Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy, safety, and tolerability in participants with obesity or overweight with weight-related comorbidities

Conditions: Chronic Weight Management

Summary: this randomized, double-blind, placebo-controlled phase iia study is designed to evaluate the efficacy, safety, and tolerability of asc30 tablets and asc30 tablets a1.


Eligibility criteria:
inclusion criteria: * have provided informed consent before initiation of any study-specific procedures. * male or female participants, non-smokers, between 18 and 75 years of age (both inclusive). * no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and other screening procedures. exclusion criteria: * have evidence of any clinically significant active or chronic disease. * have any prior diagnosis of diabetes mellitus (t1dm or t2dm), or rare forms of diabetes mellitus. * have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * have a history of acute or chronic pancreatitis. * participants with a known clinically significant gastric emptying abnormality. * have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. * have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol.
role of mri in detection of minimal hepatic encephalopathy

Conditions: Liver Cirrhoses; Hepatic Encephalopathy

Summary: introduction liver cirrhosis (lc) is irreversible fibrosis of the liver (1) and it remains a public health problem. one of the complications of the cirrhosis is hepatic encephalopathy (he) which is defined as brain dysfunction caused by liver insufficiency. pathophysiological mechanisms of he are complex and multifactorial. recognition of beginning stages of he, such as minimal he (mhe) is of most importance. objectives and originality of the project diagnosis of mhe can be challenging, time-consuming and, at least to some extent, subjective. this project will assess the role of magnetic resonance (mr) in mhe diagnosis with emphasis on multimodal imaging technique. with advanced magnetic resonance (mr) techniques, in-vivo detection of intracellular water content, estimation ph and metabolites levels with millimolar concentrations can be easily performed. this will offer to explore possible pathophysiological mechanisms of he and to evaluate the results from previous, studies that were mainly performed on animal models or cell cultures. by our best knowledge, multimodal mr approach as the investigators propose in this application has not been yet performed. the investigators will use advanced mr techniques which are currently not available in the clinical setting and require multicenter collaboration. methods the investigators will include 10-20 patients of both genders with hyperammonemia and mhe and 10-20 patients of both genders with he. diagnosis of he will be made based on results of validated neuropsychiatric test. age-matched and gender-matched control group with no gastrointestinal, neurological or psychiatric complaints and normal levels of ammonia in the blood. patients with mhe/he will be included from outpatient clinic of the department of gastroenterology, university medical centre (umc) ljubljana. healthy controls (hc) will be invited to join via internet advertisement. contraindications for hc will include gastrointestinal (emphasis on liver disease), neurological or psychiatric complaints. grade of mhe/he will be classified according to west-haven (wh) classification. patients with different degree of liver cirrhosis, which will be scored with the child-pugh (cp) score, and with no contraindications for mr (e.g. presence of metal in body) will be included. blood levels of liver enzymes and ammonia will be measured in all participants. mr scanning will include: t1- and t2-weighted mr, mrs (mega-press and press) in two voxels: striatum and cerebellum. location will be double-checked by voxel position screenshots. analysis, with voxel-positioning error compensation will be performed in gannet (www.gabamrs.com). moreover, high resolution diffusion weighted imaging (dwi), diffusion kurtosis imaging (dki), quantitative susceptibility mapping (qsm) will be performed in brain as well. liver qsm will be executed to assess iron load.


Eligibility criteria:
inclusion criteria: * known liver disease/cirrhosis exclusion criteria: * pregnancy, non compatible material with mri
the role of peripheral and tissue chitinase 3-like 1 protein levels as a bio-marker in ibd

Conditions: Inflammatory Bowel Diseases

Summary: the digestive system may be involved in various pathologic conditions, with different inflammatory, metaplastic and neoplastic aspects. as the therapeutic tool-box for digestive diseases grows and becomes more focused, at times targeting specific molecules, decision making in managing patients becomes more and more important, and must be evidence based. defining biomarkers with predictive value will theoretically allow physicians in making diagnosis, deciding on a suitable first line therapy (with specific endpoints suggesting response or indicating 2nd line therapy is indicated) and finally may suggest surgical intervention is warranted, thus forming an "individually tailored treatment" for each patient. these biomarkers may be located in the peripheral blood, in the gastrointestinal tract in general, or confined to specific intestinal lesions. chitinase 3-like 1 protein (ykl-40) is produced by different tissues (e.g. - synovium, smooth muscle, intestinal epithelium). its specific action is unknown, but several reports have described it in different inflammatory conditions including those involving the gastrointestinal system. chitinase 3 like-1 protein (ykl-40) has also been studied for its possible role in angio and onco-genesis. this study aims to evaluate the diagnostic and prognostic value of peripheral and tissue chitinase 3-like-1 (ykl 40) levels in gastrointestinal and liver diseases.

for periphery tests: 10 ml blood will be collected from all eligible subjects into sst tubes. then serum will be separated and freeze at -80 degrees until analysis of chitinase 3 like-1 protein by elisa. for tissue tests: biopsies will be taken from colons of eligible participants. one part of these biopsies will be freeze until analysis of chitinase 3 like-1 protein by elisa. the other part of the biopsies will be placed in dishes with appropriate media and will be incubated in 37 degrees in order to follow cytokine secretion for 24 h. media will be collected after 24 h and then freeze until further analysis of chitinase 3 like-1 protein by elisa. the investigators will also measure mrna levels of chitinase 3 like-1 protein in collected biopsies. the investigators will try to correlate between the chitinase 3 like-1 protein levels in the blood and in tissue among various groups of participants and will compare between healthy participants and ibd participants. the investigators will also follow mrna expression in tissue biopsies taken from all the participants.

Eligibility criteria:
inclusion criteria: * age \>18 years * signed informed consent * any patient followed or treated by the digestive disease institute team (including ambulatory, hospitalized or undergoing procedure, endoscopy, surgery, endovascular or biopsy). exclusion criteria: * pregnancy * inability to obtain informed consent * bleeding diathesis or any other condition precluding tissue biopsy.
voriconazole plasma level in intensive care unit (icu) patients

Conditions: Invasive Fungal Infection

Summary: voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive fungal infections, including invasive aspergillosis. recently, therapeutic drug monitoring of voriconazole has been issued because of wide variations and unpredictability of voriconazole blood concentration. the objective of this study is 1) to characterize the pharmacokinetics of voriconazole in icu patients on voriconazole prophylaxis or treatment, and 2) to develop and evaluate the prediction and adjustment models for voriconazole plasma levels.

patients will be randomly assigned into 2 groups: conventional adjustment group (ca group) and early adjustment group (ea group). voriconazole plasma levels will be measured on day 1 (both peak and trough levels), day 3, day 5, day 10, and day 14 (all trough levels). for ca group patients, voriconazole dosage will be adjusted according to the trough levels of day 5 (steady-state level). predefined dose adjustment protocol will be used (\ 5.5 µg/ml: 50% decrease). for ea group patients, voriconazole dosage will be adjusted according to the each measurements of voriconazole levels from day 1. adjusted dosage will be calculated using the nonmen software. the target range of trough level is between 1.0 µg/ml and 5.5 µg/ml. the appropriateness of voriconazole level (day 5, day 10, and day 14), mortality, icu stay, and the frequency of voriconazole-related adverse events will be compared. cyp2c19 polymorphism will be analyzed for all patients.

Eligibility criteria:
inclusion criteria: * patients who received voriconazole exclusion criteria: * patients allergic to azole(s)

Keywords: voriconazole therapeutic drug monitoring intensive care unit
a multi-part, double blind study to assess safety, tolerability and efficacy of tropifexor (ljn452) in pbc patients

Conditions: Primary Biliary Cholangitis

Summary: a multi-part study to assess safety, tolerability and efficacy of tropifexor (ljn452) in patients with primary biliary cholangitis


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of pbc as demonstrated by the presence of at least 2 of the following 3 diagnostic criteria: * history of alkaline phosphatase (alp) elevated above upper limit of normal (uln) for at least 6 months * positive antimitochondrial antibodies (ama) titer or if ama negative or in low titer (\<1:80) pbc specific antibodies (anti-gp210 and/or anti-sp100 and/or antibodies against the major m2 components (pdc-e2, 2-oxo-glutaric acid dehydrogenase complex)) * previous liver biopsy findings consistent with pbc * at least 1 of the following markers of disease severity: * alp ≥ 1.67 × uln * total bilirubin \> uln but \< 1.5 × uln * in addition, patients must meet the following biochemical criteria at enrollment: * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 5 × uln * total bilirubin ≤ 1.5 × uln * inr ≤ uln * taking udca for at least 12 months, or for at least 6 months and has reached maximal response to udca with a plateau in alkaline phosphatase, with no changes in dose for ≥ 3 months prior to day 1. * patients must weigh at least 40 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 40 kg/m2. bmi = body weight (kg) / \[height (m)\]2 exclusion criteria: * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception for 30 days before randomization, during dosing and for 30 days following the end of treatment. * presence of other concomitant liver diseases. * cirrhosis with complications, including history or presence of: * variceal bleed * uncontrolled ascites * encephalopathy * spontaneous bacterial peritonitis * significant hepatic impairment as defined by child-pugh classification of b or c, history of liver transplantation, current placement on a liver transplant list or current model for end stage liver disease (meld) score ≥15. * history of conditions that may cause increases in alp (e.g., paget's disease). * use of investigational drugs, or immunosuppressive drugs at the time of enrollment, or within 5 half-lives, or 30 days of randomization, whichever is longer; or longer if required by local regulations. use of high dose oral steroids to treat co-morbid conditions (e.g., airways disease) will be allowed but must be properly documented as such in concomitant medications. * currently taking obeticholic acid or have taken obeticholic acid within 30 days of randomization * previous participation in cljn452x2201 and received study medication within three months of randomization (or longer if required by local regulations).

Keywords: primary biliary cirrhosis, pbc primary biliary cholangitis
targeted fortification of pasteurized donor human milk

Conditions: Very Low Birth Weight Infant; Growth Failure; Donor Breast Milk

Summary: this randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (pdhm) in very low birth weight infants (vlbws). pools of pdhm will be analyzed for macronutrient content using the miris human milk analyzer. the control arm will receive standard of care, which is pdhm without additional protein fortification. the intervention arm will receive pdhm with a fat content of 3.8g/dl or more, with additional protein fortification of 0.67g/dl. primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

our hospital milk bank provides pasteurized donor human milk (pdhm) to very low birth weight (vlbw) infants without sufficient mother's milk, with the overall aim of lowering the risk of necrotizing enterocolitis in this population. however, with the introduction of pdhm in our setting, rates of suboptimal weight gain have increased (60.2% to 65.7%). this is likely due to the fact that pdhm is often lower in energy and protein than preterm mother's own milk. one solution to delivery adequate nutrition in this vlbws receiving pdhm, is targeted fortification, which involves measurement of the macronutrient content of human milk, and adding extra macronutrients to reach nutrient goals. in this proposed study, we will conduct a pilot randomized controlled trial of a modified targeted fortification versus standard care. this study will include preterm vlbw infants (\ 25% of pdhm use in the first week of life. 40 patients in each arm will be recruited over a period of 2 years. the intervention group will receive a modified targeted fortification, consisting of selection of high fat pdhm (3.8g/dl or more) with the addition of protein fortification of 0.67g/dl from week 2 of life until a gestational age of 37 weeks or hospital discharge, whichever earlier. the control group will receive usual regular pdhm with standard fortification using human milk fortifier as per current practice. the primary outcome is the rate of suboptimal growth (drop in weight z-score from birth ≥0.8) at discharge or 37 weeks. secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

Eligibility criteria:
inclusion criteria: * birth weight less than or equal to 1500g * born at our study hospital or transferred to study hospital within first week of life * achieving at least 40ml/kg/day of enteral feeds by day 7 of life * receiving at least 25% of pasteurized donor human milk within first 7 days of life exclusion criteria: * diagnosed or suspected inborn errors of metabolism * acute or chronic renal impairment * congenital disease associated with significant growth impairment (including, but not limited to, trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders)
mask-associated dry eye symptoms in china

Conditions: Dry Eye Syndromes

Summary: to review the relationship of increased face mask usage arising from lockdown measures instituted during the covid-19 pandemic with dry eye symptoms on chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.


Eligibility criteria:
inclusion criteria: * age \>=8 years mental health exclusion criteria: * eye diseases mental or systemic diseases
(bicalutamide) casodex vs placebo in non-metastatic early prostate cancer

Conditions: Non-Metastatic Prostate Cancer

Summary: the purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of non-metastatic cancer of the prostate gland * patient to be 18 years and above exclusion criteria: * previous systemic therapy for prostate cancer * previous history of another form of cancer (not prostate) within 5 years of study start.

Keywords: androgen antagonists prostate neoplasms
high-resolution ce-mra of children's hip joint

Conditions: Hip; Vessels; Anomaly; Magnetic Resonance; Three-dimensional Water-selective Cartilage (3D-WATSc)

Summary: the goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3d-watsc) sequence in displaying the vessels of children's hip by magnetic resonance. the main questions it aims to answer are: * could the images of enhanced 3d-watsc sequence show the healthy side hip joint vessels in children? * could the images of enhanced 3d-watsc sequence show the vascular disease of the suffering side hip joint in children? participants with unilateral hip disease will undergo the magnetic resonance examination including enhanced 3d-watsc sequence. the pelvic plain film and magnetic resonance images will be collected and analysed. researchers will compare the images of of the normal side with the images of the abnormal side to see if the enhanced 3d-watsc sequence images could show the vascular disease of the suffering side hip joint in children?


Eligibility criteria:
inclusion criteria: * children aged 6 months-14 years who are diagnosed as hip disease after screening by pediatric orthopedic surgeon in children's hospital of chongqing medical university during the study period. the hip disease contain developmental dysplasia of the hip, perthes disease, infection of the hip, inflammation of the hip, fracture of the hip, and meyer's dysplasia. exclusion criteria: * patients with bilateral hip joint disease; patients with claustrophobia;patients with metal implants (such as pacemaker implantation)
peak cough flow and cough clearance in patients with muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this study is to determine whether physiologic measures (peak cough flow, measures of respiratory muscle strength including mip, mep ,snip, and spirometry) can predict spontaneous cough clearance (as measured by a nuclear medicine study) in children with neuromuscular disease. it will also determine whether airway clearance is augmented by high frequency chest wall oscillation.


Eligibility criteria:
inclusion criteria: * age 6-21; able to cooperate with study procedures * duchenne muscular dystrophy or becker muscular dystrophy exclusion criteria: * need for mechanical ventilation during the day * recent (within 2 weeks) lower respiratory tract infection

Keywords: airway clearance duchenne muscular dystrophy peak cough flow
feasibility of laparoscopic sleeve gastrectomy in day case surgery

Conditions: Obesity

Summary: the aim of this study is to determinate the feasibility of the laparoscopic sleeve gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a day-case surgery.

the purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by laparoscopic sleeve gastrectomy could be operated according to a "day-case surgery" modality. the sequence of this study is the following: 1. patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests. 2. medical records of each patient are reviewed by an obesity-related staff: laparoscopic sleeve gastrectomy is proposed. 3. during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study 4. after obtained his consent, the surgical procedure is planned and laparoscopic sleeve gastrectomy is done in the day-case surgery unit. 5. the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...) 6. the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up. 7. follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.

Eligibility criteria:
inclusion criteria: * sufficient understanding * good observance of medical prescription * availability of a responsible adult for the first operative night * patients living nearby the hospital (1 h maximum away) * telephonic accessibility * between 18 and 60 years old adults * body mass index less than 60 kg/m2 * obesity requiring bariatric surgery * surgery validated by an obesity-related staff exclusion criteria: * patient under administrative or legal protection * obesity without has criteria * cardiovascular comorbidity * pulmonary comorbidity * curative anticoagulant therapy * bad diabetes control * body mass index higher than 60 kg/m2

Keywords: laparoscopic sleeve gastrectomy obesity management