Kornimate/medical-research-clean huggingface dataset:
tau pet imaging with 18f-av-1451 in subjects with mapt mutations

Conditions: Frontotemporal Lobar Degeneration (FTLD); Frontotemporal Dementia (FTD); Tauopathies

Summary: the study will investigate the ability of a new pet tracer, 18f-av-1451, to detect depositions of a protein, called tau, in the brains of people with a mutation in the tau gene that causes deposition of the protein, and in people without the mutation. up to three 18f-av-1451 scans will be performed (one per year) on control subjects without mapt mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.

approximately 40% of cases of frontotemporal lobar degeneration (ftld) are also associated with abnormal deposition of tau protein. the purpose of this study is to image mapt mutation carriers and their non-carrier relatives in order to study the use of this tracer as a biomarker in frontotemporal lobar degeneration with tau deposition (ftld-tau).

Eligibility criteria:
inclusion criteria: * members of families with established mapt mutations, who either have the capacity to consent to participate in the protocol, or else have designated a surrogate/proxy to consent to participate in this study exclusion criteria: * unwillingness to participate * usage of medication which significantly prolongs qt interval * pregnancy or plans for pregnancy within 90 days after participating in study

Keywords: ftld ftd
use of a biological mesh (stratticetm) for the prevention of parastomal hernia after colorectal surgery with colostomy

Conditions: Parastomal Hernia; Terminal Colostomy

Summary: in france around 5,000 colostomies are performed after elective or emergency surgery. these colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases. to reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception. nevertheless there is no data on the use of a biological mesh (stratticetm) for the prevention of parastomal hernia.


Eligibility criteria:
inclusion criteria: * patient requiring a colorectal surgery with a terminal colostomy * elective or emergency surgery exclusion criteria: * has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the pi. * has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability. * has an autoimmune disease, an immune deficiency, or is on immune suppression drugs * is pregnant, or lactating. * allergic to any porcine or collagen products. * survival \< 6 months

Keywords: strattice colostomy parastomal hernia
clinical evaluation of extensive direct composite restorations with polyethylene fiber

Conditions: Dental Caries Extending Into Dentin

Summary: the aim of this clinical trial was to compare the clinical performances of composite resin restorations with/without the polyethylene fiber to the first permanent molar teeth with extensively carious pediatric patients. a total of 75 restorations with (fc; n=38)or without (c; n=37) fiber were placed in the first permanent molar teeth. restorations were evaluated at baseline-6-12-18 months according to the modified-usphs criteria. data were analyzed with chi-square and cochran's q (p\<0.05).

fiber reinforced composite restorations developed in recent years have been presented to improve the negative properties of composite resin systems applied by the traditional method thanks to the fact that the fibers act as a crack stopper, reduce polymerization shrinkage by decreasing the the mass of composite resin material between the remaining dentin structure and the fiber. many authors having conducted tremendous experience in this field of research have reported that the polyethylene fiber is an innovative approach because it not only increases the flexural strength but also improves fracture toughness. its woven fiber orientation provides the stresses to be dispersed throughout the restoration, and therefore reinforces the restoration and the remaining tooth structure in multiple directions.

Eligibility criteria:
inclusion criteria: * no hypoplasia or any tissue abnormality in the teeth, * deep dentin caries with three tubercle loss in the teeth, need of three surface restorations with coverage of at least two adjacent cusps. * no evidence for pulpal complications * in occlusion exclusion criteria: * partly erupted teeth; -.absence of adjacent and antagonist teeth * poor periodontal status; * adverse medical history; * potential behavioral problems.

Keywords: composite resin clinical evaluation polyethylene fiber first permanent molars extensive carious
cobalamin supply and metabolism in healthy children from birth to the age of 12 months and in their mothers (cbl_neo)

Conditions: Vitamin B 12 Deficiency

Summary: introduction: infants with severe vitamin b12 (cobalamin, cbl) deficiency can develop severe, sometimes irreparable neurological damage in the first months of life. neonatal cbl deficiency is usually secondary and due to low maternal cbl stores, e.g. in vegan diets or pernicious anaemia. this cbl deficiency is then often also found in breast milk. in the austrian newborn screening (nbs) for congenital diseases of the cbl metabolism, newborns with secondary cbl deficiency are also frequently discovered. for these, the risk-benefit assessment of the invasive work-up and treatment that follows is complex. little is known about how cbl levels in maternal blood relate to those in breast milk and the corresponding levels in the child. objective: to investigate the effects of maternal nutrition and maternal cbl status on neonatal cbl levels. in the breastfeeding period, the effects of maternal nutrition on breast milk and infant cbl status will be investigated, as well as their relationship to the maternal and infant microbiome. we hypothesise that adequate cbl supply in early life is not determined by diet alone, but also by the interactions between diet and microbiome. design and methods: prospective cohort studies of 100 women and their children with measurement of cbl, methylmalonic acid, homocysteine and other metabolites of cbl metabolism in umbilical cord blood, maternal blood, dried blood spots and urine from the child at birth. the same parameters are measured in the mother's blood and breast milk after 3 and 9 months; in the child, only measurements of methylmalonic acid in the urine are carried out. a 3-day dietary record is taken from the mother at all measurement times, and from the child at the measurement times of 3 and 9 months. stool is collected from mother and child at all measurement time points to examine the microbiome relevant to cbl metabolism. a child development interview will be conducted with mothers by telephone at 12 months of age of their child. schedule: the study lasts 2 years with pre- and post-processing. the lkh bregenz has about 1200 births per year. assuming a willingness to participate in the study and an enrolment rate of about 20% of the women, a recruitment period of 6 months is planned (enrolment of first participant day 1, last participant end of study month 6; last laboratory parameter measurement end of study month 15; last child development interview study month 18).


Eligibility criteria:
inclusion criteria: * pregnant women * their newborns exclusion criteria: * children: preterm birth * children: neonatal disease * women: disease around birth * women: multiples pregnancy
proprioceptive postural control and chronic obstructive pulmonary disease (copd)

Conditions: Proprioceptive Postural Control; Chronic Obstructive Pulmonary Disease

Summary: proprioceptive weighting changes may explain differences in postural control performance. in addition, the respiratory movement has a disturbing effect on postural balance. postural balance seems to be impaired in individuals with respiratory disorders. increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. the aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria individuals with chronic obstructive pulmonary disease: * age: 40-80 years old * spirometry (post-bronchodilator) based diagnosis of copd (gold criteria) * willingness to sign the informed consent inclusion criteria healthy controls: * age: 40-80 years old * no copd (spirometry based: fev1/fvc ≥ 0.7 and fev1 \> 80%) * willingness to sign the informed consent exclusion criteria: * history of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant * one of the following conditions: parkinson, multiple sclerosis, stroke, history of vestibular disorder * respiratory disorder other than copd * α1-antitrypsin deficiency * known history of significant inflammatory disease other than copd * copd exacerbation within 4 weeks prior to study * lung surgery * recent diagnosis of cancer * therapy with oral corticosteroids in the last 6 weeks * significant cardiovascular comorbidity
safety and tolerability of mk-5478 in participants with hypertension (5478-001)

Conditions: Hypertension

Summary: this is a two part introductory clinical trial with mk-5478. part i will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of mk-5478 in young, healthy males. part ii will evaluate the safety, tolerability and pharmacodynamic effects of mk-5478 in participants with hypertension. the primary hypothesis is that single oral doses of mk-5478 are sufficiently safe and well tolerated.


Eligibility criteria:
inclusion criteria: part i: * is a male between 18 to 50 years of age * is in good health * is a non-smoker part ii: * is male of non-child bearing potential between 18 and 50 years of age * has hypertension (high blood pressure) exclusion criteria: part i and part ii: * has a history of stroke, seizures or major neurological disorder * has a history of cancer * has a history of any cardiovascular disease * is unable to refrain from the use of any prescription or non-prescription drugs * consumes excessive amounts of alcohol or caffeine * has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
a clinical study of t3011 in combination with pd-1/pd-l1 inhibitors in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this clinical study evaluated the efficacy and safety of t3011 in combination with pd-1/pd-l1 inhibitors in subjects with advanced solid tumors


Eligibility criteria:
inclusion criteria: 1. subjects with advanced solid tumors; 2. at least one measurable lesion; 3. eastern cooperative oncology group (ecog) performance status 0 or 1; 4. expected survival \> 12 weeks; 5. laboratory inspection meets the requirements; 6. for women of childbearing potential, the serum pregnancy test results must be negative prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (icf) until at least 6 months after the last dose; 7. male subjects of childbearing potential agree to use effective contraception from signing the icf until at least 6 months after the last dose; in addition, male subjects must agree not to donate sperm during this period; 8. understand and voluntarily sign the icf，willing and able to comply with all experimental requirements. exclusion criteria: 1. subjects who have received other antitumor therapy within the prescribed time prior to the first dose; 2. subjects with a history of other malignancies within the prescribed time prior to the start of study treatment. 3. at screening, subjects with a history or evidence of high risk cardiovascular disease; 4. subjects with persistent or active infection requiring intravenous anti-infective therapy; 5. subjects with autoimmune diseases or a history of autoimmune diseases; 6. subjects with known psychiatric disorders that may affect trial compliance; 7. subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment; 8. subjects requiring systemic treatment with anti-hsv drugs during the study period; 9. subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; subjects who have received any tumor vaccine in the past; 10. subjects who had undergone major surgery within the prescribed time before the first dose，and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period，or who plan to undergo major surgery during the study period; 11. subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the icf; 12. female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period; 13. the investigator considers it inappropriate to participate in this study.
effect of motor function, depression and sleep quality on attention in parkinson's disease

Conditions: Movement Disorders (Incl Parkinsonism); Parkinsonian Disorders; Attention Impaired; Movement Disorders, Functional

Summary: our study was planned to analyze motor function, endurance and sleep attention information in parkinson's patients with detailed and objective measurements.

parkinson's disease (pd) is a neurodegenerative disease that occurs with the loss of dopaminergic neurons in the basal ganglia (bg) and subsequently affects multiple brain regions. there are studies that evaluate executive functions rather than cognitive functions in parkinson's patients. however, objective evaluations of the attention parameter are quite rare. accordingly, our study was planned to examine the effects of motor function, depression and sleep on attention in parkinson's patients with detailed and objective measurements. parkinson's patients (n=27) and healthy controls (n=27) aged between 40-85 will be included in the study. balance evaluation of the individuals participating in the study was carried out by functional reaching test, one-leg standing test and berg balance scale; endurance with a 30-second sit-and-stand test; reaction time; with mobile application; muscle strength by hand dynamometer; functional mobility with time up and go test; walking speed, with 10 m walk test; attention with the p300 device; depression, with the beck depression scale; sleep quality will be assessed with the pittsburg sleep questionnaire. at the end of the study, the effects of motor functions, sleep and depression on attention will be examined and compared with healthy controls.

Eligibility criteria:
inclusion criteria: * being 1,2 or 3 according to the hoehn and yahr scale * being between the ages of 40-85 * being diagnosed with parkinson's according to upds * being able to read and write * being able to walk independently * agreeing to participate in the study after providing detailed information about the research. * mini mental test\>24 exclusion criteria: * having severe hearing/visual impairment-loss * having an orthopedic, neurological or metabolic disease that may interfere with working * having deep brain stimulation applied * those with advanced cognitive impairment * individuals with dementia * patients taking anticholinergic, antidepressive or anxiolytic medications that may affect cognition, and those with other medical or neurological causes that may cause cognitive effects.

Keywords: parkinson attention motor function sleep
study on safety, tolerability and immunogenicity of an mva vaccine administered to healthy subjects

Conditions: Smallpox

Summary: the purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male subjects, aged 20 - 55 years * signed informed consent exclusion criteria: * prior vaccination against smallpox (study part i only) * abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion. * any immune modifying therapy within 4 weeks prior to entry * participation in any other investigating drug trial * known allergy to a component which may be part of the vaccine * allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study part ii only)
human and digital support study

Conditions: Depression; Anxiety

Summary: the overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.

the overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. the meditation app of interest is the healthy minds program (hmp). the hmp app provides training in four pillars of well-being (awareness, connection, insight, purpose) through a combination of podcast-style didactic material and guided meditation practices. participants will be randomly assigned to receive or not receive an initial coaching call with a team member. participants will also be randomly assigned to receive or not receive access to email-based support. all participants with receive text messages encouraging them to engage in the practices taught in the app. participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). questionnaires and items will be selected from the set of questionnaires included in this application. the average length of time to complete questionnaires will be within 15 to 30 minutes. participants will also receive short daily surveys.

Eligibility criteria:
inclusion criteria: * adults (age ≥18) who have recently downloaded the hmp app * elevated symptoms of depression and/or anxiety * patient health questionnaire - 9 (phq-9) ≥ 5 * general anxiety disorder - 7 (gad-7) ≥ 5 exclusion criteria: * current suicidal or self-harm ideation (phq-9 item 9 \> 0) * current or past psychotic disorder * current of past bipolar disorder

Keywords: meditation app hmp healthy minds program
telehealth-enhanced assessment and management after stroke-blood pressure

Conditions: Hypertension Secondary

Summary: teams-bp is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of intensive tailored telehealth monitoring (ittm) versus intensive clinic management (icm) on blood pressure (bp) control and patient activation for bp management following stroke

the feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. the study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (black/african american, non-black/african american).

Eligibility criteria:
inclusion criteria: * diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on magnetic resonance imaging \[mri\]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting \> 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (ct) or brain mri * age ≥18 years * discharged directly home from acute care or inpatient rehabilitation * sbp\>130 at the post-acute clinic visit (within 21 days of discharge) \& at study visit 1 (within 31 days of discharge) * able to read and understand english or spanish * have access to a functioning smartphone or tablet with broadband access (required for the intervention) * willing to install and use a study-compatible physical activity monitoring application on their smartphone or smartphone of a qualifying caregiver * stated agreement to participate in either intervention to which they are assigned and attend all required study visits * consent to receiving short message service (sms) required as part of the study interventions * provision of a signed and dated informed consent form exclusion criteria: * subdural hematoma or subarachnoid hemorrhage * current participation in another stroke clinical trial precluding dual enrollment * presence of terminal illness, such as cancer, that limits life expectancy to \<1 year * diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis * pregnancy, lactation or planning to become pregnant * late-stage alzheimer's disease or related dementia * transitioned to a facility such as skilled nursing or long-term care prior to enrollment * any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial

Keywords: hypertension hypertension after stroke