Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of ai-aided auscultation with automatic classification of respiratory system sounds

Conditions: Wheezing; Rhonchi; Crackle; Lung Sound

Summary: in the present trial, the stethome electronic stethoscope will be used for pulmonary auscultation and recording of lung sounds in the pediatric study population.

multicenter, international - 2 eu sites (max. 1 in poland) and a single us site. trial centers and investigators will be identified and selected based on their clinical and research experience. the trial objective is to assess whether use of the stethome ai lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds in the categories of wheezes, rhonchi, fine crackles and coarse as compared to pulmonary auscultation by experienced physicians (general practitioners (gps) and pulmonologists). the recordings will be used to form a gold standard database of lung sounds as evaluated by an expert, independent panel according to the study protocol. the gold standard database will include approximately equal representation of wheezes, rhonchi, fine crackles and coarse crackles. moreover, the database will also include recordings without any of the previous descripted pathological sounds. the results of these two analyses, by traditional physician listening and by the stethome ai software application, will be assessed for sensitivity and specificity to the gold standard database in detection of the four lung sounds and recordings without defined pathological sounds. the stethome ai will be considered to provide clinical benefit if it demonstrates statistically better sensitivity or specificity on any of the four lung sounds as compared to the traditional physician auscultation, together with f1 score analysis.

Eligibility criteria:
inclusion criteria: * children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward (pl and eu). * children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward or treated in an outpatient clinic (us). * informed consent of parents or caregivers, according to local regulations. exclusion criteria: * skin/soft tissue disease or local infection at the site of pulmonary auscultation or any other contraindication for the pulmonary auscultation. * any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project.
tmd-specific physiotherapy in heds patients individuals with hypermobile ehlers-danlos syndrome

Conditions: Hypermobile Ehlers-Danlos Syndrome

Summary: the aim of this study is to analyze the effects of strictly defined physiotherapy in patients temporomandibular dysfunction (tmd) and hypermobile ehlers-danlos syndrome (heds). patients will be clinically examined before starting physiotherapy and fill in the questionnaires. subsequently, it will be followed up whether changes occur as a result of physiotherapy. this study is a pilot study and is intended to be hypothesis generating in nature. based on the resulting hypothesis, it will be verified by a study with a control group.


Eligibility criteria:
inclusion criteria: 1. written consent to participate in the study 2. confirmed diagnosis of heds (based on the diagnostic criteria of the current classification of 2017). 3. pain in the area of the masticatory muscles and/or the temporomandibular joints 4. command of the german language, both spoken and written exclusion criteria: 1. currently undergoing tmd-specific treatment (physiotherapy, pain therapy masticatory muscles and/or temporomandibular joint, orthopedic treatment, osteopathic treatment). 2. persons diagnosed with depression, anxiety or stress disorder 3. taking opiates 4. pregnant women 5. minors 6. persons with mental disability 7. persons who are not able to speak and write the german language 8. persons with legal representatives
the use of psychomotor vigilance testing in the assessment of pediatric obstructive sleep apnea

Conditions: Pediatric Obstructive Sleep Apnea

Summary: obstructive sleep apnea results in decreased attentiveness and response times in patients. the objective of this study is to quantify these consequences in pediatric osa patients using an already established tool for examining the results of sleep deprivation and fragmentation: psychomotor vigilance testing. pvt has been used in children, but has not been studied in pediatric osa patients. this study aims to employ pvt along the normal course of diagnosis and treatment of pediatric osa patients in our clinical practice at arkansas children's hospital. the investigators hypothesize that pediatric osa patients will exhibit decreased pvt scoring when compared to children without osa, and that pvt can be used to diagnose and monitor treatment outcomes in these patients.


Eligibility criteria:
inclusion criteria: * healthy pediatric patients ages 6-18 years old * with symptoms of osa (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches) * with physical exam findings consistent with adenotonsillar hypertrophy * those identified as good candidates for adenotonsillectomy * who are to undergo a polysomnogram as part of their preoperative work-up exclusion criteria: * history of attention deficit disorder, developmental delay, or mental retardation * children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants) * children previously treated for osa (surgically or medically) * children with significant comorbidities including other sleep-related disorders

Keywords: obstructive sleep apnea pediatric obstructive sleep apnea osa pvt psychomotor vigilance testing psychomotor vigilance task
lithium therapeutic drug monitoring; once daily vs twice daily dosing and the impact of kidney function

Conditions: Bipolar Disorder; Major Depressive Disorder

Summary: lithium is a mainstay in the treatment of bipolar disorder, and a frequently used adjunctive therapy for major depressive disorder. it is accepted practice to monitor lithium serum levels to monitor for efficacy and toxicity. however, studies on the difference in lithium levels between once and twice daily dosing, which also assess the impact of kidney function are scarce. the aim of this study is to quantify this pharmacokinetic difference, identify the impact of kidney function, in the context of estimating effects to inform feasibility and sample size needed for a larger well-powered study.

bipolar disorder is a chronic and recurring condition which causes functional impairment and increases lifetime suicide risk. major depressive disorder likewise confers a high burden of illness on the affected population, and treatment is complicated by the fact 50-70% of patients treated with an initial agent do not achieve full remission of symptoms. there are numerous clinical practice guidelines which support the use of lithium as a first-line agent for bipolar disorder, and as an adjunctive therapy for major depressive disorder. therapeutic ranges for lithium were established in the 1970s using multiple daily dose regimens, and therefore should not be directly applied to patients taking lithium once daily. the current standard of practice is to measure levels 12 hours post dose irrespective of once or twice daily administration. there is some evidence that lithium levels drawn 12 hours post dose are 10 - 26% higher when dosing lithium once daily compared to twice daily, however, the impact of kidney function on this difference has not been studied, and this difference in 12h post levels has not been confirmed via prospective data. guidance on therapeutic drug monitoring (tdm) is vague with respect to interpretation of specific lithium blood levels for once daily dosing. physicians may reduce a patient's dose based on a lithium level that is seemingly higher that target, even if the patient is clinically stable, putting the patient at risk for re-emergence of symptoms. though it is known that lithium is excreted by the kidney, the impact of kidney function on the difference in lithium levels when dosed once daily compared to twice daily is not well understood. the results of this pilot study will help identify the impact of kidney function on lithium therapeutic drug monitoring in current practice, and potentially lead to a larger multi-center study.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the inpatient psychiatry unit at mount sinai hospital treated with lithium therapy (i.e. taking lithium before admission, or initiated on lithium therapy during hospitalization) exclusion criteria: * any patients who are currently pregnant * patients taking lithium three times daily * patients taking lithium with a specific dosing frequency for a documented clinical reason.

Keywords: lithium pharmacokinetics renal kidney
clinical study using eye lipid mobilizer (elm) with heat and vibration to treat evaporative dry eye disease

Conditions: Evaporative Dry Eye Disease; Meibomian Gland Dysfunction

Summary: the goal of this clinical trial is to evaluate the eye lipid mobilizer (elm) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. the main questions aim to confirm that 1) the elm can meet its intended use by validated patient reporting outcomes and 2) to confirm that the elm device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.

the purpose of the clinical study is to evaluate the eye lipid mobilizer for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. the objective of the study is to confirm that the eye lipid mobilizer (elm) can meet its intended use by validated patient reporting outcomes. the secondary objective is the elm device can be used safety with no adverse events. the eye lipid mobilizer (elm) system is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (mgd), also known as evaporative dry eye or lipid deficiency dry eye.

Eligibility criteria:
inclusion criteria: * at least 21 years old * confirmed evaporative dry eye disease exclusion criteria: * ocular surgery, trauma, herpes infections * unwillingness to comply with study protocol * pregnant or nursing women * any subject that cannot wear an eye mask * participation in another ophthalmic clinical trial within past 30 days

Keywords: dry eye disease meibomian gland dysfunction evaporative dry eye disease eye lipid mobilizer
quercetin phytosome® chronic fatigue symptoms

Conditions: Chronic Fatigue Symptoms; Sleep; Physical Performance; Body Composition

Summary: the purpose of this study is to evaluate whether a 3-month period of quercetin supplementation (500 mg of quercetin phytosome®) is useful in the treatment of chronic fatigue, as assessed by the fatigue impact scale (fis-40). secondary end points are sleep assessment through pittsburgh sleep quality index (psqi) and muscle performance assessment through the short physical performance battery (sppb) and body composition assessment using dxa.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * chronic fatigue symptoms recorded using a self-reported fatigue score assessed using the validated fatigue impact scale (fis- 40) that comprised chronic tiredness impacts related to physical, cognitive and psychosocial functions. exclusion criteria: * patients with any active medical condition that explains chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, drug side effects, and iron deficiency anemia) * previous diagnosis not unequivocally resolved (chronic hepatitis, malignant tumors) * past neuropsychiatric disorders or current severe depressive disorder with psychotic or melancholy features, bipolar disorder, schizophrenia, delusional disorder, dementia, anorexia nervosa, bulimia nervosa * participation in another clinical trial of the same or different nature within 30 days prior to inclusion in the study * failure to provide signed informed consent * consumption of certain drugs/supplements that could affect outcome measures in the past 90 days or whose discontinuation could be a significant problem * anticoagulant treatment * pregnancy or breastfeeding * smoking, alcohol or substance abuse * obesity (bmi \> 30 kg/m²)
photographic evidence of oral precancerous lesions in current tobacco and areca nut users improves their quit rates

Conditions: Precancerous Conditions

Summary: the success of tobacco and areca nut cessation programs in individuals with oral potentially malignant disorders (opmds) is imperative for risk reduction and prevention of oral cancer. a prospective pilot interventional study where 200 participants with current tobacco and areca nut habits and opmd were randomly divided in two groups. group a ( n=100; habit cessation counselling with general and medical management for opmd). group b ( n=100; habit cessation counselling with general and medical management for opmd and visual exposure to personal intraoral photographs of oral lesions at baseline and review).

a prospective pilot interventional study was carried out in a oral medicine unit at a tertiary referral center where opmd and oral cancer screening is carried out routinely in all patients examined in the out patient department (opd). ethical clearance for conducting the study and taking serial intraoral photographs of opmd in consenting participants was obtained from the institute ethics committee.all patients in opd were initially screened for current habits of any form of tobacco and areca nut products through history and referred to the tobacco cessation clinic (tcc) for individual counselling session.this counselling was based on the toolkit issued by the world health organization (who) for delivering brief tobacco intervention under who capacity building training package.the patients then underwent detailed intraoral examination for any oral mucosal changes. those patients that were diagnosed as having any opmd as per clinical diagnostic criteria were then recruited as participants in the study. a total of 200 participants with current tobacco and areca nut habits and opmds were recruited after informed written consent and randomly assigned to the two groups. the control group a had 100 participants who received standard management protocol for opmd. the experimental group b received all the management as in control group a but were also shown their intraoral photographs of oral lesions and explained about the areas of abnormalities that were of concern. all the participants were reviewed at 1, 3 and 6 months for surveillance of opmd lesions and habit status.the data was analysed for statistically significant differences between the two groups p\<0.05.

Eligibility criteria:
inclusion criteria: * current tobacco and areca nut users. * presence of oral potentially malignant disorders exclusion criteria: • any oral lesion suspicious of malignancy.

Keywords: cessation tobacco use smokeless tobacco areca intraoral photography abstinence
effect of post-exercise nutrition on glycemia in women

Conditions: Overweight and Obesity

Summary: the purpose of this study is to assess whether post-exercise greek yogurt following a single session of aerobic exercise improves metabolic and musculoskeletal health in women with overweight/obesity.

following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires. participants will undergo baseline testing at our laboratory at the university of toronto to determine cardiorespiratory fitness, body composition and undergo exercise familiarization. eligible participants will be assigned, in a random order, to two metabolic trials approximately 4 weeks apart that involve 4 days of controlled diet and exercise. each trial takes place over 4 days, but participants are not required to come to the laboratory on all days. the two trials involve: 1) exercise + greek yogurt (gy) 2) exercise + a carbohydrate-based study supplement (ss). during the 4 day trials, participants consume controlled diets and the study supplements (gy and ss). on 1 of these days participants will perform exercise in our lab followed by the consumption of gy or ss. various outcomes will be measured throughout the trial, including glycemic control (via continuous glucose monitoring), fat oxidation, appetite and health outcomes in blood samples. throughout the duration of the study, participants will be asked to maintain their habitual diet and physical activity patterns, and maintain their current body weight.

Eligibility criteria:
inclusion criteria: * 18-45 yrs * bmi ≥27 kg/m2 * elevated waist circumference (≥88 cm) * ≤2 structured exercise sessions/week * weight stable (within ± 2kg for at least 6 months) * experiencing regular natural menstrual cycles * non-smoker exclusion criteria: * allergy to dairy foods * diagnosed lactose intolerance or an aversion to foods provided during the study (e.g., post-exercise snacks) * previous history of cardiovascular or metabolic disease * the use of medication for managing blood glucose or lipid metabolism * current use of oral contraceptives or use within the last 3 months * irregular menstrual cycles (\ 35 days) * pregnant or lactating * recreational tobacco or cannabis use * inability to perform the study exercise protocols * actively engaging in a low-carbohydrate diet (e.g., ketogenic, atkins).

Keywords: women glycemic control exercise
primary hormone-sensitive breast cancer: need-driven health care improvement by patient-centred digital application

Conditions: New Healthcare Approach

Summary: the investigators designed a prospective, 2-armed, cluster-randomized multicenter clinical trial on the effect of a by a digital application triggered intervention on quality of life and therapy-adherence among breast cancer patients, compared to standard of care.

with validated questionnaires, patient reported outcome monitoring data on quality of life, distress and therapy-adherence are collected. in case of pathologic values, the attending breast center gets advised to intervene according to individual requirements. for women with breast cancer, disease and therapy come along with loss of quality of life. therapy and its side effects often result in unauthorized discontinuation of therapy by patients. non-adherence rates to endocrine therapy (et) range from 31% to 73%. these patients have a poorer prognosis due to recurrence, progression and cancer deaths. positive effects to increase therapy-adherence were shown for bidirectional communication. furthermore the use of apps with reminder functions can increase adherence to cancer therapy. the intention within this project is to improve care of patients with primary breast cancer.

Eligibility criteria:
inclusion criteria: * primary, hormone-sensitive breast cancer * indication for adjuvant endocrine therapy (aromatase-inhibitor, tamoxifen, gnrh-analogue allone or in combination with tamoxifen/ aromatas inhibitor; combination of endocrine therapy with cdk 4/6-inhibitor/ antibody therapy/ radiotherapy) * start of endocrine therapy \<= 3 months ago * patients with public health ensurance * patients who are legally competent and able to understand and follow instructions of the study staff * present informed consent exclusion criteria: * no use of internet or digital applications * advanced, metastatic breast cancer * simultaneous serious disease * life expectancy \< 2 years

Keywords: quality of life adherence
study of durvalumab versus placebo in combination with definitive chemoradiation therapy in patient with escc

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is a phase iii, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dcrt in patients with locally advanced, unresectable esophageal squamous cell carcinoma (escc).

approximately 600 patients with locally advanced, unresectable escc (ajcc 8th cstage ii-iva) will be randomized in a 2:1 ratio to receive either durvalumab + dcrt or placebo + dcrt. the primary objectives of this study are to assess the efficacy of durvalumab + dcrt compared with placebo + dcrt in terms of progression free survival (pfs, per recist 1.1 as assessed by bicr) in pd-l1 high population.

Eligibility criteria:
inclusion criteria: * 18 years or older at the time of signing the icf. * histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (stage ii-iva). * unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy. * patients with at least an evaluable lesion per recist 1.1. * mandatory provision of available tumor tissue for pd-l1 expression analysis. * ecog ps 0 or 1. * adequate organ and marrow function. * life expectancy of more than 3 months. exclusion criteria: * histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma. * prior anti-cancer treatment for escc. * patient with a great risk of perforation and massive bleeding. * history of allogeneic organ transplantation. * active or prior documented autoimmune or inflammatory disorders. * uncontrolled intercurrent illness. * history of another primary malignancy. * active infection including tuberculosis, hepatitis b, hepatitis c, or human immunodeficiency virus. * known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Keywords: locally advanced unresectable escc pd-l1 durvalumab