cyrilzakka/clinical-trials huggingface dataset:
Cardiac Output in Children During Anesthesia

This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.

Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ.

Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and pediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the temporal patterns of cardiac output changes in otherwise healthy young children undergoing routine surgical procedures have not been systematically reported. This information is important since it will increase our understanding of hemodynamic changes in small children during anesthesia/surgery and would ultimately lead to a better anesthesia care in this patient population.

The primary objective of this pilot exploratory observational study is to describe temporal patterns of cardiac output in young children ( under18 months of age) during the perioperative period. The secondary objectives are to describe how changes in cardiac output are associated with (i) non-invasively-measured systemic arterial blood pressure; (ii) near-infrared spectroscopy; (iii) other anesthesia factors (arterial oxygen saturation, concentration of anesthesia agents, CO2 levels).

Eligibility Criteria:
Inclusion Criteria:

* age 0 to 17 months included
* undergo general anesthesia for surgery that is expected to last more than 30 minutes (combines anesthesia and surgical time)
* parental/guardian permission (informed consent) obtained
* ASA 1-3 status

Exclusion Criteria:

* structural/anatomical anomaly or other circumstances (e.g. patient positioning) making it difficult to apply the sensors to the body
* history of congenital heart diseases
* known allergy to electrodes' glue
* emergency surgery
* prematurity (born before 37 week PMA)
Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation

Advanced remote multi-parameter reporting during cardiac rehabilitation (MAPS-III). The primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the US for post-myocardial infarction (MI) patients with EF \> 35% while wearing the ZOLL AMS device for 30 to 60 days. Secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-MI cardiac rehabilitation period.

To collect baseline data on cardiac rehabilitation usage (referrals and completion) in recent post-MI patients with EF \> 35%.To collect data on AMS-derived biometric data (e.g. HR, activity) and arrhythmias, and subject-reported symptoms, beta blocker/ivabradine usage (dose/changes) and cardiovascular events. The participating centers will enroll consenting subjects in a sequential manner to avoid preferential selection of patients to participate in the study. Subjects will be consented by the center study staff, and if eligible will wear the FDA-cleared AMS device for 30-60 days. Subject demographic information and clinical history will be obtained at the time of enrollment. During the study period, the prescribing physician-investigator will be blinded to AMS data. Final subject follow-up will be at 3 months. A sample size of 150 subjects is estimated in order to have 100 subjects with at least 30 days of AMS use for analysis.

Eligibility Criteria:
Inclusion Criteria

1. Both male and female subjects who are between 21 - 75 years of age, inclusively
2. Subjects who are consented and enrolled into the study prior to discharge from the qualifying acute myocardial infarction
3. Subjects with a consistent EF \>35% post the qualifying acute myocardial infarction

Exclusion Criteria

1. Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, an implanted cardioverter defibrillator (ICD), a cardiac resynchronization therapy device, subcutaneous ICDs, pressure monitors, and loop monitors.
2. Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time.
3. Subjects with a skin condition preventing them from wearing the AMS device.
4. Subjects who are non-ambulatory for any reason.
5. Subjects who are self-reporting to be pregnant.
6. Subjects with comorbidities that would preclude adherence to a cardiac rehabilitation program - at the discretion of the physician.
7. Subjects participating or planning to participate in another interventional study during the protocol-defined study period
Trabeculectomy With Ologen

Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.

Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.

This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.

The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.


Eligibility Criteria:
Inclusion Criteria:

* Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.
* Indication for trabeculectomy with mitomycin-C

Exclusion Criteria:

* Unability to discontinue oral anticoagulants
* Difficulty in reading or speaking Dutch
* Previous ocular surgery (cataract surgery allowed)
* Pregnant and breastfeeding women
Investigating How the Brain Processes Different Experiences

The goal of this clinical trial is to test the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.

The main question\[s\] it aims to answer are:

PRIMARY AIM: Confirm that the conscious experience of open/closed correlates with P/PCC activation/deactivation.

SECONDARY AIM: Determine if changes in P/PCC activity predict clinical outcomes (GAD-7 scores) in individuals with moderate to severe anxiety after using an app.

Participants may be asked to:

* Complete a Zoom interview
* Complete online surveys at baseline and 2 months post-treatment initiation
* Complete MRIs at baseline and 2 months post-treatment initiation
* Wear a smartwatch and answer daily questions about their anxiety
* Use an app daily

Eligibility Criteria:
Inclusion Criteria:

1. 18 - 65 years
2. Able to travel to Brown University for research assessment
3. Able to speak English because all study activities will be conducted in English.
4. GAD-7 ≥ 10
5. Owns a smartphone

Exclusion Criteria:

1. If using psychotropic medication - not on a stable dosage at least 6 weeks
2. As needed (i.e., prn) benzodiazepine use
3. Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
4. MRI contraindications
5. Claustrophobia
6. Recreational drug use past 2 weeks
7. Alcohol abuse
8. Pregnancy or plans to become pregnant
9. Cohabiting with a study participant
10. Weight ≥ 300 lbs (due to inability to fit in scanner)
Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects

Teeth with furcation grade II defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade II defects with open flap debridement.


Eligibility Criteria:
Inclusion Criteria:

* Periodontal disease stage III or IV according to 2018 criteria
* Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs
* Competent to give consent

Exclusion Criteria:

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class II according to ASA classification
* Previous surgical therapy of included furcation defects
* Inability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected fractures/infractions
* Caries lesions in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention
The Impact of Professional Coaching on Early Career Academic Emergency Physicians

This research study is designed to answer the question: How does professional coaching impact early career academic emergency medicine physician goal attainment, leadership strengths, well-being, and burnout?

A recent systematic review and meta-analysis found coaching to have significant positive effects on goal attainment, well-being, coping skills, work attitudes, and goal-directed self-regulation. Randomized controlled studies of professional coaching have found significant positive effects in various settings including high school teachers and students, postgraduate students in a major university, and executives in the commercial, government, and education sectors.

Coaching provides the participant focused time with a trained professional who facilitates that participant's self-determined and self-directed problem-solving and change. Coaching helps the participant "get on the balcony" away from the action on the "dance floor" to see things from a different and broader perspective and, in doing so, enriches the participant's ability to generate options, challenge biases, understand the effects of emotions, and consider uncertainty.

This study also establishes the level of adult development of academic faculty and creates an initial qualitative dataset for further longitudinal study and theory generation for physician well-being, burnout, leadership strengths, and goal attainment.

Eligibility Criteria:
Inclusion:

* Emergency physicians
* Academic appointment of Instructor or Assistant Professor
* Work greater than 80% of their time in a residency and fellowship program approved by the Accreditation Council of Graduate Medical Education (ACGME), the American Osteopathic Association (AOA), or the Royal College of Physicians and Surgeons of Canada (RCPSC) will be invited to participate in the study.

Exclusion:

* Mayo Clinic emergency physicians are not eligible for this study.
Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.

In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might be related to time delay issues and to the measurement technology.

42 consenting patients undergoing elective off-pump coronary artery bypass grafting were included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed just above the eyebrows, and the sensors of the other monitor were placed just above the former sensors. The sensors placement was determined at random by a computerized randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All variables were recorded continuously. The study ended at the end of the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective off-pump coronary artery bypass grafting for at least 3-vessel coronary artery disease were eligible.

Exclusion Criteria:

* Patients with arteriovenous shunts, intracardiac shunts, a previous history of cerebrovascular accident, or stenosis of the internal carotid artery of \> 60% were excluded.
Non Stress Test and Music Performance

Today, many methods are used in the evaluation of intrauterine fetal well-being. Non-stress test (NST) method is mostly used in the non-invasive evaluation of fetal well-being during pregnancy and labor. NST is a procedure in which fetal heart sounds are recorded and the relationship between fetal movements and fetal heart beat is monitored.3 Various methods are used to minimize the psychological effects that occur during pregnancy. Among these methods, it has been seen in the studies in the literature that music, which is a non-pharmacological method, has a positive effect on the pregnant woman and the fetus. It is easy and enjoyable to listen to music during the routine non-stress test process. However, there are not enough studies to prove the effect of music.

The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.

expected

Eligibility Criteria:
Inclusion Criteria:

* Become literate
* Be in the 18-45 age range.
* Being at the 32nd and above gestational week
* Not carrying any risk factors during pregnancy (preeclampsia, IUGR, gestational diabetes, etc.)
* Have eaten at least two hours before the NST procedure
* No fetal defined cardiovascular disease
* The pregnant woman is open to communication and does not have mental or mental problems.
* Absence of auditory problems

Exclusion Criteria:

* Absence of illiteracy of the pregnant woman
* Uterine contraction in NST
* Pregnant women who need fetal distress and urgent intervention by the physician
Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-55 years old
* Total Cholesterol 200\~260 mg/dl or LDL-C 110\~190 mg/dl
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid

The recommended dosing regimen of zoledronic acid in Chinese osteoporosis patients is completely in accordance with the one of 5 mg per year abroad that based on the dosing regimen in Paget's disease. This dosing regimen lacks the actual supportive clinical data of Chinese patients. In addition, the overall incidence of acute phase response, the main adverse event after the first infusion, in Chinese patients is higher than that in Caucasian patients population. Moreover, the results of the similar drug clinical study in the Japanese patients shown that the purpose of effective treatment for osteoporosis could be achieved with half of the dosage in Caucasian population. Thus, it could be inferred from these that the dosing regimen of zoledronic acid might be inappropriate in Chinese osteoporosis patients. Therefore, the main purpose of this clinical trail is to compare the zoledronic acid pharmacokinetic and pharmacodynamic characteristic of different doses in Chinese postmenopausal subjects with low bone mass or osteoporosis and explore the best dosing regimen in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese postmenopausal women
2. Aged between 60 and 70.
3. Bone mineral density (BMD) values of less than 1 standard deviations (SD) below the normal adult mean.
4. Willing to participate in this study.

Exclusion Criteria:

1. Hypersensitivity to zoledronic acid or other bisphosphonate or zoledronic acid formulation (excipients).
2. Secondary osteoporosis.
3. Receiving the following drugs that affect bone metabolism prior to randomization:

(1) intravenous biphosphonates or denosumab. (2) oral biphosphonates, parathyroid hormone or its analogues, strontium, or fluoride within 12 months.

(3) glucocorticoid, steroids, immunosuppressive agents, calcitonin, calcitriol or its analogues, thiazides diuretics, long-acting estrogen/progesterone, or statins within 3 months.

4. Combine other diseases affect bone metabolism: osteogenesis imperfecta, hyperthyroidism, malignant tumors, Paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, liver failure, or renal failure.

5. Hyperthyroidism or hypothyroidism during screening.

6. Treatment with any investigational drug within the past 3 months.

7. Creatinine clearance \< 35 mL/min.

8. 25(OH)D level\< 20 ng/mL.

9. Serum calcium level \< 2.0 mmol/L (8 mg/dL), or \>2.8 mmol/L (11.0 mg/dL).

10. Fever, severe infections, severe injuries, or major surgical operation within 30 days.

11. ECG corrected QT interval (QTc) \> 480 ms.

12. Pending invasive dental procedure or in progress.

13. History of smoking within 6 months.

14. Diabetes with fasting blood glucose ≥ 7.0 mmol/L, or glycated hemoglobin (HbA1c) \>6.3%.

15. History of drug or alcohol abuse.

16. History of stroke, cerebral ischemic stroke, or cerebral hemorrhage.

17. Any physiological or medical condition which, in the opinion of the investigator, would preclude the participant from this trail.
The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery

This study will compare the incidence of postoperative nausea and vomiting during the first 24 hours following corrective jaw surgery (orthognathic surgery) in patients with and without nasogastric tube gastric decompression.

Postoperative nausea and vomiting (PONV) affects up to 60% of patients after orthognathic surgery. Multiple complex mechanisms contribute to the development of PONV, but gastric pooling of blood is speculated to be the primary stimulus in this type of surgery. Nasogastric (NG) tubes can be used for gastric decompression in the peri-operative period to evacuate gastric contents/blood, with an intent to minimize PONV. This study will directly compare the incidence of PONV in participants undergoing NG tube gastric decompression and those without NG tube gastric decompression in the first 24 hours after orthognathic surgery. Participants will be randomized into two groups including no NG tube gastric decompression or NG tube gastric decompression throughout the surgery with removal one one hour postoperatively. The presence of early and/or delayed PONV will be monitored to determine the impact of NG tube gastric decompression. This study will also evaluate the impact of other variables including type of anesthesia, length of surgery, type of surgery and patient factors on the incidence of PONV in this study population.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 16 at the time of consent undergoing orthognathic surgery for the correction of dentofacial deformities at the Victoria General Hospital during the study period.

Orthognathic surgery to include:

1. Patients who receive single-jaw surgery (i.e. BSSO \[Bilateral Sagittal Split Osteotomy\] only, or LeFort only).
2. Patients receiving double-jaw surgery (i.e. BSSO and LeFort).
3. Patients undergoing a functional genioplasty in addition to another osteotomy (i.e. BSSO and/or LeFort).

Exclusion Criteria:

* Patients will be excluded if they do not meet inclusion criteria or if they have risk factors known to directly impact PONV and/or cause delayed gastric emptying:

  1. Patients under the age of 16 at the time of consent.
  2. Patients contraindicated to undergo elective surgery, including pregnant patients.
  3. Patients undergoing a functional genioplasty procedure only.
  4. Patients taking GLP-1 receptor agonists).
  5. Patients with known gastroparesis.
Synbiotics and Growth

The primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In addition the infants' digestive tolerance of the formulae and frequency of morbidity will be investigated.

The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 weeks old. Growth and other measurements will be collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life. Although the study intervention formally ends at 16 weeks, it will be useful to have a follow up visit at 26 weeks to collect further data on the gut microflora in the sub-group of infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of benefit to the subject as they receive a weight check and clinical examination by a paediatrician and will be offered to all subjects (no invasive procedures will be carried out).

Eligibility Criteria:
Inclusion Criteria:

* Healthy new-born infant
* Infant is less14 days old on day of enrollment
* Birthweight between 2500g and 4500g
* Gestational age over 37 weeks
* Singleton birth
* Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
* Infant randomized in to a treatment group can expected to be exclusively fed the formula from enrolment until 16 weeks old
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Currently participating in another clinical trial
* Congenital illness or malformation that may affect normal growth
* Significant pre-natal and/or post-natal disease
* Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
* Receiving antibiotic treatment at time of enrolment or in the 5 previous days.
* Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment