Kornimate/medical-research-clean huggingface dataset:
breaking silence through story: a narrative medicine intervention for parents of children with urogenital conditions

Conditions: DSD; Hypospadias

Summary: the goal of this clinical trial is to learn whether a journaling intervention can reduce stress and anxiety in parents of children with urogenital conditions (such as differences of sex development and hypospadias). the main questions it aims to answer are: * does guided journaling help to reduce anxiety levels in parents of children with urogenital conditions? * what are parents' perspectives on group-based writing interventions for future support programs? participants will: * complete a short anxiety questionnaire (the general anxiety disorder-7 scale) at the beginning of the study * receive a physical journal with 5 writing prompts designed to help process emotions related to their child's condition * complete 5 journal entries over several weeks, writing about their experiences and feelings * complete the same anxiety questionnaire again after finishing the journal entries * participate in a 45-minute interview to discuss how the journaling affected their stress levels and gather feedback on potential group-based writing programs


Eligibility criteria:
inclusion criteria: * parent or legal guardian of a child (age 0-17 years) diagnosed with a urogenital condition (differences of sex development and/or hypospadias) * able to read and understand english * child receives care at boston children's hospital * willing to complete a guided journaling intervention (through writing or dictation) over a period of approximately 5 weeks * willing to participate in a 45 minute follow-up interview * able to provide informed consent exclusion criteria: * parent/guardian with severe psychiatric disorder that would interfere with participation as determined by referring physician * parent/guardian unable to complete either written journaling activities or dictation * inability to provide informed consent

Keywords: disorders of sex development hypospadias anxiety stress, psychological parents psychological adaptation writing narrative therapy qualitative research patient participation social support mental health interpersonal relations parent-child relations urogenital abnormalities female urogenital diseases urogenital diseases penile diseases genital diseases, male genital diseases male urogenital diseases congenital abnormalities gonadal disorders endocrine system diseases
anti-cancer neoantigen polypeptide vaccine to treat solid tumors

Conditions: Solid Tumor, Adult

Summary: the wes and ran-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. in this phase i study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.

1. choose appropriate patients with advanced solid cancers, with written consent for this study; 2. perform biopsy to get fresh sample for dna/rna-seqencings and bioinformatics analysis; 3. produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required; 4. to enhance the killing capability, cotreatment the patients with pd1/pdl1/ctla4 antibodies may be applied; 5. evaluate the clinical results as needed.

Eligibility criteria:
inclusion criteria: 1. patients with advanced cancer; 2. life expectancy \>12 weeks; 3. adequate heart, lung, liver, kidney, and blood function; 4. available high quality vaccine for human use; 5. informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent. - exclusion criteria: 1. had accepted gene therapy before; 2. severe virus infection such as hbv, hcv, hiv, et al; 3. known hiv positivity; 4. active infectious disease related to bacteria, virus,fungi,et al; 5. other severe diseases that the investigators consider not appropriate; 6. pregnant or lactating women; 7. systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. other conditions that the investigators consider not appropriate.

Keywords: solid tumor polypeptide vaccine immunotherapy
efficacy of transcranial direct current stimulation (tdcs) for the treatment of major depressive disorder

Conditions: Major Depressive Disorders

Summary: the aim of this study is to assess the efficacy of transcranial direct current stimulation (tdcs) as an add-on treatment for the drug-naïve major depressive disorder. meanwhile, evaluate the effect of tdcs on cognitive function of drug-naïve mdd patients. furthermore, the investigators will examine the changes in cortisol, gut microbiome and some biomarkers. the hypothesis of this study is that tdcs alleviate the depressive symptoms and improve the cognitive function of drug-naïve major depressive disorder patients with regulating inflammatory response.

this is a randomized, double-blind, sham-controlled study using transcranial direct current stimulation (tdcs) for 4-week treatment. after the intervention of tdcs, there is a follow up visit at week 8 in order to understand the long-term effects of tdcs. participants were randomly assigned 1:1 to tdcs group or sham-control group. active tdcs comprised 20 min sessions of 2 ma direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks. sham was administered similarly, but with current turned off after 30s. apart from studying the effects of tdcs on severity of depression and cognitive function, the secondary outcomes are to examine biomarkers related to inflammatory activity. scale assessments are performed before the initiation of treatment, week 1, week 2, week 3, week 4 and week8. collection of blood, excrement and saliva takes place at three time points, at the baseline, week 4 and week 8.

Eligibility criteria:
inclusion criteria: * a current episode of mdd diagnosed according to diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * age between 18 and 50 years * a total score of hamd-17 ≥ 17 * take antidepressants less than 3 days * patients are compliant with treatment according to the judgement of the treating clinician. participant or guardian has to sign informed consent. the patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised. exclusion criteria: * a history of manic episode * use of mood stabilizer * history of substance abuse or dependence * severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma. * use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial * use of immunosuppressive medication such as oral steroid hormones women in pregnancy or lactation period

Keywords: drug-naïve major depressive disorder transcranial direct current stimulation (tdcs)
via family 4 year follow-up of a family-based preventive intervention

Conditions: Mental Disorder

Summary: this study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (via family) compared with treatment as usual (tau) for children of parents with a severe mental illness. background: children of parents with a mental illness have an increased lifetime risk of developing a mental illness themselves. preventive interventions for families with children with high familial risk can potentially disrupt the transgenerational transmission. the current study is a follow-up study of a trial investigating the effect of the preventive intervention: the via family trial. the via family trial investigated the superiority of a preventive family-based intervention, via family, compared with treatment as usual (tau) in improving children's, parents' and families' functioning and well-being. eligible families had at least one parent with a lifetime severe mental illness diagnosis ( i.e. recurrent major or moderate depression, bipolar disorder, or schizophrenia spectrum disorder), at least one child between the ages of 6-12 years and lived within the frederiksberg or copenhagen (denmark). the trial had a randomized, two-armed, parallel and controlled design. the participating families were randomly assigned to both groups with an allocation ratio of 1:1. the current study is a follow-up study aiming to explore the effect of the intervention 2.5 years after post-intervention. the main research questions for the current follow-up study are: 1. do children participating in the via family intervention experience a greater decrease in symptoms of mental illness from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with children allocated to tau? 2. do parents participating in the via family intervention experience a greater decrease in perceived parental stress from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with parents allocated to tau?


Eligibility criteria:
inclusion criteria: * child must have address registered in the municipality of frederiksberg or copenhagen. * at least one of the biological parents must have a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or recurrent major depression. * the parent with a diagnosis must have had at least one in- or outpatient contact with the mental health system within the lifetime of the child. exclusion criteria: * parents who do not speak and understand enough danish to be able to give informed consent for their own and for the child's participation. * if all family members are currently engaged in an intensive family intervention program addressing parental functioning and child development, they are excluded from the study.

Keywords: familial high-risk children preventive psychiatry offspring
auto-acupressure: effectiveness for diminishing neck pain of benign origin

Conditions: Neck Pain

Summary: the purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital pressure in points of acupuncture) added to the conventional treatment.

objective: to evaluate the effectiveness of the digital pressure in points of acupuncture added to the conventional treatment for diminishing the pain in patients with cervicalgia of benign origin. material and methods: pragmatic controlled randomized clinical trial. patients with diagnosis of cervicalgia of benign origin will include. they will be randomly assigned to receive just conventional treatment or this plus auto-acupressure. the professionals will once receive instruction in the centres of health by an experienced acupuncture professional that will supervise, in a workshop, the right application of the technique, that will consist of the application of manoeuvres of auto-acupressure by the own patient during periods of 10 minutes, once in a day during one week. the pain intensity will be evaluated by means of a millimetric scale of 10 cm (0 represents the pain absence, 10 the maximum imaginable pain, numerical scale rating). the pain will be measured in the inclusion and days 1, 3, 7, 30 and 90. the sample size has been calculated to detect a minimum difference of 1.5 points (ds 2) in the scale of the pain in day 7, which implies the recruitment of, at least, 80 patients by group (if losses don't exceed 20%). also the perception of the quality of life (euroqol-5d) and the functional capacity with the scale of oswestry will be evaluated, at the beginning, and days 3, 7, 30 and 90. the measures in each point between the group will be compared control and intervention. the evolution of the repeated measures will compare between groups with a generalized estimating equation (gee) model.

Eligibility criteria:
inclusion criteria: * patients who come to consultation of primary care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation. exclusion criteria: * injuries of skin (dermatitis, burns, sores, skin cancer) in the zone to massaging * structural injuries (bony fractures or injuries of muscles and tendons) in the zone to massaging * hemorrhage or tendency to suffer hemorrhage * chronic, serious diseases * malignant diseases and marked physical deterioration * psychiatric disorders * sensitive alterations * treatment with drugs of second or third level of the scale of the who which difficult to estimate changes for auto-acupressure * no sign the informed consent * difficulty of reading comprehension or visual alterations

Keywords: neck pain
phase ii double blind placebo controlled trial of risperidone in tourette syndrome

Conditions: Tourette Syndrome

Summary: objectives: i. conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (ris) in the treatment of children and adults with moderate to severe tourette syndrome. ii. evaluate further the safety of ris in this population.

protocol outline: this is a randomized, double blind, placebo controlled study. initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study. then, patients are randomized to receive either risperidone (ris) or placebo for 8 weeks. the dose of ris is increased weekly over the first 4 weeks of treatment, as tolerated. patients continue ris for 4 additional weeks at the dose prescribed during week 4. all patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- dsm-iv diagnosis of tourette syndrome (ts) tic symptoms greater than 3 (moderate or worse) on the global clinical impression scale for ts --prior/concurrent therapy-- no concurrent use of other medications during study a minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine --patient characteristics-- hepatic: no hepatic disease renal: no renal disease cardiovascular: * no heart disease * no hypertension pulmonary: no pulmonary disease other: * not pregnant * iq at least 70 required * no other movement disorder allowed, such as tardive dyskinesia * no major depression * no pervasive developmental disorder * no autism or psychotic disorder based on dsm-iv * no alcohol or substance abuse * no hypersensitivity to risperidone * all subjects must be in good health

Keywords: tourette syndrome neurologic and psychiatric disorders rare disease
air pollution and development in the boricua youth study

Conditions: Pollution; Exposure; Neurodevelopmental Disorders

Summary: this study seeks to understand the relationship between prenatal maternal air pollution exposure and offspring risk for adhd and examine two potential -modifiable- mechanisms: prenatal maternal inflammation and offspring sleep problems. we will employ a longitudinal neuroimaging study design and leverage a well-characterized intergenerational cohort of puerto ricans to address prior literature's limitations. this will be the first study to use infant neuroimaging to disassociate the effects of prenatal pollution exposure from those of postnatal pollution exposure, adversity and disadvantage, and offspring genetic risk for adhd.

the nyspi site is currently paused and has been paused since an institutional pause on human subjects research began in june, 2023. the u.s. department of health and human services (hhs) office of human research protections (ohrp) issued an fwa restriction on nyspi research that also included a pause of human subjects research as of june 23, 2023.

Eligibility criteria:
inclusion criteria: * having been enrolled in the bys-echo birth cohort (parent study). * speaks english or spanish. * having a parent that is eligible to participate, based on criterial detailed below, and agrees to participation. * one parent must speak english or spanish. exclusion criteria: * having serious neurological disorder, excluding asd (e.g., seizure disorder). * mri contraindications (irremovable metal in body like braces, pacemakers). * claustrophobia. * having a parent that is not competent to consent (e.g., severe intellectual disability would have triggered exclusion) or under 18 years of age.
clinical research center for dementia of south korea (credos)(or crcd)

Conditions: Alzheimer's Disease

Summary: the objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of alzheimer's disease(ad) and mild cognitive impairment(mci) in korea

the specific aims of this study is (1) construction \& maintenance of cohort for alzheimer's disease(ad) and mild cognitive impairment(mci); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral \& csf markers, neuroimaging(both structural \& functional)

Eligibility criteria:
inclusion criteria: * alzheimer's disease(ad) and mild cognitive impairment(mci)will be enrolled in the study. 1. the diagnostic criteria of alzheimer's disease(ad) according to dsm iv or nincds -adrda 2. the diagnostic criteria of mild cognitive impairment(mci) a. memory or other cognitive complaint preferably corroborated by an informant b. objective memory impairment or other cognitive for age and education c. largely intact general cognitive function d. essentially preserved adl e. not demented exclusion criteria: * exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.

Keywords: alzheimer's disease mild cognitive impairment cohort study
the efficacy of selective laser trabeculoplasty

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Pseudo-Exfoliative Glaucoma; Pigment Dispersion Glaucoma

Summary: selective laser trabeculoplasty (slt) is a new method to reduce intraocular pressure in eyes with open angle glaucoma or ocular hypertension. slt may also be effective for cases with previously failed alt procedures. we will study the efficacy and safety of the slt procedure.

selective laser trabeculoplasty (slt) has been shown to be a safe, well tolerated, and effective intraocular pressure reduction therapy for several forms of open-angle glaucoma. slt produces significantly less disturbance to the trabecular meshwork and is theoretically more repeatable than the alt procedure. this retrospective research will begin with cases treated in 2001. it will evaluate whether slt is effective for patients who have had prior treatment with alt and it will determine whether the iop lowering effect is sustainable over time. it will also assess the efficacy of repeated slt procedures.

Eligibility criteria:
inclusion criteria: * patients with primary open angle glaucoma, ocular hypertension, pseudo exfoliative glaucoma, pigment dispersion glaucoma exclusion criteria: * history of prior invasive glaucoma surgery

Keywords: primary open angle glaucoma ocular hypertension pseudo-exfoliative glaucoma pigment dispersion glaucoma selective laser trabeculoplasty intraocular pressure
cyclasol® phase 1 study

Conditions: Healthy

Summary: this study is intended to investigate the tolerability and the safety of cyclosporine a containing cyclasol® eye drops compared to placebo (vehicle) in a cohort of healthy volunteers. subjects will be randomly assigned to dosing with cyclasol® eye drops or placebo (vehicle) in the first part (first period) of the study, and switched to the alternative dosing in the second part (second period) of the study. an ophthalmological assessment of the eyes will be performed, and a questionnaire will be issued in the beginning and after each dosing. additionally physical examinations, safety laboratory and ecgs will be performed, and blood samples will be analyzed for cyclosporine a and placebo (vehicle).


Eligibility criteria:
inclusion criteria: * healthy male or female subject aged 18 - 45 years * nonsmoker, for at least three months prior to first dose of trial medication * bmi from 18.5 to 29.9 (kg/m2) * corneal/conjunctival staining oxford grading = 0° * schirmer i more than 10 mm/5min * tear film break-up time (tfbut) equal or more than 10 s * intra-ocular pressure between 10 and 20 mmhg * normal funduscopy * subject will have given their voluntary written informed consent to participate in the study in their own language and are willing to comply with the protocol exclusion criteria: * history of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) * history of dry eye disease, ocular surgery, corneal disease * known hypersensitivity to the drug substance * limbal stem cell deficiency * cicatricial pemphigoid * glaucoma or known steroid response on intraocular pressure * ocular allergy or incompatibility against ciclosporin or semifluorinated alkanes * punctual occlusion * corrected vision with glasses less than 0.7 on one or both eyes * contact lens wear 3 weeks before to the planned first drug administration and/or during the study * acute infection of ocular surface (bacterial, viral, fungal...) * acute trauma of ocular surface * no acceptable methods of birth control * pregnancy or breast-feeding period (females only) * use of any drugs whatsoever (including vitamins and herbals) for fourteen (14) days prior to the planned first drug administration (excluding contraceptives in women and single use of paracetamol or ibuprofen) * topical or systemic therapy with steroids, ciclosporin, non-steroidal anti- inflammatory drugs, tetracyclines or other immunomodulatory substances within last 90 days prior to the planned first drug administration or during this trial

Keywords: phase i study tolerability safety cyclasol® eye drops
resistance training in people living with hiv/aids

Conditions: HIV/AIDS

Summary: the aim of this study will be to verify effects of resistance training in people living with hiv/aids.

the aim of this study was verify effects of resistance training in cognitive function, body composition and biochemical parameters of inflammation and oxidative stress in people living with hiv/aids. the sample was composed by patients with hiv/aids of both sexes. the patients were randomized in two groups, a exercise group (eg), which was receive intervention with eight weeks of resistance training, and a control group (cg), that was not to do exercise. the cognitive function was analyzed with stroop test and trail test; body composition was evaluated by bioimpedance; blood tests was use to analyze biochemical parameters of inflammation and oxidative stress. for statistical analysis was used anova of two factors for repeated measurements, having the (eg and pg) group and the time (pre and post exercise). level of significance adopted was p \< 0,05.

Eligibility criteria:
inclusion criteria: * clinical diagnostic for hiv/aids. * clinical condition and viral count stabilized. * have been using (haart) for 6 months or more. * not have participated in physical exercise programs in six months before beginning of study. * not have muscle or joint injuries that make it impossible to practice physical activity. * not be pregnant. exclusion criteria: * not attending more than 15% of the intervention sessions or visits to the laboratory. * aggravation of the disease. * stick to a physical activity program in addition to that offered by the study.

Keywords: exercise cognition body composition inflammatory biomarkers cd4