cyrilzakka/clinical-trials huggingface dataset:
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.


Eligibility Criteria:
Inclusion Criteria:

* Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction
* Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a "large" complex procedure with the potential of blood loss more than 50% of circulating blood volume

Exclusion Criteria:

* A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
* Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries
* Body weight exceeding 135 kg
* Cardiac arrest following trauma and prior to surgery
* Known congenital bleeding disorders
* Known pregnancy or positive pregnancy test at enrolment
Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using SWE and MFI

Primary Objective:

To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment.

Secondary Objective:

To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI.

Methodology:

Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements. Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 - 89 years;
* Able to sign an informed consent document;
* Suspected MSK injury of the lower extremity (i.e. hamstring injuries and soft tissue injuries involving the ankle).

Exclusion Criteria:

* Prior fasciotomy of same limb;
* Hemodialysis grafts of involved extremity;
* Extremity wounds preventing ultrasound imaging.
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.

To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety over the 4 hour period following breakfast.

The subjects will be randomly assigned to one of these three breakfasts and then given a Visual analogue scales of hunger and satiety which will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on 2 other days separated by at least a week to repeat the breakfast test.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and are healthy.
* Taking no regular medications other than birth control or hormone replacement therapy.
* Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.

Exclusion Criteria:

* Are a woman who is pregnant or nursing a baby.
* Have gained or lost 8.8 pounds or more in the last 3 months.
* Have diabetes or a fasting blood sugar over 126 mg/dL.
* Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
* Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.
Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.

Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteer
* aged from 20 to 35
* affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
* who accepts to take part in the study
* who has given their written stated consent
* who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude .There will be no additional test

Exclusion Criteria:

* persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
* persons who take any medication or drugs influencing the autonomic cardiovascular control
Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia

Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Since few evidence-based resources exist, the investigators propose a study to generate, refine, and pilot test an education information sheet designed to promote advanced care planning among families of persons with dementia.

To determine the feasibility, acceptability and preliminary efficacy of an education information sheet to promote advance care planning among family members of persons with advanced dementia in long-term services and support facilities.

Introducing an education information sheet containing prognosis and outcomes will be feasible, acceptable, and increase self-efficacy and do-not-hospitalize decision preferences among family members of persons with advanced dementia.

Eligibility Criteria:
Inclusion Criteria:

* Family member of a person with a diagnosis of dementia (any type)
* English-speaking family member
* Family member of a person with dementia admitted to a nursing home

Exclusion Criteria:

* Inability to understand/read English
* Advance directive already in patient chart
Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

One hundred infantry recruits will be randomly assigned to two groups. Injuries will be monitored.

One hundred infantry recruits will be randomly assigned to receive experimental infantry boots (DEFINITE-REGULATOR) or standard issued boots (modified Belleville 390 TROP).

Overuse injuries and foot injuries will be monitored over a period of 14 weeks. The intervention group will wear experimental infantry boots and the controls will wear standard issue boots.

Eligibility Criteria:
Inclusion Criteria:

* Infantry recruits on selected base

Exclusion Criteria:

* None
Gastric and Autonomic Functions in Patients With Intragastric Balloon

The study aims to measure the effect of intragastric balloon on gastric function, particularly gastric accommodation and pace making, and the possible underlying changes in autonomic function

The intragastric balloon is a space-occupying device that is hypothesized to function by inducing early satiety. Additionally, insertion of an intragastric balloon causes delayed gastric emptying; longer gastric emptying times after balloon insertion are correlated with more weight loss. The exact mechanism of function, however, is not clear and likely multifactorial. The investigators hypothesize that the intragastric balloon causes weight loss by affecting gastric and autonomic function, including pace-making and accommodation, and that the difference in responsiveness among patients may be mediated by differences in gastric function.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo intragastric balloon implantation
* Ability to comply to study schedule.

Exclusion Criteria:

* Unable to give informed consent
* Currently taking prokinetic, anticholinergic or dopaminergic agents which could potentially modify gastric motility
* Have a history of bariatric or gastrointestinal surgery
* Pregnant or preparing to conceive a child.
Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome

This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.

This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.

Enrolled infants will be randomized to a control group and an acupuncture group.

The control group will receive nonpharmacologic and pharmacologic management as per our current standard of care.

The acupuncture group will additionally receive AA. Once the infant is enrolled, he/she will be randomized to the AA group or the control group. Both groups of randomized infants will be taken daily to a designated treatment room. Infants in the control group will not receive acupuncture, and will only receive observation in the treatment room and will have review of their EMR.

If in the AA group, the investigator will evaluate the infant using an ear point locator to determine active sites prior to each needle placement. Acupuncture infants will have needles placed in any active sites found in one ear (up to 5 needles). Acupuncture sites will be alternated daily between right and left ear.

Acupuncture will be discontinued on the same day as methadone is discontinued, or if infant is cleared to be discharged home on methadone, acupuncture is discontinued when infant reaches the discharge dose of methadone.

Data for both groups will be collected on the day of enrollment, every three days during study participation, and at hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
2. Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
3. May have any of the following additional diagnoses at the time of admission: late prematurity, hyperbilirubinemia, hypoglycemia, sepsis without hypotension, respiratory distress without requiring support, or temperature instability
4. Parents give written consent prior to starting pharmacologic treatment for NAS
5. AA needles are placed within 9 hours of infant's initial NICU Finnegan score \>4

Exclusion Criteria:

1. Helix or antihelix of ear is deformed and needle is unable to be placed
2. Skin condition around the ear
3. A suspected or confirmed genetic or metabolic syndrome
4. Department of Children and Families investigation results in termination of parental rights
Magnetocardiography Endocrine Registry

Endocrine disorders like Type 2 diabetes mellitus (T2DM) represent complex cardiometabolic disease processes affecting approximately 462 million individuals worldwide and is associated with a two- to three-fold increase in cardiovascular mortality. Individuals with T2DM are at an increased risk of developing cardiovascular disease. Research has shown individuals with T2DM and no previous history of coronary artery disease are still at similar risk rates for cardiovascular events as patients with a prior myocardial infarction. The MAgenetoCardiography ENDOcrine Registry (MACENDOR) study is designed to collect CardioFlux scans on a select group of volunteers who are high-risk patients with endocrine disorders. CardioFlux is used as a noninvasive magnetocardiography (MCG) tool that analyzes and records the magnetic fields of the heart to screen volunteers for heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 250 volunteers who present to the Genetesis facility for a 5-minute CardioFlux scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of enrollment
2. Patients deemed at risk for cardiovascular disease from endocrine disorders

Exclusion Criteria:

1. \< 18 years of age
2. Patients unable to fit into device
3. Non-ambulatory patients
4. Positive response(s) on CardioFlux Pre-Screening Form
5. Patients with claustrophobia or unable to lie supine for five minutes
6. Pregnant women
7. Poor candidates for follow-up (e.g., no access to phone)
8. Prisoners
Perifollicular Doppler in Natural Cycle In Vitro Fertilization

Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.

The goal of this study is to evaluate if there is a link, in natural cycle In Vitro Fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a natural In Vitro Fertilization cycle.
* Patient under 38 years old
* Body mass indice under 35
* Ovulatory cycles between 20-35 days

Exclusion Criteria:

* Patient with a stimulation In Vitro Fertilization cycle
* Patient with a naturalIn Vitro Fertilization cycle with egg donor
* Patient with a natural In Vitro Fertilization cycle with freezing embryo
* Smoking patient
* Diabetic patient
* Patient with treatment of antihypertensive drug, anticoagulant, antiplatelet, vasodilator
* Body mass indice over 35
* Patient over 38 years old
* Patient without ovulation or cycle over 35 days
* Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE) or micro TESE
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical history of T1D with \> 5 years of duration of insulin dependence
* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
* Stable diabetic treatment
* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

-Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures

The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.

This study is a prospective, multicenter, open-label, single-arm, PMCF study. The sample size for this study will be 50 patients. Eligible patients will be treated with Tripod-Fix on Day 0 and will be followed for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form prior to any study procedures
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Skeletally mature males and females
4. 1 painful VCF which meets all of the following criteria:

   1. Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points)
   2. VCF between T6 and L5
   3. VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.
   4. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).
5. Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.

Exclusion Criteria:

Tripod-Fix is not indicated for any other application other than that for which it is designed. contraindications for Tripod-Fix include, but are not limited to: .

1. Patient presenting a loss of vertebral height \>50% compared to estimated pre-fracture height
2. Sclerotic fracture
3. Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
4. Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
5. Active infection (systemic or in the target vertebra)
6. Patient suffering from a severe or uncontrolled systemic disease
7. Patient presenting a pathological fracture with the presence of a mass within the spinal canal
8. Patient presenting neurological damage caused by vertebral fracture
9. Patient pregnant or likely to be so or breastfeeding
10. Patient vertebral anatomy not compatible with the size of the implant or instrumentation
11. Fracture geometry making the insertion of the implant impossible
Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

This study will help enhance current understanding of the impact of Acute Normovolemic Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest tube drainage 24 hours post coronary artery bypass graft surgery (CABG) surgery.

Acute Normovolemic Hemodilution (ANH) involves the removal of the patients own blood immediately at the induction of anesthesia and replacement of this blood intraoperatively with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction, and reduction of the anticoagulant components of the blood associated with bleeding during cardiopulmonary bypass graft surgery. The collected blood is isolated from the negative effects of the cardiopulmonary bypass machine.. The collected blood is then stored in anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the patient in reverse order of collection at the commencement of surgery, leaving the most cell rich blood to be re-infused into the patient last. This study will evaluate the effect in patients with and without ANH utilization on; hemostatic markers, chest tube drainage 24 hours post CABG, and need for allergenic blood transfusion. Positive effects on the hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours post CABG, and reduced number of transfused red blood cells will indicate a positive correlation with ANH utilization during isolated on pump CABG surgery.

The benefits of ANH utilization in blood conservation will benefit patients by reducing their exposure to allogenic blood transfusion with its myriad side effects.

Eligibility Criteria:
Inclusion Criteria:

1. . Subject is 18-85 years old.
2. . Subject is hemodynamically stable
3. . The subject is able to read and has signed and dated the informed consent document including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization permitting release of personal health information as approved by the investigator's Institutional Review Board (IRB).

Exclusion Criteria:

1. . Hematocrit \<30 at baseline
2. . Insufficient (Low) on pump hematocrit of \< 21%
3. . Patient is hemodynamically unstable
4. . Patient requiring an emergency procedure
5. . Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
6. . Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.

Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors.

Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity.

The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men.

The investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.

A randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and 50 years with obesity (BMI 30-39.9) according to the World Health Organization (WHO) criteria without treatment.

They will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil or placebo every day at night during 28 days.

There will be evaluated Insulin secretion, both first phase of insulin secretion by Stumvoll Inex as well as Total Insulin Secretion by Area Under the Curve of glucose and insulin and Insulinogenic Index, and Insulin sensitivity by Matsuda index.

Waist circumference, glucose and insulin levels, lipid profile and blood pressure are going to be load will be evaluated before and after intervention in both groups.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.

This protocol was approved by a local Ethics Committee and written informed consent will be obtained from all volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Age: 30-50 years
* BMI: 30 to 39.9 kg/m²
* No Pharmacotherapy during the last 3 months
* Signature Consent under Information

Exclusion Criteria:

* Cholesterol: ≥ 240 mg / dl
* Triglycerides: ≥ 400 mg / dl
* Fasting glucose: ≥ 126 mg / dl
* Diabetes mellitus.
* Hypertension
* Patients with renal, liver and / or thyroid disease
* Consumption of drugs with known effects on glucose or insulin metabolism.
* Use of cigar and / or drugs
* Hypersensitivity to tadalafil