cyrilzakka/clinical-trials huggingface dataset:
Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)

Roux-en-Y gastric bypass (RYGB) is the most common surgical procedure for morbid obesity. However, it can present serious late complications, like postprandial hyperinsulinemic hypoglycemia (PHH). Recent data suggested an increase in intestinal SGLT1 after RYGB. However, there are no data on the inhibition of SLGT1 to prevent PHH in patients with prior RYBG.

Objectives: To evaluate in patients that present PHH after RYGB: a) the effect of canagliflozin 300mg on the response to 100g glucose overload (OGTT); b) the pancreatic response after intra-arterial calcium stimulation.

Material and methods: Prospective pilot study, including patients with PHH after RYGB, matched by age and gender with healthy controls. Basal OGTT and after 2-weeks of daily 300mg of canagliflozin will be performed. In addition, venous sampling after intra-arterial calcium stimulation of the pancreas will be performed.

A prospective opened, placebo uncontrolled, pilot interventional study is performed at the Morbid Obesity Unit of the Vall Hebron University Hospital, including patients that have previously undergone RYGB at our site and were diagnosed with PHH. The control group comprises of healthy normoweight persons matched by age, most of them family members of patients included in the study. The OGTT is performed as follows: a solution of 100g glucose was administered at 8am after 10 hours of fasting. Plasma glucose and serum insulin are measured at minute -5, +30, +60, +120, +180 after the ingestion of the glucose solution. A first OGTT is performed in basal conditions. The control group only will perform the basal OGTT. A value of plasma glucose below 50mg/dl at 60-180 minutes after the administration of the glucose solution is considered positive for PHH. The patients that additionally present a value of plasma glucose\>200mg/dl during the OGTT will be selected for continuing in the study and will be prescribed canagliflozin 300mg orally daily, during 2 weeks. After 2 weeks of canagliflozin treatment, a new OGTT will be performed and, in the patients that sign the additional inform consent, the pancreatic catheterism will be realized.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PHH following Roux-en-Y-gastric by-pass, by means of 100g Glucose OGTT. Plasma glucose \<50mg/dl.
* Patients that during any time of the OGTT present at least one value of plasma glucose \>200mg/dl, besides hypoglycemia

Exclusion Criteria:

* Patients unwilling to take canagliflozin 300mg
* Patients that present with PHH following other bariatric surgery techniques
Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.

To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.

Specific aims:

1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .
2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-80)
* who are admitted to the ICU for hematemesis, or coffee ground emesis

Exclusion Criteria:

1. Patients younger than 18 yrs old or older than 80 yrs
2. Patients who refuse to consent to be in our study
3. Pregnant patients
4. Prior use of prokinetics in the last 48 hours
5. History of cardiac arrhythmia
6. Allergy to erythromycin or metoclopromide
7. Patients with QT prolongation (query 7)

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Effect of Different Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD

There is a rise in the prevalence of end-stage liver disease during the last decade. End-stage liver disease has become one of the leading causes of death in Western countries. Liver transplantation is the only curative treatment for patients with end-stage liver disease. However, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. At present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. Stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.

Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year. The participants will be randomly divided into a low-dose stem cell group (1×10\^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10\^6cells/kg per infusion), which are infused by peripheral vein. The investigators will observe ALT, AST, ALP, TBIL, ALB, PT, INR, MELD score, and Child-Pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old
2. End-stage liver disease
3. Sign informed consent

Exclusion Criteria:

1. Tumours of the liver or other organs
2. Liver transplantation recipients
3. Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
4. Other diseases that may seriously affect the survival
5. Human immunodeficiency syndrome
6. Interferon or glucocorticoid therapy within 1 year
7. Treated for mental illness
8. Participation in other clinical trials within 30 days
9. Pregnant or breastfeeding subjects
10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
11. Other circumstances that are unsuitable for participation in this study
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison

The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age
* Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
* Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.

Exclusion Criteria:

* Subjects who can not safely discontinue current prescription medications.
* Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
* Subjects with an unstable medical problem.
* Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
* Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
* Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.


Eligibility Criteria:
Inclusion Criteria:

1. adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
2. 12 years of age and older weighing at least 40 kg
3. are at ":high risk" for progressing to severe COVID-19 and/or hospitalization

High risk is defined as patients who meet at least one of the following criteria:

1. Have a body mass index (BMI) \>35
2. Have chronic kidney disease
3. Have diabetes
4. Have immunosuppressive disease
5. Are currently receiving immunosuppressive treatment
6. Are over 65 years of age
7. Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease
8. Are 12 - 17 years of age AND have
9. BMI \>85th percentile for their age and gender based on CDC o growth charts, ii. sickle cell disease OR iii. congenital or acquired heart disease OR iv. neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR

v. asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control.

Exclusion Criteria

1. Younger than 12 years of age
2. Do not meet criteria to be classified as "high risk'
The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis

The investigators intend to recruit 50 patients into an intradialytic exercise study that will measure the impact of resistance bands exercises under the guidance of an exercise physiologist on the physical function of hemodialysis patients.

The primary objective of this study will be to test the feasibility and efficacy of a 3 month exercise physiologist consultation program. Specifically, the investigator's aims will be to:

1. Test the feasibility of a 3-month exercise physiologist led program
2. Measure the effect of an exercise physiologist collaboration and intradialytic exercise on the physical function of HD patients using the 30 second STS test, handgrip strength test \[required for frailty scale\], 8-foot TUG test and patient physical activity based off of the Low Physical Activity Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Ability to understand and communicate English
* Diagnosis of ESRD and currently undergoing in-center hemodialysis
* On HD for longer than 6 weeks
* Approved by the Satellite Milpitas Medical Director and/or referring physician

Exclusion Criteria:

* Previous major amputations
* Inability to independently ambulate
* Known to be pregnant
Smoking Onset in a Biethnic Population

To conduct a prospective study of the determinants of smoking onset in adolescents attending Memphis City Schools and to determine the unique predictors of smoking onset in Black versus white adolescent females.

BACKGROUND:

Although many smoking prevention programs have been implemented on a large-scale basis, the effectiveness of these programs varies greatly. While these programs have undoubtedly prevented many young adults from starting to smoke, recent smoking initiation rates among females have consistently exceeded the rates of males and smoking initiation rates among Afro-Americans remain at high levels. More information is needed on the reasons for smoking initiation among adolescents, particularly females. Despite considerable interest in this area, virtually nothing is known regarding the reasons for adoption of smoking in Black or white females. Not a single prospective study has evaluated race-and gender-specific models for the prediction of smoking onset. For example, while it is commonly assumed that the weight-reducing qualities of smoking are associated with smoking onset among female adolescents, not a single prospective study has been conducted that documents that weight-related concerns at one age predict smoking onset at a later age.

The study was part of the Collaborative Projects on Women's Health initiative which was proposed by the NHLBI staff, given concept clearance at the February 1992 National Heart, Lung, and Blood Advisory Council, and released as a Request for Applications in April 1992.

DESIGN NARRATIVE:

The study was part of a two grant project on the Collaborative Projects on Women's Health. Dr. Robert Klesges conducted a longitudinal study to assess whether weight concerns of adolescent girls predict smoking onset at a later age. His collaborator, Dr, Linda Eck (R01HL50946), evaluated the role of smoking in dietary intake, physical activity, and metabolic rate and determined the differential effects of smoking and race on the energy balance of African American and white women.

Dr. Klesges' study was renewed in FY 1998 to continue longitudinal observation of factors relating to the onset of smoking in a biracial population of 6,967 boy and girl students first surveyed as seventh graders in 1993-94. The cohort was tracked through the end of high school and two years after high school in order to investigate the determinants of smoking onset both in high school and into the young adult years.

The study was renewed in February 2001 through January 2005 to follow-up participants for four years post-high school to assess the extent of young adult smoking onset and cessation, to determine predictors of smoking onset, and identify predictors of cessation for both early onset and late onset smokers.

Eligibility Criteria:
No eligibility criteria
Integrative Self-care Approaches for HCP Wellbeing

The purpose of this pilot study is to assess the impact of a hospital-based integrative self-care program (e.g., a. Reiki and b. Caring Science and Mindful Practice \[CSMP\] course) for interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers on their wellbeing.

The primary research procedures are:

* Participants will complete an online pre-training survey via REDCap, including a demographic questionnaire, and questions related to Physical Function, Depression, Anxiety, Fatigue, Sleep Disturbance, Social Roles/Activities, Resilience, Burnout, COVID-19 Experience, Caring Science, and Reiki Knowledge and Application.
* Participants will participate in the 4-week (virtual) CSMP and (in-person) Reiki Training course.
* Participants will complete the online post-training survey with the same questions included in the pre-training survey.
* Data analysis will be conducted by the research team using descriptive statistics, bivariate analysis, and multivariate linear/logistic regression analysis to assess for relationships between the Reiki and CSMP training and HCP wellbeing.

The research team will enroll up to 20 participants comprising of interprofessional staff including nurses, physicians and/or medical residents, physical therapists, as well as other healthcare providers.

All parts of the protocol will be conducted at CSMC.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare provider must:

  * Be 18 years or older
  * Be full-time employee of a CSMC hospital/clinic
  * MDs/DOs must have admitting privileges to a hospital and/or have private practice/ or be a current medical resident enrolled in a Cedars Sinai Medical Residency Program
  * Provide direct patient care in hospital and/or clinic
  * Consent to participating in the study

Exclusion Criteria:

* Healthcare provider who do not meet all the inclusion criteria and/or reports:

  * They do not provide direct patient care
  * Do not consent to participating in the study
Patients Treated for Wiskott-Aldrich Syndrome (WAS) Since 1990

Wiskott - Aldrich syndrome (WAS) is a rare serious medical condition that causes problems both with the immune system and with easy bruising and bleeding. The immune abnormalities cause patients with WAS to be very susceptible to infections. Depending on the specific type of primary immune deficiency diseases, there are effective treatments, including antibiotics, cellular therapy and gene therapy, but studies of large numbers of patients are needed to determine the full range of causes, natural history, or the best methods of treatment for long term success.

This multicenter study combines retrospective, prospective and cross-sectional analyses of the transplant experiences for patients with WAS who have already received HCT since 1990, or who will undergo Hematopoietic cell transplant (HCT) during the study period. The retrospective and prospective portions of the study will address the impact of a number of pre and post-transplant factors on post-transplant disease correction and ultimate benefit from HCT and the cross-sectional portion of the study will assess the benefit of HCT 2 years post-HCT in consenting surviving patients.


Eligibility Criteria:
Inclusion Criteria:

* WAS participants will be defined as males who have:

  1. thrombocytopenia (\< 100K) AND EITHER molecular diagnosis of WAS OR reduced WASP expression; OR
  2. thrombocytopenia (\< 100K) AND positive family history consistent with WAS diagnosis; OR
  3. chronic thrombocytopenia (\< 100K for minimum of 3 months) AND low mean platelet volume (MPV below normal range for age) AND EITHER recurrent and/or severe infections requiring treatment and/or eczema OR lack of antibody response to polysaccharide antigens or low IgM.
* Longitudinal Analysis (Retrospective and Prospective)

  1. Stratum A. Participants with WAS who have or will Receive HCT

     * Participants with WAS who have received an HCT since January 1, 1990
  2. Stratum B. Participants with WAS who have or will Receive Gene Transfer

     * Participants in which the intention is to treat with gene transfer with autologous modified cells
* Cross-Sectional Analysis (Strata A and B) 1. Participants with WAS who are surviving and at least 2 years after the most recent HCT or gene therapy.

Exclusion Criteria:

* As this is a natural history study, for both the Longitudinal Analysis and the Cross-Sectional Analysis we will not exclude any patients due to race or age who fit the inclusion criteria.
Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.

Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.

The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.

Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.


Eligibility Criteria:
Inclusion Criteria:

- infant \<24 months with cystic fibrosis

Exclusion Criteria:

- patient \>24 months
A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital.

Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

Eligibility Criteria:
Inclusion Criteria:

* age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography

Exclusion Criteria:

* pregnancy
* reception of reperfusion treatment before admission
* missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.
EMPOWER Rural Extension Weight Management Pilot Study

This research is to expand a virtual weight loss and weight maintenance program to rural counties of Illinois. The program uses dietary and lifestyle modifications for adults with obesity. The EMPOWER weight loss program has proven to be effective in 3 previous trials. In this research, we target a rural participant population. Individuals in rural locations are more likely to be affected by obesity and have unique barriers to weight loss related to geographic isolation including access to health care, preventative care, grocery stores, social networks, internet, and cell service.

EMPOWER is a remote weight management program that uses an online textbook platform, E-Text, and mobile web application, MealPlot. This pilot study will test for feasibility of the EMPOWER program in a rural population prior to launching a full-scale study. Acceptability measurements will be collected at 3 months to evaluate for needed changes; Participants of the pilot study will be permitted to continue on with the full program.

EMPOWER is a 1-year intervention. Data is collected via 24-hour record and daily weighing using a Wi-Fi-enabled scale. 24-hour records and daily weights are collected within the program's proprietary MealPlot website. EMPOWER consists of 17 online sessions (45 minutes/each) and 12 individual advising sessions with a nutrition coach.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years;
* BMI in overweight to above range;
* not currently pregnant or lactating;
* willing to access Wi-Fi via home or free public Wi-Fi location at least once a week for 45 minutes
* access to a working email
* willing to weigh daily and provide data either via Bluetooth, Wi-Fi, or manual input
* willing to lose 20 lb. or more and maintain a healthy weight for one year thereafter;
* Continue daily-weighing for 12-months after the year-long intervention (Daily weigh for a total of 2 years);
* fluent in reading and writing English.
* live within one of the counties of the covered Extension Education offices: Eastern (Clark, Crawford, Edgar), Northern (Jo Daviess, Stephenson, Winnebago), Western (Macoupin, Christian, Jersey, Montgomery)

Exclusion Criteria:

* age \<18 or \>75 years;
* severe chronic diseases;
* underweight to normal BMI;
* currently pregnant;
* currently lactating;
* failed to commit to daily weighing;
* failed to submit 3, 24 hour records;
* underwent bariatric surgery or planning on having bariatric surgery within the next year including: Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Duodenal Jejunal Bypass with Sleeve Gastrectomy, Duodenal Switch, Laparoscopic Adjustable Gastric Banding.