Kornimate/medical-research-clean huggingface dataset:
a multi center, study to evaluate the safety and efficacy of the vasq external support device for arteriovenous fistulas

Conditions: Vascular Access; End Stage Renal Disease

Summary: this study is a prospective, multi center, randomized, controlled study of the vasq in arteriovenous fistulas. the vasq constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the av shunt. these geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. the device is designed to improve short term maturation and long term patency of the fistula. the vasq is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.


Eligibility criteria:
inclusion criteria: * patients referred for creation of a new brachiocephalic fistula who consent to take part in the study. * aged \> 18 * male and female participants * patients willing and able to attend follow up visits over a period of 6 months exclusion criteria: * patients who require revision surgery. * having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery * target arteries smaller than 3 mm in diameter * target vein smaller than 3 mm in diameter * stenotic veins on the side of surgery as diagnosed on pre-op ultrasound * patients with prior central venous stenosis or obstruction on the side of surgery * depth of vein greater than 8 mm (on us) on side of surgery * known coagulation disorder * prior steal * known allergy to nitinol * life expectancy less than 6 months * inability to give consent and/or comply with the study follow up schedule * women of child bearing age
triangular exclusion technique in isolated posterior mitral valve leaflet prolapse for mitral valve repair

Conditions: Mitral Valve Posterior Leaflet Prolapse

Summary: the goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery the main questions aims to answer is: does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month

the surgical method isthe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long

Eligibility criteria:
inclusion criteria: * varying degrees of degenerative mv regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior mv leaflet * concomitant tricuspid annuloplasty exclusion criteria: * with mitral valve stenosis or any other manifestation of mitral regurgitation pathology. * individuals requiring surgical intervention for the aortic or pulmonary valves

Keywords: mitral valve repair;triangular exclusion technique
unn-rads scale for diagnosing lymph node metastasis in patients with history of thyroid cancer

Conditions: Thyroid Cancer; Lymph Node

Summary: in 2020, sarda-inman et al., developed the ultrasound neck node reporting and data system (unn-rads) scale that allows decision-making about when it is appropriate to perform fna of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic ln in patients undergoing tc follow-up and to validate the unn-rads scale for the diagnosis of ln metastasis in patients with a history of tc.

this study enrolled consecutive patients in follow-up for differentiated thyroid cancer (dtc) history who underwent us-guided fine needle aspiration (fna) of the lns for suspicious metastatic cervical lymph nodes. patients were included if they 1) had previous history of dtc, 2) both sexes with age over 18 years old, and 3) underwent fna of the lns for any suspected features corresponding with at least unn-rads 1. patients were excluded if they underwent fna of the lns for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the fna results were not concluded. unn-rads 1 y 2 and unn-rads 3, 4 and 5 were grouped for analysis purpose. diagnostic performance of unn-rads scale were assessed in terms of sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv), positive likelihood ratios (+lr), negative likelihood ratios (-lr) and accuracy, as well as with a receiver operating characteristic (roc) curve.

Eligibility criteria:
inclusion criteria: * 1) had previous history of dtc 2) both sexes with age over 18 years old 3) underwent fna of the lns for any suspected features corresponding with at least unn-rads 1 exclusion criteria: * 1) underwent fna of the lns for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) fna results were not concluded

Keywords: lymph node thyroid cancer ultrasonography metastasis
engyne exploring gilenya in patients with neutralizing antibodies against interferon

Conditions: Multiple Sclerosis

Summary: study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18-65 years * subjects with relapsing remitting ms defined by 2010 revised mcdonald criteria * patients with expanded disability status scale (edss) score of 0-6.5 * interferon-beta (ifn-β) treatment for at least 18 months. * positive ifn-nab titer at screening or within 6 months prior to screening * patients with disease activity despite treatment with ifn-ß measured by gadolinium-enhancing lesions on t1-weighted images on mri using a triple-dose gadolinium protocol and/or new or newly enlarging t2 lesions (t2 lesions: compared to a reference mri performed within the last 18 months) exclusion criteria: * patients with previous or current disease of immune system * active infections * cardiovascular risk patients * patients unable to undergo mri scans, including claustrophobia or history of hypersensitivity to gadolinium-dtpa other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis ms fingolimod gilenya neutralizing antibodies nab
sepsis pre-alert monitoring intervention: study to investigate targeted enhanced monitoring for sepsis

Conditions: Sepsis

Summary: sepsis is a leading cause of death worldwide, and contributes to approximately 750,000 hospitalizations per year, a third of which may die. international guidelines recommend timely interventions, including cultures, fluid resuscitation and antibiotics. following guideline bundles is associated with a decrease in mortality. key to timely intervention is timely diagnosis. using the epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis. the primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.

a means to identify patients before they become ill may improve the effectiveness of established therapies.epic's electronic medical record (epic systems, verona, wi) contains a surveillance tool that uses predictive analytics to identify patients at risk of becoming septic four hours after the alert becomes active. this affords the opportunity to intervene sooner, but it remains unclear what the best course of action should be in a population at risk of sepsis, only some of which may go on to develop the illness. we propose an automatic intervention, consisting of enhanced monitoring, that is tied to the alert. no therapeutics will be mandated. instead, additional monitoring information will lead to faster diagnosis and therapy, and improved clinical outcomes.

Eligibility criteria:
inclusion criteria: * any inpatient at nyu langone health system exclusion criteria: * not an inpatient at nyu langone health system

Keywords: hospital admission
pharmacokinetics and safety pilot study of single-dose oral and intravenous ctap101 in stage 3 and 4 chronic kidney disease subjects

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure

Summary: this study will investigate how the levels of a single dose of ctap101 changes in the body over time (pharmacokinetics, pk) and how ctap101 affects other mineral and hormonal balances (pharmacodynamics, pd) in patients with stage 3 or 4 chronic kidney disease (ckd) with vitamin d insufficiency and secondary hyperparathyroidism (shpt).


Eligibility criteria:
inclusion criteria: * body mass index between great than or equal to 18 and less than or equal to 40 kg/m2 * plasma ipth value for stage 3 ckd greater than or equal to 70 pg/ml and lower than or equal to 1000 pg/ml * plasma ipth value for stage 4 ckd greater than or equal to 110 pg/ml and lower than or equal to 1000 pg/ml * adjusted serum total calcium value greater than 8.4 mg/dl and lower than 10.0 mg/dl * serum phosphorus value greater than or equal to 2.5 mg/dl and lower than or equal to 5.5 mg/dl * serum 25-hydroxyvitamin d level greater than 15 ng/ml and lower than 30 ng/ml * hemoglobin level greater than or equal to 10 g/dl exclusion criteria: * has nephrotic range proteinuria * has liver disease or significant hepatic dysfunction * is taking cytochrome p450 3a4 inhibitors or inducers * has adult history of kidney stones and dysphagia * has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen * currently on dialysis * current serious illness such as cancer, hiv, cardiovascular event or hepatitis

Keywords: parathyroid diseases renal insufficiency kidney failure, chronic hyperparathyroidism, secondary vitamin d hyperparathyroidism renal insufficiency, chronic kidney diseases kidney failure
survival pluss: increasing capacity for mama-baby survival in post-conflict uganda and south sudan

Conditions: Neonatal Death; Preterm Birth; Low Birthweight; Neonatal Hypoglycemia

Summary: universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. yet, only 57% of pregnant ugandan women choose to deliver at health facilities. this unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in uganda. while multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. this study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. the study, a cluster randomized community based intervention trial in post-conflict northern uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.


Eligibility criteria:
inclusion criteria: * pregnant women at 28 or more weeks of gestation * residence in the selected clusters * pregnant women under 18 years of age will be included since they are considered as emancipated minors in uganda exclusion criteria: * intention to move from the study area within one year * psychiatric ailments that may inhibit the informed consent process

Keywords: facility births
early detection of pulmonary- and pulmonary vascular disease in sjögren syndrome

Conditions: Sjögren Syndrome; Pulmonary Hypertension

Summary: according to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from sjögren syndrome. however epidemiological data are based on non-invasive measurements using echocardiography. furthermore, no data are available regarding exercise hemodynamics in those patients. this study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary sjögren syndrome. patients under suspicion for pulmonary hypertension (ph) will be offered further investigations including right heart catheterization.

patients with primary and secondary sjögren syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.

Eligibility criteria:
inclusion criteria: * informed consent * diagnosis of sjögren syndrome * age: 18 - 90 yrs exclusion criteria: * uncontrolled systemic hypertension (at rest \>150 mmhg systolic or 95 mmhg diastolic) * relevant systolic (ef\ grade 1) left ventricular dysfunction * uncontrolled ventricular arrhythmias * uncontrolled supraventricular bradycardia or tachycardia * myocardial infarction within the last 12 months * pulmonary embolism within the last 6 months * larger surgical interventions within the last 12 months * musculoskeletal or vascular disease, that may affect ergometric investigations * pregnancy (anamnesis)
can hyperbaric oxygen improve erectile function following surgery for prostate cancer

Conditions: Impotence; Prostatic Neoplasms

Summary: the purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that delivers oxygen under slight pressure, to a drug treatment of pde5i (such as viagra, levitra, cialis)for men following surgery for prostate cancer will result in more men being able to continue to have erections.

prostate cancer is the most common non-skin malignancy in men in the united states, with approximately 232,000 diagnoses of adenocarcinoma projected for 2005. more than 150,000 of these men are treated with radical prostatectomy. common sequelae following successful nsrrp (nerve-sparing radical retropubic prostatectomy)include urinary incontinence and sexual dysfunction. recent advances in surgery technique and treatment have been made but in spite of aggressive management, recovery of sexual function is incomplete with fewer than one-fifth reporting return to baseline. the etiology of erectile dysfunction following radical prostatectomy results most probably from local surgical trauma and neurapraxia, which leads to corpus cavernosal hypoxemia in the post-nsrrp period. this hypoxemia is believed to impact negatively on the health and maintenance of the smooth muscle cells within the corpus cavernosum. hyperbaric oxygen therapy (hbo2t) is a unique modality that is able to provide oxygen delivery to tissues that have been damaged by traumatic injury. hypothesis: the addition of post-nsrrp hyperbaric oxygen therapy (hbo2t) to a treatment of phosphodiesterase type 5 inhibitor (pde5i) will reduce the incidence of erectile dysfunction (ed) and urinary incontinence when measured at 1, 3, 6, 12 and 18 months post-nsrrp for stage i prostate cancer.

Eligibility criteria:
inclusion criteria: * male * age 40-69 * diagnosis of stage i prostate cancer * bilateral nsrrp as primary treatment * sexual potency prior to surgery exclusion criteria: * copd, chf, diabetes mellitus * known inability to tolerate pde5i * confinement anxiety/claustrophobia * planned adjuvant or neo-adjuvant therapy * patients taking alpha blockers or nitrates * patients with retinitis pigmentosa

Keywords: impotence prostatic neoplasms hyperbaric oxygenation phosphodiesterase inhibitors
pgl4001 efficacy assessment in reduction of symptoms due to uterine leiomyomata (pearliii-extension study)

Conditions: Uterine Fibroids

Summary: this is the long-term extension of a phase iii, efficacy and safety open-label (protocol pgl09-026) with pgl4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of pgl4001 treatment. this extension study consists of three periods of 3 months open-label pgl4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.


Eligibility criteria:
inclusion criteria: * subject completed visit 6 of pgl09-026 study, 10 to 18 days after menstruation following end of treatment with pgl4001, and did not take medications forbidden by the protocol. exclusion criteria: * subject has a large uterine polyp (\> 2cm). * subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during pgl09-026 study. * subject has abnormal hepatic function at re-test. * subject has clinically significant abnormal findings at visit a or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations. * subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
follow up after survived therapy with mild induced hypothermia (mih) after restoration of spontaneous circulation (rosc)

Conditions: Cardiac Arrest; Hypothermia

Summary: sudden cardiac arrest (sca) remains one of the major leading causes of death. cognitive deficits are common in survivors of sca. postresuscitative mild induced hypothermia (mih) lowers mortality and reduces neurologic damage after cardiac arrest. the investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

consecutive patients with restoration of spontaneous circulation (rosc) after resuscitation due to out-of-hospital sca, admitted to our intensive care unit, underwent mih. hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive coolgard or non-invasive arcticsun). the core body temperature was operated at 32 to 34 °c over a period of 24 hours followed by active rewarming. neurological status was evaluated at hospital discharge and 6 months after discharge using the pittsburgh cerebral performance category (cpc).

Eligibility criteria:
inclusion criteria: * survived cardiac arrest * voluntary consent exclusion criteria: * no voluntary consent

Keywords: sudden cardiac arrest hypothermia neurological outcome
agc mode vs minimal flow in breast surgery

Conditions: Volatil Agent Consumption; Automatic End-tidal Controlled Anesthesia; Anesthesia; Functional; Breast Diseases

Summary: the aim of this study was to compare the agc mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia

modern anesthesia machines use circular systems in which ventilated gas re-circulates to a certain degree and is therefore reused, preserving temperature, and humidity. the rebreathing fraction is increased by a reduction in fresh gas flow, which leads to a considerable decrease in consumption of fresh gas and volatile anesthetics, resulting in reductions in cost and atmospheric pollution. in a closed ventilation system, only the patient's requirements for oxygen and anesthetic agents are supplemented. a fresh gas flow-rate of 0.5 l/min is defined as the minimal-flow technique. the oxygen and anesthetic gas titration can be manually controlled by the anesthetist. to assure safe and appropriate anesthesia, manually controlled anesthesia requires constant monitoring and numerous adjustments to the gas dosage by the anesthetist, especially for low- and minimalflow anesthesia. oxygen flow and volatile anesthetics can also be automatically controlled by anesthesia machines using end-tidal control (such as agc mode of maquet flow-i anesthesia machine), which ensures constant end-tidal concentration of oxygen and anesthetic gas via feedback and continuous automatic adjustment mechanisms. anesthesiologists needing to make fewer interventions during a case may have clinical importance in terms of distraction, record keeping and patient safety. in addition to this advantage, we wanted to compare the agc mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia.

Eligibility criteria:
inclusion criteria: * 18-65 years * undergoing breast surgery * asa physical status i-ii * female * operation lasting at least 1 hour * those who agreed to volunteer for the study with an informed consent form exclusion criteria: * coronary artery disease, chf * pregnancy or breastfeeding women * decompensated diabetes mellitus * kidney or liver failure * chronic obstructive pulmonary disease * opioid sensitivity * history of malignant hyperthermia * history of smoking * alcohol or drug addiction * significant anemia * sepsis * bmi \>35 * patients with allergies to the drugs used in the study

Keywords: anesthesia machine sevoflurane minimal fresh gas flow breast surgery agc mode
prospective non-interventional observational study of use of triumeq and corresponding monitoring measures in clinical practice in germany

Conditions: HIV Infections

Summary: triumph is a prospective, non-interventional observational study on the use of the fixdose combination triumeq (dolutegravir/abacavir/lamivudine) and the respective monitoring measures in the practice of hiv care in germany. the primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in hiv-infected patients under triumeq therapy in everyday routine practice in germany. the study is designed to enroll approximately 400 patients. there are no protocol-mandated visits or procedures associated with the study. each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of triumeq, due to death, withdrawal of consent, lost to follow-up. triumeq is a registered trademark of the viiv healthcare group of companies.


Eligibility criteria:
inclusion criteria: * documented hiv infection * age ≥ 18 years * hla-b\*5701-negative * decision for first initiation of triumeq therapy made by the attending physician independent of the inclusion in this observational study exclusion criteria: * prior dolutegravir therapy (cf. also capping abc in section 3.3 recruitment) * participation in a clinical trial during this study