Kornimate/medical-research-clean huggingface dataset:
cognitive-behavioral therapy for avoidant/restrictive food intake disorder: a treatment development and pilot study

Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)

Summary: the primary aim of this study is to pilot cognitive behavioral therapy (cbt-ar)for avoidant/restrictive food intake disorder (arfid) in one study for children and adolescents (ages 10-17 years) and one study for adults (ages 18-65 years).

this study is designed to pilot the cbt-ar treatment in youth with arfid to determine treatment acceptability and efficacy.this includes evaluating the efficacy and acceptability of cbt-ar in reducing primary arfid symptoms from pre- to post-treatment, and to assess whether improvement in individual symptoms is related to the timing of relevant interventions. the investigators hypothesize that from pre-treatment to post-treatment, subjects with arfid will decrease severity of self-reported arfid symptoms, decrease self-reported anxiety and depression, and improve psychosocial functioning. the investigators further hypothesize that overall, subjects with arfid will have reduced phobic avoidance, sensory sensitivity, and/or low appetite in comparison to their pre-treatment symptoms.

Eligibility criteria:
inclusion criteria: * males and females; ages 10-17 years and 18-65 years with avoidant/restrictive eating disorder or avoidant/restrictive eating patterns, characterized by either (i) eating disorder assessment-5 (eda-5) (ii) kiddie schedule for affective disorders and schizophrenia for school age children-present and lifetime version (ksads-pl) exclusion criteria: * use of systemic hormones, pregnancy or breastfeeding within eight weeks * history of psychosis by ksads-pl * substance or alcohol use disorder active within the past month by ksads-pl * active suicidal ideation * gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) * any feeding or eating disorder other than arfid determined by eda-5 * any clinically significant disordered eating as evidenced by ede-q global \> 4.0 or self-induced vomiting, laxatives, diuretics, purposeful fasting, or compensatory exercise in past 28 days * medical history of intellectual disability (iq\< 70) * has previously received more than 4 hours of cbt for arfid in the past * is currently receiving another form of psychosocial treatment for arfid (e.g., occupational therapy, speech therapy, another form of psychotherapy) and is unable to discontinue that treatment for the duration of this study.
a prehab strengthening program prior to acl surgery on lower limb structure and function

Conditions: ACL Injury

Summary: atrophy and weakness are ubiquitous after a acl rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. however, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters. the purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to acl surgery on lower limb structure and function.

recruited participants will be randomly allocated to one of the three groups of participants constituted in this study. the two first groups will receive prehabilitation prior to acl reconstruction (differing in program type). all participants will receive standardized post-surgery rehabilitation (based on international recommandations).

Eligibility criteria:
inclusion criteria: * age : 18 to 55 * first episode of acl injury * having a planed acl reconstruction * volunteer to participate exclusion criteria: * age : \ 55 * previous episode of acl injury/reconstruction * no acl reconstruction

Keywords: rehabilitation strengthening physiotherapy atrophy
eealy improvement predicts antidepressants response in adults with major depression disorder

Conditions: Major Depressive Disorder

Summary: early improvemrnt, decreased 20% in the 17 items of hamilton depression rating scale (hamd-17) at the second week of the treatment of major depression disorder (mdd), can arguably predict the remission at the 12th week. our observation study including 80 mdd patients will access resting-state function mri to finding factors which infuencing early improvemrnt, respone and remission of antidepressants.


Eligibility criteria:
inclusion criteria: * right-handed; hamd-17 more than 17; diagnosed with mdd by the structured clinical interview for dsm-iv exclusion criteria: * patients diagnosed with other condition in dsm-iv axis i; pregnency; thyroid disease; heart disease

Keywords: early improvement antidepressants major depression diorder resting-state fmri
the effect of preoperative pain education by anesthesia nurses on postoperative pain among adult patients undergoing abdominal surgery

Conditions: Postoperative Pain

Summary: to explore the effects of preoperative pain education on postoperative pain among patients undergoing abdominal surgery.


Eligibility criteria:
inclusion criteria: 1. voluntary informed consent; 2. age older than 18 years 3. abdominal surgery under elective general anesthesia exclusion criteria: 1. patients taking long-term analgesics (including opioids, non-steroids, etc.) 2. patients with preoperative chronic pain 3. have participated in clinical studies in other projects within 3 months prior to signing the informed consent form 4. subjects not considered by the investigator 5. subjects refused to participate in the study
contribution of [18f]dpa-714 pet for grading and exploration of the inflammatory microenvironment of glioma.

Conditions: Glioma

Summary: the 18-kda translocator protein (tspo) is a mitochondrial protein that is weakly expressed in the healthy brain. however, there is an increase in the expression of tspo in glial tumors. it is even associated with a higher malignancy and a shorter survival of patients. among the different tspo ligands, the most commonly used tracers in pet imaging are \[18f\]dpa-714 and 18f-ge180. we hypothesize that \[18f\]dpa-714 pet could improve the current performance for tumor grade definition in vivo, which is a major issue for the therapeutic management of gliomas.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * suspicion of an operable diffuse glioma * written informed consent (signed) * affiliated or beneficiary of a social security plan exclusion criteria: * suspicion of grade i glioma * surgical urgency (less than 8 days between the suspected diagnosis and surgery) * pregnant or breastfeeding woman * persons deprived of liberty or under guardianship * impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons
vascular assessment of regulation index arrays registry

Conditions: Concussion

Summary: the objective of this patient registry is to collect and analyze physiological data associated with baseline and brain injury identified in standard clinical practice (normal values, recovery curves, correlation between symptoms and other tests, nci index), and to assess health economics.

the key aims of the varia registry are to determine the real-life testing patterns and clinical outcomes of newly diagnosed patients with brain injury. in accordance with the primary objective, the study will collect and analyze physiological data associated with brain injury identified in normal clinical practice with specific reference to: * patient demographics, symptoms, nci index, and other test results, * baseline ranges by demographic group, * post-injury patients presenting without a baseline test to be assessed in the context of the norms for similar patients, * recovery curves by demographic, * health economics. this registry will be a prospective observational study to collect data to describe the real-life testing patterns and clinical outcomes of newly diagnosed patients with brain injury.

Eligibility criteria:
inclusion criteria: * any patient receiving a transcranial doppler for a brain injury * adolescents and adults * written informed consent obtained by the clinician (may not be required for retrospective cases) exclusion criteria: * alcohol/substance abuse within the past 6 months, patient reported * serious mental illness that might preclude subject's ability to comply with treatment

Keywords: concussion vascular assessment vascular regulation mild traumatic brain injury, mtbi traumatic brain injury, tbi cerebrovascular regulation cerebral blood flow cerebral blood flow velocity, cbfv cerebral blood flow velocity variability cerebrovascular assessment
protocol percaf 2018

Conditions: Sleep; Caffeine; Polymorphism

Summary: in this multicentric controlled study, we aims to evaluate effect of caffeine on mental performances during a sleep deprivation protocol. genetic polymorphisms are considered as a covariable.

coffee is the most consumed arousing substance in the world. caffeine is used as a natural countermeasure to maintain the performance of sleep deprived subjects. however, the effectiveness of caffeine is characterized by a large individual variability, also observed on side effects. this variability could notably be related to polymorphisms of the adenosine receptor 2a gene (adora2a) and tumor necrosis factor-alpha, a pro-inflammatory cytokine whose increase is observed during sleep deprivation. this study, under conditions of total sleep deprivation in the laboratory (40 hours of continuous awakening), examine the cross-influence of two polymorphisms (adora2a: rs5751876 and tnf-alpha: rs1800629) on the sensitivity to caffeine and on the degradation of attentional performances. physical performance, mental performance, immuno-inflammatory responses and the occurrence indesirable effects will be evaluate. this work aims to understand the mechanisms that contribute to increasing individual vulnerability and promoting protective countermeasures. the purpose of this project is to improve the recommendations concerning the daily use of caffeine and during periods of prolonged awakening, particularly in the military environment.

Eligibility criteria:
inclusion criteria: * healthy subject exclusion criteria: * treatment * history of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease * nonvoluntary * pregnancy

Keywords: sleep deprivation cognition attention
virtual reality exercise in a community highschool for children with disabilities

Conditions: Disability Physical; Developmental Disability; Physical Inactivity

Summary: the purpose of this study is to work with a community engagement group to develop and pilot a protocol for a virtual reality exergaming program for children with special needs at a high school.

a virtual reality exercise program will be run during school special physical education hours at a public high school. the program will be implemented by a person with cerebral palsy. the exercise will include rhythmic movement to music and fitness games.

Eligibility criteria:
inclusion criteria: * enrolled in school special physical education or self-reported disability * note from physician permitting participation in moderate intensity exercise or cleared for sport participation through physical examination that was on file by the school * ability to communicate in english (or a caregiver) exclusion criteria: * complete blindness or deafness * condition that may make participation unsafe
non-invasive tool to assess electrophysiological mechanisms in cardiac arrhythmias

Conditions: Cardiac Arrhythmia

Summary: noninvasive evaluation of the electrical status of the heart is based on the standard ecg but remains suboptimal due to difficulties with arrhythmia characterization and location. electrocardiographic imaging (ecgi) provides maps of cardiac electrical excitation in relation to the anatomy of the heart using an extensive number of electrodes from the body surface. the applicant will develop a systematic evaluation of the ecgi as a tool to detect cardiac regions of interest in cardiac arrhythmias.

the specific aim of this multicenter observational study is to evaluate the precision of non-invasive cardiac mapping system ecgi using multipolar intracardiac recordings as the gold standard. we will develop a non-invasive ecgi and intracardiac recordings in patients undergoing electrophysiology studies and/or intracardiac devices implantation to correlate the position of the regions of interest at predefined anatomy sites in patients with different organized arrhythmias. the long-term outcome of the electrophysiological characterization using ecgi will be also evaluated. finally, the cost-efficiency of ecgi system as a support tool in cardiac arrhythmias diagnosis will be assessed. objectives: to perform a systematic evaluation of the ecgi with recordings using multipolar intracardiac recordings as the gold standard. secondly, the study will also validate the ability of the ecgi recordings to increase the precision of the standard ecg interpretation by an expert.

Eligibility criteria:
inclusion criteria: * indication for an invasive electroanatomic study and/or intracardiac device implantation. * having obtained and signed the informed consent for study participation. * ability to stand, to be able to obtain the 3d torso reconstruction necessary for the ecgi system. exclusion criteria: * \<18 years old * inability to perform an endocardial catheterization and/or device implantation. * physical or mental disability to understand and accept the informed consent. * inability to stand to obtain the 3d torso reconstruction. * active coronary ischemia or decompensated heart failure * intracardiac clot on trans-esophageal echocardiography * pregnancy. * disorganized arrhythmias (i.e. atrial fibrillation, polymorphic ventricular tachycardia).

Keywords: non-invasive electrocardiographic imaging (ecgi)
"effects of music on preoperative anxiety in patients with femoral fractures undergoing surgery: a randomized controlled trial"

Conditions: Anxiety; Pain; Surgery; Femoral Fractures; Music Therapy

Summary: this randomized controlled trial (rct) investigates the effectiveness of music therapy in reducing preoperative anxiety among elderly patients with femoral fractures. preoperative anxiety is known to worsen physiological stability, increase pain perception, and negatively impact recovery, yet specific evidence on non-pharmacological interventions like music therapy in the orthogeriatric setting is lacking. the study will enroll 154 adult patients admitted to the orthogeriatrics unit for elective femoral fracture surgery. participants will be randomly assigned to receive either a 20-minute session of music therapy or standard care. anxiety will be measured using the apais scale, and pain will be assessed with the nrs scale, both before and after the intervention. the trial is designed as a blinded, prospective rct, with data collected and managed under current privacy regulations. by generating robust data on this low-cost, safe intervention, the study aims to improve preoperative management and patient outcomes in orthopedic surgical care.


Eligibility criteria:
inclusion criteria: * patients of both sexes, 18 years of age or older * patients with femur fracture who are candidates for surgery * able to provide informed consent. exclusion criteria: * patients with a diagnosis of hearing loss * patients diagnosed with cognitive or psychiatric disorders * patients undergoing emergency/emergency surgery

Keywords: nursing musictherapy anxiety pain
pathway study ws3 - home based metacognitive therapy for cardiac rehabilitation patients

Conditions: Depression; Anxiety; Cardiac Rehabilitation; Psychological Distress

Summary: depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key nhs policy. extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. a psychological intervention called metacognitive therapy (mct) that reduces this style of thinking alleviates depression and anxiety in mental health settings. this is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a home-based format (home-mct). the aim of the study is to evaluate the acceptability and feasibility of integrating home-mct into cardiac rehabilitation services and to provide provisional evidence of effectiveness and cost-effectiveness on home-mct.


Eligibility criteria:
inclusion criteria: 1. patients who are referred to the cr pathway who meet department of health (doh) and/or british association for cardiovascular prevention and rehabilitation (bacpr) cr eligibility criteria: * acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart * following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia * stable heart failure * stable angina is chest pain or discomfort that most often occurs with activity or stress * following implantation of cardioverter defibrillators/cardiac resynchronisation devices * heart valve repair/replacement * heart transplantation and ventricular assist devices * adult congenital heart disease identified in adulthood * other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain) 2. a score of ≥ 8 on either the depression or anxiety subscale of the hospital anxiety and depression scale 3. minimum of 18 years old 4. competent level of english language skills exclusion criteria: 1. cognitive impairment which precludes informed consent or ability to participate 2. acute suicidality 3. active psychotic disorders (i.e., two \[or more\] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms). 4. current drug/alcohol abuse (a maladaptive pattern of drinking, leading to clinically significant impairment or distress) 5. concurrent psychological intervention for emotional distress that is not part of usual care 6. antidepressant or anxiolytic medications initiated in the previous 8 weeks 7. life expectancy of less than 12 months
firmonertinib combined with chemotherapy as neoadjuvant therapy for resectable stage ⅱ-ⅲb egfr sensitive mutanted nsclc

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase ii study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage ii-iiib resectable nsclc patients.

in this open-label, single-arm, phase 2 study, 31 eligible patients with egfr mutated stage iiia-iiib resectable nsclc will be recruited to receive firmonertinib for 12 weeks combined with carboplatin/cisplatin and pemetrexed for 4 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.

Eligibility criteria:
inclusion criteria: 1. provide informed consent prior to any study specific procedures 2. at least 18 years of age 3. histology or cytology diagnose of non-small cell lung cancer within 60 days 4. ecog ps of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks 5. stage ii-iiib nsclc that is expected to be resectable, as assessed by the investigator (8 thuicctnm staging), 6. according to recist 1.1, patients have at least one measureable tumor lesion (the longest axis ≥10mm) 7. egfr mutation positive (exon 19 deletions or exon 21 l858r, with or without other egfr mutations) 8. without prior anti-tumor treatment 9. withe adequate organ function of hematology, liver and kidney 10. using adequate and effective contraception, male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age exclusion criteria: 1. dual or multiple primary nsclc 2. any prior anti-tumor treatment 3. with history of other malignancy except for radical resected tumors without recurrence for 5 years or more 4. diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting 5. with severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active hbv/hcv/hiv or other infections requiring infusion treatment 6. laboratory tests indicate insufficient bone marrow reserve or organ reserve 7. women with pregnancy or breastfeeding 8. patients with known or suspected drug allergies, or other contraindications 9. other conditions that, in the opinion of the investigator, make participation in this trial inappropriate 10. patients who are currently or previously enrolled in any other anti-tumor clinical study.
prevention of human papillomavirus (hpv) infection in paediatric kidney and liver transplant recipients and in paediatric patients with advanced chronic kidney disease

Conditions: Paediatric Kidney or Liver Transplantation; Chronic Kidney Disease

Summary: due to their immunosuppressive therapy, solid-organ transplant (sot) recipients bear a 10 to 100 times higher risk of human papillomavirus (hpv)-associated malignancies than healthy individuals. the objectives of this observational, non-interventional multi-national, multi-centre research project are to gain an insight into current hpv vaccination strategies and to investigate the immune response to different routinely administered hpv vaccines in european paediatric sot candidates and immunocompromised transplant recipients, enabling patients at risk of vaccination failure to be identified.


Eligibility criteria:
inclusion criteria: * paediatric kidney and/or liver transplant recipients * paediatric patients with ckd * who receive hpv vaccination according to country-specific vaccine schedule exclusion criteria: * no hpv vaccination according to country-specific vaccine schedule * no written informed consent