Kornimate/medical-research-clean huggingface dataset:
innovation for small-scale experiments: receptivfity test

Conditions: Pregnancy Related; Infertility, Female; Subfertility, Female

Summary: the receptivfity acts as a timing-tool for prediction of optimal pregnancy chances and provides insight into the patient's current (two months after sampling) success rate of an ivf/ivf-icsi treatment. benefits of physician decision treatment in case of an unfavorable vaginal profile and a low chance of achieving a pregnancy include reducing unnecessary morbidity and treatment cycles, stress and disappointment, while increasing efficacy of the treatment and lowering the costs needed to achieve a pregnancy. the goal of this prospective, clinical non-invasive randomized controlled study, with an additional observational study arm (for women of non-european origin) in naïve ivf or ivf/icsi patients is to evaluate the efficiency of shared decision making compared to physician decision in terms of 1. the success probability of an ivf cycle, 2. the proportion of women with a successful pregnancy 3. the number of unsuccessful ivf cycles. randomization component women of european origin will be randomized 1:1 to either the shared decision group or the physician decision group. all women of european origin may undergo one to three cycles of ivf/ivf-icsi reimbursed by the health insurance. the follow-up ends after the outcome of the last of these cycles has been determined. the desired outcome of the ivf or ivf/icsi treatment is a successful pregnancy, i.e., a pregnancy with a heart-beat at 12 weeks of gestation. observational component women of non-european origin are invited to take part in an observational component of this study. without further evaluation of the results of their vaginal microbiome, they will continue with the ivf/ivf-icsi cycle. women eligible for participation are naïve patients and the follow-up ends after the outcome of the first ivf/ivf-icsi cycle has been determined.


Eligibility criteria:
inclusion criteria: 1. naïve ivf or ivf/icsi patients 2. indication for an ivf or ivf-icsi procedure. 3. 18 years \< age \< 43 years. 4. willing to provide a vaginal swab with the receptivfity test. 5. willing to provide informed consent. exclusion criteria: 1. the use of hormonal contraceptives at the time of taking the test. 2. the use of antibiotic treatment at the time of taking the test. 3. emergency ivf for cancer or other reasons. 4. women with endometriosis pre-treated with an gn-rh analogue. 5. women having ivf for egg preservation reasons.

Keywords: vaginal microbiome ivf ivf/icsi pregnancy
relative bioavailability of an extemporaneous oral suspension of aprepitant in adolescents

Conditions: Nausea; Vomiting; Chemotherapy

Summary: the primary objective of this study is to compare the absorption of a prepared aprepitant oral suspension with that of the aprepitant capsule in children being treated with chemotherapy agents that are likely to cause vomiting.

antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (cinv) are still common and are among the most distressing side effects of chemotherapy. in a recent survey, parents of children receiving chemotherapy in ontario centres identified nausea as the fourth most prevalent and bothersome treatment-related symptom experienced by their children. aprepitant is commercially available in canada as capsules. an oral liquid aprepitant formulation would be ideal for oral administration to children.

Eligibility criteria:
inclusion criteria: * 12-18 years of age; * able to swallow whole capsules; * weighing ≥40kg; * ast, alt no more than 3 times the upper limit of normal for age and bilirubin concentrations within normal limits; * receiving 2 consecutive (within 8 weeks) eligible, though not necessarily identical, iv chemotherapy cycles; * english speaking (nausea assessment tool (penat30) has been validated only in english) * cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional (to permit self-assessment of nausea severity). exclusion criteria: * receiving very cisplatin containing chemotherapy (aprepitant capsule administration to these patients is the current standard of care at sick kids) * receiving chemotherapy within 5 days before,during or 5 days after either study cycle that is known or suspected to interact with aprepitant; that is, cyclophosphamide, doxorubicin, daunomycin, etoposide, irinotecan, ifosfamide, imatinib, paclitaxel, topotecan, vinorelbine, vinblastine and vincristine; * receiving medication known to interact with aprepitant other than dexamethasone (see appendix i for list of applicable agents and timeframe for exclusion); * pregnant or breastfeeding

Keywords: pediatrics nausea vomiting chemotherapy antiemetic
a cohort of molecular characteristics and prognosis of colorectal cancer

Conditions: Colorectal Cancer; Surgery

Summary: this study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.

in this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. the investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. the investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed as colorectal cancer * receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery exclusion criteria: * the patient refused to join the study * the patient refused to collect the biological sample * the patient refused to follow up
training grammar with meaning

Conditions: Language Disorders in Children

Summary: this study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. children will be enrolled in a half-day summer camp program for six weeks during which they will receive treatment designed to improve their language skills. children will be seen again approximately six weeks after the end of treatment to determine how much learning they have retained.

children between 4 years, 0 months and 6 years 11 months are eligible. a diagnosis of developmental language disorders will be confirmed as normal nonverbal cognitive function, passing a pure-tone audiometric screening, and a test score consistent with developmental language disorder on a standardized language test, and parent report of no other diagnosed handicapping condition. speech skills and vocabulary skills will be described via standardized testing. children enrolled in treatment are seen for up to 28 consecutive weekdays. the study starts with three days of baseline assessment of morpheme use for potential treatment targets. two are selected for study, with one treated and one tracked over the course of treatment. treatment is embedded in child-friendly activities like games, book reading, and craft activities. children are prompted to use the treated morpheme in conversation. immediately following this attempt, the treating clinician repeats the child's utterance, correcting any ungrammatical forms. half of the children will also receive explanations of what the key words in sentences mean (e.g., to twirl means to turn around fast). generalization to untreated contexts is assessed 2-3 times weekly. retention of learning is measured about six weeks after the end of treatment.

Eligibility criteria:
inclusion criteria: language scores consistent with a developmental language disorder nonverbal cognitive scores consistent with normal-range intellectual functioning exclusion criteria: hearing loss intellectual disability other handicapping conditions
effects of urban afforestation activity on mood, stress, and anxiety

Conditions: Healthy

Summary: this single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults.

the participants will perform an afforestation activity for a single session of 90 minutes. the therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.

Eligibility criteria:
inclusion criteria: * adults between 18 and 65 years. * any sex and gender. exclusion criteria: * intake of any psychotropic medication. * other severe or medically unstable diseases that may interfere with participation. * severe cognitive impairment (mini-mental state examination score \< 17 out of 30 points). * severe mental disorders in the acute phase or symptomatic phase. * severe intellectual disability. * behavioural alterations as this may interfere with their participation.

Keywords: green spaces nature-based activities urban afforestation horticultural therapy mental health mood stress anxiety
distal transradial access for percutaneous coronary intervention

Conditions: Transradial Access; Coronary Angiography; Radial Artery Intimal Medial Thickness; Distal Radial Artery Access (dTRA)

Summary: prospective randomized non-blinded study to determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery following distal radial artery access (dtra) for cardiac catheterization compared to standard forearm transradial access (ftra).

to determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery, using ultrahigh resolution (55 mhz) ultrasound, following distal radial artery access (dtra) for cardiac catheterization compared to standard forearm transradial access (ftra) at 90 days post-procedure. secondary outcome measures will include metrics of procedural success at 24 hours, as well as functional assessment of pain and motor strength of the ipsilateral upper extremity at 90 days post-procedure.

Eligibility criteria:
inclusion criteria: 1. consecutive patients undergoing elective and non-emergent tr lhc and/or pci at the inova heart and vascular institute 2. able to provide informed consent. 3. patients willing to complete a 90day post pci radial artery ultrasound. exclusion criteria: 1. patients with previous cannulation of both the right and left forearm ra's for coronary angiography and/or pci. in patients with prior cannulation of one ra, the contralateral arm may be used for this study. 2. patients who are not willing to undergo the necessary follow-up ultrasound examinations. 3. st elevation myocardial infarction or other emergent pci 4. inability to provide informed consent
metformin and esomeprazole in treatment of early onset preeclampsia

Conditions: Pre-Eclampsia

Summary: preeclampsia is globally responsible for tens of thousands of maternal and neonatal deaths each year. currently, there are no medical therapies to halt disease progression and expectant management and delivery remain the mainstay of treatment. an important step in the pathogenesis of preeclampsia is a poor placental invasion and the subsequent release of the anti-angiogenic factors soluble fms-like tyrosine kinase 1 (sflt-1) and soluble endoglin (seng)into the maternal circulation. given metformin and esomeprazole successfully mitigate key pathogenic features of preeclampsia, the investigator will study whether combining low-doses of metformin and esomeprazole may be additive or synergistic (or neither) in reducing sflt-1 and seng secretion, and mitigating endothelial dysfunction, compared to placebo.

this is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the international society for the study of hypertension in pregnancy (isshp). the population of interest involves pregnant women diagnosed with pre-eclampsia at a gestational age between 28 and 32 weeks at aswan university hospital will be invited to participate. to be enrolled, the treating team needs to have determined after their initial assessment that delivery is unlikely to be required within 48 h. a starting point of 28 weeks has been chosen as this would be the earliest gestation that aswan university hospital to be viable and are suitable to be offered expectant management the intervention involves randomization to oral esomeprazole tablets40 mg plus metformin tablets 1000 mg or identical placebo tablets from recruitment until delivery. randomization is achieved using computational random allocation, and both participants and researchers will be blinded to the intervention given.

Eligibility criteria:
inclusion criteria: * pregnant women presenting at a gestational age between 28 + 0 weeks and 32 + 0 weeks presented with preterm preeclampsia * the patient will be managed with an expectant management * give written informed consent exclusion criteria: * multiple pregnancies. * previous hypersensitivity reaction esomeprazole or metformin * contraindications to the use of esomeprazole or metformin * the patient is unable or unwilling to give consent * an established fetal compromise that necessitates delivery * the presence of any of the following at presentation: * eclampsia. * severe hypertension. * a cerebrovascular event as an ischemic or hemorrhagic stroke. * renal impairment. * signs of left ventricular failure which include pulmonary edema. * disseminated intravascular coagulation (dic) * haemolysis, elevated liver enzymes and low platelets (hellp syndrome)

Keywords: preeclampsia esomeprazole metformin
follow-up pilot study after a first stroke

Conditions: Stroke

Summary: this is a randomized follow-up study after discharge from a stroke unit after a first stroke. the patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. the hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. endpoints are mortality, recurrent stroke and handicap measured with different scales.


Eligibility criteria:
inclusion criteria: * first stroke (ischemic or hemorrhagic) * age below 85 years * living at home before the stroke exclusion criteria: * modified rankin scale 5 points * other severe disease * expected survival less than one year * severe dementia * drug or alcohol abuse

Keywords: follow-up after stroke
tolerance induction in living donor kidney transplantation with hematopoietic stem cell transplantation

Conditions: End Stage Renal Disease

Summary: kidney transplantation (kt) requires a life-long immune suppression (is). it has been well-known that long-term is inevitably causes various complication e.g. infection, toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and so on. tolerance induction showing graft function without maintenance is has been considered as a final solution in the transplantation recipients. tolerance induction can be achieved in kt recipients with donor hematopoietic stem cell transplantation (hsct). in this study, adult patients (18 and more years of age) with a human leukocyte antigen (hla)-haplotype match donor are enrolled. patients receive preconditioning treatment for hsct 1week prior to kt. bone marrow is harvested from donor under general anesthesia at the time of nephrectomy for transplantation in donor. donor bm is infused immediate post-transplantation at intensive care unit (icu). immunologic measurements including microchimerism study and protocol biopsy will be followed at several time points. is will be tapered slowly and withdrawn over a period of several months.


Eligibility criteria:
inclusion criteria: 1. all consenting adult (18 and more years of age) living donor kidney transplant recipients who have a one haplotype match donor. 2. patients who have no known contraindication to administration of rabbit anti-thymocyte globulin (atg) or radiation. 3. patients who agree to participate in the study and sign an informed consent. exclusion criteria: 1. presence of previous episode of transplantation including kidney 2. simultaneous multi-visceral transplantation 3. demonstration of donor specific antibody (dsa) or panel reactive antibody(pra) greater than 20% 4. abo blood type incompatible 5. previous treatment with rabbit anti-thymocyte globulin or a known allergy to rabbit proteins. 6. history of malignancy with the exception of non-melanoma skin malignancies. 7. uncontrolled systemic or concomitant unstable infection 8. serological evidence of hepatitis b or hepatitis c or hiv infection. 9. severe psychiatric disease 10. leukopenia (with a white blood cell count \< 3000/mm3) 11. disagreement to participate in the study and sign an informed consent.

Keywords: kidney transplantation tolerance induction immunosuppression withdrawal bone marrow transplantation transplantation conditioning hematopoietic stem cell transplantation living donor haplotype immune tolerance
clinical usefulness and efficacy of intrathoracic impedance monitoring using the optivol patient alert(tm)

Conditions: Heart Failure

Summary: in this study we investigate the clinical value and efficacy of optivol (tm) impedance measurements by medtronic (r) icd's. we aim to determine sensitivity and positive predictive value for detecting heart failure. we also investigate if left ventricular filling pattern measured by echocardiography and/or brain natriuretic peptide (bnp) level can be used to improve the positive predictive value of the optivol alert

patients who have a medtronic (r) icd equipped with the optivol (tm) impedance monitoring will be included in your study after informed consent. the optivol (tm) feature will be activated and at baseline data is collected (blood sample including bnp, electrocardiography, echocardiography, chest x-ray and icd check-up). during follow-up patients will be re-assessed in case of an optivol alert or in case of heart failure.

Eligibility criteria:
inclusion criteria: * chronic heart failure of any cause * implanted medtronic icd with optivol impedance monitoring exclusion criteria: * inability to receive informed consent

Keywords: intrathoracic impedance cardiac resynchronization therapy heart failure
evaluation of the efficacy of pulmonary vein isolation by pulsed-field ablation in persistent atrial fibrillation: a multicenter study with follow-up by implantable cardiac monitor

Conditions: Persistent Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common sustained arrhythmia in adult population. according to current guidelines for the management of af, radiofrequency (rf) ablation (including at least pulmonary vein isolation \[pvi\]) is a validated therapeutic option for persistent af. recently, pulsed-field ablation (pfa) - a new non-thermal energy - has been used to treat paroxysmal and persistent af with a high success rate in observational studies. this new technology is based on tissue-specificity on myocardium, avoiding collateral damages on adjacent structures. before confirming a superiority of pfa over existing thermal energies, prospective studies concerning an exclusive population of persistent af patients are needed, with rigorous assessment of the recurrences using continuous monitoring (insertable cardiac monitor \[icm\]). pfa efficacy using icm has never been evaluated. before considering pfa in therapeutic strategies through large-scale randomized studies using rigorous monitoring of recurrences, preliminary studies are needed in a persistent af population-only. this pilot cohort study will provide solid data of pfa efficacy (using continuous monitoring of recurrences) for future randomized studies.


Eligibility criteria:
inclusion criteria: * symptomatic persistent af (continuous episode sustained beyond 7 days) * refractory, intolerant or unwilling to take adt * signed informed consent * affiliation to medical social coverage. non inclusion criteria: * persistent long-term atrial fibrillation with ongoing episode continuous for more than 3 years; * left ventricular ejection fraction ≤ 15% ; * stage iv of the new york heart association classification; * previous atrial ablation outside the cavotricuspid isthmus; * wearer of an implantable electronic cardiac prosthesis (pacemaker or defibrillator; mci) * hypertrophic heart disease other than hypertensive hypertrophic heart disease; * severe valvular heart disease, including the presence of a mechanical mitral valve or any mitral surgery; * congenital heart disease, including atrial septal defect, patent foramen ovale treated by percutaneous closure with atrial septal prosthesis; * presence of cardiac thrombus; * myocardial infarction or percutaneous coronary angioplasty within the last 6 months; * cardiac surgery within the last 6 months; * systemic thromboembolic event less than 6 months ago; * pulmonary embolism less than 6 months ago or pulmonary hypertension requiring specific treatment; * inability to read independently * vulnerable patient: minor, patient under curatorship or guardianship
first line osimertinib in the real world: an inter-regional prospective study

Conditions: EGF-R Positive Non-Small Cell Lung Cancer

Summary: this study (flower) will investigate effectiveness, safety, progression patterns and clinical management of untreated advanced nsclc patients receiving fist-line osimertinib in the real-world.

flower is a real-world, prospective, observational study enrolling patients with histological and/or cytological diagnosis of egfr-mutant ansclc, receiving first-line treatment with the third-generation egfr-tki, osimertinib. all the patients received osimertinib at the recommended dose of 80 mg, orally, once a day. dosing interruptions or reductions required, based on individual tolerability, were managed according to clinical practice in compliance with label indications. the flower study aims at evaluating effectiveness, safety, progression pattern and clinical management of untreated egfr-mutant ansclc patients in the real-world.

Eligibility criteria:
inclusion criteria: * histological confirmed diagnosis of nsclc and egfr mutation in exon 18-21; * locally advanced inoperable or metastatic disease (stage iii and iv according to 8th edition of the tnm classification for lung cancer); * first line treatment with the third generation egfr tki, osimertinib; * age \>18 years * written informed consent exclusion criteria: patients who receive study drugs in clinical trials will be excluded.