Kornimate/medical-research-clean huggingface dataset:
avoiding hypotension in preterm neonates

Conditions: Hypotension

Summary: objectives firstly to examine in preterm neonates, whether it is possible to reduce number of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared spectroscopy in combination with predefined interventions and secondly to explore the potential impact on cerebral injury and mortality. hypothesis by using predefined interventions for changes in cerebral/peripheral oxygenation ratio investigators will reduce hypotensive episodes and use of catecholamines which will reduce cerebral injury and mortality. methods cerebral (ctoi) and peripheral-muscle (ptoi) tissue-oxygenation-index (niro 300) will be measured for 24h starting \ 5% within a 6h period, predefined interventions will be performed. primary outcome parameter will be duration of hypotensive episodes and use of catecholamines during the first 48h after birth. secondary outcome parameters will be cerebral injury and mortality.


Eligibility criteria:
inclusion criteria: * preterm neonates * decision to conduct full life support * written informed consent * age \<6 hours * no use of catecholamines before start of nirs measurements exclusion criteria: * no decision to conduct full life support * no written informed consent * age \>6 hours * use of catecholamines before start of nirs measurements * congenital malformation
a study to evaluate the safety and efficacy of covid-19 convalescent plasma (ccp) transfusion to prevent covid-19 in adult recipients following hematopoietic stem cell transplantation

Conditions: COVID-19; Hematopoietic Stem Cell Transplantation

Summary: the study is to evaluate the safety and efficacy of covid-19 convalescent plasma (ccp) transfusion to prevent covid-19 in adult recipients following hematopoietic stem cell transplantation. 72 patients will be randomized in a 1:1 ratio to receive either ccr (36 patients) or not (36 patients). patients in the ccp group will receive 200 ml of ccp at +14 days, +28 days, +2 months, and +3 months following hematopoietic stem cell transplantation. patients in the control group would be routinely given oral ursodeoxycholic acid for +14 days after transplantation. the primary goal of the study is to evaluate the safety of ccp and the incidence of covid-19 infection within +28 days after the last infusion of ccp.


Eligibility criteria:
inclusion criteria: 1. receive hematopoietic stem cell transplantation 2. be ≥ 16 years of age on the day of enrollment. 3. understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. exclusion criteria: 1. positive serological response to known hiv or active hepatitis c virus. 2. patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring. 3. unable or unwilling to sign consent form. 4. patients with other special conditions assessed as unqualified by the researchers. 5. patients suffered covid-19 infection between day 0 and infusion of ccp after transplantation. drop-out and withdrawal criteria 1. failure of engraftment within 30 days of transplantation; 2. patients who are not compliant with the requirements of the study and fail to follow the study plan. 3. patients receiving prophylaxis for covid-19 infection by methods other than this protocol during the trial. 4. a patient may withdraw from the study if he/she does not wish to continue participating in the study, and the date and reason for withdrawal shall be recorded. the investigator may also decide to discontinue a patient from the clinical study if there is an unacceptable risk.

Keywords: covid-19 convalescent plasma hematopoietic stem cell transplantation
evaluation of a dose reduction of darunavir (400 mg/d) in virologically suppressed hiv-1 patients

Conditions: HIV INFECTION

Summary: phase ii trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in hiv-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (nrti), to maintain the viral load lower than 50 copies / ml at 48 weeks of treatment.

principal objective: to evaluate the proportion of subjects virologically suppressed at week 48 (viral load=vl ≤ 50 cp/ml) under a tri-therapy containing the darunavir at the dose of 400 mg/d. secondary objectives: to evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed vl \> 50 cp/ml) confirmed by a 2nd measure made between 2 to 4 weeks, with vl ≤ 50 cp/ml and between 20 and 50 cp/ml, emerging drug resistance if virological failure, cd4 cell count evolution, hiv dna evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir cd4 cell count, darunavir plasma level, baseline hiv dna viral load.

Eligibility criteria:
inclusion criteria: * hiv-1 infected adults, * age ≥ 18 years, * with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 nrti (≥ 6 months), * virologically controlled (vl ≤ 50 cp/ml, * ≥ 1 year, * at least 2 vl spaced at least 3 months apart in the last 12 months) cd4 count ≥ 300/mm3 ≥ 6 months, * virus sensible to darunavir and the used nrti (pretreatment resistance genotypic test available) and * with no history of virological failure (vl \> 200 cp/ml after ≥ 6 months under pi and/or used nrti), * no current opportunistic infection, * renal clearance ≥ 60 ml/min if tenofovir is used, * transaminases (sgot, sgpt) plasma levels \< 2n, * hemoglobin \> 11 g/dl, * platelets count \> 150 000/mm3, * negative pregnancy test in women with childbearing potential, * informed written consent signed by both the investigator and the subject, * national insurance scheme (article l1121-11 of the french public health code), * no participation to any other clinical trial exclusion criteria: * hiv-2 infection, * current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 nrti, * virus genotypically resistant to darunavir and the used nrtis, * history of virological failure (vl \> 200 cp/ml after ≥ 6 months under pi and/or used nrti), * irregular follow-up and/or history of lack of adherence to art ≤ 12 months, * current pregnancy, * current opportunistic infection, * associated treatment containing one or more drugs interacting with hepatic cytochromes, * any addictive behaviors (alcohol consumption, drugs ...) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.
polycystic ovary syndrome (pcos): effect of letrozole and berberine

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (ir), and progression to type 2 diabetes.since the ming dynasty in china,pcos has been defined as "phlegm and wetness"infertility in traditional chinese medicine ,namely "metabolic infertility".chinese herbs have been used to treat pcos for thousands of years with good effects.berberine has also been used for diabetic patients in traditional chinese medicine for hundreds of years. recent studies have reported its effects on hyperglycemia and dyslipidemia.the purpose of this study is to determine whether letrozole combined with berberine are effective in the treatment of infertile pcos patients.


Eligibility criteria:
inclusion criteria: * chinese women * age between 20 and 40 years. * confirmed diagnosis of pcos according to the rotterdam 2003 criteria (2 out of 3): 1. oligo- or anovulation 2. clinical and/or biochemical signs of hyperandrogenism 3. polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, cushing's syndrome) * at least one patent tube and normal uterine cavity shown by hysterosalpingogram, hycosi or diagnostic laparoscopy within three years. * sperm concentration 20×106/ml and progressive motility (grades a and b) ≥50%. exclusion criteria: * use of hormonal drugs or other medications including chinese herbal prescriptions in the past 3 months. * patients with known sever organ dysfunction or mental illness. * pregnancy, post-abortion or postpartum within the past 6 weeks. * breastfeeding within the last 6 months. * not willing to give written consent to the study.

Keywords: polycystic ovary syndrome
quickopt chronic study

Conditions: Heart Failure

Summary: the purpose of this study is to demonstrate that quickopt optimization can be as an alternative method for crtp/d patients' optimization in clinical practice through the comparison of the improvement differences between the crtp/d patients with different optimization at 12 months after implantation.the hypothesis is that the heart remolding parameter (lvesv) improvement of patients using quickopt parameters at 12 months after implant is not inferior (10%) to the patients by echo optimization。

clinical studies have demonstrated that the avti from quickopttm related significantly to the max aorta vti (avti) by echo, the concordance correlation coefficient (ccc) was so high from 0.96 to 0.99. but up to now, there are no clinical trials to evaluate mid-long term clinical outcome for crtp/d patients by quickopttm and echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.

Eligibility criteria:
inclusion criteria: * • patient meets current crt-p indications and be implanted with an sjm crt-p device with v-v timing and a compatible lead system * patient is able to provide written informed consent for study participation exclusion criteria: * • patient has limited intrinsic atrial activity (≤ 40 bpm) * patient has persistent or permanent af * patient has a 2o or 3o heart block * patient's life expectancy is \<12 months * patient is \<18 years old * patient is pregnant * patient is on iv inotropic agents * patients who are ongoing other devices or agents study * patients with heart transplanted or waiting for heart transplant * patients with hypertrophic and obstructive cardiomyopathy * patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement

Keywords: crt heart failure optimization timing cycle optimization methods
exercise training post burn injury

Conditions: Burns

Summary: the purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.

even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. while exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe. this study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.

Eligibility criteria:
inclusion criteria: * burns greater than 20% total body surface area * 18 years of age and over * english speaking * post final grafting procedure exclusion criteria: * accompanying anoxic brain injury * cardiac disease or injury (american college of sports medicine acsm criteria) * quadriplegia * severe behaviour or cognitive disorders * compassionate care only

Keywords: burns
preemptive co-infiltration of dexamethasone palmitate with ropivacaine for postoperative pain in major spinal surgery

Conditions: Pain, Postoperative

Summary: patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. inadequate pain control may lead to severe complications. dexamethasone as an adjunctive infiltration to local anesthesia (la) presented a superior analgesic benefit compared with la alone in various types of surgeries. however, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. compared with dexamethasone, dexamethasone palmitate emulsion (dxp) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. to date, no studies have evaluated the additive analgesia effects of dxp on incision infiltration in major spinal surgery. the purpose of this trial is to determine whether preemptive co-infiltration of dxp emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.


Eligibility criteria:
inclusion criteria: * age 18-64 years; * patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia * american society of anesthesiologists (asa) physical status of i-iii; * anticipated full recovery and cooperation within 2 hours postoperatively. exclusion criteria: * history of spinal surgery; * inability to use a patient-controlled analgesia (pca) pump or comprehend the pain visual analog scale (vas); * body mass index (bmi)\ 35kg/m2; * peri-incisional infection; * history of diabetes mellitus and other metabolic diseases; * history of severe cardiopulmonary, hepatic or renal dysfunction; * preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value); * history of allergies to any of the study drugs; * history of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery; * use of systemic steroids within 1 week before surgery; * history of psychiatric disorders, chronic neck or back pain; * history of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively; * pregnant or breastfeeding; * refusal to sign informed consent.
human neural stem cell transplantation in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: primary aim of the trial 1. to verify safety and tolerability of expanded human fetal neural stem cells 2. to verify safety and tolerability of a microsurgery human fetal neural stem cells transplantation model 3. to recognize each change in patient's quality of life secondary aim of the trial 1. assessment of the impact of human neural stem cells transplantation on the disability of als in a clinically significant and measurable way 2. assessment of the impact of human neural stem cells transplantation on mortality (all causes)

18 patients diagnosed as definite als according to the el escorial criteria will be recruited during two years. the patients will be divided into 3 groups with different severity. each group will be less compromised than the group that went before them. their breathing measurements must be at least 60%. subjects will receive injections of the human foetal neural stem cells into the spinal cord. a variety of tests and examinations will take place every month for the first year and every three months for the next two in order to monitor the course of the disease and the adverse events.

Eligibility criteria:
inclusion criteria: * diagnosis of definite or possible als according to revised el escorial criteria * age: 20-75 years * documented progression of disease during the last 6 months. * absence of concomitant diseases * adequate assurances of adherence to protocol * the patient must be able to communicate verbally or with the use of non-verbal communication system group 1 * maximum score of 1 on walking item of als functional rating scale * forced vital capacity \> or equal to 60 group 2 * forced vital capacity \> or equal to 60 * ambulation difficulties (maximum score of 2 on walking item of als functional rating scale) group 3 * independent ambulation (score 4 on a scale als-frs) * forced vital capacity \> or equal to 70 exclusion criteria: the presence of at least one of the following will lead to patient exclusion. 1. psychiatric diseases or other neurological diseases different from als 2. other systemic diseases 3. neoplasms or other diseases reducing life expectancy 4. antecedent polio infection 5. corticosteroids, immunoglobulin or immunosuppressive treatment 6. involvement in other clinical trials 7. 2 or more critical items in mmpi 8. neuropsychological evaluation suggestive of mental deterioration or cognitive sphere disturbance. 9. impediments to mri 10. patients unable to understand informed consent form and study aims. 11. women who are pregnant or childbearing potential for the duration of the study. non-pregnant status will be documented by beta-hcg negative test 7 days before treatment start

Keywords: amyotrophic lateral sclerosis motor neuron disease stem cells safety als-frs-functional scale r and fvc (%) variation survival analysis changes in quality of life scales
study of treatment of lisfranc injuries

Conditions: Foot Injury

Summary: this trial is designed to compare different treatments on lisfranc fractures. the trial consist of 2 different strata. stratum 1: in mild injuries the comparison is between conservative treatment and operative treatment with open reduction and internal fixation (orif). stratum 2: in severe injuries the comparison is between operative treatment with open reduction and internal fixation (orif) and primary arthrodesis. the primary outcome measure will be aofas midfoot score, and secondary outcome measure will be vas foot and ankle.

the aim of this study is to find out the most effective way to treat lisfranc injuries

Eligibility criteria:
inclusion criteria: stratum 1: * nondislocated fractures affecting tarsometatarsal (tmt) joints ii and iii * dislocation \<5mm between medial cuneiforme and base of ii metatarsal (mt) * no fractures affecting tmt joints iv and v stratum 2: * affected joints tmt ii- iii + any other tmt * any dislocation \>2mm (fracture or tmt joint) * dislocation \>5mm between medial cuneiforme and base of ii mt exclusion criteria: * open fractures * extra-articular metatarsal (mt) fractures * extremely comminuted fractures with bone loss, and slight chance of gaining proper reduction with screws * patients with multiple fractures * patients with weak co-operation (dementia, alcohol use, etc.) * patients with significant neuropathy or some other neurological condition, diabetes and rheumatoid arthritis * patients with severe circulatory disorder of the lower limb * injuries over 14 days * patients with previous foot injury or surgery * pregnancy * patients who refuse to participate
vitality health incentives for physical activity

Conditions: Obesity

Summary: the aim of the study is to prospectively compare the effectiveness of diverse incentives on physical activity behaviour, in a cohort of newly-enrolled, adult members of the vitality health promotion programme based in south africa.

newly enrolled adult members of the discovery health medical plan who have, themselves, prospectively registered for the vitality health promotion programme will be eligible for the study, and will be invited to participate by discovery vitality. a final sample of 9000 adult members, who are recruited and have agreed to participate, will be randomly allocated by discovery vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed for six months.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * enrolled in vitality exclusion criteria: * under 18 years of age

Keywords: obesity sedentary physical activity exercise incentives
dedinje ffr/qfr registry

Conditions: Coronary Artery Disease (CAD); Fractional Flow Reserve

Summary: quantitative flow ratio (qfr) has shown good diagnostic performance against fractional flow reserve (ffr) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. however, the reproducibility of qfr is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 qfr procedure experience) are performing the analysis. although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with ffr, the concern about the diagnostic performance of qfr in real-world clinical practice by inexperienced users remains. the primary objective of "dedinje ffr/qfr registry" is to determine the feasibility and diagnostic performance of qfr analysis by vendor-certified inexperienced medical users in a real-world setting using ffr as the gold standard. all patients \>18 years old who present to the institute for cardiovascular diseases "dedinje" and undergo a planned or ad hoc ffr procedure will be asked to participate in the registry. ffr procedure is performed according to the standardized institutional protocol. qfr analysis will be subsequently performed offline according to a standard operating procedure.


Eligibility criteria:
inclusion criteria: * \>18 years old * had a clinically indicated ffr procedure performed (either as a planned procedure or ad hoc) exclusion criteria: * declines to participate in the registry and provide informed consent

Keywords: coronary artery disease fractional flow reserve quantitative flow ratio ffr qfr
study on the safety and efficacy of convalescent plasma in patients with severe covid-19 disease

Conditions: Severe COVID-19 Disease

Summary: currently, there is no specific treatment or vaccine for sars-cov-2 available, some drugs are being investigated as treatment, but the effect is unknown. a strategy and other method used before, in coronavirus pandemic (sars-cov in 2003 and mers-cov in 2012), was the use of immune (convalescent) plasma. passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat covid-19 disease. this research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe covid-19 disease.

a randomized clinical trial comparing administration convalescent plasma to standard therapy for severe covid-19 disease. patients will be randomized 1:1 in a single blind study. the patients with sars-cov-2 pcr confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. our primary outcomes will be disease progression and mortality, evaluate of ordinal scale for clinical improvement and. (who)

Eligibility criteria:
inclusion criteria: * o2 saturation \<93% * radiographic evidence of moderate pneumonia according to rale's classification. * acute respiratory distress syndrome (pao2 / fio2 \<300 or spo2 / fio2 ≤ 315) * authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated) exclusion criteria: * pregnant patients * history of transfusion reactions * patients with congestive heart failure * patients with a history of chronic kidney failure on dialysis * patients with multiple organ failure * patients who does not accept or agree with the treatment.

Keywords: sars-cov2 convalescent plasma severe acute respiratory syndrome