cyrilzakka/clinical-trials huggingface dataset:
Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction

This is a prospective randomized study comparing tourniquet use versus a dual-flow arthroscopy sheath in Anterior Cruciate Ligament (ACL) reconstruction surgery.

The ACL is largely responsible for knee stability and contributes to central pivot with the posterior cruciate ligament. ACL rupture is associated with a violent twisting motion of the knee, which is usually irreparable without surgical intervention.

ACL reconstruction via arthroscopy is the gold standard treatment for young, active patients with knee instability. Reconstruction is commonly performed using a thigh tourniquet to improve intraoperative visibility, reduce bleeding, and shorten procedure time. However, numerous studies associate tourniquet use with an increased risk of postoperative complications such as increased pain, muscle injury, postoperative bleeding, and deep vein thrombosis. Therefore, it seems relevant to conduct further investigations into the benefits of new methods to replace tourniquet. In this context, the dual-flow arthroscopy sheath could improve postoperative recovery after ACL reconstruction and could limit the risk of complications, thus improving ambulatory care for patients.

This study propose to compare two groups of patients undergoing ACL reconstruction: those operated on with a tourniquet versus those operated on using the dual-flow arthroscopy sheath.

Initial assessments will be conducted preoperatively. The follow-up examination will take place during the first 7 days following surgery and then at 21 days (D21), 45 days (D45), and 5 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Primary ACL reconstruction
* Age 18 years or older
* Provided informed consent prior to study participation
* Affiliated to or beneficiary of a social security regimen

Exclusion Criteria:

* Multi-ligamentous surgery
* Revision ACL surgery
* Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively
* Bleeding disorder
* Pregnant, parturient or breastfeeding women
* Patient under legal guardianship
* Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the objectives of the study objectives
Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet criteria for tympanoplasty procedure
* Willing to comply with the protocol and attend all study visits
* Able to provide written informed consent

Exclusion Criteria:

* Patients who have previously undergone middle ear or lateral skull base surgery
* Patients who would not qualify for a tympanoplasty
* Any type of platelet disorder, cancer, or ongoing systemic infection
* Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums
* Type I diabetes or other autoimmune pathology
Skin Protectant Textile Efficacy Study for Managing Skin Fold Conditions

This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Participants will be patients with skin fold conditions, which will be treated with the SPT. Healthcare providers will apply the SPT to the participants' target areas. An independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area\[s\]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the SPT is first applied (Day 0), and on Days 1, 3, and 5, during SPT changes. The Principal Investigator (PI) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. Participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. In addition, the study will include feedback from the Health Care Providers (HCPs) about the SPT and overall experience of the participants with the SPT.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥ 18 years of age.
* Individuals who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor.
* Individuals whose treatment plan permits assessment of the skin fold condition(s) for up to six days.

Exclusion Criteria:

* Individuals whose target area(s) are being managed with topical treatments such as antibiotics, antifungals, ointments including skin protectants, anti-itch products, anoperineal dressings or absorbent pads (eg, ARD®).
* Individuals with a known allergy or sensitivity to the ingredients in the SPT, such as the fabric or H2O2, as well as the tape that may be used to secure the SPT.
Cold Applications on the Pain Level of Children With Sutures

Purpose:This research was conducted as an experimental study with pretest and posttest control groups in order to evaluate the effect of post-suture cold applications on the pain level of children with sutures.

Design and Methods: This study is a randomised controlled study. In the study, there were 150 children in the experimental group and 150 children in the control group.

The experimental groups was applied at the 1st, 2nd and 6th hours after the suture application in the cold applications The different practitioners applied in the Visual Analog Scale after and before in the cold applications to the experimental and control groups

Eligibility Criteria:
Inclusion Criteria:

* parents who agreed to participate in the study

Exclusion Criteria:

* -visually impaired child
* mentally retarded child
* speech impaired children
* without chronic disease
Heart Aging When Near Vision Difficulty Begins

Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Myocardial regeneration is limited, and cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA.

The subjects (500, mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. Biomicroscopy was used to capture images of the lens nucleus in the unaccommodated state, followed by images of a 4 diopter (D) accommodated state. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences were evaluated using electrocardiography, and cardiac autonomic aging was assessed based on heart rate variability. Myocardial aging was assessed based on diastolic dysfunction.

Lens cells and proteins are encapsulated, and they are not turned over or replaced.The lens nucleus starts to form before birth, so the nucleus is one of the three oldest tissues in the body .With aging, continuous cardiomyocyte stress derails proteostasis by causing excessive autophagy and protease activation, and, ultimately, contractile and electrophysiological dysfunction. Aggregate deposition, proteostasis deterioration, and diffusion degradation between the nucleus and cortex are the main reasons for lens aging.Heart, lens, and neuronal cells change significantly with age, and they are older than cells from renewable tissues.

Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA. The subjects (500 mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences, autonomic aging, myocardial aging were evaluated using electrocardiography, heart rate variability and diastolic dysfunction. For near distance vision,compared to subjects who could see clearly from 24-28 cm, subjects who could see clearly from 29-33 cm had a 2.104-fold higher risk of a lateral e' velocity \<10 cm/s\[95%CI; 1.312-3.374\], 2.603-fold higher risk of diastolic dysfunction\[95%CI; 1.453-4.662\], 1.54-fold higher risk of a low/high frequency ratio \>3.1, \[95%CI;1.085-2.197\]. Subjective AA measurement can predict important heart aging parameters.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers, mean 50 years of age (49-51)

Exclusion Criteria:

Hypertension, Diabetes mellitus, Atrial fibrillation, Coronary artery disease, Arrhythmia, Hyperthyroidism , Anemia, Heart failure, Respiratory diseases, Severe obesity (body mass index ≥35 kg/m2),
GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes for less than 20 years and receiving at least 30 U insulin per day

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with any thiazolidinedione class of antidiabetic agents
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
The Effects of Dietary Fiber in CKD: A Systematic Review and Meta-analysis

Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline of renal function associated with increased overall mortality. Most dietary guidelines for CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods. However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as classical markers of a state of uremia in individuals with CKD. We hypothesize that increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.


Eligibility Criteria:
Inclusion Criteria:

* Dietary trials in humans
* Randomized treatment allocation
* Suitable control (low fiber)
* viable endpoint data

Exclusion Criteria:

* Non-human studies
* Nonrandomized treatment allocation
* Lack of a suitable control (high protein)
* no viable endpoint data
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.

A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1

B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days

C) To evaluate the efficacy and pharmacodynamics of Apo805K1

Eligibility Criteria:
Main Inclusion Criteria:

* A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months (before Baseline assessment) with current body surface area (BSA) involvement ≥10% and Psoriasis Area Severity Index (PASI) ≥10.
* Male and female subjects 18 to 65 years of age, inclusive.
* At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).
* Signed and witnessed written informed consent form obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.

Main Exclusion Criteria:

* Treatment of psoriasis with biologic agents within 90 days prior to Baseline assessment and during the study.
* Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic agents within 30 days prior to Baseline assessment and during the study.
* Phototherapy within 30 days prior to Baseline assessment and during the study.
* Psoriasis topical therapy within 14 days prior to Baseline assessment and during the study (exception: non-medicated emollients and tar shampoo will be allowed).
* History of liver disease or abnormal liver enzymes
* Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched controls.
* Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.
* Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere with psoriasis assessments.
* History of chronic infection or malignancy
Goal-Directed Therapy Following Cardiac Surgery

Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.

Rationale:

Goal-directed therapy (GDT) has been shown to reduce complications and length of stay on cardiac surgery patients. Unfortunately, the existing literature on GDT in CV surgery has several limitations, which creates uncertainty over the expected benefit of implementing this care element with high associated costs and impact on workflow. Hypotension Prediction Index (HPI) is a proprietary algorithm that utilizes pulse contour analysis from invasive arterial pressure monitoring to identify patients at risk for becoming hypotensive within 15 minutes. The algorithm was developed using machine learning on a large surgical/ICU data set, and then externally validated on non-cardiac and cardiac surgical patients. HPI, as part of a GDT algorithm, may allow healthcare providers to identify patients recovering from cardiac surgery who may benefit from optimization prior to becoming hypotensive and assist with selecting the most appropriate hemodynamic intervention.

Hypothesis:

Application of an HPI-based GDT algorithm will result in a difference in cumulative fluid administration over the first 24-hours of index ICU admission following cardiac surgery.

Study Design:

Unblinded randomized controlled trial pilot. Data will be used to inform/justify the feasibility, design, and implementation of a future multi-center randomized controlled trial.

Study Population:

Moderate or high-risk (EuroSCORE II \> 2%), non-emergent, adult open-heart cardiac surgery patients. Heart transplant, durable VAD implantation, or patients who require post-operative MCS support will be excluded.

Sample size= 100 (50 control : 50 intervention)

Intervention:

Patients randomized to the intervention arm will be monitored using the HPI technology and be treated following a GDT algorithm when HPI is \>50 for 48-hours or duration of invasive arterial monitoring (whichever occurs first). The GDT algorithm is a standardized approach to identifying abnormal hemodynamic parameters and administering a prescribed therapy in a step-wise fashion with fixed re-assessment intervals (see attached).

What will be different from routine care? :

1. Hemodynamic interventions (fluid, inotropic, or vasopressor therapy) will be administered when HPI \> 50 rather than MAP \< 65.
2. Choice of applied therapy (fluid, inotropic, or vasopressor therapy) will be guided by a GDT algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Planned cardiac surgery using cardiopulmonary bypass (sternotomy or MICS)
3. Preoperative European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) of 2% or more.
4. Informed consent obtained.

Exclusion Criteria:

1. Patients who refuse participation
2. Patients who are unable to give informed consent
3. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
4. Emergency surgery
5. Patients who require MCS (including ECMO, Impella, or IABP) post-operatively
Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis

In this study, we propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells IT injections in Primary Progressive Multiple Sclerosis patients.

In this study, the investigators propose, for the first time, to test the safety and the potential efficacy of repeated allogenic Adipose tissue-derived Mesenchymal Stromal Cells (ASCs) IT injections in Primary Progressive Multiple Sclerosis (PPMS) patients. In fact, even if autologous Bone Marrow-Mesenchymal Stromal Cells (BM-MSC) and ASCs have already been infused intrathecally in multiple sclerosis, repeated injections of allogenic ASCs have never been tested in this disease. The use of allogenic cells is driven by recent publications reporting decreased suppressive properties of autologous MSC from MS patients.

The hypothesis is that 3 repeated intrathecal (IT) injections of allogenic ASCs every 3 months will be safe and can lower disease progression in PPMS patients.

Preamble of infusing ASCs in the first patient, it's necessary to constitute and characterize the ASC bank. ASC will be obtained from Allogeneic human mesenchymal stromal cells derived from adipose tissue of a living donor.

Once the bank is available, MS patients will be screened and included in Rennes university hospital to received ASC's infusions.

MS patients will be followed for one year after inclusion

Eligibility Criteria:
Inclusion Criteria:

* Patient with Primary Progressive MS according to the criteria of Mc Donald 2017 (Thompson et al Lancet neurol, 2017)
* Age between 18 and 55 years
* EDSS score: 3 to 6 at inclusion
* Documented evidence of disability progression independent of relapse activity at any point in time over the 2 years prior to the screening visit
* Positive CSF with oligoclonal bands
* For women of childbearing potential (WOCBP), effective contraception as per the CFTG recommendations (version 1.1)
* Having signed a free, informed and written consent
* Affiliated to social security scheme

Exclusion Criteria:

* Inflammatory activity during the past year (relapses or new T2 MRI lesions)
* Disease Modifying Drugs during the past year
* Treatment with high dose corticosteroids during the 30 days preceding the inclusion
* Contra indication to lumbar puncture/intrathecal infusion: intracranial hypertension, puncture site infections, severe thrombocytopenia (\<50 G/L), anticoagulant or fibrinolytic treatment
* Participation in another therapeutic trial in the last 6 months
* Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to express their consent
Codesign of an Optical Device to Measure Urine Flow and Volume

The study is seeking to understand the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed. This information will be used in the design and evaluation of a device, being developed in parallel, that assesses changes to the volume and flow of urine in order to determine changes in bladder function.

In order to ensure development is optimal, the principal research objective is therefore to understand the needs of patients and healthcare practitioners (ranging from care home staff and GPs in primary care, to urologists in tertiary referral centres).


Eligibility Criteria:
Inclusion criteria The participant is willing and able to give informed consent for participation in the study.

Aged 18 years or above. Male or Female.

Exclusion criteria The participant is unwilling or unable to give informed consent for participation in the study.

Aged 17 years or younger.
Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy

The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

The main question it aims to answer are:

1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
2. OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial.

Question it aims to answer:

Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis.

I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up.

2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.

In literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. However, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. The previous studies indicate that the use of NaOCl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of NaOCl.So, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Mature permanent mandibular molars.
2. Teeth with clinical diagnosis of symptomatic irreversible pulpitis
3. Patients having normal periapical status with periapical index (PAI) score ≤ 2
4. Periodontally healthy teeth
5. Patients having physical status of class 1 or 2 according to ASA classification
6. Pulpal bleeding can be controlled within 6 minutes.
7. Presence of extremely deep carious lesion on radiograph -

Exclusion Criteria:

1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women

-