Kornimate/medical-research-clean huggingface dataset:
unified protocol: community connections

Conditions: Mental Health Issue; Anxiety Disorder; Depressive Disorder; Parenting

Summary: the purpose of this study is to administer the unified protocols for transdiagnostic treatment of emotional disorders in children (up-c) and adolescents (up-a) to youth and participants' parents and to examine the efficacy and outcomes of the treatment using standardized measures, questionnaires, interviews. the up-c and the up-a are cognitive-behavioral therapies to treat emotional disorders.


Eligibility criteria:
inclusion criteria: * children between the ages of 7-17. * youth currently resides in miami-dade county. * children and their parents must be able to speak and understand english and/or spanish sufficiently well to complete study procedures (e.g., provide their informed consent/assent, complete assessment measures and/or program materials). * at least one parent or caregiver with whom the child is living with that can accompany the child and participate in all visits (assessment and treatment). * positive endorsement of elevated emotional concerns in one of a limited range of emotional disorder domains (i.e., anxiety, depression, trauma, or obsessive-compulsive symptoms, etc.) during full diamond-kid semi-structured interview, and/or elevated anxiety or depression symptoms (t-score \> or = 65 for youth 8-17 years old; raw score \> or = 12 for children under 8 years old) on the revised child anxiety and depression scale - short form (rcads-sf; child or parent report). * youth with other types of comorbid conditions (e.g., tic/tourette's disorder, eating disorders, or disruptive behavior disorders) will not be excluded, providing a clinical area of concern is regarding one of the emotional disorder domains specified and treatment within this protocol is deemed most appropriate. * youth and parent participation in at least one in-person session if the treatment is predominantly delivered virtually. exclusion criteria: * prior receipt of at least 8 sessions of the up-c/a program at the child and adolescent mood and anxiety treatment program (camat). * psychiatric hospitalization in the previous 6 months (i.e., due to baker act, psychotic symptoms, significant suicidal ideation, danger to self or others, etc.). * another significant problem area that takes priority for services (e.g., eating disorder, substance-use disorder, primary externalizing concerns, psychotic symptoms, etc.), as identified by family report or via diamond-kid interview. * inability for family to wait for the next group treatment cohort to start, family declining therapist assignment following intake, and/or family no-showing to 3 or more scheduled sessions at camat (inclusive of intake assessment).
efficacy of red light in the treatment of pigmentary disorders

Conditions: Melasma; Lichen Planus Pigmentosus; Vitiligo

Summary: pigmentary disorders such as melasma, lichen planus pigmentosus and vitiligo can significantly affect patients' quality of life. treatment responses are usually slow and typically have limited efficacy. in recent years, low level laser therapy has been an emerging treatment modality for androgenetic alopecia, acne, wound healing and photorejuvenation. this is a prospective, double-blind, split-body, randomized controlled trial assessing the efficacy of low level laser therapy with red light for pigmentary disorders such as, melasma, lichen planus pigmentosus and vitiligo.

this will be a participant and evaluator blinded trial with random allocation of one side of the face or affected area to treatment and the contralateral side as control. random allocation of the treatment side will be performed using randomization software. participants will be treated twice a week for 12 weeks with low irradiation 650 nm +/- 5 nm red light and followed up 4 weeks after completion of treatment. a trained blinded evaluator will assess clinical outcomes on week 4, week 8, week 12 and at follow up at week 16, using validated scores.

Eligibility criteria:
inclusion criteria: * participants must be 18 years or older. * participants should be competent to give fully informed consent by themselves * should have received a diagnosis of either melasma, lichen planus pigmentosus or vitiligo either clinically or pathologically and have bilateral facial hyperpigmentation/depigmentation or bilateral similar sized depigmented/hyperpigmented patches or a single patch larger than 25 cm2. * participants must stop receiving topical treatments or phototherapy 4 weeks prior to commencing the study exclusion criteria: * known photosensitivity disorder * unable to attend follow up appointments or twice weekly treatments

Keywords: melasma lichen planus pigmentosus vitiligo low level laser therapy photobiomodulation red light pigmentation disorders
relative bioavailability study of pf-07321332/ritonavir oral powder relative to the commercial tablets in healthy participants

Conditions: Bioavailability

Summary: the purpose of this study is to estimate the relative bioavailability of pf-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. the study will also assess the effect of 3 different food vehicles on the relative bioavailability of the pf-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of pf-07321332/ritonavir oral powder in healthy adult participants.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (pe), laboratory tests, vital signs and standard 12 lead ecgs. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures exclusion criteria: * positive test result for sars-cov-2 infection at the time of screening or day -1. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged pr interval, cardiomyopathy, heart failure greater than new york heart association (nyha) 1, underlying structural heart disease, wolff parkinson-white syndrome). * any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c; positive testing for hiv, hepatitis b surface antigen (hbsag), or hepatitis b surface antibody (hcvab). hepatitis b vaccination is allowed. * use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. * participant who have received a covid-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a covid-19 vaccine at any time during the study confinement period. * a positive urine drug test.

Keywords: coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2) nirmatrelvir
diagosis of breast carcinoma: characterization of breast lesions with clearpemsonic : feasibility study

Conditions: Breast Carcinoma

Summary: breast cancer is the first cancer in women, the second etiology of death by cancer and the first cause for women between 35 and 55 years. diagnostic tools and large screening have been realized with positive impact in a recent review with 31% less likely to die of breast cancer over nearly 30 years compared to women who didn't get regular screening mammograms. diagnostic tools and treatment also are improving continuously. however, for some women, breast cancer diagnosis is difficult, in case of high density breast, breast modifications after surgery... in these cases, breast mri is currently the best imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that lead to futile biopsies. recently, molecular imaging with pet-ct scan with 18fdg has permitted to widely modify cancer treatment. however, pet-ct scan is not a good imaging tool for initial diagnostic of breast tumor because of a lack in spatial resolution about 8mm. so, researchers developed dedicated pet scan for breast, called positron emission mammography. our project is in this field of view and is named clearpemsonic. first clinical studies with pem showed very good performance of this imaging modality for initial evaluation of breast tumors. pem performance is not affected by breast density, hormonal status. spatial resolution is less than 3mm. pem seems complementary with mri, adding a better specificity value. in the field of cerimed, clearpemsonic project aims to evaluate an new imaging tool which combined pem scan and ultrasonography. technologic evaluation was made. now a feasibility study is the first step for clinical applications. the main objective of this project is to confirm the feasibility of pem scan with the clearpemsonic. secondary objectives are to compare results with other conventional imaging modalities and mri. the gold standard will be histology of the breast tumor.


Eligibility criteria:
inclusion criteria: * age \> 18 years * mammary néoplasia ready(in position) (diagnosed on histological taking of type(chap) biopsy) * waits whose realization of an imaging tep-tdm in the 18fdg is required for the coverage(care) of a mammary néoplasia. the decision of realization of this tep-tdm can be validated during a rcp. exclusion criteria: * other cancerous affection; * pregnant woman. nursing mother * patient presenting difficulties of follow-up (insufficient motivation, imminent transfer(transformation) in a city where the study cannot be led) * patient incapable to give their written consent. * patient claustrophobic or presenting a contraindication to the realization of the mri
long-term safety, tolerability and efficacy of baf312 given orally in patients with relapsing-remitting multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. it will provide data on long term safety, tolerability and efficacy of siponimod in the rrms patient population

this study was prematurely discontinued after approximately 5 years. the decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in ms on a different population.

Eligibility criteria:
inclusion criteria: * patients completed the core study baf312a2201 * written informed consent provided before any assessment of the extension study * female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception exclusion criteria: * newly diagnosed systemic disease other than ms (which may require immunosuppressive treatment) * malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions * active infections

Keywords: baf312 siponimod multiple sclerosis relapsing remitting multiple sclerosis demyelinating autoimmune diseases ms rrms inflammatory disease
a study of a novel scheimpflug device in diagnosing keratoconus

Conditions: Scansys; Pentacam; Corvis ST; Keratoconus; Subclinical Keratoconus

Summary: comparison of the screening and diagnosis ability of the novel scheimpflug-based tomography device (scansys) with pentacam and the scheimpflug-based biomechanics device (corvis st) for keratoconus.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity (bcva) ≥ 20/20; * no other eye diseases except myopia and astigmatism; * the cornea was transparent, and there was no cloud or pannus; exclusion criteria: * the presence of ocular diseases other than myopia and keratoconus; * ocular trauma; * previous ocular surgery; * patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; * pregnant and lactating women;
bariatric surgery induced chromosomal change

Conditions: Obesity, Morbid

Summary: the purpose of this study is to better understand the impact of weight-loss surgery on telomere length. telomeres are a key marker of biological aging of cells. telomere shortening is a natural process of aging. several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. new evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.

this study aims to evaluate the impact of metabolic and bariatric surgery on telomere length as well as the role of type 2 diabetes resolution and oxidative stress improvement on telomere lengthening. the investigators hypothesize that metabolic and bariatric surgery is associated with the lengthening of telomeres as a possible underlying mechanism of cancer risk reduction. it is a prospective, single-center study including patients with obesity class ii or more (body mass index ≥ 35kg/m2) and patients having had metabolic and bariatric surgery more than 12 months ago.

Eligibility criteria:
inclusion criteria: * bmi ≥ 35 kg/m2 without previous bariatric surgery (control group) or * having had sleeve gastrectomy or roux-en-y gastric bypass more than 12 months ago and without a weight regain of ≥ 15% of nadir weight (treatment group) exclusion criteria: * under 18 years of age * no informed consent

Keywords: telomere length metabolic and bariatric surgery
the effect of paracetamol on brain temperature

Conditions: Brain Injuries

Summary: the main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between h0 and h6) in patients with cerebral hyperthermia versus placebo. the investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.


Eligibility criteria:
inclusion criteria * 18-year or older patients * patient hospitalized in neuro-critical care for: * arachnoid hemorrhage * intra parenchymatous hematoma * stroke * acute brain severe injury * post-operative complication of an act of neurosurgery or programmed neuroradiology * sedation and mechanical ventilation planned \> 2 days * monitoring of intracranial temperature and pressure by intraparenchymal sensor (sophysa®) * brain temperature \> 38.5°c for more than 30 minutes exclusion criteria * known hypersensitivity to paracetamol or mannitol (excipient with known effect) * severe hepatocellular insufficiency (asat or alat \> 5n, or bilirubin \> 2n) * pharmacological intervention (administration of corticosteroids, nsaids or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours. * pregnant or breastfeeding women * previous participation in this study
managing ppd at gouverneur

Conditions: Post-Partum Depression

Summary: a stepped care pathway for managing postpartum depression (ppd) in pediatric primary care settings will be used to (1) understand context for implementation feasibility (2) evaluate benefits for mother and child. the proposed pilot project will be conducted as part of a quality improvement effort in the department of pediatrics at gouverneur health services to improve management of postpartum depression during pediatric primary care visits. this project will test the feasibility of a stepped care approach to identifying and managing depression among mothers of infants (0-6 months). this study will provide preliminary data on the feasibility of the care management protocol, implementation and fidelity measures, and training/consultation methods within a real world pediatric care practice. these data will inform and support the preparation of a large-scale nih grant. specific research questions include: 1. to pilot the feasibility of using a stepped care approach to identify and mange maternal depression within primary care pediatric care visits, with a focus on mothers of infants 0-6 months. 1. train non specialty mh providers to systematically identify maternal depression. 2. assess how effective integration of maternal depression intervention is as part of well baby visits. 2. to o examine the impact of strong, a brief 3-session ipt-based preventive intervention, on maternal and child health outcomes (e.g., maternal depression symptoms, child receipt of acute care services). secondary outcomes include maternal social support and parenting practices.


Eligibility criteria:
inclusion criteria for subjects * phq-9 scores in the 10-19 range * women with infants 6 months and younger at time of screening inclusion criteria for providers exclusion criteria: * active substance use * current treatment for depression * current/past history of schizophrenia, bipolar or other psychotic disorder; * suicidal/homicidal risks; * women with difficulties speaking or understanding english; * women under the age of 18.

Keywords: psychosocial psychotherapy maternal
repetitive transcranial magnetic stimulation in postpartum depression

Conditions: Depression, Postpartum

Summary: several factors characterize repetitive transcranial magnetic stimulation (rtms) as a strategic aid in the treatment of postpartum depression. however, up to current days there have been no studies evaluating the effects of rtms on neurocognitive and social performance of women suffering from the disorder. the present study evaluates the impacts of rtms in clinical, cognitive and social performance.

transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects. the treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. each session lasts up to 30 minutes. side effects include scalp discomfort and mild headache. no anesthesia is required. stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. the present technique has never been employed in previous studies, but risks are insignificant.

Eligibility criteria:
inclusion criteria: * major depression with a puerperal onset, according to the criteria of the dsm-iv-r (apa, 2000), as well as through a structured clinical interview (scid-1/p v 2.0) * baseline score of at least 14 points on the hamilton depression rating scale-17 items * baseline score of at least 13 points on the edinburgh postnatal depression scale. * range = 18-36 years * women who had given birth 1-6 months * any pharmacological treatment other than clonazepam (1 mg/day) exclusion criteria: * comprised ferromagnetic metallic implants * pacemakers * previous neurosurgery * history of seizures * major head trauma * alcoholism * drug addiction * any psychiatric or neurological disorder other than depression and anxiety * psychotic depression * suicidal propensities

Keywords: transcranial magnetic stimulation; postpartum depression; clinical performance; cognitive performance; social performance
effect of in situ simulation on quality of work life and multiprofessional team effectiveness in the intensive care unit

Conditions: Quality of Work Life; Burn-out; Simulation

Summary: the lack of specific, personalized training for intensive care workers can lead to a deterioration in quality of life at work, and can result in burnout, absenteeism or wanting to leave the service. the aim of this study is to assess the impact of in situ simulation on quality of work life and the effectiveness of multi-professional teamwork in intensive care.

paramedics in intensive care are particularly exposed to the risk of burnout, which is multifactorial (psychologically and physically challenging environment, life-threatening emergency context, etc.). personal assistance professions require a high level of compassion, leading to a positive feeling of compassionate satisfaction, i.e. the satisfaction of helping others. compassion fatigue leads to a reduction in job satisfaction, culminating in burnout. factors negatively influencing compassion satisfaction are the absence of specific and adapted training, or the lack of support from the hierarchy. among the pedagogical tools available, in situ simulation could be used to respond to a specific and personalized training request from a care department. the study will be carried out in the cardio-thoracic intensive care unit at montpellier university hospital, comparing 2 groups to assess the effect of simulation on paramedics. paramedics will be randomized into 2 groups, with stratification on diploma (nursing assistant or nurse): group a benefiting from a simulation program, and group b not benefiting from it during the study.

Eligibility criteria:
inclusion criteria: * paramedical staff (nurse and nursing assistant) in the cardiothoracic intensive care unit at montpellier university hospital. * acceptance of being filmed for direct video transcription during the intervention exclusion criteria: * refusal of consent or inability to give consent (guardianship, curatorship) * paramedics intending to leave the department before the end of the study. * not affiliated to a french social security scheme or not a beneficiary of such a scheme

Keywords: in-situ simulation intensive care stress quality of working life quality of care performance caregivers teamwork