cyrilzakka/clinical-trials huggingface dataset:
Priming Exercise in Type 1 Diabetes

Critical power is an important threshold in exercise physiology, and is an important determinant of the ability to tolerate high-intensity exercise. The ability to tolerate such exercise is drastically impaired in certain chronic conditions, such as type 1 diabetes. Whilst the most important physiological factors that determine critical power have yet to be determined, previous work from our laboratory suggests that it is related to the speed of oxygen uptake at the onset of exercise. This study will look to utilise "priming" exercise as an intervention to improve the speed of these oxygen uptake "kinetics", and thus critical power and exercise tolerance in individuals with type 1 diabetes. We hypothesize that oxygen uptake kinetics will be faster and critical power will be higher when exercise is performed with compared to without a prior bout of high-intensity priming exercise in a population of individuals with type 1 diabetes.

The ability to tolerate high-intensity exercise, or exercise tolerance, is a key factor that can influence clinical outcomes in a range of conditions. The "critical power" is an important physiological threshold that demarcates exercise intensities that can be sustained for prolonged periods (i.e. below critical power) from intensities that result in exhaustion in a relatively short period of time (i.e. 2-30 minutes, above critical power). Critical power is therefore a key determinant of exercise tolerance. The speed with which oxygen uptake rises at the onset of exercise (i.e. oxygen uptake "kinetics") has been shown by work from our laboratory to be a key determinant of critical power. One intervention that can acutely improve the oxygen uptake kinetics is the performance of a prior bout of high-intensity exercise, known as "priming exercise". Patients with type 1 diabetes have previously been shown to have impaired exercise tolerance compared to healthy controls. The performance of priming exercise therefore represents a potential intervention to acutely improve oxygen uptake kinetics, and therefore critical power and exercise tolerance, in type 1 diabetic individuals. The purpose of this study is therefore to assess the influence of priming exercise on oxygen uptake kinetics and critical power in a population of type 1 diabetic individuals.

Eligibility Criteria:
Inclusion Criteria:

Suffering from Type 1 diabetes with a diagnosed disease duration of 2 - 20 years and no comorbidities.

Exclusion Criteria:

History of stroke, congestive heart failure, hypertension, or cardiopulmonary disease.

Current smoking or have been smoking within the last 12 months Symptomatic autonomic or distal neuropathy HbA1c \> 64 mmol/mol Hypoglycaemia unawareness in the last 6 months Taking any medications other than insulin.
Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Eligibility Criteria:
Inclusion Criteria:

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion Criteria:

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence
Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity

An observational, multicenter, national study with retrospective real-life data collection on the combined treatment of sibutramine and topiramate (off-label use) for the treatment of overweight with comorbidity(ies) or obesity. Data from all adult patients, of both sexes, for whom combination treatment with sibutramine and topiramate, both at any dose/dosage, were prescribed between the year 2011 and the beginning of the study will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Both sexes
* Diagnose of overweight with comorbidity(ies) or obesity
* Treatment use of sibutramine combined with topiramate
* Treatment prescription between 2011 and the beginning of the study

Exclusion Criteria:

* Use of topiramate for other condition besides overweight with comorbidity(ies) or obesity
* Individual use of one of the medications (sibutramine or topiramate)
The Peripheral Blood Multi-Omics Study on Sleep Loss

Sleep plays a role in cognitive processes such as memory processing, attention processing, and overall cognitive function. In recent years, the bidirectional relationship between sleep loss and aging, as well as related neurodegenerative diseases, has garnered widespread attention. Sleep disorders are a typical clinical manifestation of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease and are closely related to the progression of these diseases. However, current research has yet to fully elucidate the physiological responses to sleep loss across different ages and cognitive levels, as well as the association and molecular basis between sleep loss, aging, and neurodegenerative diseases. This study aims to comprehensively characterize the transcriptional and metabolic changes in peripheral blood under sleep loss in populations of different ages and cognitive levels using multi-omics approaches and to preliminarily explore the role of sleep deprivation in aging and AD.

Participants meeting inclusion and exclusion criteria will include healthy subjects, MCI patients, and AD patients. General information such as age, gender, education level, medical history, family history, medication history, and surgical history will be collected. Cognitive assessments and sleep condition screenings will be conducted, with blood samples collected before and after sleep deprivation, and anxiety and depression scales administered. Blood samples will be processed using standardized methods for multi-omics analysis. Joint analyses with cognitive levels and sleep conditions will be performed to identify molecular biomarkers associated with age, cognitive levels, and key biological processes related to sleep deprivation, revealing its association with aging and AD.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form；
2. Meet the inclusion criteria for each arms.

Exclusion Criteria:

1. Failure to provide informed consent;
2. Inability to follow study procedures due to issues such as language barriers or cognitive impairment;
3. Regular use of medications that may alter the relationship between sleep and outcome variables (e.g., opioid medications, benzodiazepines, and Z drugs \[non-benzodiazepine hypnotics\]);
4. History of alcohol abuse, substance abuse, consciousness disorders, cerebrovascular disease, head injury, epilepsy, encephalitis, or other neurological disorders;
5. Diagnosis of schizophrenia, severe depression, anxiety disorders, or other severe psychiatric conditions;
6. Presence of severe arrhythmias, myocardial infarction within the last 6 months, severe pulmonary dysfunction, renal or hepatic insufficiency, severe anemia, severe gastrointestinal diseases, tumors, or other severe medical conditions.
Incremental Value of Point of Care H-FABP Testing in Primary Care Patients Suspected of Acute Coronary Syndrome

Rationale:

Thoracic complaints, possibly due to a cardiac ischemic cause are a diagnostic challenge in general practice. When an underlying ischemic cardiac condition (AMI (acute myocardial infarction), UAP (unstable angina pectoris)) is considered, referral from general practitioner (GP) to a cardiologist has to take place. However, cardiac analysis in 80% of referred patients is negative. To optimize referral decisions of GPs, new and fast diagnostics are needed.

Objective:

To assess the incremental diagnostic value for AMI of a novel rapid PoC H-FABP-test in addition to history taking and physical examination in patients presenting in daily general practice with possible AMI. In addition the cost-effectiveness of the test will be evaluated.

Study design:

Delayed type cross-sectional diagnostic study.

Study population:

Patients presenting to the GP with any new-onset chest complaint, at time of presentation not lasting for more than 24 hours, that is considered to be of possible cardiac origin by the GP.

Intervention:

Point of care Heart Type Fatty Acid Binding Protein test (PoC H-FABP-test), added to usual care. PoC H-FABP-testing, by qualitatively measuring H-FABP in one single drop of blood obtained by finger prick, is added to normal procedures of consultation and referral decision by the GP.

Main study parameters / endpoints:

Sensitivity, specificity, positive and negative predictive value of point of care H-FABP-testing for AMI, alone as well as part of a clinical diagnostic algorithm, in patients with thoracic complaints in general practice. All outcome measures, based on using an algorithm and/or point of care H-FABP-testing, will be compared to regular diagnostic assessment by the GP without using an algorithm and/or point of care H-FABP-testing. Therefore, incremental value of H-FABP-testing and/or a diagnostic algorithm is measured.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Individual participants will experience low risk, since study participation comprehends regular care except for an extra finger prick and possibly collection of one extra venous blood sample. For this low amount of disadvantage, the participant will experience no advantage either. However, results of the study will possibly be useful for similar patients in future.


Eligibility Criteria:
Inclusion Criteria:

* new-onset chest complaint, considered to be of possible cardiac origin by the general practitioner
* In case of death of identified cause patients are included as well.

Exclusion Criteria:

* all attention has to be on acute support for the patient
* symptoms are present for more than 24 hours
* oral informed consent is not given during presentation
* written informed consent is refused afterwards
* a traumatic cause is present
* complaints are presented that can be regarded as a recurrence of earlier complaints with clear diagnosis in the past
* death of unidentified cause.
The CLEVER Study - Coreg And Left Ventricular Mass Regression

This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.

A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Modified Release Formulation (COREG MR) and Atenolol in Combination with and Compared to an Angiotensin Converting Enzyme Inhibitor (Lisinopril) on Left Ventricular Mass Regression in Hypertensive Patients with Left Ventricular Hypertrophy (LVH).

Eligibility Criteria:
Inclusion criteria:

* Stage 1 or Stage 2 hypertension.
* Left ventricular hypertrophy.

Exclusion criteria:

* In atrial fibrillation.
* Takes beta-blocker for MI (myocardial infarction) or arrhythmia.
* Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary disease), liver or kidney disease.
* Uses beta-2-agonists.
* Unable to undergo MRI (magnetic resonance imaging).
* Females of childbearing potential.
Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice

This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.

The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergen source with or without mild / moderate asthma.
2. Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.
3. Patients must provide written informed consent. It is the case of children , the legal representative or tutor of the child must sign the inform consent form.

Exclusion Criteria:

1. Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.
2. Patients that according to the investigator may present difficulties to complete the patient diary.
3. Patients who are participating in another clinical trial or observational study.
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing completely resection of EGRF mutation-positive NSCLC
* Staging ⅠB (with high risk factor) to ⅢA
* PS\<2
* Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.
The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation

Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in critical care. First introduced for volume assessment in nephrology and cardiology, it is now being researched in emergency and critical care. Data is still evolving in its use in initial trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but utility of its measurement on U/S in the emergency department still has some controversy. In trauma specifically, small studies suggests benefit to the use of U/S to predict volume status, and most of these data are from one author. It is not known if this can be applied more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE, SonoSite Ultrasound) has been studied in several small studies, and only one small randomized controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one group, it is not known if it can be applied to all trauma populations.

Research question:

Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as well as or better than other methods of organ perfusion?

Hypotheses:

1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital and ICU stays, transfusions, and mortality).
2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator, number of and transfusions better than other methods of organ perfusion (tachycardia, hypotension, lactate, lactate clearance, creatinine, base deficit).


Eligibility Criteria:
Inclusion Criteria:

* Patients arriving to trauma bay aged 18 or higher
* Hypotensive (systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 65, on 2 measurements)
* Respiratory failure (requiring mechanical ventilation)

Exclusion Criteria:

* Unable to draw blood before transfusion or fluid challenge
* Patient arrests within 10 minutes of arrival
* Pregnant

Note: If inferior vena cava (IVC) not visible on ultrasound (U/S), pt will go to non-IVC group.
Rhythmic Exercise in Older Adults With Cognitive Impairment

Rhythmic physical exercise is a very promising non-pharmaceutical tool to prevent or reduce cognitive decline that occurs in people sixty years of age or older. The main objective is to determine the effect of a rhythmic exercise program on the physical, mental and cognitive performance of older adults with cognitive impairment. The main variables of the study will be: global cognitive function evaluated by the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA); attention and executive functions evaluated using the Trail Making Test (TMT) part A and B. As secondary variables, the functional abilities evaluated using the Senior Fitness Test (SFT) will be taken into account. Additionally, sociodemographic variables and variables related to health status will be evaluated. These will take into account the quality of sleep evaluated with the Pittsburgh index, the nutritional status evaluated using the Mini Nutritional Assessment-Short Form (MNA-SF) scale, and the Stress and anxiety levels will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21). All variables will be evaluated before the intervention and after it. After the intervention, it is expected that the exercise program will improve the neurocognitive performance, as well as the functional and psychological abilities of older adults.


Eligibility Criteria:
Inclusion Criteria:

* Be 60 years old or older
* Do not participate in any physical exercise program
* Present physical autonomy to participate in the physical activities required by the study.
* Present scores of \> 25 on the MMSE
* Present current affiliation to the social health security system.
* Sign the informed consent
* Understand the instructions, programs and protocols of this project.
* Complete more than 90% of the intervention with exercise.

Exclusion Criteria:

* Present medical contraindications for performing physical tests.
* Present diseases that limit cognitive performance and physical activity.
* Present vestibular diseases
* Present rheumatological diseases that can be exacerbated by stress articulate.
* Refusing to sign the informed consent
Scottish COmputed Tomography of the HEART Trial

The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.

Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.

Eligibility Criteria:
Inclusion Criteria:

* 18 and ≤75 years of age
* Attendance at the Rapid Access Chest Pain Clinic

Exclusion Criteria:

* Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
* Severe renal failure (serum creatinine \>200 µmol/L or estimated glomerular filtration rate \<30 mL/min)
* Previous recruitment to the trial
* Major allergy to iodinated contrast agent
* Unable to give informed consent
* Known pregnancy
* Acute coronary syndrome within 3 months
Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 y.o
* Breslow index \> 1mm or any Breslow index with ulcerated primary lesion
* Melanoma stage AJCC Ib, IIa, IIb, IIc, IIIa, IIIb or IIIc
* Able to undergo outpatient treatment

Exclusion Criteria:

* No contra indication for betablockers as defined by the compendium
* No clinical evidence of coagulopathy
* No unstable angina pectoris
* No AV-block II or III without pacemaker
* No severe congestive heart failure
* No untreated phaeochromocytoma
* No severe bradycardia
* No severe hypotension
* No severe impairment of peripheral arterial circulation
* No uncontrolled cardiac arrhythmia
* No severe asthma or COPD
* No uncontrolled diabetes mellitus
* No Angioneurotic edema
* No severe Aortic valve stenosis
* No severe hypertrophic cardiomyopathy
* No severe renal dysfunction
* No patients on beta blockers by inclusion
* No known adverse reaction to betablockers
* No pregnant or lactating patients can be included
* No melanoma stage AJCC IV by inclusion
* No patients requiring a specific oncological treatment