cyrilzakka/clinical-trials huggingface dataset:
Photobiomodulation for Pediatric Hypertrophic Tonsils

Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea.

The use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children

The purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting.

The investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children.


Eligibility Criteria:
Inclusion Criteria:

* Brodsky visually graded tonsils 3/4
* patient must assent, parent must consent, to all pre and post follow up including sleep testing
* patient and parent must agree to normal referral protocols regardless of participation within this study or not

Exclusion Criteria:

* visual indication of cancerous growth
* currently under treatment (pharmacologic, other) for hypertrophic tonsils
* already scheduled for surgical intervention of hypertrophic tonsils
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB


Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy based on medical examination/history at the inclusion
* Age between 18 and 55 years
* Signed informed consent
* Prepared to grant authorized persons access to the medical records
* The volunteer is likely to comply with instructions

Exclusion Criteria:

* Known exposure to TB before (or expected during) the trial
* Prior BCG vaccination
* Granulomatous disease (by chest X-ray, autoimmune screen)
* Vaccinated with live vaccine 3 months before first vaccination
* Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
* HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
* Participation in other clinical trials
* Positive Mantoux or QuantiFERON-TB Gold
* Known hypersensitivity to any of the vaccine components
* Laboratory parameters outside of normal ranges considered clinically relevant
Effects of Levosimendan on Microcirculation in Septic Shock

The present study was conducted as a prospective, randomized, controlled study to:

* investigate the effects of a combination of levosimendan and inhaled nitric oxide on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock;
* test the hypothesis that levosimendan plus inhaled nitric oxide may be effective in restoring microvascular function in septic shock.

40 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and a mixed venous oxygen saturation (SvO2) ≥ 65%, patients will be randomly allocated to be treated with either a) intravenous administration of levosimendan 0.2 µg∙kg-1∙min-1 for 24 hrs, b)intravenous administration of dobutamine 5 µg∙kg-1∙min-1 for 36 hrs(control; each n = 20). At the end of the first 24 hrs of the study period, both groups will receive inhaled nitric oxide at the concentration of 35 ppm for further 12 hrs. In all patients norepinephrine was titrated to maintain mean arterial pressure between 65 and 75 mmHg. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 24 and 36 hours.

The sublingual microvascular network will be studied using the sidestream dark field (SDF) imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Septic shock
* Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* Ventricular outflow tract obstruction
* Mitral valve systolic anterior motion
Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks

Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy (typically related to increased length of stay). However, the standard used to detect and localize the air leaks, the submersion test, is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery. Considering the prevalence of this complication and the absence of a surgical standard of care for such complications, the aim of this study is to develop a system to create and send a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lung transplant surgery
* Organ donor ineligible to donate lungs

Exclusion Criteria:

* Healthy individuals
The Assessment of Bone Health in a Clinical Setting

The study will use data already obtained through the metabolic clinical service to improve diagnosis and management of our patients.

Patients are referred for assessment of their bone health routinely have a bone density (BD) scan (DXA) and many also have a bone marker (BM) measurement, either NTx ( breakdown product of bone) or PINP ( formation product of bone). Patients diagnosed with osteoporosis are usually treated with a bisphosphonate drug which can halt or at least decrease the rate of bone loss.

BMs are measured pre- and post -treatment to assess adherence and effectiveness of treatment. BD measured by DXA is also used for this but in clinical practice is not recommended at intervals of less than 2 years. BMs show a much earlier clinical meaningful change - typically 2-6 months, vs BD -typically 2 years, thereby aiding swift knowledge of response or lack of response to treatment.

Although DXA remains the gold standard for initial assessment of bone health by measuring BD, BMs have an increasing role to play in patient follow up.

We propose to interrogate available data to explore whether utilizing BMs can provide monitoring information up to 5 years post-treatment thereby increasing the follow up time of the next DXA scan. This would ensure patients are not being subjected to scans using x-rays unduly and that a DXA scan is only performed when clinically needed. Additionally we want to investigate if BM levels pre-treatment reflect the response to treatment of the marker and BD, prediction of BM levels from age, fracture history, treatment, and does site of fracture affect BM and BD.

Previous work by other investigators has covered some of this ground but has not come up with definitive answers.

The study is expected to take 5 years and will not involve additional investigations compared to standard care.

Eligibility Criteria:
Inclusion Criteria: All patients on database -

Exclusion Criteria: Not recruiting

-
Fetal Cardiac Function Evaluation With aCMQ-Strain Fetal (STRAIN)

To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac function. Establish normality parameters and compare it with fetuses with risk factors of cardiac dysfunction.

National unicentric observational study of follow-up study of a cohort. It has been decided to conduct a study of consecutive cases, including all patients who meet the inclusion criteria during the time of the study.

Until now, there has not been an easy and convenient method to determine fetal cardiac function. Recently a new Software (Automated Cardiac Motion Quantification aCMQ) has been developed, and it seems that allows an easier analysis of this one.

This study aims to analyze fetal heart function with the Strain method in healthy patients and then compare it with fetuses with risk factors for cardiac dysfunction.

Initially, healthy pregnant patients who agree to participate in the study will be cited, after signing the informed consent, in order to evaluate the normal fetal cardiac function and see how it is modified in the different weeks of gestation.

To do this, a fetal echocardiography will be performed by the investigators at week 24, 28, 32 and 36 of pregnancy, using the aCMQ-Strain method.

Once the investigators have established normality curves, fetuses with risk factors for cardiac dysfunction of women who agree to participate in the study will be analyzed. For this purpose, a fetal echocardiography at week 24, 28, 32 and 36 of gestation, using the aCMQ-Strain method will be performed.

All tests will be carried out in the same study center and will be carried out by independent scouts.The data obtained in each test will be collected in an anonymized database for further study.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Pregnant women\> 20 weeks gestation
* Understand and accept the study procedures and sign an informed consent.

Exclusion Criteria:

* Not being able to understand the nature of the study and / or the procedures to be followed.
* Not signing informed consent
* Under 18 years of age
* Not pregnant
Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients

The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.

Primary Objective:

To prove the equivalence between two groups by comparing the ACR20 of W24 with the baseline after injecting HD203 25mg and (Enbrel®) 25mg into the patients with rheumatoid arthritis for 24 weeks.

Secondary Objective:

To compare the efficacy of ACR20, ACR50 and ACR70, etc along with safety in adverse event, vital signs, Laboratory test, physical examination and immunogenicity, etc between two groups with baseline after injecting HD203 25mg and (Enbrel®) 25mg into patients with rheumatoid arthritis for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males and females who are 20 or over
* Patients who satisfy the classification criteria of Rheumatoid Arthritis according to American Colleague of Rheumatology (ACR 1987)
* Patients who are applicable to functional status I - III of American Colleague of Rheumatology

Exclusion Criteria:

* Patients who have autoimmune diseases other than rheumatoid arthritis or have significant secondary systematic disease caused by rheumatoid arthritis
* Patients who are currently participating in other clinical studies or receiving treatment for drugs not sold in the market or for experiment
* Patients who have significant other diseases that may affect the clinical trial when judged by the clinical trial Investigator
* In the opinion of the investigator, may put the patient at risk because of participation on the study or may influence the patients' ability to participate in the study
Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms

Adult patients (\>18 years) with newly diagnosis of Ph negative myeloproliferative neoplasms (MPNs) according to WHO 2016 criteria, will be recruited to this study.

This study is the result of the collaboration the Hematology Division of Federico II University Medical School of Naples (Italy), that performed the US investigation and the IRCCS SYNLAB SDN where the patients carried out MR. The study is conducted in accordance with the Declaration of Helsinki. All subjects gave informed consent to receive both US and MR scans of the spleen.

All spleen US scans were performed by the same operator (with\>10 years of experience in abdominal US), who used an EPIQ 5 Philips instrument with a 1-5 MHz broadband curvilinear probe. The spleen was scanned in patients who were fasting, in the longitudinal and transverse planes by using an intercostal approach, a subcostal approach, or both.

The patient was placed in a supine or right-sided position until complete organ visualization was achieved. Perimeter, longitudinal diameter (LD), and area, defined as the maximum measurements with splenic borders and angles clearly defined, were measured, and SV (in milliliters) was calculated automatically. For each subject, the mean value of 3 measurements repeated on the same imaging session was calculated and recorded for final analysis. Within two weeks from the US, each patient underwent an MRI of the upper abdomen to evaluate the splenic volume. MRI examinations were performed using a 3T Biograph mMR scanner (Siemens Healthcare, Erlangen, Germany) with 4-channel flex phased-array body coil. Routine clinical abdominal MRI acquisition includes coronal T2W Half-Fourier Acquisition Single-shot Turbo spin Echo imaging (HASTE), axial T1 Dual-echo FSE, axial T2 TSE Fat Sat, and an axial diffusion-weighted imaging (DWI). The DWI includes an apparent diffusion coefficient (ADC) map that was automatically generated at the time of acquisition. At last, an isotropic 2mm3 axial Volumetric Interpolated Breath-hold Examination (VIBE) sequence for SV evaluation was acquired. For the latter, attention was paid to optimize the field of view to the spleen, in order to reduce patient's apnea and possible respiratory artifacts. A radiologist with mote than 10 years of experience in abdominal MRI reporting performed measurement of the three orthogonal diameters of the spleen for each patient. Subsequently, SV was calculated using ITK-SNAP software and semi-automatic 3D segmentation approach, firstly based on a signal threshold.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Philadelphia (Ph) negative chronic myeloproliferative neoplasms (MPN), according to WHO 2016 criteria
* age \>18 years
* execution of MRI of the upper abdomen within two weeks from the US,

Exclusion Criteria:

* patients not fulfilling inclusion criteria
Effect of Single-versus Double-limb Cycling Exercise on Blood Flow in Patients With Peripheral Artery Disease

This study will be conducted to investigate the effect of single limb cycling exercise and the effect of double limb cycling exercise on blood flow in patients with peripheral artery disease and compare between both effects.

Global populations are undergoing a major epidemiological transition in which the burden of atherosclerotic cardiovascular diseases is shifting rapidly from high-income to low-income and middle-income countries (LMICs). Peripheral artery disease (PAD) is no exception, so that greater focus is now required on the prevention and management of this disease in less-advantaged countries (Gerry et al., 2017) PAD prevalence and incidence are both sharply age-related, rising \>10% among patients in their 60s and 70s. With the aging of the global population, it seems likely that PAD will be increasingly common in the future. Prevalence seems to be higher among men than women for more severe or symptomatic disease (Michael et al., 2015).

PAD causes leg pain, impaired health-related quality of life, immobility, tissue loss and a high risk of major adverse events, including myocardial infarction, stroke, revascularization, amputation and death. The drug cilostazol, exercise therapy and revascularization are the current treatment options for the limb symptoms of PAD, but each has limitations (Jonathan et al., 2022) Few studies conducted the importance of active and passive movements and aerobic exercises for Cardiovascular especially peripheral artery disease patients as mentioned previously, thus the aim of this study is to conduct single limb cycling exercise and double limbs cycling exercise to PAD patient to determine the effect of cycling on blood flow velocity and which is more effective and leads to more benefits compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* 1. Mild to moderate PAD ( ABI ranges from less than 0.90 to 0.50) 2. Intermittent claudication / Typical claudication 3. Their age will be ranged from 50_60 years old. 4. Quitting smoking for more than 3 months 5. Body mass index (BMI) from 25.0 to 29.9kg/m2.

Exclusion Criteria:

* 1. Patients with uncontrolled pulmonary disease. 2. Patients with vascular severe complication as critical limb ischemia(ABI less than 0.5) 3. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.

  5. Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).

  6. Any patients who missed more than two weeks of the program or want to terminate the program.
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.

The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen.

There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with type 2 diabetes
* Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for \> 3 months
* Age range 30 to 70 years
* Body mass index 25-45 kg/m2
* HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)
* Less than 50% of randomized participants will have used insulin previously

Exclusion Criteria:

* Use of more than two antihyperglycemic agents within the last 3 months
* Use of more than one daily injection of any kind of insulin in the last 3 months
* Positive anti-GAD antibody (test required in screening)
* Fasting C-peptide \<0.5 ng/mL (test required in screening)
* Pregnancy (test required in screening if able to conceive) or lactation
* Excessive use of alcohol or evidence of other form of drug dependency
* Unwillingness or inability to grant informed consent
* Unwillingness or inability to perform self-monitoring of blood glucose
* Unwillingness or inability to inject insulin and/or inject exenatide
* Serum creatinine \>1.3 mg/dL in women or 1.4 in men
* Retinopathy which has required photocoagulation for treatment
* Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol
* Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control
* Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying
* Use prednisone or other systemic glucocorticoid drug in the last 3 months
* Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months
* Use of any unproven investigational drug within the last 3 months
Th17 Inducing Cytokines Pregnancy and After Postpartum

The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.

IL-17 have a synergytic effect with IL-6 and IL-23. IL-17A levels elevated with periodontal diseases. Many systemical chronic conditions such as atherosclerosis and cardiovascular disease, pregnancy may contribute increasing of IL-17 family cytokine.

Eligibility Criteria:
Inclusion Criteria:

* women 2 and 3 trimester of their pregnancy

Exclusion Criteria:

* any known systemic disease,
* periodontal treatment within the last six months,
* patients having less than 10 teeth,
* smokers,
* individuals with a BMI \> 30 kg/m2,
* gestational diabetes and preeclampsia during pregnancy.