Kornimate/medical-research-clean huggingface dataset:
retrograde versus antegrade perfusion in low-moderate hypothermia for aortic arch surgery

Conditions: Brain Function; Hemiarch Cardiac Procedure

Summary: the purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.

the purpose of this study is to compare brain function after surgical circulatory arrest (surgeon stops the heart-lung machine to work on the heart) in antegrade perfusion versus retrograde perfusion. there are 2 ways to supply blood to the brain, antegrade and retrograde perfusion. in antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. in retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain. it is standard practice to cool the patient down during this type of surgery to help protect the brain. despite measures to safeguard brain health, some patients still experience postoperative cognitive decline such as confusion, delirium and agitation. the investigators are conducting this study to see which method of perfusing the brain is superior and decreases the symptoms of confusion, delirium and agitation.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy exclusion criteria: 1. \< 18 years of age 2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit 3. current alcoholism (\> 2 drinks/day) 4. current psychiatric illness requiring pharmacotherapy 5. current drug abuse (any illicit drug use in the past 3 months) 6. hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal) 7. severe pulmonary insufficiency (requiring home oxygen therapy) 8. renal failure (serum creatinine \> 2.0 mg/dl) 9. claustrophobic fear 10. unable to read and thus unable to complete the cognitive testing 11. pregnant women 12. patients who score \<19 om the montreal cognitive assessment (moca) or ≥27 on the baseline center for epidemiological studies depression (ces-d) scale 13. patients who have pre-existing unsafe implants for 3 tesla magnetic resonance imaging (mri) 14. patients who have received chemotherapy in the last 12 months or radiation to the brain

Keywords: antegrade perfusion retrograde perfusion brain perfusion circulatory arrest
features of regional perfusion of lung consolidation

Conditions: Lung Injury, Acute; Ultrasound Therapy; Complications

Summary: the aim of this study is to evaluate the potential usefulness of lung ultrasound to assess the size and perfusion of consolidation and explore their relationships with clinical outcome.

lung consolidation is one of the most causes of hypoxia in intensive care unit(icu) settings. a quantitative measurement of consolidation would be extremely benefit for the clinical management in hypoxemia, both as an index of severity and to predict outcomes.in order to quantify the lung consolidation and its effect on clinical outcomes, a simple and quantitative scoring system of the size and perfusion of lung consolidation was proposed by lung ultrasound. subjects with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound examination. the size of consolidation and the richness of blood flow was computed upon lung ultrasound. the sensitivity, specificity and accuracy of the scoring system were calculated and compared to evaluate the diagnostic efficacy.

Eligibility criteria:
inclusion criteria: 1. admission to icu( 18yr\<age\<90yr); 2. patients presented with acute respiratory failure; 3. pulmonary consolidation by chest imaging (lung ultrasound, x ray or ct scan). exclusion criteria: 1. hemodynamic instability (i.e., severe hypotension with systolic arterial pressure\ 180mmhg; uncontrolled cardiac arrhythmias); 2. severe thoracic trauma; 3. coronavirus disease 2019; 4. pulmonary artery hypertension and pregnancy.

Keywords: lung consolidation, respiratory failure, perfusion
investigation of bioabsorbable screws in pediatric orthopedic surgery

Conditions: Pediatric; Fracture; Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures); Patient Satisfaction

Summary: this study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. conducted by the pediatric orthopedic department at children's hospital new orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). it seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.

this study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. the research will be conducted within the pediatric orthopedic department at chnola, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. the primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. this study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. the investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery after informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).

Eligibility criteria:
inclusion criteria: * primary fractures requiring fixation with cannulated screws exclusion criteria: * children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis) * secondary fractures * non-union fractures * tibial tubercle osteotomies (ttos) * slipped capital femoral epiphysis (scfes) * unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age * allergies or contraindications to screw materials
acupuncture for post-operative pain control for patients undergoing gynecological surgery

Conditions: Post-operative Pain; Gynecological Surgery; Acupuncture

Summary: this study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.

the goal of the study is to investigate acupuncture at the time of gynecological surgery as a way to decrease post-operative pain which would decrease narcotic intake and hospitalization time. to do this, the researchers will recruit non-pregnant patients over the age of 18 who are undergoing laparoscopic surgery for a benign gynecological indication. these patients will be randomized using a computer generated randomization system to receive either acupuncture or sham acupuncture pre-operatively after the induction of anesthesia. the acupuncture points used will be points proven in the literature to be associated with decreasing general pain, pelvic pain and nausea and vomiting. the needles will be placed by a anesthesiologist trained in acupuncture and they will be left in place for 15 minutes while the patient is prepped for the surgery. the sham points will be on the hands and feet and chosen at random by the gynecologic surgeon who is not trained in acupuncture. for both groups, the acupuncture needles will be removed before the first incision of the surgery. all patients will be blinded to their group allocation.

Eligibility criteria:
inclusion criteria: * female patients * over the age of 18 * scheduled for laparoscopic gynecological procedures for benign conditions of the uterus, fallopian tubes and/or adnexa exclusion criteria: * male patients * pregnancy * suspected or known malignant disease * immunocompromised * known or persistent abuse of medications, drugs or alcohol * chronic pain for greater than 3 months

Keywords: surgery acupuncture gynecology pain narcotics
clinical pharmacology of fyu-981 (subjects with hepatic insufficiency)

Conditions: Hepatic Insufficiency; Healthy

Summary: the purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of fyu-981 to subjects with hepatic insufficiency and with normal hepatic function.


Eligibility criteria:
inclusion criteria: * adult healthy subjects or adult cirrhosis patients * body mass index: \>=18.5 and \<30.0 exclusion criteria: * subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)
a randomized trial of remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic

Conditions: Tachycardia, Ventricular; Ventricular Fibrillation

Summary: the purpose of this study is to determine if remote monitoring of implantable cardioverter defibrillators (icd), compared with quarterly device interrogations in clinic, will improve patients' outcomes and satisfaction and will reduce health care costs.

sudden cardiac death (scd), usually due to a ventricular tachyarrhythmia, is the most common cause of death in the united states. the implantable cardioverter defibrillator (icd) has been shown to improve the survival of patients with a history of a heart attack and a weak heart (functioning at 30% or less) and those with symptomatic congestive heart failure symptoms (hearts functioning at 35% or less). thus, the number of patients who will require icd therapy is expected to rise exponentially over the next several years. to facilitate the follow-up of patients with icds, device companies have launched systems for remote monitoring of these devices. one such system is the medtronic carelink monitor. although this system has been proven in a multicenter, prospective study to be easy to use, it is not known whether this monitor results in improved patients' outcomes and satisfaction and in reduced healthcare costs. comparison: patient outcomes, costs, and satisfaction will be evaluated, comparing patients assigned to follow-up using the medtronic carelink monitor versus quarterly visits to an outpatient clinic.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * must have an icd with or without crt for an approved indication * must be planning to have their devices followed-up at duke * must have a telephone (land line) * willing and able to provide informed consent. exclusion criteria: * 18 years of age or younger * no telephone with land line * unable to provide informed consent.

Keywords: defibrillators, implantable
an extension study of ts-152 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to evaluate the long-term safety and efficacy of ts-152 in subjects with rheumatoid arthritis who have completed the previous study (ts152-3000-ja study or ts152-3001-ja study).


Eligibility criteria:
inclusion criteria: 1. at visit1(-4 weeks), subject must be fully informed about the study and must obtain written informed consent from the subject himself. 2. at visit2(0 week), subjects must have completed the previous study (ts152-3000-ja or ts152-3001-ja) ,and must have completed all evaluations required at the follow-up visit. etc. exclusion criteria: 1. subjects who had serious adverse drug reactions in the previous study. 2. at visit1(-4 weeks) or visit2 (0 week), subjects who have not recovered from clinically important adverse events. etc.

Keywords: ra
endometrial curettage before embryo transfer

Conditions: Infertility

Summary: studies have shown that endometrial sampling in the month prior to embryo transfer may increase pregnancy rates. we wish to test this hypothesis by performing a hysteroscopy and curettage in the month proceeding embryo transfer during ivf, ivf/icsi or frozen/thawed cycles.

it has been suggested that local injury to the endometrium doubles the rate of implantation and successful pregnancies in ivf patients. purpose 1. to determine whether performing curettage the month prior to embryo transfer (et) increases the chance of embryo implantation. 2. to study molecular attributes of the endometrium taken at curettage and to compare them to those cycles resulting in pregnancy and those which do not result in pregnancy. samples will be grown as primary culture in the research laboratory and possible molecular markers and attachment assays for endometrial receptivity will be studied. patient selection: patients undergoing ivf or ivf-icsi at ha'emek medical center/ ivf unit. woman over 35 years of age will be excluded since implantation failure is more likely to be due to genetic, chromosomal or cytoplasmic aberrations in their oocytes. proposed protocol: 1. informed consent obtained from prospective candidates. 2. participants randomly divided to three groups 1. control group 2. hysteroscopy and curettage performed on days 15-17 of menstrual cycle 3. hysteroscopy and curettage performed on days 19-22 of menstrual cycle 3. after the following menses an ivf, ivf-icsi, or frozen embryo cycle is performed according to the unit's standard protocols. 4. the primary end point of the study will be the implantation rate after et and the expression of possible molecular markers for endometrial receptivity in the pregnant patients.

Eligibility criteria:
inclusion criteria: * informed consent * in-vitro fertilization candidate * normal blood coagulation exclusion criteria: * anemia (hemoglobin under 10 mg/dl) * abnormal maternal karyotype * thrombocytopenia under 140,000 * any contraindication to hysteroscopy or in-vitro fertilization

Keywords: embryo transfer hysteroscopy curettage iv-vitro fertilization molecular markers endometrial receptivity endometrial dating
utility of the smart pilot view in clinical practice: a two center prospective observational study

Conditions: Anesthesia,General

Summary: recently, a new software program for anesthesia has been developed, called smart pilot view. this program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. the purpose of this study is to determine whether the use of this program improves the quality of anesthesia.


Eligibility criteria:
inclusion criteria: * elective surgery * general anesthesia * american society of anesthesiologists physical status: i - iii * age 18 to 90 years exclusion criteria: * combined regional and general anesthesia * expected surgery duration \< 30 minutes * central nervous system (cns) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases) * regular intake of cns active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants) * heart surgery on cardio-pulmonary bypass * relevant hepatic disease (child b or higher) * bmi \>35 * overt signs of alcohol abuse * contraindications or allergies to drugs used in the study

Keywords: anesthesia smart pilot view pain control recovery
an observational study of avastin (bevacizumab) in patients with metastatic colorectal cancer (acorn)

Conditions: Colorectal Cancer

Summary: this prospective, multi-center, observational study will assess the safety and efficacy of avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving avastin in combination with a standard of care first-line chemotherapy regimen. data will be collected for 1.5 years or until death.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer with no previous systemic treatment for advanced disease * receiving avastin in combination with a first-line standard of care chemotherapy regimen * avastin initiated at the same time as first-line chemotherapy regimen exclusion criteria: * investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer * contraindication to avastin
prevalence of alpha-1 antitrypsin dysfunction in pulmonary emphysema

Conditions: Pulmonary Emphysema

Summary: the main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult french population presenting with pulmonary emphysema. phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.


Eligibility criteria:
inclusion criteria: * pulmonary emphysema highlighted by computed tomography * ratio forced expiratory volume in 1 second (fev1) / vital capacity (vc) \< 70% measured by lung function test exclusion criteria: * hepatic transplant * patient under legal protection * patient not benefiting from the french health insurance
penn biobank return of research results program

Conditions: Cancer; Cardiovascular Diseases; Hereditary Cancer; Hereditary Cardiac Amyloidosis

Summary: the overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic health (e-health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.


Eligibility criteria:
inclusion criteria: 1. consented participant in university of pennsylvania biobank who previously submitted a dna sample for research testing 2. english speaking 3. aged 18 years or older 4. agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results 5. have an actionable mutation or have been selected as a control participant 6. have not previously received actionable results of clinical genetic testing exclusion criteria: 1. deceased assessed by electronic medical record, death index or identified after contact 2. evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing
efficacy of dolutegravir plus lamivudine in hiv-1-infected treatment-naïve adults without a baseline genotyping test

Conditions: Hiv; HIV-1-infection

Summary: the purpose of this study is to evaluate the efficacy of dtg + 3tc versus dtg + tdf/ftc over 48 weeks in hiv-1 naive patients in a real life setting with no baseline hiv genotypic resistance testing available.

this is a 48-week, phase iv, randomized, open-label, to assess the non-inferior antiviral activity (vl \ 100,000 c/ml) and screening cd4+ cell count (≤ or \>200 cells/mm3). the study will comprise: * a 28-day screening phase (which may be extended to 35 days to allow receipt of all screening assessment results). * an open-label randomized phase (day 1 to week 48). approximately 200 hiv-1 naïve adult patients will be randomized 1:1 to receive 2dr dtg+3tc versus 3dr tdf/ftc + dtg for 48 weeks.

Eligibility criteria:
inclusion criteria: 1. subject should be antiretroviral naïve (defined as \<=10 days of prior therapy with any antiretroviral agent following a diagnosis of hiv 1 infection). 2. age ≥ 18 years 3. screening plasma hiv-1 rna ≥1000 c/ml 4. cd4 cell count nadir: any value 5. effective contraception for women of childbearing potential. 6. informed consent form signed by patient and investigator exclusion criteria: 1. history of suicide ideation, intention or action. 2. evidence of hbv infection based on the results of testing at screening\* for hbv surface antigen (hbsag), hbv core antibody (anti-hbc), hbv surface antibody (antihbs or hbsab), and hbv dna as follows: subjects positive for hbsag are excluded; subjects negative for anti-hbs and hbsag but positive for anti-hbc and positive for hbv dna are excluded. 3. anticipated need for any hcv therapy during the first 48 weeks of the study. 4. acute symptomatic hiv infection. 5. any active opportunistic infection (category c, cdc 2014). 6. current pregnancy or breastfeeding. 7. no effective contraception for the women of childbearing. 8. any verified grade 4 laboratory abnormality. a single repeat test is allowed during the screening period to verify a result. 9. alt (alanine aminotransferase) ≥ 5 x upper limit of normal value (uln) or ast (aspartate aminotransferase) ≥ 3 x uln and bilirubinemia ≥ 1.5 x uln (with 35% direct bilirubinemia). 10. unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice). 11. creatinine clearance of \<50 ml/min/1.73 m2 (cockroft-gault method). 12. history or presence of allergy to the trial drugs or their components. 13. severe hepatic insufficiency (child pugh class c). 14. any available historical resistance test result.

Keywords: hiv antiretroviral treatment dolutegravir dual therapy
aromatherapy as treatment for n/v of pregnancy

Conditions: Pregnancy Emesis

Summary: a double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.

this is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of pregnancy.

Eligibility criteria:
inclusion criteria: * pregnancy at \<14 weeks gestation * english-speaking * baseline puqe score \>=6 exclusion criteria: * non-compliant with prenatal care or study procedures * hyperemesis gravidarum * allergies to perfumes, essential oils or cosmetics * abnormal sense of smell * known acute or chronic gi disease * asthma * use of prescription anti-emetics