Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficiency of a cognitive remedial program (procog-sep) designed for multiple sclerosis patients

Conditions: Cognitive Disorders; Multiple Sclerosis

Summary: cognitive disorders are well-known in multiple sclerosis (ms), even in earlier stages of the disease. they effect personal life. their management may be overlooked. the evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities. aim of the study is to evaluate the efficiency of the remedial program (procog-sep) designed for ms patients, compared to an interactive discussion program(disint) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period. main outcome criteria is evolution of srt-list before and after program.


Eligibility criteria:
inclusion criteria: * 18 ≤aged ≤ 60 at baseline * must be able to understand and read french language * must sign the informed consent form * must be affiliate to french social security * multiple sclerosis confirmed by mac donald criteria * edss ≤ 6.0 at baseline * duration of multiple sclerosis ≤ 30 years at baseline * mild cognitive disorder ( at least 2 cognitive tasks, at most 5 ) exclusion criteria: * under legal protection * treatment by corticosteroids in the past 4 weeks * cognitive remedial program already done * neuropsychologic assessment in the past 2 months * having an other chronic disease * having an other neurologic disease * alcohol or drug addiction

Keywords: cognitive disorders multiple sclerosis neuropsychology
screening of liver fibrosis using blood tests in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; NAFLD; NASH

Summary: non-alcoholic fatty liver disease (nafld) and non-alcoholic steatohepatitis (nash), are a frequent complication of type 2 diabetes and obesity. this disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). nafld is covered different liver damage in ascending order: steatosis, non-alcoholic steatohepatitis (nash), fibrosis, and finally cirrhosis. mostly, fibrosis has a determining role in the patient's status health. the fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. the purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes. to be sure of the status of the disease, the gold standard procedure remains liver biopsy. however, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with nafld. some alternative procedure exists, called fibroscan that gives some indication of liver fibrosis status. unfortunately, every diabetologist hasn't this equipment in his medical office. the investigators propose to evaluate two non-invasive biological fibrosis tests, called elift and fibrometer. the results of these two diagnostic tests will be compared to fibroscan and to liver biopsy results.


Eligibility criteria:
inclusion criteria: * age ≥ 40 years old, * type 2 diabetes mellitus for more than 6 months, * bmi \> 25 kg/m2, * waist circumference \> 94 cm (male) or 80 cm (female). * patient benefiting from a social security system. exclusion criteria: * medical follow up for liver disease, * decompensated cirrhosis, * health status that does not allow the participation of the patient, * hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute coronary syndrome,... * hba1c \> 11,0 %, * pregnancy. * patient under guardianship or curatorship or protection of justice * involvement refusal.

Keywords: nash nafld fibrosis cirrhosis type 2 diabetes mellitus
benefits of pulmonary rehabilitation in patients with severe lymphangioleiomyomatosis (lam)

Conditions: Lymphangioleiomyomatosis; LAM; Pulmonary Rehabilitation

Summary: data from patients with the orphan disease of lymphangioleiomyomatosis (lam) which performed a pulmonary rehabilitation program will be analyzed retrospectively. data will be taken from the internal data base of the reference center (schoen klinik berchtesgadener land, schoenau, germany) where these data were collected during clinical routine. data will be included from the year 2000 until now. a retrospectively matched copd cohort will be included for comparison.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of lymphangioleiomyomatosis * performed a pulmonary rehabilitation program at the reference center exclusion criteria: * missing data * repeated stay for pulmonary rehabilitation at the reference center
protective brace to prevent hand and arm injuries

Conditions: Cumulative Trauma Disorders; Carpal Tunnel Syndrome

Summary: when people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. people who frequently use hand-held power tools may develop injuries related to this vibration. this study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.

workers who use hand-held power tools absorb significant vibration energy in their arms and hands and may develop musculoskeletal disorders (msds) such as carpal tunnel syndrome and hand-arm vibration syndrome. protective braces may be worn to decrease the incidence of occupational msds. the national institute for occupational safety and health has identified key attributes for protective braces; these attributes include vibration damping, comfort, non-interference with worker dexterity, and maintenance of safe hand temperature. most currently available braces do not adequately address these niosh requirements. this study will evaluate the efficacy of a brace with piezoelectric damping material. participants in the study will be fitted with a brace on each hand. one brace will have piezoelectric damping material and the other will be a currently available, off-the-shelf commercial brace. hand-held joysticks and handles mounted to a vibration shaker table will be used to simulate power tool use. participants will undergo a series of tests designed to measure hand acceleration and vibration while grasping the study joysticks and handles. the tests will take approximately 30 minutes.

Eligibility criteria:
inclusion criteria: * normal hand anatomy and full range of motion exclusion criteria: * history of significant hand or wrist arthritis * open wounds * prior hand or wrist surgery * neuropathies * skin hypersensitivity * contact dermatitis * reflex sympathetic dystrophy

Keywords: repetitive strain injuries vibration damping protective brace piezoelectric smartwear
lithotripsy and analgesia with 3d hypnosis mask

Conditions: Renal Calculi; Pain

Summary: the study is a randomised trial of hypnosis with 3d virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.

the study is for patients undergoing shock wave lithotripsy in outpatient surgery unit. it is proposed that using hypnosis with 3d virtual reality headset will reduce the requirements for intravenous remifentanil in a randomised controlled trial of one hundred and six patients. remifentanil is an opioid commonly used for lithotripsy. shock wave lithotripsy is a commonly performed procedure associated with moderate pain and anxiety, in outpatient surgery unit. opioids can cause unfavourable side-effects, most notably respiratory depression, sedation, nausea and vomiting it is expected that by using 3d virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil. the study will measure the dose of remifentanil required by patients randomised to receive either hypnosis with 3d virtual reality headset (intervention) or no hypnosis and no 3d virtual reality headset (control group). patients will be followed up prior to hospital discharge to assess their remifentanil use and pain, anxiety, comfort and their satisfaction with 3d virtual reality headset. this new device is a non-pharmacological adjunct and can reduce pain intensity during procedure, reduce opioid use and length of stay in hospital and improve the patient experience whilst potentially reducing complications of intravenous opioid. this study findings will be of interest for patients involved in surgery or investigative procedures normally carried out with intravenous opioids or sedation.

Eligibility criteria:
inclusion criteria: - shock wave lithotripsy and outpatient surgery exclusion criteria: * epilepsy * deafness, blindness * schizophrenia, hallucinations * no french-speaking * autistic * motion sickness

Keywords: therapeutic virtual reality hypnosis
healthy living for you

Conditions: Diabetes

Summary: the goal of the study is to conduct the healthy living with diabetes (hlwd) program among black individuals in a culturally appropriate manner. this study will involve 24-30 participants in total. participants can expect to be on study for approximately 6 months.

the study objectives are to recruit and empower black healthy living with diabetes (hlwd) facilitators to deliver culturally tailored hlwd content and pilot the culturally tailored hlwd program, using the re-aim framework and proctor implementation outcomes to gather preliminary implementation data. the study team will partner with stakeholders and community organizations serving black adults, including grace fellowship church and ymca of metropolitan milwaukee. the central hypothesis is that the cultural tailoring of hlwd will increase the reach, adoption, implementation, and effectiveness of hlwd among black adults. the study aims are: 1. co-design a culturally relevant approach to the recruitment and training of black hlwd facilitators. the study team will partner with a stakeholder advisory board including: * (1) black adults with diabetes (prior hlwd participants) * (2) black community leaders * (3) current black hlwd facilitators, and * (4) current hlwd program providers (organizational leaders in settings delivering hlwd to black adults) to co-design: (a) an asset-based approach to recruiting black facilitators and (b) an adjunct training that empowers the facilitator to use a culturally relevant approach to deliver hlwd content to black adults. 2. implement the culturally tailored hlwd program among black adults. using a mixed methods design, the investigators will assess recruitment/retention rates among black adults (reach), feasibility of adoption among facilitators and program providers (adoption), participant adherence, fidelity of enactment and acceptability, fidelity of program delivery by facilitators (implementation), and pre-post impact on diabetes outcomes (effectiveness).

Eligibility criteria:
inclusion criteria: * self-identify as black/african american * have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes exclusion criteria: -

Keywords: diabetes self-management cultural tailoring healthy living with diabetes
trial in adult subjects with spinocerebellar ataxia

Conditions: Spinocerebellar Ataxias; Spinocerebellar Ataxia Genotype Type 1; Spinocerebellar Ataxia Genotype Type 2; Spinocerebellar Ataxia Genotype Type 3; Spinocerebellar Ataxia Genotype Type 6; Spinocerebellar Ataxia Genotype Type 7; Spinocerebellar Ataxia Genotype Type 8; Spinocerebellar Ataxia Genotype Type 10

Summary: the primary purpose of this study is to compare the efficacy of bhv-4157 (troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in subjects with spinocerebellar ataxia (sca).

the study was conducted in 2 phases: randomization phase (8 weeks) followed by an open-label extension phase (48 weeks). during the randomization phase, participants received either troriluzole 140 mg or matching placebo up to 8 weeks. participants who agreed to enter the extension phase continued dosing of troriluzole 140 mg for 48 weeks. the study was subsequently amended to follow participants for a total of 192 weeks in the extension phase.

Eligibility criteria:
key inclusion criteria: * subjects with a known or suspected diagnosis of the following specific hereditary ataxias: sca1, sca2, sca3, sca6, sca7, sca8 and sca10 * ability to ambulate 8 meters without assistance (canes and other devices allowed) * screening total scale for the assessment and rating of ataxia (sara) score ≥8 * score of ≥ 2 on the gait subsection of the sara * determined by the investigator to be medically stable at baseline/randomization and must be physically able and expected to complete the trial as designed key exclusion criteria: * any medical condition other than one of the hereditary ataxias specified in the inclusion criteria that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia * mini mental state exam (mmse) score \< 24 * sara total score of \> 30 points at screening * clinical history of stroke * active liver disease or a history of hepatic intolerance to medications that in the investigator's judgment, is medically significant

Keywords: spinocerebellar ataxia sca
safety and efficacy of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination tablet with ribavirin for 12 weeks in treatment-naive adults with chronic hcv genotype 3 infection

Conditions: Hepatitis C Virus Infection

Summary: this study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination (fdc) plus ribavirin (rbv) in treatment-naive adults with chronic genotype 3 hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * chronic genotype 3 hcv infection * hcv treatment-naive * hcv rna \> 10,000 iu/ml at screening * absence of cirrhosis or compensated cirrhosis * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male key exclusion criteria: * pregnant or nursing female or male with pregnant female partner * coinfection with hiv or hepatitis b virus (hbv) * current or prior history of clinical hepatic decompensation * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hcv genotype 3 (gt-3) hcv sustained virologic response direct acting antiviral gs-7977 gs-5885 ribavirin sofosbuvir ledipasvir hepatitis c hepatitis c, chronic
safety and feasibility of a novel device for assessing respiratory function in children

Conditions: Asthma in Children

Summary: this is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma). there is no product currently on the market that is comparable to this novel leo device the study consists of a single visit to evaluate the feasibility and safety of using the leo device on 20 children with clinically stable asthma. stable asthmatic children between the age of 3 and 6, inclusive, will be recruited. there will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.


Eligibility criteria:
inclusion criteria: * children aged ≥3 years old and ≤18 years old at time of consent * children with a legal guardian able to sign consent for study participation * children and caregivers able to read and understand english or spanish * investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma * children who are able to follow instructions and complete oscillometry and tidal breathing tasks exclusion criteria: * - children \ 18 years of age * adults (age ≥ 18 years) * children with complex medical conditions which may hinder their ability to complete protocol assessments * children who do not have a legal guardian to sign informed consent form * children with an active skin condition involving the area on the chest wall where the leo device will be attached. e.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment * child is determined not eligible by the assessment of the pi * fever within the 4 weeks prior to enrollment * children with any implanted medical devices, e.g. cardiac pacemaker * children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the leo device * children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.
reminders for incentive spirometry in pacu (remind-is in pacu)

Conditions: Postoperative Atelectasis; Postoperative Hypoxemia; Postoperative Pneumonia; Postoperative Pulmonary Complications; Patient Adherence; Incentive Spirometry; Respiratory Therapy; Respiratory Insufficiency

Summary: the purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the post-anesthesia care unit (pacu) increases with visual and auditory electronic reminders, as compared to not having those reminders.

this is a pragmatic single-center alternating cluster study. we will enroll adult patients who require general anesthesia for surgery and receive an incentive spirometry device during their pacu stay. automatic alarms to perform incentive spirometry will be set to either "on" or "off" in alternating weeks. the hypothesis is that patients receiving automatic audible and visual alarms will have increased rates of adequate incentive spirometry breaths compared to patients receiving no alarms.

Eligibility criteria:
inclusion criteria: * be 18 years or older; * have undergone a surgical procedure at the university of colorado hospital under general anesthesia; * have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff; * not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the insee monitor. exclusion criteria: * have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the insee monitor; * have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device); * are a part of a vulnerable population (e.g., pregnant, minors, prisoners).

Keywords: incentive spirometry postoperative pulmonary complications postoperative standard-of-care standard-of-care after surgery deep breathing patient reminders
pilot study of the effect of baclofen and bromocriptine on luteinizing hormone secretion in pubertal children

Conditions: Growth Disorders

Summary: objectives: i. evaluate the effect of bromocriptine on luteinizing hormone (lh) secretion by suppression of prolactin and stimulation of dopaminergic receptors in early pubertal boys and girls. ii. evaluate the effect of baclofen on lh secretion by stimulation of gamma-aminobutyric acid receptors in early pubertal boys and girls.

protocol outline: participants receive bromocriptine or baclofen followed by nocturnal measurements of luteinizing hormone, growth hormone, and sex steroids. pituitary reserve is evaluated with the administration of gonadotropin-releasing hormone, and in children undergoing assessment of short stature, standard provocative stimuli.

Eligibility criteria:
* short stature and/or constitutional growth delay * no epilepsy or risk of epilepsy

Keywords: constitutional growth delay endocrine disorders rare disease
a single-center observational study on the impact of symptom assessment timing on the short-term efficacy of 5-asa therapy in patients with initial-onset or relapsed mild-to-moderate active ulcerative colitis

Conditions: Ul

Summary: this study aims to collect the relevant clinical examination results of patients during the 5-asa treatment period through opportunistic sampling of patients with mild to moderate active ulcerative colitis (uc). the study compares the impact of the time nodes of the first assessment (4th, 8th, and 12th weeks) on the short-term efficacy of 5-asa. by integrating the dynamic changes of symptom scores and related biomarkers, the study clarifies the time trajectory of symptom relief in patients with mild to moderate uc, identifies the characteristics of early responders and non-responders, and further explores the association between baseline clinical features and treatment responses, thereby assisting in individualized treatment decisions.


Eligibility criteria:
inclusion criteria: 1. according to the diagnostic criteria of the china's 2023 consensus opinion on the diagnosis and treatment of inflammatory bowel disease, the disease status is newly diagnosed ulcerative colitis (uc) or mild to moderate active uc with remission followed by recurrence (modified mayo score 3-10 points); 2. age: 18-59 years old; 3. the attending physician will propose an oral mesalazine or an oral w/ topical mesalazine combined treatment plan based on the patient's condition; 4. patients who are abble to and are willing to comply with the research protocol can provide a signed and dated written informed consent form. exclusion criteria: 1. use any form of hormone within the past 14 days; 2. have received immunosuppressive therapy within the past 90 days; 3. have used infliximab, adalimumab, or vedolizumab within the past 60 days; 4. have taken anti-diarrheal drugs within the past 3 days; 5. have participated in any clinical trial within the past 3 months; 6. allergic to mesalazine or salicylic acid preparations (except sulfasalazine), including severe adverse reactions, liver and kidney diseases, heart and lung diseases, malignant tumors, etc.; 7. have had severe liver and kidney diseases, heart and lung diseases, hematological diseases and pancreatic diseases in the past; 8. pregnant or lactating women; 9. patients who have withdrawn their informed consent.

Keywords: ulcerative colitis 5-aminosalicylic acid symptom assessment timing observational study
absorption, metabolism, and excretion (ame) study of [14c]edp-938 in healthy male subjects

Conditions: Respiratory Syncytial Virus (RSV)

Summary: a phase 1, open-label study of the absorption, metabolism, and excretion of a single oral dose of \[14c\]edp-938 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * males of any ethnic origin, between 18 and 55 years of age, inclusive. * able to comprehend and willing to sign an informed consent form * in good health, determined by no clinically significant findings from medical history, physical examination (check-in only), 12-lead ecg, vital signs measurements, and clinical laboratory evaluations exclusion criteria: * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * history of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). a. subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded. * donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening. * a body surface area-adjusted estimated glomerular filtration rate (egfr) ≤ 90 ml/min per 1.73 m2 according to the chronic kidney disease epidemiology collaboration (ckd-epi) equation, at screening

Keywords: ame study