Kornimate/medical-research-clean huggingface dataset:
evaluating the performance of precision1 daily disposable contact lens in a group of heavy digital device users

Conditions: Myopia

Summary: the purpose of this study is to evaluate the performance of precision1 dd cls with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in cl wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).


Eligibility criteria:
inclusion criteria: 1. is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as pc, laptop, smartphone, or tablet); 5. is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment; 6. has a vertex corrected spherical equivalent distance refraction that ranges between -0.50d to -6.00d in each eye; 7. has a vertex corrected refractive cylinder of no more than -1.00d cylindrical correction in each eye after vertexing to the corneal plane; 8. demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log mar in each eye with precision1 contact lenses; 9. is willing to wear precision1 cls at least 5 days per week and 10 hours per day throughout the study; exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment; 7. is aphakic; 8. has undergone refractive error surgery; * for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
comparison of effects between amlodipine and hydrochlorothiazide in combination with losartan on 24-hr central blood pressure in hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (bp) and am central sbp in hypertensive patients:angiotensin ii receptor blocker (arb) plus calcium channel blocker (ccb) or arb plus diuretics


Eligibility criteria:
inclusion criteria: * hypertension patients not included exclusion criteria * mean seated sbp ≥140mmhg in patients with newly diagnosed exclusion criteria: - msdbp≥110mmhg or ms sbp ≥ 180mmhg at the screening and randomization visit
assessing the fertility status of men with spinal muscular atrophy (sma)

Conditions: Fertility Issues

Summary: this study will aim to assess the fertility status of men with spinal muscular atrophy (sma) not on disease-modifying therapies. participants will: 1. complete online questionnaires that will assess sma diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives. 2. over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using dna fragmentation testing using home collection and subsequent shipment to a central laboratory. 3. over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels. during the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.

study participants will: 1. complete online questionnaires that will assess sma diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives. 2. over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using dna fragmentation testing using home collection and subsequent shipment to a central laboratory. 3. over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels. during the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.

Eligibility criteria:
inclusion criteria: * signed informed consent form (or assent) * male and age greater than 18 years and less than 50 years of age with a confirmed diagnosis of sma at the time of signing the informed consent form (or assent) * currently not on a disease-modifying agent or therapy for sma * adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate in the study. exclusion criteria: men with a prior history of chemotherapy, radiation therapy, prostate or testicular cancer, undescended testicles and use of anabolic steroids or testosterone usage will be excluded

Keywords: men spinal muscular atrophy
comparison of quadratus lumborum block and epidural analgesia following kidney transplant surgery

Conditions: Postoperative Pain

Summary: quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block

epidural analgesia is the main choice of analgesia following kidney transplant surgery. however, continuous epidural technique had some concerning side effects such as hemodynamic instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation comfort, it could also cause hypotension which could affect graft success. quadratus lumborum (ql) block had lesser side effects thus could be an option for postoperative analgesia, however there are no study showing the safety and success rate of ql block techniques for patients who underwent kidney transplant surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective kidney transplant laparotomy surgery * agrees to participate in research * bmi \< 30 kg/m2 exclusion criteria: * declines to participate in research * contraindications to intervention procedures (epidural or quadratus lumborum block) * history of local anaesthetic allergy * systemic allergic reactions, anaphylactic reaction, cardiac arrest * failure of intervention procedures (epidural or quadratus lumborum block) * intraoperative complications (massive bleeding, hypotension)

Keywords: quadratus lumborum block continuous epidural postoperative analgesia kidney transplant
elranatamab expanded access protocol in adults with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: elranatamab is a bispecific antibody: binding of elranatamab to cd3- expressing t-cell and bcma- expressing multiple myeloma cells causes targeted t-cell mediated cytotoxicity. this expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-cd38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.

study c1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma. each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.

Eligibility criteria:
inclusion criteria: * prior diagnosis of mm as defined according to imwg criteria . * patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations. * measurable disease at screening based on imwg criteria as defined by at least 1 of the following: * serum m-protein ≥0.5 g/dl (≥5 g/l) * urinary m-protein excretion ≥200 mg/24 hours * involved flc ≥10 mg/dl (≥100 mg/l) and abnormal serum immunoglobulin kappa to lambda flc ratio (\ 1.65). * refractory to at least one imid, one pi, and one anti-cd38 antibody. * relapsed/refractory to last anti-mm regimen. * ecog performance status 0-1. * resolved acute effects of any prior therapy to baseline severity or ctcae grade ≤1. * not pregnant, willing to use contraception exclusion criteria: * smoldering mm; plasma cell leukemia; poems syndrome; waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active gvhd * previous treatment with bcma directed therapy; * active hbv, hcv, sars- cov-2, hiv or any active, uncontrolled bacterial, fungal, or viral infection. active infections must be resolved at least 14 days prior to enrollment. * any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or stage 0/1 with minimal risk of recurrence per treating physician. * previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Keywords: multiple myeloma erlanatamab expanded access mm17 magnetismm-17 bcma bcma antibody advanced multiple myeloma relapse/refractory rrmm magnetismm magnetismm us bispecific antibody
immunogenicity and safety of the japanese encephalitis vaccine ic51 (ixiaro®, jespect®) in a pediatric population in non-endemic countries

Conditions: Encephalitis

Summary: the primary objective is to assess the safety profile of ic51 in a pediatric population from regions where jev is not endemic


Eligibility criteria:
inclusion criteria: * male or female healthy children and adolescents aged \>=2 months to \<18 years at the time of first vaccination * written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable * female subjects: either no childbearing potential or negative pregnancy test. for females after menarche willingness to practice a reliable method of contraception. * the subject is planning to travel to an area where je is endemic after completion of the vaccination schedule. exposure to je should be avoided until 1 week after the second ic51 dose and subjects should return from travel to je endemic areas before the month 7 visit. the planned travel to je endemic areas should not interfere with the study visits and can take place between visit 2 + 7 days to month 7. exclusion criteria: * clinical manifestation or history of any flavivirus disease * vaccination against je (except within this protocol), yellow fever, west nile virus and dengue at any time prior or during the study * history of immunodeficiency or immunosuppressive therapy * known hiv, hbv or hcv infection * history of hypersensitivity reactions to other vaccines * acute febrile infection at each visit during which the subject receives a vaccination * active or passive immunization within 1 week before and 1 week after each ic51 vaccination.

Keywords: pediatric japanese encephalitis vaccine non-endemic countries to assess immunogenicity of purified inactivated japanese encephalitis (je) vaccine ic51
bacterial colonization in tracheostomized patients with neurological or neuromuscular disease

Conditions: Infectious Disorder of Trachea; Respiratory Tract Infections; Mechanical Ventilation Complication

Summary: patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. this study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.

at their admission in raymond poincaré hospital in the long-term ventilation unit for a ventilation check-up, patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease will be included in the study if they have no sign of pneumonia and no contact with a hospital structure within a month. these exclusion criteria allow to focus on non-decompensating patient with a respiratory flora not hospital-acquired and not modified by antibiotics. the doctor in charge of the patient will fill a questionnaire with the help of the patients or the patient's family with several items as date of tracheostomy, history of respiratory infections, history of hospitalization, characteristics of ventilation (presence of a cannula, frequency of change of filter, type of water use in the humidifier...). beside, a tracheal aspirate will be collected and send to the microbiology laboratory for bacterial culture. the tracheal aspirate will be supported as a usual clinical tracheal aspirate but each bacterial specie will be quantify and identify by mass spectrometry. antimicrobial susceptibility testing will be performed only for potential pathogenic species with a cut-off at 105.

Eligibility criteria:
inclusion criteria: * patient of majority age who signed the information note * tracheostomized patient for more than 6 months for a neurological or neuromuscular disease leaving in the community and hospitalized in raymond poincaré hospital for less than 48 hours exclusion criteria: * refusal to take part of the study * not membership in a national insurance scheme * patient under guardianship or curatorship * more than 48 hours hospitalization before tracheal aspirate * hospitalization in the previous month * evolutionary pneumonia at the admission or in the previous month (fever \>38.4°c with respiratory signs of pneumonia as cough, increase of the dyspnea, increase of expectorations associated with radiological opacities of recent appearance) * non-chronical antibiotic treatment in the previous month * patient already included during a previous hospitalization

Keywords: neuroligical or neuromuscular diseases bacterial respiratory tract flora long term tracheostomy
igfbp-3 in ovarian cancer invasion

Conditions: Ovarian Carcinoma

Summary: an ovarian cancer cell line (ovtw-59) derived from an ovarian endometrioid carcinoma was established and its sublines, labeled as p0, p1, p2, p3, and p4 with increasing invasion abilities were selected from transwell invasion chambers.using cdna microarray and verified with quantitative reverse-transcriptase polymerase chain reaction, we have identified igfbp-3 as an invasion-suppressor gene. we plan to study the role of igfbp-3 in ovarian cancer invasion.

we have successfully established an ovarian cancer cell line (ovtw-59), which was derived from an ovarian endometrioid carcinoma. its sublines, labeled as p0, p1, p2, p3, and p4 with increasing invasion abilities, were selected from transwell invasion chambers, where p0 represented the original cell line at 100th passage. by using cdna microarray and verified with quantitative reverse-transcriptase polymerase chain reaction, we have identified the differentially gene expression profiles of these ovtw-59 series cell lines in order to identify the invasion related suppressor and oncogenes from ovarian carcinoma. from these genes, we selected insulin-like growth factor binding protein (igfbp)-3, which is a suppressor gene, and found it lower expressed in higher-grade tumors and correlated with poor patient survival. in vitro, we found igfbp-3 related to the inhibition of cancer cell migration. in this study, we plan to setup stable transfected igfbp-3 cell lines in p0 and p4, and study the relationship among igfbp-3, metalloproteinase-2 (our previous studies which verified its relationship with tumor invasiveness) and insulin-like growth factor (igf)-1. we would study the changes in cytoskeletal structures and the known functions of anti-proliferation and apoptosis in igfbp-3. furthermore, we would like to investigate the mechanism of igfbp-3 in the inhibition of invasion/migration of ovarian carcinoma, either signaling through mapk or pi3k/akt pathways. finally, through xenograft, we plan to study for the possible application of igfbp-3 in ovarian cancer therapy.

Eligibility criteria:
inclusion criteria: ovarian endometrioid adenocarcinoma exclusion criteria: other types of ovaria epithelial cell carcinoma

Keywords: invasion migration metastasis igfbp-3 transfection signal transduction.
myocardial flow reserve and 99mtc-dtpa cardiac dynamic spect

Conditions: Coronary Artery Disease

Summary: new czt-based spect cameras are potentially capable of dynamic 3-d acquisition. preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mtc-labelled perfusion tracers. the flow-heart study will assess the feasibility of myocardial flow reserve measurement by means of 99mtc-dtpa dynamic cardiac spect in 20 patients.


Eligibility criteria:
inclusion criteria: * age over 18 years * patient clinically stable with known or suspected coronary disease * patient referred to caen university hospital for a myocardial perfusion spect * patient who accept to undergo subsequent additional cardiac dynamic spect using 99mtc-dtpa at rest and during pharmacological stress * informed consent dated and signed * affiliation to a social security system exclusion criteria: * contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension) * history of poor tolerance of dipyridamole injection * cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex) * left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator * recent history of myocardial infarction or unstable angina * pregnancy or lactating women * known obstructive renal or urinary disease * age under 18 years or guardianship * patient with an acute coronary syndrome or a coronary revascularization occurring between the conventional perfusion spect and the subsequent 99mtc-dtpa dynamic spect

Keywords: myocardial perfusion imaging single-photon emission computer-assisted tomography
quality of recovery after quadratus lumborum block for cesarean section.

Conditions: Postoperative Pain

Summary: the aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive quadratus lumborum block (qlb) as a part of multimodal analgesia using postoperative quality of recovery scale.

several researchers had evaluated the effectiveness of qlb in controlling postoperative pain in different patient populations. in these studies, the effectiveness of the qlb was mainly assessed by postoperative pain scores and analgesia consumption, rather than adapting any of the more comprehensive recovery scales . postoperative quality of recovery scale (postopqrs) is a relatively new recovery score, which was first published on 2010, and was designed to be a tool for assessment of multiple domains in recovery. in this assessment tool, recovery was defined as return to the pre-surgery base line scores or better. the aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive quadratus lumborum block qlb as a part of multimodal analgesia using postoperative quality of recovery scale.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists (asa) physical status ii, normal singleton pregnancy, 37 weeks gestation or more scheduled for elective cesarean section exclusion criteria: * patients refusing spinal * patients with bmi \>35 kg/m2). * expected difficult surgery (\> 3 previous sections, abnormal placentation, prolonged surgery more than 2 hours from skin to end) and estimated blood loss more than 1500). * expected difficult spinal anesthesia. * abnormal coagulation and other contraindications for spinal anesthesia and/or qlb * patient with chronic pain. * patient treated from psychosis. * patients with communication, language barriers .
effect of high frequency chest wall oscillation vests on spirometry measurements

Conditions: Cystic Fibrosis; Bronchiectasis

Summary: the impact of high-frequency chest wall oscillation therapy on spirometry values (forced expiratory volume, forced vital capacity, peak expiratory flow, forced expiratory flow and tidal volume is investigated during use of several products and comparing to baseline values.

the study will be broken into three (3) arms: * afflovest® \& the vest® * afflovest® \& incourage® * afflovest® \& smartvest® subjects will be randomly assigned to an arm. within each arm, the order of products will be also randomized. baseline spirometry (forced expiratory volume (fev1), forced vital capacity (fvc), peak expiratory flow (pef), forced expiratory flow (fef25-75%) and tidal volume (tv)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject. a product (afflovest or compressor-based vest) will be placed onto subject and turned on to the highest frequency and intensity settings. then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then the product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned on and spirometry measurements will repeated.

Eligibility criteria:
inclusion criteria: * healthy subject, ages 18 - 50 exclusion criteria: * non-ambulatory, diagnosed neuromuscular disorder, currently using any type of oscillation vest therapy, diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease), currently enrolled in a medical research study, non-english speaking