cyrilzakka/clinical-trials huggingface dataset:
Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.


Eligibility Criteria:
Eligibility Criteria:

* Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF therapy in the past.

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Current symptoms of serious medical disease
* History of cancer in last 5 years other than non-melanoma skin cancer
* Chronic serious infection
* Active TB requiring treatment in last 5 years
* Herpes zoster in last 2 months
* Any active viral infection including Human Immunodeficiency Virus (HIV)
* Serious side effects associated with previous anti-TNF therapy
Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment

This pilot clinical trial studies psycho-educational program in increasing knowledge and satisfaction and decreasing distress in younger patients with cancer receiving treatment. Psycho-educational program may increase knowledge and satisfaction and decrease distress in younger patients with cancer receiving treatment

PRIMARY OBJECTIVES:

I. Providing a psycho-educational group to young adults while examining the feasibility of such a group with patients on treatment.

II. Examining effectiveness of the program through evaluating pre-post changes in participant distress, evaluating increases in participant' knowledge regarding disease issues and coping, and evaluating participant satisfaction.

OUTLINE:

Patients undergo psycho-educational program comprising medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.

After completion of study treatment, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Currently in active treatment (diagnosed and receiving treatment within 2 weeks of initial study enrollment; active treatment includes currently receiving any of the following: chemotherapy, radiation therapy, maintenance drugs, surgery, clinical trial enrollment, or current relapse/secondary malignancy)
* Inpatient or outpatient
* Cancer diagnosis
* Physician approval
* Informed consent

Exclusion Criteria:

* Significant psychiatric or developmental issues, as determined by screening interview conducted by psychologist or clinical social worker
* Currently off treatment (longer than 2 weeks at the time of enrollment)
* In isolation or with isolation precautions
* Non-English speaking
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3

This study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.

The purpose of this study is to investigate a novel biomarker, α-aminoadipic acid (2-AAA), which may influence the risk of diabetes. 2-AAA has been identified as a novel predictor of diabetes development in humans, identifying at-risk individuals before any detectable glucose abnormalities. 2-AAA is a naturally occurring metabolite in the body, and it has no known adverse effects at normal physiological levels. 2-AAA is generated in the body from the breakdown of lysine. Lysine is one of the twenty essential amino acids, meaning that it is essential for human function, but that our body cannot manufacture it. Thus, it is acquired from dietary sources (such as meat, eggs, soybeans and legumes), with a recommended daily intake of 30 mg/kg/day. Amino acids are the building blocks of proteins, which are what allow our cells, organs and body to maintain structure and function. The investigators are interested in whether 2-AAA is increased in the body after consumption of lysine.

Eligibility Criteria:
Inclusion Criteria:

-Prior participant in 2-AAA Dietary study.

Exclusion Criteria:

* Newly diagnosed disease, including cardiovascular, renal, liver disease, or Diabetes mellitus.
* Individuals who are pregnant or lactating.
* Inability to provide written or electronic informed consent.
* Inability to fast for 8 hours.
Electromyography-biofeedback on the Motor Activation of the Extension of the Hand

Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent physiotherapy technique. Although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied.

Objective: The purpose of this research was to determine the changes that occur in the application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of the hand and the foot in subjects with cerebrovascular damage.

Design: A randomized, double-blind, two-arm parallel group study was performed.

Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the foot as a consequence of a stroke was randomized divided in intervention or control groups.

Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of 15-minute duration each of them, in the upper and lower members. On the other hand, the control group underwent another 12 sessions of 15-minute duration, in which manual physiotherapy techniques were performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a stroke
* Limitation of the hand and foot extension

Exclusion Criteria:

* Patients with some contraindication against the surface electromyography biofeedback technique, for instance, people with pacemaker, with cardiovascular antecedents, etc.
* Patients receiving other physiotherapy treatment 2 months before the beginning of the study
* Patients that decline to sign the informed consent.
Pulmonary Vein Ablation Versus Amiodarone in the Elderly

The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.

Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years at moment of screening, able to sign informed consent.
* Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.
* Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.
* No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.

Exclusion Criteria:

* EF \< 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening.
* Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade \>3)
* Acute illness: unstable angina, infectious disease.
* Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.
* Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).
* Previous ablation.
* Contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase \>2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc \>460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree AV-block.
* Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists.
* Any myocardial infarction or PCI in previous 6 months.
* CABG in previous 6 months.
* Renal dysfunction: creatinine clearance \<45 ml/min
* Severe co-morbidity. Life expectancy less than 1 year.
* Thrombus in left atrium
* Untreatable allergy to contrast media
Videoconferencing Between Ambulances and Physician Manned Rapid Response Vehicles, Effects on On-site Patient Treatment and Patterns of Referral

Physician manned rapid response vehicles are a limited resource in the prehospital handling of acute patients.

In this study mobile videoconferencing between ambulances and the rapid response vehicles enables patient consultation at a distance. Video consultation between patient and the prehospital physician can take place when the patient is at home or in the ambulance.

The primary aim of this study is to examine the effect of video consultation between physician manned rapid response vehicles and patients receiving treatment by ambulance personnel on the number of patients receiving final treatment on-site in the pre-hospital setting


Eligibility Criteria:
Inclusion Criteria:

* All patients receiving prehospital care by ambulance personnel
* Must receive either telephone or video consultation by physician in rapid response vehicle

Exclusion Criteria:

-
Siblings With Ischemic Stroke Study

The purpose of this study is to find the genes that increase the risk of developing an ischemic stroke using DNA samples collected from concordant (stroke-affected) sibling pairs.

Stroke is the third leading cause of death in the United States and a leading cause of acquired disability in adults. Each year, about 700,000 people experience stroke in the country. Ischemic stroke, which constitutes about 80 percent of all strokes, is a complex genetic disorder--the result of interactions between multiple genes and multiple environmental exposures. Genes affecting cholesterol, blood pressure, clotting, and other factors may increase the risk of ischemic stroke.

In this clinical study, investigators are studying groups of siblings in which at least two of the siblings have had an ischemic stroke. The goal of this multi-center study is to find the genes that increase the risk of developing an ischemic stroke.

To accomplish the aims of the study, researchers are using DNA samples collected from concordant (stroke-affected) sibling pairs to determine if there are regions in the human genome associated with ischemic stroke or that may harbor stroke susceptibility genes.

Two teaspoons of blood will be collected from each participant and submitted for genetic analysis. Understanding the genetic predisposition to stroke could have major benefits for public health.

Eligibility Criteria:
Inclusion Criteria:

* Subject diagnosed by a study neurologist as having had a symptomatic ischemic stroke in the past.
* Head Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) done within 7 days of symptom onset confirms absence of etiology other than ischemic stroke.
* Subject reports having at least one living sibling with a stroke.
* Subject is 18 years of age or older.

Exclusion Criteria:

* The index ischemic stroke occurred within 48 hours after a cardiovascular or cerebrovascular procedure.
* The index ischemic stroke occurred within 60 days after a non-traumatic subarachnoid hemorrhage.
* The subject has brain biopsy-proven central nervous system vasculitis.
* The subject is known to have any one of the following genetic disorders: CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy), Fabry's disease, homocystinuria, MELAS (Mitochondrial myopathy, Encephalopathy, Lactic Acidosis, Stroke), or sickle cell anemia.
* The subject has a mechanical aortic valve or mechanical mitral valve.
* The subject had untreated or actively treated bacterial endocarditis at the time of the index ischemic stroke.
The Effects of Peer-led Walking Intervention With mHealth Technology

This study will apply the peer-led walking intervention with mHealth technology to maintain physical activity and promote prenatal health. Moreover, the participants of the trained peer mentors support women walking with mHealth technology, which has pregnant women using the APP to set goals, self-monitor, and self-manage, and it will continue to promote physical activity for overweight and obese pregnant women

This study was to investigate the effectiveness of peer-led walking intervention with mHealth technology on physical activity, self-efficacy, weekly steps, exercise involvement and depression status. Participants of the trained peer mentors encourage women walking with mHealth technology, which has pregnant women using the APP to set goals, self-record, and self-monitor, and it will continue to promote physical activity for overweight and obese pregnant women.This study's results will be useful to healthcare providers who need to promote physical exercise and an active lifestyle for overweight and obese pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* women who had a pre-pregnancy body mass index of more than 25 kg/m2

Exclusion Criteria:

-
Clinical Decision Support for Safety of Opioid Transitions

The objective of this study is to evaluate the impact of clinical decision support (CDS) alert to notify providers when the opioid prescription being written will result in the patient transitioning into a new phase of opioid therapy. The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends providers reassess patient pain as well as the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and when patients transition from subacute to chronic opioid treatment (3 months). This study will evaluate a clinical decision support tool identifying patients who will be transitioning between phases as a result of an opioid prescription and suggest a review of patient pain and goals. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will not be notified that the prescription transitions the patient to a new phase but will have access to the same patient pain scales and information. The intervention arm will receive a notification of the transition and suggest review of patient needs and encourage documentation. Opioid transition orders and outcomes of patients will be examined based on medical records data collected during routine care.


Eligibility Criteria:
Inclusion Criteria: Any primary care encounter where an opioid is prescribed that transitions the patient to a different stage of opioid therapy (acute to subacute after 1 month of opioids; subacute to chronic after 3 months of an opioid)

Exclusion Criteria:

* Patients \<12 and \>89
* Patients with active cancer diagnosis in last 1 year
* Patients with hospice care/palliative care order
* Patients with sickle cell disease diagnosis
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093.

The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors.

The study is looking at several other research questions, including:

* Side effects that may be experienced by people taking REGN5093
* How REGN5093 works in the body
* How much REGN5093 is present in the blood
* To see if REGN5093 works to reduce or delay the progression of cancer
* How long it takes REGN5093 to work in the body


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
2. Willing to provide tumor tissue as described in the protocol
3. Documented presence of MET alteration as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
3. Has received radiation therapy or major surgery within 14 days as described in the protocol
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
5. Uncontrolled infection as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria apply
Glucose-Guided Eating Pilot

This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).

The primary objectives of the study are to (1) test the feasibility and acceptability of the GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE on 12-week changes in insulin resistance (IR) and body weight.

The secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking GGE to IR and (2) explore the durability of intervention effects on 24-week changes in body weight.

Eligibility Criteria:
Inclusion Criteria:

All:

1. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
2. Willing to use a continuous glucose monitor
3. Own smartphone that is compatible with Dexcom CGM.
4. Willingness to commute to GUMC for in-person study visits
5. No active cancer (except for nonmelanoma skin cancer)
6. Less than 5 lbs. weight change in previous 3 months
7. Proficient in speaking and reading English

   Postmenopausal women with pre-diabetes:
8. Age 18 years and older
9. Diagnosed as having prediabetes.
10. HbA1c (within 3 months) between 5.7% and 6.4%
11. Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)

    AYA cancer survivors:
12. Current age 21-39 years
13. Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Clinical history of type 1 or type 2 diabetes
3. Currently receiving anti-diabetics (e.g., insulin, GLP1), oral hypoglycemic agent (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers, hydroxyurea, atypical antipsychotic agents (i.e., Olanzapine, Aripiprazole) or systemic progestin-only contraceptives
4. Current or past history of an eating disorder
5. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
6. Have any contraindications for CGM, including: severe allergy to surgical adhesive, being on dialysis, receiving diathermy treatment, or scheduled CT scan or MRI during wear period
7. Growth hormone deficiency, hypoadrenal function, or hypopituitary function
Tableted COVID-19 Therapeutic Vaccine

Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.

Experimental batch of tableted thermostable vaccine obtained from pooled plasma of COVID-19 patients is produced. The goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. Baseline and post-treatment standard safety parameters will be compared. Blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
* Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)

Exclusion Criteria:

* Unable to take oral medication,
* Immunocompromised
* Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
* BMI less than 18
* Smoking history (more than one pack per day)
Diabetes Knowledge Assessment

To assess the knowledge of both type 2 diabetics and non-diabetics on diabetes, nutrition, and exercise. Although type 2 diabetics should know more about their disease and its needs, it is not expected they will know significantly more than the lay public.

A validated survey about diabetes, nutrition, obesity, and exercise will be dispersed to type 2 diabetics and non-diabetics, and then analyzed.

Eligibility Criteria:
Inclusion Criteria:

type 2 diabetic or non-diabetic, age 18 and over

Exclusion Criteria:

type 1 diabetic
Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours

A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.

A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor, nivolumab, in patients with advanced solid tumours, non small cell lung cancer and renal cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years at time of informed consent.
* Previous histologically confirmed diagnosis of RCC or NSCLC having received previously checkpoint inhibitors as part of a SoC regimen.
* Consent to mandatory paired tumour biopsies of at least one tumour site accessible for repeat biopsies. Planned sites for tumour biopsies must not have been previously irradiated and could be a target lesion of \>2 cm diameter according to RECIST v1.1 and must be approved on a case-by-case basis by the Sponsor.
* Measurable disease as per RECIST v1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Any anti-tumour therapy, including investigational therapies, within 4 weeks prior to the first dose of EXS21546.
* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per CTCAE v5.0.
* Concurrent other malignancy that could interfere with response evaluation.
* Symptomatic central nervous system (CNS) malignancy or metastases. Screening of symptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions 60 days prior to study enrolment.
* History of interstitial lung disease and/or prior immunotherapy-related pneumonitis.
* Patients who have had or are scheduled to have major surgery \< 28 days prior to the first dose of study drug.