cyrilzakka/clinical-trials huggingface dataset:
Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.

This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.

The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.

Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Stage 5 chronic kidney disease, on dialysis or not on dialysis;
* Requiring the creation of an arteriovenous fistula;
* Membership of a social insurance scheme;
* Patient having been informed and having formulated his/her oral non-opposition to participate in the research.

Exclusion Criteria:

* Contraindication to the proposed surgery ;
* Reduced life expectancy in the opinion of the investigator;
* Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
* Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
* Other surgical or medical intervention planned during the study;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or deprived of liberty.
Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients

Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.


Eligibility Criteria:
Inclusion Criteria:

1. As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC \>200 mg/dL and with no or one of the below risk factors

   * Current cigarette smoking
   * Family history of premature Coronary Heart Disease(CHD); in male first degree relative \<55 years; in female first degree relative \<65 years)
   * Hypertension (BP \>140/90 mmHg or on antihypertensive medication)
   * Low HDL-C (\<40 mg/dL)
   * Age (men \> 40 years)
2. Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
3. Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
4. Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe liver, renal, cardiac or brain diseases.
2. Pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
3. Unable to complete follow up.
4. Subjects on any medication that would affect evaluation like Statins.
Wet Time for a Foam Hand Sanitizer

Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Spectrum™ Advanced Hand Sanitizer Foam (70%) (hereby referred to as Spectrum Advanced Foam) kills over 99.99% of germs within 15 seconds while boasting double digit increases in hand moisture after two weeks of use.

In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO) published guidance that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply.

This study will evaluate the "wet time" of Spectrum Advanced Foam, which will be defined as the length of time in which the sanitizer foam stays wet on the hands while the participant rubs their hands with the foam sanitizer. The participant will first be asked to wash and dry their hands. Participants will review the appropriate hand sanitizer application steps, as detailed by the WHO guidance. Then, a 1.0 milliliter (mL) aliquot of Spectrum Advanced Foam will be dispensed from an automated dispenser to the participant's hands. The participant will be asked to rub their hands together following the WHO method for hand sanitizer application until they declare the product has dried sufficiently for the donning of medical gloves. Study personnel will measure the wet time of Spectrum Advanced foam using a stopwatch. If the 1.0 ml aliquot does not yield sufficient results to meet WHO guidelines then a 1.4 ml aliquot will be tested, however this was not the case for our study.

Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. In 2002 and 2009 the CDC and WHO published guidances that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply. The CDC specifically recommends applying alcohol-based hand sanitizers by applying the manufacturer-recommended amount of sanitizer directly to the palm of one hand and then rubbing the hands together. The sanitizer must entirely cover the surfaces of both hands and all fingers while rubbing the hands together until the product has dried. The goal of this study is to evaluate the "wet time" of Spectrum Advanced Foam, which will be defined in this study as the length of time in which the foam sanitizer stays wet on the hands while the participant rubs their hands with the foam sanitizer.

Eligibility Criteria:
Inclusion Criteria:

* Individual ≥ 18 years of age

Exclusion Criteria:

* Individual has a self reported skin condition that might result in irritation from the hand sanitizer.
* Individual has a known allergy to the ingredients in the test product.
Difficult Encounters in Pain Medicine

The investigators are seeking to determine factors associated with difficult patient encounters in an academic pain clinic. The investigators are examining 36 different variables to determine the association with "difficult" patient encounters as independently rated by a trainee and attending physician.

Pain is associated with significant psychosocial pathology include axis 1 diagnoses, opioid use and misuse, unemployment, and strained relationships, and treatments for chronic pain are often ineffective. Collectively, these factors may result in a higher prevalence of patients characterized as 'difficult', which can lead to missed diagnoses, barriers to care resulting in poorer outcomes (professional pessimism, mistrust, passive treatment, referrals to other providers or discharge), patient complaints and 'HERO' events, avoidable legal claims, and increased risk of professional burnout. Characterizing patients as "difficult" (instead of encounters) may have negative consequences for future care, and there are few studies that have explored patients' perspectives on "difficult" encounters. Although several articles have narratively explored this issue, there are few targeted at chronic pain patients, and no studies in this population that set out to determine what variables are associated with a "difficult encounter", the congruence between patients' and providers' impressions of an encounter, or whether difficult encounters are associated with pain treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Pain duration \> 3 months
* New Visit (or no visit within 3 years)

Exclusion Criteria:

* Referral only for diagnostic procedure
* Friend or relative, or direct referral from friend or relative
Effects of Ultra Processed Food on Intestinal Energy Harvest

Ultra processed food is everywhere in modern society and may contain multiple ingredients that affect the way participants' bodies store energy. Some studies have shown that eating a diet high in ultra processed foods leads to weight gain, but these foods have not been studied enough to understand why. Recently, the gut microbiome has become a potential way to measure energy balance in the human body; this is done by measuring how many calories are in the stool. The investigators propose to test a very high ultra-processed food diet where 80% of calories are coming from ultra processed food and a low ultra processed food diet where 20% of the calories are coming from ultra processed food. This study will compare stool sample energy content of the two diets.

This study will recruit people with obesity who are otherwise healthy to participate in this study. Each person will go through baseline testing before starting any of the diets. This consists of one blood draw, one metabolic test which requires each person to remain awake in a small, enclosed room that measures oxygen and carbon dioxide consumption, and one body composition test. Participants will also meet with a study dietitian to review their diet, how to track their diet, and how to collect and ship the stool samples. Each person will be assigned to either 80% or 20% level of ultra processed food in the diet to start and will continue this diet for two weeks. After the first diet phase, each participant will enter a washout period where they will return to eating however they wish and will not need to participate in any research activities. After the two weeks, each participant will return to begin another series of tests and begin the second two-week diet phase. The whole study will take approximately 9 weeks to complete.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30-40kg/m2
* weight stable
* able to download app and willing to use it for duration of study
* does own grocery shopping
* otherwise healthy

Exclusion Criteria:

* pregnancy
* history of or planned bariatric surgery
* history of anti obesity medications
Anti-fat Attitudes and Weight Stigma Among Orthopedic Surgeons

Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians.

Data will be collected through an online questionnaire consisting of four parts. Part 1 will gather socio-demographic data using nine items. Part 2 will utilize the Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. The questionnaire, comprising 13 items, will assess three subscales:1. "Dislike" measuring explicit antipathy toward fat individuals.2. "Fear of Fat" measuring personal concerns about weight or becoming overweight.3. "Willpower" measuring beliefs about personal control over being overweight. Participants will rate items on a 10-point Likert scale, with higher scores indicating greater anti-fat bias. Part 3 will include a questionnaire developed by Bocquier in 2005 to explore weight stigma among physicians, consisting of 12 items. Participants will rate items on a 6-point Likert scale, with higher scores indicating stronger weight stigma. Part 4 will investigate the therapeutic approach of orthopedic surgeons to patients with obesity using five items. Participants will items on a 6-point Likert scale, with higher scores indicating a stronger preference for a conservative approach.

Eligibility Criteria:
Inclusion Criteria: orthopedic surgeon age 18 till 80 -

Exclusion Criteria:

-
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.

The study consists of:

* A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
* An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period was followed by a 4-week elimination follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing multiple sclerosis,
* Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
* Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
* Pregnant or nursing woman,
* Alcohol or drug abuse,
* Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
* Human immunodeficiency virus (HIV) positive,
* Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Swiss Itch Registry

This project is to develop a national registry for CP patients. Patients admitted to this registry will be examined and documented with PROs, physician-based assessments, blood tests, 3D photodocumentation and, if indicated, by skin biopsies, neurophysiological testing and radiological imaging at defined timepoints. The data collection will allow deepened insights into patient needs, different mechanisms and courses of pruritic conditions, treatment outcomes and treatment-related safety issues. In addition, the collection of clinical, biological and image-based data may be used for retrospective analyses.

Pruritus (synonymous "itch") is the commonest skin-related symptom caused by numerous dermatological and non-dermatological conditions. Chronic pruritus (CP) defined by a duration of \> 6 weeks is associated with significantly impaired quality of life and high socio-economic burden. At present, a data registry to monitor and compare clinical presentation, treatment outcomes and safety issues of these patients is lacking in Switzerland. The implementation of the SWITCHR could help to i.) improve medical care of CP patients, ii.) allow standardised comparison of different pruritic conditions as well as national data with international CP populations and iii.) raise the awareness for CP in general practitioners, health care institutions, national public health authorities and pharmaceutical companies within Switzerland.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 14 years.
* Written informed consent of the patient.
* Diagnosis of CP irrespective of the International Forum for the Study of Itch (IFSI) group (I-III) and/or underlying cause (according to the judgment of the investigator).
* A Numerical Rating Scale (NRS) score of min. ≥ 4 within the last 7 days.
* Sufficient language skills (in the languages which the patient information and the consent form is available) to provide informed consent.

Exclusion Criteria:

* Any medical or psychological condition in the treating physician's opinion, which may prevent the patient in registry participation
* Lack of informed consent for registry participation.
* Refusal to complete Patient Reported Outcomes (PROs)
Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)

The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.

Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation \[spontaneous awakening trials (SAT)\] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence ("TEACH") implementation strategy.

Eligibility Criteria:
Inclusion criteria:

* Patient age \>=16 years admitted to study hospital ICU
* Intubated and mechanically ventilated

Exclusion criteria:

* Patient with pre-existing brain death admitted to study hospital for organ donation
* Died within 24 hours of intubation
A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion

To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.

This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion.

This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate).

Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject.

At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled

Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion

Exclusion Criteria:

* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
* Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents
Prospective Study of Celiac Block Injection: 1 vs. 2

The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
* Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
* Age \> or = to 18 years
* No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
* No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
* Patient must provide signed written informed consent.
* Patients that have had a previous celiac plexus block are eligible for this study

Exclusion Criteria:

* The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.