Kornimate/medical-research-clean huggingface dataset:
impact of modified specific carbohydrate diet on bronchial asthma control in children

Conditions: Asthma in Children

Summary: the aim of this study will explore if the specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them.

this study will be carried out on 30 children with moderate persistent asthma presented to the outpatient clinic of the pulmonology unit, pediatric department, tanta university hospital. all children at the start of the study will be subjected to full history taking including, full nutritional assessment, laboratory tests, pulmonary function tests, and anthropometric measurements

Eligibility criteria:
inclusion criteria: * asthmatic children with moderate persistent asthma according to the definition of national heart, lung, and blood institute guidelines, if they have daily symptoms, nighttime awakenings more than 1 time/week, but not nightly, daily use of short-acting beta-agonist for symptom control, some limitations of normal activities, and forced expiratory volume in 1 second (fev1)60-80%. * children aged from 6 to 18 years. * the children are included only if parents and children are strongly motivated to try a dietary intervention (mscd) as a complementary treatment. exclusion criteria: * children with chronic lung disease, immunodeficiency, major thoracic deformities, neuromuscular, cardiovascular, digestive, rheumatic, osteoarticular, or genetic syndromes or any adverse health conditions that can affect nutritional status were excluded from the study. * children excluded if parents and children are not motivated to try a dietary intervention (mscd) as a complementary treatment or who failed to have regular outpatient follow-up visits.

Keywords: asthma children dietary therapy specific carbohydrate diet
promoting earlier detection of breast cancer in rwanda: scaleup in the national health care system

Conditions: Breast Cancer; Benign Breast Disease

Summary: this observational study evaluates scale-up of a breast cancer early detection program in rwanda that was initially piloted in a single district. specifically investigators will examine patient volume, service delivery, loss-to-follow-up rates, and cancer detection rates noted following implementation of scale-up to 3 additional districts. for scaleup, breast cancer screening with cbe was added to a cervical cancer screening initiative, in a combined women's cancer early detection program (wcedp).

investigators previously conducted a cluster randomized controlled trial of a clinician training program to facilitate prompt evaluation of women with breast symptoms in one rural district of rwanda. subsequently, rwanda biomedical centre (rbc) has scaled up the curriculum in 3 districts, adapting the program to integrate cbe screening into a cervical cancer screening initiative. in this study, we will evaluate implementation of this combined screening initiative. investigators will assess patient volume, services, diagnoses, and loss to follow up.

Eligibility criteria:
inclusion criteria: * all women and men who are evaluated for a breast concern or receive breast cancer screening through implementation of the nationally-led early detection programs exclusion criteria: * none

Keywords: rwanda breast cancer screening early detection
prehospital transfusion strategy in bleeding patients

Conditions: Hemorrhage; Blood Component Transfusion

Summary: the aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion. a) present prehospital standard treatment including a mixture of plasma and red blood cell transfusion (rbc) transfusion b) red blood cell transfusion (rbc) only c) plasma transfusion only hypothesis: 1. transfusion strategy including a mixture of rbc and plasma is superior as compared with only plasma or only rbc strategy in terms of initial treatment of circulatory shock (expressed as base deficit). 2. endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.

rationale for the study: the warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, rbc or combination of both. despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. so far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.

Eligibility criteria:
inclusion criteria: * major bleeding requiring prehospital transfusion exclusion criteria: * transfusion with blood products already initiated
humanized cd7 car t-cell therapy for r/r cd7+ acute leukemia

Conditions: T Lymphoblastic Leukemia/Lymphoma; Mixed Phenotype Acute Leukemia; Acute Myeloid Leukemia

Summary: this is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of t cells expressing humanized cd7 chimeric antigen receptors treatment for patients with refractory/relapsed cd7 positive acute leukemia.

the patients will receive infusion of car t-cells targeting cd7 to confirm the safety and efficacy of cd7 car t-cells in cd7+ relapsed or refractory acute leukemia.

Eligibility criteria:
inclusion criteria: 1. diagnosed cd7 positive relapsed/refractory acute leukemia. 2. age 12-65 years. 3. eastern cooperative oncology group (ecog) score 0-2. 4. cd7 on leukemia is \>30% positive detected with flow cytometry. 5. patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade i/ii cardiovascular dysfunction according to the new york heart association classification. 6. patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dl. exclusion criteria: 1. patients are pregnant or lactating 2. patients with congenital immunodeficiency. 3. patients with central nervous system leukemia. 4. patients with uncontrolled active infection. 5. patients with active hepatitis b or hepatitis c infection. 6. patients with hiv infection. 7. patients with atrial or venous thrombosis or embolism. 8. patients with myo-infarction or severe arrythmia in the recent 6 months. 9. other comorbidities that investigators considered not suitable for this study.

Keywords: cd7 positive car-t
shanghai high myopia study

Conditions: High Myopia; Cataract; Visual Outcome; Genetic Anticipation

Summary: the purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. the investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.

high myopic cataract (hmc) has become a major high-risky type of cataract in china, which accounts for nearly 30% of cataract in recent years. compared to age-related cataract, hmc is characterized with earlier onset, severer lens opacities, higher incidence of vitreoretinopathy and postoperative complications compared to age-related cataract(arc). the main purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, when compared to those age-matched arc patients. on the other hand, due to the lack of research in the pathogenesis of hmc, it is difficult for the investigators to precisely evaluate its risk and prognosis, and to improve its prevention and treatment. the previous study of investigators majored in a large-sample analysis on the clinical features and related genes of hmc. after preliminary screening, eight genes were selected for further investigation: 1) genes related to pathogenesis of hmc: cryaa/ gstp1/ txnrd2;2) genes related to vitreoretinopathy: mcp1/ vegfa/ cfh; 3) genes related to postoperative complications: tgfb2/ cers2. in the present study, in order to establish a risk model of hmc from the aspect of precision medicine, the investigators are preparing to set up a comprehensive clinical database for further sequencing of selected genes (including exons, promoters, 5' utr and 3' utr sequences) on a large scale, to intensively investigate into the sites and functions of single nucleotide polymorphism (snp) correlated with clinical features of hmc. the research aim to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract, to thoroughly illustrate the influence of hmc-related genes to its prognosis and to elucidate the pathogenesis of hmc, for further promotion in the disease prevention and prognosis as well.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cataract * must be able to cooperate with the ophthalmic examination exclusion criteria: * clinical diagnosis of mental illness * mentally disabled
evaluation of the efficacy and safety of single dose tranexamic acid in reducing blood loss during colorectal cancer surgery

Conditions: Colorectal Surgery

Summary: a total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking surgery for colorectal cancer will be randomized into two equal groups one will receive tranexamic acid and one placebo. the ta group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. in the control group, patients will receive a placebo of 100 ml 0.9% normal saline. the primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.


Eligibility criteria:
inclusion criteria * asa 1 and asa 2 patients scheduled for colorectal cancer surgery. * age above 18 years \& less than 65 years. exclusion criteria: * thrombophilia or any bleeding disorder. * previous or active thromboembolic disease. * family history of thromboembolism. * known allergy to ta. * liver dysfunction. * preexisting renal dysfunction (serum creatinine \>1.2 mg/dl). * coronary stent insertion within a year prior to operation. * cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure), * lifelong warfarin therapy for thromboembolism prophylaxis.

Keywords: colorectal,blood, transfusion,haemorrhage,tranexamic acid.
the effect of remote ischemic conditioning in patients with hypercholesterolemia

Conditions: Hypercholesteremia; Endothelial Dysfunction

Summary: there is an on-going discussion weather remote ischemic conditioning (ric) is effective in limiting the damage of reperfusion injury in stemi patients. the results from recent rcts have been variable and most have not shown convincing positive results when analyzing hard endpoints. hence, there is a great need to evaluate the impact of comorbidities on the effectiveness of ric. therefore, we have designed a study to evaluate the impact of hypercholesterolemia on the ric response by evaluating ischemia-induced endothelial dysfunction. aim: to investigate the impact of hypercholesterolemia on the ric response in counteracting ischemia-induced endothelial dysfunction.

study population: we plan to include 12 poorly controlled/newly diagnosed subjects with familiar hypercholesterolemia (fh) and 12 age-matched control subjects. inclusion criteria (fh subjects) * poorly treated fh, defined as ldl-c \>5.5 mmol/l. * age, \>18 and \<65 years of age. exclusion criteria * additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure. * unwillingness to participate. * concurrently participating in another interventional trial. main exposure: remote ischemic conditioning, i.e. 4 cycles of 5 minutes of ischemia to the lower limb. comparision group: cross over design, patients preform the protocol twice, once with sham and once with ric. also a group of healthy matched controls will be recruited. outcome: change in fmd after 20 minutes of ischemia and 20 minutes of reperfusion with the exposure of either sham or ric. design: randomized interventional cross-over.

Eligibility criteria:
inclusion criteria: * poorly treated fh, defined as ldl-c \>5.5 mmol/l. * age, \>18 and \<65 years of age. * a age matched control-group. exclusion criteria: * additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure. * any condition which interfere with the outcome recording for example atrial fibrillation. * unwillingness to participate. * concurrently participating in another interventional trial.
effects of dynamic and kinesiology taping on balance and kinesthesia in healthy adults

Conditions: Dynamic Tape; Kinesiology Taping

Summary: this study aims to investigate the acute effects of dynamic tape (dt) and kinesiology tape (kt) on balance and kinesthesia of the lower limbs in healthy young adults. participants will undergo assessments of static balance and knee joint position sense before and after the application of each taping condition. the study seeks to determine whether dt or kt can provide immediate improvements in postural stability and proprioceptive accuracy.

taping techniques are commonly used in rehabilitation and sports settings to support joint function, reduce pain, and improve proprioception. dynamic tape (dt) and kinesiology tape (kt) differ in their mechanical properties and proposed mechanisms of action. while kt is elastic and mimics the properties of skin, dt offers higher elasticity and resistance, potentially providing enhanced mechanical support and proprioceptive feedback. although several studies have explored the effects of taping on balance and proprioception, direct comparisons between dt and kt, particularly when applied to both the ankle and knee joints, remain limited. this study seeks to address this gap by examining and comparing the immediate effects of dt and kt on static balance and kinesthesia of the lower limbs in healthy adults. the findings may contribute to a better understanding of the clinical relevance of different taping methods and inform decision-making in preventive and therapeutic interventions targeting lower limb stability and proprioception.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18-30 years * no current pain or injury affecting the lower limbs * willingness to participate and provide informed consent * no known allergy or sensitivity to adhesive materials exclusion criteria: * history of ankle sprain or anterior cruciate ligament (acl) injury * any lower limb injury in the past 3 months * neurological or vestibular disorders affecting balance * skin conditions or wounds at the taping sites * participation in balance or proprioception training programs in the past month
a study of ro5190591 (danoprevir) in combination with pegasys and copegus in treatment-naive patients with chronic hepatitis c genotype 1 virus infection

Conditions: Hepatitis C, Chronic

Summary: this 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with ro5190591 (danoprevir) in combination with pegasys and copegus, compared to pegasys and copegus alone, in treatment-naive patients with chronic hepatitis c genotype 1 virus infection.in part 1 of the study, patients will be randomized to receive either 1) ro5190591 300mg po every 8 hours, 2) ro5190591 600mg po every 12 hours, 3) ro5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of pegasys and copegus. if the safety and virological response data from part 1 of the study are supportive, in part 2 patients will be randomized to receive either 1) ro5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of pegasys and copegus. the anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic hepatitis c, genotype 1; * treatment-naive. exclusion criteria: * liver cirrhosis and other forms of liver disease; * hiv infection; * hepatocellular cancer; * cardiac disease.
real world multicenter national study to evaluate the effectiveness and safety of biosimilar bevacizumab elovie

Conditions: Metastatic Colorectal Cancer

Summary: colorectal cancer is one of the most common tumors and is the second most prevalent cause of cancer death, leading to almost 1 million deaths per year.elovie is a bevacizumab biosimilar medicine marketed by libbs farmacêutica, which had its registration approved by anvisa in may 2022.at the time of registration a robust evidence package was presented that included, for example, pharmacokinetic bioequivalence studies in patients with metastatic rcc (mrcc) and a phase iii study in participants with non-small cell lung cancer .conducting a real-world study to evaluate the effectiveness and safety of bevacizumab biosimilar elovie in patients with mcrc is crucial to provide relevant information on how this therapy behaves in real-world clinical conditions in brazilian population.

observational, multicenter study with real-world data from specialized cancer centers in brazil. participants over 18 years of age, of both sexes, with unresectable clinical stage iv metastatic colorectal cancer, who have received elovie® (bevacizumab biosimilar) at participating centers and who meet the eligibility criteria will be invited to participate. in this study, data on the effectiveness and safety of treatment with elovie, as well as clinical and demographic characteristics and treatment patterns will be collected. participants will undergo standard treatment and clinical follow-up as determined by the treating physician. data collection will be performed by the researcher and the data transcribed into the case report form data collection form designed specifically for the study.

Eligibility criteria:
inclusion criteria: * participants of both sexes aged 18 years or older at the start of treatment with bevacizumab. * participants diagnosed with metastatic colorectal cancer, clinical stage iv, unresectable, by clinical definition in medical records * participants who are undergoing first-line treatment with elovie and who have completed at least 1 cycle of treatment or participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than elovie) but who have currently switched to elovie and completed at least 1 cycle of treatment with it * participants with the capacity to understand and consent to their participation in the study through the free and informed consent form exclusion criteria: * participants who are or have used bevacizumab in a manner other than that described in the package insert * participants who have been treated with elovie for a period longer than 6 treatment cycles * participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than elovie) and have completed more than 2 treatment cycles with this

Keywords: elovie bevacizumab
effects of continuous positive airway pressure (cpap) treatment on glucose control in patients with type 2 diabetes

Conditions: Obstructive Sleep Apnea; Type 2 Diabetes

Summary: the overall goal of the proposed protocol is to rigorously test the hypothesis that cpap treatment has beneficial effects on glycemic control in patients with both type 2 diabetes (t2dm) and obstructive sleep apnea (osa). if our hypothesis were to be proven, this would imply that cpap treatment of osa in patients with t2dm is an essential component of their glycemic control. the proposed work is thus expected to provide additional preventive and therapeutic approaches in the management of millions of patients with t2dm.


Eligibility criteria:
inclusion criteria: * male and female subjects with type 2 diabetes on a stable medication regimen (no change in diabetic medications in the previous 3 months) will be eligible. exclusion criteria: * subjects on insulin will be excluded. * subjects with unstable cardiopulmonary disease, painful neuropathy, significant psychiatric illness, cognitive impairment and pregnancy will be excluded. * shift workers * subjects having traveled across \>2 time zones less than one month prior to the study * diagnosis of a sleep disorder other than osa by screening polysomnography * previous treatment with positive airway pressure or supplemental oxygen * requirement of supplemental oxygen or bi-level positive airway pressure for osa treatment during titration * claustrophobia or other conditions of cpap intolerance, * presence of active infection.
ticagrelor china pharmacokinetic/pharmacodynamic study

Conditions: Stable Coronary Heart Disease (CHD)

Summary: open label, single centre, randomised, phase iv, pharmacokinetic, pharmacodynamic, and safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in chinese patients with stable coronary heart disease

up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. following an 8 hour fast on single dose on day 1 and day 7; on multiple doses from day 3 to day 6. prior to the first dose of study drug there will be a screening period of maximum of 19 days. patients will report to the clinical pharmacology unit (cpu) on day -2 and will remain confined there until completion of study procedures on day 7, the patients will be discharged on day 8. in addition, patients will return to the cpu for a follow up visit 2 to 5 days after the last dose. each patients participation, including the screening period, will take approximately 33 days.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated written informed consent prior to any study specific procedures. 2. female or male chinese (as defined by chinese regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures. 3. documented stable coronary heart disease (chd) fulfilling all of the following, and taking 75-100 mg asa daily treatment: diagnosed stable angina pectoris per the guidance of chinese society of cardiology published in 2007, patients with angina severity classified as i and ii of canadian cardiovascular society grading of angina pectoris. 4. female patients without pregnant potential exclusion criteria: 1. any indication for oral anticoagulant or dual antiplatelet treatment and chronic asa with doses greater than 100 mg/day. 2. concomitant therapy with strong cyp3a inhibitors, cyp3a substrates with narrow therapeutic index, or strong cyp3a inducers within 14 days preceding the first dose of study medication and during study treatment. 3. increased bleeding risk. 4. contraindication or other reason that asa or ticagrelor should not be administered 5. patients that are scheduled for revascularization (eg, pci, cabg) during the study period