cyrilzakka/clinical-trials huggingface dataset:
Peer Support in Diabetes Management - Insulin Peer Support

This project will develop a combined model of the Shanghai Integration Model and peer support for diabetes self-management with a special focus on appropriate insulin use.

The development of contemporary diabetes care offers new hope for long and satisfying lives of those with the disease, but also provides increased challenges for integration across the many dimensions of care (varied medications in addition to insulin, specialty services, diet, physical activity, stress management, etc.) and across the many who contribute to care (specialists, primary care providers, nurses, dietitians and patient educators, family members, friends, worksites). The Shanghai Integration Model (SIM) has made great strides to integrating specialty/hospital care with primary/community care. The addition of peer support can enhance patient engagement within that integrated care. Peer support can also integrate care with the daily behaviors and patterns that optimal diabetes management requires and with the family members and others in individuals' daily lives who can support diabetes management.

The "Insulin Peer Support" project is a sub-project of "Peer Support in Diabetes Care", with special focus on appropriate insulin use in the community, to help overcome barriers in insulin treatment and improve treatment compliance. This project will develop a peer support model for diabetes management in Chinese patients undergoing insulin treatment and evaluate its effectiveness in a randomized controlled trial of 10 CHCs in Shanghai.

The project is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute,the Shanghai Municipal Commission of Health and Family Planning, the Shanghai Centers for Disease Control, and, at the University of North Carolina-Chapel Hill, Peers for Progress, widely recognized for its leadership in promoting peer support in health care and prevention.

Eligibility Criteria:
Inclusion Criteria:

* Chinese
* Has type 2 diabetes
* Receiving treatment at participating community health center
* Currently using insulin or prescribed insulin but not currently using insulin

Exclusion Criteria:

* Severe mental illness (severe depression, schizophrenia, bipolar disorder, obsessive compulsive disorder, panic disorder, PTSD, borderline personality disorder, etc.)
A Study of AL2846 on Tolerance and Pharmacokinetics

A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer.

To study the pharmacokinetic characteristics of AL2846 in the human body; To recommend a reasonable dose and indication for subsequent research.

Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors（especially Hepatocellular Carcinoma and Lung Cancer ）,at least one measurable lesion (by RECIST1.1)
* Lack of the standard treatment or treatment failure
* 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
* 30 Days or more from the last cytotoxic therapy
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients suffering from other malignancies currently or ever, except for cured cervical carcinoma in situ, non-melanoma skin cancers
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
* Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms,female QTc≥470ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification)
* Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed
* Patients with non-healing wounds or fractures
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

To study the effects of ethanol clamped at BAC 0.04% and THC (1.05 mg in a 70 kg individual) on driving.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Exposed to cannabis at least once.
* Exposed to alcohol at least once.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naive.
* Alcohol naive.
* Positive pregnancy screen
* Hearing deficits.
Supportive Expressive Therapy for Depressed and Anxious Adolescents

The purpose of the study is to investigate the effectiveness of providing Supportive Expressive Therapy to adolescents who are depressed and/or anxious.

Supportive Expressive Therapy (SET; a 16 session manualized form of psychodynamic therapy) has been well utilized with adult clients. To date, there is no known systematic study into the benefit of this method of therapy with adolescents who are depressed and/or anxious. It is thought that SET would be useful for this population as it is similar in principle to Interpersonal Relationship Therapy (IPT), which has been shown to be effective for use with depressed adults and youth. Both IPT and SET help clients explore the role they play within challenging relationships in their lives. SET, however, allows for the exploration of more relationships within the adolescents' circle. Moreover, SET explores the adolescents' perceptions of themselves, others, and their wish in relationships. Further, the SET method is more easily individualized in that it affords greater flexibility in design and possibility for change over time. Accordingly, the purpose of this study is to explore the feasibility of utilizing this method of therapy with adolescents who are depressed and anxious. We will be exploring the effectiveness of SET through the resolution of depressed and/or anxious adolescents' conflictual relationships thereby reducing their symptomatology.

Eligibility Criteria:
Inclusion Criteria:

* 15-24 year old, male \& female adolescents, primary diagnosis of depression or anxiety disorder.
* Clients with co-morbid diagnoses, suicidal ideation or taking medication would not necessarily be excluded if deemed able to partake in the proposed therapy.
* Medication dose needs to be stable for 4-6 weeks prior to starting therapy.

Exclusion Criteria:

* Clients who are actively psychotic, developmentally delayed, or have a diagnosis of bipolar disorder.
* Clients who are not fluent in English.
Real World Study of COVID-19 in a Flyover Region

Real world data are needed on remdesivir (RDV) efficacy in COVID-19, especially in the underserved populations of the United States (U.S.) Gulf Coast as initial clinical trials may not be representative of this population. Specifically, regions such as New Orleans are 60% African American, a much greater proportion of African Americans than initial RDV studies. The main hypothesis is that a real world data based study will provide specific information related to RDV efficacy in COVID-19 patients from underserved / underrepresented populations of the U.S. Gulf Coast. The main goal of this study is to provide population-centered information related on RDV related to indication (stage of disease), dosing, monitoring, efficacy and contraindications for future COVID-19 patients in this underserved region.

This study involves extracting data from 10,000 patients with Polymerase Chain Reaction (qPCR) confirmed COVID-19 infection through electronic-charts of Tulane Medical Center and University Medical Center (New Orleans, Louisiana) and Doctors Hospital at Renaissance (DHR) system (Texas). According to the inclusion criteria below and spanning from September 2019 - December 2021 we predict to include 1500 RDV treated patients and 8500 non-treated comparators, all with COVID-19, through the Research Action for Health Network (REACHnet) (link: https://eco.reachnet.org) in partnership with the Louisiana Public Health Institute (LPHI).

Statistical plan:

Following anonymized data extraction, propensity score will be used to compare primary and secondary endpoints between matched COVID-19 infected patients who received RDV to those who did not receive RDV. Patients of both cohorts will be stratified by severity. Moderate and severe respiratory distress associated with COVID-19 are defined as per US-GS-540-5773 and US-GS-540-5774 clinical trials. Through the investigator's extensive Electronic Medical Record (EMR) data collection network including diverse underserved populations of the U.S. Gulf South, they will evaluate real world outcomes of RDV treatment for COVID-19. The 2 cohorts will be compared with focus upon respiratory distress evolution, co-morbidities and other illness associated/relevant to COVID-19 course during admission, post-discharge during convalescent period of up to 6 months, and documentation of pre-admission comorbidities in the 6 months pre-admit.

Eligibility Criteria:
Inclusion Criteria:

* Positive qRT PCR for COVID-19 from a nasopharyngeal, nasal, or oropharyngeal swab or from bronchoalveolar lavage.
* Received RDV (cases) or did not receive RDV (controls).
* Age ≥ 18 years

Exclusion Criteria:

- None.
Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.

This Randomized Clinical Trial will be conducted to compare the efficacy of ethanolic extract of Aloe vera versus chlorhexidine cavity disinfectant in reducing total bacterial count of Streptococcus mutans (SM) and Lactobacilli (LB).

Dental caries remains to be a major oral health problem afflicting people, young and old, especially in developing and underdeveloped countries. Though dentistry has magically developed with newer materials and newer techniques, dental caries remains a disease of great prevalence.

The prevention and control of caries necessitates the elimination of cariogenic bacteria that produce acids responsible for the decrease of pH and starting the process of demineralization.

While the goal of restorative treatments for dental caries is to remove the infected dentin and fill the area with a suitable restorative material, failure to remove the infected teeth surface totally and achieve complete sterilization of the cavity can lead to microleakage, increased pulp sensitivity, pulpal infection and secondary caries that necessitate replacement of restoration.

Therefore, after removal of the carious dentin it is important to eliminate any remaining bacteria that may be present on the cavity walls, in the smear layer, at the enamel-dentin junction, or in the dentinal tubules. But unfortunately, no definitive and reliable criteria are available to ensure the complete removal of carious tooth structure. Many investigations have shown the presence of bacteria in the dentin even after removal of dye-stainable dentin.

Due to indiscriminate use of antimicrobials more and more pathogens are becoming resistant and posing a serious threat in rendering successful treatment of the diseases. With the rise in bacterial resistance to various synthetic antimicrobial agents, there is a considerable interest and a growing trend in the field.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with at least two occlusal deep carious lesions, one on each side, preferred from the same arch.

  * Age range 20-50 years.
  * Systematically health.
  * Adults who were able to give informed consent.
  * Teeth with radiographic evidence of carious lesion that penetrated at least the inner one half of the dentin thickness.

Exclusion Criteria:

* • Patients with clinical and radiographic signs of pulpal involvement.

  * Patients unable to return for recall appointments.
  * Inability of a patient to give informed consent.
  * Teeth with clinical and radiographic sign of pulpal involvement.
  * Teeth where isolation with a rubber dam was not possible
Feasibility of Using NeuraSignal Transcranial Doppler Robot

The purpose of this study is to determine the feasibility of using the NeuraSignal transcranial doppler robot in a neuro ICU setting to measure cerebral blood flow correlated with arterial blood pressure to generate individualized cerebral autoregulatory curves

This study aims to explore the feasibility of using the NeuraSignal transcranial doppler robot to generate cerebral autoregulation curves in adult patients admitted to the neuro ICU with a newly diagnosed brain mass. Cerebral blood flow measurements as calculated by a transcranial doppler robot will be time-correlated with arterial blood pressure measurements to generate personalized cerebral autoregulation curves. The study will be conducted prospectively and observationally on 20 patients as a pilot study for feasibility management.

Cerebral autoregulation has historically been difficult to quantify, in part due to the difficulty in measuring cerebral blood flow directly. Transcranial doppler (TCD) is a well-established method of calculating cerebral blood flow based on velocity through the middle cerebral arteries, however traditional methods of performing TCD are time consuming and require technical and procedural training. It also carries the established risk of miscalculation with variation in intra-operator technique differences and miscalculations due to inappropriate angle of the probe. The NeuraSignal transcranial doppler robot offers a potential tool to make obtaining cerebral blood flow calculations easier and, with the use of AI to determine optimal windows, significantly decreases intra-operator differences and errors associated with inappropriate probe angle. Cerebral blood flow calculated in this way can then be correlated with arterial blood pressure and used to build cerebral autoregulatory curves in near real time. This study aims to build on previous studies deriving and using personalized cerebral autoregulatory curves and determine the feasibility of using the TCD robot in this way to make individualized cerebral autoregulatory curves more accessible as a tool for personalized blood pressure management.

Eligibility Criteria:
Inclusion Criteria:

* 18-89
* Patients admitted to the Neuro ICU for blood pressure management (MAP management) after spinal surgery

Exclusion Criteria:

* Patients under 18 years (or bodyweight \<50kg if age unknown),
* prisoners
* pregnant women,
* non-English speaking,
* patients enrolled in concurrent
* ongoing interventional trial
* students of UAB
* employees of UAB
* targeting specific populations
* patients with previously diagnosed brain pathology
* patients with open wounds over temporal bones precluding transcranial doppler
Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics

To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.

In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the three modalities for at least six months were included in the analysis. Inclusion required all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only insulin treatment differentiated the three groups. Comparisons were conducted regarding Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1 month before the study started until 18 months. Sleep quality and quantity were assessed using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct costs in all healthcare systems and additional information on sick leaves were collected from the Swedish Social Insurance Agency. Comparisons were then made between the three treatment alternatives.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2-19 years at the start
* Diagnosed with Type 1 diabetes
* Min duration three months
* Willingness to participate in the study

Exclusion Criteria:

* Pregnancy
* Unwillingness to share and upload CGM data
* Reluctance to come to visit and to follow protocol
* History of allergic reaction to Dexcom CGM materials or adhesives in contact with the skin.
* Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
Use of Hair to Diagnose Breast Cancer

This study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of James et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer.

The primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (aged \>20) who are undergoing mammography, and
* Who are willing and able to provide informed consent; and
* Who have usable scalp hair

Exclusion Criteria:

* Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN: cervical intra-epithelial neoplasia) within 5 years.
Re-hospitalized Patients With Acute Coronary Syndrome

The predictors of re-hospitalization of patients with history of acute coronary syndrome

The aim of this retrospective multicenter study is to evaluate the demographic, clinical characteristics and medications of re-hospitalized for new cardiac event in patients with history of acute coronary syndrome within in 12 months.

Eligibility Criteria:
Inclusion Criteria:

Patients age \>18 years who had hospitalized for acute coronary syndrome within 12 months

Exclusion Criteria:

Patients whose previous hospitalizations data are not available Myocardial Infarction, type 2 patients
Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. It then will use this adequate staining concentration of Indigo Carmine to study whether this dye will increase the detection of polyps during colonoscopy.

Colon cancer occurs in 5% of the US population. Currently colon cancer screening is recommended at the age of 50 years old for all patients who are at average risk. Colonoscopy is considered the gold standard test for colon cancer screening. This is partly because colonoscopy not only can detect polyps which are cancer precursors but also can remove them, and thereby detecting cancer and its precursors and preventing cancer. Unfortunately recent data suggest that colonoscopy can miss a significant percentage of polyps, especially on the right side of the colon. It is thought that one of the major reasons for missing polyps in the right side of the colon is the fact that they are flat or sessile serrated adenoma, both of which are more difficult than protruding polyps to identify with ordinary colon preparation and colonoscopes. Chromoendoscopy is the application of dye during colonoscopy to enhance detection of polyps. It has been shown that it improves the detection of polyps and thus has the potential of improving the performance of colonoscopy and increasing the detection of these difficult to detect polyps. It is however cumbersome and time consuming, which has discouraged its use. Indigo carmine, one commonly used dye, is actually FDA approved as a food colorant and can be consumed orally. It is minimally absorbed. In addition it is used intravenously for diagnosis of injuries of the urinary system because it is very rapidly excreted by the kidneys. The investigators believe that taking it orally will be well tolerated, and that any of the dye that is absorbed will be rapidly excreted by the kidneys and thus quickly eliminated without any side effects. Effective staining of the colon with indigo carmine and increased detection of polyps could change the current standard of care for screening for colon cancer.

Eligibility Criteria:
Inclusion criteria:

* Patients presenting for screening or surveillance colonoscopy
* Must be aged 50 to 75 yrs
* Must be able and willing to sign informed consent

Exclusion criteria:

* Known Creatinine \>1.2
* Cirrhosis
* Pregnancy or breast feeding
* History of anaphylaxis to any dye
* History of bowel surgery or small bowel obstruction
* History of aspiration
* History of dysphagia
* American Society of Anesthesia class \>2
* History of abnormal liver function test in the last year
* History of any degree of cytopenia in the last year
A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.

This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* The subject is over 18 years old.
* The subject has been scheduled for an Optison-enhanced echocardiography exam.
* The subject has provided signed and dated informed consent.

Exclusion Criteria:

* Known hypersensitivity to perflutren, blood, blood products or albumin.
RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65

The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.

Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue
3. Provides voluntary written informed consent prior to the first trial related procedure
4. Subject agrees to attend follow-up assessments as specified in the protocol

Exclusion Criteria:

1. Age 65 years or older at time of aortic valve replacement
2. The Subject is pregnant or planning to become pregnant at the time of screening
3. Re-intervention required on the bioprosthetic aortic valve prior to screening
4. Active endocarditis or history of endocarditis on bioprosthetic aortic valve
5. Estimated life expectancy \<24 months
6. Subjects with history of or current renal failure requiring dialysis
7. Altered mineral metabolism (hyperparathyroidism, parathyroid tumors)
8. Has prior organ transplant or is currently an organ transplant candidate