Kornimate/medical-research-clean huggingface dataset:
multi-lead ecg to effectively optimize resynchronization devices: new crt recipients

Conditions: Heart Failure, Systolic

Summary: cardiac resynchronization therapy (crt), or atrial-synchronized biventricular (biv) pacing, is an fda-approved device therapy option for heart failure (hf) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. a traditional crt device has pacing leads implanted within the right atrium (ra), the right ventricle (rv), and within a coronary vein overlying the lateral or posterior left ventricle (lv). within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, lv systolic function and structure, as well as decreased hospitalization rates and mortality among patients with hf. despite improvements in crt technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. this study looks to optimize new crt device recipients using information obtained from standard ecg machines.

this is a prospective, randomized study designed to evaluate if crt device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among hf patients with a crt device implanted for standard indications. all patients will have measurement of electrocardiograms at a range of device settings. patients will be randomized in a 1:1 ratio to either the active comparator arm (standard crt programming), or the experimental arm (crt device programmed by the information obtained by ecgs). standard crt programming used in this study is simultaneous biventricular (biv) pacing with a fixed atrioventricular delay. at 6 months, control patients who were initially randomized to standard programming will have programming changed based on the ecg optimization information. patients will be blinded to randomization. change of lv size and function will be performed prior to randomization, and again \~6 and \~12 months following crt implant in both subgroups.

Eligibility criteria:
inclusion criteria: 1. patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (hipaa) form 2. age greater than or equal 18 years 3. pre-crt ef less than or equal 40% 4. patients will be receiving or have received a first-time crt device for standard clinical indications within \~2 months of study enrollment 5. adequate echocardiographic images for lv ef and lv esv determination 6. on optimal medical therapy exclusion criteria: 1. patients who are pregnant or may become pregnant 2. patient has a history of severe allergic reactions from ecg gel/ electrode adhesives 3. patient has a his bundle pacing lead 4. patient has right bundle branch block (rbbb) 5. patient is enrolled in concurrent research study that would potentially confound the results of this study 6. premature ventricular contraction (pvc) burden greater than or equal to 10%

Keywords: cardiac resynchronization therapy pacing echocardiography electrocardiography optimization heart failure
heart health after cancer treatment (heart-act)

Conditions: Breast Cancer

Summary: this is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at zuckerberg san francisco general (zsfg).

objectives: 1. evaluating feasibility and acceptability of the program. 2. evaluating the effects of the program on health outcomes including change in exercise capacity, change in quality of life, change in risk factors, and adverse events. 3. evaluating changes in patient-reported measures. outline: participants with a history of breast cancer who receive care at zuckerberg san francisco general hospital (zsfg) will receive the intervention which is comprised of a 12-week multi-disciplinary health behavior program. each participant will have an individualized assessment, goal and plan for each component of the program. follow-up for outcomes will occur at 3 months, 6 months, and 12 months.

Eligibility criteria:
inclusion criteria: * age 18+ * diagnosis of breast cancer * treated with curative intent * able to communicate in english, spanish, or cantonese * able to consent for self * receive care at zuckerberg san francisco general hospital exclusion criteria: * chemotherapy, radiation, or surgery planned in next 3 months * life expectancy \< 1 year

Keywords: health behavioral program cardiac health
predicting acute exacerbations of copd using wearable devices and remote monitoring technology with ai/ml models

Conditions: COPD; AE COPD

Summary: this study is aimed to collect real-time physiological data using two wearable devices (a biometric ring and a biometric wristband), daily lung mechanical measurements by a handheld oscillometer, and participant-reported symptoms in patients with copd remotely from their home environment. the data will be used to train and validate artificial intelligence and machine learning (ai/ml) models to predict copd exacerbations in advance of their actual occurrence. the data will also be used to test the new severity classification system for exacerbations of copd, as well as to determine important relationships between physiological measurements from the wearable devices, the handheld oscillometer, the self-reported symptoms, and the tests performed at the baseline visit.

a single-site, prospective, observational cohort study to collect high-quality multidimensional data from the wearable/portable devices, as well as symptom and exacerbation data, in high-risk patients with frequent exacerbations in order to develop a copd exacerbation predictive model.

Eligibility criteria:
inclusion criteria: * males/females, age ≥ 40, former/current smokers with ≥10 pack-year smoking history * fev1/fvc \< 0.7, with 80% \< fev1 ≤50% (moderate, 'gold 2') 50% \< fev1 ≤ 30% (severe, 'gold 3') or fev1 \< 30% (very severe, 'gold 4') copd * history of 2 or more exacerbations in the preceding 12 months requiring corticosteroids, antibiotics, or both * ability to provide informed consent * ability to access internet at least once daily exclusion criteria: * no existing copd diagnosis * any medical/cognitive/functional condition which renders inability to operate research equipment/devices, and/or to complete daily symptom response

Keywords: acute exacerbation of copd (aecopd) chronic obstructive pulmonary disease (copd) artificial intelligence/machine learning (ai/ml) remote patient monitoring (rpm) biometric wearable device oscillometry
contribution of new pancreatic mri sequences for the evaluation of tumor response in pancreatic adenocarcinomas

Conditions: Pancreas Adenocarcinomas

Summary: pancreatic adenocarcinoma is the most pessimistic digestive cancer in terms of prognosis. tumor response assessment is crucial, and the recent development of new magnetic resonance imaging sequences, such as high resolution applied to diffusion sequences (harder et al., 2022) or magnetic resonance elastography (mre) (steinkohl et al., 2021), could help address this issue.


Eligibility criteria:
inclusion criteria: * ct scan diagnosis of non-metastatic pancreatic cancer on contrast-enhanced thoraco-abdomino-pelvic ct; * adult patient: age ≥ 18 years; * patient affiliated with a social security system or beneficiary of such a system; * patient who has received complete information about the research organization and has signed an informed consent form. exclusion criteria: * patient with a contraindication to mri. * person referred to in articles l. 1121-5, l. 1121-7, and l. 1121-8 of the french public health code. * pregnant woman, parturient, or breastfeeding mother; * minor (non-emancipated) individual; * adult individual under legal protection (guardianship, curatorship, or judicial safeguard); * adult individual unable to express consent. * person deprived of liberty by a judicial or administrative decision, or person undergoing psychiatric care pursuant to articles l. 32-12-1 and l. 3213-1 of the french public health code.
allopregnanolone regenerative therapeutic for early alzheimer's disease: intramuscular study

Conditions: Alzheimer Dementia

Summary: the purpose of this study is to identifying the intramuscular dose equivalent to the 4mg intravenous dose and assess its safety and tolerability as a weekly injection.

the purpose of this bridging study is to advance the therapeutic development of allopregnanolone (allo) by using the intramuscular (im) route of administration as an alternative to the intravenous (iv) route. in order to identify the equivalent im dose we will conduct pharmacokinetic (pk) analysis previously informed by simulations and modeling. we will recruit a total of 12 participants, both males and females equally distributed, into this single-arm, open-label study. pk analysis and dose finding will take place for the initial 4 weeks; some participants may not require all 4 weeks of initial dosing to establish maintenance dose. once maintenance dose is established all participants will receive weekly administration of allo im until they complete 12 weeks total of allo exposure (5 or 6 clinic visits and 6 or 7 home-nurse visits).

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * men or postmenopausal women, aged 55 years or older * diagnosis of mci due to ad or mild ad * in good general health as evidenced by medical history and with no medical contraindications to participation * mmse \> 20 at screen * caregiver willing and capable to accompany the patient to clinic visits exclusion criteria: * daily use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the gaba-a receptor complex. * seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy. * clinically significant laboratory or ecg abnormality obtained at screening visit. * mri indicative of significant abnormality, including but not limited to evidence of a single prior hemorrhage or infarct \>1 cm3, multiple lacunar infarcts (\>1) or evidence of a single prior infarct \>1cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (e.g. abscess or tumor). * has any contraindications for mri studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with mri. * is currently enrolled in a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research or observational study judged not to be scientifically or medically compatible with this study.

Keywords: alzheimer's disease mild cognitive impairment dementia regenerative therapeutic drug development
a randomized phase iib placebo-controlled study of r-ice chemotherapy with and without sgn-40 for patients with dlbcl

Conditions: Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Summary: this is a randomized trial to estimate the activity of r-ice plus sgn-40 vs. r-ice plus placebo in patients with dlbcl. the study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving sgn-40.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of de novo or transformed dlbcl, or follicular grade 3b lymphoma. * received at least four cycles of first-line therapy with r-chop, or equivalent. * best clinical response to first-line therapy of stable disease, partial response, or complete response. * at least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive fdg-pet scan. exclusion criteria: * leptomeningeal or central nervous system lymphoma. * received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab. * received a hematopoietic stem cell transplant.

Keywords: lymphoproliferative disorders lymphoma antigens, cd40 antibody, monoclonal combined modality therapy lymphoma, large b-cell, diffuse lymphoma, non-hodgkin hematologic diseases immunoproliferative disorders lymphatic diseases
late onset alzheimer's disease

Conditions: Alzheimer Disease

Summary: the goal of this study is to is to focus on the genetic influences on alzheimer's disease (ad) risk. the investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (african american, caucasian, and hispanics) with a family history of ad and willing to participate.

the purpose of this study is to focus on the genetic influences on alzheimer's disease (ad) risk. specifically, the investigators hypothesize that one or more genes, other than the previously identified susceptibility gene apolipoprotein-e (apoe), or the 3 genes associated with early-onset familial ad, presenilin-1 (ps-1), presenilin-2 (ps-2) or b-amyloid precursor protein (app), increase the risk of ad in families with multiple individuals affected with ad. the investigators propose to test this hypothesis by performing genetic linkage analysis in order to detect the chromosomal location of genes that may increase the risk of alzheimer's disease. in addition, the investigators will study genes known to increase the risk of alzheimer's disease and other related disorders such as early onset ad, pick disease, corticobasal degeneration, progressive supranuclear palsy, and familial frontotemporal dementia with parkinsonism and lewy body dementia.

Eligibility criteria:
inclusion criteria: * established diagnosis of definite or probable ad or have a diagnosis of a related neurodegenerative disorder such as frontotemporal dementia (ftd) or lewy body dementia (lbd) (will also recruit sporadic ftd and lbd) cases. * a living sibling with probable or possible ad; * a third living relative affected with ad (onset age 50 or older) or unaffected (60 or older); * participants in the proband's generation with an identified companion serving as an informant; * participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent. exclusion criteria: * failure to identify an appropriate informant; * uncertainty of the clinical diagnosis of alzheimer's disease or other related disorder; * discovery of additional diagnosis that could account for the clinical manifestations; * unwillingness to participate; * failure to identify a living sibling with ad or other related disorder (except in the cases of sporadic ftd and sporadic lbd); * participants lacking the capacity to consent who do not have a surrogate or proxy or next of kin to provide consent.

Keywords: genetic testing genetic influence
a randomised-controlled trial of an oral microbiome immunity formula in recovered covid-19 patients

Conditions: COVID-19; Probiotic

Summary: this study aims to evaluate the effectiveness of an oral microbiome immunity formula in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities in patients who have recovered from covid-19.

sars-cov-2, the cause of covid-19, emerged as a new zoonotic pathogen of humans at the end of 2019 and rapidly developed into a global pandemic. it may develop severe or critical disease with respiratory failure requiring oxygen support and intensive care. natural infection by virus triggers an effective system immunity so that the host can resist or highly reduce the chance of re-infection. in many cases, this protection can maintain a long period of time. however, the long-term immunities (over a year) and complications from the patients are not yet very clear. we found that covid-19 survivors who have cleared the virus continued to have persistent altered gut microbiota and up to 80 percent had residue covid-19 related symptoms including fatigue, difficulty in breathing, impaired memory and hair loss up to 6 months after discharge (long covid-19). earlier studies from our cu medicine have shown a link between altered gut microbiome and covid-19 severity, and more patients who received a novel microbiome immunity formula (sim01) achieved complete symptom resolution and developed neutralising antibody than those who did not (unpublished data). research from the faculty also reported that almost 40% of people in hong kong had significant gut dysbiosis especially in elderly and patients with diabetes, obesity or chronic diseases. this study is a single-centre, triple-blind, randomized, placebo-controlled clinical trial that aims to evaluate the effectiveness of an oral microbiome immunity formula (sim01) invented by the chinese university of hong kong (cuhk) in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities (e.g. sepsis, cardiopulmonary complications, metabolic syndrome, neuropsychiatric disorders) in patients who have recovered from covid-19.

Eligibility criteria:
inclusion criteria: 1. individuals aged 18 and above; 2. subjects who are mentally capable to participate in the study and provide informed consent; 3. subjects who can communicate in chinese or english; 4. subjects who are ambulatory and do not have difficulties travelling to the clinics for follow-up; 5. subjects who do not have plans to leave hong kong in the subsequent two years after recruitment; and 6. subjects who agree to give informed consent voluntarily. exclusion criteria: 1. subjects who are unable to receive oral fluids; 2. subjects who have received surgery involving the intestine within past 30 days; 3. subjects who are pregnant or breastfeeding; and 4. subjects who are immunocompromised, e.g. on cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled hiv/aids.
safety and efficacy study of thalomid in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: the purpose of this study is to determine if thalidomide (thalomid) is effective in treating patients with chronic pancreatitis.

pancreatitis is an inflammation of the pancreas, a gland that lies behind the stomach. the inflammation may develop suddenly (acute pancreatitis) or over many years (chronic pancreatitis). the pancreas produces the hormones, insulin and glucagon to control metabolism. the hormones and enzymes flow from the pancreas through the pancreatic duct into the upper part of the small intestine. most chronic pancreatitis patients often experience chronic abdominal pain during the course of the disease. thalidomide increased the production of interleukin-10 (il-10), which is important in regulating intestinal inflammation. thalidomide is approved by the food and drug administration (fda) for a leprosy skin condition, erythema nodosum lerosum (enl), but not for the treatment of chronic pancreatitis. in this case it is considered experimental.

Eligibility criteria:
inclusion criteria: 1. age 18-75, inclusive. 2. female must be post menopausal (≥ 24 months without menses or surgically sterilized). 3. able to comprehend english. 4. chronic pancreatic pain lasting for more than 2 months. 5. history of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following: * histological confirmation * ct/mri (including calcifications, dilated cuts, dilated mpd, and /or atrophy) * ercp with cambridge score of 2 or greater 6. subject must score at least 4 cm on the vas scale during the 1-2 week lead-in-period. 7. patients must give written informed consent. 8. patients must be willing and able to comply with the fda-mandated s.t.e.p.s.® program. exclusion criteria: 1. female of child-bearing potential. 2. unable to comprehend english. 3. patients with diabetes requiring insulin. 4. evidence of gallstones on screening ultrasonography. 5. current alcohol abuse or addiction to opiate analgesics. 6. patients with existing peripheral neuropathy. 7. patients who are taking medications known to be associated with development of neuropathy: amiodarone, hydralazine, perhexiline, vincristine, cisplatin, metronidazole (flagyl), dapsone, phenytoin and disulfiram. 8. patients who have pre-existing hypercoagulable state. patients with a history of malignancy within the past 5 years, patients with a recent surgical procedure, patients with chronic immobilization causing blood stasis, patients with history of embolism or deep vein thrombosis, patients with extreme heart failure, and patients with a congenital disorder of the clotting cascade. 9. patients with active alcoholic liver disease or elevated liver function \>3xs the upper limit of normal. 10. patients will be withdrawn from the study at visit 4 (month 3) if pain score on vas scale has not improved.

Keywords: pancreatitis
the effects of pg102, a water soluble extract from actinidia arguta, on serum total ige levels

Conditions: Asymptomatic Subjects With Atopy and Elevated Serum IgE

Summary: the aim of this study was to evaluate the efficacy of pg102 at lowering levels of total ige in asymptomatic subjects with atopy.


Eligibility criteria:
inclusion criteria: * subjects who have atopy but no allergy-related symptoms * subjects with total ige levels of 300iu/ml or more * acquisition of written informed consent prior to commencement of study * no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators exclusion criteria: * individuals with normal levels of total serum ige * ue of one or more allergic drugs * serious clinical conditions (such as malignancies, severe cardiovascular disease etc.) * serious mental disorder * pregnant woman or woman of childbearing potential within 3 months * subjects who participated in other clinical trials in the past 6months * individuals who have a plan to participate in another clinical trials during this trial * subjects with a history of kiwi allergy * subjects whose conditions are inappropriate by investigators

Keywords: atopy, ige