Kornimate/medical-research-clean huggingface dataset:
asymmetrical directionality with bimodal systems.

Conditions: Hearing Loss

Summary: research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (ci) or hearing aid (ha) alone. although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. the aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.

the primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an ema tool. the aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.

Eligibility criteria:
inclusion criteria: subjects must meet the inclusion criteria described below to be eligible for this clinical investigation. 1. adults who are english speaking and aged 18 years and older. 2. individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear. 3. new and experienced bimodal users (cochlear implant + hearing aid). 4. experienced nucleus 7 or kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months. 5. individuals able to complete test measures as outlined in the informed consent and protocol. 6. individuals with access to a smart phone/device that is either ios 7.0 or android 4.0 and later who are willing to utilize their personal smart phone/device for participation in the trial. 7. individuals willing to use their personal email account for participation in the trial. - exclusion criteria: subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation. 1. individuals using sound processors in the hybrid mode. 2. bilateral cochlear implant users. 3. unable or unwilling to comply with the requirements of the study as determined by the investigator. 4. investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5. currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device. -
study of rmc-6291 in combination with rmc-6236 in participants with advanced kras g12c mutant solid tumors

Conditions: Non-Small Cell Lung Cancer (NSCLC); Colorectal Cancer; Pancreatic Ductal Adenocarcinoma

Summary: this study is to evaluate the safety, tolerability, and pk profiles of rmc-6291 and rmc-6236 in adults with kras g12c-mutated solid tumors.

this is an open-label, multicenter, phase 1b study of rmc-6291 in combination with rmc-6236 in participants with advanced kras g12c-mutated solid tumors, to identify the maximum tolerated dose (mtd) and/or recommended phase 2 dose and schedule (rp2ds) and provide a preliminary assessment of the antitumor activity of rmc-6291 in participants with krasg12c tumors. the study consists of two parts: part 1 - dose-escalation and part 2 dose-expansion.

Eligibility criteria:
inclusion criteria: * 18 years of age * histology: pathologically documented, kras g12c-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. part 1. dose escalation: solid tumors, previously treated 2. part 2. dose expansion: i. nsclc, previously treated with immunotherapy, chemotherapy, and kras g12c (off) inhibitors, ii. nsclc, previously treated with immunotherapy and chemotherapy, naïve to kras g12c (off) inhibitors, iii. nsclc, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (cns) metastases \<2 cm in size iv. solid tumors, previously treated, naïve to kras g12c (off) inhibitors. * ecog performance status 0 or 1 * adequate organ function exclusion criteria: * primary central nervous system (cns) tumors * active brain metastases * known impairment of gi function that would alter the absorption * major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment

Keywords: rmc-6291 ras (on) kras krasg12c krasg12c (on) targeted therapy metastatic cancer lung cancer lung neoplasms thoracic neoplasms non-small cell lung cancer carcinoma, non-small cell lung nsclc colorectal cancer colonic neoplasms crc appendiceal cancer kras mutation stk11/lkb1 keap1 bronchial neoplasms respiratory tract neoplasms neoplasms by site neoplasms colon cancer rectal cancer lung disease respiratory tract diseases pancreatic cancer carcinoma, pancreatic ductal pdac gastrointestinal neoplasms intestinal neoplasms esophageal cancer ampullary cancer gastric cancer gynecological cancer ovarian cancer endometrial cancer rmc-6236
endothelial vasomotor function in the framingham study

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to determine whether the presence of endothelial dysfunction is an independent risk factor for cardiovascular disease events.

background: current research suggests that loss of the vasodilator, anti-thrombotic, and anti-inflammatory properties of the vascular endothelium plays a dynamic role in the pathogenesis of cardiovascular disease. impaired endothelial function, including impaired nitric oxide-dependent vasodilation is associated with cardiovascular disease risk factors. further, there is growing evidence that endothelial function can be improved by risk modification. however, the available studies have not definitively resolved the issue of the cross-sectional correlates of endothelial dysfunction because they have been limited to small samples of highly selected patients. for example, it remains unclear whether hypercholesterolemia, hypertension, or elevated glucose levels are independent determinants of endothelial dysfunction. most importantly, no study has shown a relation between endothelial dysfunction and increased cardiovascular risk. such a demonstration would increase our understanding of the pathogenesis of cardiovascular disease and aid clinicians in identifying high risk individuals who would benefit most from intervention. design narrative: using non-invasive brachial artery ultrasound, endothelial function was examined in about 3,800 men and women of the framingham heart study. the cross-sectional correlates of endothelial function with known coronary risk factors were examined and cross-sectional analyses were performed on the relation of endothelial function to prevalent cardiovascular disease. observations were made of the adjusted relation of endothelial function to incident and recurrent cardiovascular events. the central hypothesis was that the presence of endothelial dysfunction was an independent risk factor for cardiovascular disease events. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the interaction between metformin and acute exercise

Conditions: Impaired Glucose Tolerance; Diabetes Mellitus, Type 2

Summary: physical activity is a first line treatment for patients with type 2 diabetes (t2d), however, the vast majority of patients with t2d do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated. it is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (ampk) in skeletal muscle and liver, and the activation of ampk results in many different metabolic effects, including improvements in glycemic control. because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. thus, the aim of this study is to assess the effects of acute physical activity with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur. subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo treatment in a double-blinded way. following a treatment run-in period of 17 days, two experimental days (one with acute exercise and one without acute exercise), separated by one week, will be performed in each subject. this registration concerns a sub-study of another study which has previously been registrered at clinicaltrials.gov (unique protocol id: h-17012307). the specific outcomes in this registration have not previously been registered.


Eligibility criteria:
inclusion criteria: * glucose-lowering-medication naïve t2d and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (pg) in the 75-g ogtt (7.8-11.0 mmol/l) and/or hba1c (39-47 mmol/mol) * caucasian * bmi \> 25 but \< 40 kg/m2 * low to moderate physically active (≤90 min of structured physical activity/week) exclusion criteria: * pregnancy * smoking * glucose-lowering treatment * treatment with steroids and other immunomodulating drugs * contraindication to increased levels of physical activity * liver disease (alat elevated more than 3 times above upper normal limit, or reduced levels of the liver function markers albumin and kf ii+vii+x) * renal insufficiency (egfr\<60 ml/min) * prior history of lactic acidosis * hba1c \>55 mmol/mol and/or 2-hpg in the 75-g ogtt \> 15 mmol/l
use of blood and plasma in norwegian physician-staffed helicopter emergency medical system

Conditions: Hemorrhagic Shock

Summary: the main objective of this study is to evaluate the use of rbc, fdp, wb in the treatment of exsanguinating patients by physician-staffed emergency medical services in norway, with focus on prehospital transfusion complications and safety.

this study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in norway, with the following main questions: i. are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions? ii. is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible? iii. are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment? iv. are out-of-hospital transfusion practices associated with increased waste of blood products? all patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products will be included, if they fulfill the listed criteria below: * patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding) * radial pulse \> 100 beats/min or absent/weak radial pulse * systolic blood pressure (sbp) \< 90 mmhg * altered mental status (reduced gcs) in the absence of head injury or known intoxication patients with known previous serious allergic reactions to blood product transfusions or patients who refuse blood products on religious grounds (e.g. jehovah´s witness) will be excluded.

Eligibility criteria:
inclusion criteria: * all patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below: * patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding) * radial pulse \> 100 beats/min or absent/weak radial pulse * systolic blood pressure (sbp) \< 90 mmhg * altered mental status (reduced gcs) in the absence of head injury or known intoxication exclusion criteria: * patients with known previous serious allergic reactions to blood product transfusions * patients who refuse blood products on religious grounds, e.g. jehovah´s witness
noninvasive positive airway pressure ventilation and risk of facial pressure ulcers

Conditions: Acute Respiratory Failure

Summary: to assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation.

noninvasive ventilation improves the outcome of patients with acute respiratory failure; however patient's discomfort may be responsible for up to a fifth of failures. scant literature exists on niv-related pressure ulcers and their determinants. aim of the study is to seek for determinants, if any, associated with the development of pressure ulcers related to noninvasive ventilation. study design: observational. patients treated with niv from december 2009 to december 2011 will be analyzed. main end-points: to seek for variables associated to the development of niv-related pressure ulcers in patients with acute respiratory failure.

Eligibility criteria:
inclusion criteria: * severe dyspnea at rest * respiratory rate \> 30 per minute * pao2/fio2 \< 200 (despite oxygen with venturi with a fio2 og 0.5) * use of accessory respiratory muscles * ph \ 7.10 exclusion criteria: * stemi * nstemi/unstable angina * hemodynamic instability * need for immediate endotracheal intubation * inability to protect the airways * impaired sensorium * pulmonary embolism * gastrointestinal bleeding * hematological malignancy or neoplasms with ecog performance status \> 2

Keywords: pressure ulcer noninvasive ventilation
peer support to mitigate the impact of stigma in young hiv+ pregnant & postpartum women

Conditions: Hiv

Summary: young pregnant and postpartum women living with hiv are at the greatest risk of disengagement from hiv services and suboptimal adherence to antiretroviral therapy (art). among young women, stigma is a major barrier to retention in services and adherence to art, and interventions are needed to combat stigma and improve art outcomes. the investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.

despite major reductions in mother-to-child hiv transmission (mtct), young pregnant and postpartum women living with hiv remain a vulnerable group and experience the greatest risk of disengagement from services and suboptimal adherence to antiretroviral therapy (art). hiv-related and intersectional stigmas are major barriers to uptake and retention in prevention of mother-to-child transmission (pmtct) services and drive suboptimal adherence, and young women experience unique stigmas. despite this, there are no evidence-based interventions to combat stigma and improve art outcomes in this group. peer support group interventions have shown promise in other populations, but have not been examined in young pregnant and postpartum women living with hiv. the investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in young pregnant and postpartum women living with hiv in south africa. participants will be allocated to the standard of care, in which no standardized peer support groups exist for this patient population, or to a peer support intervention.

Eligibility criteria:
inclusion criteria: * aged 16-24 years * documented hiv infection * confirmed pregnant or recently postpartum * accessing antenatal or immediate postpartum pmtct services at the study site * planning on remaining a resident of cape town for at least 6 months after enrolment * able to provide informed consent for research exclusion criteria: * significant pre-existing psychiatric comorbidity that may impact ability to consent * stated intention to move outside of cape town during the 6 months after enrolment
bronchial thermoplasty for severe asthma with dynamic hyperinflation

Conditions: Asthma; Hyperinflation

Summary: bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope this treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma. this clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).

bronchial thermoplasty is a recently validated bronchoscopic technique for the management of severe asthma that treats smooth muscle by radiofrequency to reduce its thickness. this procedure leads to improved asthma control and quality of life, but also to decreased exacerbations frequency and number of emergencies hospitalizations. this treatment requires 3 procedures every 3 to 4 weeks. the pathophysiological mechanisms underlying its effectiveness need to be better understood for an improved selection of best candidates. in particular, there is a discrepancy between the improvement observed in symptoms (acq), quality of life (aqlq) and the lack of improvement in forced expiratory volume in 1 second (fev1). investigator assume that this paradox is due to an efficiency appearing at effort, targeting dynamic hyperinflation phenomenon. the objective of this study is to evaluate the influence of bronchial thermoplasty on dynamic hyperinflation in severe asthma. the secondary objectives are to assess the effectiveness of bronchial thermoplasty (acq, aqlq) in a selected population of patients with dynamic hyperinflation and to describe bronchial wall structural changes by probe-based confocal laser endomicroscopy (pcle).

Eligibility criteria:
inclusion criteria: * severe asthma, uncontrolled despite optimal treatment according to gina (global initiative for asthma) recommendations * at least 2 exacerbations treated by systemic steroids in the last year * fev1 between 40 and 80% of predicted values and dynamic hyperinflation (defined as a decrease in inspiratory capacity by more than 500 ml during exercise) exclusion criteria: * current asthma exacerbation or respiratory infection * history of exacerbation after bronchoscopy * fev1 \< 40% of predicted values * oxygen saturation \< 90% * contra-indications to alair catheter system : pacemaker or other electronic implanted device * allergy to remifentanyl or propofol * pregnancy; breastfeeding

Keywords: thermoplasty severe asthma dynamic hyperinflation
prostatic obstruction investigation team multicenter study

Conditions: Lower Urinary Tract Symptoms

Summary: the present is a multicenter, observational study organized by the prostatic obstruction investigation team (point), with a main purpose of looking into the current status and symptom progression of male lower urinary tract symptoms patients in china.

lower urinary tract symptoms (luts) is a common medical condition negatively affecting people's quality of life worldwide. luts may be caused by structural or functional abnormalities in 1 or more parts of the lower urinary tract, including bladder, prostate, internal and external urethral sphincter and distal urethra. furthermore, evidence exists to demonstrate that luts is associate with lifestyle factors, systemic comorbidities and geriatric diseases, such as smoking, obesity, metabolic syndrome, chronic kidney diseases and chronic obstructive pulmonary disease etc. so far, there is lack of evidence to illustrate the symptom features and comorbidities among chinese male luts patients. therefore, this multicenter clinical study aims to investigate the present status and symptom progression among male luts patients in china.

Eligibility criteria:
inclusion criteria: 1. male, 45 years or older. 2. the presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc. 3. all participants have signed the informed consent form. 4. clinical data comes from 23 selected hospitals spread across china. exclusion criteria: 1. lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc. 2. diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor. 3. known neurogenic or congenital lower urinary tract dysfunction. 4. known urinary tract, prostate or pelvic surgical history. 5. existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.). 6. the presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 7. patients with poor compliance or cognitive competence.

Keywords: male lower urinary tract symptoms comorbidities chronic kidney diseases urodynamics medical therapy surgical treatment
the effect of sonographic bladder compressive technique for bag urine collection in pediatrics

Conditions: Urinary Tract Infections

Summary: aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(er) by shortening the time of er stay.

* according to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow. * get documented agreement from the caregiver if the patient meets the criteria. * while the a nurse attaches a kismo to a patient, the researcher at the bedside measures the patient's bladder size as an maximal anteroposterior (ap) and transverse (t) diameter(cm) * if the measured diameters (ap x t) is 2 x 2 or more, the research assistant check the assigned group of the patient. * if the patient assigned to the intervention group, a pressure stimulus is applied once using an ultrasonic probe to the anteroposterior wall of the bladder until the anterior \& posterior wall meet. * if the ap x t was less than 2 x 2, excluded from the study enrollment. * during the study, caregivers and the assigned nurse will be blinded

Eligibility criteria:
inclusion criteria: * body temperature of patients ≥ 38℃ reported by guardians * no definite focus of fever detected by physical examination * guardian agrees to use urine bag(kismo) collection technique exclusion criteria: * previous history of urinary tract infections * underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters) * icu treatment indicated * newly diagnosed hydronephrosis on the day of visit