cyrilzakka/clinical-trials huggingface dataset:
Noninvasive Glucose Measurements - Database and Calibration Compilation

This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.

This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with and without diabetes including pregnant women

Exclusion Criteria:

* Subject under 18 years of age
* Subjects not able to understand provided information
* Subjects without measuring sites
* Subjects with rash or wound on measuring sites
* Subjects with stained fingers, such a oil or nicotine
* Subjects not capable of holding arm/hand steadily on probe
* Subjects with thrombosis in arm/hand
The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma Patients

Prospective randomized clinical trial Compare the goal-directed fluid therapy using esophageal Doppler and classic fluid therapy

Goal directed fluid therapy becomes issue for enhanced recovery after surgery. In goal directed therapy, dynamic parameters, like stroke volume and cardiac output, is important. Esophageal Doppler is one of device which provides dymanic parameters.

In severe trauma cases, the effect of goal directed therapy is not known yet. So the aim of this study is comparing the results of goal directed therapy using esophageal Doppler and conventional fluid therapy.

Eligibility Criteria:
Inclusion Criteria:

* Severe trauma patients who undergo general anesthesia
* Initial serum lactate level \> 2mmol/L

Exclusion Criteria:

* Severe traumatic brain injury
* THoracic surgery
* Age \< 19 years old
* Impending arrest or post CPR state
* Severe facial trauma
Solving Wellness: An Initiative to Enhance Canadian Healthcare Provider Wellness

Given the high incidence of burnout, depression, and suicidal ideation among Canadian healthcare providers (HCPs), there is an urgent need to support wellness through strengthening peer networks and engaging key stakeholders. This project will explore the capacity of digital tools to educate HCPs and enable them to support their mental health. The investigators will evaluate specific research questions: Are HCPs more aware of their wellness needs? Did burnout and stress decrease? Do HCPs feel more supported by their peers? The overarching objective is to contribute towards a culture prioritizing HCP wellbeing. The investigators hope to achieve this through two outcome-oriented objectives: 1) to create resources to promote HCP wellbeing and 2) to foster a web-based HCP community. This initiative integrates big data tools, interactive online content, and the Solving Healthcare podcast to improve HCP wellness. It is anticipated that HCPs will become more aware of their wellness needs, and once they are able to identify strategies to live healthier work lives, cultural changes will take place, leading to a new attitude surrounding HCP mental health. To complete these objectives, resources will be drawn from the HELP-MD physician database and an advisory circle, and will be disseminated via a web platform and the widely known Solving Healthcare podcast. The project's significance stems from the changes it will incite in both individuals and health care institutions, inspiring long term changes in workplace culture and teaching the next generation that a balanced work life is attainable.


Eligibility Criteria:
Participant Inclusion Criteria Healthcare providers who are

* aged 18 years or older
* physicians, residents, medical students, nurses, and allied health professionals of various specialties at the Montfort Hospital and will also be open to Canadian medical professionals (physicians, residents, medical students, nurses, and allied health professionals).

Participant exclusion criteria: Healthcare providers who have previously enrolled as a member of Solving Wellness prior to project start.

Stakeholder staff inclusion criteria:

Employees who are

* aged 18 years or older; and
* whose roles provide them with direct knowledge of topics relating to physician wellness at the Montfort Hospital and of the interventions implemented during the study period (e.g., senior physicians, experts on physician wellness, health system decision makers, mental health experts, health care service managers, nurse managers, ICU managers, medical site lead, directors or department heads).

Stakeholder staff exclusion criteria: Any employees who are involved in the project design and execution (ie. advisory circle members or research team members)
Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years

When a child less than 2 years old attends the Emergency Department (ED) with an injury, carers should offer an explanation. When there is no explanation or if the explanation is inconsistent \& because the child cannot say what happened, the doctor will need to consider all possible causes including child abuse. To help exclude abuse, the doctor will request x-rays of all the child's bones to make sure there are no other unexplained fractures. This requires up to 20 x-rays, which are called a skeletal survey. Even if there are no fractures, some or all of the x-rays will be repeated in the following 7-21 days, because by that time any fractures will have started to heal and so are easier to see than on the first skeletal survey. It means that if a doctor is worried about abuse, the child may need to have up to 40 x-rays, which amounts to a significant radiation dose (more than 6 months of natural UK background radiation) \& increases the child's lifetime risk of getting cancer. 79 to 97 out of 100 skeletal surveys performed are normal. While it is of paramount importance to identify if a child is being abused, it is also important to minimise radiation dose. A camera which detects light and heat given off by the body has shown promise in some areas of medical practice. We plan to compare the results from the camera to those of the skeletal survey in 40 children below 2 years of age attending our hospital over a 6-month period. We hope to demonstrate that this technology can be used to further select children who should have a skeletal survey, reducing radiation dose in children without missing those who are being abused and sending them home to be abused again.


Eligibility Criteria:
Inclusion Criteria:

* Children between 1 month and 2 years of age having initial/follow-up skeletal survey for investigation of suspected abuse
* Healthy Control children

Exclusion Criteria:

* 1. Informed consent withheld by main carer/guardian for the skeletal survey (court order would then be issues) 2. Informed consent for participation in the research study withheld 2. Situations where informed consent cannot be obtained (e.g. inability of carer/guardian to understand written English) 3. Postmortem cases (inclusion of the demised would unduly complicate the consent process for this small pilot study)
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator

The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing \[ATP\] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).


Eligibility Criteria:
Key Inclusion Criteria:

* Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) \[shock or ATP\] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Must be hemodynamically stable

Key Exclusion Criteria:

* New York Heart Association (NYHA) Class IV heart failure
* Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization
* Hemodynamically significant primary obstructive valvular disease
* History of congenital heart disease
* Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered.
* Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list
* History of seizures or epilepsy
* Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study
* Severe renal impairment
* Abnormal liver function tests
* Currently taking Class I and Class III antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization
* Currently taking drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued 5 half-lives prior to randomization
* Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization
* Females who are pregnant or are breastfeeding
* Individuals with a subcutaneous ICD
* Body mass index (BMI) ≥ 36 kg/m\^2

Note: Other protocol defined Inclusion/Exclusion criteria may apply
L-TIL in Patients With Malignancy Resistance to Anti-PD-1 Therapy

Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy


Eligibility Criteria:
Inclusion Criteria:

* Expected lifespan is over 3 months
* malignant tumors diagnosed by pathological examination
* Imaging examination is at advanced stage with at least one measurable lesion
* Ineffective or resistant to previous anti-PD-1 therapy
* ECOG score 0-2
* Adequate organ function
* No other serious diseases that conflict with this protocol
* Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months
* witten informed consent from the patients

Exclusion Criteria:

* Severe infectious disease within 4 weeks before enrollment
* Active hepatitis B or C virus or HIV infection
* Severe autoimmune disease or immunodeficiency disease
* Severe allergies
* Severe mental disorder
* Systematically used a large amount of glucocorticoids within 4 weeks before enrollment
* With severe heart, liver, kidney insufficiency, diabetes and other diseases
* Participation in other clinical studies in the past 3 months or having been treated with other gene products
COVID-19 Biorepository

Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.

While SARS-CoV-2 has some similarities to the SARS-CoV pathogen that led to an epidemic in 2002 and 2003, there is much about the epidemiology, pathogenesis, clinical presentation, diagnosis, and treatment of the novel virus that remains unknown.3 Additional research is needed to explore the nature of the virus, its spectrum of disease, and potential therapies to combat its spread. The aim of this project will be to establish a biorepository of blood samples from patients infected with SARS-CoV-2 that can then be used by investigators to expand our understanding of COVID-19 and its treatment and, in turn, improve patient outcomes.

The COVID-19 biorepository will accomplish the following specific aims:

1. Establish a collection of biospecimens from patients with COVID-19.
2. Establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in RedCap.
3. Provide biospecimens and unique patient data to researchers investigating COVID-19. Separate IRB approval will be needed for these studies.

Eligibility Criteria:
Inclusion Criteria:

* The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
* The participant has a diagnosis of COVID-19 confirmed by COVID-19 PCR.
* Patient is 18 years of age or older.

Exclusion Criteria:

* Participant declines to participate (living patients only)
* Participant or healthcare surrogate is unable to provide informed consent (living patients only)
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.


Eligibility Criteria:
INCLUSION CRITERIA:

* Have a confirmed diagnosis of Multiple Sclerosis
* Are able to walk with or without an assisted device

EXCLUSION CRITERIA:

* Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
* Participating in other investigational drug trials
* A medical history or clinical findings that preclude entry into the study
* A medication history that precludes entry into the study
* Previously treated with 4-aminopyridine (4-AP)
Parent-Based Prevention (PBP) for Parents With Eating Disorders

Parents with eating disorders exhibit greater concerns and dilemmas about developing healthy habits in their children. Studies indicate that the offspring of parents with eating disorders have more developmental and interpersonal difficulties. Consequently, these parents should receive personalized care to enhance their parental capacity and support them in their decision making process. The Parent-Based Prevention of Eating Disorders (PBP) is a promising intervention that may help improve feeding and eating practices and children outcomes, by engaging both parents in a short-term program. This study aims to empirically evaluate the feasibility and acceptability of PBP over a wait-list control group (i.e., treatment-as-usual) in a Randomized Case Series Trial.

A parental history of an eating disorder is linked with greater risk of eating and socio-emotional problems in the offspring, and more stressful parent-child interactions. Further, parenting concerns often exacerbate existing eating disorder symptoms in parents. Parent-Based Prevention (PBP-B) is a focused intervention aimed to support parents with eating disorders and their partners in developing healthy eating and lifestyle behaviors in their children. The program also focuses on reducing mealtime conflict and improving couple communication. This study tests the feasibility, acceptability and preliminary outcomes of the Parent-Based Prevention (PBP) program for these parents and their partners. Parents with any lifetime eating disorder diagnosis who have at least one child 1-5 years old will be randomized to receive PBP immediately or following a 16-week waitlist period. This study will investigate whether PBP is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of eating and weight disorders (e.g., parental cognition associated with feeding practices and child eating behaviors and socio-emotional symptoms). The study will collect important case series data that will inform the design of larger, adequately powered studies to test ways to reduce the likelihood of eating and weight difficulties in the offspring of parents with eating disorders.

Eligibility Criteria:
Inclusion Criteria:

* A biological parent of a child between 1-5 years of age.
* A lifetime diagnosis of an eating disorder.

Exclusion Criteria:

\* Current medical condition necessitating more intensive care to manage symptoms.
Real-world Data on Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area (PACIFIC AA)

First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area

Study Design: The study is an observational review of medical records of patients diagnosed with unresectable stage III NSCLC in Taiwan, participating in an early access program (EAP). Physicians having treated patients in the EAP will be asked to recruit these patients to have their data abstracted from their medical records. Data will only be collected from routine clinical care.

Data Source(s): Centre staff will extract de-identified data from patient's medical charts. All collected data will be retrospective at time of extractions.

Study Population: Patients diagnosed with an unresectable stage III NSCLC, having not progressed after a CRT and who have received at least one dose of durvalumab following the CRT within the EAP will be the target population.

Exposure(s): Clinical characteristics, details of treatments (previous therapies, subsequent therapies), durvalumab exposure and serious AESIs Primary Outcome(s): PFS and OS. Sample Size Estimations: A target of 140 patients is estimated in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
2. Adult of age ≥ 20 years at time of study entry
3. Patients must have been enrolled in one of the Pacific durvalumab EAPs

Exclusion Criteria:

1. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

This is an extension study for all participants who completed study 211LE201 (NCT01499355) through Week 52 and did not discontinue BIIB023 or placebo. Eligible participants from Study 211LE201 will be followed for up to 108 weeks.

Participants who received BIIB023 low dose or high dose in 211LE201 will continue to receive the same dosing in this study (211LE202; NCT01930890) in addition to background therapy. Participants who received placebo in 211LE201 are randomized to receive either BIIB023 low dose or high dose in addition to background therapy.

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects who completed Week 52 of Study 211LE201 (NCT01499355) and did not discontinue BIIB023 or placebo study treatment.
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.

Key Exclusion Criteria:

* Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects' participation. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
* Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
* Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
* Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for enrollment.

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria May Apply.
Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids

Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations, current methods of cortisol measurement have limitations.

Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in real-time.

The main aim of the study is to compare cortisol levels across biological fluids (sweat, saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and non-invasive cortisol measurement device (currently under development).


Eligibility Criteria:
Healthy controls:

Inclusion Criteria:

* age between 18 and 30 years old
* normal BMI 18 to 25 kg/m2
* weight stability

Exclusion Criteria:

* pregnancy, breastfeeding, irregular menses
* any medical treatment
* any medical issues
* pilocarpine allergy, or latex allergy
* glaucoma or acute irritis