cyrilzakka/clinical-trials huggingface dataset:
Smoking Cessation Peds Asthma

The overall goal of this study is to adapt and preliminarily validate an intervention based on evidence based approaches to assist smoking parents and other family members of inner-city children ages 4 to 12 with asthma to stop smoking.This study aims (1) to adapt existing guideline-based materials used in adult medicine to create a system- and provider-level intervention for pediatrics and (2) to evaluate feasibility and acceptability of (a) procedures to recruit inner-city, ethnic minority parents and (b) intervention procedures, and to estimate intervention effects.

Investigators will adapt guideline-based interventions used in adult medicine. The intervention consists of two system-level interventions (chart reminders to prompt providers to ask about in-home smoking and a State Quit-line referral system), and a provider-level intervention (training in the PHS Guidelines, in motivational interviewing, and on how to use the system-level intervention). Investigators will implement the study in the Bellevue Pediatric Asthma Clinic and the pediatric clinic at Lincoln Hospital using a two group (pre intervention control group / post-intervention treatment group) pilot study to test the feasibility and preliminary effects of a multi-level (i.e., system and provider) intervention. The primary outcome is provider adherence to tobacco use treatment guidelines, which will be assessed by conducting parent exit interviews with 200 smoking parents (100 pre-intervention \[control group\] and 100 post-intervention \[treatment group\]). Preliminary intervention outcomes will be collected through the parent exit interviews (i.e., baseline) and 2-month post-baseline interviews with the control and treatment parents. Providers will also be interviewed regarding their satisfaction with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Parents of a child between the ages of 4 and 12 with uncontrolled asthma, brought to one of the clinics for an asthma-related visit
* uncontrolled asthma as meeting the criteria for "not well-controlled" or "very poorly controlled" asthma: (a) score of 19 or lower on the validated Asthma Control Test (ACT)45 OR (b) any of the following in the prior 12 months: (1) 2+ courses of oral steroids; (ii) 2+ Emergency Department (ED) visits for asthma; and (iii) 1+ hospitalization for asthma.
* The parents must speak English or Spanish, and have the capacity to provide consent.

Exclusion Criteria:

* Beyond these eligibility criteria, no exclusions will be made based on sex, ethnicity, or race of the child or parent.
A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.

This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy.

Dietary sodium intake is closely associated with the prognosis of chronic kidney disease (CKD) patients. Previous studies have developed an equation for estimating dietary sodium intake through 24-hour urine sodium in CKD, which are not applicable in peritoneal dialysis patients. This study aims to develop a novel equation for estimating dietary sodium intake in 20 anuric peritoneal dialysis patients, using accurately measured dietary sodium as the dependent variable and peritoneal sodium clearance and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 20 anuric peritoneal dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis vintage \>3 months.
* 18-80 years old.
* No residual renal function (urine volume\<200ml/day).
* Continuous ambulatory peritoneal dialysis or manual intermittent peritoneal dialysis.

Exclusion Criteria:

* Peritonitis in the past month.
* Acute systemic infection, cardio-cerebrovascular complications and surgical trauma in the past month.
* Uncorrected hyponatremia (blood sodium\<130mmol/L).
* Prescribed with sodium bicarbonate and other drugs containing sodium.
* Prescribed with glucocorticoids and aldosterone antagonists.
* Dysfunction of peritoneal dialysis catheter.
* Malignant tumor receiving radiotherapy and chemotherapy, severe dyspepsia or eating disorder.
* Body fluid loss due to vomit, diarrhea, massive sweating, or other causes.
* Cannot follow the research scheme.
* Refuse to participate in this study.
Cardiometabolic HIIT-RT Study

Several studies have shown relationship between exercise intensity and improvement cardiometabolic health such as body composition, endothelial function, blood pressure and blood lipids. It has been suggested that high intensity interval training and also strength or resistance training generate positive effects on metabolic risk factors, nevertheless the comparison between both types of training and their combination has not yet provided conclusive evidence. Also, it has been shown that dietary restriction has similar or more positive effects that exercise alone and the effect is greater when it is combined with exercise. For these reasons, it is necessary to clarify which type of training, in combination with a dietary restriction, is more effective to improve cardiometabolic health

The investigators hypothesized that high intensity interval, resistance training or combined training would result in similar improvements in cardiometabolic health as compared to the usual clinical care in a cohort of sedentary overweight (age 30-50 years old).

Eligibility Criteria:
Inclusion Criteria:

* Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c \<40mg/dl (men) \<50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL.
* Written informed consent.
* Interested in improving health and fitness.

Exclusion Criteria:

* Systemic infections.
* Weight loss or gain of \>10% of body weight in the past 6 months for any reason.
* Currently taking medication that suppresses or stimulates appetite.
* Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
* Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
* Asthma.
* Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
* Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
* Any active use of illegal or illicit drugs.
* Current exerciser (\>30 min organized exercise per week).
* Indication of unsuitability of current health for exercise protocol (PARQ).
* Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients

Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse event especially homozygous variant CYP2B6 \*6/\*6. This trial was designed to compare the proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between patient who did CYP 2B6 guided EFV dose and who did not.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Anti-HIV positive
* Naïve to antiretroviral drugs
* Meet the criteria to start ART to Thai National guidelines
* Sign inform consent

Exclusion Criteria:

* Body mass index (BMI) \>25 kg/m²
* Pregnant women or breastfeeding
* Received drugs that may have interaction with EFV e.g. rifampicin, fluconazole (400-800 mg), ergot alkaloid, midazolam, triazolam, ritonavir, carbamazepine, phenytoin, phenobarbitone, St John's Wort
* Having active opportunistic infections e.g. tuberculosis, cryptococcosis, histoplasmosis, penicillosis
* Hepatic dysfunction as indicated by:
* Transaminases \>5-10 × the upper limit of normal
* ALP \>5-10 × the upper limit of normal
* Total bilirubin \>2.5-5 × the upper limit of normal
Efficacy of TEAS on Chronic Pain and Survival in Patients Undergoing Hepatectomy

This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain, quality of life and survival rate in patients undergoing hepatectomy.

This study is a further observation and follow-up of the patients enrolled in the registration number NCT06341270 to further evaluate the efficacy of TEAS on postoperative chronic pain and survival in patients undergoing hepatectomy. Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS）or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6), Hegu (L14), Yanglingquan (GB34), Zusanli (ST 36) and Renying (ST9) acupoints. Patients will receive TEAS 30 min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient. Patients in the sham group will receive electrode attachment but without stimulation. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival, overall survival at 3 months and 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.

Exclusion Criteria:

Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs.
Neurofeedback and Nomophobia in Young Adults

Introduction: Given the growing increase in addiction to social networks and smartphone use in young people and its implications for health, it is necessary to investigate effective interventions for the appropriate use of these technologies and coping with possible signs of addiction.

Objective: To evaluate the effect of an intervention based on neurofeedback techniques on anxiety and other disorders associated with problematic use of mobile phones and the internet in young adults.

Methodology: Randomised controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be young adults aged 18-30 years. A sample size of 36 participants has been estimated, 18 in each group to detect a difference of 3.9 points or more on the DASS-21 anxiety questionnaire.

All participants will receive an educational workshop on the responsible use of new technologies and the promotion of healthy lifestyles. The IG, in addition to this educational workshop, will receive 20 neurofeedback sessions during 8 weeks, 2-3 sessions/week with the MUSE neurofeedback device.

A baseline and 3-month post-intervention assessment will be conducted for both groups to study change variables related to smartphone addiction (Smartphone Addiction Scale-Short Version (SAS-SV)), nomophobia (Nomophobia Questionnaire (NMP-Q)), depression, anxiety and stress (Depression, Anxiety and Stress Scale 21-item (DASS-21)) and sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Have one or more mobile devices such as smartphones.
* Have a compatible mobile device to install and use the Muse: EEG Meditation \& Sleep application.
* Be fully functional.
* Willingness to voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

* History of severe psychiatric disorders (such as schizoaffective disorders, bipolar disorder, major depressive episode with symptoms or other non-organic psychotic disorders) requiring psychiatric treatment in the 6 months prior to study entry.
* History of brain injury or other problems contraindicating the use of neurofeedback.
Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging

Autism spectrum disorders (ASD) is a neurodevelopmental disorder and is characterized by functional impairment in social communication, restricted interests, and repetitive behaviors.The children with ASD has been shown different drug responses from the normal population of children. The children with ASD maybe more prone to elevate anxiety and the difficult of sedation during MRI scanning.The purpose of this investigation was to compare the effectiveness of dexmedetomidine sedation in children with and without ASD undergoing MRI scanning.

The use of medications in adolescents and young adults with ASD is extremely common. However, few data address the effectiveness and harms of medications for procedural sedation in this population. It's advisable to be used as a first line medication with alpha-2 agonists for procedure sedation. The primary goal of this study was to compare the effectiveness of dexmedetomidine sedation, also determine the 50% and 95% effective doses in children with and without ASD undergoing MRI scanning.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II,
* Patients aged 2 years through 12 years of age scheduled for procedure sedation during MRI scanning
* Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM V (autism group) or no history of neurodevelopmental concerns (control group). Child in control group is matched to an autism spectrum disorder participant according to age, gender, and ASA level.

Exclusion Criteria:

* Known allergy or hypersensitive reaction to dexmedetomidine
* Organ dysfunction, and significant developmental delays or behavior problems
* Cardiac arrhythmia
* Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination
Metacognitive Beliefs in Obese Patients

The study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships.


Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 65 years
* Italian nationality
* Body Mass Index ≥ 35 kg/m2

Exclusion Criteria:

* Psychiatric pathologies
* Severe cognitive deficits that could compromise the completion of the questionnaires
* Absence of signed informed consent
Behavioral Nudge in Colorectal Cancer Screening

The purpose of this study is to evaluate if a behavioral nudge principle known as social norm driver can be implemented to improve fecal immunochemical test (FIT) completion rates for patients' age 45-75 years old due for colorectal cancer screening at Bellevue Hospital Medicine Ambulatory Care Clinic. The study's endpoints include FIT screening completion rate and timeliness. Secondary analysis will look at demographic information such as age group, gender, prior screening, number of prior visits at the clinic.


Eligibility Criteria:
Time Period 1 Inclusion Criteria:

1. Patient at Bellevue Ambulatory Care Medicine Clinic between 1/1/2024 and 7/1/2024
2. Age 45-75 years old

Time Period 2 Inclusion Criteria:

1. Patient at Bellevue Ambulatory Care Resident Clinic
2. Age 45-75 years old
3. Has not had a FIT test within the past year
4. Can read either English or Spanish
5. Is able and willing to provide consent

Time Period 3 Inclusion Criteria:

1. Patient at Bellevue Ambulatory Care Resident Clinic
2. Age 45-75 years old
3. Has not had a FIT test completed within the past year
4. Can read either English or Spanish
5. Is able and willing to provide consent

Time Period 1 Exclusion Criteria:

1. Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
2. Age outside of 45-75 years old

Time Period 2 Exclusion Criteria:

1. Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
2. Age outside of 45-75 years old
3. Has had a FIT test completed within the past year
4. Cannot read either English or Spanish

Time Period 3 Exclusion Criteria:

1. Patient at a clinic that is not Bellevue Ambulatory Care Resident Clinic
2. Age outside of 45-75 years old
3. Has had a FIT test completed within the past year
4. Cannot read either English or Spanish
Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in Children

Fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy. Routine blood tests can assist the doctor in making a decision, although their response times often do not allow for timely therapeutic decisions. Therefore, there is an increased risk of inappropriate prescribing antibiotics for children with viral infections, which contributes to the increase in antibiotic resistance. There is evidence suggesting the effectiveness of certain biomarkers in distinguishing viral from bacterial forms. Biomarkers of potential interest include tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein. The combination of those tests could distinguish between bacterial and viral infections with 90-94% sensitivity, 88-92.8% specificity, 59-81% positive predictive value and 97-98.8% negative predictive value. This is prospective study using biological samples that aims to evaluate the best diagnostic algorithm for obtaining an early and accurate etiological diagnosis (bacterial infection vs viral infection) of a febrile pediatric patient presenting at the Emergency Department, by comparing the standard algorithm with the diagnostic algorithm integrated with the results of the multi-analytic test.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 3 months and \< 18 years
* Access to the Emergency Department during the study period
* Fever (body temperature ≥38°C) for less than 7 days
* Absence of an infectious focus or symptoms affecting the respiratory tract

Exclusion criteria:

* Fever for more than 7 days
* Antibiotic therapy for ≥ 48 hours
* Acute gastroenteritis
* HBV (hepatitis B virus) or HCV (hepatitis C virus) infection
* Active oncologic pathology
* Metabolic pathology
* Trauma or major surgery within the past 7 days
Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution

Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose of sterofundin solution given to healthy volunteer in the resuscitation manner compared with normal saline solution.

10 healthy volunteers were randomly assigned to receive either normal saline or sterofundin for the first solution in dose of 30 mL/kg (max 2 L) over 1 hour. Blood was collected at baseline (T0), at 60 minutes (T1), 120 minutes (T2), and 240 minutes (T4) from baseline. Time to fist void after initiation of fluid and urine volume were also recorded. After wash-out period of at least 1 week, crossover studies were performed with another fluid.

Eligibility Criteria:
Inclusion Criteria:

* No underlying disease
* LVEF \> 0.5
* No current medication usage

Exclusion Criteria:

* Pregnancy or lactation
* BMI \<18 or \>25
* Fever presented in the past 2 weeks
Wellbeing and Stress Among Mobile Phone Dispatched Lay Responders

The aim of this study is to provide detailed information on state of mind, psychological wellbeing and stress for lay responders dispatched to suspected OHCA via a mobile phone application.

The Heartunner system is a mobile phone positioning system for dispatch of CPR-trained lay volunteers to nearby suspected out-of-hospital cardiac arrests (OHCAs). After downloading of a mobile phone application (The Heartrunner application), and given consent of participation, the lay responders are dispatched to nearby suspected OHCA. The lay responders are either dispatched directly to the scene of the suspected OHCA to perform CPR, or to fetch the nearest AED. The location of the OHCA and available AEDs are displayed on a map, facilitated by the Heartrunner application. The Heartrunner system is studied through "The SAMBA-trial" on clinical outcomes for OHCA patients (ClinicalTrials.gov Identifier: NCT02992873).

The psychological effects among the lay responders will be evaluated with an online survey adjacent to dispatch and after 4-6 weeks. The results of the survey will be compared both intra-individual, and to a control group of not dispatched lay responders within the Heartrunner system. Descriptive statistics regarding interventions, age, gender and former experience will also be presented.

Please see the attacehd study protocol for details

Eligibility Criteria:
Inclusion Criteria:

* Mobile phone dispatched lay responders who reached the scene a suspected cardiac arrest.
* Located lay responders who was not dispatched due to technical or human reasons (no feedback from app to system).

Exclusion Criteria:

* Mobile Phone Lay responders who declined the mission for dispatch to a suspected cardiac arrest.
* Mobile Phone Lay responders that already answered the survey.
* Mobile phone dispatched lay responders who accepted the mission but was aborted due to distance or did not reach the scene.
Impact and Burden of Postponing Elective Surgeries

Overall, little is known about the effects and burdens of postponed operations in patients with urological diseases. To investigate the consequences and develop possible strategies for overcoming these challenges, the investigators would like to evaluate the influence of operation shifts in more detail.

Medical care in Austria is struggling with staff shortages and consecutive OR (operating room) closures. The current development seems to be the result of problems that have been postponed for a long time to be accelerated by the COVID-19 pandemic. The introduction of COVID-19 vaccination and the establishment of protective measures and handling standards with infected patients made it possible to return to the regular operation. However, there is currently no noticeable improvement in the overall situation. The increasing shortage of nursing care in Austria is an increasingly urgent reason for this that affects all hospitals and care facilities. By prioritizing oncological interventions and an "oncology first" strategy at least oncological interventions and emergency interventions are performed on time. However, just looking at the waiting times for oncological interventions does not provide sufficient information of the current overall situation. The impairment for Patients with non-oncological diseases have received little attention so far given. Postponing elective surgery in patients with functional urological diseases (e.g. benign prostatic hyperplasia) can have a long-term impact on patient health and also means shifting their Surgery Burden and the stress for the patient. An American Study observed a decrease in prostate cancer diagnoses and an increase in diagnostic delays and postponements of treatments due to the pandemic, which led to greater stress and uncertainty in the affected patients.

The primary goal of this study is to record the burden on patients caused by the postponement of their surgery (mentally, physically).

Secondary outcomes include complication rates from postponement of surgery, effects on employment, awareness of the current situation (lack of care), state of health of patients upon admission to elective surgery.

Eligibility Criteria:
Inclusion Criteria:

- All patients over the age of 18 attending the Department of Urology for an elective surgery

Exclusion Criteria:

* lack of ability to give consent
* emergency operations