Kornimate/medical-research-clean huggingface dataset:
a follow-up study in patients with inherited metabolic disorders (imd) who underwent hematopoietic stem cell transplantation (hsct) with mgta-456

Conditions: Inherited Metabolic Disorders (IMD)

Summary: a follow-up study to evaluate the safety and clinical outcomes of patients with inherited metabolic disorders (imd) who have undergone hematopoietic stem cell transplantation (hsct) with mgta-456

this is a follow-up study to evaluate the long-term safety and efficacy outcomes of patients with inherited metabolic disorders (imds) who received mgta-456 for hsct in the core study. mgta-456 is an expanded cd34+ cell therapy product candidate given after myeloablative conditioning to induce rapid and sustained hematopoietic engraftment. in patients with selected imds, transplant is expected to replace defective or missing protein, and preserve neurodevelopment. patients with hurler syndrome (also referred to as mucopolysaccharidosis-1h (mps-1h)), cerebral adrenoleukodystrophy (cald), metachromatic leukodystrophy (mld) or globoid cell leukodystrophy (gld) enrolled in the core study will be eligible to participate in this follow-up evaluation.

Eligibility criteria:
inclusion criteria: * an institutional review board (irb)/independent ethics committee-approved written informed consent form must be signed and dated by the patient or legal guardian. study assents will also be prepared for children and adolescents to review when applicable. * patient completed an imd study in the mgta-456 program and was administered mgta-456 for hsct. exclusion criteria: •patients enrolled in an imd study in the mgta-456 program who did not receive mgta-456 or were withdrawn from the core study.

Keywords: inherited metabolic disorders hematopoietic stem cell transplant mgta-456 umbilical cord blood transplant hurler syndrome cerebral adrenoleukodystrophy globoid cell leukodystrophy metachromatic leukodystrophy
lower limb flexibility in duchenne muscular dystrophy: effects on functional performance

Conditions: Duchenne Muscular Dystrophy; Performance; Flexibility

Summary: the investigator investigated the effect of lower limb flexibility on functional performance of children with duchenne muscular dystrophy.

thirty children whose functional levels were in 1 or 2 according to the brooke lower extremity functional classification scale were included in the study. flexibilities of hamstrings, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. functional performance was assessed with 6 minute walk test (6 mwt) and timed performance tests. the correlation between the flexibility of lower limb muscles' and performance tests were examined.

Eligibility criteria:
inclusion criteria: * having a duchenne muscular dystrophy diagnosis, * being in the ambulatory period and climbing four steps independently, * to be able to cooperate the physiotherapist's directions, * not having any severe contracture in the lower limbs which may prevent assessments, * not having any injury or surgery involving the lower limbs during the last 6 months. exclusion criteria: children who did not provide these criteria and did not will to participate the study were excluded.

Keywords: duchenne muscular dystrophy lower limb flexibility performance
colonography versus colonoscopy in high risk patient

Conditions: Colorectal Cancer

Summary: to evaluate the acceptability of ct-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.

secondary objective: to evaluate the medical and economic impact of the implementation of ct- colonography in this setting.methodology: prospective multicenter randomized controlled trial with direct patient benefitn° of patients to be included: 600 study follow-up :1 consultation and 3 phone contacts (m1, m6 and m12)evaluation criteria:main endpoint: acceptability of the colorectal cancer screening (% of enrolled patients having actually undergone the exploration)secondary endpoints: - cost/effectiveness ratio of the 2 diagnostic tests with calculation of the economic and medical costs. - number of advanced adenoma detected in each group- number of crc cases detected in each group

Eligibility criteria:
inclusion criteria: surveillance of patients with a personal history of advanced adenoma or crc: * informed consent obtained * age ≥ 18 and ≤ 80 years old * history of advanced adenomatous polyps * or history of non metastatic crc with curative surgery and without other treatment more than 2 years before enrollment. * previous medical examination screening of patients with a family history of crc at high risk: * informed consent obtained * age ≥ 18 and ≤ 80 years old * first degree family history of colorectal cancer diagnosed \<60yrs during the five previous years-previous medical examination exclusion criteria: personal histories * age \ 80 years old * history of non adenomatous polyps * history of metastatic crc * familial adenomatous polyposis, peutz-jeghers syndrome, hereditary non polyposis colorectal cancer (hnpcc), juvenile polyposis syndrome * familial history of familial adenomatous polyposis * personal history of subtotal colectomy (but not of hemicolectomy, to confer to inclusion criteria) * colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment. * enrollment in another protocol * no health insurance affiliation family histories * age \ 80 years old * patients with one or several family histories of first degree colorectal cancer occured to unknown age or diagnosed after 60 years old. * eligible patients having already undergone colonoscopy screening * no health insurance affiliation

Keywords: colorectal advanced adenoma colorectal cancer polypectomy (endoscopic) colectomy colonoscopy with anaesthesia ct-colonography
the effect of methods used in oral antipyretic administration on the vital findings of the child with fever

Conditions: Fever; Heart Rate; Respiratory Rate; Pain

Summary: fever, one of the most common clinical journeys of childhood, makes up a fraction of emergency room admissions. about us-30. high fever, which is one of the first schools in infancy and childhood, can cause health problems such as not applying or starting the intervention. the most preferred method in the fire; antipyretic drug treatment in the hospital is routine . antipyretics play a role in control plans and estimations of facts for cars of cars, the importance of word of mouth has some problems. in children, hospital, health care, injectors are grown from the breeder after completion, they can be created by red supplementation from the effects such as rearing without completion . resistance children; aspiration is risky, wrong dose is administered. it is stated in relation to teachers and verbal medicines for health. hansen et al. working with 61 babies aged 0-24 months, using a pacifier injector and a normal injector, children and temperature monitors. they are from the nipple injector used by mothers and women. there is a need for a new modification in the existing oral drug applications that will be able to support the adaptation and readiness of the child and to be able to effectively administer the drug. this work; two different methods used to give antipyretic (medication pacifier and colored injector) were planned to be performed as pain, fever and purpose of life (respiratory rate, planning cta) for the child.


Eligibility criteria:
inclusion criteria: * applying to the pediatric emergency department with a complaint of high fever (38ºc). * being prescribed an antipyretic (paracetamol) by a physician. * those whose parents are literate and agree to participate in the study. * patients with triage color classification yellow and green. * children between 0-24 months will be included in the study. exclusion criteria: * having used antipyretics in the last 6 hours. * being prescribed an antipyretic other than paracetamol by the physician. * having trouble in sucking-swallowing coordination. * children with chronic disease and neuromotor developmental delay.

Keywords: children, oral medicine, medicine pacifier, injector, antipyretics
effect of intervention with diet and physical activity in obese pregnant women

Conditions: Obesity

Summary: purpose: to evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.

obese pregnant women with a bmi\>30 are randomized to diet + exercise, exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy. the effect on the children of mothers in this study is evaluated in the study: is it possible to reduce the number of macrosomic infants with abundant fat tissue by lifestyle intervention during pregnancy (nct01235676)

Eligibility criteria:
inclusion criteria: * age \>18 years * bmi \> 30 * singleton pregnancy * must speak and understand danish exclusion criteria: * alcohol or drug abuse * diabetes type i or other critical medical disease.

Keywords: obesity pregnancy intervention diet physical activity
face-to-face vs online physical exercise in seniors living in nursing homes (exermot-nh)

Conditions: Physical Function; Cognitive Decline; Psychological Well-Being

Summary: the benefits of multicomponent physical exercise (mpe) in the mental and physical health of older adults are widely accepted. however, during covid19 pandemic, some face-to-face programs for physical exercise were canceled. the situation was particularly complex in nursing homes (nhs) because residents were often confined to their floors and many leisure activities were canceled. online physical exercise sessions increased their popularity during the pandemic. however, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in nhs. the current project aims to assess a synchronous online mpe program's feasibility, acceptability, and effects. with this aim, first a synchronous online mpe intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face mpe, online mpe and control. participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. additionally, those in the intervention groups will also participate in 24-week individualized and progressive mpe programs performed at moderate intensity that will be focused on strength, balance, and endurance. mpe will be performed through supervised sessions (2 per week). one of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. the primary outcomes of the study will be changes in mental and physical health. secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. the dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. a mixed-model ancova will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. the statistical analysis will be performed on the whole sample and separated for sex/gender. the study received ethical approval (m10_2022_405_irazusta astiazaran). the results of this project will be transferred to institutions and entities involved in managing nhs to increase the opportunities for the residents to remain physically active.


Eligibility criteria:
inclusion criteria: * older than 65 years * a score equal to or higher than 15 out of 35 in the mec-35 (miniexamen cognoscitivo) cognitive test * a score equal to or higher than 50 out of 100 in the barthel index * able to stand-up and walk for 10 meters exclusion criteria: * unstable clinical situation * when the potential harms outweigh the benefits, according to the judgment of the healthcare personnel at the nhs

Keywords: physical exercise online nursing homes older adults
does terlipressin improve renal outcome after liver surgery

Conditions: Kidney Failure

Summary: the investigators aim to address whether terlipressin improves the renal outcome after liver surgery. therefore the investigators are planning to conduct a double-blinded randomized control trial. the investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.


Eligibility criteria:
inclusion criteria: * \>=12% risk for post-operative arf on our recently developed and validated prediction score for arf after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial exclusion criteria: * \< 18 years * liver cirrhosis * coronary insufficiency with st-elevation or st-depression in the - - intra-operative ecg as signs of an acute coronary syndrome * pregnancy and breast feed
association of agtr1 and acacb gene polymorphism and diabetic nephropathy in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: india is the "diabetes capital of the world" with 41 million indians having diabetes, with every fifth diabetic in the world being an indian and type 2 diabetes mellitus (t2dm) constitutes the major chunk of diabetes. one of the most severe complications of diabetes is the development of diabetic nephropathy. diabetic nephropathy (dn) is the leading cause of end-stage renal disease (esrd) worldwide. there are many identifiable risk factors of diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the genetic factor is the main among all. long-term observational studies show that nearly 30-35% of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. the regional variation in diabetes prevalence and in the proclivity for diabetes induced renal disease; along with reports of familial clustering of nephropathy suggest a possible genetic basis. the renin-angiotensin system (ras) has been strongly implicated in the pathogenesis of progressive renal diseases. in addition, the blockage of angiotensin ii with either ace inhibitor or an angiotensin type-i receptor antagonist has been found to prevent or delay the progression of renal injury associated with diabetes 5 and now these drugs are first-choice drugs for the treatment of diabetic subjects with hypertension. the genes encoding the renin-angiotensin system (ras), such as angiotensin-converting enzyme (ace), angiotensinogen (agt) and angiotensin ii receptor type 1 (agtr1), have been reported to be the most probable candidate genes for diabetic nephropathy. as there is no data available for agtr1 polymorphism and dn in the north indian t2dm, its out attempt to fill the scientific gap.


Eligibility criteria:
group:-1: patients with diabetic nephropathy inclusion criteria: * type 2 diabetes and duration of more than or equal to 5 years. * age between 30 to 85 years. * presence of both albuminuria and retinopathy. exclusion criteria: * patients with diagnosis of type 1 diabetes * any known nondiabetic renal disease. * patients who had a mi or had undergone cabg within 3 month. * patients who had a cva or had undergone ptca in the previous 3 months. * patients who had had a transient ischemic attack within the previous 3 months. * patients who had any history of heart failure before enrollment. * patients with uti. * pregnant patient. group:-2: patients without diabetic nephropathy same characteristic as group 1 but no evidence of diabetic nephropathy.

Keywords: type 2 diabetes mellitus diabetic nephropathy angiotensin ii type 1 receptor gene polymorphism acetyl coa carboxylase beta gene polymorphism.
an international randomized study to compare spies versus wli

Conditions: Bladder Cancer

Summary: this study is a multicenter randomized controlled trial in which the efficacy between spies assisted and wli assisted turb are compared. subjects in the experimental arm (arm a) will undergo spies assisted turb, whereas subjects in the control arm (arm b) will receive treatment with wli assisted turb only. baseline characteristics will be recorded, as well as short and long-term follow up.

this study is a multicenter randomized controlled trial in which the recurrence rates of cancer between spies assisted and wli assisted turb are compared. randomization is stratified by tumor multiplicity (single or multiple), tumor status (primary or recurrent) and macroscopic findings (papillary or flat, where cis is scored as flat lesion). patients randomized into the experimental arm (arm a) will undergo spies and wli assisted turb, whereas the patients in the control arm (arm b) will undergo wli only assisted turb. wli is chosen as control, since it is considered the gold standard for detecting bladder tumors. short and long term follow up will be recorded in order to evaluate the health gains for patients over a longer period. perioperative (30 days) complications will be compared between the two treatment arms to evaluate the safety of spies.

Eligibility criteria:
inclusion criteria: * has signed informed consent * is scheduled for treatment of a primary or recurrent nmibc * is aged 18 years or older * has or has had no tumors in the upper urinary tract * has had no previous irradiation of the pelvis exclusion criteria: * gross haematuria at the time of turb (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy) * participation in other clinical studies with investigational drugs either concurrently or within the last 30 days * pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (iud) during the treatments and for at least one months thereafter) * conditions associated with a risk of poor protocol compliance * has had instillation therapy in the six months prior to the screening visit
supplementation with beta glucan and adaptative response.

Conditions: Clinical Course

Summary: abstract: studies demonstrate that the use of nutritional supplements containing beta-glucans stimulates the immune system, modulates inflammatory activity, and promotes so-called immune training. beta-glucans are prebiotics that stimulate the growth and activity of gastrointestinal microbiota and inhibit pathogen growth. nutritional intervention is crucial for patients\&#39; positive evolution, and providing a supplement with highly bioavailable nutrients can make a difference in their nutritional, metabolic, and immune status. therefore, the study aims to verify the effectiveness of the innate and adaptive immune response to a nutritionally balanced fermented food, containing oral or enteral beta-glucans, in patients treated at 3 emergency care units in são josé do rio preto, são paulo, brazil. this is a prospective randomized study with a characteristic design involving patients treated in the medical wards of 3 emergency care unit. the following assessments will be conducted: global subjective assessment for adults and mini nutritional assessment for the elderly, sociodemographic, and laboratory evaluation.


Eligibility criteria:
inclusion criteria: patients admitted to the medical clinic ward exclusion criteria: patients unable to swallow
effect of glutamine on intestinal permeability in crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to see whether enteral glutamine supplementation improves intestinal permeability and small intestinal morphology in patients with crohn's disease.

glutamine is the most abundant amino acid in the body constituting 50% to 60% of total free amino acid pool in muscle and 20% in plasma. recently it has been reclassified as a conditionally essential amino acid due to body's inability to synthesize sufficient amount under stressful conditions like trauma and sepsis. it is an essential fuel for fibroblasts, lymphocytes and enterocytes. it plays an important role in nitrogen balance and an integral role in glucose regulation and also in acid base homeostasis. it is an essential ingredient for glutathione, an important antioxidant. during the last decade a number of experimental and clinical studies, by using enteral and parenteral glutamine supplements, have shown its beneficial role in conditions like sepsis and infection, elective surgery and accidental injury, catabolic state, fetal and critically ill low birth weight neonates and cancer. a few experimental and clinical studies have also shown its positive role in inflammatory bowel disease, which is attributed to the effect of glutamine on intestinal permeability, growth of enterocytes, enhancement of gut immunity and glutathione synthesis. so far there is hardly any well-planned randomized trial of enteral glutamine supplements in crohn's disease. hence this study is planned to evaluate effect of enteral glutamine supplements on structure and function of intestine in patients with crohn's disease. diagnosed cases of crohn's disease attending gastroenterology opd or admitted in ward at aiims will be randomized into two groups, glutamine and whey protein group. the parameters for intestinal function and structure tested will be, permeability, villous height, plasma glutamine and d-xylose absorption at the base line and at the end of the intervention. as per the available data improvement is expected in both structure and function of the intestine, which will be an important contribution in the management of this chronic disease.

Eligibility criteria:
inclusion criteria: * all the consecutive patients with crohn's disease in the remission phase with an abnormal intestinal permeability (ip) exclusion criteria: * patients in the active phase of the disease i.e. cdai score \>150 * patients with a normal intestinal permeability i.e. lmr \< 0.0373 * patients already taking a high protein nutritional supplement * patients with other associated systemic diseases like chronic liver disease, chronic kidney disease, diabetes mellitus, malignancy * patients with a special physiologic condition i.e., pregnancy or lactation. * patients lesser than 15 years (pediatric group) and more than 60 years of age (elderly patients)
estimation of pulmonary capillary blood volume in pre- and postcapillary pulmonary hypertension

Conditions: Hypertension Pulmonary

Summary: the aim of the study is to investigate the role of the non-invasive assessment of nitric oxyde (no) diffusion capacity (dlno) in the differential diagnosis of different forms of pulmonary hypertension (ph). dlno alone and in combination with the measurement of carbon monoxide (co) diffusion capacity (dlco) may help to differentiate between pre- and postcapillary forms of pulmonary hypertension. this hypothesis is based on the fact that no has a much higher affinity to hemoglobin as compared to co and may therefore its decrease may more specifically identify the limiting factors between the alveolar space and the lung capillaries including left heart failure (cardiac edema). as there are no available published data yet to answer this question investigators aim to perform a small pilot study. the results of this study may allow the planning of a prospective study.


Eligibility criteria:
inclusion criteria: * patients undergoing right heart catheterization * patients with clear precapillary ph (pawp\ 18mmhg) * signed informed consent exclusion criteria: * patients unable to perform the dlco test