cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality and Post-dry Needling Soreness

Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Previous studies have investigated spray and stretch, ischemic compression or low-load eccentric exercise as post-needling intervention procedures. There is increasing evidence supporting the role of descending pain inhibition mechanisms for paon control. The application of virtual reality as a distraction technique could active brain mechanisms during dry needling. Therefore, the objective of this study will be to investigate the effects of playing virtual reality during the application of dry needling on post-needling soreness over trigger points in the extensor carpi radialis brevis muscle. A secondary aim will be to determine the prognostic role of baseline scores of pressure pain sensitivity, related-disability, anxiety and catastrophizing levels.


Eligibility Criteria:
Inclusion Criteria for pain-free participants:

* no history of upper quadrant pain symptoms the year preceding the study
* no history of upper quadrant surgery
* presence of a latent trigger point in the extensor carpi radialis brevis muscle

Inclusion criteria for patients with elbow pain:

* pain over the lateral side of the elbow;
* pain on palpation over the lateral epicondyle or the associated common wrist extensor tendon;
* elbow pain with either resisted static contraction or stretching of the wrist extensor muscles.
* presence of an active trigger point in the extensor carpi radialis brevis muscle

Exclusion Criteria:

* bilateral symptoms;
* older than 50 years of age;
* previous surgery or steroid injections;
* other diagnoses of upper extremity (shoulder pathology, cervical radiculopathy, cervical whiplash);
* history of cervical or upper extremity trauma;
* history of musculoskeletal medical conditions (rheumatoid arthritis, fibromyalgia);
Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).


Eligibility Criteria:
Inclusion Criteria :

* Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
* Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
* Available for the duration of the study.
* Parent/legal representative willing and able to provide informed consent.
* Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
* Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.

Exclusion Criteria :

* Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
* Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
* Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
* An acute illness with fever (rectal temperature ≥ 100.4°F \[38.0°C\]) in the 72 hours preceding enrollment in the trial (defer enrollment).
* Known bleeding disorder.
* Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in the study.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital, or developmental disorder that, in the opinion of the investigator, could interfere with trial conduct or completion.
* Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.
* Known HIV, Hepatitis B, or Hepatitis C infection.
* Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
* Prior personal history of Guillain-Barré syndrome.
* Any condition that, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Using Continuous Passive Motion to Prevent Ankle Problems in ICU Patients

The goal of this clinical trial is to learn if continuous passive motion (CPM) helps prevent ankle joint contracture and muscle loss in critically ill, mechanically ventilated ICU patients. It will also evaluate the feasibility and safety of implementing CPM in this population. The main questions it aims to answer are:

Does CPM help preserve ankle dorsiflexion range of motion during immobilization in the ICU?

Can ultrasound measurements detect changes in tibialis anterior muscle condition in response to CPM?

Researchers will compare one ankle receiving CPM to the other ankle without intervention in the same patient to assess differences in joint mobility and muscle morphology.

Participants will:

Receive CPM therapy on one ankle for 30 minutes, twice daily, over a 7-day period or until ICU discharge

Undergo goniometric and ultrasound assessments at baseline and at the end of the intervention

Remain under usual ICU care and monitoring while enrolled in the study


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years
* Admitted to the ICU with acute respiratory failure requiring mechanical ventilation
* Expected to remain mechanically ventilated for at least 7 days
* Sedated and unable to participate in active mobilization
* No contraindications for passive ankle movement
* Informed consent obtained from legal representative

Exclusion Criteria:

* Pre-existing neuromuscular disorders affecting lower limb mobility (e.g., stroke with hemiparesis, myasthenia gravis)
* Recent orthopedic surgery or trauma involving the lower limbs
* Presence of lower limb amputation
* Peripheral vascular disease with critical limb ischemia
* Active deep vein thrombosis in either leg
* Significant wounds, pressure ulcers, or skin breakdown at the heel
* Pregnancy
Vitamin D for Chemoprevention

This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies.

* Participants will be asked to answer some questions about their diet, exercise and health. In addition, participants blood pressure will be taken. These assessments will occur at baseline, 3- and 6-month appointments. At baseline only, we will measure skin tone with a tool called the Photovolt 577.
* A small blood sample will be taken to see how much Vitamin D is the body and will also look at levels of other markers of disease such as proteins, hormones, and genes.
* Participants will take a vitamin pill every day for three months and be randomly assigned to one of four different types of pills.
* Participants will be called or visited at least every two weeks. They will be asked questions to determine if they have any side effects associated with high levels of Vitamin D.
* At the beginning of the second and third months, participants will be provided with more pills. At the end of the third month, another blood sample will be taken. Three months after that, the final blood sample will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 30 and 80 years
* Comfortable communicating in English
* Currently has a primary care physician
* Willing to discontinue vitamin D or calcium supplements
* Willing to have all protocol specific tests run

Exclusion Criteria:

* Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
* Pregnant or breast feeding or planning on becoming pregnant in the following year
* Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
* No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
* Cognitively impaired
* Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
* History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* With Atopic Dermatitis.

Exclusion Criteria:

* Not enough washing-out period for previous therapies.
* Any major surgery planned during the research period.
* With intestinal parasitic infection within the 6 months before screening.
* With any circumstance that is not suitable to participate in this study.
* Major surgeries are planned during the study period.
Fibrin for Chronic Multi-level Discogenic Low Back Pain

Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).

The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram

Exclusion Criteria:

* Scoliosis greater than 20 degrees
* Spondylolysis
* Spondylolisthesis greater than Grade 1
* Disc extrusion
* Disc herniations or bulges \> 4mm causing severe stenosis
* Prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty)
* Cauda equina syndrome
* Active malignancy or tumor as source of symptoms
* Evidence of prior lumbar vertebral body fracture or trauma
* Foraminal stenosis at the affected levels resulting in severe thecal sac compression
* Dynamic instability on lumbar flexion/extension radiographs
* Positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection
* Known bleeding disorder
* Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure
* Presence of ferromagnetic implants that would interfere with MRI evaluations
* Active or pending workers' compensation claims or other litigation related to the condition.
* Pregnant or plans to become pregnant over the course of study participation (2 years)
Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders

This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive.

Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.

This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning.

1. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -\> MA regimen
2. HCT-CI/Age \>4 AND/OR any IADL impairment (more vulnerable) -\> RIC/NMA regimen

   * Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine
   * Radiation therapy: total body irradiation (TBI)
   * Other therapy: anti-thymocyte globulin (ATG)

Eligibility Criteria:
Inclusion Criteria:

* are 60 years or older
* have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome
* have \<10% blasts in bone marrow prior to transplant
* have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
* Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician
* Undergoes transplantation using the allocated conditioning regimen intensity defined by the protocol-specified criteria below:

  * HCT-CI/Age \<5 and IADL normal = myeloablative regimen
  * HCT-CI/Age ≥5 and/or IADL impairment = RIC/NMA regimen

Exclusion Criteria:

* Prior hematopoietic cell transplantation
* Cord blood donors
* Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis

Immune-mediated diseases are extremely diverse - patients with the same diagnosis may see the disease progress in very different ways, and respond differently to treatments. This is because the course of the disease is influenced by multiple factors, including the patient's genes, immune system, environment, and the microbes living in their gut. Furthermore, all of these factors interact with and impact on one another. As a result, it is very hard to predict how the disease will develop in a specific patient, and which treatments will be effective. Hence, mechanistic understanding of this heterogeneity and biomarkers predictive for disease control and therapy response over time are important prerequisites of a future precision medicine in IMIDs. ImmUniverse has been formed as a European transdisciplinary consortium to tackle these unmet needs and to understand the role of the crosstalk between tissue microenvironment and immune cells in disease progression and response to therapy of ulcerative colitis (UC) and atopic dermatitis (AD).

The consortium will combine analysis of tissue-derived signatures with "circulating signatures" detectable in liquid biopsies, employing state-of-the-art profiling technologies to provide new validated diagnostics in IMID that are expected to improve patient management, lead to increased patient well-being and will significantly reduce the socioeconomic burden of these diseases. This study, being Immuniverse work package 5 (WP5), will verify the disease pathway -and mechanism signatures identified in the multi omic discovery WP2 in immune cells in affected tissue and peripheral blood. WP5 aims to further substantiate our understanding of the immune-mediated intestinal disease ulcerative colitis (UC). It will use liquid biopsies (peripheral blood) and affected UC gut inflamed and non-inflamed biopsies to generate transcriptome, proteome, DNA-methylome and miRNA signatures of immune cell subsets and analyse the association between immune cells circulating in peripheral blood and the microenvironment of affected colonic tissue.

Also this WP aims to develop a protocol to analyse and sort living immune cells from cryopreserved tissue. Ultimately, the project's findings should contribute to a better, more precise diagnosis for patients; and better information on how severe the disease is likely to be for each individual patient and how it will progress over time. Finally, the project will make it easier for doctors and patients to monitor how well a treatment is working in the future.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ulcerative Colitis
* Age ≥ 18 years
* Present in the hospital for a regular outpatient visit
* Willing and able to comply with the study related procedures
* Provide signed informed consent

Exclusion Criteria:

* Age ≤ 18 years
* Unable to give informed consent
* Unable or unwilling to comply with study-related procedures
* Crohn's Disease or IBD undiagnosed
Mobile Health Platform for Surveillance of Kidney Stone

We plan to investigate whether usage of a mobile health platform for surveillance of stone formers by itself or as an adjunct to standard office-appointments will improve patient compliance and adherence to treatment guidelines and ultimately improve patient care, satisfaction, quality of life, and decrease stone recurrence.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* urinary tract stone formers
* meet the AUA guideline indication for metabolic stone evaluation and surveillance
* willing to pursue treatment recommendations of a metabolic workup

Exclusion Criteria:

* patients without mobile phone capability to utilize GetWell Loop,
* physical or cognitive impairment precluding usage of mobile phone or answering of questionnaires
* non-English speaking
* inability to consent to the study
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy.
* At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP.
* LVEF ≥ 40%.
* Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography:
* Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure.

Key Exclusion Criteria:

* Stroke or thromboembolic event in the past 6 months.
* Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD \> 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
* Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
* More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
* Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
* BMI \> 40.
* 6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test.
* Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate \> 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline).
* Evidence of precapillary pulmonary hypertension defined as PVR \> 2 Wood units at rest, TPG \> 15 at rest or with exercise, resting RA \> 15 mmHg, or RA to PCWP ratio \> 0.7 at rest and with exercise.
* Anatomic anomaly that precludes creation of interatrial shunt.
The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft

This study aims to investigate the effects of cardiac rehabilitation on sleep quality and sleep duration in patients after coronary artery bypass graft.

Coronary artery disease (CAD) is one of the common cardiovascular diseases, including myocardial infarction and unstable angina pectoris. Using the Global Burden of Disease statistical data analysis in 2020, Khan and other scholars found that the global prevalence of CAD is about 1,655 per 100,000 people, and the prevalence rate in Taiwan is about 1759 per 100,000 people, slightly higher than the global prevalence rate. Therefore, all countries in the world attach great importance to the prevention and treatment of CAD. In addition to common risk factors such as age, metabolic disease, smoking, and poor lifestyle habits such as insufficient physical activity, the literature indicates that sleep quality and sleep duration are also significantly associated with CAD. A 2011 meta-analysis by Francesco et al. pointed out that people who sleep less than 5 hours have a higher risk of CAD and are significantly associated with higher mortality rate. Patients with CAD who self-reported poor sleep quality and short sleep duration still had a high proportion after heart-related treatment. In 1993, Redeker tracked the related symptoms of patients after coronary artery bypass graft(CABG) and found that the sleep disturbance of patients did not improve, but increased. A systematic review of the literature by Liao et al. also found similar results. The sleep quality and sleep duration of patients after CABG can be improved over time, but a high proportion of patients still complain of sleep disturbance. Therefore, the influence of sleep disturbance in patients with CAD will persist, and studies have also suggested that persistent sleep disturbance will increase the readmission rate and mortality rate of patients with CAD. Therefore, it is very important to actively manage the sleep quality and sleep time of patients with CAD.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-80 years old
* Have undergone CABG
* The score of PSQI \> 5
* Can accomplish with instructions and complete the evaluation process
* Body mass index less than 35 Kg/m2

Exclusion Criteria:

* Diagnosed with
* Sleep apnea (e.g., obstructive sleep apnea, and central sleep apnea)
* Drug or alcohol dependence
* Psychology disease
* Neurological or musculoskeletal disorders that may interfere with CR
* Uncontrolled cardiac status (e.g., unstable angina, and uncontrolled arrhythmia)
* Women in pregnancy