cyrilzakka/clinical-trials huggingface dataset:
Evaluation of EEG Power Spectrum in Patients With Traumatic Coma

Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery.

Trauma brain injury is a leading cause of chronic disorders of consciousness (DoC), posing significant socioeconomic burdens due to the extensive resources required for long-term medical care. DoC patients are clinically categorized into coma, Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS), with the latter further subdivided into MCS- and MCS+. The Coma Recovery Scale-Revised (CRS-R) remains a cornerstone for diagnosis and assessment of DoC, despite its susceptibility to fluctuations caused by various factors such as comorbidities and medication. Given these challenges, the development of objective, reliable, and convenient assessment methods of DoC is crucial. Electroencephalography (EEG) stands out for its accessibility and is recommended by guidelines. The mesocircuit model underscores the role of central thalamic neurons and their frontostriatal connections in maintaining consciousness. Based on this mechanism, EEG power spectra were categorized into 4 patterns, i.e. the ABCD model, which can be used to understand the varying levels of structural or functional deafferentation that occur in patients with DoC. Preliminary studies have shown the potential of corticothalamic EEG classification in correlating with CRS-R scores and neurological outcomes, suggesting its value in monitoring treatment effects and predicting prognosis. This multicenter prospective observational study aims to enroll patients with traumatic coma, analyze the sequential characteristics of corticothalamic EEG power spectrum, and explore their prognostic value for consciousness recovery.

Eligibility Criteria:
Inclusion Criteria:

* Coma over 28 days due to closed traumatic brain injury
* Age above 18 years old
* Consented by legal representative

Exclusion Criteria:

* Unstable vital signs
* History of mental disorder or neurodegenerative diseases
* Uncontrolled epilepsy
* Unable to record scalp EEG
* Pregnancy
Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
* Cobb angle between 35-60 degrees (inclusive);
* Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
* Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
* Appropriate candidate for posterior surgical approach;
* Patient has good general health;
* Patient has no known hypersensitivity or allergies to titanium;
* Patient's guardian signs a written informed consent form (ICF).

Exclusion Criteria:

* Any type of non-idiopathic scoliosis;
* Any main thoracic deformity that includes vertebral levels and cranial including to T2;
* Known history of existing malignancy, or any systemic or local infection;
* Spinal cord abnormalities that require treatment;
* Known neurological deficit (defined as motor grade \< 5/5);
* Known poor bone quality defined as T score -1.5 or less;
* For female Patient, pregnancy;
* Previous spine surgery that would prevent the successful performance of the MID-C system ;
* Active systemic disease, such as AIDS, HIV, or active infection;
* Active infection or the skin is compromised at the surgical site;
* Systemic disease that would affect the Patient's welfare or overall outcome of the study.
EEG Data Collection to Evaluate New Patient State Index Performance

This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI measurement.


Eligibility Criteria:
Inclusion Criteria:

* ASA status of I, II, or III.
* Subjects undergoing general surgery.
* neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.).

Exclusion Criteria:

* subjects with any deformities, diseases, or for any other reason that may present proper fit and application of SedLine sensors.
* inability to obtain subject's physiological, vital, demographics, and real time anesthesia data.
* Subjects who are pregnant.
* known history of drug abuse.
* subjects deemed not suitable for study at the discretion of the Principal Investigator.
Effectiveness of an Intervention of Pharmacotherapeutic Plans to Reduce Medication-related Problems in Geriatric Residences

Background: Patients living in Geriatric Residences (RG) have increased aging, comorbidity, spending on health resources and mortality. High drug use is associated with an increased risk of falls, disability, and death. It is estimated that 20-50% of inappropriate medications are consumed in the elderly.

Hypothesis: A pharmaceutical intervention based on a clinical review of the pharmacotherapeutic plan of patients in RG will be useful in optimizing the prescription in terms of safety, reducing by 10% or more the inappropriate prescriptions.

Objectives: Evaluate the effectiveness of a structured pharmaceutical intervention based on the clinical review of the pharmacotherapeutic plan to improve its adequacy.

Decrease inadequate prescriptions in patients admitted to RG by 10%

Methodology: Pre-post, quasi-experimental intervention study with control group with prospective follow-up of a cohort of patients in RG. The intervention consists of the clinical review of the pharmacotherapeutic plan carried out by the pharmacist and subsequently agreed in the Pharmacotherapeutic Advisory Committee.

Determinations: The study variables will be evaluated at baseline and 3 months post-intervention. The primary variable is number of inappropriate prescriptions.

Statistical analysis: Percentage change will be measured before and after the intervention. Descriptive statistics will be performed for quantitative variables such as qualitative and comparison of means and proportions.

Expected results: Achieve a 10% decrease in inappropriate prescriptions

Applicability and Relevance: This study will expand the collaboration between the Pharmacy and Primary Care physicians, promoting the continuum of care, strengthening the safety culture, and improving prescribing habits.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Pharmacological treatment with at least one drug and for a period of more than three months

Exclusion Criteria:

* Individuals who at the time of the pharmaceutical review were in hospital
* Patients nearing the end of life
* Patients whose participation was considered by the doctor responsible to be potentially detrimental
* Patients not covered by the public healthcare or pharmacy system were excluded.
Characteristics and Consequences of Coronary Angiograms Performed in Intensive Care Patients

Coronary angiography is a key examination in the management of many patients hospitalized in intensive care units. The most frequent indication remains the performance of a gesture of unblocking of part of the coronary network in the context of an acute coronary syndrome (ACS) complicated by cardiogenic shock (CS) and/or cardiac arrest. cardio-respiratory (ACR). However, there are other indications in intensive care, in particular for diagnostic purposes. Given the lack of harmlessness of this procedure in itself and the consequences of intra-hospital transport outside intensive care units for patients who are sometimes very unstable, the risk-benefit balance before performing a coronary angiography requires always be properly assessed by the resuscitating physician.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Patients hospitalized in Intensive Medicine - Resuscitation between January 1, 2015 and January 1, 2020 in whom a coronary angiography was performed.
* Patient not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

• Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists

The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.


Eligibility Criteria:
Inclusion Criteria:

* First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
* At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
* Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
* ≥ 18 years of age

Exclusion Criteria:

* Patients with valvular AF \[4 quarters prior to the index date\]
* Pregnancy \[4 quarters prior to index date\]
* Malignant cancers \[4 quarters prior to the index date or "condition after"\]
* Transient cause of AF \[4 quarters prior to index date\]
* Patients with VTE (pulmonary embolism or DVT) \[60 days before index\]
* Patients with major surgery defined as hip or knee replacement \[60 days before index\]
* Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date \[4 quarters prior to index date\]
* Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
* For sensitivity analysis : Patient with any of the events defined in the combined endpoints \[4 quarters prior to index date or "condition after"
* Patients with dialysis \[4 quarters prior to index date\]
"SVEAT" Chest Pain Scoring System

This is a prospective, observational study to assess the efficacy of the newly developed SVEAT scoring system in identifying low-risk patients who may be eligible for early discharge. Various elements of clinical information including Symptoms, Vascular history, EKG, Age and Troponin values will be checked and entered on the scoring form to calculate the SVEAT risk score. Additionally, HEART score and TIMI risk score will be calculated for the same subjects.

The primary aim is to assess the positive and negative predictive values for the SVEAT index for cardiovascular events and compare it to the HEART and TIMI Scores.

This is a prospective, observational study in patients presenting to the emergency department or admitted to clinical decision unit at Renown Regional Medical Center with a primary complaint of chest pain in a period of 12 months.

All patient \>24 years will be recruited. Exclusion criteria include patients with clear-cut acute ST-segment elevation myocardial infarction, traumatic non-cardiac chest pain, life-expectancy less than 90 days, hemodynamic instability or inability to provide informed consent. Data and scores based on commonly known TIMI\* risk score, HEART score and a newly developed SVEAT index ( Symptoms, Vascular disease, EKG, Age, Troponin) will be obtained by primary investigator trained physicians or advanced nurse practitioners as earliest as possible after their initial presentation. The care of the patients will be left to the discretion of the treating physician.

The outcome of each patient will be determined by either chart review, telephone contact or office visit as appropriate in 30 days post presentation. The sensitivity, specificity, positive and negative predictive value of SVEAT index will be calculated using standard statistical analysis. The receiver operating characteristic (ROC) curves of SVEAT index, TIMI risk score and HEART score will be generated and compared using commercially available software. P value of 0.05 or less will be considered statistically significant difference.

The primary hypothesis of the study is that scoring systems that better incorporate useful clinical information such as the SVEAT score may improve our ability to accurately identify low-risk acute chest pain patients presenting to the ED.

Eligibility Criteria:
Inclusion Criteria:

* Any patient \> 24 years old presenting to the emergency room or admitted to the clinical decision unit with chest pain.

Exclusion Criteria:

* patient with clear-cut acute ST-segment elevation myocardial infarction, traumatic non-cardiac chest pain, life-expectancy less than 90 days, hemodynamic instability or inability to provide informed consent.
SPARC: Shoulder PAtch for Rotator Cuff Tears

Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears can be managed with arthroscopic or keyhole surgery. Very large or massive tears are difficult to operate on and often have poor rates of healing. As a result surgeons have investigated the use of products to improve the outcome of surgery on massive tears.

The product that the investigators are currently using to try to improve the outcome of surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar patches have found that recovery is improved and there is a lower rate of postsurgical problems. The aim of this study is to look at whether using the patch improves pain and the clinical function of the shoulder after surgery. In addition, the investigators would like to understand how the patch works. To do this the investigators will scan (take images of) the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Ultrasound confirming massive rotator full thickness tear, unacceptable pain and disability following conservative treatment, or previous surgery that has failed, deltoid muscle that is functional, and compliance with post operative rehabilitation.

Exclusion Criteria:

* History of infection
* Neurological condition that affects the shoulder girdle
* Presence of rotator cuff arthropathy with stiffness
* Subjects with inability to give informed consent
* Pregnancy or lactation
* Malignancy
* Age less than 18 years
* Subjects currently participating in other research studies
* Subjects with the following contraindications to MRI scanning will not have an MR scan but may be asked to have alternative imaging, for example ultrasound:

  * Pacemakers
  * Surgical clips within the head
  * Certain inner ear implants
  * Neuroelectrical stimulators
  * Metal fragments within the eye or head
  * Pregnant or breastfeeding women
Ischemia-reperfusion Exercise Study

The study investigates the relationship between activation of AMP-activated protein kinase (AMPK) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake.

This will be investigated in young healthy lean male subjects.

This study aims to demonstrate the association between AMPK activation and increased insulin sensitivity in human skeletal muscle. The investigators intend to examine insulin sensitivity after various levels of AMPK activation in skeletal muscle that includes exercise at different intensities as well as exercise combined with leg blood flow restriction (ischemia). The hypothesis is that exercise combined with ischemia will result in an increased activation of AMPK compared to exercise alone, and therefore it is expected that exercise combined with ischemia will result in the greatest improvement in muscle insulin sensitivity.

Methods:

The main experiment consists of 3 experimental days (A, B and C), separated by a minimum of 14 days and carried out in a randomised order. On all the study days, the participants will arrive in the laboratory after an overnight fast. Catheters will be placed in both femoral veins and in one femoral artery. A muscle biopsy will be obtained from vastus lateralis of one leg (resting leg). Experiment A consists of one-legged muscle work for 1 hour at 70% of the leg maximum aerobic work capacity with the other leg serving as a resting control. In experiment B, the same work are performed, but with periodic at the same constricting the blood supply to the working leg (25 seconds every 2 min). Experiment C consists of one-legged muscle work for 1 hour at 70% and 95% of the leg maximum aerobic work capacity (alternately every 5 min). Immediately after each type of exercise a biopsy will be obtained from the exercising leg and the participants will rest in the fasted state for 3 hours before a third set of muscle biopsies (from both legs) will be obtained. Subsequently, insulin sensitivity will be evaluated in the participants during a 2-hour physiological hyperinsulinemic euglycemic clamp. By the end of the clamp, a final set of biopsies (both legs) will be obtained. Throughout the study day sampling of artery and venous blood/plasma samples allows for the estimation of substrate extraction by the two legs. Further, measures of artery blood flow by Ultrasound Doppler technique allow for the final calculation of substrate uptake/release across the two legs before exercise, during exercise and in recovery from exercise. Importantly, the ability for insulin to stimulate these processes can be evaluated in both a rested and in a prior exercised leg.

Eligibility Criteria:
Inclusion Criteria:

* normal weight (BMI: below or equal to 27)
* physical active on a regular basis
* cardiorespiratory fitness between 40-60 ml/kg/min
* no history or sign of type 2 diabetes, hypertension, insulin resistance or dyslipidemia

Exclusion Criteria:

* smoker
* BMI: above 27
* using any kind of medication
Transthoracic Echocardiographic Evaluation of the Cardiac Function During Transurethral Resection of Prostate in Elderly Patients

Transurethral resection of the prostate (TURP) is a standard surgical treatment for benign prostatic hyperplasia (BPH). Non-conductive irrigation fluid is used to maintain good visibility of the operating field during resection of the prostate. Absorption of this hypotonic solution into the bloodstream can cause fluid overload and dilutional hyponatremia, resulting in adverse cardiovascular and central nervous system effects, transurethral resection (TUR) syndrome. BPH is common in elderly men above 60 years old. These aged people commonly have diastolic impairment by normal physiologic change without consistent symptom. This study aimed to evaluate the cardiac function focused mainly diastolic function during TURP with transthoracic echocardiography. Also, we will focus the effets of amount of irrgation fluid on left ventricular diastolic function in patients with pre-existing diastolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Above 65years of age
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. undergoing transurethral resection of the prostate(TURP)"

Exclusion Criteria:

1. severe coagulopathy or bleeding disorder(platelet count\<75000, PT INR \>1.2)
2. short stature (under 150 cm)
3. underwent coronary artery bypass graft
4. contraindications of regional anesthesia "
A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions

Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially.

Objective: To determine the relative rates of blood culture contamination for 3 skin antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical patients.

A group-randomized crossover trial was conducted to test the null hypothesis of no difference in blood culture contamination rates among 3 antiseptic skin preparations. The sequence of 3 different antiseptic treatments was randomly assigned to 3 separate hospital floors, therefore in this trial cross-over occurred at the hospital floor level (not the individual patient level).

Also, it is possible for subjects to have multiple blood culture sets obtained during the study. Thus, the number of blood culture sets will not equal the number of unique subjects in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient on general medical, surgical, and cardiology floors
* Receipt of a peripheral blood draw for blood culture collection
* Blood draw performed by phlebotomy team

Exclusion Criteria:

* None
Evaluation of Mechanisms Responsible for Coma in Patients Affected by Fulminant, Acute and Chronic Hepatic Failure

The purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. As of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. Understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics for chronic or acute hepatic failure will be included in the study.

Exclusion Criteria:

* Patients (male or female), 18 years or older hospitalized or seen at UTMB clinics that do not have a diagnosis of chronic or acute hepatic failure