cyrilzakka/clinical-trials huggingface dataset:
WILD 5 Wellness, A 30-Day Intervention

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention".


Eligibility Criteria:
Inclusion Criteria:

* Students 18 years of age or older or 17 years of age with legal guardian written permission.
* Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"

Exclusion Criteria:

* Individuals who are pregnant or plan to get pregnant during the next 30 days.
* Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"
Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes

Important developmental processes continue until the completion of 40 weeks gestation. Even during fetal life, intrinsic and environmental factors determine the balance between health and the onset and development of diseases. Thus, it is crucial to understand the mechanisms that regulate normal development and the pathways that contribute to disease pathogenesis.

Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their secretion increases during brain development, when new neurons are being formed and existing ones are branching to assemble complex neuronal circuits. In addition to their role in promoting neuron growth and development, neurotrophins are also a product of neuronal activity. Neurotrophins are also responsible for the maintenance of peripheral sensory neurons, including those in the lungs. Airway innervation is responsible for many aspects of lung function including the regulation of airway smooth muscle tone, mucus secretion, and reactivity; therefore, a physiological expression of neurotrophins in the lungs is required for normal lung function.

Currently, there is no reliable method to identify infants who will have poor neurodevelopmental and respiratory outcomes. The ability to make such predictions would be beneficial for both making care decisions in the neonatal intensive care unit and for identifying infants who require earlier and more intense intervention. We intend to determine if neurotrophins can be utilized to predict an infant's long-term outcomes. Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their levels have been shown to increase with brain development and decrease with brain injury. Neurotrophins have also been associated with development of airway injury in the neonate and later respiratory disease such as asthma. We plan to correlate serum neurotrophin levels with respiratory outcomes and neurological outcomes.

Eligibility Criteria:
Inclusion Criteria:

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion Criteria:

unwilling or unable to give or obtain informed consent
PhysioFlow to Detect Cardiotoxicity in Chemo

PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving chemotherapy early on in order to avoid irreversible damage. In addition to that, we will test if the PhysioFlow is non-inferior to the conventional MUGA scan.

Our objective is to compare the PhysioFlow to the MUGA scan and see if the results are statistically the same using both techniques. This is what is known as a non-inferior study. The advantage of PhysioFlow is that it is non-invasive, fast and it is done at the bedside or while the patient is receiving his or her chemotherapy.

The patient will be tested with the MUGA scan, as per the standard of care, before chemotherapy is initiated and at every 3 months. The patient will also be tested with the PhysioFlow at the same dates of the MUGA scan. In addition to that, the patients will be tested at each chemotherapy cycle with the PhysioFlow.

Should the PhysioFlow indicate the patient has a cardiac toxicity as the patient is receiving chemotherapy, the results will be confirmed with the MUGA scan.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years old
2. Histologically confirmed diagnosis of cancer
3. ECOG 0 to 2
4. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
5. Able to adhere to the study visit schedule and other protocol requirements

Control Group

1. Age above 18 years old
2. No previous history of cancer
3. ECOG 0 to 2
4. Did not receive chemotherapeutic agents (even if outside the context of cancer)
5. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
6. Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

1. Age less than 18 years
2. ECOG 3-4
3. Suspected or proven severe aortic insufficiency
4. Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device)
5. Congenital cardiac deformities ,such as septal defects
6. Refuse to comply with the specified visit schedules and requirements
Necessity of Aspiration in the Ventrogluteal Site

H1: Aspiration is not necessary for IM injections applied from the ventrogluteal region.

H2: Aspiration procedure increases pain in IM injections applied from ventrogluteal region.

H3: The duration of the aspiration procedure on IM injections applied from the ventrogluteal region is effective on pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient who came to the Emergency Service Care Unit for "Diclofenac Sodium" injection
* Have no vision and hearing problems,
* Who have no disease that may affect their perception of pain
* Who can evaluate the "Visual Analog Scale" correctly, scoring 5 points or less from the VAS,
* Body Mass Index is between 18.5-24.9 kg / m2,
* Who do not have any discomfort in the extremities that will prevent them from taking the desired position,
* No complications due to intramuscular injections such as abscess, infection, tissue necrosis and hematoma in the ventrogluteal region
* No nodules or masses in the area

Exclusion Criteria:

* Patients who refuse the injection are excluded.
Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry

This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or older
* Capable of giving informed consent
* Diagnosis of cancer scheduled for treatment according to treating physician's discretion
* Life expectancy \>1 year
* For the prospective validation of HFA-ICOS risk score validation: Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs

Exclusion Criteria:

* Age \<18 years old
* Not able to give informed consent
* Life expectancy \<1 year
* Advanced-stage cancer not eligible for treatment (subjects with an indication of palliative care) according to treating physician's
The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients

The purpose of this study is to determine whether the use of rosuvastatin in Human Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels, improves blood circulation in the small arteries that provide nutrients to the heart muscle and improves neurocognitive function.

HIV is a chronic inflammatory disease. Patients with HIV are at a high risk of cardiovascular disease (CVD) which may be related to this state of chronic inflammation. HIV infected individuals are at up to four times higher risk of suffering a heart attack (also know as acute coronary syndrome).

The medicine rosuvastatin, commonly used to treat high cholesterol, has been shown to reduce inflammation in arteries in the general population and also in patients with high risk for heart problems.

72 subjects with HIV infection will be enrolled and divided into 2 groups of 36.

Group 1: Treatment Group: Participants will receive a low dose of rosuvastatin, 10mg, for 6 months in addition to their current medical therapy.

Group 2: Control Group: Participants will not receive rosuvastatin for 6 months and will continue with their current medical therapy.

Participants in both groups will undergo blood tests, Myocardial Contrast Echocardiography (MCE) scan and a Positron Emission Tomography/Computed Tomography PET/CT scan using a radioactive tracer called fluorodeoxyglucose (FDG-PET), monocyte and serum cytokine studies at baseline and 6 months.

10 subjects without HIV will also be enrolled to undergo monocyte and serum cytokine blood tests only, for comparison.

Eligibility Criteria:
Inclusion Criteria:

* 40-90 years of age
* documented evidence of HIV infection
* on standard antiretroviral therapy(ART) for \>1 years
* viral load persistently below the limits of detection while on ART
* current Cluster of Differentiation Antigen 4 (CD4) count \>350 cells/microlitre
* baseline Framingham risk score of 10-20%

Exclusion Criteria:

* uncontrolled diabetes mellitus (glycated hemoglobin (HbA1C) \>6.5% or fasting glucose \>7.0 mmol/L)
* uncontrolled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>90)
* known coronary artery disease (CAD) e.g. previous myocardial infarction, revascularization procedure, or history of angina
* chronic renal failure (glomerular filtration rate (GFR) \<60 ml/min)
* total cholesterol \>5.8 mmol/L
* Low-density lipoprotein (LDL) cholesterol \>4.0 mmol/L
* already receiving a statin for baseline dyslipidemia
* pregnant or lactating
* active untreated Hepatitis B or C
* diagnosis or clinical evidence of a concomitant inﬂammatory/autoimmune disease
* patients at baseline demonstrating regional perfusion abnormalities (confined to individual coronary territories) following stress MCE will be excluded and further management will be according to local best practice guidelines
Contribution of Anti-platelet Antibodies Identified With MAIPA Assay in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis

Immune thrombocytopenia (ITP) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. ITP is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. No major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of ITP. The gold standard analysis for the determination of platelet antibodies, is the "monoclonal antibody immobilization of platelet antigens" assay (MAIPA), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. Therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in MAIPA to determine the autoimmune nature of a thrombocytopenia at diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old;
* Patients with thrombocytopenia \<100 G/L, checked twice, having ruled out false thrombocytopenia by platelet aggregation and acute leukemia by smear;
* No treatment started;
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research);
* Person affiliated or benefiting from a social security scheme.

Exclusion Criteria:

* Secondary ITP;
* False thrombocytopenia;
* Patients who have been transfused with platelets for less than 7 days with efficacy;
* Patient treated for thrombocytopenia (48 hours of corticosteroid therapy is tolerated and is not an exclusion criteria);
* Patient with acute leukemia;
* Pregnant or breastfeeding woman;
* False thrombocytopenia;
* Patient under guardianship, curatorship or any other legal protection regime.
Use of Amnion on Partial Thickness Burns

To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.


Eligibility Criteria:
Inclusion Criteria:

* Partial thickness burn injury.
* \>2% burn injury.
* Ages 0-100 years.

Exclusion Criteria:

* Patients not expected to survive
Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids

Randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 on symptoms related to uterine fibroids

A randomized controlled trial aimed to evaluate the efficacy of a combination of Epigallocatechin gallate, vitamin D3, D-Chiro-inositol, and vitamin B6 as a treatment for uterine fibroids. The clinical study is double-blind, neither patients nor investigators know whether the subject receives the combination of Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 or the placebo. After 3 months of treatment, changes in symptoms associated with uterine fibroids, quality of life, and ultrasounds characteristics are compared between the two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for hysterectomy.
* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for myomectomy / uterine arterial embolization.
* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for treatment with magnetic resonance (MR)-guided Focused Ultra-Sound (MrgFUS).

Exclusion Criteria:

* Pregnancy.
* Breastfeeding.
* Smoking.
* Suspected malignancy.
* Patients who have undergone medical treatment for uterine fibroids within the previous three months.
* Patients allergic to the components of the product or placebo under study.
* Patients who refuse to provide informed consent to participate in the study.
Baby Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) Intervention Study

This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.


Eligibility Criteria:
Inclusion Criteria:

* licensed child care centers in North Carolina (NC) serving children birth - 2
* within 120 mile radius of Duke University
* children must be from participating center and 3-18 months of age at baseline
* read/speak English
* adult teachers from infant/toddler classrooms within participating centers
* adult parents of infant/toddlers within participating centers

Exclusion Criteria:

* child care centers outside of 120 mile radius of Duke University
* children younger than 3 months or over 18 months of age
* parents with children who intend to leave the participating center in \< 12 months
Impact of Statin Therapy on Adaptations to Aerobic Exercise

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise.

This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.

This study is expected to last about 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 25-43 kg\^m2
* Sedentary (less than 150 min of physical activity/week during last 6 months)
* Weight stable (no more than 5% change in body weight the previous 3 months)

  * \>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension).
* Stable doses of medications for 90 days
* Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Exclusion Criteria:

* Smoking
* Use of statins in the last 6 months
* Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
* Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
* History of abnormal bleeding problems
* Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications
* \>2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine
* Women who are pregnant or breastfeeding
* Individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening)
* Currently enrolled in another research study
Enhanced Assisted Reproductive Technology Pregnancy Rate by Prostacyclin Analog (Iloprost)

Human fallopian tube secretes high concentration of prostacyclin. Fallopian tube is the site for early embryo development. The effect of prostacyclin on human early embryo development is waiting to be clarified. The study hypothesis is prostacyclin can enhance early embryo development.

Huang et al, found that human fallopian tube expresses prostacyclin synthetase and cyclooxygenase. These enzyme systems synthesize abundant prostacyclin (PGI2). In the fallopian tube PGI2 causes smooth muscle relaxation, possibly facilitating tubal transport of gametes and embryos. Huang et al reported that addition of the PGI2 analogue Iloprost to embryo culture media significantly enhanced mouse embryo development to the blastocyst and complete hatched stages. The implantation and live birth rates of Iloprost cultured embryos were significantly better than non-Iloprost embryos in the mouse model. The mean weights of fetal mice were not significant different from control group. There was no teratogenic effect observed.

In a previously presented study, the investigators cultured donated frozen human zygotes in culture media with and without the addition of Iloprost. The Iloprost treated embryos showed significantly better growth rate and morphology, as determined by the size, and grading of the trophectoderm and inner cell mass.

Iloprost is FDA approved for the treatment of pulmonary hypertension. It has a significantly longer half-life than native PGI2. Iloprost is a class C pregnancy drug and has not been associated with teratogenic effects. This study intends to expand the usage of Iloprost to culture embryos.

Eligibility Criteria:
Inclusion Criteria:

* ART case

Exclusion Criteria:

* age \< 40
* no pre-implantation genetic diagnosis procedure
The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients

Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient received surgery under general anesthesia and admitted into the ICU
* The patient has been intubated and is receiving invasively mechanically ventilated with the mode of pressure support (PSV) or continuous positive airway pressure (CPAP)
* The patient requires sedative medication targeting RASS -2 to +1 for comfort, safety and to facilitate the delivery of life support measures

Exclusion Criteria:

* Age \< 18 years
* Body mass index (BMI) \<18 or \>30 kg/m2
* Pregnancy or lactation
* Brain stem tumors, myasthenia gravis, or neuromuscular diseases
* Acute severe neurological disorder and any other condition interfering with RASS assessment
* Systolic blood pressure \< 90 mmHg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors
* Heart rate \< 50 beats per minute or second- or third-degree heart block in the absence of a pacemaker
* Contraindicate or allergic to any of the study medications
* Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C)
* Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2
* Alcohol abuse