cyrilzakka/clinical-trials huggingface dataset:
My Diabetes Care: A Scalability and Usability Study

The purpose of this study is to conduct a prospective, longitudinal study on the My Diabetes Care (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

Up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care (MDC). My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate and tailored diabetes selfcare information. Patients will be invited by mail to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete a baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to MDC for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Age 18-75 years old
* Currently taking at least one medication for diabetes
* Patient at a participating clinic within Vanderbilt Medical Center or Brigham and Women's Hospital
* Able to speak and read in English or Spanish
* Reliable access to a smartphone or tablet with internet access
* Active patient web portal account (for example, My Health at Vanderbilt or Patient Gateway)

Exclusion Criteria:

* Have a medical condition that affects your memory or ability to think
* Have severe difficulty seeing or hearing
* Have a medical condition that makes it hard for people to understand what you are saying
Pregnancy Rate After Unilateral Tubal Disconnection

Unilateral disconnection of one tube that had hydrosalpinx

In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx.

We either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed

Eligibility Criteria:
Inclusion Criteria:

* infertile women either primary or secondary Hydrosalpinx

Exclusion Criteria:

* other factors of infertility
Generic Database of Moderate Preterm Infants

This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in NICHD Neonatal Research Network (NRN) centers. The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

The Moderate Preterm Registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants.

The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:

* Demographics of mother and infant
* Mother's health (e.g., pregnancy history and complications)
* Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
* Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
* Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).

These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.

Informed Consent: As required by local IRBs.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 29-33 weeks
* Inborn infants and outborn infants admitted by 72 hours.

Exclusion Criteria:

* None
National Cancer Institute Food Study

Information about Americans food choices and opinions helps researchers and law makers to develop policies and programs to promote health. For this reason, it is important to be able to collect good quality information about how people think about food. This project will compare different ways of collecting information about food from adults.

Objectives:

-To compare different ways of collecting information about food choices and opinions from adults.

Eligibility:

* Individuals between the ages of 20 and 70, recruited from a database of volunteers who wish to participate in research studies.
* Volunteers must have high-speed Internet access.
* Individuals who have previously been involved in a research study will be excluded.

Design:

-Participants will come to a research study center for three consecutive meals (approximately 45 minutes per meal). On the following day, participants will return to the study center for an interview about their food choices and opinions (approximately 45 minutes).

Eligibility Criteria:
* Eligibility Criteria
* Individuals between the ages of 20 and 70, recruited from a database of volunteers who wish to participate in research studies.
* Volunteers must have high-speed Internet access.
* Individuals who have previously been involved in a research study will be excluded.
* Subjects will be accrued from a variety of racial and ethnic groups and of varying educational achievement, though these characteristics will not be used to assess eligibility.
* All subjects will provide informed consent.
Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis

Objective disease assessment in inflammatory bowel diseases at the time of treatment initiation and during follow-up has become gold standard. However, biomarkers, such as C-reactive protein and fecal calprotectin, fail to provide information on disease extent, location or complications. Repeated endoscopic assessments are performed to evaluate mucosal response to treatment, though associated costs, availability, invasiveness and patient preference are considerable limitations. Recently, intestinal ultrasound (IUS) has gained significant momentum as a non-invasive, easily accessible and low-cost alternative for objective assessment. Accordingly, the ECCO-ESGAR guideline recognizes IUS as a potential tool for the diagnosis and for the monitoring of IBD.

Our study aim is to evaluate the change in intestinal ultrasound parameters (as measured by B-mode and SWE at baseline and week 4) to predict endoscopic response and remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore and the UCEIS during treatment with filgotinib


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Endoscopic and/or histological confirmed diagnosis of UC
* UC disease extent proximal to the rectum (ie, left-sided colitis or pancolitis)
* Moderately to severely active UC, defined by an endoscopic Mayo score of ≥ 2
* Indication for receiving filgotinib treatment

Exclusion Criteria:

* Pregnancy
* Inability to give informed consent
* Proctitis only
* Ongoing gastroenteritis
* (Sub)total colectomy
* Obesity (BMI \>35 kg/m²)
Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children

This study is to determine if a novel bio-fermented Microbiotic Composite™ can improve the digestive health and subsequent growth and quality of life parameters in a selected group of children in a district in India.

The Probiotic Microbial Composite™ is a multifaceted technology that encompasses three key areas, namely, prebiotics, probiotics and post-biotics. The first component, prebiotics, involve non-digestible food ingredients, typically oligosaccharides which act by beneficially affecting the host by stimulating growth, activity, or in fact both of specific intestinal bacteria.

The probiotic component refers to the augmentation or addition of bacteria to enhance and support the various beneficial bacteria that are inherent to the gastrointestinal tract. The bio-fermented Microbiotic Composite™ is a consortium of bacteria which can play a significant physiological role as a probiotic. This theory, termed the microbial consortium theory suggests that rather than a cumulative effect by the bacteria, there is in fact combinatorial affect by the use of several species.

The final component post-biotics, in general, mimic the beneficial health promoting effects of probiotics whilst avoiding the risk of taking live micro-organisms within the gastrointestinal tract, especially in populations such as infants and the elderly in whom the intestinal barriers, as well as, innate immune defenses can be impaired. The term typically encompasses a vast plethora of byproducts, know as metabolites, produced and secreted by the bacteria in response to their environment.

Eligibility Criteria:
The Randomized Clinical Trial (RCT) will typically involve 250 subjects randomized into two arms based on age and sex.

Following a positive outcome in the RCT (following 6 months), we envisage converting the study to an observational based study (case-study) based on ethical principles where the placebo arm of the study would be administered the test product. Each subject will be assessed for a total of two years.

Inclusion criteria:

* Inpatient setting: Children with age of 3 years to 12 years with acute diarrhea
* Outpatient setting: healthy children aged 3 years to 12 years

Exclusion criteria:

* Subjects taking any kind of prescription medication.
* Subjects taking any dietary supplements (2-week washout is permitted).
* Subjects taking any antibiotics (must have discontinued antibiotic use 12-weeks prior to beginning study). An allowance will be made to existing subjects already taking part in the study. This confounder will however have to be noted by the primary investigators.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

  * Including subjects who are bed or wheelchair-bound
  * Including subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
Small Molecule LCDM and GV Oocyte

Immature eggs obtained during the oocyte retrieval cycle are discarded as medical waste because they cannot complete fertilization, but each egg is important for people with poor clinical outcome. In vitro maturation (IVM) technique allows immature GV and MI eggs to mature in vitro, offering hope for this population to increase the clinical pregnancy rate in a single oocyte retrieval cycle. However, the clinical effectiveness of IVM clinical application is still very low, especially the utilization rate of GV eggs is extremely low. The cocktail of small molecules includes four chemical components of LCDM, which are related to cell proliferation, in vitro maturation of eggs, and protection of cells from oxidative stress. Our preliminary experiments confirmed that the addition of a certain concentration of LCDM in the culture medium can significantly improve the in vitro maturation rate and embryo utilization rate of immature GV eggs. In this study, LCDM immature oocyte culture system was used to carry out in vitro maturation culture of GV oocytes, and combined with oocyte activation technology to verify the clinical safety of LCDM in vitro culture system by observing the in vitro maturation rate, fertilization rate and embryo development results of GV oocytes, so as to provide laboratory data for clinical application of GV oocytes in special patients.


Eligibility Criteria:
Inclusion Criteria:

* ICSI cycle with more than 2 GV oocytes

Exclusion Criteria:

* The etiological diagnosis is that the man has extremely severe oligoasthenospermia and primary azoospermia. These patients can lead to low fertilization rate due to sperm, so they are excluded from the group.
Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo

This study aims to evaluate some differences in the immune system between patients with vitiligo and patients without the disease.

These differences will be evaluated by the extraction of peripheral blood that will be analyzed before the treatment and after the treatment that, in the habitual way and at the discretion of the responsible dermatologist.

Patients agreeing to participate in the study will be subjected to extraction of two tubes (20 ml) of peripheral blood (baseline) and after 12 weeks (+/- 5 days) of treatment.

Therefore, neither treatment nor follow-up visits will be modified by participation, but will be the same whether or not participate in the study.

In the case of controls, two peripheral blood tubes (20ml) will be removed in a single participation.

Patients with vitiligo will also be asked to complete questionnaires to measure stress, depression and perception of disease (PSS-10, Skindex-29, HADS, Likert) before and after 12 weeks (+/- 5 days) of therapeutic intervention .

This study will include 20 patients with active non-segmental vitiligo and 10 controls without the disease. The duration of participation in this study will be 12 weeks (+/- 5 days) for patients with vitiligo and a single participation (extraction of 20 ml of peripheral venous blood) for the controls.


Eligibility Criteria:
Inclusion Criteria:

- Patient with vitiligo without treatment

Exclusion Criteria:

* Patient with inmunosupressive disease
* Patient receiving vitiligo treatment
A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty

The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation

Specific study objectives are to determine the effect of conscious sedation on:

(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications


Eligibility Criteria:
Inclusion Criteria:

* Reducible inguinal hernia

Exclusion Criteria:

* Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease
* Body mass index \< 18.5 kg/m2 or \> 30 kg/m2
* Recurrent inguinal hernias
* Bilateral inguinal hernias
* Large inguinoscrotal hernias
* Incarcerated hernia
* Allergies to local anaesthetic and sedative agents
* Pregnancy
* Lactation
* Chronic pain syndromes
* Anxiety disorders
* Marijuana use
* Long term use of opioid or sedative agents
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea

The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (post-menopausal and/or surgically sterile)
* Aged 18 to 70 years
* Diagnosed with type 2 diabetes mellitus of eight years or less in duration
* Being treated with OAD at stable maximum doses \[defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin\] for at least three months prior to screening
* Having fasting plasma glucose levels of 150-270 mg/dL and HbA1c levels of 7.5-11.0%

Exclusion Criteria:

* Greater than 3 severe hypoglycemic episodes within six months of screen
* Pregnant, breastfeeding, or intends to become pregnant
* Clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or ALT greater than the upper limit of normal
* Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test
* Patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin \> 200 mg/day
* History of insulin use within three months of screen
* History of diabetic ketoacidosis
* Treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
* History of lactic acidosis while on metformin therapy
* Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
* Clinically significant and currently active diseases
* Clinical significant abnormalities in medical history, physical examination, or laboratory examination
Longitudinal Performance of Epi proColon

This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.

Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests.

The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years.

Eligibility Criteria:
Inclusion Criteria:

* Average-risk subjects (no family history of colorectal cancer (CRC), no personal history of polyps or CRC).
* Subjects who have a history of non-compliance for CRC screening.
* After proper counseling by a health care provider, subjects who declined colonoscopy and FIT testing.
* Subjects who are 50 years of age or greater, but less than 75 years old.
* Subjects who are able to understand and sign written informed consent (IC).

Exclusion Criteria:

* Subjects defined as having elevated risk for developing CRC based on previous history of colorectal polyps, CRC or related cancers, inflammatory bowel disease (IBD).
* Subjects with a family history of CRC, particularly with two or more first degree relatives with CRC, or one or more first degree relative(s) less than 50 years of age with CRC.
* Subjects who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as familial adenomatous polyposis (FAP) or non-polyposis colorectal cancer (HNPCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's syndrome, Turcot's (or Crail's) syndrome, Cowden's syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis, or in patients with anorectal bleeding, hematochezia, or with known iron deficiency anemia.
* Subjects who are up to date for CRC screening (FOBT within preceding 12 months, flexible sigmoidoscopy or double contrast barium enema within 5 years, or colonoscopy within 10 years).
* Subjects with comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years).
* Subjects with chronic gastritis, or who have cancer other than colorectal, or pregnant women.
Promotion of Weight Management

The identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.

The research will examine the impact of intermittent fasting to promote long term body weight maintenance following successful weight loss in overweight and obese Veterans. This research is especially relevant to the majority of Veterans who struggle with obesity and maintaining weight loss. Obesity increases the risk for storing excess calories in ectopic depots, including skeletal muscle. Intramuscular fat is related to altered substrate utilization (metabolic inflexibility) and defects in insulin sensitivity, ultimately leading to type 2 diabetes mellitus and cardiovascular disease. The objective of this proposal is to test in a randomized clinical trial the effectiveness of an intensive weight management program with and without intermittent fasting (IF) to combat weight regain and the obesity crisis in our Veterans. Further, this application proposes to examine the role of several enzymes involved in skeletal muscle fatty acid oxidation as a mechanism for efficacious long term weight management.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* 50-75 years of age
* BMI: 25-40 kg/m2
* Postmenopausal status for women

Exclusion Criteria:

* Uncontrolled diabetes (HbA1c \>10% or the current use of insulin)
* Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
* Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease
* Weight change within the past month of \>5 kg
* Self-reported alcohol or drug abuse
* Anti-coagulant medication for muscle biopsies only Impaired renal function (creatinine \> 1.5 mg/dl) History or evidence of serious liver disease (LFTs \> 2.5 x WNL)