Kornimate/medical-research-clean huggingface dataset:
efficacy of convalescent plasma to treat covid-19 patients, a nested trial in the corimuno-19 cohort

Conditions: Covid19

Summary: the coronavirus disease 2019 (covid-19) viral pneumonia is now a worldwide pandemic caused by the severe acute respiratory virus coronavirus 2 (sars-cov-2). the number of cases, and associated mortality has increased dramatically since the first cases in wuhan, china in december 2019 . to date, no specific treatment has been proven to be effective for covid-19. treatment is currently mainly supportive, with in particular mechanical ventilation for the critically ill patients (6.1% in a series of 1099 cases in china). novel therapeutic approaches are in acute need. in this context, the therapeutic potential associated with convalescent plasma needs to be explored. the objective of coviplasm trial (a nested trial in the corimuno-19 cohort) is to study the efficacy of convalescent plasma to treat sars-cov2 infected patients.

hypothesize: early administration of convalescent plasma containing polyclonal neutralizing abs may inhibit viral entry and replication (as recently suggested in vitro) and consequently blunt an early pro-inflammatory pathogenic endogenous ab response. potential donors of convalescent plasma will be identified through various means, including hospitals taking care of such patient, practitioners treating outpatients or specific social messaging. convalescent patients at least 14 to 28 days (per at date regulation regarding blood donation) after the symptoms resolution will be invited to undergo plasma apheresis, pending general eligibility such as an age between 18 and 65 years old and weight not less than 50 kg. two convalescent plasma units of 200 to 220 ml each will be transfused i.v. as early as possible and no later than 10 days after onset of clinical symptoms. in the absence of acute unforeseen adverse events in the first 3 patients, an additional 2 plasma units of 200/220 ml each will be transfused 24 hours after first 2 units: a total of 4 units / patient. transfusion monitoring, treatment and reporting of adverse events will be performed per ansm hemovigilance regulation regarding transfusion of labile blood products as well as through the specific clinical trial vigilance. an average of 120 participants will be expected (60 participants in each arm). availability of abo compatible plasma will be checked by investigator when a corimmuno patients is eligible. if so, randomization will be undertaken and patient will be offered to participate in this nested trial if he is allocated to the experimental arm. an interim analysis is performed at mid-trial, but inclusions are not frozen to wait for the interim analysis.

Eligibility criteria:
inclusion criteria: * patients included in the corimuno-19 cohort * onset of covid19 functional signs \<8 days (plasma transfusion may occur up to day 10 of onset) * mild severity as described in the who scale exclusion criteria: * pregnancy * current documented and uncontrolled bacterial infection. * prior severe (grade 3) allergic reactions to plasma transfusion

Keywords: covid 19 convalescent plasma
application of a new x-ray protective device in coronary interventional therapy

Conditions: Coronary Heart Disease

Summary: this is a multi-center, prospective and controlled clinical trial which will enroll 200 coronary arteriography or percutaneous coronary intervention with 2-4 interventional cardiologist. the interventional cardiologist performed 100 interventional procedures using either a new protective device (npd) or a traditional lead clothing (tlc). the cumulative dose outside the npd or tlc and the first operator at each height (110cm, 90cm, 50cm, 10cm) was measured. the main indicators of the study are the average x-ray shielding efficiency of the npd and the tlc at four different heights. the investigators will record all operation information in this study.

in this study, the investigators developed a new protection device (npd) and compared its effects on the reduction of radiation exposure compared with the traditional lead clothing (tlc). the npd (wlxp-006, yingnuoweite medical science and technology, co., ltd., nanjing, china) is a floor-standing medical radiation protection device mainly composed of a barrel-like frame and protective lead rubber (0.5 mm lead equivalent).

Eligibility criteria:
inclusion criteria: * consecutive patients were admitted to the group for coronary arteriography (cag) or percutaneous coronary intervention (pci). exclusion criteria: * there were no exclusion criteria, and the patients were continuously enrolled for interventional diagnosis and treatment.

Keywords: cardiology coronary angiography coronary angioplasty percutaneous coronary intervention radiation
a study of pegasys (peginterferon alfa-2a [40kd]) in patients with hepatitis b e antigen (hbeag)-negative chronic hepatitis b virus (hbv)

Conditions: Hepatitis B, Chronic

Summary: this study will evaluate the efficacy, safety, and tolerability of pegasys in participants with hbeag-negative chronic hbv. the anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.


Eligibility criteria:
inclusion criteria: * adult participants 18-70 years of age * positive test result for hbsag for \>6 months * naive to treatment for hbv * on liver biopsy, liver disease consistent with chronic hbv, with or without compensated cirrhosis exclusion criteria: * co-infection with hepatitis a, c or d, or with human immunodeficiency virus (hiv) * decompensated liver disease * hepatocellular cancer * systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug * medical condition associated with chronic liver disease
merit wrapsody™ endoprosthesis for treatment of stenosis or occlusion (wrap)

Conditions: Venous Stenosis; Venous Occlusion

Summary: the wrap study aims to expand and understand the safety and efficacy data on the wrapsody endoprosthesis system in a real-world population.

prospective, multicenter, observational study to evaluate the merit wrapsody™ endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (av) fistula or av graft (the wrap registry)

Eligibility criteria:
inclusion criteria: 1. subject provides written informed consent for study participation. 2. subject is male or female, with an age ≥ 18 years at date of enrollment. 3. subject is willing to comply with site standard of care procedures and follow-up visit schedules over 24 months. 4. subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon 5. the dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session. 6. subject has stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (av) fistula or av graft and is treated with wrapsody endoprosthesis system in accordance with device instructions for use. exclusion criteria: 1. subject has a planned surgical revision of access site. 2. subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. 3. subject has an uncorrectable coagulation disorder. 4. known hypersensitivity to nickel titanium alloy. 5. subject's hemodialysis access is anticipated to be abandoned within 6 months. 6. subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure. 7. full expansion of a percutaneous transluminal angioplasty (pta) balloon cannot be achieved during predilatation. 8. device would be placed in the superior vena cava 9. any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

Keywords: arteriovenous fistula (avf) arteriovenous graft (avg) av fistula av graft
pet and ct scans in patients with locally advanced primary rectal cancer that can be removed during surgery

Conditions: Colorectal Cancer

Summary: rationale: diagnostic procedures, such as pet and ct scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment. purpose: this clinical trial is studying how well pet and ct scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.

objectives: * determine if fludeoxyglucose f 18 positron emission tomography (fdg-pet) is superior to ct scan at monitoring rectal cancer response to radiation and chemotherapy by identifying residual rectal cancer in the rectal wall or pelvic lymph nodes in order to optimize selection of patients suitable for a sphincter preserving rectal cancer resection or a local excision. * determine the accuracy of fdg-pet in detecting extrapelvic metastatic disease in primary rectal cancer patients considered operable on the basis of currently accepted diagnostic work-up, including abdominal ct scan and chest x-ray. outline: this is a diagnostic study conducted concurrently with multimodality management. within 1-2 weeks prior to starting preoperative radiotherapy/chemotherapy, patients undergo baseline positron emission tomography (pet) imaging of the thorax, abdomen, and pelvis. patients receive fludeoxyglucose f 18 (fdg) iv followed 45 minutes later by pet imaging. patients also undergo baseline ct imaging of the abdomen and pelvis. a ct scan of the chest is obtained if the prestudy chest x-ray is abnormal. patients receive preoperative radiotherapy/chemotherapy. within 4-6 weeks of completion of radiotherapy/chemotherapy, patients undergo repeat fdg-pet imaging and ct scan. patients undergo surgical resection 1-2 weeks later. projected accrual: a total of 125 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * primary resectable rectal cancer as determined by currently accepted diagnostic work-up, including ct scan and endorectal ultrasound (eus) * must meet criteria for preoperative radiotherapy and chemotherapy: * bulky tumors and/or eus evidence of t3-4 and/or n1 disease patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant or nursing * no uncontrolled diabetes mellitus (i.e., greater than 175 mg/dl) * no intolerance of being inside pet scanner for duration of study * no vulnerable patients (e.g., mentally retarded or prisoners) prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * not specified radiotherapy: * see disease characteristics surgery: * see disease characteristics

Keywords: stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer
effect of adenomyosis on art outcomes: a prospective cohort study

Conditions: Adenomyosis; in Vitro Fertilization

Summary: previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. however, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. our research team intends to collect clinical data of infertility patients with adenomyosis receiving ivf and the detailed classification of adenomyosis according to musa criteria. finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice.

previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. however, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. our research team intends to collect clinical data of infertility patients with adenomyosis receiving ivf and the detailed classification of adenomyosis according to musa and ultrasound consensus. finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice. the detailed inclusion and exclusion criteria are as follows: inclusion criteria 1.age of all participants ≥ 20 and \< 38 years. 2.receiving ivf treatment because of adenomyosis or simple male factor. 3.conforming to musa criteria. 4. body mass index \< 30 kg/m2. 5.the level of amh ≥ 0.8 ng/ml. exclusion criteria 1. uterine fibroids (international federation of gynecology and obstetrics (figo) type 0--i--ii or type iii--iv fibroids \> 3 cm). 2. untreated endometrial polyps, hydrosalpinx or uterine adhesions. 3. rsa or rif. 4. intracytoplasmic sperm injection (icsi) and preimplantation genetic testing (pgt). 5. concurrent and/or recent involvement in other research within previous 3 months of study enrolment.

Eligibility criteria:
inclusion criteria: 1. age of all participants ≥ 20 and \&lt; 38 years. 2. receiving ivf treatment because of adenomyosis or simple male factor. 3. conforming to musa criteria. 4. body mass index \&lt; 30 kg/m2. 5. the level of amh ≥ 0.8 ng/ml. exclusion criteria: 1. uterine fibroids (international federation of gynecology and obstetrics (figo) type 0--i--ii or type iii--iv fibroids \&gt; 3 cm). 2. untreated endometrial polyps, hydrosalpinges or uterine adhesions. 3. rsa or rif. 4. intracytoplasmic sperm injection (icsi) and preimplantation genetic testing (pgt). 5. concurrent and/or recent involvement in other research within previous 3 months of study

Keywords: adenomyosis
comparing nutritional status of in-centre nocturnal hemodialysis patients to conventional hemodialysis patients

Conditions: End Stage Renal Failure on Dialysis

Summary: although hemodialysis is life-saving, unfortunately, people on dialysis often have declining health, quality of life as well as poor nutritional status. hemodialysis patients must follow a very restrictive diet, and many patients do not eat well and usually report poor appetites. a new approach to dialysis is being used in some hospitals in alberta and elsewhere, called in-centre nocturnal hemodialysis. this in-centre nocturnal dialysis allows people to receive their dialysis at a hospital or clinic while they sleep. since this in-centre nocturnal dialysis gives people 8-hour hemodialysis treatment 3 times per week (24 hours of dialysis per week) the patients have better removal of the waste products from their bodies than conventional hemodialysis (an average of 12 hours per week). also of importance, when using in-centre nocturnal dialysis, people will have more time during the day to work, spend with family, as well as have time to shop for food, to cook and even to eat, which in turn will likely result in improvement in the quality of their lives. this study will follow 10 patients on conventional dialysis and 10 patients on in-centre nocturnal dialysis for 6 months and compare their food intake, muscle mass, weight, body mass index (bmi) and nutrition-related lab tests. the purpose of this study is to determine whether there is an improvement in the nutritional status of the in-centre nocturnal hemodialysis patients compared to the nutritional status of conventional hemodialysis patients.


Eligibility criteria:
inclusion criteria: * \>18 years of age * referred to the in-centre nocturnal hemodialysis program * medically stable * undergo hemodialysis three to four times per week for a minimum of three hours per week * able to provide written, informed consent exclusion criteria: * younger than 18 years old * have a current diagnosis with palliative status (e.g. cancer) or have active disease * have had a prolonged hospitalization (\>3 weeks) within the previous 3 months

Keywords: hemodialysis nutritional status
accuracy of left subclavian regurgitation evaluated by ultrasound doppler and 4d flow mri

Conditions: Aortic Regurgitation

Summary: aortic insufficiency (ia) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. it represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. the quantification of ai is therefore important as it can remain perfectly asymptomatic for a long time. doppler echocardiography is currently the key examination to confirm the presence of valvulopathy, to allow positive diagnosis of valve leakage regardless of location, to specify the etiology and mechanism of regurgitation. the quantification of ia requires, in transthoracic ultrasound, to take into account many parameters that individually have all certain limitations. the recommendations are therefore to have an integrative approach considering a combination of different parameters and an overall interpretation. this makes it possible to evaluate with greater precision the importance of the leak. thus, there is the difficulty of quantifying moderate and severe ai for lack of a truly unique criterion. one of the evaluation criteria commonly used in transthoracic ultrasound is diastolic regurgitation in the aortic arch but this assessment is sometimes difficult. the left subclavian artery (scg) is more accessible than the aortic arch in terms of the ultrasound window. the measurements will be easier to record since the vessel is more superficial and there are fewer air interpositions than for the aortic arch. the quantification of the ai based on this new element will be compared to the other previously validated ultrasound criteria. the investigators will use this study to describe the feasibility of collecting coronary flow in the artery (iva), and they will compare systolic velocity, diastolic rate / systolic rate ratio compared to a control group without severe aortic insufficiency (grades 2 and 3). the flows recorded in the iva will be compared to the importance of the aortic leakage according to its different modes of quantification (ultrasound and mri). the aim of the study will be to show that diastolic reflux in the left subclavian artery is a marker of severe ai (grades 2 and 3) by comparing this regurgitation with that measured at the level of the aortic arch and other validated ultrasound criteria and cardiac mri.


Eligibility criteria:
inclusion criteria: * patient able to give informed consent to participate in the study * patient with transthoracic echocardiography and mri prescription exclusion criteria: * contraindication to mri * pathologies of the thoracic aorta (aneurism, dissection, stenosis) * pathologies of the left subclavian artery (stenosis, narrowing) * persistent arterial canal * arteriovenous fistula of the upper limb
validation of the french adaptation of the mswdq-23 questionnaire

Conditions: Multiple Sclerosis

Summary: ms is an autoimmune disease of the central nervous system that affects more than 120,000 people in france. the average age of onset of the disease is between 25 and 35 years. given the wide range of ages of the patients, from 4 to 80 years, the ethical and socio-economic stakes are high in order to maintain their autonomy, sociability, family and intimate life, and their employment in the best possible conditions and for as long as possible. however, to date, there are no evaluation tools in french that allow us to understand the difficulties at work of ms patients. the multiple sclerosis work difficulties questionnaire (mswdq-23) was developed specifically for ms patients and validated in english \[1\]. there is a short version of this questionnaire that facilitates its use in clinical practice \[2\]. it has been translated and validated in spanish through a multicenter study, and is currently being validated in german, but does not currently exist in french \[3\]. the main objective of the worksep project is to validate the french version of this questionnaire through a multicenter population-based cohort within the framework of the french-speaking multiple sclerosis society (sfsep). this validation study will involve the inclusion of 206 french-speaking ms patients, regardless of their professional status, all forms of ms combined, from the early stage (clinically isolated syndrome) to the more advanced stages (primary and secondary progressive forms).


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old. * native french speaker. * a diagnosis of clinically isolated syndrome or ms defined according to the 2017 mcdonald criteria. * be affiliated with the social security system. * agree to participate in the study. exclusion criteria: opposition to the use of the data
premature newborns treated with less invasive surfactant administration under heated humidified high-flow

Conditions: Respiratory Disease; Newborn Rds

Summary: nasal continuous airway pressure (cpap) or heated humidified high-flow air support with nasal cannula (hhhfnc) are among the most commonly used non-invasive respiratory support methods. the purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (pi) and plethysmographic variability index (pvi) values in premature infants treated with less invasive surfactant administration (lisa) under hhhfnc or cpap.

nasal continuous airway pressure (cpap) or heated humidified high-flow air support with nasal cannula (hhhfnc) are among the most commonly used non-invasive respiratory support methods. the purpose of this prospective study was to compare vital findings, blood gas parameters, perfusion index (pi) and plethysmographic variability index (pvi) values in premature infants treated with less invasive surfactant administration (lisa) under hhhfnc or cpap. this study was carried out in hacettepe university hospital nicu between january and december 2017. premature newborns who were on noninvazive respiratory support and were diagnosed as rds within first 72 hours of life, were taken into the study. noninvasive respiratory support was provided with nasal cpap or hhhnfc. pulse oxymetry measurements were obtained before and 5th, 30th, 60th, 120th , 360th minutes, blood gas analysis was performed immediately before and 120th, 360th minutes after surfactant administration. post-hoc, one-way difference between two independent means (two groups) statistical analysis was used. significance p \< 0.05; effect size 0.9; power (1-ß err prob) was found to be 82%.

Eligibility criteria:
inclusion criteria: * does not require intubation, * diagnosed with rds * premature newborns receiving surfactant therapy in the first 72 hours of life * those whose families give written consent exclusion criteria: * babies whose families do not give written consent * newborns diagnosed with early neonatal sepsis * newborns with inotropic requirements * neonates with hemodynamically significant pda * babies of diabetic mothers * babies with a major congenital anomaly * newborns with hemodynamic instability, * those requiring endotracheal intubation, * nec (stage 2 or higher), * those showing ich (stage 2 or higher) * babies with perfusion disorders in the first three days

Keywords: newborn respiratory distress syndrome less invasive surfactant administration heated humidified high-flow air support with nasal cannula. nasal continuous airway pressure