cyrilzakka/clinical-trials huggingface dataset:
Examining Changes in Muscle Size and Body Composition Between Two Hypertrophy Resistance Training Programs in Males

This study aims to investigate if a less physically and psychologically taxing approach to resistance training can generate equal or greater outcomes when compared to a more physically and psychologically taxing approach.

Resistance training is commonly used to improve body composition, gain strength, increase muscle size (i.e., hypertrophy) and prevent muscle atrophy (i.e., muscle wasting). The most optimal mode of building muscle remains unclear, however there are many mechanisms that can be tested to yield optimal results. One variable that can be manipulated when designing a hypertrophy-focused resistance training regimen is intensity (i.e., proximity-to-failure). Proximity-to-failure is defined as the number of repetitions remaining in a set of prescribed exercises prior to reaching momentary muscular failure (MMF). MMF is when an individual cannot complete the lowering or concentric phase of a given repetition with a full range-of-motion without deviation from the prescribed form of the exercise. For all lifters, particularly amongst older populations, it can be psychologically demanding to push to MMF, and may increase the risk of delayed onset muscle soreness (DOMS) and/or injury due to technical breakdown. In contrast, there is some evidence that suggests training to a slightly less intensity (i.e., within 1-4 repetitions in reserve \[RIR\]) may result in comparable hypertrophic results with less of a physical and psychological demand on participants.

For these reasons, this study looks to investigate if an easier (i.e., less intense) approach to training such as training with repetitions in reserve (RIR), warrants similar or better muscle hypertrophy adaptations to MMF.

Eligibility Criteria:
Inclusion Criteria:

* biological male
* age 18 years or older
* enrolled at Dalhousie university
* minimum 3-months of consistent (at least 2x/week) resistance training experience

Exclusion Criteria:

* body fat percentage 25% or greater (obese)
* use of performance enhancing drugs that aim to increase rate of muscle growth (i.e., androgenic steroids, anabolic steroids, selective androgen receptive modulators, growth hormone).
Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals

OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital signals The OASIS study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be used to predict changes in lupus disease activity. You may receive a Withings Steel HR smartwatch as part of this study. The purpose of this study is to look for factors that affect lupus disease activity and potentially predict lupus flares through non-clinical tests


Eligibility Criteria:
Inclusion Criteria:

* Female or male age 18 or older
* Participant is currently not enrolled in another study
* Able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures

Exclusion Criteria:

* NOT able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures
* Known to be pregnant
Cardiovascular Effects of Sporting Events

Major sporting events may have adverse cardiovascular effects in subjects with coronary heart disease. We also hypothesized that the adverse cardiovascular effects of sporting events are a result of psychobiological processes including stress-induced hemodynamic changes, autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic responses, all of which may in turn promote myocardial ischemia.

Observational studies suggest that exposure to sporting events may worsen symptoms of angina and trigger acute myocardial infarction. The mechanisms for this association are unknown. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of sporting events.

In a randomized crossover controlled study, 38 patients with prior myocardial infarction will be exposed to sporting events or not. Myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography, and blood pressure change will be analyzed using ambulatory blood pressure monitoring. Autonomic function will be assessed by heart rate variability. Ischemic, inflammatory and prothrombotic markers will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Previous myocardial infarction (\>6 months previously)treated by coronary revascularization
* On standard secondary preventative therapy

Exclusion Criteria:

* Angina pectoris (Canadian Cardiovascular Society grade ≥2)
* History of arrhythmia
* Uncontrolled hypertension
* Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)
* Occupational exposure to sporting events
* Diabetes
* Hepatic or renal failure
Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies for Vascular, Abdominal, and Pelvic Exams

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions.

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions. Software and hardware are always being improved, new machines replace old machines, software is updated and improved as well as devices used to produce better MRI images.

Eligibility Criteria:
Inclusion Criteria:

* male or non-pregnant female patient
* 18 years or older
* any ethnic background
* presenting to MRI for a clinically-ordered chest MRI exam.

Exclusion Criteria:

* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients or patients who are lactating.
* A patient who is claustrophobic
IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

This is a prospective, single-blind clinical investigation randomizing subjects to IVUS-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio.

The clinical investigation will be conducted at approximately 120 centers in the US, Canada, and Europe. Approximately 2,500-3,100 randomized subjects and up to 3 roll-in subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 2 years. The expected duration of enrollment is approximately 2.5 years. The total duration of the clinical investigation is expected to be approximately 4.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at screening
* PCI with stent implantation involving a high risk or complex lesion defined as involving at least one of the following characteristics:
* Chronic total occlusion
* In-stent restenosis
* Severe coronary artery calcification
* Long lesion (≥ 28 mm in length)
* Bifurcation lesion (Any Medina class that involves main branch disease with a side branch ≥2.0 mm)
* Stable angina, unstable angina, or non-ST Elevation myocardial infarction (NSTEMI), undergoing PCI of a single or multivessel coronary artery stenosis
* PCI performed with either angiography alone, or IVUS guidance used

Exclusion Criteria:

* Subjects with acute ST elevation myocardial infarction (STEMI), or cardiogenic shock
* Use of fibrinolytic therapy within 24 hours of PCI
* Planned revascularization of a target vessel as a staged procedure
* Stent thrombosis
* Use of optical coherence tomography (OCT) during the index procedure
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants greater than (\>) 18 years of age
* Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
* No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
* Verified complete or partial remission after first-line induction therapy including rituximab

Exclusion Criteria:

* Grade 3b follicular lymphoma
* Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
* Presence of central nervous system lymphoma
* Acquired immunodeficiency syndrome-related lymphoma
* Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (\>=) 5 years
Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

The study aims to develop a questionnaire that can be used to help uncover a child's risk of developing dental caries (also known as tooth decay or a cavity). The aim is to develop a practical and easily-scored risk tool that a primary medical care provider can use to help find young children with the highest risk for developing cavities.

The duration of expected time to participate is 3 years (which includes 3 dental examinations).

Eligibility Criteria:
Inclusion Criteria:

Adults

* If Primary Caregiver is the Parent/Legal guardian: The parent/legal guardian must provide written informed consent for the child and her/himself (if s/he is the primary caregiver) prior to participation.
* If Primary Caregiver is not the Parent/Legal Guardian: If another individual is the primary caregiver, then this individual must provide written informed consent for her/himself prior to participation.
* The parent/legal guardian and the participating primary caregiver must each be at least 18 years old or an emancipated minor
* The parent/legal guardian must consent and allow examination of the oral cavity of her/his child. The primary caregiver must complete the caries risk assessment questionnaire.
* The primary caregiver must be willing to participate, anticipate being the child's primary caregiver during the study period, and anticipate being available for all examinations (baseline, 18 month follow up, and 36 month follow up), in addition to intermediate contacts in between examinations.

Children

* Child must be 9-15 months of age at the time of the baseline study visit.
* Child must be generally healthy (i.e., no current medical condition that makes it difficult for her/him to receive a dental examination).
* Child must allow examination of the oral cavity.

Exclusion Criteria:

Adults

* A participant pair (adult-child) who demonstrates an inability to comply with study protocol requirements will be excluded - this determination will be at the Site Primary Investigator's discretion.
* Non-English, non-Spanish reading/speaking individuals will be excluded, as they will not be able to comprehend the consent document or complete the risk questionnaire.

Children

* Children who are in foster care at study initiation will be excluded, due to the likelihood that their primary caregiver will change multiple times during the length of the study.
* Need for antibiotic and/or sedative premedication prior to dental exam.
* Uncontrolled epilepsy.
* Active cancer treatment.
* Unrepaired congenital heart defects that would require premedication prior to dental exam.
Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age

Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (GWG), exacerbating intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease (CVD) across the lifespan. Healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, HTN, T2D, and CVD. The Diabetes Prevention Program (DPP) is a well-established, Centers for Disease Control and Prevention (CDC)-led public health program focusing on healthy lifestyle changes and is effective at reducing 5-7% of body weight, lowering risks for T2D. Interestingly, research investigating the DPP as a lifestyle intervention for other chronic conditions (i.e., overweight/obesity and HTN) is lacking, demonstrating a missed opportunity. The aim of this study is to determine the initial effects of the first 6-months and after receiving the full 12-months of the virtual DPP compared to the DPP expanded with a CDC-approved HTN prevention component (DPP+) on physical activity, diet, weight, and CVD risk factors in 30 prediabetic women (18-45 years old) with a history of excess GWG, overweight/obesity, and HTN. Participants will be recruited through University of Texas Medical Branch (UTMB) community-based clinics using Epic. The Participants will be randomized into 2 groups (DPP and DPP+) and guided through the 12-month virtual DPP or DPP+ program using UTMB DPP personnel.


Eligibility Criteria:
Inclusion Criteria:

* Women with prediabetes and eligible for the DPP, overweight/obesity, HTN (diagnosed or 3 successive high blood pressure readings), and history of excess gestational weight gain during most recent pregnancy

Exclusion Criteria:

* Pregnant and lactating women, participants planning to move out of Galveston County within the next year
Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction

The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study:

1. How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
2. How does physical activity change following ACL reconstruction;
3. Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 50 years old; isolated ACL rupture confirmed on MRI

Exclusion Criteria:

* other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups
A Clinical Study to Evaluate the Efficacy of Biologics in SpA

Spondyloarthritis (SpA) is one of the potentially debilitating inflammatory diseases that affect the whole body, primarily burdening the sacroiliac joints and the spine. It mostly affects young and middle aged adults. SpA can be classified to non-radiographic axial SpA (nr-axSpA) and radiographic axSpA (r-axSpA). The latter is ankylosing spondylitis (AS). The key to its early treatment is the radiological detection and management of sacroiliitis. To date, biologics is the most powerful anti-inflammatory drug. Recent research has shown that diffusion-weighted imaging (DWI) outperforms the sequence recommended by the Guidelines in diagnosing inflammation and assessing disease activity. Preliminary research conducted by our team has also demonstrated that apparent diffusion coefficient (ADC) is a valuable imaging biomarker. However, to date, no serum maker of comparable effectiveness has been identified. Damage-Associated Molecular Pattern (DAMP), including S100A8 and S100A9, high mobility group protein B1 (HMGB1) and Tenascin-C (TNC), may play a role in inflammation by regulating the TLR4/MyD88/NF-κB signaling pathways. The present study will enroll 20 patients with nr-axSpA and 20 patients with AS. It will utilize serum DAMP and ADC to assess disease activity before and after treatment as well as the change in and correlations of treatment outcomes, in order to identify objective and quantifiable serum and imaging markers that are beneficial in clinical applications. ADC is the primary outcome. The main hypothesis is that disease activity as measured by ADC will be reduced after 1 year of treatment from baseline as compared to before treatment at baseline. Study findings will indicate the utility of ADC as an objective indicator of disease activity for guiding therapeutic approaches and improving dosage adjustment in clinical applications.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosed with non-radiographic or radiographic axial SpA

Exclusion Criteria:

* Unable to provide written consent
* Unable to undergo MRI examination
* Pregnancy
* Unable to read and/or write Chinese
The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus

COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primary comparison in terms of safety and immunogenicity will be between two different dose levels of COV2 booster vaccine (low, high), and two different administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive subjects.


Eligibility Criteria:
Inclusion Criteria

1. Has voluntarily signed the written informed consent
2. 18-75 years old
3. Good general health
4. a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination

Exclusion Criteria

1. Pregnant, planning to become pregnant or breastfeeding women
2. COVID-19 infection within the last nine (9) months
3. Any other vaccination within the last two (2) months
Verify the Performance of the Neutral Electrode (NE) Adhesives

The purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard IEC 60601-2-2 section 201.15.101.7. A neutral electrode is placed on the body of patients undergoing surgery that involves the use of electric current, to protect them from the harmful effects of the electricity.

Two neutral electrodes will be applied to the front of your thighs. The study staff will set up and attach a pulley system to the neutral electrodes. The purpose of the pulley system is to apply a force pulling the neutral electrode away from your body. The force will be applied for 10 minutes on each neutral electrode in one direction, and then for another 10 minutes in a second direction. Site staff will mark any areas of separation and the neutral electrodes will be removed.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be willing to comply with all study procedures
* Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Exclusion Criteria:

* The participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, sunburn, etc.) at the application sites that might be adversely affected by the application of an adhesive pad.
* The participant is pregnant or breastfeeding.
The Impact of Vocational Rehabilitation on Mentally III Veterans

To study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).

Objectives: to study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).

Research Design: This prospective randomized study evaluates the impact of IPS-SE compared to VRP on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic PTSD who enter the Tuscaloosa VA Medical Center's (TVAMC) vocational rehabilitation program.

Methodology: Occupational functioning is determined primarily by whether the veteran can obtain and maintain competitive employment, and, secondarily, by time worked and wages earned for those employed. Veterans who meet inclusion criteria will be randomized to either IPS-SE or VRP. Outcomes will be assessed over a fixed 12-month observation period (beginning at randomization and computed for the entire 12-month observation period) as percent subjects employed at least one week (employed rate), and monthly employment rates (maintained employed rate). In addition, PTSD symptoms and other health-related quality of life measures will be evaluated. This strategy uses all available data during the 1-year period.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age, greater than or equal to 19 and less than 61.
* Enrollment in the TVAMC VRP
* Signed informed consent
* Chronic post-traumatic stress disorder
* Any race or ethnic origin
* Anticipation of remaining in the catchment area for the 12-month study duration

Exclusion Criteria:

* Lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment
* History of schizophrenia, schizoaffective, disorder, or bipolar I disorder
* Pending litigation
* In need of immediate detoxification.
MR-guided Tumour Boost

This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven localized prostate cancer.
* Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor)
* Low-risk: cT1-T2a, PSA \<10, and Gleason score 6
* Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7
* High-risk limited to 1 risk factor: \>T2, PSA \>20, or Gleason score \>7
* Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/\< 1/3 total prostate volume
* Planned for EBRT (+/- ADT)
* ECOG 0 or 1
* 18 years of age or older
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Prior radiotherapy to pelvis
* Radiological evidence of regional or distant metastases at the discretion of the treating physician.
* Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
* Ataxia Telangectasia and SLE
* Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury
* Severe claustrophobia