cyrilzakka/clinical-trials huggingface dataset:
Starting Technology in At Risk Type 1 Diabetes Study

Diabetes technology has revolutionized T1D management, disparities in technology access are evident among racial-ethnic minorities, patients with lower socioeconomic status and those with poorly controlled T1D (A1c\>8.5%). In order to examine whether diabetes technology can reduce diabetes care burdens and enhance outcomes among some of highest need patients, diabetes technology clinical trials must be expanded beyond the very select populations included in studies thus far (ie., mostly White, higher SES). Therefore, the investigators propose to perform a pilot RCT of hybrid closed-loop insulin pump therapy (HCL) in 40 diverse adult patients with poorly controlled T1D (HbA1c \>8.5%) from the largest academic and safety net health systems in the Los Angeles region to determine the feasibility of a RCT in this population and identify facilitators and barriers of effective use of closed loop insulin pump therapy in patients with poorly controlled T1D.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* A1c \>8.5%
* Not insulin pump user
* Primary language of English or Spanish
* Have medical insurance coverage

Exclusion Criteria:

* No measured A1c in the past year
* Have comorbidities that can result in inaccurate hemoglobin A1c
* Have cognitive, physical or mental impairment precluding diabetes technology use
* Limited life expectancy (\<1 year)
* Pregnancy
Feasibility and Efficacy of a Brief Digital Self-efficacy Training

The study investigates the effects of a digital, scalable self-efficacy training of repeated recall of self-efficacy memories on mental health outcomes, such as self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes. A total of 94 students with elevated stress levels (≤ 13 on the Perceived Stress Scale) will be recruited and randomly assigned to training and control group. Individuals will either engage in the self-efficacy training app combined with Ecological Momentary Assessment (EMA) for 1 week (training group) or in EMA only for 1 week (control group). Baseline and post assessments will measure changes in self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes.

Self-efficacy is associated with positive mental health outcomes and has been proposed as a putative contributor to therapeutic outcomes in the treatment of mental health problems. It can be enhanced through experimental inductions and the recall of autobiographical mastery experiences, which have mostly been conducted in person and in the laboratory until today.

The study will investigate effects of a digital, scalable self-efficacy training of repeated recall of self-efficacy memories on mental health outcomes, such as self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes. The study will recruit 94 students with elevated stress levels (≤ 13 on the Perceived Stress Scale) and randomly assigned them to training and control group. Individuals will either engage in the self-efficacy training app combined with Ecological Momentary Assessment (EMA) for 1 week (training group) or in EMA only for 1 week (control group). Baseline and post assessments will measure changes in self-efficacy, anxiety, stress, hopelessness, and other mental health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* being enrolled at a Swiss university
* aged between 18 and 29 years
* experiencing at least moderate stress (score of ≥13 on the Perceived Stress Scale
* owning a smartphone
* speaking fluent German

Exclusion Criteria:

-current psychiatric disorder
Congenital Heart Defects

Describe the relationship between maternal diabetes and congenital heart defects in infants born to diabetic mothers referred to NICU unit \& Outpatient clinics of Assiut University Childeren's hospital.We will compare between 2 groups. Cases will represent infants of diabetic mothers \& Conteols will represent infants of non-diabetic mothers.

Congenital heart disease is defined as a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance .The prevalence of CHD at birth has been relatively variable at 4.05 to 10.4 cases per 1000 live births in different surveys however,it is 5.0% in infants of diabetic mothers (IDMs).CHD is the most common congenital problem in children accounting for nearly 25% of all congenital malformations .CHDs are one of the significant causes of infant morbidity and mortality. Gestational diabetes mellitus (GDM) is the most common medical complication of pregnancy. It is associated with maternal and neonatal adverse outcomes. Maintaining adequate blood glucose levels in GDM reduces morbidity for both mother and baby. Pregnancy is associated with insulin resistance (IR) and hyperinsulinemia that may predispose some women to develop diabetes. Gestational diabetes has been defined as any degree of glucose intolerance with an onset, or first recognition during pregnancy. Diabetes during pregnancy could be a de novo that arises during pregnancy for the first time and could disappear or persist after delivery (gestational DM) or could start as pre-gestational, before the onset of pregnancy. The incidence of impaired glucose tolerance in pregnancy ranges between 3-10% and varies according to the average incidence of diabetes in the general Population. Specific CHDs that are more commonly seen in IDMs include ventricular septal defect (VSD), transposition of the great arteries (TGAs), and aortic stenosis (AS).Approximately one third of neonates with CHD require intervention in the first month of life . Clinical manifestation of CHD varies according to the type of lesion. Neonates with respiratory distress , cyanosis, feeding difficulties, and low cardiac output are common presentations of CHD . So diagnosis of CHD at the earliest possible time is very important as early referral and appropriate intervention in some of these cases are lifesaving.

Eligibility Criteria:
Inclusion Criteria:

The study will include infants of diabetic mothers and infants of non-diabetic mothers not previously screened for congenital heart defects.

Exclusion Criteria:

Other risk factors for congenital heart defects including congenital infections like TORCH infection, teratogenic drugs ( lithium or isotretinoin), , alcohol, or smoking.
Medical Weight Loss on Pelvic Floor Dysfunction

The goal of this observational study is to learn about the effect of medical weight loss on the symptom of pelvic floor dysfunction in obese and overweight women. The main question it aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions in obese or overweight women.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or higher
* BMI 24 kg/m2 or higher
* Willing to follow the weight loss plan set by the physician follow-up and complete this study

Exclusion Criteria:

* Urinary tract infection or gynecologic reproductive system infection in the past month
* Treatment history of pelvic floor disorders
* Pregnancy or delivery in the past half year
* Women with severe systemic disease
* No follow-up conditions
Persistent Pain and Its Impact on Quality of Life COVID-19 Patients That Required Critical Care

COVID-19 infection produces thousands of hospital admissions in a very short period of time, including critical care patients. It is expected that those who survive a severe spectrum of the disease, will present some degree of health decline in the medium and long term, becoming chronic patients.

Post-intensive care syndrome (PICS) was described by the Society of Critical Care Medicine (SCCM) as a new altered or worsening of physical, cognitive, or mental condition due to critical illness and persisting after hospitalization, including pain. Also, clinical features of infection include different types of pain, and if this pain persists, it can turn into a chronic condition. Chronic pain is a currently recognized disease, but under-treated in many cases, generating a significant deterioration in the quality of life of this patient. It is vitally important to generate early care circuits to detect and treat those expected complications, such as chronic pain in these patients. The objective of this study is to estimate the level of persistent pain and its impact on health-related quality of life after admission to an intensive care unit in patients who suffered this infection.

The presence of persistent pain and impaired quality of life in COVID19 patients who have required intensive care can affect up to a total of 50% of patients.

Main objective Estimate the level of persistent pain and health-related quality of life after admission one in intensive care unit in COVID-19 patients, a new disease that has been accompanied by great health, social and economic involvement from which we do not know the long-term consequences in this patient cohort.

Secondary goals

* Assessing patient's characteristics before ICU admissión; the prevalence of painkillers use, including opioids, history of previous pain, and comorbidities. Find relationships between these characteristics and the development of chronic pain.
* Determine if some ICU treatments and patient's characteristics may contribute to persistent pain in COVID-19 survivors ( number of prone therapies, thromboembolic complications, and medication for sedate used)
* Determine the quality of life using the SF-12 test.
* Determine pain characteristics using the ID-PAIN test.
* Determine the scale of anxiety and depression using the HADs test.

Eligibility Criteria:
Inclusion Criteria:

* Post ICU COVID 19 Survivor
* Adult 18 year or older, who gives its approval to participate

Exclusion Criteria:

* Refusal to participate
* Neurological or physical secuale, disabled to answer a questionnaire
A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold

This study will test 200 people to see if an experimental nasal spray has an effect on symptoms of the common cold if used when the symptoms start. At the first visit to the clinic, potential subjects will have tests to make sure they qualify to participate in the study.

If they qualify, they will have an equal chance of receiving the experimental nasal spray or a sham nasal spray (one that does not have the experimental formula). At the first visit, subjects will receive their assigned nasal spray and use it once at the clinic. They will also receive a booklet called a diary. Subjects will take the rest of their treatments for day 1 at home, and for the next six days, they will use the nasal spray four times per day and record their symptoms in the diary, as instructed. Then subjects will come back to the clinic for a final visit.

This is an investigation in healthy subjects with early signs of common cold. Subjects will be randomly assigned in a 1:1 ratio to receive either Polymeric Nasal Spray or a matching placebo nasal spray.

Subjects will be screened for eligibility and randomized to treatment at the Screening/ Randomization Visit (Day 1). Subjects will apply the first dose of the nasal spray at this visit under supervision. The other applications will take place at home on Day 1. On Days 2 through 7, subjects will use their assigned nasal spray as 2 sprays per nostril, 4 times per day.

One Follow up Visit will be conducted within 3 days of the last application of nasal spray.

Enrollment will continue until 200 subjects have completed the investigation (100 per treatment group). The subject and the investigative staff will be blinded to the assigned nasal spray.

Efficacy will be measured, and recorded in the subject's diary, and safety will be assessed by reported AEs and ADEs.

Eligibility Criteria:
Inclusion Criteria:

* Have early signs of a common cold: If female of child-bearing potential, have a negative pregnancy test at Screening.
* Have signed and dated the informed consent document, indicating that they have been informed of all pertinent aspects of the investigation
* Are willing and able to comply with scheduled visits, treatment plan, and other investigation procedures

Exclusion Criteria:

* Have had common cold or flu-like symptoms outside the protocol-specified parameters.
* Are current smokers as defined by the protocol.
* Have any medical history or condition or use any drug or device that (per protocol or in the opinion of the investigator) might compromise subject safety, participation in the trial, action of the investigational device, or results of the investigation..
* Are related to anyone involved with the conduct of the investigation.
Survey of Thai-Muslim Health Status

The purpose of this study was to determine the prevalence and risk factors of diabetes, hypertension, hyperlipidemia among Thai muslim population aged 35-75 years.

This was a cross-sectional study conducted in Bangkok and surrounding provinces. Approximately 1500 participants were enrolled. Study staff interviewed participants on basic demographic data, health status, physical activities, food frequency and 24-hour recall. Anthropometry (body weight, height, hip and waist circumference) and physical assessment (blood pressure)were measured. Ten milliliters of venous blood was drawn by venipuncture after a 12 h overnight fast for determination of fasting plasma glucose (FPG) and blood lipid concentrations (total cholesterol, triglyceride, and HDL-cholesterol). FPG was measured by the enzymatic colorimetric method with glucose oxidase.21 Total cholesterol was determined by the cholesterol oxidase method and serum triglycerides concentration was determined by standardized enzymatic procedures using glycerol phosphate oxidase assay.22, 23 HDL- cholesterol was measured by enzymatic assays.24 LDL cholesterol was calculated according to the method of Friedwald et al.25 All samples were analyzed when internal quality control met the acceptable criteria. Intra-and inter-assay CVs were 2.01% and 3.01% for FPG, 1.87% and 4.24% for total cholesterol, 0.93% and 11.6% for triacylglycerols, and 0.99% and 1.49% for HDL cholesterol, respectively.

Eligibility Criteria:
Inclusion Criteria:

* 35 y and older muslim
* free from severe communicable diseases and mental disorders

Exclusion Criteria:

* not able to complete the interviews or obtain blood samples for analysis
Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery

The goal of this clinical trial is to test virtual reality in adolescents undergoing minimally invasive repair of pectus excavatum surgery. The main questions it aims to answer are:

* Can virtual reality decrease anxiety in adolescents on the day of the surgery?
* Can virtual reality be used as a pain modulator in adolescents in postoperative care? Participants will be asked to wear a VR headset for a minimum of 1 hour before and after the surgery. Patients will be asked to fill out three anxiety tests: on admission, in the operating room and on the surgical ward on the day after surgery.

Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 14-18 years old
* reported chest deformity (pectus excavatum/ carinatum)
* patients undergoing MIRPE surgery in general anesthesia
* Hungarian fluency
* willing to comply with study procedures.

Exclusion Criteria:

* gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
* Head injury
* Head infection
* Altered mental status (independently from midazolam)
* Scabies or louse
* Dizziness or vertigo
* Blindness or severe vision loss
* Lack of parental/ guardian or patient consent
* Those, who has a head deformity, so VR headset does not fit well
Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* Deemed a surgical candidate for a bilateral nerve bundle preservation
* Potent
* Continent of urine
* Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
* Age \>18

Exclusion Criteria:

* Previous treatment of prostate cancer (radiation, hormones, etc.)
Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.

In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.


Eligibility Criteria:
Inclusion Criteria:

* children under 7 years old

Exclusion Criteria:

* Hyperbilirubinemia
* Skin disease at sensor attachment site
* Single ventricle physiology
One Week Assessment of The Phenacite Lens

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.

The study test lens was not the final optical design and the study results were not used for the design validation.

This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.

The study test lens was not the final optical design and the study results were not used for the design validation.

Eligibility Criteria:
Inclusion Criteria:

* A person is eligible for inclusion in the study if he/she:

  * Oculo-visual examination in the last two years
  * Between 18 and 35 years of age and has full legal capacity to volunteer
  * Has read and understood the informed consent letter
  * Is willing and able to follow instructions and maintain the appointment schedule
  * Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
  * Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.50D
  * Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \<-0.75
  * Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
  * Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

Exclusion Criteria:

* A person will be excluded from the study if he/she:

  * Has never worn contact lenses before.
  * Has any systemic disease affecting ocular health.
  * Is using any systemic or topical medications that will affect ocular health.
  * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  * Is aphakic.
  * Has undergone corneal refractive surgery.
  * Is participating in any other type of eye related clinical or research study.
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.

Current pulmonary imaging techniques are clinically regulated to machines that produce radiation. MR which does not produce radiation was not possible due to the low concentration of fluids in the open spaces of the lungs. With hyperpolarized noble gases we can now use the safe techniques of MR imaging to view the airways of the lungs, thus limiting human exposure to radiation. This technique has already been proven to be possible in human subjects but there is insufficient data show its efficacy in a clinical setting. This study is designed to image a variety of pulmonary disorders to better find possible clinical uses for hyperpolarized gas MRI.

Eligibility Criteria:
Inclusion Criteria:

* Are male or female and are 5 years or older
* Consent/assent from the patient
* Have been diagnosed with a pulmonary disease such as COPD, Asthma, or cystic fibrosis. OR Healthy Individuals.
* Must be able to hold their breath for up to 15 seconds

Exclusion Criteria:

* Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;
* Are undergoing the MR exam in an emergency situation
* Are pregnant or become pregnant at any point within the study time.
* People with psychiatric disorders will be excluded from the study.
* Are claustrophobic and can not tolerate the imaging.
* Uses supplemental oxygen
Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas

The pupose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery.
2. Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery.

Exclusion Criteria:

Patients with:

1. Metal in the body
2. ChildPugh ≥ 3
3. Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate
4. Poor cardiac or renal function with intolerant surgery or anesthesia.