cyrilzakka/clinical-trials huggingface dataset:
Microfluidic Organotypic Model for Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients

Osteoarthritis (OA) is the fastest growing cause of disability worldwide due to population ageing and increasing obesity incidence. Obese individuals have a higher risk of OA insurgence and severe progression due to several risk factors, including their systemic inflammation state and superior migratory ability of monocytes. In the present project we aim at the development of a novel 3D microfluidic organotypic model resembling the joint to investigate the migration ability of monocytes from obese and non-obese OA patients.

We hypothesize that monocytes from obese OA patients display superior migration ability and a specific pattern of chemokine surface receptors compared to monocytes from non-obese OA patients. We also hypothesize that these features lead to a superior infiltration of monocytes/macrophages to the synovial membrane in obese OA patients. Based on this, our main aim will be to highlight differences between Mo from obese and non-obese OA patients in terms of surface receptors and migration ability in a microfluidic organotypic model.


Eligibility Criteria:
Inclusion criteria

Obese OA patients

* Subscription of informed consent
* BMI ≥ 30
* age between 60-80 years included
* Kelgrenn-Lawrence equal or superior to grade III
* presence of synovitis
* patients undergoing knee replacement
* suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice

Non-obese OA patients

* Subscription of informed consent
* BMI ≤ 28
* age between 60-80 years included
* Kelgrenn-Lawrence equal or superior to grade III
* presence of synovitis
* patients undergoing knee replacement
* suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice

Exclusion criteria

Obese OA patients - HCV, HIV, HBV, TPHA infection

Non-obese OA patients

- HCV, HIV, HBV, TPHA infection
Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.

In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. The reason why individuals born preterm have exercise limitation remains unclear and may be a consequence of impact of preterm birth and associated neonatal difficulties on the development of organs important for exercise, namely the lungs, the heart, the vessels (which bring blood and oxygen to the muscles) and the muscles. It is well known that exercise benefits overall health in at-risk as well diseased populations. However, whether exercise training can improve fitness in young adults born preterm was not demonstrated and whether the cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible through exercise intervention in young adulthood is unknown.

The investigators postulate that a 14-week exercise intervention will improve exercise capacity in preterm adults, as seen in other at-risk populations, in correlation with measures of vascular health, heart and muscle perfusion and oxygenation, and pulmonary function detected by cutting edge and highly sensitive imaging and circulating biomarkers. These markers are more sensitive to pre-disease changes than traditional health measures, and are largely unexplored in preterm populations.

The investigators will:

1. Determine whether a 14-week supervised exercise training improves exercise capacity in young adults (18-29 years old) born very preterm at \<29 weeks gestational age.
2. Examine whether improvement in exercise capacity is associated with changes in (a) markers of vascular health including circulating endothelial progenitor cells and microparticles, (b) cardiac perfusion by cutting-edge oxygenation-sensitive cardiovascular magnetic resonance imaging (MRI), (c) lung regional ventilation measured by newly developed hydrogen proton (1H) MRI, (d) muscle oxygenation during exercise.
3. Compare the response of the above measures to exercise intervention between young adults born very preterm and term controls.

Eligibility Criteria:
Inclusion Criteria:

Both groups :

* Aged between 18-29 years old
* Less than 120 minutes of exercise per week
* Willingness to be part of the 14 weeks exercise intervention

Preterm group:

- Born under 29 weeks of gestation

Term group :

* Born between 37-41 weeks
* Appropriate weight fo gestational weight

Exclusion Criteria:

* Pregnancy
* conditions excludins individual from exercise
The Physical Effects of Pain Catastrophizing in Labor

The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. Other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. The investigators want to know if negative thoughts can predict this outcome.

Subjects will complete questionnaires at three timepoints: during the prenatal period, within 24-48 hours of giving birth, and 4-8 weeks postpartum. The questionnaires will measure pain catastrophizing, depression, maternal support, support and control in birth, and childbirth satisfaction. Chart review following delivery will record data such as length of labor, medication used, need for augmentation or surgical delivery, complications.

Eligibility Criteria:
Inclusion Criteria:

* At least 20 weeks of pregnancy
* Nulliparous
* Singleton pregnancy
* Low risk pregnancy

Exclusion Criteria:

* Primiparous and multiparous women
* Women who request cesarean delivery
* Women who are pregnant with twins
* Women who plan induction
* Women who deliver before 37 weeks
* Women enrolled in the "Centering Pregnancy" program at the Family Birth Center
* High risk pregnancies
* Severe mental illness that impairs cognition or function
* Suicidal ideation
* Women who do not speak English or Spanish
Nasal Naloxone for Narcotic Overdose

The goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.

This is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (TAU; administration via intravenous \[IV\], intramuscular \[IM\] or intraosseus \[IO\] delivery) versus intranasal \[IN\] for the prehospital emergency treatment of suspected opioid overdose. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to administer either standard care or IN naloxone as the initial response to a suspected opioid overdose.

Eligibility Criteria:
Inclusion Criteria:

* Presence of hyperventilation or respiratory arrest OR
* EMS assessment that the person needs naloxone for possible opioid or unknown drug overdose

Exclusion Criteria:

* EMS assessment that the participant is less than 12 years old
An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South

Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP.

Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP.

Specific Aim 1) Gather data from YBMSM (n = 20) and clinic staff (n = 10) through in-depth interviews to assess quantitative measures, intervention design, and experiences most relevant to PrEP engagement.

Specific Aim 2) Develop ACTPrEP utilizing Aim 1 data, working iteratively with experts, and an intervention "run through" with a sample of participants.

CLINICAL TRIAL IS AIM 3 ONLY

Specific Aim 3) Evaluate ACTPrEP. Enroll 66 participants. Primary outcomes will be feasibility (measured by percentage eligible, consented, randomized, and retained) and acceptability (measured by the Client Satisfaction Questionnaire). Secondary outcomes will compare ACTPrEP vs. enhanced standard of care condition (ESOC) on behavior outcomes (uptake, adherence, and PrEP persistence) and possible mediators over the course of 24 weeks. Barriers and facilitators to implementing ACTPrEP will be assessed with post-RCT qualitative interviews using the i-PARIHS framework.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Between 18-34 years old
* Male sex assigned at birth
* Identify as African American/Black
* Not enrolled in another PrEP related study
* Able to give consent
* Not taken PrEP in past 3 months
* Report having sex with a man in the past 3 months
* PrEP-eligible according to CDC guidelines

Exclusion Criteria:

* Participating in another PrEP study
* Unable to provide consent
An Exercise Intervention to Improve Overall Brain Health

The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question\[s\] it aims to answer are:

* To test the effect of moderate vs intensive exercise on Brain Care Score outcomes.
* To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with hypertension
* have a body mass index ≥ 25 kg/m2
* are between the ages of 35-65 years old
* access to a smart phone that allows installation of 2 two applications that record your workouts
* pass a fitness evaluation.

Exclusion Criteria:

* do not have hypertension
* weight over 300 lbs
* unable to pass the fitness evaluation
* BMI less than 25kg/m2
Digital Support for Supervised Exercise Therapy in Peripheral Arterial Disease

The individual restrictions of daily life for patients with PAD are more important than statistical facts for mortality and morbidity. Intermittent claudication causes a progressive reduction of the pain-free walking distance (PWD) as an expression of a worsening PAD. This decrease in physical capability results in a decline of mental health and relevantly reduces the patients' quality of life (QoL).

Supervised exercise therapy (SET) is a cornerstone in the conservative management of intermittent claudication and extends the PWD. Even though SET is easy to practice and highly cost effective, the adherence to perform SET on a regular base is rather low. The underuse of exercise can be partly explained by the lack of institutional resources, but also by both patients' and physicians' lack of interest in exercise.

Mobile health (mHealth) technologies increase the incentives and provide digital support for patients with PAD on several treatment levels. They might lead to a higher adherence to exercise training and offer new scopes in patient-centered healthcare, but so far studies show opposite results. Because app stores are flooded with health and fitness apps, specific support tools are highly desired by patients with PAD and PAD-specific solutions are missing so far. Based on this background, the investigators developed a smartphone app named TrackPAD to provide PAD-specific support for SET.

The TrackPAD pilot study was designed as a 2-armed randomized controlled trial and included patients with diagnosed and symptomatic PAD. Patients were randomized by the Center for Clinical Studies in Essen using the TENALEA software into 2 groups. The control group included participants with standard care and no further mobile intervention. The intervention group included participants with standard care and additional mHealth-based self-tracking of their physical activity using trackPAD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lower extremity PAD based on (and/or):

  * ABI ≤ 0.9 in at least one legs
  * Invasive or non-invasive imaging of stenotic lower extremity artery disease
  * Endovascular or surgical revascularization of lower extremity artery
* PAD Fontaine Stage IIa/b
* Smartphone with possibility to use TrackPAD: Android ≥ 5.0 or IOS ≥ 11.0
* Written informed consent prior to any study procedures, including a specified follow-up evaluation
* Best-medical treatment in the last 2 months in accordance with standard guidelines

Exclusion Criteria:

* Wheelchair bound, use of walking aid or walking impairment due to another cause than PAD
* Below or above knee amputation
* Acute or critical limb ischemia
* PAD Fontaine Stage I or III / IV
* No German knowledge
* Severe cognitive dysfunction
* Congestive heart failure with NYHA III-IV symptoms
* Active congestive heart failure requiring the initiation or uptitration of diuretic therapy
* Angina pectoris with CCS class 3-4 symptoms or myocardial infarction or stroke in the last 3 months
* Active arrhythmia requiring the initiation or uptitration of anti-arrhythmic therapy
* Severe valve disease
NONSPECIFIC NECK PAIN

The goal of this a randomized control trial is to carried out to examine Graston technique (GT) and muscle energy method (MET) impact on nonspecific neck pain compared to traditional physiotherapy treatment (TPT), This study aims to contrast between the outcomes of GT and MET on both pain intensity and functional disability in patients. Each participant was assigned a unique number, and then those numbers were randomly divided into three groups. Three groups were formed from a random selection of participants: GT Group (A): received 12 sessions of GT and (TPT) over the course of four weeks (three sessions per week). MET Group (B): received 12 sessions of MET treatment and (TPT) over a period of four weeks (three sessions per week). Control Group (C): received 12 sessions of traditional physiotherapy (TPT) over a period of four weeks (three sessions per week).

Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort.

Functional Disability (NDI) The Neck Disability Index (NDI) is a 10-item questionnaire used to assess the functional impairment caused by neck pain. The questionnaire covers a wide range of topics related to one's everyday life, including but not limited to: personal care, heavy lifting, work, driving, sleeping, playing, recreational, pain level, concentration, and headache. Scores range from 0 (no disability) to 5 (severe disability) for each question, with the total score out of 100 determined by adding and doubling the scores for each question. If a patient has a high NDI score, they report being more disabled as a result of their neck pain. Patients have identified a 5-10% improvement as the "minimally clinically meaningful change." This study excluded any patient with: Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis. Cervical spine fracture, Cases of disc prolapse that have been diagnosed (27), prior cervical or thoracic spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* non specific neck pain

Exclusion Criteria:

* Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis.

Cervical spine fracture. Cases of disc prolapse that have been diagnosed. prior cervical or thoracic spine surgery, (28).
Study of the Metabolism of Two Magnesium Supplements in Healthy Volunteers

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the pharmacokinetics of the following two magnesium supplements:

* Mablet (dietary supplement)
* Magnesium Sulfate (solution for infusion)


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.

Exclusion Criteria:

* Smokers,
* Using pharmaceuticals/supplements,
* Vegans/vegetarians,
* Major changes in eating habits within one week prior to study start.
Clinical Applications of Advanced Ophthalmic Imaging

The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls.

There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.


Eligibility Criteria:
Observational Phase 1 Group

Inclusion Criteria:

1. Self-reported normal healthy subjects;
2. Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
3. Who can keep the eye open for imaging.

Exclusion Criteria:

1. who can not read and sign the ICF;
2. who can not receiving ophthalmic imaging;
3. who cannot tolerate bright light during imaging.

Interventional Phase 2 Group:

Inclusion criteria

The participant will be eligible for entry in the study if s/he:

1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas and crystalline lens;
5. Initial visual acuities were 20/80 or better;
6. MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
7. Hemoglobin A1c is 10 or less;
8. Normotensive with or without medications;
9. Without retinal capillary dropout or macular edema;
10. Blood homocysteine \> 9.

Exclusion criteria

The subjects will be ineligible for entry into the study if s/he:

1. Has an active ocular disease;
2. Has had surgery or an eye injury within 6 months.
BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)

This study will evaluate functional magnetic resonance imaging (fMRI) and methods for measuring drug induced changes in cerebral blood flow as biomarkers for attention-improving drugs.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a nonsmoker
* Subject is in generally good health
* Subject has normal (or corrected to normal) vision and hearing
* Subject is right-handed

Exclusion Criteria:

* Subject has a history of any illness that would make participation unsafe or would make the study results difficult to interpret
* Subject has a history of stroke, seizures, or major neurological disorders
* Subject has a history of cancer
* Subject has permanent cosmetic or metallic implants that would interfere with measurements
* Subject has a history of sleep apnea
* Subject has a history of head injury/trauma
Molecular Processes of the Relaxation Response in Older Adults

The purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* 60-80 years of age
* healthy individuals
* willing and able to attend treatment sessions
* willing to learn how to do and practice the relaxation-response
* access to a working telephone
* read and write English

Exclusion Criteria:

* Major medical or psychiatric illness
* asthma or seasonal allergies (resulting in nitric oxide levels \>60 ppb)
* smoking
* previous relaxation-response practice
* current use of the following medications:systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
CLinical Utility of Early Intervention Including the 5-Step Precision Medicine (5SPM) Method in First-episode Psychosis: The CLUMP Project

CLUMP is a project of translational research that intends to bridge the gap between what we already know about pharmacogenetics of antipsychotic drugs and what we still do to treat patients with first-episode psychosis (FEP). We aim to improve the adherence to antipsychotic drugs and, therefore, the outcomes of patients with FEP. To achieve this aim, our objectives are to: (1) Introduce a pioneering early intervention model of Personalised Precision Psychiatry, including pharmacogenetics, for patients with FEP; (2) ascertain whether such a model can reduce the elevated discontinuation rates of antipsychotic medications in this group; (3) assess the impact of this model on pragmatic efficacy and functional measures; (4) determine whether this innovation can bring cost benefit; and (5) establish a blueprint for implementing this precision model nationally and internationally. We shall compare all-cause discontinuation rates of the first prescribed antipsychotic medication (primary outcome), discontinuation rates by causes, pragmatic efficacy and tolerability measures, functional outcomes, and healthcare costs between two cohorts of patients with FEP followed for one year. One cohort will be comprised of patients treated before the implementation of the early intervention model of Personalised Precision Psychiatry, and the other of new patients treated under this model. Also, we shall compare pharmacogenetic information, and its implications for clinical management, between these patients and another national cohort of patients with either longer-term psychotic disorders or other mental health problems.


Eligibility Criteria:
Inclusion Criteria

* Patients with a diagnosis of first-episode psychosis, either non-affective or affective.
* Patients aged 12-35 years.
* Patients followed by clinical services for at least one year, or earlier if there was evidence of antipsychotic treatment discontinuation.
* For cohort one: Patients and/or their family or legal representatives must provide written consent to take part in the CLUMP Project, including pharmacogenetics analysis.
* For cohort two: This will not be a mandatory inclusion criterion, but all patients will be approached by our research team seeking their consent to obtain their pharmacogenetic profile for research purposes.

Exclusion Criteria

* Patients with first-episode psychosis due to organic causes, for example, brain diseases such as Huntington's and Parkinson's disease, HIV, syphilis, dementia, brain tumours or cysts, or brain injury.
* Patients with moderate to severe intellectual disability.
* Patients who plan to reside (cohort one) or spent (cohort two) most of the one-year follow-up period in a locality outside of the PRINT's catchment area.