cyrilzakka/clinical-trials huggingface dataset:
Early Mobilization in Cardiac Surgery

This study was planned to determine the mobilization process and factors affecting this process in patients who underwent open heart surgery and were admitted to the cardiovascular surgery intensive care unit.

Mobilization; It is defined as "standing up, walking, being able to move and walking around, especially after the operation, when the patient stands up and walks around". Postoperative mobilization is a basic human need and one of the basic principles of nursing care. In the postoperative period, with the delay of mobilization, the patient's insulin resistance increases, muscle weakness and muscle mass loss occur, problems in pulmonary functions are experienced and the risk of thromboembolism increases.

Surgery of patients admitted to cardiovascular ICUs after open heart surgery close monitoring afterwards, maintenance of cardio-respiratory functions, healing is supported. During care in the intensive care unit Preparation of materials that may be needed by the patient, general condition of the patient and vital information monitoring symptoms, performing breathing exercises, evaluating pain and management, monitoring fluid-electrolyte balance, monitoring hemodynamic parameters, surgical wound dressing, getting the patient up as soon as possible and in bed increasing mobility. In this process, while the mobilization process of the patients is planned, the patient's The general condition and tolerance regarding mobilization should be evaluated. patient's general Depending on the suitability of the condition, turning in bed, foot-leg exercises, deep breathing and gradual mobilization, such as cough exercises, sitting in bed, standing up, and walking inform the patient and the patient's family about the methods, plan the mobilization process, The patient should be evaluated before, during and after mobilization. Early postoperative mobilization is an important component of nursing care.

Early mobilization of patients after open heart surgery, although the recommendations to increase the mobility are getting stronger, the mobilization levels of the patients are still not at the desired level. Although studies examining the early mobilization process of patients after open heart surgery have been conducted so far, findings regarding the clinical factors affecting this process are very limited.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Staying in the cardiovascular intensive care unit for 24 hours or more

Exclusion Criteria:

* Being diagnosed with a psychiatric disorder
* Do not have active bleeding
* Do not have arrhythmia
* Reporting pain intensity of 4 or above on the Visual Analog Scale
RIGHT IV Pilot Study

The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Willing and able to independently sign an English Informed Consent
* Have adequate veins for placement of IV catheters in both right and left upper extremities

Exclusion Criteria:

* Currently taking anti-coagulation medication
* Have a known bloodborne disease or bleeding tendency
* Have a known fear or adverse reaction to needles or blood
* Women who are pregnant or nursing
Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma

Patients with chronic severe asthma (CSA) have a crippling disease and current available treatments are not satisfactory. Thus, management of CSA remains a major unmet need. Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks, findings with low-dose methotrexate (MTX) are encouraging. However, larger and well designed clinical trials are required to establish the beneficial role of MTX in CSA and for the detection of the key characteristics of those who are going to respond to this drug.

This study will be the first multi-centre RCT investigating the role of an add-on immunological modifier as a clinically useful therapeutic strategy in patients with well-phenotyped chronic severe asthma. As such, this study does not overlap with any other research currently ongoing.

Patients will be recruited from the accessible asthmatic patients lists of tertiary referral centers. All patients will meet the stringent diagnostic criteria for CSA, including the requirement for the regular use of Step 5 medications (i.e. oral prednisone and/or omalizumab). The experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a total of eight visits including run-in and run-out periods. Patients will be randomly allocated to receive either MTX or matched placebo once a week as add-on therapy to their existing medication after run-in. Physiological, laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments.

We expect that MTX will reduce Step 5 medications dosage in patients with CSA without compromising the overall disease control. Improvement in several indicators of asthma severity and control will be also investigated

Eligibility Criteria:
Inclusion Criteria:

1. patients with a diagnosis of CSA taking GINA Step 5 medications (i.e. regular OCS and/or omalizumab for a minimum of 6 months);
2. failure in weaning patients completely from Step 5 medications during run-in;
3. male and female individuals age 18 - 75 years;
4. patients must be able to provide consent;

Exclusion Criteria:

1. use of immunomodulatory therapies in the preceding 3 months;
2. recent or current history of alcoholism;
3. high liver enzyme levels (greater than 2.5 times the upper limit of the normal range);
4. serum creatinine levels greater than 2.0 mg/dL
5. acute illness within 15 days of study medication administration;
6. leucopenia (below 3.0x109/L) and/or thrombocytopenia (below 100x109/L).
7. pregnancy or planning to become pregnant;
Postural Re-education in Low Back Pain

The Global Postural Re-Education is a global approach for the treatment of musculoskeletal disease. Using specific progressive posture for stretching particular shortened chain muscle the method wants to equilibrate the never-ending war between static and dynamic muscles by guiding the patient in a particular breathing pattern to maintain a correct posture and feeling it.

In some countries there is a physical therapy method called "Global Posture Reeducation" (GPR), which was developed by Philippe Emmanuel Souchard based on 20 years of clinical experience.The method consist to balance the miofascial tension probably responsible for an articular overloading. The method stretches the shortened antigravity muscles that are inside a different static muscles chains. GPR is a global approach that search the biomechanics cause in the near areas, and involves actively the patient in the postural and gestural changes.

Eligibility Criteria:
Inclusion Criteria:

* Lumbalgia Diagnosis
* Age 18-80

Exclusion Criteria:

* Migrated hernia
* Calcified disc hernia
* Spondylolisthesis
* Other physiotherapeutic interventions within 6 months of the baseline assessment.
* Surgical operation within six months of baseline
* Cancer syndrome, Neurological and rheumatic diseases
Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI

Elective percutaneous coronary intervention (EPCI) is the common treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following EPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during EPCI.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic symptoms \< 2 weeks (\> 24 hours)
* Continued ischemic chest pain \> 30min
* ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)
* Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)
* Elective coronary artery angiography was planned.

Exclusion Criteria:

* Emergency thrombolytic therapy was performed before elective coronary artery angiography
* Cardiogenic shock with no response to hypervolemic treatment or vasopressor
* Severe cardiomyopathy or valvular disease requiring intervention
* Coronary ectasia
* Severe heart failure
* Contraindication or allergy to antiplatelet drugs
* Contraindication or allergy to experimental drugs
* Unable to receive at least 1 year of dual antiplatelet therapy
* Active bleeding or extreme-risk for major bleeding
* Severe liver or renal failure
* Life expectancy \< 1 year
* Unable or unwilling to provide informed consent
* Women of child bearing potential
* Under 18 years of age
* Hemoglobin \< 90g/L
* Platelet count \< 100×10\^9/L
* Can not cooperate (with mental disorders or cognitive disorders)
Verifying the Specificity of a New Method in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients

Early gastric cancer is defined as gastric cancer that only invades mucosal or submucosal layer. The 5-year survival rate of gastric cancer can exceed 90% due to appropriate treatment. The most important consideration is whether there is lymph node metastasis. Preoperative examination including gastroscopy, endoscopic ultrasonography (EUS) and CT are not accurate enough to predict lymph node metastasis in early gastric cancer. In a retrospective study, we created a nomogram to predict lymph node metastasis in early gastric cancer. In prospective validation, the sensitivity and specificity of the nomogram was 75% and 91%, respectively. Sentinel lymph node is a promising concept in early gastric cancer. Using carbon nanoparticles as tracer, the sensitivity and specificity of sentinel lymph node predicting lymph node metastasis in early gastric cancer were 90% and 100%. Based on these results, we proposed a new method that combines the Nomogram and sentinel lymph node to predict lymph node metastasis in early gastric cancer. First, the probability of lymph node metastasis of early gastric cancer patients is calculated by the Nomogram. Those with low incidence of lymph node metastasis continue to the sentinel lymph node procedure. A patient will be considered non lymph node metastasis if his/her frozen pathology of the sentinel lymph nodes is negative during the surgery. Then the standard radical gastrectomy is performed with lymphadenectomy. By comparing postoperative pathology and sentinel lymph node frozen pathology, the specificity of Nomogram combining sentinel lymph node predicting lymph node metastasis in early gastric patients is calculated. The primary endpoint of this research is that the specificity of the above-mentioned method is over 95%.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as gastric cancer by gastroscopy
* pathologically confirmed as adenocarcinoma
* ages between 18 and 80
* gastroscopy, abdominal enhanced CT and EUS completed
* clinical stage T1N0M0
* the score of the Nomogram less than 110
* potential resectable gastric cancer
* signed informed consent

Exclusion Criteria:

* absolute indication for endoscopic submucosal dissection (ESD)
* tumor located in esophagogastric junction (EGJ)
* accepted adjuvant therap
* pregnant or breast feeding
* history of upper abdominal surgery (laparoscopic cholecystectomy not included)
* history of gastric surgery
* emergency surgery such as perforation or obstruction
* other contraindication such as dysfunction of heart, lung, kidney
Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?

The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.

This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergoing non-cardiac thoracic surgeries
* Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.

Exclusion Criteria:

* Current gabapentin use or current treatment for neuropathic pain.
* Pregnant or considering becoming pregnant.
Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure

To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.

The EXPOSURE study investigates the effects of epicardial fat on ventricular interdependence at peak exercise. Epicardial fat, the visceral fat situated directly adjacent to the heart, seems involved in the pathophysiology of heart failure with preserved ejection fraction (HFpEF). It has been suggested that an abundance of epicardial fat surrounding the heart within a closed pericardial sac may constrain the heart leading to ventricular interdependence. The study is an investigator initiatied, cross-sectional, observational study, including 50 patients with HFpEF. Patients will be stratified according to high and low epicardial fat volume measured with CMR. The primary outcome parameter is the difference in LV eccentricity index at peak exercise between the two groups. Pre-specified secondary outcome parameters between the subgroups are: 1) VO2-max, 2) LV and right ventricular (RV) diastolic strain rate, 3) slope of early LV/RV filling, 3) left and right atrial reservoir strain and emptying fraction, 4) pulmonary artery distensibility and pulsatility and 5) cardiac output, all at peak exercise. The amount of epicardial fat will be correlated with change in LV eccentricity index from rest to peak exercise, change in LV/RV diastolic strain rate, change in slope of LV/RV filling, change in atrial reservoir strain and emptying fraction, change in pulmonary artery distensibility and pulsatility, and change in cardiac output. All results will be also compared between men and women.

Eligibility Criteria:
Inclusion Criteria:

1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline.
2. LV ejection fraction ≥40%.
3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test (Figure 1).
4. \>18 years of age
5. In sinus rhythm
6. Able to perform a bicycle exercise test
7. Willing to sign informed consent

Exclusion Criteria:

1. Body weight \>140 kg
2. Atrial fibrillation or other significant arrhythmia during the assessment
3. Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
4. Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft \<3 months or untreated severe obstructive coronary artery stenosis
5. More than moderate left-sided valve disease.
6. Complex congenital heart disease.
ProAliFun_6.5_Health Effects of a Functional Pasta Enriched With Barley Beta-glucans on Healthy Subjects

The purpose of this study is to evaluate the healthy properties of a dietary intervention based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).

The hypothesis is that the gut microbiota and metabolome, the nutritional status, the redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve in healthy subjects.

This clinical trial is a prospective pilot study, lasting 4 months. A target number of 30 healthy individuals meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* aged between 30 and 70 years
* BMI between 18.5 and 24.9
* omnivorous diet
* informed consent signed

Exclusion Criteria:

* diabetes type 2
* urine protein \> 1g/24h
* antibiotics and probiotics administration by 15 days before the enrollment
* gastrointestinal, celiac, inflammatory systemic and chronic liver diseases
* recent diagnosis of cancer
* corticosteroid or immunosuppressive therapies
* previous major acute cardiovascular pathologies (heart attack, cerebral ictus)
* hyperlipidemia
* consume of alcohol
* psychiatric diseases
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting

Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS) for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.

Eligibility Criteria:
Inclusion Criteria:

* Smoking, apparently healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking within the next 6 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
* For women: Subject is pregnant or is breast feeding.
* For women: Subject does not agree to use an acceptable method of effective contraception.
The Influence of Sweet Substrates on Hunger, Gastrointestinal Hormones and the Migrating Motor Complex

In this study, the investigators aimed at evaluating the role of sweet taste receptors in the gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or acesulfame-K were compared with placebo administration for their effects on gastrointestinal motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin) and hunger feelings.


Eligibility Criteria:
Inclusion Criteria:

* BMI\<30 kg/m² for the lean volunteers
* Female or male subjects aged 18 to 60
* Subject is capable and willing to give informed consent
* Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

Exclusion Criteria:

* Female volunteer is pregnant or breastfeeding
* GI diseases, major abdominal surgery
* Volunteers that have food allergies, especially fructose intolerance
* Major psychiatric illnesses
* Volunteers that use drugs affecting the GI tract or the central nervous system
* Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
* Volunteers that have undergone surgical procedure for weight loss
A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria

The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).

The study consists of a 4-week Screening Period, a 26-week Primary Evaluation Period, and an Extension Period of up to 4 years (with the exception of any country-specific mandates), whichever occurs first.

Efficacy and safety data are reported for the 26-week Primary Evaluation Period only. Analyses were conducted separately for complement inhibitor treatment-naïve participants and eculizumab-experienced participants.

Eligibility Criteria:
Inclusion Criteria:

1. Participants from birth up to \<18 years of age and weighing ≥ 5 kilograms at the time of consent.
2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry.
3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia, history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cell transfusion due to PNH.
4. Lactate dehydrogenase (LDH) level ≥ 1.5 × upper limit of normal (ULN) for participants not being treated with eculizumab at screening and LDH level ≤ 1.5 × ULN for participants taking eculizumab.
5. Documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against Streptococcus pneumoniae and Haemophilus influenzae.
6. Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.

Exclusion Criteria:

1. History of bone marrow transplantation.
2. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
3. Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH).
4. Females who are pregnant or breastfeeding or who have a positive pregnancy test at screening or Day 1.
5. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.