Kornimate/medical-research-clean huggingface dataset:
hsk7653 in chinese patients with impaired glucose tolerance

Conditions: Impaired Glucose Tolerance

Summary: this study is being done to evaluate the efficacy, safety of hsk7653 in chinese participants with impaired glucose tolerance.


Eligibility criteria:
inclusion criteria: * impaired glucose tolerance; * bmi (body mass index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening; exclusion criteria: * history of diabetes mellitus; * history of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent; * current uncontrolled hypertension, serious nephropathy prior to informed consent; * serious heart failure (class iii-iv of the new york heart association functional classification), serious arrhythmia, and stroke within 6 months prior to informed consent; * serious gastrointestinal disease within 2 weeks prior to informed consent; * serious infection, trauma, and surgery within 3 months prior to informed consent; * history of treatment with glucagon-like peptide 1(glp-1) analogues, dipeptidyl-peptidase 4(dpp-iv) inhibitor; * treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent; * hemoglobin (hgb) \< 10.0 g/dl(100 g/l); * alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent; * active infectious diseases; * participation in another trial with an investigational drug or instrument within 3 months prior to informed consent; * women who are nursing or pregnant, or subjects with birth plans; * other protocol-defined inclusion/exclusion criteria.

Keywords: impaired glucose tolerance dpp-4 inhibitor prediabetes
effect posterior qlb on atelectasis

Conditions: Atelectasis; Block; Pediatrics; Quadratus Lumborum Block

Summary: we aimed to investigate the effect of posterior quadratus lumborum block on postoperative atelectasis in inguinal hernia surgery in pediatric patients.


Eligibility criteria:
inclusion criteria: * under 2 years old, * asa i-ii risk group * patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method * patients whose informed consent was read and approval was obtained from him and his guardian exclusion criteria: * who do not want to participate in the study, * asa iii-iv-v patients

Keywords: postoperative atelectasis ultrasound lung ultrasound score posterior qlb
clinical data registry of amblyopia patients on luminopia treatment

Conditions: Amblyopia

Summary: amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. the most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. in addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity. for the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer luminopia, an fda-approved dual action dichoptic treatment, to patients with amblyopia. since the product became commercially available in november 2022, the number of patients on luminopia therapy continues to grow. this presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. a registry of the clinical data associated with luminopia treatment, with irb oversight, will provide answers to key scientific questions using a large dataset.


Eligibility criteria:
inclusion criteria: * have a diagnosis of amblyopia * have undergone or currently undergoing luminopia treatment for a minimum of 12 weeks exclusion criteria: -have participated in prior luminopia clinical trials
outcome of children with eosinophilic esophagitis

Conditions: Esophagitis, Eosinophilic

Summary: the investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months. this study would also enable us to investigate the quality of life of these chronically ill patients

the investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. it is also planned to describe this cohort of pediatric eo patients at inclusion and throughout follow-up, and to study their quality of life. follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (peess score) and quality of life (pedsql eosinophilic esophagitis module and pedsql 4.0 generic core scales). if treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.

Eligibility criteria:
inclusion criteria: * diagnosis of oe according to the diagnostic criteria of the pnds published in july 2022 * due to start treatment. * informed consent from one of the 2 parents or the representative of parental authority. * membership of a social security scheme. exclusion criteria: -

Keywords: children eosinophilic esophagitis life quality
inter scorers agreement for osa screening scores.

Conditions: Sleep Apnea, Obstructive

Summary: four scores are usually performed to detect osa (obstructive sleep apnea) patients. these four scores are: stop-bang, p-sap, osa50 and des-osa. these scores have been previously validated. however, a comparison between scorers in the realization of these scores has never been performed.

four scores are usually performed to detect osa (obstructive sleep apnea) patients. these four scores are: stop-bang, p-sap, osa50 and des-osa. these scores have been previously validated. however, a comparison between scorers in the realization of these scores has never been performed. the aim of this study was to evaluate this agreement using statistical methods.

Eligibility criteria:
inclusion criteria: * all preoperative patients in the cabinet medical astes exclusion criteria: * patient's refusal

Keywords: sleep apnea, obstructive, mass screening
impact on quality of life and health of the continuum+ connect remote monitoring solution

Conditions: Prostatic Neoplasms; Lung Neoplasms; Breast Neoplasms; Colorectal Neoplasms

Summary: fegala is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the eortc qlq-c30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the continuum+ connect solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.

continuum+ connect is a platform, accessible from a computer, a smartphone or a tablet, allowing remote monitoring of cancer patients followed on an outpatient basis. the remotely monitored patient is invited to answer questionnaires (regarding adverse events, physiological constants and pain) at home. these questionnaires are either completed by the patient himself, if his condition allows it (self-assessment) or completed with the help of a professional on an outpatient basis (hetero-assessment). the data and alerts are transmitted in real time to the healthcare professionals in charge of the patient who analyze them and then determine the course of action to take. in order to evaluate the impact of remote monitoring by continuum+ connect on the quality of life and health of patients with metastatic cancer, the present prospective randomized multicenter study will be carried out. four main types of cancer will be studied: breast, lung, colorectal and prostate cancer.

Eligibility criteria:
inclusion criteria: 1. adult patients aged ≥ 18 years with a solid tumor (only breast, lung, colorectal, prostate cancer) at the metastatic stage followed on an outpatient basis; 2. patients initiating oral and/or injectable anticancer treatment, whatever the line of treatment, administered on an outpatient basis including day hospitalization; 3. patients who have given their written, free and informed consent; 4. patients with life expectancy of more than 3 months; 5. patients able to complete questionnaires according to the investigator's judgment, and to use the continuum+ connect electronic application either alone or accompanied by a professional (home nurse); 6. patients affiliated to a social security scheme or beneficiaries of such a scheme. exclusion criteria: 1. patients receiving home hospitalization care or being hospitalized at the time of treatment initiation; 2. patients receiving concomitant radiotherapy; 3. patients using another remote monitoring application; 4. patients enrolled in another clinical trial; 5. patients protected by law.

Keywords: remote patient monitoring metastatic cancer
effect of coenzyme q10 on diabetic children

Conditions: Type 1 Diabetes Mellitus

Summary: determine the effect of coenzyme q10 on random blood sugar and glycosylated haemoglobin

type 1 diabetes mellitus is an autoimmune disease that leads to destruction of insulin producing pancreatic beta cells. individuals with type 1 diabetes requires life long insulin replacement with multiple daily insulin injection. daily,insulin pump therapy or the use of an automated insulin delivery system. without insulin ,diabetic ketoacidosis develops and is life threatening. in addition to insulin therapy ,glucose monitoring with a continuous glucose monitor and a blood glucose monitor if continuous glucose monitor is unavailable is recommended . coenzyme q10 supplementation has beneficial effects on glycemic control especially in diabetes , and 100-200 mg per day of co q10 could achieve the greatest benefit which could provide a basis for the dietary guidelines of co q10 in patients with glycemic disorders . co q10 with a known antiinflammatory and antioxidant has beneficial effects on endothelial function and therefore minimize the microvascular and macrovascular complication in patients with type 1 diabetes mellitus. administration of co q10 for 3 months in type 1 diabetes mellitus in pediatric patients was will tolerated but had no favorable effect on endothelial dysfunction or metabolic parameters . co q10 in addition to improving the metabolic hyperglycemia , it improve hb a1c and the lipid profile. patients with type 1 diabetes , especially poorly controlled had elevation of plasma vitamin e and coenzyme q10 levels and decreased platelet redox status of coenzyme q10 which may be an indicator of increased oxidative stress ,so co q10 has an antioxidant effects. researches on this topic are limited on pediatrics and investigators search for it and will see the result.(clinical trial) co q10 is present in the forms of soft gel capsules ,oral spray , hard gel capsules and tablets . co q10 approved from age of 2 years old to 18 years old .

Eligibility criteria:
inclusion criteria: * all patients diagnosed as type 1 diabetes mellitus from age of 2 years old to 18 years old with diabetes mellitus of duration at least 1 year. exclusion criteria: * - patients diagnosed as diabetes mellitus less than 2 years old . * patients with diabetes mellitus of duration less than 1 year. * patients diagnosed as type 1 diabetes mellitus with thyroid or celiac diseases. * other types of hyperglycemia rather than type 1 diabetes mellitus.
improving genetic counseling for brca+ mothers

Conditions: Breast Cancer

Summary: genetic counseling and testing for hereditary breast cancer may reveal that you, and possibly your blood relatives, are at increased risk for the disease across the lifespan. this includes biological children, both male and female. we do not yet know the best ways to educate mothers who have a risk gene (are brca+) about whether, when, and how to share genetic information with their children or manage their thoughts and feelings. the purpose of this study is to help mothers make more informed choices about talking with children about hereditary breast cancer, provide them with age-and gender-appropriate information and emotional support, and improve their psychological well-being.


Eligibility criteria:
inclusion criteria: * mothers/primary caregivers to adolescents/young adults ages 13-24 years-old. * participating in genetic testing for hereditary breast cancer. * adequately speak/read english. exclusion criteria: - does not meet inclusion criteria.
adaptive radiotherapy for high-risk prostate cancer using multiparametric mri

Conditions: Prostate Cancer

Summary: this small study will investigate the feasibility of using multi-parametric mri to introduce and support adaptive radiotherapy treatments for high-risk prostate cancer.

mount vernon cancer centre at east and north hertfordshire nhs trust offers patients with certain cancers a treatment called adaptive radiotherapy. the aim of adaptive radiotherapy is to respond to physical changes that occur during treatment to ensure the radiation continues to be directed at the cancer and to minimise the amount of healthy tissue treated. for example, if tumour shrinkage or weight loss occurs during head and neck radiotherapy the patient may have a repeat ct scan and a new radiotherapy treatment plan after a few weeks of treatment. for patients with cancer of the bladder or cervix changes in bladder and uterus size and position can be predicted allowing the prospective creation of three radiotherapy treatment plans, each day the best fitting plan, i.e. the one that closely covers the tumour whilst giving minimal dose to normal tissues, is selected and used for treatment, this is known as plan-of-the-day adaptive radiotherapy. small changes in shape and position of the prostate occur but are generally the result of rectal changes which cannot be predicted, consequently adaptive radiotherapy based on physical change is not possible for prostate cancer treatments. however, recent literature suggests that magnetic resonance imaging (mri) can detect changes within the prostate in response to radiotherapy, some studies have seen changes as early as the second week of radiotherapy treatment. a feasibility study to investigate if these changes can support radiotherapy treatment plan adaption for prostate cancer treatments is proposed, whether the plan can be adapted to give a higher treatment dose to any areas of the prostate that show poor response to radiotherapy without increasing bowel and bladder dose is of particular interest. the treatment for patients who participate in the study would not be changed but the results may help to personalise and improve the treatment of future patients.

Eligibility criteria:
inclusion criteria: 1. new diagnosis of high-risk prostate cancer: any of: 1. gleason score of 8, 9 or 10 2. psa \> 20 3. t3/4 2. patient due to receive androgen deprivation therapy (adt) 3. prescribed 78gy/39# external beam radiotherapy 4. measurable dominant intraprostatic tumour on diagnostic imaging of at least 10mm diameter 5. ≥18 years of age 6. ecog performance status of 0-1 7. informed, written and witnessed consent to participate is required. exclusion criteria: 1. patients who are not due to receive androgen deprivation therapy (adt) 2. any contraindication to mri scanning including contraindication to mri contrast agents 3. previous radiotherapy to the pelvis 4. any physical or social reasons that would make attendance for additional visits impossible. 5. any patient with or planned for prostate fiducial markers. 6. unable to give informed consent. 7. patients currently enrolled in an interventional clinical trial.
the effects of hiv protease inhibitors in severe sepsis

Conditions: Sepsis

Summary: sepsis is the leading cause of death in critically ill patients in the united states. it develops in approximately 750,000 americans annually, and more than 210,000 of them die. despite improvements in supportive treatment, mortality has changed very little, and until recently, no sepsis-specific treatments were available. protease inhibitors have seemed to have an immune benefit that extends beyond their ability to prevent hiv replication. t cells in those patients treated with protease inhibitors have reduced rates of death than in those patients not receiving therapy.

our hypothesis is that protease inhibitor therapy will prevent apoptosis associated with sepsis, and this will be manifested as improved clinical outcome, as assessed by 28-day mortality, apache ii and iii, and sofa scores. all patients enrolled in the study will receive the standard of care for sepsis at mayo clinic rochester. patients will receive 1250 mg of nelfinavir/placebo twice each day for seven days with regularly scheduled blood draws (days 0, 4, and 7).

Eligibility criteria:
infection criteria:known or suspected infection, as evidenced by one or more of the following: wbc in normally sterile body fluid, radiographic evidence of pneumonia, a syndrome associated with a high risk of infection. modified sirs criteria: must meet three or more of the following four criteria: a temperature higher than 38c or lower than 36c, heart rate of more than 90 beats/minute, respiratory rate of more than 20 breaths/minute (or on a mechanical ventilator), wbc more than 12,000/mm(3) or less than 4,000/mm(3). dysfunctional organs criteria:must meet one or more of the following five criteria:cardiovascular system dysfunction, kidney dysfunction, respiratory dysfunction, hematological dysfunction, unexplained metabolic acidosis.
open label study telmisartan and amlodipine in hypertension

Conditions: Hypertension

Summary: the primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (t40/a5) or telmisartan 80 mg / amlodipine 5 mg (t80/a5) during long-term open-label treatment.


Eligibility criteria:
inclusion criteria: 1. patients aged at least 18 years 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial. 3. failure to respond to six weeks treatment with amlodipine 5 mg in the run-in period of the preceding trial. exclusion criteria: 1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study 2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either telmisartan 40 mg/amlodipine 5 mg or telmisartan 80 mg/amlodipine 5 mg 3. discontinuation from the preceding trial because of any adverse event or any other reason 4. known or suspected secondary hypertension 5. mean seated systolic blood pressure =\> 180 mmhg and/or mean seated diastolic blood pressure =\> 120 mmhg at any visit
prospective evaluation of elderly deformity surgery

Conditions: Adult Spinal Deformity

Summary: as the population continues to age, the prevalence of spinal deformity surgery for older patients is increasing. questions regarding the suitability of these patients to undergo large spinal procedures and whether the outcomes merit the risks involved are not well known.

225 subjects greater than or equal 60 years of age with moderate and severe adult spinal deformity requiring surgical correction will be enrolled in a prospective multicenter international study. spinal deformity will be defined as any coronal or sagittal plane spinal deformity in patients who have not undergone any previous spinal surgery (with the exception of prior decompression of a maximum of 2 levels) necessitating at a minimum a 5-level spinal fusion procedure. standard radiographs and cross sectional imaging will be performed preoperatively, postoperatively, at 24 months and 5 years after surgery. preoperative disease specific and general health questionnaires will be completed by all patients (eq-5d, odi, srs-22r, nrs for back and leg pain). follow up visits with questionnaires will be performed at 10 weeks (± 6 weeks), 12 months (± 2 months), 24 months (± 2 months) and 5 years (±6 months) post-operatively. all treatment-related aes will be documented. regression analyses will be used to evaluate the association between patient demographics, comorbidities, treatment history, spinal deformity characteristics, surgical characteristics, treatment-related aes and pre-surgical status to self-reported and radiographic outcomes after surgery.

Eligibility criteria:
inclusion criteria: * age 60 years or older at the time of surgery * diagnosis of adult spinal deformity either in the coronal or sagittal plane requiring at the minimum a 5-level spinal fusion procedure * ability to understand the content of the patient information / informed consent form * willingness and ability to participate in the clinical investigation according to the clinical investigation plan (cip) * signed and dated institutional review board (irb)/ethics committee (ec)-approved written informed consent * reconsent of patients for the 5 year follow-up if required by the irb/ec exclusion criteria: * any previous spinal procedure (except prior decompression of a maximum of 2 levels) * neurodegenerative disease or paralysis * unlikely to comply with follow-up * institutionalized individuals * any not medically managed severe systemic disease * recent history (≤ 3 months) of substance abuse (ie, recreational drugs, alcohol) or psychosocial disturbance that would preclude reliable assessment * prisoner * presence of active malignancy * has active, overt bacterial infection, systemic or local * history of recent(≤ 3 months) fracture/malignancy in the spinal region * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Keywords: spine deformity fusion elderly srs-22r