Kornimate/medical-research-clean huggingface dataset:
establishment and application of digital diagnosis and treatment system for sarcopenia

Conditions: Sarcopenia

Summary: the goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). this aims to create a digital visual tertiary prevention network for sarcopenia. research aims: evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey. establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions. participants will: engage in screening and assessment based on inclusion and exclusion criteria. be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals. key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life.


Eligibility criteria:
inclusion criteria: * age ≥45 years; * meeting sarcopenia diagnostic criteria; * consent to participate in this study exclusion criteria: * age \<45 years; * patients in acute phase of chronic illness; * infectious disease patients; * people who lack of independent mobility; * people who lack of communication or cognitive skills; * people who refusal to participate in this study
study evaluating the equivalence of gdc-229 and metronidazole vaginal gel 0.75% in the treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: this research study is being done to compare the safety and efficacy of gdc-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with bv.


Eligibility criteria:
inclusion criteria: 1. non-pregnant female aged ≥ 18 years who is in good general health 2. diagnosis of bv 3. willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial 4. subjects of childbearing potential who have a negative urine pregnancy test at the entry visit (visit 1) and agree to use an acceptable form of birth control throughout the study 5. able to understand and willing to sign the informed consent form (icf) and able to comply with the requirements of the protocol exclusion criteria: 1. history of alcohol or substance abuse 2. experienced a clinically significant medical event within 90 days 3. abnormal pap or high risk human papillomavirus (hpv) 4. history or presence of clinically significant central nervous system (cns), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease 5. pregnant, lactating, or planning to become pregnant or breastfeed during the study period 6. primary or secondary immunodeficiency 7. evidence of any vulvovaginitis at screening other than bv 8. history of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the gdc 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (oceanside pharmaceuticals), or vehicle gel 9. participating in another clinical trial

Keywords: bacterial vaginosis vaginal infection bv
dexmedetomidine as adjunctive therapy for alcohol withdrawal

Conditions: Acute Alcohol Withdrawal

Summary: this study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical icu patients. specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. in addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.

the objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. the study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. all patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.

Eligibility criteria:
inclusion criteria: 1. severe alcohol withdrawal defined by a ciwa score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. all lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount. 2. patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. lorazepam is the preferred benzodiazepine agent for patients requiring icu admission due to alcohol withdrawal. 3. informed consent within 36 hours of qualifying for the study. exclusion criteria: 1. patients \ 85 years of age. 2. patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation). 3. patients with alcohol withdrawal not requiring icu admission. 4. patients receiving epidural administration of medication(s). 5. comatose patients by metabolic or neurologic affectation. 6. patients with active myocardial ischemia or second- or third-degree heart block. 7. moribund state with planned withdrawal of life support. 8. patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine). 9. pregnant females or females suspected of being pregnant
chronic lung allograft dysfunction mri study

Conditions: Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Summary: this studies purpose is to confirm the efficacy and efficiency of using oe-mri and mri with hyperpolarized gas techniques and iodinated contrast ct scan, this will enhance understanding of clad pathophysiology. moreover, this project is foundational to performing additional studies to establish if novel mri imaging can serve as an objective confirmatory diagnostic tool for clad in post-transplant patients.

this studies purpose is to confirm the efficacy and efficiency of using oe-mri and mri with hyperpolarized gas techniques and iodinated contrast ct scan, this will enhance understanding of clad pathophysiology. moreover, this project is foundational to performing additional studies to establish if novel mri imaging can serve as an objective confirmatory diagnostic tool for clad in post-transplant patients. this observational imaging study will use 3t ute mri with varying oxygen levels (room air vs. 100% oxygen) to evaluate lung ventilation using oxygen enhanced imaging, in 50 healthy normal subjects (age 18-80). subjects will have vital signs taken, complete questionnaires and have pulmonary function test (spirometry) done, iodinated contrast ct scan and standard of care ct scans, in addition to one mri session that will include 6 series of scans. the mri scans will be taken in supine position (laying on back) and include breathing room air and 100% oxygen. oe-mri will be done in addition to mri scans with xenon-129.

Eligibility criteria:
all subjects-inclusion criteria: * ages 18-80 * english speaking subjects * willingness and ability to provide informed consent * non-smoker lung transplant patients-inclusion criteria: * \>/= 6 months from lung transplant * history of bilateral lung transplant clad-free patients-inclusion criteria: * stable spirometry with fev1 \> 90% of baseline value (average of 2 best values) and forced mid-expiratory flow (fef) (25-75) \> 75% of baseline * total lung capacity (tlc) \> 90 % of baseline * post-transplant chest radiograph without significant abnormality * no evidence of on-going lung infection or allograft rejection early clad patients-inclusion criteria: * fev1 \< 80% of baseline value (average of 2 best values) * follow up 6-months or decline in lung function (20% decrease in fev1 without evidence of infection or acute rejection) exclusion criteria: * sao2 drops below 90% (in absence of mechanical failure) during normal tidal breathing * unilateral diaphragm paralysis * evidence of acute illness on day of study * evidence of restrictive lung disease * dependence on supplemental oxygen * history of cardiac disease * pregnancy (self-declared) * lactating women * participants with metal objects in their body * known contraindication to mri examination * systolic blood pressure reading of \ 200 mmhg * diastolic blood pressure reading of \ 100 mmhg

Keywords: lung transplant
vasopressin or norepinephrine in vasoplegic shock after non-cardiac surgery

Conditions: Circulatory Shock; Non-cardiac Surgery

Summary: the purpose of the present study is to evaluate the effect of vasopressin compared to norepinephrine on the clinical complications of patients with vasospastic shock after noncardiac surgeries.

the systemic inflammatory response syndrome (sirs) is a common complication after non-cardiac surgery, impacting negatively on patient outcome and with high incidence rates. vasoplegic syndrome is the most serious complication of sirs and can happen after any type of surgery. the etiology of the vasoplegic syndrome has not yet been fully elucidated, but is known to occur more frequently in patients at high surgical risk, submitted to major surgeries, or in the presence of perioperative complications and patients with comorbidities. in this circumstance, the depletion of vasopressin stocks is described, which may contribute to the refractoriness of the shock and the lack of response to the catecholaminergic drugs. the standard treatment of perioperative vasoplegia has been adequate volume replacement and administration of vasopressors, with norepinephrine being the most commonly used. however, it is known that norepinephrine may have deleterious effects on the body and in 20% of patients with vasospastic shock it is ineffective. previous studies have suggested benefits of adding vasopressin in refractory situations, especially in septic shock. recently the vancs study (vasopressin or norepinephrine in the vasopregic shock after cardiac surgery: double-blind, controlled and randomized study) demonstrated superiority of vasopressin in the reversion of vasoplegic shock after cardiac surgery, as well as a lower incidence of renal insufficiency, atrial fibrillation and shorter hospitalization time. (anesthesiology. 2017 jan;126(1):85-93.)

Eligibility criteria:
inclusion criteria: * age greater than 18 years; * patients undergoing high-risk non-cardiac surgery; * vasopressor need within 24 hours after surgery, defined as mean arterial pressure (map) \ 2.2 ml / min / m²; * signature of the informed consent form. exclusion criteria: * allergy to vasoactive drugs; * previous use of vasopressor; * gestation; * presence of raynaud's phenomenon, altered allen's test, systemic sclerosis or vasospastic diathesis; * severe hyponatremia (na \<130 meq / l); * acute mesenteric ischemia; * acute coronary syndrome; * participation in another study; * refusal to participate in the study.

Keywords: vasopressin norepinephrine post-operative critical care
study of remdesivir in participants below 18 years old with covid-19

Conditions: COVID-19

Summary: the goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (covid-19).

pediatric participants will be enrolled as follows: pediatric participants ≥ 28 days to \< 18 years old: * cohort 1: ≥ 12 years to \< 18 years and weight ≥ 40 kg * cohort 2: ≥ 28 days to \< 18 years and weight ≥ 20 kg to \< 40 kg * cohort 3: ≥ 28 days to \< 18 years and weight ≥ 12 kg to \< 20 kg * cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * cohort 8: \< 12 years and weight ≥ 40 kg term neonatal participants 0 days to \< 28 days old: * cohort 5: ≥ 14 days to \ 37 weeks and weight at screening ≥ 2.5 kg * cohort 6: 0 days to \ 37 weeks and birth weight ≥ 2.5 kg preterm neonates and infants 0 days to \< 56 days old: * cohort 7: 0 days to \< 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5 kg

Eligibility criteria:
key inclusion criteria: * aged \< 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (irb) or independent ethics committee (iec)). * a) cohort 1: ≥ 12 years to \< 18 years of age and weight at screening ≥ 40 kg * b) cohorts 2-4: ≥ 28 days to \< 18 years of age and weight at screening ≥ 3 kg and \< 40 kg * c) cohort 5: ≥ 14 days to \ 37 weeks and weight at screening ≥ 2.5 kg * d) cohort 6: 0 days to \ 37 weeks and birth weight of ≥ 2.5 kg * e) cohort 7: 0 days to \< 56 days of age, gestational age ≤ 37 weeks and birth weight of ≥ 1.5 kg * f) cohort 8: \< 12 years of age and weight at screening ≥ 40 kg * severe acute respiratory syndrome coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr). * hospitalized and requiring medical care for coronavirus disease 2019 (covid-19). key exclusion criteria: * concurrent treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 \< 24 hours prior to study drug dosing. * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 x upper limit of normal (uln). * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m\^2 using schwartz formula for individuals ≥ 1 year of age. * creatinine above protocol specified thresholds for \< 1 year of age. * positive pregnancy test at screening only for female of child bearing potential. note: if female participants who become pregnant during the study or are discovered to be pregnant after receiving at least one dose may continue study drug, after discussion with the investigator. * on renal replacement therapies (intermittent hemodialysis (ihd), peritoneal dialysis (pd), continuous renal replacement therapy (crrt)). note: other protocol defined inclusion/exclusion criteria may apply
transvaginal low-level laser therapy to improve pelvic pain and sexual function in patients with endometriosis.

Conditions: Endometriosis; Dyspareunia; Pelvic Pain

Summary: dyspareunia is defined as pain with penetrative sexual intercourse. women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population. a prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.

active intervention: transvaginal photobiomodulation (tv-pbm) control intervention: sham transvaginal probe all subjects will complete 9 treatments over 3-4 weeks and all treatments will be performed with a sheet over the patient's pelvic area to prevent the subject from seeing the probe light, as well as a screen blocking the patient's view of the machine. subjects randomized to active therapy will undergo tv-pbm treatment during each session per standard tv-pbm treatment protocol. subjects randomized to sham will undergo blinded sham therapy using an identical probe but without photobiomodulation. sham therapy will involve the same regimen as the active arm but with the machine turned off. instead, there will be a recording of the usual noise of the machine to mimic the activation that occurs when stepping on the pedal with the machine on for tv-pbm treatment.

Eligibility criteria:
inclusion criteria: * proficient english-speaking females * pathology proven endometriosis, \>6 weeks from prior pelvic surgery * current dyspareunia exclusion criteria: * unable to comply with study protocol * pregnant or attempting to become pregnant * history of or active treatment for pelvic malignancy * currently taking light-sensitizing drugs
observation of young patients who are undergoing surgery for craniopharyngioma

Conditions: Brain and Central Nervous System Tumors; Long-term Effects Secondary to Cancer Therapy in Children; Perioperative/Postoperative Complications; Psychosocial Effects of Cancer and Its Treatment; Weight Changes

Summary: rationale: collecting information on how craniopharyngioma is diagnosed and treated may help doctors predict a patient's response to treatment and help plan the best treatment. it may also help identify the intermediate- and long-term effects of treatment. purpose: this clinical trial is collecting information on diagnosis, treatment, and quality of life of young patients who are undergoing surgery for craniopharyngioma.

objectives: primary * identify all applied therapy strategies in pediatric patients with craniopharyngioma. * correlate relapse status with different therapy strategies/modality in these patients. * determine the health status (i.e., ophthalmologic, neuropediatric, and endocrine findings) and the health-related quality of life of these patients after treatment. secondary * determine the incidence of craniopharyngioma in pediatric patients. * identify quality control measures for diagnosis and therapy in these patients. * improve long-term care through a standardized follow-up program in these patients. * determine the efficacy of endocrine substitution for postoperative hypopituitarism in these patients. * identify risk factors for developing obesity and correlate the neurotransmitter concentration of leptin and neuropeptide y in cerebral spinal fluid, serum, and craniopharyngioma cystic fluid with the likelihood of developing obesity in these patients. * determine the incidence and extent of eating disorders in these patients. outline: this is a multicenter study. patients undergo neurologic, endocrine, and ophthalmologic tests and anthropometric diagnostic measurements. patients then undergo 1 of the following surgical procedures: total resection; incomplete, subtotal, or partial resection; biopsy; or cyst pressure release. patients whose tumor relapses may undergo a second resection and/or radiotherapy. quality of life is assessed at baseline and then periodically thereafter. after surgery, patients are followed periodically. projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of primary craniopharyngioma by mri and ct scan (initial diagnosis) * patients with only cystic sellar or parasellar malformation (e.g., rathke pouch cysts or suprasellar cysts) are allowed but will undergo observation only patient characteristics: performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified prior concurrent therapy: not specified

Keywords: psychosocial effects of cancer and its treatment long-term effects secondary to cancer therapy in children perioperative/postoperative complications weight changes childhood craniopharyngioma
the effects of butyrate on children with obesity

Conditions: Insulin Resistance; Obesity

Summary: butyrate is a short chain fatty acid (scfa) produced by bacterial fermentation of undigested starch in the gut. butyrate carries out different effects at intestinal and extraintestinal level, including: immune regulation with anti-inflammatory effect at intestinal and systemic level and modulation of gut microbiota. many of these effects result from an epigenetic mechanism. shown in an animal model of obesity induced by a high fat diet (hfd), that butyrate can exercise very effective protective action against obesity through the stimulation of intestinal satiety hormones. shown always in murine model of obesity induced by hfd, that butyrate is effective in preventing and treating obesity and insulin resistance. after 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight, 30% of fasting glucose and 50% insulin resistance. in an animal model of metabolic syndrome with nafld researchers have recently demonstrated that the administration of butyrate is able to significantly reduce insulin resistance, liver damage, dyslipidaemia through a modulation of the inflammatory process. pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of butyrate is safe and well tolerated. the peak serum levels occurs 4-6 hours after oral administration. all of these data makes plausible a possible positive effect on insulin resistance in the obese child.


Eligibility criteria:
inclusion criteria: * obesity (bmi \>95° percentile) * homeostasis model assessment (homa-ir) \> 4 (obtained by calculating the product of fasting plasma insulin expressed in microunits/ml and fasting plasma glucose expressed in mmol/l divided by 22.5) exclusion criteria: * age \ 15 years * bmi \<95° centile * homa-ir \<4 * patients under pharmacological treatment for obesity (metformin) or taking vitamin e, pre-, pro- or synbiotics * simultaneous presence of other chronic diseases unrelated to obesity (cancer, immunodeficiency, cystic fibrosis, allergies, celiac disease, autoimmune diseases, neuropsychiatric disorders, type 1 diabetes, inflammatory bowel diseases, malformations of urinary or gastrointestinal or respiratory tract, chronic lung diseases, genetic and metabolic diseases, chronic hematological diseases) * history of surgery for the treatment of obesity * any medical condition that may interfere with participation in this study * participation in other clinical trials still in progress