Kornimate/medical-research-clean huggingface dataset:
randomized trial of a smartphone app designed to reduce unhealthy alcohol consumption

Conditions: Alcohol Consumption

Summary: smartphone apps targeting alcohol consumption are increasingly employed as a means to help people reduce their alcohol consumption. recognizing this potential, there has been an explosion of app development for unhealthy alcohol use, as well as other health-related behaviours. this study will recruit people who consume alcohol in an unhealthy manner. participants will be assigned by chance to one of two groups and will be contacted 6 months after consenting to the study to assess changes in their drinking. in addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption. an app with proven efficacy, made widely available and free-of-charge to canadians, will provide a much needed option to help those in need to reduce their alcohol use.

unhealthy alcohol use is common and causes tremendous harm. most people with unhealthy alcohol use will never seek formal alcohol treatment. as an alternative, smartphone apps have been developed as one means to provide help to people concerned about their alcohol use. while such apps are widely available, the large majority have little or no evidence base, and research has indicated that some may actually do more harm than good. an app with proven efficacy at reducing alcohol consumption is needed in order to capitalize on this opportunity to motivate the large number of people seeking assistance using this promising technology. this study will recruit people who consume alcohol in an unhealthy manner. participants will be assigned by chance to one of two groups to either receive access to: 1) the full app; or 2) a copy of the app where only the educational content is provided (as opposed to the full intervention content of the app). participants will be contacted 6 months after consenting to the study to assess changes in their drinking. we predict that the full app will lead to larger reductions in drinking and a more sustained impact than the educational content only app. in addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption.

Eligibility criteria:
inclusion criteria: * score of 8 or more on the alcohol use disorders identification test * currently us a smartphone running ios or android exclusion criteria: -
evaluation of compliance with management of acute coronary syndrome on discharge from cardiac intensive care

Conditions: Acute Coronary Syndrome

Summary: to study compliance with secondary prevention during the first months following discharge from the cardiac intensive care unit (cic) of patients experiencing a first episode of acute coronary syndrome : quantitative compliance over 3 months with the two principal treatments of the prescription (a statin - rosuvastatin, crestor® and a platelet aggregation inhibitor - clopidogrel, plavix®), using an electronic measure system ("intelligent blister" pack®);


Eligibility criteria:
inclusion criteria: * patient admitted to the cic unit for a first episode of acute coronary syndrome, in whom the cic cardiologist considers that crestor® -rosuvastatin is the most appropriate statin, in combination with a platelet aggregation inhibitor (plavix®-clopidogrel) * patient giving his/her oral consent to participate in the study. * patient not previously treated by a lipid-lowering drug. exclusion criteria: * patient with a known history of coronary heart disease. * patient whose treatment on discharge comprises only one of the two study treatments * patient participating or who has participated in the previous 3 months in a biomedical research study in cardiology.

Keywords: acute coronary syndrome treatment compliance cardiac intensive care unit secondary prevention cardiac intensive care unit (cic) compliance intensive care
inflammatory mediators as potential non-invasive biomarkers in subjects with eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the investigators seek to assess esophageal inflammation or lack of it in response to treatment with a novel non-invasive method that would measure eosinophil-associated inflammatory mediators in the blood and urine to determine the presence of active eosinophilic esophagitis. for these purposes, the investigators will correlate esophageal inflammatory mediators measured in blood and urine with histological findings identified on esophageal mucosal biopsies. additionally, biopsies associated mediators will be assessed relative to clinical phenotype and outcome.

the diagnosis, assessment of recurrence of inflammation, response to treatment and remission in eoe are all currently based on histological evaluation of upper endoscopic pinch esophageal biopsies. obtaining biopsies for histological evaluation by this procedure is both invasive and expensive. the purpose of our longitudinal prospective study is to evaluate and quantify a panel of novel non-invasive eosinophilic inflammatory biomarkers in the blood and urine of subjects with eoe and compare their presence and levels with the presence or absence of measures of inflammation in esophageal biopsies. while evaluation of esophageal biopsies with 15 or more eosinophils per high power field is the gold standard for diagnosis of eoe, novel predictors of clinical outcome remain unclear. the objective is to identify one or more sensitive and specific non-invasive biomarkers that could be used to monitor esophageal inflammation, and identify novel tissue-based markers that identify phenotype and outcome. this would eliminate the need for invasive serial surveillance endoscopies for the purpose of evaluating for recurrence of inflammation or response to standard therapy since symptoms alone do not adequately correlate with either the presence or absence of disease activity (inflammation) in the esophagus of patients with eoe.

Eligibility criteria:
inclusion criteria: * patient ages 1-18 undergoing upper endoscopy for suspected esophageal disease or esophageal inflammation or has histologically confirmed esophageal inflammation may be included in this study exclusion criteria: * patients with a history or current diagnosis of esophageal malignancy or subjects with graft versus host disease will be excluded from the study. * patients that are considered at high risk for biopsies at the discretion of the child's physician and/or the researcher * patients with known bleeding disorders or patients with illnesses where bleeding would pose a threat to their health * diagnosis other than eosinophilic esophagitis (eoe) i.e. inflammatory bowel disease (ibd), gastroesophageal reflux disease (gerd)
covid-19 prevalence in hiv-infected patients

Conditions: HIV Infections

Summary: north-east area of france was hit in february 2020 by the new coronavirus disease, more severely than other french regions. factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. even if nowadays hiv infection is usually well controlled by arv drugs, those patients with uncontrolled viral load and/or low cd4 cell counts, remain at higher risk of severe covid infection. in this context, the primary objective of our study is aimed at evaluating the prevalence of sars-cov-2 antibodies in a cohort of hiv-infected patients followed-up in an hiv-infection care center. secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and hiv associated factors with the presence of antibodies.


Eligibility criteria:
inclusion criteria: * adults (\> 18 years) * hiv-infected patients * subjects with social insurance * subjects able to understand study purposes, and to give a written and informed consent exclusion criteria : * subjects unable to understand informations on the study, and to provide informed consent * subjects under guardianship or curatorship * subjects under judicial protection

Keywords: hiv-infection aids antiretroviral treatment cd4 cell count plasma hiv rna sars-cov-2 antibodies
effects of octanoic acid for treatment of essential voice tremor

Conditions: Essential Voice Tremor; Vocal Tremor; Voice Tremor; Essential Tremor of Voice

Summary: essential voice tremor is a neurological condition that produces a regular, shaking quality in the voice. one form of drug treatment that produces some improvement in tremor of the hands is octanoic acid, which is a food additive that is similar to alcohol. research suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no intoxication effects. this study will determine whether octanoic acid may be useful for reducing tremor when it affects the voice. researchers are hypothesizing that octanoic acid will reduce the effects of tremor on the voice.

background: * essential tremor of the voice produces regular shaking and hoarseness in the voice, making it difficult speech difficult to understand * several previous studies have found that octanoic acid and octanol, which are related to alcohol, can improve tremor in some people without producing many side effects and without producing intoxication * researchers are interested in determining whether octanoic acid can improve tremor that affects the voice objectives: * to determine the effects of octanoic voice using voice recordings and listener ratings of voice * to determine the effects of octanoic acid on level of voice disability experienced by people with essential voice tremor

Eligibility criteria:
inclusion criteria: * participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment * participants show measurable voice tremor from recordings of the voice during screening appointment exclusion criteria: * participants have a diagnosis or show signs of parkinson's disease or another non-essential tremor movement disorder * participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder) * participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer * participants have a diagnosis of diabetes mellitus * participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study * participants have a dependence on alcohol or allergy to alcohol * participants are pregnant or lactating * participants have an allergy to soy * participants have irritable bowel syndrome

Keywords: voice tremor essential tremor essential voice tremor voice treatment octanoic acid octanol voice disorder dysphonia
imgatuzumab in patients with advanced cutaneous squamous cell carcinoma

Conditions: Cutaneous Squamous Cell Carcinoma

Summary: this study will evaluate the anti-tumor activity, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of imgatuzumab, a monoclonal antibody against epidermal growth factor receptor (egfr) with enhanced antibody-dependent cellular cytotoxicity (adcc) in patients with advanced cutaneous squamous cell carcinoma (cscc). quality of life of patients treated with imgatuzumab will also be assessed.


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of cscc * cscc of advanced stage * males or females at least 18 years of age at the time of consent * signed informed consent provided prior to any study procedures * ability to and willing to understand informed consent and comply with protocol requirements and procedures * no more than two prior lines of systemic treatment for advanced disease * patients must have at least one lesion that is considered as measurable according to the study response criteria * eastern cooperative oncology group performance status 0 or 1 * adequate function of bone marrow, liver, kidneys * availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening key exclusion criteria: * prior systemic treatment for advanced disease with any anti-egfr agent * active central nervous system metastasis * systemic anti-cancer therapy within five half-lives or two weeks, whichever is shorter, prior to first dose of the study drug * persistent toxicities from previous systemic anti-neoplastic treatments * wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention * major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention * active infection requiring therapy * concomitant use of systemic steroids at dose of \>10 mg of prednisone or its equivalent per day * known or suspected allergy/hypersensitivity to the study drug or any component of the study drug, other monoclonal antibodies, premedication medicines * concurrent participation in another investigational therapeutic clinical trial * pregnant or breast-feeding females * mental or medical conditions that prevent the patient from giving informed consent or participating in the trial * other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study note: other protocol defined inclusion/exclusion criteria apply.

Keywords: cutaneous squamous cell carcinoma epidermal growth factor receptor antibody-dependent cellular cytotoxicity carcinoma cancer
sputum and plasma levels of nociceptin and substance p in patients with asthma, copd and chronic cough

Conditions: Asthma; COPD; Cough

Summary: the aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance p with cough severity and airway hyperreactivity in patients with asthma, copd and chronic cough.

recent animal studies have found that nociceptin can inhibit cough responses induced by capsaicin. we hypothesize that sputum and plasma levels of these peptides may reflect some neurochemical alterations in airway cough reflex or neurogenic inflammation in asthma or copd. the aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance p with cough severity and airway hyperreactivity in patients with asthma, copd and chronic cough. we will enroll 260 patients (100 patients with asthma, 60 with copd and 100 with chronic cough) as well as 40 healthy subjects for this study. sputum and peripheral blood will be collected and concentrations of nociceptin and substance p will be measured by elisa. these levels will be correlated with cough severity (symptom scores), and airway hyperresponsiveness to inhaled methacholine as measured by pc20. sputum and plasma concentrations of both peptides will be rechecked after clinical improvements in cough or airway symptoms are achieved after therapy.

Eligibility criteria:
inclusion criteria:patients with asthma, copd, chronic cough - exclusion criteria:patients refusing blood sampling

Keywords: nociceptin sunstance p asthma copd cough
mngs for detection of pathogens for pulmonary infection

Conditions: Pulmonary Infection

Summary: pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. pathogen identification is crucial yet difficult for the majority of the cases. metagenomic next-generation sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. the study is designed observationally to investigate if mngs is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. both mngs and traditional paradigm of serial tests wil be performed.


Eligibility criteria:
inclusion criteria: * pulmonary infection as the primary diagnosis * bronchoalveolar lavage fluid can be obtained exclusion criteria: * when the primary diagnosis is tumor or connective tissue diseases * microbiological diagnosis is confirmed before bronchoalveolar lavage * not enough bronchoalveolar lavage fluid for mngs
molecular mri of the fibrotic heart

Conditions: Healthy; Myocardial Fibrosis; Chronic Kidney Disease

Summary: this study is a feasibility study to validate magnetizatin transfer (mt)-weighted balanced steady state free precession (bssfp) cine cardiac magnetic resonance (cmr) against current clinical gold standard diagnostics, and to determine the applicability of mt-weighted bssfp cine cmr for diagnosis of fibrotic remodeling in chronic kidney disease (ckd5) patients. participants will not receive a study drug or placebo and will not be randomized. a total of 250 participants will be enrolled into this study.

this study had two treatment arms. arm 1: participants will be enrolled in this arm if they have been referred to the gill heart institute mri center for diagnostic late gadolinium enhancement (lge) -cmr imaging of fibrosis, or if they are a healthy volunteer. if a participant is a gill heart institute referral patient , they will receive an intravenous (through a vein in the arm) infusion of gadolinium as part of their clinical examination. participants will also have electrocardiogram (ecg) waveform performed in order to gate the mri scan. the mri scan of the heart, for which the participant has been referred will last approximately 1 hour. participants will have an additional 5-10 minutes of scans performed, none of which require additional infusions. if the participant is a healthy volunteer, they will have an ecg waveform performed in order to gate your mri scan, and they will have approximately 30-45 minutes of scanning performed on their heart. participants will not receive an infusion of gadolinium. arm 2: only participants who are already participating in a study being conducted by dr. harmut malluche at the university of kentucky, department of nephrology or, if you are a healthy volunteer, will be enrolled into this arm. in this arm participants will receive an mri of their heart, lasting 30-45 minutes. participants will not receive an infusion of gadolinium.

Eligibility criteria:
arm 1 inclusion criteria: * participants between the ages of 20 and 80 * diagnosis or suspicion of myocardial fibrosis * referral for lge-cmr exclusion criteria: * confirmed acute mi within the prior 72 hours * unstable ecg or arrhythmia as determined by the referring physician * inability to hold one's breath for at least 10 seconds * standard mri safety exclusion criteria * allergic reaction to gadolinium * women who are pregnant, think they are pregnant or who breastfeeding arm 2 inclusion criteria: * participants between the ages of 20 and 80 * history of between 1-10 years of routine hemodialysis * healthy volunteers exclusion: * confirmed acute myocardial infarction within the prior 72 hours * unstable ecg or arrhythmia * inability to hold one's breath for at least 10 seconds * standard mri safety exclusion criteria

Keywords: healthy myocardial fibrosis chronic kidney disease
what matters to patients with severe hip or knee osteoarthritis?

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Summary: this clinical trial aims to investigate if shared decision-making, and the use of an in-consultation patient decision aid (ptda), increases the decisional quality and therefore treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis. finally, an evaluation will be conducted on patient-reported outcomes on pain, physical function, quality of life (qol), and patient satisfaction, up to one year after surgery.

osteoarthritis (oa) is the most common joint disease and a major cause of disability worldwide. the condition typically affects the hip or knee, and as the condition progresses it frequently causes debilitating pain and stiffness in the affected joints; thus impairing mobility, and decreasing function and quality of life(qol). approximately 10,300 primary hip arthroplasties (tha) and 10,000 primary knee arthroplasties (tka/uka) were performed in denmark in 2021. for the majority of patients with severe osteoarthritis, evidence shows that joint replacement surgery is life-changing. despite this documented effect, not all patients achieve optimal results. patient dissatisfaction following tha and tka has been reported as 7 % and 11-18%, respectively. it is hypothesized that a lack of adequate information and patient involvement in the decision process might lead to the misalignment of patients' expectations and subsequent dissatisfaction. considerable evidence shows that patients prefer more information and greater involvement. this strongly supports the concept that patients need to be actively involved in treatment decisions. accordingly, increasing patient involvement in healthcare decisions may be beneficial. shared decision-making (sdm) supports patients' active involvement in the process and improves the quality of decisions. sdm can be facilitated using a ptda, which has shown significant benefits in a range of patient groups. however, research on sdm and ptdas in patients with severe hip or knee oa is lacking. the overall aim of this project is to investigate if an in-consultation ptda increases the decision quality for patients with severe oa of the hip or knee.

Eligibility criteria:
inclusion criteria: * severe primary osteoarthritis eligible for primary total hip arthroplasty (tha) / primary total knee arthroplasty (tka) / primary partial knee arthroplasty (uka) * able to understand and read danish * informed consent exclusion criteria: * previous tha, tka, or uka on the contralateral side * cognitive impairment * non-oa-related reason for the visit * no digital mailbox (e-boks)

Keywords: hip osteoarthritis knee osteoarthritis shared decision making total knee arthroplasty partiel knee arthroplasty total hip arthroplasty decision quality hk-dqi
effectiveness of therapeutic alliance and minimal intervention for chronic low back pain

Conditions: Low Back Pain

Summary: this study aims to evaluate the effectiveness of minimal intervention and therapeutic alliance in pain, specific and general disability, global perceived effect, empathy, credibility and expectation of improvement in patients with chronic non-specific low back pain

low back pain remains a global public health problem. the classification of patients in low back pain subgroups aims to optimize the health system and provide the quantity and the type of proper technique for each patient. several factors may influence physical therapy. the therapeutic alliance may be defined as harmony or social connection between the therapist and the patient and may influence the treatment effect. the aim of this study is to evaluate the effectiveness of the addition of the therapeutic alliance to a minimum intervention for the treatment of chronic non-specific low back pain with low risk of psychosocial factors.

Eligibility criteria:
inclusion criteria * patients waiting for treatment in the waiting list of physical therapy clinics * diagnosis of chronic non-specific low back pain (over 12 weeks) * more than 18 years * able to read and write the portuguese language * low risk of psychosocial factors (less than 3 points in the start back screening tool). exclusion criteria * spine surgery history * nerve root compromise * cognitive impairment related disorders * pregnants

Keywords: low back pain empathy subgroups minimal intervention