Kornimate/medical-research-clean huggingface dataset:
aerosolized endotracheal lidocaine to avoid intracranial pressure spikes in patients with severe traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to evaluate the effectiveness of nebulized lidocaine before endotracheal suctioning (ets) compared to instilled lidocaine and the effectiveness of aerosolized lidocaine versus instilled normal saline before ets in attenuating the increase of intracranial pressure (icp) in severe head injured children and to evaluate the feasibility of a trial involving instilled lidocaine and aerosolized lidocaine for the management of ets and to evaluate the safety of nebulized lidocaine in traumatic brain injury (tbi) compared to instilled lidocaine and instilled sodium chloride (ns).


Eligibility criteria:
inclusion criteria: * patients admitted to the picu of memorial hermann children's hospital * severe tbi with a glasgow coma scale score 4-8 * intubated and mechanically ventilated with an icp monitor in place. * continuous invasive monitoring of arterial pressure * hemodynamically stable, defined by normal blood pressure for age before the ets. we will not exclude patients with norepinephrine to maintain goal blood pressures to maintain cerebral perfusion pressure(cpp). exclusion criteria: * patients with sustained icp \> 25 for more than 30 minutes mm hg despite medical or neurosurgical intervention * moderate/severe acute respiratory distress syndrome (ards) with an oxygenation index \> 8 * pulmonary hemorrhage * patients receiving neuromuscular blockade * use of other vasopressors for other causes of shock (cardiogenic, hypovolemic and septic)

Keywords: lidocaine brain injury intracranial pressure
lollipop covid-19 testing study

Conditions: COVID-19; SARS CoV 2 Infection; COVID-19 Pandemic

Summary: this study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with pcr testing. the study will be open to enrollment for both children and adults in the madison community who have at least one covid-19 symptom that has presented in the last 5 days and who have not had a positive covid-19 test for a previous illness within the past 3 months. participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.

this study will test the hypothesis that lollipop swabs are more acceptable to individuals and pcr testing is non-inferior to performing pcr on nasal swabs. to test this hypothesis, the study team will work with local community testing sites to incorporate a lollipop swab for pcr at the time a symptomatic individual receives a nasal swab for pcr that is part of the dhs program. the study will address the following two key questions: 1. are lollipop swabs more acceptable to individuals when compared to nasal swabs? 2. will lollipop swabs perform as well as nasal swabs with pcr-based testing? participants with at least one covid-19 symptom will be asked to suck on a swab for 20 seconds, like sucking on a lollipop. they then will be asked which covid-19 pcr testing they would prefer if they had to do the testing again, nasal pcr versus lollipop pcr.

Eligibility criteria:
inclusion criteria: * age 4 years or above * have at least one covid-19 symptom that has presented in the last 5 days and will undergo a nasal pcr test at a local community testing site exclusion criteria: * positive covid-19 test in the past 3 months for a previous illness

Keywords: saliva collection
comparison of ultrasound guided erector spinae plane block and ultrasound guided pericapsular nerve group block for pediatric hip surgery

Conditions: Postoperative Pain

Summary: surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. these patients may benefit from neuraxial analgesia in adjunction with general anesthesia. the reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects.

surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. these patients may benefit from neuraxial analgesia in adjunction with general anesthesia. the reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. the erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis). pericapsular nerve group (peng) block has been recently recommended by girón-arango et al. for use as postoperative analgesia in hip surgeries. it is a new regional anesthesia technique in the region between the anterior inferior iliac spine (aiis) and ilio-pubic eminence (ipe). the anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia.

Eligibility criteria:
inclusion criteria: * children of both genders * american society of anaestheologists (asa) physical activity i, ii * aged more than one year * admitted for elective pediatric hip surgery exclusion criteria: * children with severe systemic disease with american society of anaestheologists (asa) iii or iv, * children with previous neurological or spinal disorders, * coagulation disorder, * infection at the block injection site, * history of allergy to local anesthetics * bilateral hip surgery.
photorefractive keratectomy (prk) : comparison of corneal haze between two modes of de-epithelialisation (laser versus manual alcohol)

Conditions: Myopia; Astigmatism

Summary: surgical correction of ametropia. a number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with prk surgery. during traditional prk, the corneal epithelium is mechanically debrided before stromal ablation is performed. alcohol prk is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. transepithelial prk (transprk) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile. this study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (oct) of the cornea. this will confirm or refute the hypothesis of a lower occurrence of corneal haze after transprk (experimental group) versus prk with alcohol (control group). each patient will have one eye randomised to one of the two groups being compared.


Eligibility criteria:
inclusion criteria: * planned photorefractive keratectomy in both eyes * simple myopia or myopic astigmatism, refractive spherical equivalent between -0.50 and -9.0 diopters in both eyes with regular corneal topography exclusion criteria: * only one eye operated on * at least one contraindication to refractive surgery, namely : keratoconus, minimum corneal thickness \< 400 µm, severe dry syndrome, progressive corneal infection * personal history of corneal surgery * personal history of ocular pathology other than simple myopia or myopic astigmatism * pregnant or breastfeeding woman

Keywords: myopia astigmatism corneal haze trans photorefractive keratectomy alcohol photorefractive keratectomy
evaluation of the amicus rbcx system in sickle cell patients

Conditions: Sickle Cell Anemia

Summary: the purpose of this study is to evaluate the performance of the amicus red blood cell exchange (rbcx) system (exchange and depletion/exchange procedures) in patients with sickle cell disease.

the goal of red blood cell exchange is to remove a patient's red blood cells (rbcs) and replace the blood volume removed with either healthy donor rbcs and/or colloid/crystalloid solutions. depending on the rf used, the procedure can be considered an rbc exchange or rbc depletion/exchange procedure. the rbc depletion/exchange procedure is a modification of the rbc exchange procedure. the amicus rbcx protocol provides the ability to use various rfs including healthy donor rbcs or a combination of fluids, such as saline followed by rbcs. in rbc exchange and the exchange portion of the rbc depletion/exchange procedures, rbc units are used as the rf, while colloid and/or crystalloid solutions are used as the rf in the depletion portion of the rbc depletion/exchange procedures. a new operating protocol on the amicus separator that enables the device to perform red blood cell exchange (rbcx) procedures in accordance with the replacement fluid(s) (rf) prescribed by a physician for patients with sickle cell disease

Eligibility criteria:
inclusion criteria: * subjects with documented diagnosis of a type of sickle cell disorder who require rbc exchange or rbc depletion/exchange treatment. * medically stable subjects who have been previously treated for sickle cell disease with rbc exchange or rbc depletion/exchange. * subjects, or subject's legal representative, who have provided signed informed consent, and assent when applicable, prior to participation. * adequate availability of sickle trait negative, leukoreduced, blood type (abo) blood group, rhesus factor d (rh (d)) compatible, unexpired replacement rbc products. * subjects with sufficient vascular access to accommodate the rbcx procedure as determined by the medical staff responsible for obtaining intravenous access. * subjects who are able and agree to report adverse events (aes) during the required reporting period. exclusion criteria: * procedures that occur during acute hospitalization. * procedures prescribed within one week of discharge of a hospitalization. * subjects with altered mental status that would prohibit the giving and understanding of informed consent, and assent when applicable, who do not have a legally authorized representative. * drug abuse, alcohol abuse, or other factors that in the opinion of the investigator could affect the ability of the subject to comply with the requirements of the protocol. * subjects who have experienced a serious adverse event associated with an rbcx procedure in the past. * in the opinion of the investigator, subjects who have a life expectancy fewer than 30 days. * subjects who refuse blood products. * subjects who are pregnant. * subjects who fail to comply with site requirements for cessation of medication that interfere or increase procedure risk.

Keywords: sickle cell disease hemoglobin (hb) s disease hb s disease congenital hemolytic anemia
easy stretch toolkit: a pilot study

Conditions: Facial Injuries

Summary: to research the use of a novel set of intraoral tools called the easy stretch toolkit for the therapeutic management of facial burns and other facial disorders.

in this initial pilot study, we plan to recruit 20 adult or pediatric patients who have sustained facial burns or who have sustained a facial injury resulting in scarring, tightness, limited range of motion of facial skin or musculature, or fibrosis to complete the 8 week treatment. participants will need to be able to attend a weekly telehealth or in person session with the investigators and complete the entire 8 week prescriptive program. participants will be outpatient. a facial injury can be any disorder that results in scarring, tightness, limited range of motion of facial skin or musculature or fibrosis. facial burn injury or facial injury is defined as an injury to the midface or lower half of the face and may be unilateral or bilateral. participants must be in the chronic phase of recovery. chronic burns are defined as those burns that are not in the acute healing phase, ie., there are no concerns for injury to new or healing skin or wound dehiscence.

Eligibility criteria:
inclusion criteria: 1. age 7-80 2. male or female sex 3. patients who have sustained a facial burn and are now in the chronic phase, or any patient experiencing facial tightness or limited range of motion due to other problems, including patients s/p radiation to the head and neck, trauma, scarring and scleroderma 4. chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, and/or limited facial expressions 5. subject or caregiver (parent or guardian, in case of pediatric population) must be able to give informed consent 6. subject or caregiver (parent or guardian, in case of pediatric population) must be able to perform exercises at home and must be able to record time spent using the devices. 7. participants who are undergoing other treatment methods such as use of compression garments, skin grafting, radiation or other facial surgery, etc must suspend all of these treatments for the duration of the 2 month trial. 8. internet access including access to facetime, skype or zoom and email access if electing telehealth option for enrollment exclusion criteria: 1. planned or unplanned surgeries for facial skin grafting around lips or nose or oral commissure release during the upcoming 8 weeks 2. completion of any massaging or other stretching exercises or programs not specified by the investigators 3. use of new creams or topical treatments for the duration of enrollment in the study. 4. acutely burn-injured patients 5. incarceration, or pregnancy
the study of functional magnetic resonance imaging in abdominal and pelvic diseases

Conditions: Pelvic Diseases; Abdominal Diseases

Summary: the purpose of this study is to study the diagnostic efficiency of functional magnetic resonance imaging in abdominal and pelvic diseases.


Eligibility criteria:
inclusion criteria: * all patients with abdominal or pelvic diseases who provide informed consent * healthy volunteers exclusion criteria: * claustrophobic * pregnancy

Keywords: magnetic resonance imaging magnetic resonance angiography diffusion tensor imaging ideal t2* mapping magnetic resonancecine bold phase contrast diffusion-weighted imaging functional magnetic resonance imaging
bifido- and lactobacilli in symptomatic adult covid-19 outpatients

Conditions: COVID-19 Respiratory Infection

Summary: there is evidence that some types of probiotics play a role in alleviation of symptoms of acute respiratory tract infections and bursting immune response to respiratory and enteric viruses. available data serves a rationale for the study exploring a role of nutritional support with probiotics in adult outpatients with covid-19. hypothesis of the study is that a proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from covid-19 and enhance specific immune response to sars-cov-2 antigens.

one hundred adults with confirmed (pcr or antigen test) symptomatic covid-19 lasting upto 5 days will be screened for the study. when the subject meets enrollment criteria, he/she will be randomized to take an investigational product (probiotic, test dietary supplement, tds), a mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28 days after enrollment. during observation, the patient will keep respiratory illness diary. blood serum will be collected at baseline, day 0-5 (nurse visit 1), after 28-35 days (nurse visit 2), and 6 months (nurse visit 3) for evaluation of anti-sars-cov-2 antibodies to nucleocapsid and spike antigents. in 3 months, investigator/family physician will collect post-covid-19 questionnaire

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 - ≤ 65 years; 2. male or non-pregnant female; 3. informed virtual pre-consent and paper signed consent forms; 4. confirmed symptomatic covid-19 lasting 0-5 days; 5. subject understands and agrees to comply with study procedures including triple blood analysis for anti-sars-cov-2 igg; exclusion criteria: 1. risk for the complicated course of covid-19 due to: 1.1. hypertension; 1.2. diabetes mellitus; 1.3. immunosuppressive conditions; 1.4. chronic pathology of the respiratory system ; 1.5. chronic pathology of the cardiovascular system ; 1.6. malignant tumor ; 1.7. systemic inflammatory connective tissue disease ; 1.8. cerebrovascular disease ; 1.9. chronic hepatitis. hepatic cirrhosis; 1.10. inflammatory bowel diseases ; 1.11. chronic kidney disease ; 2. drug or alcohol abuse as suspected by investigator; 3. history of persistent diarrhea of any cause; 4. use of pre- or probiotics during the last 2 weeks before enrollment; 5. allergy to any components of the tds; 6. technical difficulties to perform virtual study visits. 7. inability to perform a blood test for antibodies after 6 months 8. inability to swallow capsules, or choking / coughing while eating
bilateral surgical resection of carotid bodies in patients with systolic heart failure

Conditions: Systolic Heart Failure; Peripheral Chemoreceptor Hypersensitivity

Summary: the primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. the secondary aim is to assess potential efficacy of bilateral carotid body resection.


Eligibility criteria:
inclusion criteria: * history of heart failure class ii-iii according to nyha within at least 6 months prior to inclusion * stable clinical state within at least 4 weeks prior to inclusion * subject \>= 18 years old * left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (simpson's method) * carotid body present in computer cervical angiotomography * history of exacerbated peripheral chemoreceptor sensitivity determined as \>0.6l/min/%spo2 * able and willing to give written informed consent exclusion criteria: * unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion * history of stroke, transient ischemic attack (tia), or clinically significant chronic neurological disorder * history of heart transplant * pregnancy or anticipation of pregnancy * hemodialysis or peritoneal dialysis patients * obstructive carotid atherosclerotic disease with \>50% stenosis * copd stage iii and iv according to gold 2007 * unable to perform the spiroergometric assessment * any significant anomaly in additional investigation which may increase the risk of study procedure
the procalcitonin guided antibiotics in respiratory infections in general practice

Conditions: Acute Respiratory Tract Infection

Summary: antimicrobial resistance rates have reached alarming levels and the worlds health organisation (who) states it constitutes a serious public health concern by threatening one of the most effective and mortality lowering interventions in modern medicine. part of the solution to this problem includes minimizing overuse of antibiotics. but clinical signs alone are often not reliable to guide antibiotic treatment decisions and additional tests may be warranted to assist the doctor. such tests include point-of-care biomarkers of infection like c-reactive protein (crp) and procalcitonin (pct). targeting antibiotic use to the few patients with a high probability of benefit and withholding in the many with non-serious respiratory infection is a promising strategy and readily implemented in clinical practice. the procalcitonin guided antibiotics in respiratory infections (pari) study will assess the effect of a novel point-of-care pct guided antibiotic stewardship in acute respiratory tract infections in general practice. the overall aim of the pari study is to reduce antibiotic use in patients with acute respiratory tract infections by targeting antibiotic treatment only to patients with a suspected bacterial etiology and thus likely to benefit from antibiotic therapy. the main research questions are: does the addition of a point-of-care procalcitonin test to standard care reduce antibiotic use in primary care? is the intervention safe for the patients? the pari study is a pragmatic two-arm (intervention and control (standard care) open randomized non-inferiority trial (up to 1 day difference in recovery) in general practice.


Eligibility criteria:
inclusion criteria: * age above 18 years * able to read and understand patient information about the pari trial and willing to give written informed consent prior to enrollment * acute cough e.g. less than 2 weeks probable acute upper or lower respiratory tract infection (pharyngitis, tonsillitis, otitis media, sinusitis, exacerbations of asthma or chronic obstructive pulmonary disease (copd), bronchitis or pneumonia) * c-reactive protein \>20 mg/m exclusion criteria: * symptoms present for more than 2 weeks * verified immunodeficiency or presently neutropenic (neutrophile granulocytes ≤0,5 x 109/l within the last 7 days) * severe liver failure * severe kidney failure including dialysis * sore throat and positive test for group a streptococcus * prior antibiotic exposure last 14 days up to inclusion * need for acute admission to hospital * pregnancy or breastfeeding

Keywords: primary care acute respiratory tract infection procalcitonin general practice antibiotic use
durvalumab+ gemcitabine/cisplatin (neoadjuvant treatment) and durvalumab (adjuvant treatment) in patients with mibc

Conditions: Muscle Invasive Bladder Cancer

Summary: a global study to determine the efficacy and safety of durvalumab in combination with gemcitabine+cisplatin for neoadjuvant treatment and durvalumab alone for adjuvant treatment in patients with muscle-invasive bladder cancer


Eligibility criteria:
inclusion: * patient resectable muscle-invasive bladder cancer with clinical stage t2-t4an0/1m0 with transitional and mixed transitional cell histology * patients must be planning to undergo a radical cystectomy * patients who have not received prior systemic chemotherapy or immunotherapy for treatment of mibc * ecog performance status of 0 or 1 * must have a life expectancy of at least 12 weeks at randomization exclusion: * evidence of lymph node (n2-n3) or metastatic (m1) disease at time of screening. * prior pelvic radiotherapy treatment within 2 years of randomization to study * prior exposure to immune-mediated therapy (with exclusion of bacillus-calmette guerin \[bcg\]), including but not limited to other anti-ctla-4, anti-pd-1, anti pd-l1, or anti-pd-l2 antibodies. * current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (ip). the following are exceptions to this criterion: intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (eg, ct scan premedication) * receipt of live attenuated vaccine within 30 days prior to the first dose of ip. * uncontrolled intercurrent illness * active infection including tuberculosis, hepatitis b, hepatitis c, and human immunodeficiency

Keywords: bladder cancer immunotherapy pd-l1 durvalumab (medi4736)