cyrilzakka/clinical-trials huggingface dataset:
Prospective Coronary Heart Disease Cohort

To evaluate the biomarkers for the prognosis of coronary heart disease, patients with coronary heart disease will be recruited and followed up for at least 2 years.

Patients with cardiovascular disease undergoing coronary angiography will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as socio-demographic, diet, lifestyle, psychological status and medical history. The biomarkers for the incidence of coronary heart disease and the factors contributing to the poor prognosis of coronary heart disease will be investigated based on multi-omics analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as coronary heart disease or with unexplained chest pain needed to undergo coronary angiography.
* Healthy subjects undergoing routine physical examination in the physical examination department and willing to sign informed consent will be recruited as control subjects.

Exclusion Criteria:

* With malignant tumors, infectious diseases and advanced liver diseases.
* Won't sign an inform consent.
Validation of the German Quality of Recovery-15 Questionnaire

The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.


Eligibility Criteria:
Inclusion Criteria:

* elective non-cardiac surgery
* fluency in German
* general anesthesia

Exclusion Criteria:

* postoperative intensive care unit admission
Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject

This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.


Eligibility Criteria:
Inclusion Criteria:

1. Acceptance to participate in the study, signing the informed consent document before conducting any study procedures.
2. Patient with HIV infection older than 18 years.
3. Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening
4. Plasma HIV RNA levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia \<50 copies / ml between both).
5. HbsAg negative

Exclusion Criteria:

1. Pregnant or breastfeeding woman
2. Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).
3. History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions:

   * Do not consider an exclusion criterion if the genotype performed at the time of failure does not demonstrate resistance to lamivudine and darunavir (see criteria 2).
   * Do not consider an exclusion criteria in the absence of genotype if after the episode turns to maintain a viral load \<50 copies / ml with a treatment composed of lamivudine or emtricitabine + a nucleoside + a non-nucleoside.
4. History of abandonment of treatment including lamivudine or emtricitabine, with the following exception:

   - Viral load prior to abandonment was \<50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml .
5. Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine
6. Previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used.
7. The use of concomitant medication not permitted
8. Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial
9. Any laboratory results of the following: hemoglobin\<8,0 g/dl; neutrophils \<750 cells/µl; platelets \<50.000 cell/µl; creatinine ≥ 1,5 ULN (upper limit of normal)
10. Any clinical or analytic event that, in the investigator judgment, condition the patient safety
Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome

To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing round shoulder posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder syndrome.

Background: Poor posture and abnormal scapular kinematics have been suggested as possible primary factors in developing Shoulder impingement syndrome (SIS) and also as secondary observed phenomena of SIS. Round shoulder posture (RSP) is major and common posture contributing to increase the potential for subacromial impingement or exaggerate the symptoms of SIS. Objective: To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing RSP and improving symptoms in subjects with SIS/RSP. Methods: Forty subjects with impingement age between 20 and 75 are recruited and measured on acromial distance, pectoralis minor index (PMI), posterior and anterior shoulder tightness, distance of scapular medial border, pain score and flexilevel scale of shoulder function (FLEX-SF). Clinical significance: Shoulder impingement syndrome (SIS) have been identified as the majority of reported shoulder complaints. The project will provide an effective intervention for subjects with SIS/RSP.

Eligibility Criteria:
Inclusion criteria:

1. subjects age between 20 and 75
2. Diagnosed with shoulder impingement syndrome
3. At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff

Exclusion criteria:

1. Shoulder pain onset due to trauma
2. A history of shoulder fractures or dislocation
3. Cervical radiculopathy
4. Degenerative joint disease of the shoulder
5. Surgical interventions on the shoulder
6. Inflammatory arthropathy
Injury Occurrence in Hip-hop Dance

The study will investigate the effect of structural training program and body composition on injury occurrence in hip-hop dance. Assuming that training program can significantly lower the number of injuries (experimental group will have less injuries during and at the end of the trial) and that body fat percentage negatively effects injury occurrence (dancers with higher body fat percentage will be more often injured).


Eligibility Criteria:
Inclusion Criteria:

* hip-hop dancer (active)

Exclusion Criteria:

* injured
Non-invasive Evaluation of Cerebrovascular Reactivity in Spontaneous Intracerebral Hemorrhage

Spontaneous intracerebral hemorrhage (ICH) remains a significant cause of morbidity and mortality around the globe. The most common etiology of nontraumatic spontaneous ICH is hypertensive arteriopathy (HA), while cerebral amyloid angiopathy (CAA) is the most prevalent cause of spontaneous lobar ICH in the elderly. Both HA and CAA belong to the family of cerebral small vessel disease (cSVD). cSVD involves pathological processes that affect the arteries, arterioles, capillaries, and veins on the surface and beneath the brain. The resultant changes of cSVD in the brain vasculatures can be detected with neuroimaging, includes cerebral microbleeds, white matter hyperintensities, lacunes, dilated perivascular spaces, and brain atrophy.

Investigators of this study have probe into various imaging markers in patients with cSVD. Investigators found that the lacune and cerebral microbleeds location was related to distinct underlying etiology of cSVD. Further, investigators utilized amyloid PET study to directly quantified the cerebral amyloid burden, and demonstrated the correlation between amyloid deposition and deep/superficial microbleeds ratio. The association between cerebellum microbleeds, which is a novel marker for cSVD, and the underlying pathology in patient with spontaneous ICH has been investigated. Investigators also summarized and published the current research of different cSVD imaging markers and its implication on patient care.

Cerebrovascular reactivity (CVR) represents the phenomenon that cerebral vessels dilate or constrict in response to stimuli, which provides insights into the vascular reserve information. The vascular reserve parameter is complementary to steady-state vascular index, such as cerebral perfusion or other neuroimaging markers. Measurement of CVR using advanced MR techniques is an emerging technique with multiple potential clinical utilities, and impaired autoregulation may contribute to the pathogenesis of cSVD. Recently, diminished CVR under visual stimuli has been linked to vascular amyloid deposits and related vascular dysfunction. Clarifying the mechanism of cSVD-related brain injury would be an important step towards identifying candidate treatment approaches.

The goal of this study is to understand the features of CVR in patients with cSVD-related spontaneous ICH, for the purpose of establishing new biomarkers in cSVD diagnosis and understanding the underlying pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* age between 20-90 years-old
* patient with spontaneous intracerebral hemorrhage or healthy control
* consciousness clear
* willing to receive brain MRI

Exclusion Criteria:

* renal failure or Creatinine \> 2mg/dl
* coagulopathy or hepatic insufficiency
* unstable vital sign under inotropic agents
* allergy to Dipyridamole
* pregnancy
* asthma history
* metal implant or cardiac pacemaker
Minimal Residual Disease in Peripheral T-cell Lymphoma

As T-cell receptor sequencing by LymphoTrack is an assay with high sensitivity that can be performed in peripheral blood, the investigators wish to evaluate the ability of this assay to predict which patients are at higher risk of relapse after initial therapy for peripheral T-cell lymphomas which is being given for curative intent. Additionally, as more is known about the ability of dynamic monitoring of cfDNA in B-cell lymphomas to predict relapse, the investigators wish to explore the use of this technology in T-cell lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Histologically-confirmed peripheral T-cell lymphoma being treated with curative intent. Eligible histologies include, but are not limited to: peripheral T-cell lymphoma, not otherwise specified; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma, ALK negative; and anaplastic large cell lymphoma, ALK positive.
* Plan for treatment with frontline multi-agent anthracycline containing chemotherapy for curative intent (for example, CHOP, CHOEP, EPOCH). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
* Availability of pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype, or willingness to undergo biopsy if sufficient tissue is not available at time of enrollment (e.g. 15 slides from fixed formalin-fixed paraffin embedded tumor tissue

  \*Patients who have less than 15 slides of fixed formalin-fixed paraffin embedded tumor tissue may be considered for enrollment after discussion with the study principal investigator
* Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Receiving second line of therapy or greater.
* Diagnosis of primary cutaneous T-cell lymphoma, extranodal NK-cell lymphoma, acute T-cell lymphoma/leukemia, hepatosplenic T-cell lymphoma.
Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.

The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patient understanding simple order and able to give written consent.
* Man or woman with age between 40 et 75 years
* Unilateral medial symptomatic knee osteoarthritis, defined using the American College of Rheumatology classification
* Radiologic grade II, III ou IV (Kellgren et Lawrence (KL) classification)
* Medial knee compartment (Medial K\&L g rade higher than lateral K\&L grade
* Knee pain \> 40/100 on visual analog scale and \<30/100 for the other
* No change in medical treatment for at least 3 months.
* Latest radiographic image \< 12 months before inclusion

Exclusion Criteria:

* Patient without healthcare insurance.
* Inflammatory knee arthritis,
* Indication of knee surgery
* Pregnancy, breastfeeding
* Associate neurologic or orthopaedic affection that interferes with gait analysis
* Rapidly destructive arthritis.
* Alzheimer's disease, Parkinson's disease, motor neuronal disorders
* Patient under guardianship or tutelage
Health Professional Exposure Assessment to Covid-19

Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.

This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.

Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.

Eligibility Criteria:
Inclusion Criteria:

* Staff on duty in the health facility
* Eligible to be drawn
* Beneficiary subject affiliated or entitled to a social security scheme

Exclusion Criteria:

* Minor patient
* Refusal to participate
* Patient under guardianship
* Patient under guardianship
Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting

To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation of post-operative sedation. In patients who have undergone open heart surgery, a single prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first 24 post-operative hours compared to placebo.

Post-operative nausea and vomiting (PONV) is a significant source of morbidity for patients undergoing general anesthesia, and in particular, patients undergoing cardiac anesthesia. Despite its common occurrence, literature on PONV prophylaxis in the cardiac surgical population is limited relative to other surgical populations.

A rational approach to preventing PONV would be to administer prophylaxis prior to extubation once post-operative sedation has ceased. This timing of administration would be more standardized across patients, as duration of surgery and time of extubation after surgery can vary considerably, rendering plasma levels of PONV prophylaxis agents highly variable across patients.

At St. Paul's Hospital, PONV prophylaxis has not been a routine part of cardiac anesthesia care. Furthermore, there are no standardized guidelines, and practice varies between care providers. Following surgery, patients recover from anesthesia and are extubated in the cardiac surgery ICU (CSICU). They are usually sedated on a propofol infusion for one to four hours after surgery until they are ready for extubation. When PONV occurs, the first line drug for treatment is ondansetron 4 mg. The investigators therefore propose the use of a single, prophylactic dose of ondansetron (4 mg IV), given at the time of propofol cessation. A randomized, double blinded placebo controlled model will be utilized

Eligibility Criteria:
Inclusion Criteria:

* Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:

  * Coronary artery bypass grafting (CABG)
  * Valve surgery (ie. repair and/or replacement)
  * CABG and valve surgery

Exclusion Criteria:

* Undergoing 'off-pump' CABG (not involving the cardiopulmonary bypass machine)
* With a contraindication to the study drug - including but not limited to congenital Long QT Syndrome, allergy to ondansetron, or a history of migraines
* Unable to understand the consent process, either due to language limitations or cognitive limitations if a translator or substitute decision maker is not available
* Receiving heart transplants, ventricular assist devices or on extra-corporeal membrane oxygenation (ECMO)
* Intubated for more than 12 hours post-operatively
* With a known history of PONV
* Sedated with dexmedatomine instead of propofol
Evaluating Fluciclovine PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET

The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.

PRIMARY OBJECTIVE:

I. To evaluate the detection rate of local recurrence of prostate cancer on Fluciclovine PET in patients with BCR and a negative or equivocal PSMA PET obtained within 30 days prior to the Fluciclovine PET.

SECONDARY OBJECTIVES:

I. To evaluate the correct localization rate of Fluciclovine PET in patients with positive scans.

II. To distinguish the detection rate by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), and stratify by PSA level at the time of the scan and tumor grade

III. To evaluate the change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.

OUTLINE:

Patients will be imaged with Fluciclovine PET within 30 days of the negative or equivocal PSMA scan.

A short questionnaire inquiring about the intended management will be sent to the referring physician at two timepoints: 1) the first is at the time of screening, prior to the Fluciclovine PET; and 2) the second is after the availability of the results of Fluciclovine PET.

Change in intended management will be recorded. Participants will be followed for 6 months and will be managed by their treating physician as per standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years.
* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
* Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy.
* PSA of 0.2 ng/mL or higher within 45 days of the scan.

Exclusion Criteria:

* Uncontrolled serious infection.
* Intercurrent illness or condition that would limit compliance with study requirements.
* Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.
Taste Assessment of Ozanimod

The purpose of this study is to assess the taste characteristics of ozanimod formulations, alone and mixed, in order to develop a pediatric oral form of ozanimod.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, between 25 and 80 years of age.
* Participant is a qualified sensory panelist selected by Senopsys based on training and experience

Exclusion Criteria:

* Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that might confound the results of the study or places the panelist at unacceptable risk if he or she were to participate in the study.
* Participant is a female that is pregnant, nursing, or planning to become pregnant during the study.

Other protocol-defined inclusion/exclusion criteria apply
Determining the Benefits of Improving Communication in BPAP/CPAP Users

The purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device.

Noninvasive positive pressure ventilation (NIPPV) is a crucial tool used to treat respiratory distress and failure, especially when patients have acute worsening (also called exacerbations) of emphysema or chronic obstructive pulmonary disease (COPD). This study will randomize patients who use Noninvasive positive pressure ventilation (NIPPV) to a control (non-functioning) and intervention (functioning) device to determine how well speech can be understood while wearing the device.

The purpose of this study is to determine the effectiveness of a non-invasive communication aid for BPAP/CPAP masks. This study also looks to determine the potential impact of the device on patients with obstructive sleep apnea (OSA) and the individuals that interact with the device.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be receiving BPAP/CPAP therapy in the outpatient setting (e.g. clinics, sleep centers).

Exclusion Criteria:

* Intubated or have a tracheostomy.
* Vulnerable populations (children, pregnant women, decisionally impaired adults, and prisoners).
* Speech disabilities, reading disabilities, dyslexia.