Kornimate/medical-research-clean huggingface dataset:
esge-quality improvement in endoscopy: ercp

Conditions: Post-ERCP Acute Pancreatitis

Summary: the primary aim of the present study is to compare the incidence of post-ercp pancreatitis (pep) before and after the implementation of the qic-guideline in 2017: "performance measures for ercp and endoscopic ultrasound: a european society of gastrointestinal endoscopy (esge) quality improvement initiative".

in 2017, a new guideline addressing the quality in ercp entitled "performance measures for ercp and endoscopic ultrasound: a european society of gastrointestinal endoscopy (esge) quality improvement initiative" was published. the focus of the quality improvement committee (qic) of the esge is to ensure high standard of all endoscopy examinations throughout europe by adhering to quality-improving factors (key performance indicators and minor performance indicators as defined by the esge). the study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the european society of endoscopy (esge) will actually lead to an improvement in quality. the study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the qic-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data), 3. prospectively, from 2024 onwards. the primary endpoint of this study will be the key performance indicator post-ercp pancreatitis (pep). in the esge-guideline, a minimum standard of \<10% and a target standard of \<5% was recommended. different studies described the incidence of post-ercp pancreatitis between 3,47% and 10,2%. the investigators hope that this study will lead to even greater patient safety in the future by improving findings and examination quality and therefore reduce the incidence of post-ercp pancreatitis. in addition, the aim is to harmonize the high endoscopic standards throughout europe.

Eligibility criteria:
inclusion criteria:nclusion criteria individuals eligible for inclusion are patients referred for ercp who do not fulfill one of the following exclusion criteria exclusion criteria * individuals eligible for inclusion are patients referred for ercp who do not fulfill one of the following exclusion criteria * age under 18 years * inability to understand information for participation * refusal of participation, missing cooperativity, e.g., due to age or disease * pregnant or lactating patients * patients with \> 1 ercp during the hospital stay: only the initial ercp will be evaluated exclusion criteria: -

Keywords: performance measures esge post-ercp pancreatitis quality in endoscopy
outcomes of post-operative diet in children following tonsillectomy and adenoidectomy

Conditions: Chronic Tonsillitis; Sleep Disordered Breathing

Summary: this research is being done because it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. the purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

currently it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. traditional standard of care is to recommend that patients be restricted to a soft diet post-operatively. however, the investigators believe that there may be benefit in allowing patients to eat a restriction-free diet. in this study, the investigators will compare the current standard of care verse a non-restricted diet. the purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Eligibility criteria:
inclusion criteria: * patients 3-12 years undergoing tonsillectomy and/or adenoidectomy. exclusion criteria: -
switching from tdf-based antiretroviral therapy regimens to b/f/taf in virally suppressed adults with hiv-1 infection

Conditions: HIV-1-infection

Summary: to evaluate the safety and efficacy of bictegravir/emtricitabine/tenofovir alafenamide versus tenofovir disoproxil fumarate-based antiretroviral regimens in hiv-infected individuals with virological suppression.

this study is a multicenter, randomized, controlled, open labeled clinical trial, which aims to evaluate the safety and efficacy of b/f/taf versus tdf-based antiretroviral therapy in hiv-infected individuals with virological suppression, and to evaluate the changes in quality of life and adherence after switching from a tdf-based regimen to b/f/taf in hiv-infected individuals with virological suppression.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for aids or hiv infection (ws 293-2019); * age 18 or above (included 18); * continuous administration of a tdf-based triple art regimen with a backbone of non-nucleoside reverse transcriptase or protease inhibitors ≥24 weeks and ongoing use; * maintaining virological suppression (viral load \< 50 copies/ml) for ≥ 24 weeks, and maintaining virological suppression at present; * glomerular filtration rate (egfr) ≥ 50 ml/min/1.73 m2 (calculated according to the ckd-epi formula); * ecg is normal; * white blood cell count ≥3×109/l, neutrophil count ≥1.5×109/l, hemoglobin ≥90 g/l, and platelet count ≥ 75×109/l; * alanine aminotransferase and aspartate aminotransferase ≤5×uln, direct bilirubin ≤1.5×uln, amylase≤2×uln； * those who volunteered for this study and were able to complete all follow-up visits and sign the informed consent form in accordance with the protocol. exclusion criteria: * in the 30 days(inclusive) before the screening period, an aids-related opportunistic infection or tumor occurred; * history of known past hiv resistance (confirmed hiv viral load \> 200 copies /ml) or resistance to any nucleoside (acid) analogues; * decompensated liver cirrhosis; * female subject who has a positive urine pregnancy test; * lactating women; * women who are unable to take a reasonable method of contraception during the trial (including the screening period and 30 days after discontinuation of experimental drugs); * subjects had other medical conditions requiring treatment with either of the current art regimens or other drugs which have drug-drug interaction with b/f/taf and cannot be discontinued. * being involved in other interventional clinical studies; * those with allergic constitution or known allergy to the components of the drug; * suffering from serious mental or neurological diseases; * suspected or confirmed history of alcohol and drug abuse; patients who were not considered by the investigator to be suitable for participating in this clinical trial (such as weak constitution, poor compliance, etc.).

Keywords: bictegravir/emtricitabine/tenofovir alafenamide tenofovir disoproxil fumarate hiv-1 infection
effect of whole body vibration on down syndrome

Conditions: Down Syndrome

Summary: a congenital condition known as down syndrome is typified by an excess of genetic material from chromosome 21, making 47 chromosomes in total. development of the body and brain may be impacted. about 1 in 700-1100 live births have the condition, and 1 in 700-1100 live births inherit it. heart disease, hypotonia, ligament laxity, cerebral disabilities, thyroid abnormalities, and metabolic diseases are among the physical, cognitive, and metabolic changes that define it. reduced performance, increased energy consumption, and altered gait patterns are frequently the results of motor disorders. this study intends to ascertain the effects of whole body vibrations (wbv), an activity that has been recommended for individuals with down syndrome, on gait parameters and postural control in children with this condition.

whole body vibration (wbv) and routine physical therapy (rpt) are given to group a, whereas routine physical therapy is given to group b as a control. two sessions of 20 minutes each are given to both groups twice a week. postural control and gait metrics are the outcomes that will be examined. the present investigation will be conducted over a two-month period and will be a randomized control experiment. alkhidmat hospital in sargodha and al-ghafoor hospital in bhera will provide the data. 16 participants will participate in the trial; they will be randomly assigned to two equal groups. children with ds, ages 5 to 12, of both sexes, will be eligible to participate in the study. the condition of improved comprehension of children older than five years was taken into consideration when determining the inclusion criteria.

Eligibility criteria:
inclusion criteria: * ages 5-12 * both sexes are chosen * children with down syndrome older than 5 who are more knowledgeable about the exercise to be done are given preference. exclusion criteria: * children with cardiac conditions and other conditions * atlantoaxial instability and prosthesis implantation are excluded. * ds kids who don't have their parents or legal guardians sign the consent form.

Keywords: down syndrome motor skills vibrations
efficacy study of tkcell in advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is to determine efficacy of nkcell combined folfox-4 chemotherapy in gastric cancer


Eligibility criteria:
inclusion criteria: * written informed consent. * diagnosis of histologically confirmed adenocarcinoma of the gastric * ecog performance status of 0 - 2 * at least one definite measurable lesion(s): ≥ 1 cm on spiral ct scan or ≥2cm in physical examination * adequate liver, renal, bone marrow functions as evidence by the following; absolute neutrophil count \> 1.5 x 109/l; platelets \> 7.5 x 109/l; bilirubin less than 2 mg/dl asat and/or alat \< 5 unl; serum creatinine ≤ 2 uln * minimum life expectancy of 12 weeks * effective contraception for both male and female subjects if the risk of conception exists exclusion criteria: * brain metastasis and/or leptomeningeal disease (known or suspected) * previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment. * previous oxaliplatin-based chemotherapy * surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy * hiv antibody (+), chronic hepatitis * uncontrolled infection * concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception * clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia * known hypersensitivity reaction to any of the components of the treatment. * pregnancy (absence to be confirmed by ß-hcg test) or lactation period * participation in another clinical study within the 30 days before randomization * significant disease which, in the investigator's opinion, would exclude the subject from the study

Keywords: nkcell folfox-4 gastric cancer
cmr-lupus comprehensive approach by cardiovascular magnetic resonance tomography

Conditions: Lupus Erythematosus, Systemic; Coronary Artery Disease; Myocardial Disease

Summary: in systemic lupus erythematosus (sle), cardiac manifestations, e.g. coronary artery disease (cad) and myocarditis are leading causes of morbidity and mortality. the prevalence of subclinical heart disease in sle is unknown. we studied whether a comprehensive cardiovascular magnetic resonance (cmr) protocol may be useful for early diagnosis of heart disease in sle patients without known cad


Eligibility criteria:
inclusion criteria: * diagnosis of sle, as defined by the american college of rheumatology classification criteria for systemic lupus erythematosus exclusion criteria: * age under 18 years * known coronary artery disease * impaired renal function with an estimated glomerular filtration rate less than 30 ml/min, estimated by the modification of diet in renal disease study group (mdrd) formula (45) * devices as pacemakers, implantable cardioverter-defibrillators, insulin pumps and others * metallic foreign bodies in the eyes, ferromagnetic implants labeled mr unsafe * allergy against cmr contrast media or adenosine * presence of chronic atrial fibrillation, 2nd or 3rd degree atrioventricular (av)-block, trifascicular block, asthma and severe chronic obstructive pulmonary disease
development of an intranasal proteosome influenza vaccine

Conditions: Influenza

Summary: a study to compare multiple dosage regimes of a protesomal intranasal vaccine.

a proteosome-adjuvanted trivalent inactivated influenza vaccine (p-tiv) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness. in two separate studies using the human viral challenge model, subjects were selected for susceptibility to a/panama/2007/1999 (h3n2) virus and then dosed with one of three regimens: (a/new caledonia/20/1999 (h1n1), a/panama/2007/1999 (h3n2), b/victoria/504/2000 or b/shangdong/7/1997) or placebo via a nasal spray. one or two doses were given, 14 days apart, before subjects were challenged with \~8.5 x 105 eid¬50 of a/panama/2007/1999 (h3n2) virus. immune responses to the vaccine antigens were measured, namely serum igg (via the aemagglutination inhibition assay (hai)) and nasal wash secretory iga (siga) antibodies (via elisa). viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.

Eligibility criteria:
inclusion criteria: * young healthy adults as determined by medical history, physical examination, serology (hiv and hepatitis b and c) and clinical laboratory tests. * female subjects were required to provide of a history of reliable contraceptive practice. * susceptibility to a/panama/2007/1999 (h3n2) (a serum reciprocal hai titre ≤10) was confirmed at screening. - exclusion criteria:included; * asthma, * hypersensitivity to mercurials or chicken eggs, * anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, \* chronic nasopharyngeal complaints, * abnormal electrocardiogram (ecg), * febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum. * subjects using medication or other products for rhinitis or nasal congestion, * subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start. * subjects agreed not to smoke during the quarantine phase.
study of the effects of an oral nitric oxide supplement on blood pressure in prehypertensive adults

Conditions: Prehypertension

Summary: oral supplementation of neo40(tm), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.


Eligibility criteria:
inclusion criteria: * adults between the ages of 18 to 80 years * two blood pressure readings of \>/=135/80 mmhg at rest, thus representing prehypertension * informed consent exclusion criteria: * existence of any significant internal or cardiovascular disease; * current use of any antihypertensive medication. * inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.

Keywords: prehypertension nitric oxide blood pressure functional capacity quality of life
study assessing the safety and efficacy of pegcetacoplan in post-transplant recurrence of c3g or ic-mpgn

Conditions: C3G; IC-MPGN; Renal Transplant; Complement 3 Glomerulopathy; Complement 3 Glomerulopathy (C3G); Dense Deposit Disease (DDD); Membranoproliferative Glomerulonephritis; Membranoproliferative Glomerulonephritis (MPGN); Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN); C3 Glomerulopathy; C3 Glomerulonephritis; Complement 3 Glomerulonephritis

Summary: this is a phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of c3g or ic-mpgn.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at screening * must have clinical and pathologic evidence of recurrent c3g or ic-mpgn * stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan * egfr ≥15 ml/min/1.73 m2, calculated by the chronic kidney disease-epidemiology collaboration (ckd-epi) creatinine equation for adults * no more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy * stable regimen for recurrent c3g/ic-mpgn for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization * have received required vaccinations against n. meningitidis, s. pneumoniae, and h. influenzae (type b) or agree to receive vaccinations, if applicable vaccination records are not available. vaccination is mandatory unless documented evidence exists that subjects are non-responders to vaccination. exclusion criteria: * absolute neutrophil count \<1000 cells/mm3 during screening * previous treatment with pegcetacoplan * evidence of rejection on the screening renal allograft biopsy that requires treatment * diagnosis or history of hiv, hepatitis b, or hepatitis c infection or positive serology at screening indicative of infection with any of these viruses * weight more than 100 kg at screening * hypersensitivity to pegcetacoplan or any of the excipients * history of meningococcal disease * malignancy, except for the following: * cured basal or squamous cell skin cancer * curatively treated in situ disease * malignancy free and off treatment for ≥5 years * significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would, in the opinion of the investigator, confound interpretation of the study results * participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening * known or suspected hereditary fructose intolerance.
growth and body composition in children

Conditions: Growth; Child Development; Disability, Developmental

Summary: this study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in south korea for understanding the nutritional and growth status.

* inclusion criteria for typically developing children 1. typically developing children in 5th and 6th grades of elementary schools 2. children whose parents checked the agreement form distributed by schools * inclusion criteria for children with disabilities 1. children and adolescent who are in special schools 2. children whose parents checked the agreement form distributed by schools 3. children who were able to cooperate during the body composition analysis * exclusion criteria for both groups 1. those whom do not have written informed consent 2. who are not able to stay calmly during the body composition analysis * all measurements done at two elementary schools on the day of the annual physical examination * measurement of height and body weight for growth * measurement of body composition index: inbody 770 and inbody s10, body composition analyzers

Eligibility criteria:
inclusion criteria: * those who agreed to participate both parents and a child * typically developing children: among the 5th and 6th grade of two elementary schools. * children with neurodevelopmental disabilities: among the students in a special school. exclusion criteria: * who do not want to participate * who are not possible to do the inbody examination

Keywords: growth body composition
rct gum chewing on bowel function after abdominal surgery in children

Conditions: Postoperative Ileus

Summary: traditional postoperative care has been challenged recently to improve and speedup recovery (including the return of bowel function) such that patients can be discharged to home more quickly. this approach includes earlier mobilization of the patient, and introducing solid food sooner. additionally, there is evidence in adults to suggest that "sham feeding" by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier. the aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery.

after intestinal surgery, many patients suffer from a "postoperative ileus" (poi). the cause is multifactorial and can be attributed to surgery itself, the lingering effect of the anesthetic, the use of narcotics and decreased mobility of the patient. an ileus can delay the time to full diet, thus lengthening the hospital stay of the patient - sometimes up to several weeks. there is evidence that early drinking/eating and increased mobility may accelerate the return of bowel function. "fast-tracking" is well documented in the adult literature; protocols have been put in place to enhance gi tract recovery and thus decrease the morbidity of a prolonged hospital stay and ileus. "fast-tracking" has been done in pediatric patients but not in a large rct for abdominal surgery.

Eligibility criteria:
inclusion criteria: * children more than 4 years of age * children who undergo abdominal surgery (both laparoscopic or open) * children who have an expected postoperative length of stay more than 24 hours exclusion criteria: * children who are less than 4 years of age * children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability) * children or their parents are not willing to sign consent * children or their parents are unable to follow directions regarding gum chewing, * children who have a gi dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)

Keywords: postoperative ileus gum chewing postoperative care abdominal surgery child