cyrilzakka/clinical-trials huggingface dataset:
Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital Wrinkles

The core objective of this study is to validate the safe and efficacious application of the AcusMu microneedle patch (FMD WK) to enhance the appearance of periorbital wrinkle

This clinical study is a randomized, double-blind, split-face clinical trial investigating the efficacy of AcusMu (FMD WK) for the treatment of periorbital wrinkles. Participants will attend a study center for a two-week period and undergo a two-week post-treatment follow-up after their final treatment session. Each day, they will apply one of two test products: (A) micro-needle patches containing active anti-wrinkle ingredients and (B) placebo patches beneath their eyes. The patches will be gently pressed onto the skin for 5-10 seconds and left in place for 2-8 hours, continuing this regimen for 14 days. Dermatologists will conduct evaluations at four time points during the study: on day 0, day 7, day 14, and day 28 (±2 days) from the commencement of the experiment. The evaluation process will include the calculation of a Fine Wrinkle Improvement Index specifically designed for assessing under-eye wrinkles to measure improvements. Non-invasive skin testing equipment will be employed to measure skin conditions and capture skin images for objective data analysis (Wrinkle Index). Additionally, self-assessment questionnaires will be administered to gather insights into participants' perceptions of the efficacy of micro-needle patches with active anti-wrinkle ingredients and placebo patches in improving periorbital wrinkles over the two-week duration.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 99 (regardless of race or gender).
* Diagnosed with mild or moderate periorbital wrinkles by a dermatologist.

Exclusion Criteria:

* Participants with open wounds or active infections on their skin.
* Individuals involved in other studies that could interfere with this trial.
* Pregnant, breastfeeding, or planning to become pregnant during the trial.
* Those with significant medical conditions such as cancer, liver disease, diabetes, kidney disease, or cardiovascular disorders.
* Individuals who have undergone alternative treatments for periorbital wrinkles in the past six months (e.g., laser therapy, radiofrequency).
* Participants concurrently receiving alternative treatments for periorbital wrinkles.
Angiogenesis Markers in Primiparas Versus Multiparas: Relevance to Preeclampsia Incidence

The reason for having a higher incidence of preeclampsia in primiparas may involve angiogenesis imbalance in these patients.

Primiparity is one of the main risk factors for having preeclampsia during pregnancy. Recently, sFlt-1, soluble FMS-like tyrosine kinase-1, has been shown to be a major molecule involved in the pathogenesis of preeclampsia. Higher sFlt-1 mRNA, higher serum levels of sFlt-1 as well as lower PlGF, placental growth factor, have been found in preeclamptic patients.

We intend to check the angiogenesis profile of primiparas as compared to multiparas.

Eligibility Criteria:
Inclusion Criteria:

* Every delivery

Exclusion Criteria:

* Preeclampsia or pregnancy induced hypertension
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term post-transplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex post-transplant regimen, with rates of non-adherence as high as 40% to 60%. In this population, medication non-adherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants are 10-21 years of age
* Have received a heart transplant and are followed participating pediatric heart transplant centers
* English-speaking or Spanish-speaking
* Own a smart-phone or have access to the mobile app through other devices
* Are willing to receive information through it
* Have a MLVI score of greater than 2.0 over the last year

Exclusion Criteria:

• Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent
Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

This is a single-arm, open-label, exploratory clinical study

This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* 1. Postmenopausal women aged ≥18 years, the definition of postmenopausal:

  1. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or
  2. Age \<60, natural postmenopausal state (defined as the spontaneous cessation of regular menstruation for at least 12 consecutive months, without other pathological or physiological causes), E2 and FSH at the postmenopausal levels 2. All patients were estrogen receptor (ER) positive (\>10%), HER2 -negative invasive breast cancer regardless of PR expression level. Immunohistochemistry (IHC) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization (ISH) test (HER-2/CEP17 ratio \<2.0); 3. Treatment-naive patients with stage Ⅱ-Ⅲ tumors whose tumor staging meets the criteria of the 8th edition of the American Joint Committee on Cancer (AJCC) Staging;

Exclusion Criteria:

* 1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Concurrently receiving any other anti-tumor therapy that those specified in the protocol; 3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 4. Stage Ⅳ breast cancer;
PDA for Kidneys Study

The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.

Researchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.


Eligibility Criteria:
Inclusion Criteria:

* Delivered at \<32 weeks' gestation
* ≤72 hours of age
* Inpatient at Meriter Hospital, Inc. NICU
* At least one parent/guardian is able to provide parental permission in English or Spanish

Exclusion Criteria:

* Major congenital anomalies of kidney
* Attending physician's discretion to not place NIRS sensors due to clinical concerns
* In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life
* Birth parent aged \<18
Atropine-effect During Propofol/Remifentanil Induction

Remifentanil is a widely used potent intravenous opioid with the advantage of having a short time of action. Compared to other opiates however remifentanil generates more intense hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges necessitate the administration of a combination of relatively high doses of analgesics on the one hand and a short time for postoperative recovery from anesthesia on the other. For these reasons, anesthetic management often consists of a combination of relatively high doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the investigators hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring general anaesthesia;
* Patient's age ≥ 18 years and older;
* Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

Exclusion Criteria:

* Patient's refusal;
* Pregnancy;
* Patient's age \< 18 years;
* Patients in which atropine is contra-indicated, such as severe aortic valve stenosis, hypertrophic cardiomyopathy or coronary artery disease.
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults

The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation


Eligibility Criteria:
Inclusion Criteria:

* Aged 25 to 49 years inclusive
* Males and females
* Self-report of good health

Exclusion Criteria:

* English is not first language (some of the cognitive tasks have only been validated in native English speakers)
* Habitual consumption of oily fish exceeds one fish meal per week
* Habitual consumption of n-3 dietary supplements in the previous 6 months
* Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
* Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)?
* Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
* Pregnant, trying to get pregnant or breast feeding
* Body Mass Index outside of the range 18-35 kg/m2
* High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Currently taking blood pressure medication
* Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
* Have frequent migraines that require medication (more than or equal to 1 per month)
* History or current diagnosis of drug/alcohol abuse
* History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
* History of neurological or psychiatric illness (excluding depressive illness and anxiety)
* History of head trauma
* Sleep disturbances and/or are taking sleep aid medication
* Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
* Diagnosis of type I or type II diabetes
* Heart disorder, or vascular illness
* Current diagnosis of depression and/or anxiety
* Over- or under-active thyroid
* Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
* Any known active infections
* Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
* Current or past breast cancer diagnosis and/or a mastectomy
* Health condition that would prevent fulfilment of the study requirements
* Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF

The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.


Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosed cirrhosis
* Patient with Acute Decompensation of cirrhosis
* Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
* The INR measurement has to be : 1.2 ≤ INR \< 2

Main Exclusion Criteria:

* Absence of portal vein flow
* Known or medical history of thrombotic events
* Gastrointestinal hemorrhage requiring blood transfusion
* Variceal bading or sclerosis within 4 weeks before infusion
* Septic shock or non-controlled bacterial infection
* Clinical evidence of aspergilus infection.
* Circulatory failure
* Respiratory disordered
* Coagulation disorders defined as INR ≥ 2, Fibrinogen \< 100 mg/dL or Platelets \< 50.000/mm3
* MELD score \> 30.
* Major invasive procedure within 4 weeks before infusion
* Previous organ transplantation and/or ongoing immunosuppressive treatments.
* Renal failure due to chronic kidney disease.
* Clinically significant left-right cardiac shunt.
Hyperoxia and Microvascular Dysfunction

Coronary artery disease (CAD) pathophysiology involves endothelium-dependent (e.g. nitric oxide, acetylcholine) and -independent (e.g. adenosine) vascular dilation impairment, which have been demonstrated at the level of small coronary arteries, medium sized peripheral arteries and subcutaneous microcirculation. Oxygen supplementation, which is frequently overused in clinical settings, seems harmful in acute coronary syndromes and increases microvascular resistance in myocardial and subcutaneous microcirculation through alteration of endothelium-dependent and -independent dilation by an oxidative mechanism. Whether endothelial dysfunction, that is well documented at the level of cardiac microcirculation in CAD patients, is also present at the level of subcutaneous microcirculation is unknown. Also, unknown is whether an acute oxidative stress can be used to probe myocardial microcirculatory dysfunction at the level of subcutaneous microcirculation, which is an easily accessible vascular bed for an in vivo assessment of endothelial-dependent and-independent function. Alterations in cutaneous vascular signalling are evident early in the disease processes. Thus, studying subcutaneous circulation in patients with cardiovascular risk factors could provide vascular information early in CAD processes. This study will test the following 4 hypotheses:

1. Endothelial dysfunction observed at the level of microvascular cardiac arteries is readily present at the level of subcutaneous microcirculation in a given CAD patient.
2. An acute oxidative stress such as hyperoxia can be used to test myocardial microcirculatory dysfunction at the level of the more easily accessible subcutaneous microcirculation.
3. Subcutaneous microcirculation of CAD patients has a lesser vasodilatory response to acetylcholine or sodium nipride than matched healthy subjects. In addition, CAD patients are more prone to dermal vasoconstriction in response to oxygen compared to healthy subjects.
4. Taken that oxygen is still too often given in excess in most clinical settings, the aim of this study is to rule out possible pitfalls in coronary pressure and resistance determinations in CAD patients receiving unnecessary oxygen supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Coronary angiography done in the context of suspicion of coronary artery disease (CAD)

Exclusion Criteria:

* Respiratory failure requiring intubation or supplementary oxygen
* Severe chronic obstructive pulmonary disease
* Significant arrhythmia precluding waveform analysis (e.g., excessive premature ventricular contractions or atrial fibrillation)
* Severe valvular heart disease,
* Suspected elevated central venous pressure (CVP)
* Heart failure as defined by New York Heart Association class III or IV
* Previous coronary revascularization or heart transplantation
* Severe hypertension (systolic pressure \>200 mmHg and diastolic pressure \>120 mmHg at rest)
* Contraindications to adenosine infusion
* Contraindication to acetylcholine (Ach) infusion
* Severe bronchial asthma.
MRI Hydronephrosis Study

The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis.

Ultrasound is the most commonly performed imaging modality used to assess hydronephrosis. The average renal ultrasound exam takes about 15-25 minutes to complete, however, it does have several disadvantages, including substantial operator dependence, having to rely on an adequate "sonographic window" to see the structures of interest and difficulty in visualization of portions of the kidney and urinary tracts.

Recent MRI advances have made rapid imaging possible. Such imaging has minimized motion related artifacts and need for sedation.

This study is to compare traditional ultrasound imaging to a raid noncontrast protocol MRI examination of the kidneys and urinary tract that would require no sedation and less than 15 minutes to perform.

Eligibility Criteria:
Inclusion Criteria:

* Children 2 years of age and younger
* Diagnosed with hydronephrosis and scheduled for an ultrasound scan

Exclusion Criteria:

* Healthy subjects
Subtotal Cholecystectomy for Complicated Acute Cholecystitis: a Multicenter Prospective Observational Study

We believe that subtotal cholecystectomy is a safe alternative to total cholecystectomy when the complicated gallbladder is encountered, resulting in decreased or equivalent risk of bile duct injury, major vascular injury, postoperative hemorrhage, infectious complications, and mortality. Additionally, we hope to further elucidate the expected outcomes of the varying subtypes of subtotal cholecystectomy in order to determine the safest approach, assuring the lowest need for secondary intervention, recurrent biliary disease, or need for a completion cholecystectomy.

The first reported subtotal cholecystectomy occurred in 1955. Additional case reports and studies have been carried out, further defining this terminology as a method of avoiding misidentification injuries of the biliary system or portal vasculature when critical view of safety cannot be safely achieved. Recent data supports the safety of this decision, showing equivalent morbidity rates to total cholecystectomy in a large metanalysis of 1,231 patients. Importantly, only 4 of the 30 included studies were prospective in nature, allowing definition variability and inconsistent reporting of outcomes. Additional reports showed variable data regarding effect on hospital LOS, need for secondary intervention (including endoscopic retrograde cholangiopancreatography (ERCP), percutaneous drainage bilioma, or completion cholecystectomy), infectious complications, biliary or major vascular injury, and mortality. Some studies suggest that while subtotal cholecystectomy is associated with a decreased rate of bile duct injury and a lower conversion to open operation, this comes at the cost of increasing bile leak and recurrent biliary complications. Furthermore, the relatively recent distinction between fenestrating and reconstituting subtypes of subtotal cholecystectomy remain ill-defined in many of these studies, and outcomes between the two modalities remain variable across the literature. There is an obvious need for a head-to-head, prospective comparison between these subtypes to determine the safety and efficacy of the chosen intervention. To determine the impact of these differing techniques for subtotal cholecystectomy (namely reconstituting and fenestrating subtypes) as indicated by Tokyo Criteria (Table 1), for the management of the difficult cholecystectomy on short-term and long-term patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Preoperative definitive diagnosis of acute cholecystitis (Tokyo guideline: Table 1)

Exclusion Criteria:

* Pregnant patients
* Prior history of subtotal cholecystectomy
* Percutaneous cholecystostomy tube in place
* Preoperative diagnosis other than acute cholecystitis
* Symptomatic cholelithiasis
* Gallstone pancreatitis
* Choledocholithiasis
* Malignant/benign tumor
* Others
Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)

The purpose of this project is to examine the effectiveness of computed tomographic angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). People who are hospitalized with this situation often require an angiogram to assess the heart and its arteries.

Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy with great accuracy and to guide treatment strategies in select patient populations. We are investigating that CTA may be used, as an alternative to conventional angiograms, for the risk stratification of patients with high risk NSTE-ACS.

Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram. Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be injected with a small dose of an X-ray dye and will be asked to lie still on the "scanning bed" for a period of 5-10 minutes.


Eligibility Criteria:
Inclusion Criteria:

* High risk ACS

  1. Angina \[accelerating pattern or prolonged episode (\> 20 minutes) or recurrent episode at rest or with minimal effort within preceding 24 hours\]; and (13)
  2. Elevated Troponin - T (≥0.1 ug/L) or ECG changes consistent with ischemia \[ST depression ≥ 0.1 mV, transient ST segment elevation ≥ 0.1 mV (\< 20 minutes)\]) (11;13)
* Planned conventional invasive coronary angiography

Exclusion Criteria:

* Age \< 18 years or lack of consent
* Renal Insufficiency (GFR \< 60 ml/min)
* Allergy to contrast agent
* Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
* Contraindication to radiation exposure (e.g. pregnancy)
* Uncontrolled HR
* Previous CABG or PCI/Stent
* Atrial fibrillation, frequent atrial or ventricular ectopy (\> 1 / minute)
* Unable to perform 20 second breath-hold