cyrilzakka/clinical-trials huggingface dataset:
Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to PREDICT Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients

150 patients admitted to University Hospital Southampton with heart failure will undergo comprehensive Cardiovascular Magnetic Resonance (CMR) imagining during their admission and continuous heart rhythm monitoring using wearable technology post discharge.

We hypothesise that analysis of this outcome data will discover novel CMR tissue characterisation and heart rhythm biomarkers that can be used to predict adverse clinical outcomes in heart failure populations and how individual patients will respond to specific therapies.

PREDICT-HF a low risk single centre observational study in which 150 consecutive patients admitted with a new, primary diagnosis of heart failure undergo advanced CMR to non-invasively establish their individual myocardial tissue characteristics during their initial presentation.

All study participants will be invited to participate in an optional heart rhythm and rate monitoring sub study which will involve continuous electrocardiographic monitoring for up to 2 days prior to discharge and up to 30 day immediately post discharge using a Samsung S-PATCH device.

To enable multivariate statistical analysis to be performed each study participant will undergo a range of validated investigation to comprehensively establish and monitor other recognised heart failure prognostic biomarkers.

Participants will be managed per current NICE heart failure guidelines and will undergo rigorous clinical reviews at 6, 12 and 24 months. All clinically relevant event data e.g. MACE, rehospitalisation, decompensation and arrhythmias will be meticulously recorded for each participant throughout the study period.

This study will identify novel CMR derived tissue characterisation biomarkers of adverse outcome, response to therapy and arrhythmias in a hospitalised heart failure population. It will also be the first study to utilise wearable heart monitoring technology to accurately record heart rate and rhythm data in this population and investigate the potential impact of this on patient's clinical management and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* First hospital admission with a diagnosis of HF (as defined below)
* Able and willing to provide informed consent
* Able to undergo CMR

Exclusion Criteria:

* Known or subsequent diagnosis of amyloidosis, sarcoidosis or hypertrophic cardiomyopathy
* Severe valve disease of any type requiring inpatient surgery
* Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
* Clinically apparent myocardial ischemia which requires revascularisation
* Myocardial infarction or revascularisation within the previous 60 days
* Intra cardiac mass which requires surgery
* Active endocarditis
* Septicaemia
* Pregnancy
* Life expectancy \<2 years secondary to any other cause (i.e. malignancy)
* Active treatment with chemotherapy
* Severe renal failure (GFR \<30)
To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients

Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
* At least one or more erosions have been identified on gastroscopy.
* Patients who decided to voluntarily participate in this trial and agreed in writing.

Exclusion Criteria:

* Patients who can not undergo gastroscopy
* Peptic ulcer (except scarring) and reflux esophagitis
* Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
* Patients with a history of gastrointestinal malignancies
* Zollinger-Ellison syndrome patients
* Patient with spontaneous coagulation disorder
* Patients with an allergic or hypersensitive response to a study drug
* Patients with a potential pregnancy.
* Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit)
* Pregnant and lactating women
* Those currently taking other study drugs
* patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase

Polypharmacy is common among older adults in the United States and is associated with harms such as adverse drug reactions and higher costs of care. This pilot-phase project is designed to test two electronic health record (EHR)-based behavioral economic nudges to help primary care clinicians reduce the rate of high-risk polypharmacy among their older adult patients.

Polypharmacy increases the likelihood of being prescribed and harmed by high-risk medications. As noted in the 2014 National Action Plan for Adverse Drug Event (ADE) Prevention, polypharmacy both increases the likelihood of being prescribed high-risk medications and increases the likelihood that these high-risk medications will lead to adverse drug events. This pilot-phase study is intended to test clinicians' perceptions of EHR-based nudges designed to reduce high-risk polypharmacy among patients aged 65 years or more, thereby enabling investigators to refine the nudges, and to generate outcomes data that will inform power calculations for a subsequent larger study (the main study) of the nudges' effectiveness.

In this pilot-phase study, the investigators will deploy 2 EHR-based behavioral nudges (a commitment nudge and a justification nudge) among 18 or more primary care clinicians in 3 primary care practices (6 clinicians or more per practice) affiliated with Northwestern University for approximately 4 months. The 3 practices participating in the pilot will be a convenience sample of Northwestern-affiliated practices known to study investigators.

The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3 arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification nudges. Randomization will be at the practice level, without replacement, thus assigning exactly 1 practice to each arm. All participating clinicians within a given practice will receive the same nudges.

Northwestern-affiliated practices that do not participate in the pilot will constitute a fourth arm of this pilot study.

The investigators will ask leaders of participating practices for their qualitative observations on how clinicians and patients experience the nudges (e.g., how the nudges affect workflows). The investigators also will collect data on the outcome measures before and during the approximately 4-month pilot period and compare these data to contemporaneous outcomes measures generated by Northwestern-affiliated practices that do not participate in the pilot.

Eligibility Criteria:
Inclusion Criteria:

* Primary care clinicians practicing in one of the participating Northwestern-affiliated practices

Exclusion Criteria:

* none
The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery.

Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are not fully understood, however some of the pathophysiology of POCD is similar to that of Alzheimer's disease (AD).

Insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with AD or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for POCD and POD.

This study is designed to examine the effect intranasal insulin on POCD and POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively.


Eligibility Criteria:
Inclusion Criteria:

• elective open heart surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* inability to provide informed consent
* allergy to insulin
* pregnancy
* mother tongue other than English or French
* visual or hearing impairment interfering with the ability to complete cognitive tests.
The Use of the FAST (Focused Abdominal Scan for Trauma) Scan by Paramedics in Mass Casualty Incidents

Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage patients. Volunteers in the study will include peritoneal dialysis patients ("non stable") and non-peritoneal dialysis patients ("stable"). They will use the ultrasound to perform FAST scans on the patients to determine which subjects are "stable" and which are "unstable" patients. They will record which patients they consider need transport first. This data will be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free fluid within the volunteer, they will be able to make the decision to upgrade these patients and ultimately transport them more quickly. The paramedics will be evaluated for time and accuracy with the FAST scan.

Ultrasound and the FAST (Focused Abdominal Scan for Trauma) scan is currently being used in the Emergency Department to help evaluate trauma patients. In the field a paramedic will use the START (Simple Triage Rapid Treatment) triage procedure to evaluate many patients and to help decide which patients are more critical and therefore need to be transported first. This study aims to create a mass casualty environment through the use of 10 volunteers who are on peritoneal dialysis and 10 patients who are not.

Eligibility Criteria:
Inclusion Criteria:

Paramedic - at least one year in the field, physically able to perform the test

Patients:

* (10)peritoneal dialysis patient that are able to leave dialysate in abdominal cavity for the duration of the test
* (10) subjects not on peritoneal dialysis who are available for the duration of the test

Exclusion Criteria:

* Under 18 years of age
Amino Acid Supplementation in Recovery From Traumatic Brain Injury

Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associated with many chronic disabilities. Physical alterations include reduced exercise tolerance and profound muscle weakness, whereas psychological alterations include diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues rely upon circulating blood amino acids as precursors for metabolic functions. The investigators have shown that even one year after injury, plasma valine, an essential amino acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The investigators speculate that low plasma valine concentration contributes to chronic fatigue after TBI, since valine and tryptophan compete for the same transporter into the brain, and a low plasma valine concentration will allow more tryptophan to be transported. As a consequence, increased brain tryptophan will increase serotonin production, which may significantly contribute to the development of fatigue. Thus, the investigators will test if restoring valine concentration in persons with TBI may reduce fatigue perception and improve physical and neuropsychological function. Further, the investigators have previously shown that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no data are currently available in persons recovering from TBI. Thus,the investigators will also test if EAA and/or valine can improve muscle mass in patients with TBI.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of traumatic brain injury
2. Age 18-65 years
3. Ability to sign informed consent
4. \>3 months post-injury, \<36 months post-injury
5. Ambulatory or require minimal to moderate assistance for safe ambulation

Exclusion Criteria:

1. Subjects with cardiac abnormalities considered exclusionary by the study physicians
2. Subjects with uncontrolled metabolic disease, including liver or renal disease
3. Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
4. Any subject currently on a weight-loss diet or a body mass index \>34 kg/m2
5. Recent anabolic or corticosteroids use (within 3 months)
6. Dementia
7. Inability to tolerate an upright position
8. Postural reflexes prohibiting ambulation and inability to follow 2-step commands
9. Any other condition or event considered exclusionary by the PIs and covering physician
Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients

This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.

This is a pilot study to compare PET/CT uptake of 68Ga-FAPI-46 to uptake parameters determined by Standard of Care MRI or CT with contrast. Patients with a solid tumor diagnosis who are scheduled to undergo biologic therapy will be included in the study. Following imaging, patients will begin standard of care antibody based therapy and standard of care follow-up.

This study is an open label, single institution, pilot study to determine if 68-Ga-FAPI-46 can predict tumor uptake in patients with solid tumor and if the 68-Ga-FAPI-46 uptake in the tumor positively correlates with response to antibody based therapies.

A total of 50 subjects will be enrolled in the study. Imaging will take place prior to initiation of treatment. Patients will then be administered an intravenous injection of 68-Ga-FAPI-46 after which subjects will undergo a PET/CT scan shortly after receiving the drug. Subjects will then undergo treatment as determined by their primary team. The study team will chart review subjects for 36 months ± 6 months with the possibility of extending this follow-up depending on immunotherapy treatment duration to extract treatment response information as documented by their primary treatment team.

Total duration of active participation per patient may last approximately 45 days.

The study will take around 84 ± 6 months from the time the study opens to accrual. The total duration per patient from time of enrollment to chart review is 36 ± 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years.
* Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy
* Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment.
* Have acceptable kidney function and clinical lab values.

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* Females who are currently pregnant or breastfeeding
* Severe renal disease or anuria
* Inability to lie flat or remain still for the duration of the scan.
Study of IBI323 in Patients With Advanced Malignancies

The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323


Eligibility Criteria:
Inclusion Criteria:

1. Phase Ia Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment Phase Ib cohort A Patients with IO-refractory advanced NSCLC cohort B Patients with IO-naive advanced NSCLC who have failed standard treatment cohort C Patients with advanced NSCLC who have no prior treatment and PD-L1 TPS≥1% cohort D Patients with ES-SCLC or G3 neuroendocrine tumors who have failed standard treatment cohort E Patients with advanced MPM who have failed standard treatment cohort F Patients with advanced UC who have failed standard treatment cohort G Patients with advanced nccRCC who have failed standard treatment cohort H Patients with advanced HCC who have failed standard treatment cohort I Patients with advanced NPC who have failed standard treatment cohort J Patients with advanced CC or HNSCC who have failed standard treatment cohort K Patients with advanced GC or GEJC with HER2 negative who have no prior treatment cohort L Patients with advanced TNBC who have failed standard treatment
2. Able to understand and willing to sign the ICF.
3. 18 to 75 years old.
4. Life expectancy at least 12 weeks.
5. At least 1 measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ and bone marrow functionAdequate organ and bone marrow function.

Exclusion Criteria:

1. Prior treatment with any anti- LAG-3 antibody.
2. Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
3. Any investigational drugs received within 4 weeks prior to the first study treatment.
4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
5. Symptomatic CNS metastasis.
6. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
7. Pregnant or nursing females.
Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients

This is a multi-center pilot study to examine the effectiveness of a health literacy-based intervention to improve medication adherence and self-efficacy of medication use among individuals with coronary heart disease (CHD). The specific aims are to: i) develop a health literacy-based intervention to improve medication adherence for CHD individuals with low health literacy and ii) evaluate the effects of a health literacy-based intervention on improving medication adherence and self-efficacy in CHD individuals.

The project will be conducted in 2 phases. Phase 1 is to develop the health literacy-based intervention that consists of a video and an education booklet. Phase 2 is to conduct a pilot study to evaluate the effectiveness of the intervention. A total of 60 participants with low health literacy and diagnosed with CHD will be recruited in two settings. Data will be collected at baseline and 4-weeks after enrollment. The following data will be collected:

At baseline: Socio-demographic information (e.g. age, gender, education level, income, past medical history, social support), health literacy (eligibility screening at time of recruitment), CHD knowledge, medication adherence, and medication self-efficacy.

4-weeks after enrollment: medication self-efficacy and medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years and diagnosed with CHD.
* Currently receiving pharmacological therapy such as statins, anti-platelet and/or blood thinner, beta-blockers, calcium channel blockers, nitroglycerin, and angiotensin- converting enzyme inhibitors (ACE).
* Low health literacy score of 9 or less as measured using the short-form Mandarin Health Literacy Scale (s-MHLS).

Exclusion Criteria:

* History of significant cognitive impairment, psychiatric disorders, and aphasia.
* Without access to a telephone or unable to give telephone contact.
* Currently enrolled in another program or clinical trial.
Turkish Version of Mobile Device Proficiency Questionnaire

The Mobile Device Proficiency Questionnaire (MDPQ) contains 46 questions with eight subscales, which are as follows: mobile device basics, communication, data and file storage, internet, calendar, entertainment, privacy, and troubleshooting and software management. Each question item is rated on a five-point scale based on the individual's subjective proficiency level. The scores ranged from 8 to 40 and were scored in a similar manner to in the original version. For each subscale of the MDPQ, responses for all questions were averaged. These averaged scores were then summed across subscales to come up with a total score of the MDPQ.

Information and Communication Technologies (ICT) enable users to perform various tasks with minimal effort. Today, many elderly individuals also own their own mobile devices. Mobile devices are small, lightweight and portable information terminals, and are indispensable for ICT use in our daily lives with models such as smartphones and tablet computers. In addition, in the USA and Japan, 61% and 74.2% of individuals aged 65 and over use smartphones, respectively. Mobile devices are used for various functions in daily life such as making phone calls, messaging, checking programs, shopping, paying bills and accessing entertainment content, facilitating many tasks. However, some elderly individuals who own mobile devices do not sufficiently benefit from the advantages offered by ICT. There are significant differences in internet literacy among elderly individuals, and social and socioeconomic factors can affect the digital gap among elderly individuals. Due to these social factors, efforts to eliminate digital inequality need to be increased in the future.

This study aims to adapt the Mobile Device Proficiency Questionnaires (MDPQ) to Turkish. MDPQ can serve as a basic and quantitative indicator of ICT proficiency among the elderly population. In this context, the Turkish version of MDPQ, MDPQ-T, will be created and its reliability and validity will be verified. We expect this new assessment tool to have the same high reliability and validity as the original version in the Turkish population. We also predict that the duration or frequency of use of mobile devices will be positively correlated with mobile device proficiency measured by MDPQ-T. In addition, we expect not only the accessibility of mobile devices but also the subjective importance, performance and satisfaction level of mobile device use in daily life to be positively correlated with MDPQ-T.

Eligibility Criteria:
Inclusion Criteria:

* Being a native Turkish speaker,
* Having no reading or writing problems,
* Having a mobile device such as a phone or tablet,
* Agreeing to participate in the study

Exclusion Criteria:

* Individuals with neurological diseases such as cognitive impairment, Alzheimer's, dementia, etc. will be excluded from the study.