Kornimate/medical-research-clean huggingface dataset:
strain imaging in patients with functional mitral regurgitation, treated with mitraclip

Conditions: Mitral Regurgitation; Heart Failure

Summary: the aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after mitraclip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.

this study is one of the first in terms of publication. as far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (mr) and mitraclip. as the investigator's goal is to assess the potential impact of the mitraclip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. the changes in myocardial deformation markers will be associated with the respective changes in brain-natriuretic peptide (bnp) levels, new york heart association (nyha) class status, 6-minute walking distance (6mwd) and left ventricle (lv) volumes at follow -up. the investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and lv reverse remodeling after successful edge-to-edge repair in functional mr patients during one year follow up. in specific, in this study the investigators will measure the 2-dimension (2d) strain values of the left ventricle and left atrium (global longitudinal strain-gls of the lv and peak atrial longitudinal strain - pals of the left atrium) at baseline and at one year follow up, they will appreciate the lv myocardial work and all its components (global work index-gwi, global constructed work-gcw,global wasted work-gww and global work efficiency-gwe) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse lv remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.

Eligibility criteria:
inclusion criteria: * patients with ef more than 15% and below 45% * heart failure symptoms with nyha class \>2 * moderate-to-severe and severe functional mitral regurgitation exclusion criteria: * degenerative mitral regurgitation * asymptomatic patients * nyha class iv patients not able to perform 6mwt * ef\>45% * poor echocardiographic acoustic window patients

Keywords: mitraclip functional mitral regurgitation reverse remodeling
glp-1 ra on liver omics in masld

Conditions: NAFLD; Diabetes; Obesity

Summary: in patients with type ii diabetes mellitus (t2dm) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (masld. insulin resistance, which is associated with t2dm, mediates the inflammation of these lipids, resulting in the progression of masld to metabolic dysfunction associated steatotic hepatitis (mash). hence, in t2dm, obesity, and masld, changes in the lipid profile occur, and they are interrelated. in this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with masld with intervention with glp-1 ra, which has shown to benefit t2dm and obesity.

the study involves patients with a diagnosis of masld by histology and have diabetes/obesity. the 'omics' ( lipidomics, proteomics, metabolites, and inflammatory profiles and transcriptomics) data of liver tissue and plasma of patients will be compared between patients who have received 1 year of glp-1 treatment with those who did not have glp-1 agents. the study will evaluate the changes in different 'omics' and metabolites in the liver tissue following the use of glp-1 agents in these patients

Eligibility criteria:
inclusion criteria: * known diagnosis of masld by histology, also have diabetes/ obesity * on treatment with glp-1 ra at stable dose exclusion criteria: * unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia * on immunosuppression, liver or kidney transplant * pregnancy
electric-acoustic stimulation extended follow-up post approval study

Conditions: Hearing Loss, Sensorineural

Summary: the med-el eas extended follow-up study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

the study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. study subjects will be followed for a minimum of 5 years post-implantation of the device.

Eligibility criteria:
inclusion criteria: * 18 years of age or older at the time of implantation * severe to profound sensorineural hearing loss for frequencies greater than 1500 hz (i.e., threshold no better than 70 db hl at 2000-8000 hz) * low-frequency thresholds up to and including 500 hz no poorer than 65 db hl * cnc word recognition score less than or equal to 60% in the ear to be implanted * cnc word recognition score less than or equal to 60% in the contralateral ear * english spoken as the primary language exclusion criteria: * conductive, retrocochlear, or central auditory disorder * hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 db in either direction in the last 2 years * any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures * developmental delays or organic brain dysfunction * unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations * unwillingness or inability of the candidate to comply with all investigational requirements
genetic modifiers of cystic fibrosis: sibling study

Conditions: Lung Diseases; Cystic Fibrosis

Summary: the purpose of this study is to identify modifier genes in cystic fibrosis (cf).

background: cf is a highly variable but inevitably fatal single gene disorder. several lines of evidence suggest that genetic background contributes to the variability of cystic fibrosis phenotypes. the study will develop cf as a model for the identification of modifier genes by capitalizing on the availability of a large motivated population of affected twins and siblings. the study is in response to a request for applications titled "genetic modifiers of single gene defect diseases" released in august 2000 and co-sponsored by the national institute of diabetes, digestive, and kidney diseases. design narrative: the study has four aims: 1. to identify heritable cf phenotypes by twin study. intrapair and interpair variance will be determined for selected cf phenotypes, and interclass correlations (monozygotic versus dizygotic) will be performed to identify cf phenotypes with a substantial heritable component. 2. to determine the contribution of genetic and other factors to the variability of cf phenotypes by analysis of affected sibs. variance component methods will be used to evaluate the cf phenotypes that appear to be heritable based upon other studies or the results of aim 1. 3. to identify biologic phenotypes that correlate with heritable cf phenotypes by clinical study of twins and sibs. multivariate analysis will be used to find biologic phenotypes associated with cf phenotypes. 4. to identify modifier genes and loci responsible for heritable cf phenotypes by linkage approaches. identity by descent and transmission disequilibrium methods will be used to test linkage between candidate genes/loci and heritable cf phenotypes. to identify novel loci, genome-wide scans will be performed upon sib pairs selected for extreme concordance or discordance for heritable traits.

Eligibility criteria:
inclusion criteria: * diagnosis of cf
multicenter trial of prednisone in alzheimer's disease

Conditions: Alzheimer Disease

Summary: this is a randomized placebo controlled, double blind study. patients who meet eligibility criteria and decide to participate in the study will be randomly assigned to receive either drug treatment or a placebo. neither the patients nor the participating investigators will know who is receiving the drugs and who is receiving the placebo. participation involves 15 outpatient clinic visits over a 68 week period. patients take study medication at varying doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.


Eligibility criteria:
inclusion criteria: * patients with alzheimer's disease who are in stable medical condition exclusion criteria: * patients with diabetes or severe osteoporosis

Keywords: alzheimer's disease prednisone anti-inflammatory agents
evaluating the efficacy and safety of dehypotin® in the patients with type 2 diabetes mellitus or cardiovascular disease

Conditions: Type 2 Diabetes Mellitus; Cardiovascular Disease; Hypercholesterolemia

Summary: the purpose of this study is to evaluate the efficacy and safety of dehypotin® in the patients with type 2 diabetes mellitus or cardiovascular disease. eligible patients will be randomly assigned to 1 of 2 arms, either dehypotin® or placebo, and will receive the diet advisement throughout the study.


Eligibility criteria:
inclusion criteria: * male or female * age 20-75 years * diagnosis of type ii diabetes mellitus for at least 3 months and/or clinical evident cardiovascular disease (cvd) * a hemoglobin a1c concentration has to be \< 8% before screening exclusion criteria: * women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives * known hypersensitivity to pravastatin or any of its components * have a history of homozygous familial hypercholesterolemia or known type iii hyperlipoproteinemia * significant medical illness * known serious conditions, e.g. serum creatine kinase(ck)levels 2.5 times upper limit of normal * subjects being treated with drugs influence serum lipid concentrations * subjects who have cancer or been receiving the cancer chemotherapy

Keywords: type 2 diabetes mellitus cardiovascular disease hypercholesterolemia
randomized study comparing cmf and goserelin + tamoxifen in premenopausal receptor-positive patients

Conditions: Early-stage Breast Cancer

Summary: primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.


Eligibility criteria:
inclusion criteria: * premenopausal patients with histologically verified, lymph node-negative (pt1c-pt3) or lymph node-positive (pt1a-pt3) breast cancer * hormone receptor-positive status * more than 6 histologically examined lymph nodes * laboratory parameters 1. hematopoiesis: \> 3500/µl leukocytes, \> 100,000/µl thrombocytes 2. renal function: creatinin \< 1.5mg % 3. hepatic function: got \</= 2.5 x unl 4. bilirubin: \< 1.5mg % 5. metabolic parameters: na, ca, k in normal range, normal level of blood sugar 6. blood coagulation: pz \> 60% * concluded healing process following surgery * \</= 4 weeks interval since surgery * informed consent exclusion criteria: * t4 carcinoma; inflammatory breast cancer, carcinoma in situ * simultaneous or sequential bilateral breast cancer * preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment * male patients * pregnancy or lactation * lacking compliance or understanding of the disease * general contraindication against cytostatic treatment * serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up * second carcinoma or status post second carcinoma (except for curatively treated squamous cell carcinoma of the skin or cervical carcinoma in situ)

Keywords: cyclophosphamide methotrexate fluorouracil goserelin tamoxifen breast cancer
5 years quality of life and early mobilization in icu

Conditions: Quality of Life; ICU Acquired Weakness; Morality

Summary: in a study published in 2018 the research team had collected the medical research council score (mrcs) at intensive care unit (icu) discharge. the investigators would like to be able to examine, if the preliminary results obtained by in 2020 by van aerde's team are confirmed in their cohort. the investigators hypothesize that patients with an mrcs less than or equal to 55 at discharge from the icu, have a higher mortality rate than those with a score greater than 55. the investigators would also like to examine whether or not an mrcs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post icu.

study design prospective, observational study. 1. research of vital status 2. completion of two questionnaires (short form-36 and katz index of independence in activities of daily living), to assess quality of life and level of autonomy in activities of daily living, either by telephone or completed directly by hand by the patient from his place of residence.

Eligibility criteria:
inclusion criteria: * have participated in the promorea1 study * alive at the time the questionnaires were sent exclusion criteria: * opposition to the use of vital status data * extra-national patient not on the national registry

Keywords: icu quality of life medical research council sum score mortality early mobilization
efficacy and safety of diclofenac sodium gel in knee osteoarthritis

Conditions: Osteearthritis

Summary: this study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility criteria:
key inclusion criteria * oa of the knee key exclusion criteria * other rheumatic disease, such as rheumatoid arthritis * active gastrointestinal ulcer during the last year * known allergy to analgesic drugs

Keywords: knee osteoarthritis, topical nsaid, diclofenac sodium
ex-press® p-50 and ex-press® p-200

Conditions: Glaucoma

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to assess long term clinical performance and safety outcomes for ex-press glaucoma filtration devices models p-50 and p-200.

this is a non-interventional/observational study designed as a retrospective chart review. study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the p-50 or p-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period. the overall study duration is expected to be approximately 7 months.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an institutional review board (irb) / independent ethics committee (iec) approved informed consent form authorizing data collection prior to the review of any medical records; * implanted (one eye or both) with the express p-50 or express p-200 device per indications for use for at least 5 years; * have a minimum of 5 years of recorded follow-up data; * other protocol-specified inclusion criteria may apply. key exclusion criteria: * enrolled in any clinical trial within the last 5 years; * at the time of implantation: 1. presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis. 2. pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device. 3. diagnosed with angle-closure glaucoma. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma
multicenter investigation of the glaukos® suprachoroidal stent model g3 in conjunction with cataract surgery

Conditions: Primary Open-angle Glaucoma

Summary: evaluate the safety and efficacy of the glaukos® suprachoroidal stent model g3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

this is an ide trial to evaluate the safety and efficacy of the glaukos® suprachoroidal stent model g3 (hereinafter referred to as g3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility criteria:
inclusion criteria: * mild to moderate open-angle glaucoma * characteristics consistent with mild to moderate glaucoma * use of one (1) to three (3) medications at time of screening exam exclusion criteria: * pigmentary or pseudoexfoliative glaucoma * prior incisional glaucoma surgery

Keywords: primary open-angle glaucoma poag cataract surgery suprachoroidal space suprachoroidal stent istent supra
web-based personalized feedback for university students

Conditions: Risky Alcohol Consumption

Summary: excessive alcohol consumption in university students continues for be a serious public health concern with a variety of negative consequences. there have been a number of different brief interventions developed to address this issue among university students. the current project will add to this literature by evaluating the use of a personalized feedback intervention (www.checkyourdrinkingu.net; cydu). specifically, this trial will examine whether providing access to the cydu will result in short-term reductions in drinking. this issue is important as use of these interventions is not a mandatory requirement for university students so the issue is whether making materials of this type available leads to any reductions in risky drinking. it is hypothesized that students provided access to the cydu will display greater reductions in drinking at a six-week follow-up as compared to students who were not provided access to the cydu.


Eligibility criteria:
inclusion criteria: * audit-c score of 4 or more at baseline exclusion criteria: -
text message intervention to improve cardiac rehab participation

Conditions: Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Bypass Surgery; Heart Valve Repair or Replacement; Heart Transplant; Left Ventricular Assist Device; Chronic Stable Angina; Chronic Stable Heart Failure

Summary: cardiac rehabilitation (cr) is strongly recommended for patients with coronary heart disease. however, patient enrollment and completion of cardiac rehabilitation is low. this study will examine if a mobile phone intervention that uses a text messaging program can successfully promote participation in cardiac rehabilitation.

mobile phone interventions, such as text messaging programs, have been shown to promote healthy behaviors in patients with coronary heart disease, but it is unknown whether text messaging can successfully promote participation in cardiac rehabilitation. this study will have the following aims: aim 1: adapt a theory- and evidence-based text messaging intervention to promote participation in cardiac rehabilitation. aim 2: determine whether text messaging improves participation in cardiac rehabilitation among eligible patients. this study will have two parts. in part 1, the investigators will enroll patients with heart disease to rate the acceptability of text messages. in part 2, the investigators will enroll patients to participate in a randomized controlled trial. participants will be randomized to receive text messages or no text messages for 6 months. those who have been assigned to receive the text messaging intervention will be sent several text messages per week throughout the study period. the content of these text messages is designed promote healthy behaviors and participation in cardiac rehabilitation. those who have not been assigned to receive the text messaging intervention will receive usual care. outcome measures will be assessed at a baseline visit and at a 6-month follow-up visit at the end of the intervention. additionally, some participants in the text messaging intervention group will be interviewed about their overall satisfaction and engagement with the text messages upon completion of the study.

Eligibility criteria:
inclusion criteria: * part 1: diagnosis eligible for cardiac rehabilitation within 90 days (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device, chronic stable angina, chronic stable heart failure) * part 2: hospitalized for diagnosis eligible for cardiac rehabilitation (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device) * eligible for cardiac rehabilitation * owns a smartphone capable of receiving and sending sms text messages exclusion criteria: * unable to communicate in english

Keywords: cardiac rehabilitation text messaging
trial of 2nd generation anti-cea designer t cells in gastric cancer

Conditions: Gastric Cancer

Summary: this study proposes to determine the safety and tolerability of 2nd generation designer t cells in patients with gastric cancer.designer t cells are prepared by removing white blood cells from the participant, and then modifying these cells so that they recognize tumor antigen(cea). these modified cells are then re infused back into the participant so that they can attack and kill tumor cells.eligibility for this study is diagnosis of carcinoma of the stomach with failure to respond to standard curative therapy. tumors must express cea as demonstrated by elevated serum cea \>10ng/ml and be measurable radiologically or by physical exam.

t cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remissions of cancer. however, t cells are easily tolerized to self or tumor antigens and "immune surveil¬lance" has manifestly failed in every cancer that is clinically apparent. it is the goal of this study to supply the specificities and affinities to patient t cells without regard for their "endogenous" t cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. we will achieve this by preparing chimeric igcd28tcr genes in mammalian expression vectors to yield "designer t cells" from normal patient cells. prior studies in model systems demonstrated that recombinant igcd28tcr could direct modified t cells to respond to antigen targets with il2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response. it therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. the target antigen for these studies is carcinoembryonic antigen (cea), which is prominently expressed on tumors of the stomach, colon and rectum, breast, pancreas and other sites.

Eligibility criteria:
inclusion criteria: * cea expressing gastric cancer/ge junction (\>10ng/ml) * must have measurable disease radiologically or by physical exam * must have failed potentially curative standard therapy * must be 18 years of age or older * no serious concomitant disease exclusion criteria: * prior investigational treatment * requiring systemic steroids * serious medical conditions * concurrent malignancies

Keywords: gastric cancer t cells gene transfer