Kornimate/medical-research-clean huggingface dataset:
feasibility, acceptability, and barriers to implementation of a geriatrics bundle in the icu

Conditions: Intensive Care Unit Syndrome

Summary: despite the known benefits of geriatric care models among hospitalized older adults outside the intensive care unit (icu), few studies have addressed the needs of older adults in the icu; for example, sensory impairment, functional decline, and de-prescribing of potentially inappropriate medications (pims) are rarely addressed in routine icu practice. this pilot study will evaluate the feasibility, acceptability, and barriers to implementation of a geriatrics bundle (occupational therapy, assessment and treatment of hearing impairment, and de-prescribing pims) in the icu.

outcome 4 was updated 11/8/23.

Eligibility criteria:
inclusion criteria: 1. age \> 65 years 2. hospitalized in the medical intensive care unit (micu) on the york street campus of yale-new haven hospital. 3. has not opted out of research exclusion criteria: 1. unable to provide informed consent and no proxy available 2. advance directive of "comfort measures only" (cmo) or change to cmo anticipated during this hospital admission 3. planned discharge to hospice 4. primary language other than english 5. tracheostomy with long-term ventilator dependence 6. patients with non-family conservators (e.g. a lawyer serving as the conservator for the patient) 7. unable to participate in the ot and hearing impairment interventions due to cognitive status (e.g. advanced dementia, anoxic brain injury, vegetative state, etc) or the need for deep sedation (e.g. if treatment of the critical illness requires deep sedation and neuromuscular blockade, such as in severe ards \[the acute respiratory distress syndrome\]) 8. covid-19 positive 9. already receiving ot in the icu

Keywords: geriatrics
a study evaluating the efficacy and safety of adding symlin® to lantus® (insulin glargine) in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of adding symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.


Eligibility criteria:
inclusion criteria: * has hba1c \>7.0% and \<=10.5% * has a body mass index (bmi) \>=25 kg/m2 and \<=45 kg/m2 * has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start * if taking oral antidiabetic agents, has been on a stable dose for at least 2 months exclusion criteria: * has been previously treated with symlin/pramlintide (or has participated in a symlin/pramlintide clinical study) * has received any investigational drug within 1 month of screening

Keywords: diabetes amylin symlin pramlintide insulin glargine
short stitch versus traditional suture for the prevention of incisional hernia after open hepatectomy

Conditions: Liver and Intrahepatic Bile Duct Neoplasm; Metastatic Malignant Neoplasm in the Liver; Primary Malignant Liver Neoplasm

Summary: this clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. this study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.

primary objective: i. to assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery. secondary objectives: i. to compare short-term perioperative outcomes between small bites and typical fascial closure technique. ii. to assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-l or midline incisions. iii. to assess the hernia incidence rate of kawaguchi-gayet hepatectomy complexity classifications i/ii vs. iii (hernia rate by extent of hepatectomy). iv. to assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy). v. to assess impact of small bites abdominal wall closure on health care quality of life following liver surgery. vi. to assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy. outline: patients are randomized to 1 of 2 arms. arm i (intervention): patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure. arm ii (control): patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure. after completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5/1/2021 through 11/1/2024 will be eligible for inclusion in this study * elective surgery * age \>= 18 * planned midline laparotomy incision or inverted-l incision exclusion criteria: * pre-existing abdominal hernia * history of mesh placement at prior laparotomy * pregnant women
hyaluronic acid application following frenectomy

Conditions: Frenulum; Hypertrophy, Lip

Summary: this randomized clinical study aimed to compare the outcomes of the laser-assisted frenectomy with and without topical hyaluronic acid application to evaluate the effect of ha on secondary wound healing after frenectomy surgery. the study included a total of sytemically healthy 40 patients , with high labial frenulum attachment requiring frenectomy. following laser-assisted frenectomy operation ha gel was applied to the wound surface in the test group, and no application was made to the control group the ha application was made topically to completely cover the surgical area on days 3, 7, and 14 postoperatively. photographs of the operation area were taken on days 3, 7, and 14. the changes in the area measurements between the digital images according to the healing periods were calculated on a computer. according to visual analogue scale (vas) was used to evaluate patient comfort and pain levels.

the aim of this study was to clinically evaluate the effect on secondary wound healing of the topical application of hyaluronic acid to the surgical field after frenectomy operation performed with laser, through evaluation of the amount of reduction of the wound site and postoperative pain levels.the study included a total of 40 patients who had maxillary high labial frenulum attachment and were planned to undergo frenectomy and met the study inclusion criteria. all the patients were informed about oral hygiene control and attention was paid that optimal oral hygiene was maintained throughout the study. phase i periodontal treatment was applied to patients where necessary. the area measurements of the wound site formed after frenectomy was taken immediately after the frenectomy and on days 3, 7, and 21 postoperatively. ha gel was applied topically after the frenectomy operation to the test group and not to the control group. all the surgical procedures were performed by the same surgeon.

Eligibility criteria:
inclusion criteria: * no systemic disease, * the presence of high labial frenulum attachment diagnosed according to mirko et al., -periodontally healthy or a requirement for periodontal treatment that would only require removing of dental plaque, * full mouth plaque score \<15%,probing pocket depth \<3mm in all teeth * no history of periodontal surgery. exclusion criteria: * not meet the optimal level of oral hygiene, * had any condition that could affect wound healing, * were pregnant or lactating, * were cigarette smokers or were takiing any medication that might affect the outcome of the study,
cardiac tumors interventional （radio frequency/laser ablation）therapy

Conditions: Cardiac Tumors

Summary: currently, surgical removal remains the main clinical treatment for cardiac tumor patients. however, part of tumors are hard to completely resect. also, as thoracoscopic surgeries induce great operation trauma, some patients cannot tolerate or do not will to take the operation. therefore, new methods and techniques are in urgent need. our center have a 12-year experience of intervention treatment for solid tumors and has conducted several animal experiments to verify the effectiveness of transthoracic puncture ablation and radiofrequency ablation for ventricular muscle. the purpose of this study is to conduct new method of direct transthoracic cardiac tumor-targeted radiofrequency ablation (rfa) or laser induced interstitial thermotherapy (litt), make minimally invasive treatment plans for cardiac tumor patients, and verify the safety and validity of intervention treatment in long term.


Eligibility criteria:
inclusion criteria: * cardiac tumors not suitable for surgical removal * subject has significant clinical symptoms or obstruction (or progressive obstruction increase) in inflow or outflow tracts shown in imaging evidence * cardiac tumors in ventricular chambers, myocardium, or pericardium * subject who cannot tolerate thoracoscopic removal or volunteer for the operation * subject over 12 years old exclusion criteria: * subject who has other cardiac diseases must receive surgical removal * subject has end-stage heart failure * subject has poor physical conditions and cannot tolerate the operation
eustachian tube dilation with an endovascular balloon

Conditions: Eustachian Tube Dysfunction; Eustachian Tube Dysfunction of Both Ears

Summary: the eustachian tube is a narrow tube which links the back of the nose to the middle ear. eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. it can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. this is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. numerous studies have consistently failed to support the effectiveness of medical managements. pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. more recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. this eustachian dilation catheter is not accessible in canada since the device and procedure is not covered by ohip (ontario health insurance plan) or any other health insurance in canada. in a cadaver study, we have evaluated using an endovascular balloon (balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. this endovascular balloon is health canada approved, but not for this specific use. we therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.


Eligibility criteria:
inclusion criteria: * ≥18 years old (of both sexes) * diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (oetd) * undergoing tympanoplasty or tympanomastoidectomy exclusion criteria: * patulous eustachian tube * preoperative nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the eustachian tube * ct temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression * patient unable to follow protocol for any reason * cleft palate or craniofacial syndrome * prior eustachian tube intervention * prior radiation to the head and neck
exploration of angiogenesis in decompensated developmental venous abnormalities

Conditions: Developmental Venous Anomaly

Summary: the purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.


Eligibility criteria:
main inclusion criteria: * presenting a dva requiring hyperselective catheterization * having sign an informed consent form exclusion criteria: * presenting a contraindication to the realization of hyperselective cathterism
wound infection alexis wound retractor

Conditions: Appendicitis

Summary: the purpose of this study is to determine whether the incidence of surgical site wound infection will be reduced in open appendectomy patients through the use of the alexis® wound retractor.

aim: this is a randomized comparison of open appendectomy using metal retractors and open appendectomy using the alexis® wound retractor in patients with simple and complicated appendicitis. the study is designed in order to minimize bias by standardizing the two procedures and blinding patients and nurses during the preoperative and postoperative period. after obtaining informed consent, or informed assent of minors, subjects will be randomized to either of two groups: one groups will undergo a standard open appendectomy using traditional metal retractors. the second group will undergo an open appendectomy with the use of the alexis® wound retractor. pre-operative antibiotic zosyn will be given prior to skin incision. skin prep will be betadine, duraprep or gel prep. after entering the peritoneal cavity, the alexis® retractor will be introduced and used to maintain retraction for the duration of surgery. in simple appendicitis, the patient will receive one dose of antibiotics six hours after surgery. the patient will not receive oral antibiotics at discharge. in complicated appendicitis, the patient will be given zosyn until afebrile for 24 hours and a normal white blood cell count. the patient will be discharged on oral antibiotics. follow up will occur between the 14th and 21st post operative day. at the test of cure visit, the wound will be checked for erythema, drainage, or opening. it will be assessed whether the subject received any further medical attention or received medications since discharge.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of appendicitis * open appendectomy * ability to attend follow-up visit

Keywords: appendectomy surgery infection
finess registry study

Conditions: Rhinosinusitis

Summary: a prospective, post-approval registry study assessing subject rhinosinusitis symptomatic status over time following treatment with finess sinus treatment using self-administered quality of life survey data.


Eligibility criteria:
inclusion criteria: * adults 18 years or older undergoing balloon dilation with finess sinus treatment and have provided voluntary consent to participate in registry exclusion criteria: * none
treatment of severe hypertension during pre-eclampsia: a preliminary equivalence study between urapidil and nicardipine

Conditions: Hypertension During Pre-Eclampsia

Summary: the aim of this study is to confirm that urapidil is as efficient and as safe as nicardipine to correct severe hypertension in pre-eclamptic patients. * efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmhg after 120 min of study drug administration. * safety endpoints : clinical, biological and ultrasound observation for any side effect.all infants will be observed in the neonatology unit (during 48h).


Eligibility criteria:
inclusion criteria: * patients 'written informed consent dated and signed by investigator and patient * affiliation to a social security system * single pregnancy * arterial hypertension (pas ≥140 and/or pad≥90) in the context of severe pre-eclampsia exclusion criteria: * patient under 18 year old or unable to give informed consent * protocol rejected by patient-impossibility to use non invasive blood pressure monitoring * antihypertensive treatments within 24h before inclusion * allergy to or contraindication for one of the study drugs-pre * eclampsia that does not require an antihypertensive treatment * acute eclampsia-requirement for other drugs with potential dangerous interactions with study drugs * participation to a therapeutic protocol within 6 months prior to the start of study

Keywords: pre-eclampsia-urapidil-nicardipine
quality of life in temporomandibular joint dysfunction

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: it is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics.

a recent study showed that individuals with tmd have a lower quality of life than healthy controls. in addition, it was determined in the study that investigating the quality of life is insufficient. future studies should search for psychosocial aspects related to tmd. the aim of this study is to individual the physical and psychosocial characteristics of individuals with axis i tmd and examine their relationship with quality of life.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * being in group i according to rdc/tmd axis i, exclusion criteria: * any treatment for temporomandibular joint dysfunction (tmd) in the last six months * having dental problems * having any disorder and/or disease involving structures and/or masticatory muscles associated with tmd * having a history of trauma in the head and neck region, * having previously undergone temporomandibular joint surgery, * using corticosteroid and anticonvulsant drugs * patients who have received physiotherapy and rehabilitation related to the temporomandibular joint in the last six months

Keywords: temporomandibular joint dysfunction syndrome quality of life
intranasal cocaine and temperature regulation during exercise

Conditions: Hyperthermia; Cocaine Use; Exercise

Summary: assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.

previously it was shown that intranasal cocaine attenuates skin blood flow and sweating responses during passive heat stress, when compared to placebo. however, nothing is known about the effects of cocaine on whole-body temperature regulation during mild to moderate exercise in warm environmental condition. this project will test the hypothesis that intranasal cocaine attenuates whole-body sweat rate, resulting in greater elevations in core temperature during mild to moderate exercise in warm environmental conditions. primary data include core temperature, skin temperatures, and whole body sweat rate. secondary variables include cardiovascular responses, perceptions of exercise exertion and thermal comfort, and metabolic heat production. intranasal lidocaine will be used as the placebo for cocaine. the selection of the drug administered during the first experimental trial will be randomized, with the other drug administered during the second experimental trial.

Eligibility criteria:
inclusion criteria: * 18 to 50 years of age * healthy * body mass index less than 31 kg/m\^2 * speak english * systolic blood pressure \<140 mmhg * diastolic blood pressure \<90 mmhg exclusion criteria: * subjects not in the defined age range * participants who have cardiac, respiratory, neurological, and/or metabolic illnesses * any known history of renal or hepatic insufficiency/disease * pregnancy or breast feeding * body mass less than 60 kilograms * current smokers, as well as individuals who regularly smoked within the past 3 years * individuals with a history of drug abuse within the past 5 years * individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results and when agent abstained the drug screen is negative, one example could be an over the counter supplement) * currently taking pain modifying medications

Keywords: thermoregulation sweating skin blood flow
comparison of different massages tecniques on chronic pelvic pain

Conditions: Chronic Pelvic Pain Syndrome

Summary: the aim of this study is to investigate and compare the effectiveness of transverse friction and thiele massage on pain, quality of life and sexual functions in female patients with chronic pelvic pain. the study will be performed on 20 female patients with pelvic floor muscle tenderness, who applied to the urology clinic in istanbul and were diagnosed with chronic pelvic pain.


Eligibility criteria:
inclusion criteria: clinical diagnosis of pelvic floor muscle tenderness, clinical diagnosis of chronic pelvic pain syndrome exclusion criteria: neurological pathologies ( such as hemiplegia, epilepsy, multiple sclerosis and parkinson's disease) urogynecological surgery in the last 6 months, severe pelvic prolapse, pelvic malignancy and pelvic radiotherapy.
rale versus corads/ct-severity score in covid-19

Conditions: COVID-19 Pneumonia

Summary: rationale patients with severe coronavirus disease 2019 (covid-19) frequently fulfill the criteria for acute respiratory distress syndrome (ards), with extensive and bilateral abnormalities on the chest radiography (cxr) and the chest computed tomography (ct) abnormalities. the 'radiographic assessment of lung edema' (rale) score, the 'covid-19 reporting and data system' (co-rads) score, and the 'ct severity score' may all have prognostic value in critically ill patients with acute respiratory failure due to covid-19. objectives to compare the prognostic value of the rale score, the co-rads score and the ct severity score in critically ill patients with ards due to covid-19. hypotheses the rale score, the co-rads score and the ct severity score have prognostic value (primary). the rale score, the co-rads score and the ct severity score correlate well. study design national, retrospective observational study. study population critically ill covid-19 patients with acute respiratory failure, who received at least one cxr and one chest ct scan during critical illness. method cxrs are visually scored by two independent investigators, using the rale score approach. chest ct scans are scored by an independent radiologist, using the co-rads score and the ct severity score. demographic, ventilation and outcome data are captured from the hospital systems. main study parameters/endpoints icu mortality (primary) and hospital-, 28-, 90-mortality, the number of days alive and free from invasive ventilation, duration of ventilation in survivors, and length of stay in icu and hospital. nature and extent of the burden and risks associated with participation, benefit and group relatedness participants will not directly benefit from participation, but burden is absent. the crx and chest ct scans have already been obtained as part of routine clinical care. collecting cxr for rale scoring and chest ct scans for co-rads and ct severity scoring, clinical and outcome data is of no harm for individual patients.


Eligibility criteria:
inclusion criteria: * admitted to the intensive care unit of the amsterdam umc, location 'amc', between march 1, 2020 and may 31, 2020 (the first 3 months of the first wave of the national outbreak in the netherlands) and between october 1, 2020 and december 31, 2020 (the first 3 months of the second wave in the netherlands); * rt-pcr confirmed coronavirus diseases 2019 (covid-19); and * having had received at least one chest radiograph (cxr) and one adjacent chest computed tomography (ct) scan during the period a patient was having acute respiratory failure. exclusion criteria: * age \< 18 years.

Keywords: rale score severity score corads