Kornimate/medical-research-clean huggingface dataset:
effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention

Conditions: Pressure Ulcer

Summary: the aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.

patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (pus). pu standard prevention includes repositioning, early mobilization and the use of special support surfaces. the use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. the primary objective of this study is to determine if preventive silicone dressings (mepilex® border) applied to the heels and to the sacrum in addition to pu standard prevention reduces pu incidence category ii, iii, iv, and deep tissue injury compared to pu standard alone in at risk hospital patients.

Eligibility criteria:
* major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal icu * being at "high" or "very high" pu risk according to the charité pu prevention standard: - category 3 (= partly care dependent/limited mobility in bed), 4a (= care depended, limited mobility in bed), 4b (= totally immobile) according to the jones classification modified by charité * expected minimum length of stay at least three days * informed consent (or by legal representative)

Keywords: skin, safety, wounds, intensive care
study to evaluate tulisokibart for hidradenitis suppurativa (mk-7240-012)

Conditions: Hidradenitis Suppurativa

Summary: this is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. the primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in hidradenitis suppurativa clinical response (hiscr50) at week 16 (ie, at end of double-blind treatment).

this study consists of a 16-week double-blind period and a 100-week long-term extension (lte) composed of a 40-week main extension and a 60-week optional extension.

Eligibility criteria:
inclusion criteria: * has signs and symptoms of hidradenitis suppurativa (hs) for ≥ 6 months and a clinical diagnosis of hs at screening * has moderate or severe hs * has a history of inadequate response to a course of systemic antibiotics for treatment of hs or intolerance to or has a contraindication to systemic antibiotics for treatment of hs * has ≤20 draining tunnel count at screening and randomization exclusion criteria: * has other active skin conditions that may interfere with the assessment of hs * has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy * has a transplanted organ and requires continued systemic immunosuppression * has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years * has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
comparison of air qtm intubating airway versus ambu-aura intubating laryngeal mask

Conditions: Airway Management; Obesity

Summary: supraglottic airway devices are important tools for airway management. supraglottic airway devices have been introduced into brief surgical interventions because they are less invasive than intubation and safer than mask to maintain the patency of airway after induction of anesthesia. they are inserted via the oral route and can be used in emergency conditions when tracheal intubation and mask anesthesia are challenging. air q intubating airway and ambu aura intubating laryngeal mask are two supraglottic airway devices that are widely used. aim of the work is to compare air-q intubating laryngeal airway versus ambu-aura intubating laryngeal mask regarding sealing pressure and fiberoptic intubation in class ii obese patients.

randomized comparative trial that will be performed in kasr al ainy hospital, cairo university, cairo, egypt.asa ii patients from 20 to 50 years of age, undergoing minor surgry were included in this study. 40 patients will be allocated into 2 equal groups using computerized software and enclosed in sealed opaque envelopes: gq ( n=20 ): where air-q intubating laryngeal airway will be used for ventilation \& intubation through fiberoptic bronchoscope. ga ( n=20 ): where ambu-aura intubating laryngeal mask will be used for ventilation \& intubation through fiberoptic bronchscope.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years old. * sex: both genders. * with american society of anaesthesiologists (asa) physical activity ii. * scheduled for elective surgery under general anaesthesia requiring endotracheal tube. * class ii obese patients (bmi 34.9 - 39.9 kg/m2). * surgery: short time procedures ≥ 60 minutes, ≤ 120 minutes e.g.: breast surgery, elbow or foot surgery. exclusion criteria: * • patient refusal. * patients with any respiratory tract abnormalities as laryngeal masses \& facial deformities as fracture mandible. * patients with risk of pulmonary aspiration as in full stomach patients. * patients at risk of regurgitation of gastric content as in gastroesophageal reflux disease (gerd) and pregnant females. * emergency operation. * patients with obstructive sleep apnea. * patients prepared for laparotomy or laparoscopic procedures. * patients with risk of bleeding.

Keywords: obesity air qtm intubating airway ambu-aura intubating laryngeal mask
phase 3 study of mrtx849 (adagrasib) vs docetaxel in patients with advanced non-small cell lung cancer with kras g12c mutation

Conditions: Metastatic Non Small Cell Lung Cancer; Advanced Non Small Cell Lung Cancer

Summary: this phase 3 study will evaluate the efficacy of the investigational agent mrtx849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic nsclc with a kras g12c mutation.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of nsclc with kras g12c mutation. * candidacy to receive treatment with docetaxel. crossover inclusion criteria: * evidence of recist 1.1 defined disease progression on docetaxel per bicr * ecog performance status 0-2 exclusion criteria: * prior treatment with an agent targeting kras g12c (e.g., amg 510, sotorasib). * active brain metastases. crossover exclusion criteria: * receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Keywords: kras g12c non-small cell lung cancer nsclc metastatic cancer docetaxel phase 3 clinical trial adagrasib kras krazati
cognitive behavioural therapy as an effective treatment for social anxiety, perfectionism, and rumination

Conditions: Social Anxiety Disorder

Summary: this randomized, controlled trial study was designed to examine the efficacy of cognitive behavioural therapy (cbt) on social anxiety, perfectionism, and rumination among individuals diagnosed with social anxiety in tehran, iran.

a total of 52 individuals with social anxiety disorder (sad) (68% female, mean age = 35.67) were allocated to a cbt group or to a control group. the intervention group was given one session of therapy per week over a duration of 8 weeks, while the control group did not receive any intervention and was placed on a waiting list. self-reported social anxiety, perfectionism, and rumination were measured before the cbt intervention, after the intervention, and two months after the intervention for both groups.

Eligibility criteria:
inclusion criteria: * participants formally diagnosed with sad by psychologists who determined the individual meet criteria outlined by the diagnostic and statistics manual for mental disorders (dsm-5) exclusion criteria: * if participants report a history of psychiatric disorders within the past 12 months such as schizophrenia, dementia, depression, alcohol and other drug addiction. * participants could not partake if they were pregnant * participants enroll in another psychological treatment program.

Keywords: social anxiety perfectionism rumination cognitive behavioural therapy
assessment of the effectiveness of the nect program

Conditions: Schizophrenia; Bipolar Disorder; Borderline Personality Disorder; Social Function; Self-stigma

Summary: self-stigma refers to the transformation process wherein a person's previously held social identity is progressively replaced by a devalued and stigmatized view of oneself termed "illness identity". self-stigma is a severe problem in serious mental illness (smi). self-stigma prevalence is high (41.7% of the 1229 participants with sz and 21.7% of the 1182 participants with mood disorders had moderate to high levels of is in the gamian-europe study). self-stigma was negatively associated with self-esteem, social function, wellbeing, quality of life or personal recovery and positively associated with psychiatric symptoms and depression. several psychosocial interventions (mostly combinations of psychoeducation and cognitive behaviour therapy) have been designed to reduce self-stigma and its impact on clinical and functional outcomes, with preliminary effects on self-stigma, insight and self-efficacy. narrative enhancement and cognitive therapy (nect) is a manualized structured 20-session group-based intervention . conducted by two trained facilitators the sessions combine psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma. developed in usa, nect was adapted in israel and sweden. nect showed effectiveness in reducing self-stigma and in improving self-esteem and quality of life. despite being effective on changing coping strategies, nect effectiveness on social function is still unclear. the present study aims to validate nect french adaptation and to evaluate its effectiveness on social function, self-stigma, psychiatric symptoms, self-esteem, wellbeing, quality of life and personal recovery in smi participants (schizophrenia, bipolar disorder, borderline personality disorder)


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, bipolar i or ii disorder, borderline personality disorder (dsm-v criteria, apa, 2013). * clinical stability since 3 months (total panss score \<120, madrs score \<15 and ymrs \<12 for patients with schizophrenia and madrs score \<15 and ymrs \<12 for patients with bipolar disorder). * patients who gave informed consent to participate in the study. * affiliated to a social security scheme or beneficiary of such a scheme. exclusion criteria: * pregnant or lactating women. * criteria relating to the associated pathologies entailing particular risks: * neurological disorders of vascular, infectious or neurodegenerative origin. * taking somatic drugs with a cerebral or mental impact (eg corticosteroids). * presence of an associated intellectual disability. * prohibited treatments and procedures: * subject in exclusion period of another study. * simultaneous participation in other programs having an impact on social functioning or self-stigmatization: remediation of social cognition, individual and group care targeting self-stigmatization and training in social skills.
body weight supported treadmill training as physical therapy treatment to spinal cord injury patients

Conditions: Spinal Cord Injury/Damage

Summary: the purpose of this current prospective study is to assess the effects of body weight support treadmill training (bwstt) in individuals with spinal cord injury (sci). training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. the examination consisted of (1) neurological classification by asia standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by modified ashworth scale, (3) walking independence evaluation by walking index for spinal cord injury ii (wisci ii), (4) patient's quality of life perspective by world health quality of life- bref (whoqol-bref), (5) the functional status by 10-item modified barthel index, (6) bone mass density (bmd) by dual-energy x-ray absorptiometry (dxa) scan, (7) body tissue consistency by full body dxa scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 oh vitamin d, 1,25- (oh)2 vitamin d, ostase and parathyroid hormone) by hematological tests. the results will be collected and evaluated using statistical software (i.e. spss).


Eligibility criteria:
inclusion criteria: * sci * asia classification b, c or d * clinical stable exclusion criteria: * unstable cardiac conditions * epilepsy * autonomic dysreflexia * significant musculoskeletal problems in lower extremities other than sci * parkinson's disease
population-based age-stratified seroepidemiological investigation protocol for coronavirus 2019 (covid-19) infection in the federation of bosnia and herzegovina

Conditions: Seroprevalence; Antibody; COVID-19

Summary: this study is the second cross-sectional study conducted in the region. in the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of sars-cov-2 igg antibodies among blood donors in sarajevo canton. we also assessed immune durability among seropositive participants after 6 months. in total, of 1015 blood donors aged 18-65 years in sarajevo canton between 2 november and 3 december 2020 were recruited and population-weighted seroprevalence in sarajevo canton was 19.2% (95% ci: 16.7-21.6%). the aim of this second cross-sectional study is to measure the seroprevalence sars-cov-2 antibodies and assess antibody kinetics in the blood donor population after 12 months.


Eligibility criteria:
inclusion criteria: * all individuals identified for recruitment into the investigation, resident of canton sarajevo between 18-65 years, irrespective of prior covid-19 infection. exclusion criteria: * refusal to give informed consent or to attend follow-up appointments; currently experiencing covid-19 symptoms or in the last 14 days; and close contact with a confirmed case of covid-19 within 14 days prior to donation.
modified dakin's solution in reducing radiation-induced dermatitis in patients with head and neck cancer undergoing radiation therapy

Conditions: Head and Neck Carcinoma; Radiation-Induced Dermatitis

Summary: this randomized phase 3 trial studies how well modified dakin's solution works in reducing radiation-induced dermatitis, a common skin reaction to radiation therapy, in patients with head and neck cancer undergoing radiation therapy. modified dakin's solution may reduce inflammation in the body, which may prevent or reduce dermatitis after radiation therapy. radiation therapy in this study is regulatory medical care based on the patient's needs and the radiation oncologist's judgment. it is not possible nor necessary to explicitly define the dose or duration of treatment.

primary objectives: i. to determine the proportion of patients who develop grade 3 radiation dermatitis (as defined by the stanford radiation dermatitis scoring system) as an adverse effect of radiation therapy or chemoradiation therapy for a head and neck cancer when initiating the use of prophylactic hypochlorite (hocl) (modified dakin's solution) at the start of therapy (experimental arm) compared to placebo (control arm). outline: patients are randomized to 1 of 2 arms. arm i (experimental): participants apply modified dakin's solution (0.005% to 0.010%) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. arm ii (control): participants apply placebo solution (saline) topically to the skin of the arm up to 3 hours in advance of each radiation treatment. at the time that stanford radiation dermatitis scoring system (srdss) grade e radiation dermatitis develops, the participant will transition to standard management for radiation dermatitis. srdss, by grade, is as follows. * a. no skin change * b. faint, barely detectable erythema * c. follicular rash, hyperpigmentation, evolving erythema * d. dry desquamation, brisk erythema * e. moist desquamation * f. bleeding, ulceration, and/or infection srdss grade e is roughly equivalent to the common terminology criteria for adverse events (ctcae) version 4.03 grade 3 radiation dermatitis, "moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion." after completion of study, patients are followed up at 6 to 10 weeks.

Eligibility criteria:
inclusion criteria: * head and neck cancer who plan to undergo radiation therapy to the head and neck region * at least 18 years of age * able to understand and the willingness to sign a written informed consent document. exclusion criteria: * prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy not excluded) * the physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 gy * scleroderma or discoid lupus
maternal well-being in the perinatal period

Conditions: Perinatal Depression; Anxiety; Loneliness; Mother-Child Relations

Summary: the goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.

the primary goal of this observational study si to investigate the mental health status of women experiencing their first pregnancy, with particular attention to manifestations of anxiety and depression, feelings of loneliness, and the quality of defense mechanisms employed, during the last trimester of gestation (28th-35th week of gestation) and over the course of the 18 months following the child's birth. furthermore, the study aims to conduct an in-depth analysis of the variables associated with the psychological adaptation of women during the perinatal period, with particular reference to the following exploratory objectives: * to explore the association between the investigated psychological dimensions and the quality of the bond with the child in the prenatal and postnatal periods. * to identify any significant differences in the variables of interest between women who conceived naturally and those who underwent assisted reproductive technology (art). * to detect, through qualitative methods (semi-structured interviews and focus groups), the unmet needs of women during the perinatal period, as well as their preferences and expectations regarding the nature of desirable support interventions during this period. this would enable the construction and provision of an intervention model that closely aligns with the specific needs of this patient population. the collected data will allow for the identification of individuals at higher risk of psychological distress and adaptation problems during the perinatal period, as well as potential impairment in the quality of the attachment bond with the child.

Eligibility criteria:
inclusion criteria: * age 18 years or older * adequate understanding of the italian language * willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement * women experiencing their first pregnancy * women in the last trimester of gestation (28th-35th week of gestation) who will be followed for 18 months after childbirth exclusion criteria: * age under 18 years old * women who are not able to understand the italian language * absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement * women who are not experiencing their first pregnancy * women who are not in the last trimester of gestation (28th-35th week of gestation)
respiration patterns with impedance in linq

Conditions: Breathing Exercises

Summary: the purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted medtronic reveal linq™ insertable cardiac monitor (icm) as respiratory rate monitor.


Eligibility criteria:
inclusion criteria: * suspected arrhythmia diastolic heart failure and/or in renal failure. * chronic kidney disease (ckd) in stage 5 (gfr = \<15 ml/min). * diastolic heart failure in class ii and class iii (class iv to be considered in end stage and non-reversible). * willing to sign the informed consent form. * greater than 18 years of age. exclusion criteria: * enrolled in another study that could confound the results of this study, without documented pre-approval from a medtronic study manager. * significant respiratory diseases such as copd or pulmonary hypertension. * frequent arrhythmias, including pvc's. * known systolic heart failure. * recent infection. * allergenic or rejection reaction to materials used in incision/insertion tools, reveal linq™ icm exterior or incision closure method. * active implanted cardiac medical device (e.g. ipg, icd, crt, etc). * not suitable for reveal linq™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study. * body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest. * not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes. * any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
cypress efficacy and safety study extension

Conditions: Juvenile Myopia; Myopia

Summary: this is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of sightglass vision diffusion optics technology (dot) spectacles in reducing the progression of juvenile myopia.


Eligibility criteria:
inclusion criteria: * previously a successfully completed participant in the cypress study (nct03623074) and having not exited this study for more than 30 days; * agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); * willingness to participate in the trial for up to 3 years without contact lens wear; * the subject's parent(s) or legal guardian(s) must read, understand and sign the statement of informed consent and receive a fully executed copy of the form. exclusion criteria: * known allergy to proparacaine, tetracaine, or tropicamide.