Kornimate/medical-research-clean huggingface dataset:
social safety learning in the brain oxytocin system

Conditions: Social Phobia

Summary: the investigators are conducting this research study to examine whether oxytocin enhances social safety learning (learning safety through the experience of another individual) in people with social anxiety disorder (sad) compared to healthy volunteers. oxytocin is a hormone that can also act as a chemical messenger in the brain. oxytocin plays a role in a number of functions, including responding to fear and social interactions. in this study, the investigators would like to compare the effects of oxytocin and placebo nasal sprays in adults with sad and healthy adults. this research study will compare an oxytocin nasal spray to a placebo nasal spray. about 120 people will take part in this research study, all at the university of washington (uw).

the goal of the current study is to examine the potential role of oxytocin in enhancing social learning in sad. the investigators' primary hypothesis is that vicarious extinction learning will contribute to safety learning and that oxytocin will potentiate vicarious extinction learning in patients with sad, compared to healthy controls (hc). the investigators will directly test the effect of intranasal oxytocin and matching placebo on the brain mechanisms underlying vicarious extinction learning using a novel task. 60 adults with sad and 60 healthy control participants will perform a task that involves three phases: (i) a standard social fear acquisition procedure while in a mock scanner, followed by (ii) a vicarious extinction and (iii) fear reinstatement test procedure, while being scanned during functional magnetic resonance imaging (fmri). participants will receive oxytocin or placebo prior to the extinction phase. the investigators will also measure skin conductance responses as an index of learning in each phase.

Eligibility criteria:
inclusion criteria: for clinical sample * men and women age 18-45 * women must be having regular menstrual cycles and not be taking oral contraception * primary diagnosis of social anxiety disorder for healthy sample * men and women age 18-45 * women must be having regular menstrual cycles and not be taking oral contraception * no current or lifetime history of psychiatric, neurological, or medical disorders exclusion criteria: for all groups * pregnancy or breastfeeding * positive urine drug screening test result * history of nasal pathology * current use of any psychotropic medication or steroids * active substance use disorder within the past 6 months * history of serious medical illnesses or untreated endocrine diseases * history of head injury, neurological disorder, or neurosurgical procedure * positive magnetic resonance (mr) screen for clinical sample * lifetime diagnoses of mania or psychotic disorder based on the diagnostic and statistical manual (dsm- 5th ed) * acute suicidal ideation for healthy sample * lifetime dsm-5 diagnosis of any medical, neurological, or psychiatric illness

Keywords: social phobia social anxiety disorder social safety learning intranasal oxytocin
homeless population and mental health: impact of primer la llar program

Conditions: Mental Health Disorder

Summary: the main goal is to evaluate the impact of the primer la llar housing program for the homeless population on the mental health of the participants. the hypothesis is that the housing program, which follows housing first model, for the homeless population has a positive impact on the mental health of the participants, compared to the group that does not receive the intervention -treatment as usual group (meaning the "positive impact" a lower score on the symptomatology scales and lower toxic intake in the group receiving the intervention).

the specific objectives are: identify the socio-demographic and clinical characteristics of the participants. compare the severity of psychiatric symptoms and improvement among the participants in the intervention group and the control group (depressive, anxious, psychotic or manic symptomatology, depending on the case). compare the consumption of alcohol and drugs among the participants of both groups. compare the basic daily life skills among the participants in both groups, as well as the improvement of them in the experimental group. compare the use of services and between the participants of the intervention group and the control group. intervention group receives entry to the program (which means individual and permanent housing without previous requirements such as abstinence, compliance with treatment or sobriety. control group receives treatment as usual, as they are users of homeless population network of barcelona.

Eligibility criteria:
inclusion criteria: * single people, adults (exceptionally sentimental couples, friends with positive support relationship for both). * long life on the street (minimum 1 year staying overnight on the street) and / or accommodation centers without linking, using them in a timely manner in the last year. * social needs concurrent to the lack of housing: mental illness and / or drug abuse. * functional autonomy for daily life. * have regular economic income or possibility of obtaining them. * sign informed consent form. exclusion criteria: * language barrier * severe neurological or organic pathology * severe dementia * alcoholic dementia wernicke korsakoff

Keywords: mental health housing first homeless
treatment of malaria in gabon with fosmidomycin-clindamycin

Conditions: Malaria

Summary: some antibiotics are also effective against malaria parasites. fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. a previous small study has shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of malaria parasites. the current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in gabon.

the treatment of malaria is becoming increasingly difficult due to the development of plasmodium falciparum strains resistant to commonly used antimalarials. fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late recrudescences preclude its use as monotherapy. clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies. in this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg) twice daily for three days is assessed in children with acute uncomplicated p. falciparum malaria.

Eligibility criteria:
inclusion criteria: * uncomplicated p. falciparum malaria with acute manifestation * asexual parasitemia between 1,000-100,000/μl * body weight between 5-65 kg * ability to tolerate oral therapy * informed consent, oral agreement of the child if appropriate * residence in the study area for the duration of at least 4 weeks exclusion criteria: * adequate anti-malarial treatment within the previous 7 days * antibiotic treatment for a concurrent infection * haemoglobin \<7g/dl * hematocrit \<25% * leukocyte count \>15,000/μl * mixed plasmodial infection * severe malaria, any other severe underlying disease * concomitant disease masking assessment of treatment response * inflammatory bowel disease, and any other disease causing fever.

Keywords: malaria fosmidomycin clindamycin gabon
study of infigratinib in children with achondroplasia

Conditions: Achondroplasia

Summary: this is a phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (fgfr) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with achondroplasia (ach) who previously participated in the propel study (protocol qbgj398-001) for at least 6 months. the study includes dose escalation with extended treatment, and dose expansion. the study also includes a pk substudy to fully characterize the pharmacokinetics of infigratinib in children with ach.


Eligibility criteria:
inclusion criteria: 1. signed informed consent by participant or parent(s) or legally authorized representative (lar) and signed informed assent by the participant (when applicable). 2. diagnosis of ach, documented clinically and confirmed by genetic testing. 3. at least a 6-month period of growth assessment in the propel study (protocol qbgj398-001) before study entry. 4. ambulatory and able to stand without assistance 5. able to swallow oral medication. exclusion criteria: 1. hypochondroplasia or short stature condition other than ach. 2. in females, having had their menarche. 3. height \ +2 standard deviations for age and sex based on reference tables on growth in children with ach. 4. significant concurrent disease or condition that, in the view of the investigator and/or sponsor, would confound assessment of efficacy or safety of infigratinib. 5. current evidence of corneal or retinal disorder/keratopathy. 6. history of malignancy. 7. currently receiving treatment with agents that are known strong inducers or inhibitors of cyp3a4 and medications which increase serum phosphorus and/or calcium concentration. 8. treatment with growth hormone, insulin-like growth factor 1 (igf-1), or anabolic steroids in the previous 6 months or long-term treatment (\>3 months) at any time. 9. treatment with a c-type natriuretic peptide (cnp) analog, fibroblast growth factor (fgf) ligand trap, or treatment targeting fgfr inhibition at any time. 10. regular long-term treatment (\>3 weeks) with oral corticosteroids (low-dose ongoing inhaled steroid for asthma is acceptable). 11. treatment with any other investigational product or investigational medical device for the treatment of ach or short stature. 12. previous limb-lengthening surgery or guided growth surgery. 13. fracture within 12 months of screening.

Keywords: skeletal dysplasia endochondral ossification ach shortened proximal limbs fibroblast growth factor receptor 3 fgfr3 endochondral bone formation short-limb disproportionate dwarfism dwarfism bone disease bone diseases, developmental musculoskeletal diseases osteochondrodysplasia genetic diseases, inborn inborn
multicentre clinical trial. project exime

Conditions: Menopause

Summary: objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with genitourinary syndrome of menopause. design: multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the community of madrid.

genitourinary syndrome of menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. those women with an active sexual life have fewer symptoms associated with this syndrome. objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with genitourinary syndrome of menopause. design: multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the community of madrid. population: women aged between 45-65 years with genitourinary syndrome of menopause attending to the midwife consultation. n= 250 (125 women in each group) will be included by midwifes in the primary health care consultations in the community of madrid. control group: women will receive the usual assistance. experimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. variables: main-quality of life in menopause (measured with the cervantes short-form scale). secondary- sociodemographic variables, sexual history and variables related to the genitourinary syndrome of menopause. analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. to explain the factors associated with a higher quality of life, a linear regression model would be fitted.

Eligibility criteria:
inclusion criteria: * women aged between 45-65 years with genitourinary syndrome of menopause exclusion criteria: * women who present pathologies that lead to an alteration of sexual desire * women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy * women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the genitourinary syndrome of menopause * women who could not read or write, and not understand the spanish language.

Keywords: primary health care
a study to evaluate safety and tolerability of bpt567 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a first-in-human phase ia/ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and maximum tolerated dose (mtd) or maximum adminstered dose (mad) of bpt567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.


Eligibility criteria:
inclusion criteria: * male or female aged ≥18 years at the time of signing informed consent form * measurable disease per recist 1.1 * histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography. * ecog performance status of 0 or 1 * life expectancy of at least 3 months * adequate organ and marrow function * contraception during study participation, as applicable exclusion criteria: * has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose. * treatment with biologic agents including anti-pd-1 or pd-l1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose. * received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose. * treatment with another il-18 therapy. * received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed. * certain clinically significant intercurrent disease. * primary immune deficiency. * active untreated brain or spine metastasis or leptomeningeal metastases. * known hiv seroposivitiy, although patients treated for hiv with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted. * active hepatitis a or acute or chroming hepatitis b or c infection. * received a live virus vaccine within 30 days of enrollment or a covd vaccine within 14 days.

Keywords: solid tumors
national french survey on psychological distress at work of anesthesia and intensive care residents

Conditions: Burnout, Professional; Intensive Care; Anesthesia; Depression, Anxiety; Stress, Psychological; Fatigue; Work Load

Summary: psychological distress is a significant problem for healthcare professionals and students in training. the investigator question the prevalence of this problem in french residents in anaesthesia and intensive care training.

the investigator performed an observational study on the national population of anaesthesia residents. a questionnaire was sent to all residents composed with validated questionnaires analyzing psychological distress (hospital anxiety and depression scale (hads), copenhagen burnout inventory (cbi), perceived stress scale (pss), karasek's questionnaire; work-related questions (work hours per week, night shift per month, application of safety rest after night shift, average time to start and end work, break time and time for food per day; two semi-open work-related questions (main stressor during internship, professional orientation); a free verbatim.

Eligibility criteria:
inclusion criteria: * resident of intensive care or anesthesia, french exclusion criteria: * none
autoimmune basis for postural tachycardia syndrome

Conditions: Postural Tachycardia Syndrome

Summary: the purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (pots). the investigators further hypothesize that electrical stimulation of the vagus nerve will improve pots symptoms, autoimmunity and inflammation.

the present study is designed to test the hypothesis that muscarinic autoantibody-mediated parasympathetic dysfunction contributes to the pathogenesis of pots, and that parasympathetic (vagal) stimulation improves pots symptoms, autoimmunity and inflammation. define and determine the prevalence, burden, and clinical significance of muscarinic autoantibodies in a well-phenotyped cohort of pots patients with and without gastroparesis and a matched cohort of healthy control subjects. evaluate the impact of vagal stimulation on antibody suppression, inflammatory inhibition, and symptom improvement in pots patients. non-invasive transcutaneous stimulation of the auricular branch of the vagus nerve (tragus stimulation) will be used to increase parasympathetic activity.

Eligibility criteria:
inclusion criteria: * 18-80 years old, female or male * either healthy control or individual with postural tachycardia syndrome (pots) defined as heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmhg fall in blood pressure), with chronic symptoms (\>6 months), and in the absence of other acute cause of orthostatic tachycardia * able and willing to provide informed consent * understand and be able to comply with the study procedures and restrictions exclusion criteria: * hypertension (\>150 mmhg systolic and \>100 mmhg diastolic) based on history or findings at screening * orthostatic hypotension (consistent drop in blood pressure \>20/10 mmhg with 10 min of standing) * cardiovascular disease, such as myocardial infarction within 6 months * history or presence of significant immunological or hematological disorders * history of vagotomy * currently pregnant women or women planning on becoming pregnant ≤ 3 months * inability to comply with the protocol * patients with active implants (such as a cardiac pacemaker, or a cochlear implant) healthy control subjects will be healthy, non-smoking and on no chronic medications at the time of the study. healthy control subjects will be group-matched to the pots patients for age and gender.

Keywords: pots vagal stimulation autoantibody
women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: metabolic profile in women of different body composition with polycystic ovary syndrome.

will be performed case-control study with women with polycystic ovary syndrome, according to the rotterdam criteria and body mass index between 18 to 29.9. the control group will consist of women without polycystic ovary syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. in both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. exams will be requested: metabolic profile (total cholesterol (mg/dl) and fractions, triglycerides (mg/dl), blood count, liver function (u/l) and classical glycemic index (mg/dl); hormonal profile - insulin (uiu/ml), luteinizing hormone (iu/l), follicle stimulating hormone (iu/l), thyreostimulating hormone (uiu/ml), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). body composition (bmi) will be performed by absorption technique of two low energy beams emitted by x-ray - full body densitometry (dexa). expected result: to evaluate visceral fat and truncal of patients with diagnosis of polycystic ovary syndrome without obesity.

Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome , body mass index of 18 to 29.9, without contraceptive use. exclusion criteria: * hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/ml) * cushing's syndrome * nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/ml in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal * antidiabetic and antiobesity drugs.
effectiveness of using the speedometer during colonoscopy

Conditions: Colonic Polyp; Colonic Adenoma; Adenoma Colon

Summary: purpose of protocol objective: to evaluate if the speedometer based on the real-time image analysis can help endoscopists increase their withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, during colonoscopy. hypothesis: the trial hypothesis is that use of the speedometer during colonoscopy will increase the average withdrawal time, which is defined as time spent examining the colon during withdrawal of the colonoscope, by 1.6 minutes, possibly increasing the performance of the participating endoscopists. our objective is to clarify the clinical benefits of this digital tool in colonoscopy. endpoint: withdrawal time difference between colonoscopies done without the speedometer (control period) and colonoscopies done with the speedometer (intervention period).


Eligibility criteria:
inclusion criteria: * both women and men aged 18 years or older undergoing colonoscopy for any indication at beth israel deaconess medical center (bidmc), boston, usa. exclusion criteria: * known colorectal cancer, hereditary colorectal polyposis, inflammatory bowel disease, or past history of colectomy.

Keywords: colonoscopy adenoma detection rate withdrawal time artificial intelligence