Kornimate/medical-research-clean huggingface dataset:
personalized non-invasive neuromodulation by rtms for chronic and treatment resistant catatonia

Conditions: Schizophreniform Catatonia; Treatment Resistant

Summary: investigators hypothesize that personalizing rtms targets using functional mri will allow to improve symptoms of patients suffering from chronic catatonia.

two dysfunctional networks or regions will be chosen (verum 1 and 2) based on their abnormal rcbf. in line with the symptoms, dorso-lateral prefrontal and premotor regions are expected to be chiefly concerned. a normal region regarding its rcbf will be used as placebo. targets will be stimulated using intermittent or continuous theta-burst according to the rcbf anomaly as an attempt to "normalize" their activity. the coil will be positioned using a robotic device under the control of a neuronavigation system in order to deliver a homogeneous stimulation. using a balanced blinded randomized cross-over design, patients will be stimulated on 5 consecutive days (4 sessions per day) and evaluated pre-, post-stimulation and 1 month after. in this pilot study the primary outcome measures will be the clinical global impression scale whereas mri will insure that stimulations achieved the correction of the rcbf anomalies. secondary outcome measures will include personalized target symptom scales, and scales for catatonic, apathic and obsessive-compulsive symptoms.

Eligibility criteria:
inclusion criteria: * aged from 18 to 70 y * affiliated to the health insurance * having signed an informed consent * suffering from catatonia according to the dsm5, unremitted since \> 2y * unresponsive or incomplete remission after at least one trial of benzodiazepine and/or electroconvulsivotherapy * treatment stable for \> 6 weeks exclusion criteria: * contraindication for mri, rtms or tdcs: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tdcs electrode placement. * pregnancy * severe and non-stabilized somatic pathology * patients deprived of liberty or hospitalized without their consent * patients unable to give informed consent.

Keywords: precision medicine functional neuroimaging transcranial magnetic stimulation, repetitive transcranial direct current stimulation monocentric comparative balanced, randomized double-blind cross-over 3 arms study
the impact of heat acclimation on pro- and anti- inflammatory cytokine response

Conditions: "Exposure to Heat"

Summary: there is growing evidence to conclude that part of the cascade leading to heatstroke is related to an inflammatory reaction triggered by the heat stress. the reduced ability to sustain heat stress - "heat intolerance" is also attributed to over-expression of inflammatory cytokines. acclimation to heat improves human sustainability to heat and is a leading protective factor against heat stroke. the investigators hypothesize that the lower stress encountered during the process of acclimation to heat will be reflected by an over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. this, in turn will attenuate the pathological cascade leading to heat stroke.


Eligibility criteria:
inclusion criteria: * age:18-25 * medically screened (healthy) exclusion criteria: * bmi over 22 kg/m2 * systolic blood pressure over 120 mmhg * any febrile illness during the last week preceding the study * any skin disease * diabetes * any heart conditions.

Keywords: acclimation heat cytokines stress inflammation
stretching in water and on land for patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis.

ankylosing spondylitis is a chronic, progressive disease with an unknown etiology which characterize with inflammation that leads to bone fusion in spinal joints. besides the systemic manifestations, chronic pain acquired kyphosis, diminished exercise capacity may cause pulmonary dysfunction, muscle imbalance, reduced quality of life, sleep disruptions and depression. there are strong evidence and advice on exercise should start with diagnosis. although stretching exercises are the most common exercises in this group the literature on the effectiveness of stretching exercises is scarce. the aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis. the study was carried on patients with ankylosing spondylitis followed by division of rheumatology and immunology, department of internal medicine, dokuz eylül university school of medicine. 57 patients were assessed and randomized into two group control and intervention. control group informed on the importance of exercise and given a home exercise brochure. the intervention group was also randomized into an aquatic and land stretching group and received stretching exercises two days a week for eight weeks. two patients from the control group and nine patients (three from aquatic, six from land) from the intervention group were excluded. at the end of eight weeks, except fev1, fvc, vc all results of the intervention group improved whereas an quality of health was the only result improved in the control group. when aquatic and land stretching groups the results were improved similarly. the improvements of basfi and mip of the aquatic group are superior to the land group. home exercises are playing an important role in the management of ankylosing spondylitis. addition of stretching exercises to home exercises enhances the effectiveness of the treatment. aquatic stretching exercises have some benefits than land stretching exercises.

Eligibility criteria:
inclusion criteria: * as diagnosed according to 1988 modified new york criteria volunteered with a basdai score of 3 or 4 exclusion criteria: * patients followed any physical exercise within the last 3 months prior to this study, history of cardiovascular and pulmonary disease were excluded.

Keywords: aquatherapy stretching exercises
reciprocal imitation training and musical rhythm sensitivity in autistic toddlers

Conditions: Autism; Autism Spectrum Disorder

Summary: the primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (ndbis) in autistic toddlers. toddlers receive either reciprocal imitation training (rit), an evidence-based ndbi that supports children's imitation and social communication skills, or a music-enhanced version of rit. throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.

social communication makes use of predictable, rhythmic behaviors and children are sensitive to the rhythm of social interaction from infancy. the goal of the current study is to investigate if social rhythm sensitivity, measured via children' entrained eye-looking when viewing videos of infant-directed singing, predicts autistic toddlers' response to naturalistic developmental behavioral intervention (ndbi). following eligibility testing and baseline assessments, children are randomized to receive either 30 sessions of reciprocal imitation training (rit), an ndbi that uses evidence-based strategies to support children's imitation and social communication development, or a music-enhanced version of rit that embeds music and rhythm within the rit platform (merit). children's imitation skills are assessed before and after the intervention programs. children's rhythm sensitivity is assessed via repeated eye-tracking sessions throughout baseline, intervention, and two-weeks after the intervention ends.

Eligibility criteria:
inclusion criteria: * diagnosis of autism / autism spectrum disorder * 18-36 months of age exclusion criteria: * major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age \<=34 weeks.

Keywords: autism imitation social communication rhythm music
cost-utility analysis of the use of the paro robotic seal by elderly patients with moderate or severe cognitive disorders in institutions: a randomised study.

Conditions: Cognitive Impairment

Summary: many residents from establishments for dependent elderly people (ehpad) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis. studies have proven the beneficial effect of the therapeutic seal robot paro® in behavioural disorders. the present project aims to complement these data with a medico-economic study. at present, the only study of this type has been carried out in australia, and is not transposable to france.


Eligibility criteria:
inclusion criteria: * patients over 70 years of age * with moderate or severe neurocognitive disorders of any etiology (mini mental state examination (mmse) less than or equal to 20, or not feasible) * resident in ehpad (establishment for dependent elderly people) or usld (long-term care unit ) in permanent accommodation for more than 1 month at inclusion exclusion criteria: * patient with presumed life expectancy of less than 3 months * mini mental state examination (mmse) not feasible for any reason other than cognitive impairment (e.g. stroke aphasia), without dementia * known carrier of multi-drug resistant bacteria * carrier of pace-maker (precautionary advice from manufacturer) * refusal to participate to the study (trusted person, guardian or curator or patient depending on the patient's mental state) * patient under court protection * prior inclusion in an interventional study that may alter the interpretation of the results of the analysis * patient not affiliated to a social security system or beneficiary of such a system

Keywords: paro non-pharmacological intervention economic evaluation cognitive impairment
comparative analysis of the th17 cellular response in active and inactive pemphigus vulgaris patients

Conditions: Pemphigus Vulgaris; Bullous Dermatoses; Autoimmune Diseases

Summary: this study will compare the pattern of th17 immune response in active and inactive pemphigus subjects. skin and serum samples will be taken at the moment of enrollment.

pemphigus is an autoimmune disease characterized by production of autoantibodies against desmogleins 1 and 3, which are part of the epidermis desmosomes. the first line of treatment are corticosteroids with or without the use of adjuvants (e.g. azathioprine, mycophenolate or rituximab). t lymphocytes are responsible for the initiation and maturation of the humoral response and the b cell activation required for the production of autoantibodies. in the last decade, the th17 immune response has been implicated in the pathogenesis of pemphigus. recently, the existence of tertiary lymphoid organ-like structures within the skin lesions was suggested. this structures contain t lymphocytes, b lymphocytes and plasma cells; these cells interact and create a local microenvironment for the production of autoantibodies. most of the t cells in this structures are t helper cd4+ and express il-21, and half of them produce il-17. in this study the investigators aim to evaluate comparatively the th17 and t regulatory immune response in the lesional skin and serum of active and inactive pemphigus subjects that are treated with corticosteroids with or without adjuvants and a third group of healthy subjects. the investigators will study skin and serum due to the difference of lymphocytes and cytokines in both tissues. the primary hypothesis is: active pemphigus vulgaris subjects will have different levels of th17 response in comparison to inactive patients. the investigators will use descriptive statistics, association and correlation test of hypothesis.

Eligibility criteria:
inclusion criteria: 1. current cutaneous activity of pemphigus 2. subjects will be treated with corticosteroids with or without adjuvants 3. accept and sign the informed consent exclusion criteria: 1. pregnancy 2. concurrent autoimmune diseases with skin lesions 3. concurrent diagnosis of cancer 4. concurrent active infectious disease

Keywords: pemphigus th17 il-23 il-17 autoimmune bullous disease
restore claims characterization study

Conditions: Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome

Summary: the purpose of this study is to characterize the pain coverage capability of the restore spinal cord stimulation (scs) and assess health outcomes.


Eligibility criteria:
inclusion criteria: * has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: failed back syndrome, degenerative disk disease (ddd), herniated disk pain refractory to conservative and surgical interventions, peripheral causalgia, complex regional pain syndrome (crps) or reflex sympathetic dystrophy (rsd). * primary pain in the lower half of the body. exclusion criteria: * requires, or will in the future, diathermy treatments. * had implanted spinal cord stimulation system within the last six months.
a study of bms-986224 in healthy subjects and heart failure patients with reduced ejection fraction

Conditions: Heart Failure

Summary: the purpose of this study is test the safety and tolerability of bms-986224 and its effects on the body in healthy subjects and subjects with chronic heart failure with reduced ejection fraction


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: healthy subjects (part a and b) * healthy subjects, as determined by no clinically significant deviations in medical history, physical examination, ecgs, vital signs, and clinical laboratory determinations * subjects must be willing and able to complete all study-specific procedures and visits * additional criterion for japanese subjects in groups bj1 to bj3: subjects must be first generation japanese (born in japan and not living outside of japan for \> 10 years, and both parents are ethnically japanese) heart failure patients (part c) * left ventricular ef \ 25%, as assessed by cardiac mri within 3 months of first dose of study drug; or left ventricular ef \ 25% as assessed by echocardiogram at screening or within 3 months of first dose of study drug; left ventricular ef * heart failure is considered to be stable at the discretion of the investigator (i.e., no acute cardiovascular \[cv\] events or hospitalization (including emergency room visits) for cv causes within 3 months of first dose of study drug * regular sinus rhythm at screening and no history of atrial fibrillation in the past 12 months exclusion criteria: healthy subjects (part a and b) * major surgery within 4 weeks of (first) study treatment administration * inability to be venipunctured and/or tolerate venous access * subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited, to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 6 months of the first dose of study drug heart failure patients (part c) * current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption * major surgery within 4 weeks of (first) study treatment administration * inability to be venipunctured and/or tolerate venous access other protocol defined inclusion/exclusion criteria could apply
an investigational study of experimental medication bms-986165 in participants with moderate to severe crohn's disease

Conditions: Granulomatous Colitis; Crohn's Disease; Crohn's Enteritis; Granulomatous Enteritis

Summary: the purpose of this study is to assess the safety and effectiveness of bms-986165 compared to placebo in participants with moderately to severely active crohn's disease.


Eligibility criteria:
inclusion criteria: * documented diagnosis of crohn's disease (cd) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution * must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments * must have active moderate to severe cd * men and women must agree to follow specific methods of contraception, if applicable exclusion criteria: * severe or fulminant colitis that is likely to require surgery or hospitalization * presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than crohn's disease * previous exposure to bms-986165 in any study * any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant other protocol-defined inclusion/exclusion criteria apply
early treatment of anterior open bite using the rapid molar intruder

Conditions: Open Bite

Summary: this study evaluated the efficacy of rapid molar intruder (rmi) in treating anterior open bite in the mixed dentition. the study sample consisted of 40 patients who had a skeletal anterior open bite. the sample was allocated randomly into two groups: the rmi group and the control group. the skeletal, dentoalveolar and soft tissue changes occurring after treatment were assessed by using lateral cephalometric images.

many appliances have been used to treat skeletal anterior open bite (aob) malocclusion, such as removable appliances, extra-oral appliances (vertical chin cup and vertical head gear), fixed appliances, orthognathic surgery and functional appliances. treatment with these appliances produces soft and hard dentofacial tissue changes. many studies have been carried out in order to study these changes. in this study, the investigators treated aob using rmi. patients were divided into two groups to evaluate the efficacy of rmi. rmi group: rapid molar intruder was applied. control group: untreated control group. in order to evaluate the changes occurring, lateral cephalometric images were taken in both groups at the beginning of the treatment (t1) and after 9 months of the first cephalograms (t2).

Eligibility criteria:
inclusion criteria: 1. patients in the mixed dentition 2. chronological age between 8 and 12 years 3. skeletal class i or ii malocclusion 4. skeletal anterior open bite was assessed clinically and then confirmed radiographically: sn/gome was greater than 33°, mm was greater than 27 5. no general problems 6. good oral health exclusion criteria: 1. presence of periodontal diseases 2. presence of general diseases, syndromes or cleft lip and palate 3. patients with previous orthodontic treatment

Keywords: anterior open bite rapid molar intruder mixed dentition
adaptation of the pcip for spanish speaking adolescents and families

Conditions: Post-Traumatic Stress Disorder in Adolescence; Post Traumatic Stress Disorder

Summary: this study will implement a brief post-traumatic stress disorder (ptsd) intervention for children, the primary care intervention for ptsd (pcip) delivered through telehealth (computer or smart phone delivery), to 10 spanish speaking youth and their families. mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. following re-aim guidelines, the investigators will assess: reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. to understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. this treatment ranges from 1-3 sessions which last 30-50 minutes per session. the first session will cover psychoeducation about ptsd symptoms in children that can be delivered to the parent or both the parent and child. the first session will also teach the parent and child a breathing technique to combat the physiological impact of ptsd in children. the subsequent sessions will be tailored to meet the needs of the child's most distressing ptsd symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. each session contains coping skills that the parent and child can learn together. there is also material for parents to address behavior problems in youth. this treatment will be delivered via telehealth. all treatment materials have been developed in both spanish and english.


Eligibility criteria:
inclusion criteria: * patient referred to the shark program * patients must be at least 12 years old * screened for probable ptsd on brief ucla reaction index, or at provider discretion of clinical relevancy. * if patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study in english or spanish; * patient is able to complete study activities in english or spanish. exclusion criteria: * suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days; * patient is over the age of 22

Keywords: primary care ptsd post traumatic stress disorder randomized pilot feasibility trial spanish speaking adaptation
monitoring drug-induced uveitis

Conditions: Uveitis; Uveitis Drug-Induced; Eye Diseases; Uvea--Diseases

Summary: several drugs and chemotherapies seem to induce uveitis. this study investigates reports of uveitis, including the international classification of disease icd-10 for treatments in the world health organization (who) global individual case safety report (icsr) database (vigibase).

several drugs and chemotherapies seem to have an impact on the eyes and are responsible of uveitis. those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. this study investigates the main characteristics of patients affected by uveitis side effect imputed to drugs. a causality assessment according to the who-umc (world health organization - uppsala monitoring center) is systematically applied.

Eligibility criteria:
inclusion criteria: * case reported in the who's pharmacovigilance database till 01/04/2019 exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: uvea toxicity chemotherapies drugs