Kornimate/medical-research-clean huggingface dataset:
isotretinoin versus excimer light an adjuvant in treating onychomycosis

Conditions: Onychomycosis

Summary: 3 groups of patients with onychomycosis will be recruited. group a will receive itraconazole alone. group b will receive itraconazole + low dose isotretinoin and group c will be treated with itraconazole + excimer light sessions.

the sample size will be calculated by a statistician based upon the rate of onychomycosis cases attending at the outpatient clinical. 3 equal groups of patients will be included. inclusion criteria include: -definite diagnosis of dermatophyte onychomycosis using koh examination and a fungal culture - a washout period of at least 1 month of any previous therapy -age\> 16 years exclusion criteria include: -pregnancy and lactation -any active infection or inflammation in or around the nails other than onychomycosis -patients with liver diseases, heart disease and diabetes steps of performance and techniques used: 1. complete history taking. 2. detailed local examination: local examination will be done for the nail to detect swelling, induration, erythema around the nail, local pain and presence of pus during the sessions. patients with proven onychomycosis clinically, dermoscopically and through culture will be included in the study. the included patients will sign an informed written consent before the beginning of the study, and the study will be done under the approval of the ethical committee for postgraduate studies and research of faculty of medicine, zagazig university. onychomycosis severity index (osi) will be used for grading of onychomycosis severity where 0=no onychomycosis,1-5= mild onychomycosis,6- 15=moderate onychomycosis, and 16-35=severe onychomycosis. the patients will be divided into 3 equal groups: group 1: (itraconazole group); all patients will be prescribed itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects. group 2 : will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol. treatment protocol consists of low dose isotretinoin 20mg, every other day for a 3- month course. after completion of the course, treating dose of isotretinoin will be maintained for 4-6 weeks to prevent recurrence, and to improve healing. during treatment, an infrequent application of the previous therapies will be permitted. group 3: will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. nails will be treated with xecl2 excimer light (eximal elite device).

Eligibility criteria:
inclusion criteria: * patients with onychomycosis exclusion criteria: * pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.
influence of the covid-19 epidemic on stress and heart-rate variability in health-care workers

Conditions: Stress; Heart Rate Variability, Biomarker of Stress; Burnout

Summary: the covid-19 pandemic is an exceptional and particularly anxiety-provoking health situation. in particular, for healthcare professionals who come into contact with patients who are contaminated or suspected of contamination, such as emergency rooms. the management of these patients requires reinforced protective equipment. however, in the context of this pandemic, data is currently non-existent on the objective measurement of the stress of these professionals. sinus variability of heart rate is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc.).

this is an observational study. in the emergency room, each participant will wear a heart rate monitor and a consumer watch throughout the working day (there will be no measurement on duty at night, nor measurement at home). the days will be notified as being in the "covid sector", "non-covid sector" or "trauma room". each participant will complete a questionnaire comprising visual analog scales on the feeling (health concern, stress, fatigue, quality of sleep, anxiety, morale, burnout, decisional latitude, psychological demand, support, self-esteem), time of start and end of work, and socio-demographic data (sex, age, weight, height, smoking)

Eligibility criteria:
inclusion criteria: * emergency health care worker exclusion criteria: * refusal to participate

Keywords: stress coronavirus hazmat epidemics
phase i clinical study to evaluate the safety and efficacy of ssgj-706 monotherapy for patients with advanced solid tumors

Conditions: Advanced Solid Tumors Patients

Summary: this study includes two parts, different part has different administration frequencies of ssgj-706.

this study is a study of ssgj-706 monotherapy in advanced solid tumors. this study includes two parts, different part has different administration frequencies of ssgj-706. part a is qw and part b is q3w. each part will assess the efficacy and safety of the preset several dose levels of ssgj-706 in advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. histologically and/or cytologically documented advanced or metastatic solid tumors . 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. expected survival \>=3 months. 5. signed informed consent form. exclusion criteria: 1. known uncontrolled or symptomatic central nervous system metastatic disease. 2. adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (national cancer institute common terminology criteria \[nci ctcae\] v.5.0). 3. inadequate organ or bone marrow function. 4. pregnant or breast-feeding woman. 5. known allergies, hypersensitivity, or intolerance to ssgj-706 the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: solid tumors
adolescent to adult patient-centered hiv transition (adapt) study

Conditions: HIV; AIDS

Summary: one of the distinct challenges faced by emerging adults with hiv is the transition of their care from their long-term pediatric hiv provider to treatment within an adult hiv program. the consequences of an unsuccessful transition can range from difficult to catastrophic. the adolescent to adult patient-centered hiv transition (adapt) study is a prospective cohort trial of an innovative intervention targeting gaps in care that are major drivers of loss in the art continuum of care cascade among adolescents and increasing missed opportunities to engage adolescents into care.

the specific aims of adapt are: 1. to inform strategies for transition services in resource-limited settings; 2. to examine the developmental, clinical, and other factors that predict a successful transition; and, 3. to gain fundamental insight on implementation barriers among african adolescents through the application of the ego-network defined social support that will inform targets for structured intervention. adapt will be conducted in central, southern, and northern nigeria at selected pepfar sites supported by the institute of human virology, nigeria. to address aim 1 the investigators will conduct six focus groups including: adolescent patients, parents and health care providers. to address aim 2, the investigators will conduct a cluster randomized clinical trial. the two interventions are based on prior evidence-informed engagement strategies: 1) educational interventions and 2) interventions that use a peer transition advocate who prepares the adolescent and their parents for transition. the investigators will enroll 300 patients (150 patients in each arm). the sites will be assigned to either the intervention arm or a control arm. the primary outcome will be successful transition, keeping two follow-up appointments within a nine months period following transition. secondary outcomes, as recommended by focus group participants will also be measured. to examine the potential role of social network components and characteristics of both egos and alters on primary outcomes, a generalized estimating equation (gee) approach will be used to explore the associations between primary outcomes and factors at the ego, alter, and network levels. the finding from this study will guide institution of best practices for transitioning adolescents in nigeria and other countries lower and middle income countries with similar challenges and potential for high impact.

Eligibility criteria:
inclusion criteria: * hiv infected patients between the ages of 16-19 years of age * patients who have been in care at the study site facility for a minimum of 1 year * patients who plan to transition their hiv care to one of the selected study sites * patients who are able to provide informed consent exclusion criteria: * hiv infected patients who have significant cognitive impairments(e.g., mental retardation) * patients planning to transition their hiv care outside the selected study facilities
evaluation of music on the level of anxiety felt during external radiotherapy sessions

Conditions: Radiotherapy Side Effect

Summary: this is a prospective study with a historical comparator. each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the music-care device.

the retrospective phase (historical comparator) includes all patients with an initial hads score \> 7 who were treated with radiotherapy during 6 months preceding the start of the prospective study. the prospective phase involves all patients with an initial hads score \> 7 who will be treated with radiotherapy and who will benefit from music sessions (music-care). the study will be conducted over a fixed period of 12 months (6 months recruitment and 6 months follow-up) from the first patient receiving music sessions. anxiety will be assessed by hads self-questionnaires, before radiotherapy, at the end of the first week and at the end of radiotherapy. these evaluation parameters will therefore be compared to the 6-month period prior to the start of the study (retrospective phase).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * patients undergoing radiotherapy for curative treatment * patients with at least 15 sessions of radiotherapy * patients with an anxiety score \> 7 on the total a of the hads scale at the time of medical consultation exclusion criteria: * minor patients * pregnant or breastfeeding patients * patients with major hearing loss * patients with psychotic disorders * patients who do not understand or read the french language * patients under guardianship or deprived of liberty * patients requiring radiotherapy with respiratory servo-control (the music-care cannot be used due to technical constraints)

Keywords: anxiety
pre transplant rapamycin treatment in islet transplantation alone

Conditions: Diabetes Mellitus, Type 1

Summary: numerous changes to the original edmonton protocol have been proposed in the attempt of improving the still unsatisfactory long-term function of ita. rapamycin may blunt the early inflammatory response to islet transplantation in the liver, thus favoring islet engraftment. aim of the investigators study was to evaluate the effect of a pre-transplant treatment with rapamycin in patients with type 1 diabetes receiving islet transplant alone and immunosuppression according to the edmonton protocol.

pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/ml). during the pre-transplant rapamycin treatment rapamycin trough levels, renal and liver function, white blood cells count, total lymphocytes and lymphocytes subpopulations, hemoglobin, fibrinogen, cross-linked fibrin degradation products, c-reactive protein, exogenous insulin requirement every week for the first month, and monthly thereafter are measured. induction and maintenance immunosuppressive regimen after each islet infusion is administered according to the edmonton protocol (daclizumab, rapamycin, target trough levels: 12-15 ng/ml during the first 3 months and 10-12 ng/ml thereafter and tacrolimus 2 mg/day,target trough levels: 4-6 ng/ml). islets are infused into the liver through the portal vein under local anesthesia portography is performed before and after infusion. the islet function is evaluated measuring fasting c-pep, eir, and hba1c, immediately before the first islet infusion and subsequently every day for the first week, and then weekly for the first month ; every month after the last islet infusion for the first year and every 6 month thereafter.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * ≥5 years of type 1 diabetes * hypoglycaemia unawareness * progression of chronic complications of diabetes despite intensive insulin regimen exclusion criteria: * overt kidney disease * chronic liver disease * hepatic haemangioma * severe cardiomyopathy * untreated coronary artery disease

Keywords: islet transplantation insulin independence c-peptide secretion
a study to evaluate the feasibility of the decentralized clinical trial in south korea

Conditions: Functional Dyspepsia

Summary: the goal of this study is to evaluate the feasibility of a decentralized clinical trial in south korea. the main questions it aims to answer are: * does decentralized elements feasible in korea? * does mastic gum alleviates symptoms and modifies stool microbiome in korean patients with functional dyspepsia?

the trial aims to evaluate decentralized elements in south korea, including clinical laboratory testing using local laboratories, medication adherence assessment using wearable devices, analysis of self-kit specimens, delivery and tracking of investigational medication, real-time remote interview of subjects and e-consent acquisition. mastic gum is registered with the ministry of food and drug safety in south korea as a dietary supplement for gastric health, and the study aims to explore the effect on the gastrointestinal symptoms and composition of the stool microbiome.

Eligibility criteria:
1) inclusion criteria 1. adults aged 19 to 75 years old at the time of consent. 2. the sum of the intensity and frequency score of the six major symptoms (epigastric pain, early satiety, postprandial fullness, bloating, belching and nausea) of the self-evaluation questionnaire for dyspepsia (seq-dyspepsia) is 12 or more. 2) exclusion criteria 1. those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract. 2. subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis. 3. have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease. 4. pregnant or lactating women 5. have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered. 6. aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests 7. subjects who are expected to take other medications within the study period that may affect the evaluation of the effectiveness of the study substance (gastrointestinal motility promoters, acid secretagogues, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, anticholinergics, erythromycin, corticosteroids, antidepressants, etc. 8. those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.
safety and efficacy of hl tablet in non-alcoholic fatty liver disease patients

Conditions: Non-alcoholic Fatty Liver Disease

Summary: this study evaluates the safety and efficacy of hl tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. the patients are allocated to three groups; low dose, high dose, and placebo control group.


Eligibility criteria:
inclusion criteria: 1. age between 19 and 75 2. non-alcoholic fatty liver disease patient * diagnosed by abdomen ultrasonic examination * non-drinker (alcohol intake per week : female-under 140g, male-under 210g) 3. alt or ast higher than normal range (not over 4 times normal range) 4. voluntary agreement and enrollment exclusion criteria: 1. the ratio of ast/alt over 2 2. type i diabetes mellitus patient 3. any dysfunction of liver besides non-alcoholic fatty liver disease 4. alcoholic fatty liver disease patient or heavy drinker 5. prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months 6. patient taking any product which affects the bmi or hyperlipidemia 7. any dyscrasia that investigator considers not to appropriate for this study 8. bariatric surgery within 6 months 9. any disease which is able to change the distribution of cytokines 10. any treatment that affects liver functions within 1 month 11. participation in other clinical trials within 3 months 12. person who can not use mrs 13. pregnancy or breast-feeding 14. fertile women who do not use contraception 15. sensitive to the investigational product 16. any conditions that the investigator considers not to appropriate for this study
assess urine biomarkers to predict nephropathy in fabry disease

Conditions: Fabry Disease

Summary: the purpose of this research is to collect biological samples (urine) to develop assays for immune biomarkers to possibly in the future be able to screen subjects with fabry disease and be able to understand better progression of nephropathy in fabry disease and predict nephropathy in fabry disease.

this is a study to assess the markers related to autophagy, apoptosis, pyroptosis, and inflammatory markers related to nfkb, tnf-alpha, and tgf-β1 pathways in the urine. urinary biomarkers will then be compared to the standard measures of kidney function and proteinuria: gfr, cystatin-c, b2m, bikunin, ngal. gb3 and lyso-gb3, urine microalbumin, and urine protein-to-creatinine (upcr) ratio. investigators will also analyze the role of therapy, especially for the inflammatory responses in participants on stable enzyme replacement therapy (ert) with that of patients naïve to therapy. there will be a total of 25 biomarkers that will be assessed during the study. biomarkers of inflammation 1. il-4 2. il-6 3. il-8 4. il-10 5. il-12 6. il-18 7. mcp1 8. tgf-β1 9. ifn-γ 10. tnf-α 11. il-1β 12. rantes 13. baff 14. april 15. pai-1 biomarkers of kidney function and proteinuria 16. b2m 17. bikunin 18. ngal 19. osteopontin 20. clusterin 21. creatinine acute kidney injury 22. kim-1 23. ykl-40 24. egf 25. ck-18 m30

Eligibility criteria:
inclusion criteria: * male and female subject is greater than 18 but not older than 80 years. * subject willing to sign the informed consent and/or assent. * confirmed diagnosis of fabry disease based on deficient α-gal a enzymatic activity and molecular analysis demonstrating pathogenic variants in the gla gene. exclusion criteria: * any other known genetic condition associated with ckd. * evidence of hepatitis b or c infections or other chronic infectious diseases, * pregnancy or breastfeeding. * any other chronic condition, as per pi's discretion, that makes the subject ineligible.

Keywords: urine collection biomarkers ckd early detection
a study to evaluate the effects of mavacamten in healthy participants

Conditions: Healthy Participants

Summary: the purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.


Eligibility criteria:
inclusion criteria: * body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit. * healthy, as determined by physical examination, vital signs, 12-lead ecgs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on day -1. participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded. * cytochrome p450 (cyp2c19) normal (\*1/\*1), rapid (\*1/\*17), or ultra-rapid (\*17/\*17) metabolizer, as determined by genotyping during screening. exclusion criteria: * current or history of clinically significant cardiac condition, including but not limited to arrhythmia, lv systolic dysfunction, coronary heart disease; current, history, or family history of hcm; or evidence of prior myocardial infarction based on ecgs. * current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting. * any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention. note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: hypertrophic cardiomyopathy (hcm) left ventricular (lv) hypertrophy bioequivalence left ventricular outflow tract obstruction heart diseases cardiovascular diseases
comparison of postoperative recovery between tiva and inhalation agent

Conditions: Enhanced Recovery After Surgery

Summary: this prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. we hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.

adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). the quality of recover after surgery using the qor-15k was assessed by a investigator at postoperative day (pod) 1, 2, and 3. the primary outcome is the qor-15k at pod 1, 2, and 3 after surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia * american society of anesthesiologists (asa) physical classification i-ii * willingness and ability to sign an informed consent document exclusion criteria: * do not understand our study * american society of anesthesiologists (asa) physical classification iii or more * allergies to anesthetic or analgesic medications * chronic pain, chronic analgesic or antidepressant or anticonvulsant use * medical or psychological disease that can affect the treatment response * patients who receive mechanical ventilation more than 2 hours after surgery

Keywords: quality of recovery after surgery anesthetic method