cyrilzakka/clinical-trials huggingface dataset:
Pocus Triage in Patients Presenting to the Emergency Department with Abdominal Pain

Introduction and Objective: This study aimed to reveal the effect of classical triage and Bedside Focused Ultrasonography (POCUS) in addition to classical triage on diagnosis, treatment, emergency department follow-up and its relationship with triage models in patients presenting to the emergency department with abdominal pain complaints.

METHOD: This randomized, controlled, prospective study was conducted with a total of 262 volunteer participants who were divided into two groups as 127 classical triage and 135 POCUS in addition to classical triage with non-traumatic abdominal pain. The decision of which participant would be included in which group was made at a 1:1 ratio using a computer-aided randomization table. The researcher did not intervene in the clinical processes in any way. In this study, the effect of POCUS application performed in addition to classical triage on clinical processes (imaging request, initial analgesia administration time, consultation request, emergency department stay and outcome) in the primary outcome and on triage systems in the secondary outcome were evaluated. IBM SPSS 21.0 software was used for statistical analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Present to the emergency room with abdominal pain
* No history of trauma in the last 48 hours
* Stable hemodynamics

Exclusion Criteria:

* According to the 3-way triage, the color code is red
* Being under the age of 18
* Being pregnant
* Having a history of trauma within the last 48 hours
* Being morbidly obese
* Having mental retardation
* Having repeated emergency room visits
* Being referred from the polyclinic to the emergency room with a diagnosis
* Filling the study form incompletely
Cardiovascular Function in Acute Leukemia

An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.

Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age,
* New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included).
* Signed the informed consent form

Exclusion Criteria:

• Unable to provide informed consent
Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.

Ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (SAIH) and norepinephrine requirement during caesarean section.

The mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the Bezold-Jarisch reflex, leading to vasodilation and hypotension. Peripheral serotonin receptors, 5-Hydroxytryptamine3 (5HT3), are required for the activation of the Bezold-Jarisch reflex. In a rabbit model, a 5-HT3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the Bezold-Jarisch reflex.

Eligibility Criteria:
Inclusion Criteria:

* Age from 19 to 40 years old.
* Singleton pregnancies with a gestational age of at least 37 weeks.
* pregnant women are scheduled for elective caesarean delivery.
* Patients with stable vital signs.
* Patients with normal laboratory investigations.
* patients undergoing spinal anaesthesia for caesarean delivery via Pfannenstiel incision with exteriorizaion of the uterus.

Exclusion Criteria:

* Patient's refusal.
* Age \< 19 or \> 40 years.
* Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
* Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
* Patients with cardiac morbidities.
* hypertensive disorders of pregnancy as pre-eclampsia.
* peripartum bleeding.
* Patients with respiratory morbidities.
* Convulsions.
* Bleeding diathesis.
* Known allergy to any drugs used in this study.
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women

The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab


Eligibility Criteria:
Inclusion criteria

* Study participant must be minimum 18 years at the time of signing the informed consent form (ICF)
* Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study
* Study participant has voluntarily decided, prior to having knowledge of this study, to cease breast milk feeding (by any means) in relation to her current period of lactation. Study participant agrees to cease or suspend breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means) or donate expressed breast milk for 8 weeks following administration of rozanolixizumab. Participants may decide to resume breast milk feeding 8 weeks after administration of rozanolixizumab, with the agreement that any breast milk collected (to maintain milk supply) during that 8-week period will be discarded
* Study participant is female

A female participant is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:

* A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the Sampling Period and for at least 1 week after the last dose of study treatment OR
* Not a WOCBP (ie, premenopausal female with documented hysterectomy, documented bilateral salpingectomy, or documented bilateral oophorectomy)

Exclusion criteria

* Study participant has history of breast implants, breast augmentation, or breast reduction surgery
* Study participant has received live vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study
* Study participant has received treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Study participant has had exposure to more than 3 new chemical entities within 12 months prior to dosing
* Study participant has had an active clinically significant infection within the last 6 weeks
Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever

RATIONALE: Comparing results of three different thermometers used to measure body temperature may help doctors find the most accurate thermometer to detect fever and plan the best treatment.

PURPOSE: This clinical trial is studying three different types of thermometers to measure temperature in young patients with fever and without fever.

OBJECTIVES:

Primary

* Determine agreement between three different types of temperature-measuring instruments: the temporal artery scanner, the digital oral thermometer, and the infrared tympanic thermometer calibrated to an oral setting, in pediatric patients who are febrile and afebrile.

Secondary

* Determine similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring in these pediatric patients.
* Determine differences in agreement of the various temperature devices in non-neutropenic pediatric patients versus neutropenic pediatric patients.

OUTLINE: This is a prospective study.

During an afebrile episode, the patient's temperature is measured twice using the following 3 devices: a temporal artery scanner, a digital oral thermometer, and an infrared tympanic thermometer calibrated to an oral setting (total of 6 temperature measurements per afebrile episode).

During a febrile episode, the patient's temperature is measured twice using all 3 devices as above, and then at 2 and 4 hours after administration of an antipyretic medication (total of 18 temperatures per febrile episode).

Patients' temperatures are recorded for a maximum of 3 afebrile or febrile episodes.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Febrile or afebrile
* Patient at the Mark O. Harfield Clinical Research Center

  * Previously enrolled in an IRB-approved Clinical Center protocol

PATIENT CHARACTERISTICS:

* Able to hold an oral thermometer in mouth
* No acute life-threatening infection
* No ear, nose, or throat (aural) abnormalities
* No severe mucositis

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent enrollment on a behavioral research study
Rehabilitation Through the Italian Version of the Teen Online Problem-Solving (TOPS) Program

The study aims at evaluating the feasibility and the efficacy of the Teen On-line Problem Solving program (TOPS) in improving executive functioning and behavior problems in adolescents with neurological condition aged 11-19 years.

In order to control for placebo effects, participants are randomized into two intervention conditions. Group 1 performs the regular version of the TOPS, while Group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.

Adolescents with neurological condition often present with executive dysfunction and behavioral and social problems. Ad hoc rehabilitation may significantly ameliorate such difficulties. With this aim, the Teen On-line Problem-Solving program (TOPS) could represent a suitable opportunity of intervention, as it aims at helping patients to improve executive and behavioral functioning. The program consists of a web-based platform composed of 10 core sessions and eventual supplementary sessions, providing information and activities on executive functioning, behavioral strategies, social skills. injury-related issues and health and wellness. The program is delivered remotely, with patients performing the intervention at home, together with their families. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled along the entire duration of the intervention to monitor the activities related to the program and the real-life problem-solving process that patients are required to perform during the intervention.

Assessment of executive functions and behavioral problems is conducted before and after the training (immediate post training assessment and follow-up assessment 6 months after the end of the training), in order to investigate the presence of significant changes after the intervention. Both questionnaires and performance-based measures are used.

Participants are randomized into two groups: Group 1 performs the regular version of the TOPS, while Group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.

Based on the average effect of TOPS program reported by a meta-analysis available in the literature (Corti et al., 2019; Hedge's g = 0.39) we estimated a small-to-moderate effect size of f =0.2 (f was calculated based on Hedge's g value). Power analysis was conducted by using GPower3 software. Assuming a correlation of 0.50 between repeated measures and setting the alfa level at P \< 0.05, a sample size of 21 subjects per group is required to obtain 80% of power with our 2 groups x 3 time points design.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of neurological condition (non-progressive aquired brain injury, brain tumor, epilepsy etc.)

Exclusion Criteria:

* history of abuse
* familiarity for psychiatric hospitalization
Acute Exercise and Pancreatic Endocrine Function

Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures
* Age 30-70 years
* BMI 20-40 kg/m2

Exclusion Criteria:

* Treatment with insulin
* Contraindication to exercise as determined by ECG
* Pregnancy
* Active weight loss in the previous 6 months
* Actively engaged in exercise training programs
* Evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.

This is a multi-center, open-label, randomized study. Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study. Patients who receive prenatal care at Christiana Care may be approached if an induction of labor is scheduled and consented at their prenatal visit. All indications for induction will be included except those specifically mentioned as exclusion criteria. Any contraindication for vaginal delivery would exclude the subject. After informed consent is obtained, the Foley catheter will be placed and the subject will be randomized to receive oxytocin (study group) or not (control group). After Foley catheter removal or expulsion, the remainder of the induction course was left to the discretion of the primary provider. Prior to randomization, the subject will be placed into the nulliparous or multiparous group.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Pregnant, singleton gestation, vertex presentation
* Admitted for induction of labor between gestational ages 24 - 42 weeks
* Bishop score \<6

Exclusion Criteria:

* Multiple gestation
* Non-vertex presentation
* Latex allergy or latex-free Foley catheter to be placed
* Fetal death
* Anomalous fetus
* Placenta/vasa previa
* Placental abruption (known or suspected)
* Intrapartum bleeding
* Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal variability AND decelerations of any kind, OR late decelerations occurring \>50% of contractions
* 2 or more previous cesarean section, myomectomy, or classical cesarean
* Need to use ripening agents prior to Foley placement
* Spontaneous labor
* Active genital herpes
* Inability to consent
* Any contraindication to a vaginal delivery
Stick Versus Quadricep Exercise for Knee Osteoarthritis

This study aims to compare the efficacy between Boonme stick exercise and quadriceps strengthening exercise in knee osteoarthritis.Patients diagnosed as knee osteoarthritis using Altman criteria will be randomized into 2 groups using simple random technique. Patients will be instructed and trained for both quadriceps or Boonme stick exercise by one-trained physical therapist. All patients will be treated with behavioral modification, NSAIDs and analgesic drugs and regularly follow-up . Assessment included visual analogue scale, exercise compliance, WOMAC and patient satisfaction were done by an assessor in a blinded fashion.


Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis using Altman criteria

Exclusion Criteria:

* problem of communication ability
Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model

This study evaluates the effect of a competency based model on program quality in Swedish preschools for Children with autism spectrum disorder (ASD). Half of the participating preschools will receive "treatment as usual" (Early Intensive Behavioral Intervention (EIBI) provided to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will receive the above as well as, in-service training and monthly on-site coaching sessions also involving preschool staff other than the paraprofessional (competency based model). It is hypothesized that the competency based model will improve program quality, child's engagement, preschool staff knowledge, allegiance and self-efficacy compared to the comparison group.

Almost all children in Sweden between two and five years attend preschool including children with Autism spectrum disorder (ASD). High quality and structured early intervention programs grounded in the principles and procedures of applied behavior analysis have been found in numerous research studies and reviews to significantly improve developmental outcomes, adaptive behaviors and learning outcomes of preschool children with ASD.

A prerequisite of which is a high quality learning environment that includes both the physical set-up, learning climate and competence of staff. The primary purpose of this project is to improve program quality for preschool children with ASD through a competency based model grounded in ecological systems theory sustainable over time and applicable within the Swedish service support system. In total approximately 16 preschools will participate, half of which will receive "treatment as usual" EIBI to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will also receive obtain in-service training and monthly on-site coaching through habilitation. Involved habilitation specialists will obtain in-service training prior to the onset of the study on how to use the Autism Program Environment Rating Scale (APERS), the basic tenets of coaching based on the concept of reflective and collaborative dialogues in which the preschool teachers knowledge of the child and context are taken into account.

It is hypothesized that the competency based model will improve program quality, child's engagement, adaptive behavior, increase preschool staff knowledge, allegiance and self-efficacy compared to the comparison group only receiving supervision in implementing a comprehensive program.

Eligibility Criteria:
Inclusion Criteria:

* Autism diagnosis
* Receiving comprehensive program/EIBI implemented in preschool setting with supervision from habilitation center

Exclusion Criteria:

-
Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 75 years of age.
* Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
* Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
* Capable of providing written informed consent.
* No known contraindications to treatment with sirolimus.

Exclusion Criteria:

* Pregnant or lactating.
* Acute rejection within 90 days prior to study randomization.
* More than one biopsy proven acute rejection episode prior to study randomization.
* Previously received or are receiving an organ transplant other than kidney.
* Receiving sirolimus prior to entry.
* Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
* Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
* History of malignancy in the past 5 years.
* Require dialysis at the time of study entry.
Operational Trial of Dayzz App

Sleep deficiency is a hidden cost of our 24-7 society, with 70% of Americans admitting that they routinely obtain insufficient sleep, 30% of US workers report sleeping less than 6 hours per night, and it is estimated that 50-70 million individuals have a sleep disorder. Undiagnosed and untreated sleep disorders are associated with poor health outcomes for the individual and generate substantial costs for the employer. Diminished alertness resulting from sleep deficiency or undiagnosed and untreated sleep disorders contributes to absenteeism, presenteeism (diminished work performance at work), health care expenditure, occupational injuries, workplace accidents, and commute-related motor vehicle crashes; all of which result in substantial direct and indirect costs. The investigators have shown that adverse impacts on employees and employers can be mitigated through a sleep health education and sleep disorder screening program which have been implemented in a variety of industries. Further, smartphone apps are becoming popular. Dayzz has created a personalized sleep training app that evaluates sleep issues and offers a holistic sleep improvement solution. It is unique in that the sleep app uses evidence-based, big-data-based algorithms to provide personalized sleep training plans. The sleep solutions are tailored to the individual user and leverages unique motivational strategies and continuous supportive messaging. The investigators hypothesize that the Dayzz app, offering a personalized, scientifically based sleep training plan, might further promote improved health, safety and well-being. This clinical trial will implement the sleep health education and sleep disorders screening program in combination with the Dayzz app.

Specifically, the investigators will test the hypotheses that:

Primary Aim 1: Early Dayzz participants who use the app will report positive changes in sleep behavior as compared to the Late Dayzz participants.

Primary Aim 2: Early Dayzz participants who use the app will have increased sleep duration and sleep quality as compared to the Late Dayzz participants.

Secondary Aim 1: Early Dayzz participants who use the app will have fewer unscheduled absences and higher performance/productivity as compared to the Late Dayzz participants.

Secondary Aim 2: Early Dayzz participants who use the app will have improved mood and alertness and increased energy as compared to the Late Dayzz participants.

Secondary Aim 3: Early Dayzz participants who use the app will report fewer adverse health and safety outcomes as compared to the Late Dayzz participants.

Secondary Aim 4: Early Dayzz participants who use the app will have lower health care costs over a 9-month follow-up period as compared to the Late Dayzz participants.

Eligibility Criteria:
Inclusion Criteria:

* Employee of Harvard University or Harvard-affiliated institution or hospital.
* Nominally work a day schedule.
* Own and use a smart phone.
* Regularly use a smart phone app (i.e., once per week).

Exclusion Criteria:

* Regularly work evening, night or rotating shifts.
* Pregnant or breast-feeding.