Kornimate/medical-research-clean huggingface dataset:
myocardial injury and quality of life after covid-19

Conditions: COVID-19; Myocardial Injury; Myocarditis Post Infection

Summary: in this observational study follow-up and dynamic observation will be conducted on the participants recovered from pneumonia caused by covid-19. the main goal is an early diagnosis and detection of myocardial (heart) injury and quality of life in participants recovered from covid-19 and follow-up in selected participants with present signs of myocarditis and/or myocardial fibrosis.

the main goal of this observational non-interventional study is the evaluation of prevalence of myocardial injury (heart injury) of the participants recovered from the novel coronavirus infectious disease (covid-19). participants with signs of myocarditis (pericarditis) and/or myocardial fibrosis, and with a threat of heart failure development and other outcomes are selected into this study. in this cohort the percentage of participants having myocardial injury based on the level of high-sensitivity troponin, echocardiography (decreased left ventricle ejection fraction, abnormalities of wall motion, right ventricle dysfunction, increased size of heart chambers above referential values, presence of pericardial effusion), cardiac mri with contrast enhancement (presence of edema on t2-weighted images, presence of early and late gadolinium enhancement phenomenon, local motion abnormalities, increased size of heart chambers above referential values, presence of pericardial effusion). at 6 months of the dynamic follow-up, mri with contrast enhancement will be repeated in the participants with established myocardial injury at inclusion to assess the percentage of the participants having ongoing myocardial injury. the secondary goal of the study is evaluation of quality of life of the patients recovered from the novel coronavirus infectious disease (covid-19) by the means of eq-5d and/or dasi questionnaire using the descriptive system of 5 components of quality of life related to the wellbeing, and visual analogue scale.

Eligibility criteria:
inclusion criteria: * adult patients of age above 18 years with diagnosed sars-cov-2 infection based on the pcr (polymerase chain reaction) and/or quantitative tests of igm and igg antibodies in serum; * pneumonia development confirmed by chest computed tomography; * negative pcr test for sars-cov-2 at the time of inclusion into the study; * stable patient state allowing outpatient follow-up; * signed informed consent. exclusion criteria: * absence of convincing data confirming sars-cov-2 infection of a participant at the time of inclusion; * absence of medical records regarding previous treatment of covid-19; * low compliance and unwillingness to undergo defined examinations; * absence of informed consent.

Keywords: covid-9 myocardial injury myocarditis
multiple-dose pharmacokinetics study of tolvaptan tablets in chinese patients with hepatocirrhosis

Conditions: Hepatic Cirrhosis; Ascites

Summary: for hepatic cirrhosis subjects with ascites or lower extremities, to study pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

this study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in chinese adult patients with confirmed child-pugh class b（score 7-9） hepatocirrhosis (accompanied by ascites). trial design: 1. open, single-center, multi-dose pharmacokinetics study 2. study population: chinese adult patients with confirmed child-pugh class b (score 7-9) hepatocirrhosis (accompanied by ascites) 3. dosage and mode of administration of investigational product: oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment. 4. study duration: screening: 14 days in maximum; treatment(s): 7 days; observation: 1 day

Eligibility criteria:
inclusion criteria: 1. hepatic cirrhosis with ascites or lower extremities edema 2. hospitalized patients 3. 18 years old\~75 years old 4. inform consent form signed exclusion criteria: 1. patients with any of the following diseases, complications or symptoms: * hepatic encephalopathy (coma degree classification note 1 grade 2 or above); * malignant ascites; * spontaneous bacterial peritonitis; * likely to have gastrointestinal bleeding during the study period; * heart failure (nyha note 2 class ⅲ andⅳ); * anuria (daily urine output below 100ml); * dysuria induced by urinary tract stenosis, calculus, or tumor. 2. patients with any of the following history: * with gastrointestinal bleeding within 10 days prior to screening; * with cerebrovascular accident within 1 month prior to screening; * with gout attack within 1 month prior to screening; * with allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.). 3. patients whose systolic blood pressure is below 90mmhg during screening; 4. patients with abnormal values in the following lab examination indicators: serum creatinine higher than 2.5 times the upper limit of normal range, serum na+\>145mmol/l(or higher than the upper limit of normal range), serum k+\> 5.5 mmol/l, uric acid\>476µmol/l, child-pugh score\>10 5. patients ineligible for oral medication 6. patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures; 7. patients having taken blood products including albumin products within 4 days prior to application of investigational product; 8. patients having participated in clinical trials of other drugs within 1 month prior to screening; 9. patients used to participate in clinical trials of tolvaptan and take the said drug; 10. patients determined by the investigator as illegible for the study.

Keywords: hepatic cirrhosis patients with ascites
umbilical cord blood-derived mesenchymal stem cells in regeneration of sweat glands and body repair

Conditions: Sweat Gland Diseases

Summary: patients with skin injury treated with umbilical cord blood-derived mesenchymal stem cells,such as deep burn damaged sweat glands,effectiveness of umbilical cord blood-derived mesenchymal stem cells in regeneration of sweat glands and body repair is determined.


Eligibility criteria:
inclusion criteria: * burn area:10-20％tbsa exclusion criteria: * have influence on the speed of wound healing of patients with chronic diseases
outcomes of severe osteoporotic fractures hospitalized in france: the cross cohort

Conditions: Severe Fragility Fracture

Summary: the purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in france, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.

in france, the burden of osteoporotic fractures has been studied using cross sectional data from the french hospital national database. the availability of fracture liaison service in the main french cities allows the recruitment of a high number of these targeted patients. a large national multicenter, longitudinal, prospective cohort of patients hospitalized for severe osteoporotic fracture, the cross cohort ("cohorte sur les risques d'une ostéoporose sévère"), in order to update data on prognosis (refracture, mortality), epidemiology and of severe osteoporotic fractures.

Eligibility criteria:
inclusion criteria: * men and women aged above 60 years, living in france and hospitalized for severe fragility fractures in response to low-energy trauma (e.g., a fall from standing height). * vertebral fractures have to be confirmed by an x ray examination. * to be eligible for the study the patient has to be included and interviewed within 12 weeks of the fracture event's diagnosis. note : patients in guardianship or curatorship can be included in this protocol. * informed and free consent given and form signed and dated exclusion criteria: * non severe fracture (for example wrist fracture), pathological fractures, high trauma fractures and per prosthetic fractures. * non registration with a social security scheme (holder or beneficiary).
a study of gzr18 injection in obese/overweight patients

Conditions: Obesity; Overweight

Summary: this study is a multicenter, randomized, placebo-controlled phase ii clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of gzr18 injection in chinese adult obese/overweight subjects.


Eligibility criteria:
* inclusion criteria: 1. male or female aged 18-65 years (inclusive). 2. obese subjects (bmi≥28 kg/m2), or overweight subjects (24 kg/m2≤bmi\<28 kg/m2) with at least one comorbidity. 3. able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the icf voluntarily. * exclusion criteria: 1. limb deformities or defects affecting height and body weight measurement. 2. pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug. 3. history of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization. 4. alcohol abuse history within 6 months prior to screening. 5. subjects who are known or suspected to be allergic to glp-1 drugs or excipients. 6. subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.
study of the myoscience tissue remodeling device for facial rejuvenation

Conditions: Facial Rhytides

Summary: a prospective, non-randomized study to evaluate the performance of the myoscience tissue remodeling device for the treatment of glabellar lines (frown lines), lateral orbital lines (crow's feet), and frontalis lines (horizontal forehead lines).


Eligibility criteria:
inclusion criteria: * the subject must be a female 30 to 70 years of age. * the subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity. * the subject must have a wrinkle rating of at least "1" at rest in one or more of the following treatment areas (glabellar, lateral orbital, or frontalis). * the subject must have signed an informed consent form. * the subject should not have undergone any other facial cosmetic procedures at or above the level of the cheekbones within the past 6 months. * the subject should not be participating in any other facial cosmetic research study. exclusion criteria: * the subject is on a regular regimen of prescribed or over-the-counter anticoagulants. * the subject has an infection or skin problem at the injection site. * the subject has a history of facial nerve palsy. * the subject has marked facial asymmetry. * the subject has ptosis. * the subject has excessive dermatochalasis. * the subject has deep dermal scarring. * the subject has thick sebaceous skin. * the investigator is unable to substantially lessen facial lines by physical separation. * the subject has a history of neuromuscular disorder. * the subject has undergone prior surgery that alters the subcutaneous anatomy of the areas being treated. * subjects with laxity of the canthal tendon and/or with lower lid retraction, and subjects who recruit their zygomaticus major muscle to animate their crow's feet. * the subject has any physical or psychiatric condition that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.
vulnerability/resilience factors influencing the developmental trajectories and adaptive methods of children and adolescents in child welfare system.

Conditions: Behavior, Child; Child Development; Child Development Disorder; Adolescent Development; Adolescent Behavior; Child Mental Disorder; Child Behavior Disorders; Adolescent - Emotional Problem

Summary: assess the prevalence of medico-psychological characteristics at the time of placement (m0), their appearance / disappearance and during the two years following placement (m12 and m24) by age group in children / adolescents in child protective services and placed full-time in the structures of seine-maritime and eure as well as in nursery in le havre or rouen


Eligibility criteria:
inclusion criteria: * minor adressed to child protective services * minor placed full time exclusion criteria: * non affiliation to social security system * non accompanied minor * minor and/or parfents not understanding french * minor informed and refused participation * parents or tutor having refused participation of their child

Keywords: child preschool adolescent psychiatry psychology child protective services social sciences child protection social services psychiatric disorders attachement developmental trajectories
the effect of tele-health education provided in the postpartum period in the covid 19 pandemic

Conditions: Postpartum Depression; Anxiety State

Summary: in the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.

in the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.

Eligibility criteria:
inclusion criteria * literate * giving birth at term (between 38-42 weeks of gestation) * being on the 7th postpartum day, * participation in the study is voluntary, * absence of any psychiatric illness, * women who have characteristics such as not using any psychiatric medication. * baby with normal birth weight and apgar score of 8 and above * those who have not developed postpartum complications * speaks and understands turkish exclusion criteria: women who do not meet the sample selection criteria -

Keywords: postpartum depression mother-baby attachment anxiety
role of b mode and color doppler sonography in differentiation between pleural neoplasm and inflammatory pleural thickening in correlation with ct findings

Conditions: Pleural Thickening

Summary: pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm. there is malignant thickening : methoselioma, metastasis and non malignant thickening. trans thoracic usn is a reliable , safe and gold standard for studying pleura.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed as having pleural thickening with or without pleural effusion. exclusion criteria: * emphysema or contraindication to pleural biopsy
pregnancy outcomes and medical costs according to gestational diabetes mellitus diagnostic criteria

Conditions: Gestational Diabetes

Summary: the aim of the study is to evaluate differences in pregnancy outcomes and medical costs depending on gestational diabetes diagnostic criteria used (one vs two-step approach).

due to hyperglycemia and adverse pregnancy outcomes study results, a new gestational diabetes mellitus (gdm) diagnostic criteria was defined using a one-step approach (75-g oral glucose tolerance test -ogtt-). however, not all scientific societies have accepted and have implanted this new diagnostic criteria. the lowest glycemia cut-off of this criteria regarding the two-step approach entails an increase in gdm incidence with discordant studies about its cost-effectivity. it will be assessed if pregnancy outcomes and medical costs are different depending on diagnostic criteria used.

Eligibility criteria:
inclusion criteria: * age 18-50 years * no expectation that subject will be moving out of the area of the clinical center during the next year * informed consent form signed by the subject exclusion criteria: * preexisting type 1 or 2 diabetes * advanced hiv( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucose solution.
cardiovascular complications and covid-19 (covcardiovasc-study)

Conditions: COVID; Acute Coronary Syndrome; Myocardial Infarction; Myocarditis; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Summary: patients with covid-19 in the intensive care unit (icu) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). they present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. high levels of ddimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with covid-19 management.


Eligibility criteria:
inclusion criteria: - all consecutive patients with covid-19 infection admitted to the icu or hospitalized because of severe form (eg: hypoxia, orthopnea, pneumonitis, kidney insufficiency) will be included exclusion criteria: - patients under 18 years
consultatm crt-d clinical evaluation study

Conditions: Tachyarrhythmias; Heart Failure; Ventricular Dysfunction

Summary: the purpose of the consulta clinical study is to evaluate the overall system safety and clinical performance of the consulta implantable cardioverter defibrillator with cardiac resynchronization therapy (crt-d).

the consulta crt-d is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy. the study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers. to allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the consulta device. data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, system modifications, technical observations, study deviations, study exit, upon notification of new or updated adverse events and in case of death.

Eligibility criteria:
inclusion criteria: * patients who have an indication for a defibrillator. * patients who are optimally treated with medication. * patients who are new york heart association (nyha) class iii or iv exclusion criteria: * patients with a life expectancy less than the duration of the study. * patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients. * patients with mechanical tricuspid heart valves.
randomized, controlled trial of endoscopic ultrasound-guided bilateral celiac plexus neurolysis vs celiac ganglia neurolysis to control pain in inoperable pancreatic cancer patients with inadequate pain control by pain killer

Conditions: Pancreatic Neoplasms

Summary: pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. so eus-cpn(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. so it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. this more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. to evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of eus-cgn(endoscopic ultrasound guided celiac ganglia neurolysis) vs. bilateral eus-cpn(endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.


Eligibility criteria:
inclusion criteria: 1. at least 19 years old age (above 70 years old age, need the consent of the legal representative) 2. inoperable pancreatic cancer patients 3. pancreatic cancer patients with inadequate pain control by pain killer (vas score 4 points or more) 4. patient who agree to participate in this study exclusion criteria: 1. abnormal clotting (international normalized ratio ≥1.5) 2. reduced platelet count (≤50000/μl) 3. use of anticoagulation agents 4. presence of gastric and/or esophageal varices 5. anatomical deformity due to past surgery
a dose-escalation study of the safety and tolerability of orally administered tg101348 in patients with myelofibrosis

Conditions: Myelofibrosis

Summary: the purpose of this study is to evaluate the safety and tolerability of orally administered tg101348 in patients with myelofibrosis.

tg101348 is a potent small molecule inhibitor of janus kinase 2 (jak2). this is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expanded cohort, dose-confirmation phase. the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of tg101348 in patients with myelofibrosis will be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia) * at least 18 years of age. * ecog ps 0, 1, or 2. exclusion criteria: * any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. * major surgery or radiation therapy within 28 days prior to initiation of study drug.

Keywords: primary myelofibrosis post-polycythemia vera myelofibrosis post-essential thrombocythemia myelofibrosis