cyrilzakka/clinical-trials huggingface dataset:
Collaborating to Implement Cross-System Interventions in Child Welfare and Substance Use

As a result of the opiate crisis, child welfare agencies have experienced an increase in the number of children in foster care as parental substance use puts children at greater risk of maltreatment. To facilitate implementation of the Sobriety Treatment and Recovery Team (START) model, this study (1) identifies collaborative strategies associated with effective implementation and service outcomes given system and organizational context, (2) uses this evidence to specify strategies and develop a decision support guide to help agency leaders select collaborative strategies, and (3) assesses the feasibility, acceptability, and appropriateness of the decision support guide.

This is a multi-staged, mixed methods study that leverages a naturally occurring policy experiment in southern Ohio. In aim 1, we will examine the collaborative strategies associated with implementation and service outcomes, given the context with 17 counties engaged in the Ohio START pilot project. We will use a convergent mixed methods design, and integrate our qualitative and quantitative data using qualitative comparative analysis. For aim 2, we will specify the collaborative strategies and develop a decision support guide using the VA's model of implementation strategy development (diagnose barriers, and convene an expert panel to design strategies). For aim 3, we assess the feasibility, acceptability, and appropriateness of the decision support guide using a sequential mixed methods design. In the first quantitative phase, we will conduct a randomized vignette experiment with agency directors in the 71 Ohio counties that are not involved in the Ohio START pilot project to compare the decision support guide with general implementation support. Our second qualitative phase (which is dominant), will examine feasibility more in-depth by piloting the guide and conducting descriptive case studies with up to three new counties.

Eligibility Criteria:
Inclusion Criteria:

* Our participants included implementation support professionals who provide training and technical assistance to child welfare agencies in Ohio that are implementing Ohio START. All individuals will be adults and recruited based on their employment/position.

Exclusion Criteria:

* Individuals who do not provide implementation support.
Effect of Hebal and Synthetic Medicamentss on Enterococcus Feacalis

this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases.

we evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases by taking three samples from root canal , the first sample after removing gutta percha from root canal system, the second sample after shaping with protaper universal files and cleaning with 2.5% sodium hypochlorite , the third sample after 7 days from application of the medication .

samples will be diluted into ten fold serial dilution and then the diluted samples will be cultured on bile esculin agar as it is selective media for enterococcus feacalis.

bacterial reduction will be determined and comparision will be made .

Eligibility Criteria:
Inclusion Criteria:

* Single rooted teeth.
* Teeth have clinical signs and symptoms of endodontic failure as sensitivity to percussion, pain, swelling or fistula.
* Teeth with radiographic features of endodontic failure as persistent periapical lesion or widening of periodontal ligament.

Exclusion Criteria:

* • Teeth with fractures of the crown or root.

  * Teeth with periodontal pocket deeper than 4mm.
  * Teeth have procedural error like ledge, broken instrument, or perforation.
The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes

The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.

The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
* Absence of orders for deployment or permanent change of station
* Willingness to recruit up to 19 patients prior to randomization
* Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Exclusion Criteria:

* Specialist physicians
* Orders for deployment or permanent change of station
* Unwillingness to recruit up to 19 patients prior to randomization
* No prior experience with management of type 2 diabetes in adults
* Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
Restoration Anatomic Acetabular Shell Revision Study

This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
* Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
* Subject is skeletally mature.
* Subject is a male or non-pregnant female.
* Subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

* Subject has a non-Stryker retained stem at the time of study device implantation.
* Subject has a Body Mass Index (BMI) \> 45.
* Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
* Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days).
* Subject has a known sensitivity to device materials.
* Subject is a prisoner.
The Effect of Technology-Based Cognitive and Artistic Therapeutic Activities on the Mental Status of Children With Cancer

This research will be carried out to determine the effects of technology-based cognitive and artistic therapeutic activities on the mental state of children receiving cancer treatment. The research will be conducted in a single-blind parallel group randomized controlled trial design. A program consisting of six two-week sessions will be implemented. The program will include many artistic activities such as therapeutic and drawing.

In the study, a program consisting of technology-based cognitive and artistic activities will be applied to children followed up with cancer diagnosis. Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 9-18,
* Those receiving cancer treatment,
* At least two months have passed since the start of treatment,
* Those who have internet access on their smartphone or computer

Exclusion Criteria:

* Those who have experienced an important life event other than illness (parents' divorce, death, moving, etc.) in the last six months,
* Those who have not received chemotherapy treatment,
* In the terminal period,
* Children with a severe psychological diagnosis
Vitamin A Supplementation in Children With Moderate to Severe COVID-19

Severe acute respiratory syndrome (SARS)-like coronavirus 2 (Sars-CoV-2) pandemia is considered to be the current major global health issue. With no specific treatment or vaccine known to be licensed, empowering the immune system to overcome the inflammatory status associated with the late stages of the disease, particularly by anti-inflammatory nutrients, is of great concern.

Effective in reducing both the morbidity and mortality of respiratory infections, including measles, vitamin A and its derivatives are reported to enhance the immune system and/or antibody response to virus vaccinations in children, particularly those with vitamin insufficiency. Retinoids are, therefore, proposed as an adjunct therapy in the treatment of COVID-19. The study is aimed to investigate the effects of vitamin A supplementation on disease improvement in pediatric and adolescent patients with either moderate or severe COVID-19 disease.


Eligibility Criteria:
Inclusion Criteria:

* 1) aged between 1-month to 18-year old (boy or girl), 2) definitive or clinical diagnosis of severe acute respiratory syndrome (SARS)-like coronavirus 2 (SARS-COV-2) infection (by either a positive SARS-COV-2 polymerase chain reaction (PCR) test or a suggestive computed tomography (CT) scan, 3) no history or evidence of cancer or renal, hepatic, endocrine or viral disorders (including HIV/AIDS), 4) no history of supplementation either with vitamin A (VA) or with a multivitamin containing VA within the last 4 months, and 5) not participated in other clinical trials.

Exclusion Criteria:

* 1) mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.
Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting

The purpose of this study is to determine whether doxycycline (Periostat) at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass (CPB).

This proposal is for a randomized, placebo-controlled, double-blinded study of the use of doxycycline in patients requiring CABG surgery. Patients will be randomized 1:1 to receive either doxycycline or placebo.

This study will be conducted in a blinded manner. The pharmacy will randomize patients and will have the randomization code. The code will only be broken in the case of an emergency and the event will be fully documented.

In addition to standard care, patients will receive oral administration of 20 mg of doxycycline or placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.

Myocardial atrial biopsies will be taken at 2 time points during the CABG procedure: during cannulation of the right atrium and 10 minutes after cross-clamp release. Tissue will be analyzed for MMP-2 and -9 activity and TnI and MLC-1 levels.

A Swan-Ganz-Catheter will be placed in the pulmonary artery over 24 hours to measure hemodynamics (LVSWI).

A coronary sinus catheter will be placed under echocardiographic guidance prior to initiation of CPB (will be removed 20 minutes after cross-clamp release).

Patients will have an additional ECG on post-operative days 1 and 3.

Additional blood will be drawn to determine doxycycline plasma levels, MMP-2 and -9 activity, total gelatinolytic activity, and levels of troponin I and T products at the following time points: pre-induction, prior to initiation of CPB, 10 and 20 minutes following the release of the aortic cross clamp (arterial and venous) and 3, 6, 24 and 72 hours post aortic cross clamp removal (venous). Each of the above samples will require 6 mL of blood for a study total of 72 mL. At the time of each blood draw we will measure and record the hematocrit value.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Aged 18 through 80 years, inclusive
* Scheduled for primary CABG surgery with CPB

Exclusion Criteria:

* Females of childbearing potential
* Emergency CABG
* Previous sternotomy
* Planned simultaneous surgery (i.e. valve repair or carotid endarterectomy)
* Myocardial infarction within 48 hours
* Pre-operative atrial fibrillation
* Pre-operative ventricular pacing or left bundle branch block (LBBB)
* Known hypersensitivity to tetracycline class antibiotics
* Renal failure requiring dialysis
Early Silent Graft Failure in Off-pump Coronary Artery Bypass Grafting: A Computed Tomography Analysis

Aortocoronary bypass surgery is one of the most common operations in the western world. The goal of the surgeon is to perform a complete revascularization of the coronary arteries with the best, available bypass material.

Aortocoronary bypass surgery can be performed with (on-pump) or without (off-pump) the heart lung machine. If the operation is performed without the heart lung machine, the heart is continuously beating while the surgeon sews the bypass to the diseased coronary artery. In randomized trials, the benefits of the off-pump technique in the hands of experienced surgeons in terms of shorter operating times, less transfusions and less pulmonary and renal complications were proven. A criticism of the off-pump technique is the reduced number of distal anastomoses, which means that fewer coronary arteries may be connected with bypass grafts because of the technically sophisticated situation. A worse quality of the connection (anastomosis) between coronary artery and bypass is often discussed, leading to a bypass occlusion already in the early stage after surgery resulting in more re-interventions on the coronary vessels. So-called silent bypass failure without clinical correlation has been examined in three relevant studies including both, the on- and the off-pump technique, with inhomogenous results. In addition to the technique, other parameters such as the degree of narrowing (stenosis) of the diseased coronary artery and collateralization of a closed coronary artery may play a role in early occlusion.

All bypass patients after off-pump surgery receive routinely a computed tomographic examination of the heart. With this method, silent bypass occlusions without clinical correlation, i.e. cardiac infarction, elevated cardiac laboratory parameters or ECG changes, can be detected easily. In case of an occlusion of a relevant bypass, an intervention before discharge can be planned and performed.

We would like to investigate the occlusion rate of this retrospective patient cohort after off-pump surgery and the potential risk factors, that may influence on early graft failure. We hypothesize, that early graft failure depends not only on the choice of the graft material, but also on the local grade of coronary stenosis, the collateralisation of occluded coronary vessels and the intraoperative flow results, as well as on the region of the target vessel.


Eligibility Criteria:
Inclusion Criteria:

* patients after off-pump coronary artery bypass grafting
* postoperative computed tomography for the evaluation of the bypass patency before discharge

Exclusion Criteria:

* Operation with a heart-lung machine
* Combined interventions
* Postoperative emergency coronary angiography
* There is a documented rejection
Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly

The goal of this clinical trial is to primarily evaluate the efficacy of AVTR101 to placebo on physical performance in sarcopenia patients.

Participants will:

Take AVTR101 or a placebo three times daily for 12 weeks Visit the clinic once every 4 weeks for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 65 years or older at the time of screening
* Appendicular skeletal muscle mass (ASM) measured by dual-energy x-ray absorptiometry (DXA), men \< 7.0 kg/m2, women \< 5.4 kg/m2
* Handgrip strength, men \< 28 kg, women \< 18 kg or 5-times sit-to-stand ≥ 12 second or 6 meter walking speed \< 1.0 m/s
* nutrition status confirmed by mini nutritional assessment (MNA) is higher than 8 at the time of screening
* body weight ≥ 35 kg and BMI is between 15\~30 kg/m2 at the time of screening
* After fully understanding the written consent, which includes compliance with the requirements and restrictions listed in the trial protocol and describes the overall nature and purpose of the clinical trial, including potential risks and side effects, the subject (or representative) voluntarily A person who signed a written consent form as

Exclusion Criteria:

* Patients with neuromuscular or nervous system diseases (e.g. Parkinson's disease, Lou Gehrig's disease, stroke affecting lower extremity function, muscular dystrophy, epilepsy, multiple sclerosis, etc.
Computerized Assessment for Patients With Cancer

This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.

* This study includes two groups of participants: 1) Clinician Participants and 2) Patient Participants.
* Patient participants will have already completed one ESRA-C 2 report, which is a usual report in the clinic. If they decide to participate in the study, that report will be used in the study as the first report (Timepoint 1). In addition, they will complete a second report (Timepoint 2) and two more reports (Timepoint 3 and 4). Timepoint 3 will be 6-8 weeks after the participants treatment begins; Timepoint 4 will be 2-4 weeks after their treatment ends.
* The Timepoint 2 report will be within 24 hours before a clinic visit. The conversation between the patient participant and the health care providers will be audio recorded.
* Half of the patient participants will also see additional information in the computer program. The patient participants that are in this group can complete as many more ESRA-C 2 reports as they wish and will be able to read additional information about managing symptoms and quality of life issues, view graphs of their reports, add journal entries, and share all their reports with caregivers.
* Clinician Participants will be asked to report brief demographics (age group, gender, race/ethnicity, position). During clinic appointments, research staff will place a 3" by 5" audio-recorder in the exam room just prior to some of the participant's visits. Recordings will be de-identified before coding.
* After these visits, a research staff member will ask the clinician participant to report briefly on their satisfaction in the visit. The participant can check their responses on a piece of paper or dictate them.

Eligibility Criteria:
Eligible clinician participants (Inclusion):

* Nurses, physicians, or physician assistants
* Perform consults/exams in clinics that have implemented routine use of the ESRA-C 2 screening tool as a standard of care

Eligible patient participants (Inclusion):

* 18 years of age or older
* Diagnosis of malignant disease
* Plan to have treatment in a study clinic
* Speak and read English at a 6th grade level or higher
Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture

The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III).

The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric hip plate and cannulated screw fixation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.

Exclusion Criteria:

* Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
the Effect of Exercise and Oral Supplement Intervention in Sarcopenia Markers in Hemodialysis Patients

Objective: To assess the effect of different post-exercise oral nutritional supplement intake timing on sarcopenia indicators in hemodialysis patients.

Study Design: 24-weeks Randomized Control Trial (RCT), includes 12-wk intervention period and 12-week follow up period.

Setting \& Participants: Maintenance hemodialysis patients who were older than 20 years old meet sarcopenia diagnosis criteria.

Intervention: Group A: During intervention period, participants have 3 times exercise program per week. Each program is 30 minutes of resistance exercise and aerobic exercise. Participants take oral supplement in 1 to 2 hours after exercise program. Group B: Participants have the same exercise program and oral supplement as Group A. However, they take oral supplement in 2.5-4 hours after exercise program. Group C: Participants only take oral supplement. Control group: Participants maintain usual diet and physical activity without any intervention.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis treatment longer than 3 months
* Hemodialysis treatment 3 times treatment per weeks
* Kt/V≥1.2 or URR≥65%
* Taking foods by oral
* Meeting the criteria of sarcopenia.

Exclusion Criteria:

* Soy allergy
* Amputation
* Significantly edema
* Receiving palliative care
* Severe angina
* Unstable arrhythmias
* Severe infection
* Heart failure (class 4 of New York Heart Association scale)
* Central venous catheter or femoral arteriovenous fistula
* Pacemaker
* Pregnancy
* Severe paleness
* Severe difficulty breathing
* Chest pain
* Hospitalization 3 months before recruited in this study
* Oral supplement intolerance diagnosed by the doctor or dietitian
* Bone injury/nerve damage/cognition impairment affecting physical activity intervention