Kornimate/medical-research-clean huggingface dataset:
pediatric apple watch study

Conditions: Arrhythmia in Children

Summary: specific aim #1 - to determine the accuracy of apple watch ecg tracings heart rate in children. specific aim #2 - to determine if extended monitoring with the apple watch can identify arrhythmia events that were not detected by short term clinical monitoring.


Eligibility criteria:
inclusion criteria: * all pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring * patients with developmental ability (as determined by patient and parents) to safely wear the apple watch and utilize the patient activated trigger buttons on both the clinical monitor and the apple watch. exclusion criteria: * age \< 6 years. those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor. * inability to effectively utilize the triggered features of the monitor or watch * patients unable to utilize the apple watch.
observational study of people with complete hand amputation using a multi-grip myoelectric prosthesis a following using a standard myoelectric prosthesis

Conditions: Amputation of Upper Limb

Summary: cases of unilateral or bilateral upper limb amputation result in functional and aesthetic disability and a marked deterioration in quality of life. amputees may use no prostheses, or use a combination of cosmetic prostheses, body-powered prostheses, or myoelectric prostheses (mhp). among mhp, there are standard mhps with a single degree of freedom (dof) and one grip type, and multi-grip myoelectric hand (mg-mhp) with multiple dof. amputees who do not use a prosthesis or a cosmetic prosthesis appear to have more difficulties in their daily activities and a greater disability than those who use body powered or myoelectric prostheses. while theoretically a mg-mhp offers the potential for subjects to perform more natural movements than a standard mhp, clinical evidence substantiating the advantages of mg-mhp over standard mhp in daily life remains inconclusive. it remains essential to compare the advantages of mg-mhps versus standard mhps regarding functionality in daily life, quality of life and overall satisfaction among subjects who agree to transition from their standard mhp to a mg-mhp. the primary objective of this study was to assess upper limb function (specifically, the upper limb function component of the orthotics and prosthetics users' survey (opus) questionnaire) provided by a specific mg-mhp, i-limb®, compared to a standard mhp in subjects with complete hand amputation. the subjects participating in the study were patients equipped with mhp, coming to the center for a mg-mhps hand test. if the prescription for the mg-mhps hand was validated, the patient was then followed in the study for 8 to 10 weeks.


Eligibility criteria:
inclusion criteria: * patient aged over 18 years old * patient with a unilateral acquired or congenital complete amputation * patient using a standard myoelectric hand prosthesis for at least 4 weeks * patient who has an indication of a multi-grip myoelectric hand prosthesis , according to a multidisciplinary team exclusion criteria: * pregnant women * patient under guardianship * patient with multiple amputations

Keywords: amputation of upper limb observational study i-limb multi-grip myoelectric hand prosthesis function
pre-probiotic supplementation for post-covid fatigue syndrome

Conditions: Long COVID

Summary: the goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue syndrome.


Eligibility criteria:
inclusion criteria: * age 18 - 65 years * covid-19 positive test within last 3 months (as documented byvalid pcr or antigentest * moderate-to-severe fatigue (20-mfi test total score \> 43.5) * at least one of additional covid-19 related symptoms (anosmia,ageusia,breathingdifficulties,lungpain, body aches, headaches, difficulties concentrating etc.) exclusion criteria: * other pulmonary and cardiovascular conditions * history of dietary supplement use during the past 4 weeks * organic gastrointestinal (gi) disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the gi tract. * bowel surgery or short bowel syndrome. * medication or supplement which can impact the gut microbiome, including: antibiotics, antimicrobials, or antifungals in the two months * probiotic or prebiotic supplements in the last 4 weeks

Keywords: prebiotic probiotic metabolism fatigue
pulmonary disease in patients undergoing hematopoietic stem cell transplantation

Conditions: Post Hematopoietic Stem Cell Transplantation

Summary: this will be a retrospective study and analysis of subjects who have undergone a hematopoietic stem transplant (either at osumc or external location) and were seen at osumc at any time between 01jan2000 and 30jun2011. this study will determine factors influencing pulmonary disease and associated treatment strategies.


Eligibility criteria:
inclusion criteria: * adult patients who have undergone a hematopoietic stem transplant (either at osumc or external location) and were seen at osumc at any time between 01jan2000 and 30jun2011. * age \> 18 years exclusion criteria: * age \<18 years * prisoners
validation of the italian version of the pro-ctcae

Conditions: Malignant Neoplasms

Summary: the aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the italian version of the pro-ctcae in a large group of patients. in particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.

this is a prospective observational study, conducted in italian cancer centers located nationwide. the investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific eortc module has been produced, plus all remaining cancer types classified as "other setting". the study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. enrolled patients will be asked to complete a subset of the pro-ctcae items based on cancer type, and the following instruments used as anchors to measure psychometric properties: * eortc quality of life disease-specific module, if a linguistically validated italian version exists, or the general qlq-c30, if the italian version is not available. * the hospital anxiety and depression scale (hads) * the patients' global impression of change (pgic) scale

Eligibility criteria:
inclusion criteria: * diagnosis of any type of cancer •≥18 years of age. * female or male * with at least two planned clinic visits (a return visit within 3-6 weeks) to avoid the need of extra visits * actively receiving treatment for cancer (going to receive the second or further cycle) * any ecog performance status (ps) * able to complete questionnaire by themselves or with assistance, by using a tablet * able to speak and understand italian * providing informed written consent exclusion criteria: * having any kind of psychiatric disorder or major cognitive dysfunction hampering the provision of informed consent. * having received more than 5lines of therapies * currently participating in other trials which imply the completion of patient reported outcomes (pros) in the same period * other important acute medical conditions.

Keywords: pro-ctcae eortc qlq-c30 or disease-specific questionnaire hads pgic scale performance status quality of life
a study evaluating the efficacy and safety of vx-445/tezacaftor/ivacaftor in cystic fibrosis subjects, homozygous for f508del

Conditions: Cystic Fibrosis

Summary: this study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (elx, vx-445) in triple combination (tc) with tezacaftor (tez) and ivacaftor (iva) in subjects with cystic fibrosis (cf) who are homozygous for f508del.


Eligibility criteria:
key inclusion criteria: * homozygous for the f508del mutation (f/f) * forced expiratory volume in 1 second (fev1) value ≥40% and ≤90% of predicted mean for age, sex, and height key exclusion criteria: * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status * solid organ or hematological transplantation other protocol defined inclusion/exclusion criteria may apply
continuity of care and use of urgent healthcare in multimorbid patients

Conditions: Multimorbidity; Continuity of Care

Summary: chronic disease management is a public health problem that faces monitoring difficulties related to complex care pathways. this study will analyze the use of unscheduled or urgent care according to the continuity of care in multimorbid patients

the prevalence of chronic diseases in the population is increasing significantly. it represents a new challenge for doctors and health authorities. however, patients often have at least two chronic diseases. these are referred to as "multimorbid" patients, whose continuity of care has not been well studied to date. this observational study evaluates the association between the continuity of care in multimorbid patients seen in general practice and their use of urgent healthcare, their quality of life and their burden of treatment.

Eligibility criteria:
inclusion criteria: * over 18 years of age, seen in consultation in the office by an investigating doctor, with a follow-up for more than 12 months in the office, presenting at least two chronic disease , having given their written consent to participate in the study exclusion criteria: * seen at home * unable to respond (cognitive problems or language barrier)

Keywords: continuity of care primary care multimorbidity quality of life
selinexor and haag with/without hma in relapsed/refractory acute leukemia (aml) patients

Conditions: Relapsed/Refractory AML

Summary: the purpose of this study is to evaluate the efficacy and safety of selinexor and haag +/- hma in relapsed/refractory acute leukemia (aml) patients.

this protocol corresponds to a single-center, open-label, single-arm, exploratory study designed to determine the efficacy and safety of the combination of selinexor with haag +/- hma in patients with relapsed or refractory aml. the patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment according to patient's wishes. each cycle of treatment will compromise 2 weeks of selinexor treatment, and at least two weeks off treatment. the new cycle will not start if there is an ongoing grade 3 or higher non-hematologic toxicity or persistent grade 3 neutropenia in patients achieving cr. study design allows 20 patients. treatment will consist of selinexor 60 mg/day orally on d1,4,8,11, hht 1 mg/day intravenously on days 3 to 9, cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9, aclacinomycin 10 mg/day intravenously on days 3 to 6, g-csf 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram, dac 20 mg/m2/day intravenously on days 1 to 5. whether to add hypomethylating agents was decided by the investigator according to the patient's disease degree and tolerance status. if patients had previously been exposed to decitabine, azacitidine will added this regimen, aza 20 mg/m2/day subcutaneously on days 1 to 7.

Eligibility criteria:
inclusion criteria: 1. men and women aged ≥18 years. 2. diagnosis of aml (defined according to the 5th of the world health organization \[who\] 2022 criteria) of any type except for acute promyelocytic leukemia (apl; aml m3)and the following conditions were met: relapsing or refractory aml 3. eastern cooperative oncology group (ecog) performance status of ≤ 2. 4. female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for six months after their last dose of medication. 5. patients whose expecting survival time will be more than 3 months. 6. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. exclusion criteria: 1. aml transformed from chronic myeloid leukemia. 2. patients with apl/aml m3. 3. presence of cns leukemia. 4. uncontrolled infection or other serious disease. 5. unstable cardiovascular function: cardiac ejection fraction (ef)\<0.5, or congestive heart failure (chf) of nyha class ≥ 2. 6. unstable liver and kidney function:tbll≥2.0 mg/dl, ast≥3×uln, ccr≥50 ml/min, spo2\<92%. 7. known human immunodeficiency virus (hiv) infection. 8. active hepatitis b or hepatitis c infection. 9. pregnant and lactating women. patients with other commodities that the investigators considered not suitable for the enrollment.
risk factors of porphyria cutanea tarda (pct)

Conditions: Porphyria Cutanea Tarda

Summary: comparison of patients with documented pct and hcv infection, documented pct without hcv, hcv infection without pct and controls without hcv or pct. single blood + urine sample uptake to investigate : mutations in hfe gene, uroporphyrinogen decarboxylase activity, hcv genotye, history of disease.


Eligibility criteria:
inclusion criteria: * porphyria cutanea tarda /hcv negative porphyria cutanea tarda/ hcv positive hcv positive hcv negative controls

Keywords: porphyria cutanea tarda hepatitis c hemochromatosis
different doses of anti-thymocyte globin to treat child severe aplastic anemia

Conditions: Severe Aplastic Anemia

Summary: severe acquired aplastic anaemia (saa) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. immunosuppressive treatment with antithymocyte globulin (atg)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. however ,there are no clinical trials to illustrate the response and complete remission rate with different doses of atg.and there are no data reported on children with saa so far.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of childhood acquired severe aplastic anemia(saa) exclusion criteria: * clinical diagnosis of no childhood acquired severe aplastic anemia(saa)

Keywords: atg saa immunosuppressive treatment cyclosporine
comparing the expected benefit of extra-corporeal-shockwave therapy (eswt) treatment to standard care in treating diabetic foot ulcers

Conditions: Diabetic Foot

Summary: the purpose of this study is to determine if extra-corporeal-shockwave therapy (eswt) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. diagnosed with diabetes. 3. an active diabetic ulcer larger than 5 cm2 4. sufficient limb perfusion.(e.g no compartment syndrome ankle brachial index (abi)\>=0.5 exclusion criteria: 1. pregnancy. 2. the patient is under another research protocol. 3. one of the following: a. abi\<0.5 c.significant arterial-venous injury. d. lymphedema. 4. the patient underwent chemotherapy or radiotherapy 60 days or less prior to recruitment date. 5. sufficient noncompliant. 6. sickle cell anemia, hiv, immunodeficiency, hgb anemia, dvt, chronic renal failure, systemic use of steroids
factors affecting mortality and morbidity in trauma patients followed in intensive care unit

Conditions: Trauma, Multiple; Trauma Injury

Summary: in this study, the demographic and clinical characteristics of trauma patients followed up in the intensive care unit of the anesthesiology and reanimation clinic of the health sciences university okmeydanı training and research hospital for a 2-year period were evaluated prospectively to determine the morbidity and mortality rates and to determine the factors affecting these rates. data.

trauma is an important health problem that causes increased morbidity and mortality. most of the patients are taken into intensive care and followed up in intensive care with severe and multitrauma and constitute an important part of the critical diseases followed in the intensive care unit. at the same time, these fatal injuries cause a serious public health problem both economically and socially. according to world health organization data, 5.8 million people die each year due to trauma. trauma is seen more frequently at a young age and the most common cause is motor vehicle accidents and it is the first cause of death between 1-44 years. there is a strong relationship between deaths caused by trauma and factors such as age, gender, cause of trauma, and trauma area. in addition, the duration of icu and mechanical ventilator stay, supportive treatments, trauma scores, and scores such as apache 2 and sofa routinely used in intensive care have been shown to be strongly associated with mortality. therefore, the demographic data, trauma scores, mechanical ventilator requirement, renal failure, inotropic need, intensive care scores such as apache 2, sofa, re-operation, re-operation, intensive care stay, blood replacement need, wound infection and morbidity and mortality in trauma patients will be effective.

Eligibility criteria:
inclusion criteria: * trauma patients followed up in the intensive care unit between 14 october 2019 and 15 october 2021 * all trauma patients over the age of 18 who signed the informed consent form and agreed to participate in the trial exclusion criteria: * patients under the age of 18 * patients who refused to participate in the study * non-traumatic patients

Keywords: trauma mortality morbidity
evaluation of the pharmacokinetic profile, pharmacodynamic effects, acceptability and tolerability of an oral amiodarone solution of 15 mg / ml in children with supra ventricular tachycardia

Conditions: Supraventricular Tachycardia

Summary: the supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics. amiodarone is an antiarrhythmic drug used in this indication. pharmacokinetic, efficacy and safety data are not known in the pediatric population due to the lack of a suitable specialty available on the market. the development of an amiodarone oral solution formulation adapted to this age group should provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy, acceptability and tolerability of the drug.


Eligibility criteria:
inclusion criteria: * child (boy or girl) with supra ventricular tachycardia diagnosed by ecg recording. * child aged 0 to 11 years. * child whose parents / legal representative (s) agree to sign a consent form. * child whose opinion / agreement has been / has been attempted to be collected. * child and parents / legal representative (s) being ready and able to participate in the study, understanding and committing to respect the procedures of the study throughout its duration. * child enrolled in a social security scheme. * child with a body mass index between the 3rd and the 97th percentile. exclusion criteria: * a child with a known hypersensitivity to the active ingredient, iodine or any of the excipients of the study formulation. * child who has already been treated with amiodarone (as a capsule or with the oral injectable form) * impossibility of taking blood samples. * hyperthyroidism (tsh \<laboratory low standard). * disruption of liver function (asat\> 3n and / or alt\> 3n). * renal impairment (cl creat \<30 ml / min) * hepatic insufficiency (tp or factor v \<70%) * inotropic support. * uncorrected severe ionic disorders. * extension of the qtc space before the implementation of the treatment (\> 450 ms). * non-paired sinus disease. * concomitant treatment with a drug which has an absolute contraindication with amiodarone. * child with gastrointestinal disorders such as malabsorption syndrome. * weight \<2.5 kg. * child whose mother was treated with amiodarone during pregnancy. * child who received another product under investigation or participated in another study within 60 days of the start of this study.
a research study of how different doses of a new medicine nnc0148-0287 c (insulin 287) work on the blood sugar in people with type 1 diabetes when it is taken once a week

Conditions: Diabetes Mellitus, Type 1

Summary: this study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. the study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. the participant will get both of the insulins in a random order. insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. the participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. there will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. all doses will be injected under the skin. the study will last for about 16 to 24 weeks. the participant will have 27 visits with the study doctor.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * current daily basal insulin treatment greater than or equal to 0.2 u/kg/day * body mass index between 18.5 and 29.0 kg/m\^2 (both inclusive) * hba1c less than or equal to 9.0% exclusion criteria: * history or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) * known or suspected hypersensitivity to trial products or related products