Kornimate/medical-research-clean huggingface dataset:
rehabilitation for functional memory symptoms after concussion

Conditions: Mild Traumatic Brain Injury; Functional Neurological Disorder

Summary: this study aims to evaluate the feasibility of novel cognitive behavioural therapy (cbt)-based intervention designed to improve functional memory symptoms after concussion. participants will be randomized to cbt or an attention-matched control intervention (cognitive rehabilitation). the primary outcomes for this trial are feasibility metrics, including recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention.

background: although objectively measurable memory impairments typically resolve within weeks after sustaining a concussion, many people continue to perceive memory problems one year later. there are no known effective treatments for this condition. a promising new approach may be to target psychological mechanisms that perpetuate excessively negative perceptions of memory ability. methods: a pilot randomized controlled trial to evaluate the feasibility of a new cognitive behavioural therapy (cbt)-based treatment program specifically designed to improve persistent memory complaints after concussion. the main inclusion criteria will be (i) concussion in the past 6 to 24 months, (ii) research diagnosis of functional cognitive disorder. participants will be randomized (1:1) into one of two groups: cbt or cognitive rehabilitation. individuals in both groups will participate in 11 x 50-minute sessions delivered over zoom videoconference, co-facilitated by clinical psychology graduate students under the supervision of a registered clinical psychologist. aims: to evaluate the feasibility and potential efficacy of cbt for functional memory symptoms after concussion. approach: prespecified feasibility criteria on recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention will determine the success of the pilot trial. the investigators further hypothesize that cbt will be associated with greater reductions in memory concern compared to the control intervention. implications: the results of this pilot study will inform a larger, more definitive clinical trial focused on testing efficacy.

Eligibility criteria:
inclusion criteria: * age 18-65 years old * fluent in english * have regular access to the internet * sustained a concussion according to the world health organization neurotrauma task force definition between 6 and 24 months ago * meet diagnostic criteria for functional cognitive disorder exclusion criteria: * performance validity test failure * unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.), * unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year) * probable alcohol or drug use disorder * taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate) * contraindication(s) for mri

Keywords: concussion functional cognitive disorder
new markers of glycation to predict gestational diabetes mellitus and macrosomia.

Conditions: Macrosomia, Fetal; Gestational Diabetes Mellitus in Pregnancy

Summary: gestational diabetes mellitus (gdm) increases the risk of macrosomia and other adverse pregnancy outcomes. screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. the objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to hba1c (reference) as predictors of gdm, macrosomia and other adverse outcomes, in pregnant women.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea) 3. gestational age at inclusion \<28 weeks of amenorrhea 4. participant affiliated with or beneficiary of a social security scheme 5. collection of patient consent. exclusion criteria: 1. gestational age at inclusion ≥ 28 weeks of amenorrhea 2. multiple pregnancy 3. known diabetes prior to pregnancy 4. history of bariatric surgery 5. expected delivery in another maternity unit not participating in the study 6. person deprived of liberty by judicial or administrative decision 7. guardianship or curatorship 8. participant not affiliated or not benefiting from a social security scheme.

Keywords: skin autofluorescence glycated albumin, hba1c glycation biomarkers macrosomia gestational diabetes mellitus
a non-interventional study of rayos in adult patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the overall objective of the study is to assess the effectiveness of switching from immediate-release prednisone (conventional) therapy to delayed-release prednisone (rayos) in patients with moderately to severely active rheumatoid arthritis (ra), managed according to standard of care in clinical practice settings.

adult rheumatoid arthritis (ra) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. once entered, participant baseline data were captured and they were switched to delayed-release prednisone and followed for approximately 12 weeks. study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and in general good health (investigator discretion) with a recent stable medical history other than related to ra disease activity * ra diagnosis is ≥ 6 months according to acr and/or eular classification criteria for diagnosis of active ra * morning stiffness duration of at least 45 minutes at study entry * ra disease activity as defined by das28 of ≥ 3.2 at study entry * currently receiving conventional immediate-release prednisone ≥ 2.5 milligram (mg) every morning and previously agreed to switch to rayos * willing and able to sign an informed consent form (icf) exclusion criteria: * patient is unwilling to participate in the non-interventional study

Keywords: ra delayed-release prednisone immediate-release prednisone non-interventional
photobiomodulation protocols in the analgesia of chemotherapy-induced oral mucositis in children

Conditions: Mucositis Oral

Summary: chemotherapy-induced oropharyngeal mucositis (om) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia. photobiomodulation (pbm) by low level laser therapy (lllt), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. available pediatric studies highlighted positive/promising results of pbm with excellent safety and no adverse effects. nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines. considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two pbm protocols with same pbm parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced om of who grade 2 or higher.


Eligibility criteria:
inclusion criteria: 1. male or female children aged ≥ 3 years and \< 18 years. 2. hospitalization in an oncology or hematology department in the participating centres. 3. patients with oropharyngeal mucositis of grade 2 or higher (who grading system) related to cancer chemotherapy, including conditioning for hematopoietic stem cell transplantation (hsct). 4. written informed consent of both patient's holders of parental authority, and patient's assent when applicable. 5. patients affiliated to a french social security insurance or equivalent social protection. 6. absence of any physical or psychological disability that may interfere with the lllt application. exclusion criteria: 1. patients with a solid cancer lesion in the area of low-level laser application. 2. history of cervicofacial radiotherapy. 3. application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization. 4. hyperthyroidism defined by tsh \< 0.4 iu/ml at inclusion. 5. patients susceptible to epilepsy seizure. 6. patients with pacemaker. 7. patients refusing to wear retinal goggles during low-level laser 1. patients with a solid cancer lesion in the area of low-level laser application. 8. patients protected by law (guardianship and safeguarding of justice). 9. pregnant female patients as determined by positive serum pregnancy test at screening. 10. lactating female patients who are actively breast feeding. 11. participation in another clinical trial involving oral care.

Keywords: children oral mucositis chemotherapy photobiomodulation
the effect of community building through virtual, team-based exercise on burnout

Conditions: Burnout, Professional; Burnout, Student; Community Building; Mentorship; Exercise

Summary: this study is a randomized controlled trial that will look at whether virtual, team-based exercise improves burnout, sense of community, and mentorship connections among medical students, residents, fellows, and physicians.

participants will be randomized to either a control group or an intervention group. the intervention group will be further randomized onto teams that will exercise for 3 months. all exercise (including walking, biking, lifting, yoga, and 40+ exercises) will be tracked via user's smartwatches (ie apple, garmin), smartphone fitness apps (ie mapmyrun), or manual upload, converted into metabolic equivalent of a task (met) minutes, and displayed on online leaderboards. group activities will be encouraged by awarding raffle tickets for prizes to those who submit pictures with their teammates. primary outcomes will be burnout, sense of community, and mentorship connections, with the hypothesis that getting everyone together for this team-based exercise will improve these metrics. after 3 months, both the control and intervention group will be enrolled in 3 months of the intervention to assess secondary outcomes: long-term burnout, sense of community, and mentorship connections, as well as adherence.

Eligibility criteria:
inclusion criteria: * harvard medical students (hms) * massachusetts general hospital (mgh) residents, fellows, or attendings exclusion criteria: * non hms students or mgh residents, fellows, or attendings

Keywords: burnout, professional burnout, student community building mentorship exercise
vx-445/tez/iva expanded access program for cystic fibrosis (cf) patients heterozygous for f508del mutation and a minimal function mutation (f/mf genotypes)

Conditions: Cystic Fibrosis

Summary: the purpose of this program is to provide elexacaftor(elx, vx-445)/tezacaftor(tez)/ivacaftor(iva) combination therapy to cf patients in critical need who are 12 years of age and older, heterozygous for f508del and a minimal function (mf) mutation in response to unsolicited physician requests.


Eligibility criteria:
inclusion criteria: 1. patients who have f/mf genotypes and who meet at least 1 of the following criteria: * the percent predicted forced expiratory volume in 1 second (ppfev1) is \<40 for a minimum of 2 months before the date of the request, or * documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications exclusion criteria: 1. patients with severe hepatic impairment (child-pugh class c) 2. history of any other comorbidity that, in the opinion of the treating physician, might pose undue risk in administering elx/tez/iva to the patient 3. pregnancy other protocol defined inclusion/exclusion criteria may apply
the efficacy of polidocanol injections as a treatment of chronic achilles. tendinopathy

Conditions: Chronic Achilles Tendinopathy

Summary: chronic achilles tendinopathy is a common disease especially in adults. the golden standard in treatment has up to now been excentric exercises but with varying success. a new hypothesis is that this chronic pain is due to neo vascularisation. in a pilot study sclerosing injections with polidocanol have had a successful efficacy. our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.

48 patients with chronic achilles tendinopathy for more than 3 months who have tried excentric exercises without success will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.

Eligibility criteria:
inclusion criteria: * 18 year old, ultrasound verified achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive exclusion criteria: * dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of polidocanol or lidocaine, granulation tissue of more than 50 % of the achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,

Keywords: chronic achilles tendinopathy polidocanol ultrasound efficacy rct
clinical trial of ac225-psma radioligand therapy of metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the death of prostate cancer patients is mainly due to metastatic castration-resistant prostate cancer. though some new therapies has been tried to prolong the life-span of mcrpc patients, a dilemma was encountered for the drug-resistance. the psma rlt has been tested its efficacy and safety for the therapy of these patients. in our clinical trial, a new psma ligand will been used to be labeled with ac225. this will be a prospective pilot clinical trial. 20 mcrpc patients who was incapable of 2rd adt or chemotherapy will be recruited in this clinical tiral. the efficacy and safety of 225ac-psma will be evaluated after the administration.


Eligibility criteria:
inclusion criteria: * pathologically confirmed prostatic adenocarcinoma. * clinically or imaging confirmed metastatic castration resistant prostate cancer. * conventional treatment failure or not available. * psma avid of lesions confirmed by psma pet/ct. * hematopoietic function, kidney and liver function is normal. * can follow the study plan and can timely follow-up. * agree to sign the informed consent. exclusion criteria: * pathological types other than the prostatic adenocarcinoma of prostate cancer. * not psma avid of lesions confirmed by psma pet/ct. * concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ. * concomitant diseases are not suitable for radioactive therapy. * other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.

Keywords: mcrpc, psma radioligand therapy, efficacy, safety
neurophysiology and anatomy of severe intraventricular hemorrhage (ivh)

Conditions: Intracranial Hemorrhages; Prematurity

Summary: currently, when premature infants develop severe intraventricular hemorrhage (ivh), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. these children will be likely to develop cerebral palsy or severe cognitive delays. the purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe ivh and controls. the goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of ivh in premature infants. these baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe ivh.


Eligibility criteria:
inclusion criteria: * birth weight \< 1500 grams for all inborn infants and age less than 14 post-natal days * birth weight \< 1500 grams for all outborn infants transferred to the vch nicu within the first 72 hours after birth and age less than 14 post-natal days * parents agree to their infant's participation and give informed written consent. exclusion criteria: * unable to obtain informed consent. * congenital brain malformations leading to hydrocephalus * genetic and metabolic disorders leading to cerebral pathology
selecting the best ventilator hyperinflation settings

Conditions: Respiratory Failure; Respiration Disorders

Summary: ventilator hyperinflation (vhi) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. thus, the aim of this study was to compare six modes of vhi, concerning physiological markers of efficacy and safety criteria, in order to support the optimal vhi settings selection for mechanically ventilated patients. in a randomized, controlled and crossover study, 30 mechanically ventilated patients underwent 6 modes of ventilator hyperinflation. the maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), overdistension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.

background: ventilator hyperinflation (vhi) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. thus, the aim of this study was to compare six modes of vhi, concerning physiological markers of efficacy and safety criteria, in order to support the optimal vhi settings selection for mechanically ventilated patients. methods: in a crossover study, every included mechanically ventilated patient underwent six modes of vhi in a randomized order: volume control continuous mandatory ventilation (vc-cmv) with inspiratory flow = 20lpm (vc-cmv20), vc-cmv with inspiratory flow = 50lpm (vc-cmv50), pressure control continuous mandatory ventilation (pc-cmv) with inspiratory time = 1s. (pc-cmv1), pc-cmv with inspiratory time = 3s. (pc-cmv3), pressure support ventilation (psv) with cycling off = 10% of peak inspiratory flow (psv10), and psv with cycling off = 25% of peak inspiratory flow (psv25). the maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), over-distension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.

Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation for more than 48h exclusion criteria: * mucus hypersecretion (defined as the need for suctioning \< 2-h intervals), * absence of respiratory drive, * atelectasis, * severe bronchospasm, * positive end expiratory pressure \> 10cmh2o, * pao2-fio2 relationship \< 150, * mean arterial pressure \< 60mmhg, * inotrope requirement equivalent to \>15 ml/h total of adrenaline and noradrenalin, * intracranial pressure \> 20mmhg

Keywords: respiratory therapy positive pressure respiration physical therapy modalities
a performance evaluation of the enlite 3 sensor

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to support the use of the enlite 3 sensor in arm and thigh in subjects age 14 - 75 years and provide additional characterization of the enlite 3 sensor performance in arm in subjects age 14 - 75 years.

the study is a multi-center, randomized, prospective single-sample correlational design without controls.

Eligibility criteria:
inclusion criteria: 1. subject is 14 - 75 years of age at time of screening. 2. a clinical diagnosis of type 1 or 2 diabetes for a minimum of 9 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. adequate venous access as assessed by investigator or appropriate staff 4. subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (the term "established" refers to a ratio that has been previously defined and tested prior to screening visit). subjects without established ratios may participate under observation only. exclusion criteria: 1. subject will not tolerate tape adhesive in the area of enlite 3 sensor placement as assessed by qualified individual. 2. subject has any unresolved adverse skin condition in the area of enlite 3 sensors or device placement (e.g., psoriasis, rash, staphylococcus infection) 3. subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. subject is female and has a positive pregnancy screening test 5. females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator. 6. subject is female and plans to become pregnant during the course of the study 7. subject has had a hypoglycemic seizure within the past 6 months. 8. subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit. 9. subject has had an episode of diabetic ketoacidosis (dka) within the past 6 months prior to screening visit. 10. subject has a history of a seizure disorder. 11. subject has central nervous system or cardiac disorder resulting in syncope. 12. subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (tia), cerebrovascular accident (cva), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease. 13. subject has a hematocrit(hct) lower than the normal reference range. 14. subject has a history of adrenal insufficiency

Keywords: type 1 diabetes type 2 diabetes enlite 3 sensor continuous glucose monitoring
the visual performances of a progressive multifocal intraocular lens with extended depth of focus

Conditions: Cataract; Presbyopia

Summary: the purpose of this observational, non-controlled, multicenter trial with a retrospective design is to evaluate the visual performance of one cohort of patients who received the edof mini well® intraocular lenses following refractive lens exchange (rle) or cataract surgery.

the study aims at evaluating the visual performance of the edof mini well® in qualitative and quantitative terms of the progressive vision. the cohort of subjects includes all patients submitted in the six involved centers. for the surgical procedure for cataract extraction or refractive lens exchange (rle) using the mini well® with a pre-operative visit (from the day - 60 to day -1 before surgery) and a post-operative follow-up visit performed 30-60 days after implant.

Eligibility criteria:
inclusion criteria: * any gender and age above 18 years * refractive lens exchange (rle) or cataract surgery * symmetrical preoperative keratometric astigmatism \< 0.75 d * healthy corneas, not treated surgically exclusion criteria: * previous corneal surgery (i.e. pterygium, refractive surgery) * eye diseases with visual acuity \< 20/32 * pseudoexfoliation * abnormal pupil size and position. * use of contact lens 30 days before the preoperative visit. * corneal warpage

Keywords: extended depth of focus cataract surgery presbyopia correction