Kornimate/medical-research-clean huggingface dataset:
sars-cov-2 antibody response in children aged 5-11 years following vaccination against covid-19

Conditions: COVID-19 Vaccine

Summary: there are few data on the immunogenicity of the pfizer-biontec bnt162b2 vaccine for the prevention of covid-19 disease and of side effects in children aged 5-11 years. therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the bnt162b2 covid-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.

the pfizer-biontec bnt162b2 vaccine has proven efficacy and safety for the prevention of covid-19 disease in adults and adolescents aged 12 years and older. efficacy and safety were recently shown also for children aged 5-11 years. side-effects are common, including some rare but important side-effects such as myocarditis. myocarditis post pfizer-biontec bnt162b2 vaccination was described mostly among male adolescents and young adults. there are few data on the immunogenicity of the vaccine and of side effects in children aged 5-11 years. therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the bnt162b2 covid-19 vaccine in children aged 5-11 years. this is a prospective cohort study assessing the immunogenicity of the bnt162b2 covid-19 vaccine in children. the study population will be composed of children aged 5-11 years at the schneider children's medical center, with no contraindication for covid-19 vaccination. upon enrollment in the study, participates will be requested to complete an enrollment questionnaire and a blood sample for baseline serological evaluation will be obtained. the study follow-up period will be 6 and a half months from receipt of the first dose of the vaccine. the study will last 6 months from the date of the approval of the study protocol. blood samples for immune response evaluation will be taken at intervals of 28 days (+/- 14) until 6 and a half months from receipt of the first dose of the vaccine. samples will be tested for antibodies to sars-cov-2 at the microbiology laboratory at the rabin medical center. symptomatic participants with any respiratory symptoms or other symptoms suggestive of covid-19 disease will be tested for sars-cov-2 by rt-pcr, at laboratories certified by the ministry of health.

Eligibility criteria:
inclusion criteria: age 5-11 years exclusion criteria: administration of covid-19 vaccine\>21 days prior to enrollment, contraindication for covid-19 vaccine such as, known hypersensitivity to a component of the vaccine or its excipients congenital or acquired immunodeficiency (including recipient of systemic steroids ≥2 mg/kg or ≥20mg/day, within two weeks prior to enrollment)
study of the safety and pharmacokinetics of ce-326,597 in patients with asymptomatic gallstones

Conditions: Obesity

Summary: the study is designed to assess whether repeated dosing with ce-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic. in addition, the study will characterize the pharmacokinetics of ce-326,597.


Eligibility criteria:
inclusion criteria: * body mass index between 30-40 kg/m2, inclusive * evidence of asymptomatic cholelithiasis on screening abdominal ultrasound exclusion criteria: * patients with unstable medical conditions, such as diabetes, stroke, heart attack. * females of childbearing potential or those who may be pregnant or breast feeding. * patients with inflammed gallbladder, evidence of stones in bile ducts on screening abdominal ultrasound, history of symptoms indicating active gallbladder disease or gallbladder removal.

Keywords: safety in patients with asymptomatic cholelithiasis/gallstones.
early commencement of adjuvant chemotherapy for colon cancer

Conditions: Colon Cancer

Summary: this study sets up the final study end point and three detailed goals as the following. the main objective of study: this trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer. detailed goal of study: the primary endpoint: this study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate. the secondary endpoint: this study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. this study will also assess the quality of life and side effects of chemotherapy.

chemotherapy regimen: folfox-6, every 2weeks, total 12 cycles treatment * day1: oxaliplatin 85mg/m2 * day1: leucovorin 200mg/m2 * day1: 5-fu 400mg/m2 iv bolus * 2,400mg/m2 over 46 hours

Eligibility criteria:
inclusion criteria: * eligibility rule of enrollment * rectal adenocarcinoma that were 15 cm or more from the anal verge * pathologically diagnosed stage ii or iii disease * patients who meet the discharge criteria within 10days after surgery * patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography exclusion criteria: * an ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective * a past history of chemotherapy * tumor with obstruction or perforation * tumor with distant metastases * synchronous tumor * relative or absolute contraindications of chemotherapy * recent mi, cva, nitrate medication * severe cardiovascular disease, psychiatric disease * severe hepatic dysfunction (got, gpt ≥100iu/l) * renal dysfunction (cr ≥2mg/dl) * the concurrent presence of other severe medical diseases

Keywords: colon cancer chemotherapy adjuvant
adenoma detection rate with a new pediatric colonoscope with a short turn radius (pentax retroview) compared with a standard pentax pediatric colonoscope

Conditions: Colonoscopy

Summary: the purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. the investigators wish to effectively demonstrate the utility of the new colonoscope (pentax retroview colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * age \> 40 * surveillance colonoscopy (history of adenomas) exclusion criteria: * poor or fair bowel prep * difficult first insertion * familial polyposis * inflammatory bowel disease * pregnancy * active gi bleeding * prior colonic or rectal resection * conserved sattus * colonoscopy less than 3 years ago * screening colonoscopy * colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits

Keywords: colonoscopy colon cancer screening
cronic pressure wounds and relation with gender

Conditions: Wound

Summary: there is no exact scientfic data about gender relationship with cronic pressure wounds (cpw). this research is aimed first to reveal gender relationship with cpw and aimed secondarily to reveal the gender related couse(es).

there is no exact scientific data about gender relationship with cronic pressure wounds (cpw). researches about this subject is generally related to prevention and management of the process. but gender difference is not exactly researched in the literature. this research is aimed first to reveal gender relationship with cpw and aimed secondarily to reveal the gender related couse(es).

Eligibility criteria:
inclusion criteria: * cronic pressure wound patients exclusion criteria: * operated cronic pressure wounds

Keywords: gender
a point-of-care electrochemical-based device for rapid detection of fibrinogen on type a aortic dissection surgery

Conditions: Hypofibrinogenemia

Summary: this study compares the results of the existing fibrinogen concentration monitoring technology to the electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in type a aortic dissection surgery.

electrochemical-based device for rapid detection of fibrinogen is a novel poc diagnostic method, which is suitable for operating theatres and emergency rooms. the novel fibrinogen detection based on gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a poc assay of fibrinogen detection for critically ill patients. this single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional clauss laboratory reference method.

Eligibility criteria:
part1 phase i-laboratory calibration. the electrochemical method was employed to detect the fibrinogen concentration of standard quality control materials with varying concentration gradients, and the corresponding current values were recorded for constructing a standard curve of fibrinogen concentration. phase ii-assay performance using clinical samples. subject is 18 years and underwent routine hemostasis analysis. using human biological samples already collected for routine hemostasis analysis, the samples were centrifuged at 2500g for 15 min at room temperature, to obtain ppp (residual platelet count of \<10 × 10\^9/l) and stored at-20℃used for determination by electrochemical method within 2 weeks, each clinical sample was tested three times part2 inclusion criteria: subject underwent surgery for acute type a aortic dissection at our hospital, subject is 18 years, subject requires routine teg measurement, subject use human fibrinogen concentrate during surgery. exclusion criteria: use extracorporeal membrane oxygenation after surgery, inability to obtain written informed consent
analgesia nociception index for pain monitoring in intensive care units

Conditions: Stress Related Disorder; Pain; Intensive Care Unit Syndrome

Summary: the aim of this study is to examine the usability of ani in patients who will be treated in intensive care unit.

the aim of this study is to examine the usability of analgesia nociception index in patients who will be treated in intensive care unit ( a- cardiovascular b- surgical c- internal diseases), mechanically ventilated and lacking communication. the investigators will examine whether the positive inotropic/vasoconstrictor agents will have any effect on analgesia nociception index.

Eligibility criteria:
inclusion criteria: * intensive care cardiovascular patients group 1 - patients aged from 18 to 80 years, scheduled for elective isolated coronary bypass graft (cabg) for 2-4 vessel disease, without any perioperative complications, and who were postoperatively monitored via the analgesia nociception index in the cardiovascular intensive care will be included. * intensive care internal diseases group 2 - patients aged from 18 to 80 years, intubated or tracheostomized, in mechanical ventilation with pressure-controlled ventilation mode, under perfusion neuromuscular blocker, normothermic, non-cooperative and/or sedated and neuromuscular blocker * intensive care patients (obese) group 3 - post bariatric surgery, over 40 bmi exclusion criteria: * intensive care cardiovascular patients group 1 patients who required emergency surgery, had significant preoperative chronic pain, had autonomic nervous system anomalies and patients with rhythm will be excluded from the study. * intensive care internal diseases group 2 ramsey sedation scale under 5, cooperative, with spontaneous breathing effort and extremity movement, non sinusal cardiac rhythm * intensive care patients (obese) group 3 - patients under 40 bmi

Keywords: analgesia nociception index intensive care unit pain monitoring
a study of shr-1707 in healthy young adult and elderly subjects

Conditions: Alzheimer's Disease

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of shr-1707 in healthy young adult and elderly subjects.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent 2. male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in part 1 and aged between 55 years and 80 years (inclusive) in part 2 3. total body weight of 45\~100 kg (inclusive), with a body mass index (bmi) of 19\~28 kg/m2 (inclusive) 4. subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects 5. wocbp agree to take effective contraceptive methods exclusion criteria: 1. severe injuries or surgeries within 6 months before screening 2. positive hepatitis b virus (hbsag), hepatitis c virus (hcv-ab), or human immunodeficiency virus (hiv-ab) at screening 3. alt, or ast or total bilirubin level \<1.5x upper limit of normal range (uln) at screening or baseline visits 4. qtcf \> 450msec (male), qtcf \> 470msec (female) in 12-lead ecg test during screening and baseline 5. known history or suspected of being allergic to aβ antibody 6. use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose \[the dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use\]), or within 5 half-lives 7. live (attenuated) vaccination within 1 month before screening 8. blood donation or loss of more than 400 ml of blood within 3 months; or received blood transfusion within 3 months before screening. 9. history of alcohol abuse in the past 12 months of screening 10. history of illicit or prescription drug abuse or addiction within 12 months of screening 11. more than 5 cigarettes daily for 12 months before screening 12. participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening 13. researchers and relevant staff of the research center or other persons directly involved in the implementation of the program 14. the instigators determined that other conditions were inappropriate for participation in this clinical trial
outcome of children post mechanical ventilation

Conditions: Post Intensive Care Syndrome

Summary: mechanical ventilation is a life-saving therapy widely used in picu, but not without adverse effects. the mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. this lack of knowledge can lead to delays in management and thus hinder the recovery of children. the aim of this study is to determine the impact on the functional and respiratory outcome of pediatric patients after a stay a picu of the province of quebec.

this is a prospective longitudinal cohort study of pediatric patients requiring mechanical ventilation for at least 48 hours, in all 4 picus in the province of quebec (canada). in follow-up picu clinics, children and family outcomes will be evaluated 2, 6 and 12 months post picu discharge.children and their families will be enrolled locally from each picu, their baseline data will be collected by local research staff and their post-discharge outcomes will be followed centrally from the centre hospitalier universitaire sainte-justine. the specific aims are to determine the functional, respiratory and neurocognitive function of picu survivors and health related quality of life. psychosocial status of the child and parents will also be determined. the primary goal is to describe the impact of a critical illness and mechanical ventilation on picu survivors and their families in order to improve the health and well-being of picu survivors and their families, and ultimately to improve the care of children after a picu stay.

Eligibility criteria:
inclusion criteria: * patients \< 18 years of age; * admission to a picu at the centre hospitalier universitaire sainte-justine (chusj), montreal children's hospital (mch), centre hospitalier universitaire de québec - université laval (chul) or centre hospitalier universitaire de sherbrooke (chus); * patients with invasive mechanical ventilation for ≥48 hours. exclusion criteria: * patients admitted for congenital heart surgery
effectiveness of paritaprevir/r - ombitasvir, ± dasabuvir, ± ribavirin in patients with chronic hepatitis c in canada

Conditions: Chronic Hepatitis C

Summary: the interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (abbvie regimen) ± ribavirin (rbv) for the treatment of chronic hepatitis c (chc) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. this observational study was the first effectiveness research examining the abbvie regimen ± rbv, used according to local label, under real world conditions in canada in a clinical practice patient population.

this was a prospective, multi-center observational study in participants receiving the interferon-free abbvie regimen ± rbv in canada. the prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. adults chronically infected with hcv, receiving the interferon-free abbvie regimen, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (eot), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[svr12\] and sustained virologic response 24 weeks after the end of treatment \[svr24\]).

Eligibility criteria:
inclusion criteria: * treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis c (chc), genotype 1 or 4, receiving combination therapy with the interferon-free abbvie regimen ± ribavirin (rbv) according to standard of care and in line with the current local label * if rbv was co-administered with the abbvie regimen, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * participants had to voluntarily sign and date an informed consent form prior to inclusion into the study * participants must not have participated or intended to participate in a concurrent interventional therapeutic trial exclusion criteria: * none

Keywords: chronic hepatitis c effectiveness influence of adherence patient reported outcomes ombitasvir/paritaprevir/ritonavir ± dasabuvir chronic hepatitis c genotype 1 chronic hepatitis c genotype 4
effect of the visual information change in functional dystonia

Conditions: Dystonia; Dystonic Disorders; Torticollis; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations

Summary: cervical dystonia occurring only during the writing task is a rare form for which there is no established treatment. many authors agree that alteration of sensory integration is associated with dystonia. similar disturbances in the integration of oculomotor information could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such as handwriting. we hypothesize that orthoptic treatment by wearing prisms when writing (i) will reduce the abnormal posture of the head occurring whilst writing and remove the associated nuchal pain; (ii) the correction after a period of systematic wearing of the prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head position after the suppression of the prisms.


Eligibility criteria:
inclusion criteria: case * presenting a cervical dystonia that occurs only during handwriting tasks, diagnosed by a neurologist specialised in movement disorders * being treated or not by injection of botulinum neurotoxin (but last injection \> 3 months before the initial assessment) control * no cervical dystonia * same sex, age (± 5 years), socio-professional level and hand laterality as the cases exclusion criteria: case * cervical dystonia occuring in other circumstances than handwriting * neurological disease other than cervical dystonia (e.g. parkinson's syndrome) * pain, trauma or pathology of the cervical spine of another cause than cervical dystonia and which have required medical or surgical treatment in the last 6 months preceding the initial assessment control * cervical disorders requiring medical or surgical treatment in the last 6 months prior to the tests * neurological disease affecting the cervical region or the writing hand * uncorrected visual disorders