cyrilzakka/clinical-trials huggingface dataset:
Serratus Anterior Plane Block in Pediatric Patients

The aim of this work is to study the efficacy of ultrasound guided serratus anterior plane block in pediatric patients undergoing thoracic surgeries.

It is a randomized controlled trial.

It is a prospective randomized controlled study. It is designed to estimate and compare the analgesic effect of single shot serratus anterior plane block in pediatric patients undergoing thoracic surgeries with fentanyl infusion versus fentanyl infusion alone as the control group. Our primary outcome will be the total dose of intra-operative fentanyl boluses.

Randomization will be achieved by using an online random number generator. Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the serratus anterior plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6 months-3 years.
* American Society of anesthesiology (ASA) I and II.
* Pediatric patients undergoing thoracic surgeries (with anterior thoracotomy incision).

Exclusion Criteria:

* Patients whose parents or legal guardians refusing to participate.
* Preoperative mechanical ventilation.
* Known or suspected coagulopathy.
* Infection at the site of injection.
* Known or suspected allergy to any of the studied drugs.
* Elevated liver enzymes more than the normal values.
* Procedures with anticipated significant hemodynamic stability.
* Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen (BUN) more than 20mg/dl).
Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)

The purpose of this study is to assess the efficacy of Eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (CPAP) in patients newly diagnosed with obstructive sleep apnea (OSA).

CPAP is the treatment of choice for patients with OSA. However, patients are frequently intolerant of this therapy initially. After continued use, tolerance is achieved. However, this initial discomfort or intolerance frequently leads to a patient-initiated discontinuation of therapy. It has been shown that CPAP use at 1 month predicts use at 6 months and 1 year. Patients who initially struggle with or are intolerant of CPAP frequently abandon therapy and are unlikely to use it long term. To prevent this, sleep physicians often prescribe short courses of sedatives to help improve initial tolerance and promote better compliance with therapy. However, the effectiveness of this practice has not been validated in a clinical trial. Compliance, in reference to this study is the willingness of the patients to follow the prescribed course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Newly diagnosed with OSA who are prescribed CPAP therapy

Exclusion Criteria:

* Patients \< 18 years old
* Patients over 65 years
* Pregnant women
* Patients with chronic liver disease
* Patients who abuse alcohol
* Patients taking narcotics or using sedative-hypnotic agents such as Ambien, Klonopin or Benadryl
Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study

Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators.

Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death.

In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization.

Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic severe heart failure with reduced ejection fraction (LVEF ≤40%,)
* Age \> 20 years
* Consent capacity
* Sinus rhythm
* Suitable for a drug conversion from AT1/ACE inhibitors to sacubitril/ valsartan

Exclusion Criteria:

* Age \< 18 years
* Atrial fibrillation
* Pregnancy
* Lack of consent capacity
* Contraindications for a therapy with sacubitril/ valsartan
Visual Outcomes and the Predictive Factors in Chinese Patients With Diabetic Macular Edema Treated With Ranibizumab

The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME).

The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME). Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), as well as predictive factors including best-corrected visual acuity (BCVA) were assessed.

Eligibility Criteria:
Inclusion Criteria:

* 1) patients (aged\>18 years) with DME who had a best-corrected visual acuity (BCVA) between 20/32 and 20/200, and CRT≥300μm; 2) clinically significant DME confirmed by both fundus fluorescein angiography (FFA) and optical coherence tomography (OCT) (Spectralis HRA+OCT; Heidelberg Engineering, Germany); 3) decreased vision caused by foveal thickening from DME, which could not be explained by any other cause.

Exclusion Criteria:

* 1) previous anti-VEGF or laser treatment; 2) proliferative diabetic retinopathy who required immediate panretinal photocoagulation; 3) active proliferative diabetic retinopathy; 4) other causes for macular edema, for example, branch retinal vein occlusion; 5) other causes of visual loss in the study; 6) unstable systemic conditions, for example, uncontrolled blood pressure, stroke, renal or kidney failure.
(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis

This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.


Eligibility Criteria:
Key Inclusion Criteria:

* 1. Patient must have SM, confirmed by Central Pathology Review of BM biopsy, and central review of B- and C-findings by WHO diagnostic criteria.
* 2. Patient must have moderate-to-severe symptoms based on minimum mean total symptom score (TSS) of the ISM Symptom Assessment Form (ISM-SAF) over the 14-day eligibility screening period.
* 3. Patient must have failed to achieve adequate symptom control for 1 or more Baseline symptoms.
* 4. For patients receiving corticosteroids, the dose must be ≤ 20 mg/d prednisone or equivalent, and the dose must be stable for ≥ 14 days.
* 5. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.

Key Exclusion Criteria:

* 1. Patient has been diagnosed with any of the following WHO SM subclassifications: cutaneous mastocytosis only, smoldering SM, SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia, or mast cell sarcoma.
* 2. Patient must not have received prior treatment with avapritinib.
* 3. Patient must not have had any cytoreductive therapy including but not limited to masitinib and midostaurin, or investigational agent for \< 14 days or 5 half-lives of the drug (whichever is longer), and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \< 28 days or 5 half-lives of the drug (whichever is longer), before beginning the 14-day ISM-SAF eligibility TSS assessment.
* 4. Patient must not have received radiotherapy or psoralen and ultraviolet A (PUVA) therapy \< 14 days before beginning the 14-day ISM-SAF eligibility TSS assessment.
* 5. Patient must not have received any hematopoietic growth factor the preceding 14 days before beginning the 14-day ISM-SAF eligibility TSS assessment.
* 6. Patient must not have a QT interval corrected using Fridericia's formula (QTcF) of \> 480 msec.
The Effect of Proprioceptive Neuromuscular Facilitation and Mirror Therapy on Range of Motion, Pain, Functionality, Kinesophobia and Quality of Life in Patients With Upper Extremity Burns

Purpose of the study; The aim of this study was to investigate the effect of two different exercise programs on joint patency, pain, functionality, kinesophobia and quality of life in upper extremity burn patients. Lütfi Kırdar Training and Research Hospital Burn and Wound Center and unilateral upper extremity burns will consist of individuals aged 18-65 years. 48 burn patients who volunteered to participate in the study will be included in the study. Demographic information of the cases will be recorded. Joint range of motion and pain will be evaluated with the Visual Analogue Scale (VAS) before and after the treatment program. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to evaluate upper extremity functions. TAMPA Kinezophobia questionnaire will also be used for kinesiophobia. To evaluate the quality of life, Burn-Specific Health Scale developed for burn patients will be used.

Joint range of motion of the subjects will be measured with a goniometer. Pain will be evaluated with the Visual Analogue Scale (VAS). In order to evaluate the upper extremity functions, the validity and reliability of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, conducted by Tülin Düger et al. The TAMPA Kinezophobia questionnaire, which has been validated and validated in 2011, will be used for kinesiophobia. The Burn-Specific Health Scale developed for burn patients will be used to evaluate the quality of life. The validity and reliability study of the questionnaire was conducted by Mehmet Adam et al.

Eligibility Criteria:
Inclusion Criteria: -18-65 years of age, -the unilateral upper extremity burn, -the understanding of the given information, the application of mirror therapy and the ability to accurately express the level of pain that prevents cognitive, affective and verbal communication There is no problem and no visual impairment, - Turkish reading and writing, - Paralysis, plaster, etc. that will prevent movement in the extremity opposite the burned extremity. to be cognitive enough to understand the surveys,

- Agreeing to participate voluntarily in the study -

Exclusion Criteria:

* T.C. Ministry of Health Kartal Lütfi Kırdar Training and Research Hospital Burn and Wound Center treated patients between the ages of 0-18,
* Burn patients who refused to participate in the study, - Patients with bilateral upper extremity burns
Effectiveness of Ofatumumab in Real-world Practice

This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration \[FDA\] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy \[DMT\]), discontinuation of enrollment, or end of study period on 31 December 2023.


Eligibility Criteria:
Inclusion criteria:

1. Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
2. One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
3. One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision \[ICD-10\] code G35.xx) any time before the index date and up to 6 months after the index date.
4. Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
5. Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.

Exclusion criteria:

None.
Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunctional prognosis of thrombolytic patients has been a hot topic in the world.

Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate.

Based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years;
2. Diagnosis of anterior circulation infarct;
3. First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
4. Time from onset to treatment ≤4.5 hours;
5. SBP/DBP ≤ 180/110mmHg;
6. No hemorrhagic imaging changes showed in CT;
7. Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

1. History of stroke within 3 months;
2. History of intracranial hemorrhage;
3. Suspected subarachnoid hemorrhage;
4. Intracranial tumour, vascular malformation or arterial aneurysm;
5. Major surgery within 1 month;
6. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
7. Platelet count \< 100×109／L;
8. Heparin therapy or oral anticoagulation therapy within 48 hours;
9. Severe disease with a life expectancy of less than 3 months;
10. Blood glucose \< 50 mg/dL (2.7mmol/L);
11. Patients who have received any other investigational drug or device within 3 months;
12. Researchers consider patients inappropriate to participate in the registry. -
Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients

This is a prospective, single-site, non-randomized, acute feasibility clinical study. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Many pacemaker patients have cardiac conduction system disease and thus need ventricular pacing. Traditional ventricular pacing causes ventricular dyssynchrony that in turn causes cardiac contraction dysfunction. CRT pacing provides better ventricular synchronization, but not the optimal, especially in patients with narrow QRS. CRT non-response rate is at 30%. His bundle pacing utilizes naturel His bundle-Purkinjie system to provide optimal physiological pacing. But many pacing-indicated patients have abnormal His bundle-Purkinje system, thus His bundle pacing cannot provide optimal pacing in patients with abnormal cardiac conduction system. Moreover, the pacing threshold is high during His bundle pacing. More recently, left bundle branch pacing is proposed. However, LBBP will generate right bundle branch block pattern, another kind of weak ventricular synchronization. Thus, the investigators propose to excite the left and right bundle branches area simultaneously to normalize ventricular synchronization. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 80 years old
* Subjects who are willing to provide Informed Consent
* Subjects who have pacing indications or indications for CRT, and will receive pacemaker or CRT therapy

Exclusion Criteria:

* Subjects who have contra-indications for pacing therapy or CRT
* CRT up-graded subjects
* Ventricular hypertrophy
* Subjects who have medical conditions that would limit study participation
* Subjects who are pregnant or have a plan for pregnancy during the study
* Subjects who are not willing to provide Informed Consent
Intra Cranial EEG Activity During Dexmedetomidine Sedation

Various parts of the brain are sensitive to various anesthetics.We like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for DBS electrode removal under sedation.

Cortical and sub cortical structures will have different sensitivities to various anesthetics.The objective of this study is to look at the changes in the intracranial electroencephalographic (EEG) characteristics during dexmedetomidine sedation and to determine the differences in the EEG characteristics between cortical and subcortical structures.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation

Exclusion Criteria:

* Lack of informed consent
* Hypersensitivity to dexmedetomidine
* Language barrier
* Emergency surgery
Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.

Introduction: Local cryotherapy induces vasoconstriction, which leads to a reduction in the inflammatory process. However, the efficacy of local cryotherapy as a coadjuvant in snakebite treatment with F(ab')2 antivenom is unknown.

Objective: Determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom.

Material and methods: Subjects with snakebite envenomation accident grade II, according to the Christopher-Rodning classification, were enrolled from the Clinical Toxicology Service of the Hospital Juárez de México. One group of patients received F(ab')2 antivenom therapy (antivipmyn®) plus local cryotherapy, and another group received only F(ab')2 antivenom therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders and any age with a snake bite of poison grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.

Exclusion Criteria:

* Patients of both genders and any age with a snake bite of poison grade I, III or IV who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly

The immune system undergoes a range of changes as individuals become elderly. These may manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or malignant disease. Multiple underlying factors contribute to this phenomenon of immunological aging, and in this study the investigators will examine the possibility that inadequate diet may be one such contributing factor. Fruit and vegetable intake, which can be low in the elderly, is associated with reduced chronic disease risk. This proposal will test the hypothesis that increased fruit and vegetable intake may positively affect clinically relevant measures of immune function. One hundred healthy volunteers aged 65-85 years following a low fruit and vegetable diet (\<=2 portions/d) will be recruited and randomised to continue following their normal diet, or to consume at least 5 portions of fruit and vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status will be assessed before and after the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Age 65-85 years
* Habitual consumption of fruit and vegetables \<= 2 portions daily

Exclusion Criteria:

* Those on special diets, taking nutritional supplements or medications known to affect immune function or absorption of nutrients
* Excessive alcohol consumption (\>28 U/week men or \>21 U/week women)
* BMI\>35 kg/m2
* History of diabetes or dementia
* Pneumovax II vaccination within previous 2 years
* Inability to provide informed consent
* Any other problem which would prevent adherence to a high fruit and vegetable diet
* Recent infection (\<3 weeks since completion of any antibiotic course or symptoms of viral illness)