Kornimate/medical-research-clean huggingface dataset:
the corneal and conjunctiva sensation before and after pterygium surgeries

Conditions: Pterygium

Summary: the purpose of this current study is to examine the sensation of the corneal and conjunctiva sensation before and after pterygium surgeries by cochet bonnet esthesiometer and to examine epidemiological, clinical and imaging factors the influence the sensation


Eligibility criteria:
inclusion criteria: * patients that suppose to undergo pterigyum surgery exclusion criteria: * patients with anterior segment diseases patients that underwent anterior segment surgeries patients with 7th nerve palsy

Keywords: cochet bonnet esthesiometer
drug use investigation for hepsera (adefovir) tablet

Conditions: Hepatitis B

Summary: this post-marketing surveillance (pms) is conducted to collect safety and efficacy data among subjects with chronic hepatitis b and hepatic cirrhosis b who is treated with adefovir tablets.


Eligibility criteria:
inclusion criteria: * subjects with chronic hepatitis b or hepatic cirrhosis b * subjects treated with adefovir tablets exclusion criteria: * none
efficacy of microcurrent therapy after eccentric exercise

Conditions: Delayed Onset Muscle Soreness

Summary: 15 participants will be included in the present study. they will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months: * session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery. * session 2 and 5: experimental session (the test battery followed by the provocative task, the test battery, the one-hour "treatment" and the test battery again). * session 3 and 6 (performed 2 days later): the test battery. the test battery included flexibility, functional, pressure pain threshold tests. the provocative task was an isokinetic eccentric task for knee flexors and extensors. the treatment was either a microcurrent therapy or a placebo microcurrent therapy.

objective: to study the efficacy of microcurrent to reduce doms (delayed onset muscle soreness) occuring after an eccentric exercise methods: experimental protocol participants will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months: * session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery. * session 2 and 5: experimental session: the test battery followed by the provocative task, the test battery, the one-hour "treatment" (real microcurrents at one of the session and placebo microcurrents at the other one) and the test battery again. * session 3 and 6 (performed 2 days later): the test battery. before starting session 2, patients will be randomized into the microcurrent group or the placebo microcurrent group. three months later, participants will change of group. the test battery: it will be conducted by a blind (to the treatment) investigator. it will include knee flexor and extensor flexibility tests, a functional test (unilateral " counter-movement jump "), a pain to measure pain threshold of thigh muscles and an isometric maximal voluntary contraction (mvc) test of knee flexors and extensors. the provocative task: 40 isokinetic eccentric contractions of knee flexors and extensors. the one-hour treatment: with the participant lying on an examination table, several electrodes were located over the muscles involved in the provocative task. the microcurrent therapy was then started. it was stopped after 5 seconds in the "placebo group" and after one hour in the real "microcurrent group". the microcurrents were delivered by the machine b-e-st®. follow-up: in addition to the 48hours follow-up (session 3/6), participants will fill in a pain visual analogue scale each day after the session 2/5.

Eligibility criteria:
inclusion criteria: * asymptomatic subjects exclusion criteria: * practice of sports \>3h per week * present pain in the lower limbs * history of thigh muscle injuries * recent injury (last 3 months) of the lower limbs * recent (last 3 months) plyometric exercises or lower limbs strengthening program.

Keywords: microcurent pain flexibility
efficacy and safety of multimode thermal therapy in the treatment of early peripheral lung cancer

Conditions: Lung Cancer

Summary: the purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.

this is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. the enrolled patients were stage ia lung cancer patients with lung lesions found on chest ct, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. follow-ups are performed after the multimode thermal therapy. the primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. the secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as t1n0m0, stage ia (including new-onset lung cancer after surgery and multiple primary lung cancer); 3. the ecog ps score is 0-2; 4. expected survival ≥6 months; 5. negative driver gene mutation: driver genes were defined as egfr, alk, ros1, ret; 6. agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent. exclusion criteria: 1. patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy; 2. patients whose chest ct indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy; 3. severe liver and kidney function and coagulation function abnormalities, platelet count \<70×109/l; 4. poor control of malignant pleural effusion; 5. patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months; 6. the patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.); 7. those who have undergone surgical operations or had allogeneic organ transplants within 1 month; 8. primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.); 9. pregnant and lactating women; 10. long-term use of steroid; 11. other circumstances considered inappropriate for participation in this study.
an immunogenicity and safety trial of mva-bn in adults living with hiv for the prevention of mpox infection, in kinshasa, drc

Conditions: Mpox (Monkeypox)

Summary: this is an open-label, phase 2, immunogenicity and safety trial of the mva-bn vaccine for the prevention of mpox in adults living with hiv with different level of cd4 counts in kinshasa, drc. the study team aims to investigate whether the administration of 2 standard subcutaneous doses of the modified vaccinia ankara of bavarian nordic (mva-bn) vaccine given 28 days apart, is immunogenic and safe when administered to people living with hiv (plhiv) with different levels of cd4 counts in the democratic republic of the congo (drc). enrollment will be stratified according to three different subgroups based on cd4 counts assessed during visit 1a: \<200 cells/µl; 200 to 499 cells/µl; ≥ 500 cells/µl. a total of 600 participants will be included in the trial, with 200 participants per subgroup. all participants will be invited to 6 trial visits over a period of 7 months. this study will take place in cooperation with the national programme for the fight against aids (pnls), the 'programme elargi de vaccination (pev)' and the 'institut national de santé publique (insp)'. as part of the response to the current mpox epidemic in drc, a large cohort of about 10,000 individuals living in kinshasa will be vaccinated in this program. vaccination will take place in the centre hospitalier kabinda (chk) and the pakadjuma health centre. all people living with hiv (plhiv) with the intention to be vaccinated in the chk, will be asked for their willingness to participate in the mbote-hivax clinical trial until the sample size of 600 participants needed for this clinical trial is reached.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 45 years at time of informed consent * able and willing to provide written informed consent * infected with hiv and receiving combination antiretroviral therapy (art) for ≥ 8 weeks prior to study entry and vaccination * preparedness to follow the study schedule * willingness to use contraception for 1 month after each vaccination (only for women of childbearing potential) exclusion criteria: * a known history of mpox and/or smallpox * a known history of vaccination with 1st, 2nd or 3rd generation smallpox vaccines, or vaccine platforms that contain mva as a vector * planned mva-based vaccination (other than study vaccination) during the trial * close contact to a confirmed mpox case in the 3 weeks prior to study enrollment * uncontrolled severe infection or other condition requiring hospitalization * pregnancy * history of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine

Keywords: mva-bn vaccination mpox
study to assess the effect of multi-herb formulae and an ashwagandha root formula on the modulation of the stress and related symptoms

Conditions: Stress

Summary: two unique proprietary formulations of adaptogens vl-g-e12 formulation and an herbal blend containing vl-g-a57 is one of the most well-known adaptogens that has been used for years to enhance positive mood states, deepen sleep, and improve memory. the product has been proven to have a role in improving depression, enhancing work performance, eliminating fatigue and treating symptoms of asthenia subsequent to intense physical and psychological stress. the extract was tested on antidepressant, adaptogenic, anxiolytic, nociceptive and locomotor activities at doses of 10, 15 and 20 mg/kg, using predictive behavioral tests and animal models. the results show that this product extract significantly, but not dose-dependently, induced antidepressant-like, adaptogenic, anxiolytic-like and stimulating effects in mice. studies reveal that this shrub has antimicrobial (including antibacterial, antiviral, antifungal, antiprotozoal, antimalarial, anthelmintic), anti-inflammatory, anti-diabetic, anti-hypercholesterolemia, anti-hypertensive, anti-carcinogenic, and immunomodulatory effect.the aim of the current study is to assess the adaptogenic effects of two potential investigational products vl-g-a57 and vl-g-e12 their adaptogenic effect shall be investigated by assessing several clinical symptoms of hpa axis dysfunction such as stress, anxiety, sleep quality, fatigue, mood etc.


Eligibility criteria:
inclusion criteria 1. male and female subjects ≥18 and ≤ 65 years' old with active lifestyle, moderate physical activity level as per international physical activity questionnaire - short form (ipaq - sf) 2. bmi: 18 to 29.9 kg/m2 3. rsq-w (restorative sleep questionnaire-weekly version) score less than or equal to 50 4. pss scores ranging from 27-40 5. all participants will be encouraged to not make any major lifestyle changes during the study period. 6. they will be informed that any major changes may result in exclusion from the study. 7. participants willing to provide written informed consent. exclusion criteria 1. subjects with a medical history of heart disease, respiratory disorders, metabolic or lifestyle disorders, seizure disorders, or other chronic health conditions requiring medication were excluded. 2. individuals who currently, or in the past 6 months suffered from any diagnosable mental-health disorder (as assessed by the mini international neuropsychiatric interview 5.0.01 ) or were taking apsychotropic medication or other herbal preparation were also excluded from participating in the study. 3. subjects with a blood pressure range of systolic ≥ 140 mm hg and diastolic ≥ 90 mm hg. 4. subjects on any sleep medication since last 3 months 5. subjects with a history of severe intrinsic sleep related disorders. 6. subjects who have taken ashwagandha or any sleep or other supplements within the last three months, 7. people with a known hypersensitivity to ashwagandha 8. subjects who work on a night shift 9. nursing or pregnant women
clinical study to assess efficacy and safety of a new compression system in the management of venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: the primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system kit biflex® with regard of the 4-layer compression system profore® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.

this trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in france, with 2 parallel groups of 100 patients each. the study will be conducted in patients suffering from venous leg ulcer (stage c6 of the ceap classification for chronic venous disorders). the patients will be randomised at the inclusion: they will receive with either kit biflex® or the reference device (profore®) for maximum 16 weeks (or until full healing). investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks.

Eligibility criteria:
inclusion criteria: * inpatients or outpatients. * agreeing to wear a multilayer compression system throughout the study period. * presenting with an active venous leg ulcer: duration between 1-24 months (whether a new ulcer or a recurrent ulcer); surface area between 2-50 cm2; venous, superficial or post-thrombotic ulcer confirmed by doppler ultrasonography (dated within six months). * with ankle circumference between 18-25 cm to allow the laying of the compression system. * able to follow the study instructions. * having read the information sheet and dated and signed the informed consent form. * covered by a health insurance system. exclusion criteria: * scheduled surgery for the ulcer during the 16 weeks following inclusion. * clinical superinfected ulcer not controlled oral antibiotics. * malignant ulcer. * ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface. * deep vein thrombosis within the last 3 months. * corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study. * radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study. * erysipelas and lymphangitis. * lower extremity arterial disease or microangiopathy (ankle brachial pressure index \ 1.3). * uncontrolled non-insulin dependent diabetes (hba1c\> 8%). * insulin-dependent diabetes. * confined to bed. * with any uncontrolled severe and progressive disease. * with a known or suspected hypersensitivity to any of the components of the study devices. * who had participated in a previous clinical study within the past 3 months. * pregnant women.
neurophysiologic biomarkers in rett syndrome

Conditions: Rett Syndrome; RTT; Rett Syndrome, Atypical

Summary: the goal of this observational study is to identify candidate biomarkers in individuals with rett syndrome (rtt). the main questions it aims to answer are: * do these biomarkers change during clinical changes in individuals with rtt? * are biomarkers stable over time in clinically stable individuals? * do these biomarkers correlate with severity of rtt? participants will be asked to undergo an electroencephalogram (eeg) with measurements of evoked potentials (ep) to measure electrical activity in the brain. researchers will compare findings in individuals with rtt to those in typically developing individuals to see if there are differences between the two groups.

the main goal of the project is to identify potential biomarkers that can become measures for intervention and other translational studies and, at the same time, provide insight into abnormal synaptic activity and pathogenesis of rtt. therefore, the proposed assessments will be performed with females with rtt and age matched typically developing females. these electrophysiological assessments will be compared to established clinical outcome measures from previous work in the nih funded rett and rett related disorders natural history study. the neurophysiological parameters for rtt will be correlated with each other and also to disease staging, overall clinical severity scores and through exploratory analyses with specific clinical features. the investigators will also be testing procedures to perform the recordings, electrode types and placement, and ways to reduce movement and artifact within the data to establish best practices.

Eligibility criteria:
inclusion criteria: 1. rett group: females ages 3-18 (inclusive) with a clinical diagnosis of rtt with a likely pathogenic or known pathogenic variant in mecp2. 2. likely rett group: females from 1 year to \< 5 years of age with mecp2 variant if regression has not yet occurred or child is within 6 months of last skill loss. 3. typically developing (td) group: females age matched to rtt population (1-18) with no developmental or cognitive concerns as assessed using the child/adult behavioral checklist, survey of well-being of young children (\ 5 yo). exclusion criteria: rett and likely rett groups: 1. presence of a duplication in mecp2 or any other identified pathogenic mutation in another gene. 2. active medical conditions not typically found in rtt. typically developing group: 1. score below norms on the performance tests 2. have a known neurological disorder (excluding migraine) 3. being on neuroactive medications.

Keywords: biomarker eeg evoked potentials mecp2
efficacy and safety study of orvepitant for chronic cough in patients with idiopathic pulmonary fibrosis

Conditions: Cough; Idiopathic Pulmonary Fibrosis

Summary: orv-pf-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with ipf.

the study will be a multi-center, double-blind, randomised, placebo-controlled 2-period cross-over study in subjects with chronic cough due to idiopathic pulmonary fibrosis (ipf). subjects will participate in one of two cohorts (cohort 1 and cohort 2). cohort 1 will evaluate a 30 mg orvepitant dose and cohort 2 the 10 mg dose. within each cohort, subjects will be randomised to receive either orvepitant or placebo in the first treatment period (treatment period a) followed by the alternate treatment in treatment period b. there will be a wash-out period of 3 weeks between the two treatment periods. subjects will be randomised 1:1 to each of the two treatment orders and 1:1 to each cohort. subjects will enter a screening period of between 14 and 28 days to determine eligibility. eligible subjects will be randomised at the baseline visit and will participate in two identical 28 day treatment periods with the wash-out period between them. there will be a total of 8 visits including the screening, baseline and final follow-up visits.

Eligibility criteria:
key inclusion criteria: * diagnosis of ipf established according to the 2018 or 2022 joint ats/ers/jrs/alat clinical practice guideline * fev1/fvc ratio ≥0.65 at the screening visit * haemoglobin-corrected diffusion capacity of carbon monoxide (hb-corrected dlco) ≥25% within 12 months of the screening visit * arterial oxygen saturation on room air or oxygen ≥90% at screening * life expectancy of at least 12 months * cough that is attributed to ipf, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to screening * mean daily ipf coughing severity scale score ≥5 (after rounding) during the second week of the baseline assessment period key exclusion criteria: * recent respiratory tract infection (\<8 weeks prior to screening) * recent acute exacerbation of ipf (\<8 weeks prior to screening) * current smokers or ex-smokers with \<6 months' abstinence prior to screening * emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan * mean early morning cough scale score ≥5 and rest of the day cough scale score \<5 (after rounding) during the second week of the baseline assessment period (assessed at visit 2) * cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis
a study measuring effects on intima media thickness: an evaluation of rosuvastatin 40 mg (meteor)

Conditions: Hypercholesteremia

Summary: the purpose of this trial is to see if rosuvastatin will be effective in decreasing the thickness of the walls of the arteries in the neck for people who already have some evidence of thickening of these walls.


Eligibility criteria:
inclusion criteria: * maximum imt \>1.2 mm and 3.5 mm at any location in the carotid ultrasound studies conducted at both visit 2 (week -4) and visit 3 (week -2) * subjects with age and no other risk factor: fasting ldl-c at visit 1 (week -6) is \>120 mg/dl (3.1mmol/l) and \<190 mg/dl (4.9 mmol/l) * subjects with 2 or more risk factors and a 10-year coronary heart disease (chd) risk \ 120 mg/dl (3.1 mmol/l) and \<160 mg/dl (4.1 mmol/l) exclusion criteria: * use of pharmacologic lipid-lowering medications (eg, hmg-coa reductase inhibitors, fibrate derivatives, bile acid binding resins, niacin or its analogues at doses \>400 mg) within 12 months prior to visit 1 (week -6). * clinical evidence of coronary artery disease or any other atherosclerotic disease such as angina, mi, tia, symptomatic carotid artery disease, cva, cabg, ptca, peripheral arterial disease, aaa.

Keywords: hypercholesteremia
turkish validity and reliability of the social frailty index

Conditions: Elderly; Frailty; Quality of Life

Summary: the aim was to examine the validity and reliability of the social frailty index in turkish among older adults. 65 years and above older adults will be included included in the study. older adults who agree to participate in the study will first be administered the hodkinson mental test. those who score 6 points and above will be included in the study. to evaluate the validity of the \&#34;social frailty index\&#34;, social inclusion scale, older people\&#39;s quality of life-brief (opqol-brief) and lubben social network scale will be applied to the participants. to determine the reliability of the \&#34;social frailty index\&#34;, older adults who do not receive any treatment will be tested and re-tested at one-week intervals.


Eligibility criteria:
inclusion criteria: * getting a score of 6 or above on the hodkinson mental test exclusion criteria: * -having another chronic disease that can cause pain * having a neurological disease * being blind * having an orthopedic, neurological or mental disability