body composition, metabolic health
bioactive glass or allogenic bone in pediatric bone cysts

Conditions: Bone Cysts

Summary: the finnish paediatric orthopedic study group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, bonalive®) in treating bone cysts in children (18 years or younger). the trial is carried out in five university hospitals (turku, helsinki, tampere, oulu, kuopio) in finland.

twenty patients will be randomized into each group. in all university hospitals the treatment protocol will be same. randomization will be performed using a sealed envelope technique. before surgery all patients will be examined clinically. after conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures. if the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively. surgical technique: surgery will be done by experienced paediatric orthopaedic surgeons. normal orthopaedic exposures will be used. the cyst is opened so that square window is done to the cortex. a sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. a mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. the tumour is resected as thoroughly as possible. after curettage 5% phenol is inserted to the cavity and it is neutralized with saline. cyst volume is evaluated using saline (ml). then the cyst is filled with morsellized femoral head allograft or bioactive glass (bg-s53p4) according to randomization. the biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. if the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. if the cyst is in hand region then the granule size is 0,5-0,8mm. at the end of the operation the window's roof is inserted back. all the time x-ray is used to ensure that the whole cyst is treated properly. osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture. after surgery the diagnosis will be confirmed histopathologically. all patients will receive standard anesthesia. postoperatively an x-ray will be taken. radiographic controls after surgery will be held at 1 mo, 3 mo, 6mo, 12mo and 24mo. three months control and two years control will be accompanied with mri. if the cyst is found after a pathologic fracture, the fracture is healed first with the cast +/- traction and mri will be taken before surgery.

Eligibility criteria:
inclusion criteria: 1. suspected aneurysmatic bone cyst in all areas, not spinal. 2. other large simple bone cyst in load bearing areas 3. simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas exclusion criteria: 1. malignancy 2. bone marrow disease 3. other than aneurysmatic or simple bone cyst 4. a secondary aneurysmal bone cyst (abc associated with another underlying lesion)
phase 2 extension study of ambrisentan in pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: amb-220-e is an international, multicenter, open-label study examining the long-term safety of ambrisentan (bsf 208075) in subjects who have previously completed myogen study nct00046319, "a phase ii, randomized, double-blind, dose-controlled, dose-ranging, multicenter study of bsf 208075 evaluating exercise capacity in subjects with moderate to severe pulmonary arterial hypertension".


Eligibility criteria:
inclusion criteria: * must have completed visit 14/week 24 of the nct00046319 study. * women of childbearing potential must have a negative urine pregnancy test at the screening/enrollment visit and agree to use a reliable double barrier method of contraception until study completion and for \>=4 weeks following their final study visit. * must have completed the down-titration period of nct00046319 prior to enrollment in amb-220-e and will meet the following additional criteria: * subjects with a diagnosis of hiv must have stable disease status at the time of screening/enrollment. * must be stable on conventional therapy for pah for \>=4 weeks prior to the screening visit. exclusion criteria: * chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the screening visit. * intravenous inotrope use within 2 weeks prior to the screening visit. * females who are pregnant or breastfeeding. * contraindication to treatment with an endothelin receptor antagonist (era).
pf-04191834 single dose bronchodilatory study in asthma.

Conditions: Asthma

Summary: study to determine the bronchodilatory effects of pf-04191834 compared with zileuton in patients with asthma


Eligibility criteria:
inclusion criteria: * persistent mild/moderate asthma for at least 6 months. * reduced lung function * reversible airway obstruction exclusion criteria: * pregnant/nursing females. * liver function tests greater than upper limit of normal (uln)

Keywords: bronchodilator
study of sleep disorders in prodromal and definite parkinsons disease

Conditions: Parkinson Disease; REM Sleep Behavior Disorder (iRBD)

Summary: multicenter controlled study of sleep disorders in isolated rem behavior disorder and parkinson\&#39;s disease (sompark)

sleep disturbances are common and understudied in established or prodromal parkinson\&#39;s disease. the purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in pd and isolated rbd.

Eligibility criteria:
inclusion criteria: common to all groups: * age superior 18 years * patients who have received complete information about the study from an investigator and who fully consent to participate. for parkinson disease (pd): * patients followed for pd diagnosed according to international criteria for the diagnosis of pd (mds criteria), * a moca score greater than 20/30 * no treatment with deep brain stimulation. for rem sleep behavior disorder (rbd): * diagnosis of rbd according to icsd-3 criteria: presence on polysomnography of an abnormal elevation of muscle tone during rem sleep (more than 18% of rem sleep without chin atonia) and/or the presence of rem sleep behaviors on video-polysomnography, * absence of progressive neurodegenerative pathology: absence of diagnostic criteria for pd, multiple system atrophy, or lewy body dementia. for healthy controls: - no neurological or psychiatric disease exclusion criteria: common to all groups: * pregnant or breastfeeding women * subjects under guardianship/conservatorship * persons deprived of liberty.

Keywords: parkinson disease isolated rbd sleep
clinical study of kangfuxin and basic fibroblast growth factor in promoting the healing of donor site

Conditions: Fibroblast Growth Factors; Wound Healing

Summary: the main objective of this study is to observe whether basic fibroblast growth factor and kangfuxin liquid can promote the wound healing in the donor area and further evaluate the healing quality.


Eligibility criteria:
inclusion criteria: * male / female patients aged 20-50; * burn area ≤ 30% tbsa; * patients who need auto skin grafting due to burns or skin defects due to trauma; * the donor area is 100cm2, and the thickness of skin is 0.25mm (split thickness skin donor site group)/0.40mm (medium thickness skin donor site group). the donor site is the body part with similar skin color and sufficient skin area (except scalp); * not involved in clinical trials of other drugs; * subjects who have agreed to participate in the clinical study and signed the informed consent. exclusion criteria: * subjects who were previously allergic to similar products or related components of test products; * subjects with other systemic or local skin diseases that may affect wound evaluation; * subjects with significant organ dysfunction / failure or other serious diseases, including clinical related cardiovascular disease or myocardial infarction within 12 months before enrollment; malignant tumor; serious neurological or psychiatric history; serious infection; active disseminated intravascular coagulation; * subjects with moderate malnutrition (bmi \< 17kg / m2) and severe anemia (hb \< 60g / l); * subjects proposed to use immunosuppressant, steroid hormone, epidermal growth factor and other drugs that may affect the wound healing of the donor skin within 3 months before admission or during the study period; * participated in clinical trials of any other drugs or medical devices within 3 months; * history of major diseases that may affect general physical condition and other patients who are not considered by the researchers to be eligible for this study.

Keywords: basic fibroblast growth factor,kangfuxin,wound healing
early identification of age-related hearing impairment

Conditions: Hearing Loss, Age-Related

Summary: the need for future hearing rehabilitation is enormous. world health organization (who 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. this study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process.

the investigational device used in the study is part of the otoscreen hearing screening system that is developed by aalto university. the investigational device consists of the following parts: * digital otoscope * user interface control unit. the investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires, digital otoscopy, and audiometry. the investigational device is used together with a ce-marked audiometer that is intended for hearing screening testing.

Eligibility criteria:
inclusion criteria: • must be able to understand finnish or swedish exclusion criteria: • clinical diagnosis of hearing loss
single arm study of multi-gyn actigel plus for treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: open, single arm trial that intends to confirm the safety and efficacy of multi-gyn actigel plus for treatment of bacterial vaginosis. adult women will be diagnosed by the gynaecologist based on the amsel criteria at day 0. they will use the product for 7 days and will come to the practice at day 21. the primary endpoint is the clinical cure rate of bacterial vaginosis at 3 weeks after start of treatment.


Eligibility criteria:
inclusion criteria: * women diagnosed with bv (3 out of 4 amsel criteria positive, with at least presence of clue cells (\>20%) * women of childbearing potential * aged \>18 years * signed written informed consent form * willing to comply to the follow-up schedule exclusion criteria: * current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis * presence of trichomonas and/or candida albicans in vaginal smear during examination of the smears for amsel criteria (clue cells detection) * current genital malignancies * chemotherapy for any reason in last 6 months * radiotherapy in the genitourinary system in the last 12 months * use of antibiotics for any reason in the last 14 days * pregnancy or currently attempting to conceive * lactation * use of other treatment for vaginal conditions during the course of the clinical investigation * known allergies to ingredients of the product * concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
phase i study of palomid 529 a dual torc1/2 inhibitor of the pi3k/akt/mtor pathway for advanced neovascular age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: palomid 529 is a dual torc1/2 inhibitor of the pi3k/akt/mtor pathway having broad activity in angiogenesis and cellular proliferation. palomid 529 will be examined to determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity in the study eye between 20/100 and 20/800 (between 53 and 4 etdrs letters read), and better or equal to 20/200 (minimum of 34 letters read) in the fellow eye. * subfoveal choroidal neovascularization (cnv) due to amd * total area of the lesion (including blood, neovascularization and scar/atrophy) must be \< 12 da. * only 1 eye will be treated in the study. if both eyes are eligible, the investigator will select the eye with the most active cnv * clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening * intraocular pressure of 21 mm hg or less * retinal thickness ≥ 250 μm by oct, with presence of intraretinal or subretinal fluid exclusion criteria: * any retinovascular disease or retinal degeneration other than amd * serous pigment epithelial detachment without the presence of neovascularization * previous posterior vitrectomy or retinal surgery * any periocular infection in the past 4 weeks * concomitant therapy with anti-vegf therapies, e.g. avastin, lucentis or macugen, or previous use of these agents within 60 days of screening * concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening * significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography * cataract surgery in the study eye within 3 months of screening * intraocular surgery in the study eye within 3 months of screening * presence of ocular infection in the study eye * presence of severe myopia (-8 diopters or greater) in the study eye
safety of various mode of delivery of iron supplement on iron toxicity markers in preschool children

Conditions: Iron Overload; Oxidative Stress

Summary: the purpose of study is to evaluate and compare the effect of iron supplementation when given as iron tablet or fortified biscuit or combined with zinc in the form of tablet on morbidity and iron toxicity markers among children aged 24-36 months.

the study will be carried out in two phases in sangam vihar, delhi. the survey will be conducted to identify children in the age group of 24-36 months. after obtaining consent, an enrollment form with detailed socio-demographic information about the child will be filled. blood and urine samples will be collected for estimation of iron status, oxidative stress, immune and interleukin markers. based on iron status, two randomization lists will be generated i.e. one for iron sufficient and other for iron deficient children. children will be randomly allocated to receive one of the four interventions (60 in each group) for 180 days. the intervention will be either iron tablets (it) or iron and zinc tablets (iz) or biscuits fortified with iron (ib), or placebo tablets (co). children in the iron groups (it and ib) will receive 12.5 mg/day of iron. children allocated to receive iron and zinc (iz group) will receive 10 mg/day of zinc in addition to 12.5 mg/day of iron. the fortified biscuits (ib) will be formulated by cftri, mysore, india and will have iron in the form of iron sulphate. the iron (it group) or iron and zinc (iz group) fortified dispersible tablets will be procured from who manufactured by nutriset (maluanlay, france). tablets will have iron salt in the form of ferrous sulphate and zinc in the form of zinc sulphate. the interventions at the baseline on day 3, on day 30 (on completion of phase -i) and on day 180 (on completion of phase-ii) will be given at the clinic prior to the post 3 hour blood collection. regular supplementation will be given at home. children will be followed up on a biweekly basis by the field worker for delivery of the intervention, collection of morbidity and compliance information from the mother/caretaker of the child. during follow-up, blood sample for interleukin levels will be taken in the event of an illness such as diarrhea, pneumonia, fever and severe illness/hospitalization. at the completion of phase-i (on day 30) and phase - ii (on day 180), the blood and urine samples will be collected again for estimation of iron status, oxidative stress, immune and interleukin markers.

Eligibility criteria:
inclusion criteria: * between 24-36 months of age * not severely malnourished or ill requiring hospitalization * willing to stay in the study area for 6 months * consent to participate exclusion criteria: * not consented * severely malnourished or ill requiring hospitalization

Keywords: iron iron toxicity markers oxidative stress markers iron supplementation ntbi iron over load interleukin levels iron status acut phase reactants preschool children
licorice and home blood pressure

Conditions: Hypertension,Essential

Summary: out-of-office blood pressure is more strongly associated with cardiovascular risk than office blood pressure. licorice is known to raise blood pressure, but no previous studies have measured the effects on home blood pressure. the aim of this study is to analyze the association between licorice intake and home blood pressure.

healthy volunteers will be invited to participate in a randomized, non-blinded, cross-over study. participants will be randomized to either of two groups with a 1:1 allocation ratio, stratified by sex. intervention will be sweet licorice and control will be salty licorice. a run-in period of 1 week will be followed by a 2-week intervention/control, a 2-week washout period, another 2-week control/intervention period and again a 2-week washout period. home blood pressure will be measured continuously, and blood samples (including potassium and aldosterone) will be collected every two weeks. analyses will be made comparing baseline characteristics of the two groups, intervention/control and washout period results of the two groups to look for potential carry-over effects, and finally comparing intervention and washout period results respectively to the baseline data to look for the effects of licorice.

Eligibility criteria:
inclusion criteria: * age 18 to 30 years exclusion criteria: * known hypertension, cardiovascular disease, kidney disease, liver disease, hormonal disease, peanut allergy, eating disorder or headache disease (including tension headache and migraine) * known alcohol abuse or drug abuse (including cannabis and anabolic steroids) * treatment with hormonal drugs (including oral contraceptives * known intolerance to licorice intake
evaluation of the immunogenicity and reactogenicity of a pneumococcal conjugate vaccine in healthy adults

Conditions: Streptococcus Pneumoniae

Summary: to compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy uk adults aged 50-80 years, and subsequent antibody persistence and response to boosting.


Eligibility criteria:
inclusion criteria: * written informed consent for participation in the study; ages between 50 and 80 years at recruitment exclusion criteria: * lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent. * current participation in any other clinical trial * any vaccination in the previous month (except influenza vaccination which can be given at any time during the study) * prior pneumococcal conjugate vaccine (pnc) * 23 valent pneumococcal vaccine(ppv) in last 5 years * severe general or local reaction to a previous dose of pnc or ppv * patients currently immunocompromised as listed in uk handbook "immunisation against infectious disease" ed 1996 * patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study * patients in whom pneumococcal vaccination (ppv) is currently recommended as per the uk handbook "immunisation against infectious disease" * deferral of vaccination if acute systemic illness or temperature \>38c on day of vaccination