Kornimate/medical-research-clean huggingface dataset:
a neuro-technological intervention for adolescents with gad

Conditions: Generalised Anxiety Disorder

Summary: this study aims to evaluate the safety and acceptability of a basic neuro-technological intervention in the treatment of adolescents with generalised anxiety disorder (gad). our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro- / bio-feedback-based virtual reality (vr) game interface that is driven by a novel algorithm.

this study is a single-arm open-label test of feasibility. the recruitment target is 30. outpatient adolescents diagnosed with gad will be recruited to undergo 8 x 30 minutes intervention sessions over 4 weeks. participants who are enrolled will continue to receive treatment-as-usual prescribed by their treating psychiatrist, except for the use of psychotropics. this population is selected as they could elucidate whether our intervention can be beneficial as an early intervention program for gad. during the 8 bi-weekly intervention sessions, participants will don a head-mounted vr display set and a mobile eeg-biosensor. the hardwares are non-invasive.

Eligibility criteria:
inclusion criteria: * between 13 to 18 years of age inclusive * literate in english language * newly diagnosed with generalised anxiety disorder: current episode, based on computerised diagnostic interview schedule for children (c-disc) * if on medication, dosage stable or unchanged for at least preceding 8 weeks * has parental consent exclusion criteria: * diagnosis (as defined by dsm-5) of: anxiety disorder induced by medication, substance, or another medical condition; obsessive compulsive disorder; bipolar disorder; any psychotic disorder (lifetime); intellectual disability (i.e. iq\<70); autism spectrum disorder; attention-deficit/hyperactivity disorder * history of substance or drug use disorder (as per dsm-5 criteria) within the last 3 months * neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents) * metal in the cranium, skull defects, or skin lesions on scalp (e.g. cuts, abrasion, rash) at proposed electrode sites * irregular heart rhythms or heart problems * severe visual or hearing impairment * prior experience with mindfulness-based therapy (e.g. mindfulness-based stress reduction \[mbsr\], mindfulness-based cognitive therapy \[mbct\])

Keywords: brain computer interface neuro technological intervention neurofeedback
the efficacy and safety of sphenopalatine ganglion pulsed radiofrequency treatment for cluster headache

Conditions: Cluster Headache

Summary: the investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.

the investigators aim to investigate whether the sphenopalatine ganglion pulsed radiofrequency treatment is better than traditional sphenopalatine ganglion nerve block technology and provides medical evidence for the clinical application and promotion of sphenopalatine ganglion pulsed radiofrequency treatment to provide a minimally invasive, safe, and effective treatment for patients with cluster headache who do not respond to drug treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of cluster headache is confirmed according to the diagnostic criteria of the 2018 international classification of headache disorders 3rd edition (ichd-3); * patient's age is between 18 and 60 years; * patients seek treatment in the pain clinics of hospitals participating in the study within 5 days of the onset of the cluster period; pain conditions of patients remain the same after conservative treatment of conventional oral medication, or the reduction rates are less than 50% in pain degree during headache attacks, headache attack frequency, duration of each headache attack, and auxiliary analgesic drug dosage; and * patients signed the informed consent. exclusion criteria: * abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiogram, and chest radiograph; * infection at the puncture site; * previous mental illness; * previous history of narcotic drug abuse; * history of anticoagulant and antiplatelet aggregation drugs; * implantable pulse generator; * previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction; * pregnant or breastfeeding patients.

Keywords: cluster headache, pulsed radiofrequency
primary nasal cell culture as a tool for personalized therapy in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: characterization of cftr function and expression in nasal primary cells collected from patients with cystic fibrosis in comparison to their parents, healthy heterozygotes and healthy controls

3 groups of subjects are enrolled cf subjects according to their genotypes (aiming to enroll patients carrying 2 cf causing mutations with no cftr expression/function, and patients carrying at least 1 mutation with residual function, such r117h) parents or siblings of the cf subjects, as healthy hétérozygotes healthy controls all these subjects experience nasal brushings. from these nasal brushings,nasal cells are expanded, and cultured in air liquid interface to obtain polarized epithelium. this epithelium is then studied in ussing chamber experiments to characterize the level of camp dependant chloride transport and sodium reabsorption. apical expression of cftr is assessed by immunofluorescence. results will allow to define the variability of cftr function and expression criteria in subjects with the same genotype. such data are crucial for interpretation of the effect of cftr modulators.

Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis with 2 mutations in cftr * healthy heterozygotes with 1 mutation in cftr * healthy subjects with no familial history of cystic fibrosis and no symptoms suggesting cystic fibrosis exclusion criteria: * smoking

Keywords: biomarker
a latino msm focused pre-exposure prophylaxis uptake intervention

Conditions: HIV

Summary: the clinical study will evaluate the feasibility and acceptability of a culturally tailored behavioral intervention to improve uptake of pre-exposure prophylaxis for hiv prevention among at-risk latino men who have sex with men.

the clinical study will evaluate the feasibility and acceptability of a brief small group and peer navigation behavioral intervention to improve uptake of pre-exposure prophylaxis (prep) for hiv prevention among at-risk latino men who have sex with men. the brief intervention consists of 4 small group sessions with concurrent peer navigation and counseling. study participants will be randomized to either an intervention or control condition. participants in the control condition will receive usual care for prep promotion (i.e., referral to prep services). the study will determine the feasibility and acceptability of the intervention among latino men who have sex with men and assess the preliminary impact of the intervention compared to control condition in facilitating prep uptake.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * assigned male at birth * identifies as latino/hispanic origin * hiv-negative or hiv status unknown * man who has had sex with other men in the past 24 months * not currently using prep for hiv prevention exclusion criteria: * male under 18 years of age * not identifying as being of latino/hispanic origin * man who has not had sex with other men in the past 24 months * identifies as cisgender or transgender female/woman * assigned female at birth

Keywords: hiv prevention pre-exposure prophylaxis latino men who have sex with men
grow2gether pilot study

Conditions: Childhood Obesity

Summary: this is a randomized controlled pilot trial of a peer-based, social media intervention to prevent obesity in infants.

this novel intervention, delivered to mothers primarily through private facebook groups, will promote behavior change through peer and self-modeling photo/video activities. in this study, investigators will implement the intervention with small peer groups of 6-12 mothers, beginning during the 3rd trimester of pregnancy. investigators will assess feasibility and acceptability of the intervention, and explore its impact on outcomes, particularly behaviors associated with healthy growth.

Eligibility criteria:
inclusion criteria: * receiving prenatal care from hospital of the university of pennsylvania (hup) obstetrics practices * age 18 years and older * able to provide informed consent * able to speak, read and write in english * enrolled in medicaid at the time of study enrollment * overweight or obese (bmi ≥ 25, calculated using height and weight recorded at a prenatal visit prior to 14 weeks of pregnancy) * in ≥ 20th week of pregnancy * plan to receive their child's primary care services from children's hospital of philadelphia (chop) care network * own a smartphone with both a data and text plan * able to use their phone to obtain photographs and videos prior to enrollment exclusion criteria: * current diagnosis or history of major mental illness, as indicated in medical record by notation of (1) diagnosis or history of condition (2) current use or history of antidepressants or other psychotropic medication, or (3) referral to, or under care of a psychiatrist. * multiple pregnancy (twins, triplets, etc.) * severe morbidity (significant cardiac disease, significant organ dysfunction, transplant recipient, etc.)

Keywords: infants mothers social media obesity prevention
manual dexterity modifications after application of tsms over the primary motor cortex (m1)

Conditions: Stroke; Neurologic Disorder; Manual Dexterity

Summary: transcranial static magnetic field stimulation (tsms) is a novel brain stimulation technique that has been shown to be safe and effective in modifying biological parameters when applied to the cerebral cortex. its application decreases cortical excitability, regardless of the polarity of the magnetic field, reducing the amplitude of motor evoked potentials (mep). tsms is presented as a potentially useful tool in the management of the interhemispheric inhibition, a condition present in neurological pathologies such as stroke or multiple sclerosis. despite having demonstrated neurophysiological effects in previous studies, the effects of tsms application on force production and manual dexterity, have not yet been clearly established. the present study aims to evaluate changes in force production, manual dexterity, and fatigue after unilateral application of a tsms session on the primary motor cortex (m1). it is hypothesized that the application of tsms will momentarily decrease the parameters of strength and manual dexterity in the upper limb contralateral to the stimulated cortex, without changes in the strength and dexterity of the unstimulated hemibody. these parameters may show an increase in the unstimulated hemibody. if the hypothesis is confirmed, it could be considered a valid treatment for health conditions presenting interhemispheric inhibition.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years. * absence of cognitive impairment. * adequate understanding of verbal and written information, sufficient to complete the tests. exclusion criteria: * presence of metallic implants (e.g., neurostimulator, pacemaker, cochlear implant, or metallic elements in the head or around the eyes). * diagnosis of epilepsy or being under treatment with antiepileptic drugs. * diagnosis of unstable cardiovascular disease. * diagnosis of any disease or condition that may interfere with this study. * use of drugs that may influence with neuromuscular function (muscle relaxants or some analgesics...).
mi varnish for the prevention of white spot lesions

Conditions: White Spot Lesion; Orthodontic Treatment

Summary: the current study aimed to determine if mi varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the mi varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes.difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the enamel decalcification index (edi) scores.

orthodontists face two common iatrogenic treatment side effects, root resorption and enamel decalcification, with the latter occurring at a much higher frequency. while the processes that lead to enamel demineralization are understood, methods to diminish or perhaps eliminate degradation of enamel surfaces are being searched for. a new product, mi varnish, is current available and has been shown in some initial case reports to be useful in reducing white spot lesions. it contains a special milk-derived protein recaldent tm (cpp-acp) in which the casein phosphopeptides (cpp) bind to teeth, dentin, and oral mucosa while the amorphous calcium phosphate (acp) releases calcium and phosphate. the current study aimed to determine if mi varnish has an effect in preventing the formation of white spot lesions for patients undergoing orthodontic treatment. 33 subjects were prospectively recruited for the project as the mi varnish group, with a control group of 29 orthodontically treated subjects who received routine treatment and oral hygiene regimes. the study group received the mi varnish on the day of bracket bonding. subjects were recalled initially for 4 weeks (twice) and then at 3 monthly intervals. difference in prevention of white spot formation between the control and the study groups were evaluated through photographic records and clinical examination by using the enamel decalcification index (edi) scores.

Eligibility criteria:
inclusion criteria: * patients seeking orthodontic treatment and receiving routine treatment and oral hygiene regimes. exclusion criteria: * any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study; * patient is currently using any investigational drug or any other investigational device; * patient plans to relocate or move within six months of enrollment.

Keywords: enamel decalcification
a multicenter study to evaluate the effects of switching to aripiprazole 12 weeks on the sexual dysfunction from risperidone or paliperidone in patients with schizophrenia spectrum disorders or bipolar spectrum disorders

Conditions: Sexual Dysfunction; Hyperprolactinemia

Summary: this trial designed to investigate the effect of switching to aripiprazole from risperidone or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.


Eligibility criteria:
inclusion criteria: 1. age: 12-55 years (male), 12-40 (female) 2. diagnosis: schizophrenia spectrum disorders \& bipolar spectrum disorders (only korea) by dsm-iv-tr 3. receiving ris or pali with stable dose for \> 1 month by their physician; 4. prolactin level adult: \> 20 ng/ml (male), 25 ng/ml (female) child/adolescent: \> 20 ng/ml (male, female) 5. children and adolescents (age: 12\~17 years) having more than one sexual system dysfunction measured by 5 of the 48 uku items (galactorrhoea, gynecomastia and erectile dysfunction for male, galactorrhea, amenorrhoea/oligomenorrhoea, and dry vagina for female) or adults (age: 18\~55 years) who are considered to have sexual/reproductive dysfunction if they had either a total score of 19 or higher; a score of 5 or higher on one question; or a score of 4 or higher on 3 questions. 6. subjects who have consented to participate by signing an informed consent form. - exclusion criteria: 1. medical disorder or psychiatric comorbidity or condition known to affect prolactin, sex hormone balance or bone metabolism (i.e., unstable medical disease, cushing's disease, chronic renal failure, thyroid dysfunction, eating disorder) 2. history of hematological and/or solid malignancies 3. physical or functional obstruction to food intake or impaired digestive/absorptive function 4. known hypersensitivity to any study medication (risperidone, paliperidone, and aripiprazole) 5. insulin requiring diabetes mellitus or poorly controlled diabetes mellitus (hba1c \> 9% or change of antidiabetics treatment within the 12weeks prior to screening) 6. uncontrolled hypertension (sbp/dbp 140/90 mmhg), congestive heart failure (nyha class iii or iv), other significant cardiovascular illness (myocardial infarction, unstable angina, cardiac arrhythmia etc.) 7. baseline qtc interval of \> 450 msec 8. hepatic and/or renal dysfunction 1) bilirubin level ≥ 1.5 upper normal limits 2) ast/alt ≥ 3 unl or 3) serum creatinine ≥ 1.5 9. any patient hospitalized for acute exacerbation of their condition within 2 months of randomization 10. recent (within the past 1 month) or planned treatment with prohibited medications in the protocol -

Keywords: schizophrenia risperidone paliperidone aripiprazole
antenatal yoga intervention for depressed and anxious women

Conditions: Anxiety Depression

Summary: the aim of this study is to determine if a hospital-based antenatal yoga program (hb-ayp) is a feasible, acceptable and potentially efficacious intervention for women with antenatal anxiety and/or depression?

anxiety and depression are the most common psychological symptoms reported in pregnant women and can result in adverse obstetric, neonatal and post-partum mental health outcomes. although there is a range of effective first-line treatments for anxiety and depression, these treatments are not without limitations. concerns about the safety of antidepressant medication during pregnancy, lack of access to affordable psychosocial treatments and reluctance to seek mental health care due to stigma may prevent pregnant women from receiving optimal care for their symptoms. recently, there has been growing interest in alternative and complementary approaches to manage anxiety and depression. these approaches may offer women with antenatal anxiety and depression an alternative treatment option that may be more acceptable and perceived as more holistic and less stigmatizing than conventional mental health care. one way to optimize access to yoga therapy during prenatal care is to implement an antenatal yoga program within a public healthcare system. accordingly, the overarching aim of this study is to evaluate the feasibility of a hospital-based antenatal yoga program (hb-ayp) plus treatment as usual for anxiety and depression, and obtain preliminary data on its potential efficacy relative to treatment as usual plus biweekly clinical monitoring(tau) this pilot research will provide much needed preliminary data that will set the foundation for designing a fully-powered prospective randomized controlled trial (rct) of a hb-ayp. in the long term, it is hoped that this line of research will influence evidence-based clinical guidelines for managing antenatal anxiety and depression and service delivery.

Eligibility criteria:
inclusion criteria: healthy women in their second trimester of an uncomplicated pregnancy with elevated levels of anxiety and/or depression (based on the phq-9 and gad-7) will be eligible to participate - exclusion criteria: i) a lifetime history of psychosis, ii) symptoms of mania/hypomania in the past 12 months; iii) a history of substance use disorders in the last 6 months; iv) a history of self-harm in the last 6 months; v) high suicide risk; vi) engaged in a regular formal meditative practice at least once a month over the past 12 months; and vii) yoga postures are contraindicated.
efficacy and safety of immunoglobulin intravenous (human) 10% (newgam) in primary immune thrombocytopenia

Conditions: Primary Thrombocytopenia

Summary: newgam is a newly developed human normal immunoglobulin solution for intravenous administration (igiv). this study will evaluate the safety and efficacy of newgam 10% in patients with primary immune thrombocytopenia.

the primary objective of the study is to assess the efficacy of newgam in correcting the platelet count. the secondary objective of the study is to evaluate the safety of newgam. safety will be assessed by monitoring vital signs, physical examination, evaluation of adverse events (ae) and laboratory parameters, and viral safety testing.

Eligibility criteria:
inclusion criteria: 1. age of ≥ 18 and ≤ 65 years. 2. confirmed diagnosis of chronic primary immune thrombocytopenia (itp) (diagnosed with a threshold platelet count \< 100x10\^9/l) of at least 12 months duration. 3. platelet count of no more than 20x10\^9/l with or without bleeding manifestations. 4. freely given written informed consent from patient. 5. women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropin \[hcg\]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study. exclusion criteria: 1. thrombocytopenia secondary to other diseases (such as acquired immunodeficiency syndrome \[aids\] or systemic lupus erythematosus \[sle\]), or drug-related thrombocytopenia. 2. administration of intravenous immunoglobulin (igiv), anti-d immunoglobulin or thrombopoietin receptor agonists, or other platelet enhancing drugs (including immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for: * long-term corticosteroid therapy when the dose has been stable during the preceding 3 weeks and no dosage change is planned until study day 22. * long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose has been stable during the preceding 3 months and no dosage change is planned until study day 22. 3. unresponsive to previous treatment with igiv or anti-d immunoglobulin.

Keywords: itp primary immune thrombocytopenia