Kornimate/medical-research-clean huggingface dataset:
effectiveness of exparel tap block in breast free flap reconstruction

Conditions: Postoperative Pain; Breast Reconstruction

Summary: transversus abdominis plane (tap) block is a useful tool in pain management after abdominal surgery. it is a regional nerve block that targets t6-l1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. it is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. tap block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. furthermore, it is used in plastic surgery procedures such as deep inferior epigastric perforator (diep) free flap or transverse rectus abdominis myocutaneous (tram) flap, as they involve extensive amount of abdominal soft tissue incision. previous studies have shown that tap block in these procedures significantly reduce post-op pain and narcotic pain medication use. more recently, exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. various surgical disciplines have adopted this agent as part of their pain management protocol. however, there are no literatures that describe the effect of tap block using exparel for breast free flap population. the study hypothesize that delivering tap block with exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. the investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.


Eligibility criteria:
inclusion criteria: * all female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at uva medical center exclusion criteria: * subjects with ages \<18 years * allergy to local anesthetic * inability to tolerate standard postoperative pain management regimen (tylenol, toradol, and oxycodone prn) for any reason * subjects who cannot read or understand english * subjects who are pregnant

Keywords: tap block regional block eras liposomal bupivacaine free flap
the pioneer-iv study is comparing clinical outcomes between angiography-derived physiology guidance to usual care in an all-comers pci population with unrestrictive use of the ht supreme sirolimus-eluting stent

Conditions: Coronary Artery Disease

Summary: pioneer-iv is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to lrdp and usual care in an all-comers patient population (including patients with high bleeding risk, hbr) undergoing pci with unrestrictive use of the ht supreme sirolimus-eluting stent. patients will be randomized to either angio-based physiology guidance angio-ffr (quantitative flow ratio and coronary angiography-derived ffr, caffr) or local routine diagnostic procedure (lrdp) and usual care. patients will be treated with 1-year p2y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2\*1270) patients. all patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (asa) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). at 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.


Eligibility criteria:
inclusion criteria: * patient has chronic stable angina, acute coronary syndromes or silent ischemia; * presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation; * the vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length); * patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the ethical committee and is willing to comply with all protocol-required (follow-up) evaluations. exclusion criteria: 1. patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice); 2. known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or p2y12 inhibitors; 3. planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (dapt) within 12 months of procedure; 4. concurrent medical condition with a life expectancy of less than 3 years; 5. currently participating in another trial and not yet at its primary endpoint; 6. active pathological bleeding; 7. history of intracranial haemorrhage.

Keywords: coronary artery disease ischemia quantitative flow ratio (qfr) p2y12 monotherapy drug-eluting stent physiology guidance angio-ffr coronary angiography-derived ffr (caffr)
effect of conjugated linoleic acid on body fat in overweight children

Conditions: Overweight

Summary: the prevalence of overweight children has increased dramatically over the last decade, and many overweight children will remain overweight as adults. conjugated linoleic acid (cla), a naturally occurring dietary fatty acid, has shown promising results in reducing body fat among adults, and we propose to test the efficacy of cla supplementation on body fat accretion in 6 to 10 year old children who are overweight or at risk of overweight.


Eligibility criteria:
inclusion criteria: * age 6 to 10 years * body mass index greater than 85th percentile * tanner stage i exclusion criteria: * medical condition * dairy allergy

Keywords: conjugated linoleic acid, body fat, children, overweight
evaluation of consistency of staphvax manufacturing lots

Conditions: Staphylococcal Infections

Summary: this study answers a u.s. food and drug administration requirement for evaluation in people of the consistency of manufacturing of a vaccine. subjects are randomized to one of three lots of vaccine. the antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.


Eligibility criteria:
inclusion criteria: * healthy, * written informed consent, * negative serum pregnancy test if appropriate, * expect to comply with protocol procedures and schedule exclusion criteria: * known hiv, * immunomodulatory drugs, * malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer), * active infection in the 2 weeks prior to study injection, * serious s. aureus infection within the last 3 months prior to injection, * use of investigational drugs, vaccines or devices within the prior 30 days, * hypersensitivity to components of staphvax
clinical and radiographic outcomes in arthroscopic cuistow procedure and arthroscopic modified bristow procedure

Conditions: Shoulder Dislocation

Summary: to evaluate the clinical and radiographic outcomes of arthroscopic chinese unique inlay bristow procedure (cuistow procedure) and arthroscopic bristow procedure in treating recurrent anterior shoulder instability.

aim: to compare the clinical and radiographic outcomes following the arthroscopic chinese unique inlay bristow (cuistow) procedure and the arthroscopic bristow procedure. background: the cuistow procedure is a modified bristow surgery in which a mortise and tenon structure was added to the contact surface between the coracoid tip and the glenoid. in previous study, patients received cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). however, no comparative studies was performed. study design: retrospective comparative case-cohort study methods: patients who underwent the arthroscopic cuisotw procedure and modified bristow procedure between jan 2017 and mar 2018 were selected. 70 patients with recurrent anterior shoulder instability were included. radiological evaluations with 3d ct scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, university of california at los angeles scoring system (ucla score), american shoulder and elbow surgeons score (ases score), rowe score, subjective shoulder value (ssv) and active range of motion were completed by independent observers and analyzed.

Eligibility criteria:
inclusion criteria: 1. a glenoid defect ≥10% but \<25%, 2. participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect \<25% of the glenoid or without defect 3. failure after bankart repair. exclusion criteria: 1. multidirectional shoulder instability (mdi), 2. uncontrolled epilepsy 3. pathological involvement of other soft tissue such as the long head of the biceps or a rotator cuff tear 4. previous shoulder stability surgery other than bankart repair 5. follow-up was less than 2 years or incomplete follow-up data.

Keywords: bristow shoulder dislocation inlay
clinimetric and instrumental characterization of fighter pilots with flight-related neck pain.

Conditions: Neck Pain

Summary: the objective of the study is to detect the state of clinical and instrumental factors related in fighter pilots with non-specific mechanical neck pain.

a prevalence study (descriptive, observational, cross-sectional) was carried out, in which clinimetric variables (range of active cervical movement, motor control and electrical activity), perceived pain (using nsmnp and algometry) and disability were evaluated. the sample (n = 18) is divided into instructors (n = 7) and students (n = 11). the objective of this study is to characterize descriptively at the sociodemographic level and to know the state of health in relation to clinimetric variables of the fighter pilots of the talavera la real air base (badajoz) to determine the risk of developing an neck injury.

Eligibility criteria:
inclusion criteria: * numerical pain rating scale. participants rated the intensity of their neck pain at rest on an 11-point numeric pain rating scale (nprs), where 0 was no pain and 10 maximum pain .the pilots airforce were asked to indicate the pain levels that they experienced when they wake up in the morning. cleland et al reported that the minimal detectable change (mdc) and minimal clinically important difference (mcid) for the numeric pain rating scale were 1.3 and 2.1 points, respectively, in patients with mechanical neck pain. * joint position sense. this test assesses the ability to relocate the head to its natural posture, and is a test of cervical proprioception. it consists of a visual measurement of error in moving the head to the initial neutral position after active cervical rotation. if the average difference between the initial and final position is equivalent to an error of 4.5 degrees, it is considered abnormal and the subject could be included in the study. exclusion criteria: * cervical pain that occurs with irradiation to the upper limbs and / or radiculopathy. * cervical spine surgery. * have received physical therapy treatment six weeks prior to data collection. * being involved in an on-going medico-legal dispute.

Keywords: nonspecific chronic neck pain fighter pilots
neoadjuvant imatinib in dermatofibrosarcoma protuberans

Conditions: Dermatofibrosarcoma Protuberans

Summary: the purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.


Eligibility criteria:
inclusion criteria: 1. patients ≥ or equal to 18 years of age. 2. suspected or documented diagnosis of dermatofibrosarcoma protuberans (dfsp). patients with suspected diagnosis of dsfp must have dfsp confirmed by pathology at the local institution prior to dispensing and the start of imatinib. 3. patient is medically able to undergo surgical resection of the dfsp and resection of the dfsp is recommended for clinical management of the disease. 4. patient has at least one site of measurable (macroscopic) disease. 5. performance status 0, 1 or 2 eastern cooperative oncology group (ecog) (see section 7.1). 6. adequate end organ function, defined as the following: total bilirubin \ 1.5 x 109/l, platelets \> 100 x 109/l. 7. female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. 8. written, voluntary informed consent. exclusion criteria: 1. patients who will receive radiation therapy to the site of dfsp prior to resection. 2. patients with grade iii/iv cardiac problems as defined by the new york heart association criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study). 3. female patients who are pregnant or breast-feeding. 4. patients who have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) that may worsen because of imatinib. 5. patients who have known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). 6. patients who have a known diagnosis of human immunodeficiency virus (hiv) infection. 7. patients who have received chemotherapy within 4 weeks prior to study entry. 8. patients who have had a major surgery within 2 weeks prior to study entry. incisional biopsy or partial excision of dermatofibrosarcoma protuberans to establish the diagnosis and/or to collect pretreatment tumor tissue does not qualify as major surgery.

Keywords: newly diagnosed or recurrent
exploring the mechanisms of indoxyl sulfate production by oral tryptophan challenge test

Conditions: Healthy; Chronic Kidney Diseases

Summary: cardiovascular disease (cvd) is prevalent in patients with chronic kidney disease (ckd) and is associated with extremely poor prognosis. traditional risk factors for the general population, such as diabetes mellitus, high blood pressure, and dyslipidemia, are more common in patients with ckd but cannot fully explain the increased risk of this population. new evidence suggests that the uremic milieu itself plays a critical role in the development and progression of cvd. the gut microbiota is markedly altered in ckd, with overgrowth of bacteria that produce uremic toxins. indoxyl sulfate (is) is among the most representative gut-derived uremic toxins and has been most frequently implicated as a contributor to the pathogenesis of cvd in ckd. is is converted from indole, a gut bacteria metabolite of dietary tryptophan, by two hepatic enzymes, cyp2e1 and sult1a1. the majority of studies have assessed is toxicity in cultured cells and animal models. however, human data have been conflicting and the benefit of using orally administered adsorbents to reduce is levels in unselected ckd patients was not supported by results from the recent randomized controlled trials. is levels may fluctuate widely from time to time with dietary intakes. the investigators hypothesize that a postprandial is concentration may more reflect its toxicity than a single time point (fasting or predialysis is) concentration measured in clinical studies. therefore, the investigators plan to establish an oral tryptophan challenge test (otct) by using an oral loading of 2 gm tryptophan to simulate the postprandial increase of plasma is. the investigators will recruit 60 healthy volunteers to undergo otct. a pharmacokinetic study of is after the otct will be performed in 20 of them to verify and simplify the design of otct protocol. the results of otct will be integrated with whole metagenome analysis of fecal microbiota and genetic polymorphism analysis of cyp2e1 and sult1a1 to explore the mechanisms of is production. in addition to the known genes in microbe produces indoles, other supporting bacteria or genes will be examined by using metagenomic shotgun sequencing data.


Eligibility criteria:
inclusion criteria: * (1) age older than 20 years * (2) no exposure to antibiotics or probiotics within the 3 months before entering the study. exclusion criteria: * (1) recent gastrointestinal discomfort (such as nausea, vomiting, abdominal pain, constipation, or diarrhea) or * (2) a history of chronic diseases including diabetes mellites, hypertension, cvd, ckd, liver disease, malignancy, and autoimmune disease. * (3) pregnancy or breast feeding * (4) currently use of antipsychotics, hypnotics, demerol, dextromethorphan, tramadol, pentazocine
reducing high school athletes' prescription opioids misuse and diversion through the student athlete wellness portal

Conditions: Prescription Opioid Misuse

Summary: the goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.

the goal of this proposal is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention. the new program, the student athlete wellness portal (sawp), will be a brief, web- and smartphone-based curriculum, and will encourage resistance to cultural influences to misuse prescription opioids. this portal, which was created based on formative interviews with athletes, coaches, athletic trainers, and school administrators, will be tested in a feasibility trial. one hundred and two high school athletes completed a pretest, participated in the treatment (the sawp) and completed posttest assess their knowledge, perceptions, and behaviors relating to opioid medication.

Eligibility criteria:
inclusion criteria: * english-speaking male and female adolescents * ages 13-19 * attending middle or high school * playing at last one interscholastic sport * parental consent exclusion criteria: * no parental consent * outside the age range * not participating in interscholastic sports * not in middle or high school * participated in the phase i research
diagnostic performance of positron emission mammography in breast cancer

Conditions: Breast Cancer

Summary: investigate the accuracy of pem in detection of breast cancer.

investigate the accuracy of positron emission mammography as non invasive method for early detection of breast cancer especially small sized cancers.

Eligibility criteria:
inclusion criteria: * patients suspected with breast cancer. exclusion criteria: * patient with glucose level \>200 mg/dl. * pregnant patients
ephedrine, phenylephrine and metaraminol effects on maternal cardiac output, uterine blood flow and fetal circulation

Conditions: Preeclampsia

Summary: it is a prospective clinical trial with random distribution that intends to investigate maternal and fetal effects of ephedrine, phenylephrine and metaraminol during cesarean delivery in patients with pre-eclampsia.

spinal anesthesia has become the main anesthetic technique for cesarean delivery due to avoidance of failed tracheal intubation risk, improvement of post-operative analgesia and promotion of early mother-neonate bonding. spinal anesthesia should be safe and comfortable for mother and child when referring to the side effects, including hypotension. the choice of the best vasopressor in this context is approaching to a resolution, favoring phenylephrine use. however, studies on high-risk pregnancies are still required, such as uteroplacental insufficiency, preeclampsia and intra-uterine growth restriction cases. the purpose of this study is to compare the effects of the vasopressors ephedrine, phenylephrine and metaraminol on maternal cardiac output, uteroplacental and cerebral fetal blood flow in patients with preeclampsia under spinal anesthesia for cesarean delivery. sixty pregnant patients will be recruited and randomly assigned to receive either ephedrine, phenylephrine or metaraminol, making a total of three groups with 20 patients each. variables to be analyzed are uterine arterial pulsatility index, umbilical arterial pulsatility index, fetus middle cerebral artery pulsatility index, maternal cardiac output, maternal cardiac frequency, maternal mean arterial blood pressure and maternal peripheral vascular resistance. these variables will be recorded in three moments: before the spinal anesthesia with the patient in dorsal recumbent and left displacement of the uterus, after spinal anesthesia in dorsal recumbent and after vasopressor bolus. averages will be calculated in these intervals and then compared to the alteration caused by spinal anesthesia and the return to basal levels after drug intervention.

Eligibility criteria:
inclusion criteria: * preeclampsia patients * after 34 weeks pregnant exclusion criteria: * patients' refusal * obstetric emergency * contraindications to spinal anesthesia * obesity

Keywords: vasopressor cesarian delivery hypotension maternal cardiac output uteroplacental blood flow cerebral fetal blood flow preeclampsia
oculusgen (ologen) collagen matrix implant for phaco-trabeculectomy in primary glaucoma: a case-control study

Conditions: Cataract; Glaucoma

Summary: the objective of this study is to determine the safety and effectiveness of the oculusgen™ (ologen) biodegradable collagen matrix implant in hacotrabeculectomy surgery. the primary endpoint is to prove the effectiveness via the reduction of iop, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

ologen™ collagen matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy) within 60 days from the time of implantation, ologen™ collagen matrix is totally degraded. postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed

Eligibility criteria:
inclusion criteria: 1. age 18 years or over. 2. at least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy. 3. visually significant cataract with visual acuity of less than or equal to 6/12. 4. subject able and willing to cooperate with investigation plan. 5. subject willing to sign informed consent form. exclusion criteria: 1. known allergic reaction to collagen. 2. subject is on warfarin and discontinuation is not recommended. 3. subject with normal tension glaucoma or aphakic glaucoma. 4. subject with corneal disease. 5. participation in an investigational study during the 30 days proceeding phacotrabeculectomy. 6. ocular infection within 14 days prior to phacotrabeculectomy. 7. pregnant or breast-feeding women. 8. monocular subject.

Keywords: patients with cataract and glaucoma ologen oculusgen collagen matrix phacotrabeculectomy aeon astron trabeculectomy tissue engineering mitomycin-c