Kornimate/medical-research-clean huggingface dataset:
lot-to-lot consistency of sci-b-vac™ in adults

Conditions: Hepatitis B Vaccines

Summary: a controlled trial to assess the lot-to-lot consistency of sci-b-vac™ in adults

the primary objective of the study is to verify that the manufacturing equivalence of sci-b-vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of sci-b-vac™ to a three-dose regimen of engerix-b® in adults.

Eligibility criteria:
inclusion criteria: * any gender * age 18-45 years * healthy, as determined by a physical examination and values of laboratory tests * if female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method * able and willing to give informed consent exclusion criteria: * previous vaccination with any hep b vaccine (hbv) (licensed or experimental) * treatment by immunosuppressant within 30 days of enrollment * history of immunological function impairment * pregnancy or breastfeeding * immunization with attenuated vaccines (e.g. mmr) within 4 weeks prior to enrollment * immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrolment * has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period * subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment * has received granulocyte-macrophage colony stimulating factor (g/gm-csf) or erythropoietin (epo) within 30 days of enrollment or likely to require gm-csf or erythropoietin during the study period * any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease. * any skin abnormality or tattoo that would limit post-vaccination injection site assessment * history of allergic reactions or anaphylactic reaction to any vaccine component * unwilling, or unable in the opinion of the investigator, to comply with study requirements * immediate family members of study center staff * current or past hepatitis b infection or prior vaccination as evidenced by hbv markers * known hepatitis c infection or positive hepatitis c serology at screening, unless treated and cured * known human immunodeficiency virus (hiv) infection or positive hiv serology at screening * renal impairment with glomerular filtration rate (gfr) \<90 ml/min/ 1.73 m2 at screening * bmi ≥ 35 * uncontrolled hypertension * diagnosis of type 1 or type 2 diabetes or hba1c ≥ 6.5% at screening * any laboratory test abnormality that would be considered of grade 1 severity or above as per fda guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator.

Keywords: hepatitis b vaccines
computerized cognitive training program for older persons with mild dementia

Conditions: Dementia

Summary: little is known about the effects of computerized cognitive training programs on mild dementia patients' health. the purpose of this study was to examine the effects of a community-based computerized cognitive training program.

little is known about the effects of computerized cognitive training programs on mild dementia patients' health. the purpose of this study was to examine the effects of a community-based computerized cognitive training program.however, most of these studies were not randomized controlled trial and the samples of these studies were mostly healthy older persons, patients with brain injuries, or with moderate and severe dementia. a lack of studies for effects of these programs on patients with mild dementia using randomized controlled trials was found. the purpose of this study was to examine the effects of a community-based computerized cognitive training program.

Eligibility criteria:
patients' inclusion criteria: * aged 65 or older, * being diagnosed as having mild dementia by a neurologist, and * being able to communicate in mandarin or taiwanese. patients' exclusion criteria: * vision or hearing impairment. caregivers' (proxy) inclusion criteria: * living with the dementia patient, * the family member spending the most time on the patient's care, and * \>20 years old. caregivers' (proxy) exclusion criteria: * terminally ill

Keywords: cognitive function depression quality of life community-based computerized cognitive training program randomized controlled trial
valve performance of the sapien 3 ultra resilia valve: a prospective registry with central echocardiography analysis.

Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Summary: the issue of valve durability has become one of the most important aspects in the tavr field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. the sapien 3 ultra resilia valve represents the last generation of the sapien valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up

prospective observational registry including patients with severe aortic stenosis undergoing tavr with the sapien 3 ultra resilia valve. all patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. transthoracic echocardiography (tte) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a centralized echocardiographic core lab at the quebec heart and lung institute. the measurements obtained in the core lab regarding transvalvular gradient, eoa, ppm and pvl at 1-3 months will determine the primary outcome of the study.

Eligibility criteria:
inclusion criteria: * inclusion criteria - patients with severe aortic stenosis undergoing transarterial tavr with the sapien 3 ultra resilia valve. * successful valve implantation of the sapien 3 ultra resilia valve. varc-3- defined technical success defined as: * freedom from mortality * successful access, delivery of the device, and retrieval of the delivery system * correct positioning of a single prosthetic heart valve into the proper anatomical location * freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - absence of severe procedural or in-hospital complications (varc-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture. exclusion criteria: * age \>80 years * severe pulmonary disease (fev1 \<50% predicted or need for home oxygen) * severe renal dysfunction (egfr \<30 ml/min/1.73m2) * frailty (clinical frailty scale \> 4) * severe coronary disease (syntax score \>32) * left ventricular ejection fraction ≤30% * moderate-to-severe mitral regurgitation * severe tricuspid regurgitation * pulmonary systolic pressure \>60 mmhg * sts-prom \>5% * any disease leading to a life expectancy \<5 years
pilot study of the contribution of fractional exhaled nitric oxide as a prognostic marker of response to anti-pd-l1 immunotherapy in non-small cell lung cancer

Conditions: Metastatic Non-small Cell Lung Cancer

Summary: based on the use of the patient's natural defences, immunotherapy mobilizes the immune system to recognize and destroy cancer cells, and it has revolutionized the treatment of lung cancer. however, the effectiveness of immunotherapy varies from patient to patient. at present, we have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a given individual. current scientific data identifies a number of molecules produced by the cancer cells and their environment which can be detected by various means (blood tests, breath analysis, etc.). the aim of this study is to understand whether the amount of nitric oxide (no) present in the breath is a more accurate predictor of response to immunotherapy. participation in this study involves breath testing (to measure feno (fractional exhaled nitric oxide)) before receiving the first infusion of immunotherapy, and at the follow-up visit after the 4th course of immunotherapy.


Eligibility criteria:
inclusion criteria: * patients with metastatic nsclc * patient not previously treated * pd-l1 tumor expression \> 50%, to be treated with immunotherapy alone after validation by a multidisciplinary consultation meeting. * patients over 18 years of age * patient having given his/her non-opposition * patient who speaks and reads french exclusion criteria: * patients previously treated for nsclc * patient with oncogene addiction or a first-line targetable rearrangement * patient not suitable for immunotherapy alone * patient having received corticosteroid treatment in the 15 days prior to feno. * patient on inhaled corticosteroid at time of inclusion. * blood eosinophilia \> 500 /mm3 * patient on 24-hour oxygen therapy * contraindication to immunotherapy * inability to perform feno measurement manoeuvres * pregnant, parturient or breast-feeding women * person under judicial protection (curatorship, guardianship) * person subject to limited judicial protection * adult unable to express their non-opposition * patient refusing to participate in the study
health, fitness, and quality of life in adolescent girls with turner syndrome

Conditions: Turner Syndrome; Turner Syndrome Mosaicism, 45, X/46, XX or XY; Turner Syndrome Mosaicism 46,X,I(X)(Q10)/45,X; Turner Syndrome Karyotype 46,X With Abnormal Sex Chromosome , Except I(Xq)

Summary: this study plans to learn more about how the energy system works in girls with turner syndrome. this is important to know so that the investigators understand how turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life.


Eligibility criteria:
inclusion criteria: * female * age 12-21 years * 45,xo karyotype in \>50% of cells tested with a diagnosis of turner syndrome (ts) * tanner stage 2-5 for breast development exclusion criteria: * growth hormone treatment within the past 3 months * diagnosis of type 1 or type 2 diabetes * untreated hypertension with blood pressure \> 99%ile for sex, age and height or \>140/90 * weight \> 300 lbs * height \< 54" * aortic sinus of valsalva or ascending aorta z-score \> 2 * other cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures, including vigorous exercise * pregnancy

Keywords: turner syndrome 45,xo body composition cardiometabolism quality of life fitness
arrhythmogenic risk assessment in coronary artery ectasia patients

Conditions: Coronary Artery Ectasia

Summary: the investigators thought to explore arrhythmias outcome - hidden arrhythmias, ecg features: tp-te interval and tp-te/qtc ratio, fqrs among patients with coronary artery ectasia as compared to normal coronary artery patients.

all patients will be subjected to: a. full history taking: - including age, sex, history of dm, htn, dyslipidemia and body surface area. b. holter monitoring for 24 hours: * heart rate variability * hidden arrhythmias * hidden ischemia by monitoring st segment changes c. twelve lead ecg: * fqrs in baseline ecg * qt dispersion. * tp-te interval and tp-te/qtc ratio * tp-te dispersion

Eligibility criteria:
inclusion criteria: * subjects with suspected cad who are referred for elective coronary angiography and/or interventions exclusion criteria: 1. patients with a history of cardiomyopathy and myocardial infarction (mi), left ventricular hypertrophy (lvh), pathological q wave on ecg, typical left bundle block or right bundle block, incomplete right bundle block, or paced rhythm on ecg. 2. patients with severe renal impairment 3. post cabg patients 4. patients of acute coronary syndrome

Keywords: coronary artery ectasia
efficacy and safety study of cvt-301 in parkinson's disease patients with off episodes

Conditions: Idiopathic Parkinson's Disease

Summary: this randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled cvt 301 compared with placebo in pd patients experiencing motor response fluctuations (off phenomena) as an outpatient (i.e., at home) and in the clinic. patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (cvt-301-004e) study.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd) diagnosed between the ages of 30 and 85 years; * hoehn and yahr stage 1-3 in an "on" state; * require levodopa-containing medication regimen at least 3 times during the waking day; * experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness; * are on stable pd medication regimen; * total daily ld dose \<1600 mg/day; * able to perform a spirometry maneuver in the on and off states; * normal cognition confirmed by mmse score ≥25 exclusion criteria: * pregnant or lactating females; * previous surgery for pd or plan to have stereotactic surgery during the study period; * history of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year; * known contraindication to the use of levodopa; * any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety; * any contraindication to performing routine spirometry.

Keywords: parkinson's disease motor fluctuations levodopa inhaled drugs off episodes
fluid overload and pulmonary function

Conditions: Water-Electrolyte Imbalance; Intensive Care Units; Pediatric; Critical Illness; Length of Stay; Respiratory Failure; Esophageal Atresia

Summary: esophageal atresia is a rare but severe malformation, and it requires early surgery. coloesophagoplasty is surgical repair of the esophageal with an isoperistaltic transverse colon graft. in the postoperative period after coloesophagoplasty children require careful monitoring of fluid balance, because clinically significant fluid overload can lead to dysfunction of various organs and systems.

esophageal atresia (ea) is a defect of the embryogenesis of the laryngotracheal tube. there are isolated forms of ea and combinations with a tracheoesophageal fistula (tpf). esophageal plastic surgery with an isoperistaltic transplant from the transverse colon was performed in children with ea. after this surgical intervention children require observation in the intensive care unit (icu). during this period, infusion therapy satisfies physiological needs and compensates for physiological and pathological losses. however, it is not always possible to compensate for the body's fluid needs and maintain a normovolemic state. thus, fluid overload develops. it is based on a pathophysiological process when severe operational stress leads to the damage of glycocalyx in the vascular wall. as a result, albumin freely passes into the interstitium, and oncotic pressure rises in tissues. fluid overload in the intra- and postoperative period can be a factor in an unfavorable outcome, leading to organ damage, as well as death.

Eligibility criteria:
inclusion criteria: * аge from 1 month to 3 years * ea with / without * tracheoesophageal fistula (tpf) * сoloesophagoplasty. exclusion criteria: * аesophageal burn, * oesophageal peptic stenosis, * congenital heart disease * cardiotonic support in the postoperative period * renal malformations * bacterial pneumonia in the postoperative period, * bronchopulmonary malformations.

Keywords: liquid liquid overload mechanical ventilation infant preschool child respiratory failure coloesophagoplasty esophageal atresia
evaluation of the 755nm alexandrite laser for the treatment of scars

Conditions: Scars

Summary: evaluate the safety and efficacy of removing unwanted scars using a 755nm alexandrite laser.


Eligibility criteria:
inclusion criteria: 1. is a healthy male or female between 18 and 85 years old. 2. has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them. 3. is willing to consent to participate in the study. 4. is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits exclusion criteria: 1. is hypersensitive to light exposure. 2. has active localized or systemic infection. 3. is taking medication(s) for which sunlight is a contraindication. 4. has a history of squamous cell carcinoma or melanoma. 5. has a history of keloid scarring. 6. has used oral isotretinoin (accutane®) within 12 months of initial treatment or plans on using during the course of the study. note: skin must regain its normal degree of moisture prior to treatment. 7. has a history of immunosuppression/immune deficiency disorders (including hiv infection or aids) or use of immunosuppressive medications. 8. is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 9. is allergic to lidocaine, tetracaine or xylocaine with epinephrine. 10. has any other reason determined by the physician to be ineligible to participate in the study.
blood donation from warfarin users for the development of poc inr monitor

Conditions: Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis

Summary: this study is to further develop and optimise the design and manufacturing process of a handheld device to monitor and manage warfarin (blood thinning anticoagulation drug) therapy. the device comprises of a handheld instrument and a disposable test strip and reports how blood coagulation is working in terms of standardised units called international normalised ratio (inr). a single drop of fresh whole blood and plasma will be added to the strip and the inr result displayed on the instrument. blood samples are to be collected from patients attending a hospital based inr clinic who are on warfarin therapy. the samples are to be used in a series of experiments in the laboratory to test the microvisk poc inr monitors accuracy, precision, stability and robustness.

the number of patients receiving anticoagulation therapy with warfarin and other vitamin k antagonists has been rising in recent years. increasing life expectancy is increasing the proportion of the population having conditions such as atrial fibrillation and venous thrombosis, where primary and secondary prevention of thromboembolic complications are best achieved with anticoagulation. unpredictable pharmacokinetics, widespread interactions with drugs and food and the narrow therapeutic window make closely monitoring vitamin k antagonists a necessity. portable point of care (poc) coagulometers which measure pt from capillary whole blood and provide an inr reading within a few minutes are already widely available throughout north american and europe. they give comparable results when compared to laboratory based systems are popular with patients and significantly shorten the duration of clinics. in addition, the united kingdom department of health has been encouraging the use of anticoagulation services in primary care trusts the aim being to provide inr monitoring in community clinics and general practice surgeries relieving pressure on hospital services and reducing inconvenience for patients. although coagulometers are now commercially available the microvisk inr testing system has been designed to have advantages, particularly in terms of test robustness, user comfort, ease of use and reduction of user error. the present trial has been designed to develop the second generation microvisk inr test system; blood samples will also be used to optimise manufacturing processes and verify the quality of test strip lots.

Eligibility criteria:
inclusion criteria: 1. subject is male or female, greater than 18 years of age 2. subject is receiving warfarin (or warfarin-like) therapy as part of their clinical care 3. subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent exclusion criteria: 1. subjects aged \<18 years of age 2. subjects who are unable to give written consent
bone bioactive liquid efficiency in improving dental implant osteointegration oral soft tissue hellingand oral surgery

Conditions: Wound Healing Disorder; Wounds and Injuries; Wound Surgical

Summary: the investigators implanted 264 galaxy ts implants (with or without bbl) in 33 patients across both jaws. implant stability and osseointegration were assessed using initial stability quotient (isq) measurements, computed tomography (cbct) scans and pain evaluations at various intervals post-surgery. further, implant surfaces were examined using scanning electron microscopy (sem) and atomic force microscopy (afm). in vitro studies evaluated the efficacy of bbl on dental pulp pluripotent stem cells (dppscs) osteogenesis, and inflammatory factor modulation in human macrophages.

ensuring implant stability and longevity is pivotal for patient satisfaction and quality of life. our recent discovery, bbl, novel bone bioactive liquid, demonstrated promising properties in improving implant surfaces, alleviating pain, and expediting oral healing. in this multi-center randomized, double-blind clinical trial, investigators sought to evaluate the impact of bbl on the clinical performance of galaxy ts implants. methods investigators implanted 264 galaxy ts implants (with or without bbl) in 33 patients across both jaws. implant stability and osseointegration were assessed using initial stability quotient (isq) measurements, computed tomography (cbct) scans and pain evaluations at various intervals post-surgery. further, implant surfaces were examined using scanning electron microscopy (sem) and atomic force microscopy (afm). in vitro studies evaluated the efficacy of bbl on dental pulp pluripotent stem cells (dppscs) osteogenesis, and inflammatory factor modulation in human macrophages.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * sufficient residual bone volume to accommodate implant placement without requiring bone augmentation, minimum ridge height and width of ≥ 9mm and ≥ 6mm, respectively, and healed bone sites with a minimum of 1 months of post-extraction healing. exclusion criteria * patients with alcoholism. * smoking habits. * history of illicit drug use were excluded. * patients with heart diseases. * diabetes. * previous bone regenerative or augmentation procedures. * bleeding disorders. * compromised immune systems. * history of radiation therapy * treatment with steroids or bisphosphonates

Keywords: bone bioactive liquid dental implant oral wound healing
a master protocol study of orforglipron (ly3502970) in participants with hypertension and obesity or overweight (attain-hypertension) gzl2

Conditions: Hypertension

Summary: gzl2 is an independent study conducted under the gzpl master protocol. gzl2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.


Eligibility criteria:
inclusion criteria: * refer to the gzpl master protocol study for screening eligibility. exclusion criteria: * refer to the gzpl master protocol study for screening eligibility.