cyrilzakka/clinical-trials huggingface dataset:
Fixation for the Treatment of Femoral Neck Fractures

The femoral neck fracture is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other .

The incidence of femoral neck fracture accounts for 3.6% of all fractures, is the most prevalent injuries which commonly encountered among older people with high mortality, morbidity and young fit healthy ones who subjected to high-energy trauma . Non-union or avascular necrosis of femoral neck fracture which lead to loss of labor capacity and death, is the most commonly occurred complication and results in considerable burden for family. The treatment is difficult and challenging, and to minimize the negative results such as limited mobilization or other complications, it is essential to take active prevention and appropriate treatment depending on fracture pattern and patients' characteristics as early as possible. However, current implant selections for femoral neck fractures remain a topic of greater interest and controversy, and vary substantially from each other depending on the extent of displacement, fracture configuration, physiological age of the patient, bone quality or other relative factors. Nonoperative management is considered only when patients are seriously ill or presented with excessive surgical risk.

Eligibility Criteria:
Inclusion Criteria:

* closed femoral neck fracture
* no fractures at other sites
* surgical treatment with cannulated compression screws or PFNA
* follow-up time greater than 1 years.

Exclusion Criteria:

* the absence of severe cognitive dysfunction,
* the presence of a pathological femoral neck fracture
* previous femoral neck fracture, treated with other internal fixations and surgical treatment with open reduction.
CORE-COMPARE Pilot Study

The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans.

The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21-85 years
* Clinical history suggestive of CHD who are referred by their primary cardiologist for further evaluation via Computed tomography angiography (CTA) will be asked to participate.
* Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
* Ability to understand and willingness to sign the Informed Consent Form.

Exclusion Criteria:

* Known allergy to iodinated contrast media.
* History of multiple myeloma or previous organ transplantation
* Elevated serum creatinine (\> 1.5mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula
* Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
* Evidence of severe symptomatic heart failure (NYHA Class III or IV);
* Known or suspected moderate or severe aortic stenosis
* History of prior percutaneous coronary intervention (PCI) in one or more vessel or history of coronary arterial bypass grafting (CABG)
* Suspected acute coronary syndrome
* Presence of any other history or condition that the investigator feels would be problematic
Effects of Real-time Feedback During Decline Walking on Kinematic and Kinetic Gait Parameters in a Healthy Population

Control of the dynamic functional leg alignment (dFLA) and biomechanical load are important joint related aspects regarding the development of osteoarthritis (OA). Research on level walking with feedback on load related parameters provided innovative treatment possibilities. Concerning walking on sloped surfaces, fundamental biomechanical knowledge exists. However, deeper insights into the control of the dFLA during decline walking, and the usefulness of real-time feedback are missing.

This study is set up as cross-sectional observation of gait under four conditions, which follows a randomized sequence in order to avoid carry over effects. Thirty (30) participants aged between 18 and 35 years will be included. They will complete a three-dimensional gait analysis on a 5-m ramp with 10° inclination. Afterwards they will be observed under four different conditions a) self-paced walking b) self-paced walking with internal focus of attention, c) self-paced walking with real-time feedback, and d) condition c speed-matched walking, on a 10° declined split belt treadmill. The primary outcome parameter will be the frontal knee range of motion (fKROM). Secondary outcomes include the ground reaction force loading rate, spatial-temporal parameters, sagittal frontal and transversal kinematics, and kinetics for the lower extremities.

The findings should improve the understanding of effects of real-time feedback on the control of the dFLA and lower limb loading. Results will be published in a peer-review journal.


Eligibility Criteria:
Inclusion Criteria:

1. age from 18-35 years
2. body mass index from 18.5 to 29.99 kg/m²
3. no chronical joint diseases and/or OA surgery
4. no neuro-motor diseases

Exclusion Criteria:

1. non-physiological and non-symmetrical gait patterns
2. severe outliers (more than two standard deviations)
Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth

Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication with only a third of survivors . It is due to a series of phenomena involving microcirculation disorders . Cerebral oximetry is a new technique to evaluate the microcirculatory status . To this day it is used in cardiovascular surgery at risk of cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of action seem to change all the phenomena responsible for microcirculatory reperfusion disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C. However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.

The hypothesis of this study is that cerebral oximetry value will be different in patients subjected to two different levels of therapeutic hypothermia in the aftermath of an extra- hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying the benefit of this technique.


Eligibility Criteria:
Inclusion Criteria:

* Patient presented with an extra-hospital cardiac arrest resuscitation and to benefit from therapeutic hypothermia using a servo system to its temperature (CoolGard 3000 ® system)
* Age\> 18 years and \<80 years

Exclusion Criteria:

* Major Patient protected by law
* Private person administrative or judicial freedom
* Neurological or traumatic cause of cardiac arrest
* Pregnancy
Sutureless vs Sutured Gastroschisis Closure

This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.

Eligibility Criteria:
Inclusion Criteria:Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.

Exclusion Criteria:Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.
Value of Chest Ultrasonography in ILD Screening

The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation.

Interstitial lung disease (ILD) refers to a group of disorders that are characterized by varying combinations of inflammation and fibrosis involving the space between the epithelial and endothelial basement membranes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) diagnosed with ILD
* All patients must fulfil the 2018 criteria for HRCT chest finding for the diagnosis of Usual interstitial pneumonia (UIP) form

Exclusion Criteria:

* Patients with cardiac diseases (Left-sided Heart failure, pulmonary edema) \[they may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings\].
* Patients with chronic kidney diseases (as patients presented with nephrogenic pulmonary edema may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings).
Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism

The aim of the project is to identify new risk indicators of PFO. The evaluation of the R-L shunt is based on the newly developed precise measurement technique. Moreover, this measurement of R-L shunt is feasible in a case when R-L shunt is present only intermittently. Multicentric study with 150 patients.

The aim of the proposed project is to identify new risk indicators of PFO. The evaluation of the R-L shunt is based on the newly developed precise measurement technique. Moreover, this measurement of R-L shunt is feasible in a case when R-L shunt is present only intermittently.

Detection and quantification of R-L shunt will be realized by the original INNTHERM® ® system (Innova Medical s.r.o., Velká Dobrá). This system is based on the principle of thermodilution.

The basic assumption of our study is the hypothesis, that the size of the R-L shunt (and especially its maximum size during intra-abdominal pressure increase) is a risk factor for the development of paradoxical embolism (from pulmonary to systemic circulation). The most critical consequence of paradoxical embolism is the development of ischemic stroke.

Such measurement with an unequivocal accuracy has never been done so far, due a lack of technology precise enough.

Precise quantification of R-L shunt will allow a more accurate prediction of high-risk patients, especially after correlation with commonly used methods. PFO is now an indication for implantation of percutaneous occlusion device only in case of secondary prevention of stroke, i.e. in a group of patients who have had an ischemic stroke.

Prospectively, precise and better identification of a risk group of these patients could lead to cost reduction of treatment. This cost reduction is crucial for young working-age patients who can be treated before a major irreversible brain injury occurs.

A parameter applicable in primary prevention saves the cost of ischemic stroke treatment and other systemic embolism; additionally it will contribute to cost reduction during aftercare treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥18 and \< 60 years
2. Cryptogenic stroke or Systemic embolization due to paradoxical embolization via Patent Foramen Ovale
3. The patient indicated for occlusion of PFO with catheter occluder

Exclusion Criteria:

1. Inability to perform spiroergometry
2. Inability to perform Transesophageal echocardiography (TEE)
3. Inability to perform proper Valsalva maneuver
4. Inability to understand and/or signed informed consent form
5. Contraindication of Patent Foramen Ovale occlusion by any medical reason or patient refusal
Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial

The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.

The Jarvik 2000 Heart is a silent compact axial flow impeller pump of 1 inch diameter, weighing 90g with a displacement volume of 25ml. The pump is implanted into the apex of the left ventricle by left thoracotomy, or by mid-sternotomy, or by the subcostal approach. A vascular graft offloads to either the descending thoracic aorta, the ascending thoracic aorta, or the abdominal aorta. The impeller rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to seven L/minute. At higher speeds the pump can produce 10 L/minute. Power is provided through an abdominal drive line.

Eligibility Criteria:
Inclusion Criteria: (The following are general inclusion criteria; more specific criteria are outlined in the study protocol).

* Transplant listed UNOS status IA or IB patients.
* BSA \>1.5 m2 and \<2.3 m2.
* Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP).

Exclusion Criteria:(The following are general exclusion criteria; more specific criteria are outlined in the study protocol).

* Known risk factors or conditions that would contraindicate LVAD implantation or adversely affect patient survival.
* Evidence of end organ dysfunction.
* Known coagulopathy or contraindication of anticoagulation or antiplatelet agents.
* Systemic infection.
* Malignancies not in remission.
* Current participation in investigational trials with other devices, drugs, or biologic agents.
Balloon Tamponade Vs B-Lynch In Placenta Previa

Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

After approval from hospital ethical committee, patients fulfilling the inclusion \& exclusion criteria were recruited after taking informed written consent for surgery. Patients were allocated to group A and B using computer generated random sample allocation.

In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters.

In group B, B-lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy
2. Late Third Trimester pregnancy (35+ weeks to 39 weeks)
3. Placenta Previa confirmed by ultrasonography
4. Elective Caesarean Section.

Exclusion Criteria:

1. Multiple gestation
2. Placenta accreta Spectrum (accrete/increta/percreta)
3. Bleeding diathesis
4. Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.
5. Serious medical or surgical diseases.
Robotic-assisted Pedicule Screw Placement

The main objective of the study is to evaluate the feasibility of using the robotic assisted device ROSA™ for pedicle screws placement. This device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.

The medical device subject of this research is the surgical robot ROSA™ designed for cranial surgery, and used here in another application, spinal surgery - more specifically for the placement of pedicle screws.

It is intended for spine surgeons to treat diseases requiring the placement of pedicle screws through posterior open surgery approach or minimally invasive surgery.

The system allows the precise guidance of instruments as defined by the surgeon on patient radiological images. The expected performance is a good rate of pedicle screws placement, increasing the performance observed with the conventional method. This system can be transported from one operating room to another, and stored in a storage room.

It interfaces with the most common intra -operative surgical imaging systems (mobile C-arms available at Montpellier University Hospital). Further versions of the device will enable the use of 3D intra-operative imaging systems such as the O-arm from Medtronic.

The main objective of the study is to evaluate the feasibility of using the robot ROSA™ for pedicle screws placement. In this study, the robot will be used with an open surgery approach, which is a first step in demonstrating the potential of the robot.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from lumbar back pain for more than 3 months
* Consent signed

Exclusion Criteria:

* pregnant patient
* patient nursing
Effect of Montelukast on Basophils, In-vitro

Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Allergic asthma or allergic rhinitis
* age 12+

Exclusion Criteria:

* smokers
Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.

Background:

Minimally invasive techniques for cardiac surgery should be formally evaluated.

Design:

Randomized, single-blind, monocentric trial.

Interventions Compared:

Median sternotomy versus minimally invasive technique.

Eligibility Criteria:

Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class \< = 3, left ventricular ejection fraction \> = 40%.

Primary Outcome:

Forced expiratory volume and peak expiratory volume/second at 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Indication of isolated aortic valvular replacement
* Preoperative ASA class \< = 3
* Left ventricular ejection fraction \> = 40%
* Signed informed consent

Exclusion Criteria:

* Aortic or mitral insufficiency \> 3
* History of cardiac surgery
* Acute pulmonary edema
* Endocarditis
* Chronic renal insufficiency decompensation
* Operative coagulation disorders regardless of etiology
ADELANTE: a Randomized Controlled Trial to Improve Engagement in Care for Latinos with HIV

The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.

Participants will be Latinx/Hispanic individuals age ≥18 years who are at least 6 months since initiation of HIV treatment and have evidence of viral non-suppression (HIV RNA ≥200 cpm). Participants will be recruited from two Ryan White-funded clinics in geographic priority areas in the US Ending the HIV Epidemic (EHE) Plan due to high HIV incidences and prevalence. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver a manualized problem-solving intervention that is framed around an HIV-focused telenovela, or drama-based film. The CHW will deliver five sessions within 6 months. The CHW will assist in problem-solving to improve behavioral activation and self-management skills and help participants adhere to HIV treatment and attend medical appointments. The CHW will also link patients to resources. In the enhanced care condition, participants will receive 5 phone calls. They will not receive the intervention or access to navigation beyond routine care. Measurements will occur at baseline, month-3, month-6, and month-12 post randomization by study staff blinded to the allocation status of participants. Participants will be remunerated for each assessment.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Latino/Latina/Latinx/Hispanic; adults 18 years and over; with HIV infection confirmed by standard laboratory results available in the medical record; 6 or more months from initial entry into care with a medical provider who can prescribe HIV antiretroviral treatment; receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center/Harris Health System; and medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 12 months prior to assessment of eligibility, as it is typical for providers to obtain laboratories prior to a clinic visit in preparation for counseling.

Exclusion Criteria:

* Lacks capacity to consent (measured by a validated screener), plans to move out of the county in the next 6 months, or currently participating in an HIV intervention study with ongoing follow-up.