cyrilzakka/clinical-trials huggingface dataset:
SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A

The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures, however, have not been studied for patients undergoing tonsillectomy and adenoidectomy (T\&A) procedures. The goals of this study are to determine if SZMN block can be utilized for pain control and decrease morbidity in pediatric patients undergoing T\&A.

Patients between 6 months and 18 years undergoing T\&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into either the suprazygomatic maxillary nerve (SZMN) block treatment cohort or the control cohort i.e standard of care.

After anesthesia induction, patients randomized into the SZMN- treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur near the temples above the cheek bones.

Participants enrolled into the control group will receive standard of care with no changes to their anesthetic or surgical care. Both groups will be asked for their verbal pain scores in the PACU and we will track their opioid consumption throughout the next few days after their procedure.

Eligibility Criteria:
Inclusion Criteria:

* Ages 0-18
* Give consent/parental consent to participate in study
* Patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria:

* Participants who do not consent or have parental consent
* Patients who are clinically unstable or require urgent/emergent intervention
* Patients under age 6 months
Role of Topical Tranexamic Acid in Total Hip Arthroplasty

Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age.
* Male or female.
* Degenerative joint disease of hip joint.
* Primary uncemented total hip arthroplasty.
* Willingness to participate in the study, follow up at regular intervals

Exclusion Criteria:

* Known allergy to tranexamic acid
* History of any acquired disturbances of color vision
* Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males)
* History of previous myocardial infarction
* History of arterial or venous thromboembolic disease
* History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.5, or a prolonged partial thromboplastin time
* Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
* Breastfeeding
* Refusal of blood products
* Preoperative use of anticoagulant therapy within five days before surgery
* Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
* Major comorbidities (e.g. severe ischemic heart disease )
* Severe pulmonary disease
* Preoperative blood donation
* Participation in another clinical trial involving pharmaceutical drugs
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

Part A ( for Healthy volunteers) of the study is completed.

Part B dose-escalation study is completed. Recruitment in dose expansion is completed.

Part C study in subjects with treatment-resistant/intolerant is ongoing for the enrolled subjects.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written, and dated, informed consent
* Male or female aged ≥ 18 years
* Willing and able to comply with the scheduled visits
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Part C).

Exclusion Criteria:

* Presence of T315I (PART C)
* Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
* Inability to undergo venipuncture and/or tolerate venous access
* Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
* Known or suspected history of significant drug abuse as judged by the Investigator
* Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
* Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant
* Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ
Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

The sealing of fossae and fissures is an effective procedure in preventing occlusal caries lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel lesions. In addition, there are no studies in the literature that have compared the longevity of sealings performed with the different sealants available in the market. Thus, the objective of this study is to evaluate the efficacy of fossae and fissures sealings performed with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous molars. This is a multicenter clinical study of non-inferiority, randomized, controlled, double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized into two groups using a distributed randomization list in mixed envelopes that will be open only at the time of the procedure. The teeth allocated in the test group will be treated with the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and 18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and quality of life, will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Children with at least two deciduous and/or permanent molars with occlusal caries lesions scores 1, 2 or 3 of the Icdas (Ismail et al., 2007) will be included, one on each side, preferably from the same arch.

Exclusion Criteria:

* Patients with special needs;
* using orthodontic appliances;
* with systemic diseases;
* Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp impairment;
* teeth with fistula and/or abscess;
* teeth with spontaneous painful symptomatology.
Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods Study

The goal of this study is to evaluate the use of aspirin for the prevention of preeclampsia among moderate -to- high-risk pregnant women in tertiary care hospitals in Nigeria followed by a qualitative study to evaluate the barriers and facilitators of aspirin use in prenatal care for the prevention of preeclampsia in Nigeria. The main question\[s\] it aims to answer are:

1. Is Aspirin used for the prevention of preeclampsia among pregnant women in Nigeria?
2. What factors promote or prevent the utilization of Aspirin for preeclampsia prevention among pregnant women in Nigeria.

Nigeria has the highest burden of maternal mortality worldwide accounting for over 1 in 4 of global maternal deaths. In a 2022 nationwide analysis of maternal outcomes in 76,563 deliveries across referral-level hospitals in Nigeria, hypertensive disorders of pregnancy (HDP) including preeclampsia accounted for 32% of maternal deaths. Studies have linked the pathophysiology of preeclampsia to peripartum cardiomyopathy (PPCM) which is prevalent in Nigeria.5,6 Patients with PPCM were 4 times as likely to have preeclampsia that patients without PPCM. Among known evidence-based interventions for HDP, aspirin prophylaxis stands out as among the most highly effective in preeclampsia prevention. A comprehensive understanding of utilization patterns, or lack thereof, as well as the identification of barriers and facilitators, can inform implementation studies aimed at increasing adoption of this highly effective and cost-effective intervention.

Aims:

1. To conduct a multisite cross-sectional study to evaluate the utilization of aspirin use for the prevention of preeclampsia amongst moderate- to high-risk pregnant women in tertiary care hospitals in Nigeria. We hypothesize that there is underutilization of aspirin for the prevention of preeclampsia amongst pregnant women at moderate- to high-risk of preeclampsia in Nigeria.
2. To conduct a qualitative research study to evaluate facilitators and barriers to aspirin use in prenatal care for prevention of preeclampsia in Nigeria. We hypothesize that there is underutilization of aspirin for the prevention of preeclampsia amongst pregnant women at moderate- to high- risk of preeclampsia in Nigeria.

Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant woman \> 18 years old / emancipated pregnant minors (\<18years), according to the stipulations of the Nigerian National Health Research Ethics Committee (NRHEC)
* \>12 weeks' gestation attending antenatal care clinics on 2nd or subsequent visit
* Those presenting to the labor and delivery room.

Exclusion Criteria:

* Unable to provide consent
Pre-Hospital Use of Plasma for Traumatic Hemorrhage

Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital.

The purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

INVESTIGATIONAL PLAN This will be an open-label, non-blinded, randomized clinical trial to investigate mortality (30 days) and morbidity of Type A thawed Plasma (TP) versus NS infusion at earliest contact, administered by Emergency Medical Service (EMS) supervisors to subjects who have sustained severe Polytrauma / Major hemorrhage (PTr / MH). The total study is expected to last 2 years with 210 patients enrolled.

The two EMS agencies involved in the study will each have one EMS supervisor quick-response vehicle (QRV) equipped with an approved, validated refrigeration unit for TP transport. EMS personnel trained in plasma administration and recognition of reactions may administer up to 2 units of TP to subjects approved for study enrollment. Blood samples for coagulation and lipid testing will be drawn prior to TP administration by EMS personnel,and repeated by hospital personnel at 30 minutes, 8 hours, and 24 hours post-injury.

This study is approved for "Exception from Informed Consent" (EFIC). Once the patient has reached VCUMC and has been entered into the VCUMC health care system, the treating team will advise the Study Coordinator (SC) whether or not a subject is able to consent. As the plasma administration will occur in the field prior to arrival to VCUMC, the SC will make every effort possible to obtain consent from the subject or legally authorized representative (LAR) for continued study participation before the next intervention (8 hour blood specimen collection). The attempts to contact the LAR will be documented in detail. If a subject lacks the ability to provide his/her own consent by the end of day 30, the consent signed by the LAR will be the consent document in force at the subject's completion of the study and no further consent will be sought.

Eligibility Criteria:
Inclusion Criteria:

* Blunt or penetrating trauma,
* Blood Pressure (BP) systolic \<70 mmHg or BP 70-90 mmHg with Heart Rate (HR) \> 108 Beats Per Minute (BPM),
* Ongoing hemorrhage with unstable vital signs

Exclusion Criteria:

* Wearing opt-out wrist band,
* Wearing medical alert jewelry / bracelet, etc. indicating Jehovah Witness or similar with objections to blood transfusions,
* Refusal to participate (by subject or LAR),
* Communication barrier at the time of eliciting refusal (non-English speaking or non-Spanish speaking),
* Not expected to survive transport to Virginia Commonwealth University Medical Center (VCUMC),
* Documented Do Not Resuscitate (DNR) order found,
* Cardiac arrest or Cardio-Pulmonary Resuscitation (CPR) prior to randomization
* Penetrating head trauma,
* Known / obvious pregnancy,
* Prisoner,
* Burns \> 20% of body surface
Pseudo-PDT in Central Serous Chorioretinopathy

Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* patients with best-corrected visual acuity (BCVA) of 20/200 or better;
* presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);
* presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

Exclusion Criteria:

* any previous treatment for CSC;
* evidence of choroidal neovascularization or other maculopathy on fundus examination.
Intravoxel Incoherent Motion (IVIM) Magnetic Resonance Imaging in Multiple Sclerosis

Intravoxel incoherent motion (IVIM) is technique based on diffusion-weighted imaging (DWI). In this study, the investigators evaluate the use of IVIM in patients with Multiple Sclerosis.

Intravoxel incoherent motion (IVIM) is technique based on diffusion-weighted imaging (DWI), it is achieved through an MRI acquisition with multiple small b value to extract perfusion data. It has been shown to be a promising technique in evaluation of many brain conditions. This study seeks to assess intravoxel incoherent motion (IVIM) parameters in characterizing plaques and specific tissues in multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 18 years or older.
2. Relapsing-remitting MS diagnosed as per Macdonald criteria

Exclusion Criteria:

1. Contraindication to MRI. For example, metal implantation in the body, claustrophobia and pregnancy.
2. Patients who are unable to tolerate the scans without moving the head as a result of symptoms such as tremor, spasticity, involuntary movements and spasms, cognitive impairment, coughing, and shortness of breath.
Relationship Between Dopamine Genetics, Food Reinforcement, Energy Intake and Obesity

The purpose of the study is to determine whether the presentation of various foods produces an increase or decrease in responses on a motivational computer task. In addition, the study determines if energy intake or motivation to obtain food is related to the dopamine receptor genotype.

One of the most important research areas in obesity is developing a better understanding of individual differences in factors that influence excess energy intake and positive energy balance. One key to understanding these individual differences is determining what factors underlie the motivation to eat. We have demonstrated in a series of studies that obese adults and children are more motivated to work for palatable, favorite foods than leaner peers and that those high in food reinforcement consume more food in an ad libitum eating task than those who do not find food as reinforcing. Dopamine (DA) is one of the major neurotransmitters involved in establishing the reinforcing value of food, and low levels of dopamine activity and a reduction in the number of DA receptors is associated with obesity. The general aim of the proposed research is to build upon this research to examine relationships between food reinforcement, obesity, and polymorphisms of genes within the dopaminergic system.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* 18-50 years of age
* No known eating disorder
* Moderate liking for study foods
* No current diagnosis of psychiatric disorder (e.g., anxiety or depression)
* Not on medications that would interfere with appetite (e.g., methylphenidate) or dopaminergic activity
* Non-diabetics

Exclusion Criteria:

* Smoker
* Pregnant women
* Current diagnosis of a psychiatric or eating disorder
* Dietary restrictions that would interfere with participation
* On medications that could interfere with appetite or olfactory responsiveness or use of antidepressants or any medication or dietary supplement that could affect appetite or dopaminergic activity
* Excessive use of alcohol (\>21 drinks/week), alcoholism,current addiction to opiates, cocaine or stimulants
Remineralization Effect of βTricalcium Phosphate Nanoparticles Versus FunctionalizedβTricalcium Phosphate Nanoparticles

The study collects Sixty non carious sound human permanent premolars from Tanta University's maxillofacial surgery department. The teeth are cleaned and prepared, and randomly assigned into four groups. The specimens are analyzed using an EDX analysis scanning electron microscope, and surface micro-hardness is determined using a Digital Display Vickers Micro-hardness Tester.

The study involves collecting Sixty non carious sound human permanent premolars from an outpatient clinic at Tanta University's maxillofacial surgery department. The teeth are selected for their absence of caries, hypocalcification restoration, fracture fluorosis, and cracks. The teeth are cleaned and prepared for the study, including demineralization and artificial incipient enamel carious lesion preparation. The teeth are randomly assigned into four groups: functionalized Nano ᵦ tricalcium phosphate particles, Nano ᵦ tricalcium phosphate particles, sodium fluoride mouth wash, and artificial saliva. The pH of all groups is adjusted at 7. The specimens are treated in a daily pH cycling regime, with daily solution replacements. The specimens are then dried and analyzed using an Energy Dispersive X-Ray (EDX) analysis scanning electron microscope. The element content distribution of calcium and phosphorus elements is measured, and the specimens are evaluated at base line, after demineralization, and after 2, 4, and 6 weeks. Surface micro-hardness is determined using a Digital Display Vickers Micro-hardness Tester.

Data will be collected, presented, and statistically analyzed using SPSS software package system using ANOVA at a significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* The selected teeth were free from caries, hypocalcification restoration, fracture fluorosis and cracks

Exclusion Criteria:

-
Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients

This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.

After obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. Randomization of the groups was done in a computer environment.

Eligibility Criteria:
Inclusion Criteria:

* Those who are 18 years or older,
* Receiving hemodialysis treatment for at least 3 months,
* Receiving hemodialysis treatment three times a week,
* Does not have any open wounds in the area to be applied,
* No active fistula in the arm to be treated,
* Does not have a hearing impairment,
* Sufficient to understand the questions,
* Open to communication and cooperation,
* Volunteer and willing for research

Exclusion Criteria:

* Having an active oncological problem or receiving oncological treatment,
* Those with health problems that require contact isolation,
* The number of dialysis sessions changed during the study,
* Those who lost their lives while working,
* Those who had a kidney transplant during the study,
* Those who want to leave voluntarily at any stage of the study