cyrilzakka/clinical-trials huggingface dataset:
Systemic Steroids Plus Antibiotics in Sleep Apnea Syndrome in Children

The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS.

We will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. We will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. If not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.

Eligibility Criteria:
Inclusion Criteria:

* Polysomnogram results showing mild obstructive sleep apnea.

Exclusion Criteria:

* Significant medical problems
* Chronic medication intake (except bronchodilators and inhaled steroids)
* Allergy to penicillin or its derivatives.
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults

The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
2. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
3. Able to swallow multiple capsules.

Key Exclusion Criteria:

1. History of stomach or intestinal surgery or resection
2. Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
3. Participants who, in the opinion of the Investigator (or designee), should not participate in this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One

Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.

Searching for other materials or other fabrication technologies has been one of the goals to help to re-innovate the fabrication of complete dentures , which would greatly influence completely edentulous Patient satisfaction. The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

SLA has been used in dental fields like maxillofacial prosthesis , wax pattern fabrication for crown bridge , removable partial denture 19, but still complete denture was reported in a very few reports indicating that RP is not yet successfully applied in Complete denture manufacturing 19-21A randomised trial is therefore needed to asses accurately wether the introduction of rapid prototyping in complete denture fabrication is successful or not in comparison to the conventional technique and to discover the possible challenges in this recent technique and the ways to overcome it.

Retention of complete dentures and patient satisfaction has been reported in many studies22-26. Patients have showed a higher satisfaction, as retention of both maxillary and mandibular complete dentures increased.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 40-70 years.
2. Patients who can understand and respond to a written questionnaire in Arabic.
3. Cooperative patients

Exclusion Criteria:

1. Pathological changes of residual ridges.
2. Patients with debilitating systemic diseases.
3. Patients with xerostomia.
4. Patients with flabby and flat ridges.
5. Patients with allergy to acrylic resin
6. Patient with sever undercuts, or irregular bony exostosis
Naltrexone for Prolonged Grief Disorder

This is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (PGD). Participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Lives within a reasonable distance from NYPH for convenient clinic visits.
* Can speak, read, and write English proficiently.
* Meet diagnostic criteria for PGD based on the DSM guidelines
* If a female patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while she is taking the study drug. Female patients who are planning to use oral hormonal contraception during this time must have initiated it at least 2 months prior to the baseline visit.
* If a male patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while he is taking the study drug.

Exclusion Criteria:

• Having recently started taking/prescribed medications for any psychiatric illness (e.g.

SSRIs for MDD) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included.

* Having recently started psychotherapy for any psychiatric illness within the past 3 months; participants who have been receiving psychotherapy for longer than 3 months can be included.
* Prior history of recently active (e.g. within the past 3 months) opioid dependence.
* Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including opioid antagonists for alcohol or opioid dependence, all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide).
* Possible future use of opioids during the study (e.g. for surgery).
* Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril), or any other clinically relevant medication that has potential to cause liver injury with concurrent use of naltrexone.
* Currently pregnant, lactating, or planning to become pregnant during the study.
* Active hepatitis or liver disease.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal on initial laboratory examination. Screen positive for active suicidal thoughts or behaviors.
Core Muscle Strength in Women with Primary Dysmenorrhoea

The aim of this study is to compare core muscle strength, core muscle activations, and pelvic tilt angles in women with and without Primary Dysmenorrhea (PD).

The study included 27 women with PD and 27 healthy women without primary dysmenorrhea. Demographic and menstrual information of the participants was recorded. The "Sport-Specific Core Muscle Strength \& Stability Plank Test" protocol was applied to evaluate the core muscle strength of the participants. Pelvic floor, transversus abdominis, and multifidus muscle activations were assessed using the NeuroTrac® MyoPlus 2 dual-channel EMG ETS device. Pelvic tilt measurement was performed using the Apecs-AI Posture Assessment and Correction System®. Menstrual pain and symptoms were evaluated using the Menstrual Symptom Scale.

This study found that women with PD had higher muscle activations, lower pelvic tilt angles, and more severe menstrual symptoms. We believe these results may contribute to the etiology of PD.

Eligibility Criteria:
Inclusion Criteria:

* Participants must meet the following criteria to be included in the study:

Age between 18 and 35 years

Diagnosed with Primary Dysmenorrhea (PD) according to the PD consensus criteria, which include:

Presence of menstrual pain within the first few years after menarche A Visual Analog Scale (VAS) pain score of 4 or higher in the last six months No pelvic pathology Having a regular menstrual cycle (21-35 days) No uterine disorders

Exclusion Criteria:

The sample size for the study was determined using the G\*Power software (latest version 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany).

Since our study consists of two groups (participants with and without Primary Dysmenorrhea), the power analysis was conducted using the "Means: Difference between two independent means (two groups)" method.

Based on similar studies, an effect size of d = 0.726 was used for the calculation.

With a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.Pregnancy or suspicion of pregnancy Active sexual life History of childbirth Use of an intrauterine device (IUD) History of surgery involving the abdomen, spine, or pelvic region within the last year Diagnosis of secondary dysmenorrhea Body mass index (BMI) of 30 or higher
Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery

A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.

This is a prospective, single-center, single-blinded, randomized controlled trial comparing the effect of an opioid-free general anesthetic versus a traditional anesthetic with a restricted quantity of opioid on postoperative opioid consumption following laparoscopic bariatric surgery. The study population will be composed of 196 subjects undergoing laparoscopic bariatric surgery at Virginia Mason Medical center randomized into two groups. The control group will receive a traditional opioid restrictive general anesthetic. The study group will receive an opioid-free anesthetic technique.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent

Exclusion Criteria:

* Any opioid use within 4 weeks prior to surgery
* Chronic antiemetic use
* Conversion of laparoscopic to open surgery
* Patients unable to provide post-operative pain scores
* Pregnant or lactating patients
* Patients under 18 years of age
* Refusal or inability to provide informed consent
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients

This study is intended to investigate the pharmacodynamic drug-drug interaction as well as the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

Patients with stable CAD defined by

* coronary artery stenosis in any of the 3 main coronary vessels \> 50% documented by coronary angiography within last 36 months
* or history of myocardial infarction
* Age: 30 to 80 years (inclusive) at the first screening examination
* Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²

Exclusion Criteria:

* Intervention e.g. revascularization by percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) during the last 3 months
* Progressive angina with symptoms of worsening of angina within the \< 3 months prior to the first screening examination
* History of recent (\< 6 months prior to the first screening examination) myocardial infarction or unstable angina
* Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
* Insulin dependent diabetes mellitus
* Clinically relevant cardiac ischemia at screening
* Clinical significant persistent ischemia, which should be ruled out by clinical judgment of the investigator, based on medical history, available clinical data e.g. past angiograms or preexisting or current exercise testing with any imaging technique (e.g. dobutamine stress echocardiography, adenosine or dobutamine stress cardiac magnetic resonance imaging (CMR), scinthigraphy or exercise ECG)
* Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III
* Systolic blood pressure below 110 or above 160 mmHg at first screening visit
* Diastolic blood pressure above 100 mmHg at first screening visit
* Heart rate below 50 or above 100 beats / min (taken from ECG measurement) at first screening visit
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\*2 at first screening visit
Simplified Anti-Thrombotic Therapy for FFR

Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR calculation, no study has evaluated the optimal anti-thrombotic regimen in patients undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in patients with intermediate coronary artery stenosis undergoing FFR calculation during elective coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* All patient regardless of sex, or age were eligible for the study if they were scheduled for an elective coronary angiography using a femoral approach, and were agreeable to participate in the study after signing informed consent, and had a coronary stenosis in any major native epicardial coronary artery between 50-70% determined by quantitative angiography that was an adequate target for FFR at the discretion of the operator.

Exclusion Criteria:

* Exclusion criteria included patients requiring mandatory DAT, patient undergoing radial access due to concomitant anticoagulation, patients with contra-indications or intolerant to DAT, patients with severe left ventricular hypertrophy defined as a wall thickness greater than 14 mm by echocardiography in the septal or lateral wall, patients with hypertrophic cardiomyopathy, left ventricular function less than 30%, severe aortic valvular stenosis defined as an aortic valve area of less than 1 cm2, presenting with an acute coronary syndrome in the past two weeks, hemodynamic instability, cardiogenic shock, reported allergy to clopidogrel, aspirin or bivalirudin, planned to be anticoagulated during or previous to the time of the coronary angiography, using Prasugrel or Ticagrelor, patients with coronary arteries unsuitable for FFR calculation due to severe tortuousity and/or calcification, lesions supplied by a bypass conduit, any mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study such that the patient is unable to give appropriate informed consent or refusal or inability to sign an informed consent .
Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary hypertension.

32 patients with CTEPH (confirmed by right cardiac catheterization and imaging) will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) evaluation of peripheral muscle strength by isokinetic dynamometry; 4) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (\~ 75% of maximal work-rate) with non-invasive evaluation of central hemodynamics and peripheral muscle oxygenation. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (\~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.

Eligibility Criteria:
Inclusion Criteria:

* CTEPH confirmed by RHC and imaging
* NYHA FC II-IV

Exclusion Criteria:

* Limitation to cycling
* Recent syncope or clinical deterioration
Detection and Management of Acute Kidney Injury (AKI) in Low and Low Middle Income Countries: A Pilot Feasibility Project

This feasibility study will be conducted at 4 international sites located in Asia (Dhahran, Nepal); Africa (Blantyre, Malawi and Kilimanjaro, Tanzania) and Latin America (Cochabamba, Bolivia).

Each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1 regional referral hospital) that service the population around the site area. Patients presenting at a health care clinic or hospital emergency department with signs and symptoms associated with high and moderate risk of developing AKI will undergo a point of care (POC) test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and a urine dipstick test for color, protein, glucose, blood and specific gravity. Patients who meet the study inclusion criteria will be approached for consent. Patients enrolled in the study will be followed throughout the health care evaluation and tracked through their course by location i.e. health care center, hospital, and home. Outcomes will be recorded through 6 months following the health care evaluation.

The protocol will have an initial observation phase, during which relevant healthcare staff and the research team will be trained to identify patients at moderate or high risk of AKI and use of the point of care (POC) test for serum creatinine, saliva urea nitrogen dipstick (exclusively in Malawi), and urine dipstick test. During this phase patients will be tracked throughout the health care evaluation, however the teleconsultation will not be implemented and no specific guidance for managing the patient will be provided.

During the subsequent intervention phase, the research team will interact with the local healthcare providers to and the teleconsultation physician, providing guidance on the management of the patient based on a standardized protocol. Protocols for patient care will be pre-specified, with minor adjustments to meet local requirements.


Eligibility Criteria:
Inclusion Criteria:Presence of Signs and Symptoms determining AKI risk

* Decreased urine volume
* Hypotension/ shock
* Coma
* Jaundice
* Confusion
* Dyspnea
* Symptoms of respiratory infection
* Petechia, ecchymosis, bleeding
* Hypertension (in pregnancy)

Exclusion Criteria:

* Chronic kidney disease in patients receiving regular dialysis treatment
* Kidney transplant patients
* Unable to give informed consent
Sequential Treatment of Extra-Corporeal Shock Wave Combined With aUtologous Bone marRow Mesenchymal Stem Cells on Patients With ischEmic Heart Disease : the S-CURE Study

This study is designed to evaluate the efficacy, safety and tolerability of autologous bone marrow derived mesenchymal stem cells compared to placebo (sham operation) when administered via percutaneous coronary infusion to patients with ischemic heart disease, who are screened by D-SPECT and have pretreated with 3-month cardiac shock wave therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant, non-lactating females;
2. Chronic ischemic heart failure, previous anterior myocardial infarction \> 3months;
3. Viable myocardium is detected by D-SPECT;
4. LVEF \< 50% measured by echocardiography or NYHA II-IV;
5. No planed reasonable revascularization procedures;
6. At least 30 days standard medical therapy for heart failure before screening;
7. Worsening heart failure within 6 months or have a NT-proBNP ≥1000 pg/mL or BNP ≥200 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤425 meters at screening;
8. Written informed consent.

Exclusion Criteria:

1. Ventricular thrombus;
2. Myocardial infarction, TIA or stroke \< 3 months;
3. CRT/CRT-D implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, heart failure-related device interventions, or cardiac shunt implantation;
4. Active infection or fever;
5. Chronic inflammatory disease;
6. HIV infection or active hepatitis;
7. Hemoglobin A1c (HbA1c) ≥ 9% at screening;
8. Body mass index (BMI) ≥ 40 kg/m2 at screening;
9. Chronic kidney disease (CKD) requiring dialysis (Stage 5) or estimated creatinine clearance \< 30 mL/min/1.73㎡ at screening;
10. Allergies to any equine, porcine, or bovine products;
11. Abnormal laboratory values at screening：Platelets \< 50,000 μL;Hemoglobin \< 9.0 g/dL; Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \> 3 times the upper limit of normal (ULN);
12. Pregnancy;
13. Mental retardation;
14. Participation in other clinical study \< 1 month.
A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair

Background: Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In a few studies oral ketamine has been used successfully for procedural sedation as well. The efficacy of using a combination of oral midazolam and oral ketamine for procedural sedation has been studied only for invasive procedures in children with malignancies. No randomized controedll studies were performed using this sedative combination in children requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to oral midazolam for procedural sedation in children requiring laceration repair compares to oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study. Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral ketamine group. Both groups will be given the same volume of medications. Midazolam will be given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given. Patient monitoring will be conducted according to the American Academy of Pediatrics (APP) and the Israeli health ministry guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Main outcome measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive statistics will be used to describe the study population. Data will be analyzed using t- tests for continuous data and Fisher exact test for categorical data.

Key words: sedation, children, ketamine, midazolam, emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Age: 1 years - 10 years
* Any child with laceration requiring sedation

Exclusion Criteria:

* Major trauma
* Closed head injury associated with loss of consciousness
* Abnormal neurologic examination in a previously normal child
* Significant developmental delay or baseline neurological deficit
* A patient with seizures
* Elevated intra-cranial pressure
* Hypersensitivity to midazolam or ketamine
* Hypertension
* Hyperthyroidism or a patient receiving thyroid replacement
* alcohol intoxication or a history of alcohol abuse
* Acute or chronic respiratory, cardiac, renal or hepatic abnormalities
* Glaucoma
* Known psychiatric disease
* ASA score of more than 2
* Informed consent cannot be obtained from legal guardian