Kornimate/medical-research-clean huggingface dataset:
group therapy supported internet-based cbt for adolescents with social anxiety disorder - a feasibility trial

Conditions: Social Anxiety Disorder

Summary: the primary objectives of this study is to test the feasibility and efficacy of group-therapy supported internet-delivered cbt for adolescents (13 - 17 years) with social anxiety disorder. investigators will conduct an open trial with n = 30 participants. participants will be assessed at baseline, immediately after treatment and at a 6-month follow-up.

social anxiety disorder (sad) among youths is highly prevalent and causes significant impairment in the lives of the affected. in spite of cbt being the most effective treatment, evidence suggests that many young people with this disorder do not have access to good-quality cbt. internet-based cbt is, as numerous prior studies have shown, an effective method to treat psychiatric conditions in adults, but little is known about icbt for adolescents and there are but a few controlled studies on icbt for children and adolescents with anxiety disorders. this pilot trial will evaluate the feasibility and efficacy of a blended icbt-treatment where internet-based and group-based sessions are combined. furthermore, as icbt is a novel format in the treatment of psychological problems in young people, it is essential to evaluate the feasibility and acceptability of the technical solutions that carry the active treatment. the study will also include genotyping of participants to further our understanding of etiology of sad and to explore the relationship between genetic variations and treatment outcome. additionally, as there is little known about the affect of asd symptoms on treatment outcome in face-to-face cbt in general, and in icbt in particular, the association between autistic traits and treatment outcome will be evaluated. lastly, the role of attentional processes in the maintenance of social anxiety has been scarcely studied and an aim with the current study is to further our understanding of the cognitive factors that underlie sad

Eligibility criteria:
inclusion criteria: * a principal diagnosis of social anxiety disorder, as defined by dsm-5 * ability to read and write swedish * daily access to the internet through a computer or similar device * a parent or caregiver that is able to co-participate in the treatment * participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment exclusion criteria: * diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder * present risk of suicide * ongoing substance dependence * occurrence of domestic violence * completed cbt for any anxiety disorder within the last 6 months (defined as at least 5 sessions of cbt including in vivo exposure sessions)

Keywords: cognitive behavioral therapy; guided self-help adolescent
rapid activity of platelet inhibitor drugs study

Conditions: ST-segment Elevation Myocardial Infarction

Summary: the aim of the rapid study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, prasugrel and ticagrelor, in 50 patients with stemi undergoing ppci with bivalirudin monotherapy.

fifty consecutive patients with stemi undergoing ppci with bivalirudin (gp iib/iiia not allowed ) will be randomized to receive 60 mg prasugrel loading dose (n= 25) or 180 ticagrelor loading dose (n= 25) before ppci. the loading dose will be performed as soon as possible in the emergency room or in the cath lab. in the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered. all interventions will be performed by the femoral approach according to current standards. the use of thrombectomy before infarct-related artery stenting, of everolimus eluting stent and of closure devices will be strongly encouraged. bivalirudin will be administered as a bolus 0.75 mg/kg followed by 1.75 mg/kg/h infusion during pci. after pci a reduced bivalirudin infusion of 0.25 mg/kg/h for 4 hours will be allowed. dual antiplatelet therapy (100 mg aspirin associated with 5 or 10 mg prasugrel or 180 mg ticagrelor) will be recommended for 12 months. residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2, 4, 8 and 12 hours by a point-of-care test verifynow bedside available in the intensive cardiac care unit. high residual platelet reactivity will be defined as a platelet reactivity units (pru) \> 240 by verifynow. at the same time point, activated clotting time (act) will be also assessed. follow-up will be performed by outpatient visits or telephone interviews at 6 months.

Eligibility criteria:
inclusion criteria: 1. patients presenting within 12 hours from the onset of symptoms with stemi 2. informed, written consent exclusion criteria: 1. age \< 18 years 2. active bleeding; bleeding diathesis; coagulopathy 3. history of gastrointestinal or genitourinary bleeding \<2 months 4. major surgery in the last 6 weeks 5. history of intracranial bleeding or structural abnormalities 6. suspected aortic dissection 7. any previous tia/stroke 8. administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, gpi. 9. known relevant hematological deviations: hb \<10 g/dl, platelet count \<100x10\^9/l 10. use of coumadin derivatives within the last 7 days 11. chronic therapy with prasugrel or ticagrelor 12. known malignancies or other comorbid conditions with life expectancy \<1 year 13. known severe liver disease, severe renal failure 14. known allergy to the study medications 15. pregnancy

Keywords: platelet inhibitor st-segment elevation myocardial infarction stent prasugrel ticagrelor
radico pid cohort (radico-ild cohort in english)

Conditions: Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse; Paediatric and Adult Patients

Summary: the main objective is to describe the phenotypic features of the paediatric and adult patients with idiopathic interstitial pneumopathy/pneumopathy interstitial diffuse (iip/pid), at diagnosis and during the follow-up. these data will be critical for the description of the natural history of the various forms of iip/pid.

the french radico-pid : idiopathic interstitial pneumopathy registry is an ongoing observational prospective and retrospective cohort with longitudinal long-term follow-up includes pediatric and adult patients with idiopathic interstitial lung disease (ild) from the reference and competence centers.

Eligibility criteria:
inclusion criteria: * clinical criteria: chronic respiratory insufficiency manifestations including dyspnea/tachypnea, cough, and cyanosis during exercise or at rest * radiological criteria: characteristic chest high-resolution computed tomography (hrct) abnormalities including widespread ground glass or alveolar attenuation, reticulation often associated with traction bronchiectasis, and honeycombing * functional criteria: pulmonary function test abnormalities reflecting a restrictive pattern and including: loss of lung volume, vital capacity (vc), total lung capacity (tlc); reduction in the diffusion capacity of the lung for carbon monoxide (dlco), gas exchange abnormalities, and altered ventilatory response to exercise * patients (parents/guardians for paediatric/patients) having given an informed consent to participate in the protocol * patients affiliated to the "regime national d'assurance maladie" exclusion criteria: * patients with diffuse parenchymal lung diseases caused by drug toxicity, immunodeficiency, proliferative disorders including histiocytosis, and metabolic disorders * patients (parents/guardians for paediatric patient) not able to approve/understand the protocol
0.12% chlorhexidine oral care for the prevention of non-ventilator hospital-acquired pneumonia

Conditions: Hospital-acquired Pneumonia

Summary: chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. however, it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of non-ventilator hospital-acquired pneumonia among hospitalized patients.

participants will be classified into three groups, applied twice a day by care givers. oral colonization will be tested in the baseline, day-3, day-7, and at the discharge. quantitation of colonization of the oral cavity by oral rinses and respiratory pathogens were measured.

Eligibility criteria:
inclusion criteria: * hospitalized patients \> 20 years old without ventilator exclusion criteria: * known hypersensitivity to or intolerance of chlorhexidine or listerine

Keywords: 0.12% chlorhexidine oral rinse hospital-acquired pneumonia
evaluation of invisible preparation behaviors of middle and high school students in sports facilities (priceless)

Conditions: Sports Injury; Prevention; Training; Hydration; Nutrition; Sleep; Mental Health; Physical Well-Being

Summary: the investigators define the invisible preparation (ip) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. this includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. if some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field. the cms (brest metropolitan area sports medicine centre, france) aims at preserving the health of young athletes. prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the ip. under the direction of the brest university hospital, priceless (invisible preparation of middle and high school students in sports institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the ip.


Eligibility criteria:
inclusion criteria: * middle and high school students * being part of a sports institution (club, sport section at school, local training institution, or elite training institution) * absence of opposition from the patients or their legal representatives exclusion criteria: * primary school and college students * refusal to participate * significant mental or psychological disability, making it impossible to obtain reliable answers
ultrasound guided octreotide lar injection in acromegaly

Conditions: Acromegaly

Summary: approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide lar. this may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (im) compartment. ultrasound guidance of im injections may improve accuracy of placement of im injections and increase drug levels, thereby improving efficacy of octreotide lar for the treatment of acromegaly. the purpose of this study is to determine whether octreotide lar drug levels differ if given by ultrasound-guided im injection or by regular im injection in patients with acromegaly.


Eligibility criteria:
inclusion criteria: * diagnosis of active acromegaly based on evidence of a pituitary tumor * historical serum insulin-like growth factor (igf)-i levels or a lack of suppression of growth hormone (gh) \< 1 ng/ml during an oral glucose tolerance test * previous treatment with a stable dose of octreotide lar for at least 3 months * no previous treatment with a stable dose of octreotide lar for at least 3 months after receiving 3 months of octreotide lar during a run-in phase prior to any other study-related activity exclusion criteria: * uncontrolled diabetes mellitus * pregnant or breast feeding * current gallstones * history of hepatic disease, except patients with \< 3 x uln lfts indicative of hepatic steatosis * past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix * history of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous gh therapy * history of investigational drugs administered or received within 30 days of study entry * known hypersensitivity to octreotide lar * any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor

Keywords: acromegaly octreotide lar ultrasound guidance
intensive treatment on periodontitis in aortic stenosis

Conditions: Aortic Valve Stenosis; Periodontitis

Summary: the goal of this clinical trial is to determine if standardized periodontal therapy can effectively slow the progression of aortic valve stenosis in adult patients diagnosed with moderate aortic valve stenosis and coexisting gingivitis or mild-to-moderate periodontitis. the main questions it aims to answer are: can periodontal therapy slow the progression of aortic valve stenosis? is chronic periodontitis an independent risk factor for the accelerated progression of aortic valve stenosis? researchers will compare a group of patients receiving standardized periodontal therapy to a control group receiving only oral hygiene education to see if periodontal treatment results in a slower progression of aortic valve stenosis. participants will undergo initial screening to confirm eligibility based on aortic valve peak velocity and periodontal status. they will then be randomly assigned to either the treatment group, which will receive comprehensive periodontal therapy, or the control group, which will receive only oral hygiene education. participants will be followed up regularly over a 36-month period, with assessments including echocardiograms to monitor the progression of aortic valve stenosis, periodontal examinations to assess oral health status, and blood tests to measure relevant serum biomarkers. the study will also track any cardiovascular events and adverse events related to the interventions.


Eligibility criteria:
inclusion criteria: * aged 18 years or older. * aortic valve peak velocity (vmax) between 3.0 and 3.9 m/s. * diagnosis of aortic valve stenosis identified as degenerative aortic valve stenosis. * presence of gingivitis or mild-to-moderate periodontitis confirmed by periodontal probing or panoramic dental radiography. * willingness to participate in the study and signing of informed consent. exclusion criteria: * end-stage renal disease with egfr \&lt; 15 ml/min/1.73m² (according to the cockcroft \& gault formula). * pregnant, breastfeeding, and women of childbearing age (except those with effective contraception). * factors that may affect study follow-up or adherence to periodontal therapy. * patients unwilling or unable to undergo comprehensive periodontal treatment. * patients who do not consent to participate in the study.
gi-270384 study in patients with mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the aim of this double blind, placebo controlled, study is to evaluate activity consistent with efficacy provided by 14 days administration of gi270384x, and to provide preliminary pharmacokinetics and safety/tolerability of 14 days administration of gi270384x in patients with mild to moderate active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * females can be of childbearing or non-childbearing potential * subjects who have relapsing (relapsed = 6 weeks ago; this being at least a second episode) mild to moderate uc (score of 4 - 11 on the mtwi at screening and with an endoscopy score of = 2). diagnosis of uc originally must be established by sigmoidoscopy or colonoscopy, and have compatible histology. * as confirmed through signed informed consent, the subject must understand and be able, willing and likely to fully comply with study procedures and restrictions exclusion criteria: * subjects with severe uc according to the mtwi (score \>11) and subjects who have been in relapse for \> 6 weeks. * subjects are not eligible for this study if they have crohn's disease, proctitis (where the extent of inflammation = 15 cm), bleeding disorders, or active ulcer disease. * positive stool culture for enteric pathogens (including salmonella, shigella, yersinia, aeromonas, plesiomonas or campylobacter). * presence of clostridium difficile toxin present or with ova or parasites as detected by microscopy.

Keywords: gi-270384 colitis patients ecam oral
a trial investigating the pharmacokinetic properties of fiasp in children, adolescents and adults with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of fiasp (faster-acting insulin aspart) in children, adolescents and adults with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female aged 6-64 years (both inclusive) at the time of signing informed consent * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index (bmi) for children and adolescents (male and female) between the 3rd and 97th bmi percentile and for adults equal to or below 28.0 kg/m\^2 exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
a trial of tta-121 on autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: to test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and to compare effect sizes of different doses


Eligibility criteria:
inclusion criteria: 1. diagnosis of autism spectrum disorder based on diagnostic and statistical manual of mental disorders-v with score exceeding the cut-off value of 10 for qualitative abnormalities in social reciprocity on autism diagnostic interview revised (adir) 2. full scale intelligent quotient above 80 as measured using the wechsler adult intelligent scale-iii 3. written informed consent for participating the trial exclusion criteria: 1. diagnosis of bipolar disorder or schizophrenia spectrum disorder 2. primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectr um disorder 3. instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders 4. history of changes in medication or doses of psychotropics within one month before registration 5. current treatment with more than one psychotropics 6. history of hyper-sensitivity to oxytocin 7. history of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes 8. history of alcohol-related disorders, substance abuse, or addiction 9. family history of male breast cancer 10. subject who has severe complications 11. known hypersensitivity to some drugs and foods 12. subject who is not able to consent contraception during study period 13. participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent 14. other subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study
treatment w/ tri-luma® cream & intense pulsed light (ipl) vs a mild inactive control cream & intense pulsed light (ipl) in melasma

Conditions: Melasma

Summary: this study is to evaluate the efficacy and safety of tri-luma® cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) when used sequentially with a series of intense pulsed light (ipl) treatments in subjects diagnosed with moderate to severe melasma during a 10 week treatment period.

same as above.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with moderate to severe melasma on both sides of the face (investigator's global assessment (iga) at baseline must be 3 or 4.) exclusion criteria: * subjects with a diagnosis of skin cancer (basal cell carcinoma (bcc), squamous cell carcinoma (scc), melanoma) in the areas to be treated * subjects with prior facial intense pulsed light (ipl), resurfacing, deep or chemical peels within 6 months of the date of study entry * subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study
lungvitamin d and omega-3 trial (lungvital)

Conditions: COPD; Asthma; Pulmonary Function; Pneumonia

Summary: the vitamin d and omega-3 trial (vital; nct 01169259) is an ongoing randomized clinical trial in 25,871 u.s. men and women investigating whether taking daily dietary supplements of vitamin d3 (2000 iu) or omega-3 fatty acids (omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. this ancillary study is being conducted among participants in vital and will examine whether vitamin d or fish oil reduces respiratory morbidity, including copd and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.

chronic obstructive lung disease (copd) and pneumonia are leading causes of death in united states and worldwide. copd, which is also a significant source of disability, is increasing in prevalence. approximately 14 million adults have asthma, which leads to approximately 12 million missed work days per year in the united states. in adults, copd and asthma often coexist. treatment options for copd are limited, and prevalence of vitamin d deficiency is high. copd lung disease (copd, asthma, airflow obstruction), and most copd additional co-morbidities responsible for copd progression (e.g., respiratory infections/pneumonia, muscle weakness, cardiac failure) may benefit from vitamin d supplementation therapy, but this requires rigorous testing. marine omega-3 fatty acids work through different pathways from vitamin d to affect inflammation. observational studies and clinical trials suggest that consumption of fish and/or fish oil may protect against copd, asthma or pneumonia, but the data are not consistent. thus, there is a compelling need for a clinical trial to evaluate the potential benefits or risks of vitamin d and fish oil supplementation on copd and asthma exacerbations, airflow obstruction and decline of lung function, and risk of pneumonia. the primary outcomes of interest in lung vital are copd exacerbations; airflow obstruction and decline of pulmonary function; and pneumonia. asthma exacerbations and asthma control are secondary outcomes. a tertiary goal is to assess whether the effects of the interventions differ by baseline dietary intake or baseline blood levels of the nutrients. depending on the primary outcome, lung vital will be conducted among all participants in vital (nct 01169259), or in subsets of the vital population who were followed by detailed respiratory questionnaire and/or lung function testing.

Eligibility criteria:
* this study is open to all vital participants (nct 01169259). population includes men 50 years of age or older and women 55 years of age or older in the united states * participants who live in selected metropolitan areas of the u.s. (where we set up the infrastructure for clinic or home visits), are eligible for pulmonary function measurements.

Keywords: copd asthma pulmonary function pneumonia