cyrilzakka/clinical-trials huggingface dataset:
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.


Eligibility Criteria:
Inclusion Criteria:

* Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA \<50 copies/mL at screening.
* Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
* Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

Exclusion Criteria:

* Has HIV-2 infection.
* Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection.
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma.
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies.
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period.
* Has a documented or known virologic resistance to DOR.
* Female expects to conceive or donate eggs at any time during the study.
Comparison of Gray-scale Inverted Rib Series With Conventional Ones in Rib Fracture Detection by Emergency Physicians and Medical Students

There were many studies which examined the availability of inverted gray-scale chest X-ray for increasing the detection of lung nodules. In emergency medicine, rib fracture is an important part for patient's disposition, so investigators designed this study to evaluate the availability of inverted gray-scale chest X-ray for the detection of rib fracture.


Eligibility Criteria:
Inclusion Criteria:

* Emergency resident who want to participate

Exclusion Criteria:

* Emergency resident who does not want to participate
A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a

To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

Objectives

Principal objective

To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

Secondary objectives

To analyze the HIV viral sequences present in the CD4 + lymphocytes with other membrane HIV reservoir markers, currently being identified, in these same patients

Methodology

Pathophysiological study, in patients infected by multi drug-resistant viruses

Estimated enrollment

21 participants (total and per group)

Intervention

167mL blood sample in EDTA tube:

* 160mL (16 tubes of 10mL): for IGH (Institute of Human Genetics-Montpellier)
* 7mL (1tube of 7mL): to measure HIV-RNA in centers

Estimated planning or Study / Trial timetable

Study start date: September 2017

Enrollment period: 12 months

Total study duration: 24 months (analyses included)

Estimated study/trial completion date: September 2019 (one year after enrollment of the last patient)

Study design

Cross-sectional survey, 167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated to ANRS139 TRIO trial, and still followed in centers
* Who remained in virological success since the participation at the trial: 90% of HIV-1 RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are tolerated
* Genotypic resistance profiles available at baseline and before trial
* Age ≥ 18 years
* Affiliate or beneficiary of a social security system (the State Medical Aid or AME is not a social security system).
* Written informed consent signed by the person and the investigator before any exam performed in the study.

Exclusion Criteria:

* HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial
* Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
* Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
Arthroscopic Treatment of Bursal-side Rotator Cuff Tears in Shoulder Joint

A retrospective analysis was performed on patients with bursal-side partial-thickness rotator cuff tears who underwent arthroscopic surgery from January 2009 to December 2011. To investigate the diagnosis and arthroscopic treatment of partial rotator cuff bursa lateral tear, and to evaluate the postoperative functional outcome and tendon healing.

To study the surgical method and clinical effect of arthroscopic treatment for partial tear of rotator cuff bursa. A retrospective analysis was performed on patients bursal-side partial-thickness rotator cuff tears who underwent arthroscopic surgery from January 2009 to December 2011. Preoperative X-ray and MRI were performed. Rotator cuff repair was performed during the operation. UCLA shoulder scoring scale was used to evaluate the joint at preoperative and final follow-up.

Eligibility Criteria:
Inclusion Criteria:

* From January 2009 to December 2011, patients with bursal-side partial-thickness rotator cuff tears who underwent arthroscopic surgery at Peking University Third Hospital and were followed up.

exclude:

Exclusion Criteria:

* Patients with frozen shoulder and unstable shoulder joints.
The Study on the Clinical Utility of Liquid Biopsy in Breast Cancer

Through this prospective clinical trial,the investigators will focus on the relationship between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and other biomarkers) and the status of primary tumor to discuss its application for assessing prognosis and individualized therapeutic direction. Moreover, the relationship between the circulating tumor cell subpopulations based on epithelial-mesenchymal transition and molecular pathological classification of breast cancer will be determined, which may enable the determination of the value of its application in therapeutic decision making.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥18 years with histologically confirmed breast cancer.
* The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time.

Exclusion Criteria:

* The patients who has begun medication for breast cancer.
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound

Current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. Nonetheless, the impact of PCSK9 inhibitors on the stability of carotid plaques remains insufficiently elucidated, with a notable scarcity of relevant clinical studies. This investigation seeks to address this gap through a real-world study conducted among patients with arterial sclerosis in Asia. The primary aim is to evaluate the effects of small interfering RNA (inclisiran) on carotid plaque characteristics as assessed by ultrasound, thereby contributing valuable data to inform clinical practice.

In a meticulous study evaluating the impact of inclisiran on patients with atherosclerosis and carotid plaques, data were systematically gathered across multiple time points. The assessment encompassed:Blood Samples: Analyzed at baseline (Month 0) and subsequently at Months 1, 2, 3, 5, 9, 11, and 12, examining biochemical markers, lipid profiles, and liver and kidney function tests.Carotid Ultrasound: Conducted at Months 0, 3, 9, and 12, monitoring the carotid intima-media thickness, maximum carotid plaque thickness, carotid plaque area, carotid plaque volume, and carotid lumen stenosis area for thorough analysis.Clinical Records: Documented in detail the baseline clinical information, biochemical markers, imaging findings, and any adverse cardiovascular or cerebrovascular events that occurred throughout the study period. This approach ensures a comprehensive understanding of inclisiran\&#39;s effects over time, encompassing both biochemical and imaging parameters, while tracking potential adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients with carotid plaques as indicated by ultrasound
* Men and women aged 18-75 years;
* LDL-C \&gt;3.4 mmol/L without regular statin therapy or LDL-C \&gt;1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.

Exclusion Criteria:

* - Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
* Prior use of PCSK9 inhibitors;
* Prior history of hemorrhagic stroke;
* Prior coronary artery bypass grafting or coronary intervention;
* Inability to perform OCT imaging or unclear imaging;
* Severe renal insufficiency (creatinine clearance \&lt; 30 mL/min);
* Severe hepatic dysfunction;
* Baseline triglycerides \&gt; 5.6 mmol/L;
* Pregnant or lactating women;
* Life expectancy not exceeding 1 year;
* In the judgment of the investigator, unsuitable for this study for any reason.
ADHD Treatment for Latino Families

The current pilot study aims to close the existing gap in our knowledge about effective psychosocial treatments for Latino families by providing preliminary data regarding the acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators that will support a future R01. Specifically, the current pilot study is the first step in a larger program of research aimed at definitively determining if culturally-modified ADHD treatment outperforms standard treatment when examining engagement and acceptability outcomes, as well as symptomatology and parental functioning, and if so, which treatment modifications are necessary and for whom. The following study aims will be examined.

1. Aim 1 is to explore if the culturally-modified treatment results in better engagement and acceptability outcomes (i.e., parental attendance, retention, engagement, and satisfaction) than standard treatment and to determine the strength of these effects.
2. Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD symptomatology, as well as parental functioning (i.e., parenting stress and efficacy), to explore if the modified treatment results in similar or greater improvements than standard treatment, and to determine the strength of these effects.
3. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral and cognitive acculturation) that may explain the relationship between treatment type (i.e., standard versus culturally-modified) and outcomes and to determine the strength of these interactions.


Eligibility Criteria:
Inclusion Criteria:

* Children must

  1. Self-identify as Latino and be between the ages of 5 and 13 years at the time of the initial assessment
  2. Receive a primary diagnosis of ADHD
  3. If medicated for ADHD, be on a stable dose of medication for at least two weeks prior to the assessment
* Participating parents must

  1. Self-identify as Latino
  2. Be fluent in Spanish
  3. Be able and willing to provide informed consent and comply with the study procedures, including being assigned either to standard or culturally-modified treatment
  4. Have no immediate plans to pursue other treatment for their child's ADHD or to change their child's medication (if already medicated) over the next eight weeks

Exclusion Criteria:

* Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder
Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) Pilot Study

The purpose of this study is to test the feasibility and acceptability of an adapted psychosocial intervention, called Emotion and Symptom-focused Engagement for Caregivers (EASE-CG), to reduce traumatic stress symptoms and other psychological distress and increase well-being in primary caregivers of patients newly diagnosed with acute leukemia.

Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) is a brief psychotherapeutic intervention designed for primary caregivers of patients newly diagnosed with acute leukemia (AL). The EASE-CG intervention was adapted from a previous psychotherapeutic intervention for adult patients newly diagnosed with AL, called Emotion and Symptom-focused Engagement (EASE). In a previous pilot trial, EASE was associated with reductions in traumatic stress and physical symptom burden in adult patients with AL.

EASE-CG is a sub-study of a multi-center, longitudinal, mixed-methods study on the experience of traumatic stress in primary caregivers of patients newly diagnosed with AL within three months of admission to the hospital (Main study). The purpose of this sub-study is to conduct a non-randomized, mixed-methods pilot study to test the feasibility and acceptability of EASE-CG. A subset of caregivers of pediatric patients from the Main study will be approached to participate in EASE-CG. Quantitative measures will be administered at baseline, 1, 3 (primary endpoint), 6, 9, and 12 months (Main study endpoint). Participants may be invited to brief, semi-structured interviews.

The study will take place at the Hospital for Sick Children; the largest leukemia treatment center in Canada for pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified primary caregiver (i.e., person assuming the majority of care activities) or co-primary caregiver (i.e., assuming at least 40% of care activities alongside another co-primary caregiver) of an adult or pediatric patient who is newly diagnosed with acute leukemia within 3 months of admission to the Princess Margaret Cancer Centre or the Hospital for Sick Children
* Age ≥18 years
* Fluency in English

Exclusion Criteria: none
LDL-c Level Variability and Trained Immunity

Statin treatment significantly reduces the incidence of cardiovascular events. However, cholesterol variability is associated with the risk of adverse events such as mortality, myocardial infarction, and stroke. The previous research found that the inflammatory activity of peripheral blood mononuclear cells in mice fed with intermittent high-fat diet was significantly increased, and the cholesterol variability had an impact on the trained immunity of peripheral blood mononuclear cells, thus aggravating the atherosclerosis in mice.

We plan to compare the differences in serum LDL-C levels after intermittent atorvastatin treatment and continuous atorvastatin treatment, and investigate the impact of this difference on the trained immunity of peripheral blood mononuclear cells.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate, understand and sign an informed consent form;
2. Age ≥ 18 years old, male or postmenopausal female (defined as amenorrhea over 2 years with relevant clinical characteristics, such as age over 55 years old or menopausal cardiovascular symptoms such as hot flashes, night sweats, palpitations, etc.). Women with hysterectomy and/or bilateral oophorectomy may also be considered for inclusion in the group;
3. Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c\>3.4mmol/L

Exclusion Criteria:

1. Previous cardiovascular history;
2. Statins should not be discontinued in high-risk groups for cardiovascular events;
3. Any known organ dysfunction;
4. Intolerance to statins;
5. Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
6. Participating in other clinical trials;
7. Unable to follow the study procedure.
Comparison of Low-intensity Extracorporeal Shockwave Therapy and Low-intensity Laser Effects in Adhesive Capsulitis

The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate whether they are superior to the control group.

In this study, 60 adhesive capsulitis with age range 18-65 who applied to Kırsehir Ahi Evran University Training and Research Hospital were examined.Adhesive capsulitis is also called arthrofibrosis, which involves excessive adhesion formation along the glenohumeral joint. It is a disease of unknown etiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis, central nervous system involvement, arm immobilized for a long time, trauma or fracture, infectious diseases, etc. Includes post-mortem situations.

Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.

low-level laser therapy supports cell proliferation and tissue regeneration with its anti-inflammatory and photobiostimulation properties.The pressure waves of ESWT pass through fluids and soft tissues and exert their effects in areas of impedance change such as bones and soft tissue spaces. These waves have mechanical and cellular effects. The most important of these effects are temporary damage to the neuronal cell membrane or increased permeability. These mechanisms may facilitate neovascularization and cellular regeneration in tissues.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients who have received "adhesive capsulitis" by clinical and examination
* Patients with loss of range of motion in the capsular pattern (external rotation \> abduction \> internal rotation) will be included in the study.
* Patients who consent to participate in the study according to the informed consent form will be included in the study.

Exclusion Criteria:

* Upper extremity injury in the last 6 months
* Shoulder injection in the last 6 months
* Existing open wound in the upper extremity area
* Prior upper extremity surgery
* The patient has a systemic infection
* Uncontrolled hypertension in the patient
* Inability of the patient to cooperate
* The patient's unwillingness to participate in the study
* The patient has a malignancy
Mediastinitis and Staphylococcus Aureus

Cardiac surgery with extracorporeal circulation (ECC) yields a deep immune system dysfunction that exposes patients to postoperative infectious complications. Among these, post-operative mediastinitis with Staphylococcus aureus (SA) generates significant morbidity and mortality. Two radically different approaches have been proposed in recent years to reduce the incidence of this complication. A first approach has attempted, without real success, to decrease postoperative immunosuppression. The second, more efficient, consisted of screening and preoperatively treating patients colonized with SA. However, although its incidence has decreased, postoperative mediastinitis remains a terrible nosocomial infection. The authors believe that a thorough analysis of the immunological changes induced by cardiac surgery will initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby decreasing the risk of nosocomial infections. In addition, a study of the interactions between the operated (host) and staphylococcus aureus (pathogenic) immune systems will provide a better understanding of the mechanisms that expose patients to this bacterium.

In particular, changes induced by the ECC will be evaluated on:

* Indoleamine 2,3-dioxygenase activity (IDO)
* Apoptosis of lymphocytes and dendritic cells
* Polymorphonuclear neutrophils (PMNs)
* Myeloid Derived Suppressor Cells (MDSC )

After general anesthesia and arterial catheterization and prior to the start of ECC, blood samples will be taken for flow cytometry studies, for the purification of PMNs and monocytes. The purified PMNs and monocytes will then be used for the measurement of cytokine, phagocytosis and bactericidal production capacities.

The morning following surgery, blood samples will be taken and follow the same process.

Eligibility Criteria:
Inclusion criteria

* Patients over 18 years of age
* Patients who require cardiac surgery (valvular and / or coronary) with extracorporeal circulation.

Non inclusion criteria

* Chronic respiratory diseases,
* Preoperative left ventricular dysfunction (LVEF \<50%),
* Immunosuppression (HIV infection, systemic corticosteroid therapy, history of cancer in the year before surgery),
* Persons subject to legal protection (safeguard of justice, curatorship, guardianship),
* Persons deprived of liberty.