Kornimate/medical-research-clean huggingface dataset:
sleep disordered breathing (sdb) prevalence and cardiovascular outcomes of myocardial infarction (mi) survivors

Conditions: Acute Myocardial Infarction; Sleep Apnea

Summary: the amisleep study is nested in the "frenchie" registry. the objective is to use routine clinical and polygraphic data to capture sdb/sas (sleep disordered breathing/sleep apnea syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes. specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (acs), tia, stroke or death). the ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether sdb/sas treatment can improve this risk.

all patients included in the "frenchie" registry (acute myocardial infarction (ami) patients hospitalized within 48h from symptom onset) are eligible, and will be asked for their written informed consent for this nested study in case of the absence of any non-inclusion criteria. baseline clinical examination and laboratory tests are based on the usual care and are those collected in "frenchie". a simplified polygraphy is performed during the hospitalization for ami. starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours. together with the polygraphy, questionnaires will be given to the patient regarding general sleep quality polygraphic data will be scored in centralized manner. results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. if necessary, the core-lab will provide tele-counseling regarding sdb management to centers. follow-up will be performed through the national administrative databases, as in the "frenchie" registry.

Eligibility criteria:
inclusion criteria: * patient included in frenchie registry (cf. nct04050956 for frenchie registry's selection criteria) * signed consent for ami-sleep study exclusion criteria: * patient under treatment for sdb/sas prior to its inclusion in frenchie registry * cognitive disorientation and communicative disabilities (left to investigator's discretion) not able to fill-out a questionnaire * severe diseases with anticipated mortality less than 6 months

Keywords: acute myocardial infarction sleep apnea outcomes
early identification of subclinical atherosclerosis using non-invasive imaging research (eisner)

Conditions: Atherosclerosis; Coronary Artery Disease

Summary: early identification of subclinical atherosclerosis by noninvasive imaging research (eisner) is a multi-study research program being conducted at cedars-sinai medical center. the principal objective of this randomized trial (referred to as "study 1") is to assess whether coronary artery calcium (cac) scanning provides clinical benefit thus improving patient outcomes in asymptomatic subjects with intermediate coronary artery disease (cad) risk. additionally, the study is designed to assess the value of combining the cac scan with the framingham risk score (frs) and measurements of serum or plasma biomarkers to predict outcomes.

at baseline eligible subjects underwent a clinic visit where they were randomized 2:1 to a "scan group" which had complete cardiac risk assessment and cac scanning or a "no scan group" which had only complete cardiac risk assessment. both groups underwent a private counseling session with a trained nurse practitioner to review their results and receive customized health behavior suggestions based on current american heart association guidelines for primary prevention of heart disease. subjects were followed up for changes in clinical status, medication use and specific health behaviors at one year after baseline. annually for four years, subjects were followed up for subsequent diagnostic testing, therapy, and outcomes related to their cardiac health. at four years after baseline, all subjects (from both groups) returned for a repeat clinic visit to have a complete cardiac risk assessment and cac scanning. year 4 cac scanning was performed in both the "scan group" and "no scan group". additional long-term followup is being conducted under a separate protocol.

Eligibility criteria:
inclusion criteria: * no symptoms of cad * intermediate risk of cad, defined as either: 1. male with age of 55-80 years or female with age 65-80 years or 2. male of 45-54 years and at least one cad risk factor or female with age 55-64 years and at least one cad risk factor * risk factors include: smoking, high blood pressure, high total or ldl cholesterol, low hdl cholesterol, diabetes, family history of early cad.) exclusion criteria: * history of cvd including heart attack, cardiomyopathy, peripheral artery disease, angina, revascularization, and cva (stroke) * prior coronary calcium scan or coronary angiogram * pregnancy * required radiation badges for work (csmc radiation safety ruling) * clinically unstable health status or significant medical co-morbidity

Keywords: atherosclerosis coronary artery disease cardiac risk factors coronary calcium scan prevention
a study to evaluate efficacy and safety of oral bay63-2521 in patients with pulmonary arterial hypertension (pah)

Conditions: Pulmonary Hypertension

Summary: the aim of the study is to assess the efficacy and safety of different doses of bay63-2521 given orally for 12 weeks, in patients with symptomatic pulmonary arterial hypertension (pah).


Eligibility criteria:
inclusion criteria: * male and female patients with symptomatic pah (idiopathic, familial, associated pah due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use) * treatment naive patients and patients pre-treated with an endothelin antagonist or a prostacyclinanalogue (except i.v.). exclusion criteria: * all types of pulmonary hypertension except subtypes of venice group i specified in the inclusion criteria, severe copd (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.

Keywords: pulmonary arterial hypertension ph stimulator
phase 3, randomized, placebo-controlled study of tinlarebant to explore safety and efficacy in geographic atrophy

Conditions: Geographic Atrophy

Summary: this phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (lbs-008) in subjects diagnosed with ga.

subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. the study treatment will be administered orally once daily from baseline (day 1) through the final day of month 24.

Eligibility criteria:
inclusion criteria: * subjects must have a confirmed diagnosis of ga with atrophic lesions in 1 or both eyes. * minimum bcva is required in the study eye exclusion criteria: * the presence of diabetic macular edema or macular disease in either eye. * diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye. * uncontrolled diagnosed glaucoma in the study eye

Keywords: lbs-008 tinlarebant ga
charcot-marie-tooth disease (cmt) biological sample collection for ipsc generation and biobanking

Conditions: Charcot-Marie-Tooth Disease; Healthy

Summary: the new york stem cell foundation (nyscf) research institute is performing this research to accelerate charcot-marie-tooth disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store the samples for future use. through this research, researchers hope to identify future treatments or even cures for charcot-marie-tooth disease.

researchers at the new york stem cell foundation (nyscf) research institute study diverse diseases, conditions, and traits by creating stem cells from biological samples. these "pluripotent" stem cells can become any cell in the human body, including cells that may be difficult, invasive, or impossible to obtain directly. additionally, researchers perform genetic testing to learn more about dna, a material in most cells that contains instructions for the body's development and functions (such as traits like eye color and risk of certain diseases). a piece of dna that determines the specific role of a cell is called a "gene." if the instructions in a gene are abnormal, this can lead to disease. participation in the study involves: (1) completion of health questionnaires, (2) providing a skin and/or blood sample from which stem cells may be created, (3) collection of a saliva sample for genetic analysis, and (4) possible future followup to provide additional information or learn about other research studies. this study is not a clinical trial.

Eligibility criteria:
inclusion criteria: * age 5 years or older. * diagnosis of charcot-marie-tooth (cmt) disease or healthy controls. * adults must provide written informed consent unless physical limitations preclude signing. * minors undergoing skin collection for research purposes must have a cmt diagnosis and must participate with parent/guardian consent. * minors undergoing blood and/or saliva collection for research purposes or who transfer biological samples from a procedure outside the research may have a cmt diagnosis or serve as a healthy control and may participate with parent/guardian consent. exclusion criteria: * wards of the state. * for prospective skin samples: history of keloid formation, coagulation disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection. * for prospective blood samples: coagulation disorder or other medical conditions that increase the risks associated with blood collection. * for all prospective sample collections: subjects who refuse to adhere to nyscf's and/or a collaborating site's safety protocols will be excluded. subjects with an aids diagnosis and cd4 count of less than 200 cells per microliter of blood will be excluded due to increased risk of infection.

Keywords: charcot-marie-tooth
treatment use of generex oral-lyn™ in patients with diabetes

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the objective of this treatment ind protocol is to provide generex oral-lyn™ to patients with serious or life-threatening type 1 or type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (protocol gen-084-ol). this protocol is intended as a substitute for the single patient ind mechanism to obtain generex oral-lyn™.


Eligibility criteria:
study is closed

Keywords: diabetes insulin therapy
global prospective, observational cohort of adult patients with primary sclerosing cholangitis (wind-psc study)

Conditions: PSC

Summary: develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in psc.

global, multi-center longitudinal observational cohort study. collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, psc-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with psc.

Eligibility criteria:
inclusion criteria: 1. adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an informed consent form (icf). 2. confirmed clinical diagnosis of large duct psc based on current aasld guidelines (bowlus 2023). exclusion criteria: 1. clinically significant acute or chronic liver disease of an etiology other than psc (with or without presence of features of aih). 2. small-duct psc. 3. clinically diagnosed secondary or igg4-related sclerosing cholangitis. 4. clinically diagnosed acute cholangitis and currently receiving treatment. patients on chronic suppressive antibiotics will be allowed to enroll. 5. udca dose \>28 mg/kg 6. evidence of current or historical decompensated cirrhosis based on the following clinical events: * ascites \> grade 2 and requiring treatment * esophageal or gastric variceal bleeding requiring hospitalization * hepatic encephalopathy (as defined by a west haven score ≥ 2) * spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \>250/mm3 in the absence of an intra-abdominal source of infection * aki-hrs according to aasld guidelines (flamm 2021) 7. prior liver transplantation 8. meld-na score \>15. for subjects on anticoagulation medication, baseline inr determination for meld score calculation should take this use into account. 9. participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to psc and which, in the opinion of the investigator, has an expected survival of less than 48 weeks. 10. participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent. 11. prisoners or participants who are involuntarily incarcerated. 12. participants who are currently participating in an interventional clinical study. 13. absence of data in medical records to assess inclusion and exclusion criteria.
pf-00299804 as a single agent, in patients with advanced non-small cell lung cancer who have failed chemotherapy and erlotinib

Conditions: Carcinoma, Non Small Cell Lung

Summary: to assess the antitumor efficacy measured by the objective response rate of oral pf-00299804 taken daily, as single agent in patients with advanced nsclc who failed at least one chemotherapy + erlotinib.


Eligibility criteria:
inclusion criteria: * advanced non-small cell lung cancer (nsclc) * prior treatment with and failure of at least one regimen of chemotherapy and erlotinib. * prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment. * measurable disease . * eastern cooperative oncology group (ecog) performance status 0-2 * tissue available for kras/ egfr testing * creatinine clearance \> 40 cc/min or serum creat \< 1.5 x uln exclusion criteria: * chemotherapy * radiotherapy * biological or investigational agents within 4 weeks of baseline disease assessment. * patients who lack of tolerance of erlotinib therapy.

Keywords: non-small cell lung cancer advanced previously treated
partial response to proton pump inhibitors (ppi) treatment: the cost to society and the burden to the patient - a study in the us

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in gerd patients who are partial-responders to ppi treatment.


Eligibility criteria:
inclusion criteria: * at least 6 month history of gerd symptoms * treated with unchanged optimized ppi treatment for any gerd indication during a consecutive 4 week period * remaining gerd symptoms despite optimized ppi treatment * able to read and write in us english, and able to comply with study requirements exclusion criteria: * patients that have not experienced any gerd symptom improvement at all during ppi treatment * involvement in the planning or conduct of the study * involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months

Keywords: gerd ppi partial responders
the proactive diagnostic value of hemostatic biomarkers in disseminated intravascular coagulation

Conditions: Disseminated Intravascular Coagulation

Summary: the project was undertaking by qilu hospital of shandong university, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.

disseminated intravascular coagulation (dic) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. however, current diagnostic systems can not recognize dic at its reversible phase, causing suboptimal treatment outcomes. consequently, the current diagnostic criteria for dic lacks earlier laboratory indicators. therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (tat), soluble thrombomodulin (stm), tissue plasminogen activator inhibitor complex (tpai-c), α2-plasmin inhibitor plasmin complex (pic) and anti-thrombin iii (atiii), in evaluating dic, allowing for proactive diagnosis before the disease progresses into its irreversible phase.

Eligibility criteria:
inclusion criteria: * 18 years old, non-perinatal period, a hospitalization length of≥3 days. exclusion criteria: * primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.

Keywords: thrombosis coagulation hemostatic biomarkers dic
radioembolization of primary and secondary liver malignancies and the effect on the immune system

Conditions: Hepatocellular Carcinoma; Secondary Malignant Neoplasm of Liver

Summary: the goal of this study is to understand the immunologic effects radioembolization has on the immune system. this will be done by evaluating the changes on biopsy, peripheral blood monocytes, and cytokines.

this is a single institution non-interventional study designed to evaluate the immune reaction to radioembolization (re) of primary and secondary malignancies of the liver. re has been established as a standard of care treatment for both primary and secondary cancers of the liver. the treatment consists of a mapping, or planning angiogram, followed by a delivery angiogram where the dose of yttrium 90 (y90) is delivered. data has been published on the immune modification powers of external beam radiation (xrt). however, very little data is available on the ways in which re modifies the immune system. the goal of this study is to determine changes in the peripheral blood monocytes, cytokines and the treated and untreated liver tumors through sample collection prior to and for 12 weeks after standard of care re. the prior to, the re delivery procedure patients will have a blood draw to evaluate for levels of 11 immunologically relevant cytokines (il-1α, il-1β, il-2, il-6, il-10, il-12p70, il-18, tnfα, ifn-ϒ, fit ligand 3, and mcp-1). these blood draws will be repeated at 7 days (- 2 days, + 5 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after re. the patients will also have the infiltration of immune relative cells into treated tumors evaluated. this will be done by the patients undergoing biopsy of the largest tumor to be treated prior to treatment and at 2 weeks (±7 days) following re. if patients have other areas of tumor, which are not included in the initial treatment site, these areas will also be biopsied. finally, the change in immunologically important peripheral lymphocytes will be collected. this will be done with a blood draw on the day of, but prior to re serving as an internal control. patients will then also have blood draws performed at 7 days (±2 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after re.

Eligibility criteria:
inclusion criteria: * biopsy or image (in the setting of hepatocellular carcinoma (hcc)) diagnosed hepatic malignancy * total bilirubin \< 2 mg/dl * ecog status ≤ 2 * life expectancy \>3 months as documented in the medical record by the enrolling physician * age \>22 years * lesion \>2.0 cm which is amenable to percutaneously biopsied exclusion criteria: * unwilling or unable to attend all study related follow ups * technetium 99 macro aggregated albumin (maa) lung shunt fraction \>20% * arterial anatomy which precludes the ability to safely perform re * inr \> 1.8 or platelet count \<50,000 which cannot be corrected * patients who are unable to hold anticoagulation and/or antiplatelet therapy in the periprocedural setting

Keywords: peripheral blood monocytes cytokine
spacer comparison in adult asthmatics

Conditions: Asthma

Summary: spacers are used by people with respiratory diseases who have problems using mdis (metered dose inhalers). this study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.

a randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from seretide™/advair™ 250 hfa mdi without spacer and with aerochamber-max spacer and volumatic™ both in their washed and unwashed states in adult subjects with mild or intermittent asthma.

Eligibility criteria:
inclusion criteria: * non-smoking with a bmi of 19 - 30 * diagnosed with mild or intermittent asthma and taking medication for it. exclusion criteria: * taking oral corticosteroids or inhaled fluticasone propionate * have certain medical conditions or are not otherwise healthy.

Keywords: asthma spacer
establishing the validity and reliability of a dexterity assessment tool

Conditions: Myelopathy Cervical; Cervical Spondylosis; Spinal Cord Compression

Summary: every year, thousands of canadians are diagnosed with degenerative cervical myelopathy (dcm), a form of non-traumatic injury caused by spinal cord compression in the neck. while dcm causes a range of symptoms, one of the most disabling is loss of hand dexterity. surgical decompression is standard treatment for dcm, but reduced dexterity often remains. the investigators have developed a portable, easy-to-use dexterity assessment tool for measuring hand dexterity. hand function is often assessed using tools incapable of measuring subtle changes in function, limiting a clinician's ability to monitor progression of or recovery from a disease over time. the hope is that if subtle changes in function are identified early, leading to an early dcm diagnosis and treatment, this may prevent patients from experiencing a greater loss of hand function. the goals of this study are to determine the relationship between dexterity and myelopathy severity, as well as to establish the validity and reliability of the dexterity tool. this will be done by assessing dexterity using the dexterity tool in dcm patients (to determine the relationship between disease severity and dexterity, and measure validity) and healthy participants (to establish reliability).


Eligibility criteria:
inclusion criteria for patient participants * has been diagnosed with dcm * are between the ages of 35 and 75 years * has no other neurological disorder inclusion criteria for healthy participants * are between the ages of 35 and 75 years * has no neurological disorder exclusion criteria for all participants: • does not fluently speak and read english