cyrilzakka/clinical-trials huggingface dataset:
Continuous Glucose Monitoring in the Intensive Care Unit

The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients.

The specific goals are 1) to work with intensive care unit (ICU) staff, in a respiratory ICU setting, to determine how best to place and maintain Dexcom G7 continuous glucose monitors (CGMs) on patients and how to place recording devices and chargers in that environment, 2) download CGM readings to the Dexcom Dashboard in an analyzable format, and 3) to compare simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. The primary analytical goal is the correlation of CGM glucose measurements with those obtained in the course of routine care. A secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation).

Study subjects will be patients admitted to the 6-ICU UMass Memorial Medical Center (UMMMC) University Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. All enrolled volunteers will have a Dexcom G7 CGM place on the skin according to manufacturer's specifications. The devices will remain in place for 10 days or until discharge from the ICU

Eligibility Criteria:
Inclusion Criteria:

Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized.

* Persons with either type 1 or type 2 diabetes.
* Persons of either sex.
* Persons of any age over 18.
* Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent.
* English or Spanish speaking adults.

Exclusion Criteria:

* Persons unable to provide informed consent.
* Cognitively impaired persons whose LAR declines to provide informed consent.
* Patients receiving hydroxyurea, which interferes with sensor function.
* Patients receiving high dose acetaminophen (\> 4 gm/day), which interferes with sensor function.
* Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy.
* Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy.
* Persons who are pregnant.
* Prisoners.
Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents

The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.

Oral contraceptive pills have traditionally been prescribed in a cyclical manner, where there are 21-24 days of active pills and 4-7 days of placebo pills or a pill-free interval, creating a 28-day cycle. It has now been proven that as long as a woman has both estrogen and progesterone, her uterine lining is protected and is thin. To that effect, a new OCP (Seasonale®, Barr Laboratories, Pomona, NY) has been packaged in the United States that combines 84 days of active pills with 7 days of placebo pills. This allows a withdrawal bleed every 3 months.

Like in adult women, OCPs are the most popular form of birth control and cycle control in adolescents. But, for a variety of reasons, adolescents tend to have poorer compliance when taking OCPs. Adult women tend to be noncompliant about 6% of the time, but, by the end of one year, adolescents have a non-compliance rate of 34-66%.

There have been few studies that even describe improved compliance and decreased ovarian follicular development in women who take OCPs continuously, which could be beneficial in decreasing the rate of adolescent pregnancy. The majority of the studies looking at continuous use of OCPs have been performed in adult women. At present, there has been only one article that has addressed the use of continuous OCPs in adolescents. Sucato and Gold discussed the indications of continuous use of OCPs, how to prescribe them, and what type of progestin to use; but they did not specifically examine compliance or the safety and efficacy of continuous OCPs in adolescents. We plan to evaluate these issues in our study.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 15 to 18
* Presenting to the Gynecology and Adolescent Medicine Clinic for contraception

Exclusion Criteria:

* Prior use of the study medication with no improvement in symptoms
* Any medical condition that indicates continuous OCPs (i.e. acute menorrhagia, dysmenorrhea that did not previously respond to cyclical OCP use)
* Personal history of or current thromboembolic disorder
* First-degree relative(s) with thromboembolic disorder
* Cerebrovascular disease
* Coronary artery disease
* Cardiac valvular disease
* Hypertension (systolic blood pressure \> 160 mmHg or diastolic \> 100 mmHG)
* Diabetes with retinopathy/neuromyopathy/nephropathy)
* Breast cancer
* Endometrial cancer
* Undiagnosed abnormal uterine bleeding
* Cholestatic jaundice of pregnancy
* Hepatic tumor
* Known or suspected pregnancy
* Less than 6 months postpartum if breastfeeding
* Classic migraine with aura or any other neurological signs
* Gallbladder disease
* Taking any medications known to affect the efficacy of OCPs (i.e. phenytoin, phenobarbital, primidone, carbamazepine, griseofulvin, rifampin)
Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses

The overall objective of this study is to compare the effect on simulated driving performance of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.

In this crossover study, subjects wore lotrafilcon B MV (AOAMV) and lotrafilcon B MF (AOAMF) soft contact lenses as randomized for 2 weeks each. Subjects were assessed using a standardised driving simulation for each of the two treatments. A fresh pair of lenses was dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD) and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional same-day assessment. Habitual correction was worn for an acclimatization drive in the driving simulator during Period 1.

Eligibility Criteria:
Inclusion Criteria:

* Current soft contact lens wearers (for 1 month or more) with distance spherical power requirements of +1.00 to + 4.00 diopters (D) or -1.00 to -10.00D, and who have never tried and then failed in monovision or AOAMF.
* Medium to high presbyopia, i.e. spectacle add requirement of +1.50D or more.
* Astigmatism, if present, ≤1.00D in both eyes.
* Distance visual acuity (VA) correctable to 20/30 (+0.2 logMAR) in both eyes.
* Within the normal ranges for binocular vision for distance (8Δ exophoria, ≤8Δ esophoria), vertical phoria = 1.5Δ hypo or hyper.
* Full United Kingdom driving license held for at least 3 years, with at least 2000 miles driven per year.
* Willing to wear study lenses at least 5 days per week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Existing AIR OPTIX® Multifocal CL user.
* Sphere requirement in the range +0.75 to -0.75D in both eyes.
* Previous refractive surgery.
* Ocular/systemic medical condition or medical treatment contra-indicating contact lens wear or driving simulation.
* Participation in a clinical study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.
Costimulatory Molecules as Biomarkers in Cystic Fibrosis

The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate

Exclusion Criteria:

* Presence of HIV
* Presence of Lymphoma/Leukemia
* Presence of Lung or other solid organ Transplant
* Pregnancy
Biomarkers and Preeclampsia Outcomes

Prospective, observational, monocentric, non-interventional study.

In practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs \& symptoms and standard biological tests are available for patient individualized care. Hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage.

REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.

Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed preeclampsia
* Singleton pregnancy
* Between 26 weeks of gestation and 37 weeks of gestation \& 6 days

Exclusion Criteria:

* Multiple pregnancies
The Clinical Acceptability of Unsedated Colonoscopy

The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.

Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.

Eligibility Criteria:
Inclusion Criteria:

* adult outpatients

Exclusion Criteria:

1. previous colorectal surgery
2. indication to a bi-directional endoscopy
3. indication to a partial examination
4. patients' refusal or inability to provide informed consent and
5. advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)
Exercise Training in Women With Cardiac Devices

Cardiac implantable electronic devices (CIED) are established treatments for a variety of cardiac arrhythmias. Women with CIED have lower fitness and lower quality of life compared to men with CIED. Moderate-intensity continuous training (MICT) is the most prescribed exercise for women. However, high-intensity interval training (HIIT) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over MICT in men with CIED. There is a need to quantitatively evaluate the feasibility and effects of a virtual HIIT vs. virtual MICT program on the physical, quality of life, and mental health of women with CIED. Furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. This mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual HIIT and MICT program in women with CIED.


Eligibility Criteria:
Inclusion Criteria:

1. Women (i.e., female sex assigned at birth) with CIED (≥6 months since implant)
2. Women with CIED in optimal medical therapy and functioning;
3. Patient is able to perform a symptom-limited CPET;
4. Patient is able to read and understand English or French.

Exclusion Criteria:

1. Patient is currently participating in routine exercise training (\>2x/week);
2. Patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
3. Patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment;
4. Patient does not have an internet connection or a device with a camera and speakers;
5. Patient with any device troubleshooting at resting or during exercise;
6. Patient is unable to provide written informed consent;
7. Patient is unwilling or unable to return for follow-up visits at week 12;
8. Patient is unwilling to be randomized to HIIT or MICT; or
9. Pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.


Eligibility Criteria:
Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions
Analysis of FAZ in Diabetic Retinopathy Using OCT Angiography

Study and assessment of characteristic changes in foveal avascular zone during different stages of diabetic retinopathy using OCTA.

OCTA is superior to other retinal imaging techniques like fluorescein angiography(FA) as it does not require dye injection, Intravenous dye injection is time consuming and can have adverse side effects. Furthermore, the edges of the capillaries can become blurred due to dye leakage and imaging of the retina can only be 2D when using FA.

OCTA provides both structural and functional (i.e. blood flow) information in tandem. The "corresponding" OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology.

In diabetic retinopathy OCTA can show choriocapillaris abnormalities and/or retinal microvascular abnormalities such as microaneurysms, vascular remodeling adjacent to the foveal avascular zone (FAZ), enlarged FAZ, and capillary tortuosity and dilation through different stages. OCTA can show smaller vascular changes not detectable by FA.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients suffering from different stages of diabetic retinopathy.

Exclusion Criteria:

* Other ocular problems affecting vision including glaucoma, cataract, amblyopia, hypertensive retinopathy, vein occlusion and uveitis.
Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer

RATIONALE: Hypnosis may be effective in reducing pain and other side effects in women undergoing surgery for breast cancer.

PURPOSE: This clinical trial is studying how well hypnosis works in reducing pain and other side effects in women undergoing surgery for breast cancer.

OBJECTIVES:

* To test the feasibility of hypnosis as a pre-operative intervention for the reduction of surgical- and anesthesia-related symptoms in women undergoing lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection for locally recurrent breast cancer.
* To identify the physical symptoms (i.e., pain, nausea, and vomiting) and psychological symptoms (i.e., anxiety and distress) of patients undergoing hypnosis.
* To determine the length of stay in the Post Anesthesia Care Unit of patients undergoing adjunct hypnosis.
* To describe patient satisfaction with the hypnosis experience.
* To determine the effect size and calculate the sample needed for a randomized clinical trial using the results of this study.

OUTLINE: Patients undergo a scripted hypnotic intervention over 15 minutes within 1 hour prior to their planned surgical procedure. Upon completion of the intervention, patients proceed to the Preoperative Holding Area of the Surgery and Post Anesthesia Care Unit where they receive the standard of care for lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection.

Patients undergo collection of demographic information (i.e., age; gender; ethnicity; marital/partnered status; spiritual practice; family members in the home; stress management history; experience with the continuum of imagery/hypnosis practices; perceptions of concentration abilities; and favorite aromas, colors, and scenes from nature) at the time of consent using the Demographic Survey Questionnaire. They also undergo assessment of physical and psychological symptoms (i.e., pain, nausea, vomiting, anxiety, and generalized distress) at baseline (immediately prior to hypnotic induction) and after the intervention (prior to discharge from the Post Anesthesia Care Unit).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Scheduled for breast surgery (i.e., lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection) with Dr. Garbaroglio
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Able to speak and read English
* Able to follow instruction
* No uncontrolled major comorbid mental conditions (i.e., thought disorders)
* No uncontrolled major physical conditions (i.e., untreated congestive heart failure)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent reconstruction surgery
Defining the Clinical Potential of Mass Response As a Biomarker for Patient Tumor Sensitivity to Drugs

The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.


Eligibility Criteria:
Inclusion Criteria:

* Sample collection or biopsy of tumor is clinically indicated as part of SOC
* Prior to preceding onto therapy for treatment

Exclusion Criteria:

* Unable to obtain sufficient sample
Understanding Daily Changes in BDD Risk Using Smartphones

Body dysmorphic disorder (BDD) is associated with high risk for suicide attempts (22-28%) and substance use disorders (49%), underscoring the importance of accurate, real-time risk detection in BDD. This study aims to use smartphone-based digital phenotyping to develop and validate unobtrusive, time-sensitive, and ecologically valid measures of key risk factors for suicide and substance misuse in BDD: negative affect states. As next steps, this research can be extended to detect risk transdiagnostically, with the goal of enabling just-in-time interventions to target suicide and substance misuse across psychiatric illnesses.


Eligibility Criteria:
Inclusion Criteria:

* Adults age \>=18
* Current primary diagnosis of BDD
* BDD severity \>= moderate
* Living in US
* English proficiency
* Owns an Android or iOS (Apple) smartphone
* Has regular Wifi-enabled internet access for data downloads
Role of Exenatide in NASH-a Pilot Study

We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.

Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD Activity Score (NAS) prior to therapy and after 28 weeks of therapy. We used the following criteria to define our primary outcome: (i) no worsening of fibrosis score, (ii) improved score by at least one point in hepatocyte ballooning, (iii) either (a) improvement in NAS by 2 or more points spread across at least two of the three NAS components, or (b) post-treatment NAS equal or greater than 3.

Eligibility Criteria:
Inclusion Criteria:

* Well documented NASH based on clinical and histological criteria. Liver biopsy must have been obtained within 12-months prior to initiation of the study.
* Subjects must have known diabetes (either diet controlled or only on Metformin or sulfonylureas such as glyburide or glipizide).
* Subjects must be 18 year or older.

Exclusion Criteria:

* Co-existing etiologies for chronic liver disease (hepatitis B or C, autoimmune or hemochromatosis, etc.).
* Clinical or histological evidence of cirrhosis.
* Alanine aminotransferase or aspartate aminotransferase \> 300 IU/L.
* Uncontrolled diabetes (hemoglobin A1C greater than or equal to 9%).
* Insulin or TZD dependant DM.
* Known human immunodeficiency virus infection.
* Current or history of significant alcohol consumption within past 5 years. Significant alcohol consumption is defined as \>20 grm/day in females and \>30 grms/day in males or if alcohol consumption cannot satisfactorily be quantified.
* Serum creatinine of greater than or equal to 2 mg/dl.
* Active, serious medical disease (cardiac, renal, pulmonary, dermatologic, psychiatric illness) with likely life expectancy less 5 years.
* Current or previous malignancy with expected life expectancy less than 5-years (other than basal cell cancer of the skin).
* Use of drugs historically associated with NASH.
* Histological evidence of malignancy, 4+ iron deposition, or any other type of liver disease.
* Active substance abuse, such as alcohol,inhaled or injection drugs with the previous one year.
* Known intolerance or allergy to exenatide (Byetta).
* History of neuroglycopenia.
* Women of childbearing potential must have had a negative pregnancy test prior to starting the study and should be willing to avoid pregnancy during the study period.
* Women must not be nursing.