cyrilzakka/clinical-trials huggingface dataset:
Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)

This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.

This is a single-arm,multicenter,phase 2 study to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma.The response will be evaluated every 2 cycles.Patients who achieved complete remission(CR) or partial remission(PR) will receive further treatment,and there are 6 cycles of RMO regimen for the induction.The patients with stable disease(SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens.After total 6 induction cycles,the investigators evaluate the efficiency again.After 6 cycles,the patients who receive CR or PR,can tolerate Autologous Hematopoietic Stem Cell Transplantation(AHSCT) will be candidates of high-dose chemotherapy and stem rescue.The patients who achieve CR or PR,cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance.The patients with SD or PD will receive salvage regimen.

Eligibility Criteria:
Inclusion Criteria:

* primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy;
* Aged 18-70 years
* Signature of informed consent;
* At least one measurable lesion;
* Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin\<2XULN,ALT\<4XULN,AST4XULN
* The expected survival time is at least 3 months

Exclusion Criteria:

* Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX
* History of other malignancies that may affect the compliance of the research protocol or the analysis of the results
* Severe cardiac insufficiency
* Other antitumor treatments were used
* Human immunodeficiency virus(HIV)antibody is positive
* Pregnant or lactating women
* Researchers consider if anyone not suitable for enrollment.
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients

The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis.

The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter.

As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, over 18 years,
* Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days,
* Written informed consent
* Social security

Exclusion Criteria:

* Antibiotic therapy during selection phase,
* Partial or complete catheter occlusion during selection phase,
* Venous pressure at dialysis connection \> 300 mmHg,
* Known allergy to ethanol,
* Patient involved in any other clinical trial or in the exclusion period
* Severe co-morbidity
* Acute or chronic infectious disease
* Evolutive neoplasia,
* HIV, HCV positive serology at inclusion,
* Scheduled surgery
Pre-post Spinal Popliteal Block

This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.

This is a retrospective chart review to determine the non-inferiority of performing lower extremity peripheral nerve block placement under spinal anesthesia compared to its pre-spinal counterpart.

Primary outcome:

- The investiigators will be looking into persistent abnormal neuropathic symptoms lasting more than 7 days following a sciatic popliteal nerve block.

Eligibility Criteria:
Inclusion Criteria:

* ambulatory foot surgery
* ambulatory ankle surgery
* use of spinal Anesthesia
* use of pre-spinal anesthesia nerve block techniques
* use of sciatic nerve block

Exclusion Criteria:

* all other surgeries
Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments

The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing and able to observe good oral hygiene and attend for the study visits.
* Subjects with ≥1 visible and accessible early caries lesion present.
* No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.

Exclusion Criteria:

* Active carious lesions
* Facial surface restorations
* Deciduous teeth
* Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
* Intrinsic and extrinsic strains
* Physically and mentally challenged volunteers
* Patients with systemic diseases under medication
* Smokers
Emergence Agitation in Pediatric Strabismus Surgery

This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective subumbilical surgery,
* physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria:

* history of airway problem,
* upper respiratory tract infection within 2 weeks,
* developmental delay,
* neurological or psychological disease,
* history of allergy to the drugs in our protocol were excluded in this study.
Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions

There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.

Eligibility Criteria:
Inclusion Criteria:

* age 5-18 years
* extremity fracture requiring reduction with sedation in emergency department

Exclusion Criteria:

* allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine
* multi-system trauma
* history of psychosis
* pregnancy
* illicit drug use
* developmental delay
* non-english speaker
Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults

Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of the great arteries.

After ASO obstruction of the transposed coronary arteries with resulting reduced perfusion of the heart at stress or abnormities of the right ventricular blood flow resulting in increasing heart rate as well as abnormities in pulmonary flow can appear. In this single centre trial a large homogeneous group of young adults after surgery for transposition of the great arteries (TGA), the so called artery switch operation (ASO), will undergo magnetic resonance imaging (MRI) of the heart at rest and under drug- induced stress to receive data of the functional status of the heart and its perfusion as well as data of the pulmonary arterial perfusion.

Also obstruction of the pulmonary arteries will lead to reduced perfusion and cardiopulmonary exercise capacity.

Therefore the MRI data will be compared to cardiopulmonary exercise capacity data determined by cardio pulmonary stress test (CPX) concerning the feasibility of a correlation of the data and possible generalisation of the results leading to long term assessment of coronary perfusion and myocardial status after ASO for recommendations of physical activity of the young adults.

Eligibility Criteria:
Inclusion Criteria:

* former EMAH (adults with congenital heart defects) patients \> 18 years old
* after neonatal ASO for TGA at the Department of pediatric cardiac surgery
* also if applicable with a correction of an aorta isthmus stenosis neotal or in infancy

Exclusion Criteria:

* contraindications of MRI as metallic implants, claustrophobia
* contraindications of MRI contrast agents
* severe chronic kidney disease (estimated glomerular filtration rate \< 30 ml/min)
* contraindications of exercise stress test with dobutamine or cardiopulmonary exercise stress test (e.g. instable angina pectoris, complex arrhythmia)
* disabled persons not able to perform cardiopulmonary exercise stress test
* pregnancy and breast feeding
Reduced-pressure Pneumoperitoneum and Intraperitoneal Saline Washout to Alleviate Pain Following vNOTES Hysterectomy

vNOTES, initially employed for cholecystectomy, appendectomy, and nephrectomy, made its debut in the field of gynecologic surgery in 2012. The advantages of vNOTES-such as minimized postoperative discomfort, quicker recovery, and superior cosmetic results-combined with gynecologists' familiarity with the vaginal approach, have contributed to the swift global adoption of vNOTES in gynecological procedures. Preliminary trials have demonstrated its safety and practicality.

Although laparoscopy plays a crucial role in surgical procedures, post-operative pain remains a major concern linked to this minimally invasive technique, despite being less intense than the pain from a laparotomy. Visceral pain after laparoscopy can stem from the stretching of the peritoneum and diaphragm caused by pneumoperitoneum, as well as from inflammatory cytokines released due to blood accumulation in the abdominal cavity. This pain is typically described as a dull, widespread ache found in the abdominal or thoracic region and often extends to the shoulders. It corresponds to a rise in painkiller use aligned with Enhanced Recovery After Surgery strategies for both preoperative and postoperative stages. Moreover, the Trendelenburg position could intensify shoulder pain due to increased diaphragm irritation from pneumoperitoneum.

Effective pain management promotes early movement, lowering the risk of blood clots and decreasing lung complications like atelectasis or pneumonia. Additionally, postoperative pain negatively impacts the quality of life immediately after surgery. To lessen both the occurrence and intensity of post-surgical pain, numerous experts advocate for the use of multimodal therapy in surgical patients.

The aim of this study was to evaluate the efficacy of combined low-pressure CO2 pneumoperitoneum and intraperitoneal infusion of normal saline for reducing the incidence and severity of postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received vNOTES hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, transobturator tape insertion, colporrhaphy, or sentinel lymphadenectomy.
* ASA status I-III
* Voluntary participation

Exclusion Criteria:

* Surgery time greater than 3 h,
* suspected infection or malignancy or rectovaginal endometriosis
* participation in other clinical trials.
* presence of pre-surgical shoulder pain or any acute or chronic pain syndromes
* cognitive impairment or communications disorder,
* previous use of opioids for chronic pain,
A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients

The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.

Over 1 million patients receive mechanical ventilation every year in the United States. In mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. Currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. The purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. This pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring mechanical ventilation with a diagnosis of

  * Acute Respiratory Distress Syndrome
  * Cardiogenic Pulmonary Edema
  * Pneumonia
  * Chronic obstructive pulmonary disease

Exclusion Criteria:

* Patients who are considered too unstable to undergo this investigation by their primary physician
* Comatose patients, or patients with severe debilitating neurological disease
* Renal insufficiency (Sr. Creatinine \> 2 mg/dL)
* Heart block (second or third degree heart block) or sinus bradycardia (heart rate \< 60 beats per minute)
* Pregnancy
Non-Stage-Matched Intervention to Enhance High School Female Students' Readiness to Engage in Regular Physical Exercise

A non-stage-matched intervention based on the Transtheoretical Model of Change

The proposed intervention would be non-stage-matched intervention based on the Transtheoretical Model of Change.

The study sample would include high school female students (72 for the study group and 72 for the control group). The study participants will be randomly allocated and assigned into each of the study and control groups.

Participants will go through pretest, intervention, posttest 1, and posttest 2. There will be a 12-2eeks interval between the intervention and each of posttest 1 and posttest 2.

Eligibility Criteria:
Inclusion Criteria:

* High school female students who do not experience any physical disability

Exclusion Criteria:

* High school female students who experience any physical disability
Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Signaling Pathways

This study aims to evaluate the effects of leucine and branched-chain amino acids supplementation on skeletal muscle remodeling signaling pathways induced by resistance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Sedentaries
* Must be able to exercise
* Must be able to swallow tablets

Exclusion Criteria:

* Use of nutritional supplements
* Use of anti-inflammatory drugs
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
* Equal to or greater than 8 years and not older than 13 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 1.50 D.
* Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
* Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
* Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
* History of myopia control intervention
* Absence of strabismus by cover test at near or distance wearing correction.
* Absence of amblyopia
* Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.

Exclusion Criteria

* Vulnerability of subject
* Participation in any clinical study within 30 days of the Baseline visit.
* Sibling of existing participant of this study
Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation

The hypothesis of this study is Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation (NAD-CPR) would improve survival of out-of-hospital cardiac arrest (OHCA).

Out-of-hospital cardiac arrest (OHCA) is a major health problem, occurring in about 1 in 1,500 adults in the developed countries each year. Although layperson CPR and defibrillation are crucial components of chain of survival, layperson CPR rate and it's quality is low and public-access defibrillation (PAD) program is not cost-effective.If trained bystanders can know the information of occurrence of OHCA and nearest place for automated external defibrillator (AED) at the same time by dispatch center, these neighborhoods could run and give high quality CPR and early defibrillation. If this protocol ,Dispatcher-Activated Neighborhood Access Defibrillation and Cardiopulmonary Resuscitation(NAD-CPR), is introduced to community, it may improve survival of OHCA.

Eligibility Criteria:
Inclusion Criteria:

* all OHCA with presumed cardiac etiology more than 15 years old
* assessed by emergency medical service (EMS) providers dispatched by dispatch center
* dispatcher detected OHCA patients

Exclusion Criteria:

* OHCA with non-cardiac etiology
* prolonged cardiac arrest with a suspected duration more than 30 minutes
* cases with rigor mortis or rivor mortis, decapitated or decomposed body
* Non detected cases by dispatcher
Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery

Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.

Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing valvular heart surgery associated to post capillary pulmonary hypertension with a mean pulmonary arterial pressure (mPAP)\>30mmHg or pulmonary vascular resistance (PVR)\>3Wu.

Exclusion Criteria:

* patients younger than 18 years old
* ischemic cardiomyopathy
* Ejection Fraction (EF)\<30%
* severe Chronic obstructive pulmonary disease (COPD) with oxygen and bronchodilators therapy
* chronic pulmonary disease, chronic renal failure on dialysis
* hepatic failure
* patients with orotracheal intubation and already admitted to the ICU before the intervention