Kornimate/medical-research-clean huggingface dataset:
neoadjuvant cadonilimab plus chemotherapy for locally advanced esophagogastric junction and gastric cancer trial

Conditions: Gastric Cancer; Esophagogastric Junction Cancer

Summary: for locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage t and n stage,treated distant micrometastases early , and finally improve the long-term survival. combination of perioperative pd-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.cadonilimab, a tetravalent bispecific antibody targeting pd-1 and ctla-4, is designed to retain the efficacy benefit of combination of pd-1 and ctla-4 and improve on the safety profile of the combination therapy. the aim of this study is to evaluate the efficacy and safety of cadonilimab plus chemotherapy for locally advanced esophagogastric junction and gastric cancer.

locally advanced esophagogastric junction and gastric cancer could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. neoadjuvant chemotherapy can downstage t and n stage, treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. however, the therapeutic effects remain unsatisfactory.cadonilimab (ak104), a novel bispecific antibody simultaneously targeting pd-1 and ctla-4, was designed to boost anti-tumor activity with a favorable safety profile.this study was a single arm, open-label clinical study to evaluate the efficacy and safety of combination with cadonilimab and chemotherapy for neoadjuvant treatment of resectable locally advanced adenocarcinoma of the gastro-esophageal junction.

Eligibility criteria:
key inclusion criteria: 1. confirmed gastric and gastroesophageal junction adenocarcinoma by gastroscopic biopsy histopathological examination. 2. imaging (ct/mri) and diagnostic laparoscopy confirmed at the stage of ct3-4an1-3m0(ajcc 8th) . 3. physical condition and organ function allow for for larger abdominal surgery. 4. adequate haematological, renal and liver function. key exclusion criteria: 1. patients who have her2 positive confiemed with ihc3+ or ihc2+ and fish positive. 2. confirmed at stage iv (ajcc 8th) or unresectable by investigator. 3. prior chemotherapy, radiotherapy, surgery immunotherapy or molecular targeted therapy for gastric cancer. 4. patients are allergic to study medication and its ingredients. 5. known active autoimmune diseases. 6. presence of other uncontrolled serious medical conditions.

Keywords: bispecific antibody neoadjuvant immunotherapy and chemotherapy
home-based versus partner-friendly clinic testing to enhance male partner hiv-1 testing during pregnancy

Conditions: Male Partner; HIV Counseling and Testing; Home Based; Pregnancy

Summary: the investigators hypothesize that home based hiv counseling and testing can increase male partner uptake of hiv testing during pregnancy. the investigators study aims through a randomized clinical trial to determine whether a home-based model (hbm) versus a partner-friendly clinic model (pfm) can increase male uptake of hiv counseling and testing during pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant women and their male partners exclusion criteria: * non-pregnant, minors, inability to live in study area for 6 weeks

Keywords: male partner hiv counseling and testing home based pregnancy
clinical study to evaluate the efficacy and safety of desoximetasone (dsxs) with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: efficacy and safety of dsxs (taro pharmaceuticals, u.s.a., inc.) in patients with moderate to severe atopic dermatitis

a randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the efficacy and safety of dsxs (taro pharmaceuticals, u.s.a., inc.) in patients with moderate to severe atopic dermatitis

Eligibility criteria:
inclusion criteria: - male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (ad) exclusion criteria: - lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
lumber spine mobilization and spinal traction on lumber radiculopathy.

Conditions: Lumbar Radiculopathy

Summary: lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. this study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. a randomized control trial will be conducted at atta jaspal hospital and trauma center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups a and b. group a will be treated with smwlm, conventional electrotherapy, and traction without a belt, and group b will be treated with smwl, conventional electrotherapy, and lumbar traction with a belt. a pretreatment baseline will be set for pain, rom, and disability at the lumbar spine by using the nprs, inclinometer, and odi questioner. follow-up will be conducted after 4 weeks of post-treatment sessions. the intensity of pain, range of motion, and disability index will be evaluated using the nprs, inclinometer, and odi questionnaire. the data will be analyzed using spss software version 26. the conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses.

low back pain (lbp) is one of the primary causes of disability worldwide. most people-between 50% and 80%-experience lbp at some point in their life. it limits the ability to perform daily activities, such as walking, standing, or lifting objects. it can also lead to decreased mobility, reduced work productivity, and increased healthcare costs. radiating pain is commonly caused by lumbar intervertebral disk abnormalities, which are linked with nerve root irritation and affect 3% to 10% of people with generalized low back pain. sciatica, another name for lumbar radiculopathy, is a disorder marked by pain, weakness, numbness, or tingling sensations that radiate down the lower back along a nerve root, frequently into the buttock, thigh, and lower leg. one or more lumbar nerve roots are usually compressed, irritated, or inflamed as a reason.

Eligibility criteria:
inclusion criteria: * age of 16-50 years of both sexes, unilateral radiculopathy in the distribution of specific nerve with positive straight leg raise (slr). * mild to moderate disability and pain on a scale of nprs \< 7, minimum chronicity of 1 month, and maximum 6 months exclusion criteria: * patients with previous spinal surgery' * any bony or soft tissue systemic disease. * patients with diagnosed case of co morbidities such as malignancies , ra or fractures that causes bilateral leg pain

Keywords: lumber radiculopathy low back pain quality of life traction
pharmacokinetic/pharmacodynamic study of mp-513 with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of mp-513 on 24-h glycemic control in patients with type 2 diabetes for 4 weeks administration.


Eligibility criteria:
inclusion criteria: * patients who are 20 - 75 years old * patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug * patients whose hba1c is ≥6.5% and \<10.0% * patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug. exclusion criteria: * patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc) * patients who are accepting treatments of arrhythmias * patients with serious diabetic complications * patients who are the excessive alcohol addicts * patients with severe hepatic disorder or severe renal disorder. * patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Keywords: insulin resistance
internal fixation or joint replacement therapy for aged hip fracture patients

Conditions: Intertrochanteric Fractures

Summary: to evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.

patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. the unstable fractures were a2 and a3 (31 a2.2 and 3, and 31 a3.3) according to the ao classification. the investigators will use a prospective randomized approach to determine the treatment procedure for patients. the patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. all patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. the two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. the investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.

Eligibility criteria:
inclusion criteria: * intertrochanteric fractures of the femur need surgery * male and female, age more than 75 years old * combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders * the patient is still able to tolerate surgery through the anaesthesia and related department assessment * signed written informed consent exclusion criteria: * no complications associated with internal medicine * mild fracture displacement and conservative treatment required * multiple trauma involving more than one organ system * known to have progressive malignant neoplasms * it is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study

Keywords: intertrochanteric fracture, medical complications
remote ischemic conditioning with local ischemic postconditioning in high-risk st-elevation myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: the rip-high trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (rip) and local ischemic postconditioning (postc) vs. standard of care on clinical outcome in high-risk st-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

coronary reperfusion by percutaneous coronary intervention is mandatory to salvage ischemic myocardium and to reduce definite infarct size. however, reperfusion itself also causes irreversible myocardial damage - a phenomenon described as reperfusion injury. reduction of ischemic and reperfusion injury by ischemic conditioning has been identified as a potential target to reduce myocardial damage. remote ischemic conditioning and local ischemic postconditioning might be in particular of clinical benefit in higher risk stemi patients with killip class ≥2, where mortality rates are high. the remote ischemic conditioning with local ischemic postconditioning in high-risk st-elevation myocardial infarction patients (rip-high) trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning and local ischemic postconditioning vs. standard of care on clinical outcome in high-risk st-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: * acute chest pain lasting \<12 h * st-elevation at the j-point in two contiguous leads of ≥2 mm in men ≥40 years, ≥2.5 mm in men \<40 years and ≥1.5 mm in women (regardless of age) in v2-v3 and/or ≥1 mm in all other leads (52). * new or presumed new left bundle branch block or right bundle branch block. * killip class ≥ii on hospital admission or requirement of diuretics because of clinical congestion. * written informed consent. exclusion criteria: * killip class i on hospital admission. * prior fibrinolysis. * conditions precluding use of ric (i.e. paresis of the upper limb, presence of an arteriovenous shunt). * pregnancy. * age \<18 years. * severe co-morbidity with a life expectancy \<6 months. * participation in another trial.

Keywords: remote ischemic conditioning local ischemic postconditioning percutaneous coronary intervention
ckd-828 (40/5mg) pharmacokinetic study

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetic characteristics of ckd-828 (fixed dose combination tablet; telmisartan and s-amlodipine) in healthy volunteer.


Eligibility criteria:
inclusion criteria: * a healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight. * have not any congenital or chronic diseases and medical symptom. * appropriate for the study judging from examinations(interview, vital signs, 12-lead ecg, physical examination, blood, urinalysis result on screening). * able to participate in the entire trial. * signed the informed consent form prior to the study participation. exclusion criteria: * take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administraion. * the evidence of acute disease within 28 days prior to the first ip administraion. * disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s). * relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication. * hypersensitivity telmisartan or amlodipine. * sbp\<90mmhg or dbp\<50mmhg. * abnormal laboratory result(s): ast or alt \> 1.25 times of upper limit / total bilirubin \> 1.5 times of upper limit. * a drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first ip administration. * diet(especially, grapefruit juice-within 7 days prior to the first ip administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s). * donated whole blood within 60 days prior to the first ip administraion. * participated in the other clinical trials within 90days prior to the first ip administraion. * medicine within 10 days prior to the first ip administraion? does the medication affect this trial. * appropriate for the trial judging from principal investigator.

Keywords: ckd-828 hypertension primary hypertension healthy volunteer s-amlodipine telmisartan amlodipine pharmacokinetic phase 1
randomized controlled trial on visual field training

Conditions: Glaucoma

Summary: unreliability and visual field variability is a known problem with automated perimetry in both developing and developed country settings. this study will look at the effects of a computer program that allows new patients to practice the visual field exam before taking the actual exam. our hypothesis is that the intervention group will have less variability as measured by mean deviation between exams and greater reliability as measured by the standard unreliability indexes of false positive rate, false negative rate, and fixation losses.

3 study visits. visit 1: baseline visit for consent, getting baseline data and finally randomizing the patient. those randomized to intervention get their first session of simulated visual field (2 per eye) on a regular computer for training purposes. visit 2: 1 to 2 days after baseline. the intervention group gets 1 practice test per eye. then both groups get a regular automated visual field visit 3: 1 to 2 weeks after baseline. the intervention group gets 1 practice test per eye. then both groups get a regular automated visual field. study ends, patient gets seen by the patient.

Eligibility criteria:
inclusion criteria: * 18 years old or greater * referred to the glaucoma clinic for examination due to suspected glaucoma or glaucoma diagnosis * no more than 1 automated visual field test within the last 4 years exclusion criteria: * patients who cannot remain seated for 10 minutes * patients with neck problems that prevent them from using the field analyzer properly

Keywords: automated perimetry visual fields reliability vision tests/standards randomized controlled trial false positive reactions false negative reactions fixation, ocular mean deviation variability program software glaucoma/diagnosis visual field tests/methods aged humans female male prospective studies reproducibility of results
cross-linking as treatment in infectious keratitis

Conditions: Infectious Keratitis

Summary: to compare between scxl and acxl for treatment of infectious keratitis

standard epithelium-off cxl, 30 minutes soaking time with riboflavin, 30 minutes uva corneal irradiation continuous mode (group a). accelerated cxl 11 minutes soaking time with riboflavin, 8 minutes uva corneal irradiation pulsed mode (group b).

Eligibility criteria:
inclusion criteria: * fungal infectious keratitis * bacterial infectious keratitis * must be not responding to medication exclusion criteria: * viral keratitis * pregnancy and lactation
comparison between supervised group exercise and home exercise program for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: physical exercise is a widely recommended treatment modality for osteoarthritis, which can be performed through a supervised group exercise or a home exercise program. however, up to now only little research has been conducted on the home exercise program in brazil. the objective of this study is to compare the efficacy between supervised group exercise and home exercise program in people with knee osteoarthritis. methods: the study population consists of 46 men and woman with knee osteoarthritis aged between 40 and 65. the patients should be clinically diagnosed with knee osteoarthritis and classified in kelgreen-laurence grades i, ii and iii. primary outcomes are the westerm ontário and mcmaster universities (womac), lower extremity functional scale (lefs), pain catastrophizing scale (pcs), tampa scale for kinesiophobia, 40-meter walk test, isometric strength of hip (abduction and adduction) and knee (flexion and extension) and postural control. the patients are randomized into 2 groups, with one group receiving 12 sessions of supervised group exercise and the other group following an exercise program at home. the program lasts 6 weeks with both groups receiving the same exercise protocol consisting of stretching, isometric and isotonic exercises for major muscle groups in both lower extremities. the mann-whitney u test is used to examine the anthropometric variables. the anova is used to compare outcomes before and after treatment. a value of p\< 0.05 is considered to be statistically signifcant.


Eligibility criteria:
inclusion criteria: * age between 45 and 65 years; * kellgren-lawrence grade i, ii and iii with knee osteoarthritis determined clinically and radiographically. exclusion criteria: * history of surgery in the lower limb; * patients who performed physiotherapy in the last six months; * disease or disability which contraindicate the performance of the exercise training (vestibular problems, cardiorespiratory, rheumatic and neurological diseases).

Keywords: exercise therapy physical therapy
mother milk as a eye drop & premature retinopathy

Conditions: Retinopathy of Prematurity

Summary: the aim of this study is to investigate the effect of using breast milk as eye drops on rop (retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.

study design: prospective randomized placebo controlled trial setting/participants: premature babies who are at high risk for retinopathy of prematurity (rop) during their stay in the neonatal intensive care unit (nicu). the study will be carried out at baskent university and it is planned that 70 participants will be included in the study. study interventions and measures: after the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. in the control group, %0.9 normal saline will drop as same amount. primary outcome is any stage of rop, secondary outcome is severe rop (laser requiring rop).

Eligibility criteria:
inclusion criteria: * infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight. exclusion criteria: * infant death before first examination for rop * parents who want to leave from the study * contraindications for breast milk use (active hiv infection, active tuberculosis, cmv infection) * inborn error of metabolism like galactosemia. * congenital eye development disorders like agenesis, or situations that do not allow retina examination. * other lethal congenital molformations * congenital infections that affect the retina like torch infections.

Keywords: breast milk retinopathy of prematurity
effect of inulin on gut microbiota and gut barrier in chronic kidney disease

Conditions: Chronic Kidney Disease 5D

Summary: an adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. however, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.


Eligibility criteria:
inclusion criteria: * men and women in a ratio of 1:1 * age 18-75 years * body mass index 25.0 - 39.9 kg/m\^2 * end-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months exclusion criteria: * malignant diseases * recent or current hospitalization * postoperative phase * acute infections * malnutrition * antibiotic treatment within the last 4 weeks * regular intake of probiotics and/or prebiotics * change of body weight of more than 2 kg in the month prior to study entry * known drug or alcohol abuse changes applied in july 2022 according to amendment no. 1: * two inclusion criteria were changed to improve recruitment * age range was changed from 18-70 to 18-75 years * bmi range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m\^2 * the intervention scheme was adapted to increase patient adherence * a 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days changes applied in january 2024 according to amendment no. 2: * one inclusion criteria was changed to improve recruitment * bmi range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m² * last visit was brought foward by 4 weeks.

Keywords: hemodialysis fiber zonulin short chain fatty acids dietary analysis