Kornimate/medical-research-clean huggingface dataset:
an intervention study of compound silymarin in patients with non-alcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) has become the most prevalent liver disorder in china. the aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with nafld.

non-alcoholic fatty liver disease (nafld) has become the most prevalent liver disorder in china but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. silymarin is a mixture of flavonoids extracted from seeds of silybum marianum or milk thistle, and its major active compound is silibinin. because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in nafld. furthermore, some traditional liver protective chinese medicines are also helpful in controlling the progression of nafld, such as pueraria, schisandra and salvia miltiorrhiza. at present, there are few reports on the combination of silymarin and these traditional chinese medicines in the treatment of nafld. this study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with nafld.

Eligibility criteria:
inclusion criteria: * subject's bmi is ≥ 22.0 kg/m2 and \< 33.0 kg/m2; * subject is diagnosed with nafld according to the chinese non-alcoholic fatty liver disease prevention guide 2018; * a mildly elevated of alt level (≥ 30 u/l for male, ≥ 19 u/l for female) or an ast/alt ratio \< 1.0; * must be able to swallow tablets. exclusion criteria: * ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female; * patients with certain hepatic diseases such as gallstones, hepatitis c, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease; * be taking medicines or supplements that would influence the liver function, lipid metabolism; * patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, cushing syndrome, mauriac syndrome, etc; * patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease; * body weight change are more than 10% in previous 3 months; * patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product; * subjects are allergic to the ingredients in the test or control samples; * woman who is pregnant or breastfeeding; * subjects cannot meet the requirements of compliance in the pre-experiment period; * subjects who fail to sign the informed consent forms.

Keywords: nonalcoholic fatty liver disease silymarin inflammation lipid metabolism
community based mental health screening and referral

Conditions: Mental Health; Depression; Anxiety Disorders; Community Health Services; Women's Health

Summary: this feasibility study aims to evaluate the implementation of a community-based mental health screening, referral, and resilience-building intervention for flood-affected women of reproductive age (wra) in a rural district of dadu, sindh, pakistan. the quasi-experimental study uses a comparison group and involves training lady health workers (lhws) to conduct mental health screening using gad-2 and phq-2 tools, refer screen-positive women to basic health units (bhus) for further assessment, and conduct group sessions on mental health awareness and climate resilience. bhu doctors will reassess referred women using gad-7 and phq-9, provide psycho-counseling, and refer severe cases to tertiary care. the study will assess feasibility, acceptability, appropriateness, and effectiveness of the intervention to inform scalable mental health strategies for disaster-prone settings.

this study evaluates the feasibility and implementation of a community-based mental health screening, referral, and resilience-building intervention for women of reproductive age (wra) affected by the 2022 floods in the dadu district of sindh, pakistan. the intervention engages lady health workers (lhws) to screen wra using validated tools-gad-2 and phq-2. women scoring ≥3 on either scale will be referred to basic health units (bhus), where trained facility-based doctors will reassess them using the gad-7 and phq-9 instruments. based on the diagnosis, wra with mild to moderate symptoms will receive two structured counseling sessions, while those with severe symptoms will be referred to tertiary care with logistical support. in parallel, lhws will conduct monthly group sessions to raise mental health awareness, address stigma, and build community resilience to climate change-related hazards such as flooding. these sessions, based on a standardized curriculum, are open to all wra regardless of screening status and focus on stress management, coping strategies, and emotional support. the study employs a quasi-experimental design with a comparison group across selected union councils. the intervention will be evaluated through baseline and end-line quantitative surveys as well as qualitative assessments via focus group discussions (fgds) and in-depth interviews (idis). the primary outcomes include feasibility, acceptability, appropriateness, and awareness levels, while the secondary outcome assesses the effectiveness of the intervention in reducing symptoms of depression and anxiety. the findings will guide future efforts to integrate mental health services into primary care and community-based disaster preparedness strategies in pakistan and similar contexts.

Eligibility criteria:
inclusion criteria: * women of reproductive age (wra) 18-49 years in the targeted area

Keywords: mental health screening flood-affected women mental health referral mental health support screening and referral program health services accessibility
intranasal insulin for covid-19-related smell loss

Conditions: Anosmia; Smell Loss; Paraosmia; Hyposmia; COVID-19

Summary: the aim of this study was to quantify the improvement in olfaction of 27 post-covid-19 patients, after three intreventions of intranasal insulin during a four week period, with the help of the threshold, discrimination and identification (tdi) score evaluated with sniffin sticks®.


Eligibility criteria:
inclusion criteria: * covid-19 in the last 3 to 18 months and who persisted with anosmia, hyposmia or other olfactory dysfunction chronically and without improvement exclusion criteria: * nasal tumors, chronic sinusitis, drug-induced sinusitis, nasal polyposis, neurodegenerative disease, smoking, pregnancy hypoglycemia and a previous diagnosis of diabetes mellitus or anatomical malformations such as septal deviation, rhinosinusitis or choanal atresia
clinical trial on the use of cell therapy in the treatment of patients with amyotrophic lateral sclerosis

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Summary: our working hypothesis is that the injection of autologous bone marrow mononuclear cells (bmnc) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with als during the evolution of the disease

our working hypothesis is that the injection of autologous bone marrow mononuclear cells (bmnc) has a positive effect on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with als during the evolution of the disease. this hypothesis is based on experimental work done in animal models of als and the results of our previous phase i clinical trial. in this clinical trial (tcim / als, clinicaltrials.gov identifier: nct02286011) we studied with electrophysiological techniques (in a small number of patients with als) the effects of intramuscular injection of a single dose of bmsc in the tibialis anterioris (ta) muscle. . the results indicate that this is a safe procedure and show the presence of a positive and apparently transitory effect on the size and number of motor units of the ta muscle.

Eligibility criteria:
inclusion criteria: * diagnosis of als defined or probable according to the criteria established by the world federation of neurology * age between 18 and 70 years. * patient who offers sufficient guarantees of adherence to the protocol. * neurophysiological data confirming lower motor neuron involvement at the lumbar and cervical level. * assessment of the motor deficit in the dorsal flexion of both feet (between 3 and 5 points on the mrc scale). exclusion criteria: * mellitus diabetes. * other diseases that may be associated with polyneuropathies. * previous history of cerebral stroke. * previous pathology of the peripheral nervous system that affected one or both lower or upper limbs, with or without clinically evident neurological sequelae. * pregnant or actively breastfeeding patients * patients physiologically capable of becoming pregnant, unless they are using a reliable contraceptive method (annex iii) * patients with cardiac, renal, hepatic, systemic, immune disease that may influence the survival of the patient during the test. * positive serology for hepatitis b, hepatitis c or hiv. * clinical and anesthesiological criteria that contraindicate either sedation or the extraction of bm itself (alteration of the coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, skin alteration in the puncture site, etc.) * inclusion in other clinical trials in the last 6 months. * inability to understand informed consent.
characterization and outcomes of patients screened for transcatheter tricuspid valve replacement

Conditions: High-surgical Risk Patients with Severe Tricuspid Regurgitation

Summary: the tri-recruit study was conducted of 340 consecutive patients for ttvr screening using lux-valve via the trans-jugular vein approach at seven cardiac centers. patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.


Eligibility criteria:
inclusion criteria: * (i) age \> 18 years old; (ii) tr severity ≥ severe; (iii) new york heart association (nyha) functional class ≥ ⅱ; (iv) failed gdmt; (v) euro-score \> 4. exclusion criteria: * (i) left ventricular ejection fraction \ 60 mmhg; (iii) prior tv surgery or left-sided valve surgery within the past 6 months; (iv) irreversible poor right ventricular function; (v) concomitant significant lesion needed for other major cardiac procedures or infective endocarditis.
treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin g4-related sclerosing cholangitis by corticosteroids

Conditions: Autoimmune Pancreatitis; IgG4-related Sclerosing Cholangitis; Obstructive Jaundice

Summary: this study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin g4 (igg4)-related sclerosing cholangitis in adults. half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.


Eligibility criteria:
inclusion criteria: * adults greater than 18 years-old; * autoimmune pancreatitis and/or igg4-related sclerosing cholangitis; * obstructive jaundice exclusion criteria: * malignancies; active infections; * pregnancy or breast feeding; * standard contraindications to ercp; * unwillingness or inability to consent for the study
roll over study from 1199.30 bibf 1120 in idiopathic pulmonary fibrosis (ipf)

Conditions: Pulmonary Fibrosis

Summary: the aim of this trial is to offer continuation of bibf 1120 treatment for patients with idiopathic pulmonary fibrosis (ipf) who have completed a prior clinical trial with that drug. the primary objective will be to establish the long term tolerability and safety profile of bibf 1120 in idiopathic pulmonary fibrosis (ipf). as a secondary objective the effects of long term treatment with bibf 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.


Eligibility criteria:
inclusion criteria: 1. patient with a primary diagnosis of ipf (according to the 2000 american thoracic society/european respiratory society (ats/ers) criteria, who are willing to continue trial medication. 2. written informed consent signed prior to entry into the study, in accordance with international conference on harmonisation-good clinical practice (ich-gcp) and local law 3. completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial) exclusion criteria: 1. any disease that may put the patient at risk when participating in this trial. reconsider carefully all exclusion criteria of trial 1199.30. however, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable. 2. participation in another experimental clinical trial (except 1199.30) in the last 8 weeks. 3. women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy. highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intra uterine devices (iuds), sexual abstinence or vasectomized partner. female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 4. sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential). 5. patients who require full-dose anticoagulation (e.g. vitamin k antagonists, heparin, hirudin etc). 6. patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy. 7. known or suspected active alcohol or drug abuse. 8. patient not compliant in previous trial, with trial medication or trial visits.
to compare the effects of oxytocin and carbetocin on intraoperative hemodynamic changes in cesarean section surgeries.

Conditions: Cesarean Section

Summary: to compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.

the study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. the study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an asa score of i-ii. the patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each. all cases will receive routine preparation for general anesthesia. all patients placed on the operating room will receive two large-bore vascular access. for anesthesia induction 2 mg/kg propofol and 0.5 mg/kg rocuronium will be used. anesthesia will be maintained with 60% air, 40% oxygen and 2 mac sevoflurane.demographic data of the patients (age, height, weight), asa score and surgical time will be recorded. during the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. in addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. all data will be recorded and statistical analysis will be made.

Eligibility criteria:
inclusion criteria: * patients scheduled for caesarean sections * between 18-40 years * asa i-ii group * those who will undergo general anesthesia * those between 35-40 weeks of pregnancy * 1st and 2nd caesarean sections exclusion criteria: * those who prefer spinal or epidural anesthesia * those who are outside the age range of 18-40 * those who are asa iii and above * those with ht, dm, cardiac and respiratory diseases * preeclampsia, eclampsia, hellp * those with a history of drug use that affects the cardiovascular system * placenta previa, placenta acreta, placenta acreta

Keywords: cesarean section oxytocin carbetocin uterotonic intraoperative bleeding
role of the interaction between advanced glycation end products and their receptor rage in the development and the progression of the uremic vasculopathy of hemodialyzed patients

Conditions: Hemodialyzed Patients

Summary: chronic kidney disease (ckd) is associated with an extensive vasculopathy and high cardiovascular mortality as well as an accumulation of uremic toxins. among the latest, advanced glycation end-products (ages) interact with rage. investigators aimed to analyze the role of rage in the calcification process of hemodialyzed patients, in a correlative and prospective study. vascular calcifications will be assessed by xray and tomodentimetry while accumulation of ages will be measured in the serum and in the skin (non invasive). additionally factors influencing rage activation such as genetic polymorphism and level of soluble forms of rage will be measured and analyzed.


Eligibility criteria:
inclusion criteria: * renal impairment * hemodialysis for more than 3 months * have agreed to participate in research * affiliated to a social security scheme * major exclusion criteria: * diabetes , for diabetes induces accelerated formation of advanced glycation end products , which could then be a confounding factor in our study. * protected by law . * minors * pregnant women * matt or pigmented skin because the skin hyperpigmentation interfere with reading the skin fluorescence giving falsely elevated values . * having an aneurysm of the abdominal aorta known * suffering from a progressive neoplastic disease
comparison of gait pattern between simultaneous and staged knee arthroplasties

Conditions: Bilateral Knee Osteoarthritis

Summary: total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. in the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. the major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively

patients with bilateral end-stage knee osteoarthritis will be included in the current study. bilateral total knee arthroplasty will be performed simultaneously or staged according to the preference of the patients. we will have two groups: staged total knee arthroplasty and simultaneous total knee arthroplasty groups. the patients will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (knee society scores and knee injury and osteoarthritis outcome score), life quality (sf-12), and smart-phone based gait analysis. all data will be calculated as mean and standard deviation values. the student's t-test will be used for statistical analysis of the patient data. statistical calculations will be performed using spss vn.22.0 software (ibm spss statistics for windows, version 22.0. armonk, ny, usa).

Eligibility criteria:
inclusion criteria: clinical diagnosis of bilateral primary knee osteoarthritis age 55 to 85 years must be able to walk without support exclusion criteria: rheumatological joint diseases previous knee surgery neuromuscular diseases unilateral knee osteoarthritis insufficiency of knee collateral ligaments.

Keywords: bilateral knee arthroplasty gait analysis smart-phone
shoe modification and knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this trial will assess the ability of shoe inserts to relieve pain and disability in people with knee osteoarthritis (oa) in the inner (medial) aspect of the knee.

osteoarthritis (oa), the most common joint disease in humans, is a significant cause of pain and disability. its prevalence increases with age, leading to about 65-85% of those age 65 years and older having oa. involvement of the knee with oa is the main reason for significant functional impairment as it alters ambulation through pain and stiffness. nonpharmacological management of knee oa includes the use of orthotic supports such as wedged insoles for varus or valgus knee deformities to relieve pain and improve function in the early stages of this joint disease. although these interventions are desirable because they are simple and inexpensive, we do not have a clear understanding about their efficacy in relieving pain and disability in people with knee oa. we also do not know whether there is a relationship between changes in joint biomechanics that occur with wedged insoles and changes in function and progression of oa. furthermore, information is lacking regarding which patients would benefit from wedged insoles. answering these questions will be critically important in the development of guidelines for the prescription of wedged insoles in knee oa. patients in this study will be evaluated at baseline and after wearing the lateral-wedged insoles immediately and after wearing the insoles for four weeks. the participants will wear lateral-wedged insoles for the painful knee(s) for as many hours and for as many days of the week as they can tolerate. some subjects may use a neutral position insole for an asymptomatic knee.

Eligibility criteria:
inclusion criteria: * ability to walk 30 feet without a walking aid * ability to stand unaided * ability to understand verbal instructions * ability to give informed consent exclusion criteria: * history of knee trauma or surgery including arthroscopic surgery in the past 6 months * severe obesity (\>30 kg/m2) * neurological disease * injury or amputation to the lower extremity joints * history of other types of arthritis * symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee * intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6 months * poor health that would impair compliance or assessment such as shortness of breath with exertion

Keywords: lateral wedge inserts shoe inserts
heat versus ice in the acute management of neck and back strain injuries

Conditions: Back Strain; Neck Strain

Summary: muscle sprains of the back and neck are very common. in addition to pain and antiinflammatory medications the use of either cold or hot packs has been recommended. in the current study we will compare ice packs and heat packs to see which is more effective at relieving pain from back and neck sprains while in the emergency department.

as above

Eligibility criteria:
inclusion criteria: * adult patients with acute neck or back pain who are able to consent and are in pain on arrival to emergency department. exclusion criteria: * those unable or unwilling to consent, those with suspected fractures or neurologic deficits.

Keywords: muscular sprain acute back pain acute neck pain heat treatment cold treatment