cyrilzakka/clinical-trials huggingface dataset:
SEMAGLUTIDE VERSUS GLP-1 RECEPTOR AGONISTS. EFFECTIVENESS , SAFETY AND QUALITY OF LIFE IN PATIENTS WITH DIABETES MELLITUS 2. OBSERVATIONAL, PROSPECTIVE AND MULTICENTER STUDY. SEVERAL STUDY.

Introduction:

GLP-1 receptor agonists (aGLP1) act increasing pancreatic insulin secretion in response to the glucose, they reduce glucagon secretion and reduce appetite by acting in the central level. Several aGLP1 were approved through different clinical trials where they showed efficacy in the glycemic control and reduction in cardiovascular events. They also showed weight loss in different clinical trials with patients with diabetes mellitus 2 (DM2) and also in specific clinical trial where the weight loss was the primary endpoint (STEP study).

Objective:

The objective is to evaluate and compare the weight loss in patients with DM2 treated with the different aGLP1 for the first time. Secondary endpoints are HbA1c reduction, changes in quality of life and physical activity and the safety of these drugs.

Design:

It is a postauthorization, multicenter, non-randomized and prospective study. Patients that will start treatment for the first time with aGLP1 will be recruited in 10 primary care centers in SERGAS Galician Hospitals for a period of 6 months and 44 weeks of follow-up. The primary endpoint will be to evaluate the wight loss with the different aGLP1 and the secondary endpoint will be HbA1c reduction, changes in the quality of life through the EuroQol-5D and changes physical activity through the SF-12 questionnaire, and also the safety of these drugs. The sample size will be of 360 patients.

Statistical analysis:

Previous studies showed efficacy in weight loss with semaglutide about (3,6-4,9 kg), while with other aGLP1 the weight loss was smaller , about (0,86-2,96 kg).

Based in these data and with a 5% of significance level, a weight loss average in the aGLP1 group of 2,5 kg, average in semaglutide group of 4,2 kg, and combination deviation of 3,0kg, including 360 subjects we will have a statistical power above 90% to detect differences through T-test for independent samples.

The justification of this simple size was performed with the statistical software SPSS 3.0

Conclusions:

The SEVERAL study will try to provide information about weight loss efficacy, changes in quality of life, physical activity and safety of the aGLP1in patients with DM2 that start treatment with these drugs in the real life (Real-World Evidence)


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or over
* To start with the first funded dose of GLP1 receptor agonists ( BMI \> 30Kg/m2)
* Treated with another oral antidiabetic

Exclusion Criteria:

* Diagnosis of diabetic retinopahty and family history of thyroid cancer
Assessment of 3D Transperineal Ultrasound Imaging w/ Matrix Array Transducers in Prostate Radiotherapy

SPECIFIC STUDY AIMS

1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.
2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.

SPECIFIC STUDY AIMS

1. To evaluate congruence between pelvic anatomical structures segmented on MRI and/or CT scans co-registered with transperineal US scans acquired with an optically and/or electromagnetically tracked matrix array ultrasound transducer.
2. To estimate the achievable accuracy of anatomy tracking based on 3D US matrix-array transducer imaging and grey-level based image registration algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Men that will undergo prostate radiotherapy as a primary treatment or post-prostatectomy.
* Age 18 or older
* Ability to understand and sign informed consent

Exclusion Criteria:

* Younger than 18 yrs old
* Inability to provide written and spoken consent.
* Patients with implanted actively controlled devices that may be subject to electromagnetic interference from the UroNav/PervuNav electromagnetic tracking used in the study.
Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors

The aim of this study is to assess the impact of endocrine changes and their correction on survival and organ function in heart and lung transplant recipients. This study also features an investigation of the hormone levels and hormonal replacement therapy of the donors to study its role in the function of the transplanted hearts and lungs.

Thyroid hormones (TSH, thyroxine, tri-iodothyronine), cortisol and the antidiuretic hormone will be studied.

The former two hormone levels will be defined in the recipients just before transplantation and three days later. In the case of the donors all three hormones will be recorded at the time of the explantation. The investigators would like to record the hormonal replacement therapy in all our patients as well to see it's effect on survival and on the transplanted organ function.

After the transplantation during the hospital stays all the important hemodynamic parameters, laboratory parameters, the result of the medical imagings, the medication, the length of ICU and hospital stay and the complications were recorded.

Recipients will be followed for five years. Organ function will be assessed every three month for a year, after than every six month for further four years. Investigator would like to record the result of the cardiac echocardiography, spirometries, imaging, and complications. Our purpose is to compare these results against the endocrine disorders and the replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age admitted for heart or lung transplantation and their organ donors.
* written consent from the recipients

Exclusion Criteria:

* lack of consent
* non-evaluable patient due to insufficient clinical information
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls

This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions.

The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.


Eligibility Criteria:
Inclusion Criteria:

* resident of USA
* speaks English
* have private computer with Internet

Exclusion Criteria:

-
Probiotic on Atopic Dermatitis in Infant

The clinical trial will be carried out in China Medical University Hospital. The overall plan is a double-blind trial. All recruited 1-3 years old atopic dermatitis (AD) patients are divided into two groups, 50 in each group and 100 in two groups. The two groups are placebo and Bifidobacterium longum CCFM1029. The entire evaluation plan lasts for nine months. The number of probiotic bacteria is 50 billion per capsule, and the number of bacteria taken by the subjects is 50 billion per day (one capsule before bed each day). During the planning period, the eczema area and severity index (EASI) score of the patient's dermatitis was evaluated every three month, and the score differences of dermatitis before and after taking probiotics was observed. Three months before and after blood tests for IgE, ECP, TSLP, IFN-γ, IL-4, IL-5, IL-13, TNF-α, CCL5(RANTES), TGF-β, IL-1ra, and evaluation of probiotic supplementation, whether that can reduce allergies and inflammatory indexes in the body. In addition, subjects must perform two fecal samplings before and after the trial, and the isolated DNA was analyzed using the next-generation high-throughput sequencing method (NGS) for subject fecal flora changes. Comparing the two groups before and after taking the capsule, whether the intestinal flora changed. Statistical analysis of the relationship between changes in intestinal flora and the degree of AD. Through the above test, the investigators evaluated whether Bifidobacterium longum CCFM1029 can regulate the pediatric intestinal flora and relieve the inflammatory response in the body, thereby regulating atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were between 1 and 3 years old.
* For patients diagnosed with atopic dermatitis by a professional physician and the EASI score is greater than 10, the type and frequency of drugs used during the experiment should be recorded.
* The subject's parents agree to join the trial and sign the informed consent form.

Exclusion Criteria:

* The patient who has a history of allergic reactions, or the use of other highly sensitive or contraindicated drugs (allergy to antibiotics or antipyretics).
* The patient who has taken oral immunosuppressants and systemic steroids within the past 2 weeks.
* The patient who has consumed probiotic-related products (including drops, lozenges, capsules, powder or yogurt) within the past 1 month.
* The patient who has participated in other clinical studies within the past 1 month.
* The patient who has received immunotherapy within the past 1 year.
* The patient who suffering from major diseases (with a IC card for severe illness), congenital diseases.
* The patient who is not suitable to participate in the trial as assessed by the professional physician.
99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer

Prostate cancer (PCa) is currently the most common cancer in men in Finland (www.cancerregistry.fi). Although prognosis is very good in majority of men, it is noteworthy that still up to 20% of PCa cases are metastatic at the time of initial diagnosis and yearly 900 men die because of prostate cancer. Robust primary staging is, therefore, one of the most important prognostic factors, and it is crucial for treatment decision. Despite their low sensitivity to detect metastasis, bone scintigraphy (BS) and contrast enhanced whole body computed tomography (ce-wbCT) are recommended by current guidelines for primary staging in men at risk of metastasis.

MIP-1404 is a small-molecule PSMA inhibitor that can be used in SPECT systems (99mTc-MIP- 1404 SPECT/CT). 99mTc-MIP-1404 SPECT/CT is performed by a single IV bolus of 99mTc-MIP-1404, which binds with high affinity to extracellular domain of PSMA molecule. As of March 2020, a total of 629 subjects have received 99mTc-MIP-1404 injection averaging 740 ±111 MBq (20 ± 3 mCi) per administration in prospective clinical trials. 99mTc MIP-1404 has been well tolerated following a single IV dose at 740 ± 111 MBq in both healthy volunteers and patients with confirmed metastatic prostate adenocarcinoma. In prospective and retrospective studies, it has shown high potential to detect prostate cancer lesions in primary staging. In fact, Goffin et al. reported a sensitivity of 50% and specificity of 87% detecting local lymph node metastasis in radically operated patients when histopathology was used as a reference. This corresponds closely to the sensitivity of PSMA-PET.

PROSTAMIP is a randomized prospective single-institutional study to demonstrate superiority of 99mTc-MIP-1404 SPECT/CT compared to traditional imaging modalities (99mTc-HMDP planar BS plus ce-wbCT).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
* Subjects must be male, aged 18 years or above at Baseline
* Histopathologically confirmed high risk (Gleason ≥4+4, PSA ≥20 and/ or cT≥3a) acinar or ductal adenocarcinoma of prostate

Exclusion Criteria:

* Allergy/sensitivity to study medications or their ingredients
* Subjects unable to provide written informed consent
* Subjects who have any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
* Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Subjects who have androgen deprivation therapy initiated before enrolment
* Subjects who have claustrophobia
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery

The goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).


Eligibility Criteria:
Inclusion Criteria:

* Children 1 month- 18 years of age
* Undergoing Cardiac surgery for the first time and requiring CPB
* Surgeries for both cyatonic and acyanotic heart disease

Exclusion Criteria:

* Pre-mature babies (\< 28 weeks at birth)
* Neonates
* Prior cardiac requiring CPB
* Surgeries requiring CPB \> 6 hours
* Surgeries requiring second run of CPB
* Patients requiring additional steroids during first 24 hours of CICU stay
* Patient expires within the initial 24 hours CICU stay.
* Compromised immune system - that is, known immunodeficiency or use of
* immunomodulatory therapy.
* Peri-operative presence of two or more clinical or laboratory signs of active infection that were not attributable to any other cause: fever more than 100°F, heart rate or respiratory rate more than the normal range for age, white blood cell count more than 15% of the upper limit of normal, and an elevated C-reactive protein level above baseline.
* Preoperative mechanical ventilation, and preoperative need of inotropic agents or mechanical circulatory support.
* Patient already receiving steroids
Jewel Electrophysiology (EP) Lab Study

Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.

The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of both genders of at least 18 years of age.
2. Subjects who are scheduled for a standard EP clinical procedure where fast VT or VF may spontaneously occur or may be induced.

Exclusion Criteria:

1. Subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned EP procedure.
2. Subjects who have taken amiodarone in the past 3 months.
3. Subjects with an existing unipolar pacemaker.
4. Subjects who exhibit a left ventricular ejection fraction (LVEF) less than 20% (as assessed by techniques such as echocardiography, magnetic resonance imaging, or radionuclide angiography) within the last 6 months.
5. Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart failure exacerbation within the previous 30 days.
6. Subjects who exhibit unstable angina.
7. Subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management.
8. Subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing.
9. Subjects who are allergic to or have had a known adverse reaction to medical adhesives.
10. Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied.
11. Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm.
12. Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months.
13. Subjects who cannot provide or have diminished capacity to provide informed consent.
14. Any condition that an Investigator believes would interfere with the intent of the study or is not in the best interest of the patient.
15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.
Relationship Between Lymph Node Ratio and Survival Rate in Preoperative Chemoradiation Rectal Cancer Patients

Colorectal cancer is the most-common cancer of the gastrointestinal tract. The number of positive lymph nodes and total number of lymph nodes retrieved are important prognostic factors. In patients who do not receive preoperative chemoradiation, the total number of lymph nodes should be more than 12 nodes to predict accurate staging. In cases of locally-advanced rectal cancer when patients receive neoadjuvant chemoradiation it is sometimes impossible to retrieve adequate amount of lymph nodes due to the chemoradiation effect. Therefore, this study was to evaluate and predict survival rates based on positive lymph node ratio.

The primary endpoint of this study was to assess the lymph node ratio as another predictor for survival rate in preoperative chemoradiation rectal cancer patients. The other secondary objective was to determine the relationship between total harvested lymph nodes and survival rate in each stage. This is a retrospective, single-centered study, collecting data of patients from January 2011 to December 2017. Including a total of 163 patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation. Using Cox regression and Kaplan-Meier survival analysis to determine whether the lymph node ratio can be used to predict the survival rate and determine the cut-off value to distinguish the prognosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal cancer who underwent surgery following neoadjuvant chemoradiation.
* Patients have tissues confirmed by Pathology
* no metastasis before surgery

Exclusion Criteria:

* Distant metastasis during surgery
Different Regimens in Influenza Postexposure Chemoprophylaxis in Children

Although the vaccination is the preferred method of influenza prevention, there are some occasions on which a postexposure prophylaxis (PEP) is required. Two neuraminidase inhibitors (NAIs) may be used in chemoprophylaxis in children: oral oseltamivir, and inhaled zanamivir. Both, oseltamivir and zanamivir, are effective in treatment and in prophylaxis of influenza, and the efficacy is calculated to reach 70-90%. Oseltamivir is used more frequently, since zanamivir is licensed in older children (5 years of age and above), and children under the age of 5 years are at higher risk of influenza complications. Oseltamivir use correlated in children with higher risk of vomiting, with no increased risk of other adverse events, including those observed in adult patients (nausea, renal events, and psychiatric effects). The PEP may be indicated by individual patient's characteristics (e.g. patients in high-risk group) or epidemiological reasons, i.e. prevention of institutional outbreaks.The one research that analyzed efficacy of 3-days PEP versus 7 or 10-days and showed overall efficacy of shorter oseltamivir prophylaxis to be high and comparable to that of longer regimens. The study included several pediatric patients and made the investigators perform such an analysis in pediatric population. In this randomized controlled trial, the investigators aimed to compare efficacy, safety, and costs of 3 versus 7-days prophylaxis with oral oseltamivir in children hospitalized. The hypothesis is that 3-days duration of PEP is not less effective than 7-days PEP, and patients might gain from lower number of adverse reactions related to drug administration.

Only applies to patients hospitalized due to other than influenza reasons. If a proven contact with influenza has taken place (influenza diagnosed by signs/symptoms and positive rapid influenza diagnostic test and/or PCR), a patient may be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized at the Pediatric Ward
* age: 0-18 years old
* confirmed contact with a person diagnosed with influenza
* patient's, patient's parent/tutor's informed consent

Exclusion Criteria:

* lack of an informed consent
* more than 48 hours after the first contact with influenza
* severe adverse reaction to the drug- discontinuation of the prophylaxis
* important to a parent/tutor drug intolerance (e.g. lack of tolerance of a drug's taste)
* new contact with influenza after chemoprophylaxis has finished
Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.

Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.


Eligibility Criteria:
Inclusion Criteria:

* First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs
* Trainees who have performed \<5 intrauterine device insertions
* Trainees who plan to provide intrauterine devices in their clinical practice

Exclusion Criteria:

* None
Virtual Teach-to-Goal Education vs. Brief Education for Children

The purpose of this study is to evaluate the effectiveness of two different ways to teach hospitalized children how to use a metered dose inhaler and to follow-up after discharge home from the hospital to determine durability of the education.

Asthma is the most common chronic childhood condition and has significant adverse consequences. One in 12 United States children has asthma, resulting in 13.4 million missed school days, 1 million emergency department visits, and 140,000 hospitalizations annually.

A key barrier to self-management of asthma is improper use of respiratory inhalers, which limits disease control. Better inhaler technique is associated with improved asthma outcomes for children. Assessment and education of inhaler technique are recommended at all healthcare encounters, however it is limited in practice because it is resource intensive (both personnel and time) and lacks fidelity. Thus, low-resource interventions that accurately teach inhaler skills are needed to impact pediatric asthma outcomes.

Teach-to-Goal (TTG) is a patient-centered strategy that uses tailored rounds of teaching and assessments to ensure mastery of inhaler technique. Studies show it is effective but resource intensive. A "virtual TTG" (V-TTG) intervention represents an opportunity to deliver inhaler technique education with a high-fidelity, low-resource, and feasible strategy. The module utilizes innovative learning technology with video demonstrations and assessment questions to tailor education to each user; the cycles of assessment and education continues until satisfactory mastery is achieved.

This study evaluates the comparative effectiveness of this high-fidelity, low-resource, and feasible model (V-TTG) versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with severe asthma via a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. The child is between the ages of 5-10 years old
2. The child is admitted for an asthma exacerbation, wheezing, or bronchospasm
3. The child is admitted to the Pediatric Hospital Medicine Service at Comer Children's Hospital
4. The child is prescribed albuterol

Exclusion Criteria:

1. The child/parent decline or unable to provide consent/assent, do not speak/read English
2. The child cannot use an inhaler by themselves without a mask
3. The child previously participated in this study
4. The child is currently in the pediatric intensive care unit (PICU)