cyrilzakka/clinical-trials huggingface dataset:
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers

This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.

This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification 3 and 4).

A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic for up to 16 weeks.

The specific aim of the study is to assess the ability of the product to sustain an optimal dermal layer. The time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM) and safety data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
* target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
* target wound that is not amendable to primary closure
* target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
* adequate perfusion to the extremity
* laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)

Exclusion Criteria:

* untreated infection of soft tissue or bone
* untreated autoimmune connective tissue disorders
* body mass index (BMI) of ≥ 50
* undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
* active liver disease (e.g. hepatitis A-G),
* have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
* pregnant
* enrolled in any other interventional clinical research trial
* an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.
The Effect of Integrating CAMH Into PHC and Traditional Healers' Practice in Uganda: a Randomized Controlled Trial

This randomized controlled trial will compare the effect of a CAMH integration package on yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses, midwives and clinical officers who provide PHC services to children and adolescents in 42 health centers; and eligible traditional healers.

The overall goal of the study is to increase access to mental health services for children and adolescents in Uganda by improving entry through primary health care workers and traditional healers.

The main objective of the study is to measure the effect of integrating child and adolescent mental health (CAMH) into primary health care (PHC) and into traditional healers' services on CAMH case identification in 2 districts in Eastern Uganda, so as to improve entry into mental health services.

The specific objectives are:

1. To estimate the effect of CAMH integration into PHC on case identification, measured by the number of new non- epilepsy CAMH diagnoses.
2. To assess the feasibility and effect of integrating CAMH into traditional healers practice, measured by the number of CAMH referrals from community to clinics per month.
3. To assess the acceptability of CAMH integration among PHC workers and traditional healers
4. To estimate the costs associated with the integration of CAMH into PHC and traditional medicine

Eligibility Criteria:
Inclusion Criteria:

* 1. Public (government health system) 2. No psychiatric nurse allocated

Exclusion Criteria:

* mhGAP training in the previous 3 years
Salad Bars in the National School Lunch Program: Impact on Dietary Consumption Patterns in Elementary School Students

This project is a research study looking at what foods students choose and eat during school lunch and examines how salad bars impact what children eat.

This project applies a wait list control cluster randomized controlled trial to evaluate school salad bars. This project uses digital images (pictures) of labeled trays in the cafeteria before and after children eat lunch. This project also asks cafeteria workers about their thoughts about salad bars and their experiences with the salad bar program.

Eligibility Criteria:
Inclusion Criteria:

* Students: All K-6th grade students at target schools who participate in the school lunch program on rating day
* Cafeteria staff: All cafeteria personnel at the randomly selected target schools will be eligible to complete surveys

Exclusion Criteria:

* Students: Unsure sex of child
* Cafeteria staff: None
Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years

Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis. The investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the participants will be followed for an expected average of 3 years.

According to the Correa's hypothesis, the combination method using serum pepsinogen levels and serum Helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries (Korea, Japan, and China), most of the aged population are have current or had past H. pylori infection. Therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.

Eligibility Criteria:
Inclusion Criteria:

* Korean adults older than 18 year-old
* Subjects who agreed on serum pepsinogen tests, H. pylori serology, and upper gastrointestinal endoscopy on the same day

Exclusion Criteria:

* Subjects who had past history of gastric surgery
* Abnormal endoscopic or laboratory finding that require further treatment
* Any evidence of malignancy other than gastric neoplasm
Transcutaneous Bilirubinometry in Neonates With the Bilicare System

The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.


Eligibility Criteria:
Inclusion Criteria:

1. Parental informed consent
2. Male and female newborns with a GA ≥ 35 wks
3. Enrollment at age \> 6 hrs until neonatal discharge
4. Pre-phototherapy

Exclusion Criteria:

1. Infants requiring respiratory assistance (such as mechanical ventilation)
2. Severe or life-threatening congenital anomalies
3. Hematomas at the point of measurement on both ears
4. Neonates undergone blood transfusion
MISC-IPV: a Community-Based Intervention for Children Traumatized by Intimate Partner Violence

This study adapts and evaluates preliminary outcomes of the Mediational Intervention for Sensitizing Caregivers (MISC) for women and children of color who have survived domestic violence.

The investigators propose that the adverse effects of Intimate Partner Violence (IPV) trauma on children can be interrupted through an intervention that enhances maternal caregiving capacity delivered by paraprofessional caseworkers. The objective of this application is to adapt an established caregiver intervention program, Mediational Intervention for Sensitizing Caregivers (MISC), for the IPV context (thereafter named MISC-IPV). Guided by an evidence-based framework for adapting caregiver-child training programs, the investigators take a three-phase approach (Adapt, Process Evaluation, Outcome/Mediator Evaluation) with the central hypothesis that acceptability and feasibility of MISC-IPV will be demonstrated and that MISC-IPV will show positive preliminary outcomes through the mechanism of enhanced maternal caregiving. In acknowledgement of significant health disparities faced by IPV-affected African American women, the investigators will conduct our research with African American women and their children. Successful completion of the project will result in a scalable community-based approach to IPV exposure that may provide a model for future integration of child-focused work into existing woman-focused IPV programs.

Eligibility Criteria:
Mother inclusion criteria:

1. Enrolled in Harris County Domestic Violence rehousing program
2. Fluency in English

Mother exclusion criteria:

1. Active suicidality
2. Intellectual disability
3. Active psychotic disorder

Child inclusion criteria:

1. Exposure to domestic violence
2. 7-11 years old in a family

Child exclusion criteria:

1. Intelligence quotient below 75,
2. Active psychosis
3. Severe autism
4. Below age 7 or above age 11
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)

The purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector.


Eligibility Criteria:
Inclusion Criteria:

* Subject fulfills all inclusion criteria for the PS0014 \[NCT03598790\] study
* Subject is considered reliable and capable of adhering to the DV0002 protocol (eg, able to understand and complete questionnaires, willing to self-inject, able to use investigational device according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator

Exclusion Criteria:

* Subjects are not permitted to enroll in DV0002 if any of the PS0014 \[NCT03598790\] study exclusion criteria are met
Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia

To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time.


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the sarcopenia criteria established by the Asian Working Group for Sarcopenia (AWGS) in 2014
* Stable condition and generally good health status
* Good compliance and ability to collaborate well with the physician
* Undergoing hemodialysis three times per week for at least three months, with a KT/V ≥ 1.2
* No significant cardiovascular or cerebrovascular complications (such as severe heart failure, severe arrhythmias, angina, and cerebrovascular diseases)
* Patients with sarcopenia who met the clinical diagnostic criteria were selected to ensure the quality of the included patients

Exclusion Criteria:

* Inability to complete handgrip strength, 6-meter walk test, 10 sit-to-stand tests, and the use of bioelectrical impedance analysis (BIA) due to contraindications
* Coexistence of mental illness or severe cognitive or communication disorders
Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.

OBJECTIVES:

* To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL).
* To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects.
* To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell).
* To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL.

OUTLINE: This is a multicenter study.

DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping.

Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia (ALL)
* Previously enrolled in COG-9900, COG-C1991, COG-AALL03B1, COG-AALL05B1, COG-AALL08P1, or other current COG or legacy trials for ALL AND consented to submit blood and marrow samples for biological research studies
* Meets ≥ 1 of the following criteria:

  * Germline DNA that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after Day 28 of remission indication therapy, or is known to come from a sample that contained \< 10% leukemic blasts
  * ALL blast DNA that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained \> 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of ALL diagnosis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
DPBRN Development of a Patient Based Provider Intervention for Early Caries Management

This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.

Phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment).

Phase 2 - field tested the patient brochure

Phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.

Eligibility Criteria:
Inclusion Criteria:

* dentists enrolled in the Dental Practice-Based Research Network (DPBRN) who participated in DPBRN Assessment of Caries Diagnosis \& Caries Treatment and DBPRN Reasons for placing the First Restoration on Permanent Tooth Surfaces

Exclusion Criteria:

* patients under 19 years of age
The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis

Rheumatoid Arthritis is a chronic debilitating inflammatory autoimmune disease of unknown etiology .

Although the pathogenesis of Rheumatoid Arthritis is multifactorial, the contribution of cytokines is undoubtedly pivotal in the progression of the inflammatory process. One cytokine gaining recognition for its importance in the inflammatory process is Macrophage migration inhibitory factor .

Macrophage Migration Inhibitory Factor is a multipotent cytokine involved in a broad range of functions including induction of proinflammatory mediators as well as demonstrated roles in both innate and adaptive immunity. It was originally identified in the culture medium of activated T lymphocytes as a soluble factor that inhibit random migration of macrophages .

Macrophage Migration Inhibitory Factor induces synoviocytes expression of key proinflammatory genes including TNF, IL-1, IL-6, IL-8. Moreover, it also regulates the function of endothelial cells and B cells and is implicated in the control of synoviocytes proliferation and apoptosis via direct effects on the expression of the tumor suppressor protein P53. In Rheumatoid Arthritis, increased Macrophage Migration Inhibitory Factor levels have been demonstrated in serum, synovial fluid and tissue correlating with disease activity.

Hydroxyapatite 25 vitamin D3 is a hormone primarily synthesized in human skin under the stimulation of ultraviolet radiation. Beyond its endocrine role in bone metabolism, Vitamin D3 is endowed with remarkable immunomodulatory properties. The effects of Vitamin D3 on the immune system include the enhancement of microbicidal ability of monocytes macrophages and the down-modulation of inflammatory cytokines produced by T lymphocytes.

Some epidemiological studies have reported an inverse association between serum 25(OH)vitamin D3 concentrations and Rheumatoid Arthritis disease activity and severity. In addition, some studies have reported inverse correlations between serum 25(OH)vitamin D3 and circulating inflammatory markers and cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Any patient aged 18 or older
* satisfying 2010 ACR/ EULAR Rheumatoid Arthritis classification criteria will be included .

Exclusion Criteria:

* Any patient with arthritis other than Rheumatoid Arthritis
* Individuals with other autoimmune diseases
A Laboratory Model for Heroin Abuse Medications - 8

The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."

Abuse of prescription opioid medications has increased dramatically in the U.S. during the past decade, as indicated by a variety of epidemiological sources. However, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. The current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order.

Eligibility Criteria:
Inclusion Criterion

1. DSM IV criteria for opioid dependence
2. No major mood, psychotic, or anxiety disorder
3. Physically healthy
4. Able to perform study procedures
5. 21-45 years of age
6. Current use of i.v. heroin in amounts/frequencies
7. Not seeking treatment for opioid dependence

Exclusion Criterion

1. DSM IV criteria for dependence on drugs other
2. Participants requesting treatment
3. Participants on parole or probation
4. Pregnancy or lactation
5. Birth, miscarriage or abortion with 6 months
6. Recent history of or current significant violent behavior
7. Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study
8. Hepatitis with SGOT or SGPT \> 3 times normal
9. Significant suicide risk
10. Current or history of chronic pain
11. Sensitivity, allergy, or contraindication to opioids
MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus

This randomized, double-blinded, cross-over study aim to evaluate the effects of shunt treatment in idiopathic normal pressure hydrocephalus (iNPH) by measuring cerebral ventricular volume and clinical symptoms at different shunt opening pressures. Further, proteins in the cerebrospinal fluid (CSF) will be compared before and after shunt surgery.

The participants are evaluated before surgery and one month, two months, three months and three months plus one day after surgery. At each evaluation point a MRI of the brain with volumetric sequences is performed and clinical data is collected (Walking speed and steps for Time up and go, 10m walking and 3m walking backwards. Mini Mental State Examination, balance, gait, self rating of incontinence, Epworth Sleepiness Scale).

At surgery, all patients are given a ventriculoperitoneal (VP) shunt (Strata ® ) with an opening pressure setting of 1.5. After the first evaluation, one month postoperatively, participants are randomized to either a higher (2.5) or a lower (1.0) opening pressure, ratio 1:1. The opening pressure setting is blinded both for patients and the clinician during the subsequent clinical evaluations. At two months, the opening pressure is crossed over to the alternative setting (2.5 or 1.0). At three months, all participants receive the lowest shunt opening pressure (0.5) with the final evaluation the next day.

Semiautomatic measurement of the lateral as well as the third cerebral ventricles will be performed using the MRI scans and volumetric software: SyMRI (SyntheticMR AB, Linköping, Sweden)

CSF is collected at three times for each participant, from the lumbar spine pre- and 3 months postoperatively and intracranially during surgery. Further, intracranial CSF is taken through the Rickham Reservoir at the 3 months postoperative evaluation. After CSF from the participants has been collected, a single batch mass spectrometry will be performed with all the samples simultaneously.

Sample size was determined to achieve 80% power for a two tailed paired t-test for a mean change in ventricular volume of 8ml, estimated from postoperative change in ventricular volume in a previous study.

Hypotheses:

* The volume of the ventricular system in the brain decreases significantly after shunt-surgery.
* The ventricular volume is larger at high opening pressures compared to low opening pressures of the shunt.
* The decrease in ventricular volume is related to clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic normal pressure hydrocephalus and planned treatment with shunt surgery.

Exclusion Criteria:

* Ongoing anticoagulation treatment
* Ongoing Clopidogrel treatment
* Mini mental state examination results of 15 or lower.
* Contraindications to magnetic resonance imaging.