Kornimate/medical-research-clean huggingface dataset:
ursodeoxycholic acid in patients with nafld - clinical observation

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: patients with nafld indicated for ursodeoxycholic acid treatment ("by spc: cholestatic hepatitis") will be offered an observational study. examinations will be performed before the treatment and after 6month period. laboratory parameters, non-invasive indices, liver elastography, cardiovascular parameters and liver mr spectroscopy will be performed.

patients with nafld newly indicated for ursodeoxycholic acid treatment will be offered an observational study. clinical examinations, blood sampling, ultrasound examinations of the liver and liver elastography will be performed. non-invasive indices evaluating liver fibrosis and steatosis based on common anthropometric and laboratory parameters (fli, nafld fibrosis score, bard score, apri, fib-4) will also be evaluated. the examinations will be repeated after 6 months of treatment (all as part of regular routine check-ups performed in patients with nafld). before and after the follow-up, patients will be offered examinations as part of cardiovascular disease (ultrasound examination of the carotid artery and endothelial dysfunction) and examinations for quantification of hepatic steatosis by mr spectroscopy. statistical processing: individual parameters will be evaluated before the start of monitoring and after 6-month monitoring. a difference of p≤0.05 will be considered a statistically significant change.

Eligibility criteria:
inclusion criteria: * individuals with nafld with alt elevation and cholestatic features who are indicated for standard treatment with ursodeoxycholic acid according to spc ("hepatitis of various etiologies with cholestatic syndrome"). exclusion criteria: * previous treatment with ursodeoxycholic acid. * diagnosis of cirrhosis at the start of the study. * etiology of liver disease other than nafld. * presence of malignant disease. * cardiovascular comorbidity: chd / chd on pharmacological therapy, history of myocardial infarction, stroke and coronary / carotid intervention. * pregnancy.

Keywords: nafld liver steatosis liver fibrosis ursodeoxycholic acid
application of serum bile acid profile in the diagnosis of gastric cancer

Conditions: Gastric Cancer

Summary: in this study, the composition and level of serum bile acids in patients with gastric cancer and non-gastric cancer were analyzed by detecting the serum bile acid profile, so as to develop new serological diagnostic methods for early diagnosis and treatment of gastric cancer.


Eligibility criteria:
inclusion criteria: 1. age between 18-70, both gender; 2. the gastric cancer group was early gastric cancer or advanced gastric cancer diagnosed by endoscopic examination and pathological biopsy. the non-gastric cancer group included patients without gastric lesions, superficial gastritis, chronic atrophic gastritis, intestinal metaplasia or dysplasia diagnosed by gastroscopy or pathological biopsy; 3. informed consent was obtained. exclusion criteria: 1. the patients have diseases that affect bile acid metabolism, such as liver cirrhosis, gallstones or inflammatory bowel disease, behcet's disease, etc; 2. due to other diseases, the patient took drugs affecting bile acid metabolism, such as cholestyramine, anti-inflammatory lidan tablets, danshu capsules, ursodeoxycholic acid, obticholic acid, schisandrin b, tanshinone ⅱa, yinzhihuang, etc; 3. pregnant women; 4. primary tumors of other systems were diagnosed; 5. those with poor physiopathological conditions, such as chronic kidney disease requiring long-term dialysis; 6. patients with mental illness; 7. patients who have received radiotherapy or surgery previously; 8. those with poor adherence or difficult to follow up.

Keywords: serum bile acid biomarker
efficacy of patellar taping and electromyographic biofeedback training at various knee angles on quadriceps strength and functional performance in patellofemoral pain syndrome

Conditions: Patellofemoral Disorder; Anterior Knee Pain Syndrome

Summary: this study compared the effects of patellar taping and electromyographic-biofeedback (emg-bf) guided isometric quadriceps strengthening at different knee angles in patello-femoral pain syndrome (pfps).

a total of 60 adult male athletes aged 18 to 45 years were recruited. subjects will be included with the history of knee pain during activities such as descending and ascending stairs, squatting, and running, had positive j sign (lateral tilt of patella), and a sign of patellar malalignment on the radiograph. individuals with a history of fracture around the knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of the knee will be excluded from the study. the protocol was submitted to and approved by the ethical sub-committee of the college of applied medical science, majmaah, saudi arabia (ethics number: murec-nov./com-2o20/11-2). participants were requested to sign a written informed consent form approved by the institution ethics committee. participants were randomly assigned to group a (experimental group): electromyography biofeedback (emg-bf) guided maximum voluntary isometric contraction exercise with patellar taping; group b (control group): sham emg-bf guided maximum voluntary isometric contraction without patellar taping. the outcome measure for this study will be the mean changes in maximum voluntary isometric contraction (mvic) of the quadriceps muscle at different angles, pain intensity, single-leg triple hop test (slth), and functional status up to 6 weeks.

Eligibility criteria:
inclusion criteria: * knee pain during activities such as descending and ascending stairs, squatting, and running, * positive j sign (lateral tilt of patella), * sign of patellar malalignment on the radiograph exclusion criteria: * fracture around the knee, * patella dislocation, * knee deformity (e.g., genu varum), * knee flexion contracture, * ligaments/meniscal injuries, and * osteoarthritis of the knee.

Keywords: pain; strength; function; pfps; athletes; sltht
screening for liver fibrosis by using non-invasive methods ( fibro scan) in patients with elevated liver enzymes

Conditions: Elevated Liver Enzymes

Summary: background: fibrosis assessment by transient elastography or fibro scan is validated in chronic hepatitis c, however limited data are available in chronic hepatitis b and in non alcoholic fatty liver disease (nafld). aims: document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, safed,bar ilan university. israel. methods: fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. liver stiffness measurement, age, gender, bmi, will be measured. questionaire on soft drink consumption, coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. expected results: we expect that the liver stiffness (normal 1-6 kpa) will be higher in nafld patients than in viral hepatitis patients for the same age ,same bmi, and the same duration of disease. more over, we expect serum aspartate aminotransferase (ast) values will emerge as the most important independent predictive variable of fibrosis and not serum alt. a significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. conclusions: this prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with nafld.


Eligibility criteria:
inclusion criteria: * male or female subjects * more than 18 years of age * patients with elevated liver enzymes * written informed consent exclusion criteria: * patients refusing to participate to the study and to provide written informed consent * clotting disorder * ongoing treatment with anti-coagulant or anti-aggregant * advanced or decompensated cirrhosis (child-pugh class c) * hepatocellular carcinoma * other cancer * history of surgery for brain aneurysm * pace maker or defibrillator * ocular metal foreign body
physical health of residents in psychiatric institutions

Conditions: Physical Health

Summary: aim of the study: to investigate if the intervention described in this protocol has an effect on patients' and staff's physical health. null hypothesis: there is no difference in waist circumference, body weight, quality of life and the rate of polypharmacy between the intervention and control groups after six months.

background: the prevalence of physical health problems among patients suffering from psychiatric illnesses is above that seen in the average population (1). cardiovascular diseases (2) and metabolic disorders (3;4) are common in persons diagnosed with schizophrenia (5;6). a fact that has been known for many years (7), and there has been no decrease in the prevalence of physical illness in connection with the decentralization of the psychiatric treatment which has taken place in the western world during the last 30-40 years (8). meta-analyses describe increased physical morbidity among patients with psychiatric diseases and increased mortality on account of somatic diseases (7). one of the reasons for the increased mortality could be the use of second generation antipsychotics that in some cases cause weight gain and metabolic syndrome which is associated with a two to threefold increase in cardiovascular mortality and a twofold increase in all-cause mortality (3;9). these effects would be expected to contribute to even higher mortality in the following years (10). the use of more than one antipsychotic drug, polypharmacy, might also play a role (11;12). psychiatric societies, national and international health authorities advise against the use of polypharmacy (13). the quality of the general health care in patients with severe mental illness and the consensus about the prevention of somatic illness in this group of vulnerable patients need to be improved and there is evidence signifying the importance of the situation (14;15). we need more knowledge about how to integrate the prevention and care of somatic illness to this group of patients with severe psychiatric illness. this study investigates ways to improve the physical health of people with a psychiatric diagnosis.

Eligibility criteria:
inclusion criteria: * living in one of the 6 institutions in region nordjylland exclusion criteria: * not capable of speaking danish

Keywords: physical health mental illness prevention waist circumference
individualized comprehensive rehabilitation program in chronic knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis is a common condition characterized by pain and functional disability in older people. prevalence increases with age and is more frequent in older women. the aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

the main symptoms of knee osteoarthritis are pain and functional disability. these symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. it is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * diagnosis of primary symptomatic koa according to the criteria of the american college of rheumatology * women aged older than 65 years * pain predominantly over the last 3 months * kellgren and lawrence score ≥2. exclusion criteria: * ankle, hip or foot severe disorders * chronic back pain * alzheimer's disease, parkinson's disease, motor neuron disorders. * diabetes mellitus * cardiac or respiratory insufficiency * inability to understand the procedure
a study of rc48-adc combined with toripalimab for first-line treatment of urothelial carcinoma

Conditions: Urothelial Carcinoma; HER2-expressing

Summary: this is a phase 3, open-label, multicenter, randomised, controlled study designed to compare rc48-adc in combination with js001 to chemotherapy alone in previously untreated her2-expressing unresectable locally advanced or metastatic urothelial carcinoma.

this is a phase 3, open-label, multicenter, randomised, controlled study to evaluate the efficacy and safety of rc48-adc,a recombinant humanized anti-her2 monoclonal antibody-monomethyl auristatin e (mmae) conjugate, in combination with js001,a pd-1 monoclonal antibody, for the treatment of previously untreated her2-expressing unresectable locally advanced or metastatic urothelial carcinoma.

Eligibility criteria:
inclusion criteria: * expected survival ≥12 weeks. * locally advanced unresectable or metastatic uc with histopathological confirmation, including uc originating from the renal pelvis, ureters, bladder, or urethra. * participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: participants that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; participants that received adjuvant chemotherapy following cystectomy with recurrence \>6 months from completion of therapy are permitted. * at least one measurable lesion based on recist version 1.1 * her2-expressing status determined by the central laboratory to be ihc 1+, 2+ or 3+. * ecog performance status score: 0 or 1. * adequate cardiac, bone marrow, hepatic, renal, and coagulation functions. exclusion criteria: * known hypersensitivity to rc48-adc or toripalimab or any of its components. * history of major surgery within 4 weeks of planned start of trial treatment. * toxicity from a previous treatment has not returned to grade 0-1. * prior adcs or pd-1/pd-l1 inhibitor therapy. * active central nervous system (cns) metastases. * known active hepatitis b, active hepatitis c, or human immunodeficiency virus (hiv) infection. * history of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above. * other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes. * active autoimmune diseases that require systemic therapy over the past 2 years. replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed. * assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Keywords: urothelial carcinoma her2-expressing rc48 first-line
a randomized study evaluating the therapeutic equivalence of two butoconazole nitrate vaginal cream, 2% formulations

Conditions: Vulvovaginal Candidiasis

Summary: this was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to gynazole-1 (butoconazole nitrate) vaginal cream, 2% in the treatment of vulvovaginal candidiasis caused by candida species.


Eligibility criteria:
inclusion criteria: * female subjects, at least 18 years of age * presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis * signed and dated informed consent exclusion criteria: * were pregnant, nursing, or planning a pregnancy within the study participation period * had evidence of any bacterial, viral, or protozoal infection * had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the test product ingredients * had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study

Keywords: bioequivalence butoconazole vulvovaginal candidiasis
nanodropper use in primary open-angle glaucoma patients: a non-inferiority trial

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Summary: this randomized, single-masked, crossover, non-inferiority trial aims to evaluate the safety and efficacy of nanodropper-mediated microdrops of ocular hypotensive topical treatments (experimental intervention) compared to standard drops of the same medication(s) (active comparator) in wilford hall ambulatory surgical center (whasc) primary open-angle glaucoma (poag) and ocular hypertension (ohtn) patients.

the primary objective of this study is to compare changes in intraocular pressure (iop) in a population of poag and ohtn patients in response to administration of 1) standard drops of iop lowering medications and 2) nanodropper-mediated microdrops of iop-lowering medications. the hypothesis is that nanodropper-mediated microdrops of iop-lowering medications will not result in a significant difference in iop relative to standard drops of iop-lowering medications after three months of daily eyedrop administration with each delivery system. the primary outcome measure for this efficacy endpoint will be mean iop (mm hg) ± sem. a secondary objective of this trial is to evaluate nanodropper's safety and usability. surveys that have been designed to gain an understanding of the differences in side effects and usability between using nanodropper-mediated microdrops compared to standard eyedrops will be administered to patients at the enrollment visit and at each follow-up visit.

Eligibility criteria:
inclusion criteria: * poag/ohtn patients above the age of 18 years. * on a maximum of 2 iop lowering medications. * stable disease without progression in iop, optic disc cupping, rnfl changes, and visual field changes within the previous 1 year. exclusion criteria: * glaucoma not of the poag or ohtn variety or other retinal diseases. * progression of disease within the preceding 1 year (iop elevation, optic disc cupping, visual field changes). * using more than 2 iop-lowering medications. * iop-lowering surgical interventions or lasers except for slt. slt may have been completed 6+ months prior to study start date.

Keywords: nanodropper primary open angle glaucoma microdrops ocular hypertension
laparoscopic versus open mesh repair of bilateral primary inguinal hernia

Conditions: Bilateral Inguinal Hernia

Summary: the best approach for simultaneous repair of bilateral inguinal hernia is controversial. the aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia

this prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. group i treated by laparoscopic trans-abdominal pre-peritoneal (tapp) repair using 2 separate meshes, group ii treated by open pre-peritoneal (pp) single mesh repair, while group iii treated by bilateral lichtenstein repair. the 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction. .

Eligibility criteria:
inclusion criteria: * patients with painless uncomplicated primary bilateral inguinal hernias exclusion criteria: * immune compromised patients * coagulopathy * chronic liver or renal disease * high-risk patients unfit for major surgery (asa iii or iv), * massive scrotal hernias, recurrent or complicated hernias * groin pain due to any other pathology * previous infra-umbilical surgery
validity of fractional exhaled nitric oxide and impulse oscillometry in patients with cough variant asthma

Conditions: Cough Variant Asthma

Summary: the aim of the research is to evaluate the clinical value of fractional exhaled nitric oxide(feno) ,impulse oscillometry(ios) and mid-expiratory flow (mef) in patients with cough variant asthma.

the present study has the following objectives: to evaluate the relationship between bhr and mid-expiratory flow, to assess the diagnostic accuracy of fractional exhaled nitric oxide，impulse oscillometry and mid-expiratory flow in cva with special regard to its discriminating value between cva and other causes of a chronic cough, to estimate prognostic value of bhr and fractional exhaled nitric oxide (feno) count in predicting response to asthma treatment.

Eligibility criteria:
inclusion criteria: age 18-65 years old. cough as the sole or predominant symptom lasting for at least 8 weeks, with no radiographic evidence of lung diseases. exclusion criteria: treatment of any oral corticosteroid in the last 4 weeks, and respiratory tract infection within 8 weeks. smoking (min. 6 months) had asthma or other lung diseases, including obliterative bronchiolitis, bronchiectasis,and cystic fibrosis.

Keywords: cough variant asthma chronic cough fractional exhaled nitric oxide impulse oscillometry forced mid-expiratory flow
low-intensity focused ultrasound for treatment-resistant depression

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Summary: the investigators are proposing to demonstrate safety and efficacy of lifup for treatment resistant major depressive disorder in a ten-patient pilot study. lifup is an emerging treatment with the advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. this study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.

the purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (lifup) for treatment resistant depression (trd). participants will receive either lifup or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course. the initial visit will involve consent and an mri scan, followed by several more either active or sham treatments outside of the mri environment delivered over the course of two days over one week. response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments.

Eligibility criteria:
inclusion criteria: * male or female * age 18-70 * normal or corrected-to normal vision and hearing * primary diagnosis of major depressive disorder, moderate/severe per dsm-5 (madrs \>20) * the duration of the illness must exceed one year * must be medically stable as determined by investigator * patient must have attempted and failed treatment with at least 2 ssri and 1 augmentation * history of rtms is permitted, but not required exclusionary criteria: * diagnosis of primary dsm-5 depressive disorder other than mdd * anxiety disorders such as gad are permitted as long as mdd is primary * diagnosis of schizophrenia or bipolar disorder * current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of mdd) * contraindication to enter the mri environment. * pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). * urine pregnancy test: if the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, iud, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. * inability to adhere to treatment schedule. * initiation of new antidepressant treatment at the time of study randomization.

Keywords: focused ultrasound neuromodulation