cyrilzakka/clinical-trials huggingface dataset:
Protein S100 Beta as a Predictor of Resuscitation Outcome

Management of cardiac arrest is complicated by the lack of a readily available tool identifying individuals who are likely to be successfully resuscitated. S100 beta is a protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific Enolase) is another protein that originates in the neurons themselves. In the laboratory, the concentration of these proteins correlate with evidence of brain damage after head trauma, stroke and exposure to low levels of oxygen. The concentration of these proteins in the blood of human survivors of cardiopulmonary resuscitation in humans is much higher than in patients who were resuscitated but did not survive. However, it is still unclear whether survivors from cardiopulmonary resuscitation have higher levels of these proteins in their blood if they survive with neurological injury secondary to the arrest and resuscitation.

Hypothesis: In humans, the blood concentrations of protein S100 beta and NSE during and after resuscitation can predict who will die despite cardiopulmonary resuscitation and who will survive with neurological injury secondary to the arrest and resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.

Exclusion Criteria:

* Patients with do-not-resuscitate orders or an advance directive to that effect.
* Patients with intracranial hemorrhage
Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.

The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant.

The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results.

To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists).

The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ERCP with written informed consent given
* Staff allocated in the endoscopy unit

Exclusion Criteria:

* Rejection to participate in the study
* ERCP procedures performed by fellows in training
Effect of Ankle Splinting on Vascular Function in Aging

Endothelial function of the skeletal muscle vasculature declines with advancing age. Although aerobic exercise training is commonly prescribed to combat loss of endothelial function in the elderly, the rate of compliance to training programs is low. Contrary to aerobic exercise training, stretching exercise is widely performed in elderly patients to increase muscle flexibility and to prevent muscle atrophy induced by immobilization. However, it remains unknown as to whether regular stretching of the calf muscles using ankle dorsiflexion splinting improves muscle blood flow. The purpose of the proposed work is to test the hypothesis that performance of ankle dorsiflexion splinting improves endothelial function and lower leg muscle blood flow in older adults. Ankle dorsiflexion splinting will be performed on the randomized leg for 30 minutes, 5 times per week for 4 weeks. Leg vascular measures will be performed on the splinted and non-splinted legs prior to and at the end of the 4-week intervention.

Older adults will be recruited in this study. Vascular function will be assessed before and after the 4-week ankle splinting intervention. To examine the acute effects of splinting, vascular measures will also be obtained before and immediately following 30 min of ankle splinting. All procedures will be performed at the Integrative Cardiovascular Physiology Laboratory at the University of Florida.

Participants will have one leg randomly assigned to using a splint to stretch the calf muscles 30 min per day, 5 days per week for 4 weeks, while the contralateral non-splinted leg will serve as an internal control.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 60 to 79 years.
* Women will all be postmenopausal and must not take hormone replacement therapy.
* Sedentary, defined as no regular exercise training.

Exclusion Criteria:

* No evidence of heart disease evidenced by abnormal resting ECG, angina or ECG evidence of acute myocardial ischemia during the exercise test, no history of any relevant acute cardiac event (myocardial infarction, episode of heart failure)
* No history of deep vein thrombosis.
* No history of Type I or II diabetes mellitus.
* No history for renal or liver disease.
* No history of seizures, or other relevant on-going or recurrent illness.
Sensitivity Diagnosing Traumatic Knee Injuries With and Without Injection of Blue Dye Into the Knee Joint

The purpose of this study is to determine if adding blue dye improves the saline load test, which is a way to detect a traumatic intraarticular knee injury by injecting normal saline into the knee and looking for outflow through the wound.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with diagnosis warranting elective knee arthroscopy

Exclusion Criteria:

* Pregnant women
* Decreased knee range of motion (flex \< 125, ext \<0)
* Active infection of knee joint
* history of or current intraarticular knee malignancy
* history of open traumatic injury of the knee
A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* High risk of prolonged air leak due to at least one of the following reasons:

  * Preoperative FEV1\<80%
  * DLco \< 80%
  * LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
  * Anticipation of intraoperative adhesions (ie, redo surgery)
  * Previous induction chemotherapy for locally advanced NSCLC
  * Chronic steroid use
  * Pleural mesothelioma
* Candidate to one of the following major thoracic surgical intervention:

  * Decortication
  * Reintervention on the same side of the previous intervention
  * Segmentectomy
  * Lobectomy with incomplete fissures on CT scan
* Written informed consent.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
* Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
* Known hypersensitivity to bovine proteins or brilliant blue (FD\&C Blue No.1)
Evaluating Violence Against Women Screening in Mexico

The overall goal of this proposed study is to develop the state of knowledge in the area of gender-based violence and reproductive health by conducting a randomized controlled trial to improve the health care provider's capacity to screen for intimate partner violence and to mitigate associated risk among women health clinic patrons of reproductive age (ages18-44) with recent experiences of physical or sexual partner violence in Mexico City and its surrounding area.

The specific research objectives are as follows:

1. To increase mid-level health care providers' capacity to identify Intimate Partner Violence (IPV) and assist women with risk mitigation
2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care worker screening and counselling program on (a) past year severe IPV (sexual or physical), including severe IPV; (b) reproductive coercion (c) use of community-based resources and safety planning; and (d) quality of life; versus minimum standard of care
3. To qualitatively examine which programmatic components may serve as mechanisms for observed changes stated in the second objective
4. To synthesize study findings and a) create recommendations for clinic-based intervention programs to address IPV in low and middle income countries and b) disseminate information as reports, presentation, and peer-reviewed publications


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-44
* Currently in heterosexual relationship with a male partner
* Responds in affirmative to past year sexual or physical violence

Exclusion Criteria:

* Cognitive impairment (slurred speech, inability to follow directions)
* Seeking treatment for life threatening emergency care
* Intends to relocate within 2 years.
European Database on Catheter-directed Treatment of Pulmonary Embolism.

The main goals of EuroPE-CDT is to assess the currently applied catheter-directed treatment (CTD) techniques and strategies in pulmonary embolism (PE) patients and to determine the short term efficacy and safety of this invasive procedure.

This is a prospective (and retrospective, if required data are available), non-interventional, multicenter study. We intend to obtain data on basic patients characteristics, pulmonary embolism severity, catheter-directed treatment procedures and short term outcome. We are planning to include approximately 150-200 patients suitable for analysis by the end of 2020. Anonymized data of consecutive PE patients treated with CTD in European centers will be collected in the database.

Eligibility Criteria:
Inclusion Criteria:

* acute pulmonary embolism
* catheter-directed embolectomy

Exclusion Criteria:

* appropriate data not available
An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between 6 and 17 years of age
* Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview
* Participants with a score of ≥13 on the Pediatric Anxiety Rating Scale (PARS)
* Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL and CGI-Anxiety severity of ≥ 4
* Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the Concomitant Medications section of the protocol.
* Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria

Exclusion Criteria:

* I.Q. \< 70
* DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder
* History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
* Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
* Pregnant or nursing females
* Organic brain disorders
* Uncorrected hypothyroidism or hyperthyroidism
* Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
* History of renal or hepatic impairment
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
* Current diagnosis of schizophrenia
* History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
* Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
* A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
* Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.
The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition

The aim of the study is to assess the impact of Lactobacillus plantarum 299v on nutritional status, tolerance of enteral diet and the quality of life. Administration of this probiotic may potentially improve nutritional status and tolerance of enteral diet. It also may provide positive effect on quality of life.

Study group consists of patients with cancer who are qualified for home enteral nutrition in Nutritional Counselling Center Copernicus in Gdansk. The control group will receive home enteral nutrition and placebo. The experimental group will receive home enteral nutrition and Lactobacillus plantarum 299v. The study is prospective and double-blind. The parameters for evaluation of nutritional status are: BMI, body mass analysis, level of total protein and albumin in blood serum, total lymphocyte count, NRS 2002 method. Assessment of the quality of life and tolerance of enteral diet will be done by questionaires.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 yr.,
* the presence of cancer, artificial access to the alimentary tract (naso-gastric tube, gastrostomy, percutaneous endoscopic gastrostomy, jejunostomy, microjejunostomy),
* qualification for home enteral nutrition,
* written consent to take part in the study

Exclusion Criteria:

* age \<18 yr.,
* patients requiring home parenteral nutrition,
* patients who are not being able to attend the visit in the study centre.
Presentation and Outcomes of Acute Appendicitis During COVID Pandemic

Acute appendicitis (AA) is a frequent cause of acute abdominal pain in emergency rooms around the world \[1\]. The lifetime risk of developing AA is estimated to be about 8% \[1-3\]. The severe acute respiratory syndrome SARS-CoV-2 Coronavirus (COVID-19) pandemic has raised difficult situations for healthcare systems and organizations around the world, with direct and indirect implications for patient care delivery. COVID-19 causes a wide range of clinical symptoms, including fever, dry cough, myalgia, and exhaustion, with pulmonary involvement in many cases. According to the World Health Organization (WHO), The effect of the COVID-19 pandemic on acute appendicitis and surgical care is unknown due to a lack of evidence. To see how appendicitis care has changed as a result of the COVID-19 pandemic, this study compares clinical presentation, investigative modalities, treatment procedures, and outcomes before and after the pandemic.

Acute appendicitis (AA) is a frequent cause of acute abdominal pain in emergency rooms around the world \[1\]. The lifetime risk of developing AA is estimated to be about 8% \[1-3\]. The SARS-CoV-2 Coronavirus (COVID-19) pandemic has raised difficult situations for healthcare systems and organizations around the world, with direct and indirect implications for patient care delivery. COVID-19 causes a wide range of clinical symptoms, including fever, dry cough, myalgia, and exhaustion, with pulmonary involvement in many cases. According to the World Health Organization (WHO), The effect of the COVID-19 pandemic on acute appendicitis and surgical care is unknown due to a lack of evidence. To see how appendicitis care has changed as a result of the COVID-19 pandemic, this study compares clinical presentation, investigative modalities, treatment procedures, and outcomes before and after the pandemic. This is a multicenter prospective cohort study that was conducted for patients presented with Acute Appendicitis (AA).

Eligibility Criteria:
Inclusion Criteria:

patients with acute appendicitis

Exclusion Criteria:

* patients with acute appendicitis less than 12 years
* malignant appendix
Effects of Red Wine and Cognac on Coronary Circulation

Red wine consumption is associated with reduced cardiovascular disease mortality, and the cardioprotective properties may be partly related to its ability to improve endothelial function. The purpose of this study was to determine whether moderate doses of red wine, de-alcoholized red wine and cognac improve coronary flow reserve.

Moderate consumption of red wine is associated with reduced coronary artery disease mortality. Cardioprotective effects of red wine may be partly related to its ability to improve endothelial function. Red wine increases endothelium-dependent flow-mediated dilatation of the brachial artery acutely after ingestion. Moreover, a heavy dose of red wine (ethanol 1.0 g/kg) has been shown to increase coronary flow reserve (CFR) as measured with transthoracic Doppler echocardiography. CFR depicts the relative increase of coronary blood flow in response to maximal myocardial hyperemia induced by adenosine. It is reduced in atherosclerosis and various conditions associated with the dysfunction of coronary microcirculation, such as diabetes and hypercholesterolemia.

Both ethanol and antioxidative polyphenols have been implicated in beneficial endothelial effects of red wine. However, their relative contributions remain uncertain in vivo. It has been suggested that red wine has stronger vasoactive properties than other alcohol beverages, and even de-alcoholized red wine may be sufficient to improve flow-mediated dilatation of the brachial artery. Cognac is also known to contain polyphenols, but its effects on coronary circulation have not been evaluated.

The purpose of this randomized controlled cross-over study was to determine with transthoracic echocardiography whether moderate doses of red wine improve CFR in response to adenosine in healthy humans. We also studied contributions of ethanol and antioxidants by comparing the effects of equal doses of alcoholic and de-alcoholized red wine, and cognac on the plasma antioxidant capacity and CFR.

Eligibility Criteria:
Inclusion Criteria:

* healthy males

Exclusion Criteria:

* smoking, medication of any kind
Efficacy of Iatrosedation and Music Therapy to Attenuate Dental Anxiety

Dental anxiety is a common problem encountered in the dental clinics that affect both patients and dentists. Adequate management of the dental anxiety is critical for optimal treatment outcomes of the patient. In this clinical trial, a total of sixty patients were randomly assigned to three groups as follows: Group 1, Iatrosedation, Group 2, Music Therapy, and Group 3, Control. Patients in all of the three groups underwent dental crown preparation. . To measure the anxiety levels of the patients, heart rate was measured using a pulse oximeter, and verbal rating scale scores were assessed

Dental anxiety is a common problem encountered in the dental clinics that affect both patients and dentists. Adequate management of the dental anxiety is critical for optimal treatment outcomes of the patient.

This study aims to assess the efficacy of different anxiety reduction techniques (Iatrosedation and music therapy) in adult patients for dental crown preparations.

In this clinical trial, a total of sixty patients were randomly assigned to three groups as follows: Group 1, Iatrosedation, Group 2, Music Therapy, and Group 3, Control. Patients in all of the three groups underwent dental crown preparation. To measure the anxiety levels of the patients, heart rate was measured using a pulse oximeter, and verbal rating scale scores were assessed. One-way ANOVA, Post hoc, and Spearman's correlation was used to compare the mean values of the three groups.

Eligibility Criteria:
Inclusion Criteria:

* patients who were above 18 years of age
* no systemic diseases
* no previous dental treatment experience
* showed willingness to participate

Exclusion Criteria:

* patients below the age of 18 years
* medically compromised
* previous history of dental treatment
Breathing With a Facemask Exercise Performance

This study will determine the dyspnea response in chronic lung disease volunteers during treadmill walking with and without added inspiratory resistance. This study will also determine the level of dyspnea and exercise sense of effort in individuals walking on a treadmill when elevations occur. Comparisons will be made of a participant's exercise response with and without increased inspiratory resistance. In this study, exercise performance will be analyzed based on physiological and perceptual measures. The participant will undergo two sessions: one session will be a standard exercise walking test without an inspiratory resistance; the other session will be the same standard exercise walking test while breathing with an inspiratory resistance equal to a N95 facemask (R=10-15 cmH2O/L/sec). Performance will be determined by physiological measures. Perception will be determined by scores based on numerical scales and automatically with the forehead Vitality remote monitoring sensor.


Eligibility Criteria:
Inclusion Criteria:

* Former pulmonary rehabilitation patients that are now participating in maintenance exercise classes
* Males and females with an age range of 18 years or older
* Subjects must be able to walk on treadmill for multiple sessions

Exclusion Criteria:

* The subjects in each experiment will be recruited for a distribution of gender, ethnicity and age