cyrilzakka/clinical-trials huggingface dataset:
Southeastern Collaboration to Improve Blood Pressure Control

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".

In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.

Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.

The study's 4 arms are:

1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques
3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.


Eligibility Criteria:
Inclusion Criteria:

* African American adults aged 19-85 years
* Uncontrolled HTN, defined as BP \>140/90 mm Hg at the time of study enrollment
* Black Belt resident
* English speaking
* Willing to work with a peer coach
* Willing to sign informed consent

Exclusion Criteria:

* Plans to move out of the area within the next two years
* Advanced illness with limited life expectancy
* Pregnant or plans to get pregnant in the next year
* Advanced chronic kidney disease (estimated glomerular filtration rate \<45 ml/min/1.73 m2)
* Unwillingness to work with a peer coach or to sign informed consent
Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?

The primary objective is to assess and evaluate the improvement of wound healing (edema at 5th day post operatively) as a primary outcome, and secondary objective is to assess and evaluate the wound closure and the decreasing of the occurrence of the oronasal fistula as a secondary outcome among children with cleft palate, using plasma rich growth factor between nasal mucosa and palatal mucosa

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy patients (American Society of Anesthesiologists -ASA I and II); not older than 6-18 months
* Patients with primary non-syndromic isolated cleft palate
* Apprehensive to be in the study.

Exclusion Criteria:

* Patients with recurrent palatal fistula
* Existence of syndromic cleft palate
* Blood diseases and platelet disorders (hematological disease)
* Systematic disease radiotherapy or chemotherapy for malignancy
A Retrospective Analysis of Patients With Full Thickness Wounds on a Case by Case Basis

To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Subjects who demonstrated characteristics of interest (e.g. healing) as determined by the PI will be chosen for case studies.

All wounds at the Southwest Regional Wound Care Center (WCC) are managed using anti-biofilm strategies. When determining the therapeutic course for a patient and his full thickness wound, all management agents that are available are considered for use; and the clinician uses his judgment to determine the most appropriate tools to use that will give the patient the most likely chance of success. Some of the agents that are used are novel, and it is appropriate to demonstrate to others the potential usefulness of these agents

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years old
* Retrospective analysis
Pilot Study of Open-label Placebo to Treat Major Depressive Disorder

Placebo pills (pills with no active ingredients) have been shown in research studies to somehow produce self-healing processes. The purpose of this study is to determine whether people will be willing to enter an open-label non-deceptive placebo treatment for Major Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in the context of a supportive physician-patient relationship.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18-60 years old.
* Current Major Depressive Disorder (MDD)

Exclusion Criteria:

* Pregnant women or women of child bearing potential not using a medically accepted means of contraception.
* Patients who are a serious suicide or homicide risk.
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
* The following Diagnostic and Statistical Manual of Mental Disorders-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last year; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; 7) acute bereavement; 9) severe borderline or antisocial personality disorder; 10) current primary diagnoses of panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD) (disorders that present as chief complaint and/or have their onset preceding the onset of major depressive disorder).
* Uncontrolled seizure disorder.
* Patients with mood congruent or mood incongruent psychotic features.
* Current use of other psychotropic drugs. Exception: Patients who have been on a stable dose for 30 days of classes of medications such as non-benzodiazepine sedatives, anxiolytic benzodiazepines, non-narcotic analgesics may be included. Flexibility will be allowed based on physician discretion.
* Clinical or laboratory evidence of hypothyroidism.
* Patients who have taken an investigational psychotropic drug within the last year.
* Patients who have not responded to two or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g.,for six weeks or more) over the past five years.
* Any concomitant form of psychotherapy (depression focused)
STRIDE: Stress Reduction in Dementia Caregivers

The investigators aim to conduct a feasibility, proof of concept randomized controlled trial (RCT) of a smartphone app intervention (Healthy Minds Program; HMP) versus Wellness app (WA) among heterogeneous stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The investigators will test its feasibility (primary outcomes) and its preliminary effect in improvement in caregiver stress, emotional distress (depression and anxiety), sleep, and mindfulness. Participants will be randomized to one of the two conditions described above

Using the NIA 2 year R21 grant mechanisms, we will examine the feasibility (markers of acceptability and demand), and proof of concept of Healthy Minds Program (HMP) versus Wellness App (WA) in decreasing stress, emotional distress and sleep dysfunction in heterogeneous, geographically diverse, stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). Participants in each arm will be asked to practice for 10 min/day.

To achieve our aims, we will conduct a single blind, pilot, feasibility, proof of concept randomized controlled trial (RCT) of HMP (12 weeks, \> 10 minutes daily) versus WA; 12 weeks, \>10 minutes daily). Assessments will be conducted at baseline, post program (12 weeks later) and at 20 weeks follow-up (\~2 months after post-test). Caregivers will also complete weekly assessments.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. English fluency and literacy
3. Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
4. Perceived Stress Scale (4 items) version \>= 6
5. Willing to be randomized
6. Care recipient must score \>1 on the functional assessment scale (FAST)

Exclusion Criteria:

1. Any planned change in psychotropic pharmacologic treatment for the duration of the study
2. Use of any consumer-based mindfulness meditation app for more than 60 min/month in the past 6 months.
3. Current participation in a meditation program (e.g., mindfulness-based stress reduction, mindfulness-base cognitive therapy, etc.)
4. Major illness known to worsen dramatically or require surgery in the next 20 weeks (study duration)
5. Active treatment for cancer (chemotherapy, radiation)
6. Imminent placement of care recipient in a nursing home or with another caregiver (within 4 months).
7. Involvement in another clinical trial for caregivers.
8. For participants age 65 and older: four or more errors on the Short Portable Mental Status questionnaire (SPMSQ)
Hamstring Active Release Technique in Cervicogenic Headache

It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. In addition, when the muscles around the neck are tensed, the muscles in the limbs are also tensed, so that if the tone of the hamstring muscles is decreased, SLR test score increased, and the tone of the sub-occipital muscles is reduced. Active release technique is found to have an effect on hamstring flexibility.

Cervicogenic Headache (CGH) is a secondary and often unilateral headache that is known by referring pain from soft or hard cervical structures to occipital, temporal and frontal regions. There are some fascial connections between suboccipital muscles with dura mater and C2 vertebra. Presumably, fascial restriction in one part of the body causes unusual stress in other parts of the body due to fascial continuity. It has demonstrated that increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. This occurs because the superficial fascial back line of the myofascial chain connects from the neck to the lower extremity, and the soft tissue in the cervical spine links the dura and suboccipital muscle fascia. Therefore, it is probable that if the tone of the hamstring muscles is decreased (passively, with a fascial treatment or with active movements), the tone of the knee flexors (hamstring muscles) is reduced and the amplitude of hip flexion is increased, thereby increasing the straight leg raise (SLR) test score. Active release technique (ART) is a type of manual therapy used for treating soft tissue injuries. Problems with muscles, tendons, ligaments, fascia and nerves are successfully treated with it and is found to have an effect on hamstring flexibility.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral headache (in the same side) related by pain, movement and sustaining position of neck started from the occiput spread to the tempro-frontal region for more than 3 months.
* Pain and tenderness at the upper cervical segment's palpation.
* Movement restriction in cervical region, especially in the upper cervical rotation.
* Positive SLR test for hamstring muscle less than 80◦.

Exclusion Criteria:

* Malignancy.
* Other types of headaches, including migraine, tension type, other serious headaches.
* History of head and neck trauma or surgery.
* Pregnancy.
* Physiotherapy for headache in the last 3 months.
Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform

This is a multi-center prospective cohort study. The purpose of this study is to investigate the relationship between bone metabolic markers and other non-traditional risk factors with kidney function progression, cardiovascular and cerebrovascular diseases, and bone loss in patients with CKD G3-5ND. In the meantime, this study is to explore a new mode of management and complication monitoring through mobile communication in chronic kidney disease patients.

Abnormal mineral bone metabolism of chronic kidney disease (CKD-MBD) is the most common complication of CKD. It involves kidney, bone metabolism, parathyroid gland, cardiovascular and cerebrovascular organs. It is an independent risk factor for progression of CKD to end-stage renal disease (ESRD), vascular and cardiac valve calcification, and cardiovascular and cerebrovascular events. However, less data concerning the relationship between bone metabolic index, such as high blood phosphorus and cardiovascular diseases, bone mass reduction and fracture is available in Chinese adult patients. This study is a multi-center prospective cohort study to explore the relationship between bone metabolic markers and other non-traditional risk factors with renal function progression, cardiovascular and cerebrovascular diseases, and bone loss in patients with CKD G3-5ND. Based on the sample size estimation, 3360 subjects should be enrolled in this study. The primary outcome is progression to ESRD (start dialysis or kidney transplantation) or doubling of serum creatinine, as well as cardiovascular events and all-cause mortality.

At present, the follow-up and the management of complications of CKD patients are not enough. The popularity of mobile communication in China provide the possibility to strengthen the follow-up and complications management in CKD patients and save human resources. This study is to explore a new mode of collecting datas through mobile communication in chronic kidney disease patients.

Eligibility Criteria:
Inclusion Criteria:

* at least two measurements of serum Cr (with a minimum interval of 3 months), , 10≤eGFR≤60ml/min/1.73m\^2

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis (HBV or HCV) services
* Acute mycardial infarction within the last six months
* NYHA Class III or IV heart failure at baseline
* Ongoing chemotherapy or immunosuppressive therapy (in the preceding 6 months to treat renal or immune disease)
* Current renal replacement therapy
* Current pregnancy or breastfeeding women
* Any organ transplantation
* Currently participation in an interventional clinical trial
The Effect of Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia

This study will be carried out with individuals diagnosed with schizophrenia who continue to community mental health. Social skills training will be applied in the study. This study will be conducted to examine the effect of social skills training on praxis and social functionality in individuals with schizophrenia.

This study will be conducted to examine the effect of social skills training on praxis and social functionality in individuals with schizophrenia. Test of Upper Limb Apraxia (TULIA) will be used for praxis assessment. Social Functioning Assessment Scale (SFAS) will be used for social functioning assessment. In this study, individuals with schizophrenia will be examined with the Model of Creativity Ability as an occupational therapy model and role playing activities will be determined according to the model. In secondary outcomes, the effect of social skills training on the symptoms of schizophrenia will be examined. therefore Scale for the Assessment of Positive Symptoms - SAPS and Scale for the Assessment of Negative Symptoms - SANS will be used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Being an individual with a diagnosis of schizophrenia registered with the Community Mental Health Center
* Volunteering for the study and having written consent

Exclusion Criteria:

* Be under the age of 18 or over the age of 65
* Having a physical disability that limits participation in group activities
Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion

TAVI has become a credible alternative to conventional cardiac surgery in aged high-risk patients with aortic valve stenosis. A large part of these procedures are performed with sedation using remifentanil target-controlled infusion plus local anesthesia. However, a significant proportion of the patients experience postoperative delirium, with subsequent worsened outcomes, time-consuming interventions, and increased costs. The use of hypnosis before and during TAVI could decrease the incidence of postoperative delirium thanks to less opioids and hypnotics consumption. Thus, the investigators ought to evaluate the potential advantages of hypnosis vs. remifentanil target controlled-infusion during TAVI procedures.

Each included patient will randomly be assigned either to the hypnosis group or to the remifentanil group. Patients of the hypnosis group will have one preoperative and one perioperative hypnosis session with a qualified anesthesiologist. Patients of the remifentanil group will receive sedation with remifentanil, administered using a pre specified target controlled-infusion protocol.

Incidence of delirium will be recorded in the cardiac intensive care unit (CICU) during the first 72 postoperative hours, using the Confusion Assessment Method in the ICU (CAM-ICU). Incidence of other complications such as episodes of oxygen desaturation, vascular wound, stroke, general anesthesia requirement and inhospital death will be recorded, as well as procedure duration, hospital length of stay, patient satisfaction and operator comfort.

Transcatheter aortic valve implantation (TAVI) procedures are frequently complicated with postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring transfemoral approach TAVI without general anesthesia
* For adult patients : age greater than or equal to 18 years
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Patient whose age is less than 18 years
* Approach with general anesthesia
* Patient not responding to Hypnosis: unmotivated, non-cooperating, not confident
* Other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure
* chronic psychosis, bilateral deafness without hearing aids,
* emergency procedure,
* inability to communicate (severe dementia, non-French speaker),
* declined participation
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV

The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs.

This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children.

This study is seeking for participants who:

* Are 1 day to less than or equal to 60 months of age
* weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms.
* Have been tested to have RSV by medical tests.
* show signs of LRTI.

All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it.

Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home.

The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.


Eligibility Criteria:
Inclusion Criteria:

* 1 day to ≤60 months of age and weight ≥2.5 kg to ≤23 kg
* Positive RSV diagnostic test, antigen or molecular test
* Evidence of Lower Respiratory Tract Infection (LRTI)

Exclusion Criteria:

* Premature infants (gestational age less than 35 weeks) AND \<1 year of post-natal age
* Neonates with intrauterine growth restriction
* Expected to receive an antiviral for another viral infection within 10 days of screening
* Suspected or confirmed clinically significant moderate or severe bacterial infection that may interfere with the evaluation of response to the study intervention
* Known to have significant comorbidities that would limit the ability to administer the study intervention or evaluate the safety or clinical response to the study intervention
Novel Biomarkers for Early Renal Injury in Children With Sepsis

Toxicosis often leads to multiple organ failure (MODS), with the kidney being the primary target organ due to its sensitivity to infection and ischemia. The kidney's vulnerability makes it a potential early indicator of organ failure, implying that further organ failure may occur later, thereby increasing the risk of patient mortality. Several studies conducted on sepsis patients in the Pediatric Intensive Care Unit (PICU) have revealed that 40.32% of sepsis patients experienced complications with acute kidney injury (AKI), and the case fatality rate could rise to 70% once AKI occurred. The Kidney Disease Improving Global Outcomes (KDIGO) scale is commonly used as a diagnostic criterion for AKI. However, the kidney's robust reserve function poses a challenge for early identification, diagnosis, and intervention of AKI since significant increases in creatinine levels and a sharp decrease in urine volume already indicate severe kidney damage. This situation calls for the development of alternative methods.

In our previous study, we discovered a strong correlation between urinary oxygen partial pressure and renal organ function impairment in children with sepsis. Building upon traditional biochemical indicators such as blood lactic acid levels, we will incorporate non-invasive tests like urine partial pressure of oxygen, renal ultrasound, and cardiac ultrasound, as well as novel markers like KIM-1, to establish a model for early recognition and assessment of kidney damage in children with sepsis. By utilizing commonly used biomarkers and the precise effects of urinary oxygen partial pressure, we aim to improve early identification and accurate intervention evaluation for pediatric sepsis kidney injury. This research will provide a crucial foundation for the development of early warning systems, diagnostic guidelines, and treatment protocols for pediatric sepsis kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* From May 2021 to December 2024, the study focused on patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days. Specifically, patients with severe infection and those who underwent pediatric neurosurgery were diagnosed with sepsis according to the international standard for childhood sepsis established in 2005, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study spanned from 1 month to 16 years old.

Exclusion Criteria:

* Children who enter PICU 24 hours and die or exit PICU within 24 hours; Genetic metabolic diseases; Congenital immune deficiency; Can't sign an informed consent form.