Kornimate/medical-research-clean huggingface dataset:
study of the safety and efficacy of lcz696 on arterial stiffness in elderly patients with hypertension

Conditions: Hypertension

Summary: the study examined the efficacy of lcz696 in comparison to the arb olmesartan on central aortic systolic blood pressure (casp) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (sbp) and widened pulse pressure (pp).


Eligibility criteria:
key inclusion criteria: 1. male and female patients ≥ 60 years of age. 2. patients with essential hypertension, untreated or currently taking antihypertensive therapy. 3. untreated patients must have an office mssbp ≥150 mmhg and \<180 mmhg at visit 101 and visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to visit 1. 4. treated patients must have an office mssbp ≥140 mmhg and \<180 mmhg at visit 102 (or visit 103) and mssbp ≥150 mmhg and \<180 mmhg at visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to visit 1. 5. all patients must have pulse pressure \>60 mmhg at visit 201. pulse pressure is defined as mssbp- msdbp. 6. patients must have a difference in mssbp within +/-15 mmhg between visit 201 (randomization) and the visit immediately prior to visit 201. key exclusion criteria: 1. malignant or severe hypertension (grade 3 of who classification; msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg) 2. history of angioedema, drug-related or otherwise. 3. history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension. 4. transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke. 5. history of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1. 6. history of atrial fibrillation or atrial flutter during the 3 months prior to visit 1, or active atrial fibrillation or atrial flutter on the ecg at screening.

Keywords: hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
prediction of new regression equation among a group of egyptian children

Conditions: Regression Equation; Teeth Measurement

Summary: aim of the study: prediction of new regression equation using digital analysis for determination of mesiodistal width of permanent teeth among a group of egyptian children. research question what is the combined mesiodistal dimensions of canines and premolars in a group of 12-15 years old egyptian children and from it can the new regression equation predict the size of unerupted canines and premolars?

tooth size varies significantly between racial groups so mesiodistal dimension in permanent teeth of egyptian children differ from any international equation, and to the present data, few studies on the mesiodistal dimension of teeth for egyptian population (salem et al., 2023). tooth size and shape varies from one person to another, from males and females and from one ethnic group to the other depending on genetic factors (aljuaid et al., 2021).as mandibular incisors are the first teeth to erupt in the permanent teeth and if their dimensions could perhaps be used for predicting the width of unerupted teeth, then it may be advantageous for analysis of mixed dentition at an early age (moyers, 1976).environment and genetics both affect tooth size and it's strongly linked to sex and ethnicity. males' teeth are larger in size than those of the females and africans have larger teeth than europeans (aldeeb, 2021). rationale tooth size differs among and within populations. tooth size specifically the mesiodistal dimension has an important role in normal occlusion and in arch space analysis as it affects treatment planning and the final results in orthodontic treatment. (abozeid et al., 2019). malocclusion is a common esthetic and functional problem in the world. it's a developmental condition caused by alteration in normal development (ghorbani et al., 2018). the majority of malocclusion, which starts during the mixed dentition period, can be treated and eliminated in its severity if it was managed early (abozeid et al., 2019).predicting the size of canines and premolars that have not yet erupted is essential for accurate diagnosis and planning of the optimal course of action throughout the mixed dentition. the exact forecast reveals the difference between the amount of space needed and that which is now available, providing the first component of a successful therapy (salem et al., 2023)

Eligibility criteria:
inclusion criteria: - 1. subjects age between 12-15 years. 2. positive subjects acceptance for participation in the study. 3. full set of the permanent dentition from left 1st permanent molar to right 1st permanent molar. 4. subjects selected with no previous orthodontic treatment to eliminate possibility of any interproximal reduction. 5. intact marginal ridge exclusion criteria: - 1. subjects with history of systemic diseases. 2. subjects who have any sensitivity or adverse reactions to any of used materials. 3. subjects with morphologic anomalous.
improving patient understanding of macrosomia

Conditions: Macrosomia, Fetal

Summary: the purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * greater than or equal to 36 weeks gestation. exclusion criteria: * unable to provide informed consent
medtronic resolute onyx 2.0 mm clinical study

Conditions: Coronary Artery Disease

Summary: the purpose of this trial is to assess the safety and efficacy of the resolute onyx zotarolimus-eluting coronary stent system for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent.


Eligibility criteria:
inclusion criteria: * must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (cabg) surgery * must have evidence of ischemic heart disease * must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent or b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent * target lesion(s) must be de novo lesion(s) in native coronary artery(ies) exclusion criteria: * known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * history of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative * history of a stroke or transient ischemic attack (tia) within the prior 6 months * active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months * history of bleeding diathesis or coagulopathy or will refuse blood transfusions * concurrent medical condition with a life expectancy of less than 12 months * currently participating in an investigational drug or another device trial that has not completed the primary endpoint * documented left ventricular ejection fraction (lvef) \< 30% at the most recent evaluation
extra - abdominal versus intra - abdominal repair of the uterine incision at cesarean section

Conditions: Cesarean Wound Repair

Summary: to evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair, and to study is there superiority of one technique over the other in terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post operative ( until day 4 after operation ) measurements , secondary outcomes, long-term outcomes and subjective outcomes. primary outcomes: intra - operative ( during the operation up to 4 hours from anesthesia ) * nausea and vomiting * intraoperative hypotension * intraoperative pain post operative ( 4 hours from anesthesia and until release from hospital ) * blood transfusion * venous thromboembolism * febrile morbidity * endometritis * wound infection * death subjective measures: * complain of pain 1-10 on day 1 post operative * time until walking * number of days until having bowel movement * overall satisfactory secondary outcomes: * operative time * estimated blood loss ( ebl ) - hemoglobin levels * hospital stay

cesarean section (cs) delivery is one of the most frequent surgical procedures to be performed worldwide and rates of cs delivery are increasing. in the late 80's, the rate of caesarean deliveries was 10-13 % in most of the big hospitals in israel, and today it reaches up to 20-25% of all deliveries. numerous different surgical techniques for caesarean section delivery have been described, and the debate about the optimal caesarean technique to minimize surgical morbidity is ongoing. one of the more controversial issues regarding caesarean technique is the manner by which uterine repair is conducted after delivery of the infant(s) and placenta. two techniques are being used depending on the uterus position during repairmen : in situ within the peritoneal cavity (intra- abdominal repair) or temporarily exteriorized onto the mother's abdomen (extra- abdominal repair). arguments in favor of temporary exteriorization include better visualization of any uterine extensions and more rapid uterine repair with consequent reductions in both operative time and intraoperative blood loss. opponents of extraabdominal repair argue that this technique increases rates of intraoperative nausea and vomiting, adnexal trauma on replacement, possible infection, and venous air embolism (vae) . on this study the investigators prospectively recruit women who are about to be electively operated. the patients will be randomized into two groups - extra- abdominal versus intra-abdominal uterine repair using computer randomization. different charts will be for first cs delivery versus recurrent cs delivery. the patient won't know to which group she was designated . on day three after operation - she will be asked to fill out questionnaire with one of the investigators for subjective measurements

Eligibility criteria:
inclusion criteria: * singleton pregnancy * term pregnancy exclusion criteria: * chorioamnionitis * uterine rupture * hysterotomy - adhesiolysis

Keywords: caesarean delivery uterine incision repair
immunogenicity and safety of an intramuscular a/h5n1 inactivated, split virion pandemic influenza vaccine in adults

Conditions: Influenza; Orthomyxoviridae Infections

Summary: the trial is a phase ii, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. objectives: * to describe the immune response 21 days after each vaccination. * to describe the safety profiles following each vaccination.


Eligibility criteria:
inclusion criteria: * aged 18 to 60 years on day of inclusion. * informed consent form signed. * able to attend all scheduled visits and to comply with all trial procedures. * for a woman, inability to bear a child or negative urine pregnancy test. * for a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination. exclusion criteria: * systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9). * febrile illness (oral temperature \>= 37.5°c) on the day of inclusion. * breast-feeding. * previous vaccination with an avian flu vaccine. * participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination. * planned participation in another clinical trial during the present trial period. * congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy. * chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders). * current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures. * receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. * receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * planned receipt of any vaccine in the 4 weeks following any trial vaccination. * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Keywords: influenza a/h5n1 strain orthomyxoviridae infections influenza pandemics
accessible mobile health and wellness

Conditions: Physical Disability; Neurologic Dysfunction

Summary: can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being?


Eligibility criteria:
inclusion criteria: * \[for community participants/caregivers/family members\] ability to demonstrate clear communication and understanding of english. * \[for participants with neurological physical conditions\] neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses * \[for educational seminars\] \> 6 years of age. * \[for wellness/exercise clinic\] 18 65 years of age * \[for wellness/exercise clinic; participants with neurological physical conditions\] clearance by primary care or treating physician exclusion criteria: * \[for participants with neurological physical conditions\] unstable fractures * \[for participants with neurological physical conditions\] uncontrolled hypertension (combined systolic/diastolic \> 140/90 mmhg) * \[for participants with neurological physical conditions\] enrollment of individual deemed by study staff to be unsafe
adaptivestim objectifying subjective pain questionnaires

Conditions: Failed Back Surgery Syndrome

Summary: this is a prospective, multi-center, correlation study in which the investigators aim to explore the relationship between subjective pain questionnaires and the adaptivestim accelerometer output.

the aim of this research is to gather the necessary information relating to the patient his subjective self-report and the more objective information from the implanted ipg (restoresensor). such subjective information can be gathered from the adaptivstim output. the main focus of this study is to explore the relationship between the subjective reporting of functional disability with the odi, sleep quality with the actiwatch and psqi, pain intensity with the nrs-diary and the objective measurement of functional positions with the adaptivestim in patients receiving high density spinal cord stimulation.

Eligibility criteria:
inclusion criteria: * fbss patients treated with scs (ipg = restoresensor) who achieved a steady state (steady state is considered when the parameters didn't changed for at least one month) * age \> 18 years exclusion criteria: * patients with parkinson's disease * patients immobilised due to limb/pelvis/costal fractures * stroke patients with mrs\>3

Keywords: spinal cord stimulation adaptivestim
quality of care in centers providing extracorporeal membrane oxygenation

Conditions: Cardiogenic Shock; Myocardial Infarction; Cardiac Arrest; Extracorporeal Circulation; Complications

Summary: cardiac arrest centers are specialized in treating critically ill patients with severe cardiovascular diseases, such as cardiac arrest, cardiogenic shock or acute myocardial infarction. diagnostic and therapeutic measures, such as the use of devices for extracorporeal life support, require highly specialized training and skills. apart from extensive medical expertise, physicians and nurses may be exposed to exceptional levels of occupational stressors. therefore, excellent medical, psychological and inter-personal training of the medical staff is essential to improve patient outcomes. assessment of quality of care is important to provide continuous improvement in patient care and team performance. to the best of our knowledge, there is no study which examined the quality of care in cardiac arrest centers across key dimensions of quality of care. therefore, we aim to assess a bundle of key dimensions, that is psychological strain (p), resource utilization (r), interaction (i) between doctoral and nursing staff, costs of care (c) and education (e) programs for staff (price scheme). a cross-sectional study will be conducted with doctors and nurses, using a digital quesitonnaire that will cover the five dimensions of the price scheme.


Eligibility criteria:
inclusion criteria: * adult medical doctors or nurses * permament staff in the cardiac arrest center * cardiac arrest center that provides therapy with extracorporeal membrane oxygenation (ecmo) exclusion criteria: * no permanent employment in a cardiac arrest center * non-adult staff * not a medical doctor or nurse * cardiac arrest center that does not provide therapy with ecmo
primary anastomosis after left colectomy in emergency cases

Conditions: Complete Obstruction

Summary: the aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of intervention.

spirit 2013 checklist: recommended items to address in a clinical trial protocol and related documents\*

Eligibility criteria:
inclusion criteria: * patients presenting to the emergency department with obstructed left colon * patients aged between 18 and 80 years old * decision of laparotomy is made * intraoperative conditions are favorable for anastomosis (e.g., good vascularity, no severe sepsis, no marked tissue edema, no thickened peritoneum) * patient agrees to participate in the study exclusion criteria: * severe diffuse peritonitis (e.g., peritoneal thickening, thickened bowel loop, severe tissue edema, and pyogenic membrane) * marked decreased tissue vascularity due to distension * irresectable mass * rectal mass * patients refusing to participate in the study

Keywords: left colon mass
multicomponent intervention study- blood donors with high cholesterol

Conditions: Lipid Metabolism Disorder

Summary: the purpose and objective of this study is to improve cholesterol treatment among blood donors with fh (familial hypercholesterolemia).

this is a single center randomized, two arm trial. the two study arms include usual care (standard notification) and implementation bundle intervention. ut southwestern medical center will be the main study site and carter blood care will serve as the recruitment site. screening/baseline visit: donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. a 20 ml blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline ldl-c. follow-up phone call: at 3 months post-randomization, participants in both arms will be briefly contacted by phone by the research assistant to thank them for their participation and to answer any study related questions. end of study 6 month visit. participants will engage in a virtual visit for end of study procedures. at this follow-up visit, the research assistant will assess for any adverse events and direct the participant to collect a fasting blood sample for repeat ldl-c measurement. the research assistant will administer an electronic survey and knowledge questionnaires. additional clinical visits as desired by the participants' physicians will be allowed at their discretion.

Eligibility criteria:
inclusion criteria: * blood donors from carter bloodcare with high cholesterol meeting medped fh criteria * age 18 to 75 years exclusion criteria: * currently taking medication to lower cholesterol * taking any medication that can interact with statins * pregnancy * identified secondary cause of elevated lipids * chronic liver disease or significantly elevated liver function tests (\> 3 times upper limit)

Keywords: blood donors high cholesterol ldl cholesterol
peep titration and lung recruitment potential assessed by 3d eit

Conditions: ARDS; Respiratory Failure

Summary: in a population of ards patients, we explore the influence of different peep levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal peep and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3d-eit.


Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation. * diagnosis of ards was based on the berlin definition * lung recruitment potential assessment and peep titration was proper for the ards patients determined by the attending doctor exclusion criteria: * under 18 years of age. * pregnant women; * ribcage malformation * any contraindication to the use of eit (e.g. automatic implantable cardioverter defibrillator, and implantable pumps). * hemodynamic instability, unable to tolerate high peep; * high-risk individuals with pneumothorax, mediastinal emphysema, etc.

Keywords: ards eit 3d-eit
a phase 2 study of bgj398 in patients with recurrent gbm

Conditions: Recurrent Glioblastoma or Other Glioma Subtypes

Summary: this is an open-label non-randomized, multicenter, phase ii study of bgj398 administered to adult patients with histologically confirmed gbm and/or other glioma subtypes with fgfr1-tacc1, fgfr3-tacc3 fusion and/or activating mutation in fgfr1, 2 or 3.

patients were enrolled in two groups. group 1 enrolled patients who are not candidates for surgery. group 2 was planned to enroll patients who are surgical candidates. patients from both groups were evaluated for tumor response and progression by mri every 8 weeks until disease progression or discontinuation from study using rano criteria.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed gbm and/or other glioma subtypes at the time of diagnosis or prior relapse. 2. written documentation of local or central laboratory determination of amplification or translocation to fgfr1-tacc1, fgfr3-tacc-3 fusion and/or activating mutation in fgfr1, fgfr2,or fgfr3 3. rano defined tumor progression by mri in comparison to a prior scan 4. patients must have received prior external beam radiotherapy and temozolomide. exclusion criteria: 1. history of another primary malignancy 2. prior or current treatment with a fgfr inhibitor 3. neurological symptoms related to underlying disease requiring increasing doses of corticosteroids 4. patients must not be taking enzyme inducing anti-epileptic drug (eiaed). if previously on an eiaed, the patient must be off of it for at least two weeks prior to study treatment.

Keywords: bgj398, recurrent glioblastoma' recurrent gbm, fgfr,