Kornimate/medical-research-clean huggingface dataset:
phase 1 safety study with intravitreal (ivt) regn2176-3 in patients aged 50 years and older with wet amd

Conditions: Neovascular Wet Age-related Macular Degeneration (AMD)

Summary: the primary objective of the study is to investigate the safety of intravitreal (ivt) regn2176-3 in patients with neovascular wet age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: key criteria: men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (cnv) secondary to wet amd. exclusion criteria: 1. any prior treatment with an inhibitor of pdgf (platelet-derived growth factor) or pdgfr (platelet-derived growth factor receptor) 2. active neovascular amd in the fellow eye requiring treatment 3. scar, fibrosis, or atrophy in the study eye involving the center of the fovea 4. presence of retinal pigment epithelial tears or rips involving the macula in the study eye 5. prior vitrectomy in the study eye 6. any history of macular hole of stage 2 and above in the study eye 7. any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery 8. history of corneal transplant in the study eye 9. positive serum human chorionic gonadotropin (hcg)/ urine pregnancy test at the screening or baseline visit the information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.
a study to explore association patterns between digital outcome assessments from the konectom™ platform and magnetic resonance imaging (mri) measures of brain tissue damage

Conditions: Multiple Sclerosis (MS)

Summary: the purpose of the study is to explore association patterns between digital outcome assessments from konectom and mri measures of brain tissue damage.


Eligibility criteria:
inclusion criteria: * should be enrolled in multiple sclerosis partners advancing technology and health solutions (ms paths). * participant (or participant's legal representative) has the ability to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. * should have literacy of written language in which the software and instructions for use are displayed (user interface \[ui\], instructions). exclusion criteria: * unable or unwilling to provide informed consent. * inability to use a smartphone as per physician's opinion. * not owning a konectom-compatible smartphone. * other unspecified reasons that, in the opinion of the investigator or biogen, make the participant unsuitable for participation in the sub-study. a participant only needs to complete the assessments deemed necessary by the investigator. note: other protocol defined inclusion/exclusion criteria may apply.
refining risk prediction models for older adults using electronic health records

Conditions: Predictive Modeling

Summary: this study aims to improve how lab results are communicated to older adults by refining a predictive model that uses electronic health record (ehr) data. the model was originally developed to estimate the risk of chronic kidney disease (ckd) progression. researchers will use existing health data to test and improve the accuracy of the model and explore how it might be adapted for use in other health conditions. the study does not involve direct interaction with patients and is conducted entirely using de-identified data in a secure environment.


Eligibility criteria:
inclusion criteria include, but are not limited to: * being over the age of 65; having at least 5 years of clinical follow up; and having a serum creatinine lab test conducted exclusion criteria: * patients younger than 65 years old * patients with less than 5 years of clinical follow-up * patients from health systems outside of the uc health network.

Keywords: lab result communication risk stratification
mindfulness based cognitive therapy for recurrent depression

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to investigate the effectiveness and possible mediating factors of mindfulness based cognitive therapy (mbct) for recurrent depression.

mindfulness based cognitive therapy (mbct) is a 8 session group intervention and is well described by several authors. previous studies showed mindfulness based cognitive therapy (mbct) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes. study aims are: 1. to replicate previous findings in the netherlands, by a research team which did not develop the intervention 2. to investigate if mbct is applicable for patients with recurrent depression and current depressive symptoms 3. to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment in this study, patients are randomly assigned to a mbct intervention group or a waiting list control group. patients allocated to the waiting list control condition will receive the mbct course three months later. all patients who participated in a mbct training will be assessed during the year following the completion of the mbct course. we aim to include about 220 patients.

Eligibility criteria:
inclusion criteria: * 3 or more previous depressive episodes * if treated with medication: constant dose of at least 6 weeks exclusion criteria: * bipolar disorder * psychotic disorder * neurological or somatic illness affecting depression or outcome measures * current alcohol or drugs dependency * acute need of psychiatric treatment

Keywords: recurrent major depressive disorder mindfulness based cognitive therapy randomized controlled trial
comparative study of skin prick allergy test measurements between current manual procedure and nexkin dspt device

Conditions: Allergy

Summary: clinical trial with the aim to evaluate the level of agreement in wheal size measures in allergy skin prick testing (spt) between the electro-medical device nexkin dspt® and the manual measurement procedure used in the daily practice.

the purpose of the trial is to evaluate the concordance of measurements obtained by the nexkin dspt device versus the measurements obtained manually. a prospective clinical trial study was conducted at clínica universidad de navarra. spt will be tested in the same way as during a routine visit, with the only difference being that the images of the arm required for the device to operate will be captured. nexkin dspt device is a non-invasive device, which does not perform the procedure of puncture and appearance of papules. the device is only used to read the test results. there is no risk to the patient or the healthcare professionals involved in capturing images with the device. device does not provide a diagnosis and it is not a substitute for sound medical judgment. the study will prospectively include patients attending the allergy consultation (sample size calculated in 93 patients) with positive (histamine) and negative (saline solution) controls. fifteen minutes later, two consecutive readings with the device and two manual readings were performed by two different nurses. the area of the histamine wheals was measured automatically by nexkin dspt and after the manual procedure measured manually by planimetry.

Eligibility criteria:
inclusion criteria: 1. patient to be tested with aeroallergen and/or food battery prick tests. 2. patient over 12 years of age. 3. patient, or his/her representative, who has given consent to participate in the study. 4. patient who has not taken an antihistamine for more than 3 days. 5. women of childbearing age who, at the time of taking the clinical history, declare that they are not pregnant. exclusion criteria: 1. patients who are to be tested with a prick number greater than 40. 2. patients who are to be tested with a prick number less than 40, but for whom it is necessary to place more than two rows of allergens in at least one of the arms. 3. patients who have taken an antihistamine within the previous 3 days. 4. patients who are being treated with antidepressants or other drugs with an antihistamine effect. 5. patients who suffer severe atopic dermatitis affecting the forearms. 6. patients with dermographism. 7. patients who are to undergo intradermal testing. 8. pregnant women or women suspected of pregnancy.

Keywords: skin prick test allergy skin testing spt 3d imaging allergy testing allergy test reading automatic measurement
va cultivating access to resources, education, and skills for dementia caregivers

Conditions: Dementia; Caregivers; Neurodegenerative Diseases; Brain Diseases

Summary: the purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of veterans with dementia.

according to va estimates, nearly 500,000 veterans suffer from dementia. there is currently no cure for dementia. ultimately, dementia will have a large impact on quality of life in veterans and families, lead to expensive nursing home placement, and decrease life expectancy for patients and family caregivers. the experience of high burden in a caregiver for a veteran with dementia increases the likelihood of permanent nursing home placement and can separate veterans from their families. to address the high burden of caring for a veteran with dementia, the investigators aim to study the effect of a rehabilitative intervention for family caregivers of veterans with dementia. this novel approach will use video technology that can reach caregivers in rural areas who do not have easy access to major va medical centers.

Eligibility criteria:
inclusion criteria: inclusion criteria -- participants must: * be adults (age 18) * report distress associated with being the primary caregiver for a veteran family member with all-cause dementia * reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined * provide at least one hour of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the veteran with dementia can also be utilized; e.g., respite, home health aide, other family members, etc.) * be proficient in spoken and written english * be capable of providing informed consent exclusion criteria: exclusion criteria -- potential participants will be screened and excluded for: * current or lifetime history of any psychiatric disorder with psychotic features * prominent suicidal or homicidal ideation * having met dsm-iv criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months * presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation * diagnosis of probable or possible dementia * a telephone cognitive screen score of \< 20 * participation in another caregiver intervention within the past year * lack of regular access to a telephone * illness that would prevent 24 months of study participation * planned transfer of care receiver to another caregiver or nursing home within 12 months

Keywords: dementia caregivers neurodegenerative diseases brain diseases cost of illness stress, psychological depression vital statistics mortality behavioral symptoms residential facilities emergency medical services long-term care
a comparison of the studer pouch versus the t-pouch orthotopic neobladder urinary diversion in bladder cancer patients

Conditions: Bladder Cancer

Summary: this is a prospective, randomized study of two types of continent ileal neobladder construction in patients undergoing cystectomy for primary bladder cancer. patients will be randomly assigned to have either a t-pouch or a studer pouch constructed at the time of their surgery. they will be followed long-term to determine the relative advantages and disadvantages of the two types of diversion. the investigators' hypothesis is that the inclusion of an antireflux mechanism in the t-pouch will result in significantly fewer episodes of symptomatic urinary tract infection, and will have a lower incidence of upper tract dilation and loss of renal function over the long term.


Eligibility criteria:
inclusion criteria: * all patients undergoing radical cystectomy for bladder cancer who are considered candidates for a neobladder reconstruction are eligible for enrollment. * diagnosed with primary bladder cancer (any histology). * scheduled to undergo a radical cystectomy (cystoprostatectomy in men and anterior exenteration in women). * felt by the treating physician to be a candidate for an orthotopic neobladder urinary diversion. * be competent and willing to sign the informed consent. * patients may have received previous radiation therapy or intravesical or systemic chemotherapy. patients with documented metastatic disease are not excluded as long as they are felt to be candidates for a continent neobladder urinary diversion. exclusion criteria: * patients undergoing radical cystectomy for any malignancy other than primary bladder cancer (for example prostate cancer or colon cancer invading the bladder,or a gynecologic malignancy), or non-malignant disease (such as a neurogenic bladder or radiation cystitis). * unwilling or unable to sign the informed consent. * not eligible for an orthotopic neobladder reconstruction. * a history of other malignancy (except for stage i cancer treated with curative intent without evidence of recurrence, clinically localized prostate cancer either untreated or treated with prostatectomy or radiation therapy or hormone therapy,or non-melanoma skin cancer) within the previous 5 years.
explorative study on a new device' ability to register hydration change in elderly subjects during rehabilitation.

Conditions: Dehydrated, Water-Electrolyte Imbalance, Malnutrition

Summary: test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.


Eligibility criteria:
inclusion criteria: * elderly patients eligible for rehabilitation exclusion criteria: * subjects with end stage cancer
safety evaluation of a lifestyle modification program in.form 1.1

Conditions: Obesity

Summary: the study evaluated and compared the safety, tolerance and acceptability of a lifestyle modification program with or without nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors.

to investigate the safety, tolerance and acceptability of a low-glycemic load diet combined with exercise and lifestyle modification education (diet) or a similar program with a meal replacement formula and targeted nutraceuticals (prog) in generally healthy, overweight subjects, forty to fifty subjects with two or more cardiometabolic risk factors, aged 18 to 69 will be randomized into different arms, 13-week intervention trial. to evaluate safety and tolerability, questionnaires were collected weekly. additionally, baseline, week 9 and 13 fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. vitals signs, weight and body composition were monitored weekly.

Eligibility criteria:
inclusion criteria: generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required: * to be overweight or obese (bmi ≥ 27 kg/m2 and ≤ 50 kg/m2), * to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men), * and demonstrate signs of cardiometabolic dysfunction. specifically, subjects were required to have: * elevated ldl cholesterol ≥ 130 mg/dl * and/or elevated tg defined as tg ≥ 130 mg/dl. additionally, subjects were required to have at least one of the following criteria (unless subject had both elevated ldl and tg): * hdl \< 50 mg/dl for women and \< 40 mg/dl for men, * blood glucose ≥ 100 mg/dl, hba1c ≥ 5.7%, * or homeostatic model assessment of insulin resistance (homa-ir) score defined as ≥ 2.0. exclusion criteria included: * pregnancy * lactation * recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements * recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia * chronic use of over-the-counter medication which would interfere with study endpoints including nsaids, laxatives and antacids * allergy or intolerance to study products * serious, unstable medical conditions including known infection with hiv, tuberculosis or hepatitis; cardiovascular disease; diabetes mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse; * abnormal laboratory findings * participating in or planning to begin a weight loss diet during the study period * difficulty in swallowing pills * lifestyle or schedule incompatible with the study protocol.
finnish genetic study for arrhythmic events

Conditions: Sudden Cardiac Death; Acute Coronary Event

Summary: finnish genetic study for arrhythmic events (fingesture is a prospective case-control study assessing the characteristics and genetic background of consecutive series of autopsy verified out-of-hospital victims of scd vs. survivors of an acute coronary event in a specific geographical area in northern finland.


Eligibility criteria:
inclusion criteria: * sudden cardiac death verified by medicolegal autopsy (cases) * acute coronary event (increased troponin levels/ecg markers of ischemia/angina pectoris; two out of three criteria) (controls). exclusion criteria: * sudden death due to other causes (cases). * acute coronary event patients who died during hospitalization (controls).
phenotype/genotype correlation in a family with early onset osteoarthritis

Conditions: Osteoarthritis

Summary: this study will investigate the genes responsible for osteoarthritis. individuals with osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible for this study. family members may also participate. patients will talk with investigators who will explain the study and its possible implications for the patient and family and answer questions. the patient's medical records will be reviewed, a personal and family history will be taken, and a physical examination will be done. two procedures may be done including blood sampling (which will be used for dna (genetic) studies) and x-rays (to define osteoarthritis grade). if no known mutations responsible for osteoarthritis will be detected, participating family members will be interviewed by telephone about their personal and family health history and will have a blood sample drawn for dna testing, and x-rays.

we will investigate the clinical manifestations and molecular genetic defects of human osteoarthritis. families with osteoarthritis of known or suspected genetic basis will be enrolled. individuals will undergo clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. genetic linkage studies may be performed for disorders in which the genetic bases is not yet known.

Eligibility criteria:
inclusion criteria: * individuals (and family members) with early onset osteoarthritis according to the following definition: * symptomatic oa before 50 years old * no obvious causes of oa (imc \> 30, dysplasia,joint traumas) * at least three oa locations exclusion criteria: * individuals younger than 18 years old.
machine learning-based longitudinal study of post-icu syndrome development trajectory in critically ill patients and construction of clinical early warning models: a research protocol for longitudinal study

Conditions: Intensive Care Unit Syndrome; Prediction; Cognitive Impairment; Sleep Disorder; Memory Disorders

Summary: this project intends to track and evaluate whether post-icu syndrome will occur 7 days, 1 month, 3 months and 6 months after icu patients are transferred out of the icu through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-icu syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-icu syndrome.


Eligibility criteria:
inclusion criteria patients : * length of stay in icu ≥24h; * age ≥18 years old; * conscious when leaving icu, communicating with investigators without barriers; * informed consent. family members： * one family member ≥18 years of age was selected for each patient; * assume the main role of caring for patients and medical decision-making; * no history of mental illness or other serious organic diseases; * informed consent and voluntary participation in this study. exclusion criteria patients : * have been in icu for more than 24h within 3 months before this admission; * transferred to another icu; * cognitive impairment existed before icu admission (bdrs \> 4 points); * severe hearing impairment, dysarthria, etc., which cannot be followed up; * unable to complete the questionnaire survey due to serious illness. family members: * family members refuse to participate in the study due to their own reasons; * severe hearing and language impairment, unable to cooperate with researchers.

Keywords: post-icu syndrome prediction model development trajectory
the effectiveness of aspirin on preventing pre-eclampsia

Conditions: Pre-Eclampsia

Summary: this study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.

currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. however, the applicable population and use method of aspirin are still controversial in clinical practice. this study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Eligibility criteria:
inclusion criteria: * age between 18-55 years * gestational age between 12-20 weeks of pregnancy * high risk of developing pre-eclampsia * at least one of the following risk factors: pre-eclampsia in a previous pregnancy , multiple pregnancy，diabetes mellitus(type 1 or 2), chronic hypertension，renal disease, autoimmune disease. * at least two of the following risk factors: primiparity，pre-pregnancy body mass index ≥28kg/m2, age ≥35 years, family members have a history of pre-eclampsia. * maternal informed conset obtained exclusion criteria: * contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk) * patient with known intention to terminate pregnancy * fetal abnormalities detected （including but not limited to major fetal malformation and fgr） * severe heart, liver, renal disease who can not burden the experiment * alcohol and drug abuse * being in another drug experiment within 3 months

Keywords: pre-eclampsia, aspirin