cyrilzakka/clinical-trials huggingface dataset:
Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.

This study will assess the bioavailability of aliskiren and valsartan as a single tablet compared to the same doses of the two drugs given as two separate tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects 18 to 45 years (inclusive) of age in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiogram, and laboratory tests at screening and baseline..
* Female subjects of child bearing potential must be using a double-barrier local contraception i.e. intra-uterine device plus condom, or spermicidal gel plus condom for at least 3 months prior to Study start or postmenopausal females must have had no regular menstrual bleeding for at least 1 year prior to inclusion (Menopause will be confirmed by a plasma FSH level of \>40 IU/L) or female subjects must have been surgically sterilized at least 6 months prior to screening with supportive clinical documentation.

and all female subjects must have negative pregnancy results at screening and each baseline (regardless of reported reproductive status).

* Body mass index (BMI) must be 18 - 30 kg/m2 (inclusive) and subjects must weigh at least 50 kg.
* Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure, 90-140 mm Hg, diastolic blood pressure, 50-90 mm Hg, pulse rate, 40 - 90 beats per minute (bpm)

Exclusion Criteria:

* Smokers (use of tobacco products within the previous 3 months). Smokers will be defined who reports tobacco use or has a urine cotinine value of ≥ 300 ng/mL.
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetominophen is acceptable, with supportive clinical documentation..
* Participation in any clinical investigation within a minimum of 4 weeks prior to dosing (or longer if local regulations apply).
* Significant illness within the 2 weeks prior to dosing.
* Lactating and breast feeding females.

Other protocol-defined inclusion/exclusion criteria may apply
Vitamin D Deficiency in Adolescent Girls

Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in adolescent girls and how these levels vary with other hormonal measurements. We will also be looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D alters the levels of FGF23 and other factors including insulin resistance.

Fibroblast growth factor 23 (FGF23) is a newly discovered hormone. Its primary function is to regulate phosphate metabolism, which it does both by directly regulating phosphate excretion through the kidney as well as by regulating vitamin D activity. What controls FGF23 levels is still under investigation; potential factors include dietary phosphate intake and vitamin D levels.

In this pilot study, we aim to investigate what the normal levels of FGF23 are in healthy girls and how these are related to other measurements of bone and mineral metabolism. Since vitamin D deficiency is very common in healthy girls, we expect a subset of the subjects in this study to be vitamin D deficient. We will then randomize these girls to vitamin D repletion or placebo and follow changes in FGF23 levels. Vitamin D deficiency has also been implicated in insulin resistance which is a precursor to diabetes. We will therefore also look at changes in insulin resistance with vitamin D repletion.

Eligibility Criteria:
Inclusion Criteria:

* healthy girls aged 9-18 years

Exclusion Criteria:

* significant cardiac, hepatic, oncologic, or psychiatric disease
* a history of malabsorption, kidney stones, hypoparathyroidism, or growth hormone deficiency
* pregnancy
* diabetes mellitus
* BMI\>/= 99th percentile for age and sex
* fracture within the preceding 3 months
* hypogonadism (no pubertal development by age 12, absence of menarche by age 14)
* serum calcium \<8 mg/dl or \>11 mg/dl
* radiographic evidence of rickets
* use of medications know to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (\>1000 units per day), excessive doses of vitamin D (\>20,000 units/day), calcitriol, growth hormone, or anti-convulsants.
* use of hormonal birth control
Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities

Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice.

One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes.

The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions.

The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles.

At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI.

The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of musculoskeletal disease (MSD) of the limbs;
* Need for mono- or polyaxial correction by one or more osteotomies;
* Presence of specific consent to participate in the trial;

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients who do not undergo radiological follow-up examinations for VSP or for whom the radiological record is insufficient to conduct VSP;
* Patients who undergo different interventions for correction of MSD (growth modulation interventions by epiphysiodesis and hemiepiphysiodesis, progressive correction by external circular/hexapodal fixation);
* Pregnant or lactating women
Food-Effect Study in Healthy Participants

This study will evaluate the effect of food on the pharmacokinetics (PK) of a single dose of lasmiditan in healthy participants.

An open-label, cross-over, two-period, randomized, sequential study in order to investigate the effect of food on the pharmacokinetics of lasmiditan 200 mg. Two single doses of lasmiditan will be administered with the participants in fed and fasted states.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-50 years.
* Able and willing to give written informed consent.
* Females of child bearing potential must be using or willing to use a medically acceptable method (as defined by the Investigator) of birth control.
* Body mass index (BMI) within 19 and 29.9 kilograms per meter squared (kg/m²).
* No clinically significant abnormalities (as determined by the Principal Investigator) in hematology, blood chemistry and urinalysis lab tests at screening.
* No history of alcohol or drug abuse within the past year. Negative urinary drugs of abuse and alcohol screen determined within 21 days of the start of the study and at check-in Day -1.
* Must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.

Exclusion Criteria:

* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
* Pregnant or breast-feeding women.
* Use of any prescription within 14 days prior to dosing (except hormonal contraceptives) or over the-counter medications, including vitamins and herbal or dietary supplements within 7 days prior to dosing unless approved by the Investigator and Medical Monitor.
* History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol; a positive urine screen for drugs of abuse or alcohol.
* History of orthostatic hypotension with or without syncope.
* At imminent risk of suicide (positive response to question 4 or 5 on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) or had a suicide attempt within 6 months prior to screening.
* Participation in any clinical trial of an experimental drug or device in the previous 30 days.
* Positive Hepatitis C antibody, Hepatitis B surface antigen, or positive human immunodeficiency virus (HIV) antibody.
* Donated plasma in the 7 days or blood in the 3 months preceding study drug administration.
* Inability to communicate well with the Investigator and study staff (i.e., language problem, poor mental development or impaired cerebral function).
* Inability to fast or consume the food provided in the study.
* Relatives of, or staff directly reporting to, the Investigator.
Understanding and Improving Diabetes Care for Ethnic Minorities

In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. The intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes
* At least one Hemoglobin A1c value greater than 7.5% in the year prior to recruitment.

Exclusion Criteria:

* Age above 80 years
* patients with dementia or other serious mental health problems that would prevent them from participating in the intervention.
* patients with other serious medical problems that would prevent them from participating in the intervention.
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide

Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.

GEHC has decided not to provide this detail

Eligibility Criteria:
Inclusion Criteria:

* Study subjects must be adults with confirmed or suspected aorto-iliac stenosis.
* The subject must have been referred for Digital Subtraction Angiography.

Exclusion Criteria:

* The subject has a known hypersensitivity to either conventional X-ray or gadolinium based MR contrast media including, but not restricted to, the investigational product.
* The subject is lactating.
* The subject is pregnant as defined by a serum or urine beta-HCG pregnancy test obtained within 24 hours before administration of the investigational product.
* The subject received or is scheduled to receive MRI contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product.
* The subject received or is scheduled to receive X-ray contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product.
* The subject received an investigational product other than OMNISCAN (gadodiamide) within 30 days prior to OMNISCAN administration or will receive an investigational product within the follow-up period proposed for this study.
* The subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months.
* The subject has a serum creatinine value of \>= 3.5 mg/dL (309.4 µmol/L).
* The subject has previously been included in this study.
* The subject has a contra-indication for MRI according to accepted clinical guidelines.
* The subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement.
Breakfast Consumption and Energy Balance in Active Adult Males

Exercising in the fasted state results in greater fat oxidation during exercise and results in decreased caloric intake in the meals after exercise. However, the studies that examine fasted vs. fed exercise utilize a carbohydrate-based breakfast, which can increase blood glucose and insulin concentrations, which is considered a negative consequence. A protein breakfast, which can increase satiety and rest of day energy intake could also increase resting energy expenditure as well as fat oxidation during exercise. However, comparisons between fasting exercise and pre-exercise breakfast macronutrient intake (i.e., carbohydrate vs. protein) have not been made. Therefore the purpose of this study is to investigate if eating breakfast and the composition of this breakfast before exercise has an effect on the food eaten throughout the rest of the day.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* regularly participate in exercise for at least 150 min per week
* run at least 3 days per week for 30 minutes
* able to complete a VO2max test
* able to exercise for 45 min moderate intensity exercise at one time without breaks

Exclusion Criteria:

* not participating in structured exercise of 150 min/week for the past 6 months
* not running at least 3 days per week for 30 minutes
* not attaining a VO2max of 50 ml/kg/min (60th percentile fitness classification according to the American College of Sports Medicine)
* currently smoke or quit smoking less than one year ago.
* diagnosed with or are being treated for a cardiovascular disease, high blood pressure, fibromyalgia, irritable bowel syndrome or a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol.
* food allergies or sensitivities.
* not willing to have blood drawn on 4 occasions during each trial (16 total times)
Dynamic Vision Testing and Concussion Management Dream Team 65

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play."

Eligibility Criteria:
Inclusion Criteria:

* • California State University Northridge athletes

  * Participants are able to give consent to participate in the study
  * Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
  * Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
  * Sampling of convenience on a volunteer basis

Exclusion Criteria:

* • Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.

  * The initial 6- condition BESS score is \>20 errors
  * The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test.
Effectiveness, Complications, and Mortality of TLE in Patients.

The number of devices for cardiac pacing and defibrillation has increased in recent years. However, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. The Achilles' heel of cardiac implantable electronic devices (CIEDs) is the risk of infections and lead failure, which, when untreated, can be the cause of poor outcomes and a high mortality rate. Abandoned leads predict serious adverse events, such as lead infections, death, electrical interference, or potential problems during future TLE procedures. Therefore, it is crucial to extract them, presuming the decision is warranted based on a patient's individual risk. TLE is a standard treatment for device-related complications, and while TLE procedures are relatively rare in comparison to the number of CIEDs that are implanted, the need for TLE has grown in recent years due to the aging population, an increasing number of upgrades of pacing systems, and a related rise in infection rates. According to the European Lead Extraction ConTRolled Registry (ELECTRa), the most frequent indication for TLE is CIED infection, with the majority of them being local infections. The second most common reason for TLE is lead dysfunction, which is observed in 38.1% of cases. In such cases, the treatment must be fast and effective. TLE is the first-line treatment for those patients and prevents further serious or even lethal complications. However, the goal of TLEis often to remove leads and also maintain access in the occluded vein by moving the sheath over the lead to the lead myocardial interface. TLE technology has recently shown substantial progress in improving the safety and effectiveness of the procedure. As a rule, single traction is the primary method of treatment, followed by more aggressive techniques such as locking stylet, mechanical sheaths, powered extraction sheaths, and femoral snares.

Data obtained in previous studies. indicated that identifying predictors of such undesirable adverse events appeared essential for optimizing the procedural technique. Another vital element to address were patients deemed at high risk of stricter follow-up and stronger secondary prevention strategies; notably, infected TLE patients have unique characteristics. The analysis of independent predictor outcomes could, thus, allow clinicians to better identify high-risk TLE patients. In light of this, the current registry aimed to investigate the composite short-term outcomes for infected and non-infected patients in real-world populations.


Eligibility Criteria:
Inclusion Criteria:

Consecutive patients who underwent TLE between 2016 and 2022 entered the EXTRACT Registry.

Exclusion Criteria:

- no
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice.

Investigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study

Oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. Due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. If the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid AF ablation would be unnecessary.

This would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.

Eligibility Criteria:
Inclusion Criteria: • subjects capable of giving informed consent,

* Male or female
* Aged between 18 and 80 years
* Undergoing ablation under general anaesthetic with planned isolation of the left atrial posterior wall or who have previously undergone either catheter or surgical ablation for AF with LA posterior wall isolation

Exclusion Criteria:

* Unable or willing to give fully informed written consent
* Turned down for general anaesthetic
* Pregnancy
* Terminal illness
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate.