Kornimate/medical-research-clean huggingface dataset:
cbt-based and motivational interviewing supported psychoeducation in obese individuals

Conditions: Obesity

Summary: the aim of this study is to examine the effects of cognitive-behavioral and motivational interview-supported psychoeducation on emotional eating and psychological resilience in obese individuals. the study will be conducted with a randomized controlled experimental design. the sample of the study will consist of 102 obese individuals in total, 51 in the experimental group and 51 in the control group, who meet the inclusion criteria. a cognitive-behavioral and motivational interview-supported psychoeducation program will be applied to the experimental group. all patients will be evaluated at three time points: pre-test (baseline), post-test (8 weeks), and follow-up test (3 months after the post-test). no intervention will be applied to the control group. the emotional eating scale and psychological resilience scale will be used as data collection tools in the study. as a result of the study, the hypothesis that the cognitive-behavioral and motivational interview-supported psychoeducation program is effective in reducing the emotional eating levels of obese individuals and increasing their psychological resilience levels will be tested. the findings of the study will contribute to the importance and effectiveness of psychological approaches in the treatment of obesity.


Eligibility criteria:
inclusion criteria: * obese individuals (body mass index 30 kg/m2 or more) * between the ages of 18-65 * not having any psychiatric disorder or not using psychiatric medication * volunteering to participate in psychoeducation * being in a physical and mental condition that will allow them to adapt to treatment * signing the informed consent form exclusion criteria: * having communication problems * having a medical condition (e.g. cushing syndrome, hypothyroidism) or taking medication that causes obesity * having a psychiatric diagnosis (e.g. depression, anxiety disorder, eating disorder) or taking psychotropic medication * being pregnant or breastfeeding * participating in another diet or exercise program

Keywords: obesity, cognitive behavioral, motivational interviewing
a study on the effects of midazolam on delirium after sevoflurane anesthesia in pediatric strabismus surgery

Conditions: Child; Anesthesia Morbidity; Delirium on Emergence

Summary: sevoflurane with its rapid induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. however, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. the purpose of this study is to verify that the prophylactic use of midazolam, which is a gaba a receptor inhibitor, given five minutes before the end of strabismus surgery reduces the incidence of emergence agitation after sevoflurane anesthesia in children. simultaneously, this study aims to find out the proper dose of midazolam with minimum disturbance to patient's emergence time.

sevoflurane is associated with a high incidence of emergence agitation in children. the etiology of emergence agitation is unclear. some studies proposed that emergence agitation was related to a variable rate of neurologic recovery rate in different brain areas and immaturity of neurons. inhalation anesthetics have been known to exert transient paradoxical excitatory effects in both animals and human patients, especially in children. the gamma(γ)-aminobutyric acid (gaba)a receptor is the target depressant effect site of most anesthetic drugs including sevoflurane. midazolam acts on the benzodiazepine binding site of gabaa receptors and results in inhibitory effects on the central nervous system. the effect of midazolam premedication, as well as midazolam administration at the end of surgery, on suppressing emergence agitation has been studied. however, the effect of midazolam on emergence agitation is still controversial. this study aims to figure out the effect of midazolam at the end of surgery on emergence agitation during the recovery period, and find out the proper dose of midazolam with minimum disturbance to patient's emergence time.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i and ii patients * aged one to 13 years scheduled to undergo strabismus surgery under general anesthesia * willing to be assigned to any of the study intervention groups exclusion criteria: * refusal by parents * neurological disease * developmental delay * history of any previous surgery * airway disease * american society of anesthesiologists physical status score of iii or iv

Keywords: emergence agitation midazolam sevoflurane strabismus
interest of topical spironolactone's administration to prevent corticoid-induced epidermal atrophy

Conditions: Cutaneous Atrophy Due to Corticosteroids

Summary: the purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent topical glucocorticoids which are the treatment of choice for many inflammatory skin diseases. this atrophy results in fragile skin, delay of healing, purpura, irreversible striae, telangiectasia and secondary infections. up to now, no treatments can prevent efficiently skin atrophy. the mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is expressed in human epidermis but its actual function is unknown. experimental results in animals obtained in inserm unit u772 by dr n farman suggest that spironolactone which is a mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote healing. study description we propose to test clinically these hypotheses for the first time on humans, at the cic in bichat's hospital on healthy volunteers: 1- by applying on the skin a highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by applying or not spironolactone on wounds after 3-mm punch biopsies.

Eligibility criteria:
inclusion criteria: * healthy volunteers of both sex, aged between 20 and 50 years * woman with effective contraception and pregnancy test negative before inclusion. * subject considered healthy after a detailed review (interview, clinical examination) * subject belonging to a social security scheme (beneficiary or have the right) * subject having signed a free and informed consent * integrity of the skin at forearms * subject available the next 7 weeks and able to go to cic once a day from monday to friday * subject accepting four skin biopsies at d29 * no washing forearms during 2 hours after applications exclusion criteria: * chronic alcoholism * drug-addiction (comprehensive interview with a sampling in case of doubt) * woman pregnant or breast-feeding * subject involved in another trial or in exclusion period of another protocol * subject has already received more than 3700 euros in compensation for damages suffered constraints in the past 12 months for his involvement in biomedical researches * subject has already participated in this protocol * phototypes 5 and 6 * clinical skin atrophy * history of severe chronic skin disease * problems of healing * treatment with oral corticosteroids, mineralocorticoids or spironolactone (aldactone, flumach, practon, spiroctan, spironone, aldactazine, aldalix, practazin, spiroctazine ...)

Keywords: aldosterone clobetasol atrophy skin epidermis wound healing mineral corticoid receptor spironolactone
mechanisms of mitochondrial defects in gulf war syndrome

Conditions: Gulf War Syndrome; Mitochondrial Disease

Summary: the purpose of the study is to investigate possible causes for gulf war syndrome. gulf war syndrome is associated with increased incidences of amyotrophic lateral sclerosis (lou gehrig's disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. abnormalities in the part of the cell known as mitochondria have been delineated in gulf war syndrome. mitochondria are the "power plants" of the body. mitochondria take the food you eat and break the food down into a form of energy that the body can use. the investigators propose that gulf war syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. this study will be the first investigation of mitochondrial function in gulf war syndrome. the investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify gulf war syndrome, and ultimately develop treatment protocols for gulf war syndrome.


Eligibility criteria:
inclusion criteria: * short-term memory loss or a severe inability to concentrate that affects work, school or other normal activities * muscle pain, myalgias * pain without redness or swelling in a number of joints * intense or changing patterns of headaches * unrefreshing sleep * after any exertion, weariness that lasts for more than a day exclusion criteria: * organ failure (e.g. emphysema, cirrhosis, cardiac failure, chronic renal failure) * chronic infections (e.g. hiv/aids, hepatitis b or c) * rheumatic and chronic inflammatory diseases (e.g. systemic lupus erythematosis, sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis.) * major neurologic diseases (e.g. multiple sclerosis, neuromuscular diseases, epilepsy or other disease requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits) * diseases requiring systemic treatment (e.g. organ or bone marrow transplantation; systemic chemotherapy; radiation of brain, thorax, abdomen, or pelvis) * major endocrine diseases (e.g. hypopituitarism, adrenal insufficiency) * myocardial infarction, heart failure * morbid obesity (body mass index \>40) * permanent psychiatric exclusions: lifetime diagnoses of bipolar affective disorders, schizophrenia or any subtype, delusional disorders of any subtype, dementias of any subtype, organic brain disorders, and alcohol or substance abuse within 2 years before onset of the fatiguing illness. * history of allergic reaction to lidocaine * history of keloid formation with skin incisions.

Keywords: gulf war syndrome gulf war illness mitochondrial defects mitochondrial disorders persian gulf syndrome
evaluate safety, tolerability, pk of tbaj-876 in healthy adults

Conditions: Pulmonary Disease; Tuberculosis, Pulmonary; Tuberculosis; Multi Drug Resistant Tuberculosis; Drug Sensitive Tuberculosis; Drug-resistant Tuberculosis; Mycobacterium Tuberculosis Infection

Summary: a phase 1, partially blind, placebo controlled, randomized, combined single ascending dose (sad) with a food effect cohort (part 1), multiple ascending dose (mad) (part 2), and relative bioavailability (rba) (part 3) study to evaluate the safety, tolerability, and pharmacokinetics of tbaj-876 in healthy adult subjects

this study is a three-part, partially blinded, placebo controlled, combined single ascending dose with food-effect, multiple ascending dose study, and a single dose relative bioavailability study conducted at one study center in the united states. safety will be assessed throughout the study for all subjects. safety assessments will include physical examinations, vital signs, serial ecgs, cardiac monitoring, adverse events (aes), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).

Eligibility criteria:
key inclusion criteria: all volunteers must satisfy the following criteria to be considered for study participation: 1. is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening. 2. has a body mass index (bmi) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg. 3. is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to grade 1 per dmid toxicity tables), as deemed by the investigator. 4. has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing. 5. if assigned to receive study drug under fed conditions, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required. key exclusion criteria: 1. history or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. 2. any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis). 3. has a positive test for hepatitis b surface antigen, hepatitis c antibody, or hiv at screening. 4. current or history of prolonged qt syndrome15. family history of long-qt syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer). 5. if assigned to the fasted/fed cohort, is lactose intolerant.

Keywords: tbaj-876 diarylquinoline darq
evaluation of genetic signature in endometriosis disease by non invasive sampling

Conditions: Endometriosis; Hypofertility

Summary: endometriosis is a disease that affects 10-15% of the general population and 50% of infertile women. it is characterized by the presence of endometrial tissue outside the uterine cavity. endometriosis can lead to infertility by interfering through endocrine and mechanical alterations on the function of the ovaries, fallopian tubes, and uterus. the aim of the study is to define the differential expression of a cluster of rnas tissue driven for the identification of an rna profile in saliva, specific for endometriosis. this study focuses on the expression of genes involved in the control and regulation of apoptosis, cell survival, metabolism, cell adhesion and invasion, angiogenesis, inflammation, and estrogen receptor expression levels.

retrospective selection based on anamnestic criteria of: 50 patients with diagnosed endometriotic adnexal pathology (case, ca), 50 patients with non-endometriotic adnexal pathology (control, co) and 50 patients with no gynecological pathology, not undergoing surgery (analytical control). the study involves collecting a saliva sample from all patients involved in the study, and performing a biopsy from both patients with endometriotic adnexal pathology (ca) and patients with non-endometriotic adnexal pathology (co).

Eligibility criteria:
inclusion criteria: * case population (ca), patients with endometriotic adnexal pathology * control population (co), patients with non-endometriotic adnexal pathology * analytical control population (c-), patients with no gynecologic pathology, not undergoing surgery exclusion criteria: * women with ages outside the inclusion range * pregnant patient * patient with a personal history of cancer * patient infected with hiv

Keywords: endo
effect of the fifa 11+ injury prevention program on performance & movement control in young female athletes

Conditions: Injury of Anterior Cruciate Ligament

Summary: in response to high injury rates in soccer, the fédération internationale de football association (fifa) developed an injury prevention program called the "11+". it is designed to replace a standard warm-up and takes about 20 minutes to complete. the program has proven remarkably effective in decreasing the rate of injury in soccer players. however, uptake of the 11+ has been less than desired. adoption of the program may be increased if additional benefits can be demonstrated and the program is introduced at a younger age. the goals of this study are to (1)establish that young athletes can tolerate the program, and (2)measure the effects of the 11+ program on the physical performance of 10-12 year old girls. three teams will be randomly assigned to the intervention group and carry out the 11+ program for the duration of the indoor soccer season. another 3 teams will continue with their usual warm-up. pre- and post-intervention, balance, agility, core strength and movement control will be assessed in all athletes. the investigators hypothesize that the athletes will tolerate the program well and that the intervention group will improve on the performance tests significantly more than the control group.


Eligibility criteria:
inclusion criteria: * bonivital club level soccer athlete exclusion criteria: * any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)
ichoose decision kidney aid for end-stage renal disease patients

Conditions: End-Stage Kidney Disease; Kidney Failure, Chronic; Kidney Transplantation

Summary: the investigators developed ichoose kidney -- a shared decision-making support tool accessible through ipad, iphone, or the web -- to provide esrd patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. the ichoose kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. the tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with esrd. this will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. one group of patients will receive standard education alone during their scheduled transplant evaluation. the second group will receive the standard education as well have the provider use the ichoose kidney aid with them. the project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation. this study will assess how well the ichoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. the study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.


Eligibility criteria:
inclusion criteria: * diagnosis of end-stage renal disease (esrd) and on dialysis for \< 1 year * english-speaking * subjects coming in for transplant medical evaluation * age \> 18 years exclusion criteria: * severe cognitive or visual impairment
a study of lcar-hl30 in subjects with relapsed/refractory hodgkin's lymphoma and anaplastic large cell lymphoma

Conditions: Hodgkin's Lymphoma; Anaplastic Large Cell Lymphoma

Summary: this is a prospective, single-arm, open-label, exploratory clinical study of lcar-hl30 in adult subjects with relapsed/refractory hodgkin's lymphoma and anaplastic large cell lymphoma.

this is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of lcar-hl30, a chimeric antigen receptor(car)-t cell therapy in subjects with relapsed/refractory hodgkin's lymphoma and anaplastic large cell lymphoma. patients who meet the eligibility criteria will receive lcar-hl30 infusion. the study will include the following sequential stages: screening, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment and follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participate in clinical research. 2. aged 18 to 75 years, either sex. 3. eastern cooperative oncology group (ecog) score 0-1 (dose escalation phase). ecog score 0-2 (dose expansion period). 4. histologically confirmed hodgkin's lymphoma or anaplastic large cell lymphoma with positive cd30 expression. 5. at least one evaluable tumor lesion according to lugano 2014 criteria. 6. expected survival ≥3 months. 7. clinical laboratory values in the screening period meet criteria. 8. effective contraception. exclusion criteria: 1. prior antitumor therapy with insufficient washout period. 2. previous treatment with car-t therapy, allogeneic hematopoietic stem cell transplantation. 3. severe underlying diseases; 4. hepatitis b virus surface antigen (hbsag), hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis c virus ribonucleic acid (hcv rna) or human immunodeficiency virus antibody (hiv-ab) positive. 5. presence of other serious pre-existing medical conditions that may limit patient participation in the study. any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

Keywords: hodgkin's lymphoma anaplastic large cell lymphoma
effect of telerehabilitation on handwriting performance in children with adhd: rct

Conditions: Handwriting; Telerehabilitation; Fine Motor Skills

Summary: this is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder.

it is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and hyperactivity disorder and their families will participate voluntarily. an informed consent form, bot-2 and minnesota handwriting test will be sent to volunteer participants via e-mail. an evaluation session on zoom application will be held for each participant with the participation of the occupational therapist, child and family. after the evaluation, the participants will be randomized and allocated to study and control groups. fine motor skills training will be given to the study group 3 sessions a week. the training will be given on the zoom application and the duration is 8 weeks. at the end of 8 weeks, the evaluation will be done again with bot-2 and minnesota handwriting test. the control group will be evaluated with bot-2 and minnesota handwriting test for the second time after waiting 8 weeks and will receive fine motor skills training.

Eligibility criteria:
inclusion criteria: * to be in the age range of 6-8, * diagnosed with attention deficit hyperactivity disorder-predominantly inattentive subtype according to dsm-5 and adhd rating scale-5, * continuing individual education, * after being informed about the study have agreed to participate in the study. exclusion criteria: * children with an additional physical and neurological problem to accompany

Keywords: adhd handwriting occupational therapy telerehabilitation