Kornimate/medical-research-clean huggingface dataset:
conversion or neoadjuvant therapy in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this multicenter retrospective study which included patients with hepatocellular carcinoma (hcc) who received conversion or neoadjuvant therapy to explore the best treatment options and the best benefit group.

more than 50% patients with initial hepatocellular carcinoma (hcc) are diagnosed as intermediate or advanced stage diease. transarterial chemoembolization and systemic therapy are main treatments for these patients. with the rise of targeted drugs and immunotherapy, more and more patients with advanced hcc have access to curative treatment, thereby extending their overall survival time. in clinical practice, there are many combinations used to treat these patients. however, the safety and efficacy of conversion or neoadjuvant therapy in hcc patients remains controversial. the aim of this project is to establish a multicentre database from guangxi province, china, to include as many hcc patients receiving conversion or neoadjuvant therapy as possible. hcc patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (haic), transcatheter arterial chemoembolization (tace), tyrosine kinase inhibitors (tkis), immune checkpoint inhibitors (icis), or radiotherapy were retrospectively enrolled. the purpose of this project is to explore the best beneficiaries of conversion or neoadjuvant therapy, the best treatment strategy, and the follow-up treatment options after successful conversion therapy. the ultimate objective is to provide evidence for the necessity and feasibility of conversion or neoadjuvant therapy for patients with hcc. the data for this study were derived from the database of the regional registry platform entitled "guangxi liver cancer clinical study alliance (guidance)" sponsored by the guangxi anticancer association liver cancer committee. all of the included patients were not previously reported and were not enrolled in those industry-sponsored clinical trials.

Eligibility criteria:
inclusion criteria: * histologically or clinically confirmed diagnosis of hcc. * patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (haic), transcatheter arterial chemoembolization (tace), tyrosine kinase inhibitors (tkis), immune checkpoint inhibitors (icis), or radiotherapy. * eastern cooperative oncology group performance status (ecog-ps) of 0 or 1. * with child-pugh 5\~7 scores. exclusion criteria: * concurrent with other malignancies within 5 years. * incomplete medical data. * follow-up time less than 3 months.

Keywords: conversion therapy neoadjuvant therapy
dynamic imaging of variation in lupus nephritis

Conditions: Lupus Nephritis

Summary: to use a variety of renal imaging modalities, including diffusion weighted imaging (dwi), blood oxygen level dependent (bold) imaging, t1rho (t1rho) imaging, and dynamic contrast enhanced magnetic resonance imaging (dce-mri) to evaluate the intra-renal blood flow, perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus nephritis (ln) and compare these parameters to renal biopsy findings to determine whether dwi, bold, t1rho, and dce-mri may provide a set of non-invasive tools to assess renal function and pathology in ln.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent agreeing to all study procedures, before any study- specific procedures are done. 2. male and female subjects 18 to 65 years of age, inclusive. 3. subjects currently being evaluated for new or recurrent ln with a soc kidney biopsy planned or being evaluated for iga nephropathy and with a soc kidney biopsy planned. 4. patients with ln must meet american college of rheumatology (acr) or systemic lupus collaborating clinics (slicc) criteria for systemic lupus erythematosus (sle). 5. subjects with a life expectancy \>6 months. exclusion criteria: 1. participation in another investigational study during same time period. 2. contraindication to receiving a gbca. 3. more than 2 previous lifetime exposures to a gbca. 4. any contraindication to mri, including metal implants, claustrophobia or morbid obesity. 5. acute or chronic severe renal insufficiency (glomerular filtration rate \[gfr\] \<40 ml per minute per 1.73 m2). 6. subject requiring dialysis. 7. presence of pre-existing renal disease unrelated to sle or iga nephropathy, respectively. 8. acute renal insufficiency of any severity caused by the hepato-renal syndrome. 9. previous or pre-existing nephrogenic systemic fibrosis. 10. history of clinically significant anti-phospholipid syndrome. 11. chronic liver function impairment, indicated by liver function tests (aspartate aminotransferase \[ast\], alanine aminotransferase \[alt\]) \>2-fold upper limit of normal. 12. platelet count \<50,000/μl. 13. hemoglobin \<8.0 g/dl. 14. history of or presence of central nervous system (cns) disease such as active lupus cerebritis or multiple sclerosis that might compromise blood brain barrier function. 15. infection that is clinically relevant, particularly hepatitis b virus (hbv), hepatitis c virus (hcv) and/or human immunodeficiency virus (hiv). 16. pregnant or nursing females, or females not using effective contraception. 17. inability or unwillingness to return to the research site clinic for study visits at baseline and at 6 months.
cifasd 5 tdcs and cognitive training

Conditions: Fetal Alcohol Spectrum Disorders

Summary: this is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tdcs) for children and adolescents (ages 8 - 17 years) with prenatal alcohol exposure (pae).

prenatal alcohol exposure (pae) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. individuals with fetal alcohol spectrum disorders (fasd) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. despite the profound public health burden posed by fasd, there have been very few treatment studies in this population. this study will examine the effects of a cognitive remediation training augmented with transcranial direct current stimulation (tdcs) in children and adolescents with pae. the study involves a baseline visit with cognitive testing, 5 sessions of tdcs (including the baseline visit) with active and sham arms, a 6th visit for cognitive testing.

Eligibility criteria:
inclusion criteria: * documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated fasd diagnosis (fas, partial fas, or arnd). * an available parent or legal guardian capable of giving informed consent exclusion criteria: * substance abuse in the participant * neurological condition or other developmental disorder * serious psychiatric disorder known to affect brain functioning and cognitive performance birthweight \< 1500 grams * mri contraindication * tdcs contraindication
exercise-based frailty intervention in lung transplantation (xfit)

Conditions: Frailty; Lung Tranplant Candidate

Summary: the goal of xfit study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in lung transplant candidates in their own home. the main questions xfit aims to answer are: * is xfit safe? * is xfit feasible and acceptable by participants? * is xfit effective in improving frailty and physical function as reflected in patient-reported outcomes. participants will: - participate in the 8-week xfit program or enhanced standard of care

we will randomize 70 patients who reflect the diversity and spectrum of illness seen in the general lung transplant candidate population to either xfit or enhanced standard of care. an interventionalist with expertise in exercise physiology and remote interventions will deliver 8 weekly sessions using video-conference software in participants' homes. these sessions feature one-on-one exercise training and targeting of behavioral barriers to optimizing physical activity using motivational interviewing principles. establishing safety is our primary outcome. we will secondarily establish feasibility and acceptability, and explore responsiveness six-minute walk distance, frailty, patient reported outcomes . we anticipate that this first-of-its kind study in solid organ transplantation will establish fundamental safety, feasibility, and accessibility data needed inform larger scale interventions.

Eligibility criteria:
group 1 inclusion criteria: * age 18 - 65 years * lung transplant candidates * speaks english or spanish * ≤ 8lpm o2 on 6mwt * sppb score ≤ 10 exclusion criteria: * lives alone * bmi \< 18.0 kg/m2 * engaged in clinical pulmonary rehabilitation program * severe phtn (rhc mpap ≥ 30 mmhg or tte pasp ≥ 60mmhg or moderately/severely reduced rv systolic function on tte * deemed unsafe by site pi group 2 inclusion criteria: * age 18 - 75 years * speaks english or spanish * ≤ 15lpm o2 on 6mwt * sppb score ≤ 10 exclusion criteria: * lives alone * bmi \< 18.0 kg/m2 * engaged in clinical pulmonary rehabilitation program * severely reduced rv systolic function on tte * deemed unsafe by site pi

Keywords: frailty lung transplant prehabilitation remote intervention
treatment of breast cancer-related lymphedema with stem cells and fat grafting

Conditions: Lymphedema

Summary: breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. currently, lymphedema is primarily addressed conservatively with compression garments. regenerative medicine may provide a new treatment option for lymphedema. this phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.


Eligibility criteria:
inclusion criteria: * unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection. * cancer free for at least 1 year * the patient understands the nature and purpose of this study and the study procedures and has signed informed consent. * the opposite upper extremity is healthy (no lymphedema). * asa score of 1 or 2. * the patient is able to read, understand, and complete danish questionnaires. * pitting lymphedema isl grade 1 or 2. * a minimum circumference difference of 2cm or a minimum volume difference of 200ml. exclusion criteria: * pregnant or lactating. * bilateral lymphedema * current or previous malignancies other than breast cancer. * insulin-dependent diabetes. * diagnosed with any form of psychotic disorder, which may impact study participation. * not ceased smoking during treatment. * active implantables (e.g. pacemaker or neurostimulator) * unrealistic treatment expectations. * known hepatitis, hiv or syphilis infection.
embryo developmental capacity after egg banking in an ovum donation program

Conditions: Infertility

Summary: for an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. very recently, improved and new methods are yielding satisfactory results. in particular, vitrification is providing excellent results for both survival and clinical outcomes. however, to evaluate the over all out come there are other parameters to be considered. in this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs. the aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. the study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.


Eligibility criteria:
inclusion criteria: * 18-35 year old * normal response (8-15 follicles) to long protocol of ovarian stimulation with hcg * donors with normal menstrual cycles (21-35 day duration) * donors with bmi between 18-25 kg/m2 exclusion criteria: * donors with two or more previous miscarriages * polycystic ovary syndrome * donors with antecedents of poor embrionary quality not attributed to masculine factor * donors with drop of estradiol of more than 10% or estradiol plateau. * donors with a high response\>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hcg)
regulatory bcells in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. one such challenge is the excess cardiovascular disease observed in patients with systemic lupus erythematosus . coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with systemic lupus erythematosus.regulatory b-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses

regulatory b cells have been identified as an il10 producing b cells subsets that are characterized by the expression of cd19 cd24hicd38hi . breg cells can inhibit inflammatory responses in autoimmune disease, like systemic lupus erythematosus, via the production of il-10 (an antiatherogenic cytokine) which will suppress tnf- α production by monocytes leading to inhibition of t cell-mediated inflammation. regulatory b have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . evidence suggests breg in autoimmune disease may be dysfunctional . in this proposal, we suggest il-10 production by breg confers an atheroprotective role. in systemic lupus erythematosus, regulatory b ability to control atherosclerosis is reduced therefore, we will test the hypothesis that regulatory b play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in regulatory b from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .

Eligibility criteria:
inclusion criteria: * clinical and laboratory diagnosis of systemic lupus disease. * must be adult. exclusion criteria: * patients with clinical atherosclerotic vascular disease * pregnancy.
technical innovation protocol for mr & us plaque imaging: reproducibility.

Conditions: Atherosclerosis

Summary: the aim of this study is to develop non-invasive mri, and mrs approaches that will quantify the plaque composition and lipid content of plaques and will have the potential for repeated in vivo measurements. simultaneously this study aims to develop us plaque imaging as a screening tool to select plaque phenotypes of interest for clinical trials (a large lrnc). for plaque composition imaging by mri the researchers aim to increase scan resolution and decrease scan time. for quantifying plaque lipid content the researchers aim to develop an mrs protocol. subsequently, the researchers intend to study the reproducibility of plaque composition and lipid content measurements by mri, mrs and ultrasound in subjects that have carotid artery plaques.


Eligibility criteria:
inclusion criteria: * patients, with 30 to 70% carotid artery stenosis on ultrasound duplex, who will not go for endarterectomy. exclusion criteria: * metal in the body, as a result of e.g. pacemaker or artificial cardiac valves; claustrophobia; surgery performed in the area of measurement (carotid artery region); cardiac arrhythmias.
update on the detection of frailty in older adults

Conditions: Strength; Quality of Life; Functional Independence; Functionality; Pain; Sarcopenia; Anxiety; Kinesiophobia; Depression

Summary: the main objective is to update the diagnostic assessment of frailty by correlating several variables with the ultrasound image of the frail elderly patient. secondarily, the investigators intend to collect and analyze data on functional capacity and quality of life variables on the evolution of musculoskeletal symptoms, as well as on pain and psychological variables. similarly, it is intended to make a record of different profiles and subtypes of frail older adult patients to be stored in machine learning in order to establish therapeutic intervention plans that allow both the evaluation and treatment of patients.

the present cohort study will be conducted in 500 older adults diagnosed with frailty. the correlation of the demographic variables, physical functionality tests and psychoemotional constructs that will be analyzed in this study with the ultrasound image obtained from the patients will improve the ultrasound diagnosis of frailty, providing new information that will facilitate the work of healthcare personnel in the diagnosis and management of frailty. similarly, the use of machine learning will allow institutions to extract data on different patient profiles, signs and symptoms of frailty and the different risk factors that affect frailty patients, which will improve treatments and favor the development of educational programs tailored to the patient's needs.

Eligibility criteria:
inclusion criteria: a diagnosis of signs and symptoms of frailty by a geriatric physician in the research group will be used as the primary inclusion criterion. frailty will be assessed and diagnosed using the frailty phenotype and the clinical frailty scale. exclusion criteria: * acute myocardial infarction in the last 3 months and/or unstable angina pectoris * uncontrolled arrhythmia, recent thromboembolism and terminal illness. * patients undergoing mmii unloading or mmss/mmii fractures in the last three months. * patients with a functional gait index of 1 (inability to walk) * severe pain (7/10 vas) * previous neuromuscular pathology presenting with weakness * medication that does not allow the patient's actual muscle reaction to be assessed * severe cognitive impairment that would prevent collaboration and understanding of the tests to be performed. * cardiovascularly unstable patients and uncontrolled arterial hypertension.

Keywords: frailty quality of life sarcopenia ultrasound
nasonex® nasal suspension 50 μg long-term designated drug use investigation (study p05876)

Conditions: Allergic Rhinitis

Summary: the investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: * patients who are treated with nasonex for perennial or seasonal allergic rhinitis. exclusion criteria: * patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection \[symptoms may exacerbate\] * patients with a history of hypersensitivity to any ingredient of this drug
a study of safety and efficacy of tildacerfont in females with polycystic ovary syndrome and elevated adrenal androgens

Conditions: Polycystic Ovary Syndrome

Summary: an investigation of the safety and efficacy of tildacerfont in women with pcos and elevated adrenal androgens

this is a phase 2 study to evaluate the efficacy, safety and tolerability of 3 doses of tildacerfont in approximately 39 women with pcos and elevated adrenal androgens assessed by elevated dheas levels. subjects will be randomized 2:1 (tildacerfont:placebo) at baseline. the study will consist of 3 consecutive 4-week treatment periods at each dose level. duration of participation is approximately 25 weeks.

Eligibility criteria:
inclusion criteria: * female subjects aged 18 to 40 years old at screening visit * diagnosis of pcos (either historical or during screening) according to nih (1990) criteria * dheas level \> age-matched upper limit of normal (uln) at screening visit * agree to follow industry standard contraception guidelines within protocol exclusion criteria: * evidence of: 1. history of congenital adrenal hyperplasia (cah), cushing's syndrome, pituitary or adrenal disease 2. clinically significant hyperprolactinemia 3. thyroid stimulating hormone (tsh) \ 4.5mu/ml at screening 4. cortisol levels concerning for adrenal insufficiency 5. other findings suggestive of secondary cause for anovulation and/or hyperandrogenemia * total testosterone levels \>140 ng/dl, dheas \>650 mcg/dl, virilization or other signs or symptoms concerning for ovarian hyperthecosis or androgen-secreting tumors * medical conditions that require glucocorticoid treatment within 30 days of screening and throughout the duration of the study * clinically significant unstable medical conditions, illness, or chronic diseases * prior hysterectomy or bilateral oophorectomy * females who are pregnant or nursing

Keywords: pcos elevated adrenal androgen adrenal disorder polycystic ovary syndrome womens health
the cleveland cardiometabolic cohort

Conditions: HIV; Lipodystrophy

Summary: in this observational study, the investigators will examine the changes in body composition in hiv-infected subjects before and after initiation of hiv treatment, and look at the correlations with changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

the effects of lifestyle factors on body composition changes after antiretroviral therapy (art) are unknown, and as such, investigators will use this prospective observational cohort to study relationships between lifestyle factors, including diet, physical activity and illicit drug use, with changes in body composition after art. in addition, the effect of the body fat changes will be correlated to changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.

Eligibility criteria:
inclusion criteria: * hiv-1 infection as documented by any licensed elisa test kit and confirmed by western blot at any time prior to study entry. hiv-1 culture, hiv-1 antigen, plasma hiv-1 rna, or a second antibody test by a method other than elisa is acceptable as an alternative confirmatory test * provides written informed consent and is capable of reading and comprehending the informed consent * is not currently taking antiretroviral therapy and has never been on such treatments in the past. exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped \>6 months prior to study entry * is planning on starting antiretroviral therapy as part of routine clinic care exclusion criteria: * pregnancy or lactation

Keywords: hiv lipodystrophy