cyrilzakka/clinical-trials huggingface dataset:
Role of Microparticles in Covid-19 Infection

Among the distinctive features of Covid-19, numerous reports have stressed the importance of vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by apoptotic/stimulated cells are reliable markers of vascular damage released upon pro-inflammatory conditions and behave as active participants in the early steps of clot formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial cells.

Circulating MPs will be isolated from Covid-19 patients with lupus anticoagulant, from coronary artery diseases patients and from healthy volunteers without cardiovascular risk factors. Quantification of MPs will be realized by prothrombinase assay. Primary endothelial cells (ECs) from porcine coronary artery or porcine pulmonary artery will be isolated and cultured. ECs will be exposed to circulating MPs. Phenotypical changes (ACE2 expression, cytoadhesins, cytokines, tissue factor expression) of ECs will be examined. Susceptibility of ECs to SARS-COV-2 infection will be determined.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients: age \> 18 yr
* SARS-COV-2 infection within 12 months and positive lupus anticoagulant
* Patients with cardiovascular risk factors: at least among
* Hypertension, Dyslipidemia, Diabetes mellitus, obesity, smoker, Healthy volunteers

Exclusion Criteria:

* Significant comorbidities (active cancer, auto-immune diseases...)
Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder, which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. No effective treatment is available. MSA patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA as other neurodegenerative diseases cause profound declines in functioning ; thus, many patients require caregivers for assistance with daily living. Caregiving can also be extremely stressful, and many caregivers experience declines in mental health. All of these repercussions contribute to the deterioration of the caregiver's quality of life and they can have an impact on the patient, in particular, on the patient's survival. Improving quality of life is a major element and identifying effective targeted interventions would bring immediate and direct benefit to patients and their families. In this context, it seems that a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) developed by Mittelman could contribute to improve disease management and better coping with daily living difficulties. The NYUCI strategy combines sessions of individual and family counseling, support group participation, and additional on-call telephone consultations in a flexible counseling approach that is tailored to each caregiving family

Eligibility Criteria:
Patients Inclusion Criteria :

* Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria
* Living at home
* Presence of at least one close person (family caregiver or not) in the entourage
* Unified Multiple System Atrophy Rating Scale (UMSARS) IV ≤4
* Written informed consent
* Patient covered by the national health system

Caregivers Inclusion Criteria :

* Age \> 18
* Able to answer to study scales and survey
* Written informed consent

Patients Exclusion Criteria:

* Unified Multiple System Atrophy Rating Scale (UMSARS) IV \> 4
* Absence of at least one close person

Caregivers Inclusion Criteria :

- Enable to answer to study scales and survey
Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity

This study will assess the impact of a randomized intervention aimed at increasing consumption of whole grain foods among children from low-income households that participate in the Special Nutrition Assistance Program (SNAP, or "food stamps"). A total of 60 obese children (8 to 16 years) will be recruited from a clinical population (Healthy Eating Active Living Program) at University of California San Francisco (UCSF) Benioff Children's Hospital Oakland. Participants and their caregivers will all receive education about whole grain foods, and will be randomized to either an intervention or control group. The intervention group will receive a monthly reimbursement allotment of up to 10% of their usual SNAP benefit for specific whole grain foods purchased during the three month study period. The control group will not have the financial incentive for purchasing whole grain foods during the 12 week study period. The investigators will assess the feasibility of the intervention, the impact of the intervention on household grocery purchases, and the impact on the child's anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of metabolic risk.

RUN-IN PHASE (Weeks -4 to 0)

* Participants will participate in a "run-in phase" where they will be asked to keep all grocery receipts for a 4 week period

RANDOMIZATION (Week 0)

* Child participants with caregivers who are able to successfully complete the run-in phase are then randomized at that point to be either in the intervention arm or the control arm.
* Patients will be block randomized by age group (8-11 and 12-16).

ACTIVE PHASE (Weeks 0-12)

* Participants will be given education about whole grains and whole grain preparation. Intervention and control participant activities described elsewhere.

RETURN VISIT (Week 24)

* 12 weeks after the completion of the active phase of the study, patients will be asked to return for a final visit at the research center, during which they will also have blood tests and other study activities repeated for one final time.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI greater than 95th percentile for age and gender)
* Low-income family currently participating in SNAP ("food stamps")
* Participant and caregiver speaks either English or Spanish

Exclusion Criteria:

* medications to lower lipid levels (statins), which would affect insulin sensitivity (e.g. metformin, abilify) or which are known to affect serum cholesterol (e.g. carbamazepine).
* Type II diabetes
Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% \~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria:

* Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).

The objective of this trial is to determine whether Cetuximab and radiation preceded by an induction chemotherapy, may be superior to an established chemoradiation program for HNC (RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Histologically or cytologically confirmed diagnosis of HNSCC
* Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically unresectable or medical contraindication for surgery)
* At least one uni-dimensional measurable lesion either by CT scan or MRI
* Signed written informed consents prior to beginning protocol

Specific procedures:

* Tumor tissue available for immunohistochemical staining of EGFR expression and HPV
* Life expectancy of \> 3 months at study entry
* ECOG Performance Status of \<2 at study entry.
* Effective contraception if risk of conception exists.
* Neutrophils \> 2.0/mm³, platelet count \> 100,000/mm³, and hemoglobin \> 10 g/dl
* Normal liver function
* Serum creatinine \> 1.25 x ULN and/or creatinine clearance \> 60 ml/min

Exclusion Criteria:

* Prior systemic chemotherapy and/or radiotherapy
* Known peripheral neuropathy \> grade 2 NCI-CTC version 3.0
* Known chronic heart failure
* Prior surgery, excluding prior diagnostic biopsy
* Known drug abuse
* Active uncontrolled infection
* Other concomitant anticancer therapy
* Distant metastasis
* Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy not indicated in the study protocol
* Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months before study entry
* Medical or psychological condition that would not permit the patient to complete the trial or sign informed consent
* Nasopharyngeal carcinoma WHO type II or III
* Known allergic reaction against any of the components of the treatment
* Pregnancy (absence confirmed by beta-HCG test) or lactation period
* Any prior or on-going investigational medication
* Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice.

The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.


Eligibility Criteria:
Inclusion Criteria:

* Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and
* Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period)

Exclusion Criteria:

* \<18 years of age
* \<2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation
* Valvular heart disease
* Transient cause of NVAF
* Venous thromboembolism
* Hip or knee arthroplasty
* Malignant cancer
* Pregnancy
* \>1 oral anticoagulant prescribed (on index date)
Prevalence of Gag Reflex in Healthy Persons and Across Different Patient Groups and Its Relevance in Dysphagia Screening

The aim of this study is to assess the prevalence of gag reflex in healthy young and healthy older subjects as well as in acute stroke patients, in patients with Parkinsons´s Disease, Myasthenia gravis, Multiple Sclerosis and in geriatric patients.

In the clinical swallowing examination in acute stroke setting it is assumed that the absence of gag reflex is a predictor of aspiration risk. According to Daniels et al. (1997) aspiration can be predicted with 96% sensitivity in case of absent or abnormal gag reflex. In clinical experience of investigators testing of gag reflex highly depends on patients´compliance and individual anatomical features such as Mallampati score. Furthermore, even if gag reflex is absent, swallowing does not have to be impaired.

The presence of gag reflex in healthy cohorts and dysphagic patients has been examined in a few studies. Davies et al. (1995) have shown that in 37% of healthy volunteers gag reflex was absent. Ramsey et al. (2005) have shown that approx. 89% of the patients without gag reflex had dysphagia and 31% without dysphagia had a gag reflex. In both studies it was not stated to what extent the gag reflex could be examined in case of a high Mallampati score.

The present study aims at assessing the prevalence of gag reflex in healthy and neurological cohorts. The study protocol foresees testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluating present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.

All patients are tested once by one examiner.

Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

1. Healthy participants:

   Neurological diseases Pre-diagnosed dysphagia Percutaneous endoscopic gastrostomy (PEG) tube Head and neck tumours Chemo- and/or radiotherapy in the head and neck area Reflux disease Chronic obstructive pulmonary disease (COPD) Previous surgeries on the cervical spine or thyroid gland Vocal cord paresis
2. Geriatric patients Neurologic diseases
3. Stroke patients Head and neck tumours Chemo- and/or radiotherapy in the head and neck area Reflux disease COPD Previous surgeries on the cervical spine or thyroid gland Vocal cord paresis
4. Neurologic patients without stroke Head and neck tumours (except of intracranial tumors= Chemo- and/or radiotherapy in the head and neck area Reflux disease COPD Previous surgeries on the cervical spine or thyroid gland Vocal cord paresis
Pain and Placebo Analgesia. Does Extended Information About Dental Procedures Reduce Pain Induced by Dental Treatment?

Information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. In this study it will be investigated whether this finding translates to the dental clinic. It will be investigated whether information that suggested that minimal pain will be experienced during filling therapy, can reduce the pain associated with that procedure compared to a group that receives standard information. All patients will receive the same amount of anesthesia and similar procedures during filling therapy. It is predicted that extended information should reduce pain, and that the reduction in pain should be associated with a reduction in stress.


Eligibility Criteria:
Inclusion Criteria:

* Patients to be treated for dental caries
* Patients should be able to read and communicate in Norwegian

Exclusion Criteria:

* Patients with life threatening diseases
* Patients taking pain killers for other reasons on the day of treatment
Biomarker Discovery and Application in Bladder Cancer

The investigators' long-term objective is to research and develop innovative new tests which diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine samples. The investigators plan to detect methylated DNA targets and control targets by methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples from bladder cancer positive and negative patients to determine its sensitivity and specificity in detecting bladder cancer. The investigators plan to use patient sera as a tool to detect tumor specific antigens expressed by bladder cancer cell lines. Once a bladder tumor specific protein is identified, the investigators will assess its presence in the urine of bladder cancer patients and absence in healthy patients by enzyme-linked immunosorbent assay (ELISA). The investigators plan to use both in vitro models and patient clinical samples to elucidate the role of bladder epithelial cells in mediating BCG immunotherapy and identify biomarkers of treatment effectiveness. Once a biomarker is identified, the investigators will assess its presence in the urine of bladder cancer and absence in healthy patients.

Once the investigators determine the feasibility of these tests, the investigators will further perform an extensive clinical study, comparing the tests to existing diagnostic methods. This study will provide the foundation for FDA approval, which is required for tests to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The investigators' tests will improve early detection of bladder cancer, thereby improving patient health and decrease cancer deaths, a key mission of the National Institutes of Health.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old

Exclusion Criteria:

* No exclusion criteria
Tibial Tunnel Placement for ACL Reconstruction

Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral tunnel placement, very little attention has been given to the tibial tunnel. Researchers have suggested that the tibial tunnel be placed in the center of the ACL footprint, which they described as being approximately 43% of the way (anterior-to-posterior) across the proximal tibia at its widest extent. However, others have suggested that a more anterior placement may yield improved biomechanical and clinical results. The center of the ACL footprint and the posterior aspect of the anterior horn of the lateral meniscus does not yield tibial tunnel placement a consistent percentage of the way across the tibial plateau; therefore, guidelines should be based on intraoperative fluoroscopic measurements. However, the question remaining is what percentage of the anterior-to-posterior distance across the tibia is the ideal location for the tibial tunnel in ACL reconstruction. This study will help answer that question.

Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction will be considered for enrollment. Eligible patients will be allocated to one of two groups based on the location of the tibial tunnel (anterior vs. posterior) during the surgical procedure. In addition to a baseline (pre-operative) evaluation, participants will return for follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24 months.

The primary objective of this study is to collect subjective and objective measures of knee-related function in patients with an anterior vs. posterior placed tibial tunnel through 24 months postoperative care.


Eligibility Criteria:
Inclusion Criteria:

* Age at time of randomization: 16 - 50 years (skeletally mature)
* Primary, uncomplicated ACL reconstruction
* Autograft (STG or BPTB)

Exclusion Criteria:

* Multiple ligament knee injury (full thickness)
* Revision ACL reconstruction
* ACL reconstruction with allograft
* Meniscectomy \> 75%
* Treatable articular cartilage lesions
* Diagnosis of tibiofemoral or patellofemoral osteoarthritis (Kellgren Lawrence grade \> II)
* Valgus alignment on long-leg cassette (weight bearing line outside of joint center)
* Prior surgery in the ankles, knees, or hips
* Clinical evidence of hip disease
* Patellofemoral joint instability
* Significant patellar or tibiofemoral mal-alignment
* BMI \> 35
* Type 1 Diabetes Mellitus
* Known connective tissue disorder (e.g. Ehlers-Danlos)
* Peripheral neuropathy
* Neurovascular/ circulatory disorder
* Any form of inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout, lupus, etc.)
* Significant co-morbid conditions as determined by the investigator (e.g. malignancy, renal, hepatic disease, etc.)
* Known or suspected psychological disorder
Glooko mHealth Advantage Study

The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2 diabetes managed via usual care alone and usual care augmented with remote monitoring using Glooko

In this study, the investigator wants to evaluate if diabetes self-management supported by a mobile application, which captures a subject's blood glucose readings, lifestyle and medication information and shares it with the subject's certified diabetes educator (CDE) to enable remote monitoring, improves their glycemic control compared to standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act (HIPAA) or other privacy authorization prior to any participation in study.
2. Subject has self-reported type 2 diabetes.
3. Subject has HbA1c ≥ 7.5% and ≤ 12.5% measured within 30 days of screening visit.
4. Subject is on a stable diabetes therapeutic regimen of two or more diabetic medications (e.g., metformin plus one other antihyperglycemic agent) and/or insulin therapy for at least 2 months before screening visit. Dose changes or adjustments made within 2 months is acceptable as long as the patient has been on the medication regimen for 2 months or longer.
5. Subject is ≥ 18 and ≤ 75 years of age.
6. Subject is a male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
7. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):

   1. Condoms, sponge, diaphragm, or intrauterine device;
   2. Oral or parenteral contraceptives for 3 months prior to screening visit;
   3. Vasectomized partner;
   4. Total abstinence from sexual intercourse
8. Subject is able to speak, read and write in English
9. Subject has a Glooko compatible smartphone/device with an active data plan or access to Wi-Fi and downloaded at least one mobile application on their phone on their own.
10. Subject has performed self-monitoring of blood glucose at least five (5) times within two (2) weeks prior to screening visit.

Exclusion Criteria:

1. Subject has type 1 diabetes.
2. Subject has advanced disease (physical or psychological) that would prevent them from being able to comply with study tasks and considered exclusionary by the study physicians.
3. Subject has been on medication or therapy within the last 2 months that severely affects blood glucose levels (e.g. corticosteroids).
4. Subject has visual impairment which severely limits his/her ability to see or use the mobile application.
5. Subject is a participant in another clinical study that has not been approved as a concomitant study by Glooko.