cyrilzakka/clinical-trials huggingface dataset:
Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury

This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury.

The 2019 edition of the International Guidelines for Clinical Prevention and Treatment of Stress Injury states that stress injury, as a globally prevalent health issue, significantly reduces the quality of life for patients and their families, increases economic burden, and leads to significant expenditure on medical resources. In recent years, the incidence and mortality rate of pressure injuries in hospitalized patients have been increasing year by year. Therefore, there is an urgent need to find a more effective treatment method for pressure injuries in clinical practice. Human umbilical cord mesenchymal stem cells (huMSCs) have immunomodulatory and anti-inflammatory effects. Platelet rich plasma (PRP) can also secrete various nutritional factors, which can effectively promote wound healing. Therefore, the combination of the two may be a more effective treatment method for pressure injuries. At present, there are few reports on the combination of PRP and huMSCs for the treatment of pressure injury. In this study, the investigators aim to evaluate the effectiveness and safety of PRP combined with huMSCs for stage 3 and 4 pressure injuries, In order to promote their clinical application.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old, regardless of gender;
* Patients with stage 3 and stage 4 pressure injuries (According to National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) classification system for pressure ulcers);
* There were no complications affecting the wound healing;
* After through debridement for the first time, the wound volume meets the requirement of "10-100cm3"; Platelet count before treatment 100\~300×109/L;
* The patient voluntarily participates and signs an informed consent form.

Exclusion Criteria:

* Individuals with coagulation dysfunction or hemorrhagic diseases;
* People with skin diseases, diabetes and immune diseases;
* Individuals with mental or psychological disorders;
* Individuals with allergies to multiple drugs;
* Pregnant or lactating women;
* Those who need to take medication that affects platelet and coagulation function for a long time or in the near future, but have not stopped taking medication within the past week.
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.

The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided consent,
* Patients about to undergo idiopathic epiretinal membrane surgery,
* Patients undergoing first-line macular surgery

Exclusion Criteria:

* Persons not covered by national health insurance
* Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
* Preoperative amblyopic eye
* Insufficiently transparent media making it impossible to do the examinations
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis

There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.

For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. To date there has been no literature evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. The results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures.

Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
* Anticipated spinal fusion surgery

Exclusion Criteria:

* Individuals younger than 11 years and older than 18 years
* Individuals with scoliosis carrying additional diagnoses of illness.
Online "Pain, Stress & Emotions" Class in Chronic Pain

Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, \& Emotions". Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks after class attendance.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain condition (pain \> 3 months)
* Access to the internet
* English fluency

Exclusion Criteria:

* Ongoing legal action or disability claim
* Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients

This study is sought to investigate any predictors including biomarkers for atrial high rate episodes (AHRE) occurrence in patients without prior history of atrial tachyarrhythmias receiving cardiac implantable electronic device (CIED).

Atrial high rate episodes (AHRE) are noticed up to 70% in patients receiving cardiac implantable electronic device (CIED) even in the absence of prior history of atrial tachyarrhythmias. AHRE is clinically important because it is considered to be associated with clinical atrial fibrillation, stroke, mortality, and heart failure hospitalization. Therefore, predictors of AHRE might be useful for early detection of AHRE susceptable CIED recipients. Biomarkers as well as clinical characteristics will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving cardiac implantable electronic device

Exclusion Criteria:

* patients who disagree for blood sampling to analyze not commonly used clinical biomarkers
* patients not followed-up at least 12 months after implanting device
Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.

The uterine septum (US) is the most common congenital uterine malformation, accounting for about 75% of Mullerian anomalies. Transcervical resection of septum (TCRS) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. TCRS is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. Some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for Asherman syndrome. The adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (IUD) or Foley catheter in the uterine cavity. Unlike the case of Asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case TCRS. In this study, the investigators will compare the postoperative adhesion formation rates who will receive Foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of Foley catheter therapies in reducing postoperative adhesion formation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;
* Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;
* Written informed consent obtained.

Exclusion Criteria:

* ongoing pregnancy;
* Peroperative fever or infections;
* Malignancy;
* Precious pelvic inflammatory disease;
* Uterine fibroid (\>3cm size);
* endometriosis;
* Contraindications for anesthesia;
* Not able to read and/or understand informed consent.
" SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"

The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Monitoring CNI dosages is fundamental for the clinician, in order to find the right balance between toxicity and prevention of rejection. Several recent studies suggest that a Radio Residual Concentration / Dosage (C0 / D) less than 1.05 (patients with rapid metabolizers) is associated with poor graft function (eGFR) and decreased kidney transplant survival. LCPT prolonged-release tacrolimus (Novel Once-Daily Extended-Release Tacrolimus. Prolonged-release tacrolimus: Envarsus®) is a marketed form of tacrolimus with interesting pharmacokinetic properties: daily intake, reduction of the absorption peak (Meltodose® technology ) and reduction of the total CNI dose by 30% to obtain an equivalent CO compared to other molecules on the market (Advagraf®, Prograf®). Thus, the use of LCPT in patients rapid metabolisers in relay of Advagraf® or Prograf® could make it possible to decrease renal toxicity while preserving rejection, by increasing the C0 / D ratio.

The investigators propose a pilot study aiming to study a prospective cohort of rapid metabolisers patients put on Envarsus at one month of transplant compared to a historical cohort, in terms of C0 / D ratio, function and survival of the renal graft.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* 1st or 2nd kidney transplant
* Transplantation from a deceased donor (Encephalic death or arrested heart Maastricht III) or living donor
* C0 / D ratio \<1.05 at one month of kidney transplant
* Renal graft function \<60ml / min (eGFR estimate by CKD-EPI or MDRD).

Exclusion Criteria:

* Patient ≤ 18 years old, under guardianship or protected
* Graft rank ≥ 3
* Renal graft function \<30 ml / min (eGFR estimate by CKD-EPI or MDRD)
* Presence of pre-transplant DSA (threshold\> 2000 MFI)
* Occurrence of histologically proven rejection during the 1st month of transplant
* Presence of another functional transplant (heart / lung / liver / pancreas) or kidney bi-transplant
* Transplantation from a living donor
* Transplantation from an arrested heart donor Maastricht II
Communication Issues in Patient and Provider Discussions of Immunotherapy

This trials studies communication issues in patient and provider discussions about immunotherapy. The goal of this study is to describe where patients have heard about immunotherapy, what the participants understand about it, how physicians and other healthcare workers describe immunotherapy, and how educational videos may support patient knowledge about immunotherapy.

PRIMARY OBJECTIVES:

I. To identify misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources and assess if these misestimations persist post-provider conversation about immunotherapy.

II. To qualitatively describe patient reported misunderstandings and to assess patient understanding of technical terms and metaphors used in the immunotherapy conversation.

III. To identify provider and patient preferences for information to be communicated about immunotherapy.

IV. Develop videos that describe immunotherapy and test their efficacy in improving understanding using pre and post methodology.

OUTLINE:

Patients and their providers undergo observation during a conversation about immunotherapy. Then participate in an interview over 20 minutes. Understanding of educational videos is then tested.

Eligibility Criteria:
Inclusion Criteria:

* AIMS 1-3: All patients and providers who may have a discussion about immunotherapy at the Winship Cancer Institute
* AIM 4: Any cancer patient
Modulation of H-reflex After Application of Electric Currents in Healthy People

The purpose of this study is to determinate whether the application of electric currents produce changes in the excitability of alpha moto neurone. Moreover evidence whether the effect of the electric currents can change the tone of the muscle under stimulation in healthy volunteers

In the last years several experimental studies have evidenced that the transcutaneous electric nerve stimulation (TENS) in peripheric application can cause a decrease of spasticity and modulation of H-reflexes.

But if the application is in the central nervous system the results are different. So the purpose of this study is quantify the modulation of the excitability of alpha moto neurone when the application of the current is in the central nervous system compared with a sham group.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

* Neuromuscular disease
* Epilepsy
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area
* Osteosynthesis material in the upper limb
* Diabetes
* Cancer
* Cardiovascular disease
* Pacemaker or other implanted electrical device
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
* Sensitivity disturbance in lower limb
First-in-human Study of MRT-6160 in Healthy Subjects

The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.

The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans.

Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1

Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days

Detailed Description:

The purpose of this study is to:

Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or females 19-65 years of age
* Non smoker who has not used nicotine and tobacco containing products for at least 3 months prior to start of study
* Able to swallow oral medications
* Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
* Underwent surgical intervention or an operation within 4 weeks prior to start of study
* Has active TB, latent TB, a history of TB, or had close contact with a person with active TB within 8 weeks prior to the first dosing
* Female subject with a positive pregnancy test or who is lactating
* Positive urine drug or alcohol screen results
* Positive COVID-19 results indicating recent or current COVID-19
* Positive results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus or history of resolved hepatitis
* Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study
Pathophysiological Characterization of the Neuromuscular Function of a Population With Multiple Comorbidities Suffering From Chronic Renal Failure in Pre-dialysis.

The evolution of chronic kidney disease (CKD) causes a systemic upheaval on the body and a deep fatigue is very often described by patients (50-70% of the patients) even before the start of dialysis (pre-dialysis). This fatigue has many origins, and one of them probably stems from a deterioration of neuromuscular abilities. Very few studies have examined the physiological aspects of neuromuscular fatigue in pre-dialysis patients, and shedding light on potential deficits at this level would allow safe and efficient implementation of adapted physical activity programs.

Our study aims to characterize the pathophysiology of neuromuscular capabilities in chronic advanced renal failure in pre-dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (Age\> 18 years) who have signed the informed consent form
* Social security coverage
* For patients in the Chronic Kidney Disease group: Glomerular filtration rate less than 60 ml/min of creatinine for more than three months

Exclusion Criteria:

* Dermatological conditions of the upper limbs which would contra-indicate Electromyographic electrodes being positioned
* Gestating women
* Patients with known neuromuscular conditions
* Patients with dementia
* Patients with acute heart failure
* Patients with a history of surgery of the evaluated limb
* Patients included in an interventional study involving administration of treatments other than routine care
* For the patients in the Chronic Kidney Disease group: patients currently undergoing dialysis or in a pre-dialysis program (e.g. with a dialysis fistula already in place).
Evaluation of Modified Adhesives With Dexcom G6 Sensor

The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older;
2. No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);

Exclusion Criteria:

1. Extensive skin changes/diseases that preclude wearing the required number of devices (e.g., history of severe reactions from adhesive wear, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
2. Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)
Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.

Insufficient evidence supports the feasibility and the efficacy of current nutritional recommendations to prevent obesity. The purpose of this study is to test the hypothesis that family dietary coaching would improve nutritional intakes and health indicators in free-living children and adults.

Intervention: the 1013 participating families (1013 children and 1013 parents) are randomly assigned to Group A (advice to reduce fat and to increase complex carbohydrates), Group B (advice to reduce both fat and sugars and to increase complex carbohydrates) or a control group (no advice). GA and GB receive monthly phone counseling and Internet-based monitoring. Main outcome measures are changes in nutritional intakes and body mass index throughout the intervention in both children and adults. Secondary outcomes included changes in fat mass, physical activity, fasting blood indicators and food-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* second- or third-grade pupils
* affiliation with the French Health Care System
* written informed consent

Exclusion Criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators
Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil

Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.

Randomized controlled parallel open-label study in persons living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.

Participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. Follow-up is 48 weeks. Data is collected at baseline and week 48.

Primary outcome is changes in weight from baseline of more than 2 kg.

Secondary outcomes are virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 18 years old with diagnosed HIV and at least 6 months of ongoing treatment with dolutegravir/ doravirin/lamivudine will be included. Patients must have a plasma viral load (HIV-RNA) \< 50 copies/ml at inclusion. For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period

Exclusion Criteria:

* Patients will be excluded in case of pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine the presence of hepatitis B antigen (HBsAg) or HBV DNA, cancer within past 5 years, pregnancy or breastfeeding. Any case of diabetes, cardiovascular disease or other chronic illness must be considered stable as assessed by the treating physician.