cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation

This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..

Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. Clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. Supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth.

For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale.

The following outcomes will be generated from the sloughing data:

1. Whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12;
2. Subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Internal (University of Birmingham Dental School) panellists only
2. Willing to sign an informed consent form and complete a medical history questionnaire.
3. Must be available for the duration of the study.
4. Must be a current non-smoker and not chew tobacco.
5. Have a minimum of 8 teeth in both upper and lower jaws, which are free from obvious untreated caries or significant periodontal disease

Exclusion Criteria:

1. Show unwillingness, inability or lack of motivation to carry out the study procedures
2. Are pregnant or breastfeeding females.
3. Are diabetic.
4. Have severe oral mucosal problems.
5. Orthodontic banding or removable partial dentures
6. Have an active cold sore.
7. Have any oral piercings.
8. Have a mouth ulcer or who experience mouth ulcers on a regular basis, Lichen Planus Vesiculo-Bullous disorders
9. Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, will effect either the scientific validity of the study or if the volunteer's participation would affect their well being
10. Volunteers who are at risk from transient bacteraemias.
11. Regular use of medication, which could interfere with study objectives or affect the validity of the study.
12. Have or have had a medical or dental condition, which in the option of the dentist would make them unsuitable for inclusion.
13. Have problem of bleeding after brushing.
14. Must not be a regular user of chlorhexidine mouthwash, or have used it within the past 6 weeks.
15. Has allergic responses to dental/oral hygiene products or components in the formulation of the toothpaste.
16. The subject is participating in other studies testing oral care products.
17. The subject is an employee of Unilever.
The Human Microbiome in Immune-Mediated Diseases

The immune system is influenced by the commensal microbes that live in the gut and on the skin. This study aims to characterize the microbiota of subjects with autoimmune disease in order to determine whether certain microbial species may cause or worsen immune-mediated diseases

This is a combination of a defined pilot microbiome study as well as exploratory mechanistic research with candidate commensals identified based on known structures accessible in public databases. In the observational prospective two-center study, subjects will be followed for 8 weeks. The study will consist of a total of 3 study visits (0, 4 and 8 weeks). Screening and baseline visits (week 0) will take place at the same time. A study window period of +/- 7 days will be allowed for follow-up study visits. The mechanistic in vitro research with subjects' blood cells and candidate commensals will typically require between 2-4 visits for sampling, but will not be limited by the frequency of visits.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Diagnosis of an immune-mediated disease by a healthcare provider, including but not limited to: systemic lupus erythematosus, subacute cutaneous lupus erythematosus

Exclusion criteria for pilot study (subjects enrolled in the exploratory mechanistic study arm will not be required to meet exclusion criteria and may be enrolled if the investigators believe that the subject can help address the scientific aim)..

Exclusion Criteria:

* Ongoing chronic infection (viral, bacterial or fungal) including known HIV, Hepatitis B/C
* Acute infection receiving any antibiotics or any use of antibiotics within 90 days prior to screening
* For skin swab collection (see also appendix D):

  * No use of topical antibiotics within 7-days prior to collection of swab, other than use in normal hand washing.
  * No use of topical antimicrobial products (as outlined in appendix F) within 48 hours prior to collection of swab
  * Subject must not have bathed within 8-hours of swab collection.
* For oral swab collection (see also appendix D):

  * No use of antiseptic mouth washes (as outlined in appendix F) within 48 hours of swab collection
  * Subjects must not have brushed teeth or flossed within 8-hours of swab collection
* Major gastrointestinal surgery less than 5 years prior to enrollment (with the exception of appendectomy)
* Any Gastrointestinal bleeding history
* Inflammatory Bowel Disease diagnosed by biopsy
* Bulimia or anorexia nervosa
* Probiotics (greater than estimated 109 cfu or organisms per day) within 90 days prior to enrollment (with the exception of fermented beverages, milks or yogurts).
* Morbid obesity (BMI ≥ 40)
* Type I Diabetes Mellitus
* Diabetes Mellitus type 2, poorly controlled defined as Hgb A1c greater than 8% on medical therapy
* Malignancy within one year prior to screening (with the exception of non-metastatic squamous or basal cell skin carcinomas and cervical carcinoma if received curative surgical treatment)
* Known illicit drug or alcohol abuse
Functional Recovery Measurement : Comparing Early Active Mobilization Versus Immobilization After Extensor Tendon Repair in Zones IV to VIII

Functional recovery measurement : Comparing early active mobilization versus immobilization after extensor tendon repair in zones IV to VIII.

Immobilization for six weeks has been the postoperative protocol for the patients with hand's extensor tendon repair in our institute. In this study early mobilization of the hand i.e. also an internationally followed way, is compared with the aforementioned immobilization protocol to see which turns out to be a better option in the interest of the patient.

patients selection in both groups will be random by using close envolupe technique.

In group A ( immobilisation) physiotherapy will start by the end of 4th week and the upper limit of flexion would be 45 degrees.

In group B ( EAM) physiotherapy will start by the end of 1st week and the upper limit of flexion would be 30 degrees.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender having simple lacerations of extrinsic extensor tendons · of the hand in · Verdan's zones IV-VIII

  * Age range 18 to 65 years
  * Sharp Cut Injury

Exclusion Criteria:

* Patients with complex injured hands like significant skin loss, bone and/or joint injuries. · Flexor tendon injuries.

  * Partial tendon lacerations
  * Tendon injuries at multiple levels
Effects of Sulforaphane for Patients With Chronic Kidney Disease

Patients with Chronic Kidney Disease (CKD) have many complications associated with inflammation, oxidative stress and intestinal dysbiosis, which are closely related to the progression of kidney failure and cardiovascular disease. Sulforaphane, an isothiocyanate found in cruciferous vegetables (Family: Brassicaceae) is recognized as one of the most important activators of erythroid nuclear factor 2 related to factor 2 (Nrf2). However, clinical evidence to assess the effects of sulforaphane in patients with CKD is scarce, and there are no studies that have investigated its effects on the expression of genes and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of sulforaphane on transcription factors and inflammatory markers in patients with CKD.

This is a longitudinal, randomized, crossover study with patients with CKD on hemodialysis and in non-dialysis patients.

Both groups will receive 4g of sulforaphane per day for 2 months and the placebo group will receive 4g of corn starch colored with chlorophyll for 2 months. Peripheral blood mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone oxidoreductase 1 (NQO1), HO-1, VCAM-1, E-selectin, NLRP3, IL-1B, IL 18, PGC1-α, sentrins, NRF2, NRF-1 e TFAM mRNA expression by a quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).The serum concentration of other cytokines and growth factors will be detected by means of a multiparametric immunoassay based on magnetic microspheres marked with XMap (Luminex Corp, USA) before and after supplementation.

Eligibility Criteria:
Criteria

Inclusion Criteria:

* Aged 18 to 75 years
* Clinical diagnosis of Chronic Kidney Disease
* Conservative treatment group: CKD stages 3 and 5 receiving nutritional treatment for at least 6 months
* Hemodialysis group: Hemodialysis patients for more than 6 months

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Autoimmune diseases
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS
The Effect of Synbiotic and Diet Modification Among Overweight or Obese Hong Kong Chinese

Synbiotic is a nutritional supplement that contains both prebiotic and probiotic. Probiotics are beneficial microorganisms, while prebiotics are foods that help the growth of beneficial microorganisms in the gut. In the study, dietary intervention with fruits and vegetables and/or synbiotic supplementation with be administered to Hong Kong Chinese subjects for eight weeks. Changes in the composition and diversity of intestinal microbiota, and markers indicative of obesity, chronic inflammation and metabolic dysfunction will be assessed throughout the whole period. This study will further provide a scientific basis for the intake of synbiotics for reducing the risk of overweight and obesity among Hong Kong Chinese. Furthermore, the results will bridge to further research into the most desirable gut microbiome profile, hence facilitating personalised nutrition for optimal health.

This is an 8-week randomized controlled dietary interventional trial.The objectives of this study include:

* To investigate the effects of synbiotic supplementation and/or dietary intervention with fruits and vegetables on gut microbial diversity and composition, and on inflammation, metabolic functioning, overweight and obesity among Hong Kong Chinese
* To study whether the changes in gut microbial diversity and composition upon the interventions in Hong Kong Chinese are correlated with metabolic functioning and inflammation, as well as overweight or obesity

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥90cm in men and ≥80cm in women
* BMI \>23.0kg/m2

Exclusion Criteria:

* Practicing dietary restrictions
* Using cholesterol-lowering, antihypertensive, anti-inflammatory drugs or Chinese medicines
* Consuming laxatives, any gastrointestinal medication, probiotics, prebiotics, synbiotics or antibiotics
* Smokers
* Alcohol abuser
* Currently pregnant or lactating
Smart Phone Delivered Cognitive Behavioral Therapy for Adults with Psoriasis and Co-Morbid Depression Symptoms

A single arm, pilot study in which all eligible participants will be enrolled in an 8-week coach-guided smartphone delivered CBT program. The full duration of the program, with follow-up interview, will be 9 weeks.

1. To demonstrate the feasibility and acceptability of coach-guided, smartphone-delivered CBT for depression among adults with psoriasis
2. To demonstrate the preliminary efficacy of coach-guided, smartphone-delivered CBT on the symptoms of depression and psoriasis

Primary endpoints

* Percentage of participants who engage with at least 6/8 (75%) modules
* Median Client Satisfaction Questionnaire-8 score at week 8
* Change from baseline in PHQ-9 at week 8

Secondary Endpoints

* Rate of participant dropout
* App acceptability to participants, as measured by the uMARS
* Change from baseline in Skindex-16 at week 8
* Change from baseline in PSI at week 8
* Change from baseline in AAI at week 8
* Frequency \& severity of related adverse events
* The patient perspective on the feasibility and acceptability (qualitative)

Analysis Plan Investigators will assess the feasibility of smartphone-based CBT by reporting the proportion of participants who engaged with at least 75% of the treatment modules and assess patient acceptability with descriptive statistics summarizing the Client Satisfaction Questionnaire scores. Paired t-tests will be used to examine the differences in the pre- and post- treatment PHQ-9 scores, in all patients who complete the baseline study visit. Additionally, secondary outcomes (dropout rates, patient feedback from the Mobile Application Rating Scale, Skindex-16, Psoriasis Symptom Inventory, Appearance Anxiety Inventory) will be reported descriptively. Post-treatment interviews will be transcribed, edited for clarity, coded to identify themes and summarized.

Eligibility Criteria:
Inclusion Criteria:

* • Adults aged 18 years of age and older

  * Dermatologist confirmed diagnosis of psoriasis
  * Current depression symptoms, defined as a PHQ-9 score of 5 or greater
  * Current psoriasis symptoms, defined as a scaled score of "mild" on any of the Skindex-16 subscales
  * Participants must be proficient in English and have access to an Android or iOS smartphone

Exclusion Criteria:

* Previous participation in CBT for depression
* Current participation in any type of psychotherapy
* Those on psychotropic medications must be taking a stable dose for 2 months prior to enrollment and be willing to remain at a stable dose during the 8-week study
* Current elevated suicide risk (see Section 5.3 for details)
* Individuals who are incarcerated or compulsory detained
* Any uncontrolled or poorly controlled chronic medical condition that may interfere with an individual's ability to participate in the clinical trial
Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress

The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Participants must self-assess themselves as being in good health.
* Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week)
* Aged 25 to 60 years at the time of randomisation
* Fluent in English
* Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI).

Exclusion Criteria:

* Member of own household currently participating in this trial
* Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
* History of seizures or epilepsy
* Shift working or have a history of shift work within the previous six months
* Currently, or within the previous 8 weeks, consuming any prebiotic or probiotic products/supplements (including specifically oligosaccharides)
* Participation in any other intervention research trials
* Sleeping at a location other than their usual residence more than two nights per week during participation
* Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
* Current or recent mood disturbances or Axis I disorders
* Current misuse of alcohol and/or drugs
* Current smoker
* Recent (within the last 12 weeks) infection and/or use of antibiotic medication
* Pregnant, seeking to become pregnant or lactating
* Those using (including within the last 2 weeks) proton-pump inhibitors
* Milk allergy
mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers

This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to traditional measurements of the Nonin Lifesense Capnograph. This is a non significant risk device.

In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to traditional measurements of the Nonin Lifesense Capnograph.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 21 - 70

Exclusion Criteria:

* Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
* Medications that could compromise a participant's ability to participate in the study
* Documented medical history of respiratory or cardiovascular disease
* Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
* Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
* Recent (≤ 1 month) surgical procedure of any kind
* Current participation in another investigational clinical trial
* Inability to provide informed consent
Study of the Prevalence of Diabetes and Pre-diabetes in Réunion Island

In view of the new priority given to diabetes in Réunion and the implementation of an ambitious plan to combat the disease at regional level, which includes the identification and management of pre-diabetes, the need for up-to-date data on the extent of these 2 diseases (diabetes and pre-diabetes) has become essential.

These two diseases have known risk factors: age, overweight, obesity, high waist circumference, family history, hypertension, eating habits and physical activity, all of which form part of a risk score for developing diabetes: the Findrisk recommended by the Haute Autorité de Santé for identifying people at risk of diabetes. Given the specific population characteristics of Réunion compared with Finland, where this score has been validated, it would seem important to be able to measure these risk indicators in the population as a function of carbohydrate status in order to check that the proposed thresholds are appropriate for the population of Réunion.

Finally, cardiovascular risk has been described as early as the pre-diabetes stage. Given the young age of onset of diabetes in Réunion and the high proportion of diagnoses of diabetes made following the occurrence of a cardiovascular complication, the study of the prognosis of carbohydrate status on the occurrence of complications using the social security information system will be offered on a voluntary basis to study subjects (via a probabilistic social security link).


Eligibility Criteria:
Inclusion Criteria:

* Have lived in Réunion island for at least one year
* Be aged between 18 and 75
* Affiliated to or benefiting from a social security scheme
* Free, informed and signed consent

Exclusion Criteria:

* No main residence on the island or fixed address for at least one year on the island
* Participation in experimental research
* Pregnant women
* Adults under guardianship or legal protection
* Not understanding French
Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)

Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.

In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).


Eligibility Criteria:
Inclusion Criteria:

* PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
* Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands

Exclusion Criteria:

* Previous (history) SARS-CoV-2 infection, independent of the current episode
* Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis