Kornimate/medical-research-clean huggingface dataset:
bioenergetics and metabolism in pediatric populations

Conditions: Obesity; Type 2 Diabetes Mellitus; Insulin Resistance

Summary: the investigators want to learn more about obesity, the development of insulin resistance, and type 2 diabetes in children. the investigators will do this through collecting information about children's health and conducting experiments on a variety of samples.


Eligibility criteria:
inclusion criteria: * age 5-9 years and tanner stage as reported by parent no greater than stage 1 or age 5 years - 17 years 5 months, diagnosed with type 2 diabetes mellitus or insulin resistance * either healthy lean (bmi≥ 5th percentile and \<85th percentile for age/sex) or obese (bmi ≥ 95th percentile for age/sex) * for those with bmi≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of bmi≥ 95th percentile for age/sex for at least six months prior to study enrollment exclusion criteria: * genetic or physical conditions impacting mobility over past year as determined by the principal investigator (pi) * having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, cushing's), hepatic, autoimmune, cardiac and renal disorders. also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids * taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants * bmi\<5th percentile for age/sex (classified as underweight based on centers for disease control and prevention growth charts) * subjects determined ineligible by the pi.

Keywords: obesity pediatric health type 2 diabetes insulin resistance metformin therapy
omegaven protocol:intermediate size patient population

Conditions: Parenteral Nutrition Associated Liver Disease

Summary: children requiring prolonged courses of pn are at risk for developing pn associated liver disease. we hypothesize that although omega-6 fatty acid emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver and resulting in steatotic liver injury. we further hypothesize that a fat emulsion comprised of omega-3 fatty acids (i.e., fish oil) such as omegaven® would be beneficial in the management of steatotic liver injury by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.


Eligibility criteria:
inclusion criteria: - 1. inborn and transferred newborns born between the gestational age of 22-40 weeks who develop chronic liver failure, secondary to parenteral nutrition. 2. patients will be pn dependent (unable to meet nutritional needs soley by enteral nutrition) and are expected to require pn for at least another 30 days 3. patients must have diagnosis of parenteral nutrition associated liver disease (pnald) as defined by serum direct bilirubin greater than 2mg/dl on 2 consecutive occasions 4. have had pnald for at least four weeks prior to planned omegaven initiation 5. direct bilirubin \> 2.0 mg/dl 6. signed patient informed consent. 7. the patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic pn, avoiding overfeeding, reduction/removal of copper and manganese from pn, advancement of enteral feeding, and the use of ursodiol (i..e., actigall®). exclusion criteria: - 2. other causes of chronic liver disease (hepatitis c, cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,) 3. severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease, 4. bleeding disorder; 5. biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia. 6. the parent or guardian or child unwilling to provide consent or assent in rare instances, patients diagnosed with pnald may later be found to have liver disease due to other causes in addition to the use of pn (i.e., inborn errors of metabolism, viral infections ). such causes may not be known at the time of enrollment and will not preclude them from continuing in the study.
feasibility of intravaginal artesunate as adjuvant hpv & cervical precancer treatment in kenya

Conditions: Human Immunodeficiency Virus; Human Papillomavirus; Cervical Precancer

Summary: the objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve human papillomavirus (hpv) treatment outcomes in women living with human immunodeficiency virus (wlwh). the study will evaluate whether women who use artesunate will have higher hpv clearance at 6 months, compared to those who used a placebo. the study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.

wlwh face up to six times increased risk of cervical cancer, as a result, cervical cancer is a leading cause of death in this population. cervical cancer is caused by persistent infection with the human papillomavirus (hpv), resulting in precancerous changes that if not adequately treated, progress to cancer. thermal ablation is a commonly used treatment for cervical precancer in kenya and other low- and middle-income countries (lmics). current treatments for hpv or cervical precancer, including thermal ablation, are associated with high rates of treatment failure in wlwh. in a recent study from zambia, only 44% of wlwh had cleared hpv at six months following thermal ablation treatment. other studies have demonstrated up to 30% recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment. persistent infection with hpv following precancer treatment is a key risk factor for treatment disease recurrence.

Eligibility criteria:
inclusion criteria * age 25 years or older * known hiv seropositive status * on antiretroviral therapy for \> 90 days prior to enrollment * weight ≥50 kg at study entry\* * positive hpv screening test and within 4-8 weeks of thermal ablation * ability to provide informed consent * planning to stay within the study locale during the duration of the study (24 weeks) * agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study exclusion criteria * current pregnancy or breastfeeding status * current or past history of invasive cervical cancer * history of total hysterectomy * currently receiving systemic chemotherapy or radiation therapy for another cancer * current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent) * current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin * have medical comorbidity that, in the opinion of the investigator, would interfere with study participation * prior chemotherapy within 30 days prior to day 1 of study treatment * male at birth

Keywords: intravaginal self-administer artesunate intravaginal artesunate vaginal pessaries
role of slowly digesible starch on diabetes risk factors

Conditions: Prediabetes

Summary: the purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.

in a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. for the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. the investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.

Eligibility criteria:
inclusion criteria * have a body mass index between 30 and 44.9 kg/m2 * are 35-65 years of age * have pre-diabetes, which means impaired fasting glucose (ifg) * are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing * are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study * are willing to maintain weight throughout the study exclusion criteria * have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer * have a fasting blood glucose less than 100 mg/dl or greater than 125 mg/dl * have an average screening blood pressure \> 150/100 mm hg * are a pre-menopausal woman but do not have a regular menstrual cycle * are pregnant or breastfeeding * chronically use medications including diuretics, steroids, and adrenergic-stimulating agents * have emotional problems such as clinical depression or other diagnosed psychological conditions * use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study * have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study * have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal) * chronically consume alcohol (\> 4 servings per day) or actively smoke cigarettes (\> 1/4 pack per day) * are on any chronic medication that has not had a stable dose for 1 month or longer * are required to perform of any kind of heavy physical activity * have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.
study of the cellular diffusion of tacrolimus across the membrane of mononuclear cells

Conditions: Hemochromatosis

Summary: pharmacokinetics of tacrolimus are highly variable and may result in graft rejection (underdosing) or toxicity (overdosing). the risk of transplant rejection and the toxicity of tacrolimus can be reduced by pharmacological therapeutic monitoring of the molecule, based on the measurement of residual blood concentrations. nevertheless, some patients are victims of rejections or toxic signs even though their blood concentrations are in the therapeutic target. the aim of the study is to describe the pharmacokinetics of tacrolimus diffusion in mononuclear cells as well as the kinetics of effect of the drug on its target protein

factors responsible for pharmacokinetic variability of tacrolimus are multiple: compliance, diet, drug interactions and also genetic polymorphism of cytochrome p450 3a5 (cyp 3a5) and efflux protein abcb1 (p-glycoprotein, p-gp). the mechanism of action of tacrolimus is based on inhibition of calcineurin in t cells. therefore, tacrolimus intra-lymphocyte concentration may be a finer marker of the risk of transplant rejection or toxicity. the degree of inhibition of calcineurin in the t lymphocyte could also be a pharmacodynamic marker more relevant than the blood concentration. the hypothesis that the abcb1 efflux pump is the main factor limiting the diffusion of tacrolimus into mononuclear cells is advanced. the diffusion of tacrolimus into mononuclear cells and the impact of the abcb1 efflux pump on this diffusion have not been studied to date. the effect kinetics of the drug on calcineurin in mononuclear cells is also unknown. the aim of the study is to describe the pharmacokinetics of tacrolimus diffusion in mononuclear cells as well as the kinetics of effect of the drug on its target protein: calcineurin in the presence or absence of an efflux pump inhibitor abcb1 at room temperature and at 4 ° c (in order to inhibit all transport proteins) from blood obtained from 18 patients undergoing bleeding as part of maintenance treatment for hemochromatosis.

Eligibility criteria:
inclusion criteria: * adult (age \> 18 years old); * phlebotomy as part of the maintenance treatment of hemochromatosis; * having received the information on the protocol and not having indicated his opposition to participate; * not receiving immunosuppressive therapy; * not receiving drug treatment that can induce or inhibit the protein abcb1 (rifampicin, carbamazepine, phenobarbital, phenytoin, efavirenz, amiodarone, azole antifungals, calcium channel blockers). exclusion criteria: * participation in another protocol whose procedures are incompatible with the realization of the study; * adults who are subject to legal protection (protection of justice, guardianship) and persons deprived of their liberty; * pregnant women.

Keywords: tacrolimus pharmacokinetics
efficacy of shoulder mobilisation versus conventional immobilisation for nonsurgically proximal humerus fracture

Conditions: Shoulder Fracture

Summary: background: nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. we assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.

methods: we randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment. the primary outcome was functional assessment of the shoulder (constant score) at 3 months. secondary outcomes were functional assessment at 6 weeks and at 6 months, change in pain (on a visual analogue scale) and passive range of motion.

Eligibility criteria:
inclusion criteria: * impacted nonsurgically treated proximal humerus fracture * patients over the age 20 exclusion criteria: * pre-existing shoulder pathology * neurological disorders of the upper limbs * indication for surgery of the shoulder * combined polytrauma * difficulties with language or comprehension to understand a rehabilitation program and information

Keywords: nonsurgical proximal humerus fracture rehabilitation physiotherapy randomised controlled trial
cooperative adenomyosis network

Conditions: Dysmenorrhea; Metrorrhagia; Infertility, Female; Pathology; Ultrasonography; Radiography

Summary: to set up a cooperative network by enrolling 5000 patients with adenomyosis(am) from multiple centers.based on the network platform and database,the investigators try to explore the diagnostic strategies for am and carry out epidemiological survey on the semeiology of am.in addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment, the etiology of am and endometriosis,the perspective investigation of the malignant transformation of am ;the high-risk factors of am,and finally propel the formation of expert consensus and clinical guidelines about am which suitable to chinese conditions.

5000 women diagnosed of adenomyosis(am) with pathology, transvaginal ultrasonography or magnetic resonance image（mri）will be enrolled from nationwide multicenters. the investigators would build up network platform, and database with the registered data within 6 months. 30-month follow-up with an interval of at least once every 6 months will be done for every patient ，and update the database timely. based on the network platform and database,we try to explore the diagnostic strategies for am and carry out epidemiological survey on the semeiology of am.in addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment,the etiology of am and endometriosis,the perspective investigation of the malignant transformation of am ;the high-risk factors of am,and finally propel the formation of expert consensus and clinical guidelines about am which suitable to chinese conditions.

Eligibility criteria:
inclusion criteria: * women diagnosed of adenomyosis by pathology, transvaginal ultrasound or mri. exclusion criteria: * refusal to join the study

Keywords: adenomyosis diagnosis treatment epidemiology complications
safety and immunogenicity of three influenza vaccines adults ages 18 and older

Conditions: Influenza

Summary: evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.


Eligibility criteria:
inclusion criteria: 1. male or female ages 18 years and older. 2. individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up. exclusion criteria: 1. individuals recently vaccinated against influenza 2. subjects with contraindications to receive influenza vaccine 3. please contact the site for additional eligibility criteria

Keywords: influenza influenza vaccine novartis adults
a phase i study of ql1604 for advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: in this study, patients with advance solid tumors will be treated with ql1604 monotherapy.


Eligibility criteria:
key inclusion criteria: * 18-75 years; * at least one measureable lesion as defined per recist version (v) 1.1 * histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis * adequate important organ function key exclusion criteria: * active autoimmune disease orautoimmune disease history * meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of \> 10 mg/day or equivalent hormone) for more than 2 weeks) * known hypersensitivity to protein macromolecules, and/or any of ql1604 excipients * radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks) * active hepaititis b or c infection * both hbsag and anti-hcv ab positive
frequency-time analysis of pathological lung sounds: detection and quantification of pathological sounds in patients with cystic fibrosis, pulmonary fibrosis or copd (chronic obstructive pulmonary disease)

Conditions: Pulmonary Fibrosis; Chronic Obstructive Pulmonary Disease; Cystic Fibrosis

Summary: the main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, copd or pulmonary fibrosis.

secondary objectives the other objectives of this study are : 1. to evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation. 2. to evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method. conduct of research this is a single-center, non-randomized, open-label study involving 60 male and female patients aged 18 to 65, eligible for a scheduled consultation as part of their usual pathological follow-up (routine care). lung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition. recordings will be made using a 3m littmann© model 3200 electronic stethoscope. the stethoscope works with eko software, which will be installed on a touch-sensitive tablet or computer, enabling local storage of recorded data. whatever the patient's pathology, the physician will listen to 10 lung sites defined in the protocol. at least one breath per pulmonary site will be recorded during the consultation. if a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, copd * not opposed to participating in the study exclusion criteria: * person under court protection, guardianship or curatorship * person deprived of liberty by judicial or administrative decision * patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion.
study comparing urinary diversion (transurethral/suprapubic) after radical prostatectomy

Conditions: Pain; Catheter Complications

Summary: the study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (eerpe) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.

patients are randomized 1:1 in the different arms recording of qol measured by visual analogue ( pain )scale,eortc qlq -c 30 and qlq - pr 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate, * subjects treated by conventional or robotic assisted laparoscopic prostatectomy * be willing/able to adhere to follow up visits exclusion criteria: * subjects treated by retropubic or perineal prostatectomy subjects with known bladder cancer * contraindications for anticholinergic drugs * waist measurement \> 100 cm * no written informed consent * age \< 18 years * subjects with known narrow-angle glaucoma

Keywords: pain measurement
stereotactic body radiation therapy (sbrt) for prostate cancer

Conditions: Prostatic Neoplasm

Summary: the purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.

external beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a monday through friday basis. recent phase i/ii studies from seattle and palo alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. these data, combined with markedly improved convenience for patients, make radiosurgery (sbrt) for early-stage prostate cancer an enticing option. the goal of this study is to offer a radiosurgical option to patients within the sharp system under the umbrella of an irb-approved study.

Eligibility criteria:
inclusion criteria: * male with any age (typically 50 to 70 years old) with a low risk disease. this is defined as a gleason's score of 6 or less, clinical stage of t2a or less, and a psa of less than 15. we will also include patients with gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension. exclusion criteria: * prior surgery or radiotherapy for prostate cancer, psa over 10, gleason scores 7, 8, 9, or 10 (except gleason 7 as noted, above), or clinical stage t2b, t2c, t3, or t4.

Keywords: neoplasms urogenital neoplasm genital neoplasms, male