Kornimate/medical-research-clean huggingface dataset:
intra-operative feed back on traction force during vacuum extraction: safe vacuum extraction alliance

Conditions: Hypoxic Ischemic Encephalopathy; Neonatal Convulsions; Subgaleal Hematoma

Summary: the objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates. by randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.

the most common indications for vacuum extraction are dystocia and/or fetal asphyxia. the safety of assisted vaginal delivery with vacuum extraction has been discussed since its introduction almost fifty years ago. serious complications such as asphyxia, intracranial hemorrhage and seizures are overrepresented at vacuum extraction compared to spontaneous vaginal delivery. little has been done to improve the procedure since the introduction. safety measures recommended include restricting total time and number of pulls, a full 34 week gestation, and station of the head at the spines or below. a general advice is also to avoid excessive traction force. there is no general agreement to what a safe traction force might be. with exceeding force there seems to be an increased risk for rupture of the sagittal sinus and tearing of the falx at its attachment to the tentorium. furthermore, when the fetal head is becoming exceedingly elongated and flattened, and as the cup pops off it might cause damage to the brain and blood vessels. during the procedure the obstetrician is under significant stress and the subjective element of the evaluation of traction force is a concern. the difficult decision of whether to continue a heavy extraction or abort the operation is made under stressful conditions and based mostly on subjective impressions. to provide the obstetrician with more objective information, the investigators developed a new device consisting of an intelligent handle hooked to the chain of a regular metal cup.

Eligibility criteria:
inclusion criteria: * medical or social reasons for vacuum extraction with a metal cup, gestational age ≥37+0 weeks, singleton, cephalic exclusion criteria: * multiple pregnancy, breech presentation, gestational age \<37+0
what are the determinations of adult progressive ckd? the renal impairment in secondary care (riisc) study

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease (ckd) affects up to 16% of the adult population and is associated with significant morbidity and mortality. people at highest risk from progressive ckd are defined by a sustained decline in estimated glomerular filtration rate (egfr) and/or the presence of significant albuminuria/proteinuria. accurate mapping of the bio-clinical determinants of this group will enable improved risk stratification and direct the development of better targeted management for people with ckd. to address these requirements we have established the renal impairment in secondary care (riisc) study; riisc is enrolling a cohort of patients at high risk from progressive ckd and compiling a comprehensive and detailed bio-clinical phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent follow-up.


Eligibility criteria:
inclusion criteria: * decline of egfr of ≥5mls/min/year or ≥10mls/min/5years * and/or urinary albumin-creatinine ration (acr) ≥70 mg/mmol on three occasions * and/or ckd 4 or 5 (pre-dialysis) exclusion criteria: * renal replacement therapy * immunosuppression
correlation between nol index after stimulus and post-operative opioid, pain, pre-operative phenotype

Conditions: Pain, Postoperative; Anesthesia; Catastrophizing; Nociceptive Pain

Summary: this study evaluates the correlation between nol index response to standardized stimulus under general anesthesia and the post-operative pain, assessed by opioid consumption and numerical pain scores after video-assisted thoracoscopy (vats).

the nol index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. this monitor is better than any other parameter in grading nociception under general anesthesia. more recently, it has recently been shown a strong correlation between nol index response to nociceptive stimulus and the level of opioid analgesia during surgery. no study has evaluated that nol could predict post-operative pain so far. it has not yet been proven that nol was correlated with post-operative opioid consumption or with post-operative pain scores. some phenotypic factors were previously shown to correlate with post-operative pain and opioid consumption, such as psychological factors and tests, or also assessment of some pre-operative nociceptive thresholds (nt). pain catastrophizing was proven in several studies to correlate with acute post-operative pain. so far, no study compared each of these preoperative psychological factors or nociceptif thresholds to the nol index response to intraoperative standardized pain stimulus in terms of correlation with post-operative opioid requirements and pain scores. moreover, there is no study evaluating the pro-inflammatory protein profiles that might likely be correlated to inter-individual differences in nol response after this standardized nociceptive stimulus under general anesthesia. this study will assess the level of correlation between nol index response to standardized stimulus under general anesthesia and the post-operative pain, assessed by opioid consumption and numerical pain scores after video-assisted thoracoscopy (vats). it also evaluates the correlation between nol index response to standardized stimulus under general anesthesia and pre-operative phenotype and post-operative pain biomarkers.

Eligibility criteria:
inclusion criteria: * adult patient (age 18 or older) * asa status i, ii or iii * elective video assisted thoracoscopy under general anesthesia exclusion criteria: * history of coronary artery disease * serious cardiac arrhythmia (including atrial fibrillation), * history of substance abuse, * chronic use of psychotropic and/or opioid drugs, * use of drugs that act on the autonomic nervous system (including β-blockers), * history of psychiatric diseases, * allergy to any drug used in the study protocol, * refusal of the patient * unexpected difficult airway requesting excessive, possibly painful airway manipulations * unexpected intraoperative complications requiring strong hemodynamic support (transfusions, vasopressors, inotropes) * conversion to thoracotomy

Keywords: monitoring biomarker thoracoscopy
dy001: safety and effectiveness of dyme as an agent for selective staining of the anterior capsule during cataract surgery

Conditions: Mature Cataracts

Summary: the primary objective of this study is to test the hypothesis that dyme is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (ccc) by selectively staining the anterior capsule. secondary objectives are to compare the safety and effectiveness of dyme to that of a smaller dose of the same api.


Eligibility criteria:
inclusion criteria: * have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery; * be aged at least 18 years old at the time of enrollment; * be able to tolerate a surgical procedure for up to 3 hours; * be in a medical condition suitable for cataract surgery; * able and willing to participate in study examinations and visit schedule; and * understand and freely consent to participate in the study. exclusion criteria: * in either eye, ocular infection or inflammation within the past 3 months; * known allergy to bbg 250; * uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; * active treatment for cancer or systemic infection within the past month; * active treatment with systemic corticosteroids within the past month; * previous participation in this study for the contralateral eye; * participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer; * unwillingness to participate in the study or inability to give informed consent; or * any medical condition that in the opinion of the investigator may compromise the research subject's safety or ability to participate in the study.
spermqt prospective observational trial

Conditions: Male Infertility

Summary: the goal of the study is to validate the ability of the epigenetic sperm quality test (spermqt) to assess a man's sperm quality and corresponding success of infertility treatments.

this prospective study will consist of analyzing a man's semen sample to determine the patient's spermqt score and following the success of each fertility treatment to produce a pregnancy and live birth. physicians and patients will be blinded to spermqt results.

Eligibility criteria:
inclusion criteria: * the subjects have been recommended to pursue iui, or they have recently completed an iui (regardless of outcome) * male partner is under 45 years of age * female partner is under 38 years of age * the total motile sperm count from the raw semen analysis must be greater than or equal to 10 million exclusion criteria: * the female or male partner have a bmi equal to or greater than 40 * the male partner has undergone male testosterone replacement therapy in the last 6 months * either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses * there are any known factors contributing to female factor infertility, such as but not limited to: * severe endometriosis (stage 3 or higher, endometrioma on ovaries) * multiple uterine fibroids 5cm or larger * severe asherman's syndrome * severe mullerian anomaly * lack of tubal patency in at least one fallopian tubes

Keywords: epigenetics
studying rna in samples from younger patients with t-cell acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer purpose: this laboratory study is looking into rna in samples from younger patients with t-cell (t) acute lymphoblastic leukemia (all).

objectives: * characterization of the transcriptomic landscape in diagnosis and relapse of t-cell acute lymphoblastic leukemia (all) and the direct comparison with corresponding physiological samples (human thymus). * perform high-throughput transcriptome ribonucleic acid (rna) sequencing using matched diagnostic t-precursor pediatric all samples (peripheral blood or bone marrow). outline: archived peripheral blood and bone marrow samples are analyzed for long non-coding rna (incrna) expression and sequencing.

Eligibility criteria:
disease characteristics: * peripheral blood and bone marrow samples from pediatric patients with diagnosed and relapsed t-all patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: t-cell childhood acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia
prediction of uterine atony after vaginal delivery by elastography

Conditions: Postpartum Hemorrhage

Summary: prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. the investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. this study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. one co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * cephalic presentation * maternal age \> 18 years old * nulliparous * healthy uncomplicated pregnancy * gestational age between 37-42 weeks of gestation * spontaneous labour and delivery * uncomplicated progression of labour (cervical dilatation at \>1 cm/h) * administration of less than 3 units of oxytocin during the second stage of labour * patient having read, accepted and signed the consent form exclusion criteria: * antepartum hemorrhage in the present pregnancy * protracted second stage of labour (more than two hours from full dilatation to delivery) * more than 30 minutes of active pushing * bmi \> 35 kg/m2 * distance from skin to uterus \> 8 cm * age \> 35 years old * instrumental deliveries * bleeding disorders * polyhydramnios * diabetes * pre-eclampsia * high blood pressure * use of anticoagulant medications * clinical chorioamnionitis * placental abnormality (low-lying or abruption) * fetal macrosomia * uterine fibroids * uterine anomalies * previous uterine scar * multiple pregnancy * placental retention * inability to follow procedures or insufficient knowledge of project language * inability to give consent * refusal to participate

Keywords: postpartum hemorrhage uterine atony shear wave elastography
study with dual therapy including lamivudine (300 mg qd) plus raltegravir (1200 mg qd) in virologically suppressed hiv-1 infected patients experiencing inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions with their current regimen

Conditions: HIV Seropositivity; HIV Infections; HIV-1-infection

Summary: phase 3b, single arm, simplification study with dual therapy including lamivudine (300 mg qd) plus raltegravir (1200 mg qd) in virologically suppressed hiv-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.


Eligibility criteria:
inclusion criteria: * eligible patients will be males or females at least 18 years of age. women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study. * patients seropositive for hiv-1 using standard diagnostic criteria. * patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen * patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/ml). * patients who have signed informed consent to participate in the study. exclusion criteria: * pregnancy, lactation, or planned pregnancy during the study period. * previous failure to an integrase inhibitor-containing regimen. * previous failure to a lamivudine or emtricitabine-containing regimen. * resistance mutations to lamivudine or integrase inhibitor if any resistance test had been previously performed. * any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment. * chronic hepatitis b.

Keywords: lamivudine raltegravir
the rapid switch from 1st generation somatostatin analogues to pasireotide in acromegaly

Conditions: Acromegaly

Summary: this is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of time to switch (tts) from first-line to second-line medical therapy in acromegaly.

the study will retrospectively collect clinical, laboratory and anamnestic data of approximately 100 patients evaluated at the uos involved in the study in last 5 years and 6 months. acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide lar or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. the tts is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of gh levels ≥1 μg/l and igf-1\>1.3×uln (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.

Eligibility criteria:
inclusion criteria: * adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age * patients inadequately controlled with first generation somatostatin analogues (gh ≥1 μg/l and igf-1 \>1.3×uln) * second line medical treatment (pasireotide; pegvisomant only; combination pegvisomant + 1st generation ssa) after use of first-line medical treatment * at least 12 months of follow up during 2nd line therapy * signature of the informed consent to the study exclusion criteria: * age ≤18 years * pregnant and/or breastfeeding women * patients unable to understand and sign the informed consent

Keywords: somatostatin analogues pasireotide pegvisomant
a multiple-dose escalation study to evaluate the safety, tolerability and pharmacokinetic of hs-10383

Conditions: Cough

Summary: this study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of hs-10383 in healthy subjects using a randomized, double blind, placebo controlled, single center study design.

hs-10383 is a selective p2x3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. this phase 1b study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of hs-10383 administered orally to healthy subjects.

Eligibility criteria:
inclusion criteria: 1. healthy participants aged from 18 to 45 years 2. subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily sign the informed consent; 3. male weight ≥ 50kg, female weight ≥ 45kg, body mass index {bmi, bmi=weight/height 2 (kg/m2)} is controlled within the range of 18\~26 (including the critical value); exclusion criteria: 1. the following medical histories, such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system and tumor, etc., were screened. evaluated as unsuitable to participate in this study; 2. any known presence or history of hypogeusia, abnormal taste or dysgeusia; 3. any known presence or history of severe allergies, or known to be allergic to the components of the test drug; 4. use of any drugs, including prescription drugs, over-the-counter drugs or herbal preparations, cannot be avoided or expected to start 2 weeks (or 5 half-lives) before screening and throughout the study period; 5. any findings of electrocardiogram outside from normal, such as the qt interval (qtcf) corrected by the fridericia formula, the absolute value of qtcf for males is \>450 ms, and the absolute value of qtcf for females is \>470 ms; 6. any findings of blood pressure or pulse in resting state outside from normal a: such as systolic blood pressure \ 100 bpm;

Keywords: rucc, p2x3
efficacy of bucelipase alfa (bssl) in patients with cystic fibrosis and pancreatic insufficiency

Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Summary: the purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with bssl

in this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. after the baseline period, patients will enter a treatment period of 6 days where a fixed dose of bssl will be administered. the primary efficacy measurements will be made by collecting stool during the last three days of each period.

Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis and pancreatic insufficiency who are able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to produce stools \>= 5 times per week

Keywords: cystic fibrosis pancreatic insufficiency bucelipase alfa bile salt stimulating lipase bssl coefficient of fat absorption
decatecholaminisation of septic shock with dexmedetomidine and in-hospital mortality

Conditions: Septic Shock; Sepsis

Summary: the study aims to determine whether the infusion of dex in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

during septic shock, acute stress response includes neural and humoral autonomic flaring, which tend to be beneficial in the short term. once shock occurs, it is a failure of the compensation trial. in addition, chronic autonomic stimulation risks myocardial injury, immunosuppression, insulin resistance, and thrombo-embolic tendency. the investigators hypothesized that dacatecholaminisation with dexmedetomidine - as calibrated by heart rate control - would reduce the in-hospital mortality in septic shock, whether the patient is mechanically ventilated or not. the study aims to determine whether the infusion of dex in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) patients of either sex who develop septic shock with heart rate (hr) \> 90 beats per minute (bpm). we choose the definition of septic shock as the start of norepinephrine (ne) infusion to maintain the mean arterial blood pressure (map) of ≥ 65 mmhg in a case of sepsis (≥ 2 sirs criteria plus suspicion or confirmation of infection). exclusion criteria: * patient refusal or inability to obtain consent * failure of hemodynamic stabilization or hemoglobin \< 7 gm/dl at time of inclusion * severe cardiac dysfunction (ejection fraction (ef) \< 30%) * history of heart block or patient on pacemaker * chronic liver disease (child-pugh classification c) * severe valvular heart disease * pregnancy

Keywords: dexmedetomidine randomized controlled trial
relationship of mindfulness, artistic activities and quality of life

Conditions: Quality of Life

Summary: methods: this study has the descriptive-correlational method and the statistical population was all artistic females of bojnord city in 2018. in this study, 200 women of carpet weavers were selected by cluster random sampling. participants filled out researcher-made questionnaires on how to do artistic activities, mindfulness, and quality of life. data were analyzed using the pearson correlation coefficient and hierarchical regression (moderator).


Eligibility criteria:
inclusion criteria: * be female, having 21 -60 years old, to work in workshops of weaving carpet, be literacy exclusion criteria: * be male, having under 21, upper 60, no work in workshops of weaving carpet , having psychotic disorders, be illiteracy