cyrilzakka/clinical-trials huggingface dataset:
Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)

Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.

Breath analysis offers a unique opportunity to non-invasively retrieve unlimited samples of relevant information on the ongoing internal biochemical processes, as parts of the most volatile components in blood reach the gas phase and are subsequently exhaled (e.g. detection of ethanol in breath). Analysis of exhaled breath provides biochemical information about the metabolism and the pathophysiological state. Chemical analysis of exhaled breath with mass spectrometry identified numerous volatile organic compounds (VOCs) \[low molecular weightcomponents:\< 500 Dalton (Da)\]. Using Big Data analytics, specific patterns of diverse respiratory disease (e.g. for COPD and asthma) can be identified and the different diseases can be distinguished from each other. Specific Big Data Analytics might also improve the management of disease (e.g.avoiding of exacerbations) by identifying early signs of exacerbation risk.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years at study entry

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Known pregnancy
Mobile Application For Educating Diabetics About Foot Care

Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels.

The universe of this randomized controlled study consisted of 130 patients who had presented to a training and research hospital in Istanbul. The data were collected during the period March-September 2017 with an Information Form, the Diabetic Foot Knowledge Scale, Diabetic Foot Care Self-efficacy Scale, Foot Self-care Behavior Scale and a Feedback Form on the Mobile Application Training.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as a Type 2 diabetic according to ADA criteria at least six months prior to the study,
* being 18 years of age and over,
* being literate and fluent in Turkish,
* not having an active foot ulcer,
* owning and being able to operate a smart phone,
* not having any communication or mental problems,
* consenting to participating in the research.

Exclusion Criteria:

* Patients with advanced retinopathy and those wishing to withdraw from the research were excluded from the study.
Data Sharing Project Part 2

Patient data from clinical records are increasingly recognised as a valuable resource and a number of global initiatives exist to promote and enable the sharing of data. However, some mental health service-users have expressed concerns about the use of their data by services, but these have not been explored in depth and the acceptable limits of data sharing remain unclear. The purpose of the study is to present different approaches to data sharing, with examples taken from across the world, varying in levels of anonymity and amounts of data stored and shared, with a view to extracting relevant principles directly from mental health service users. The primary objective of this study is to understand from service-users the limits of acceptable pseudonymised data sharing and data collection methods. This will inform the wider scientific community about any emerging questions and issues on pseudonymised clinical data sharing. We aim to explore the level of benefit service-users would accept, in exchange for the level of pseudonymised data they provide. Additionally, this study aims to investigate what service-users consider "identifiable" data, for example whether they consider demographic or location data or purely their real name to be identifiable. This study will ensure service-user views are an integral contribution to future pseudonymised data sharing systems, maximising applicability and acceptability. This study will use qualitative methods, in the form of focus groups, to gather service-user views. Focus groups will consider what participants believe to be identifiable data, who should get access, how should individuals and/or companies get access, how should data be protected and whether these answers change if pertaining to mental health information. Focus group data will be analysed using thematic analysis. Themes produced will be presented to participants in a second focus group. Participants will be encouraged to expand or change anything.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who have experience of using mental health services or experienced mental health difficulties in the past.
* Aged 18 and above.
* Able to give informed consent.
* Ability to speak fluent English.

Exclusion Criteria:

* If identified through C4C, participants whose care team specify concerns regarding taking part in the study.
* People in whom significant concerns have been raised relating to risk, where risk refers to the extent to which an individual poses a threat to themselves (e.g. self-harm or suicidal intent).
* Inability to give informed consent, as judged by the clinician responsible for a service user's ongoing care, where applicable.
Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.

This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
* Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
* Age ≥ 18;
* Able to provide written informed consent.

Exclusion Criteria:

* Implanted electronic device (e.g., pacemaker, neurostimulator);
* Pregnancy;
* Major psychiatric or medical condition that could interfere with study participation;
* Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
* Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score \< 4 (scale: 0-5);
* History of seizure during year before stroke or \> 1 post-stroke seizure;
* Significant cognitive or language impairment that would interfere with informed consent or study participation;
* Severe dysphagia;
* Bradycardia defined as resting heart rate \< 50 bpm;
* Nonsustained ventricular tachycardia;
* Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome);
* History of asystole;
* History of recurrent vaso-vagal syncope;
* Hypotension defined as blood pressure \< 90/60 mmHg.
Early Extubation and Postoperative Complications After Liver Transplantation

This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Intensive care unit (ICU) extubation group: delay extubation in the ICU following liver transplantation. The primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.

Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study. Inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. Exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (West Haven criteria III or IV); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. The primary objectives was a composite of 30-day all-cause mortality, in-hospital AKI, or in-hospital moderate to severe pulmonary complications. Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery. The secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, ICU and postoperative hospital lengths of stay, and total hospital cost.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Undergoing liver transplantation

Exclusion Criteria:

* Re-transplantation
* Multi-organ transplants
* Intra-operative deaths
* severe encephalopathy (West Haven criteria III or IV)
* patients who had preoperative mechanical ventilation or fulminant hepatic failure
* Incomplete clinical data
Traumatic Hemothorax Drainage and Daily Lavage: Pilot Study

This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

This hemothorax (HTX) treatment study will evaluate the effects of chest tube size and daily lavage on HTX management outcomes. A total of 20 stable trauma patients requiring a chest tube for HTX will be recruited and consented. These patients will then undergo either 28Fr or 14Fr chest tube placement, depending on the preference of the treatment team at the time of placement. The study will include 10 patients with each type of chest tube (28Fr and 14Fr). Daily lavage will then be performed at 24h and 48h post-placement. Patients will be compared to historical control patients from the trauma registry who received either 28Fr or 14Fr chest tube placement followed by an initial lavage only. The primary endpoint will be the need for additional interventions such as tPA, additional chest tubes, thoracoscopic surgery (VATS), or thoracotomy. Secondary endpoints will include X-ray appearance at 72 hours, volume of HTX on CT at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide consent for the research study
2. More than 15 years of age
3. Presence of acute traumatic HTX or HTX-PTX diagnosed on chest CT scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 mL)
4. Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
5. Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
6. Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.

Exclusion Criteria:

1. Less than 15 years of Age
2. Prisoner
3. Pregnant due to the risk of CT scans
4. HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment
5. Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging
Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy

The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy.

External oblique intercostal plane block (EOIPB) was reported by Elsharkawy et al . It is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , EOIPB has the benefit of being performed when the patient is supine. It also has an advantage over serratus intercostal plane block (SIPB) in that it produces greater analgesia throughout the midline of the abdomen.

Dexmedetomidine is used for sedation in patients admitted to the intensive care unit (ICU). Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression . Several studies have shown that dexmedetomidine has an anesthetic sparing effect, which has led to its use as a general adjuvant for prolonging peripheral nerve block duration.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II-III.
* Scheduled for splenectomy.

Exclusion Criteria:

* Body mass index (BMI) ≥35 kg/m2
* History of abdominal surgery.
* Infection at the injection site.
* Drug abuse.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Pregnancy.
* Severe cardiovascular problems.
* Diabetic neuropathy.
Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults

The study aims to evaluate, for the first time, the post-prandial effects of a single oral administration of Serendipity Berry Sweet Protein sweelin® compared to glucose and stevia, as a commercial sweetener, in healthy adults. The study design is a single center, randomized, crossover study.

Each subject will receive a single oral dose of sweelin® compared with an equivalently sweet dose of glucose and stevia dissolved in a water beverage with flavor.

The advantage of a crossover design is that it will allow to compare the blood glucose and insulin levels of each subject to his baseline in every test beverage, and to remove the inter-subject variability. The post-prandial effects will be monitored with multiple blood sampling up to 120 minutes post dosing.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects
2. Age 18-70 years
3. BMI between 18.0 and 33.0 calculated as Weight (Kg)/Height (m2).
4. Stable weight in the last 3 months (+/-5kg).
5. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Subjects with a significant allergic response or history of food allergies deemed clinically significant or exclusionary for the study.
3. Diabetes mellitus or use of medications affecting glucose metabolism.
4. Subjects with any gastrointestinal disease which may affect absorption
5. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
6. Subjects which have undergone major surgery in the last 3 months.
7. Subjects who are non-cooperative or unwilling to sign the consent form.
Characterizing Breast Cancer With 18F-FES PET/CT

18F-fluoroestradiol (FES) is radioactive labeled estradiol, developed for in vivo visualization of estrogen receptor (ER) using positron emission tomography (PET). In this prospective study, 18F-FES PET/CT will be used to evaluate ER activity of metastatic disease and their potential sensitivity to endocrine therapy in ER-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed metastatic ER-positive breast cancer;
* 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Tailored Approaches to Stroke Health Education

The overarching goal of the proposed intervention is to reduce stroke disparities by overcoming pre-hospital barriers related to emergency stroke treatment and facilitating the appropriate response to acute stroke using a novel culturally-tailored and sustainable approach developed by an experienced transdisciplinary team. Building on our previous work, in which the investigators have identified barriers to increasing stroke literacy and behavioral intent to call 911, the investigators will develop and evaluate the effectiveness of a novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-minute films (in English and Spanish), in minority populations in New York City (NYC). Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.

Stroke is the leading cause of adult disability and costs U.S. taxpayers \>$60 billion annually. Interventions designed to educate patients to seek treatment sooner when a stroke occurs may increase low rates of treatment with thrombolysis (current rates 3% national average). Thrombolysis can increase the odds of minimal to zero disability from stroke if emergency medical system response times and in-hospital response times are optimized (maximum time from symptom onset to intravenous thrombolysis is 4.5 hours). Black and Hispanic Americans have higher stroke incidence compared to Whites and are less likely to receive thrombolysis for acute stroke. The latency to hospital arrival is largely dependent on patients' recognition of stroke symptoms, and immediate presentation to the emergency department. The investigators have found very low stroke literacy rates among Blacks and Hispanics compared to Whites, which may, in part, be responsible for disparities in acute stroke treatment.

Eligibility Criteria:
Inclusion Criteria:

1. No prior history of stroke;
2. High risk (defined as a history of one or more stroke risk factor (hypertension (HTN), diabetes, tobacco, abdominal obesity, heart disease, high cholesterol);
3. Over age 34 years at onset of intervention (we have selected this age cut off due to the large increase in stroke incidence among minority groups at age 34 );
4. Self-identified as Black or Hispanic; and
5. Member of a church congregation who lives in a household with a telephone.

Exclusion Criteria:

1. Participant is unable to give consent;
2. A modified Rankin score \> 4 at baseline;
3. history of dementia; and
4. terminal illness, or other medical illness resulting in mortality \< 1 year.
Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders

Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none or to few antibodies after a standard immunization with 3 vaccines. These individuals are defined as non-responders. The investigators wish to investigate if mounting another kind of immune response, called the cellular immune (CMI) response, protects these non-responders.

Aim/Hypothesis

Primary aims:

1. To estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization

   Secondary aims:
2. To establish the prevalence of serological non-responders after a standard course of HBV vaccination.
3. To assess the safety of the vaccine.
4. Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization
5. To compare the immunological profile before and after a standard HBV vaccination regimen on non-responders and responders
6. Establish a rapid test for measuring CMI after being HBV vaccinated.

A total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months from all participants. The blood will be analysed to see if there is antibodies or/and if there is mounted a cellular immune response by measuring on parameters called cytokines.


Eligibility Criteria:
Inclusion Criteria:

* Signed participant information and consent
* Age over 18 years
* Women of childbearing potential must use effective contraceptives

Exclusion Criteria:

* previous HBV infection
* previous HBV immunization
* pregnancy (or planned pregnancy within 6 months)
* allergy to contents in the vaccine (formaldehyde).
Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. Data collection will proceed until 36 subjects from 2 groups have been trained.

To determine the effect of constraint induced movement therapy (CIMT) on locomotor function in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be blocked by gait speed into slow (\< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection will proceed until 36 subjects from 2 groups have been trained.

Eligibility Criteria:
Inclusion Criteria:

1. age between 21 and 75 years;
2. history of unilateral, supratentorial, ischemic or hemorrhagic stroke;
3. no prior stroke;
4. demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);
5. able to stand and walk (\>10 meters) without physical assistance.

Exclusion Criteria:

1. significant cardiorespiratory/metabolic disease;
2. other neurological or orthopedic injury that impairs locomotion;
3. scores on the Mini Mental Status examination \< 24;
4. stroke of the brainstem or cerebellar lesions;
5. uncontrolled hypertension (systolic \> 200 mm Hg, diastolic \> 110 mm Hg);
6. botox injection within 6 months of starting the study.