cyrilzakka/clinical-trials huggingface dataset:
Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment

This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.

This study is comprised of 2 active phases, all conducted with registered users on BecomeAnEX.org, a well-established smoking cessation website.

Phase I involves the initial development and optimization of the text message intervention. The investigators will examine the impact of 4 experimental text message intervention features on smokers' adherence to a web-based cessation intervention during the first 3 months of program enrollment. The investigators will utilize a full factorial design where participants will be randomized to 1 of 2 levels of each of the following features: 1) personalization (yes/no), 2) integration (yes/no), 3) dynamic tailoring (yes/no), and 4) message intensity (standard vs. decreasing). The primary outcome in Phase I will be a composite metric of utilization.

Phase II involves a 2-arm randomized trial that compares WEB alone to WEB plus the text message intervention from Phase I that yields optimal adherence (WEB+OA_TXT). The randomized trial will use a repeated measures design, with assessments at baseline, 3, 9, and 15 months. Follow-ups at 3, 9, and 15 months correspond to 0, 6, and 12 months post-treatment. The primary outcome is 30-day point prevalence abstinence (ppa) at 9-months. The investigators will assess and validate smoking status at all follow-ups. Other outcomes include motivation to quit, quit attempts, and continuous abstinence.

Eligibility Criteria:
Inclusion Criteria:

* US residency
* Current smoker
* Access to and willingness to receive text messages on a mobile phone
* Access to Internet
* Access to and willingness to receive email communication from study personnel

Exclusion Criteria:

* None
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.


Eligibility Criteria:
Key Inclusion Criteria:

* Experiencing at least two (2) documented episodes of paroxysmal atrial fibrillation in the last 3 months preceding study entry with clinical indication for atrial fibrillation (AF) ablation per guidelines. At least one episode should be documented by rhythm strip or ECG.
* Indicated for AF ablation according to current European Heart Rhythm Association (EHRA) guidelines.
* Prescribed with oral anticoagulation therapy, in indicated patients per the latest EHRA guidelines.
* Willingness and able to remain on anti-coagulation therapy as per the latest EHRA guidelines.
* Left atrial diameter \< 5.5 cm as measured and image ((computed tomography (CT)/ transesophageal echocardiogram (TEE)/ transthoracic echocardiogram (TTE)/ magnetic resonance imaging (MRI) or intracardiac echocardiography (ICE)) documented within previous six months up to pre-procedure.
* Sustained AF (\>5 min uninterrupted) during the electrophysiology procedure. If the subject is not experiencing spontaneous, sustained AF, it may be induced by burst pacing (typically from the coronary sinus) with or without isoproterenol infusion in conventional clinical fashion.

Key Exclusion Criteria:

* New York Heart Association heart failure (NYHA) Class III - IV.
* Ejection fraction \< 40% (within previous six months).
* History of myocardial infarction (MI) within the past three months.
* Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study.
* Atrial septal defect (ASD) closure device, left atrial appendage (LAA) closure device, prosthetic mitral or tricuspid valve, or permanent pacemaker.
* Any previous AF catheter ablation.
* History of prior cardioversion for AF lasting \> 48 hours.
* Continuous AF episode lasting \> 7 days immediately prior to the procedure without a sinus rhythm.
Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the HUFSFB and HUSJI From 2019 - 2020

The purpose of this study is to identify the association between analgesic management with blockade of the iliac fascia versus intravenous analgesia with the presence of delirium during hospital stay in patients admitted to the orthogeriatric clinical care center, to determine the opioid consumption of both groups of patients during hospitalization and determine the risk factors that may be associated with a greater presentation of delirium.

Nowadays, with the increase in the geriatric population, there is evidence of an increase in the prevalent conditions in this group, finding within them fragility hip fractures. Additionally, most of these patients have a large number of associated comorbidities, which may require greater specialization in care.

To reduce the possible complications that may be related, different management protocols have been implemented, including pain management strategies such as preventive analgesics, regional blocks, and early surgery. Conventional treatment with the use of intravenous medications can have unwanted effects in geriatric patients with hip fracture, especially in those with greater comorbidity, since medications such as opioids can cause multiple adverse effects, including delirium. Also, not treating pain properly can cause complications such as depression and ulcers in addition to delirium.

This is why the objective of this study is to define whether there is any association between the presentation of delirium in patients over 65 years of age with hip fracture who undergo iliac fascia block upon admission compared to those who receive only IV analgesia Therefore, this retrospective cohort study will be carried out with which it is sought to contribute to the knowledge to continue carrying out early pain management, with the aim of achieving better pain control, a decrease in opioid consumption and thus having a lower number of patients with delirium during hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years of age with a diagnosis of hip fracture due to fragility who are admitted to the Orthogeriatric clinical care center at the Santa Fe de Bogotá Foundation and the San José Infantil University Hospital between January 2019 and December 2020. These two institutions are selected Since they have a model of care for this type of patient, it is similar and therefore comparable.

Exclusion Criteria:

* Patients diagnosed with delirium on admission to the emergency room.
* Patients with hip fracture caused by high energy trauma
* Patients with hip fracture related with tumoral disease or metastasis
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

The objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with any known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.
Self-management of Type 1 Diabetes Under Functional Insulin Therapy

Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Therefore, self-management of patient with type 1 diabetes must be systematically assessed in order to evaluate the effectiveness of education programs .The main objective of this prospective controlled randomized monocentric study is to assess the impact of functional insulin therapy on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes Self-care scale (CIDS) test.

170 patients with type 1 diabetes, volunteering for education to functional insulin therapy, will be recruited by the Department od Endocrinology, Diabetes, Nutrition of Montpellier University Hospital.

After inclusion, the patients will be randomized in 2 groups: group 1 will be immediately trained to functional insulin therapy and group 2 will be trained at the end of the study. The patients will be met as outpatients 3 months after inclusion. The primary endpoint will be the global score for CIDS questionnaire.

Secondary endpoints will include: HbA1c level at month 3, frequency of hypoglycemia from inclusion to month 3, scores for each of the 20 items of CIDS questionnaire.

An ancillary study will assess: the acceptability of the new EAD questionnaire which specifically evaluates the self-management of diabetes, the concordance validity of EAD and CDIS questionnaires, the reproducibility test-retest, the internal consistency and the sensitivity to change of EAD questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes from at least 1 year
* Age from 18 to 70 (70 not included)
* Basal-bolus multiple-dily insulin injections or insulin pump (CSII)
* Informed consent
* Affiliated or benefit from an insurance regimen

Exclusion Criteria:

* Type 2 diabetes
* Unable to make mathematic calculation
* Pregnancy, breast-feeding or absence of effective contraception
* Psychiatric and/or cognitive status uncompatible with study
* Eating disorders
* Law protected person, vulnerable person
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study

Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for wheat allergy. However, commercial wheat extracted for skin prick test have less precise test result compared to extract from omega-5 gliadin, which is one of the major allergen with immediate wheat allergy.


Eligibility Criteria:
Inclusion Criteria:

* A patient with the age of 1-15 year old
* A history of symptoms that suspected of type 1 hypersensitivity (eg. Urticaria, angioedema, wheezing, anaphylaxis) occur within 4 hours after wheat ingestion.
* Patients attend in allergy clinic, pediatric department, Siriraj hospital since 2007-2012

Exclusion Criteria:

* First sign and symptom happens more than 4 hours since wheat ingestion
* Have underlying disease such as heart disease, epilepsy etc.
* Have contraindication for performed skin prick test
Exercise Intensity and Appetite in Adolescents

Acute exercise has been shown to affect subsequent energy intake in obese adolescents. Indeed, it has been shown several times that an intensive bout of exercise (above 70% of the individual maximal capacities) can reduce energy intake at the following meal in obese adolescents, with no modification of his appetite feelings.

Although this results has been replicated several times, it remains unknown if those nutritional adaptations are due to post-exercise modifications of some gastro-peptides implicated in appetite control, as detailed in adults.

The aim of this work is to question whether or not post-exercise energy intake is explained by appetite-regulating hormones that are affected by the exercise bout in both lean and obese youth.

After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:

* anthropometric measurements
* Body composition assessed by dual energy x-ray absorptiometry
* Maximal aerobic test

They will then randomly complete the following conditions:

* CON: a control day without exercise;
* HIE: an exercise day with an exercise set at 75% of the capacities
* LIE: an exercise day with an exercise set at 40% of the capacities

The exercises or the rest condition will be done by the end of the morning and a buffet meal will be proposed during which the participants will be asked to eat as much as wanted.

Blood samples will be drawn before, after, 15 after and 30 minutes after the exercise to assess the main appetite regulating hormones involved in appetite regulation (PYY, Cholecystokinin ...) appetite feelings will be assessed throughout the day at regular interval using visual analogue scales.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 15 years old adolescents
* Obese according to international values for BMI
* Being registered to the national social security insurance
* no eating disorders
* no medications
* metabolic disorders

Exclusion Criteria:

* metabolic disorders
* food disorders
* physical disability
Non Culprit Lesion Study

The aim of the present study is to compare the evolution of non culprit lesions after treatment by BVS versus optimal medical therapy at 2-years follow- up

Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modifications of plaque morphology, especially the lipid content which is considered as one of the main factor leading to recurrent MACE after an ACS.

The interaction between the polymer Platform and the vessel wall, the effect of the everolimus on neointima growth and cellular response into the media could reduce the inflammatory process into the vulnerable plaque could be different Under OMT and BVS implantation.

Eligibility Criteria:
Inclusion Criteria:

* STEMI and multivessel ASCL
* Successful and uneventful primary PCI
* Non culprit lesion \> /= 2.5mm RVD suitable for investigation by FFR
* At least one segment of minimum 10 mm length containing a non culprit lesion

Exclusion Criteria:

* non compliant profile
* patient not able to sign an IC
* cardiogenic shock
* left main disease
* GFR\<30ml/min/m2
* previous CABG
* LVEF\<35%
Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

In the current COVID-19 pandemic, many patients have an acute respiratory distress syndrome (ARDS). Among mechanisms related to COVID-19 acute respiratory distress syndrome, cytokine storm and secretion of IL-6 play a central role. ARDS management involves intubation for protective mechanical ventilation, deep sedation and curarisation.

During intensive care unit (ICU) hospitalization, improvement of hematosis induces a switch from a controlled ventilation mode to a withdrawal ventilation mode, such as Spontaneous Ventilation with Pressure Support (SP-PS) or Adaptative Support Ventilation (ASV). This step is essential prior to considering complete weaning from controlled ventilation and sometimes ends with a failure. In this case, deterioration of hematosis and/or ventilatory mechanics is observed.

At the same time as withdrawal failure, the investigators observed biological inflammatory rebound in some patients. Therefore, influence of inflammatory biological parameters, including IL-6, on withdrawal failure, needs to be investigated. To this end, the investigators decide to dose different inflammatory markers - such as IL6, C-Reactive Protein (CRP), Procalcitonin (PCT) - in patients with acute respiratory distress syndrome due to COVID-19, during standard of care. Indeed, in patients with acute respiratory distress syndrome not due to COVID-19, the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn. In addition, IL6 rise is associated with poor prognosis for patients with COVID-19 and longer stays in intensive care.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Patients with COVID-19 (positive COVID PCR)
* Use of intubation for mechanical ventilation

Exclusion Criteria:

* Use of Extracorporeal Membrane Oxygenation
* Treatment with Tocilizumab (anti-Il6)
* Pregnant woman
* Patients under protective administration or deprived of liberty
Determination of Sufentanil in Breast Milk of Puerpera

To determination of sufentanil in human breast milk during the administration of the sufentanil via the analgesic infusion pump and after the administration, to determine whether the breastfeeding after clinical anesthetic or analgesic administration has an effect on the infant and provide a reference for the security issues.

The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min, A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min, A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2 for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20yr to 38yr
* Height 155\~170 cm
* Weight 65\~85 Kg
* American Society of Anesthesiologists statuses I or II
* Normal cardiac and pulmonary function
* Undergoing elective Cesarean section
* Willing to provide breast milk

Exclusion Criteria:

* pregnancy induced hypertension
* gestational diabetes
* gestational heart disease
Effects of Cryotherapy on Knee Function

The knee joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers

Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of knee function by the modified Star Excursion Balance Test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 28 years old
* healthy
* no musculoskeletal complaints

Exclusion Criteria:

* failure to follow protocol
* complaints of injury or pain during the assessments
Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes

To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with mild diabetes without prior medications or impaired glucose tolerance

Exclusion Criteria:

* Pregnancy
* Recent major cardiac, renal and hepatic disease
* Intolerance to alcohol
* Allergy to acarbose treatment
A Study Collecting Remote Data in People With an Overweight Condition or Obesity on a Weight Management Program

The purpose of this study is to collect health data related from participants living with an overweight condition in a decentralised clinical study set-up. All data will be collected remotely using an app downloaded on your personal smartphone and devices (watch and scale).

Participants will participate in this study for 24 weeks. The study does not include any study medicine.


Eligibility Criteria:
Inclusion Criteria:

1. Informed electronic consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Willingness to consent via the e-consent process before any study-related activities (study- related activities are any procedure related to recording of data according to the protocol
3. Male or female, age above or equal to 18 years at the time of signing informed consent
4. Body mass index (BMI) above or equal to 25 kg/m\^2
5. Undergoing at least one of the following weight management program(s) as prescribed/ agreed upon by the treating physician:

   1. Diet regime aimed at losing weight and/or
   2. Exercise regime aimed at losing weight and/or
   3. Prescription of any approved anti-obesity medication (according to standard practice)
6. Willingness to follow study procedures
7. Willingness to, and capable of using the study devices and app
8. Fluent in oral and written Danish language
9. In possession of a compatible smartphone (minimum Android 10 and iOS14) throughout the study that has a reliable internet connection, regular connection to 4G/5G network, or Wi-Fi and that has the capability of downloading the study app and connecting with the smartwatch, the body composition scale and the data hub)

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Participation in any study investigating an overweight condition or obesity
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
4. Type 1 or type 2 diabetes
5. Currently under treatment with any GLP-1 RA with the indication of improving glycaemic control
6. Currently using a pacemaker, an implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy (CRT) due to the electrical effects of the body composition scale
7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method during the study duration