Kornimate/medical-research-clean huggingface dataset:
edge ai-deployed digital twins for predicting disease progression and need for early intervention in infectious and cardiovascular diseases beyond covid-19 - investigation of biomarkers in dermal interstitial fluid

Conditions: Heart Failure

Summary: the study will investigate, if inflammatory and cardio-circulatory biochemical biomarkers are detectable in dermal interstitial fluid (disf) of heart failure patients, and if there are detectable kinetics of these biomarkers during a cardiopulmonary exercise test. for disf extraction the pelsa system - an investigational device - will be used.


Eligibility criteria:
inclusion criteria: * subject suffers from heart failure (according to esc 2021 heart failure guidelines). * age of subject is ≥18 years. * subject is female or male. * signed written informed consent. * for female subjects: 1. confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or 2. if being of childbearing potential: 1. negative highly sensitive urine or serum pregnancy test before inclusion, and 2. practicing a highly effective birth control method (failure rate of less than 1%): 1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or 2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or 3. intrauterine device (iud), or 4. intrauterine hormone-releasing system (ius), or 5. bilateral tubal occlusion, or 6. vasectomised partner, or 7. heterosexual abstinence. * subject is capable to perform cardiopulmonary exercise testing. exclusion criteria: * subject is breastfeeding. * subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study. * subject is treated with immunosuppressive drugs at enrolment. * subject requires renal replacement therapy. * subject has a known colonisation or infection with multi-drug-resistant pathogens. * subject has an open wound in or near the sampling area. * subject has any type of tattoo or piercing anywhere in or near the sampling area. * subject shows an inability to comply with all the study procedures and follow-up visits. * subject is unwilling to consent to saving and propagation of pseudonymised medical data for study reasons. * subject is legally detained in an official institution. * subject is dependent on the sponsor, the investigator or the study sites. * subject participates in a study according to amg/ctr that investigates immunosuppressive or anticoagulant drugs at the time of this study.
prognostic value of the age, creatinine, and ejection fraction score for non-infarct-related chronic total occlusion revascularization after primary percutaneous intervention in acute st-elevation myocardial infarction patients: a retrospective study

Conditions: Cto, Acef Score

Summary: the age, creatinine, and ejection fraction (acef) score has been used to evaluate the clinical prognostic to patients who underwent pci. however, it is not known if acef score could evaluate the prognostic of recanalization of non-infarct-related coronary arteries (non-ira) chronic total occlusions (cto) in patients who successful underwent primary pci. the objectivity of current study was to assess the prognostic value of acef score in acute st-segment elevation myocardial infarction (stemi) patients with non-ira cto after successful primary pci.


Eligibility criteria:
among the 2952 patients with stemi successful treatment by pci, 395 patients (13.4%) had a non-ira cto lesion. 18 patients were excluded from current study as they death within 7 days (n=6) or were not to follow-up (n=7). due to unavailability of ejection fraction or renal function before cto-pci, acef score could not be calculated in 5 patients. the remaining 377 patients (95.4%) were finally analyzed in the study. 279 patients performed a staged cto-pci attempt(ranging 7-28 days) and was successful in 221 of them. due to low possibility of pci success or patients refused to perform pci, 98 patients did not undergo the pci attempt. the patients were then divided into successful cto-pci group (221 patients) and failed/ non-attempted cto-pci group (156 patients). -
celecoxib for thyroid eye disease

Conditions: Thyroid Eye Disease

Summary: thyroid eye disease (ted) is an autoimmune disorder in which the immune system attacks orbital tissues, resulting in characteristic changes in eyelid position, globe position in the orbit, extraocular muscle balance, and optic nerve function. ted is a potentially blinding disease, and current treatments largely consist of nonspecific reduction of inflammation using corticosteroids or radiation therapy. regardless of treatment, once ted progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital changes become fixed and can be modified only by surgery. the investigators propose to treat a cohort of patients with active ted using a selective cox-2 inhibitor, celecoxib, and to compare these patients to an observational control group. the investigators hypothesize that celecoxib will reduce the severity of disease and/or prevent progression to proptosis, diplopia, and corneal exposure or compressive optic neuropathy.

the investigators intend to use celecoxib, a non-steroidal anti-inflammatory drug approved by the food and drug administration (fda) for the treatment of pain, osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as a treatment for active ted. in vitro data have shown that transformation of orbital fibroblasts into adipocytes is mediated by cyclooxygenase-2 (cox-2), and a case report suggests that cox-2 inhibition can improve ted in the acute phase. thus, the investigators intend to evaluate the efficacy of cox-2 inhibition in the treatment of active ted and its ability to improve both the acute inflammatory signs and more permanent fibrotic changes of quiescent disease. the investigators will enroll patients with active ted and treat them for 3 months (a characteristic period of disease activity) and compare this to standard treatments for mild active ted (observation, with over the counter interventions such as lubrication with artificial tears) to assess efficacy.

Eligibility criteria:
inclusion criteria: * recent diagnosis of thyroid eye disease (within the past 3 months) * have ocular symptoms or signs of ted with a clinical activity score (cas) of at least 3 exclusion criteria: * pregnancy * previous treatment with corticosteroid for ted for \>2wks * previous treatment with orbital radiation for ted * impaired renal function * impaired hepatic function * treatment with antihypertensive medications except beta-blockers * history of congestive heart failure, cardiac valvular disease, or coronary artery disease * allergy to nsaid or previous adverse reaction (ie. gi bleeding) * vision loss due to compressive optic neuropathy
a study to test the safety, tolerability, and efficacy of an antibody, regn7999, injected under the skin for the treatment of iron overload in adult participants with non-transfusion dependent β-thalassemia, using mri scans to measure iron levels in the body

Conditions: Non-transfusion Dependent Beta-thalassemia (NTDT)

Summary: this study is researching an experimental drug called regn7999 (called "study drug"). the study is focused on patients with non-transfusion dependent beta-thalassemia. the aim of the study is to see how safe and effective the study drug is. the study is looking at several other research questions, including: * whether the study drug lowers extra iron levels in the body * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. clinical diagnosis of ntdt as described in the protocol 2. iol, defined as lic ≥ 5 mg fe/g dw as measured by r2\* mri at screening 3. serum ferritin ≥ 300 ng/ml as described in the protocol key exclusion criteria: 1. hemoglobin ≤ 8 g/dl 2. any rbc transfusion within 12 weeks of visit 3 3. for part a only: any ict use in approximately 12 weeks prior to screening as described in the protocol 4. for part b only: if on ict, any change in iron chelation therapy (ict) dose in approximately 12 weeks prior to screening as described in the protocol 5. any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol 6. absolute contraindication to mri 7. diagnosis of cirrhosis of the liver 8. diagnosis of chronic kidney disease (ckd) stage 4 or higher note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: beta-thalassemia resultant iron overload (iol)
the influence of an orthopaedic manual physical therapy and sensory training on somatoperception in patients with chronic low back pain

Conditions: Low Back Pain

Summary: individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or s1. two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. this study will assess tpd changes after a course of standard physical therapy care with the addition of sensory training.


Eligibility criteria:
inclusion criteria: * deers eligible * 18 to 64 years old * low back pain \&gt; 3 months * numeric pain rating scale minimal pain rating of 3/10 in the last seven days * must be able to commit to 6-10 treatment sessions over a period of at least 6-we exclusion criteria: * history of spinal surgery * history of spinal injections or nerve ablations in the past year * history of traumatic brain injury (tbi) * history of cerebral vascular accident (cva) * currently pregnant * active cancer * symptoms below the knee * non-msk condition contributing to low back pain * chronic pain conditions to include chronic regional pain syndrome and fibromyalgia * autoimmune diseases (to include ankylosing spondylitis, lupus, rheumatoid arthritis) * currently under litigation related to low back pain * currently going through medical evaluation board (meb) * retiring or separating from the military within a year * currently receiving physical therapy for low back pain

Keywords: two-point discrimination physical therapy somatoperception tactile acuity
clinic, family & community intervention for children with overweight and obesity (stanford goals)

Conditions: Obesity

Summary: stanford goals is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (mmm) approach to treating overweight and obese children. primary research question: will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (mmm) community-based intervention to treat overweight and obese children significantly reduce bmi compared to an enhanced standard care/health and nutrition education active comparison intervention?

single-blind study with all outcomes assessors (data collectors) and investigators masked (blinded) to intervention assignment. intention-to-treat analysis.

Eligibility criteria:
inclusion criteria: * 7-11 years of age * bmi greater than or equal to the 85th percentile for age and sex on the 2000 u.s. centers for disease control and prevention (cdc) bmi reference exclusion criteria: * have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated with obesity, type 1 diabetes, type 2 diabetes taking medication, chronic gastrointestinal diseases, chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), aids or hiv infection, pregnancy); * take medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone); * have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason); * have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in english or spanish, child two or more grade levels delayed in school for reading and writing in her native language); * are unable to read, understand or complete informed consent in english or spanish; * plan to move from the san francisco bay area within the next 36 months. * are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the principal investigator.
scalp blocks effect on postoperative nausea & vomiting after craniotomy

Conditions: Postoperative Nausea and Vomiting

Summary: in this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of ponv after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time

patients will be recruited after admission to the hospital for surgery. randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study patients will be randomly divided into two groups using a computer generated random number chart. group s received scalp block with 20 ml of 0.5% bupivacaine, whereas group c received scalp block using 20 ml normal saline and will be considered as control group.

Eligibility criteria:
inclusion criteria: * asa i and ii patients, * aged 18 to 50 years, * 70-80 kg, * undergoing elective supratentorial craniotomy exclusion criteria: * patients under 18 years of age, * pregnancy, * emergency surgery, * patients with a glasgow coma score (gcs) less than 15, * those with documented allergy to bupivacaine, * regular communication not possible, * patients requiring prolonged mechanical ventilation (\> 2 hours after end of surgery) will be also excluded
evaluation of modified treatment regimens for treatment of heavy menstrual bleeding using the heroption® system

Conditions: Menorrhagia

Summary: the her option® cryoablation therapy system is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. this is a non-incisional procedure, which can be performed in a physicians office with minimal sedation. initial fda clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the cryoprobe repositioned in the contralateral cornu. since completion of the early studies, many physicians have experimented with varying freeze patterns using longer freeze durations and/or additional freezes at the fundus and the lower uterine segment. the results, as reported in the literature, indicate that these extended freeze patterns produce significantly better results than the original regimen.

american medical systems, inc. (ams) hypothesized that the original treatment pattern used to support a previous fda approval for the her option® cryoablation therapy system for treatment of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients.

Eligibility criteria:
inclusion criteria: * pre-menopausal adult women 30 years of age or older who have completed childbearing * heavy or prolonged menstrual bleeding * willing and able to complete all follow-up exams as required by protocol exclusion criteria: * known or suspected endometrial cancer or pre-malignant change of the endometrium * untreated cervical dysplasia * hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe * uterine myomas \> or = to 3 cm in diameter * past history of invasive treatment for abnormal uterine bleeding or uterine myomas * history of classical (not low transverse incision) cesarean section * active genital or urinary tract infection or acute pelvic inflammatory disease (pid) * intrauterine device (iud) in place * other medical conditions could be exclusionary upon evaluation for study treatment

Keywords: menorrhagia excessive uterine bleeding cryoablation menstrual disorder endometrial ablation abnormal uterine bleeding dysfunctional uterine bleeding
compare bleeding risk between cold and hot snaring polypectomy for small colorectal polyp: a randomized control trial

Conditions: Colorectal Polyp

Summary: in this randomized control trial the investigators aim to compare the bleeding complication between cold snaring and hot snaring polypectomy with a large sample size.

the investigators will enroll subjects who receive screening or surveillance colonoscopy with small colorectal polyp, 4 to10 mm in size, from multiple centers in taiwan. subjects who are less than 40 years old and has contraindication will be excluded from this study. all the candidates for enrollment will sign the inform consent at the outpatient clinic. once the candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy will be randomized into either cold snaring or hot snaring polypectomy group. in the group with cold snaring, polypectomy will be done without electrocautery. in the hot snaring group, the polypectomy will be performed with electrocautery. the bowel preparation and colonoscopy insertion are the same in both groups as conventional colonoscopy method. the colonoscopy will be performed by experienced endoscopies who performed more than 100 polypectomies per year.

Eligibility criteria:
inclusion criteria: * candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy exclusion criteria: * subjects who are less than 40 years old and has contraindication will be excluded from this study
nebulized mgso4 in persistent pulmonary hypertension of newborn

Conditions: Persistent Fetal Circulation; Persistent Pulmonary Hypertension of the Newborn; PPHN

Summary: the aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of pphn.

the effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.

Eligibility criteria:
inclusion criteria: newborns with pphn fulfilling the following: 1. born at ≥ 37 weeks gestational age. 2. birth weight between 2.5 and 4 kg. 3. post-natal age between 6 and 72 hours. 4. connected to mechanical ventilation with an oxygenation index (oi) \> 30 on two occasions at least 15 minutes apart. 5. documented pphn confirmed by echocardiography. exclusion criteria: 1. failure to obtain informed consent. 2. infants of mothers who received magnesium sulfate within 48 hours before labor. 3. congenital heart diseases (other than pda and foramen ovale). 4. major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia). 5. prior need for cardiopulmonary resuscitation. 6. mean arterial blood pressure (mabp) \< 35 mmhg despite therapy with volume infusions and inotrpic support. 7. impaired kidney function. 8. prior administration of pulmonary vasodilators.

Keywords: neonate persistent fetal circulation persistent pulmonary hypertension of the newborn pphn magnesium sulfate nebulizer hypoxia
study of the risk of prematurité according to the balance of bacterial flora vaginale

Conditions: Preterm Birth

Summary: objective to compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries

material and methods case-control study nested in a cohort of pregnant patients in the first trimester. inclusion criteria. : case is defined as spontaneous preterm births between 22 and 36 weeks in one of the 14 centers. the "control" patient will be considered as the following delivery over ≥ 37 weeks in the same center. multiple pregnancies, medical interruptions of pregnancy and deaths in utero will be excluded. regarding the vaginal flora of cases and controls, the microorganisms will be researched and quantified by molecular methods. expected results patients and control patients will be compared for their demographic, obstetric, clinical and microbiological data. the parameters related to the risk of spontaneous prematurity at the p \<0.20 threshold will then be analyzed by multi-level logistic regression. implications at a time when the link between bacterial vaginosis and prematurity is controversial, the detection - or not - of microorganisms linked to the risk of prematurity will be a key issue.

Eligibility criteria:
inclusion criteria: * case: spontaneous preterm births between 22 and 36 weeks in one of the 14 centers * controls : the following delivery over ≥ 37 weeks in the same center exclusion criteria: * multiple pregnancies, medical interruptions of pregnancy and deaths in utero

Keywords: bacterial vaginosis vaginal microbiota molecular methods next generation sequencing
impact of preterm body composition at discharge on 2 years neurological development (asq evaluation)

Conditions: Other Preterm Infants

Summary: neonatal nutritional management consists in reproducing miming uteri growth kinetic. since the seventies, nicu (neonatal intensive care unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. however, nutritional practices and strategies have significantly evolved during these last years, influenced by baker nutritional imprinting concept (2002). actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. in this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. epipod try to focus the link between heterogenous proteic input dispensed in our nicu (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.


Eligibility criteria:
inclusion criteria: * preterm newborns (\< 35 weeks gestation). * final clinical discharge (no transfer) * oral parental consent. * nantes nicu neonatal management in the first 5 days of life exclusion criteria: * congenital pathology inconsistent with peapod investigation (beckwith-wiedemann syndrome, lipodystrophia with abnormal constitutional fat mass level). * pathology inducing neurodevelopment troubles. * transfer in an other hospital before discharge * hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with peapod measurement