cyrilzakka/clinical-trials huggingface dataset:
Student Outcomes of Integrative Mental Health Services

The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual school-based therapy on students' mental health and school-related outcomes, and test whether changes in school outcomes are mediated by changes in student mental health.

This project will implement and evaluate the Child STEPs (see Weisz et al., 2012) treatment approach through a randomized controlled trial (RCT) at 27 K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists, to guide their selection and sequencing of the STEPs modules. The project will include an evaluation of the effectiveness of STEPS compared to "treatment as usual" (known as Usual Care or UC) on students' mental health and school-related outcomes, and an analysis of whether changes in school outcomes are mediated by changes in student mental health.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in grades 2-7
2. Have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
3. Clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-traumatic Stress Disorder Reaction Index

Exclusion Criteria:

1. Mental retardation
2. Pervasive developmental disorder
3. Eating disorders
4. Children for whom attention problems or hyperactivity are the primary referral concern
5. Active psychosis and/or a suicide attempt in the previous year
Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care

Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, the investigators evaluated a combination intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming.

The investigators conducted a quasi-experimental pilot study of a combination behavioral intervention based on the concepts of social norms and priming. The intervention included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was developed using tools from marketing research and patient-centered design. The hypothesis was that the intervention would improve retention in care and adherence to ART among patients living with HIV infection (PLHIV). The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. The investigators reviewed medical records of a random sample of exposed and unexposed adult PLHIV to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Living with HIV infection
3. Receiving HIV primary care at one of the two study clinics
Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions

The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.

Medical providers are often faced with patients whose source of pain may be the result of an inflammatory response caused by trauma or disease. By managing the patient's inflammation, the clinician may see improved response to traditional pain management therapy and existing protocols.

Also, degenerative arthritis of spinal and extremity joints may lead to significant low back, knee, hip, shoulder pain etc, as the ratio of cartilage degradation to cartilage formation increases with age. An amniotic tissue derived product may prove to be an ideal non-steroidal and potentially regenerative therapy for use by the medical provider due to its unique characteristics.

The orthopedic application of amniotic fluid dates back to at least the 1930's. The placental membranes produce an array of immunosuppressive and anti-inflammatory molecules, which make these tissues suitable for use as a wound covering \[or as an anti-inflammatory\] in a clinical setting. In addition to structural properties, placental membrane and amniotic fluid (AF) is a rich source of growth factors, including organic compounds and nutrients, hyaluronic acids, amino acids, antioxidants and stem cells.

AF's anti-inflammatory actions may be mediated in part by its secretion of anti-inflammatory cytokines including interleukin-10, inhibin, activin, and interleukin-1 receptor antagonist as well as anti-inflammatory protease inhibitors such as ∞-1 anti-trypsin inhibitor and inter-a-trypsin inhibitor. AF may modulate acquired immunity by suppressing alloreactive responses and down regulating production of Th1 and Th2 cytokines.

In addition to having known anti-inflammatory qualities, placental membrane cells, derived from the layer of trophoblast cells covering the developing embryo, do not express MHC Class II antigens, which are responsible for the rapid rejection of allografts in humans. Because AF is immune privileged, it is an ideal allograft with no known graft-versus-host disease (GVHD).

The amniotic fluid product may provide not only an anti-inflammatory response, but also potentially yield regenerative effect or reduce further cartilage degeneration.

The objective of this study is to evaluate an amniotic fluid tissue product in the treatment of pain due to all types of musculoskeletal conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and over.
2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.

4) Competent to understand the study protocol and provide voluntary informed consent.

Exclusion Criteria:

1. Active Infection
2. Pregnancy, Lactating
3. Clotting disorder
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)

Declines in serum calcium during exercise may cause increases in markers of bone resorption. This study will determine if preventing the decline serum ionized calcium experienced at the onset of exercise through the use of a "calcium clamp" also prevents increases in blood biomarkers associated with bone resorption.

Participants will undergo two identical walking exercise sessions on a treadmill. One session will occur until continuous calcium infusion and the other will be under continuous saline infusion. C-telopeptide, parathyroid hormone, total calcium, and serum ionized calcium will be monitored to distinguish differences in bone activity under the two conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 60-80 y
* Currently taking a bisphosphonate medication

Exclusion Criteria:

* Use of medications (other than bisphosphonates) in the past 6 months known to affect bone metabolism (e.g., thiazide diuretics, oral glucocorticoids)
* Bone Mineral Density (BMD) t score \< -3.0 at the total hip or lumbar spine
* Known disease or condition associated with intestinal malabsorption
* Moderate or severe renal impairment defined as an estimated glomerular filtration rate of \<60 mL/min/1.73m2 based on the Modified Diet in Renal Disease (MDRD) equation
* Chronic hepatobiliary disease, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed
* Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
* Serum calcium \<8.5 or \>10.3 mg/dL Serum 25(OH)D \<20 ng/mL; volunteers with abnormal serum 25(OH)D values may be re-considered for participation in the study if serum 25(OH)D is \>20 ng/mL after vitamin D supplementation
* Uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications
* History of type 1 or type 2 diabetes
* Cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist
* Diagnosis or history of asthma
Feasibility Study of Multidimensional Rehabilitation in the Metaverse

The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform.

The investigatorse intend to invite colorectal cancer survivors and their families to use the metaverse multi-dimensional rehabilitation platform. Interviews with users, user experience optimization of the metaverse multi-dimensional rehabilitation platform, and then evaluation of the platform through system usability evaluation. Gain insight into the experience of colorectal cancer survivors using the metaverse multi-dimensional rehabilitation platform, and understand their opinions and suggestions to explore the usability of the metaverse multi-dimensional rehabilitation platform.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing adjuvant therapy after radical colorectal cancer resection; Age over 18 years old, under 65 years old, non-pregnant; Volunteering to participate in the research of this topic; Mobile phones are available

Exclusion Criteria:

* Patients with multiple cancers; Have special dietary needs.
Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring

Evaluation of an novel smartphone algorithm designed to estimate blood pressure based on collected optical signals on patients against the reference method, (radial arterial catheter) in patients admitted in the post anesthesia care unit after major surgeries.

The purpose of the study is to compare the blood pressure values measured by a mobile application used with a smartphone and the values measured by reference method, which is the radial arterial line

Patients admitted to the post-anesthesia care unit after major surgeries (Erasme hospital)

Patient's arterial pressure will be measured with both measurement methods (novel smartphone application and the invasive arterial line).

The placement of an arterial line is standard of care in the investigators institution for patients scheduled for major surgeries. These patients spend 24 hours in the post-anesthesia care unit after their surgery for acute care management. Patient's blood pressure will be measured in parallel (same arm) with the mobile application and with the reference equipment (radial arterial line). Measures will be done during five times ( so five times one minute of recordings).

Blood pressure values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients in the post-anesthesia care unit after major surgery
* equipped with an arterial catheters for perioperative management
* Informed Consent as documented by signature
* Good understanding of written and oral speaking

Exclusion Criteria:

* Patients that cannot sign informed consent
* Patients in emergency situation, are not legally competent, cannot understand the situation
* Known contact dermatitis to nickel/chromium
* Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
* Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease

This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of adalimumab, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with acute VKH divided into two groups: adalimumab therapy group and traditional therapy group.

For adalimumab therapy group, an initial dose of 80 mg adalimumab was administered subcutaneously followed by a maintenance dose of 40 mg every two weeks, and data will be collected prospectively with regard to ophthalmologic outcomes. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to one year to determine efficacy and side effects.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of adalimumab in treatment of acute VKH.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 to 70 years of age.
2. Subjects who do not have previous, active or latent tuberculosis (TB).
3. Subject must have Vogt-Koyanagi-Harada disease less than one month.
4. Subject who were previously treated with systemic glucocorticoid less than one week.
5. Subject meets at least 1 of the following criteria:

1)patients who reject using systemic glucocorticoid because of the long-term side effects. 2)patients with other high-risk or systemic disease were limited by the use of glucocorticoid. 3)patients with a little reparation of retinal detachments after a week treatment with powerful systemic glucocorticoid(≥1mg/kg/day).

Exclusion Criteria:

1. Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
2. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
3. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
4. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
5. Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
6. Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.
Therapeutic Schools: Affect Management and HIV Prevention

Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent attending therapeutic school

Exclusion Criteria:

* Adolescent is HIV positive
* Adolescent is developmentally delayed
* Adolescent is pregnant
* Adolescent has a history of sexual crime
Latino Semaglutide Study

The purpose of this study to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as being of Hispanic/Latino ethnicity
* BMI \>30
* Age 18-75 years old
* Able to provide informed consent before any trial related activities

Exclusion Criteria:

* Current cancer treatment
* Diabetes, Type 1 or Type 2
* Eating disorders
* Medication use targeting the GPL-1 system
* In the last 30 days, attempted to lose weight by lifestyle modification alone or with the use of anti-obesity medications resulting in more than 5 pounds of weight loss.
* History of bariatric surgery
* Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped.
* Pregnant or planning to become pregnant in the next 8 months
* Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the intensive lifestyle intervention.
* Any contraindication to semaglutide 2.4 mg including personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2, hypersensitivity to semaglutide 2.4 mg or any product components.
* Any known or suspected allergy to semaglutide 2.4 mg or related products
* Previous participation in this trial, either initial screening or group randomization
A Study of Characterizing Cognitive Decline and Functional Cardiac Senescence in Healthy Korean Volunteers

* Although aging process appears to be generally characterized, investigators have been paid much attention to the specific target molecules, which leads to discover the clinical markers of the senescence. The present study is to investigate the clinical and biological profile of cognitive decline and functional cardiac senescence in healthy middle aged and elderly Korean volunteers.
* This study was conducted as a cross-sectional, single-center, comparative clinical study.
* Each volunteer was given informed consent for checking cognition and cardiac function. Blood and urine samples were collected to analyze genome, proteome, and metabolome to assess cognition and cardiac function of its muscle enzymes.

* The protocol of this study was developed as the first assessment of the three to four series of clinical research on senescence.
* This design of the study is a non-interventional, single-center, single-visit design for investigating the cognitive decline and cardiac function including heart muscle enzyme activity, which have been considered one of the key points in aging process.
* Volunteers visit the study site during the screening period, informed consent for study participation and blood draw are given respectively, then, the eligibilities are met, participants visit the study site just once within two weeks.
* The participants undergo the following five procedures for 2-3 hours; out-patient visit,

  1. additional demographic interview including covariate factors (depression status, marital status
  2. vital sign check
  3. the questionnaire for cognitive function
  4. blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
  5. electrocardiogram (ECG), then they are discharged.
* Their safety follow-up is monitored in a week (± 1 day) by a phone-call from the study associates.
* To evaluate cognitive function, several cognitive batteries were used, 3MSE (Modified-Mini Mental State Examination), ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale); for cognitive biomarkers, Apolipoprotein E, Type-3 metabotropic glutamate receptors.
* To evaluate cardiac function including its enzyme activity: HRV (heart rate variability), CRP (c-reactive protein); Cardiac Troponin T.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects \>= 45 and \<= 80 years of age
* who understands the study procedures signs informed consent forms

Exclusion Criteria:

* who \> 150 mmHg in systolic or \< 95 mmHg in diastolic blood pressure
* who \> 110 mg/dl in fast glucose level
* Smoking \> 20 cigarettes/day
* Alcohol \> 3 units/day (1 unit = pure alcohol 10 milli Liter)
* Caffeine \> 5 cups of coffee or tea/day
Pediatric Performance and Satisfaction of Oticon Medical Ponto on Softband.

The study is a non-interventional, observational, study on users of Ponto sound processors who use their sound processors on a softband solution. The purpose of this study is to assess subjective benefit by evaluating performance and overall satisfaction of the Ponto on a Ponto Softband in pediatric users.


Eligibility Criteria:
Inclusion Criteria:

* currently using Oticon Medical Ponto sound processor on Oticon Medical Softband

Exclusion Criteria:

* not
Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition

The term perceptual awareness refers to subjective experience... or the phenomenology associated with the processing of a sensory stimulus. The term metacognition refers to our ability of introspection, knowledge and control of our own cognitive processes. The objective of this research is to establish the contribution of the basal ganglia and thalamus to the perceptual awareness and meta-cognition, using deep brain stimulation coupled with electroencephalography.


Eligibility Criteria:
Inclusion Criteria:

* Major patient in need of brain stimulation therapy for motor disorders (Parkinson's disease, tremor, dystonia) or psychiatric disorders (OCD).
* Outpatient or inpatient follow-up
* Fluent in French and able to understand the study procedures
* informed consent
* Patient affiliated to social security
* Written agreement to participate in the patient's study
* Intellectual abilities compatible with the performance of cognitive or motor tasks

Exclusion Criteria:

* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturient women, mothers, etc.) who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
* Patients in whom transient cessation of stimulation is not tolerated
* Subject in period of exclusion from another study
* Subject cannot be contacted in case of emergency
* Subject under administrative or judicial supervision