cyrilzakka/clinical-trials huggingface dataset:
Development of a Predictive Algorithm for the Risk of Rehospitalization of Patients With Heart Failure

Heart failure is a chronic disease whose prevalence, due to the aging of the population, is increasing. In France, the prevalence of this pathology is 2.3% (it reaches 10% in the over 75 years) and affects nearly a million patients.

The rehospitalization of patients with heart failure affects 25% of patients within 1-3 months of hospital discharge, and 66% at 1 year while 75% of hospitalizations are preventable. These readmissions result in decreased quality of life and increased mortality; from an economic point of view, hospitalization accounts for 70% of expenses related to the management of heart failure. Avoiding rehospitalization is therefore a major public health issue. The current predictive scores remain perfectible, even though risk factors for readmission have already been the subject of numerous studies. The identification of patients at risk of rehospitalization is still an issue, especially for patients with preserved left ventricular ejection fraction. Targeting patients requiring appropriate care remains an issue.

The rise of innovative statistical techniques around Big Data in health opens new perspectives for the scientific exploitation of data available in electronic medical records, for example in the field of prediction. This study aims to explore the risk of rehospitalization in heart failure patients by analyzing routine data collected in medical records and by mobilizing artificial intelligence algorithms. A review of the literature confirms the innovative nature of such an approach: the majority of the studies identified implemented a prospective collection of data; only 20% of the studies mobilized the medical file; no French study used the new machine learning algorithms.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients with heart failure hospitalized in the cardiology department ath GHPSJ between january 2015 to december 2018

Exclusion Criteria:

* Patient opposing the use of his data for this research
* Patient under tutorship or curatorship
* Patient deprived of liberty
Cervical Spine Clearance in Obtunded Trauma Patients

The optimal method of clearing the cervical spine in obtunded trauma patients is unclear. Computed tomography (CT) identifies most injuries but may miss ligamentous injuries. Magnetic resonance (MR) imaging has been widely used to exclude ligamentous injuries. We postulate that with the new generation of CT scanners, MR imaging is not needed to rule out significant injuries. Our protocol for clearing the cervical spine in obtunded trauma patients depends on CT alone. We are prospectively following these patients and performing a clinical examination when they are awake to show this is a safe approach.

All OBTPs with gross movement of all four extremities admitted to MetroHealth Medical Center (MHMC), the regional Level I Trauma Center in Cleveland OH, who underwent a CT CS at MHMC between October 2006 and September 2008 will be included. Prospective data will be collected on these patients including age, gender, mechanism of injury, Glasgow Coma Scale (GCS) on admission, results of CT CS, GCS at the time of collar clearance, day of collar clearance, collar complications, date of reexamination, and results of reexamination. We will define an obtunded patient as a patient who was unable to reliably describe the presence or absence of CS symptoms in the opinion of the examining physician. Patients needed to have gross movement of all four extremities to be included in the study; if they did not, they were excluded. The presence or lack of sensory examination was not evaluated for the purposes of this study. We will define cervical collar complications as skin breakdown identified either by the skin care team during weekly rounds in the intensive care unit or by the treating physician at any time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will include all patients (including children) after blunt trauma in whom cervical spine injury has not been ruled out admitted to MetroHealth Medical Center from 10/1/2004-9/30/2006.

Exclusion Criteria:

* We are excluding patients with an obvious neurologic deficit attributable to the cervical spine.
* We are excluding patients with abnormalities of the cervical spine that are identified on either plain films or CT.
* We are also excluding those patients in whom the cervical spine can be cleared clinically due to normal mental status.
Ultrasound Determination of Needle Depth in Epidurals in Adult Patients

The introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural space. The investigators propose a prospective study of use of ultrasound in a large heterogeneous group of surgical candidates to define the relationship between the actual needle depth (ND) to the epidural space and measured ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound is a component of ultrasound imaging that might improve current technique, and might lead to faster performance of the epidural. Use of ultrasound may also improve the efficacy and safety of epidural placement.

The null hypothesis of this study is that ultrasound depth is similar to the needle depth in adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this case is defined as a female currently near or going through labor.


Eligibility Criteria:
Inclusion Criteria:

* The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery.

Exclusion Criteria:

* Parturients, prisoners and patients younger than 18 years old will be excluded from this study.
Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 1,400 participants (approximately 700 participants per treatment group) with OIC will be randomized at approximately 225 study centers to receive either 0.25 milligrams (mg) CB-5945 twice daily (BID) or a matching placebo BID for the 52-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for safety, tolerability, and quality of life from the first dose of study drug through Week 56.

Eligibility Criteria:
Inclusion Criteria:

* Is taking a stable daily dose of opioids of ≥30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
* Has constipation that is caused by the chronic use of opioids
* Is willing to use only the study-provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (for example, lubiprostone) during the study period (from Screening until the last study assessment).
* Is able and willing to refrain from facilitating defecation via manual maneuvers (for example, digital evacuation or support of the pelvic floor) during the study period (from Screening to the last study assessment)

Exclusion Criteria:

* Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example, obstruction) or contribute to bowel dysfunction
* Has evidence of intestinal obstruction
* Has a history of rectal bleeding not due to hemorrhoids or fissures
* Has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
* Is taking antispasmodics (for example, dicyclomine), antidiarrheals (for example, loperamide), prokinetics (for example, metoclopramide), or locally acting chloride channel activators (for example, lubiprostone)
* Is taking non-opioid medications known to cause constipation (for example, iron sulfate therapy or tricyclic antidepressants)
New Clinical Score for Deep Vein Thrombosis

A new Clinical Score (CS) to rule out Deep Vein Thrombosis (DVT) has to be derived and internally validated (with bootstrap method), from patients suspected of DVT in Italy. Primary care physicians (general practitioners) in Lombardy will be instructed to inform patients suspected of DVT about this research and get in touch with the team to get details and, eventually, volunteer for the study. The CS includes categorical variables and a continuous variable: the differential leg skin temperature measured with a low-cost handheld infrared thermometer in object surface mode.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of deep vein thrombosis.

Exclusion Criteria:

* under 18 years of age
Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.

400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.

Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of study entry.
2. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:

   * Clear Cell Sarcoma (CCS)
   * Epithelioid Sarcoma (ES)
   * Perivascular Epithelioid Cell neoplasm (PEComa)
   * Desmoplastic Small Round Cell Tumours (DSRCT)
   * Malignant Solitary Fibrous Tumours (mSFT)
   * Alveolar Soft Part Sarcoma (ASPS)
   * Epithelioid Hemangioendothelioma (EH)
   * Low-Grade Fibromyxoid Sarcoma (LGFS)
   * Sclerosing Epithelioid Fibrosarcoma (SEF).
3. Localized/locally advanced or metastatic disease.
4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).
5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.
6. Patient followed in the center within a standard of care procedure or clinical trial.
7. Archived tumor specimen at initial diagnosis available (before treatment initiation).
8. Evaluable disease (measurable as per RECIST 1.1) or not.
9. ECOG Performance status 0-3.
10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
11. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Diagnosis of all other histotypes of soft tissue sarcoma.
2. Any condition contraindicated with procedures required by the protocol.
3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
5. Pregnant or breast-feeding woman.
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary bypass for heart surgery. It is also often used after surgery and may be particularly helpful for children with heart disease. In order for this medication to be helpful and to minimize risks associated with taking the medication, it is important to provide correct dosing for this medication. Based on evidence from studies of other medications used during heart surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass is different from dosing in other settings. The purpose of this study is to evaluate how the heart-lung bypass machine affects dexmedetomidine levels in the body.


Eligibility Criteria:
Inclusion Criteria:

* \< 2 years of age
* Sufficient venous access to permit administration of study medication.
* Supported with cardiopulmonary bypass (CPB)
* Receiving dexmedetomidine per standard of care.
* Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

* \<38 weeks post menstrual age
* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
* Previous participation in this study
* CPB circuit primed with clear fluid
Evaluating Tele-Emergency Care in Costs and Outcomes for Rural Sepsis Patients

Sepsis is a life-threatening emergency for which provider-to-provider telemedicine has been used to improve quality of care. The objective of this study is to measure the impact of rural tele-emergency consultation on long-term health care costs and outcomes through decreasing organ failure, hospital length-of-stay, and readmissions.

Sepsis is responsible for over 1.7 million hospitalizations at a cost of $26 billion annually, making it the most expensive acute care condition in US hospitals. High-quality early sepsis care has been associated with decreased organ failure, shorter ICU and hospital length-of-stay, and improved survival. Rural sepsis patients are more likely to be transferred to tertiary centers, and they also have higher mortality and health care costs. ED-based telemedicine (tele-ED) consultation between a rural provider and a board-certified emergency physician may deliver the expertise to reduce care delays and improve outcomes while avoiding unnecessary costs.

In 2017, the study team partnered with Avera eCARE, the largest tele-ED provider in North America, to implement a standard telemedicine-based sepsis care pathway. Subsequently, the investigators showed (using patient-level primary data collection across several networks) that tele-ED use was associated with improved adherence with international sepsis guidelines.

In addition to its association with short-term clinical outcomes, however, the study team hypothesize that telemedicine may also decrease costs. The investigators have shown that high-quality sepsis care is associated with decreased readmissions and post-discharge mortality. High quality care may also prevent organ failure, avoid ICU admissions, reduce mechanical ventilation and vasopressor use, decrease ICU and hospital length-of-stay, and decrease post-discharge care-primarily through reducing avoidable organ failure. All of these factors are likely to have a significant effect in terms of reducing healthcare cost.

The objective of the proposed project is to measure the effect of tele-ED consultation at reducing healthcare costs and long-term outcomes in sepsis patients in rural EDs. The following primary hypotheses will be tested:

* Total healthcare expenses and 90-day mortality will be lower in patients treated in a tele-ED hospital, with the effect primarily through reduced hospital length-of-stay and fewer readmissions.
* Total expenses and mortality will be lower in cases where tele-ED is used vs. matched controls in non-tele-ED hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis, according to ICD-10 codes

Exclusion Criteria:

* No infection diagnosed in the ED
Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study

The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment

Exclusion Criteria:

* Patient's opposition
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin

This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1
* HbA1c ≥7.0% and ≤9.0%

Exclusion Criteria:

* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.
* Renal impairment as defined by a creatinine clearance \<60 mL/min
* Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection

The rates of symptomatic COVID19 infection, hospital admission among COVID19 cases and survival would be quantified in patiens chronically treated with antihistamines or amantadine, with the aim of determining the role of antihistamines and amantadine in the evolution of COVID19.

BACKGROUND: According to previous reports, all 84 eldery residents in nuersing homes in Yespes (Toledo, Spain), had a 100% of positive serology for COVID-19 in June 2020, but none died nor hospitalized after receiving early treatment with antihistamines. Other case reports have suggested a protective role of amantadine, since infected patients showed a very mild COVID19 infection.

OBJECTIVES.Determine the role of antihistamines and amantadine in the evolution of COVID19.

METHODS. Describe the rate of hospitalization, ICU, survival, postcovid syndrome and thrombosis among COVID 19 cases having antihistamines and amantadine as chronic treatments.

The rates would be stratified by age groups and compared with the same age groups of the population assigned to the public free Access Terrassa Health Consortium.

Eligibility Criteria:
Inclusion Criteria: Patients having chronic treatment with antihistamines or amantadine -

Exclusion Criteria: None

-
NGS for Spine Surgery Patients

During revision spinal surgery for aseptic indications, there remains a concern that the failure may have resulted from undetectable subclinical infection. In the common revision indications of hardware loosening and adjacent segment disease it is possible that bacterial colonization and low-grade infection precipitated the failure event. There is also significant controversy on the role infectious processes have in the development of degenerative disc disease (modic changes). In particular, this study will investigate whether discogenic colonization with Propionibacterium acnes (P. acnes) can be associated with modic changes. Whereas, in surgery for known spinal infection, epidural abscess and septic revisions, it is possible that standard culture techniques fail to detect polymicrobial flora or accurate speciation. This may lead to inappropriate antibiotic management that is not addressing the range of pathology present. There remains an incomplete understanding of the role that subclinical infection plays in aseptic spinal revision surgery and degenerative disc disease


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years of age undergoing spinal surgery

Exclusion Criteria:

* All patients \<18 years of age undergoing spinal surgery
Antipsychotic to Treat Psychosis Syndrome

This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.

The investigators investigated whether administration of atypical antipsychotics could alleviate prodromal symptoms and be well tolerated by subjects with psychosis syndrome and psychosis risk syndrome.

Eligibility Criteria:
Inclusion Criteria:

* were help-seeking young individuals in outpatients service
* aged 16-30 years
* fitted one of the following Criteria: Psychosis-risk Syndromes (COPS-SIPS) or Psychotic Syndrome (POPS-SIPS) or DSM-IV diagnosis of schizophreniform disorder

Exclusion Criteria:

* a previous diagnosis of any psychotic disorder or bipolar disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
* symptoms fully accounted for by an Axis 1 disorder or sequelae of drug/alcohol use;
* neurological disorders or organic disorders affecting the central nervous system, substance-related disorders or mental retardation as defined by the DSM-IV criteria;
* history treatment of antipsychotic or antidepression, mood stabilizers or electroconvulsive therapy;
* diagnosed as having a serious and unstable medical condition.
Functional Impact of Interval Training on Muscle Mass and Strength in Obese Adults

The primary objective was to investigate the effectiveness of interval training and to evaluate the best available method for measuring body composition and functional capacity.

Thirty obese subjects consecutively voluntarily participated in the current study. They ranked sedentary according to their level of activity (≥ 30-minute moderate physical activity 3days/wk). The training sessions were divided into the warm-up phase, training phase and a cool-down phase. The training programs were completed 3days/week for 12 weeks. Body composition was calculated by skinfold thickness method and bio-impedance before and after training. Similarly, aerobic capacities were measured by lactate threshold testing and by Astrand submaximal testing.


Eligibility Criteria:
Inclusion Criteria:

* 30 obese (BMI ≥ 30) and
* Sedentary lifestyle subjects (sample size was calculated by using WHO sample size calculator)
* Age 30-45 years and
* Hypercholesteremia

Exclusion Criteria:

* hypertension,
* diabetes,
* cardiovascular diseases
* systemic diseases