cyrilzakka/clinical-trials huggingface dataset:
Intubation with Different Angled Intubation Tubes Using C-macr D Blade Videolaringoscope;

In this study we compared post-operative sore throat, ease and time of intubation, hoarseness, subglottic damage and hemodynamic changes to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade.

In this study we compared the ease of intubation, time needed for intubation, subglottic damage, postoperaitve sore throat, hoarseness and hemodynamic response to orotracheal intubation using three different intubation stylets with C-MAC R videolaryngoscope D- blade. After the approval of the Ethics Committee, patients were randomized into three groups with closed envelope technique. In Group A endotracheal tube (ETT) is shaped into an angel of 90 degrees, in Group B 80 degrees and in Group C 60 degrees with three different stylets. Laryngoscopy was performed using D-Blade in all 3 groups. Heart rate and blood pressure before and after intubation, time from the entrance of the laryngoscope into the mouth to the passage of the vocal cords, time from the appearance of the cords to intubation, Cormack-Lehane (C-L) classification were recorded. Subglottic damage was examined with fiberoptic bronchoscope. Patients were evaluated regarding postoperative sore throat and hoarsness at 30 minutes, 4, 12, 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA score I-II
* Elective operations
* Supine pozition
* 18-65 years
* No history of surgery in the last 6 months
* No history of airway related surgery
* No anticipated difficult airway

Exclusion Criteria:

* Abdomen, thorax, head-neck surgeries
* Smoker
* Chronic alcohol abuse
* Occupational inhaler agent exposure
* Patients with malignancies
* Patients with a history of radiotheraphy to head-neck region
* Patients with congenital anomalies at head-neck region
* Patients with diagnosed abnormalites of head -neck movements
* Non-cooperatied patients
* Non-oriented patients
Modulation of Lung Injury Complicating Lung Resection

The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.

Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.

Eligibility Criteria:
Inclusion Criteria:

* Elective lung resection for cancer

Exclusion Criteria:

* Age less than 18 years
* Women of child-bearing age or potential
* Known allergy to N-acetylcysteine
* Oral steroid in the preceding 1 month
* N-acetylcysteine in the preceding 1 month
* Unable to receive standardised anaesthetic approach
Effect of Zinc on Barrett's Metaplasia

Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:

1. can this zinc administration cause molecular-level changes in the Barrett's tissue?
2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.

Eligibility Criteria:
Inclusion Criteria:ages 18-80; prior diagnosis of Barrett's esophagus -

Exclusion Criteria:unable to provide written, informed consent; prior history of Barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin)

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Effects of Tai Chi Exercise on Innate and Adaptive Immune Function

Tai Chi is a traditional Chinese martial art that has been practiced for many centuries. Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai Chi practices have been well established. A potential immune response effect of Tai Chi practice is a frequent claim; however, this is an under-researched area. Therefore, in this study, the researchers will examine the effects of Tai Chi on innate and adaptive immune function.

Tai Chi, a traditional Chinese martial art that has been practiced for many centuries, has only recently gained the interest of researchers in Western countries as an alternative form of exercise. Tai Chi combines deep diaphragmatic breathing and relaxation with many fundamental postures that flow imperceptibly and smoothly from one to the other through slow, gentle, and graceful movements. Based on the maximum oxygen consumption (VO2max) measured during the practice, Tai Chi is characterized as a low- to moderate-intensity form of exercise. Tai Chi has been applied as a rehabilitation program in patients with heart failure, hypertension, acute myocardial infarction, arthritis, and multiple sclerosis. Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai Chi practices have been well established. A potential immune response effect of Tai Chi practice is a frequent claim; however, this is an under-researched area. A nonrandomized controlled study of 60 elderly subjects found that the total number of circulating T cells were significantly higher in the Tai Chi group (who regularly practiced Tai Chi for 4 or more years) than in the untrained group. Irwin et al. demonstrated that older adults with no previous Tai Chi experience after practicing for 15 wks (1-3 times/wk), a nearly 50% increase in varicella zoster virus specific, cell-mediated immunity was found. Thus in this proposed study, we will examine the effects of regular Tai Chi practitioners on innate and adaptive immune function.

Eligibility Criteria:
Inclusion Criteria:

* Has been practicing Tai Chi Chuan (TCC) for at least 3 days a week for at least 12 months.

Exclusion Criteria:

* Any chronic systemic diseases (e.g., coronary artery disease \[CAD\])
* Has cognitive impairments.
Intervention by a Cardiologist and Geriatrician in Elderly Patients After Admission Due to Heart Failure.

Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. This visit will be done at the same time. The main gial of this study is to evaluate whether the combined intervention of a cardiologist and a geriatrician reduces hospital all-cause rehospitalizations at 1 year.

Patients will be invited to participate on the day of hospital discharge. Once the informed consent has been signed, patients will be randomized with a 1: 1 ratio to conventional follow-up (cardiologist) or combined follow-up (ambulatory visit with cardiologist and geriatrics on the same day). Randomization will be stratified according to the presence or absence of criteria of frailty and ventricular function (cut-off 50%) to ensure that both groups are balanced. This stratification will be achieved by generating 4 different randomization lists. Frailty will be assessed using the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale. Randomization will be carried out by administrative staff independent of the study following a computer generated randomization scheme.The first visit will be made in less than 10 days after discharge from the hospital. Lawton and Barthel index and Pfeiffer test and quality of life test will be done in both groups.

The cost associated with care in the hospital is collected in each patient and therefore the total cost of the admissions, ambulatory visits and emergencies of each patient will be retrospectively evaluated.

In patients in the intervention arm the following areas will be evaluated: social sphere (Social and family evaluation scale of Gijón (abbreviated and modified) (Barcelona version), functional capacity (Barthel index and Lawton index), cognitive sphere (Pfeiffer test), emotional sphere (Geriatric Depression Scale Yesavage), nutritional status (Mini-Nutritional Assessment Short Form, plasma albumin), comorbidity (Charlson index) and the presence of geriatric syndromes (falls, polypharmacy, ulcers pressure, constipation, incontinence, insomnia.) Interdisciplinary interventions will be carried out in each of the areas evaluated.

Follow-up will be carried out at the heart failure clinic of the Cardiology Department at 3, 6 and 12 months. A clinical event evaluation committee will be appointed, consisting of 2 independent cardiologists, who will blindly adjudicate the events that occurred during the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).

Exclusion Criteria:

* Patients in palliative care.
* Patients with chronic pathologies with expected life expectancy \<1 year.
* Patients discharged to a skilled nursing facility
* Patients with heart valve replacement during index admission
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).

Eligibility Criteria:
Inclusion Criteria:

1. IgA nephropathy confirmed by pathological biopsy;
2. Male or female aged ≥ 18 years old;
3. Average 24-hour urine total protein ≥ 0.75 g/24 h
4. Estimated GFR (using the CKD-EPI formula) \> 30 mL/min per 1.73 m\^2;
5. Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.

Exclusion Criteria:

1. Patients with clinically significant abnormal laboratory tests at screening;
2. Evidence of rapid eGFR decrease \> 15 ml/min during screening;
3. Renal or other organ transplantation prior to, or expected during, the study;
4. Patients with secondary IgA nephropathy;
5. Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;
6. Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
7. Immunocompromised individuals.
HAIC Plus A+T for Patients With High-risk HCC: a Single-arm Phase 2 Trial

Atezolizumab plus bevacizumab is the first-line treatment for patients with advanced hepatocellular carcinoma. However, the prognosis for high-risk hepatocellular carcinoma is still poor, with a median overall survival of 7.6 months. Hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin is effective in large hepatocellular carcinoma or hepatocellular carcinoma with major portal vein tumor thrombus. Our previous showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab (programmed cell death protein-1 antibody) had a powerful anti-tumor effect for high-risk hepatocellular carcinoma, with a median overall survival of 18 months. Thus, the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus atezolizumab plus bevacizumab for patients with high-risk hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* High risk disease: Vp-4 based on the Japanese standard, bile duct invasion, or tumor occupancy ≥50% of the liver
* Eastern Cooperative Oncology Group performance status of 0 to 2
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics.

However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day.

In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated.

This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be screened for entry into the study.

After the initial 3 weeks double-blind treatment period, patients will be given the option to enter a six-month double-blind continuation study.

Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory parameters are total sleep time, sleep quality, morning alertness and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and aged 18-80 years.
* Are willing to take a 6-SMT level evaluation test.
* Suffering from primary insomnia according to DSM-IV. criteria (307.42 primary insomnia, Appendix 24.3) .
* Sleep latency of at least 20 minutes.
* Have not been using benzodiazepines (BZD) and non-BZD hypnotics for the past 2 weeks or more.
* Have not been using psychotropic treatments for the past 3 months or more.
* Are stabilized on non-psychotropic treatments for more than 1 month.
* Are willing to sign a written informed consent to participate in the study.

Exclusion Criteria:

* Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.
* Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.
* Pharmacological immunosuppression.
* Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
* According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition).
* Severe neurological, psychiatric disorders (especially psychosis, anxiety and depression) and alcoholism.
* Other serious diseases that could interfere with patient assessment.
* Pregnant or breast feeding women.
Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

1. Chinese patients,aged 6 years and older，female or male
2. Diagnosed as allergic asthma according to the guideline for Chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition）
3. Meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the GINA (Global Initiative for Asthma)，it refers to those who can achieve complete control under the GINA Step 3 treatment; for severe asthma, it refers to those who need Step 4 or Step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing Step 4 or Step 5 treatment.
4. The patients included in the study were positive for specific immunoglobulin E (sIgE), or had a positive skin prick test (SPT) with D.pteronyssinus and D. farinae allergens.
5. Patients who will initiate AIT or omalizumab combined with AIT according to real life clinical standards of practice.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

1. Uncontrolled asthma or forced expiratory volume in one second (FEV1) is lower than 70% of the predicted value.
2. Currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (ACEI) 3．With severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.

4．Pregnant or planning pregnancy.
Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury

This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.


Eligibility Criteria:
Inclusion Criteria:

* patients with major abdominal surgery (e.g. gastrectomy, hemi-/colectomy, resection of sigma or rectum, resection of liver, esophagectomy)
* patients following severe burn injury (burn surface area \>= 15%)
* age \>= 18 years
* informed consent

Exclusion Criteria:

* no informed consent
* emergency surgery
* immunocompromising diseases (e.g. HIV+, AIDS, Lymphoma or NonHodgkin-Lymphoma, Autoimmune-Diseases)
* pre-existing liver or renal failure
* chronic therapy with corticoids
Comparison of the Effects of Dexmedetomidine and Lidocaine on Blood Pressure and Heart Rate Response

Endotracheal intubation is considered a definitive therapy and the gold standard for airway management. However, this procedure carries several risks, including sudden increases in blood pressure and heart rate. These spikes in blood pressure and heart rate can be tolerated by healthy individuals, but for patients with cerebrovascular and cardiovascular risk factors, they can be extremely dangerous and even life-threatening. Various techniques and drug choices can be employed to prevent the hemodynamic surges associated with endotracheal intubation, including the use of anesthetic drugs from the α2-adrenergic agonist and amide classes. One of the α2-adrenergic agonists commonly used to prevent hemodynamic surges during endotracheal intubation is dexmedetomidine, while one of the amide drugs frequently used for this purpose is lidocaine.

Dexmedetomidine works very selectively on noradrenergic receptors distributed both within and outside the central nervous system, particularly in the pons and medulla. Presynaptic stimulation of α2 receptors can reduce the release of norepinephrine and the activation of postsynaptic α2 receptors. Lidocaine works by inhibiting sodium channels within cells, preventing the occurrence of action potentials and the transmission of impulses along nerves. Lidocaine also acts by blocking calcium and potassium channels as well as N-methyl-D-aspartate (NMDA) receptors.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-59 years.
* Patients scheduled for oral intubation.
* Physical status ASA I and II (American Society of Anesthesiologists).
* Patients with Mallampati classification I-II.

Exclusion Criteria:

* History of allergy to the drugs that will be used.
* Pregnant patients.
* Patients taking medications that affect blood pressure and heart rate, such as vasodilators, adrenergic blockers, antiarrhythmics, and cardiac stimulants.
* Patients with arrhythmias, AV block, liver disorders, hypertension, and hypoalbuminemia.
* Patients who have been given opioids within the last 24 hours.
* Patients with predicted intubation difficulties.