Kornimate/medical-research-clean huggingface dataset:
glycar post market multicenter study

Conditions: Congenital Premature Cardiac Closure; Cardiac and Great Vessel Reconstruction and Repair; Peripheral Vascular Reconstruction and Repair

Summary: prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study

this real-world, single-arm, multi-center, observational, non-interventional prospective registry will enroll up to 100 consecutive subjects undergoing cardiac and/or vascular repair or reconstruction surgery in 10-12 investigative sites in the european union (eu), south africa and usa. the study is aimed at providing real-world evidence of the glycar pericardial patch device performance and incidence of clinical outcomes in patients undergoing cardiac and/or vascular repair or reconstruction surgery related to glycar pericardial patch.

Eligibility criteria:
inclusion criteria: * patients (to be) treated with glycar pericardial patch as per ifu and standard clinical practice. * the patient or patient's legal representative signs an ec/ irb approved informed consent form prior to the study participation intraprocedural inclusion: glycar pericardial patch was implanted, or implantation attempted during the index procedure. exclusion criteria: * no study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the ifu.

Keywords: bovine pericardial patch
effect of rosiglitazone on the vascular biology of human fat tissue

Conditions: Metabolic Syndrome; Insulin Resistance

Summary: insulin resistance is a common condition that can lead to type 2 diabetes. one of the commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin resistance. rosiglitazone appears to work on fat cells. animal studies suggest that rosiglitazone may work by increasing blood vessel growth in fat cells. the purpose of this research is to see if rosiglitazone also increases blood vessel growth in human fat cells. the investigators will compare results from before and after being on rosiglitazone for 6 weeks.

adipocytes play a crucial role in the control of metabolic homeostasis, by sequestering excess calories in the form of triglycerides, and secreting cytokines that control systemic fuel utilization. sustained excess calorie consumption results in adipocyte hypertrophy and hyperplasia, and like any expanding tissue, requires increased capillary expansion to nourish the enlarged adipose tissue mass. recent reports indicate that decreased capillary density in adipose tissue of obese individuals correlates with insulin resistance, suggesting that an imbalance of angiogenesis and adipogenesis may underlie this condition. to determine whether improvement in insulin sensitivity is related to changes in adipose tissue capillary development, we conducted a randomized, double-blind, placebo-controlled trial to determine capillary density, angiogenic growth potential, and metabolic parameters in healthy human volunteers before and after treatment with rosiglitazone, a potent insulin sensitizer.

Eligibility criteria:
inclusion criteria: 1. overweight but otherwise in good general health. 2. age 18 - 55 years. 3. normal glucose tolerance. 4. stable weight with bmi (27-44). 5. stable medication use for the preceding month. 6. bp \< 150/90. 7. negative pregnancy test (\*hcg), if female and of childbearing potential. 8. practicing, and willing to continue to practice appropriate contraception throughout the study if a female of childbearing potential. exclusion criteria: 1. serious medical illness. 2. pregnancy. 3. tobacco use within the past 6 months. 4. prior or current treatment with a thiazolidinedione. 5. patients who have received an investigational drug in the past 30 days. 6. use of systemic corticosteroids. 7. known or suspected allergy to rosiglitazone or any component of the preparation
women's international transcatheter aortic valve implantation registry

Conditions: Symptomatic Aortic Stenosis

Summary: the study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

wintavi is an international, multi-centre, prospective, observational registry. the purpose of this study is to collect 'real-world' data regarding the clinical utility of all commercially available transcatheter aortic valve implantation (tavi) devices for percutaneous aortic valve implantation in female patients with severe aortic stenosis (as) requiring treatment. data collected in this study will provide additional information on the understanding of the safety and device performance in a 'real-world' setting and how to best treat patients with severe as. this will include quality of life questionnaires (kccq).

Eligibility criteria:
inclusion criteria: 1. severe as determined by echocardiogram and doppler, defined as: mean gradient \>40 mmhg or peak jet velocity \>4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2 2. symptomatic as demonstrated by angina, congestive heart failure, nyha functional class ≥ ii, or syncope 3. logistic euroscore suitable for tavi 4. patient must have other conditions (such as severe airways disease, porcelain aorta, previous thoracic radiotherapy, childs pugh class b and c liver disease) such that the multi-disciplinary team (interventional cardiologists, cardiothoracic surgeons and cardiac anaesthesiologists) agree that co-morbidities render savr of high or prohibitive risk. 5. patient has been informed of the nature of the registry and has provided full written informed consent according to hospital practise exclusion criteria: 1. patient is not an eligible candidate for tavi 2. untreated clinically significant (\> 70% obstruction) coronary artery disease in the proximal segments of main branches suitable for revascularization 3. echocardiographic evidence of intra-cardiac mass, thrombus or vegetation 4. hemodynamic instability (e.g. requiring inotropic support) 5. active endocarditis or sepsis within 6-months prior to the study procedure 6. use of investigational device without ce mark

Keywords: tavi women aortic stenosis varc2
the boss study: an acute evaluation of anatomical and geometric changes using the bladder on a stick system (boss)

Conditions: Functional Mitral Regurgitation; Heart Failure

Summary: the objective of the boss study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

mardil medical is developing an investigational device for functional mitral regurgitation intended to provide ventricular support with adjustable inflatable chambers to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation. in doing so, mardil medical is interested in exploring the anatomical and geometric annular and ventricular changes that occur when strategically positioned external inflatable chambers are applied to the outside of the heart. favorable benefits of circumferential reduction in ventricular wall stress favoring left ventricular (lv) remodeling and acute reshaping of lv segments subtending the deformed mitral valve apparatus needs to be better understood. mardil medical is pursuing this study as an initial phase in the acute evaluation of anatomical and geometric changes using the bladder on a stick system (boss).

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * patient undergoing open chest cardiac surgery via sternotomy * signed informed consent by patient or legally authorized representative exclusion criteria: * any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior valve surgery, cabg, epicardial pacing leads, pericarditis, history of mantle radiation, or other procedure involving pericardial access)

Keywords: functional mitral regurgitation heart failure
hydromorphone vs fentanyl in children undergoing tonsillectomy surgery

Conditions: Obstructive Sleep Apnea; Tonsillitis

Summary: a rct to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

this is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. an otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at slch. patients will be randomized 1:1 in block sizes of 5 per group. patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.

Eligibility criteria:
inclusion criteria: 1. children ages 2 to 15 years old 2. presenting for tonsillectomy or adenotonsillectomy surgery 3. american society of anesthesiologists physical status (asaps) classification 1, 2 or 3 4. provide informed consent / assent (as appropriate) exclusion criteria: 1. additional concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures 2. revision tonsillectomy or revision adenotonsillectomy surgery 3. known pregnancy 4. any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
the relationship between brain mri phenotypes, genes and cognitive outcome in chd adults

Conditions: Congenital Heart Disease

Summary: the main purpose of this proposal is to perform novel mri analyses to determine the brain organizational changes associated with altered executive function and the modulating role of variants in neuroresilience and hypoxia response genes in adults with d-transposition of the great arteries (d-tga).

aim 1 is structured to determine the relationship between sulcal patterns(measured by mri) and executive function in adults with d-tga and if this relationship is modified by (a) presence of neuroresilience gene apoe ε2 or ε4 alleles, or (b) damaging variants in hypoxia response genes. aim 2 is designed to determine the relationship between structural connectivity using rich club (measured by mri) and executive function in adults with d-tga and if this relationship is modified by (a) presence of neuroresilience gene apoe ε2 or ε4 alleles or (b) damaging variants in hypoxia response genes. in aim 3, the investigators will determine the relationship between functional connectivity using rich club (measured by mri) and executive function in adults with d-tga and if this relationship is modified by (a) presence of neuroresilience gene apoe ε2or ε4 alleles or (b) damaging variants in hypoxia response genes.

Eligibility criteria:
inclusion criteria: * persons who participated in the boston circulatory arrest, ph and hematocrit studies at boston childrens hospital as children (n\~300). * normally-developed age- and sex-matched young adults who are able to provide informed consent to undergo the mri portion of the study and limited neuropsychological evaluation (iq assessment as well as neuropsychological tests for which normative references are not available). exclusion criteria: * for controls - inability to complete the mri (implanted metal, claustrophobia, personal history of mental illness, brain injury, prior brain intervention). * intellectual impairment precluding completion of the study questionnaires independently * unable to speak and read english fluently
team science (the liver health study)

Conditions: Steatotic Liver Disease of Mixed Origin (MetALD)

Summary: liver damage from alcohol intake and weight-related behaviors is preventable and treatable only through lifestyle changes. this mixed-methods randomized controlled trial compares standard and enhanced approaches to screening, brief intervention, and referral to treatment/prevention (sbirt/p) to identify and intervene for metabolism- and alcohol-associated liver disease (metald). our multidisciplinary team aims to show that integrating results of noninvasive liver screening with fibroscan®, a painless ultrasound that measures stiffness and fat in the liver, can optimize our brief intervention. the study population is adults age 21+ who speak spanish or english from underresourced communities with alcohol- and weight-related risks for metald.


Eligibility criteria:
inclusion criteria: * be at least 21 years of age. * exceed alcohol intake screening guidelines for metald. * have a body mass index (bmi) \>=25 kg/m2. * be able to speak and read english or spanish to provide written informed consent and understand written and oral instructions in english or spanish. exclusion criteria: * pre-existing liver disease or hepatocellular carcinoma or prior liver transplant. * pre-existing medical conditions that, in the opinion of the investigative team, would interfere with research participation (e.g., loss of kidney function, uncontrolled infections, multiorgan failure, uncontrolled upper gastrointestinal bleeding, other active malignancies except skin cancer). * pre-existing mental health conditions that, in the opinion of the investigative team, would interfere with the ability to provide informed consent and understand written and oral instructions (e.g., hepatic encephalopathy, psychotic disorder diagnosis or symptoms). * current pregnancy. * be anyone who, based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification. * currently receiving formalized psychosocial treatment for an alcohol use or drug problem and/or newly taking medications for an alcohol use or drug problem. * currently receiving formalized behavioral weight management treatment and/or newly taking weight loss medications.

Keywords: metabolism and alcohol-associated liver disease motivational interviewing personalized feedback
first-in-human single ascending dose study of lna043 in patients scheduled for total knee replacement

Conditions: Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Summary: this study is designed to evaluate the safety and tolerability of ascending single doses of lna043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. in addition, this will help to establish the presence of lna043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.


Eligibility criteria:
key inclusion criteria: * male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening * patients diagnosed with primary osteoarthritis of the knee assessed locally for whom a total knee replacement is planned * general health status acceptable for total knee replacement surgery in the opinion of the investigator * stable medications within 3 months prior to enrollment (such as appropriate pain medication, antibiotics prophylaxis) and standard of care key exclusion criteria: * presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder * prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (aci) or else, at the same knee * any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 2 months prior to enrollment * bmi \> 40; presence of uncontrolled diabetes or hyperthyroidism * large effusion in the knee to be replaced, more than (\>)1 cm fluid in the suprapatellar space at the midline * corticosteroid use by any route except topical and nasal in the 3 months prior to enrollment * history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases * pregnant or nursing (lactating) women * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant

Keywords: primary osteoarthritis, total knee replacement, cartilage
guided versus conventional periapical endodontic surgery

Conditions: Endodontic Disease; Endodontic Re-treatment Failure

Summary: this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.

the aim of this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. patients having mandibular posterior teeth indicated for endodontic surgery will be selected. full medical and dental history will be obtained from all patients. patients will be randomly assigned to either guided endodontic surgery or conventional endodontic surgery. surgical procedures will be done under magnification. root-end cavities will be filled using mta.post surgical instrucions will be given to patients. surgical time will be recorded. clinical and radiographic success will be asses at 6 and 12 month.

Eligibility criteria:
inclusion criteria: 1. patients in good general health. 2. patients with age ranging between 18-50 years with no sex predilection. 3. posterior teeth with an indication for endodontic surgery. 4. patients' acceptance to participate in the study. exclusion criteria: 1. patients with allergy to materials or medications used in the trial. 2. pregnant female patients. 3. teeth with pathoses associated with vertical root fracture. 4. severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).

Keywords: endodontic surgery guided surgery 3d guide
nurses helping sudden cardiac arrest survivors recover after getting an implantable cardioverter defibrillator (icd)

Conditions: Sudden Cardiac Arrest

Summary: to determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an icd

this study is one of the first large randomized clinical trials of nursing interventions aimed at improving health outcomes after receiving an icd. written informed consent was used in the study.

Eligibility criteria:
inclusion criteria: * first time sudden cardiac arrest with icd implantation during hospitalization, over age 21 years, working telephone in the home, deliverable address for 1 year exclusion criteria: * receiving an icd for primary prevention of sudden cardiac arrest, inability to read, speak, or understand english, no telephone at home or no current address, cognitive or physical impairments that prohibited ability to give informed consent.
the related factors with resilience in caregivers whose child with leukemia

Conditions: Condition 1. Children With ALL Are Still Alive and the Age of 18 Years of Age.; Condition 2. Has Been Completed to Guide the Treatment Regimen Were in Remission.; Condition 3. Caregiver Can or Taiwanese Language Communicator.

Summary: the purpose of this study was to explore caregivers stress, family functioning, social support and family resilience of families whose children had acute lymphoblastic leukemia. the significantly correlation among caregivers stress, family functioning, social support and family resilience was also explored.


Eligibility criteria:
inclusion criteria: 1. diagnosed as acute lymphoblastic leukemia children, children with cancer are still alive and the age of 18 years of age. 2. has been completed to guide the treatment regimen were in remission. 3. caregiver can or taiwanese language communicator. exclusion criteria: - children with metastatic cancer who end chemical treatment of more than one year
system to evaluate the risk of lymph node metastasis preoperatively in cervical cancer

Conditions: Cervical Cancer

Summary: the lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of lnm in cervical cancer patients before operation.

lymph nodes metastasis (lnm) was proved to be a critical risk factor related to the survival to cervical cancer survival. however, preoperative pelvic magnetic resonance imaging (mr) or computed tomography (ct) tests are less sensitive to assess the risk of lymph node metastasis. pet-ct is too expensive and radiative to be widely used in clinical practice. a model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cervical cancer * figo stage ib1-iia1 * undergone radical hysterectomy with pelvic lymphadenectomy * peformed pelvic mri examination preoperatively exclusion criteria: * had distant metastases diagnosed before or during the surgery * underwent neoadjuvant radiotherapy preoperatively * underwent neoadjuvant chemotherapy preoperatively * incomplete or inaccuratemedical records
imaging brain fluids during breathing

Conditions: Healthy

Summary: this study will perform magnetic resonance imaging (mri) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation.

cerebrospinal fluid (csf) flow is essential for brain health, as it clears waste products from the brain. this study will investigate how breathing affects the flow of csf around the brain. the investigators will perform high resolution magnetic resonance imaging (mri) scans in participants who are breathing in specific patterns or performing simple tasks and test the effects on csf flow. participants will complete an imaging study visit in which the investigators will image their brain activity while they perform simple tasks, including paced breathing tasks. the participants will be split into two arms: (1) paced breathing (25 participants low resolution, 15 participants high resolution), (2) transcutaneous vagal nerve stimulation (25 participants low resolution, 15 participants high resolution). the mri scans will take place in the 7 tesla mri scanner at massachusetts general hospital.

Eligibility criteria:
inclusion criteria: * adult age 18-70 years exclusion criteria: * no ferrous metal implanted in head or body * no history of major head trauma * no neurological or psychiatric disorder * not using medication that affects brain function * no implanted electronic devices (e.g. pacemaker) * no implant that poses an mr contraindication * not pregnant, suspect they are pregnant, or seeking to become pregnant * not claustrophobic * no piercings or jewelry that cannot be removed * does not weigh more than 250 pounds * normal or contact-corrected normal vision exclusion for transcutaneous vagus nerve stimulation (tvns) arm: * conditions of skin or anatomy that affect left auricle or forehead skin and could impact placement of electrodes for tvns or forehead stimulation * diagnosis of significant cardiovascular or cerebrovascular disease \[e.g. congestive heart failure, stroke, cardiac conduction disorders (including: bundle branch block, heart block, long q-t syndrome), history of asystole or non-sustained ventricular tachycardia. * bradycardia (defined as resting heart rate \<50 bpm) * hypotension defined as blood pressure \<90/60 mmhg

Keywords: glymphatics cerebrospinal fluid