cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Quickly Diagnostic Saliva Tests for SARS-CoV-2

Coronavirus disease 2019 or COVID-19 is a highly contagious infectious disease. Symptoms of the disease are non-specific (fever, cough, dyspnea and fatigue), common with many seasonal viruses, which complicates the diagnosis. For mild forms, which represent the vast majority of cases, hospitalization is not necessary and treatment is symptomatic. However in more severe cases, hospitalization is required and sometimes even admission to an intensive care unit.

Several diagnostic tests are already available, but they require, in all cases, the intervention of qualified health personnel to carry out the sample, which includes a risk of contagion and an expensive and time-consuming laboratory analysis and reagents. These tests are therefore not very suitable for massive screenings.

We want to evaluate the performance of a detection test performed on a salivary sample in the diagnosis of SARS-CoV-2. This test will be non-invasive, performed without any analytical device and will restore its qualitative result "infected versus non-infected" in less than 1 hour (30min objective).

Study taking place at the Montpellier University Hospital, comparing a salivary sample group with active infection (participants) for SARS-COV2 with a salavary sample tested negative (cured, convalescent and negative) for SARS-COV2 (healthcare workers ,participants)

Eligibility Criteria:
Inclusion Criteria:

- Control subjects (COV2- group): Participants ( Healthcare staff, patients and DRIVE participants) negative for SARS-CoV-2

- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR DRIVE participants.

Exclusion Criteria:

* Eligibility Criteria:

Inclusion Criteria:

- Control subjects (COV2- group): Healthcare staff presumed and diagnosed negative for SARS-CoV-2

- Infected subjects (COV2 + group): Patients diagnosed positive for SARS-CoV-2 hospital staff known to be positive and coming to do a control PCR

Exclusion Criteria:

* Not affiliated with a French Social Security Systemscheme or equivalent system
* Persons deprived of their liberty, adult protected under guardianship or vulnerable persons
Retrospective and Prospective Follow-up of Patients With Primary Hyperoxaluria Type 1 Treated With Lumasiran in France.

Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by mutation in the AGXT gene encoding the hepatic peroxisomal enzyme AGT. Reduced AGT activity results in increased glyoxylate and oxalate production, causing the formation of kidney stones, nephrocalcinosis and renal failure. Clinical trials of Lumasiran have provided information on the efficacy and safety of Lumasiran in the treatment of primary hyperoxaluria type 1. However, they do not provide data on long-term efficacy, safety and patient management. As part of the post-marketing follow-up of Lumasiran, in agreement with the authorities, this study proposes a retrospective and prospective follow-up over 5 years of pediatrics and adults patients treated in France with a standardized clinical, biological and radiological follow-up. The main objective is to monitor the evolution of PH1 parameters and particularly oxaluria before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with primary hyperoxaluria type 1 who has been treated with Lumasiran, since the beginning of the ATU (temporary authorization for use) and in post-marketing.

Exclusion Criteria:

* Opposition of the patient or his legal representatives for minors.
* Not covered by social security.
Accelerated Treatment of Endocarditis

Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant financial burden on the health systems. Current guidelines fail to use available clinical and paraclinical, data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the individual patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 475 patients, approx. 125 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus).


Eligibility Criteria:
Inclusion Criteria:

* Admitted with left-sided infectious endocarditis (duke criteria)
* \< 14 days of relevant antibiotic treatment for endocarditis
* One of the following bacteria: Streptococci, enterococcus faecalis, staphylococcus aureus
* \> 18 years old

Exclusion Criteria:

* Known immune incompetency,
* Relapse endocarditis with 6 months,
* Unable to give informed concent
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness

Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation

Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent graft will be in accordance with its FDA-approved indication for symptomatic portal hypertension and per the manufacturer's instructions for use. Liver stiffness will be measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed at times which are standard of care before and after TIPS creation. Primary objectives include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Secondary objectives include change in portosystemic gradient, clinical success as measured by difference in frequency of repeat paracentesis post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy. Exploratory objectives include serum biomarkers of liver stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
* Age \>18, Age \<80
* Capable of giving informed consent

Exclusion Criteria:

* Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
* Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
* BMI \>35 and/or cirrhosis due to non-alcoholic steatohepatitis (due to inaccurate elastography measurements in patients with fatty liver)
* Urgent or emergent TIPS for bleeding
* Portal vein thrombosis with in the main, 1st, or 2nd order branches of the portal vein
* Hepatic vein thrombosis (ie no Budd Chiari syndrome)
* Excessive alcohol use defined as more than 2 oz in 24 hours on any individual day within the last 30 days
* Inability to provide informed consent
* Pregnant or nursing women
* Enrollment in concurrent therapeutic trial for symptomatic portal hypertension
Multi-Centre Post-Market Data Collection

This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age 21 or above at the time of the surgery.
2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:

   1. herniated disc and/or osteophyte formation
   2. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.)
   3. Failed a minimum of 6 weeks conservative treatment
5. Written informed consent given by subject

Exclusion Criteria:

* Inclusion Criteria: All answers must be YES to be eligible for the study.

  1. Age 21 or above at the time of the surgery.
  2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
  3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
  4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:

     1. herniated disc and/or osteophyte formation
     2. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.)
     3. Failed a minimum of 6 weeks conservative treatment
  5. Written informed consent given by subject

Exclusion Criteria: All answers must be NO to be eligible for the study.

1. Moderate to advanced spondylosis
2. Diagnosis of osteoporosis
3. Active systemic infection or infection at the operative site
4. Pregnancy
5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs
6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
7. Severe pathology of the facet joints of the involved vertebral bodies
8. Previous diagnosis of osteopenia or osteomalacia
9. More than one immobile vertebral level between C1 and T1 from any cause
10. Morbid obesity
11. Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
Twilio Well-Child Visit Pilot Open Trial

This project will use Twilio as a platform for a text messaging campaign to implement timely follow up with parents/guardians of children ages 0 to 17 years who have no-showed for WCVs. The first phase of the study will be an open trial to assess feasibility and acceptability of three different reminder messages, analyze preliminary data, and collect feedback from participants using interviews to identify the top one or two performing messages. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. These findings will be used to conduct the second phase of the study, a randomized controlled trial.

Well-Child visits (WCV) are an opportunity to maximize the health and future well-being and development of children. Missed visits, however, can result in negative outcomes for patients and families and for the healthcare system. For patients, missed primary care visits can result in greater Emergency Department (ED) visits and hospitalizations, and in delays in diagnosing a variety of medical conditions, including identification of child abuse and neglect. For healthcare systems, missed visits result in decreased efficiency, lower quality measures, decreased provider productivity, and loss in revenue. Although smart phones are nearly ubiquitous, even among more economically disadvantaged populations, literature to date has reported only on using text messages for pre-visit reminders. There is a tremendous opportunity to study use of text messaging to engage families in follow-up for missed WCV. Even more so, testing the use of text messages with different content is missing, as well as using text messages to invite patients to share reasons for missing the last WCV.

Eligibility Criteria:
Inclusion Criteria:

Patients included in text messaging campaign (caregivers receive text messages):

* Are 0-17 years
* No-showed for a well-child visit scheduled at one of five locations: Pediatrics-Downtown Health Plaza, Family Medicine-Piedmont Plaza, Pediatrics-Winston East, Family Medicine-Peace Haven, or Pediatrics-Clemmons
* Have a phone number on record for a primary caregiver
* With primary language for contact that is English or Spanish

Caregivers must be 18 years or older

Exclusion Criteria:

Patients who:

* Are 18+ years old
* No-showed for a different type of visit, or no-showed for a WCV at a different practice location
* Already rescheduled their appointment by the time the sample list was generated
* Have primary language specified that is not English or Spanish.

Caregivers who are under 18 years old
Evaluation of the ECOM™ Monitor for Continuous and Non-invasive Measure of the Cardiac Output in Cardiac Surgery Patients

The objective of the study is to estimate the reliability of the determination of the cardiac output measured by the ECOM™ device. This study will be performed with the latest version of the software which should give better results than those published previously. Two techniques of measure of the cardiac output will be compared: the reference measure by trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.


Eligibility Criteria:
Inclusion Criteria:

* Patients over18 years
* Needed cardiac surgery,
* Needed a monitoring by transesophageal ultrasound ,
* Benefiting from a social security scheme
* Having given their written consent.

Exclusion Criteria:

* Pregnant or breast-feeding women,
* Allergy to polyvinylchloride (PVC),
* The patients for whom a difficulty of ventilation with a mask or intubation is envisaged,
* Contraindication to transesophageal ultrasound, a steady cardiac arrhythmia, a flight or an aortic shrinkage.
Hamstring Stretch Effect (STRETCH-HAMS)

Randomized clinical trial to evaluate the elongation of the hamstrings after making different types of stretching. One group receives a stretch of global postural reeducation (RPG), another group receives a mobilization of sciatic nerve, and a third group received a placebo treatment. The evaluation of these treatments are done previously, immediately after and 20 min later. The test used to evaluate elongation are the Sit and Reach and active knee extension (AKE test).

Randomized clinical trial to evaluate the elongation of the hamstrings after making different types of stretching and mobilizations used in physiotherapy. This study is realized with university students to be long time studying in sitting position, and each subject is randomly assigned to one of three different groups. One group receives 10 minutes of global postural reeducation stretching (RPG), another group receives 10 minutes of bilateral mobilization of sciatic nerve, and a third group received a placebo treatment. The evaluation of these treatments are done previously, immediately after and 20 min later. The test used to evaluate elongation are the Sit and Reach and active knee extension (AKE test). The order of measurement of each test is also randomized in each subject. The intervention is always applied to the same physical therapist, and measurements were always performed by another physiotherapist blinded.

Eligibility Criteria:
Inclusion Criteria:

* college students spend four hours or more for day sitting

Exclusion Criteria:

* college students do not spend four hours or more for day sitting
* subjects with a traumatic problem, injuries or subjects in treatment of this injuries at the moment of the study
Extension Study of BMN 044 in Duchenne Muscular Dystrophy (DMD)

The aim of this study is to provide continuing access to BMN 044 treatment for subjects previously treated with BMN 044. The information gained from this study is expected to further characterize the efficacy and safety of BMN 044 over a longer treatment period.

This is a phase 2 multi center, multi national, open label, long term extension study. Up to approximately 50 male subjects with Duchenne Muscular Dystrophy (DMD) who have previously been treated with BMN 044 will be enrolled. Subjects will receive either IV infusions or SC injections at pre-defined doses.

Safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy assessments will be conducted at regular intervals throughout the study.

Subjects will be permitted to continue in this study until the subject meets any of the defined withdrawal criteria, BioMarin decides to halt the clinical development of BMN 044, or BMN 044 receives marketing authorization.

Eligibility Criteria:
Inclusion Criteria:

* Subjects previously treated with BMN 044 or a comparator treatment in a BMN 044 Sponsored Study or Investigator Initiated Trial and who are not eligible for another ongoing BMN 044 study.
* Continued use of glucocorticosteroids for a minimum of 60 days prior to study entry with a reasonable expectation that the subject will remain on glucocorticosteroids for the duration of this study.
* Willing and able to comply with all study requirements and procedures.
* Willing and able to provide written, signed informed consent, or in the case of subjects under the age of 18 years(or 16 years, depending on the region), provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to the conduct of any research-related procedures.

Exclusion Criteria:

* Subjects who have previously been treated with BMN 044 who had a serious adverse experience or met safety stopping criteria, that remains unresolved, which in the opinion of the Investigator could have been attributable to BMN 044.
* History of significant medical disorder which may confound the interpretation of safety data
* Acute illness within 4 weeks prior to the first dose of BMN 044 (Week 1) which may interfere with the measurements.
* Symptomatic cardiomyopathy.
* Baseline aPTT above the upper limit of normal (ULN).
* Baseline platelet count below the lower limit of normal (LLN).
* Use of anti coagulants, anti thrombotics or anti platelet agents within 28 days of the baseline visit.
* Prior use of any investigational product (other than BMN 044) or investigational medical device must be discussed with the Medical Monitor prior to screening.
* Current or history of drug and/or alcohol abuse.
Music Therapy for Palliative Care Patients

This study aims to find out if music therapy is effective in improving the quality of life of palliative care patients. It will do this by comparing palliative care patients who receive music therapy with those who do not receive music therapy.

Quality of life (QOL) is very important for palliative care patients, and includes the physical, psychological, social, and spiritual aspects of a patient's life. Music therapy is often used to help palliative care patients and there is some evidence that music therapy helps improve their quality of life, especially in relation to reducing levels of pain. Many palliative care patients and their families have also said that music therapy is helpful. However, more research is needed to help healthcare providers and funders decide if music therapy really is a useful treatment for patients receiving palliative care.

Eligibility Criteria:
Inclusion Criteria:

Only patients deemed able to engage with interactive music therapy will be invited to join the study. Eligibility will be assessed by a clinician during inpatient admission using the Eastern Cooperative Oncology Group (ECOG) scale and the Abbreviated Mental Test (AMT).

* Patients will be eligible if they have an ECOG performance status of 0, 1, 2 or 3 (0 indicating the patient is asymptomatic, 1 the patient is symptomatic but fully ambulatory, 2 the patient is symptomatic and confined to bed for less than 50% of the day, and 3 the patient is symptomatic and confined to bed for more than 50% of the day)) indicating they are able to engage with interactive music therapy. - Eligible patients will also have a score of 7 or more on the AMT, indicating they are capable of providing meaningful informed consent and accurate responses to the study's primary outcome measurement tool.
* Patients with communication difficulties will also be eligible if they are able to indicate their responses to the questionnaire.
* Musical skills are not required. Prior musical skills will not lead to exclusion from the study. The patient must freely consent to participation following receipt of information about the trial.

Exclusion Criteria:

* Patients will be excluded from the study if they have an ECOG performance status of 4 (4 indicating the patient is severely symptomatic and completely bedridden) or a score of 6 or less on the AMT, indicating they may not be capable of providing fully informed consent or accurate responses to the study's primary outcome measurement tool.
* Participants who decide not to consent will be excluded from the trial. Patients will be assured that this decision will have no implications for the care that they receive.
Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System

This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system.


Eligibility Criteria:
Inclusion Criteria:

* 1)Nuclear medicine radiographers with experience in manual prepa-ration of radiopharmaceuticals.

  2) Nuclear medicine healthcare professionals with experience in radiopharmaceutical administration.

  3) Ability to provide written informed consent.

Exclusion Criteria:

* 1) Nuclear medicine radiographers without experience in manual preparation of radiopharmaceuticals.

  2) Nuclear medicine healthcare professionals without experience in radiopharmaceutical administration.

  3) Inability to provide written informed consent.
Effects of Obesity on COPD

The purpose of this study is to investigate whether obese COPD patients experience more or less discomfort in daily life. Furthermore the investigators will evaluate if body composition or body fat distribution has effects on symptoms and performance.

Chronic Obstructive Pulmonary Disease (COPD) and Obesity are two major health problems. The prevalence of both is growing and there is a complex interaction between COPD and obesity. On the one hand obesity impairs lung function, with decreasing static lung volumes being the most significant effect. On the other hand there seems a beneficial role of obesity on lung function in COPD patients. This is because obese COPD patients tend to have less hyperinflation than non-obese COPD patients . An interesting question is what the net effect of these changes in lung function is on respiratory symptoms and quality of life.

In this observational study, the investigators will compare obese and non-obese COPD patients. Pulmonary function, dyspnea and quality of life will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD by a Pulmonologist defined as an obstructive lung function test with FEV1/FVC \< 0.7 and FEV1 \< 80% predicted
* No exacerbation of COPD at time of inclusion
* Age \> 18 years
* Able to perform lung function tests and fill in the questionnaires.

Exclusion Criteria:

* Not able to perform lung function tests or fill in the questionnaires
* Diagnosis of Asthma
* Diagnosis of neuromuscular disease
* Diagnosis of heart failure
* Treatment for lung Malignancy in the past
* Active Malignancy