cyrilzakka/clinical-trials huggingface dataset:
Rapid Non-invasive Detection of Aortic Stenosis

Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.

The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.

The Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.

After informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (\~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects \>60 years of age
2. Ability to understand and sign informed consent
3. Willingness to undergo study protocol (in Pasadena CA)

Exclusion Criteria:

1. Inability to provide informed consent
2. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck)
3. History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery
4. History of aortic valve surgery or transcatheter aortic valve replacement
5. Absent carotid pulse on initial examination (inability to palpate the carotid pulse)
6. Open skin lesions at the site of Vivio application/examination
7. Presence of a carotid bruit on examination
Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation

This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .


Eligibility Criteria:
Inclusion Criteria:

* occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy

Exclusion Criteria:

* Erectile dysfunction
* Hypo or hyperthyroidism
* Hypogonadism
* Hyperprolactinemia
* Drug abuse
* Psychiatric disorders or related medications
Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design

The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.

The goal of this study is to perform a kinematic evaluation of a MB and FB knee prosthesis designs (Triathlon, Stryker, USA), by means of fluoroscopy and RSA and compare the different designs. The findings of this study will contribute to improve total knee designs and improve rehabilitation strategies.

Objectives:

1. To evaluate if there is micromotion of the prosthesis with respect to the bone and if there is a different migration pattern between the designs.
2. To assess and compare the in vivo kinematic patterns of the knee designs by means of fluoroscopy. This will be done on a subset of the patients (the first 20 patients able to perform step-up and lunge motions 6 months post-operatively in a controlled manner without the use of bars and walk more than 1 km)
3. To evaluate if the polyethylene bearing in the mobile bearing is rotating and if this changes over time.
4. Results of the RSA study will be used to correlate the kinematic parameters (fluoroscopy) with the migration results in order to identify factors of risk for the survival of total knee prostheses.

Eligibility Criteria:
Inclusion Criteria:

* Patient (minimum age of 18 years old, no maximum age limit) is diagnosed with osteoarthritis or rheumatoid arthritis and requires primary arthroplasty.
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
* Patient has no major deformities (i.e. sagittal and coronal deformities are less then 15 degrees)
* The ability to perform a lunge and step-up motion without the help of bars or a cane.
* No or slight pain during activity according to the Knee Society Pain Score

Exclusion Criteria:

* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The individual has a functional impairment of any other lower extremity joint besides the operated knee
* Patient has a flexion contracture of 15° and more
* Patient has a varus/valgus contracture of 15° and more
* Patients requiring revision arthroplasty
* The patient does not understand the Dutch or English language good enough to participate.
* The use of walking aids
* The inability to walk more than 500 meters
Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners

Patients with cancer are at a significantly increased risk of experiencing a venous thromboembolism (VTE). VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism) and is a leading cause of condition of being diseased and death among cancer patients. The goal of the study is to gather information how often venous thromboembolism (VTE) occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners.


Eligibility Criteria:
Inclusion Criteria:

* Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included. From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected.

Exclusion Criteria:

* None
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda

This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV/AIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.

Study Design Aim 1. The investigators will conduct a parallel cluster-randomized hybrid Type 2 effectiveness-implementation trial at 16 sites.

Aim 2. Within the Aim 1 study, the investigators will nest a longitudinal observational study in both arms of the cluster-randomized trial to determine the feasibility, acceptability, and appropriateness of a peer-navigation strategy for TB-EC. The investigators will concurrently assess biological adherence using urine biomarkers) and will also perform a mediation analysis of social and behavioral factors (i.e., TB knowledge, perceived social support, general self-efficacy, HIV/TB stigma) to identify causal mechanisms of impact. Finally, the investigators will pilot and culturally adapt study instruments in a pilot study prior to the trial.

Aim 3. The investigators will also conduct a qualitative and mixed methods studies to assess the implementation fidelity and context of the peer-navigation strategy for TB-EC:

1. Process evaluation of intervention fidelity to quantify the adoption, reach, implementation, and maintenance of the peer navigation strategy,
2. In-depth interviews with people with Tuberculosis (PWTB) with and without HIV,
3. In-depth interviews with and direct observation of peer navigators, and
4. Focus-group discussions (FGDs) with healthcare workers.

The focus of this registration is Aim 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

TB outcomes:

* Sites will enroll consecutive adults and older adolescents (age ≥18) recorded as new TB cases in the on-site National TB Program TB treatment register.

ART outcomes:

* Participants must be documented as a People Living with HIV (PLH) in the TB register.

Exclusion Criteria:

TB outcomes: Individuals who are

* transferring in from off-site
* diagnosed with possible or confirmed drug-resistant TB
* residing \>40 km from the clinic
* lacking mental capacity to participate in peer counseling

will be excluded from this study.

ART outcomes:

* The investigators will exclude those with TB meningitis or TB pericarditis for which immediate ART is contraindicated; and those with central nervous system TB or TB osteomyelitis because these forms of TB have a different treatment duration.
Asynchronies in NIV With External Gas

NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age,
* hospital admission for acute chronic respiratory failure,
* home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night).

Exclusion Criteria:

* Patients with underlying psychiatric disease were excluded
NETTUNIT - Italy-Tunisia Cross-border Environmental network_1

Retrospective, case-crossover study aiming to use environmental pollutant data for assessing the associated risk of visiting the emergency room (ER) for respiratory or cardiovascular problems in the territory of the Caltanissetta Provincial Health Authority (Italy). All the ER visits for respiratory and/or cardiovascular disorders in the hospital of Gela (Italy) and Niscemi (Italy) from 2010 to 2019 will be considered.


Eligibility Criteria:
Inclusion Criteria:

* All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019.

Exclusion Criteria:

* Emergency room visits for other diseases.
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.

The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing genicular RFA will be eligible for inclusion in the study
* Patients with knee pain, baseline average of \> 4/10
* X-ray evidence of osteoarthritis of the knee
* Pain duration of \>6 weeks and no previous knee surgeries
* Patients will also only be included who have never undergone a RFA on the affected knee

Exclusion Criteria:

* Individuals who do not have evidence of osteoarthritis on X-ray,
* Secondary gain expected to influence treatment outcomes
* Poorly controlled psychiatric condition that could affect outcome (e.g. active substance abuse) or impose a barrier to participation
* Chronic opioid use and anticoagulation therapy that cannot be stopped and could warrant a different treatment approach (e.g. phenol ablation)
* Severe motion sickness
* Seizure disorder
* Vision loss
* Pregnant
* Nursing
A Prospective Cohort with Patient Navigation As an Intervention for Breast Cancer Patients

The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows:

* Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment?
* Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.

-General Objective: To implement an oncological navigation platform for breast cancer patients receiving treatment at Maputo Central Hospital (HCM) over a proposed period of 12 months after project approval by the local IRB.

-Specific Objectives:

* Develop an oncological patient navigation system for breast cancer patients treated at HCM.
* Establish a prospective cohort of navigated breast cancer patients (with invasive or ductal carcinoma in situ) treated at HCM in 2024-25 (recruitment period of twelve months).
* Collect diverse epidemiological data from navigated patients during the proposed study period.
* Describe the following variables: time from first symptom until first medical consultation (in days), time from first medical consultation to cancer diagnosis (in days) and time from diagnosis to first treatment (either surgery or neoadjuvant treatment) in days.
* Compare time from first symptom to diagnosis (in days) and time from diagnosis to first treatment (in days) to a historical cohort published by Brandão M. et al (The Oncologist, 2021).
* Collect overall survival data in this cohort for thirty six months after last patient recruited for future publication.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18 years and older
* will undergo breast cancer treatment at HCM
* consent to participate

Exclusion Criteria:

* male
* less than18 years of age
* history of other previous malignancies (including breast cancer)
* history of breast cancer treatment initiated elsewhere
* lack of consent to participate
Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD

Social difficulties are serious and frequent complicating factors in the treatment of post-traumatic stress disorder (PTSD). To better understand how treatment of post-traumatic stress disorder impacts neural mechanisms of social cognition, the investigators are examining behavior and brain processes associated with response to Trauma Management Therapy. Understanding the behavioral and neural impact of psychotherapy may contribute to development of more effective treatments for PTSD.

PTSD is associated with significant interpersonal difficulties that interfere with functioning. As such, this work is intended to evaluate the empirical support for a novel treatment that fills a significant gap in the treatment options available to Veterans with PTSD who suffer with interpersonal difficulties. In this study the investigators will (i) evaluate the efficacy of Trauma Management Therapy (TMT) for treating PTSD-related interpersonal dysfunction, as well as PTSD-related fear and anxiety, and (ii) evaluate neural mediators of clinical improvements associated with TMT.

This work will provide insights into the mechanisms by which treatments may lead to improvements in social functioning, informing both the biological basis of psychotherapy and the development and refinement of alternative therapeutic interventions targeting social impairments.

Treatment seeking Veterans with PTSD will be randomized to one of two treatments: (i) Trauma Management Therapy, consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based social and emotional rehabilitation, or (ii) Exposure + Comparison Treatment Group consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based psychotherapy. Veterans enrolled in both the TMT and EXP+GRP arms will undergo functional neuroimaging as they engage in an emotional image viewing task, as well as two social interaction tasks. Neurobehavioral assessments will be made prior to and following completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female veterans of all ethnicities
* Meet diagnostic criteria for post-traumatic stress disorder (assessed by study staff)
* Fluent in English
* Able to see computer display clearly
* Able to provide informed consent
* Able to follow written or verbal instructions

Exclusion Criteria:

* history of seizures
* history of stroke
* Cushing's syndrome
* history of moderate to severe traumatic brain injury
* electroconvulsive therapy within 5 years
* history of chemotherapy for cancer
* contraindications to fMRI
* pregnancy
* diagnosis of schizophrenia, schizoaffective disorder, delusional disorder and/or organic psychosis
Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children

The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.

In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.

Eligibility Criteria:
Inclusion Criteria:

1. 8-17 yrs of age at date of enrollment.
2. Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.

Exclusion Criteria:

1. Chronic pain or chronic use of narcotic or other prescription pain medications.
2. Use of pain medication within 24 hours before surgery
3. Prior major abdominal surgery
4. Evidence of acute inflammation
5. Patients with acute cholecystitis
6. Bleeding / coagulation disorder
7. Seizure disorder
8. Renal dysfunction
9. Infection at injection sites for TAP block or trocar placement
10. Contraindication to LWI or TAP block procedure, as determined by surgeon or anesthesiologist performing the procedure (including, but not limited to, previous incision distorting anatomy or inability to visualize anatomical planes)
11. Any known allergy to medications used in this study
12. Patient unable to verbalize pain score or independently assess pain level
13. Unstable patient in need of emergent intervention at surgeon discretion
14. Patients who are known to be pregnant
15. Patients who are currently prisoners
16. Children in custody of the state
17. Subjects will a BMI \>/= 50
18. Investigator discretion for any other reason
Painless Synovitis in Patients With Longstanding Rheumatoid Arthritis

There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands.

The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings.

A sonographic examination (Gray-scale and power Doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.

Introduction/Objectives:

There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The mean of this is still unknown and does not exist studies in the literature that assessing the predictors of this behavior or synovial potential to cause bone erosion.

The objective of this study is to compare painless synovitis (called "cold" synovitis) with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings, articular damage (x-Ray and sonography), clinical, laboratory and demographic variables in RA patients.

Methods: Cross-sectional study with RA patients, which will be evaluated metacarpophalangeal joints of patients without local painful. Sixty RA patients will be selected in the Federal University of São Paulo ambulatory (Unifesp). The patients will be divided in two groups of thirty patients each: "painless synovitis" Group and "painful synovitis" Group. All patients will be measured through clinical evaluation, hands ultrasound and laboratory parameters (erythrocyte sedimentation rate, ESR; rheumatoid factor, RF; anti-cyclic-citrullinated peptide antibodies, CCP) on the same day. The clinical evaluation will be measured by a trained rheumatologist with experience in joint physical examination (synovitis). This measure will be done before the sonography examination and the assessment tools will be: painful joint count; swollen joint count; painful visual analogue scale (VAS 0-10); swollen VAS; activity disease VAS; measurement of grip strength and pinch with Jamar dynamometer and Preston Pinch Gauge; 28 joint Disease Activity Score (DAS 28); Stanford Health Assessment Questionnaire (HAQ); Cochin Hand Functional Scale (CHFS) and patient clinical evaluation. The level of statistical significance will be 5%.

Eligibility Criteria:
Inclusion Criteria:

* longstanding rheumatoid arthritis
* chronically painless synovitis in the hands or painful

Exclusion Criteria:

* uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism
* change of basic drug in the last 3 months