Kornimate/medical-research-clean huggingface dataset:
utility of novel braf test for melanoma

Conditions: Melanoma

Summary: this primary purpose of this study is to obtain blood samples from participants with both early and later stages of melanoma (stage ii/iii and stage iv). the researchers hope to better understand an abnormal protein found in many melanoma tumors called the brafv600 mutation. there will be two separate cohorts (groups) of participants on this study. you will be placed in one of the groups. group 1-for participants with advanced melanoma: your existing tumor tissue sample will be compared to the blood samples given in order to further analyze and to understand the brafv600e gene mutation. group 2-for participants with stage ii/iii melanoma: following surgery, blood samples will be collected and analyzed. understanding the brafv600e gene mutation in melanoma will help the researchers better understand the disease, and help plan treatment options for people with melanoma of all stages in the future.

there will be no extra clinic visits for this study. these research blood samples will be drawn at the same time as your regularly scheduled blood draws that are part of standard care for melanoma. about 2 to 4 teaspoons of blood will be drawn for each research sample. depending on which group you are in, you will have either a one time blood draw or ongoing blood work for 1-2 years.

Eligibility criteria:
inclusion criteria: * biopsy proven advanced (unresectable stage iiic or stage iv)or high risk (stage ii or stage iii) malignant melanoma exclusion criteria: * history of a different malignancy except for the following circumstances: disease-free for at least 2 years and deemed by the investigator to be at low risk for recurrence; or non-metastatic prostate cancer, cervical cancer in situ and basal cell or squamous cell carcinoma * known history of a different braf mutant malignancy

Keywords: biomarker braf blood-based
quality of sexual life of prep users

Conditions: HIV Pre-exposure Prophylaxis Use; Adult

Summary: the study will recruit participants on the occasion of their visit in a sexual health center or another hiv pre-exposure prophylaxis (prep) facility in france. prep users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that prep has an impact on the quality of sexual life.

prep aims to protect against hiv; more broadly, prep is a holistic process, addressing vaccination (hepatitis a, hepatitis b, human papillomavirus, mpox), sexually transmitted infection diagnosis, mental health, issues related to psychoactive substance use, etc. this process is likely to impact not only "classical" health areas, but also fields concerning more widely the quality of life. in particular, the investigators emit the hypothesis that prep is associated with an increase of the quality of sexual life. the investigators have therefore designed a study based on a self-administered anonymous questionnaire to explore how prep user evaluate their quality of sexual life and how they perceive the impact of prep on this topic. adult prep users will be recruited through billboard in sexual health center or another prep facility in france. a qr (quick response) code will be displayed, giving access to the questionnaire. participation to the study is limited to fill once the questionnaire.

Eligibility criteria:
inclusion criteria: * current prep use * adult exclusion criteria: * unwilling to participate

Keywords: prep (hiv pre-exposure prophylaxis) quality of life sexual life
a multiple dose study of pf-04620110 in healthy overweight or obese subjects

Conditions: Healthy

Summary: pf-04620110 is a novel compound proposed for the treatment of type 2 diabetes mellitus. the primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of pf-04620110.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years * body mass index (bmi) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Keywords: multiple dose study in overweight healthy subjects body weight
national survey on infiltrative breast cancer

Conditions: Infiltrative Breast Cancer

Summary: the purpose of this observational study is to describe radiological, clinical and histological characteristics of women with infiltrative breast cancer.


Eligibility criteria:
inclusion criteria: * women\> or = 18 years old * women with newly diagnosis of infiltrative breast cancer * agree to take part in this study exclusion criteria: * women with other malignant tumor (except in situ cervical carcinoma or treated basal cell carcinoma) * women with in situ ductal carcinoma or in situ lobular carcinoma

Keywords: infiltrative breast cancer-clinical practice women with infiltrative breast cancer
characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis

Conditions: Myasthaenia Gravis

Summary: the goal of this observational study is to learn about the characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis. the main question it aims to answer is: does diaphragmatic ultrasound predict prognosis of myasthenia gravis in six months? participants diagnosed as myasthenia gravis will take the diaphragm ultrasound examinations.


Eligibility criteria:
inclusion criteria: * 1: patients who seek treatment at the first affiliated hospital of chongqing medical university and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors 2: serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins 3: repeated electrical stimulation examination showed a decrease in wave amplitude. exclusion criteria: * 1: patients with lung disease or heart failure, or a history of non-invasive ventilator or tracheotomy
the risk factors of cardiovascular disease in elderly diabetic patients: a prospective cohort study

Conditions: Diabetes Mellitus; Cardiovascular Diseases; Complication Diabetic

Summary: in the previous cohort studies focused on diabetes in china, there were few studies on elderly patients with diabetes. the aim of this prospective cohort study was to investigate the prevalence, management and nutritional status of elderly diabetic patients aged ≥65 years in shanghai and suzhou communities, and record the occurrence of endpoint events.

this is a multicenter, observational, prospective cohort study.we plan to collect the baseline information in three years, and follow up every two years for at least 10 years. the study will enroll 5000 elderly diabetic patients aged ≥65 years and be conducted in shanghai and suzhou. the primary outcomes include mace(major adverse cardiovascular events) , all-cause mortality, and chronic complications of diabetes and so on.

Eligibility criteria:
inclusion criteria: * men or women aged 65-100 years old; * patients who had been diagnosed with diabetes mellitus. exclusion criteria: * patients with psychiatric disorders or impaired cognitive function; * patients who cannot or reject to sign the consent form.
identification of the genetic causes of rare diseases with negative exome findings

Conditions: Rare Diseases; Genetic Predisposition to Disease

Summary: the genome + project will enroll patients (n = ca. 100) and their healthy parents with unclear molecular cause of the disease, suspected genetic cause of the disease and previous detailed molecular analysis like whole exome sequencing (wes) did not lead to the identification of the disease causing mechanism. as well healthy parents of those affected for trio analysis (exception of one parent is not available for the study).

in the genome+ study (monocentric, prospective, open-label diagnostic study), patients with molecularly undiagnosed diseases will diagnostically be analyzed by means of omics technologies or re-analyzed using existing datasets. the following questions will be leading the study: primary: • identification of the molecular causes of unclear rare diseases secondary: * improve number of diagnoses for patients with rare diseases * further characterization of the identified putative disease causes * increase number of patients receiving appropriate therapy after successful diagnosis. in addition, healthy parents of the subjects may be included in the study to perform parent-child (trio) analyses. in addition, phenotype and omics data will be shared within the university hospital tübingen, germany and with external collaborators to improve the diagnostic rate of the patients included in the study. storage of blood or tissue samples is not primary goal of this project, but may be necessary for further analyses.

Eligibility criteria:
inclusion criteria: * unclear diagnosis * suspected genetic cause of the disease * previous detailed molecular analysis like whole exome sequencing (wes) did not lead to the identification of the disease causing mechanism * healthy parents of those affected for trio analysis (exception of one parent is not available for the study) exclusion criteria: * missing informed consent of the patient and her/his parents

Keywords: rare diseases genetic predisposition whole exome sequencing whole genome sequencing (wgs) wgs-trio analysis
clinical performance of existing wearers of avaira sphere following a refit with clariti elite sphere

Conditions: Myopia

Summary: the aim of this dispensing study is to evaluate the clinical performance of existing wearers of avaira sphere lenses following a refit with clariti elite sphere over 4 weeks of daily wear.

this is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual avaira sphere lenses following a refit with clariti elite sphere lenses. subject's habitual avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of clariti elite sphere lenses for 4 weeks of daily wear. after the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years * is an adapted avaira sphere contact lens (cl) wearer (at least 1 week in avaira sphere) * has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive) * has a spectacle cylinder up to 0.75d in each eye. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter. * patient contact lens refraction should fit within the available parameters of the study lenses. * is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * is willing to comply with the visit schedule exclusion criteria: * is not a habitual wearer of avaira sphere lenses * has a contact lens prescription outside the range of the available parameters of the study lenses. * has a spectacle cylinder ≥1.00d of cylinder in either eye. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has contact lens best corrected distance vision worse than 20/25 (0.10 logmar) in either eye. * presence of clinically significant (grade 2-4) anterior segment abnormalities * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
comparison of the accuracy of different periodontal probes for peri-implant pocket registration

Conditions: Peri-Implantitis; Peri-implant Mucositis

Summary: various types of periodontal probes (e.g., metal probes, plastic/bendable probes, electronic periodontal probes) are used for peri-implant pocket depth registration; however, depending on the shape and size of the prosthetic restoration an accurate peri-implant pocket registration might be impeded with standard metal probes. there is currently no systematic assessment of which probe is more accurate in peri-implant pocket registration. therefore, peri-implant pocket registration of 50 patients with a screw-retained prosthetic restoration will be recorded with 3 different periodontal probes; i.e., with a metal probe, with a plastic probe, and with an automatic periodontal probe, before and after removal of the prosthetic restoration.


Eligibility criteria:
inclusion criteria: * screw-retained prosthetic implant restoration exclusion criteria: - cemented prosthetic implant restoration
covid-19, post-acute sequelae of sars-cov-2 infection (pasc) and influenza treatment system with machine learning

Conditions: COVID-19; Post-COVID-19 Syndrome; Influenza

Summary: this is an open-tabled, one-arm observatory trial to assess the effectiveness and safety of the autonomous treatment system based on machine learning in patients with covid-19, post-acute sequelae of sars-cov-2 infection and influenza.

this study has enrolled 27 patients diagnosed with covid-19, post-acute sequelae of sars-cov-2 infection, and influenza. of these patients, 26 are outpatients, and 1 is hospitalized. after screening based on the inclusion and exclusion criteria, eligible patients will receive prescriptions recommended by the autonomous treatment system based on machine learning in this observational trial. the objectives of this study are: 1. to compare the classifications made by our machine learning system with those by physicians to assess the model's reliability and accuracy; 2. to evaluate covid-19-related hospitalizations or deaths from any cause through day 28; 3. to determine if the machine learning system's recommended prescription alleviates symptoms of covid-19, post-acute sequelae of sars-cov-2 infection, and influenza; 4. to monitor participants who tested positive for the covid-19 for 28 days after initiating treatment, looking for potential rebound cases. participants will use an online application to receive the recommended prescription results and will forward these results to a physician for verification. patients are instructed to complete the online analysis every 3 days or whenever their symptoms change, whichever comes first. they are also asked to adhere to the prescribed medication regimen. research physicians will conduct follow-ups with patients every 3 days via phone calls. the potential treatments patients may receive include any of the following traditional chinese medicine formulas: lizcovidcure-1, lizcovidcure-2, lizcovidcure-3, lizcovidcure-4, and lizcovid-5.

Eligibility criteria:
inclusion criteria: * either male or female (14 years or older), and their covid-19 vaccination status was not a factor for inclusion. * subjects with any high-risk conditions * subjects with positive sars-cov-2 rapid antigen results in 30 days * subjects with post covid-19 syndrome exclusion criteria: * pregnant individuals * subjects with known histories of allergic reactions to medical herbs commonly used in traditional chinese medicine (tcms)
single radiolabeled dose study to investigate the absorption, metabolism and excretion of [14c]-etc-1002

Conditions: Hyperlipidemia

Summary: this phase 1 study will assess the mass balance recover of carbon-14 (14c) labelled etc-1002 and the routes and rates of excretion of \[14c\]-etc-1002


Eligibility criteria:
inclusion criteria: * healthy male volunteers * bmi 10-35 kg/m2 exclusion criteria: * hx of cv, renal, hepatic, chronic respiratory or gi disease * hx of drug or alcohol abuse * smoking within 12 mos of screening
the evaluation of the safety and the efficacy of transanal total mesorectal excision

Conditions: Rectal Cancer

Summary: the purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. transanal visualization will be using endoscopy. at the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility criteria:
inclusion criteria: * age: 20-80 years * biopsy-proven adenocarcinoma of the rectum * clinical staging, (t1 or t2 or t3) with n0m0 * rectal cancer located 4-12 cm from the anal verge * ecog performance status 2 or less exclusion criteria: * synchronous colon cancer or other malignancy * obstructing rectal cancer * pregnant or breast-feeding * receiving any other study agents * fecal incontinence * history of prior colorectal cancer or inflammatory bowel disease * bmi \> 30 * t3 rectal cancer not treated preoperatively with full-course chemoradiation

Keywords: rectal neoplasms colorectal neoplasms transanal surgery
monpsy&moi: a digital platform for collecting patient-reported experience and outcome measures in psychiatry

Conditions: Schizophrenia Disorders; Bipolar Disorders; Major Depression

Summary: mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. despite their impact, patient-reported experience measures (prems) and outcome measures (proms) are underutilized in psychiatry. monpsy\&moi®, a digital platform funded by atih and dgos, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across france. the study consists of two stages: stage 1 (no feedback): monpsy\&moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. objectives include assessing implementation feasibility, validating adaptive questionnaires (premium), and identifying predictors of patient outcomes, such as relapse and healthcare utilization. stage 2 (with feedback): focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). this stage evaluates the impact of providing prems/proms feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes. monpsy\&moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. it also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. the platform integrates with national healthcare databases (snds) to enhance data analysis and predict patient trajectories. the study will involve over 22,000 participants in stage 1 and 1,100 participants in stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. results aim to demonstrate the feasibility, acceptability, and efficacy of monpsy\&moi® in improving mental health outcomes and guiding national psychiatric care policies. by empowering patients and clinicians with actionable insights, monpsy\&moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings


Eligibility criteria:
inclusion criteria: * residing in france. age between 18 and 65 years at the time of inclusion. receiving care in one of the 12 participating psychiatric facilities, with a confirmed diagnosis of: schizophrenia spectrum disorders (e.g., schizophrenia, schizoaffective disorder). bipolar disorders. major depressive disorders. a valid email address. ability to read and understand french. non-opposition to participating in the study (based on informed consent). exclusion criteria: * primary diagnosis of an organic mental disorder, including: dementia. stroke. traumatic brain injury. individuals deprived of liberty by judicial decision (e.g., incarcerated patients).
is there a correlation of natriuretic propeptide type b with an intraoperative low cardiac output?

Conditions: Cardiac Surgery; Low Cardiac Output; Natriuretic Peptide B

Summary: low output syndrome is a common complication in patients undergoing cardiac surgery. its incidence was reported to be 2 to 6%. morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.natriuretic propeptide type b (nt-probnp) is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after cardiac surgery. cardiac index and nt-probnp will be correlated with morbidity and mortality. a critical threshold value for intraoperative cardiac index and nt-probnp will be calculated.

low output syndrome is a common complication in patients undergoing cardiac surgery. its incidence was reported to be 2 to 6% \[1\]. in patients suffering from low output syndrome cardiac output is severely reduced due to myocardial failure. among other reasons for myocardial failure, ischemia, insufficient myocardial protection during aortic cross-clamping, and severely reduced ventricular function prior surgery are the most common risk factors for low output syndrome. low output syndrome is treated with positive inotropic drugs and mechanical assist devices \[2\]. morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense. if cardiac output cannot be increased cardiac failure persist and vital organs are hypoperfused. critical and prolonged hypoperfusion results in single and multi organ failure. until today a definite threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy is not completely known. cardiogenic shock is diagnosed by clinical signs and it is not diagnosed by cardiac output or cardiac index. the critical value for a severely reduces cardiac index was reported to be in a range of 1.75 to 2.5l/min/m² \[3-5\]. natriuretic propeptide type b (nt-probnp) is a biological marker for the diagnosis, prognosis and therapy of cardiac failure after cardiac surgery \[6,7\]. the primary objective of this prospective observational study in 150 patients undergoing cardiac surgery with an intraoperative measured cardiac output \<2l/min/m² is to monitor nt-probnp for 7 days. cardiac index and nt-probnp will be correlated with morbidity and mortality \[8\]. a critical threshold value for intraoperative cardiac index and nt-probnp will be calculated.

Eligibility criteria:
inclusion criteria: * adult patient undergoing cardiac surgery * written informed consent * cardiac index before cardiopulmonary bypass \<2l/min/m² exclusion criteria: * missing consent * serum creatinine \>1.5mg/dl \[\>123µmol/l\]

Keywords: cardiac surgery low cardiac output natriuretic peptide b mortality morbidity