cyrilzakka/clinical-trials huggingface dataset:
Stress Levels and Mental Well-Being Among Slovak Students During e-Learning

Introducing restrictions on human contact has been effective in preventing the uncontrolled spread of COVID-19, however, it appears to have negatively impacted mental health. Psychological problems in different age groups occur with different intensity and duration of the pandemic. This study was aimed to assess the impact of introducing distance learning (e-Learning) on the stress levels and mental well-being among Slovak Students.

Socially isolated young people, condemned to constant contact with the Internet, find themselves in sorrowful situations where their basic need were impossible. Previous studies report that university students report high levels of stress, anxiety, and depression, which affects student motivation and attitudes toward learning; however, to date, no such studies have been conducted on a population of Slovakian Students. This study considered 4 Slovak universities. Using standardized questionnaires, students' mental status during e-Learning was assessed at the beginning of the summer semester (February, March 2021).

Eligibility Criteria:
Inclusion Criteria:

* Students attending the course cycle

Exclusion Criteria:

* Inability to self-complete the research questionnaires;
* Psychiatric or psychological treatment, likewise taking medications that affect the psyche during the research project;
"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection

How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound must meet the two principles of "unobstructed drainage" and " reduced tension closure".This concept is similar to the concepts of closure of enterostomy in rectal cancer patients. It was reported that use of cross-stitch closure can significantly reduce complications of closure of enterostomy. So the investigator ever used the "cross" closure to reconstruct the perineal wound of APR, which was really decrease the complications of perineal wound. However, more clinical trails was needed to confirm the conclusion.

Perineal wound problems after abdominoperineal resection (APR) for rectal cancer is reported in up to 25%～66% of patients,if the perineum does not heal primarily, the secondary wound healing may prolong hospital stay, may necessitate surgical reintervention, and often requires intensive wound care for several months. Great efforts have been taken to reduce the complications of perineal wound of APR, but the incidence of the perineal wound complications are not effectively decreased.

It was reported that one of the most important factors to determine the primary healing of perineal wound is whether the anterior sacral drainage and perineal stump drainage are sufficient and effective or not, which is similar to the concept of closure of enterostomy.

Previously, it was reported that "cross" closure is an effective method of skin closure for stoma reversal, which allows increased surgical exposure, reduces suture, smooth drainage, aesthetic healing simplifies wound care, and gives a neat cosmetic result.

Therefore, because of the success use of "cross" closure in stoma reversal to reduce the complications of perineal wound, the investigator used the "cross" closure to reconstruct the perineal wound of APR, and it really can decrease the complications of perineal wound. However, more clinical trails are needed to confirm the conclusion.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75 years old;
2. ECOG performance status: 0-2;
3. Histologically confirmed rectal cancer or anal canal cancer;
4. Completely resected the primary tumor;
5. No evidence of distant metastasis;
6. Tolerable general anesthesia;
7. Total radiation dose of 45-50 Gy needed if the patient needs to receive routine segmental radiotherapy;
8. Provision of written informed consent.

Exclusion Criteria:

1. Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage;
2. Extralevator abdominoperineal resection needed;
3. American Society of Anesthesiologists (ASA) IV or V;
4. Combined with other tumors;
5. Severe mental illness;

(7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
Web-based Intervention to Prevent Risky Driving

The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.

The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving teen drivers licensed in the previous 90 days. The intervention will focus on promoting teen driver attention to the roadway.

The investigators will use a randomized controlled trial (RCT) experimental design for this feasibility study, randomizing to the intervention or control group. The investigators will complete a baseline assessment and follow up with participants at 1-month, 3-months and 6-months post-intervention delivery.

This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on simulated driving performance, self-reported driving behaviors, crash and citation data.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
2. Pennsylvania driver's license for 90 days or less at time of assent
3. Personal email address and computer and internet access
4. Willingness to travel to CHOP twice to complete simulated assessment
5. Ability to read and write English

Exclusion Criteria:

1. Self-reported of claustrophobia, migraine headaches, or motion sickness
2. Self-reported current pregnancy
3. . Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.

URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in human esophageal tumors. We identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent esophageal cancer
* Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*2402
* Laboratory values as follows 2000/mm3\<WBC\<15000/mm3 Platelet count\>100000/mm3 Bilirubin \< 3.0mg/dl Asparate transaminase \< 150IU/L Alanine transaminase \< 150IU/L Creatinine \< 3.0mg/dl
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal metastasis
* Decision of unsuitableness by principal investigator or physician-in-charge
An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin

The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.

The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic vists.

The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study:

* Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial.
* Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (PRV-06009)
* Must have completed the previous double-blind study to week 12.
* Provide written informed consent and authorization for protected health information

Exclusion Criteria:

* Study drug compliance less than 50% in PRV-06009
* Any ongoing serious adverse event from PRV-06009
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum.

The investigators will also examine possible associations between GLP-1 treatment and peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fMRI).

The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue exenatide (Bydureon®).

Secondary endpoints comprise both physiological/metabolic parameters and cognitive measurements:

* Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes of the HbA1c(average blood glucose levels), cholesterol and triglycerides. Moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate.
* Cerebral endpoints will be investigated via functional magnetic resonance imaging (fMRI); including potential neuroprotective effects of exenatide. The main focus is potential hippocampal volume changes and potential changes in cerebral blood flow. Functional MRI will provide this data and the images will be correlated to both cognitive tests and questionnaires.
* Cognitive endpoints comprise potential improvements in cognition with focus on specific memory tests (BACS, DART and Rey's Complex Figure) and possible improvements in subjective quality of life (questionnaires).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 65 years
* Diagnosis of the schizophrenia spectrum (ICD-10: F20.x, F25.x)both in-patients and out-patients will be included
* Current and unchanged treatment with at least one antipsychotic drug (FGA and/or SGA and/or depot treatment)
* BMI ≥30 kg/m2
* HbA1c \< 6,5 %

Exclusion Criteria:

* Substance dependence (ICD-10: F1x.2 (apart from nicotine addiction F17.2))
* Diabetes or HbA1c ≥6.5%
* Contraindications to MRI (metal implants, pacemakers, severe claustrophobia, ≥150 kg (max. bed weight in the MRI scanner))
* Previous head trauma with a loss of consciousness for more than 5 minutes
* Pregnancy (screened by urine human chorionic gonadotropin (hCG),lactation or no acceptance to use effective contraception during the intervention period
* Severe somatic disease, including inflammatory bowel disease and chronic ketoacidosis
* Allergy to exenatide
* Coercive measures according the Danish Law of Psychiatry
* conditions that according to sponsor are not congruous with participation in the study
The Integration of Physical Activity Into the Clinical Decision Process of People with Type 1 Diabetes

Every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. The purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. At least 25 people with type 1 diabetes will be asked to perform 25 sports activities of at least half an hour, wear an activity tracker (day and night) and chest strap (during sports activities), and log data on food intake, periods and type of physical activity, and feelings (e.g., sick, stress) in a diary app. Diabetes data such as insulin administration and sensor data will be collected through diabetes management platforms. The primary endpoint involves a database containing data on glucose, insulin administration, physical activity, and food intake of people with type 1 diabetes for statistical analyses and visualizations regarding the relationship between physical activity and blood glucose response.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* 18-80 years old
* Type 1 diabetes ≥1 year
* Using a CGM for more than 6 months
* Using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months
* No use of adjunctive therapies, such as SGLT2-inhibitors or GLP-1 analogues
* No known diabetic gastroparesis
* HbA1c of the last two diabetes consultations are both \<10%
* Being physically active at least twice a week on two separate days for 30 consecutive minutes

Exclusion Criteria:

* Age \<18 years or \>80 years
* People with type 2 diabetes, people with secondary diabetes
* Begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion
* Not using CGM prior to inclusion
* Known diabetic gastroparesis
* HbA1c \> 10% during one of the last two diabetes consultations
* Not willing to use an activity tracker, the diary app or the food app
* Not being physically active on a regular basis
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
* A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
* Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
* Written informed assent obtained from the subject if/as required by local regulations.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject

  * Has practiced adequate contraception for 30 days prior to vaccination, and
  * Has a negative pregnancy urine test on the day of vaccination, and
  * Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Child in care
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Fever at the time of enrolment.
* Acute disease at the time of enrolment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Ongoing aspirin therapy.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).

Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Clear cornea
* Pupil mydriasis ≥ 7mm
* In the bag Intraocular Lens (IOL)

Exclusion Criteria:

* Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
* Previously operated eye
* Proliferative diabetic retinopathy
* Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis
Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

Lumbar discectomy study, collection and evaluation of incidence of large annular defects.

This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18-75 years of age, and skeletally mature
2. Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1.
3. Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
4. Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

1. Prior surgery at the index lumbar vertebral level.
2. Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
3. Morbid obesity (BMI ≥ 40 kg/m2)
4. Investigational drug or device use within 30 days
Predicting Concussion Outcomes with Salivary MiRNA

The purpose of this study is to identify changes in salivary ribosomal nucleic acid (RNA) expression that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.

The purpose of this study is to characterize longitudinal salivary RNA expression in 600 children with mTBI and identify RNA patterns that predict length and characterof concussive symptoms, as well as the response to therapy.

Hypothesis: Specific RNAs will be differentially regulated in children with prolonged mTBI symptoms across the acute and sub-acute time periods. The investigators predict that a set of RNAs with differential expression in children with mTBI will be statistically associated with functional measures of mTBI symptoms as well as the duration of concussive symptoms.

Rationale: Preliminary studies show that miRNA is altered in adults with varying degrees of TBI and that salivary RNA is altered by disorders of the CNS. These studies indicate that serum-based miRNA may be used as an accurate biomarker for differentiating adults with and without TBI. Whether similar patterns can seen in the saliva of children following mTBI remains to be seen. Furthermore, the influence of confounding variables such as gender, mechanism of injury, and previous mTBIs on RNA profiles has not been explored. The investigators propose to investigate these questions by examining salivary RNA from 600 children (ages five to twenty-one years) with a clinical diagnosis of mTBI (as well as 100 age-and gender-matched controls, recruited from the Penn State Pediatric Concussion Clinic, Emergency Department, and the affiliated primary care clinics). The investigators plan to prospectively follow 600 children with mTBI for 1-month post-concussion, tracking subjective symptoms with the Child Sports Concussion Assessment Tool (SCAT-5), and objective symptoms of balance and cognition. Saliva will be collected via swab at three time-points (at initial clinical presentation, 1-2 weeks, and 4-weeks after the date of initial mTBI). Expression of salivary RNA taken at initial presentation will be compared against symptom duration (where prolonged post-concussive symptoms are defined as those lasting \>4 weeks) and character (as measured numerically by Post-concussion symptom inventory self-report and ClearEdge scoring). The investigators plan to identify a set of salivary RNAs that can easily be used to predict clinical course for pediatric patients following a diagnosis of mTBI.

Eligibility Criteria:
Inclusion Criteria:

* 5-21 years with mild traumatic brain injury that occurred within 7 days of enrollment

Exclusion Criteria:

* Sever traumatic brain injury
* Skull fracture
* Concurrent upper respiratory infection
* Patients whose primary language is not English
* Periodontal infection
* Wards of the state
* Ongoing seizure disorder,
* Drug or alcohol dependency
Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System

The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine clinical practice following FDA pre-market approval of the System. Outcomes will be reported up to 5 years following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent on-label treatment (as defined below) with the Beta-Cath™ 3.5F System (30, 40 or 60mm) for in-stent restenosis (ISR) after coronary stenting.

  1. On-label treatment for the 30 and 40mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with discrete lesions (treatable with a 20mm balloon) in reference vessel diameters (RVD) ranging from 2.7mm to 4.0mm
  2. On-label treatment for the 60mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with lesions \<40mm in length in RVD ranging from 2.7mm to 4.0mm
* Patients must have undergone brachytherapy treatment at least 6-8 months prior to enrollment in this retrospective study and the date of their treatment must be:

  1. On or after February 8, 2002 for the 30/40mm 3.5F System
  2. On or after June 25, 2003 for the 60mm 3.5F System

Exclusion Criteria:

* Patients who do not give informed consent
* Patients who do not meet the inclusion criteria