cyrilzakka/clinical-trials huggingface dataset:
Reliability and Validity of the Athlete Fear Avoidance Questionnaire in Turkish

High levels of fear avoidance can lead to chronic pain and disability and can predict rehabilitation time in the sports-related injury population. Therefore, taking fear avoidance into account may be useful in creating the most appropriate and effective rehabilitation plan, thus shortening the time to return to play. The aim of our study is to verify the validity and reliability of the Athlete Fear Avoidance Questionnaire (AFAQ) in Turkish.

Sports injuries are a frequent occurrence that many athletes experience annually. Although sports injuries cause physical pain and disorders, they also have a psychological impact. One common psychological response to sports injuries is the fear of re-injury. Other potential psychological reactions of an injured athlete include anxiety, depression, frustration, tension, and decreased self-esteem. Psychological responses to sports injuries are typically highest immediately after the injury and decrease during the rehabilitation process. However, they often relapse just before returning to sports. If left unaddressed, these heightened psychological responses can impede rehabilitation progress and delay the return to sport.

Currently, there are several scales available to measure an athlete's readiness to return to play, such as the Sports Inventory for Pain and the Injury-Psychological Readiness to Return to Sport Scale. However, it is important to note that some of these surveys were conducted with student populations rather than athletes. Additionally, these scales are designed to be applied at the end of the rehabilitation process. The Athlete Fear Avoidance Questionnaire (AFAQ) was specifically developed to assess fear avoidance or pain-related fear in athletes.

The fear avoidance model was developed to explain how individuals experiencing exaggerated pain perception separate 'pain experience' and 'pain behavior' from the actual pain sensation. High levels of fear avoidance can lead to chronic pain and disability and can predict rehabilitation time in the sports-related injury population. Therefore, considering fear avoidance may be helpful in developing an appropriate and effective rehabilitation plan, ultimately reducing the time required to return to play. The purpose of our study is to validate and assess the reliability of the Athlete Fear Avoidance Questionnaire (AFAQ) in Turkish.

Eligibility Criteria:
Inclusion Criteria:

* Being a licensed athlete for at least 5 years, being active in sports and training for the last 1 year, and weekly training intensity of at least 5 hours per week.

Exclusion Criteria:

* It was defined as having a history of visual, mental or systemic disease.
Protein Turnover in Healthy and Overuse-diseased Tendon

The goal of this clinical trial is to examine the regional protein turnover in tendon tissue from patients with chronic patellar tendinopathy and comparing this to healthy controls. Further we will examine the effect of resistance training on protein turnover in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Physical active men and women
* Body mass index 18,5 - 30 kg/m2

Inclusion Criteria for the chronic tendinopathy group:

* Debut of symptom \> 90 days prior to inclusion.
* Subjective activity related pain in patella tendon.
* Clinical symptoms of patella tendinopathy.
* Ultrasound verification of at least 1 in three of the following: Enchanced anterior-posterior diameter, increased Doppler signal and/or a hypoechoic area in the diseased part of the tendon.

Exclusion Criteria for all participants:

* Former knee surgery or injuries to the patella tendon.
* Local injection of corticosteroids within 12 months.
* Medication that affects protein synthesis in tendon tissue.
* Former/current use of anabolic steroids or growth hormone.
* Smoking
* Known rheumatoid disease or diabetes.
* Former participation in trials using deuterated water and 15N tracers.
* Treatment for patella tendinopathy within 3 months.
Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19

The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of hospital admission.
2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase \[RT\]-PCR) or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
3. COVID-19 illness (symptoms) of any duration, including both of the following:

   1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.) and/or clinical assessment (evidence of rales/crackles on the exam) with peripheral oxygen saturation by pulse oximetry (SpO2) \<94% on room air
   2. Any One of the following related to COVID-19: i. Ferritin \> 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) \> 300 units per liter (U/L), iii. D-Dimers \> reference range, or iv. C-reactive protein (CRP) \> 40 milligram per liter (mg/L)
4. Subjects provides informed consent prior to the initiation of any study procedures.

Exclusion Criteria:

1. Subjects requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2 ≤ 150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration \[eg, 0.21 for room air\]).
2. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
3. The subjects have had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
4. A medical condition in which the infusion of additional fluid is contraindicated.
5. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
6. Known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy.
7. Women who are pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.
8. Subjects for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
9. Currently participating in another interventional clinical trial with investigational medical product or device.
10. Subjects previously requiring long-term oxygen therapy (home oxygen therapy).
Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up

A long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography angiography (CCTA).

92 patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.

All patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography received dietary and lifestyle recommendations and were referred to outpatient specialist care at their place of residence.

As part of this study, patients will be invited for a follow-up visit consisting of a cardiological and dietician consultation and additional tests, including CCTA, to assess the long-term impact of the intervention on the progression of atherosclerotic plaques, including high-risk plaque component.

Additionally, the occurrence of cardiovascular events, change in laboratory parameters and change in body weight composition will be analyzed.

Eligibility Criteria:
Inclusion criteria:

* completion the DISCO-CT study (NCT02571803)
* willingness to participate in the long-term follow-up at site

Exclusion criteria:

* contraindications to perform coronary computed tomography angiography (history of severe reaction to iodine contrast media, uncontrolled thyreotoxicosis and/or severe renal impairment with glomerular filtration rate \< 30 ml/min)
* no consent to participate
Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH

Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device.Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure.

The primary objective of this study is to explore Vaporization efficacy and safety when treating PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with recommended settings.


Eligibility Criteria:
Inclusion Criteria:

* Subject will be older than 18 years of age
* Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
* Subject is a candidate for surgery treatment
* Subject is willing and has signed the Informed Consent Form
* AUA score ≥ 12
* Qmax \<15 mL/s

Exclusion Criteria:

* Need to perform concomitant procedure, other than prostate vaporization
* PVR \> 300mL
* Current Urine retention and Pdet \<40 cm H20
* Documented or suspected prostate cancer and / or bladder cancer
* Neurogenic bladder disorder / neurogenic voiding dysfunction
* Urethral strictures
* Previous prostatic, bladder neck, or urethral surgery
* Known history of spinal cord injury
* Urogenital trauma
* Bladder neck stricture
* Evidence of urinary tract infection
* History of chronic prostatitis
Oral Health Promotion: Youth as Agents Of Change

This upstream communication study may aid in our understanding of the nature of the parent-adolescent relationship and how we can use this relationship to promote better oral health of the parents and adolescents.

Given the proliferation of social media as a tool for health communication, this proposed pilot study will be conducted with adolescents and their parents in the greater Richmond area, including Petersburg, and examines whether disseminating oral health information to adolescents via Facebook will have a greater impact on their sharing of the message to their parents than providing them the information in written format- using a pamphlet. We hypothesize that parents in the Facebook arm of the intervention will be more likely to report receiving the oral health message from their child than those in the pamphlet arm. Further, this study investigates whether parents whose adolescents re provided the information via Facebook will have greater increase in intent to schedule dental appointments and dental appointment scheduling behaviors than parents whose children are in the pamphlet group. We hypothesize that parents in the Facebook group will report greater increase in dental appointment scheduling than those whose adolescents are in the pamphlet group. Lastly, we would like to explore whether parents and adolescents in the Facebook arm will have greater increase in oral health knowledge and greater decreases in perceived barriers to oral health activities, both which may be related to increases in parents' dental appointment scheduling.

Eligibility Criteria:
Inclusion Criteria:

* enrolled in grades 7 through 12
* between the ages of 12 and 18
* currently living in the same household as their legal guardian(s) who agree to participate in this study
* live in the greater Richmond and Petersburg area
* uses a smartphone
* has not had a dental appointment in the past 6 months

Exclusion Criteria:

* not between the ages of 12 and 18
* do not live with their legal guardian (s)
* are not residents of the greater Richmond and Petersburg area
* have had a dental appointment in the past six months
* legal guardian does not agree to participate
Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)

Guidelines lack high quality evidence on optimal postoperative chest tube and pain management after surgery for primary spontaneous pneumothorax (PSP). This results in great variability in postoperative care and length of hospital stay (LOS). Chest tube and pain management are prominent factors regarding enhanced recovery after thoracic surgery, and in standardised care they are crucial to improve quality of recovery and decrease LOS.

Historically, postoperative chest tubes are left in place for at least a fixed number of 3-5 days, irrespective of absence of air leakage. This period was deemed necessary for adequate pleurodesis and prevention of recurrence. However, it is suggested that removal on the same day of surgery is safe and associated with a reduced LOS.

Regarding postoperative pain management, thoracic epidural analgesia (TEA) is the gold standard for postoperative pain management following video-assisted thoracic surgery (VATS). Although the analgesic effect of TEA is clear, it is associated with hypotension and urinary retention. Therefore, unilateral regional techniques, such as paravertebral blockade (PVB), are developed.

The investigators hypothesize that early chest tube removal accompanied by a single-shot paravertebral blockade (PVB) for analgesia is safe regarding pneumothorax recurrence and non-inferior regarding pain, but superior regarding LOS when compared to standard conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

* All patients operated for PSP
* Age ≥ 16 years
* Able to read and understand the Dutch language
* Mentally able to provide informed consent
* Patients should have a preoperative chest CT scan in order to exclude evident secondary pneumothorax. Previously made CT scans, within a time range of maximum 5 years, are accepted. The identification of blebs or bullae on CT scan is not defined as secondary pneumothorax.

Exclusion Criteria:

* Previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only) or ipsilateral thoracic radiotherapy
* Underlying lung disease that provoked the pneumothorax (secondary pneumothorax): genetically proven Birt-Hogg-Dubé syndrome, periodic pneumothorax in female patients in reproductive age with known endometriosis (or known catamenial pneumothorax), pulmonary cystic fibrosis, active pneumonia, lung fibrosis, chronic obstructive pulmonary disease (COPD), pulmonary ipsilateral malignancy
* Contra-indications for TEA (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, sepsis and mechanical spine obstruction)
* Patients chronically (\>3 months) using opioids will be excluded since postoperative baseline opioid requirement will be higher and TEA remains the preferred technique for these patients
* Allergic reactions to analgesics used in the study
Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)

The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-SURG will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).

SMART-SURG is a large, cluster-randomized, multiple-crossover trial of 0.9% saline versus physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasma-Lyte© A) with regard to the incidence of major adverse kidney events by 30 days in patients admitted to non-medical intensive care units. All patients admitted to participating non-medical intensive care units at Vanderbilt University medical center who are 18 years or older will be enrolled. The study will occur in one-month blocks. Each participating ICU will be randomized to an initial fluid group (0.9% saline or physiologically balanced isotonic crystalloids). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of the months are assigned to 0.9% saline and half of the months to physiologically balance fluid. The primary endpoint will be major adverse kidney events by 30 days (MAKE30 is the composite of death, new renal replacement therapy, or persistent renal dysfunction at discharge). All aspects of study design, intervention, and data collection will be harmonized with an ongoing, independent study addressing the same question in the medical intensive care unit at Vanderbilt University during a similar study period (SMART-MED). A pre-specified data analysis plan will dictate the harmonized analysis of SMART-MED and SMART-SURG.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to a participating non-medical intensive care unit (ICU) at Vanderbilt University Medical Center

Exclusion Criteria:

* Age\<18 years old
PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis

Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta classification differentiates mild, moderate, and severe acute pancreatitis, and each of these categories correlates with morbidity and mortality. Mortality remains high, between 10% and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30% of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to remove the infected intra-abdominal material, preferably using minimally invasive techniques such as percutaneous and endoscopic drainage, which have been proven beneficial. In several studies biological markers such as procalcitonin and interleukin 8 were effective in predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying risk factors may help to improve standardized strategies for early diagnosis and treatment, and then patients outcome. Our primary objective was to identify risk factors for IPN in patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe the management and outcomes of IPN

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity or ICUs at the Nantes University Hospital, from January 1, 2012, to december 31, 2015. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to the development of an infected pancreatic necrosis (highly suspected or proven), and the differences of these characteristics between two groups were evaluated. Potential risk factors were collected and studied by using multiple logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>18 years) with acute necrotizing pancreatitis admitted in an ICU between January 2012 and December 2015 for moderately severe or severe acute pancreatitis were included.
* Organ failure that resolves within 48 h (transient organ failure) and/or local or systemic complications without persistent organ failure or persistent organ failure (\>48 h)

Exclusion Criteria:

* mild acute pancreatitis, defined as no organ failure or local complication (No necrosis or peri-pancreatic collection)
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Gynecological disease (benign disease)
* Patients who Written informed consent
* Patients without clinically significant lab

Exclusion Criteria:

* having enrolled another clinical trials within 1 month
* Immunosuppression or autoimmune disease
* Anticoagulant, general steroids within a week from surgery
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
* Patients with previous history of surgery at the same operate site
Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction

The purpose of this study was to perform an evaluation of the structural changes in the abdominal wall after harvesting a DIEP flap in breast reconstruction.

14 women undergoing secondary, unilateral breast reconstruction were recruited to the study and underwent a 2 year postoperative CT scan of the abdomen (without contrast).

Structural changes were assessed by comparing the abdominal CT scans performed prior to surgery with the 2 year postoperative CT scans.

The purpose of this study was to perform an evaluation of the structural changes in the abdominal wall after harvesting a DIEP flap in breast reconstruction.

14 women undergoing secondary, unilateral breast reconstruction were recruited to the study and underwent a 2 year postoperative CT scan of the abdomen (without contrast).

Structural changes were assessed by comparing the abdominal CT scans performed prior to surgery with the 2 year postoperative CT scans.

The following structural changes were evaluated at four specific levels of the abdomen by two radiologists (among the authors): 1) rectus diastasis, 2) thickness and width of the rectus muscles, 3) thickness of the adipose tissue, 4) hernias (in the zone between the xiphoid process and the symphysis).

The measurement levels chosen were: 1) 7 cm below the xiphoid process, 2) umbilicus level, 3) "central zone" (between level 2 and 4), 4) 5 cm above the symphysis

Statistical analysis were performed to see if the structural measurements were significantly different comparing preoperative CT versus 2 year postoperative CT.

Eligibility Criteria:
Inclusion Criteria:

* Secondary, unilateral breast reconstruction with a DIEP flap
* All smokers stopped smoking 4 weeks prior to surgery

Exclusion Criteria:

* Metastatic disease
* Bilateral breast reconstruction