cyrilzakka/clinical-trials huggingface dataset:
Myocardial Deformation Imaging After Acute Alcohol Excess

Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac dysfunction. In general, patients consuming alcohol more than five years are at risk for the development of dilated cardiomyopathy. As only few data about immediate changes in left ventricular function after acute excessive alcohol ingestion are available, this study sought to close this gap.

Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12 hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography will performed at baseline and at follow-up regarding conventional parameter \[as left ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)\] and myocardial deformation data \[as layer specific global circumferential (endo GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain\].


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects who are not used to alcohol
* subjets who had an excessive alcohol Ingestion up to 12 hours before echocardiography

Exclusion Criteria:

* any heart disease
* subjects under 18 years
Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
* Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
* Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

* Study eye with zonular laxity or dehiscence.
* Study eye with pseudoexfoliation.
* Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
* Study eye with diabetes with any evidence of retinopathy.
* Study eye with evidence of glaucomatous optic neuropathy.
* Study eye with history of uveitis.
* Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Subjects taking systemic medication that may increase sensitivity to UV light.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* Study eye with history of ocular herpes simplex virus.
* Study eye with history of a congenital color vision defect
Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children

Postoperative ileus is common in children. There are various method to prevent postoperative ileus. In this study, the investigators will explore the role of sucking lollipop after operation on the recovery of gastrointestinal function in children.

Postoperative ileus is a common occurrence among children undergoing major operations, including gastrointestinal and spinal surgeries. It can result in physical discomfort, extended hospital stays, delayed resumption of activity and poor satisfaction with surgical care. The pathophysiology and course of postoperative ileus occurs in three phases: increased sympathetic activity, release of inflammatory mediators and vagal activation as ileus resolves. Multiple risk factors of postoperative ileus have been identified in various studies, including general risk factors such as significant blood loss, male gender and medical comorbidities like chronic obstructive pulmonary disease (COPD), as well as risk factors specific to the surgery, such as the laparotomy approach, emergency surgery and stoma formation.

Chewing gum, as a form of sham feeding, has been employed in adults and children as a modality to decrease risk of postoperative ileus. There has been concrete evidence that it could result in expedited recovery of gastrointestinal function after surgery in adult populations. However, it may not be a feasible option for infants and young children. Lollipop, on the other hand, is easier to apply in children which only require the action of sucking. It can stimulate the cephalic phase of digestion via vagal cholinergic stimulation and release of gastrointestinal hormone (gastrin and motilin) through its taste and absorption of sugar. The current evidence of lollipop in the recovery of postoperative gastrointestinal function in children is limited with only two randomised controlled trial published so far with satisfactory outcomes, yet both were not indexed and were not carried out in accordance with Consolidated Standards of Reporting Trials (CONSORT). Based on these reasons, the investigators plan to carry out a prospective, multiple-centred, non-blinded, randomized controlled trial using a parallel arm design on the effect of lollipop on recovery of gastrointestinal function after operation in children. Children recruited will be randomly assigned into either lollipop group or non-treatment group; lollipop will be given to children in treatment group after operation. Their outcomes will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving major abdominal surgery (e.g.appendicectomy, choledochal cyst surgery, bowel resection etc)

Exclusion Criteria:

* Patients with neurological conditions that preclude sucking/swallowing.
* Patients under sedation and/or mechanical ventilation and/or ionotropic support in the post operative period.
* Patients with known food allergy or allergy to food coloring agents
Omecamtiv Mecarbil Post-trial Access Study

The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
* Participant has completed GALACTIC-HF.

Exclusion Criteria:

* Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason.
* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment.
* Female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment.
* Female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
Heart Rate Variability Augmentation With RR2 Neuromodulation Device

Brief Summary: A randomized double-blinded, sham-controlled, crossover study

Condition or Disease: impaired autonomic balance measured by heart rate variability

A randomized double-blinded, sham-controlled, crossover study

Condition or Disease: impaired autonomic balance measured by heart rate variability

Intervention/treatment:

Device: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation system

Study Design:

Study Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation: Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in healthy adults

Eligibility Criteria:
Inclusion Criteria:

-

Inclusion criteria :

1. Healthy male and female volunteers ages 25-60
2. 2 minute HRV measurement with SDNN\<35 ms (below 35 ms)
3. Participants able and willing to comply with the study protocol
4. Participants able and willing to sign a written informed consent

Exclusion Criteria:

-

Exclusion criteria :

1. Participant with a known cardiovascular disease
2. Participants with COPD
3. Participants with any known history of epilepsy
4. Participants with detected arrhythmia on test day
5. Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.)
6. Heavy smokers (more than 1 package of cigarets a day)
7. Participants with a plan to change medications
8. History of vasovagal syncope
9. Pregnancy or bleeding
10. Participants enrolled in another clinical trial
Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)

This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays


Eligibility Criteria:
Inclusion Criteria:

* Subject has BMI (Body Mass Index) less than 32 kg/m\^ 2
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months
* Subject does not have a history of any bleeding disorder

Exclusion Criteria:

* Subject is a pregnant or nursing female
* Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)
* Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)
* Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort)
* Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies
* Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study
* Subject regularly uses antacids or other OTC medications (4 or more times per month) for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e.g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years
* Subject has a history of poor wound healing or a tendency to form keloids
Regional Anesthesia in Hip Arthroscopy

The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.

Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
* Age 18-45 years old
* Not pregnant
* No history of neuropathic pain
* No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
* Willing and able to comply with post-operative hip arthroscopy protocol
* No documented allergy to anesthetic agents
* Able to attend follow up appointments

Exclusion Criteria:

* Allergy to regional anesthetic
* Age \<18 or \>45 years
* Pregnant females
* History of neuropathic pain
* Radiographic signs of osteoarthritis (Tönnis grade 2)
* Unable to speak/understand English
* Currently imprisoned
* Unwilling/unable to provide consent
Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Ossification of Posterior Longitudinal Ligament(OPLL) by observation inpatients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with OPLL and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2019.12.31.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Vernon-Mior Neck Disability Index (NDI), quality of life, and Patient Global Impression of Change (PGIC), etc.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with OPLL by C spine X-ray or MRI or CT
* Paithents who was admitted to Jaseng hospital of Korean medicien.
* Patients have agreed to participate the study.

Exclusion Criteria:

* Patient hospitalized under 3 days
* Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
* Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, fibromyalgia, rheumatoid arthritis, gout, and so on)
* Patients had cervical spinal surgery within 3 months
* Patients diagnosed with C spine fracture by C spine X-ray or MRI or CT
* Patients deemed unable to participate in the clinical research by other researchers
* Patients haven't agreed to participate the study.
MDR SureLock All-Suture Anchor

To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.

Patient-reported outcomes data have been collected among patients undergoing shoulder labrum repair with SureLock all-suture anchors from January 2014 to June 30, 2020. These patients have completed clinical and quality-of-life outcome instruments pre-operatively, and have been stored securely in the OBERD database. Pre-op scores will be compared to post-op scores and analyzed using a one-way ANOVA test with a post-hoc Scheffe procedure.

Patient identifying information will be removed and de-identified codes will be used. Any new prospective data gathered prospectively for the purposes of this study will be entered and stored securely as above.

Data collection forms will consist of the following Patient-Reported Outcome Surveys: WOSI Index, ASES Shoulder Score, and the SF-12.

Eligibility Criteria:
Inclusion Criteria:

* 14 to 45 years of age
* Surgery performed between 1/1/14-12/31/2021
* Recurrent shoulder instability resulting from an isolated anterior and/or posterior glenoid labral tear
* Completed pre-operative data (WOSI, ASES, SF-12)

Exclusion Criteria:

* Diagnosis of concomitant SLAP tear
* Diagnosis of concomitant full-thickness rotator cuff tear
* Greater than 10% loss of glenoid bone
* Greater than 25% humeral head defect
* Prior surgical intervention for the treatment of shoulder instability (in either the affected shoulder or the contralateral shoulder)
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult subject ages 18-64 years.
2. Individuals willing to provide written informed consent
3. Individuals in good health.
4. Individuals who can comply with study procedures and follow-up.

Exclusion Criteria:

1. Individuals with history of cognitive or behavioral impairment or psychiatric disease,
2. Individuals unable to understand and follow study procedures,
3. History of significant illness,
4. History of chronic medical condition or progressive disease,
5. Allergy to any vaccine component or adverse event related to a vaccine component,
6. Impairment/alteration of the immune system,
7. Presence of progressive or severe neurological disorder,
8. Pregnant or breast-feeding,
9. Female of Child-bearing potential unwilling to use acceptable method of birth control,
10. Presence of medically significant cancer,
11. Receipt of investigational product within 30 day prior to entry into the study,
12. History of previous or suspected illness from avian flu caused by H7N9 virus,
13. History of H7 vaccination,
14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
17. History of drug or alcohol abuse within the past 2 years,
18. Body Mass Index (BMI) greater than or equal to 35kg/m2,
19. Individuals conducting the study or their immediate family members.
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

This is a prospective, multi-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA) and participants with celiac disease (CeD) and type 1 diabetes (T1D). This study will enroll HAs only in Part A and CeD and T1D patients only in Part B.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing (Day 1).
* Healthy individuals without known current or chronic medical conditions, including no history of any autoimmune diseases, in the opinion of the Investigator.
* Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2.
* Body weight ≥ 45and ≤ 100 kg.
* Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to each dose.
* Persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from Day 1 through the duration of the study.

Exclusion Criteria:

* Clinically significant findings in physical examination (PE), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ECG), and safety laboratory parameters at Screening in the opinion of the Investigator.
* Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation with estimated glomerular filtration rate (eGFR) \&lt; 90 mL/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of Screening.
* Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
* Receipt of an investigational drug within 28 days or 5 half-lives (whichever is longer) of the investigational drug(s) prior to Day 1.
* Positive serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis (Hep) B surface antigen, or Hep C.
* Positive test results for drug screen, including alcohol, at the time of Screening or on Day 1 prior to randomization.
* Use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/week within 30 days prior to (first) dosing.

Participants must abstain from nicotine use while inpatient.

* History of receiving a live vaccine within 1 month of Screening.
* History of splenectomy.
* History of COVID or influenza vaccine within 2 weeks prior to Screening.
* Planning to receive any vaccinations during the study period.
* History of recurrent infections of uncertain cause.