Kornimate/medical-research-clean huggingface dataset:
a single dose study investigating the absorption and elimination as well as the tolerability of varenicline transdermal delivery system (e.g., a patch) as compared to oral varenicline in adult smokers.

Conditions: Smoking Cessation

Summary: 1. to evaluate the absorption and elimination of varenicline formulation a transdermal delivery system \[tds (patch)\] compared to varenicline immediate release tablet (chantix®). 2. to evaluate the adhesion of the varenicline formulation a patch. 3. to evaluate the safety and tolerability of a single application of the varenicline patch and a single oral dose of the varenicline immediate release tablet (chantix®).


Eligibility criteria:
inclusion criteria: * healthy adult smokers exclusion criteria: * significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease * illegal drug usage

Keywords: varenicline bioavailability transdermal smoking cessation
mitral valve prolapse (mvp) - france study

Conditions: Mitral Valve Prolapse

Summary: this prospective nation-wide (france) study aims to search for susceptibility genes in mvp using a genome wide analysis and comparing results obtained in 1000 patients with mvp and 1000 non-mvp subjects.

two mvp populations will be defined in that study, either with the classical barlow (myxomatous) disease or the fibroelastic degenerescence (thin and redundant leaflets). mvp adult patients (\> 18 year-old) will be included if they present the following 1) or 2) criteria : 1. 2d-echocardiographic mitral leaflet prolapse on the parasternal long-axis view \> 2 mm and leaflet thickness \> 4 mm or mitral regurgitation \> 2 + (using color doppler) 2. previous surgery for pure severe mitral regurgitation due to mvp with barlow disease or fibroelastic degenerescence (with operative report available) patients will be excluded in case of associated heart disease (hypertrophic cardiomyopathy, rheumatismal disease...) or syndromic disease (marfan, ehlers-danlos...). around 30 (cardiology, cardiovascular surgery) french centers will participate to this study. an e-crf will be used to collect clinical data. a genetic core lab will collect the dna samples. an echocardiographic core lab will collect and read all the echo recordings. dna analysis will be compared between the patient group and spouses of the patients used as controls. in case of inadequacies concerning group size or age, available genotyped cohorts will be used.

Eligibility criteria:
inclusion criteria for mvp patients : * male or female subject ≥18 years * affiliation to the french social insurance system * written informed consent * idiopathic mvp defined by the presence of criteria 1) and 2) or of criterion 3) : 1. echographic mvp \> 2 mm on the left ventricular parasternal long-axis view 2. echographic myxomatous valve (thickness \> 4 mm) or significant mitral regurgitation (\> 2 + using color doppler) 3. history of mitral valve surgery for pure mitral regurgitation due to mvp (myxomatous or fibroelastic deficiency) with available detailed operative report. exclusion criteria : * presence of heart disease causing mvp (rheumatic, hcm...) * syndromic disease (marfan, ehlers-danlos...) inclusion criteria for healthy subject : * male or female subject ≥40 years * absence of mvp or absence of mitral valve dystrophy * caucasian

Keywords: mitral valve prolapse echography genetic study study case-witness patients with a mitral valve prolapse
pharmacokinetics of carbapenem antibiotics in obese patients.

Conditions: Obesity

Summary: tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.

the purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the imp.

Eligibility criteria:
inclusion criteria: * hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs * bmi more or even 40 * written informed consent exclusion criteria: * bmi \< 40 * pregnancy or lactation in women * emergency surgery * history of serious allergy or intolerance to β-lactam antibiotics * systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry * ongoing intraabdominal infections * terminal illness * severe diseases of the liver, e.g. cirrhosis of the liver with alt or ast \> 6 x upper limit of normal (uln) and bilirubin \> 3 x uln * severe renal insufficiency with a creatinine clearance ≤30 ml/min. * neutrophil count \< 1000 cells/mm3 * platelets \< 75000 cells/mm3 * coagulation studies (inr) \> 1.5 x uln * ongoing chemotherapy and/or radiotherapy * ongoing therapy with valproin acid (in case of ertapenem administration).

Keywords: obesity pharmacokinetic ertapenem meropenem
chronic care management with wearable devices in patients prescribed positive airway pressure therapy (mpap) trial

Conditions: Obstructive Sleep Apnea

Summary: the goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). the main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. participants assigned to the delayed program will receive usual care while waiting for the program to begin.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio. our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote pap usage among patients with obstructive sleep apnea.

Eligibility criteria:
inclusion criteria: * prescribed pap therapy from the sleep center for \> 1 week * have an active profile in our center's resmed airview or respironics care orchestrator accounts for \> 1 week * non-adherent with pap therapy * willing to continue using current pap device for 28 days continuously * have an electronic device compatible with the wearable app exclusion criteria: * diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder * use home oxygen * unstable medical or psychiatric illness * planned non-use of pap therapy (e.g., waiting for replacement of recalled pap device) * planned surgery or hospitalization during study period * planned extensive travel during study period * history of repeated non-attendance at clinic visits

Keywords: wearable pulse oximetry sleep apnea treatment adherence
screening the patient for oral intake: applicability of the yale swallow protocol in patients across disease categories

Conditions: Oral Intake; Dysphagia; Swallow Difficulty

Summary: with 98 swallow screening tools already developed, dysphagia remains under-screened and undiagnosed. even for patients at high risk of oropharyngeal dysphagia (i.e., hospitalized aged, post-stroke, parkinson's disease, head and neck cancer, or those had ≥ 48 hours of endotracheal intubation), swallow screening is not systematically performed. nurses, as front-line providers, are bombarded with patients' dysphagia. we witnessed patients' subsequent poor outcomes, including delayed oral intake, dependence on the feeding tube, increased pneumonia, prolonged hospital length of stay, and increased in-hospital. despite many calls for nurses to perform bedside screens for timely management, there is a lack of census on what tools to use (98 available, many claimed to be valid) and whether nurses are capable of safely performing these screens, especially when facing across-disease patients. without a screening tool that is used universally across different diseases to assess whether patients can safely engage in oral intake, clinical healthcare professionals will face significant challenges in conducting the screening. meanwhile, we found the common, shared items, i.e., consciousness, voice/speech, coughing, oral motor movements, and water drinking tests or swallowing trials, are included in most swallow screening tools, suggesting these items are essential basics for oral intake safely. therefore, instead of creating a new screening tool, the aim of this study is to extract the common, shared items among existing swallowing screening tools and assemble them into a swallow screening protocol that can be administered by nursing staff for triage whether inpatient populations are at risk of unsafe for oral intake. after conducting a systematic review and assessing the quality, we found the yale swallow protocol was identified as a high-quality swallowing screening tool and was used for screening the risk of aspiration across diverse outpatients who were referred for further swallow assessment. however, whether the yale swallow protocol can be implemented in acute care settings to screen for "oral intake" requires further warranted for its applicability. therefore, this study aims to test the applicability (i.e., accuracy, responsiveness, time-spending, and safety) of the yale swallow protocol when used to screen for 'oral intake,' with speech therapists' evaluations serving as the reference standard for inpatients across various disease categories.


Eligibility criteria:
inclusion criteria: * hospitalized patients with any of the following conditions: (a) head-and-neck cancer, (b) stroke, (c) parkinson's disease, (d) post-extubated, and (e) aged above 65 years. * aged above 18 years. exclusion criteria: * patients will be excluded if they are (a) feeding-tube dependent (gastrostomy tube, nasogastric tube), (b) nil per os (npo), or (c) with airborne-transmitted diseases (e.g., open tuberculosis or sars).

Keywords: swallow dysphagia screening
optimizing fidelity of interpersonal psychotherapy

Conditions: Depression

Summary: the study is designed to develop and validate an instrument to measure quality and adherence to ipt for research and training purposes. the measure is now being used to evaluate training in ipt.

the study is a randomized trial comparing 4 different methods of follow-up training in ipt. following initial 2-day training, participant therapists will be randomized to either individual supervision, group supervision, an internet-based training program, or autodidactic training. participants will be followed for a year to determine their use of ipt, outcomes with patients, and adherence and quality of ipt in 4 case portfolios. the adherence measure for ipt developed in phase i of the project is being used as the gold standard measure of ipt fidelity.

Eligibility criteria:
inclusion criteria: * active and licensed therapist conducting psychotherapy treatment; naïve to training in ipt exclusion criteria: * inactive or not treating patients
early access of mk0518 in combination with an optimized background antiretroviral therapy (0518-023)

Conditions: HIV Infections

Summary: this is a treatment use study to provide early access to mk0518 for the treatment of hiv-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. enrollment in this study is patient driven. investigators are not proactively assigned. there is no target sample size and duration of the study is indefinite. for information on how to enroll in the study, see link below.


Eligibility criteria:
inclusion criteria: * hiv positive patients who have limited or no treatment options and have documented resistance exclusion criteria: * patient has previously been on mk0518 therapy
retrospective study of patients with type 2 diabetes mellitus on dapagliflozin therapy in taiwan

Conditions: Type II Diabetes Mellitus

Summary: retrospective study of patients with type 2 diabetes mellitus on dapagliflozin therapy in taiwan.


Eligibility criteria:
inclusion criteria: 1. outpatient equal to or more than 20 years of age. 2. t2dm patient initiated dapagliflozin after may 1st 2016 as a second line or third line oral anti-diabetic therapy, either as add-on or switching from one to another. or initiating dapagliflozin as adjunctive therapy for t2dm subjects treated with insulin. 3. completed follow-up of at least 6 months regardless of continuation on dapagliflozin therapy. 4. will provide completed and signed written informed consents. exclusion criteria: 1. subjects with a history of sglt2 inhibitor therapy other than dapagliflozin prior to baseline. 2. subjects with type 1 diabetes. 3. treatment with other investigational drugs concurrently during the retrospective data collection period.
diagnostic accuracy of optimized diffusion-weighted imaging for detecting anterior ischemic optic neuropathy

Conditions: Neuro-Ophthalmology

Summary: the patient presents to the ophthalmological emergencies and / or to the internal medicine department. noia clinical discovery patient referred in radiology for brain and visual mri. the two sequences added by the research (8 minutes) will be added to that of the treatment.


Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient with suspected noia, evoked after clinical examination by a specialized ophthalmologist * for which a brain and visual mri is planned * express consent to participate in the study * affiliate or beneficiary of a social security scheme exclusion criteria: * contraindication to mri (electrical device, metallic foreign body, claustrophobia) * patient benefiting from a legal protection measure * pregnant or breastfeeding woman
diagnostic of iron deficiency by means of non invasive measurement of zink protoporphyrin ix

Conditions: Iron-deficiency

Summary: znpp is being build in the case of a functional iron deficiency. zinc instead of iron is implemented into protoporphyrin ix. this zincprotoporphyrin (znpp) can be detected non invasively. non invasive and invasive optical measurement of znpp will be compared. additionally znpp measurements will be compared to other iron deficiency parameters for validation by the investigators.

zinc-protoporphyrin (znpp) will be measured by a fluorescence technique. restricted wave light (407/425 nm) is used to detect znpp in the bloodstream non-invasively through the oral mucosa. the spectroscopic measurements are translated into a znpp value (mumol/mol heme). the non-invasive measurement of znpp is validated and compared to optical measurement of znpp in whole blood and high performance liquid chromatography (hplc) measurement of znpp in whole blood. the znpp value is compared to other iron-deficiency parameters: ferritin, transferrin saturation and soluble transferrin receptor.

Eligibility criteria:
inclusion criteria: * patients seen preoperatively in the anesthestic clinic * patients \> 18 years of age * understood and signed patient consent exclusion criteria: * transfusion of blood products 8 weeks prior to screening * pregnancy * porphyria
ha35 acute alcohol study

Conditions: Healthy Controls

Summary: eligible subjects will be asked to take a placebo/treatment capsule for a total of 3 days and then participate in a study visit on the fourth day. this study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. the study will take approximately 3-4 hours and a designated driver will need to drive the participant home. on the fifth day, you will be asked to return to drop of the 24-hour urine collection.

interested subjects will be assessed for eligibility and a written informed consent will be obtained. the screening visit will consist of a medical exam, clinical labs (if not available in medical record), and questionnaires. those who pass the screening will be eligible for a baseline visit (may be combined with screening if appropriate labs are already done). the baseline visit will include collection of blood, urine, and stool samples, body composition measurements, and randomization into either ha35 or placebo groups. patients will be instructed to take the ha35 or placebo daily in the morning before breakfast 3 days prior to the day 4 visit. patients will be informed that they will need to have a driver that is known to them for the day 4 visit. in the morning of the day 4 visit, confirmation of a driver will occur prior to starting study procedures. during the day 4 visit, patients will have an acute ethanol challenge where they will need to consume 2ml/kg of vodka in 100ml of juice in under 60 minutes. muscle biopsies will be collected before and after the challenge and blood will be collected throughout the day. in addition, patients will be given lactulose/mannitol/sucralose/sucrose cocktail to measure gut permeability. the costs of any of these tests/procedures will not be billed to the patient and will be covered by the department. the participant will not be responsible for any costs.

Eligibility criteria:
inclusion criteria: * alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men * ability to understand and willingness to provide written consent exclusion criteria: * any known chronic illness including but not limited to cancer (except non-melanoma skin cancer) * poorly controlled diabetes (hemoglobin a1c \>9.5 g/dl) * untreated hyper/hypothyroidism * uncontrolled hypertension or hypercholesterolemia * end-stage renal disease * liver disease of any etiology * coronary artery disease or stroke * active intravenous drug use * history of gastric bypass * medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids) * pregnancy * past alcohol use disorder * abnormal clotting factors
the effect of vitamin a with and without zinc and multivitamin supplementation on malaria morbidity in ghanaian children

Conditions: Malaria

Summary: the aim of this study was to determine the effect of combining vitamin a (va), zinc (z) and multivitamins (mv- a, b1, b2, b6, b12, c, d and e) on malaria morbidity

a total of 542 children aged between 6-59 months received either: (i) va (control) or (ii) va \& z (vaz) or (iii) va, z \& mv (vazm). va was delivered as a single dose while mv and z were delivered daily. malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.

Eligibility criteria:
inclusion criteria: * under 5years * will stay in the community for 10years exclusion criteria: * chronic diseases

Keywords: malaria vitamin a zinc multivitamin
safety, pk and pd relationships of rls-0071 in patients with acute exacerbation of chronic obstructive pulmonary disease

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary: aecopd is a major cause of hospital admission and mortality. they contribute to long-term decline in lung function, physical capacity, and quality of life (qol). rls-0071 is a novel peptide being developed for the treatment of aecopd. this study is designed to evaluate the safety and tolerability of rls-0071 in the treatment of adults with moderate exacerbations of copd.

this is a randomized, double-blind, placebo controlled trial in hospitalized participants with acute exacerbation of chronic obstructive pulmonary disease (aecopd) to evaluate the safety, tolerability, preliminary efficacy, pk, and pd of rls-0071 compared to placebo in the treatment of aecopd. the dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. participants will be followed for efficacy and safety for 30 and 60 days after the final dose. rls-0071 or placebo will be given as add-on therapy to soc management for acute exacerbations of copd.

Eligibility criteria:
inclusion criteria: * hospitalized participants with a prior diagnosis of copd including spirometry within the prior year documenting a postbronchodilator fev1/fvc ≤ 0.7 and an fev1 ≤ 80%, and a clinician identified admitting diagnosis of aecopd: acute increase in dyspnea, sputum volume or purulence - without other attributable cause. * participants must have a moderate exacerbation of copd according to the rome guidelines * ≥ 10 pack-years smoking history. exclusion criteria: * endotracheal intubation or mechanical ventilation. * participants with severe exacerbation of copd according to the rome guidelines * participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status * interstitial lung disease. * current or prior history of asthma. * known hypersensitivity, allergy, or reaction to polyethylene glycol (peg) * preexisting autoimmune disease: history of autoimmune disease and/or use of chronic steroids of \>10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment * current renal dialysis or renal dialysis planned or anticipated in the next 7 days. * has confounding medical conditions, including: 1. diabetic coma, 2. uncontrolled new york heart association class iv congestive heart failure, 3. uncontrolled angina, 4. stroke or transient ischemic attack (tia) within 4 weeks before study entry, 5. clinically significant arrhythmias not controlled by medication, or 6. idiopathic pulmonary fibrosis, * has a weight \>120 kg at screening. * known pregnancy, a positive pregnancy test at screening, or lactation for wocbp. * has systemic immunosuppression/immune deficiency