cyrilzakka/clinical-trials huggingface dataset:
Montmorency Cherry Juice and Uric Acid Metabolism

Cherries have been show to possess the ability to reduce uric acid concentrations and inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds than other cherries and hence makes the expectation possible that Montmorency cherries will lower uric acid and inflammation.

Plasma and urinary uric acid concentration, plasma phytochemical content and inflammatory biomarkers will be measured in order to elucidate the effects of an acute dose of tart cherry juice on indices related to the condition of gout.

Participants will be required to attend the laboratory at a range of time points over two periods of 96 hours, separated by a 7 day washout period, to provide blood samples. In order to provide a baseline sample, participants will attend the laboratory in the morning following an overnight fast and voiding of any urine. Following this participants will be given 30mls (30 mls provides 323 mg/380 µmol of anthocyanins) of tart cherry juice or placebo, diluted with 60 mls of water to consume within 10 minutes. Participants will be required to consume identical dosages of the supplement immediately prior to evening meals and breakfasts (or same time each morning following blood sampling if non-breakfast eater) over the next 96 hours. Further blood and urine samples will be collected at 1, 2, 3, 5, 8, 24, 26, 48, 50, 72, 74 and 96 hours and will require participants to return to the laboratory at each of these time points. Following the first period of supplementation participants will complete a 7 day washout period in which they will not be required to attend the laboratory. Following the washout period they will repeat the supplementation period consuming the supplement they did not receive during the first period.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy males/females between the ages of 18-40 years

Exclusion Criteria:

* underlying clinical pathology
A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354

To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.

To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 milligram (mg) and 300 mg compared with 150 mg given intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent is obtained prior to any study related procedure taking place
* Males, aged 19-55 years
* No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
* A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
* Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
* A negative screen for drugs of abuse and alcohol
* Body mass index (BMI) between 18-30 kilogram per square meter (kg/m\^2), inclusive
* No other clinically significant abnormality on history and clinical examination
* Able to comply with the requirements of the protocol.

Exclusion Criteria:

* Any active concomitant disease including psychological disorders
* History of medication that might carry over effects into study
* Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354
* Participation in another investigational medicinal product study within 3 months of the start of this study or 5 half-lives of the previously administered investigational medicinal product (IMP), whichever is the longer except methodological studies in which no IMP was given
* Any acute illness in the 2 weeks before Day 0 (Visit 2)
* Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
* Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first degree relative of the aforementioned
* Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol
* The subject's primary care physician recommends the subject should not take part in the study
* Subjects with immunodeficiency disorders
* Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Comparison of Acute Effect of Different Manual Techniques on Muscle Fascia Stiffness

There are studies investigating the effect of different massage methods on muscle fascia stiffness but the results do not support each other. In addition, there is no study to investigate the effect of MLD on muscle fascia stiffness. The aim of this study is to determine the acute effect of MLD and classical (Swedish) massage (KM) on muscle fascia stiffness after exercise.


Eligibility Criteria:
Inclusion Criteria:

* Being health and woman
* No systemic problem preventing exercise
* Having sufficient level of perception to perceive commands
* BMI≤25

Exclusion Criteria:

* Having a history of injury and surgery through the Quadriceps femoris muscle in the last three months
* Having a disease that will affect myofascial structure features
* Having a disease that will affect normal body temperature
* Chronic pain in Quadriceps femoris muscle that has been going on for the last three months.
The Effect of Erythropoietin in the Treatment of Scleral Necrosis

Patients with acute avascular lesions of the conjunctiva and sclera will be included in the study. Patients will undergo a complete eye examination including a slit lamp, intraocular pressure measurement, and fundoscopy with dilated pupil. At the same time, laboratory examination including measurement of fasting blood sugar (FBS) level, complete blood count (CBC) and systemic blood pressure will be performed. Patients will be randomly divided into three groups. The groups will receive sham drops (normal saline), erythropoietin 3000 units in normal saline, and erythropoietin 6000 units in normal saline every 6 hours respectively. Meanwhile, all patients will receive the usual treatments based on the cause of scleral necrosis.

Eye examinations will be done daily in the first week, every other day in the second week, and then twice a week until the complete recovery of avascular lesions. In each examination, with fluorescein staining, the size of the conjunctival epithelial defect will be determined. Also, the dimensions of the avascular area of the sclera will be determined. Other examinations include measurement of visual acuity and intraocular pressure, and the patient will be evaluated in terms of iris and retinal neovascularization. The photoslit lamp will be done before starting the study and then every week.

Complete healing of the lesion is defined by complete vascularization and epithelization of the ischemia site. After the complete recovery of conjunctival and scleral necrosis, the erythropoietin drop will be stopped and the examinations including blood pressure measurement, CBC, diff and FBS will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute conjunctival and scleral avascular lesions resulting from ocular surgery (such as pterygium resection, glaucoma, strabismus, vitreous and retinal surgery), chemical and thermal burns, and collagen-vascular disease.

Exclusion Criteria:

* a history of ocular surface tumors
* a history of tumors in any part of the body
* iris and retinal neovascularization for any reason
* proliferative diabetic retinopathy
* and systemic hypertension
* if the sclera is severely thinned and the risk of perforation of the globe is imminent, the patient is excluded from the study.
The Effectivenes of Family Club Denmark #Strongertogether

The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD)

The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD). Participants are 200 vulnerable families with children aged 2-12 years, who would like to participate in a family club.

The study is a prospective controlled trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are allocated to intervention after a first-come-first-serve principle. When the maximum number of participants in a specific family club is reached, any further families will join the wait-list and be offered participation after 6 months.

Most participating families will be characterized by at least one of the following:

* Single parent
* Small or no network
* Low level of support
* Low income
* Physical or mental health problem
* Unemployed
* Loneliness
* Lack of contact with other adults
* Difficulty with creating relationships
* Having a hard time making ends meet during the week

A family club consists of up to 9 families. Most families are vulnerable but each club also includes nun-vulnerable families. The club is run by 3-6 volunteers who have received a 1-day training. Participants meet every two weeks for 6 months (12 sessions).

FCD is based on four principles: 1. Meal community; 2. Play, learning, and togetherness; 3. Support and advice; 4. Bridging to the civil society and the public sector

The 12 sessions center around 7 value posters:

1. Fun with smiles
2. Together but not in line
3. The time is now
4. Notice and say thank you
5. More than me
6. Courage to dare
7. Taste the world Data are collected at baseline, and after 6 and 12 months. The study is conducted in the Region South in Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Family with at least one child 2-12 years old.

Exclusion Criteria:

* Not able to fill out questionnaires in Danish
Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.

The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL respectively.

The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses.

Considering the modified optical profile of the ICB00 IOL, the primary objective will be the evaluation of visual performance at intermediate distance.

Eligibility Criteria:
Inclusion Criteria:

* clinically significant bilateral cataract (BCVA \<20/40, cataract must be the primary cause of visual impairment)
* axial length between 21 and 27 mm
* the patient must be able to read, understand and provide written informed consent,
* the patient must be willing and able to comply with all study and follow-up procedures
* preoperative refractive cylinder ≤ 0.75 D

Exclusion Criteria:

* anterior segment pathology that could significantly affect results (e.g., chronic uveitis, iritis, corneal dystrophy, keratoconus)
* diabetic retinopathy
* uncontrolled glaucoma and/or intraocular pressure IOP\> 24 mmHg
* all types of infections (acute eye disease, external/internal infection, systemic infection)
* traumatic cataract
* pupillary abnormalities including aniridia and/or pupil diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm
* microphthalmia
* amblyopia
* degenerative visual disorders (for example macular degeneration, optic nerve atrophy or retinal disorders)
* previous intraocular and corneal surgery
* systemic or ocular pharmacotherapy, which may impact visual acuity and/or cause floppy iris syndrome and/or insufficient dilation in the opinion of the investigator
* patients who are unable to fixate for a prolonged time (e.g. strabismus, nystagmus)
* period of pregnancy or breastfeeding for female patients
Imaging Biomarkers for TMS Treatment of Depression

The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of major depressive disorder
* Male and female subjects, ages 22-65
* Have failed at least 1 antidepressant medication at adequate dose and duration
* On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy

Exclusion Criteria:

* Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
* Active substance abuse, including alcohol
* Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
* No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
* Pregnant or trying to get pregnant
* Failed to respond to an adequate course of electroconvulsive therapy (ECT)
* Previous treatment with TMS
* Current depressive episode longer than 5 years
The Immediate Effect of Mulligan's Mobilization With Movement on Shoulder Girdle' Pain, Range of Motion and Muscle Activity, in Subjects With Shoulder Impingement Syndrome

The aim of present study was to evaluate the immediate effect of Mulligan's mobilization with movement on shoulder girdle' pain, range of motion (ROM) and muscle activity, in subjects with shoulder impingement syndrome

A randomized, single-blind, placebo-controlled clinical trial was conducted with a sample composed by twenty-four volunteers with SIS, divided in Mulligan's MWM and Placebo groups. Pain intensity in Neer impingement signal and Hawkins-Kennedy impingement test, pressure pain threshold (PPT) on the lateral aspect of shoulder, ROM of shoulder scaption until onset of pain, as well as the activity of trapezius (upper, middle and lower fibers) and serratus anterior muscles during this movement, were evaluated before and immediate (post-) intervention. The Mulligan's MWM group received a mobilization with movement technique in the glenohumeral joint (sustained posterolateral glide during shoulder scaption), while no effective intervention was performed in the Placebo group.

Eligibility Criteria:
Inclusion Criteria:

Participants had superolateral shoulder pain and two out of four specified objective signs and symptoms:

* positive Neer test;
* positive Hawkins-Kennedy test;
* painful limitation of active arm elevation (flexion, abduction, scaption);
* pain or limitation with functional movement patterns of hand behind back or hand behind head.

Exclusion Criteria:

* physician diagnosis of adhesive capsulitis;
* grade III rotator cuff tear;
* calcific tendinosis confirmed by radiology;
* systemic or neurological disorder;
* cervical radiculopathy; a history of shoulder surgery;
* corticosteroid injection within the past month;
* subjects who had received physical therapy intervention for their shoulder within the past three months.
Mobile Stress Management Program for African American Women

The unjust social, economic, and environmental conditions that African Americans face throughout their lives lead to pervasive health disparities. These disparities are driven by healthcare differences. They are driven by economic differences. Those with less financial wealth have poorer health as compared to those with higher socioeconomic status. And yet, even when controlling for these two important social determinants of health, race still predicts morbidity and mortality.

What can account for this? Stress. African Americans experience more stress than their White peers. The story is even more dire for African American women who simultaneously face both racial discrimination and sexism. Indeed, gendered racial discrimination is nearly ubiquitous for Black women at all socioeconomic levels. It is also a distinct form of stress, with unique outcomes compared to other non-race-or-gender-related stressors. Finally, stress has clear downstream negative effects on health.

At present, there is no mobile cognitive-behavioral stress management intervention (m-CBSMi) designed to help African American women manage racial and nonracial daily stress. The investigators intend to fill this void. Using proven CBSMi techniques, participants will learn how to manage their stress through text messages and integrated mobile web content. Supportive texts will inspire, motivate, and affirm the life experiences of participants. Educational texts will increase knowledge, develop skills, and reduce barriers to adaptive coping. A library of individually tailored videos will be delivered to each participant. All mobile web content will be accessible only through touch-based links embedded within text messages, making it easy and effortless to view this material.

During Phase II the investigators will complete development of the m-CBSMi. Then, the investigators will examine the effectiveness of the m-CBSMi to reduce stress among African American female participants. Participants will be randomly assigned to either the intervention condition or to a matched control condition. Secondary measures will assess coping, well-being, subjective health, gendered racial identity, and knowledge.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Black; own a smartphone; have at least limited English literacy skills; report perceived discrimination; and be moderately stressed. The discrimination must be due to race or gender and the frequency must be at least "a few times in the past year" or more. In addition, they must report a score of 6 or higher on the 4-item Perceived Stress Scale (PSS).

Exclusion Criteria:

-
Pretreatment With Estradiol Valerate

The present study is set up to evaluate the efficacy of a programmation by administration of estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days during the luteo-follicular transition period of the menstrual cycle.

See Section Interventions

Eligibility Criteria:
Inclusion Criteria:

\< 36 years old on day of randomisation FSH \< 12 (in the early follicular phase) Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.

Regular menstrual cycles of 21-35 days, presumed to be ovulatory. BMI between 18 and 29 (both inclusive) 1st or 2nd trial IVF or ICSI

Exclusion Criteria:

≥ 36 years old on day of randomisation Endometriosis ≥ grade 3 PCOS Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle) Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Feasibility of Gallium-68-tilmanocept PET/CT for Sentinel Lymph Node Detection in Endometrial Cancer

This pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping in patients with endometrial cancer.

Rationale: Currently, the use of indocyanine green (ICG) is the most widely accepted sentinel lymph node (SLN) mapping technique in endometrial cancer but the acquired SLN detection rates greatly vary. We propose that adding preoperative imaging with the radiotracer Gallium-68-tilmanocept (68Ga-tilmanocept) PET/CT can further improve SLN mapping in patients with endometrial cancer and reliably guide the surgeon towards the true SLN intraoperatively.

Objective: To evaluate the feasibility of sentinel lymph node imaging with 68Ga-tilmanocept PET/CT.

Study design: Non-randomised, single-centre, single-arm pilot study in the UMC Utrecht.

Study population: Patients with clinically stage I-II high/high-intermediate risk endometrial cancer scheduled for robot-assisted pelvic and para-aortic lymphatic staging (including SLN procedure). A total of 10 patients will be included.

Intervention (if applicable): Preoperative cervical injection of 68Ga-tilmanocept followed by preoperative PET/CT imaging (in adjunct to the standard-of-care: intraoperative injection with indocyanine green (ICG) with real-time near-infrared (NIR) fluorescence imaging). Injection of 68Ga-tilmanocept is performed by the gynaecologist in an outpatient setting. The PET/CT (PET + contrast enhanced CT abdomen) will be performed 30-90 minutes after tracer injection.

Main study parameters/endpoints: Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping, which is evaluated by its SLN detection rate.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Extra burden for subjects concerns an additional site visit for cervical injection followed by PET/CT imaging with a total duration of two hours (including waiting time of \~60 minutes). The preoperative injection with 68Ga-tilmanocept while patient is awake adds minimal discomfort to the patient. The extra administration of 10 MBq 68Ga-tilmanocept followed by PET/CT, resulting in a radiation of 6.3 mSv, is considered an acceptable radiation burden to the subjects. Adverse reactions after injection of radiolabelled tilmanocept rarely occur. No additional blood samples, follow-up visits or physical examinations are needed during this study. The additional site visit does not delay the scheduled standard care.

Subjects may benefit from this study since the SLN detection rate could be increased and/or faster by adding 68Ga-tilmanocept PET/CT to the diagnostic procedure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer;
* Scheduled for robot-assisted full pelvic and para-aortic staging;
* Age ≥18 years and able to provide informed consent.

Exclusion Criteria:

* Pregnancy or current breastfeeding;
* Prior severe allergic reaction to iodine;
* Severe renal insufficiency (stage 3 or 4);
* Clinical or radiological evidence of metastatic disease.
Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment

Post-stroke cognitive impairment is common in stroke survivors. Cognitive function is related to walking ability. The dual task walking is required for daily activities, however, such ability is even more challenging than single walking for people with stroke. The purpose of present study is to investigate the effects of combining cognitive and treadmill training on cognitive function and dual task walking performance in chronic stroke patients with cognitive impairment.

This is a single-blinded, randomized controlled trial with pre- and post-measurements. 24 subjects will be recruited, and randomly assigned to one of two groups: cognitive training during treadmill training group (experimental group) and treadmill training group (control group). The intervention for both group will be 30 minutes per session, 3 sessions per week for a total of 4 weeks. Statistical data analysis will use the SPSS 25.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to compare between time and groups. The significant level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* age over 50 years old
* chronic stroke (onset \>6 months)
* with mini-mental state examination (MMSE) score≧24
* Montreal cognitive assessment (MoCA) score\<26 (impaired cognition)
* ability to walk independently for at least 10 meters without assistive devices or support
* ability to read and write cognitive tests

Exclusion Criteria:

* diagnosis of dementia
* unstable physical condition
* any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study
* visual or auditory disturbances