cyrilzakka/clinical-trials huggingface dataset:
Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace

The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain.

The main questions are:

Can BFR exercise integrated into the daily work tasks reduce knee pain (primary outcome) and improve function and work ability among hospital workers with or at increased risk of chronic knee pain? Participants in the intervention group will for shorts bouts during their workdays integrate BFR into their daily work tasks involving walking, whereas the control group will continue as usual.


Eligibility Criteria:
Inclusion Criteria:

* Hospital workers working at least 20 hours per week with or without chronic knee pain (\>3 months)

Exclusion Criteria:

* Life-threatening disease
* Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection)
* Systolic/diastolic blood pressure above 160/100 mmHg
Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

This project tests the feasibility and preliminary proof of concept for a mindfulness-enhanced adaptation of Pivotal Response Treatment on parenting stress and child communication, using a randomized controlled design.

One of the core features of Autism Spectrum Disorder (ASD), social communication impairment, presents in a variety of ways, including reduced functional language use and social initiations, which often warrant intensive intervention services. Additionally, parents of children with ASD demonstrate increased levels of parenting stress when compared to parents of typically developing children and children with developmental delays. Elevated parenting stress has been shown to diminish positive treatment outcomes, which lends support to develop methodologies to concomitantly target child and parent behaviors. The current randomized control trial (RCT) uses a dual-pronged approach to directly target both child communication deficits and parenting stress within a group format. This RCT combined an empirically supported behavioral therapy, Pivotal Response Treatment (PRT), with components from Acceptance and Commitment Therapy and Mindful Parenting for reducing parenting stress. Caregivers and their minimally or pre-verbal child with diagnosed or suspected ASD were randomly assigned to one of the following supplemental conditions: mindfulness-enhanced PRT (mPRT) or psychoeducation-enhanced PRT (pPRT) as an active control condition. The current study assessed feasibility and acceptability in addition to demonstrating proof of concept in regard to additive effects of mPRT compared to pPRT.

Eligibility Criteria:
Inclusion Criteria:

* For children: minimally verbal or nonverbal, 1.5 to 6 years old, current or suspected autism spectrum disorder diagnosis, demonstrated ability to make meaningful vocalizations
* For parents: willingness to attend group treatment sessions, record weekly videos, and share videos in a group setting

Exclusion Criteria:

* For children, no active medical problems (e.g., unstable seizure disorders)
* For parents, no severe mental health problems (e.g., suicidal intent, psychosis)
Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan

The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.

A four year prospective non-randomized feasibility implementation study for lung cancer screening in a targeted high-risk population of heavy (ex-)smokers by low-dose CT, combined with a smoking cessation intervention. It will be coordinated by a consortium of researchers from UZA and UAntwerpen.

Lung cancer (LC) remains the leading cause of cancer mortality, worldwide and in Belgium. Prevention and early detection are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. Besides, other indicators of compliance, quality and turn-around-time will be estimated. It will give insights in the feasibility and potential challenges of implementing a LDCT lung cancer screening program in our region. This implementation project is in line with the European Commission Council recommendation of December 2022 to explore the feasibility and effectiveness of LDCT in a high-risk population. Findings from this study will contribute valuable evidence for policymakers and stakeholders. Furthermore, an implementation pilot is a prerequisite for a future high-quality population-based screening program.

Eligibility Criteria:
Inclusion Criteria:

The target population consists of all adult inhabitants from the following municipalities of the ELZ ZORA: Mortsel (2640), Edegem (2650), Boechout (2530), Kontich (2550), Lint (2547), Hove (2540), and having a (TBA) % risk of developing an incidental lung cancer in the following 6 years (calculated a by risk prediction model)

1. Males and females
2. 55 -74 years old
3. Fitness for any kind of curative therapy for lung cancer
4. Absence of prior (lung) cancer in the 5 preceding years (excluding skin basal cell carcinoma and early stage cervical cancer)
5. Having a GP or related trusted health care provider

Exclusion Criteria:

1. participant may not have any symptoms (cough, pain when breathing in...)
2. Body weight \>140 kg in view of the maximum charge of the CT-scan table
3. The (rare) hereditary Li-Fraumeni syndrome which gives the carriers an excess risk of X-ray induced oncogenesis
The Importance of Insulin Action in the Brain for the Immune System During Physical Activity

The goal of this clinical trial is to clarify the interaction of central insulin action and physical activity with the immune system.

Therefore, participants will undergo bicycle spiroergometer tests. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

This research project aims to investigate if the brain insulin action regulates the immune system via the autonomous nervous system during physical activity.

Therefore, insulin action in the brain will be introduced by application of insulin as nasal spray (on one day) versus carrier solution as placebo nasal spray (on another day) in a randomized, blinded fashion. Spray administration will be performed 30 minutes before a 60 min bicycle spiroergometer test at 70 % VO2max that will introduce a postprandial state. On placebo day, the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate i.v. insulin bolus. Using this approach, brain-derived regulation of the immune system including the stimulation of immune cells via cytokines, physical performance, activity of the autonomous nervous system and gene-expression of leukocytes will be examined.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 24 kg/m2
* no known primary diseases
* hormonal contraception with a single-phase preparation

Exclusion Criteria:

* Alcohol or drug abuse
* Smoking
* At screening: Hb \< 12 g/dl for women and Hb \< 14 g/dl for men
* Any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.
Post-prandial Glucose in Healthy Subjects

The study is designed to determine the extent to which foods containing different levels of plant-based ingredients affect blood glucose responses in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Willing to give consent to participate in the study in writing;
* Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
* Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
* Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
* Willing to comply to study protocol during the study;
* Agreeing to be informed about medically relevant personal test-results by study physician;
* Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
* Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
* Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive) as judged by the research physician.

Exclusion Criteria:

* Being an employee of Unilever or CRO;
* Chronic smokers, tobacco chewers and drinkers;
* Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
* Use of medication which interferes with study measurements including vitamins, tonics;
* Reported intense exercise ≥10 h/week;
* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
* Blood donation for 2 months prior to screening;
* Urine analysis that showed any drug abuse;
* Allergy to any food or cosmetics;
* If female, not being pregnant or planning pregnancy during the study period;
* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Kyphotic Measure Using Distance From the Wall

Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of the tools to discriminate the functional ability impairments relating to kyphosis when compare with gold standard (Cobb's method), and compare among physical therapy, VHS and caregiver?

1. To further develop an innovation to measure kyphosis using distance from the wall, a Kyphosis wall distance tool (KypDisT).
2. investigate validity of the measurements in terms of 2.1 Concurrent validity of conventional C7WD and KypDisT as compared to a gold standard (Cobb's method).

   2.2 Discriminative ability of conventional C7WD and KypDisT on functional abilities in elderly with different severity of kyphosis.
3. To investigate the reliability of the measurements in terms of 3.1 Test-retest reliability of conventional C7WD and KypDisT. 3.2 Reliability of conventional C7WD and KypDisT comparing among physical therapy, VHS and caregiver.
4. To explore the distance to indicate risk of spinal fracture to indicate a risk of spinal fracture.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling elderly with different degrees of kyphosis,
* Aged at least 60 years
* Body mass index between 18.5-29.9 kg/m2
* OWD \>0 cm.

Exclusion Criteria:

* Present signs and symptoms that may affect participation in the study, i.e. unstable medical condition, pain or inflammation in the joints of the lower extremity (pain scale \> 5), having sequelae of neurological deficits
* Unable to understand and follow a simple command used in the study.
HRT Versus MOS for Endometrial Preparation Prior to FET in PCOS Patients

Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients with polycystic ovarian syndrome (PCOS)

Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \< 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle \> 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS as defined by the Rotterdam criteria.
* Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).

Exclusion Criteria:

* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities or myoma.
* Previous uterine surgery.
Use of Sublingual Tacrolimus in Adult Blood and Marrow Transplant Patients

Researchers are trying to learn more about using sublingual (absorption under the tongue) tacrolimus in blood and marrow transplant patients.

Initial doses will be given via sublingual route and a steady state trough level will be collected after 4 consecutive doses. Participants will then switched to oral tacrolimus, the dose adjusted for a goal trough 8-12ng/mL, and another steady state trough will be drawn.

Eligibility Criteria:
Inclusion Criteria:

* Individuals will be identified from within the adult allogeneic BMT program at Mayo Clinic in Rochester, Minnesota
* Adults prescribed tacrolimus for treatment or prevention of Graft Versus Host Disease (GVHD)

Exclusion Criteria:

* Vulnerable populations
* Patients with contraindications to tacrolimus, inclusive of hypersensitivity, history of posterior reversible encephalopathy syndrome or calcineurin-inhibitor induced thrombotic microangiopathy
* Lacking the capacity to consent in English and declining to participate in research
Elomia - Digital Mental Health and Well-Being

This study is testing the acceptability and efficacy of an AI enabled mental health chatbot (Elomia) as a resource of college student wellness.

Elomia is a generative AI program that can respond to text users type in with unique responses that are designed to address therapeutic targets like stress, anxiety, procrastination, feeling overwhelmed and so on. Elomia was "trained" by real therapists with expertise in cognitive-behavioral therapy who responded to many different real people typing about their concerns. Thus, Elomia can suggest a number of different evidence based therapeutic strategies and can help the user process negative feelings, think through problems, plan solutions, and trouble shoot things that might get in the way of implementing those strategies. Elomia's arsenal includes:

* exercises for calming;
* exercises for falling asleep;
* grounding techniques;
* exercises to reduce anxiety;
* breathing exercises;
* exercises to improve self-esteem. The algorithm determines the user's need for one or another type of help while communicating with the chatbot and suggests an exercise to ease their emotional state. Elomia is not a substitute for professional care, and will detect when a person needs something more than a chatbot and will suggest connecting with other resources. More information about Elomia can be found via this website: https://elomia.com/

The ultimate goal of this study is to explore whether a mental health chatbot is acceptable and can improve symptoms of depression, anxiety, stress, and promote general psychological well-being in college students. The investigators will compare Elomia to a curated collection of digital wellness resources that are typically provided to students at our University.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate student at the University of Pennsylvania.
* At least 18 years of age.

Exclusion Criteria:

\* Severe depression or suicidality as indicated by Beck Depression Inventory score of \>= 30, and/or a score of 2 or 3 on the Item (the suicide item) of the Beck Depression Inventory
Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.

In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks.

To compare effect (ocular surface damage) and safety of preservative-free Latanoprost/Tafluprost to Benzalkonium chloride-preserved Latanoprost in primary open angle glaucoma or normal tension glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female diagnosed with glaucoma, age 19 or over
* Written informed consent to participate in the trial

Exclusion Criteria:

* Patients who have received or have plans lacrimal puntual occulsion
* Use of contact lenses
* Any other Glaucoma except primary open angle glaucoma/normal tension glaucoma (ex) Closed anterior chamber angle/ angle-closure Glaucoma)
* Any condition limiting patient's ability to participate in the trial
The DIEP-Flap as a Model of Ischemia-Reperfusion

It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.


Eligibility Criteria:
Inclusion Criteria:

* patient is undergoing a DIEP-breast reconstruction, unilateral as well as bilateral
* is aged 18 years or older

Exclusion Criteria:

* diabetes mellitus
* diseases of the kidneys
* diseases of the liver
* patients who are taking immunosuppressants
Neuroendocrine Tumors of Old Patients in the West of France

Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French National Cancer INstitute (INCa) Rare Cancer Plan.

The project is in the form of an analysis of elderly population (75 years or over) with a diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be analysed in order to improve the care of rare cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* 75 years old or over at the time of diagnosis
* Patient with G1/G2/G3 neuroendocrine tumor diagnosed by pathological analysis
* Patient whose medical file was examined by RENATEN (National Network for the treatment of neuro-ENdocrine sporadic and hereditary disease Tumor) meetings or other multidisciplinary consultation meeting between 01/01/2014 and 31/12/2017
* Patient with care in private and public centers in the West of France

Exclusion Criteria:

* Patient with cancer other than a neuroendocrine tumor
* Patient with a G4 neuroendocrine tumor
* Patient who has objected to the study and collection of his medical data
* Refusal of participation
Effects of the Low-level Laser Therapy on Inflammatory Profile of the Patients With Coronary Artery Bypass Surgery

Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and surgical procedures to treat these disorders have grown dramatically in recent years. Since the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis, many techniques have been used to improve the outcome of surgery and reduce their side effects. The low-level laser therapy (LBP) has been widely used in clinical practice for pain relief purposes, reducing inflammation and stimulating tissue healing. However, the effect of this therapy has been little elucidated in patients with cardiac disease. The objective of this study is to evaluate the effect of low level laser therapy on the inflammatory profile and cardiac tissue healing markers of patients in the postoperative period of CABG surgery.

This study will be conducing in a large hospital that is reference in Cardiovascular diseases treatments. 38 patients will be randomized for placebo or 6J low-level laser therapy (LLLT). The inflammatory profile and cardiac tissue will be assessment before and after de LLLT.

Eligibility Criteria:
Inclusion Criteria:

* Patients after elective coronary artery bypass surgery, hemodynamically stable, without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 45 and 75 years of age, who have performed the first surgery

Exclusion Criteria:

* Patients with decompensated heart failure; other associated surgery; presence of any comorbidity such as: unstable angina; sequel of stroke; photosensitivity; use of cardiac pacemaker; Diabetes mellitus (due to the negative effect of diabetes on wound healing).