Kornimate/medical-research-clean huggingface dataset:
fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia (feto)

Conditions: Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary Artery Hypertension

Summary: the purpose of this research is to gather information on the safety and effectiveness of a new procedure called fetoscopic endoluminal tracheal occlusion (feto).


Eligibility criteria:
inclusion criteria: * singleton pregnancy * normal fetal karyotype with confirmation by culture results. results by fluorescence in situ hybridization (fish) will be acceptable if the patient is \> 26 weeks. * isolated left cdh with liver up * gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (us) o/e lung area to head circumference ratio (lhr) \< 25% (measured at 180 to 296 weeks) at the time of surgery; o/e lhr 25% to \<30% (measured at 300 to 316 weeks) at time of surgery. * gestational age at feto procedure with o/e lhr \<25% at 27 weeks 0 days to 29 weeks 6 days; with o/e lhr 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (lmp) and evaluation of first ultrasound * patient meets psychosocial criteria exclusion criteria: * multi-fetal pregnancy * history of natural rubber latex allergy * preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of feto balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa * psychosocial ineligibility, precluding consent: * inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial * patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution. * right sided cdh or bilateral cdh, isolated left sided with o/e lhr ≥30% (measured at 180 to 295 weeks) as determined by ultrasound * additional fetal anomaly and chromosomal abnormalities by ultrasound, mri, or echocardiogram at the fetal treatment center. no cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring * maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * history of incompetent cervix with or without cerclage * placental abnormalities (previa, abruption, accrete) known at time of enrollment * maternal-fetal rh isoimmunization, kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * maternal hiv, hepatitis-b, hepatitis-c status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. if the patient's hiv or hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment uterine anomaly such as large or multiple fibroids or mullerian duct abnormality * participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Keywords: fetal lungs fetal surgery congenital diaphragmatic hernia tracheal occlusion pulmonary hypoplasia
prophylaxis of deep vein thrombosis following total hip arthroplasty

Conditions: Osteoarthritis, Hip; Femur Head Necrosis; Femoral Neck Fractures

Summary: this prospective study compares an oral direct factor xa inhibitor with lmwh for thromboprophylaxis in the patients undergoing tha.


Eligibility criteria:
inclusion criteria: * male or female without childbearing potential aged ≥20 years who were scheduled for elective primary tha exclusion criteria: * recent history of active bleeding or vte * known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding * persistent blood pressure of ≥160mmhg systolic and/or ≥100 mmhg diastolic at baseline * myocardial infarction or cerebrovascular accident within three months of the scheduled surgery * major surgery in the prior three months * renal insufficiency with a creatinine clearance \ 6 hours after the end of surgery
telemedicine clinical trial for cognitive behavioral therapy in familial dysautonomia

Conditions: Familial Dysautonomia

Summary: this is a single-blind, placebo-controlled, telemedicine clinical trial to assess the efficacy of cognitive behavioral therapy (cbt) in adult patients 18 years and older with familial dysautonomia (fd) and anxiety and/or depression and/or obsessive compulsive or related disorders. the trial will enroll 20 adult patients each with fd who have anxiety and/or depression and/or obsessive compulsive or related disorders by the dsm v criteria. enrolled participants will be allocated to receive, in a non-randomized fashion, weekly 5-10 min talking sessions (i.e., placebo) for 8 weeks, followed by weekly 30-60 min cbt sessions during 8 weeks. although investigators will be un-blinded to the intervention, participants will be blinded to the expected effects of each intervention. both the talking sessions (i.e., placebo) and cbt sessions will be performed via telemedicine either via a hipaa secure telemedicine platform or the telephone based on the preference of the individual patient. if a patient specifically requests talking or cbt sessions to be performed in person, this will be accommodated. the use of telemedicine is to accommodate disability and potential physical limitations of this unique patient population. the cbt sessions will be supervised by lily armstrong, certified mental health therapist and dr. thomas boes, nyu clinical assistant professor in the departments of psychiatric and neurology.


Eligibility criteria:
inclusion criteria: * diagnosis of familial dysautonomia (fd). * dsm-v criteria of major depressive disorder or anxiety disorder or obsessive-compulsive behaviors. * stai score ≥ 25 or a phq-9 depression scale score ≥ 5 or greater. * willing and able to complete 8 sessions of placebo and 8 sessions of cbt. * if taking an antidepressant it will be maintained at a constant dose throughout study and concurrent talk therapy from another therapist will not be initiated during the study. * moca score of 14 or greater. exclusion criteria: * current suicidal attempt or suicidal ideation (subjects with a past history of suicidal ideation or attempt are eligible to participate). * patients starting psychoactive medications within 3-months prior to screening.

Keywords: telemedicine
caudal versus intravenous dexmedetomidine for caudal analgesia in children

Conditions: Pain

Summary: the aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of dexmedetomidine (1 µg.kg-1) co-administered with bupivacaine for caudal analgesia or intravenously in children undergoing infra-umbilical surgery.

dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.but which route of administration of dexmedetomidine is the most beneficial remains unknown. the investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal bupivacaine in children undergoing infra-umbilical surgery. 75 children (asaⅰorⅱ,aged 1-6 yr) undergoing infra-umbilical surgery were included in this study. anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. anesthesia was maintained with sevoflurane 2-3% in oxygen-air.then,caudal block was applied. patients were randomly assigned in three groups. group b-dcau (n = 25): caudal bupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;group b-div (n = 25): bupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;group b(n = 25): bupivacaine 0.25% and 10 ml normal saline intravenous

Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists (asa) - i * scheduled for lower abdominal and perineal surgery * under general anesthesia exclusion criteria: * hypersensitivity to any local anesthetics * patient has history of allergy, intolerance, or reaction to dexmedetomidine * infections at puncture sites * bleeding diathesis * preexisting neurological disease * children with uncorrected cardiac lesions * children with heart block
liver mri for colorectal cancer liver metastasis: comparative effectiveness research for the choice of contrast agents

Conditions: Colorectal Cancer

Summary: magnetic resonance imaging (mri) has been widely used for problem-solving tool in the evaluation of hepatic lesions, and it has been shown to have better sensitivity than ct for detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm. after introduction of a liver-specific hepatobiliary mr contrast agent, gadoxetic acid, gadoxetic acid-enhanced mri (gd-eob-mri) has been increasingly used for evaluation of liver lesion including crlm. however, compared to conventional mri with extracellular contrast agent (eca-mri), gd-eob-mri has different pharmacodynamic characteristics, and is more expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection. the purpose of this study was to compare the clinical outcome and diagnostic performance of gd-eob-mri and eca-mri for evaluation of focal hepatic lesion in newly diagnosed colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. patients with surgically proven colorectal adenocarcinoma 2. patients who underwent abdominopelvic ct and liver mri for initial staging before any treatment 3. no past or concurrent malignancy other than colorectal adenocarcinoma. exclusion criteria: 1. precontrast abdominopelvic ct 2. precontrast liver mri 3. liver mri using contrast other than extracellular agent or gadoxetic acid 4. the interval between ct and liver mri was longer than 4 weeks 5. patients who had suspected multiple hepatic metastases (\> 10) on ct 6. distant metastasis other than liver and 7. unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.

Keywords: colorectal cancer liver mri contrast gadoxetic acid
a study to assess the efficacy and safety of two dosing regimens of alefacept in subjects weighing between 100kg and 150kg with moderate to severe chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: comparison of two dosing regimens of alefacept in subjects weighing between 100kg and 150kg with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * body weight between 100kg and 150kg * diagnosis of chronic plaque psoriasis with body surface area (bsa) involvement of ≥ 10% * candidate for phototherapy or systemic therapy for psoriasis * cd4 + t lymphocyte counts \> lower limit of normal exclusion criteria: * clinically significant abnormal hematology values or blood chemistry values * alt or ast value of ≥ 3x the upper limit of normal * other types of psoriasis * serious infection within 3 months prior to 1st dose of study drug * antibody positive for hiv * history of malignancy * history of severe allergic or anaphylactic reactions * history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease

Keywords: chronic plaque psoriasis alefacept
observational retrospective study on spinal analgesia in laparoscopic and laparotomic hysterectomy

Conditions: Pain, Postoperative; Hysterectomy; Morphine; Anesthesia, Spinal

Summary: perioperative multimodal analgesia, defined by the use of various analgesic medications targeting different drug receptors, provides adequate pain relief with minimal or no opiate consumption. therefore, it represents one of the cornerstone of enhanced recovery after surgery (eras) protocols, as the reduction in opioid use and the associated side effects may eventually reduce length of hospital stay, increase patient satisfaction and minimise the risk of long-term opioid use. regional and neuraxial anesthesia techniques are key interventions to provide successful analgesia in the context of a multimodal strategy. intrathecal morphine, for its effectiveness and potential of reducing the need of intravenous postoperative opioids, seems an attractive option in the case of hysterectomy, one of the most common major surgical procedures performed in women, associated with severe postoperative pain even when performed laparoscopically. the aim of our observational retrospective study is therefore to compare the analgesic efficacy and the safety of morphine administered by intrathecal route versus intravenous route during the first 48 hours after performance of laparoscopic/laparotomic hysterectomy.


Eligibility criteria:
inclusion criteria: * adult women american society of anaesthesiologists (asa) physical status \<= 3, scheduled for elective hysterectomy under general anesthesia between january 1st 2019 and december 31st 2021. exclusion criteria: * patients with american society of anaesthesiologists (asa) status \> 3, * opioid use or history of opioid dependence, * chronic use of analgesic medications, * psychiatric disorders, * surgery including upper abdominal procedures (for example liver mobilization and diaphragm peritonectomy/resection, splenectomy) or xifo-pubic incision
abundance and distribution of lipids and proteins in nonalcoholic fatty liver disease (nafld)

Conditions: Nonalcoholic Fatty Liver Disease

Summary: nonalcoholic fatty liver disease (nafld) is the most common type of liver disease in the united states. the incidence of nafld is very similar to that of obesity, type 2 diabetes, and the metabolic syndrome. the investigators hypothesize that there may be a relationship between over-nutrition, decreased physical activity and the development of fatty liver. the purpose of this study is to identify the types of fats and proteins, and the quantity of each, that are associated with increased severity of nafld.


Eligibility criteria:
inclusion criteria: * 18-65 year of age * undergoing elective abdominal or bariatric surgery * may have normal or elevated alt/ast levels exclusion criteria: * presence of viral hepatitis * significant alcohol use * intercurrent infections * use of any thiazolidinediones

Keywords: nonalcoholic fatty liver disease (nafld) nonalcoholic steatohepatitis (nash) obesity lipidomics proteomics
efficacy of letrozole versus clomiphene citrate on ovulation induction in patients with polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome

Summary: we aimed this study to determine and compare frequency of induction of ovulation in women with polycystic ovarian syndrome treated with letrozole versus clomiphene citrate as published literature shows variations.

discrepancy between ovulation induction rate and pregnancy rate is related to anti-estrogenic effects on cervical mucus and endometrium and long acting gonadotrophins are more effective than clomiphene citrate. this study was aimed at comparing frequency of induction of ovulation in women with polycystic ovarian syndrome treated with letrozole versus clomiphene citrate.

Eligibility criteria:
inclusion criteria: * diagnosed cases of polycystic ovarian syndrome. exclusion criteria: * all women having endocrine disorders like thyroid disorders. * women having hyperprolactinemia.
checkpoint inhibitor-induced liver injury

Conditions: Immune-Mediated Hepatitis

Summary: in this multi-center prospective observational study, the investigators plan to identify the incidence and risk factors for checkpoint inhibitor-induced liver injury and characterize biochemical, genetic, immunological, and histological features associated with it.

checkpoint inhibitor-induced liver injury (chili) is a new incompletely understood category of hepatotoxicity which is distinct from other types of drug-induced liver injury (dili) such as direct or idiosyncratic dili. the data regarding the incidence and risk factors is lacking. therefore, 'in-depth phenotyping' together with data from the control group exposed to checkpoint inhibitors (cpi) is necessary to develop refined algorithms incorporating cpi-related factors, host genetic and environmental risk factors that would enable pre-empting chili. the aim of the study is to enroll two deeply phenotyped cohorts (patients who developed chili and patients who are starting checkpoint inhibitors) and obtain biological samples at multiple time points.

Eligibility criteria:
inclusion criteria: both patient groups and control group: • able to give written informed consent or potential participants who have developed encephalopathy related to chili as a response to checkpoint inhibitor therapy, who lack the capacity to give written informed consent and have a consultee (personal or nominated) - for chili patient group only chili group: patients who developed checkpoint inhibitor-induced liver injury and meet the following criteria: 1. meets one of the following analytical thresholds at enrolment (visit 1) * alanine transaminase (alt) exceeding 5 times the upper limit of normal (uln) or * alt exceeding 3 times uln plus bilirubin exceeding 2 times uln or * alkaline phosphatase (alp) exceeding 2 times uln with accompanying elevations of gamma-glutamyl transferase in the absence of known bone metastases driving the rise in alp level 2. absence of other known causes of liver injury after detailed investigations patients who developed chili but did not meet the above criteria at enrolment or who were found to have a different cause for their liver injury after further investigations will be excluded from the analysis control group: consecutive patients with cancer who have a clinical indication to start checkpoint inhibitors. a small proportion of patients will develop chili following their checkpoint inhibitor treatment and will be classified as cases. exclusion criteria: * patients who are treated with cytotoxic chemotherapy concurrently with checkpoint inhibitors. * on the judgment of chief investigator that the person has certain alternative explanations to the acute event (rather than chili).

Keywords: immune checkpoints inhibitors immune-related adverse events hepatotoxicity liver injury
physiotherapy and capsulitis

Conditions: Arthritis

Summary: multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.


Eligibility criteria:
inclusion criteria: * primary idiopathic phase 2 capsulitis * diagnosis of capsulitis confirmed by shoulder dilatation * patients between 18 and 70 years of age * exclusion criteria: * secondary capsulitis * shoulder pain of other etiology * cognitive disorders * patients less than 18 years, and more than 70 years of age
testing a novel dairy protein to counteract immunosenescence

Conditions: Immunodeficiency

Summary: aging populations experience a decline in adaptive immune system function also known as immunosenesence. nutritional approaches to stimulate and strengthen the immune system are needed for this growing segment of the population. a controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response. our objective was to examine the immune stimulating effects of dairy protein subjected to ultraviolet radiation (uv-c) radiation treatment process instead of pasteurization. participants were 21 healthy individuals over 60 years of age who consumed 6 g of the dairy protein or a comparison, soy isoflavone protein, twice a day for eight weeks. dtap vaccine administered at week 4. non-parametric t-tests revealed a significant increase in tetanus antibodies in the dairy group compared to the soy group at week 8. these findings suggest additional benefits of uv-c treated unheated dairy protein as a solution to counteract immunosenescence, but warrant further study in elderly and other populations that might benefit from immune system stimulation.


Eligibility criteria:
inclusion criteria included participants be more than 60 years of age. volunteers underwent a physical examination and health assessment by a physician to ensure the absence of exclusion criteria which were regular consumption of greater than one unit of milk and/or milk products (milk, yogurt, fresh cheese, etc.) a day at the time of enrollment, known milk allergy, food faddism, other non-traditional diet, prolonged consumption of dairy supplements (greater than one daily during the previous four weeks), use of tobacco products in the previous 10 years, underlying neoplasia or immunological disease, including hypergammaglobunemia, renal disease or failure, use of steroids or immunosuppressive drugs in the previous eight weeks, reduced physical activity (new york heart association classes iii-iv). having received a dtap vaccine within the last five years was an exclusion criteria for the study, but patient records were incomplete for many volunteers on this aspect. therefore, volunteers with an initial tetanus antibody level above 3 iu/ml were excluded from the study results as the volunteer was assumed to have had the dtap vaccine within the last 5 years.
a post-market study to evaluate adverse event incidence rates in patients with skin of color undergoing correction of nasolabial folds with hylaform, hylaform plus and captique.

Conditions: Facial Wrinkles

Summary: to assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with hylaform, hylaform plus or captique.


Eligibility criteria:
inclusion criteria: * bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale exclusion criteria: * pregnant/lactating women * patients who previously received permanent facial implants or using over-the-counter products
phase 2 study of lum-201 in children who have previously completed the lum-201-01 trial (oragrowth213)

Conditions: Growth Hormone Deficiency

Summary: this is a multi-national trial. the goals of the trial are to study the growth response to lum-201 administration in children with idiopathic growth hormone deficiency (ghd) previously treated with daily rhgh for 12 months in the lum-201-01 trial.

this trial will have one screening/baseline visit with tests to assess if subjects are eligible to start study therapy. the screening/baseline visit can coincide with the month 12 visit in the lum-201-01 trial. subjects will receive the same dose of lum-201 as a daily oral dose each morning. lum-201 will be adjusted for body weight increments at each clinic visit, as applicable. the trial consists of 12 months of treatment. after screening, subjects will return to the clinic for 5 visits. during four of these clinic visits, safety laboratory samples will be collected.

Eligibility criteria:
inclusion criteria: * parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable. * must have previously completed 12 months of daily rhgh treatment as part of the lum-201-01 pghd trial. * is eligible for study participation as confirmed by the principal investigator (pi) exclusion criteria: * has a medical condition that, in the opinion of the pi and/or mm, adds unwarranted risk to use of lum-201. * uses any medication that, in the opinion of the pi and/or mm, can independently cause short stature or limit the response to exogenous growth factors. * has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system cyp3a4 that metabolizes lum-201

Keywords: lum-201 pghd height oral