Kornimate/medical-research-clean huggingface dataset:
supportive program for mother with bpd

Conditions: Parent-child Problem; Borderline Personality Disorder

Summary: borderline personality disorder (bpd) is characterized by a pervasive pattern of instability of interpersonal relationships, self-image and emotions as well as marked impulsivity. when patients have children, they are at high risk of severe emotional and relational disturbances (withdrawal, low self-esteem, depression, suicidal thoughts). in addition, studies support the effectiveness of parental guidance group to reduce emotional and behavioral difficulties of children. to our knowledge there are no programs directed to mothers with bpd who received a controlled evaluation. from experience with parental guidance, data from the observation of children of patients with bpd and psychosocial programs directed to patients bpd, we have built for preventive intervention. the supportive program for mothers with bpd (supmother-b) consists of 10 group sessions providing information (education, childcare, care specific to bpd) and promotes mother-child interactions (observation, games). purpose: compare the effect of a program (supmother-b) group, of 10 sessions, offered to mothers with a bpd in addition to a minimal intervention (diagnostic announcement and provision of health care resources) on behavior withdrawal of children at 6 months compared to a group of mothers receiving only minimal intervention. primary outcome: difference at 6 months between the experimental and control groups on scores on the assessment scale withdrawal (alarm distress baby (adbb)).


Eligibility criteria:
inclusion criteria: mother: * women with children and at least one child aged 2 months to 2 years, borderline personality disorder with sidp (structured interview for dsm personality disorders) * age above 18 years * written consent child: * ages between 2 months and 2 years, * parental consent for research participation. exclusion criteria: mother: * chronic psychotic disorder, major depressive disorder, current mania or hypomania, * legal protection, * if no child can be included, the mother cannot be included. child : •major psychomotor development disorder or psychiatric disorder according to the investigator.

Keywords: bpd (borderline personality disorder) mother/child
feasibility and effects of a pickleball program for people with parkinson disease

Conditions: Parkinson Disease

Summary: pickleball is a fast-growing sport that has been shown to improve social integration, life satisfaction, function, and cognitive function in older adults. parkinson disease is a neurodegenerative disorder characterized by bradykinesia, rigidity, tremors, and postural instability. exercise has been shown to improve physical and cognitive function in people with parkinson disease (pd). the purpose of this study is to assess if a community pickleball program can be a feasible and effective for people living with pd.the primary aim of this study is to assess the feasibility of a group pickleball program for people with pd. secondary aims is to assess the effects of a 6-week pickleball exercise program on balance, gait, cognition, upper extremity function, pain, and quality of life in people with pd. this will be a pre-test, post-test single-group, prospective, mixed-methods study with 1- month follow-up. sixteen participants will be enrolled in a 6-week pickleball program, at a frequency of twice a week for one hour each session. feasibility will be assessed by retention rates, adherence rates, resources, and number of adverse events. quantitative data to be collected will include the mini-bestest, gait and body posture variables, parkinson's disease questionnaire-8, the shirt-buttoning task, 9 hole peg test, grip strength, pd-pain classification system, and the national institutes of health toolbox cognition battery. additionally, participants will be scheduled for small semi-structured focus group interviews to gain qualitative data about their experiences of the program. it is hypothesized that a pickleball program for people living with pd will be a feasible activity and will result in improvements in balance, gait, cognition, upper extremity function, and quality of life. additionally, it is hypothesized that participants will have a favorable opinion on the activity.


Eligibility criteria:
inclusion criteria: diagnosis of idiopathic parkinson disease, able to walk without an assistive device, and able to tolerate 45 minutes of activity with occasional seated rest. exclusion criteria: diagnosis of any other neurologic disorder, any current illness, injury, or cognitive function that would prevent ability to perform the study tasks, and not regularly participating in pickleball (less than 3 times a month).
peripheral reservoir of hiv dna in monocytes pivotal to cognition in hiv

Conditions: HIV Infections

Summary: sixty hiv participants will be enrolled and stratified by pbmc hiv dna levels, either high (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells). individuals will be enrolled into each group until filled. screening pbmc hiv dna levels will be performed at search in real-time with less than one-week turn around time. all individuals will intend to initiate arv due to meeting moph guidelines for such. the protocol team will work with the primary care physician to facilitate initiation of standard arv care; however, initiation of arv is not a requirement of the study and arv will not be provided by the study.


Eligibility criteria:
inclusion criteria: * hiv-infected individuals meeting moph criteria to initiate haart and planning to initiate haart within a month of screening. * consequently, all participants will have plasma cd4 counts at less than 250 cells. exclusion criteria: * head injury with loss of consciousness greater than 1 hour or cognitive sequela * current/past illicit drug use or positive drug screen for methamphetamines, amphetamines, or cocaine at screening or entry. * any of the following laboratory abnormalities: * pt/ptt \> the upper limit of normal (uln) or inr \> 1.1 * hemoglobin \< 9.0 mg/dl * alt \> 5x uln * serum creatinine \> 2x uln or creatinine clearance \< 30 cc per min by cockroft-gault formula * acute illness within 30 days prior, persistent and active aids-defining oi of any organ system or autoimmune disease. * current or recent fevers or meningeal signs suggestive of cns opportunistic infection * cns opportunistic infection, past or present (patients diagnosed with opportunistic infection after csf examination will be excluded from further analysis. in such a situation, an additional patient will be enrolled) * history of pre-existing neurologic disease to include stroke, multiple sclerosis or psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, major depression, or post traumatic stress disorder. patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll. * known learning disability including dyslexia or unable to read or write basic thai * positive hepatitis c serology (hepatitis c ab) * confusion or other signs and symptoms of metabolic encephalopathy or delirium * other conditions that could explain neurocognitive decline in the opinion of the investigator such as hypothyroidism, vitamin b12 deficiency or neurosyphilis * pregnancy or metal objects that would preclude mri

Keywords: hiv dna in monocytes
tumorspecific t-cell immunity in bladder cancer as prognostic marker

Conditions: Bladder Cancer

Summary: bladder cancer is generally susceptible to immunotherapeutic measures. the investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific t-cells and regulatory t cells. the found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy. it is hypothesized that those patients with a high number of tregs and no tumor-specific t-cells have a worse prognosis.


Eligibility criteria:
inclusion criteria: * histologically confirmed muscle-invasive urothelial carcinoma * age \> 18 years * hemoglobin \> 10g/dl * signed informed consent * karnofsky index \< 70% exclusion criteria: * clinically relevant second malignancy * severe comorbidities (e.g. nyha iii, end-stage renal disease) * chronic infectious disease (hiv, tuberculosis) * immunosupression * severe psychiatric diseases * blood donation in the last 4 weeks

Keywords: bladder cancer chemotherapy t cells immunotherapy tumor-specific immunity in bladder cancer
a study to describe routine treatment pathways in participants with major depression and active suicidal ideation with intent in italy

Conditions: Depressive Disorder, Major; Suicidal Ideation

Summary: the purpose of the study is to describe the pharmacological and non-pharmacological treatment utilization pathways in italian routine clinical practice of participants with major depressive disorder (mdd) and active suicidal ideation with intent.


Eligibility criteria:
inclusion criteria: * participant must meet diagnostic and statistical manual of mental disorders (5th edition) (dsm-5) diagnostic criteria for single episode or recurrent major depressive disorder (mdd), based upon clinical assessment * in the physician's opinion the current depressive episode is moderate-to-severe in terms of severity. * in the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's current active suicidal ideation with intent * participant must be capable of discernment * participant must be able to read and write in the italian language * participant must have signed the informed consent form (icf) indicating that he/she understands the study purpose and is willing to participate in the study * participant is in the site's catchment area, as evaluated by the investigator exclusion criteria: * participant currently (that is, at the time of enrolment and based upon clinical assessment) meets dsm-5 criteria for psychotic disorder, bipolar or related disorders, antisocial personality disorder, borderline personality disorder, intellectual disability, autism spectrum disorder, dementia * participant meets the dsm-5 severity criteria for moderate or severe substance or alcohol use disorder (except for nicotine or caffeine) within the 6 months before enrolment, based upon clinical assessment * participant has participated in or is currently enrolled in any clinical trial with experimental treatments within the current major depressive episode
study of inflammatory mechanisms in epidermolysis bullosa simplex- dowling meara

Conditions: Epidermolysis Bullosa Simplex Dowling Meara

Summary: introduction: epidermolysis bullosa simplex-dowling-meara (dm-ebs) is a rare genodermatosis characterized by spontaneous or post traumatic large cutaneous blisters. no curative treatment is actually available. some data suggest a role of inflammation in the occurrence of blisters. the aim of this study is to study the epidermis inflammatory mechanisms in dm-ebs. material and methods: a first retrospective immunohistochemical study will be led on remainder skin biopsies of dm-ebs patients took for the diagnosis. a second clinical multicentric prospective study will be led on 8 patients older than 1 year with severe dm-ebs. after informed written consent, they will answer to a standardized questionnaire. in case of flare of the disease, the liquid and the top of the blisters will be took. samples will be analyzed in the pr nicolas 851 inserm unit. after centrifugation of the liquid blisters, the repartition of inflammatory cells will be evaluated by fluorescence activated cell sorting on the pellet. markers of inflammation will be evaluated on the surnageant with luminex® technical with a multiplex targeting cytokines and chemokines. an immuno-histochemic analysis in association with a quantitative pcr will be made on the top of the blisters. if unknown, genotypic study will be made. perspectives: a better comprehension of physiopathological mechanisms in dm-ebs could offer new therapeutic ways.


Eligibility criteria:
inclusion criteria: * male or female * older than 1 year-old * severe dowling meara epidermolysis bullosa (more than 2 blisters per day) * systematic written informed consent * child consent * affiliated to french social security exclusion criteria: * younger than one year-old * no consent * non affiliated to french social security * participation to another clinical trial within 3 months ago * intercurrent disease justifying the withdrawal of the study * own patient decision to stop the study, withdrawal of informed consent

Keywords: dowling meara epidermolysis bullosa inflammation
assessment of hemostatic profile in liver cirrhosis

Conditions: Coagulation Disorder

Summary: our study included both in- and outpatients suffering from liver cirrhosis attending the out- and inpatient care of the department of hepatology. demographic and biochemical data as well as medical history including cause of liver cirrhosis, end stage kidney failure and medication with anticoagulants were recorded. to assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (mea) using multiplate (adp-, aspi- and trap-test) and thrombelastometry using rotem (extem, intem, fibtem).


Eligibility criteria:
inclusion criteria: * liver cirrhosis * age of ≥ 18 years * platelet count of at least 70 / nl exclusion criteria: * transfusion of platelet concentrate three weeks prior to inclusion * pregnancy * age \< 18 years * missing informed consent
method comparison and clinical specificity study: evaluation of the infinium hd cytogenetic abnormality test

Conditions: Post-natal Cytogenetics

Summary: the study will determine the performance of the infinium hd test. * the primary objective of the study is to assess the performance of the infinium hd test using banked dna samples extracted from whole blood patient samples derived from the intended use population. * the secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the infinium hd test.


Eligibility criteria:
method comparison - sample inclusion criteria the following are criteria for inclusion of extracted genomic dna samples in the method comparison sample pool: 1. sample is from a patient referred for post-natal cytogenetic testing. 2. sample gender is known. 3. sample quantity available for testing is ≥ 1 microgram of genomic dna at a concentration of 60-80 nanograms per microliter (60-80ng/µl). 4. sample is extracted genomic dna from edta or heparin-anticoagulated whole blood. 5. sample has been stored at 2 to 8°c or -15 to -25°c for no greater than three years from the date of extraction. 6. sample has been tested by a reference method. acceptable reference methods include karyotype, fish, qpcr, mlpa, and methylation analysis. method comparison - sample exclusion criteria 1. sample is from a patient not referred for post-natal cytogenetic testing. 2. sample is from a patient referred for cytogenetic oncology testing. 3. sample quantity \< 1 microgram of genomic dna or less than 60 nanograms per microliter (60ng/µl). 4. sample was improperly stored or was extracted from a sample that was improperly stored. 5. sample was tested by an illumina array during standard of care testing. clinical specificity - sample inclusion criteria the following are criteria for inclusion of extracted genomic dna samples in the clinical specificity sample pool: 1. sample gender is known. 2. sample is from a patient not referred for post-natal cytogenetic testing. 3. sample quantity available for testing is ≥ 1 microgram of genomic dna at a concentration of at least 60-80 nanograms per microliter (60-80ng/µl). 4. sample is extracted genomic dna from edta or heparin-anticoagulated whole blood. 5. sample has been stored at 2 to 8°c or -15 to -25°c for no greater than three years from the date of extraction. clinical specificity - sample exclusion criteria 1. sample is from a patient referred for post-natal cytogenetic testing. 2. sample quantity \< 1 microgram of genomic dna or less than 60 nanograms per microliter (60ng/µl). 3. sample was improperly stored or was extracted from a sample that was improperly stored.
monitoring of nocturnal hypoglycemia using earlysense monitoring device

Conditions: Type I Diabetes

Summary: this study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the earlysense es 16 device as a tool in the management of hypoglycemia in pediatric type i diabetes patients.

the study patients are children, 12-18 years old, suffering from type i diabetes. each patient will participate in the trial for 30 days. during this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the earlysense device which is put in the patient's bed. these measured values will be compared to: 1. glucose values measured by a "guardian rt" device - an approved device for cbgm - continuous blood glucose measurement; 2. glucose levels tested by sbgm -self blood glucose measurement. these comparisons will show whether the earlysense device is applicable in predicting hypoglycemia events in type i diabetes patients.

Eligibility criteria:
inclusion criteria: * age between 12-18 years * diagnosis of type i diabetes for at least a year * home close to participating center * guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the informed consent form. exclusion criteria: * recent (within 3 months) admission to emergency room or intensive care unit (icu) due to any condition unrelated directly to diabetes. * any other pre-existing medical pathology unrelated to diabetes. * inability of the patient or his guardian to use the guardian rt.

Keywords: diabetes hypoglycemia monitor children with type i diabetes
evaluation of sleep apnea related inflammation with crp, esr and neutrophil tolymphocyte ratio

Conditions: Obstructive Sleep Apnea

Summary: there is some evidence suggesting that osa is associated with low level of systemic inflammation and oxidative stress. low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. detection of altered inflammatory markers in osas patients may predict the degree of nocturnal sleep disturbance and associated systemic inflammation and presence of comorbidities. recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte ratio (nlr) have been proposed as an indicator of systemic inflammation. to our knowledge, nlr has not been studied in osas. we conducted the present study to evaluate the association between osas and inflammatory markers crp, esr and nlr.


Eligibility criteria:
inclusion criteria: subjects who were referred for polysomnography (psg) testing and performed the test were included exclusion criteria: patients with malignancy, diabetes mellitus, dyslipidemia, cardiovascular disease or hypertension, chronic inflammatory processes, thyroid dysfunction, chronic hepatic disease, renal failure, any acute- subacute infectious disease within past 2 months, if data are incomplete such as blood sample testing results, if they were unable to perform complete psg testing. -
a phase i study of safety and pharmacokinetics of nevirapine in hiv-1 infected pregnant women and neonates born to hiv-1 infected mothers

Conditions: HIV Infections; Pregnancy

Summary: to determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in hiv-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. to determine the short-term safety profile of mothers receiving zidovudine (azt) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving azt during the first 6 weeks of life. treatment of hiv-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to hiv-1 during parturition, decreasing the neonate's risk of infection.

treatment of hiv-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to hiv-1 during parturition, decreasing the neonate's risk of infection. pregnant women in active labor receive single doses of oral nevirapine. the neonates of the first 4-6 (per amendment 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (per amendment 8/27/96, was 4) patient cohort receive a single dose of nevirapine. if neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (per amendment 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * azt (mothers and neonates). * oral asthma inhalers (mothers). concurrent treatment: allowed: * phototherapy (neonates). mothers must have: * hiv infection. * estimated gestational age \>= 34 weeks. * no active opportunistic infection at study entry. per amendment 8/27/96: * a pre-enrollment plasma hiv-1 rna level greater than 10,000 copies/ml. exclusion criteria co-existing condition: mothers with the following symptoms or conditions are excluded: * intrauterine growth retardation. * fetal anomaly incompatible with life as determined by pre-entry ultrasound. * participation during current pregnancy in any other therapeutic or vaccine perinatal trial. * known hypersensitivity to any benzodiazepine. * serious bacterial infection. concurrent medication: excluded: * any antiretroviral other than azt. * corticosteroids (other than oral asthma inhalers). * anticoagulants. * any clavulanic acid-containing formulation (e.g., augmentin, timentin). * benzodiazepines other than study drug. * phenobarbital. * barbiturates. * antacids. * magnesium sulfate. prior medication: excluded: * prior nevirapine. current use of illicit substances and/or active chronic alcohol use.

Keywords: pregnancy pregnancy complications, infectious acquired immunodeficiency syndrome aids-related complex nevirapine