cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program

This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient's use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and MyChart messaging.

Using a mixed-methods design, this study will be completed in three phases. For Phase 3, we aim to conduct a randomized control trial with 400 patients with pre-diabetic, all of whom will be using the dDPP application. Half of enrolled patients will be randomized to the intervention group and receive automated targeted messaging.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, BMI ≥ 25 kg/m2 (\> 22 kg/m2 if self-identified as Asian)
* Must be a NYU Langone patient
* A diagnosis of prediabetes (either diagnosis of prediabetes or an HbA1C level of 5.7%-6.4% in past 12 months) or diabetes risk factors (BMI ≥ 25 kg/m2 or \> 22 kg/m2 if self-identified as Asian
* Safe to engage in moderate physical exercise (as determined by their PCP)
* Sufficient English to be able to complete the enrollment process
* Has app-capable device with data to use the dDPP application and receive text messages

Exclusion Criteria:

* Diagnosed with diabetes
* Patients whose weight may vary considerably over the study's timeframe for reasons other than the intervention (e.g. cancer, pregnancy, ascites, severe CHF)
* Patients with severe psychiatric disease or dementia
* Active health condition that prevents them from engaging in moderate exercise
Not Invasive Monitoring at Cardiac Recompensation

The aim of this study is to find out if data can be provided by external sensor technology which is suitable for controlling the therapy of patients with cardiac recompensation.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute or chronic cardiac decompensation with and without pulmonary oedema
* male and female patients aged at least 18 years

Exclusion Criteria:

* pregnancy or breast feeding
* implanted pacemaker / CRT / ICD exept Medtronic OptiVol
* patients being unable to consent
Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs

This is a prospective study of manual wheelchair users with spinal cord injury (SCI). The users will be their own controls. The primary purpose of the study is to evaluate the ability of the power assist device SmartDrive to increase the ability to be mobile.

The hypothesis of the study is that the SmartDrive will enable the user to be more active, both in commuting longer distances with less strokes needed, and managing single difficulties stopping them from activity. The two assessments selected, distance travelled and the daily diary, should directly reflect the impact of the SmartDrive. In addition, the the International Spinal Cord Society (ISCoS) pain data set, Wheelchair User's Shoulder Pain Index (WUSPI) and Wheelchair Outcome Measure (WhOM) will be used. In WhOM, the participants will state some activities they perform in their wheelchair that are important to them, and how satisfied they are with their current level of performance of that activity. After the intervention period the satisfaction is reassessed. This will enable to capture the effect SmartDrive usage has on the participant's daily life (beyond distance commuted and pain level).

After enrollment, the participants will be followed for two weeks using their wheelchair without SmartDrive. After attaching the SmartDrive, they will have three weeks to get into a use of the device on a regular basis in their everyday life, and then follows two consecutive weeks of study intervention and data collection. To capture the long-term effect and allow for season variability, follow-up data will be collected at three and six months after start of study intervention.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
* 18 years of age inclusive, at the time of signing the informed consent.
* Motor level C6-L3 Spinal Cord Injury, American Spinal Injury Association Impairment Scale (AIS) A-C since at least six months
* Full time manual wheelchair users, able to propel their own wheelchairs independently
* Eligible reason for SmartDrive prescription (Self-reported shoulder pain, and/or decreased physical endurance for propulsion, limiting user from activity)

Exclusion Criteria:

* Cognitive impairment affecting the ability to operate the SmartDrive, as deemed by prescribing clinician
* Weigh more than 150 kilos due to the technical specification of the SmartDrive
* Currently participating in another clinical study anticipated to affect the outcome or ability to compete this study
* Planned change from daily routines during the following two months, such as holiday, move, change jobs
* For any other reason not suitable for participation in the study, as deemed by prescribing clinician
* Do not use a smart phone
Performance of Acceleromyography With and Without Preload

The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* General anesthesia \> 1 hour
* Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
* Written informed content

Exclusion Criteria:

* Neuromuscular disorders, hepatic and renal dysfunction
* Medication expected to interfere with the neuromuscular blocking agent
* Allergy to any medication used during anesthesia
* Body weight less or exceeding 20% of the ideal body weight
* Pregnancy or breastfeeding
Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma

For cancers, such as mesothelioma, that spread to the lining of the stomach, detecting the cancer is very difficult with CT or MRI scans. Researchers at the University of Chicago want to find out if the new experimental MRI and ultrasound imaging techniques do a better job of detecting these cancers. Researchers will use new MRI and ultrasound techniques to see if it can find evidence of cancer that has spread to the lining of the abdomen, and right now these new techniques are only used for research.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Biopsy-proven MPM
3. Surgery for PM planned at UCM within 60 days
4. Able to tolerate CT, MRI, US scans, and surgery
5. Able to provide written informed consent
6. For women of child bearing age, ability and willingness to use appropriate contraceptive methods before imaging and for a period of 365 days thereafter.

Exclusion Criteria:

1. Pregnancy / Breastfeeding
2. Allergy or intolerance to iodinated or gadolinum contrast dyes
3. Contraindications to CT or MRI imaging including chronic kidney disease with GFR \<60mL/min/1.73m2
4. Bioimplants unsuitable for MRI imaging (activated by mechanical, electronic, radiofrequency, or magnetic means), such as cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps
5. Permanent tattoos or eyeliner with magnetic dyes
6. Subjects with shrapnel or metal fragments lodged in the body
7. Anxiety, claustrophobia, or any medical condition that would preclude lying still in an MRI scanner for 1-1.5 hours
8. Cardiac, circulatory, or perspiration problems leading to impaired thermoregulation
9. Respiratory or cardiac impairment limiting the ability to lie flat
10. Inability to breath-hold for MRI acquisition
11. Vascular or aneurysm clips or any other surgical implant that is not MRI-compatible
12. Any other ferromagnetic bioimplant that would be damaged by MRI
13. Mental, cognitive, or mental health impairments that preclude the subject from providing informed consent or adhering to the treatment protocol
14. Subjects unable to adhere to the protocol or communicate effectively with researchers
15. Imprisoned subjects
16. Subjects with history of prior CRS/HIPEC or other peritonectomy surgery that might alter characteristics of the peritoneum
Summertime: Kids in Motion

This is a 3-week randomized crossover study to determine the effect of the prior night's sleep duration on energy-balance related behaviors of diet and physical activity the following day. In Week 1, child participants will sleep their usual amount. In week 2, participants will be randomized to either a sleep restricted or a healthy sleep condition for 4 nights. In week 3, participants will cross over to the opposite sleep condition for 4 nights.

Individuals of Mexican descent comprise the largest proportion of the Latino population in the United States and they suffer high rates of obesity. Short sleep is a risk factor for obesity. An improved understanding of the underlying behavioral mechanisms by which short sleep duration may impact obesity among Mexican American children is critical to prevent and/or reduce obesity and chronic disease in this population. This research will focus on behavioral mechanisms (i.e., diet and physical activity) that link sleep duration to obesity. Mexican American 8-10-year-olds will participate in a 3-week crossover study to examine: 1) contextual factors (i.e., bedtime routines, sleep hygiene, familism) that may impact sleep; and 2) the impact of prior night's sleep duration on diet and physical activity the subsequent day. This research design will make it possible to examine whether sufficient sleep is protective of energy balance (e.g., healthful dietary intake/patterns and physical activity) as well as contextual factors related sleep.

Eligibility Criteria:
Inclusion Criteria:

* Mexican American child-mother pairs which will include: child 8-10 years old; mother/female guardian; English/Spanish speakers; mobile phone user.

Exclusion Criteria:

* Children with major illnesses and/or with sleep apnea for which children
* In families where 2 children are eligible for participation, a child will be selected at random to participate in the study.
* The investigators will exclude fathers from this study for reasons due to statistical power
COMBO Endoscopy Oropharyngeal Airway in Sedated Gastrointestinal Endoscopy for Obese Patients

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. This is particularly true for obese patients, who have a higher incidence of hypoxia. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in obese patients undergoing gastrointestinal endoscopy under sedation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18≤ Age ≤70.
* BMI ≥ 28 kg/m².
* The ASA classification ranges from I to II.
* Patients have signed the informed consent form.
* Patients undergoing gastroendoscopy and colonoscopy procedure.
* The estimated duration of the procedure does not exceed 45 minutes.

Exclusion Criteria:

* Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
* Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
* Profound renal insufficiency necessitating preoperative dialysis.
* A confirmed severe liver dysfunction.
* Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
* Elevated intracranial pressure.
* Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
* Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
* Pregnancy or lactation.
* Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
* Urgent surgical intervention.
* Polytrauma.
* Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
* BMI\<28 kg/m².
* Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
* Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
* Presently engaged in concurrent participation in additional clinical trials.
* Patients considered ineligible by researchers for inclusion in this clinical trial.
The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery

Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.

Total hip arthroplasty (THA) is associated with moderate blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis. Most clinical studies reported potential benefit of the treatment demonstrated by less estimated blood loss (EBL), reduced hemoglobin/hematocrit (HH) change, and reduced transfused packed red blood cells (PRBC). However, bleeding complication may be affected more significantly by the degree of surgical trauma and comorbidity of patients than coagulation abnormality. Further, the frequency and severity of fibrinolysis during these procedures have not been well studied. Additionally, TXA administration may increase the tendency of postoperative venous thrombosis by inhibiting fibrinolysis in already prothrombotic patients. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on clinical outcome in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during primary THA.

Eligibility Criteria:
Inclusion Criteria:

* The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty.

Exclusion Criteria:

* Exclusion criteria include patient's refusal, patients with history of significant coagulopathy or on anticoagulation therapy. Female patients who are pregnant or nursing will be excluded. In addition, patients with anemia (Hb \< 8 g/dL) or who received blood transfusion within one week before surgery will be excluded. Patient receiving subcutaneous heparin on the same day prior to surgery will be also excluded.
Usage Test on a New Cosmetic Product: Mouthwash

The goal of this clinical trial is to learn if a new mouthwash can help soothing oral mucosa in adult patients with sensitive gums. The main questions it aims to answer are:

* Does the investigated mouthwash soothe red gum?
* Has the mouthwash antibacterial activities? Researchers will compare with a marketed mouthwash to see if the observed effect is due to the formula or to the general rinsing effect of any mouthwash.

Participants will be asked to use the investigated mouthwash or the comparative mouthwash twice a day for 21 days.

Severity of gingival inflammation is evaluated using the Loë \& Silness scale, which includes 4 scores (0=no inflammation, 3=Significant inflammation, redness, accentuated hypertrophy with spontaneous hemorrhagic tendency and ulceration) by the dentist, on Day 0 and on Day 7.

Presence of dental plaque is evaluated using the Loë \& Silness scale, which includes 4 scores (0=no dental plaque, 3=Abundant plaque along the gingival margin; the spaces between the teeth are filled with plaque) by the dentist, on Day 0 and on Day 7.

Changes in the gingival microbiota is evaluated through the analysis of bacteria on D0 and D7 by swab sampling on the occlusal and buccal surfaces at the gum line.

Tolerance (adverse effects) will also be studied by recording any adverse effect.

Eligibility Criteria:
Inclusion Criteria:

* Person (man, woman) aged 18 or over,
* Person with a gingival index ≥ 2 (according to Loë \& Silness) on at least 10% of teeth (i.e. 3 teeth) at the inclusion visit
* Person capable of following the instructions for using the product,
* Person agreeing to come for a dental consultation 7 days (+/- 1 day) after the inclusion visit,
* Volunteer informed and having signed their informed consent form,
* Volunteer person affiliated to a social security scheme (Art L1121-11 of the CSP).

Exclusion Criteria:

* Person who has regularly used mouthwash in the last month,
* Person suffering from periodontitis
* Person having a scaling treatment planned in the session, or having had a scaling treatment in the 6 months preceding the inclusion visit,
* Person having had antibiotic or antifungal treatment in the 3 months preceding the visit,
* Person taking anti-coagulant or anti-aggregant or immunosuppressive or anti-cancer treatment (chemotherapy or radiotherapy of the head and neck)
* Person at risk of infective endocarditis,
* Person with a known sensitivity or allergy to one of the components of mouthwashes, including components derived from essential oils (Eucalyptol, thymol, menthol, limonene).
* Volunteer participating in intervention research.
* Vulnerable people referred to in articles L. 1121-5 to 8 and L. 1122-1-2 of the Public Health Code (institutionalized volunteers, deprived of their liberty or placed under legal protection (guardianship or curatorship).
KNOW-CKD Cohort, Phase II Study

The goals of KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence. KNOW-CKD Phase I has enrolled 2,238 patients and these patients were divided into four major subgroups depending on the specific causes of CKD : glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, and polycystic kidney disease. In progress, renal progression, complications, and cardiovascular disease of these patients are followed up now.

Since there was a lack of information related to patients' lifestyle, it is necessary to conduct various studies that can be applied to actual clinical status through evaluation of nutrition, cognitive functions, and lifestyles of patients with CKD in South Korea. In addition, researches for high risk patients including diabetic nephropathy, advanced CKD and elderly patients are needed. Thus, KNOW-CKD phase II will enroll the CKD subjects at a more advanced-stage, and older patients than KNOW-CKD phase I subjects.

KNOW-CKD phase II Investigator Group comprises nephrologists, epidemiologists and statisticians from multi-centers in South Korea. KNOW-CKD phase II will enroll 1,500 individuals with estimated glomerular filtration rate between 20 and 60mL/min/1.73m2 (CKD-EPI\[Cr\] equation) between 2019 and 2021 and follow them until 2016 (for 5\~7 years). Unlike phase I, patients diagnosed with glomerulonephritis and ADPKD will be excluded in Phase II.

At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, and anemia. Nutritional evaluation through skin fold, hand grip test, bioelectrical impedence analysis, and 7-point subjective global assessment (SGA), food frequency questionnaire (FFQ) will be conducted in a subgroup of patients. Information on the medical history, health questionnaires, QOL, K-MoCA will also be collected. Web-based case-report forms (CRF) will be used for the systematic management of the patient data.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-79 years
* Estimated glomerular filtration rate 20-60mL/min/1.73m2 based on CKD-EPI(Cr) equation
* Non-dialysis dependent (NDD)

Exclusion Criteria:

* Autosomal dominant polycystic kidney disease
* Unable or unwilling to give consent
* Previously received chronic dialysis
* Previous any organ transplant
* Patients who diagnosed heart failure with NYHA class 3 or 4
* Known liver cirrhosis (Child-pugh class 2 or 3)
* Pregnant women
* Single kidney due to trauma or donation
* Patients who received immunosuppressive agent within the past 1 year
* Patients who diagnosed with glomerulonephritis through kidney biopsy