cyrilzakka/clinical-trials huggingface dataset:
Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients

Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after

Use an 8-10 MHz Doppler probe with a gel smeared over the sensor. Place the Doppler probe on the pulse area at a 45-60° angle to the skin surface.

Move the probe to find the most precise and robust arterial pulse before inflating the cuff.

The cuff is inflated about 20 mm Hg above the point where the arterial Doppler sound disappears.

Then slowly deflate until the Doppler sound reappears and records this value. The blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel.

If the flow is still detected at the maximum inflation rate (300 mmHg), the cuff should be deflated immediately to avoid pain.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus Type 2

Exclusion Criteria:

* Chronic Heart Failure
* Chronic Kidney Diseae
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula

Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).

Objectives of the Study:

Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons

Aim of the Study:

Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.

Specific Objectives:

Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.

Primary safety endpoint: Peri procedural complication rate

Secondary endpoints:

* Technical success (\<30% residual stenosis without postdilation)
* Access circuit dysfunction free survival (Time to event) based on functional criteria
* Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria

  * \>18 year old
  * Dysfunctional dialysis fistula
* Radiocephalic
* Brachiocephalic
* Brachiobasilic

Clinical criteria for diagnosis of dysfunctional fistula:

* Swelling of the fistula limb
* Prolonged bleeding after withdrawing access needles
* Abnormal pulsations or weak thrill.
* Functional criteria for the diagnosis of dysfunctional criteria:
* Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,
* A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.
* Non-thrombosed

Exclusion Criteria:

* Dysfunctional arteriovenous (AV) grafts
* Thrombosed fistulas
* Intra-stent stenosis
* Stenoses not responding to balloon angioplasty and requiring stenting.
* Stenosis less than 50%
* Surgical intervention that excludes the treatment segment from the access circuit
* Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
* Location of isolated stenosis central to the thoracic inlet.
* Women who are breastfeeding, pregnant or are intending to become pregnant
* Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.
* Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
Predicting Oxygen Desaturation in Chronic Obstructive Pulmonary Disease (COPD) Patients

Oxygen desaturation (SO2 \< 88-90%) during walking is a common clinical feature of Chronic Obstructive Pulmonary Disease (COPD) patients. By a predicted analysis our study is aimed to evaluate anthropometric and functional characteristics of COPD patients correlated with oxygen desaturation during Six-minute walking test (6MWT).


Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* Ability to perform 6MWT
* Normal oxygen saturation at rest and at the begin of 6MWT

Exclusion Criteria:

* No-COPD patients
* Chronic Respiratory Failure patients in Long-term oxygen therapy (LTOT)
* Any co-morbidities
Effectiveness of Three Interventions to Reduce Fear of Falling and Improve Functionality in the Elderly

Fear of falling is a major health problem among community-dwelling older adults that may contribute to avoidance of activities that they are capable of performing. Studies show that the fear of falling may lead to a continual, complex decline in older adults that includes a loss of auto efficacy, restriction of physical activities and social participation, physical frailty, falls and disability. Apart from these effects, the fear of falling may also have financial implications for health care systems and the general public. Several interventions have been shown to reduce fear of falling with multifactorial interventions, including physical and behavioral components, being most successful. Behavioral components usually comprise strategies to reduce catastrophic thinking and fear-related avoidance behaviors while physical components usually comprise falls prevention exercise programs. However, multifactorial programs are not always feasible or preferred by older people. In this framework, the objective of this works is to assess the effects (benefits and effectiveness) of three interventions programs (Tai Chi, postural control exercises and behavioral therapy intervention) to improve functionality and decrease fear of falling in older people living in the community.

Fear of falling is common among elderly people. Fear of falling can be associated with reductions in physical and social activities and negative impacts on quality of life. Several interventions have been shown to reduce the fear of falling, but their effectiveness has not been compared. The objective of this study is to evaluate the effectiveness of three interventions programs to improve functionality and decrease fear of falling in the Elderly. Effective interventions to lessen fear of falling could therefore have significant consequences for individuals, their families and healthcare delivery systems.

Methods/Design: This is a controlled, randomized clinical trial of individual assignment, carried out on community living elderly, from Manizales (Colombia) who reporting fear of falling with restriction of activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older people
* People who reported fear of falling
* "Leganés Cognitive Test" ≥23
* SPPB ≤ 9

Exclusion Criteria:

* Some cognitive affection and/or medical condition that may affect the intervention
* Permanent use of wheelchair
* People who have received prior protocolized management for fear of falling
Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution. It would also give us answers to:

* How does embolic efficacy compare to current available embolic agents?
* Does enhancement on rotational CT correlate with embolic distribution?
* How does embolic distribution compare with tissue infarction?
* Does the density of embolic packing correlate with degree of infarction and volume loss?
* How predictable is superselective target embolisation?
* Does embolic distribution vary with anatomy and gland size?
* Does embolic distribution tally with glandular enhancement/ transitional zone vascularity?
* If visible, what is the effect and significance of non target embolisation? This is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics.

Data will be added to our on going local registry of patients who have undergone this procedure . This will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (PVA) and other spherical agents such as Embospheres and Embozenes.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS\>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate \< 12ml/s Medically refractory BPE \> 6 months (or unable/ unwilling to tolerate medical treatment due to side effects)

Exclusion Criteria:

* Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA \> 4 or high SWOP risk need prostate biopsy Urodynamics - non-obstructed eGFR ≤ 45ml min-1m-2
Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children

To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children with obstructive calcular anuria and acute renal failure due to ureteric calculi to identify selection criteria for initial urinary drainage method to improve drainage, to decrease complications and to facilitate subsequent definitive clearance of stones as this comparison is lacking in literature

Eligibility Criteria:
Inclusion Criteria:

* children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones

Exclusion Criteria:

* Patients with grade 0-1 hydronephrosis
* fever, pyonephrosis or sepsis.
* any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).
Apexification Treatment With MTA(Mineral Trioxide Aggregate) and Ca(OH)2

Ninety immature teeth with necrotic pulps and periapical lesions on patients (aged 16-40y) were treated with AT using MTA (45 teeth) or CH (45 teeth) between 2015 and 2018. The patients were contacted for follow-up examination at 12 to 48 months after treatment. The treatment outcome based on clinical and radiographic criteria was assessed by calibrated examiners and dichotomized as "healed+healing" or "not healed". The age, gender, stage of root development, preoperative signs and symptoms of apical periodontitis and size of periapical lesion were recorded.

The aim of the study was to evaluate and compare the influence of various predictors on outcomes of apexification treatment (AT) using either mineral trioxide aggregate (MTA) or calcium hydroxide (CH) to treat permanent immature anterior teeth with necrotic pulps and periapical lesions in adults. Ninety immature teeth with necrotic pulps and periapical lesions on patients (aged 16-40y) were treated with AT using MTA (45 teeth) or CH (45 teeth) between 2015 and 2018. The patients were contacted for follow-up examination at 12 to 48 months after treatment. The treatment outcome based on clinical and radiographic criteria was assessed by calibrated examiners and dichotomized as "healed+healing" or "not healed". The age, gender, stage of root development, preoperative signs and symptoms of apical periodontitis and size of periapical lesion were recorded. The effect of potential clinical variables on the treatment outcome of AT was evaluated clinically and radiographically during a 12-48-month follow-up. In order to assess the cumulative successes of CH and MTA after AT, Kaplan-Meier survival analysis and log-rank test was used(p\>0.05).

Eligibility Criteria:
Inclusion Criteria:

* patients without a systemic disease and compromised immune status
* patients had immature teeth with periapical lesions with or without previous endodontic treatment.

Exclusion Criteria:

* patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss),
* teeth with contraindications for endodontic treatment (root fracture, unrestorable tooth, replacement resorption or previous surgical endodontic treatment).
COvid Pandemic Institutional maNaGement

Covid-19 has increased organizational tensions within health services (lack of resources, difficulties in recruiting healthcare professionals , elderly and polypathological patients, etc.) and tested the reliability of health facilities. This project aims to draw lessons so that hospitals can transform themselves while improving their reliability to face future crises and other exceptional situations.

Research hypothesis:

Crisis management arrangements lack sensitivity to uncertainty, which manifests itself in lower quality of care and efficiency losses for the entire institution.

The virtuous practices implemented during the crisis spontaneously incorporated principles of the highly reliable organization.

The integration of principles from complexity theory into the management of institutions promotes high reliability organization.

Sustaining these virtuous practices in order to anticipate and cope with crises requires the activation of two interconnected levers: a shared vision (by patients, healthcare professionals, ARS, HAS, and the Ministry in the first place) of the meaning of the action taken by hospitals, and the development of a policy enabling hospitals to become both learning and highly reliable.

Main objective:

To evaluate the management process of the Covid-19 epidemic by the university hospitals of the Auvergne-Rhône-Alpes region, and the structures linked to them (establishments in their territory, ARS, user associations), in terms of points of improvement and good practices. This evaluation concerns the preparation, management and exit phases of the crisis.


Eligibility Criteria:
Inclusion Criteria:

* Establishments :

  * 4 university hospitals: Lyon, St Etienne, Clermont Ferrand, Grenoble
  * Establishments in the same territories, public and private
* Professionals and members of the institutions' bodies:

  * Governance: management and chair of the CME
  * Management (care, communication, medical, technical, logistics, IT, personnel)
  * Clinical and public health cluster governance
  * Medical, paramedical and non-medical staff in the departments most concerned (emergency and EMS reception, intensive care, infectiology, hygiene, virology, imaging, occupational medicine in particular)
  * Organizations representing the personnel
  * Members of the users' representatives committee
* Adult patients hospitalized for at least 48 hours during the study period (quantitative study by questionnaires).

Exclusion Criteria:

* none
The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)

Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)

Patients, once eligibility has been verified, will then be randomized (1:1) to one of the following groups: Gruop 1: STL primary suture. Group 2: STL primary suture + onlay flap Patients in both groups will then undergo surgery STL with primary suture; in those of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. 4 months after surgery, questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire) and swallowing rehabilitation (SOAL questionnaire). Demographic and preoperative data will be collected, data relating to pre-(chemo-)radiotherapy and pre-STL clinical staging, as well as the interval in days between the end of (chemo-)radiotherapy and surgery, perioperative data, type of eventual unilateral or bilateral laterocervical lymph node emptying, the type of pharyngotomy suture, the type of flap possibly used, the packaging of the tracheoesophageal fistula for positioning the voice prosthesis, the definitive histological examination.

The patient must undergo a radiological examination for loco-regional and distant staging before the STL (CT or MRI) and a biopsy demonstrating the recurrence/persistence of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:

  1. pre (ChT-)RT staging: cT1/T2/T3 N0/N+;
  2. pre STL staging: rcT1/cT2/ Selected cT3 cT4a (extension to thyroid cartilage and/or prelaryngeal tissues) N0/N+ (clinically and radiologically).
* Indication for STL surgery (no pharyngeal mucosal resection);
* Functional total laryngectomies after radical (chemo-)radiotherapy treatment;
* Age \> 18 years;
* Signature of informed consent and ability to complete in-office questionnaires.

Exclusion Criteria:

* STL extended to the pharynx and/or total pharyngeal laryngectomies;
* Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension;
* Previous open organ preservation surgery (OPHL).
Health Literacy Project

Evaluating changes in knowledge, attitude, and practices (KAP) related to epilepsy and its treatment as a result of an educational intervention among adolescents with epilepsy to determine if improved KAP about epilepsy results in improved medication adherence and less perceived stigma.

This proof-of-concept study aims to evaluate the impact of a targeted health literacy intervention on knowledge and attitudes about epilepsy and its treatment, and reported medication adherence and stigma among adolescents with epilepsy in Uganda.

Research Questions:

1. What is the impact of a culturally relevant information session on the knowledge of epilepsy and its treatment among adolescents with epilepsy in Uganda?
2. What is the impact of such an educational session on reported medication adherence and reported stigma among this group?

The investigators hypothesize that a culturally relevant educational intervention will significantly improve knowledge about epilepsy and its treatment, increase medication adherence, and reduce stigma among adolescents with epilepsy in Uganda. This hypothesis is based on the premise that tailored health literacy interventions can address specific misconceptions and barriers to care, thereby improving health outcomes for PWE (persons with epilepsy) in contexts burdened by significant treatment gaps and cultural stigmatization.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with a diagnosis of epilepsy attending a clinic at one of the study sites.
* Ages 12-18 years
* Ability and willingness to provide informed assent and guardian consent to participate in the study.
* English, Runyankole or Luganda language proficiency.

Exclusion Criteria:

* Unable or unwilling to provide informed consent or assent to participate in the study.
* Developmental/cognitive challenges that hinder participation in the intervention or completion of surveys.
User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).

The aim of this study is to evaluate the acceptability, safety and efficiency of the Palliate intervention.

The Palliate intervention is a nurse-led process that includes training and documentation materials to support lay carers in administering top up medications to loved ones at the end of life at home. The Palliate intervention was designed based on the CARiAD\* intervention using user testing and has been successfully piloted and rolled out in Central and North West London National Health Service (NHS) Foundation Trust.

\*CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in homebased dying patients.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older and able to communicate in English.

Exclusion Criteria:

* Individuals aged less than 18 years old and/or unable to communicate in English.
Platelet-rich Plasma Intradermal Injection Combined With 308 nm Excimer Light for Treating Stable Acral Vitiligo

The goal of this clinical trial is to learn if platelet-rich plasma (PRP) works to treat acral stable vitiligo in adults. It will also learn about the safety of platelet-rich plasma. The main questions it aims to answer are:

* Does PRP combined with 308 nm excimer phototherapy improve the efficacy compared to 308 nm excimer light alone in the treatment of vitiligo of the extremities?
* What medical problems do participants have when taking PRP intradermal injections?

Researchers will compare PRP to a placebo (a look-alike substance that contains no drug) to see if PRP works to treat acral vitiligo.

Participants will:

* Receive PRP intradermal injections once a month and 308 nm excimer phototherapy twice a week, or the same frequency of saline injections and phototherapy for 6 consecutive months
* Visit the clinic once every 1 month for evaluations
* Keep a diary of their symptoms or side effects during follow-up

Vitiligo is an acquired skin disorder characterized by depigmented macules, and one of the conventional treatment principles is to promote the differentiation of stem cells at the follicular bulge into melanocytes, but vitiligo of the extremities is clinically difficult to repigmentation and resistant to treatment due to its lack of hair follicles. Platelet-rich plasma (PRP) is a concentrated platelet plasma obtained by in vitro isolation of autologous whole blood, and its effect on repigmentation of vitiligo at the extremities and the potential mechanism remain unclear. The investigators investigated the efficacy of PRP on acral vitiligo by a single-center, prospective, self-controlled clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-segmental vitiligo stable for more than half a year;
* At least 1 separate stable lesion on each of the dorsum of the right and left hands, proximal fingers, distal fingers and palms;
* The area of white spots is less than 10 % of the total body surface area and more than 1 % of the total body surface area;
* Those who have not received systemic treatment of vitiligo and phototherapy or related treatments within 1 month ≥ 1 year without significant efficacy;
* Voluntary signing of informed consent.

Exclusion Criteria:

* Pregnant and lactating women;
* Those who have used glucocorticoids or other immunosuppressants in the last 3 months;
* Suffering from haematological disorders such as coagulation abnormalities and thrombocytopoietic disorders;
* Those who are allergic to ultraviolet light and photosensitive treatment;
* Scar constitution;
* Those with current or previous history of skin cancer or family history of skin cancer;
* Those with infectious diseases such as HIV, syphilis, hepatitis B or C;
* Those with other serious systemic diseases;
* Patients who, in the judgement of the investigator, are not suitable for inclusion in this trial.