cyrilzakka/clinical-trials huggingface dataset:
Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED)

Midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern of hemodynamic instability. We would like to investigate that the low dose midazolam could be used rather than the standard recommended dose, and also compare it to the etomidate, recently used sedatives, with respect to the side effects and the easy performance of intubation.


Eligibility Criteria:
Inclusion Criteria:

* patients who need rapid sequence intubation in emergency room

Exclusion Criteria:

* in hypotension(systolic blood pressure less than 90 mmHg
* severe trauma patients
* pregnant
* allergic to midazolam, etomidate
Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

The purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therapy devices. This system consists of patient tools, a new heart failure risk score and a new clinician website. This study will evaluate this new system as a whole and establish the feasibility of implementing it into clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to provide written informed consent
* Subject is at least 18 years of age
* Subject is willing and able to comply with the Clinical Investigation Plan
* Subject is currently enrolled in the Medtronic CareLink® Network
* Subject is currently a New Heart Association (NYHA) functional class III or NYHA functional class II with a heart failure related hospitalization within the past 180 days
* Subject has a Medtronic Concerto®/Consulta® cardiac resynchronization therapy (CRT)device implanted for at least 180 days
* Subject has been prescribed daily oral diuretic therapy for the management of heart failure

Exclusion Criteria:

* Subject is enrolled in a concurrent study with the exception of a study approved by the INDICATE HF Clinical Trial Leader
* Subject has a life expectancy of less than 1 year
* Subject's CRT device has an estimated battery life of less than 2 years
Tadekinig Alfa (IL-18BP) Rescue Therapy for CAR T Cell Related Cytokine Release Syndrome (CRS) and HLH-like Syndrome

This is a pilot, open-label study to assess the safety and feasibility of using investigational drug(s) as rescue therapies for CAR T cell related CRS and HLH-like syndrome (CRHLS).

This pilot, open-label trial will allow for co-enrollment of subjects participating in University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell studies. As utilization of this investigational drug may be required emergently in the event of qualifying safety events post CAR T cell infusion, subjects may be consented/enrolled at the time they receive an investigational CAR T cell product. If/when use of this investigational drug is deemed clinically necessary, rescue therapy may then be initiated.

Cohort 1: Will allow for the use of Tadekinig alfa, an interleukin-18 binding protein that binds and neutralizes IL-18. IL-18 is a key mediator in systemic inflammatory conditions such as MAS/HLH, which may contribute to the severity of CAR T cell-related cytokine release syndrome (CRS) and HLH-like syndrome (CRHLS) and impact response to standard therapy. In addition, subjects experiencing other IL-18 driven toxicity post CAR T cell therapy which is non-responsive to conventional treatment may also receive rescue therapy with Tadekinig alfa as per clinical discretion.

Eligibility Criteria:
Inclusion Criteria:

1. Signed, written informed consent
2. Male or female patients age ≥ 18 years
3. Have been co-enrolled in a University of Pennsylvania-Sponsored, CCI-Initiated CAR T cell clinical trial.
4. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria:

1. Pregnant or nursing (lactating) women.
2. Known hypersensitivity to the active substance or one of the excipients of the investigational product(s).
The Impact of Maternal Microbes on Infant Health Programming

MAMI aims to characterize maternal microbes to be transferred to neonates and determine their function in infant health programming.

Recent reports suggest that early microbial colonization has an important role for in promoting health. This may contribute to reduce the risk of chronic diseases such as obesity, allergies and inflammatory conditions. Advances in understanding host-microbe interactions imply that maternal microbiota plays a crucial role on health programming. This process begins in utero and it is modulated by mode of delivery and diet. The investigator's previous data has shown that i) specific shifts in milk microbial composition are associated with lactation time and mode of delivery, ii) milk microbes drive the infant microbiota composition; iii) maternal microbiota dysbiosis may be transferred to the infant. However, factors defining maternal microbiota and its biological role upon infant's health are not yet fully understood. Hence, this project aims to characterize maternal microbes to be transferred to neonates and determine their function in infant health programming. The specific aims are:(1) understanding how the maternal microbiome is influenced by host and environmental factors;(2) characterizing the microbial core and bioactive compounds transmitted to the offspring mainly via breastfeeding and their key roles in the microbial modulation and host response;(3) understanding the interactions among breast milk bioactive compounds and their role in infant health;(4) shedding light on how maternal microbes influence the infant immune system.

Results obtained will demonstrate the interaction between infant nutrition, microbes and host response in early life and its key role in health programming, enabling new applications in the field of personalized nutrition \& medicine.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* Healthy woman (no medication, no diabetes, no pre-gestational thyroid problems)
* Postpartum woman (beginning of the puerperium).

Exclusion criteria:

* Non-compliance with any of the inclusion criteria.
* Medication and drugs
* Health problems at the immunological and metabolic levels.
EHR-embedded OCDT in Breast or GI Cancer

This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.

For patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.

* Participants will complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
* Participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. The survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit.

  * The first 100 participants to complete the survey will receive a passive care team alert for responses (per DFHCC policy)
  * The second 100 participants to complete the survey will receive an active care team alert for responses.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 or older
* Male or Female
* Scheduled visit at DF/HCC within the BOC or GCC
* Diagnosis of advanced breast cancer or gastrointestinal cancer
* Prescribed any OCDT within prior 5 days of screening
* English as the primary language (as documented in the EHR, written or spoken, and patient interpreter needed flag = no)
* Mobile number listed in EHR to allow participation in ePP portion of the study
* Women of any pregnancy status
* Patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of OCDT or death, whichever occurs first

Exclusion Criteria

* Adults unable to provide verbal consent
* Pediatric patients
* Patients without access to a electronic device (including tablet, computer, aptop or smartphone)
Microbiome, Atopic Disease, Prematurity

There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies.

Our specific aims are:

1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics.
2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns.
3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age.

The investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children's Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together this data will provide a unique opportunity to identify potential shifts in the microbiome associated with nutrition, asthma and allergy in preterm infants. Ultimately, the investigators may be able to discover ways to prevent the development of asthma and allergies during this early window of opportunity.


Eligibility Criteria:
Inclusion Criteria:

* premature infant equal or less than 34 weeks of age

Exclusion Criteria:

* hypoxic ischemic encephalopathy, congenital anomaly that affects gastrointestinal system, unable to follow up
Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC

Eligibility Criteria:
Inclusion Criteria:

* Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
* Age 18 and older
* Pretreatment isolate of M. avium complex available for MIC determination
* Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
* Available for long term followup

Exclusion Criteria:

* History of macrolide or rifamycins allergy
* Laboratory evidence of mycobacterial resistance to azithromycin
* Children less than 18 years of age
* If a menstruating female, not pregnant and on adequate birth control
* HIV+ or at risk
Single Ventricle Outcome

The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Congenital disease is the most common cause for infant death from a birth defect. Approximately 30,000 infants are born each year with congenital heart defects.Over one-third of those babies will require cardiac surgery. A particularly lethal cardiac defect is one with single ventricle physiology. The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Eligibility Criteria:
Inclusion Criteria:

* All patients with single ventricle physiology scheduled for ultimate Fontan surgical palliation at Children's Healthcare of Atlanta will be eligible.
* All subjects must sign informed consent prior to enrollment in study.
PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.

Introduction: This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.

Method and analysis: A total of approximately 302 patients undergoing elective laparoscopic surgery will be enrolled. Participants will be randomly assigned to either a electrical stimulation group or a placebo group, with computer-generated randomization and concealed allocation using sealed envelopes. The electrical stimulation group will receive PC point electrical stimulation 30 minutes before surgery until 24 hours postoperatively, while the placebo group will wear a wristband without stimulation. The primary outcome will be the incidence of postoperative nausea and vomiting, with secondary outcomes including the incidence of nausea and vomiting within 24 hours after surgery, gastrointestinal and hemodynamic indices, postoperative recovery, hospital stay and cost, and complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-65 years;
2. Patients undergoing elective laparoscopic surgery;
3. American Society of Anaesthesiologists(ASA) Grade 1 to 3;
4. Anesthesia: General Anesthesia, Tracheal Intubation;
5. BMI: ≥18, \<28;
6. Gender: female
7. Patients or their family members are able to comprehend the study protocol and are willing to participate in this research by providing written informed consent.

Exclusion Criteria:

1. There are incisions or scars in the wearing position of the device;
2. There is a local infection in the wearing position of the device;
3. upper extremity nerve injury;
4. history of spinal cord surgery;
5. Participated in other clinical trials within 4 weeks;
6. suffering from severe central nervous system disease or mental disorder;
7. Patients need to return to the ICU after surgery.
Roy Adaptation Model Based Strengthening Program and Social Media Addiction

In this pretest-posttest, randomized controlled study, the effect of the empowerment program developed based on Roy Adaptation on the healthy lifestyle behaviors, self-esteem and social media addiction of nursing students will be examined. The hypothesis of this study is that the empowerment program based on Roy Adaptation Model reduces Social Media Addiction, increases Healthy Lifestyle Behaviors and Self-Esteem.

The universe of this study was composed of 411 nursing students studying at Mersin University's faculty of nursing.The data were collected using the Bergen Social Media Addiction Scale from 384 nursing students who accepted to participate in the study between 09 January 2020 - 09 March 2020.From the scale developed by Andresan et al in 2017 and adapted to Turkish by Demirci in 2019, 110 nursing students who scored 3 or more out of at least 4 out of 6 items or scored 18 or more out of the total score constituted the sample of the study.110 nursing students were assigned to the experimental and control groups (55 experimental and 55 control groups) by block randomization.7 separate focus group sessions were held online between 01 September 2020 - 01 October 2020 with 55 student nurses in the experimental group. Using the literature and data obtained from the first stage of the study (analysis of focus group sessions), a strengthening program based on the Roy Adaptation Model was made.The necessary corrections and additions were made to the program by obtaining expert opinions from field experts regarding the program created. Empowerment program based on Roy Adaptation Model will be applied to 55 student nurses in the experimental group between 01 February 2021 - 01 May 2021 through online group sessions. The Bergen Social Media Addiction Scale, Rosenberg Self-Esteem Scale and Healthy Lifestyle Behaviors Scale, which were applied as a pre-test in the first session of the application, will be applied as a post-test in the 12th session.

Eligibility Criteria:
Inclusion Criteria:

* agreeing to participate in research
* students who score 3 or more out of at least 4 out of 6 items or score 18 or more out of the total score in the Bergen Social Media Addiction Scale.

Exclusion Criteria:

* who do not agree to participate in the research
* students who scored 3 or less from at least 3 out of 6 items in the Bergen Social Media Addiction Scale, or who scored 17 or less out of the total score
Comparison of Ovulation Induction Cycle Outcomes Between Early and Late Dose Increments for Low Dose Gonadotropin Step-up Protocol Among Infertile Women Diagnosed With Polycystic Ovary Syndrome: Prospective Randomised Trial

Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome (PCOS). First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with PCOS.

Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome. First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with polycystic ovary syndrome.

We will start low dose step-up ovulation induction treatment by using 50 IU recombinant FSH for 21-39 years old non- obese patients (BMI \<30 kg/m2) diagnosed with PCOS and . We will perform folliculometry on 7th day of ovulation induction. In case of absence for at least one \>10 mm dominant follicle, we will randomise these women by using blind envelope selection method for assignment of early or late dose incerement groups. Half of the patients will receive 25 IU dose increment on 7th day of ovulation induction, remaining half will receive dose increment on 14th day of ovulation induction. We will continue ovarian stimulation without any other dose increment until 35th day of stimulation as deadline time restriction. We will perform folliculometry and serum estradiol measurement intermittently during ovulation induction. We will record ovulation induction cycle outcomes and clinical pregnancy results of the study group following finalization for treatment cyle of each patient. We will compare ovulation induction cycle outcomes of these two dose increment groups.

Eligibility Criteria:
Inclusion Criteria:Infertile women who have been diagnosed with PCOS based on Rotterdam criteriae and who have not succeeded to get pregnant by using oral ovulation induction agents and whose BMI levels are \<30 kg/m2 will be included to the study.

Exclusion Criteria:Infertile women with tubal diseases, male factor infertility, endometriosis, previous pelvic surgery history, chronic systemic disease, BMI levels\>30 kg/m2 and who are not voluntary to attend to the study will be excluded from the study.
The MELAcare Study: A New Method for Surveillance of Melanoma Patients

The aim of this study is to evaluate a new method of follow-up for patients with low and intermediate risk (stages IA-IIA) melanoma. The investigators will compare different tools for patient support and education combined with clinician supported skin self-examination (SSE) to the current standard-of-care. The hypothesis is that meta-cognitive strategies and clinician supported SSE can lower fear of cancer recurrence (FCR) and promote effective SSE on a regular basis without compromising the detection of new primary melanomas and/or metastases.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and understand Danish language
* Willing and able to give written informed consent
* Surgical treatment of a clinical stage IA-IIA melanoma within 3 months of inclusion

Exclusion Criteria:

* Advanced melanoma, clinical stages IIB, IIC, III, or IV
* Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma)
* History of melanoma skin cancer prior to the index diagnosis
* Previous cancer, excluding non-melanoma skin cancer
* Comorbidity that makes skin self-examination impossible (e.g. physical or mental disabilities, dementia or decreased cognitive function)
* non-detection of sentinel node in IB and IIA patients
Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.

Oral probiotics have previously been shown to prevent necrotizing enterocolitis in preterm infants. A few reports of sepsis by a probiotic bacteria have impeded implementation of oral probiotic supplementation in most NICUs. Considering the proven immunomodulatory effect of maternal probiotics on breastfed infants of atopic mothers, we would like to explore the indirect effects of maternal probiotics on preterm infants

Eligibility Criteria:
Inclusion Criteria:

* Mothers of preterm infants
* Pumping breast milk

Exclusion Criteria:

* Neonatal congenital anomalies
Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score


Eligibility Criteria:
Inclusion Criteria:

* Large renal pelvic stone
* Upper calyceal stone
* Middle calyceal stone

Exclusion Criteria:

* lower calyceal stone
* Bilateral simultaneous PCNL
* Need for 3 percutaneous tracts intraoperative
* Morbid obesity (BMI \>40)
* Non opaque renal stones.
* Refuse to complete study requirements