Kornimate/medical-research-clean huggingface dataset:
biothrax® (anthrax) vaccine in pregnancy registry

Conditions: Pregnancy Complications; Pregnancy Outcome; Congenital Abnormalities

Summary: the purpose of this study is to determine if inadvertent receipt of the biothrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.

this study will use a convenience sample and passive referral to enroll participants. for the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey). outcomes among infants born to women enrolled in the registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.

Eligibility criteria:
inclusion criteria: * female active duty service member * received one or more dose of biothrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period. exclusion criteria: * non-service member, non-active duty pregnant female.

Keywords: maternal mortality obstetric labor, premature eclampsia pre-eclampsia abortion, spontaneous diabetes, gestational pregnancy, ectopic hydatidiform mole fetal death live birth still birth premature birth sex ratio birth weight
inspiron sirolimus eluting stent performance in bifurcation coronary arteries treated using provisional technique

Conditions: Bifurcation Lesion; Coronary Artery Disease

Summary: evaluate the efficacy of the inspiron sirolimus eluting stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.


Eligibility criteria:
inclusion criteria: * patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (medina 1-1-0, 1-0-0, 0-1-0). exclusion criteria: * acute myocardial infarction (stmi); * chronic occlusion; * cardiogenic shock; * ejection fraction ≤ 20%; * thrombocytopenia (≤ 50 mil); * dapt contraindication; * life expectancy of less than 12 months.
surgical site infections and the microbiome: understanding the pathogenesis of surgical site infections

Conditions: Open GI Surgery

Summary: this is a prospective, observational study of patients undergoing open gi surgery. at the time of operation, samples will be collected from the incision site and gi tract. the study will follow patients up to 30 days postoperatively, monitoring for signs of ssi. samples will be taken from all patients who develop ssi. sequencing will be performed on a subset of samples based on our specific aims. * aim 1: conduct a case-control study of patients with ssi and age-, sex-, diagnosis-, and wound class-matched control patients without ssi, comparing microbiome alpha diversity and community composition with 16s rna sequencing to determine the association with ssi. * aim 2: identify the strain of bacteria isolated from ssis using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation.


Eligibility criteria:
inclusion criteria: * we will include adult patients (age ≥ 18 years) * undergoing open abdominal surgery during the study period. * open abdominal surgery will include any abdominal procedure entering the peritoneal cavity through a midline incision with a skin incision that is 5cm or greater. exclusion criteria: * patients with planned minimally invasive surgery including laparoscopic or robotic surgery as these patients have lower rates of surgical site infections (ssis). patients who have a laparoscopic or robotic surgery converted to open surgery will be excluded. * appendectomy and cholecystectomy as these patients have lower risk of ssi. * vascular, gynecological, obstetric, urological or transplantation. * trauma patients. * patients without source control at the index operation including those with an open abdomen, no fascial closure, or temporary abdominal closure device (such as abthera dressing). * pediatric patients (age\<18 years). * patients who decline swab/specimen collection.
efficacy of prophylactic fluconazole therapy in preterm and very low birth weight neonates in preventing invasive fungal infection.

Conditions: Invasive Candidiases

Summary: invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. these infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of h2 antagonists, and steroids. infection with candida species is the third most common cause of bloodstream infection in premature infants. mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing \<1500g at birth. invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. the present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.


Eligibility criteria:
inclusion criteria: * preterm babies born less than 34 weeks of gestation * very low birth weight babies (weighing \< 1500 g at birth) * babies \<72 hours of age exclusion criteria: * babies \>72 hours of life * syndromic babies * babies with suspected metabolic disorders
evaluation of the effectiveness of the remedee solution in fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. these symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition. remedee labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. these endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep. the remedee solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment. the hypothesis of this study is that regular use of the remedee solution for three months improves the quality of life of fibromyalgia patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of fibromyalgia according to the american college of rheumatology criteria (wolfe et al., 2016), * fiq score ≥ 39 (moderate and higher forms) on the day of inclusion (d0), * with a smartphone that runs on android 8 and ios 12 or later, * agreeing the installation of the fibrepik app on the smartphone, * agreeing the collection of the number of steps measured by the smartphone, * agreeing the installation of the google fit app for patients whose smartphone runs on android (necessary for the collection of the number of steps), * wrist size compatible with the size m or l of the wristband template, * affiliated to the social security system or beneficiary of such a system, * who have signed a consent to participate. exclusion criteria: * with a characterized depressive episode according to the dsm 5, * substantial change in treatment in the three months prior to inclusion and in the months to come: change in analgesic level, introduction of a new treatment. * with a chronic inflammatory pathology (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, lupus,...), * person in civil proceedings, * having a dermatological pathology on the wrists, such as oozing dermatosis, hyper sweat or an unhealed lesion, * with a surgical implant, tattoo or piercing on one of the wrists, * allergic to metals and/or silicone, * referred to articles l1121-5 to l1121-8 of the french public health code (csp): pregnant, parturient or nursing woman; person deprived of liberty by judicial or administrative decision; person subject to a legal protection measure or unable to express his/her consent; person under psychiatric care * in a period of exclusion from other interventional research.

Keywords: pain sleep disturbances millimeter waves
coronary flow reserve (cfr) in cardiovascular risk stratification

Conditions: Ischemia, Myocardial; Ischemic Heart Disease

Summary: cfr has been studied for few years using 82 rubidium pet (positron emission tomography) /ct. cfr has shown to be correlated with cardiovascular events occurring in the 10 following years. cfr also helps to identify multivessel coronary disease. few studies have shown the possibility to calculate cfr during myocardial perfusion spect on new ultrafast czt cameras.

evaluate the contribution of czt spect cfr in cardiovascular risk stratification: correlation with clinical scores, with calcium score, and when pathological with coronarography findings especially fractional flow reserve (ffr).

Eligibility criteria:
inclusion criteria: * patients referred for myocardial ischemia screening exclusion criteria: * patient already suffering from coronary disease with angioplasty, bypass surgery or myocardial infarction. * contraindications related to the stress test: acute coronary syndrome \<5 days unstable angina stenosis of left main artery untreated uncontrolled severe rhythm disorders uncontrolled heart failure * contraindications to dipyridamole and regadenoson: hypotension (systolic \ 70% or bilateral\> 50% dipyridamole and regadenoson allergy * patients with pacemaker, or who have had valvular surgery, * well-known dilated cardiopathy * pregnant or breastfeeding women, * minor people * persons under guardianship or under guardianship

Keywords: cfr spect czt coronary calcium score scintigraphy myocardial perfusion
genomics of primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis (PSC)

Summary: primary sclerosing cholangitis (psc) is a progressive liver disorder of unknown cause. current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of psc. this study is being done to investigate whether genes make people more likely to develop psc. discovery of these genes will help us to better understand how psc developes and subsequently, to apply new approaches for its prevention, diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * men, women, and children between the ages of 5-90 with a history of psc. * psc patients who have had a liver transplant are eligible. * family members (1st degree relatives) of enrolled psc patients are eligible. exclusion criteria: * individuals with no history of psc or those unable to provide consent.

Keywords: primary sclerosing cholangitis psc cholestatic liver disease
effects of backward gait training in chronic stroke patients

Conditions: Chronic Stroke Patients

Summary: loss of motor control after stroke, muscle weakness, abnormal movement patterns, spasticity, range of motion limitations and sensory dysfunction, resulting in a decrease in the load transferred to the affected limb, changes in gait pattern and balance skills. post-stroke muscle weakness has been shown to occur not only in the lower and upper extremity muscles but also in the respiratory muscles. it was found that the plantar pressure distribution in the affected side feet was decreased in individuals with stroke and this situation negatively affected the walking function. a systematic review of treadmill training revealed that treadmill training significantly increased walking speed and walking distance. learning to walk backwards is also recommended to improve the movement components required for walking forward. as a result of the investigations, although there are studies about the effects of back-walking training on walking and balance function in chronic stroke patients, there is no study investigating the effects on plantar pressure distribution and respiratory parameters. therefore, this study, which planned to investigate the effects of treadmill retching training on balance, plantar pressure distribution and respiratory parameters in chronic stroke patients, will contribute to the literature.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * more than 6 months have passed since the onset of stroke * first time stroke diagnosis * being between the ages of 40-65 * spasticity severity in lower extremity less than 3 according to modified ashworth scale, * being medically stable * ability to walk 10 meters and above without assistance exclusion criteria: * presence of other neurological or orthopedic diseases that affect standing and walking involving the lower limbs * uncontrollable hypertension * having been diagnosed with any pulmonary disease * severe cardiac conditions * uncontrollable dm * lack of cooperation

Keywords: chronic stroke patients balance plantar pressure distribution respiratory parameters backward gait training
incagn01876 in combination with immunotherapy in participants with recurrent or metastatic head and neck squamous cell carcinoma

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma; Advanced Malignancies; Recurrent Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to determine the safety, tolerability, efficacy, pk and pharmacodynamics of incagn01876 when given in combination with retifanlimab. the study will consist of 2 parts: a safety lead-in part (part 1) followed by a dose expansion part (part 2).

the purpose of this study is to determine the safety, tolerability, efficacy, pk and pharmacodynamics of incagn01876 when given in combination with retifanlimab in participants with gitr expression in recurrent or metastatic hnscc who have progressed on or after prior systemic therapy including anti-pd-(l)1 therapy. the study will consist of 2 parts: a safety lead-in part (part 1) followed by a dose expansion part (part 2)

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed recurrent or metastatic hnscc (oral cavity, oropharynx, hypopharynx, or larynx), that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). participants with squamous cell carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded. * documented progression on or after pd-(l)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic hnscc. exception: treatment group b (part 2, expansion): pd-(l)1-naïve. * ecog performance status of 0 to 1. * measurable disease based on recist v1.1. * mandatory pre-treatment and on-treatment tumor biopsies. * gitr-positive tumor confirmed by central laboratory before study treatment start. * willingness to avoid pregnancy or fathering children. exclusion criteria: * have received chemotherapy, targeted small molecule therapy or curative radiation within 21 days of first dose of study drug; prior mab for anticancer therapy other within 28 days of first dose of study drug; or investigational study drugs or devices within 28 days or five half-lives prior to enrollment unless approved by medical monitor. * prior treatment with any tnf super family agonist therapy. * have not recovered to ≤ grade 1 from toxic effects of prior therapy. * laboratory and medical history parameters not within the protocol-defined range before the first administration of study treatment. known active hbv or hcv, or known to be seropositive for hiv. * have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * known active infections requiring systemic treatment.

Keywords: carcinoma carcinoma, squamous cell squamous cell carcinoma of head and neck anti-pd-(l)1 therapy hnscc scchn
adductor longus tenotomy & the bkfo test

Conditions: Adductor Tendinitis

Summary: the bent knee fall out test (bkfo) is a common test for hip adductor flexibility. it is unknown whether the bkfo actually tests the the adductors or potentially hip range of motion instead. in this study, the bkfo test is performed in the operating theater before and after an adductor longus tenotomy.

adductor-related groin pain is the most common type of groin pain in athletes, and pain at the proximal adductor longus insertion is a key finding in the diagnosis of longstanding groin pain. "tightness" or "shortening" of the adductor longus is considered both a cause and effect of pain, that can lead to increased tension at the proximal insertion, thus playing a role in the persistence of longstanding adductor-related pain. for patients who do not respond sufficiently to non-surgical procedures, an adductor longus tenotomy is a surgical option that is considered to reduce tension at the proximal adductor longus insertion assisting in reduction of pain and return to sport. the bent knee fall out test (bkfo) is one of the most commonly used tests to test adductor flexibility. this test involves a combined hip movement with hip flexion, abduction, and external rotation, and a high result is generally considered to be related to adductor muscle "tightness", specifically that of the adductor longus. it is uncertain whether the bkfo test is actually measuring adductor muscle flexibility or hip joint range of motion, as the test results may also be affected by a femoral head cam morphology. a slightly different test, called the patrick faber's test, involves a similar movement and is mainly used as a hip joint pain provocation test. by cutting the adductor longus tendon, thereby removing the effect of potential adductor longus "tightness", it will be possible to show if and how much the flexibility of this muscle affects the bkfo test results. this will assist in future considerations of what this test is actually testing. the aim of this study is to investigate the immediate effect of an adductor longus tenotomy on the results of the bent knee fall out test.

Eligibility criteria:
inclusion criteria: * adults (\>18 years old) * athletes (recreational or elite) * clinical diagnosis of adductor-related groin pain * patients undergoing unilateral or bilateral adductor longus tenotomy by one general surgeon. exclusion criteria: * no specific exclusion criteria were present other than refusal to participate in the study.
neostigmine/glyco-pyrrolate 50 mikrogram/kg or sugammadex 2 mg/kg for reversal of neuromuscular blockade in elderly patients

Conditions: Neuromuscular Blockade, Residual

Summary: the aim of this study is to determine the time to tof ≥ 0.9 after either neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg in patients with age ≥ 75 years. the hypothesis of this study is that sugammadex 2 mg/kg provides a faster time to tof ≥ 0.9 compared to neostigmine/glycopyrrolate 50 mikrogr/kg.

numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications. although the use of neuromuscular blocking agents (nmbas) to improve surgical condition are still debated, they are routinely administered in the clinical setting during anesthesia both to facilitate tracheal intubation and impair the surgical conditions. however, elderly patients administered nmbas during anesthesia have an increased risk of postoperative residual neuromuscular block which is associated with more frequent episodes of hypoxemia, postoperative pulmonary complications, discomfort and longer hospital length of stay. to prevent postoperative residual block it is strongly recommended to employ neuromuscular monitoring perioperatively, performed by train-of-four (tof) stimulation, which enables the anesthetist to titrate the depth of block and to reverse the block if spontaneous recovery has not occurred upon conclusion of surgery. it is possible to reverse rocuronium induced neuromuscular blockade with either neostigmine/glycopyrrolate (an acetylcholine esterase inhibitor) or sugammadex (a modified cyclodextrin). however, the optimal choice of reversal agent for rocuronium induced neuromuscular blockade in elderly patients is unknown. there is a need for studies investigating which reversal agent is optimal in elderly patients. this randomized, parallel group trial will compare neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg for reversal of rocuronium induced blockade in elderly patients (≥ 75 years) undergoing robot surgery.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 75 years old 2. informed consent 3. scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation 4. american society of anesthesiologists (asa) physical status classification i to iv 5. can read and understand danish exclusion criteria: 1. known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate 2. neuromuscular disease that may interfere with neuromuscular data 3. severe renal impairment defined as egfr \< 30 ml/min 4. indication for rapid sequence induction 5. known intestinal or ureter obstruction 6. known peritonitis