cyrilzakka/clinical-trials huggingface dataset:
Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection

The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from approximately 40 chronic HBV for biomedical research program led by VGTI Florida.

During chronic HBV infection, a dynamic balance between viral replication and the host immune response is pivotal to the pathogenesis of liver disease. HBV specific T-cell function is impaired in patients with chronic HBV infection characterized by low levels of antiviral cytokines, impaired cytotoxic T lymphocyte activity, and persistent viremia. However, the mechanism underlying this T-cell malfunction in chronic HBV infection has not been completely understood.

The biomedical research on the samples obtained during this study will include, among other studies, advanced flow cytometry to study the Treg and activation markers, negative regulatory molecules and phenotype of CD4 and CD8 subsets using the extended panel markers developed at VGTI Florida. Additional antibody panels for measuring functional CD4 responses by ICS, DC subsets, activation, and signaling pathways by phos

Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic HBV infection documented by presence of HBsAg for at least 12 months currently untreated for HBV infection or under stable antiviral therapy

Exclusion Criteria:

* Prior use of HBV therapeutic vaccine
* Currently treated with interferon alpha or other immune modulator(s)
* Acute HBV infection
* Chronic inactive HBV carrier
* under an acute flare/reactivation of HBV infection defined as symptoms of acute hepatitis and recent elevation of aminotransferase (over 10 x ULN) or bilirubin levels
* Known co-infection with HCV, HDV, and/or HIV
* Under renal dialysis
* For female patients, pregnant or breastfeeding
* Cirrhosis, hepatocellular carcinoma or liver transplantation
* active autoimmune disease including autoimmune hepatitis
The Role of Sedation Technique in EBUS-TBNA

There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).

The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up.

Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes were enrolled. Demographic and clinical data, procedural reports and cytological findings were collected from medical records. Computed tomography (CT) or PET/CT scans were prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and radiological follow-up data.

Eligibility Criteria:
Inclusion Criteria:

* EBUS-TBNA

Exclusion Criteria:

* No exclusion criteria
Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease

The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.

Persons with Parkinson disease will be enrolled to determine the effects of a community walking program with a music-based device on adherence, quality of life, walking speed and walking activity. The walking program will be carried out independently by participants in their home/community environment. Noninvasive functional assessments commonly administered in clinical practice will be used to measure the variables of interest.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic, typical Parkinson disease.
* Modified Hoehn and Yahr stages 1-3 per physical exam.
* Able to walk independently without physical assistance or an assistive device.

Exclusion Criteria:

* Diagnosis of atypical Parkinsonism.
* Moderately or significantly disturbing freezing episodes during daily walking.
* Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
* Significant hearing impairment.
* Currently participating in physical therapy.
* Cardiac problems that interfere with the ability to safely exercise.
* Orthopedic problems in the lower extremities or spine that may limit walking distance.
ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing.

The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.

First study of ADX48621 in male and female Parkinson's disease patients with levodopa-induced dyskinesia. Four weeks, double-blind, placebo-controlled dose titration from 50 mg once daily up to 100 mg three times daily, at the start of week 4. Safety and tolerability assessed by adverse events enquiry, heart rate and blood pressure, 12-lead ECG, haematology and biochemistry. Efficacy assessments include Abnormal Involuntary Movement Scale (AIMS), Unified Parkinson's Disease rating Scale (UPDRS) patient PD symptom diaries, Hospital Anxiety Depression Scale (HADS), patient and clinician global impression of change in PD and dyskinesia (PGIC and CGIC).

Eligibility Criteria:
Inclusion Criteria:

* outpatient with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
* experiences moderately disabling dyskinesia (screening visit UPDRS 33 score≥2)
* has an mAIMS score at baseline ≥ 7 with a score ≥ 3 in at least one body area

Exclusion Criteria:

* surgical treatment for Parkinson's disease (e.g. Deep Brain Stimulation, within the last year or planned during the study)
* unstable co-existing psychiatric disease including cognitive impairment that, according to the Investigator, could interfere with the conduct of the study
* has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
* is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening

Other protocol-defined inclusion and exclusion criteria may apply
Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

People with a spinal cord injury (SCI) characteristically have low levels of high-density lipoprotein-cholesterol (HDL-c; "good cholesterol") and high levels of low-density lipoprotein-cholesterol (LDL-c; "bad cholesterol"), and are at a higher risk of developing cardiovascular health problems, such as heart disease, heart attack and stroke, than the able-bodied population. A common way for able-bodied people to improve their lipid profile is through exercise; however, SCI people, especially tetraplegics, are often unable to achieve and maintain a level of exercise needed to obtain these benefits. It is therefore clinically important to find an effective, safe and inexpensive method of increasing HDL-c levels in people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of cardiovascular health issues.


Eligibility Criteria:
Inclusion Criteria:

* Having chronic tetraplegia (at least on year since injury)
* 18 years or older
* Having below normal fasting blood plasma levels of HDL-c (\<1 mmol/l)

Exclusion Criteria:

* Currently taking omega-3 supplements
* Currently taking medications for abnormal cholesterol
* Having a heart attack or stroke in the past one year
Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects must have a PiZZ genotype confirmed at screening
* Plasma AAT levels indicating severe deficiency at screening

Key Exclusion Criteria:

* History of a medical condition that could negatively impact the ability to complete the study
* Solid organ, or hematological transplantation or is currently on a transplant list
* History of use of gene therapy or RNAi therapy at any time previously

Other protocol defined Inclusion/Exclusion criteria may apply
Rare Glycogen Storage Diseases Natural History Study

The purpose of this study is to collect and study key medical data about several ultra-rare GSDs (Glycogen Storage Diseases) including, but not limited to, GSD types 0a, 0b, VII, X, XII, XIII, XV, PRKAG2 syndrome and Danon disease.

The immediate goal of this research is to create a natural history database to collect information from individuals who have a rare GSD. A repository of clinical, laboratory, and biochemical information on individuals with a rare GSD will allow a more definitive description of the different subtypes to be developed, which will permit development of treatment strategies in the future.

Duke will be the only site where this study takes place. However, since these are rare disorders, participants who receive care at other institutions will be included. The investigators will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of their disorder. Prospective data collected from patient charts after enrollment will be captured as well. Participant's medical records will be continually reviewed for the duration of the study.

Data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver, muscle, and nerve function testing, and urine and blood laboratory results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a rare GSD, including 0a, 0b, VII, X, XII, XIII, XV, PRKAG2 syndrome or Danon disease

  * Two variants in the gene associated with the specific GSD type (for autosomal recessive diseases)
  * One variant in the gene associated with the specific GSD type (for autosomal dominant or X-linked diseases)
  * Deficient enzyme activity in liver, muscle, skin fibroblast or other tissue
  * One variant in causative gene with evidence of disease, per a clinician
  * Histology as confirmed by a clinician
* Able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative)
* Able to provide consent for release of medical records
* Pregnant women with a diagnosis of a rare GSD will be included

Exclusion Criteria:

* Unable to provide informed consent for participation for one's self or by legally authorized representative/legal guardian/parent
Effect Psychological Triaging Intervention on Students' Psychological Distress and Resilience Capacity

This study aimed to investigate the effect of the psychological triaging intervention (PTI) on the psychological distress and resilience capacity levels among the intern-nursing students during the COVID-19 crisis.

Research Hypothesis

Intern-nursing students who attend PTI exhibit lower COVID-19 related psychological distress level and higher resilience capacity than those who receive routine psychological support.

The intern-nursing students' psychological well-being and resilience are of indispensable significance during these unprecedented days. 64 Intern-nursing students. Sixty-four intern-nursing students who completed a preliminary survey and demonstrated both high level of psychological distress and low resilience capacity as a result of their exposure to patients with COVID-19 during their internship period were randomly assigned to two equal groups and the study group were engaged in the PTI intervention which followed the path of RAPID Psychological First Aid model.

The PTI intervention followed the path of RAPID Psychological First Aid model of John Hopkins University (Everly\& Lating 2012). The content of the PTI represents a simple structure that is revolved around five core phases including (R: establishing rapport and reflective listening, A: assessment, P: prioritization, I: intervention and D: disposition\& follow up).

Eligibility Criteria:
Inclusion Criteria:

* Exposed to patients with COVID-19

Exclusion Criteria:

* Did not exposed to patients with COVID-19
Periareolar Approach in Minimally Invasive Cardiac Surgery

Overall Goal: To study the feasibility and safety of "periareolar minimally invasive surgery" protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach).

* Objective1: Test the hypothesis that, the periareolar approach is more feasible and safer than the inframammary approach.
* Objective2: Identify risk factors that are predictive of the need for periareolar approach.
* Objective3: Assess outcomes and postoperative results of both periareolar and inframammary approach.

The first successful cardiac operation was performed in 1896, in Germany by Rehn (1), followed by the first successful cardiac valve operation in 1912 by Tuffier (2) and the first successful mitral valve operation in 1923 (3).

In 1956, Lillehei repaired multiple valvular lesions through a right thoracotomy using cardiopulmonary bypass (4).

In the 1990s, the success of laparoscopic operations in general surgery renewed an interest in minimally invasive approaches for cardiac surgery. Navia and Cosgrove (5) and Cohn et al. (6) performed the first minimally invasive valve operations via the right parasternal and transsternal approaches. Remarkably, excellent exposure was achieved through smaller incisions, thereby making complex valve repair possible and safe.

In 1996, Carpentier et al. (7) performed the first video-assisted mitral valve repair through a minithoracotomy using ventricular fibrillation. With more experience, video-assisted, 2-dimensional endoscopes and robotics were introduced by Carpentier (7) and Chitwood (8,9).

In 2009 Poffo et al (10,11) describe a new technique of minimally invasive cardiac surgery. He and his colleagues adopting periareolar access for mitral valve surgery since 2006 and published this technique in 2009.

However, due to its feasibility and safety, was soon incorporated as an ideal access for other cardiac pathologies such as tricuspid valve disease, atrial septal defect, atrial fibrillation, and pacemaker leads endocarditis. This led Poffo and his colleagues to publish a long-term result on his technique in 2018 supporting the use of periareolar access as a routine surgical technique for correction of several cardiac pathologies, especially in women. (12)

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoes mitral or tricuspid valve surgery.
* lesion of right side of the heart.

Exclusion Criteria:

* patients undergoing aortic valve or CABG surgery.
* surgery of left side of the heart.
Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?

The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.

Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective open or laparoscopic colectomy
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Participation in concurrent intervention trials
* Need for a stoma
* Known hypersensitivity or allergy to coffee
* Expected lack of compliance
* Impaired mental state or language problems
* change in surgical procedure
Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA)

Laparoscopic cholecystectomy is a frequently performed surgical procedure and is considered the gold standard for treating symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain can impair recovery quality and increase the risk of postoperative pulmonary complications as a risk factor for chronic pain development. Multimodal analgesia, including opioids, is used to limit pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.

Nerve blocks provide better pain control, reduce opioid consumption in the postoperative period, and offer advantages such as fewer side effects and a lower risk of pulmonary and cardiac complications.

In our clinic, a multimodal analgesia approach is preferred for patients undergoing laparoscopic cholecystectomy. In addition to intravenous analgesic agents, peripheral nerve blocks are administered based on patient preference (for all eligible and consenting patients).

This study aims to compare the postoperative analgesic efficacy of the Transversus Abdominis Plane (TAP) Block and the Modified Thoracoabdominal Nerve Block with a Pericostal Approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. Standard analgesic methods are applied to patients who do not consent to peripheral nerve block administration.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* Body mass index 18 to 30 kg/m2
* Elective laparoscopic cholecystectomy surgery

Exclusion Criteria:

* Under 18 and over 65
* ASA score IV and above
* Advanced co-morbidity
* History of bleeding diathesis
* Patient refusing the procedure
* Chronic opioid or analgesic use
* Patients who will operate under emergency conditions
* Block injection site infection
* Known allergy to local anesthetics
* Pregnancy
Face-to-face Intubation in Morbidly Obese

Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. In immobilised trauma victims, with limited access to the head, suspected cervical spine injury or in sitting positioned patient an intubation performed by a person standing in front of a patient might be the only chance of airway management. Moreover, in case of general anesthesia in bariatric patients, face-to-face (inverse) method is increasingly being considered due to upper body elevation position, recommended in this group of patients.

This was a parallel randomised controlled trial in patients scheduled for planned sleeve gastrectomy in Barlicki University Hospital, Lodz, Poland. Randomization and allocation to trial group were carried out by drawing envelopes by independent observer before a procedure. Randomized and recruited participants were 76 adults (typical intubation n= 36, face-to-face intubation n=40). Main outcome was a time of intubation using Airtraq video laryngoscope measured by independent assistant.

Aim : The aim of the study is to evaluate the effectiveness and safety of face-to-face intubation in airway management.

Methods : Patients admitted to hospital for elective sleeve gastrectomy procedure will be included in the study protocol. Before induction of anaesthesia the draw of the method will be held. The choice of method of intubation (inverse or typical) will be random.

1. All patients will be positioned with the elevation of the upper body about 30 degrees. The standard anesthesia monitoring involves electrocardiogram, pulsoxymetry, non-invasive blood pressure and end-tidal carbon dioxide.
2. Patients will be pre-oxygenated for 5 min. with 100% oxygen using facemask.
3. The induction of general anesthesia will be performed by the intravenous administration of 1-2 µg.kg-1 of fentanyl and 2-2,5 mg.kg-1 propofol.
4. After mask ventilation possibility is confirmed, rocuronium in a dose of 0,6 mg.kg-1 will be given.
5. After obtaining an optimal muscle relaxation (90 s.) patient will be intubated. In face-to-face method an anesthetist is standing in front of a patient. In typical intubation an anesthetist is standing behind the patient's head.
6. In case of prolonged face-to-face intubation (\>120 s) or 2 unsuccessful attempts, patients are supposed to be intubated in a traditional way with the same video laryngoscope.
7. General anesthesia will be continued with desflurane and a mixture of the oxygen and air, volume-controlled ventilation parameters will be adjusted to age and ideal body weight.

Eligibility Criteria:
Inclusion Criteria:

1. BMI \> 40 kg.m-2
2. Patients qualified for planned sleeve gastrectomy.
3. Patients of I and II class of ASA scale.
4. Patients without history of difficult intubation.

Exclusion Criteria:

1. Patients in life threatening states.
2. Patients of III, IV, V and VI class of ASA scale.
3. History of difficult intubation.