cyrilzakka/clinical-trials huggingface dataset:
Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery

The primary objective is to evaluate the effect of Gradusox™ compression hosiery on the local tissue oxygenation and compare this effect against that achieved by standard compression hosiery.

After being informed about the study, all participants giving written informed consent will be randomised by closed envelope randomisation to either a) first, GraduSOX on their right leg and Sigvaris on their left leg, then GraduSOX on their left leg and Sigvaris on their right leg, or b) first, GraduSOX on their left leg and Sigvaris on their right leg, then GraduSOX on their right leg and Sigvaris on their left leg.

Participants will attend the clinic and be fitted with their stockings. Non-invasive probes will be taped to the skin above the inner ankle on both legs - these take measurements for SO2, oxyHb and deoxyHb every second. Measurements for these variables will be taken for 15 minutes whilst participants are not wearing stockings, as well as with stockings (worn in the order assigned to them). During these 15 minutes, participants will lie in supine for 5 minutes, then in sitting position for 5 minutes, then will return to supine for the last 5 minutes.

Between each stocking, participants will be asked to take a 10 minute walk and return to the recliner in supine to re-equilibrate for a further 15 minutes.

The total time that measurements are taken for per participant is 50 minutes.

Eligibility Criteria:
Inclusion Criteria

* Adults aged 18 and over.
* Have known previous venous insufficiency that has been treated.
* Have no known current contraindication to the wearing of graduated compression hosiery.
* Have an ankle brachial pressure index (ABPI) between 0.8-1.2.
* Have no active ulceration.
* Are physically able to apply and remove hosiery kits safely.
* Have had successful surgery at The Whiteley Clinic and have had at least one follow-up to show no residual venous disease.

Exclusion Criteria

* Under the age of 18.
* Have known arterial insufficiency (an ABPI of below 0.8).
* Have active ulceration.
* Be physically unable to put stocking on their own legs.
* Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, significant ankle oedema.
* Unable to give informed consent.
* Pregnant.
* Fragile skin that may be damaged whilst trying to apply or remove compression stockings.
* Previous DVT or complicated varicose veins that were not able to be completely treated and left residual venous reflux disease.
Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects

Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.

One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.

In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.

Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.

Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.

Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.

After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).

During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.

Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.

Eligibility Criteria:
Inclusion Criteria:

- Healthy, without allergies and with the age 18 years or above

Exclusion Criteria:

* Heart failure
* Signs of kidney injury/failure
* Severe allergies
* Pregnancy
Poplar-type Propolis Dry Extract ESIT12 : Nutrikinetic and Bioavailability Studies

The aim of this study is to investigate phenolic compounds from ESIT12, a poplar-type propolis ingredient, bioavailability and nutrikinetics by measuring urinary excretion and metabolic profile over 48h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male and female with 40% min. and 60% max. of each sex.
4. Aged 25 to 69 years old
5. BMI range (18.5 - 29.99)
6. In good general health as evidenced by medical history
7. Ability to take oral supplementation and be willing to adhere to the regimen
8. Agreement to adhere to Lifestyle Considerations (controlled diet) throughout study duration

Exclusion Criteria:

1. Current use of any medication or food supplement
2. Antibiotic use less than 12 weeks before the study
3. Pregnancy or lactation
4. Known allergic reactions to components of the supplement, i.e., bee products (specially propolis) and known allergy (general)
5. Metabolic disorders or any kind of disease
6. Current smoker
Pain Navigator Tool for Self-management in Back Pain: PATiENCe Trial

This study explores the experience of physiotherapists and patients using the Pain Navigator Tool during outpatient musculoskeletal consultations.

Chronic pain is the largest cause of disability globally and affects up to 28 million people in the UK alone. Nearly half of those who experienced chronic pain in Europe reported receiving insufficient pain management. Conventional treatments commonly used in physiotherapy continue to show only moderate effects in pain management. A potential avenue to improve the global effect of treatments may lie in exploring non-specific treatment moderators such as the therapeutic alliance (TA). Findings suggest that it is linked with engagement in rehabilitation and is a strong predictor of treatment outcomes and adherence. This study aims to evaluate and compare the quality of practice with or without the Pain Navigator Tool (PNT). Understanding the impact of the PNT on therapeutic alliance would open an avenue to improve chronic pain management, reduce healthcare-related expenses and increase the quality of life in the population studied. In addition, exploring the experience of the physiotherapists with using the PNT will provide an in-depth understanding of its use and applicability in similar settings.

The aims of this study are to:

1. To evaluate and compare the quality of practice with or without the PNT in patients with chronic low-back.
2. To collect preliminary data on the usability and practicality of the PNT for physiotherapists.

Eligibility Criteria:
Inclusion Criteria:

Patient:

* Participant aged \>18 years
* Low-back pain for more than three months
* Able to read and speak English to a level allowing satisfactory completion of the study procedures
* Initial appointment with a participating physiotherapist

Physiotherapist:

* 2 years of experience in treating patients with chronic pain
* Currently working in an MSK outpatient clinic
* Able to read and speak English to a level allowing satisfactory completion of the study procedures

Exclusion Criteria:

Patient:

* Low-back pain is not the primary reason for physiotherapy appointment
* Return appointment with physiotherapist
REACH OUT: to Reduce High Blood Pressure in the Emergency Department

One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition.

Hypertension is very prevalent in the emergency department (ED), but significantly undertreated. The overall goal of this project is to develop a text messaging intervention to improve hypertension care in the ED. This will first be done by testing the feasibility of identifying hypertensive patients in the ED, and the response rate to text messages.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 y/o)
* At least one BP of systolic blood pressure (SBP) ≥160 or a diastolic blood pressure (DBP) ≥100 or only BP performed prior to enrollment is SBP ≥160 or a DBP ≥100 (If the patient has repeated measurements after achieving Criteria 1, but prior to being enrolled, at least one of the repeat BP remains SBP ≥140 or a DBP ≥90)
* Must have mobile phones with text-messaging capability
* Likely to be discharged from the ED

Exclusion Criteria:

* Adult who is in an urgent condition
* Unable to read
* Non-English speaking
* Incarcerated/ institutionalized resident
* Pregnant, or has a pre-existing condition that makes follow-up for 4 months unlikely.
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.

The trial is sponsored by Bayer Yakuhin, Ltd.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older at obtaining informed consent
* Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
* Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion Criteria:

* Patients with ovarian chocolate cysts
* Patients with fibroid needed to be treated
* Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
* Patients with undiagnosed abnormal vaginal bleeding
* Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
* Patients aged 35 years or older who smoke at least 15 cigarettes per day
* Patients with migraine accompanied by prodromata
* Patients with pulmonary hypertension or valvular heart disease
* Patients who are regularly taking nutritional products that contain St. John's Wort
* Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
* Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Identification of Pattern and Factors Affecting Recurrence in Head and Neck Carcinoma

The study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence.

The investigators will evaluate the local experience in treatment of head and neck SCC by retrospectively analyzing the incidence and location of recurrence, either; local recurrence (LR), regional recurrence (RR), or distant mets in eligible head and neck cancer patients treated with IMRT and VMAT in the period from 2018 till 2022 to allow a follow-up for at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged more than 18 years. Patients with primary non nasopharyngeal head and neck squamous cell carcinoma. Patients who were intended to receive radical treatment delivered by IMRT and VMAT techniques.

Exclusion Criteria:

* Adults who had double malignancies. Metastatic HNSCC cases.
Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control

Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Periodontitis with three or more periodontal pockets with a probing depth (PD) \> 5mm
* Bleeding of these periodontal pockets on probing
* Have at least 20 natural teeth
* Provide informed consent and willingness to cooperate with the study protocol
* Age \>25 years old
* Absence of other significant oral infections.
* Primary Hypertension on stable treatment

Exclusion Criteria:

* Clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks
* Hospitalization for any reason within the past 3 months; Life expectancy of \< 3 years;
* Allergic disorders; History of chronic infectious disease, Chronic Obstructive Pulmonary Disease (COPD), tuberculosis; chronic hepatitis B or C infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease;
* Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
* Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
* Non-basal cell malignancy or treated myelo or lymphoproliferative disease within the past 5 years;
* Known HIV positive; Immunizations within past 3 months
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Primary pulmonary hypertension.
* Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
* Individual is pregnant or nursing
* History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.

Introduction: Gynoid hydrolipodystrophy (HLDG) or cellulitis is a subcutaneous tissue disorder, with several strategies for its treatment, such as caffeine and iontophoresis. Objective: To evaluate the effects of caffeine-associated iontophoresis for the treatment of HLDG. Methods: In a longitudinal study, participants will be evaluated for: photographic documentation, ultrasound imaging, thermography and quality of life questionnaire. If included, they will be separated into 3 randomized groups (n = 30). G1: use of base gel (n = 10); G2: use of iontophoresis and gel with caffeine (n = 10) and G3: use of iontophoresis alone (n = 10). The groups will be treated with 10 sessions, 2 times per week. After that they will be reevaluated. Statistical analysis: The software used will be the SPSS StatisticalPackage (IBM SPSS Statistics, Chicago, IL, USA). The data distribution will be analyzed by the Shapiro-Wilk test. In case of normal distribution, the data will be described as mean ± standard deviation; otherwise, as median \[interquartile range 25-75%\]. For comparison of the data, we will use ANOVA and for comparison of means the Tukey test and case not normal distribution, krulskal-Wallis test and the Dunns test. The level of statistical significance adopted will be P \<0.05. Expected contributions: It is expected that investigators can contribute to the treatment of patients with HLDG and analyze the effects of iontophoresis with caffeine, both in clinical and scientific practice, providing a method that is valid and reliable for this purpose; multidisciplinary training of highly qualified human resources and the strengthening and consolidation of a research team.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate cellulite diagnosis will be included, according to the validated Photonumeric scale of cellulite severity
* Body mass index less than 30 (kg / m2)

Exclusion Criteria:

* Individuals who have a deregulated menstrual cycle who are pregnant;
* Breastfeeding or using some hormone;
* Antibiotic medication including steroids over 1 month of treatment of skin diseases; •Sensitivity or hypersensitivity of the skin;
* Use of the same or similar cosmetics or remedies on the glutes within 1 month;
* Surgical procedure (liposuction and skin treatments) in the region to be treated or planning some procedure within the study period;
* Chronic debilitating diseases such as asthma, diabetes or hypertension;
* Atopic dermatitis
Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth

Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.

The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small (\~4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.

Eligibility Criteria:
Inclusion Criteria:

* Pre-existing indication for surgical extraction of impacted teeth
* Age 16-65

Exclusion Criteria:

* Ages less than 16 or over 65
* No pre-existing indication for surgical extraction of impacted teeth
Effect of Vestibular Rehabilitation on Trunk Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis

The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.

• The Cawthorne Cooksey exercises and conventional program of physical therapy were administered.

Eligibility Criteria:
Inclusion Criteria:

* Aged 35-55 years.
* Ambulatory without assistance.
* Diagnosed with relapsing-remitting MS by a neurologist, with approximately five relapse attacks in the hemiparesis type with a muscular tone of 1 or 1+ depending on the MAS, or modified Ashworth scale.
* All individuals were evaluated by a neurosurgeon to confirm central vertigo using test of Dix Hallpike.
* Degree of MS-related disability based on the enlarged disability status scale, ranging from 2-2.5.

Exclusion Criteria:

* People with musculoskeletal deformities.
* People with inner ear abnormalities.
* People with psychiatric disturbances or seizures.
REtinaL Imaging & Ambulatory BLood PrEssure

High blood pressure is a common condition which generally does not have any symptoms. Its estimated that around one third of people with high blood pressure do not know they have it. The back of the eye called the retina is one of the few places in the human body allowing easy observation of blood vessels. This study aims to see if simple non-invasive imaging of the blood vessels of the retina will highlight people with high blood pressure.

This will be a prospective, single centre study recruiting patients who are attending the ambulatory blood pressure clinic at the Western General Hospital. Suitable patients will be approached, and if they consent will have pictures of the back of each of their eyes taken. These pictures will then be reviewed, with certain measurements taken of the small blood vessels which can been seen at the back of the eye. These measurements will then be compared to the participants blood pressure readings to see if they might accurately correlate to blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Attending ambulatory blood pressure clinic
* Able to undertake ambulatory BP measurement
* Able to undertake single clinic-based BP measurement
* Able to undergo UWF retinal imaging with a SLO
* Aged 18 to 90
* Able to give informed consent

Exclusion Criteria:

* People with known history of retinal surgery
* People under the age of 18 years.
* People that cannot: manoeuvre themselves to the SLO unaided, sit upright in a chair or wheelchair or position themselves comfortably for imaging.
* People with epilepsy
Evaluation of Breastmilk Microbiota as a Function for Immunity

The aim of this study is to evaluate the difference of breast milk microbiota between mothers with and without vaginal infections during pregnancy.

The maternal microbiota is one of the relevant factors in the development of the infant's immune system, whereby the colonization of microbes in human begins at birth, when the newborn baby is exposed to maternal vaginal, gastrointestinal microbiota and as well as the microbes from the external environment. The neonatal intestine is colonized by symbiotic bacteria can be divided into four main steps; (i) acquisition of maternal vaginal, colonic, and skin flora at birth; (ii) introduction of oral feedings (breastfeeding or formula feeding); (iii) weaning; and (iv) acquisition of complete adult colonization.

Breastfeeding is associated with the protection of the infants from either infections or infection-related conditions, such as gastroenteritis, upper and lower respiratory tract infection, acute otitis media, urinary tract infection, neonatal septicaemia and necrotizing enterocoltis. The protection is through the combination of action of the breast milk components, such as maternal immunoglobulins, immunocompetent cells, or variety of anti-microbial compounds. Besides that, breast milk also contains prebiotic substances which may selectively stimulate the growth of limited number of beneficial bacteria in the gut.

A total number of 100 lactating mothers are needed for this study. Subjects will be recruited from HUSM Kubang Kerian, USM Main Campus Penang, and Institut Perubatan \& Pergigian Termaju USM Penang. The subjects will be explained on all related information in the consent form prior to signing. The procedure of collecting sample is hands must be washed before milk expression, and nipples are cleaned with sterile water and alcohol swab. 15mL of fresh breast milk will be collected into a tube and stored at -20℃ until further analyses.

Eligibility Criteria:
Inclusion Criteria:

* Lactating women
* Willing to commit throughout the experiment

Exclusion Criteria:

* Long term medication due to certain illnesses for over 3 months during pregnancy
* Gestational diabetes during pregnancy
* History of diabetes, coronary heart disease, and hypertension in life
* BMI before pregnancy above 24.9
* Consuming probiotic product during pregnancy
* Consuming probiotic product during lactation period