Kornimate/medical-research-clean huggingface dataset:
anakinra for covid-19 respiratory symptoms

Conditions: COVID-19 Infection; ANAKINRA Treatment; Optimized Standard of Care (oSOC)

Summary: the main objective of the anaconda-covid-19 trial is to assess the efficacy of anakinra + optimized standard of care (osoc) as compared to osoc alone on the condition of patients with covid-19 infection and worsening respiratory symptoms. success defined as patient alive and free of invasive mechanical ventilation (imv) and free of extracorporeal membrane oxygenation (ecmo) at day 14.


Eligibility criteria:
inclusion criteria: * male or female≥ 18 years of age * written informed consent of the patient or a proxy * ability for participant to comply with the requirements of the study * hospitalized patient with covid-19 defined as * positive sars-cov2 rt-pcr * or typical covid-19 radiographic infiltrates on the ct scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non covid-19 diagnosis ruled out. * patient with respiratory symptoms and requirement of oxygen therapy as defined: * oxygen therapy \>= 4l/min to maintain sp02\>92% and respiratory rate \>=24/min. * or patients under oxygen \>= 1l/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy \>= 2l/min to maintain sp02\>92%. * inflammatory component c-reactive protein ≥ 50mg/l. * patients within the first 20 days from the onset of the first covid-19 symptoms * probabilistic antibiotics therapy according to local practice non-inclusion criteria: * respiratory failure related to other cause than covid-19 * patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain sp02\>92% * infectious diseases such as severe bacterial infections, aspergillosis, hiv, active hcv, active hbv, active tuberculosis * contra indication to anti-il1 receptor * known hypersensitivity to anakinra * absolute neutrophil count (anc)\< 1500/mm3 * liver cirrhosis child-pugh score c * live or attenuated vaccine in the past 8 weeks * pregnant or breast-feeding women * patients with either legally protected status or who have been deprived of their freedom * patient included in other interventional therapeutic research (e.g. = concurrent participation in french covid-19 is accepted) * patients who have received previous treatment by anti-il6r, anti-il-6, anti-il1r, anti-il1 or anti-tnfα within 21 days preceding inclusion * absence of health insurance * existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.
prolonged progesterone to prevent preterm birth from ivf - et

Conditions: Preterm Birth

Summary: to investigate the incidence of preterm birth in ivf fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment

participant: 20-40 years old, ivf fresh embryo transplantation, singleton pregnancy, blood/urine hcg (+) control group: the administration of vaginal progesterone (90mg/d) began from positive hcg in blood/urine until 12 weeks of gestation. regular delivery examinations were conducted, and cervical length was detected by b-ultrasound at 12, 16, 20 and 24 weeks of gestation respectively, while fetal growth and development were monitored. follow-up was continued until the end of delivery. trial group: the administration of vaginal progesterone (90mg/d) began from positive hcg in blood/urine until 24 weeks of gestation. regular delivery examinations were conducted, and cervical length was detected by b-ultrasound at 12, 16, 20 and 24 weeks of gestation respectively, while fetal growth and development were monitored. follow-up was continued until the end of delivery. observation index: the gestational age of delivery, symptoms of preterm birth and gestational age, gestational age at preterm birth or abortion, fetal growth and development, neonatal outcomes, and drug-related adverse reactions were recorded for each participant.

Eligibility criteria:
inclusion criteria: * 1. 20-40 years old 2. met the conditions of assisted reproductive technology and underwent ivf fresh embryo transplantation 3. singleton pregnancy 4. patients volunteered and signed informed consent prior to the trial. exclusion criteria: * 1. \>40 years old 2. history of miscarriage or cervical insufficiency in the second trimester 3. abnormal ovarian function or surgical history: decline in ovarian reserve, premature ovarian failure, turner's syndrome, ovarian cyst excision, pcos perforation/coning, chocolate cyst surgery, ovarian cone resection 4. uterine deformities: including single horn uterus, double horn uterus, residual horn uterus, saddle uterus, infantile uterus, double uterus, mediastinal uterus 5. diseases affecting uterine shape: uterine adhesions, uterine submucosal myomas or polyps, adenomyosis, chronic inflammation of the endometrium 6. abnormalities in cervical morphology or function. 7. history of total cervicectomy, conical excision, and cervical insufficiency 8. vaginal inflammation: refractory candida vaginitis, bacterial vaginosis, persistent mycoplasma-positive vaginosis, persistent chlamydia-positive vaginosis 9. b ultrasonography indicates twin or multiple pregnancies 10. patients with severe medical and surgical diseases 11. participants who had participated in other clinical trials during the 90 days or had received any investigational clinical drug during the 30 days prior to the trial 12. patients with no long-term follow-up or poor compliance 13. the investigator believes that there are any factors that may affect participants' participation in the study or the evaluation of the results
dose-finding study with act-132577 (aprocitentan) in participants with essential hypertension

Conditions: Essential Hypertension

Summary: the main objective will be to evaluate the dose-response of act-132577 (aprocitentan) on diastolic blood pressure (dbp) in participants with grade 1 or 2 essential hypertension. secondary objectives will be to evaluate the dose-response of act-132577 on: systolic blood pressure (sbp); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (abpm) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of act-132577.

participation in the study is planned to last up to 18 weeks. a single-blind placebo run-in period of 4 to 6 weeks after which participants will be randomized into a double-blind treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study visit approximately 12 weeks after randomization.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure * no contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening * mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s): -- mean (of 5 measurements) sitting diastolic blood pressure (sidbp) ≥ 90 to \< 110 mmhg measured by office blood pressure measurements (obpm). * women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception exclusion criteria: * severe hypertension (grade 3): mean sitting systolic/diastolic bp (sisbp/sidbp; measured by obpm) ≥ 180/110 mmhg, respectively. * secondary hypertension * known hypertensive retinopathy greater than keith-wagener grade 2 * myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 months prior to randomization * unstable angina within 6 months prior to randomization * heart failure new york heart association class iii and iv * valvular defects (such as severe aortic or mitral valve disease) and/or hemodynamically relevant rhythm disturbances * clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident within 6 months prior to randomization. * subjects working night shifts * body mass index \ 40 kg/m2 * treatment with any medication which may affect bp (e.g., treatment of psychiatric diseases, ophthalmic preparations) * treatment with strong cytochrome p450 3a4 (cyp3a4) isoenzyme inhibitors or inducers * treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1 month prior to screening (visit 1) * treatment with another investigational treatment within 1 month prior to screening (visit 1) * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
comparison of bone graft and photodynamic therapy in class ii furcation

Conditions: Furcation Defects

Summary: this is a surgical comparative clinical trial which aims to assess class ii buccal furcation defects treated with xenograft alone or preceded by antimicrobial photodynamic therapy.

to test the efficacy of photodynamic therapy (indocyanine green) along with placement of xenograft (cerabone®-natural bovine bone grafting material, botiss biomaterials) to treat a class ii furcation defects. the topical study was designed as a randomized controlled, single blinded (patient), split mouth clinical trial with 14 participants. in the control group, the defects were filled with xenograft (cerabone®) whereas the test group received photodynamic therapy (indocyanine green) in addition to grafting. radiovisiography technique was used to observe the possible changes in the furcation region at baseline and 9 months postoperatively.

Eligibility criteria:
inclusion criteria: systemically healthy subjects age group of 25-60 years presence of class ii furcation defect on buccal surfaces of mandibular molars as determined by clinical and radiographic evaluation. vertical probing depth (vpd) ≥4mm horizontal probing depth (hpd) ≥4 mm gingival margin (gm) coronal to or at the level of the roof of the furcation exclusion criteria: current and former smokers administration of antibiotics in the last 6 months history of any periodontal therapy in the past 6 months known allergic responses to bovine derived graft materials and photosensitizers. pregnant and lactating women.
fentanyl sublingual spray for the treatment of acute procedure-related pain in a monitored setting

Conditions: Chronic Pain

Summary: participants will be selected from patients who have been scheduled at the site for treatment of chronic pain without sedation. they will receive either fentanyl sublingual spray or a matching placebo sublingual spray that delivers no medication. participants may take pain killers at any time after the procedure for pain relief. they will be given a diary card, which they will take home. they will record the name of the medication taken, the time, and dosage. the study coordinator will call participants about 24 hours after the procedure to collect information from the diary card and follow up information about pain and side effects (adverse events) after they left the site.

participants will be separated into opioid-experienced and opioid-naïve groups. participants in each group will be randomly allocated in a 3:1 ratio to receive fentanyl sublingual spray (fss) or a matching placebo sublingual spray (pss) 10 minutes before the scheduled procedure. based on fda guidelines, opioid-experienced fss participants will receive fss 400 µg, and opioid-naïve fss participants will be further randomized in a 1:1 ratio to receive either 100 µg or 200 µg. all participants randomized to placebo receive the same matching pss, regardless of opioid experience. pain and sedation will be recorded multiple times during the scheduled procedure. if rescue medication is needed during the procedure, local anesthetic standard of care for the procedure will be administered and recorded in the study record. efficacy and safety/tolerability of fentanyl sublingual spray will be evaluated among and between the treatment groups.

Eligibility criteria:
inclusion criteria: * has scheduled an interventional procedure for treatment of pain without sedation * has cleared pre-operative assessment * is able to read or understand informed consent form, and gives consent to participate in the study exclusion criteria: * is taking any form of fentanyl * has oral pathology that would prevent effective absorption of study medication * was treated with an investigational drug within protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding), 3) the analysis of results
impact of shared decision-making with decision aids on acoustic neuroma treatment choice: a randomized controlled trial

Conditions: Neuroma, Acoustic

Summary: patients with acoustic neuroma had several treatment options. one of standard treatment is to receive the gamma knife stereotactic radiosurgery, other options included suboccipital craniotomy and conservative treatment. thus, shared decision making (sdm) is necessary to aid patients to choose an appropriate treatment that suits their needs. the investigators have developed a decision aids (das) and plan to conduct a randomized controlled trial (rct) to evaluate its impact on acoustic neuroma patients. the measurements include a battery of interview-based questionnaires and evaluations of decision regret and post-treatment depression. the investigators expect the das would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.


Eligibility criteria:
inclusion criteria: 1. patients with acoustic neuroma. 2. tumor diameter ≤ 3.5cm. 3. the tumor type is schwannoma. exclusion criteria: 1. patients with acoustic neuroma less than 20 years old 2. pregnant woman 3. patients can not cooperate with gamma knife treatment 4. patients with acoustic neuroma who do not have their own abilities 5. tumor diameter \> 3.5cm.

Keywords: decision aids shared decision making
intestinal akkermansia muciniphila in prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: prostate cancer has the highest incidence and is the second leading cause of cancer death in men in western countries. androgen deprivation therapy is the backbone treatment. however, after a latency hormone sensitive prostate cancer (hspc) usually progresses to castration-resistant prostate cancer (crpc) requiring treatments including next generation hormonal therapies with abiraterone acetate (aa). this, with limited survival. a particularly challenging area of interest to improve outcome in cancer is the interaction between the microbiome and anti-cancer therapies. emerging data demontrate in pre-clincal studies that prostate cancer alters the microbiota, with loss of diversity and depletion of beneficial bacteria including a. muciniphila. in the other hand, androgen deprivation therapy, reverses these effects. specifically, in advanced disease with castration-resistant prostate cancer (crpc), it has been shown in small studies that abiraterone acetate, can modulate patient-associated gastro-intestinal microbiota through promoting the growth of a. muciniphila. the goal of our study is to confirm that aa could promote fecal akkermansia muciniphila growth and to use the enrichment of fecal akkermansia muciniphila as a minimally invasive biomarker of response to aa in first line metastatic crpc.


Eligibility criteria:
inclusion criteria: * be willing and not opposed to the study * be ≥ 18 years of age at the time of inclusion. * histologically or cytologically documented adenocarcinoma of the prostate. * have metastatic castration-resistant prostate cancer with castrate-level testosterone (\<50 ng/dl) during the study * initiation of abiraterone acetate therapy or any other next-generation hormonal therapies within 15 days after inclusion * participants must be able and willing to comply with the study visit schedule and study procedures * affiliated with french social security exclusion criteria: * crpc patients who were previously treated with any next generation hormonal therapies in a metastatic crpc setting * person under legal protection * inability to obtain the non-opposition
impact of catecholamine spill-over on outcome after rdn and ep ablation

Conditions: Hypertension

Summary: despite a rapidly increasing number of renal denervation (rdn) procedures, only little is known regarding the patient or procedural characteristics influencing the outcome. none of the detectable variables like number of ablation points, temperature rise, impedance drop, have been shown to correlate with the blood pressure (bp) reduction. in this study, the investigators assess different patient and procedural characteristics, like exact patient medication, stress hormones, heart rate variability, and focus on the change of the catecholamine spill-over, and the impact on bp and heart rate after rdn and after ep ablation. the investigators hypothesize the correlation between reduction of catecholamine spill-over due to denervation and the bp reduction. in this study, the investigators will assess 40 patients undergoing rdn and 40 patients undergoing ep ablation.


Eligibility criteria:
inclusion criteria: * medically-indicated renal denervation * age over 18 years * written informed consent exclusion criteria: * pregnancy * expected compliance problems * current participation in other studies

Keywords: rdn renal denervation catecholamine spill-over blood pressure electrophysiology ablation
uroflow measurement with electromyography (emg) to identify lower urinary tract symptoms (luts): conducted on healthy children

Conditions: Lower Urinary Tract Symptoms; Urologic Diseases

Summary: nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions in clinical practice. the tendency to use uroflowmetry as a first-line screening tool is based on the inexpensiveness, time efficiency, comfort of the patient, etc. however, it is stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate diagnosis. in regard to this, the international continence society indicated that the addition of pelvic floor electromyography might increase the accuracy of this assessment. despite this recommendation, uroflowmetry in combination with electromyography has not been conducted in a healthy population. the initial objective of this study was to examine whether adding electromyography to standard uroflowmetry in a healthy paediatric population would change the representation of parameters, especially of voiding patterns. in addition, the influence of several factors on uroflow parameters was analysed to complement current literature.


Eligibility criteria:
inclusion criteria: • normal development exclusion criteria: * (recurrent) urinary tract infections * luts which interfered with daily life * fecal incontinence * history of genitourinary or renal surgery * medication for incontinence during the last 3 months * pelvic reeducation during the last 6 months * neurologic problems influencing continence
by pass surgery with stem cell therapy in chronic ischemic cardiopathy

Conditions: Ischemic Heart Disease

Summary: surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after cabg even if substantial amount of myocardial viability is present. a value of \> 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization. recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.

the screening of patients will be performed after contrast coronar ventriculography realized for diagnostic or prognostic purpose. subsequently all patients will be evaluated by cardiac ce-mr and pet imaging for verification of inclusion criteria. patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories. during the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-mr and pet imaging at 1 year. additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.

Eligibility criteria:
inclusion criteria: * chronic ischemic heart disease * left ventricular dilation (end systolic volume \>140 ml) * poor global contractile function (ejection fraction \<40%) * substantial amount of residual viability (\>30% of left ventricle)

Keywords: chronic ischemic cardiomyopathy with residual viability surgical coronary revascularization stem cell therapy chronic ischemic heart disease severe impairment of global contractility left ventricular dilation residual viability