cyrilzakka/clinical-trials huggingface dataset:
Creating VIP Corps to Reduce Maternal Deaths

The goal of this observational study is to create and rigorously evaluate a violence intervention and prevention corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students; and to develop a novel maternal injury surveillance system (MISS) to complement an existing maternal violent death registry in Kentucky.

The participant population defined in this study are undergraduate and professional students within their last educational year in a helping professionals program at the University of Kentucky, ages 18-30. This study will permit the creation of effective programming to train the next generation of health and social service professionals prepared to help reduce Kentucky's maternal mortality and injury rates over time with implementation.

Aim 1:

1. Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
2. Develop a novel maternal injury surveillance system (MISS) as a complement to an existing maternal violent deaths registry to accurately and reliably enumerate maternal injuries and deaths due to violence.

Aim 2:

1. Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
2. Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
3. Prospectively evaluate the effectiveness of a novel VIP training as the intervention condition relative to an attention control (SU/D and IPV awareness), to increase knowledge of the effects of intimate partner violence (IPV) on health outcomes, report intimate partner violence (IPV) screening behaviors, intimate partner violence (IPV) detection, and to reduce intimate partner violence (IPV) frequency among patients and clients over time.

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in a helping professions program
* 18 years of age through 30 years of age
* Students whom will have direct interaction with patients or clients that may experience interpersonal violence (IPV)

Exclusion Criteria:

* Students not enrolled in a helping professions program
* Students under age 18 or over age 30
* Students with no direct interaction with patients or clients
Relationship Between Fertility Hormone Patterns and Pregnancy Rates.

The purpose of this study is to determine if certain patterns of hormone levels during the menstrual cycle are correlated with different pregnancy outcomes.

Proov tests are fertility tracking tests. They are used for monitoring ovulation at home, and are able to measure one or more hormones. These hormones can predict and confirm ovulation. Tracking these hormones can help a woman understand if she is ovulating, and can help to identify problems that could be preventing pregnancy.

After giving permission to access your testing history collected in the Proov app from March 2020 to April 2022, you will complete an online survey about your fertility test results and pregnancy status. You will also be asked information regarding your age, race, smoking status, and BMI. Your test results logged in the Proov app will be shared automatically. You will need 10-20 minutes to fill out the fertility survey.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 18 - no limit
3. Have completed one full cycle using the Proov app

Exclusion Criteria:

1. Male
2. Have not completed one full cycle using the Proov app
Healthy Eating Education for Latinos

This intervention aims to evaluate the efficacy of a pilot educational intervention with deep-structure cultural tailoring for Latino ethnic groups on diet quality compared to general, surface-level healthy-eating messages.


Eligibility Criteria:
Inclusion Criteria:

* Aged 25-65 y/o
* Self-reported Hispanic/Latino heritage
* Able to understand and answer questions in Spanish or English
* Living in the Boston, MA metro area for the past 6 months and not planning to move in the next 6 months
* Has a cellphone with the capacity of receiving text messages and gives consent for the Study to text this number as part of the intervention

Exclusion Criteria:

* Younger than 25y or older than 65y
* Not Hispanic/Latino heritage
* Has condition or impairment that affects mental, cognitive, or memory abilities; such as Alzheimer's disease or stroke
* Has been diagnosed with cancer, diabetes (type 1 or 2), heart condition, major stomach condition (examples: coronary heart disease, heart attack, stroke or stroke, allergies, or severe diet restrictions)
* Does not understand Spanish or English
* Pregnant
* Under the care of an institution
* Living in another state outside of Massachusetts or planning to move in less than 6 months
* No cellphone with text capabilities (or cannot be used to receive texts from the Study)
Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)

Chronic heart failure (CHF) is a major and growing public health problem and poses economic burden on the society. There is a need for a safe, equipment-free, low-cost, and easily implemented exercise-based cardiac rehabilitation program for CHF patients in China. Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms of traditional Chinese exercise and it could have value to be integrated into a exercise-based cardiac rehabilitation program for CHF patients, together with education, evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin exercise as the central component, has been developed in Guangdong Provincial Hospital of Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with CHF in China, and it will be based on a randomized controlled trial and a qualitative study.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 years or above
2. diagnosed with chronic heart failure
3. clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month
4. NYHA functional class II or III

Exclusion Criteria:

1. patients who have contraindications to cardiopulmonary test
2. patients who have contraindications to exercise training
3. Patients who have serious acute or chronic organic disease or mental disorders
4. history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months;
5. history of cardiac arrest within 1 year;
6. history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension;
7. inability to perform a bicycle stress test;
8. severe cognitive dysfunction precluding informed consent or understanding of exercise concepts;
9. current regular Baduanjin or current participation in a conventional cardiac rehabilitation program
10. current participation in another trial.
Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism

Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance as patients with PA are more susceptible to cardiovascular and cerebrovascular morbidity and mortality than blood-pressure-matched hypertensive patients.

Current guidelines indicate that mineralocorticoid receptor (MR) antagonists and laparoscopic adrenalectomy are the principal treatments for PA.Laparoscopic adrenalectomy is recommended for patients with aldosteronoma or unilateral adrenal hyperplasia. During the past two decades, catheter-based arterial embolization or computed tomography (CT)-guided radiofrequency thermogenesis have been used for aldosteronomas treatment. Although these procedures are claimed to be effective for treatment of aldosteronomas, the evidence comes mostly from case reports or small series. In addition, some PA patients refuse surgery and are intolerant of the adverse effects of MR antagonists; others have persistence of PA after adrenelectomy, but respond poorly to MR antagonists. An alternative therapy is needed in such cases.

In recent years, adrenal artery ablation has also been used to treat primary aldosteronism, which can reduce the level of aldosterone and blood pressure, but its efficacy and safety are not clear. To confirm the effect of adrenal artery ablation on blood pressure, RAAS system and blood potassium, the researchers conducted a parallel control clinical study of patients with primary aldosteronism (Aldosteronoma).


Eligibility Criteria:
Inclusion Criteria:

* Primary aldosteronis diagnosed by increased aldosterone-to-renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
* Aldosteronoma had lateralization by adrenal venous sampling (AVS) and confirmed with CT
* Signed informed consent and agreed to participate in this study.

Exclusion Criteria:

* Aldosterone cancer.
* Hyperkalemia.
* Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
* Secondary hypertension except the primary aldosteronism.
* Adrenergic insufficiency.
* Heart failure with NYHA Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
* Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts.
* Liver dysfunction or the following history of liver disease: AST or ALT 2 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
* Coagulation dysfunction.
* Pregnant women or lactating women.
* Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
* Allergy or any contraindications for contrast agents and alcohol.
* Refused to sign informed consent
Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors

This is a pilot study designed to assess the safety and feasibility of administering a dietary supplement to patients undergoing cancer treatment with a dual immune checkpoint inhibitors (ICIs) for solid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients starting dual immune checkpoint inhibitor therapy (ipilimumab and nivolumab in any dose combination) for solid cancer treatment per FDA approved indications.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients with a history of colectomy and/or gastric bypass.
* Patients with a known diagnosis of inflammatory bowel disease or irritable bowel syndrome.
* Patients with active Clostridium difficile infection. Active infection is defined as a stool sample positive for Clostridium difficile toxin by EIA and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.
* Inability to take oral supplements
* Patients with existing gastrointestinal symptoms including abdominal pain, diarrhea (watery stool), nausea and/or actively requiring regular anti-emetics.
* Patients with symptomatic bowel metastasis including pain, severe constipation, or gastrointestinal bleeding.
* Receiving antibiotic within 14 days of ICI therapy initiation.
* Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
Wound Irrigation Comparative Effectiveness Study

The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.


Eligibility Criteria:
Inclusion Criteria:

• Ault patients requiring Total Shoulder Arthroplasty

Exclusion Criteria:

* Age younger than 18 years
* History of shoulder infection
* Antibiotic therapy within 2 weeks of surgery
* Cortisone infiltration within 3 months prior to surgery
* Allergy to CHG
* Diagnosis of rheumatoid arthritis
* Immunocompromised patients
The Effect of Melatonin and Vitamin C on COVID-19

This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria

* COVID-19 positive test (outpatient testing),
* Age \>50 (chosen based greater risk for older patients to be vitamin deficient, age \>65 not used so as not to be too restrictive in the inclusion criteria)
* Experiencing symptoms for \<5 days prior to enrollment
* Able to read and write in English or Spanish
* Able to access REDCap daily
* Valid email address
* Current has a Lancaster General Health primary care physician

Exclusion Criteria

* COVID-19 test ordered pre-procedure for asymptomatic screening
* Currently taking vitamin C supplements
* Currently taking melatonin supplements
* Currently hospitalized
* Deceased
* Currently pregnant
* Currently incarcerated
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 40 to 70 years
* Subject in good health
* Desire improvement in periorbital wrinkles
* Subject provides informed consent and agrees to attend follow-up visits
* Subject signs a HIPPA authorization

Exclusion Criteria:

* Pregnant or lactating
* Has an active systemic or local skin disease that may alter wound healing
* Has significant scarring in test areas
* Has significant open facial wounds or lesions
* Has severe or cystic acne on the face
* Has a metal stent or implant in the face area
* Is a current smoker or has a history of smoking in last 10 years
Pilot Survey of Dengue Fever in Solomon Islands

Since 2009, Kaohsiung Medical University Hospital organized a medical team to provide the medical service for people in Solomon Islands thru Taiwan Health Center at the local. In addition to Malaria and pulmonary tuberculosis, the investigators also found dengue virus, Japanese Encephalitis virus, Chikungunya virus infections and intestinal parasitic infections might be the existing but overlooked and neglected medical issues in Solomon Islands. These infections show similarity in clinical manifestations and usually difficulty in clinical diagnosis, instead these infections rely on the laboratory identification with good laboratory quality and facility.

In this study, the investigators plan to investigate the local people, either from the community or the hospitals, to identify the prevalence and incidence of dengue fever, including laboratory identification of related infections for differential diagnosis, including Japanese Encephalitis virus, Chikungunya virus and intestinal parasitic infections. Intestinal parasite survey has been the routine long-term service offered by the Kaohsiung Medical University Hospital in Solomon Islands. At the same time, the subjects enrolled in this study will also be asked the common medical illness in Solomon Islands (i.e. malaria, pulmonary tuberculosis and metabolic syndrome etc.) in order to delineate the association of dengue fever and these acute and chronic illness.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer
* reported dengue virus infection volunteer
* people who understand the purpose of the study and agree the to sign the informed consent

Exclusion Criteria:

* people who refuse to join the study
Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.

The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .

Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.


Eligibility Criteria:
Inclusion Criteria:

* Intubated mechanically-ventilated patients within the first 24 hours of admission
* And/or patients with total body surface area (TBSA) burn-injured \>20 %
* And/or patients with at least 10% full-thickness burns
* And/or receiving vasopressors within the first 24 hours of admission
* And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)

Exclusion Criteria:

* Admission delay to ICU \> 24 hours post burn
* Age less than 18 years
* Pregnancy
* Chronic renal impairment with a baseline eGFR \< 15 ml/min
* Patients with chemical or electrical burns
* Coexisting non-burn trauma
* Patients moribund on admission or dead within 72 h from admission
* Patients with do-not-resuscitate orders
Epidemiology of Body Mass Index Rebound

To investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study.

BACKGROUND:

Obesity is the most prevalent nutritional problem in the United States. It appears that both the prevalence and severity of obesity have been increasing in recent years. Obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to treatment. This places a premium on prevention. However, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. Recently, it has been shown that the timing of body mass index (BMI) rebound may be a predictor of future obesity. BMI increases during the first year of life. It then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown that BMI rebound at a young age is associated with increased risk of obesity later in life. Currently, very little is known about the epidemiology of BMI rebound.

DESIGN NARRATIVE:

The investigation is a cohort study designed to follow 320 children from age three to age seven years. The study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. Parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake.

Eligibility Criteria:
No eligibility criteria
Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC

This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old;
* first-diagnosed, driver gene-negative non-small cell lung cancer patients with histopathological confirmed diagnosis (Stage IIA-IIIB);
* at least 1 measurable lesion as defined by RECIST version 1.1; an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1;
* no prior systemic therapy or radiotherapy;
* the patients are eligible for indications for surgical resection and amenable to - neoadjuvant immunotherapy or chemotherapy after multidisciplinary evaluation;
* signing the written consent before enrollment in the study;
* participants need to have adequate pulmonary ventilation and diffusion function to allow surgical resection by pre-enrolment pulmonary function testing;

Exclusion Criteria:

* refusal of participation or inability to give a clear consent;
* requiring treatment with systemic glucocorticoids and other - immunosuppressive agents;
* use of antibiotics within the previous 3 months or the presence of an infectious disease requiring antibiotic therapy;
* probiotics within 3 months prior to enrolment;
* presence of obstructive pneumonia, cancerous cavities, active tuberculosis;
* the presence of bronchiectasis, combined lung infections, pulmonary fibrosis, uncontrolled diabetes mellitus;
* the presence of primary tumors elsewhere;
* receiving chemotherapy or any other cancer treatment prior to enrolment;
* participants with brain metastases confirmed by brain MRI with contrast prior to enrolment;
* active or pre-existing autoimmune disease;
* the presence of uncontrolled comorbidities, including heart failure, uncontrolled hypertension, unstable angina, interstitial lung disease;
* positive test for hepatitis B surface antigen or hepatitis C ribonucleic acid requiring treatment;
* known positive history or positive test results for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
* history of allergy to study drug components;
* women who are pregnant or breastfeeding;
* previous treatment with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibodies.