Kornimate/medical-research-clean huggingface dataset:
building regulation in dual generations - telehealth model

Conditions: Maternal Depression; Child Development; Child Mental Health

Summary: families who experience maternal mental illness and a variety of chronic stressors are currently underserved by the parenting programs. the investigators propose that impairments in maternal self-regulation, which result in unsupportive parenting, directly impact children's own self-regulation and neurobiology, leading to risk for intergenerational transmission of mental illness. the objective of this study is to develop and evaluate a program that is targeted at improving underlying self-regulatory mechanisms in both mothers with depression and their 3- to 5-year-old children. it is hypothesized that children exposed to maternal mental illness will have greater self-regulatory deficits across emotional and behavioural domains compared to children not exposed to mental illness. the effects of maternal mental illness are expected to be compounded for children of mothers reporting a higher degree of chronic stressors, including poverty, housing instability, violence, and low social support. further, it is hypothesized that taking a dual-generation intervention approach to addressing self-regulatory mechanisms underlying psychopathology at the level of the mother, child, and dyad (i.e. parenting interactions) will improve both maternal capacities and child outcomes. a feasibility study has been conducted in-person (nct04347707). results from this trial showed positive effects on child and mother well-being as well as parenting skills. our current study will be conducted remotely due to the covid-19 pandemic to adhere to public health guidelines to reduce in-person contact and physical distance. the objectives for this study are two-fold: 1) establish a better understanding of the self-regulatory processes that are altered in preschool-aged children exposed to maternal mental illness, and determine the mediating role of parenting behaviours, as well as the moderating impact of chronic stress exposure; and 2) evaluate a novel dual-generation intervention for mothers with mental illness using a virtual format and their 3- to 5-year-old children based on existing gold-standard evidence-based approaches.


Eligibility criteria:
inclusion criteria: * must have a 3-5 year old child * the child must not have a diagnosed developmental delay * must have full or joint custody of the child * must meet current criteria for a major depressive episode * must be 18 years of age exclusion criteria: * child is outside of the 3-5 year old age range * the child has a diagnosed developmental delay * mother does not have full or joint custody of the child * mother did not meet current criteria for a major depressive episode (control group)
surgical removal of idiopathic epiretinal membrane with and without the assistance of indocyanine green.

Conditions: Idiopathic Epiretinal Membrane, Cataract

Summary: it was the aim of the present study to prospectively compare the functional and morphological outcome of idiopathic epiretinal membrane surgery with and without the assistance of indocyanine green (icg). the main outcome measure was improvement of best-corrected visual acuity (bcva). this was treated as an open question and we had no hypothesis which of the two therapies was superior.


Eligibility criteria:
inclusion criteria: * patients with iem and cataract or posterior chamber intraocular lens pseudophakia complaining of loss of visual acuity and metamorphopsia during the past six months. exclusion criteria: * other retinal disease, non-idiopathic epiretinal membrane, glaucoma or history of retinal detachment.

Keywords: indocyanine green, toxicity, epiretinal membrane, visual field defect
a pilot study of monitoring insulin levels and treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with alpelisib for metastatic breast cancer.

Conditions: Metastatic Breast Cancer; Hyperinsulinism; Hyperglycemia Drug Induced

Summary: the goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.

1. to assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with alpelisib for metastatic breast cancer. 2. to assess the feasibility and safety of treatment with pioglitazone in these patients. 3. to assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol. 4. to assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol. 5. to assess the median progression free survival of patients treated according to this protocol

Eligibility criteria:
inclusion criteria: * patients with er positive her2 negative metastatic breast cancer, harboring an activating pik3ca mutation, scheduled to start treatment with alpelisib and fulvestrant. * ages 18 - 85 * ecog performance status 0, 1 or 2 * ability to understand and willingness to sign a written informed consent. exclusion criteria: * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of alpelisib * uncontrolled diabetes mellitus, defined as hba1c above 8% * diabetes mellitus controlled by insulin * uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * pregnancy * known allergy to pioglitazone
trial in periodontal tissue regeneration using fibroblast growth factor-2

Conditions: Periodontitis

Summary: the present clinical trial clarified that basic fibroblast growth factor-2 (fgf-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.


Eligibility criteria:
inclusion criteria: * diagnosed as 2- or 3-walled vertical intrabony defect \>=3 mm deep from the top of the remaining alveolar bone * with mobility of the tooth of degree 2 or less * with width of attached gingiva appropriate for guided tissue regeneration exclusion criteria: * concomitant administration of adrenal cortical steroid within 4 wks after the surgery * administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug * coexisting malignant tumour or history of the same * coexisting diabetes (hba1c \>= 6.5%) * an extremely poor nutritional condition (serum albumin concentration \<2 g/dl) * pregnancy or lactation
fetal loss in women with unprovoked thromboembolism (flute)

Conditions: Venous Thromboembolism; Fetal Death

Summary: the purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (vte) who do not have identifiable inherited thrombophilia compared with women who have the diagnosis of venous thromboembolism (vte) excluded.


Eligibility criteria:
inclusion criteria: * female * at least 18 years of age * symptomatic for unprovoked venous thromboembolism (deep vein thrombosis \[dvt\] or pulmonary embolism \[pe\]) * at least one pregnancy not terminated intentionally exclusion criteria: * previous vte in patients with current vte excluded

Keywords: venous thromboembolism vte thrombophilia fetal loss
the effect of remote ischemic preconditioning on diastolic function in coronary artery bypass surgery between diabetic and non-diabetic patients

Conditions: Coronary Artery Disease; Diabetes Mellitus; Diastolic Function

Summary: this randomized controlled study aims to evaluate the effects of remote ischemic preconditioning (ripc) on diastolic function in patients undergoing coronary artery bypass grafting (cabg). the study will compare diabetic and non-diabetic patients to determine whether ripc improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the e/e' ratio at multiple time points during the surgery.


Eligibility criteria:
inclusion criteria: * all adult patients scheduled for elective isolated on-pump cabg surgery for two- to three-vessel coronary artery disease. * both males and females will be included. * in the diabetic groups: type ii diabetes currently requiring and adhering to insulin therapy for at least the past 3 months * during cardiopulmonary bypass, the temperature will range from 28-33°c using an esophageal temperature probe. * antegrade warm cardioplegia will be given by the cardiovascular perfusionist. * baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery exclusion criteria: * combined cabg and valve surgery, emergency cabg. * type i diabetes, type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months * peripheral vascular disease (pvd) affecting the upper limbs. * acute coronary syndrome (acs); acute or recent myocardial infarction. * left ventricular ejection fraction ≤30%. * serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation. * renal failure, defined as egfr \< 30 ml/min/1.73 m² or requiring renal replacement therapy (dialysis). * liver failure, including child-pugh class b or c cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.

Keywords: coronary artery bypass surgery diastolic function remote ischemic preconditioning
effects of low versus high carbohydrate diet during rehabilitation on cardiovascular function and metabolism in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Overweight

Summary: compared to the traditional low fat diet for overweight patients with type 2 diabetes, recent evidence shows that low carbohydrate/high protein diets lower triglycerides and postprandial glucose levels more effectively. however, it is not known, whether this diet can also improve the subclinically impaired myocardial function in type 2 diabetes. this prospective parallel group and cross over design study compares the effects of a low glycemic and insulinemic diet (logi®) with an isocaloric traditional low fat diet during a three weeks rehabilitation programme with aerobic exercise for overweight type 2 diabetes patients testing the hypothesis, that the low carbohydrate diet improves myocardial function and insulin resistance.

this is a single center, short term therapy controlled and prospective study with blinded analyses of the ultrasound data in 41 patients with type 2 diabetes either on dietary control or oral antidiabetic medication. after recruitment and informed consent, patients are randomized to two treatment arms matched for age and concomittant antidiabetic and cardiovascular medication in one treatment arm, the diet is based on the logi components: 25% low glycemic index carbohydrates, 30% protein, 45% fat, taken for 3 weeks combined with aerobic exercise, while in the other treatment arm, the isocaloric traditional low fat diet is based on 55% mixed glycemic index carbohydrates, 20 % protein and 25% fat taken for three weeks and combined with the same aerobic exercise protocoll but followed by a two weeks period with logi diet and maintained exercise. in both treatment arms, antidiabetic and antihypertensive medication are maintained and/or adapted as necessary and recorded. all patients receive life style instructions and are updated in their skills of measuring quantity of foods and designing diet plans based on food groups. laboratory, clinical and ultrasound investigations are performed before and at the end of the three weeks programme and, in the cross over group, also at the end of the subsequent diet programme.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * oral antidiabetic medication or dietary control * overweight exclusion criteria: * coronary artery disease

Keywords: diastolic function postmeal glucose insulin resistance low carb diet type 2 diabetes
evaluation of the role of propionibacterium acnes in the inflammatory lesions associated with acne vulgaris

Conditions: Acne

Summary: the purpose of this study is to determine the response of acne patients and healthy control patients to the p. acnes bacteria. half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the p. acnes bacterium. anywhere from 1 to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for further analysis in the lab to determine whether the inflammation in these pimples can be reduced using anti-p.acnes antibodies.


Eligibility criteria:
inclusion criteria: * fits into one of the following diagnostic groups: 1. healthy subject with no active skin disease or history of skin disease 2. diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified leeds criteria with no reported use of topical acne treatments within the past 2 weeks prior to enrollment in the study, and no reported use of oral acne treatments during the past 4 weeks prior to enrollment in the study 3. diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified leeds criteria who has used any topical acne treatments in the 2 weeks prior to enrolling in the study, or who has used any oral acne treatments during the 4 weeks prior to enrolling in the study 2. age 18-60 years 3. male or female of any race and ethnicity 4. subject agrees to comply with study requirements exclusion criteria: 1. subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study 2. subject has netherton's syndrome or other genodermatoses that result in a defective epidermal barrier 3. pregnant or nursing females 4. immunocompromised subjects (e.g., lymphoma, hiv/aids, wiskott-aldrich syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history. 5. subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol 6. subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression) 7. active viral or fungal skin infections at the target areas 8. are currently receiving lithium now or within the last 4 weeks. 9. ongoing participation in an investigational drug trial 10. use of any systemic immunosuppressive therapy less than four weeks prior to screening. 11. subjects with diabetes 12. injured, broken skin that, per the investigator, may lead to poor wound healing 13. subjects with allergies to anesthetic medications
metacognitive therapy for obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the goal of this clinical trial is to learn if metacognitive therapy can be effective in a chinese sample of obsessive compulsive disorder (ocd) . the main questions it aims to answer are: can metacognitive therapy significantly reduce participants' levels of obsessive-compulsive symptoms? can metacognitive therapy significantly improve participants' metacognitive adaptations? the researchers will compare metacognitive therapy to a control condition without psychotherapy to see if metacognitive therapy is effective in treating ocd. participants will: receive the metacognitive therapy intervention or under control conditions for 8 to 15 weeks. be assessed for symptoms and metacognitive beliefs at pre-intervention, post-intervention and 12 weeks post-intervention

this study will be a randomised controlled clinical trial. participants who meet the enrolment criteria will be randomised into an experimental group and a control group. participants in the experimental group will receive 8-15 weeks of metacognitive therapy, while participants in the control group will receive the same amount of time of regular treatment without psychotherapy components. the researchers will assess participants' obsessive-compulsive symptoms and metacognitive levels before, after, and 12 weeks after the intervention. assessment measures will be the yale brown obsessive-compulsive scale (y-bocs) and the metacognition questionnaire (mcq-30). by comparing the assessment results of the two groups of participants, conclusions will be drawn as to whether metacognitive therapy can have a positive effect on a chinese ocd sample.

Eligibility criteria:
inclusion criteria: * two psychiatrists with the title of deputy chief physician or above jointly determine that the above diagnostic criteria were met * education level of junior high school or above, without mental retardation or audio-visual disorders * participation in the study is voluntary, and the informed consent is signed by the patient or his/her guardian exclusion criteria: * loss of or insufficient self-awareness, the presence of hallucinations, delusions, and other psychotic symptoms * the presence of severe depression, or self-inflicted suicidal attempts and behaviors * the presence of a history of alcohol or drug abuse * refusal of psychotherapy, or the ineffectiveness of those who had been involved in a full course of psychotherapy.

Keywords: obsessive-compulsive disorder metacognitive therapy
factors influencing wound healing after anal fistula surgery

Conditions: Anal Fistula Surgery

Summary: the objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. the primary questions this study aims to answer are: 1. does the use of the growth factor (new epi) contribute to accelerating wound healing, reducing the risk of infection, and enhancing patient recovery speed after surgery? 2. do other factors, such as infection, nutritional status, diabetes, surgical methods, patient age and overall health, immune status, and lifestyle habits, affect the healing of surgical wounds?


Eligibility criteria:
inclusion criteria: * patients over 18 years old. * have undergone anal fistula surgery with complete surgical records. * no significant surgical contraindications, such as:acute infection or inflammation,severe cardiopulmonary insufficiency,coagulation disorders,immunodeficiency,local skin lesions. * understand and are willing to participate in the study.willing to sign the informed consent form. exclusion criteria: * patients under 18 years of age. * pregnant or breastfeeding women. * individuals with pre-existing severe heart, liver, or kidney diseases. * individuals with active infections or systemic diseases. * individuals who have previously undergone similar surgeries. * individuals with immune dysfunction (such as hiv infection).

Keywords: ep ithelial growth factor new epi anal fistula surgery wound care
randomized trial of the neochord ds1000 system versus open surgical repair

Conditions: Mitral Valve Insufficiency

Summary: the objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).


Eligibility criteria:
inclusion criteria: * is a candidate for mitral valve repair with cardiopulmonary bypass * has grade iii moderate or grade iv severe degenerative mitral valve regurgitation * primary segmental prolapse of the a2 or p2 segment or prolapse extending to an adjacent segment (p1, p3, a1, a3) who have a single eccentric regurgitant jet on echocardiogram * anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement * anatomic and general suitability exclusion criteria: * prior mitral valve surgery * concomitant cardiac procedures * other cardiac procedures within 3 months

Keywords: degenerative mitral regurgitation
nephronophthisis : clinical and genetic study

Conditions: Nephronophthisis

Summary: to describe evolution of nephronophthisis

to specify the long term evolution of nephronophthisis in terms of renal disease as well as extra-renal damages for patients having a confirmed diagnosis of nphp1, nphp2, nphp3, nphp4, nphp5, nphp6 or nphp8 gene mutation

Eligibility criteria:
inclusion criteria: * nphp1, nphp2, nphp3, nphp4, nphp5, nphp6 or nphp8 gene mutation * 7 years old and older exclusion criteria: * mri contra-indications

Keywords: extra renal damages
brain attack surveillance in corpus christi--cognitive (basic-cognitive)

Conditions: Dementia; Dementia Alzheimers; Dementia, Vascular; Dementia, Mixed

Summary: the mexican american population in the u.s. is rapidly growing and aging. this project seeks to determine the prevalence and outcomes of cognitive impairment and dementia in mexican americans. it also seeks solutions to help patients with cognitive impairment and dementia and their caregivers get the resources they need.

hispanic/latinos will comprise more than 30% of the u.s. population by mid-century, and mexican americans account for the largest share of this growing segment of society. this proposal aims to use door-to-door surveillance in nueces county, texas, a non-immigrant, bi-ethnic community, to determine the prevalence and trajectory over time of cognitive impairment and dementia in mexican americans and non hispanic whites. the study will elucidate the mechanisms that explain the hypothesized ethnic disparity in alzheimer's disease and alzheimer-related dementias by evaluating the roles of vascular disease risk factors, educational attainment and socio-economic status among others. this research will also delve deeply into the differences in informal caregiving for mexican american and non hispanic whites with cognitive impairment and dementia. caregiver burden and mental and physical health of caregivers will be examined toward efforts to develop interventions that build resilience in caregivers. a novel ability of this population-based study is to examine community resources for both patients and caregivers, and how these provisions differ by ethnicity. using a rigorous mixed methods approach the study will identify the gap between available resources and needs for those with cognitive impairment and dementia. in this way we will be well positioned to propose ethnic-specific testable interventions that promote mental and physical health for those with cognitive impairment and dementia, as well as for those family members who provide the care. this research will therefore lead to improved well-being, autonomy and outcomes among those with cognitive impairment and dementia and their caregivers. the investigative team members have conducted research in this community for 20 years and are experts in mexican american culture and health, cognitive impairment and dementia, epidemiologic methods, community needs assessment and health behavior research. as the mexican american population continues its tremendous growth and aging it is vitally important to better understand the prevalence and outcomes of cognitive impairment and dementia in this population, and to rapidly develop interventions that address the burden of these common conditions in mexican american adults, families, and communities.

Eligibility criteria:
inclusion criteria: 1. \>64 years of age 2. moca \< 26 3. nueces county resident at least 6 months a year 4. english or spanish speaking 5. community dwelling or nursing home exclusion criteria: none

Keywords: caregiving hispanic mexican american epidemiology community