cyrilzakka/clinical-trials huggingface dataset:
The Impact of Outdoor Sports Practice on the Well-Being of Disabled People

Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.

This is a national cross-sectional study to investigate the impact of outdoor sports practice on the well-being and self-esteem of people with disabilities.

The study is based on a survey of FFH members practicing outdoor sports. The survey will be distributed between October and November 2023 via the federation's internal communication system. Data will be collected on outdoor sports activity, psychological impact and barriers to practice.

Analyses will be made between able-bodied and disabled members, between types of disability, and between types of outdoor sport practiced (water, land and air).

Analysis will be based on anomysed data and will respect the MR004 methodology.

Eligibility Criteria:
Inclusion Criteria:

* Being a member of the French Handisport Federation between September 2022 and August 2023
* Practicing outdoor sports

Exclusion Criteria:

* Persons who have objected to be contacted by e-mail
Impact of Aging on Cytokine Production by Innate Immune Cells

The main goal of this study is to investigate the impact of aging on the responsiveness of peripheral blood immune cells. To this aim, the investigators will take advantage of a recently described syringe-based assay system that can reproducibly assess induced, innate or adaptive immune responses. Briefly, a total of 50 healthy volunteers will participate to this study: 25 will be older than 18 and younger than 30, and 25 will be older than 55. A total of 14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing poly(I:C), R-848, LPS, CpG, or no stimulus, respectively. After 22 hours of incubation at 37°C, cellular supernatants will assessed for levels of 10 different chemokines using a MesoScaleDiscovery multiplexing platform.


Eligibility Criteria:
Inclusion Criteria:

* volunteers will be invited to settle an appointment with the Nice University Hospital (CHU de Nice) Research Clinical Center (CRC).
* being between 18 and 30 year-old (group Y) or being older than 55 year-old (group O),
* ability to understand and speak French,
* being registered at the Social Security,
* acceptance to be serologically tested for HIV and HVC,
* considered healthy based on both past medical records and the clinical examination performed at the inclusion visit,
* exhibiting a body mass index (body mass divided by the square of their height) comprised between 18.5 and 30.0 kg/m2.

Exclusion Criteria:

* having participated to a drug clinical trial since less than 3 months,
* having traveled to a tropical or a sub-tropical country over the past 3 months,
* being pregnant or a lactating mother (for women),
* having performed intensive physical exercise over the past 12 hours,
* following a specific diet for medical reasons,
* over-drinking, i.e. more that 50 g of pure alcohol every day,
* having taken an immuno-suppressive or immuno-modulatory drug over the past two weeks, or for at least 14 consecutive days over the past 6 months,
* having been vaccinated over the past 3 months,
* declaring not being on an empty stomach for less than 12 hours,
* having received a blood transfusion or intravenous immunoglobulins over the past 3 months,
* declaring being HIV- or HVC- positive,
* having suffered from an infection since less than 3 weeks,
* exhibiting a positive urine pregnancy test at the inclusion visit,
* suffering from a severe/chronic/relapsing pathology, i.e. inflammatory bowel disease, psoriasis, atopic dermatitis, rheumatoid arthritis, multiple sclerosis, type I or type II diabetes, Parkinson's disease, and (p) having been diagnosed with a cancer and not being in a remitting period for less than 5 years.
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH\&RC standard of care. Compare the safety and the frequency of adverse effects of treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital \& Research Center (KFSH\&RC) age 1-12 years

Exclusion Criteria:

* Weight ≥ 40 kilograms
* Allergies to the study drug
* Refused to take the study drug
* Severe learning disability
* Patient on Digoxin medication
* Patient on beta-blocker medication
* Cardiac disease with abnormal conduction system
* Nasal anatomical abnormality
Performance Improvement: Does Mock Code Simulation Improve the Confidence Level of Newly Graduated Nurses?

The study is a descriptive correlational study over three surveys that will examine the improvement of confidence level associated between the implementation of mock code training simulation and the real live event.

Participants will be asked to respond online to a questionnaire or survey launched via Survey Monkey®. Demographic information will be collected first Appendix B. A self-reported confidence level via the Student Satisfaction and self-confidence in learning scale will be utilized and serves as a data collection tool. The scale will be deployed via email as a scale A B and C Appendix C to each study participant and is the same scale. The participants will complete survey A after completion of the initial educational simulation training the survey B will be completed when the participants attended an unannounced simulation activity. Survey C will be completed after the first actively involved Code Blue situation. The survey is a 13-item instrument designed to measure student satisfaction five items with the simulation activity and self-confidence in learning eight items using a five-point scale. Reliability was tested using Cronbach's alpha: satisfaction equals 0.94 self-confidence equals 0.87 Franklin Burns and Lee 2014.

Eligibility Criteria:
Inclusion Criteria:

All newly graduated nurses and nurse fellows in a residency training program at MCMC Able to read and understand English

Exclusion Criteria:

Clinical staff not affiliated with the residency and fellowship program.
Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing

Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound.

Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD) and presence of recession of the gingival margin (Rec) will be recorded on six sites/tooth in the area selected for periodontal surgery by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe at a 0.3 N probing pressure. Surgery will be performed following a standardized protocol by a single operator.

After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.

The patients will be allocated in one of the three distinct study groups as it follows:

* Group A: no administration of mouth rinses after surgery (control group)
* Group B: administration of a hyaluronic and 0.2% chlorhexidine mouth rinse (test group 1)
* Group C: administration of chlorhexidine 0.2% mouth rinse (test group 2).

Post-treatment photographs of surgical incision will be taken immediately after periodontal surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Periodontal Wound Healing Index (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.

At T3, T7, and T14 the following clinical parameters will be recorded for each tooth in the surgical area: PPD, Rec, PI, and BOP. The clinical examinations will be performed by calibrated examiner blind to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* males or females of age range between 18 and 70 years,
* good health status,
* indication to perform periodontal surgery,
* patients willing to give informed consent,
* compliance to the study follow-up,
* plaque index (PI) score 0 and
* bleeding on probing (BOP) \<25%

Exclusion Criteria:

* pregnancy or breast-feeding,
* therapy with oral contraceptives,
* indication to antibiotic therapy prior to surgical treatment,
* chronic infections,
* systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
* previous therapy with the mouth rinses employed in the present study, and
* smoking habit (\>20 cigarettes per day, and/or pipe or cigar smoking).
Genetic Factors on Outcomes of Kidney Transplant Patients With Tacrolimus-based Therapy

The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan.

Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after kidney transplantation. Many genetic and clinical factors had been found to have effect on TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still controversial.

In this retrospective study, investigators will review records of kidney transplant patients with TAC based immunosuppression recruited from a previous study (IRB approval number: 201512005RINC) to understand the influence of clinical and genetic factors on their 3-years clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival and safety issues of kidney transplant patients.

Eligibility Criteria:
Inclusion Criteria:

1. Kidney transplantation
2. 20-65 years old
3. Receiving tacrolimus-based immunosuppressants
4. Were recruited in a previous trial

Exclusion Criteria:

1. Human immunodeficiency virus-positive status
2. Retransplantation or multiorgan transplantation
3. Non-Asian
Spirometry Using Electrical Impedance Tomography

The main aim of this study is to test spirometry measurements using EIT with a calibration using tidal volume obtained from the simultaneous standard spirometry measurement. Another goal is to compare, based on the calibration, the spirometry parameters obtained from separate measurements using EIT and the standard spirometry using a pneumotachograph.

All spirometry measurements will be conducted in accordance with the latest available standards of the American Thoracic Society (ATS) and European Respiratory Society (ERS) from the year 2005, including their emendation from 2017.

Adding the pneumotachograph and antibacterial filter to the respiratory system can lead to increased dead space, flow resistance, and change the respiratory pattern. All of these negative features and reduced patient co-operation affect the measured results and their interpretation. The aim of this study is to test spirometry measurement using EIT and evaluate such spirometry parameters as forced vital capacity (FVC), forced expiratory volume exhaled in the first second of a forced expiration (FEV1) and ratio of FEV1/FVC called Tiffeneau index (TI) based on recalculation using the calibration constant. The study will be conducted using Ergostik (Geratherm, Germany) spirometer and EIT system Pulmovista 500 (Dräger, Germany).

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females \> 18 years old
* Signed informed consent has been obtained

Exclusion Criteria:

* Pregnancy
* Cardiac pacemakers
* Electrically active implant
* Critical illness
* Intrathoracic metal implants
* Value of body mass index (BMI)\>50
STRIDE Study - A Study in Subjects With LOPD Who Are Currently Being Treated With ERT

The purpose of the study is to evaluate changes in key clinical outcome measures (eg, motor, respiratory, fatigue) in adult subjects with late-onset Pompe disease (LOPD) subjects receiving standard-of-care enzyme replacement therapy (ERT). Additionally, information gained may be used in the design and conduct of future studies in LOPD subjects.

The objective of this study is to evaluate the baseline characteristics and degree of change over time in clinical outcome measures commonly used to evaluate patients with LOPD.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has a diagnosis of Pompe disease based on documented deficiency of GAA activity and a documented GAA mutation.
2. Male and female subjects between 18 years and 75 years, inclusive and ≥ 50 kg.
3. Subject must be currently receiving standard-of-care ERT (alglucosidase alfa) at a dose of 20 mg/kg dose every other week.
4. Subject must have been on ERT for the preceding 2 years or more.
5. Subject must have an upright forced vital capacity (FVC) within 35 to 90% of predicted normal (NHANES III reference values), based on the higher of the screening or baseline value, if their 6 minute walk distance (6MWD) is \> 200 m. Subject must have an upright FVC within 40 to 90% of predicted normal (NHANES III reference values), based on the higher of the screening or baseline value, if their 6MWD is ≤ 200 m. If FVC is between 80 and 90% of predicted normal, the subject may enter the study if the percent predicted FVC value drops by 10% predicted or more in supine position
6. Subject is able to walk at least 100 m in the 6MWT and the assessment is noted as valid.

Exclusion Criteria:

1. Subject has received any investigational therapy or pharmacological treatment for Pompe disease, other than alglucosidase alfa within 30 days or 5 half lives, whichever is shorter, prior to the Baseline Visit or is anticipated to do so during the course of the study
2. Subject is on any of the following prohibited medications within 30 days of baseline:

   * miglitol (eg, Glyset)
   * miglustat (eg, Zavesca)
   * acarbose (eg, Precose, Glucobay)
   * voglibose (eg, Volix, Vocarb, Volibo)
3. Subject requires use of invasive or non-invasive ventilatory support for \> 6 hours a day while awake.
4. Subject has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator, pose an undue safety risk to the subject or compromise his/her ability to comply with protocol requirements. This includes clinical depression (as diagnosed by a psychiatrist or other mental health professional) with uncontrolled or poorly controlled symptoms.
5. Subject is breastfeeding, or is pregnant or planning to become pregnant within the next 2 years.
6. Other exclusion criteria according to the Lumizyme/Myozyme instructions for use.
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.


Eligibility Criteria:
Inclusion Criteria:

* Patient with SJM CRM device implanted for more than 90 days

Exclusion Criteria:

* Suspicion of lead dislodgment
Limiting Adverse Birth Outcomes in Resource-Limited Settings

The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of adverse outcomes is high. The Investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. The resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.

This is a prospective multi-country cohort study of up to 15,000 women admitted to the hospital for delivery or for management of respiratory infection. Women will be recruited and screened for study participation at the time of presentation to the hospital. Participants will be assessed through hospitalization, labor, delivery, and discharge and at 1- and 6-week postpartum contacts. Liveborn infants will be enrolled at birth and followed through 42 days of life. The pilot phase of this protocol will enroll up to 500 women in labor and their newborns and follow them through labor, delivery, and 42 days postpartum.

Eligibility Criteria:
Inclusion Criteria for women enrolled:

* Maternal age of majority
* Intrauterine singleton pregnancy
* Admission to the hospital for ANY of the following:

  1. vaginal delivery
  2. cesarean delivery in the presence of signs/symptoms of parturition, elevated blood pressure, or fever
  3. management of respiratory infection\*
* Ability and willingness to provide written informed consent
* Willingness to adhere to study procedures
* Willingness to provide locator information for follow-up

  * Inclusion of participants admitted to hospital for management of respiratory infection applicable to Zambia site only.

Exclusion Criteria for women enrolled:

* Admission to the hospital for cesarean delivery in the absence of signs/symptoms of parturition, elevated blood pressure, or fever
* Any condition (social or medical) that, in the opinion of study staff, would make participation unsafe or not feasible. Study staff may note physical, psychological, or social conditions that are not explicitly stated in the eligibility criteria that could make some women poor candidates for study participation.
Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography

The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with the PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.

The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Patients who received a polymer-free or a permanent-polymer sirolimus-eluting stent about 5 years ago without in-segment intervention since, will be evaluated by OCT regarding the healing pattern and the late lumen loss of the stent.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with with previous implantation of polymer-free or permanent-polymer sirolimus-eluting stents 5 years ago due to ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study and assessment by OCT.
* In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

* Intervention in the segment of the study stent after the index procedure
* Target lesion located in the left main trunk.
* In-stent restenosis with difficulty to pass the OCT device
* Acute myocardial infarction
* Known allergy to the study medications: Sirolimus, rapamycin, probucol or stainless steel.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Patient's inability to fully cooperate with the study protocol.
Postoperative Radiotherapy for Oral Squamous Cell Carcinoma After Neoadjuvant Therapy and Surgery

The treatment guideline for locally advanced resectable oral squamous cell carcinoma (LAROSCC) is surgery + postoperative radiotherapy/chemoradiotherapy. Though the treatment is intensive with serious harm to quality of life, the survival of patients is poor. Neoadjuvant therapy has been evaluated in a number of clinical trials for LAROSCC, but failed to directly improve the overall survival. On the other hand, de-escalation of treatment followed by neoadjuvant is also been explored with some promising results. This study is to retrospectively include patients with LAROSCC who received neoadjuvant therapy and surgery. Survival between patients in two cohorts (cohort 1: received postoperative radiotherapy, cohort 2: received no postoperative radiotherapy) are to be compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving neoadjuvant therapy and surgery for oral squamous cell carcinoma from January 2008 to December 2021
* Oral squamous cell carcinoma histology (including tongue, gingiva, cheek, floor of mouth, hard palate and posterior molar area)
* Clinical stage III/IVA (T1-2/N1-2/M0 or T3-4/cN0-2/M0, AJCC 2018) for the primary lesion
* Surgical resection samples that can be evaluated for pathological remission rate

Exclusion Criteria:

* Severe/active systemic disease
* Previously radiotherapy or neck lymph node dissection for the head and neck region
* Evidence of tumor recurrence or metastasis in physical examination or imaging (ultrasound, CT, MRI) before initiation adjuvant radiotherapy
* Evidence of severe/unrelieved side effects of neoadjuvant therapy or severe postoperative complications before initiation adjuvant radiotherapy
Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty

25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have a Zimmer Persona PCR or PS TKA.
* Subjects must be at least six months post-operative.
* Subjects will have KSS greater than 75.
* Participants must be able to perform the required activities - stepping up and a deep knee bend.
* Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
* Bilateral subjects may be included in the subject population

Exclusion Criteria:

* Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy.
* Subjects without the required type of knee implant.
* Subjects who are unable to perform stepping up and deep knee bend.
* Subjects who are unwilling to sign Informed Consent/HIPAA documents.
* Subjects who do not speak English and/or French