cyrilzakka/clinical-trials huggingface dataset:
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 to ≤ 80 years of age
* On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
* Fasting LDL-C ≥ 85 mg/dL
* Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) \> 8.5%)
* Uncontrolled hypertension
* New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30%
* Uncontrolled cardiac arrhythmia
Effects of an Exercise Program on Reaction Time and Mouse Accuracy in Esports Athletes

This study is intended to evaluate the effects of an exercise program on the change of electronic sports (esports) athletes' reaction time and mouse click accuracy. The benefits of participation are directly related to exercise, and include improved thinking, performance, sleep, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. University of Miami electronic sports (esports) club team members

Exclusion Criteria:

1. Non- University of Miami electronic sports (esports) club team members
2. Individuals who are not able to participate in a full body exercise program, whether due to injury or an underlying medical condition
3. Individuals who cannot comprehend basic instruction on exercise whether due to a cognitive impairment or language barrier (ie: non-English speaker).
Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System

This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.

Several studies have shown promising results of taVNS to treat various disorders such as depression, anxiety, Alzheimer's disease, headache, obesity, and diabetes. However, no mechanistic studies have investigated the taVNS neural network and autonomic nervous system effects of this technique. Therefore, we aim to assess how taVNS can affect EEG metrics and HRV and assess its safety. Also, we aim to evaluate predictors that can influence the response to taVNS, so understanding the variables associated with response to taVNS can help the design of future clinical trials to maximize the effects of this intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Subject is older than 18 years.
3. Subjects should be naive to the stimulation (taVNS)

Exclusion Criteria:

1. Pregnancy.
2. Subjects who have had a neuropsychiatric or a cardiac disorder diagnosis and have received treatment and chronic medication in the past six months, or who have functional deficits as a result.
3. History of alcohol or drug abuse within the past 6 months as self-reported.
4. Presence of the following contraindication to transauricular vagus nerve stimulation

   1. Ferromagnetic metal in the head and in the cranium (e.g., plates or pins, bullets, shrapnel)
   2. Implanted cranial electronic medical devices (e.g., cochlear implants)
   3. Implanted cardiac devices (e.g., pacemaker)
5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease).
6. Uncontrolled epilepsy, as defined by previous clinical seizures in the past 3 months in patients with treatment for epilepsy.
7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).
Efficacy of Probiotics on Physical Performance

Efficacy of probiotics on physical performance


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 40 years, at the time of signing the informed consent form
* Provides signed and dated informed consent form
* Engaged in competitive sports and regularly training
* Non-anemic, iron-deficient
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Use of probiotics
* Use of iron supplementation
* Use of ascorbic acid (Vitamin C) supplementation
* Hypersensitivity to any of the ingredients in the investigational product (IP)
Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.

A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Patients with type 2 diabetes mellitus
* Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
* Patients with Fasting Plasma Glucose \<15mmol/L(270mg/dL) on screening

Exclusion Criteria:

-
Clinical Utility of Intraoperative Parathyroid Scores System in Thyroidectomy

Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy.

IPSS includes transplantation Parathyroid Scores and in situ Parathyroid Scores, the investigators will establish the Intraoperative Parathyroid Scores System by parathyroid size and Blood supply, and recording IPSS, according to certain rules. Parathyroid hormone and calcium were test in d0, d1, d14, d60 post operation. The correlation between Intraoperative Parathyroid Scores and PTH calcium were calculated, and ROC curve and logistic regression were tested for the prediction value.

Eligibility Criteria:
Inclusion Criteria:

1. postoperative pathology confirmed as thyroid papillary carcinoma;
2. for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy;
3. preoperative serum calcium, parathyroid hormone levels were normal;
4. intraoperative and postoperative clinical data integrity, standardized follow-up patients;
5. parathyroid is a tumor violation.

Exclusion Criteria:

1. serious underlying disease;
2. age greater than 60 years of age or combined with arteriosclerotic disease;
3. patients with postoperative loss;
4. patients with parathyroid disease.
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).


Eligibility Criteria:
Inclusion Criteria

- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Exclusion Criteria

* Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients

The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* Poorly controlled asthma;
* Average use of over 2 puffs of albuterol per day in the previous 7 days OR Having symptoms of asthma on 5 of the last 7 days OR Awakening at night due to asthma at least once in the previous 7 days OR Having been treated with a course of oral or intravenous steroids at least once in the last 3 months.

Exclusion Criteria:

* Subjects receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis;
* Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, oral or intranasal anticholinergics;
* History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis or cystic fibrosis;
* History and/or presence of any clinically significant cardiovascular disease, clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.
Neuropeptides and Venous Pelvic Pain

Mechanisms of the development of pain in chronic venous diseases (CVD), including pelvic congestion syndrome (PCS), are studied incompletely. The existing hypotheses of the occurrence of venous pelvic pain (VVP) do not allow to answer the question why some patients have no pain syndrome while others have very pronounced pain despite the same morphofunctional changes in the pelvic veins? The investigators are planning to carry out a study aimed at studying the content of calcitonin gene-related peptide (CGRP) and substance P (SP) in the serum of patients with pelvic veins and pelvic pain, and to study the relationship between the values of CGRP and SP in these patients.

The first phase of the study includes a set of 3 patient groups: the first is patients with pelvic vein dilation and blood reflux through them in combination with venous pelvic pain; the second is patients with pelvic vein dilatation without venous pelvic pain. The third, control group will include healthy female volunteers without pelvic veins and any chronic pain syndromes.

At the second stage of the study, a study will be made of the levels of calcitonin gene-related peptide (CGRP) and the substance P (SP) in the serum using an ELISA method. In addition, after studying the content of the CGRP and SP in the serum of volunteers, the investigators expect to obtain the reference values of these neuropeptides. In this phase of the study, a statistical analysis of the data obtained will be carried out, a correlation analysis between venous pelvic pain and the level of the CGRP and CP.

The data for each patient will be entered into a specially designed patient questionnaire. It will include clinical and ultrasound data, results of ELISA.

Eligibility Criteria:
Inclusion Criteria:

* The reproductive age of the woman
* Blood reflux in the parametric, uterine, gonadal veins
* The absence of any concomitant pathology, accompanied by chronic pelvic pain

Exclusion Criteria:

* The absence of blood reflux in in the parametric, uterine, gonadal veins
* The presence of diseases, the clinical course of which suggests the presence of chronic pelvic pain and other varieties of chronic pain, including migraine
* Pregnancy
Application of Manual Therapy to Archers

The aim of this study is to: (i) characterize the effect of repeated archery shots on the EMG parameters of certain selected upper limb muscles; and (ii) evaluate how manipulation of the initial two-second tension phase, in particular involving muscle stretching, affects these EMG parameters after repeated shots.

EMG measurements will be collected for selected muscles in the shoulder joint and forearm, at points: initially at the beginning, after the athletes have performed 50 and another 50 archery shots, and finally after undergoing manual therapy. The main phase of muscle testing will take place in the Aiming phase.

Eligibility Criteria:
Inclusion Criteria:

* Actively training as an archer at least twice a week for six months;
* In good health, with no recent injury or illness;
* Over 18 years of age;
* Engagement in all phases of the study.

Exclusion Criteria:

* Any injury or illness present at the time of the study;
* Recent history (within six months) of upper extremity injury (shoulder, elbow, or wrist), joint pain, lower extremity joint hypermobility, or neurological/connective tissue disease.
* No training participation
* No consent for study
Association Between Dose Dialysis by Kt and Mortality

The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* \> six months on hemodialysis
* Receiving 3 sessions of dialysis per week
* Having 5 or more valid measures of Kt during the month

Exclusion Criteria:

* active chronic inflammatory diseases
* Liver cirrhosis
* Neoplasms
* Chronic immunosuppression or use of anti-inflammatory
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).

The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 216 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U\&amp;CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U\&amp;CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.

Eligibility Criteria:
Inclusion Criteria:

* child will be 8 - 36 months old when study treatment will be delivered
* child has a diagnosis of Perinatal Arterial Stroke (PAS)
* parent permission to provide the child's clinical MRI to the study
* child has hemiparesis
* parent(s) willing to participate in the home therapy component
* one parent English language proficient and will take the lead in interacting with study staff and completing self-administered forms and interviews in English

Exclusion Criteria:

* child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)
* child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days
* child received botulinum toxin in past 3 months
* child is a ward of the state or other agency
Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels.

The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.

Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects aged 18 to 90
2. Able to provide informed consent
3. Willing to accept autologous or allogenic blood transfusion
4. Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Pre-operative administration of allogenic blood bank products in the previous 3 months
2. Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
3. Significant active infection or sepsis defined by positive blood culture or positive wound culture
4. Hemoglobin less than 7 g/dl
Intracoronary Tirofiban on No-Reflow Phenomena

The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct related arterial (IRA) flow related to better ventricular performance and lower mortality rate in patients with STEMI. In addition, no-reflow phenomena may limit the benefits of re-canalization of the IRA.

In recent years, many mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI. Although current guidelines recommend that small molecule GPI should be administered as an upstream bolus followed by a continuous infusion in patients with STEMI, changes in clinical practice may obviate the need for GPI dosage or routes in current practice. Previous studies have shown that intravenous and intracoronary administration of GPI improve the prognosis and significantly reduce mortality in patients with STEMI. Recently, the Ongoing Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial found that the use of tirofiban started during the pre-hospital phase as upstream therapy for primary percutaneous coronary intervention (PCI) and continued for up to 18 hours infusion after the procedure showed an improvement in the markers of reperfusion. Additionally, a reduction was demonstrated in the death in recurrent myocardial infarction in urgent target vessel revascularization and thrombotic bailout. However, in the current literature there are insufficient data regarding the role of intracoronary administration of GPI inhibitors in patients with STEMI who developed the no-reflow phenomenon. The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary PCI.

Eligibility Criteria:
Inclusion Criteria:

- Patients with ST-elevated myocardial infarction who developed no-reflow phenomena

Exclusion Criteria:

* Treatment with thrombolytic drugs in the previous 24 hours
* Known malignancy
* Pain to balloon time \>6 hours
* Uncontrolled hypertension (\>180/110 mmHg)
* Bleeding diathesis
* Thrombocytopenia
* End-stage liver disease
* Cardiogenic shock
* Renal failure
* Life expectancy of less than 1 year
* Contraindication for the use of tirofiban.
Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation

Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation.

Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation.

Stimulation protocol: The intensity and position of phrenic nerve stimulation were individualized. The frequency was set to 10Hz, 15Hz, and 20Hz. The duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital
* Patients receiving invasive mechanical ventilation (via endotracheal tube or tracheostomy)
* Patients who have been on invasive mechanical ventilation (via endotracheal tube or tracheostomy) for more than 48 hours
* Patients who have listened to and understood the explanation of the purpose and procedures of the study and have voluntarily agreed to participate. In cases where the patient has impaired consciousness or cognitive function and is unable to consent, the patient's legal representative has agreed to the patient's participation in the study.

Exclusion Criteria:

* Patients with implanted or externally applied electrical devices (such as pacemakers, defibrillators, implantable defibrillators, vagus nerve stimulators, spinal cord stimulators, gastric stimulators, diaphragm stimulators, etc.)
* Patients with a history of neck tumors, cervical spine instability, or neck surgery
* Patients with internal jugular vein catheters, infections, or inflammatory signs at the electrical stimulation site, making percutaneous phrenic nerve access impossible
* Patients with neurological or neuromuscular diseases that significantly affect respiratory muscle function
* Patients currently receiving neuromuscular blocking agents
* Patients already diagnosed with or suspected of having phrenic nerve paralysis
* Patients with elevated hemidiaphragm observed on chest X-ray
* Patients with pleural effusion occupying more than one-third of the pleural space or pneumothorax requiring chest tube insertion, as seen on chest X-ray
* Patients who are confirmed or presumed to be pregnant
* Patients with a body mass index (BMI) ≥ 40
* Patients for whom life-sustaining treatment has been decided to be withdrawn and who have no plans for active treatment