Kornimate/medical-research-clean huggingface dataset:
effect of oral magnesium supplementation on type ii diabetes mellitus guided by serum ionized magnesium level

Conditions: Type 2 Diabetes; Magnesium Disorder

Summary: studies have shown that type 2 diabetic patients (t2dm) may have low serum magnesium levels leading to poor control and outcome of the disease. supplementation with mg might improve overall diabetic control and disease outcome. however, there is yet no consensus on whether the ionized (img) or the total mg (tmg) level should be used as a basis to determine the status of mg in the blood. recently it was shown that img may correlate better with diabetes control than tmg. therefore, mg supplements to diabetic patients may improve their disease status. unfortunately, and to the best of our knowledge all of the available trials on mg supplementation guided by img levels were conducted on healthy volunteers rather than t2dm patients, and they were all for a short period of time (10 days to 10 weeks). here we hypothesize that supplementations of t2dm patients with mg based on serum img levels correlate better with diabetes control and prognosis. such hypothesis is supported by a retrospective study that concluded that img correlate better with bp control than tmg. in addition, another trial that investigated the effects of three mg dietary supplements; mg oxide, mg citrate and mg carbonate on healthy female young adults, showed that only mg oxide led to an increase in the levels of img and tmg concentrations when compared to baseline. furthermore, a case-control study on older diabetic patients revealed a significant association between img and hba1c. this study aims to investigate the effect of supplementing mg oxide tablets versus placebo tablets guided by serum img levels in t2dm patients with or without hypomagnesemia on diabetic control and prognosis.


Eligibility criteria:
inclusion criteria: * adults (≥18 years old). * treated with oral hypoglycemic agents (oha) ± insulin regimen. * had hba1c ≥ 7% in the last 3 months exclusion criteria: * hba1c of \< 7%. * fully dependent patients as per clinical frailty score * end stage renal disease (creatinine clearances (crcl) at \< 10ml/min) * with neuromuscular disease * with active solid or hematological malignancies. * with cognitive disorders. * with the following regular medications (baloxavir marboxil, calcium/sodium polystyrene sulfate, raltegravir, or unithiol) due to x category drug-drug interaction (contraindicated combinations) when given concurrently mg oxide
respiratory trends during blood transfusions in newborns.

Conditions: Blood Transfusion Complication; Blood Transfusion Associated Adverse Reactions; Respiratory Complication; Respiratory Morbidity

Summary: the prevalence of transfusion reactions is between 1 and 11% of transfusions. most reactions are mild and do not pose a life-threatening risk to the patient. more serious problems may be the only manifestations that lead to suspicion of a transfusion reaction. most noninfectious transfusion reactions are immune-mediated. two main types of reactions can be distinguished: taco (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and trali (transfusion related acute lung injury, non-cardiogenic pulmonary edema). although trali are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. other signs of trali are hypotension and tachycardia, while in taco arterial hypertension with positive water balance can be observed. according to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. factors associated with these reactions are low birth weight and low gestational age. however, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used. therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.


Eligibility criteria:
inclusion criteria: * admitted newborns requiring blood transfusions as per local practice and/or international guidelines exclusion criteria: * newborns with major malformations * need for palliative care * lack of informed consent
the effects of exercise on behavior and fitness in children with asd

Conditions: Autism Spectrum Disorder; Behavior

Summary: this study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism.

this study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism. local primary schools who have an autism spectrum disorder (asd) class will be approached to participate in the project. the age profile of the children will be 4-12 years of age and they will have mild-sever levels of autism. the exercise intervention programme will be delivered 3 times per week in the schools over an 8 week period. children will be fitness tested to assess the change in fitness levels over the 8 week period. questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in behaviour levels as a result of the exercise intervention programme.

Eligibility criteria:
inclusion criteria: • diagnosis of autism spectrum disorder exclusion criteria: • any medical condition which excludes the child from partaking in exercise
"nuance hearing" for attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aim of the current study is to examine whether the ability to avoid irrelevant auditory stimuli and focus hearing, enabled by the device developed by "nuance hearing", may help students with adhd in classroom listening situations by significantly reducing background distractions.


Eligibility criteria:
inclusion criteria: * diagnosis of attention deficit hyperactivity disorder (adhd) according to diagnostic and statistical manual of mental disorders, 5th edition (dsm iv) * have fulfilled the "test of variables of attention" * with normal hearing exclusion criteria: * moderate to severe co-morbid psychiatric disorders * neurological chronic disease

Keywords: attention deficit/hyperactivity disorder
feasibility of non-invasive glucose monitoring by using photothermal deflectometry

Conditions: Diabetes Mellitus Type 2; Diabetes Mellitus Type 1; Healthy

Summary: this study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

the investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form). the clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. at least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 or type 2 diabetes or no diabetes * for subjects with diabetes: glycated haemoglobin (hba1c) \<10% * age ≥ 18 years * male or female or diverse * an understanding of and willingness to follow the protocol * signed informed consent exclusion criteria: * severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment * hypoglycemia unawareness * have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for freestyle libre 3) that could interfere with the accuracy of glucose measurements. * female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy) * serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection * severe diabetes related complications (i.e. macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy * known severe tape reactions or allergies * any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse * not able to understand, write or read german * dependency from the sponsor or the clinical investigator

Keywords: non-invasive glucose monitoring photothermal deflectometry
translational and clinical aspects of metabolic, anabolic and endothelial dysfunction in heart failure

Conditions: Heart Failure With Reduced Ejection Fraction HFrEF

Summary: in patients with hf cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion

in patients with hf cardiac output, metabolism and endothelial function will be studied during and after treatment with ghrelin infusion (single dose). the following parameters will be collected: routine clinical parameters, endothelial function, cardiac structure and function by echocardiography, non-invasively assessed cardiac output and hemodynamics, serologic and of cardiac and renal function, sympathetic and ras activation, metabolism, anabolic hormone function, inflammation, fibrosis, oxidative stress and apoptosis. 15 patients each group in are adequate to detect a difference between groups and before vs after ghrelin administration in metabolism, anabolic function and endothelial function with a power of 90% and two-sided significance of 5%.

Eligibility criteria:
inclusion criteria: 1. current or past signs of clinical hf according to the framingham criteria 2. lvef\<40% 3. nt-probnp \> 300 ng/l exclusion criteria: 1. inability to or unwillingness to provide informed consent, 2. participation in research study that involves research drug administration or contraindication to any of the clinically indicated procedures.

Keywords: cardiac output
safety and efficacy of desferasirox in chinese patients with iron overload and aplastic anemia

Conditions: Iron Overload

Summary: the study is designed to collect safety and efficacy of desferasirox in chinese patients with iron overload and aplastic anemia.


Eligibility criteria:
inclusion criteria: * patients presenting with transfusion-related iol as shown by a sf level of ≥ 1000 ng/ml at start of study * history of transfusion \>20 international units or 100 ml/kg of red blood cells * underlying transfusion-dependent illness: * aa: clinically diagnosed aa with bone marrow confirmation of the diagnosis * age ≥ 18 years, male or female * written informed consent obtained from patient prior to any screening procedures. exclusion criteria: * patients with serum creatinine \> uln or with significant proteinuria as indicated by a urinary protein/creatinine ratio (upcr) ≥ 1.0 mg/mg in a non-first void urine sample at baseline. if serum creatinine is found to be \> uln or upcr is found to be ≥ 1 mg/mg the test can be repeated after 1 month. * creatinine clearance \<40 ml/min * patients with other than aa transfusion-dependent underlying illnesses * patients with a previous history of clinically relevant ocular and/or auditory toxicity related to iron chelation * any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. the investigator should be guided by evidence of any of the following: * history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding * history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection * history of pancreatic injury or pancreatitis; indications of impaired pancreatic function/injury as indicated by abnormal lipase or amylase * history or presence of impaired renal function as indicated by creatinine or blood urea nitrogen (bun) values equal or above uln * history of urinary obstruction or difficulty in voiding other protocol-defined inclusion/exclusion criteria may apply

Keywords: phase 4 desferasirox iron overload aplastic anemia
evaluation of three ss-oct and one pci optical biometers in eyes with dense cataract

Conditions: Optical Biometer, Cataracts

Summary: to describe and compare the acquisition rate between different biometers in eyes with advanced cataracts

to describe and compare the acquisition rate between different biometers in eyes with advanced cataracts

Eligibility criteria:
inclusion criteria: * locs iii cataract classification with a grade of ≥3 for nuclear, cortical or posterior subcapsular. * dli index, from the itrace device, should be ≤ 5. exclusion criteria: * previous continuous contact lens wear * ocular trauma * intraocular lens surgery * poor fixation * corneal disease (i.e. keratoconus)

Keywords: optical biometer, cataracts
docicar: cardiac dysfunction in cirrhosis

Conditions: Cirrhosis; Cirrhotic Cardiomyopathy

Summary: patients with cirrhosis have a altered cardiac response to stress. this study evaluate the cardiac response by mri during dobutamine stress. hypothesis: impared increase in cardiac output, cardiac index, ejection fraction.


Eligibility criteria:
inclusion criteria: * non alkoholic cirrhosis exclusion criteria: * coma hepaticum * primary cardiac diseases
regular use tiotropium and tolerance to bronchoprotection in mild asthma

Conditions: Asthma

Summary: the study will assess if regular use of tiotropium (i.e. daily) results in loss of bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma.

a single dose of an inhaled muscarinic antagonist will protect against methacholine induced bronchoconstriction and increase the dose of methacholine required to cause bronchoconstriction about 4 doubling doses. beta agonist bronchodilators also shift the dose response curve to the right but the protection against methacholine induced bronchoconstriction is lost (i.e. tolerance develops) with regular use. this study will determine if bronchoprotection is lost following regular use of tiotropium. this will be a randomized, double-blind placebo controlled study to assess the development of tolerance following regular use of tiotroium in a population of mild asthmatics. tiotropium will be administered at the clinically recommended dose (5mcg/day) for a total of 8 days. methacholine challenges will be performed at baseline (pre-treatment), at one hour post first dose and on day 8, one hour after the final dose. the same will dosing schedule and assessments will occur with an identical placebo inhaler.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma * asthma is currently well controlled using only occasional bronchodilators * baseline lung function (fev1) is greater than 65% of the predicted value * exhibit bronchoconstriction to inhaled methacholine at a dose of 200mcg or less exclusion criteria: * women who are pregnant or breastfeeding. * diagnosis of another lung condition or medical condition that would pose a risk to the participant if enrolled in the study * current smokers of nicotine products (e.g., cigarettes). * users of cannabis or other inhaled recreational products (e.g., e-cigarettes or other vaping products) on a daily basis * respiratory infection within 4 weeks of entering the study * use of any anticholinergic agent within 30 days prior to the beginning of the study (e.g., ipratropium or the study treatment tiotropium). * known hypersensitivity to tiotropium bromide or components of tiotropium formulation (e.g., benzalkonium chloride), to atropine or its derivatives.

Keywords: tiotropium bronchoprotection tolerance methacholine pd20
clinical intervention of idecalcitol combined with whey protein powder and exercise for sarcopenia

Conditions: Sarcopenia

Summary: this clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. after enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. the experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. the experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. the entire intervention period lasted for 24 weeks. through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.


Eligibility criteria:
inclusion criteria: * age 30 or above; * meeting the diagnostic criteria for sarcopenia according to the definition of awgs; ③ able to walk, willing to accept a comprehensive intervention plan, and guarantee to complete the treatment course; ④ both patients and their families agree to participate in this study and sign the informed consent form. exclusion criteria: * resting systolic blood pressure \> 200 mmhg or resting diastolic blood pressure \> 100 mmhg; * severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia; * acute stroke within the past 2 years; * severe airway obstruction; * lower limb fractures in the past 1 year or upper limb fractures in the past 6 months; * hypercalcemia (corrected albumin serum calcium \> 2.60 mmol/l); * active malignant tumors; ⑧ chronic kidney disease stages 5; * mental illness or severe cognitive impairment; * long-term immobilization; ⑪ other diseases that may interfere with the evaluation of muscle mass, muscle strength, and physical function; ⑫ unable to cooperate with treatment due to other reasons; ⑬ life expectancy less than 6 months.

Keywords: sarcopenia intervention idecalcitol whey protein powder exercise
carboplatin, paclitaxel, and temozolomide for patients with metastatic melanoma

Conditions: Melanoma

Summary: the number of melanoma cases has been steadily increasing over the past few decades. for many patients with metastatic melanoma, there are no effective therapies. the goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. the rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. specifically, a previous phase i study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. the efficacy of this combination is now being studied in this phase ii trial.

Eligibility criteria:
inclusion criteria: * all patients with biopsy proven advanced melanoma are eligible if there is measurable disease. * patients must have a life expectancy of at least 12 weeks. * prior surgery, immunotherapy, minimal chemotherapy (1 drug for less than 4 months), or radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks from study entry, and patient should have completely recovered from such procedures. * patients must have a zubrod performance status of 0-2. * patients must sign an informed consent. * patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1500 cells/mm3, hemoglobin \> 8 g/dl, platelet count ≥ 100 000/mm3. * patients should have a normal hepatic function with a total bilirubin \< 1.5 the upper limit of normal (uln) and serum glutamic oxaloacetic transaminase (sgot) or serum glutamic-pyruvic transaminase (sgpt) \< 2 times the upper limit of normal (uln),and adequate renal function as defined by a serum creatinine ≤ 1.5 times the uln. * men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and at least for 3 months. * patients with brain metastases are eligible if they have been appropriately treated, are asymptomatic exclusion criteria: * pregnant women or nursing mothers are not eligible. * patients must not receive any other concurrent chemotherapy or radiation during this trial. * patients with severe medical problems that would interfere with the therapy are not eligible.

Keywords: metastatic melanoma skin cancer paclitaxel carboplatin temozolomide
the effect of mechanical ventilation on the occurrence of myocardial ischemia: a pilot study

Conditions: Myocardial Ischemia; Hypoxia

Summary: the goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-cabg. additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-cabg.

cabg is the most effective therapy for patients suffering from coronary artery disease, a condition which annually affects 126 million people worldwide. during this surgery, cardiopulmonary bypass (cpb) takes over the function of the heart and lungs. as a result of the emergence of minimally invasive cardiac surgery (mics) (e.g. endoscopic-cabg), peripheral cpb with femoral arterial cannulation became the most commonly utilized strategy. however, the use of retrograde arterial perfusion is not without risk. it may result in the upper body and coronary arteries being perfused with deoxygenated blood. the hypoxemia will induce myocardial ischemia and this can harm the cardiac myocytes. a solution for this inconvenience is still lacking. literature reports that establishing adequate ventilation support should help overcome this phenomenon. however, this approach has not yet been investigated in a clinical trial. in general, this phenomenon is not well recognized in the typical surgical setting, and limited research has been done. the goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-cabg. additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-cabg.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * patients undergoing their first elective endo-cabg procedure * patients capable of signing the informed consent * patients able to speak dutch or french exclusion criteria: * ongoing participation in another trial * ejection fraction \< 50% * lung diseases (copd, asthma) * use of corticosteroids

Keywords: cardiac surgery ventilation