Kornimate/medical-research-clean huggingface dataset:
accuracy of risk prediction scores in pregnant women

Conditions: Congenital Heart Disease; Pregnancy

Summary: management of pregnancy and risk stratification in congenital heart disease (chd) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. we aim to compare the accuracy of the main published scores including carpreg ii score in prediction of maternal complications during pregnancy in chd patients.

since the end of the 20th century, surgical and medical care progresses have significantly improved prognosis and quality of life of patients with congenital heart diseases (chd). currently, women with chd expect to experience a "normal" life and express a strong maternity desire. during the last decade, several scores have been used to predict outcome of pregnancy in women with cardiovascular heart diseases. it has been suggested that the mwho classification was more appropriate than the previous ones (e.g. harris, zahara and capreg classifications) in predicting cardiac complications in chd. more recently, a new risk score stratification (carpreg ii) have been published to improve maternal risk stratification. this retrospective study will include all pregnant women with chd who were follow up in our institution from january 2007 to june 2018 until 6 months postpartum. the investigators will collect demographic and clinical data, type and complexity of chd (houyel and bethesda classification), and pregnancy outcomes. pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes. the discriminatory power of each risk scores was assessed by the area-under-the receiver-operating characteristic (roc) curve (auc). in order to assess the reproducibility of scores classification assigned to chd patients, all pregnancy scores from this cohort were assessed by 3 independent observers and, thereafter, estimated cronbach's coefficient alpha.

Eligibility criteria:
inclusion criteria: - all patients with congenital heart diseases who deliver in our institution during the study period exclusion criteria: - women with acquired cardiovascular diseases

Keywords: risk score maternal complication
oxygen wound therapy feasibility study

Conditions: Chronic Leg Ulcer

Summary: determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.


Eligibility criteria:
inclusion criteria: * patients with hard to heal lower leg wounds as determined by the treating clinician. * patient has a wound area greater than the area of the interface * aged 16 years and over * able to provide informed consent exclusion criteria: * lower limb wounds with bone or tendon exposed * infected wounds which require treatment with antibiotics * wounds with critical bioburden requiring a medicated dressing * wounds that require dressing changes more than every second day, for example high exudating wounds * wounds with slough covering more than 30% of the wound surface
correlation between the cobb's angle and the forward head posture in patients with adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis (AIS); Forward Head Posture

Summary: purpose of this study to detect if there is correlation between the cobb's angle and the forward head posture in patients with adolescent idiopathic scoliosis. and if there is correlation between the cobb's angle and the cervical sagittal curve angle in ais. and also if there is correlation between the cobb's angle and deep flexors muscles endurance in ais

the prevalence of sagittal profile imbalance in adolescent idiopathic scoliosis is not known exactly as little research is available in this context (nasser et al., 2023) thought based on previous studies that a forward head corrective exercise program combined with conventional rehabilitation improved three-dimensional scoliotic posture and functional status in patients with adolescent idiopathic scoliosis. (alia diab et al., 2012) up to our knowledge there is no significant evidence that there is correlation between craniovertebral angle (cva) and idiopathic scoliosis by cobb's angle. so we need to make a simple assessment method of the severity of scoliosis and its impact on head position through a simpler method by observing the cervical curvature through photos for cva, this can help to avoid unnecessary radiological examination. in addition, it also may help in paying the attention to the correction of cervical spines, head position and cervical muscles endurance during conservative treatment of scoliosis. also studying cervical sagittal alignment deformities will help in surgical operations to maintain or restore sagittal physiological curvature side by side with correction of coronal scoliosis angle in order to prevent adjacent segment degeneration after the fusion operation.

Eligibility criteria:
inclusion criteria: * 1- patients with ais. 2- patient with forward head posture cva less than 48 degress. (fard et al .,2021) 3- patients aged between 10 and 18 years, (upasani et al., 2007). 4- patients who underwent posterioanterior (pa) and lateral x-ray radiography, and cobb angle \>10°.(nasser et al.,2023) 5- patients with lenke types (1 to 6). 6- no previous spine surgery ((wang, et al., 2017). exclusion criteria: * 1- patients with congenital scoliosis (including hemivertebrae, butterfly vertebrae, and failure of segmentation), (shu-man han et al., 2022 and nasser et al., 2023). 2- other developmental thoracic deformity (funnel chest etc.). 3- scoliosis with definitive reasons (secondary to neurofibromatosis, marfan syndrome, and syringomyelia). 4- patients with neurologic deficit or spondylolisthesis (upasani et al., 2007). 5- history of spinal trauma and infection, and metabolic bone disease.

Keywords: forward head scoliosis craniovertebral angle
clinical trial of gaia-102 for refractory/relapse neuroblastomas and other malignant pediatric solid tumors

Conditions: Refractory/Relapse Neuroblastoma; Pediatric Solid Tumors

Summary: single cohort a(gaia-102 alone): confirm the safety of gaia-102 alone for refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for phase ii. cohort b(gaia-102 with dinutuximab): confirm the safety of gaia-102 with dinutuximab, filgrastim, teceleukin combination for refractory/relapse neuroblastoma and decide recommended dose for phase ii. cohort c(gaia-102 with nivolumab):confirm the safety of gaia-102(follow the recommended doses in cohort a) with nivolumab. cohort c(gaia-102 with nivolumab):confirm the safety of gaia-102(follow the recommended doses in cohort a) with nivolumab


Eligibility criteria:
inclusion criteria: 1. patients who have been confirmed to have the following malignant tumor by histological examination * single cohort : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) . * combination cohort : neuroblastoma. 2. patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline. 3. patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs. 4. patients aged from 1years to 24 years at the time of obtaining consent. 5. patients with performance status(ps) over 50 (lansky performance status score less than 16 years old) or (karnofsky performance status over 16 years old) at the time of obtaining consent. exclusion criteria: 1. patients with brain metastases. 2. patients diagnosed with cancerous meningitis 3. patients who received allogeneic hematopoietic stem cell transplant. 4. patients with active autoimmune disease.
efficacy and safety of hrs-7535 tablets in t2dm subjects poorly controlled with metformin and sglt2i.

Conditions: Type 2 Diabetes

Summary: 2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the safety and efficacy of hrs-7535 in subjects with type 2 diabetes who have inadequate glycemic control on metformin and sglt2i.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, 18-75 years of age at the time of signing informed consent; 2. have t2dm (based on the 2020 chinese diabetes society \[cds\] diagnostic criteria) 3. hba1c为7.5%≤hba1c≤11.0% at the screening visit； 4. fpg≤15 mmol/l at the screening visit; 5. have been treated with an sglt2i with metformin, for at least 8 weeks; 6. at screening and random visit, 20.0 ≤bmi≤ 35.0 kg/m2; 7. able and willing to provide a written informed consent exclusion criteria: 1. have type 1 diabetesmellitus; 2. history of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 3. any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 4. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 5. surgery is planned during the trial; 6. female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
the beacon registry: best expert agreement for care of occult myocardial infarction (mi) nationally

Conditions: Chest Pain

Summary: the purpose of this registry is to assess and improve the process of care and health outcomes of patients presenting to the emergency department with chest pain suspected to be of cardiac origin. the study will identify which methods facilitate the diagnosis and risk stratification of st elevation myocardial infarction (stemi) or non stemi, including patients with occult myocardial infarction (mi), and result in a shorter time to definitive diagnosis and treatment.

the beacon registry is a multi-center data collection and follow-up registry. participating sites will collect information on patients presenting to the emergency department (ed) with chest pain. the purpose of the beacon registry is to evaluate the impact of new technologies, practice patterns and initiatives on patient time to diagnosis, patient time to treatment, patient survival and overall economics.

Eligibility criteria:
inclusion criteria: * patients presenting with chest pain suspected to be of cardiac origin. exclusion criteria: * none

Keywords: chest pain stemi ua/nstemi acs emergency department
comparison between uppp and tonsillectomy in adult osa

Conditions: Obstructive Sleep Apnea

Summary: the aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.

patients are after baseline psg 1 included and randomized to either uppp or te. they are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. they all undergo surgery within two months and thereafter psg 2 after 6 months and psg after 4 years. at psg they fill in questionnaires and measurements of blood pressure.

Eligibility criteria:
inclusion criteria: * ahi more than 15 * friedmans stage i and ii * tonsil size 2, 3 and 4 * bmi below 34 * failed use of cpap and dental device exclusion criteria: * severe cardiovascular or neurological disease * prefers strongly one surgical method * asa iv
a study to investigate multiple sclerosis relapse prevention with mrna-1195 compared with placebo in participants aged 18 to ≤55 years

Conditions: Multiple Sclerosis

Summary: the primary objective of this trial is to evaluate the safety and reactogenicity of mrna-1195 in participants with multiple sclerosis.


Eligibility criteria:
inclusion criteria: * medically stable as determined by investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and review of any previously conducted cardiac monitoring. * participants who are epstein-barr virus (ebv)-seropositive at screening. * participants who have been previously diagnosed with clinically isolated syndrome, radiologically isolated syndrome, or multiple sclerosis within 24 months of screening visit (that is, early in their multiple sclerosis course) and in the opinion of the investigator have been neurologically stable for at least 30 days prior to visit 1/day 1. * a participant who could become pregnant is eligible to participate if they are not pregnant or breast/chest feeding. exclusion criteria: * acutely ill or febrile (temperature ≥38.0 degrees celsius (℃) \[100.4 fahrenheit °f\]) within 72 hours prior to or at screening or day 1. * history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 \[covid-19\] regardless of vaccine type) within 28 days before or after the day 1 study injection, or within 14 days before or after day 1 study intervention for the influenza vaccine. * any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) * participants with any documented history of myocarditis, pericarditis, or myopericarditis. * has donated ≥450 milliliter (ml) of blood products within 28 days prior to screening or plans to donate blood products within 28 days post-study injection. note: other inclusion and exclusion criteria may apply.

Keywords: multiple sclerosis mrna-1195
melanocyte transplantation for patients with stable vitiligo.

Conditions: Stable Vitiligo

Summary: vitiligo is an acquired skin disease that significantly impacts the quality of life of patients. medical treatment of vitiligo includes the use of melanocyte transplantation but the results are variable. this single center, single blind clinical trial comparing another treatment and also no treatment was designed to assess the efficacy of autologous monocyte transplantation in monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. patients will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane and will provide an untreated area as a control.

main objective: the main objective is to assess the efficacy of autologous transplantation of monocytes in monolayers grown on a biological substrate of amniotic membrane in the treatment of stable vitiligo. using a system of digital imaging analysis the percentage of re-pigmentation obtained will be studied after 3, 6 and 9 months of treatment. secondary objectives: to demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with melanocytes in monolayers. to assess how rapidly epithelialization occurs and the cosmetic result in the short and long term of the areas treated with each of the techniques. to assess if de-epidermization with co2 laser may be by itself a stimulus for the reservoir of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation obtained with this procedure is merely postinflammatory as a result of trauma to the epidermis.

Eligibility criteria:
inclusion criteria * patients must voluntarily provide informed consent before any of the tests included in the trial which do not form part of standard treatment can be performed. * mentally stable patients, suffering from piebaldism, vitiligo of metameric distribution, focal or generalized vitiligo which has remained stable for at least one year without de-pigmentation or spontaneous re-pigmentation after standard medical treatment. * a minimum hypopigmented area to treat of 100 cm2 (at least 30 cm2 for each of the therapeutic options). * for women of child-bearing age, a negative pregnancy test. exclusion criteria: * women who are pregnant or breast-feeding. * positive results in any of the blood tests given * concomitant serious illness. * patients who have received any agent currently the focus of research in the 30 days prior to their inclusion. * patients currently participating in another clinical trial or receiving any other agent currently the focus of research.

Keywords: vitiligo, amniotic membrane, malanocytes, c02 laser.
staff management about food allergy into restaurants

Conditions: Food Allergy

Summary: assessment of the knowledge levels of restaurant personnel about food allergies. a structured questionnaire was given through a telephonic interview to evaluate the responses of the respondents.

food allergy is a common disease affecting children and adults in europe. it's a burden for patients, with an important impact on quality of life. dining in restaurants may be dangerous for allergic consumers. currently in france, little training on food allergies is included in the generic food hygiene training that is compulsory for only a minimum of one member of the staff of a restaurant.

Eligibility criteria:
inclusion criteria: * etablished in metz or strasbourg * restaurant staff member exclusion criteria: -

Keywords: food allergy, restaurant staff
improving walking with heel-to-toe device

Conditions: Parkinson

Summary: introduction: the purpose of this study is to test the efficacy potential of using real-time positive auditory feedback to improve gait pattern in people with parkinson's disease (pd). the components of walking are commonly affected in patients with pd. gait training for pd is usually based on verbal cues from the therapist that are only moderately effective. based on good principals of gait and neuroplasticity, the heel-to-toe (heel2toe) sensor was developed to provide real-time auditory feedback during walking training. methods: a two-group, randomized feasibility trial is planned with repeated measures of gait parameters and walking outcomes. participants will be assessed at baseline, 3 and 6 months. outcomes after the 5 training days will be obtained directly from the hee2toe device for both groups (with and without auditory feedback). the primary outcome is walking capacity measured by the six-minute walk test and the standardized walking obstacle course. gait parameters will be captured by the heel2toe device expected contributions: gait training using the heel2toe sensor will be potentially effective for improving walking pattern in people with pd.

as this is a feasibility study, the main analysis will focus on within-group change over the intervention period of 3 months using indices of reliable change(36). this method assesses the number of people who changed in each of the groups based on the magnitude of change relative to pre-post variability and correlation. we will estimate the proportion of people with reliable change. estimates from the pilot study will be used to plan the main trial if the pilot demonstrates feasibility. for the maintenance period, reliable change from baseline will also be estimated and used to identify the proportion of people who maintained reliable change or who gained/lost this status. the study is designed to detect a minimal important within-group change of moderate magnitude or greater (effect size ½ standard deviation) with adequate precision. a sample size of 20 in the intervention with completed follow-up will provide a 95% confidence interval with precision that excludes an effect size of 0.03.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson disease and be independent in ambulation without use of walking aid exclusion criteria: * exercising three or more time per week; * had any additional illness that restricted their function * showing difficulty reading, understanding or speaking either french or english

Keywords: gait walking capacity neuroplasticity motor learning quality of life
janagliflozin treat t2dm monotherapy

Conditions: Diabetes Type 2

Summary: the purpose of this study is to assess the effect of janagliflozin relative to placebo on glycated hemoglobin (hba1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and population pharmacokinetics.

a multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 weeks extension period), to evaluate the efficacy and safety of janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with t2dm who are not achieving an adequate response from diet and exercise to control their diabetes. approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with janagliflozin 25 mg or 50 mg. during the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. study drug will be taken orally once daily.

Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of t2dm (meet the diagnostic criteria for diabetes issued by the world health organization in 1999) * patients must have a hemoglobin a1c (hba1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline. * drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening). * body mass index: 18.0\~35.0 kg/m2 (both inclusive) exclusion criteria: * history of type 1 diabetes mellitus (t1dm), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by cushing's syndrome or acromegaly) * more than 10% change in body weight within the 3 months before screening * any laboratory test indicators meet the following standards: * fasting plasma glucose ≥ 15 mmol/l * aspartate aminotransferase, alanine aminotransferase levels \> 3 times the upper limit of normal (uln); total bilirubin \> 1.5 times uln * hemoglobin \< 100 g/l * egfr \< 60 ml/min/1.73m2 * fasting triglycerides \> 5.64 mmol/l (500 mg/dl)