cyrilzakka/clinical-trials huggingface dataset:
Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)

The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one year, and the incidence of adverse cardiovascular events.

The primary research question is whether early initiation of PCSK9 inhibitor therapy during hospitalization for ACS patients in a real-world Chinese setting can increase the rate of lipid goal attainment, shorten the time to reach guideline-recommended lipid levels within one year, and improve the risk of adverse cardiovascular events.

Researchers will compare three lipid-lowering strategies: PCSK9 inhibitor therapy (with or without statins ± Ezetimibe/Hybutimibe), statin plus Ezetimibe/Hybutimibe therapy, and statin monotherapy, to assess the potential of PCSK9 inhibitor drugs in accelerating lipid goal achievement and reducing adverse cardiovascular events in ACS patients.

Participants will:

Receive PCSK9 inhibitor therapy (with or without daily statins ± Ezetimibe/Hybutimibe) every two weeks, or daily statin plus Ezetimibe/Hybutimibe therapy, or daily statin monotherapy.

Undergo follow-up assessments of relevant laboratory indicators at baseline, 3 days after admission, discharge, and 1, 3, 6, and 12 months post-discharge.

Record the occurrence of major adverse cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. This hospitalization for ACS, which includes ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unstable angina pectoris (UA) with a GRACE score of intermediate to high risk.
3. Written informed consent must be obtained from eligible patients prior to study enrollment.
4. LDL-C ≥1.8 mmol/L in patients using statin; LDL-C ≥2.6 mmol/L in those not taking statin in the last 4 weeks.

Exclusion Criteria:

1. Received PCSK9 inhibitor therapy within 3 months.
2. Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.
3. Patient has a history of renal or cardiac transplantation.
4. The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.

Patients judged by the investigator to be unsuitable for enrollment.
Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries

In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF

In this study we investigate the relation between Red Cell Distribution Width and post operative atrial fibrillation after open heart surgery as it's a major complication with high incidence, this complication prolong the in hosoital stay, postulated mechanism of Post Operative Atrial Fibrillation that it's due to inflammation and oxidative stress, after applying specific inclusion and exclusion criteria, recording the preoperative labs including RDW and follow up patients 48 hours post operative in the ICU and recording post operative labs and ECG, and compare the RDW of patients developed POAF and patients who didn't develop POAF

Eligibility Criteria:
Inclusion Criteria:

* Female or Male patient with range of age 35-65 years
* Elective Cardiac surgery
* Cardiopuomonary bypass machine used
* Normal Sinus Rhythm

Exclusion Criteria:

* Echo showing left atrial diameter above 4 cm
* Patient on rythm control medications
* Patient undergoing emergency surgery
* History of cardiac Tachyarrhythemia
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial

The goal of this multisite clinal trial is to evaluate the implementation of the home-based Graded Repetitive Arm Supplementary Program (GRASP) at rehabilitation clinics across several hospitals. The main questions it aims to answer is:

• the efficacy of the home-based GRASP program relative to the conventional occupational therapy intervention on improving health outcomes, including UE motor function, daily function, quality of life, and motor control strategies.

Stroke participants will be randomly assigned to either the Home-based GRASP group or the conventional occupational therapy home program group. Each group will undergo an 4 to 6-week intervention (3 sessions/week) with evaluations conducted before, immediately after, and 3 months post-trial, assessing clinical and kinematic measures. Interviews and surveys will be conducted to gain insights into the perspectives of patients regarding the implementation of the home-based GRASP program.


Eligibility Criteria:
Inclusion Criteria:

* are aged 20 years or older
* have upper extremity hemiparesis due to the first-ever stroke
* have some voluntary movement in the affected UE
* are able to follow 2-step instructions

Exclusion criteria:

* orthopedic conditions affecting the arm/hand or other neurological conditions
* severe pain that prevents movement in the affected arm and hand
* unstable medical status
Dose Escalation of IPI-493 in Hematologic Malignancies

The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and schedule of IPI-493 in patients with hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* \>/=18 years old
* ECOG 0-1
* confirmed hematological malignancy
* refractory to available therapy or for which no therapy is available
* adequate hepatic, renal function

Exclusion Criteria:

* active CNS malignancy
* prolonged QT interval
* significant GI/liver disease
* other serious concurrent illness or medical condition
Can RFID Technology Capture Stair Walking

There are two main aims for this study:

1. conduct a proof-of-concept study illustrating how radio-frequency identification technology can be used to document the timestamps and duration of stair walking (ascending and descending stairs), and detect if an individual is stationary in the stairwell.
2. assess the association of a 4-min bout of self-paced stair walking with changes in blood pressure, mood, and perceived exertion.

Objective, passive methods for measuring physical activity participation can minimize error associated with self-report bias and cognitive processing. This study will test the utility of radio frequency identification (RFID) for the measurement of stair walking within buildings. RFID readers will be placed at stairwell entrances on each floor. Participants will wear a RFID tag. As the participant walks past the different readers going up and down the stairs, the reader will log the date and time. The frequency and duration of time in the stairwell can be calculated, as can an estimated speed.

There are known effects for blood pressure (hypotensive) and moodafter exercise. However, few studies have assessed this effect for short bouts (\<10 minutes) of exercise. Participants will have their pre- and post-stair walking blood pressure measured to determine the hypotensive and mood enhancing effects of four minutes of stair walking at a comfortable pace. Participants also will rate the exertion level of four minutes of stair walking at a self-selected pace.

Eligibility Criteria:
Inclusion Criteria:

* in desired age range

Exclusion Criteria:

* Unable to or uncomfortable climbing stairs
* Not cleared for exercise using the Physical Activity Readiness Questionnaire (PAR-Q+)
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.

Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age, or older
* have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
* have clear central corneas
* have a corneal thickness of 450 microns or greater at the proposed incision site
* have corneal transplantation as the only remaining option to improve their visual function

Exclusion Criteria:

* under 21 years of age
* have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
* do not have clear central corneas
* do not have a corneal thickness of 450 microns or greater at the proposed incision site
* do not have corneal transplantation as the only remaining option to improve their visual function
Ultrasound Guided IV Access in a Pediatric Emergency Department

The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.

The proposed study is a randomized trial of ultrasound guided IV access compared to traditional IV access in patients determined to have difficult IV access based on the Difficult Intravenous Access (DIVA) scale. Patients enrolled in the study will be randomized to traditional IV access or ultrasound guided IV access. If randomized to ultrasound guided IV access, the IV will be placed under direct visualization. Following IV placement or when attempts at IV access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding IV placement. The follow-up phase examining duration of the IV and any related complications will continue until the IV placed as part of the study has been removed.

Eligibility Criteria:
Inclusion Criteria:

* Emergency department patients ages 0-18 years
* Requiring IV access as determined by emergency department attending physician
* Predicted difficult IV access as defined by a revised DIVA score \>3

Exclusion Criteria:

* Unstable patients triaged as a Level 1 triage acuity
* Patients who refuse IV access
* Non-English speaking parent/guardian
* No study team member available to enroll patient
* Parent/guardian does not consent
* Allergy to ultrasound gel
Pre-emptive US Guided Superior Hypogastric Plexus Block in Pelvic Cancer Surgeries : a Randomized Double-Blinded Study

The superior hypogastric plexus (SHP) is a retroperitoneal structure with a predominance of afferent sympathetic nerve fibers. The perception of central pelvic pain is thought mainly to involve transmission through this plexus. Therefore, blocking or of SHP has been used to treat pelvic pain.

Ultrasound guided superior hypogastric plexus block there is 2 equal groups:

Group S (SHPB group 18 patients) ultrasound guided SHPB is done after induction of balanced general anesthesia (fentanyl, propofol and rocuronium) using 20 ml Bupivacaine 0.5% before skin incision, Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9% instead of bupivacaine. Patients of both groups will receive patient controlled analgesia using morphine with continous background infusion of morphine 1.5 mg/h with adding granisterone 2mg/60 ml and ability to give bolus of 0.5 mg morphine on demand.

• Dosing and administration; Group S (SHPB group 18 ultrasound guided SHPB ) using 20 ml Bupivacaine 0.5% before skin incision.

Group C (Control group 18 patients) in which same technique will be done but using normal saline 0.9%

Eligibility Criteria:
Inclusion Criteria:

* ASA II,III.
* Patients undergoing pelvic surgeries.

Exclusion Criteria:

* Patients refusal,
* Coagulopathy,
* Infection.
Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

The purpose of this study is to assess the effects in improving life self-care ability of stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos for 90 days.

The study is a randomized, double-blind, placebo controlled, multi-center trial. We aim to enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less than 72 hours after onset. Participants will be randomized into Tongxinluo capsule treatment group with the capsule administration of 4 granules tid. for 90 days, while the patients in the control group receive placebo capsule. NIH Stroke Score of the subjects is 4-22 at randomization. Evaluations of efficacy and safety will be taken at baseline, 7 days, discharge date and 90 days. Neuroimaging \[magnetic resonance imaging (MRI) scans\] will be obtained at baseline and 90 days after therapy. The primary efficacy endpoint is the proportion of Modified Rankin Scale (mRS) ≤1 at 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stoke within 72 after onset, confirmed by MRI or CT.
* Age 35-75 years, inclusive.
* Patients with the first attack or patients with stroke history(modified Rankin Scale score 0-1).
* Clear signs of localization of nervous system, NIHSS score 4 to 22.
* Patient or proxy has signed informed consent.

Exclusion Criteria:

* Hemorrhage diseases according to head CT or MRI, such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, haemorrhage after cerebral infarction.
* Transient Ischemic Attack (TIA).
* Severe disturbance of consciousness: 1a of NIHSS score\>1 point; Difficulty in swallowing, unable to take oral capsules; any of 5a, 5b, 6a, 6b of NIHSS score\>2 point.
* Convinced of stroke caused by brain tumor, brain trauma, hemopathy, etc.
* Hemorrhagic tendency patients.
* Patients with endovascular treatment after the onset of stroke.
* Patients with dementia, severe Parkinson's disease, mental disorders, limb dysfunction caused by other diseases or other conditions that may affect the therapeutic efficacy.
* Uncontrolled hypertension (≥200 mmHg systolic or ≥110 mmHg diastolic) or hypotension (≤90 mmHg systolic or ≤60mmHg diastolic); severe hyperglycemia(blood glucose ≥400 mg/dl) or hypoglycemia( blood glucose≤50 mg/dl).
* Severe hepatic insufficiency defined as transaminase values \> 2x upper limit of normal; severe renal insufficiency defined as values serum creatinine\> 1.5x upper limit of normal; cardiac dysfunction or other serious systemic disease with life expectancy ≤3 months.
* Patients with concurrent malignancy or ongoing anti-tumor therapy.
* Patients with history of being allergic to the trial medicine.
* Pregnancy, breastfeeding or potential pregnancy.
* Within three months or currently participating in another investigational study.
* Any other condition that in the opinion of the investigator should preclude study participation.
Colposcopy Education Using Operant Learning

Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education

Identifying information will be removed and operant learning techniques will be applied to better educate residents on colposcopy.

Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent
* age 21or older
* undergoing clinically indicated colposcopy

Exclusion Criteria:

* under 21 years of age
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia

Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
2. ASA class 1-3

Exclusion Criteria:

1. Patients with coagulation abnormalities
2. End organ diseases of liver, lung or kidney
3. Severe aortic stenosis
4. High degree AV block
5. Heart failure
6. Patients on MAO inhibitors
7. History of seizures or epilepsy
8. Glaucoma
Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery

The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).

The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30). The total study population size (N = 60) was determined by power analysis using a free online calculator for continuous variable comparison with two-sided equality. The hypotheses for this study is that a trigeminal nerve block LB-ERAS will confer better pain control to patients undergoing OGS compared to conventional bupivacaine and no ERAS protocol. We speculate that hospital stay, pain scores, duration to first postoperative oral intake, opioid pain medication requirements, and ORAE's will all be less in the TG than the CG. We postulate that the volume of oral nutrition tolerated in the first 48-hours postoperatively will be greater in the TG than the CG. Liposomal bupivacaine will be injected after a minimum of 20 minutes have passed since the pre-operative nerve block was administered. The patients' subjective pain experienced will be quantified by a traditional 10-point visual analogue score (VAS) in the post-anesthesia care unit (PACU), at time of admission to the post-operative recovery room, throughout the inpatient recovery period, and at time of discharge. The time to tolerance of first oral intake will be measured in hours. The amount of first-48-hour oral intake will be measured in milliliters (mL). We believe that a LB-ERAS protocol will result in lower necessary doses of opioid pain medications. This will be measured as first 48-hour total mg/kg dosage of opioid pain medication converted to oxycodone-equivalents by standard conversion ratios. The incidence of ORAE's will be tallied by the number of necessary prn doses of symptomatic management anti-pyretic and anti-nausea medications. We expect this to be lower in the TG. The degree of respiratory suppression will be measured by first 48-hour respiratory rate between CG and TG patients, which we expect to be lower in the CG relative to higher opioid pain medication totals.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing orthognathic surgery at Dell Children's Medical Center will be intended for inclusion in the study.

Exclusion Criteria:

* Only those patients with insufficient data in their medical records or contraindications to the administration of liposomal bupivacaine (hepatic disease or allergy to amide local anesthetics) will be excluded from the study.
Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery

The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH, ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. As a primary outcome, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

Background: The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH(n=29), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH (n=29)is not applied. Intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning from CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH). As a primary outcome, the inter-group difference between maximal clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control. As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, and s-Cr are determined Intergroup differences of data at T2 are performed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

Exclusion Criteria:

* preoperative renal failure requiring reran replacement therapy
* preoperative liver disease
* preoperative low cardiac output (EF \< 50%)
* Preoperative IABP application, Atrial fibrillation, Pacemaker
* contraindication for applying TEE
* intraoperative withdrawal