cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.

Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.

The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.

Eligibility Criteria:
Inclusion Criteria:

* First or second cadaveric kidney transplantation
* Age over 18 years old
* Specific indications or contraindications for cyclosporine or tacrolimus are absent
* Informed consent

Exclusion Criteria:

* Specific indications for use of cyclosporine or tacrolimus
* Specific contraindications for use of cyclosporine or tacrolimus
* Participation in another interventional clinical trial
* Pregnancy or lactation
Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education

The goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. The main questions it aims to answer are:

Is a structured postpartum remote blood pressure monitoring intervention with education and individualized medication initiation/adjustment follow-up by televisit feasible? Does a structured program reduce the occurrence of postpartum hypertension, ED visits, hospital readmissions, and adverse outcomes?

Participants will:

View an educational video on HDP post-delivery Receive 1-2 times daily text messages for 6 weeks postpartum Have their blood pressure medications adjusted to lower targets post partum


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years.
2. Postpartum status.
3. Experience new-onset hypertension during pregnancy.
4. Enrollment in Connected MOM.
5. Ability to provide informed consent.
6. Establish medical care within the Ochsner System to facilitate data collection.

Exclusion Criteria:

1. History of preeclampsia or gestational hypertension during previous pregnancy
2. History of chronic hypertension
3. History of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection)
4. History of ischemic CVA
5. History of Congestive heart failure
6. Renal dysfunction
7. Liver dysfunction
8. Left ventricular dysfunction
9. Congenital heart disease
10. Still birth at delivery
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea

The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 25-70 years
* Diagnosis of papulopustular rosacea
* Eligible for Oracea treatment

Exclusion Criteria:

* Allergies to components of investigational product and/or hypersensitivity to tetracyclines
* Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
* Used topical rosacea treatment within 30 days prior to baseline visit
* Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
* Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
* Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
* Have planned surgical procedures during the course of the study
* Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
* At risk in terms of precautions, warnings, and contraindications
Extracellular Water in Covid 19 Pneumonia

According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Based on this similarity, extracellular fluid of lungs and diffuse alveolar damage should be observed in covid 19 pneumonia as well. Extracellular water (ECW) can be determine by using whole body bioimpedence system (NİCaS). The aim of this study is to investigate the effect of ECW on the clinical apperence of covid 19 pneumonia clinical course.

Increase in the extracellular water of lungs is the major pathophisilogy of ARDS. According to various studies Covid 19 pneumonia has a very similar clinical course to Acute Respiratory Distress Syndrome (ARDS) which has clarified by Berlin definition. Depending on the similarity of Covid 19 and ARDS; evaluation of ECW ,can be a determinant of clinical apperence of covid19 pneumonia. The aim of this study to find the corelation between ECW and severty of the pneumonia.

In this prospective -controlled research, the patients who were diagnosed with Covid-19 pneumonia will be evaluated. The ones in the intensive care will be considered as severe, and the ones in the ward will be considered as mild clinical course pneumonia. İn both groups, in addition to other heamodynamic parametres, ECW will be recorded using non-invasive body biooimpedence method by NİCaS machine. The total amount of patients will be 52, 26 each two groups.

The ward and intensive care patients will be connected to the NİCaS machine to determine ECW and statistically significantchanges will be recorded. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.

the severety of illness will try to be detected.Gpower 3 for Mac Os (Faul, F., Erdfelder, E., Buchner, A., \& Lang, A.-G. (2009). Statistical power analyses using G\*Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41, 11491160.) was used for istatistical power analysis.The power analysis was done priorly and based on the T-test.In order to provide enoughsample magnitude power, which is 0.8, it was calculated that each group should have 26 patients which makes at total of 52 Statistical method: The normal distribution of data will be evaluated using Kolmogorov-Smirnov test. Parametric ones will be used in normal distrubitions, non-parametric ones will be used in abnormal distrubitions. İntergroup ECW values will be compared via independent sample T test. In catagoric data, the comparisons will be made with Pearson Ki square test, and the p values less then 0.05 will be considered as significant.

Eligibility Criteria:
Inclusion Criteria:

Covid 19 pneumonia, hospitalized patients older than 18

Exclusion Criteria:

younger than 18 years old, patients not infected with covid 19
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, as determined by medical history and physical examination.
* Aged 4 to \< 7 years at the time of study vaccination on Day 0.
* Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
* Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Exclusion Criteria:

* Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
* History of documented invasive meningococcal disease or previous meningococcal vaccination
* Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
* Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
* Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
* Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
* Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
* Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
* Enrolled in another clinical trial.
* Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
* Personal or family history of Guillain-Barré Syndrome (GBS).
Performance for French Pediatric Intensive Care Units

Introduction. The measurement of severity scores in adult and pediatric resuscitation provides a tool for evaluating the clinical performance of resuscitation services. No pediatric studies have investigated the association between current procedure and diagnostic cost indices with pediatric ICU patient severity and mortality.

Objectives. The main objective of this project in real-life situations, in 14 French pediatric intensive care units, is to validate the recently available PIM3 and PRISM IV severity scores, which take into account the clinical dimension of performance in pediatric intensive care.

This project is a French multicenter prospective observational research project involving 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP). All patients under 18 years of age admitted to the 14 pediatric intensive care units affiliated with the GFRUP and voluntarily participating in the project will be included in the study.

Expected outcomes are: Validation of PIM3 and PRISM IV scores in a French population to assess clinical performance. To develop a predictive model of mortality and a predictive model of cost in French pediatric intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* All patients under 18 years of age admitted to the 14 pediatric intensive care units and voluntarily participating in the project will be included in the study.

Exclusion Criteria:

- Children of age of reason or parents/legal guardians of children refusing participation in this project will be excluded from the study.
Comparison of the Effects of Different Protein Diet in Hemodialysis Patients

Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patient

Exclusion Criteria:

1. Hemodialysis less than 3 months
2. Age \< 20 years or \>90 years
3. Serum albumin \< 3 g/dL，
4. Daily protein diet \< 0.6 gm/kg/day or \> 1.2 gm/kg/ day，
5. Cannot obey the diet plan: Gastrectomy, difficult in swallowing
6. Active infection, severe illness: cancer patient, liver cirrhosis, etc.
7. Unable to cooperate in the study
Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient

This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric patient after induction of sevoflurane 8 vol%

Twenty-two subjects were given informed consent before study enrolled. Anesthesia was induced by 8% sevoflurane with 6 L flow of 100% oxygen. IV cannulation was attempted at 2 min in the first child in each group. The time for cannulation in the next child was stepped up or down by 15 s depending on positive or negative response, respectively, in the previous child. Children were recruited till a minimum of six pairs of failure-success sequence which was obtained in the group. The mean of midpoints of the failure-success sequence was calculated to obtain the time for cannulation in 50% of the group.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-3 year
* Physical state ASA I dan II
* Parents of patients who agreed to participate and sign informed consent.

Exclusion criteria:

* Patients with difficult airway
* There's allergic reaction or drug's side effect after induction
* There's cardiorespiratory problem such as anaphylactic shock, aritmia, severe hypotension, desaturation before-on-or after induction
Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion

The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.

Intrathecal opioids have been used to manage postoperative pain in pediatric patients for a wide variety of surgeries , including adolescent and adult PSF. Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief.

The mid-transverse process to pleura (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetics (LAs) are administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament at the level of injection, and frequently to adjacent levels.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Exclusion Criteria:

* Patient with morbid obesity (body mass index \>40 kg/m2).
* Patients with pre-existing infection at block site.
* Known allergy to study drugs.
* Coagulation disorder.
* History of psychiatric illness.
* Pre-existing neurological deficits.
* Presence of any pre-operative pain or history of chronic pain.
* History of regular analgesic.
Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
* Patients with resectable lung cancer
* One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma

Exclusion Criteria:

* Patients with metastatic lung cancer (Stage IIIB-IV)
* Patients who underwent chemotherapy or radiotherapy
* Patients with other malignancies
Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons

In this trial researchers want to learn more about the occurrence of pregnancies growing outside the womb over the last decade (2009-2018) and the potential risk factors associated with pregnancies growing outside the womb. Electronic data in women who were age 15 to 44 years abstracted from health care systems such as electronic health records (EHR), regional claims systems and administrative databases were used to address research questions on ...

* occurrence and trends of pregnancies growing outside the womb;
* influence of method of contraception used on occurrence and trends of pregnancies growing outside the womb;
* potential risk factors associated with pregnancies growing outside the womb;
* trends in management of pregnancies growing outside the womb over the last decade.

The overall goal of this study is to assess the incidence rate of ectopic pregnancy over the last decade in a representative population of US women and potential risk factors associated with ectopic pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women of age 15 to 44 years between 01-Jan-2009 and 31-Dec-2018
* Women enrolled in health plans Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Southern California (KPSC)
* Women with at least 12 months membership in KPNC and KPSC prior to enrollment
Phase II Proof-of-concept Study of APD421

Evaluation of efficacy of APD421 in preventing nausea and vomiting caused by cisplatin


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age
2. Ability and willingness to give written informed consent
3. Patients scheduled to receive, on day 1 of their chemotherapy, a first cisplatin chemotherapy infusion at a dose of 50 mg/m2 or greater
4. Karnofsky performance score ≥ 60%
5. Adequate cardiac, hepatic and renal function

   * QTc interval \< 500 ms
   * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \< 5 x upper limit normal (ULN)
   * Bilirubin \< 3 x ULN
   * Creatinine \< 2 x ULN
6. Adequate haematological function

   * Haemoglobin ≥ 9 g/dL
   * White blood count ≥ 3.0 x 109/L
   * Platelet count ≥ 100 x 109/L
7. For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards.

Exclusion Criteria:

1. Patients scheduled to receive, prior to or in the 24 hours after cisplatin, any chemotherapeutic agent with a high or moderate emetic risk, see Appendix 4.
2. Patients scheduled to receive paclitaxel or docetaxel
3. Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin administration
4. Patients receiving APD421 for any indication within the last 2 weeks
5. Patients who are allergic to APD421 or any of the excipients of APD421
6. Patients with a pre-existing vestibular disorder
7. Patients being treated with regular anti-emetic therapy including corticosteroids
8. Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
9. Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
10. Patients being treated with xxx
11. Patients receiving benzodiazepines, unless on a stable dose for at least one month prior to the expected date of study entry
12. Patients with pre-existing nausea or vomiting in the 24 hours before receiving cisplatin chemotherapy, e.g. anticipatory emesis
13. Patients who are pregnant or breast feeding
14. Patients with a history of alcohol abuse
15. Patients with pre-existing, clinically significant cardiac arrhythmia
16. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
17. Patients who have participated in another study within the previous 28 days
Effect of Distress Tolerance Training on Problematic Internet Use and Psychological Wellbeing Among Faculty Nursing Students

The Internet is a social environment as well as a tool. In this digital environment, where students interact with each other, live, and generally comprehend their cultures, college students learn information. The Internet has become essential to college students' daily lives and education. The World Health Organization (WHO) has cautioned that increased screen usage and gaming may occur during the COVID-19 pandemic. Due to this, there is an increased chance of Internet and gaming addiction, leading to more distress and concern for students' psychological well-being. Therefore, university students needed an intervention program to overcome these problems. The researchers in the present study will use distress tolerance. Distress tolerance (DT) is defined as one's ability to continue engaging in goal-directed behavior in the face of emotional, cognitive, or physical discomfort. Eventually, the present study aimed to The present study aims to:

Assess the impact of distress tolerance training on problematic internet use and psychological wellbeing among university nursing students.

Research Hypothesis:

Nursing students who receive distress tolerance training will exhibit lower problematic internet use and better psychological wellbeing than those who didn't receive it


Eligibility Criteria:
Inclusion Criteria:

* Students that are not participating in any other type of psychotherapy.
* Students who scored high on Problematic Internet Use Questionnaire (PIU).

Exclusion Criteria:

* Students who have a history of mental illness.
* students who are more than 30 years old.