cyrilzakka/clinical-trials huggingface dataset:
The Use of PRP and BMC in Patients With Internal Disc Disruption Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption

The condition being studied is chronic low back or leg pain in patients with internal disc disruption (IDD). The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).

This multi-center randomized controlled pilot trial will be the first to evaluate the response of PRP and BMC for discogenic pain by direct comparison. The investigators propose to incorporate a crossover design that compares placebo to two treatment modalities (i.e. Neutrophil-Poor PRP \[NP-PRP\] and BMC).

If the investigators can demonstrate statistically significant and clinically meaningful improvements in study's primary and secondary outcome measures, this study will have identified a natural, effective and sustainable treatment for discogenic back pain that currently accounts for the highest level of disability in US. This will help guide physicians in the choice of care between surgical and conservative treatment options when treating patients.

Eligibility Criteria:
Inclusion Criteria:

* A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without contained protrusions
* Age greater than 18 and less than 70 years
* Maintained intervertebral disc heights of at least 50%
* Pain not generated from facet joints, sacro-iliac joints or any pathology other than discogenic origin.
* Pain is not responsive to conservative treatment measures (oral medications, epidural steroid injections, physical therapy)
* Pain persists for an extended period of time (i.e., at least 3 months)
* High intensity zone (HIZ) in annular fissure detected on T2 or STIR MRI, degenerated discs or contained disc protrusions.
* No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
* English speaking

Exclusion Criteria:

* Disc extrusions, disc sequestrations, severe spinal stenosis, or severe disc degeneration with grade 5 Pfirmann index or with Modic 3 level change.
* Patient refusal
* Presence of a known bleeding disorder
* Pregnancy
* Systemic or local infection
* Presence of an unstable medical or psychiatric condition
* Prior intradiscal procedure (ie. IDET, Nucleoplasty)
* Inaccessibility to discs such as fusion
* Non-English speaking
* Prior fusion surgery
Mavacamten Pregnancy Surveillance Program

The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first)
* At least 15 years of age or older at the time of enrollment
* Informed consent or institutional review board/ethics committee-approved waiver of informed consent

Exclusion Criteria:

- None
The Effect of Stress Management Training Applied to Nurses

Perception of workload and stress are very important issues in occupational health. The aim of the study was to investigate the effect of stress management training on nurses' individual workload perception and stress. A sample of 56 nurses who agreed to participate in the study was selected by the nurses themselves as the experimental (n = 28) and control group (n = 28). The data collection tools will be applied before the intervention and after the intervention.

Introduction: The feeling of stress and individual workload perception are an uncomfortable situation for individuals, are important factors that affect the physical and mental health and quality of life of health professional. Perception of workload and stress, which are basic elements in the field of occupational health, are important factors in coping with problems arising from working conditions and increasing the efficiency of work. Increased individual workload perception and stress are quite common, especially in nurses with intense working conditions.

Aim: The aim of the study was to investigate the effect of stress management training on nurses' individual workload perception and stress using a non-randomized, waiting list comparison design.

Method: A sample of 56 nurses who agreed to participate in the study was selected by the nurses themselves as the experimental (n = 28) and control group (n = 28). In the study, stress management training will be applied to the intervention group (40 min/week and 6 weeks in total). The data collection tools will be applied before the intervention and after the intervention.

Conclusion: The main result of the study is to determine that stress management training attempt for the nurses is effective in reducing the levels of stress and workload perception in the nurses. It is thought that the results of the study will support the nurses mentally, socially and culturally and will guide the programs that will improve the occupational health of the nurses.

Eligibility Criteria:
Inclusion Criteria:

* being a nurse
* were working in the institution at the time of the study;
* not have visual or hearing disorders;
* not have any diagnosed chronic disease that potentially
* prevented participation in the study; did not have a mental health problem;
* agreed to participate in the study.

Exclusion Criteria:

* have a known physical or neurological disease
* not working in the institution at the time of the study
Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients

The purpose of this study is to determine the:

* Natural history of calcification posttransplantation
* Natural history of BMC following renal transplantation
* Reverse correlation between calcification score and aortic calcifications following renal transplantation
* Correlation of IMT, BMC, PWV and biochemical variables
* Correlation of IMT, BMC, PWV, biochemical variables and outcome
* Predictors of CV disease after transplantation
* Predictors of IMT progression, BMC loss and PWV progression after renal transplantation


Eligibility Criteria:
Inclusion Criteria:

* Incident renal transplant patients or combined renal/pancreas transplant patients
Cook Like A Boss Online: A Virtual One-week 'Camp-style' Cooking Intervention

Cook Like A Boss Online is a public engaging virtual cooking camp styled intervention evaluating an adapted theory-driven co-created intervention designed to improve perceived cooking competence.

Cook Like A Boss Online is a virtual cooking camp styled intervention, providing engaging virtual cooking activities for children to take part in safely from their homes during the COVID-19 pandemic. The online intervention is adapted from the original theory-driven, age-appropriate and co-created 'Cook Like A Boss' intervention (Dean et al., 2022), into daily cooking videos emailed to parents for children to cook along to, aiming to improve perceived cooking competence and wellbeing. Children aged 9-12 years will be recruited from across the island of Ireland (Republic of Ireland and Northern Ireland) to take part in the intervention. Due to the uncertainty of the pandemic and the need for the intervention to run five days consecutively (i.e. over a school holiday), it is deemed unethical to have a delayed intervention control group and all children will be provided the opportunity to take part in the intervention. Study outcomes include perceived cooking competence, perceived motor competence, wellbeing and process evaluation measures and will be collected at baseline and post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Within age range
* In primary school (before exposure to Home Economics)

Exclusion Criteria:

* Outside age range
* In secondary school
Lowering Serum Uric Acid to Prevent Acute Kidney Injury

Acute kidney injury is associated with a rise in serum uric acid during cardiovascular surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury. We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for acute kidney injury. The preoperative lowering of serum uric acid will reduce the incidence of acute kidney injury following cardiovascular surgery.

The study will be a prospective, double-blind, placebo-controlled, randomized, clinical trial, initiated and implemented conjointly by the Nephrology and Cardiovascular Surgery Departments at Shands Hospital at the University of Florida in Gainesville, FL. We propose to study whether lowering uric acid provides significant renal and cardiovascular protection in subjects undergoing cardiovascular surgery. Up to 30 patients presenting for elective or urgent cardiovascular surgery with uric acid level \> 6.5 mg/dl and estimated glomerular filtration of 30 - 60 ml/min will be included in the study. Patients recruitment will continue until up to 30 patients have completed the study, taking into account expected patient loss due to withdrawal of consent, incomplete study and other reasons.

Patients will be randomized to a control group or rasburicase group. Rasburicase or identical placebo will be administered to each group after randomization. A selected number of patients may undergo additional testing for mechanistic (non-clinical) secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, and
2. Undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, other CV surgery, and
3. Preoperative serum uric acid \> 6.5 mg/dL, and
4. Preoperative estimated glomerular filtration rate of \>30ml/min/1.73m2 or higher, but less than 60ml/min/1.73m2

Exclusion Criteria:

1. Prior history of allergy/adverse reaction to Rasburicase
2. History of any organ transplant
3. Preoperative intra-aortic balloon pump (IABP)
4. Known glucose 6-phosphate dehydrogenase (G6PD) deficiency
5. Current use of natriuretic peptides
Acute Response Capsaicin Flare Study

Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.

Proof of mechanism in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 50 years inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Skintype I-III with a distance from base of scaphoid to antecubital fossa \>26cm on their forearms.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
* Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months.
* 12-lead ECG demonstrating QTcF \>450 msec at screening.
* Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms.
Montelukast - a Treatment Choice for COVID-19

The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.

To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19. In this study, investigators have evaluated the effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and combination therapy.

Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously monitored throughout the study.

The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. The findings have shown that combinational therapy of ML with continuous observation of liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed COVID-19
* Patients who are not directly admitted to ICU

Exclusion Criteria:

* Patients, who were already on immunosuppressants
* Patients with age \> 80
* Patient with any known allergies to montelukast
Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain

The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms .

Chronic perineal pain is the anorectal and perineal pain without underlying organic disease, anorectal or endopelvic, which has been excluded by careful physical examination, radiological and endoscopic investigations. So, perineal and vaginal pain after vaginal delivery has been associated with tissue trauma related to operative vaginal delivery, perineal laceration, and episiotomy.

Studies assessing chronic pain after vaginal delivery report 2% to 10% of women with pain at six months and later, almost exclusively in mothers who had an assisted vaginal birth. Postpartum pain intensity is usually higher when it is related to vaginal delivery than to cesarean delivery and more severely affects the woman's quality of life and mood.

Eligibility Criteria:
Inclusion Criteria:

1. The age of the subjects will be ranged from 20 to 35 years.
2. All participants had vaginal delivery with episiotomy.
3. They are in late post partum period over 6 months
4. Their BMI will be ranger from 25 to 30 kg/m2.
5. All participants have mechanical low back pain.
6. All participants have perineal pain.
7. The Number of parity Ranged from 2-3 times.

Exclusion Criteria:

1. Females will be excluded if they have any spine or lower extremities injuries or previous surgeries.
2. Females with radicular back pain.
3. Inability to understand the written and verbal instruction.
4. Females had irregular menstrual cycle
Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest

Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Samples will be analysed in batch for biomarkers of brain injury, inflammation etc.

Primary outcome is functional outcome (modified Rankin Scale 4-6) at six months after cardiac arrest.

Secondary outcomes are neurocognitive function according to the Montreal Cognitive Assessment (MoCA), Symbol Digits Modalities Test (SDMT).

Eligibility Criteria:
Inclusion Criteria:

* Survivors of out-of-cardiac arrest who participate in the extended follow-up study of the STEPCARE trial at selected sites only

Exclusion Criteria:

* Patients not participating in the extended follow-up at participating sites
A Research Study to Test the Effectiveness of MK0217 in Patients With Paget's Bone Disease (0217-206)(COMPLETED)

To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

Exclusion Criteria:

* Patient cannot stand or sit upright for at least 30 minutes
* Patient has difficulty swallowing or problems with digestive system
Irreversible Electroporation(IRE) For Unresectable Head and Neck Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Head and Neck Neoplasms.

By enrolling patients with unresectable Head and Neck Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Head and Neck Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Head and Neck Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth

By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational soft skills program, Supported, Comprehensive Cognitive Enhancement \& Social Skills (SUCCESS), for Transition Age Youth (TAY). The first step (years 1-2) involved adapting the intervention for autistic TAY by including feedback from multiple stakeholders and developing a curriculum to be implemented in both High Schools and Transition programs for the specific needs of autistic TAY and alpha piloting it. It involved understanding further the educational context for TAY students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. Step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the TAY SUCCESS intervention and further refining the curriculum and protocols. Findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. The study results were disseminated through the ACHIEVE group as well as at conferences, website and publication.

Aim: With our ACHIEVE partners , develop the High School Supported, Comprehensive Cognitive Enhancement and Social Skills (SUCCESS) program to fit the needs of transition-age youth with ASD within the community educational system.

1. Standardize the TAY SUCCESS program by developing a facilitator manual, student workbook and corresponding support person materials.
2. Develop a training protocol that can be individualized and implemented within the HS educational system to provide initial training and ongoing coaching for educators to reach and sustain intervention fidelity.

Aim: Conduct a pilot study to examine the feasibility, acceptability, and implementation procedures (recruitment, randomization, retention \& training strategies) of TAY SUCCESS and to obtain estimates of effects to support a future large-scale effectiveness trial.

1. Examine intervention feasibility, acceptability, satisfaction, and sustainability.
2. Examine preliminary outcomes (executive functioning and social functioning)

Eligibility Criteria:
Inclusion Criteria:

* autism spectrum disorder
* 15-22 yrs
* communicative English language
* enrolled in participating high school or transition program

Exclusion Criteria:

* intellectual disability
* Other significant mental health
iSTAT Comparison Study, IRB3785

Pleural fluid glucose levels measured with bed-side point of care methods such as finger stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.

This is a prospective study which will identify patients in VAMC with a diagnosis of pleural effusion and undergoing diagnostic thoracentesis.The investigators plan to analyze the two bedside point-of-care fluid glucose testing methods (I- STAT device and finger stick glucometer) to measure pleural fluid glucose levels. The results obtained from these two methods will be compared to the traditionally in lab measured pleural fluid glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.

Exclusion Criteria:

* Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.
Myocardialbridge Bypass Graft Surgery Efficacy Verification

Myocardial Bridge Bypass Graft surgery is introduced to relieve the unmedical symptoms of patients with long-segment or deep myocardial bridge, clinical outcomes will be collected to verify the effectiveness of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with myocardialbridge requiring drug therapy or surgical intervention.

Exclusion Criteria:

* patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason
Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study

42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).


Eligibility Criteria:
Inclusion Criteria:

* single Miller I GR defects ≤3mm at upper anterior or premolar teeth
* systemically healthy
* identifiable cemento-enamel junction (CEJ)
* PD ≤3 mm

Exclusion Criteria:

* periodontal surgery experience in the past two years
* excessive contacts
* mobility
* caries
* loss of vitality
* smoking
* pregnancy