cyrilzakka/clinical-trials huggingface dataset:
A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function

NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening.
* Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups:
* For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min)
* Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min
* Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min
* Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
* Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure) as judged by the investigator.
* Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
Evolocumab in Acute Coronary Syndrome

Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

In a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in NSTEMI patients (1) decreases LDL-C during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by Positron Emission Tomography (PET) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months.

This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population. It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.

Eligibility Criteria:
Inclusion Criteria:

* Non ST segment elevation myocardial infarction
* Troponin I \>/ 5.0 ng/dL
* Permission of attending physician

Exclusion Criteria:

* ST elevation myocardial infarction
* Patients requiring invasive hemodynamic support
* Scheduled for cardiac surgery
* Current or prior treatment with a PCSK9 antibody
* Current participation in an intervention clinical trial
* Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
* Contraindication to statin therapy
* Subject likely not able to complete protocol related visits or procedures
* Latex allergy
* History of hypersensitivity to any monoclonal antibody
Changes in Lumbar Region Temperature During Auricular Acupressure at Kidney Point

In Traditional Medicine, auricular acupressure (AA) is one of the non-pharmacological treatment methods commonly utilized due to its safety and convenience. AA involves the application of a taped seed of Vaccaria (with a diameter of 2mm) on specific ear acupoints to manage various disorders. Among these, chronic lower back pain is prevalent. According to Traditional Medicine, the Kidney point is selected for this condition due to the belief that "The lumbar region is the house of the Kidneys". However, evidence supporting this correlation is still lacking. In this study, the aim is to assess the relationship between the Kidney point and the lumbar region by monitoring changes in skin temperature through the application of AA on this acupoint.

Healthy volunteers meeting all selection criteria and not violating exclusion criteria will be recruited for the study.

Before commencement, participants will acclimate to the environment for 15 minutes, allowing stabilization of blood pressure, heart rate, respiratory rate, and body temperature. The room will be enclosed and shielded, ensuring no direct sunlight or other radiation sources enter. Room temperature, pressure, humidity, and ventilation will be consistently maintained throughout the study.

The participants will be randomly divided into two groups: one receiving auricular acupressure (AA) first followed by sham auricular acupressure (SA) (AA-SA group), while the other group will receive SA first followed by AA (SA-AA group).

Blood pressure, heart rate, respiratory rate, body temperature, lumbar region temperature, and side effects of auricular therapies will be continuously monitored.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 23 kg/m2.
* Demonstrates alertness and cooperativeness.
* Vital signs within normal limits.
* Voluntary informed consent.

Exclusion Criteria:

* Anxiety, depression, or stress based on the Depression Anxiety and Stress Scales 21 (DASS-21).
* Presence of disorders or use of medications affecting body temperature.
* Received any form of heat therapy for the lower back within the past week (e.g., acupuncture, heat pads, patches, massage).
* Applied chemical or pharmaceutical products to the skin area under investigation prior to the study.
* Current disorders or pathologies in the lumbar region.
* Engaged in nighttime activities or experienced insomnia the night before the research day.
* Participated in sports activities within 2 hours before the study.
* Used stimulants within 24 hours prior.
* History of alcohol or substance addiction.
* History of hypersensitivity reactions to any form of acupuncture.
* Existing injuries or lesions at acupoints and areas investigated in this study.
* Women currently menstruating, pregnant, or breastfeeding.
* Prior experience with auricular therapies.
* Currently participating in other intervention studies.
Investigation of the Effects of Sedentary Behaviour and Moderate Exercise on Glucose Tolerance and Insulin Sensitivity

Individuals with pre-diabetes or diabetes would benefit from low impact methods that would improve their insulin sensitivity and aid in maintaining glucose homeostasis. Physical activity helps the body decrease its insulin resistance and burn excess sugar. Many diabetics also suffer from obesity and specific forms or durations of physical exercise may not be viable options for these individuals. Determining whether short bursts of moderate exercise improve blood glucose levels in healthy humans may identify a further method for diabetics to improve their glucose homeostasis.

The aim of this study is to determine the most effective moderate exercise that can be completed in 3 minutes and its effectiveness on improving glucose handling, in response to a single day of standardized high-fat and high-carbohydrate feeding in comparison to periods of prolonged sitting.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI between 18-30 kg/m²
* non-smoker

Exclusion Criteria:

* pregnant
* diabetes
* kidney disease
* liver disease
* cardiovascular disease
* cancer
Mutations, Hormone Therapy (HRT) and Venous Thromboembolism

To assess the interaction between hormone replacement therapy and the prothrombotic mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the incidence of venous thromboembolism (VTE) in a population-based case-control study conducted at Group Health Cooperative of Puget Sound (GHC).

BACKGROUND:

Epidemiologic studies have identified Factor V Leiden as the most common cause of heritable thrombophilia, a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of venous thromboembolism (VTE). In pre-menopausal women, the use of oral contraceptives is associated with a 4-fold increase in VTE risk, and the joint effects of oral contraceptive use and Factor V Leiden carriership increase the VTE risk of by a factor of 35. Recently, the results of several observational studies and randomized clinical trials suggest that in post-menopausal women, the use of hormone replacement therapy is associated with a 3-fold increase in VTE risk. Whether post-menopausal women with prothrombotic mutations experience a similar 20-fold increase in risk when they take post-menopausal hormones remains unknown.

DESIGN NARRATIVE:

In this case-control study, post-menopausal women with a first episode of objectively confirmed venous thromboembolism, and population-based controls were identified and recruited from the GHC enrollment files. Controls were frequency matched to the cases on age and calendar-year. Data collection included a review of ambulatory medical record and a telephone interview. The GHC computerized pharmacy database was used to assess exposure to hormone replacement therapy. A venous blood specimen was obtained from consenting subjects, processed into aliquots of white cells, plasma, and red cells, and stored at 70 degrees C prior to laboratory analysis. DNA was extracted from white cells, and molecular genotyping assays were conducted to assess carriership of prothrombotic mutations.

Eligibility Criteria:
No eligibility criteria
Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI

To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI

This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic，CK-MB.The major adverse cardiovascular events will be observed.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent must be obtained prior to any study procedure.
2. Age\>18 years.
3. Subjects of STEMI who underwent primary PCI within the first 12 hours.

Exclusion Criteria:

1. Allergic to Salvianolate injection
2. Mechanical complications
3. History of severe renal or hepatic insufficiency
4. Pregnant or breastfeeding women
5. Pool compliance,greater risks result from the study
The Effect of Processing on Food Reward

The minimally processed diets of our ancestors have been rapidly replaced by UPFs driving poor diet to become the leading risk factor for preventable death globally. Hence, it is essential to understand what properties of UPF are driving their overconsumption to reduce diet-related mortality. To address this gap in knowledge this proposal will test:

* If UPFs have a greater post meal metabolic response when compared to MPFs an essential signal for food reward
* Through the use of an auction task paradigm if UPFs overvalued and if this value is differentially encoded in the brain This study is a fully cross-over design in that each participant receives all conditions and therefore serves as their own control. All orders of foods will be counterbalanced. Although participants cannot be blinded to the conditions as they must be aware of the foods they are eating, they will not be made aware that the key manipulation is food processing. On different days participants will come to the lab and consume a meal containing either minimally or ultra-processed foods as determined by the widely used NOVA (not an acronym) scale. These conditions will be consumed in a whole room metabolic chamber allowing for simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). These measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial). All participants will also undergo a Becker-Degroot-Marschak auction paradigm that consists of foods that are either minimally or Ultra-processed in the MRI scanner. Food value will be measure in participants' willingness to pay for each food and Neural responses will be measured during presentation of the food cues.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5-24.9 kg/m2
* Not pregnant or planning to become pregnant during study participation Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
* Able to speak and write in English
* Participants must be able to see a computer display clearly with or without vision correction (eyeglasses, contacts).

Exclusion Criteria:

* Claustrophobia (this would make lying in an MRI scanner or indirect calorimetry canopy very uncomfortable).

  2. History of head injury resulting in loss of consciousness for more than 10 minutes 3. Current or past diagnosis of diabetes or metabolic disorder (thyroid disease, etc.) 4. Contraindications to MRI: Individuals with pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

  5. History of alcohol or drug dependence 6. Active neurologic disorder 8. Diagnosed eating disorder 9. Food allergies or restrictive diet
Biomarkers in Endometriosis

Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.

Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.

Eligibility Criteria:
Inclusion Criteria:

* primary infertility
* normal semen analysis of the partner
* normal BMI.

Exclusion Criteria:

* hormonal therapy in the last year,
* irregular menstrual cycle,
* previous pelvic surgery,
* history of previous pelvic inflammatory disease,
* smokers and patients with autoimmune diseases,
* malignant or suspected malignant diseases,
* previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries
Visual Performance Following Implantation of Presbyopia Correcting IOLs

The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* patients with normal ocular examination apart from cataract.

Exclusion Criteria:

* previous ocular surgery.
* ocular pathology or corneal abnormalities.
* an endothelial cell count below 2000 cells/mm2.
* corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).
Reliability of Kinovea Software for Measurement of Transtibial Amputee Knee Kinematics

The primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. The secondary objective was to calculate the absolute reliability by calculating the Standard Error of Measurement (SEM), SEM% and Minimal Detectable Change at 95% confidence interval (MDC95). The SEM value represents the extent to which a score changes during the repetition of the measurement. The MDC is the minimum change in the measurement that is considered a true change in the measured activity that is not due to error.


Eligibility Criteria:
Inclusion Criteria:

* Having a unilateral below-knee (transtibial) level amputation,
* Using a prosthesis and being able to walk with the prosthesis,
* Body mass index less than 30,
* No contracture in the intact or amputated knee.
* Not having had any surgery related to the knees.
Influence of Muscle Relaxation on a Closed-loop Anesthesia System

Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for a surgical procedure which not require a myorelaxation

Exclusion Criteria:

* age less than 18 years,
* ASA III and above,
* pregnant woman
* combined general and regional anesthesia,
* history of prolonged myorelaxation due to a decrease in cholinesterase,
* patient with a known lack in cholinesterase,
* history of cerebral or psychiatric central,
* allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
* known hypersensitivity to remifentanil or to an other derivative of fentanyl,
* presence of a pacemaker,
* psychotropic or agonist-antagonist morphine treatment,
* planned post-operative sedation.
Prospective Evaluation of Computerized Physician Order Entry in the Emergency Department

This study will evaluate various performance metrics of emergency department operations after the implementation of computerized physician order entry in an academic emergency department.

The study will be a prospective before-after study comparing various operational and performance metrics before and after the implementation of a computerized physician order entry system in the emergency department.

The investigators will collect 6 month before, 6 month after of data along with a 2-4 week washout period. The investigators will also administer a computerized physician order entry survey after the study is completed. This confidential survey will be emailed to all ED nurses, residents, and attendings using RedCap. Consent will be implied if they choose to participate.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive adult patients (Age \>=18) presenting to the Emergency Department during the study period will be included in the study.

Exclusion Criteria:

* Patients who eloped, left without being seen, or signed out against medical advice will be excluded.
A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions

A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 45 kg (99 lbs).

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive uring drug screen.
Comparing the Efficiency of Three Third-generation Supraglottic Airways as an Intubation Route

A "can't intubate, can't oxygenate" situation is life-threatening and the physician must be prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is associated with complications. In both of these situation and as recommend by different societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an intubation conduit to ease the airway access. The objective of this randomized controlled trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the fastest intubation time in an adult population, with the objective of minimizing complications related to these situations. The investigators will conduct a three-arm trial to compare different outcomes related to the installation of the SGA and its use as an intubation conduit. The results of this trial will inform the anesthesiologist on which device to use on to have close in case of airway emergencies.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* ASA score of 1-3
* Elective or urgent surgery planned to last at least 30 minutes under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Any contraindication to the use of SGA devices considered by the anesthesiologist (Uncontrolled gastro-eosophageal reflux, oropharyngeal pathology or gross deformation, etc.)
* Any contraindication to the drugs planned by the trial
* Pregnancy
* Severe or uncontrolled obstructive pulmonary disease
* Significant cervical spine anomaly
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin

Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia, and hemodynamic changes.

Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.

Eligibility Criteria:
Inclusion Criteria:

* Level III NICU consultants and residents will be eligible to participate in the study

Exclusion Criteria:

* There are no exclusion criteria for this study