Kornimate/medical-research-clean huggingface dataset:
open-label extension of erydex study iedat-04-2022

Conditions: Ataxia Telangiectasia

Summary: this is an international, multi-center, prospective, open-label, non-comparative study to provide erydex treatment to ataxia telangiectasia (a-t) patients who complete the iedat-04-2022 trial on the neurological effects of erydex on subjects with ataxia telangiectasia (neat trial).

the iedat-05-2024 study aims to provide erydex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the iedat-04-2022 (neat) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. the open-label extension (ole) treatment period will be 12 months. participants will be considered to have completed the study when visit 14 (safety follow-up) has been performed.

Eligibility criteria:
inclusion criteria: * body weight ≥15 kg * participation in iedat-04-2022 study and its completion, including final efficacy and safety assessments exclusion criteria: * safety contraindications for continuation of treatment, as determined by the investigator * clinically significant immune impairment that, in the opinion of the investigator, precludes further treatment with corticosteroids * current neoplastic disease or previous neoplastic disease not in remission for at least 2 years. * requiring treatment with a systemic corticosteroid
aphakia versus pseudophakia in children under 2 years undergoing bilateral congenital cataract surgery

Conditions: Congenital Cataract

Summary: the purpose of this study is to document the safety and efficacy of primary iol implantation in children below 2 years of age undergoing congenital cataract surgery.

the use of iols in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. the refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. nevertheless, the use of iols in children younger than 2 years remains controversial. exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of iols in the first two years of life. further more, there is concern about the unknown risks of an iol over the long life span. currently, there are 3 methods of optical rehabilitation following congenital cataract surgery : 1. primary iol implantation. 2. aphakic glasses. 3. contact lenses. at present, there is no randomized clinical trial reported to document the safety and efficacy of iol implantation in children less than 2 years. aim : to compare the technical outcome (safety) and functional outcome (benefits) following primary iol implantation and aphakia in children less than 2 years.

Eligibility criteria:
inclusion criteria: * children less than 2 years * congenital cataract * bilateral cataracts * iol fixation - bag/ciliary fixated exclusion criteria: * microphthalmos (mean axial length 2 sds less than normal for age) * microcornea (horizontal corneal diameter \<9.5 mm-asper that particular age) * iris coloboma * phpv * aniridia * \*glaucoma - iop more than or equal to 25 mmhg * one eyed * cataract surgery already performed in fellow eye

Keywords: congenital cataract children younger than 2 years aphakia primary iol implantation
evaluation of diagnostic accuracy of ceus for hcc diagnosis

Conditions: Hepatocellular Carcinoma

Summary: this study aims to compare the diagnostic accuracy of contrast-enhanced ultrasound (ceus) for diagnosing hepatocellular carcinoma (hcc) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (mri) using non-invasive diagnostic criteria (american association for the study of liver disease (aasld or liver imaging reporting and data system (li-rads) v2018 and korean liver cancer study group- national cancer center korea (klcsg-ncc) v2018).


Eligibility criteria:
inclusion criteria: * high risk group of developing hcc * hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (ct) * newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (rfa) site or resection margin) in patients with history of hepatic resection or rfa for hcc and in remission more than a year * scheduled for gadoxetic acid-enhanced liver mri * signed informed consent exclusion criteria: * hypersensitivity for ultrasound contrast media * pregnancy * history of recent treatment for hcc in a year * standard of reference is not available * severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)

Keywords: ceus gadoxetic acid mri
study of efficacy and safety of welt-ed for eating disorder (wctp-ed-b-01)

Conditions: Eating Disorders; Binge Eating; Binge-Eating Disorder

Summary: the purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (welt-ed) based on cognitive behavioral therapy (cbt) for the treatment of eating disorders. the main questions it aims to answer are: * is welt-ed as effective as standard treatment in reducing the symptoms of eating disorders? * is the welt-ed safe for use in the target population without causing adverse effects? participants will: * undergo assessments to determine their baseline health status and severity of eating disorder symptoms. * use welt-ed or receive standard treatment as directed for the duration of the study period (8 weeks). * participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.


Eligibility criteria:
inclusion criteria: * adults aged between 19 and 65 years * diagnosed with an eating disorder according to icd-10. f50.0 anorexia nervosa f50.1 atypical anorexia nervosa f50.2 bulimia nervosa f50.3 atypical bulimia nervosa f50.4 overeating associated with other psychological disturbances f50.5 vomiting associated with other psychological disturbances f50.8 other eating disorders f50.9 eating disorder, unspecified) * have a binge eating frequency (as per item 14 of the ede-q) of 4 or more times over the past 4 weeks (28 days) at the time of screening. * able to use a mobile application (app) on a smartphone without difficulty. * after receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent. exclusion criteria: * previously received cognitive behavioral therapy for the treatment of an eating disorder. * have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, roux-en-y gastric bypass). * have a bmi less than 17 kg/m\^2 or more than 40 kg/m\^2 at the time of screening. * diagnosed with a major psychiatric disorder according to the mini. * have a past or current diagnosis of schizophrenia or bipolar disorder. * at risk of suicide (c-ssrs score of 4 or higher) or have attempted suicide in the past 2 weeks. * have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months. * pregnant or planning to become pregnant during the trial period. * participated in another clinical trial within 4 weeks prior to screening. * have a history of alcohol or substance abuse. * considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.

Keywords: digital therapeutics digital cognitive behaviorial therapy app based intervention
effectiveness study of single photon emission computed tomography (spect) versus positron emission tomography (pet) myocardial perfusion imaging

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare pharmacologic stress myocardial perfusion pet with pharmacologic stress myocardial perfusion spect in a near-simultaneous, head-to-head comparison in the same patient. the investigators hypothesize that pharmacologic stress myocardial perfusion pet will prove superior to pharmacologic stress myocardial perfusion spect as a first-line diagnostic test for higher-risk patients with known coronary artery disease (cad) who present with symptoms consistent with possible worsening of their cad.


Eligibility criteria:
inclusion criteria: * history of coronary artery disease * new or worsening symptoms * out-patients and in-hospital patients exclusion criteria: * creatinine above 2.5 mg% * pci within prior 6 months * pregnant females * cardiomyopathy (lvef below 40%) * significant valvular heart disease * body mass index greater than 38

Keywords: myocardial perfusion imaging single photon emission computed tomography positron emission tomography
discovery: a study examining the prevalence of ttr mutations in subjects suspected of having cardiac amyloidosis

Conditions: Familial Amyloidotic Cardiomyopathy (FAC)

Summary: the purpose of this study is to characterize the frequency of ttr mutations in subjects suspected of having cardiac amyloidosis


Eligibility criteria:
inclusion criteria: * males or females \>18 years old * history of evidence suggestive of cardiac amyloidosis * subject is willing and able to comply with protocol required assessments and provide written informed consent exclusion criteria: * known diagnosis of primary (al) amyloidosis * known diagnosis of hereditary cardiomyopathy or cardiomyopathy due to aortic stenosis * patient is currently pregnant

Keywords: cardiomyopathy heart failure fac amyloid transthyretin (ttr)
seroprevalence of covid-19

Conditions: Covid19

Summary: coronavirus disease pandemic has been started in late 2019. since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 september, 2020. . herd immunity is achieved when enough people become immune to a virus to stop its spread. around 70% to 90% of a population needs to be immune to protect the uninfected. in a spanish study of more than 30,000 people estimates that around just 5% of the spanish population has developed antibodies

aims of work: a cross-sectional study to detect the seroprevalence to covid 19 in chronic hemodialysis patients and compare it with the covid 19 seroprevalence in healthy control in sohag governorate egypt methods: after taken informed consent according to sohag university ethical committee a questionnaire on coronavirus symptoms will be asked including epidemiological characters and history of previous covid 19 infection and infection control measures to prevent it 5 ml of the blood sample will be taken for igg antibodies testing with a chemiluminescent microparticle immunoassay.

Eligibility criteria:
inclusion criteria: * patient accept to participate exclusion criteria: * vaccinated people
an epidemiological investigation on correct wearing of mask by hood test

Conditions: Respiratory Infectious Diseases

Summary: the purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. the research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. it is of great significance to covid-19 's practical prevention and control.

1. overall design：this study uses the methods of cross-sectional survey and chance sampling. 2. sign the informed consent form. 3. investigation on the basic situation of personnel: the gender, age and education level of the subjects were analyzed as the factors influencing whether the mask was worn correctly or not. 4. investigation on the types of wearing masks： 1) the types of masks worn by the subjects were recorded as the basis of stratified statistics. 2) mask suitability testing： 1. visual inspection whether the mask is close to the face with obvious gaps. 2. breathing test are there any obvious gaps or whether the cotton around the mask is blown when the subject taking a deep breath. 3. spray test the ft-30 qualitative fitness test system of 3m company was used to test the suitability and correctness of wearing mask. in the spray test, all subjects underwent a sensitivity test to prove their ability to smell the bitterness of the reagent, and then sensitive subjects can participate in the hood test.. in order to objectively reflect the overall situation of the subjects, it is necessary to cover many ages and educational levels of men and women.

Eligibility criteria:
inclusion criteria: 1. healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, persons under the age of 18 need to obtain the consent of their legal guardians； 2. the subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects； 3. people who volunteered to take part in the study； 4. there was no respiratory infection in nearly one month. exclusion criteria: 1. people with a history of allergies, including those who are allergic to pollen, dust mites, etc； 2. people with any history of drug allergy； 3. people who have participated in the experiment are not allowed to participate in this study for the second time; 4. pregnant women； 5. the healer after covid-19 's infection； 6. after questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test； 7. those who are participating in clinical trials of other drugs / devices； 8. subjects with poor compliance or unwilling to cooperate with the operation as required； 9. the researchers believe that any other situation that may affect the evaluation of the study.
exploring the mechanisms of resistance of stem cells myeloproliferative opposite of tyrosine kinase inhibitors in 3d model niche endosteal

Conditions: Myeloproliferative Disorders

Summary: myeloproliferative disorders (mpd) include chronic myeloid leukemia (cml) (ph +) and essential thrombocythemia (et), the polycythemia vera (pv), myelofibrosis (mf) called smp ph. cml is the ultimate model of carcinogenesis. smp is a characterized by a malignant monoclonal proliferation of a pluripotent hematopoietic progenitor determined by the presence of a balanced translocation between chromosomes 9 and 22 (ph chromosome) which leads to major changes of a large number of cell functions. investigators now believe that within the bone marrow exist two types of "hematopoietic niches' niche osteoblastic / endosteal and vascular niche, controlling the maintenance and differentiation of hematopoietic stem cell pool. the endosteal niche, is a hypoxic region near the endosteal trabecular, which provides protection to deeply dormant stem cells. data from the literature suggest that in the smp, especially cml, the interaction of malignant stem cells with the microenvironment niche endosteal could favor their survival and resistance to treatment. the therapeutic management of cml was upset by the use of tyrosine kinase inhibitors (tkis). however, despite these advances, even in situations of undetectable residual disease, it has been observed relapses of the disease stopped tki leaving suggest that there is a resistance of leukemic stem cell to tki. work in the group bipoa "bio engineering and pathophysiology osteo-articular" helped develop a 3d model of ex vivo bone formation, which can mimic the endosteal niche. the goal is to apply this model to the smp of hematopoiesis by referring to normal hematopoiesis. it will be tested the hypothesis that the endosteal ex vivo recess of the 3d modeling allows to highlight a special interaction can promote the persistence of the leukemia stem cell despite the use of effective therapies.


Eligibility criteria:
inclusion criteria: * patients with llc (chronic myeloid leukemia)
a study of the efficacy and safety of pxl770 versus placebo after 12 weeks of treatment in patients with nafld

Conditions: Nonalcoholic Fatty Liver

Summary: this study will assess the efficacy and safety of 3 doses of pxl770 versus placebo after 12 weeks of treatment.

the study will be performed in patients with nonalcoholic fatty liver disease. the primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by mri-pdff).

Eligibility criteria:
inclusion criteria: * patients have given written informed consent * body mass index (bmi) ≥ 25 to ≤ 50 kg/m² * for patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug * estimated glomerular filtration rate (egfr) ≥ 60 ml/\[min\*1.73m²\] * alanine amino transferase (alt) \> 20 iu/l in females and \> 30 iu/l in males * hepatic steatosis (mri-pdff ≥ 10%) * effective contraception for women of child bearing potential exclusion criteria: * evidence of another form of liver disease * evidence of liver cirrhosis * evidence of hepatic impairment * positive serologic evidence of current infectious liver disease * history of excessive alcohol intake * acute cardiovascular disease with 24 weeks prior to screening * uncontrolled high blood pressure * any disease which in the investigator's opinion which in the investigator's opinion would exclude the patient from the study * use of non-permitted concomitant medication * pregnancy or lactation
effects of moderate physical activity on glycemic control in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus.

to the best of authors knowledge so far the studies have been conducted on different modes of moderate physical activity on glycemic control in type 2 diabetes, current study goal is to evaluate which mode of moderate physical activity has more significant result on glycemic control in type 2 diabetes and is sustainable in pakistani society according to the socioeconomic status and cost effectiveness of the modes of moderate physical activity.

Eligibility criteria:
inclusion criteria: * participants falling in this category would be recruited into the study. * male/female * diabetic type 2 patients * age: 30-70 years * bmi \>25 * overweight * fat % in male\> 25 * fat % in female \>35 * hba1c level more than 48mmol/mol or \>6.5% * fasting plasma glucose level \>126 mg/dl (7.0 mmol/l) * random plasma glucose level \>200 mg/dl (11.1 mmol/l) * physically active ( have no mobility problems) exclusion criteria: * participant failing to fall in this category would be excluded of the study. * type 1 diabetes * insulin dependant type 2 diabetes * gestational diabetes * hypertension * cigarette smoking * cardiovascular disease * cerebrovascular disease * cardiopulmonary disorders * cognition problems * peripheral artery disease * dyslipidemia * proliferative or preproliferative retinopathy * nephropathy * neuropathy
the association between pelvic floor muscle function, diastasis recti and postpartum pelvic girdle pain - a matched case control study.

Conditions: Pelvic Girdle Pain; Diastasis Recti and Weakness of the Linea Alba; Pelvic Floor Disorders

Summary: background: pregnancy-related pelvic girdle pain (pgp) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joint (sij). the pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. the endurance capacity for standing, walking, and sitting is diminished. the diagnosis of pgp can be reached after exclusion of lumbar causes. the pain or functional disturbances in relation to pgp must be reproducible by specific clinical tests. lack of accurate and early diagnosis of the pgp postpartum may contribute to development of chronic condition, lowering quality of life years after delivery. there is uncertainty regarding the association between the function of the pelvic floor muscles (pfm), diastasis recti and postpartum pelvic girdle pain (pgp). although widely researched abroad, there is a paucity in research about biopsychosocial profile of women with postpartum pgp in poland. objectives: the aim of this one-to-one matched case-control study it to examine whether there is any difference in pfm function and diastasis recti between women with and without clinically diagnosed pgp. additionally, differences in biopsychosocial profile (depression, anxiety, stress, catastrophizing and kinesiophobia) will be assessed. materials and methods: because of low incidence of researched condition, a case control study will be the study design of choice. women 6-24 weeks after delivery with postpartum pgp will be matched with those with no pgp. subjects' assessment will consist of palpation examination of diastasis recti (inter-recti distance) and pelvic floor muscles. perineometry of the pelvic floor will also be conducted. additionally, several questionnaires for the assessment of mental processing will be used: depression anxiety stress scale 21, pain catastrophizing scale and tampa scale of kinesiophobia. participants will be matched according to age, parity and time postpartum. expected results: to our knowledge, postpartum pelvic girdle pain has not been extensively studied in poland so far. the study will bring information about the possible associations with postpartum pgp. we hypothesize that the study will confirm our clinical observations about pelvic floor dysfunction and maladaptive mental processing in women with postpartum pgp.


Eligibility criteria:
inclusion criteria: * vaginal labour (including vacuum extractor or forceps) or caesarean section * for group with pgp: pain due to pgp * for control group with no pain - no pain due to pgp * agreement to participate exclusion criteria: * diseases that can mimic pgp f.ex. scheuermann disease, rheumatoid arthritis, ehler's-danlos syndrome, hip dysplasia.