cyrilzakka/clinical-trials huggingface dataset:
Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB

The purpose of this study is twofold: 1) to test the feasibility of integrating a simple bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the standard care delivered in the Aeromedical Evacuation system and 2) to observe and document any changes in pain scores and in-flight related symptoms and factors (e.g. sinus block/pain, ear block pain, nausea/air sickness) typically monitored during transportation of wounded warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* NRS Pain rating \> 0
* Military beneficiaries undergoing aeromedical evacuation from RAB to AAFB

Exclusion Criteria:

* Medically unstable or otherwise unable to participate including those with the inability to consent
* Allergy to metals
* Ear trauma
* Sepsis
* Unhealed wounds on the ears
* Piercing or scar tissue in any of the ear acupuncture point areas
* Pregnancy
Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent;
* Postmenopausal;
* Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;
* Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;
* Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;
* Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;

Exclusion Criteria:

* Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;
* Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator;
* Current or previously treated brain metastasis or leptomeningeal disease;
* Prior therapy (\> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible);
* Requires treatment for tuberculosis or HIV infection;
* Radiation therapy within 7 days before randomization;
* History of another invasive cancer within 5 years before randomization;
* History of seizure or any condition that may predispose to seizure;
* Clinically significant cardiovascular disease;
* Active gastrointestinal disorder;
* Major surgery within 28 days prior to randomization;
* Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;
* Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;
* Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;
* Hypersensitivity reaction to exemestane.
Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe]

The rationale of the study is to collect structured data in the neuropsychological, clinical neuroradiologic and neurorehabilitation fields in children/young people affected by congenital and juvenile myotonic dystrophy. Children affected by the congenital form (CDM1) present important brain alterations present since birth while, on the contrary, patients with the adult form of DM1 often present a degenerative, slowly progressive neurocognitive picture. Promising therapies that aim to correct the molecular mechanism underlying the symptoms of adult forms of DM1 are under development, but their potential role at the level of the nervous system and in particular in forms of CDM1 (which appears to be a distinct disorder of neuronal development) is also to be clarified.

To this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies.

A. Recruitment of patients with a defined diagnosis of Myotonic Dystrophy type 1 (see following inclusion and exclusion criteria)

B) Clinical and cognitive evaluation

1. neurological and neuromuscular examination, compilation of the MIRS-muscle scale and EPWORTH scale-daytime sleepiness (1 session of approximately 1 hour);
2. administration of a neuropsychological battery, in order to define the level of cognitive functioning and to frame a detailed function-specific profile (multiple sessions to be defined based on the collaboration of the patients) investigating the following areas:

   1. intelligence quotient;
   2. attention;
   3. memory;
   4. visual-constructive skills and executive functions
3. psychiatric examination and administration of psychological tests (MMPI-2, Minnesota Multiphasic Personality Inventory 2) to investigate any psychopathologies (behavioral disorders, anxiety disorders, developmental disorders, hyperactivity/attention deficit) and to define the psychological-behavioral profile and adaptive (Vineland Adaptive Behavioral Scale)
4. neuroimaging examination through Morphological magnetic resonance and Diffusor Tensor imaging and Voxel Based Morphometry protocols
5. based on the clinical conditions, a cardiological evaluation will also be carried out (including instrumental tests such as Electrocardiogram ECG, echocardiogram and 24-hour ECG) and pneumological evaluation (with recording of nocturnal oximetry, spirometry), eye examination, phoniatric examination and logopedic evaluation (aimed at evaluating chewing/swallowing)

Eligibility Criteria:
Inclusion criteria:

1. genetically defined diagnosis of Steinert myotonic dystrophy
2. age \<35 years
3. reading and signing the informed consent. For the congenital form: presence of hypotonia and weakness at birth, for the juvenile form: onset between 1 and 10 years with normal pre-perinatal history.

Exclusion criteria

1. other concomitant pathologies that completely prevent the execution of clinical assessments
2. presence of devices and prostheses that prevent the execution of the MRI
3. lack of family compliance. -
Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock

Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its external validity is hampered by the numerous limits and the heterogeneity of the studies. To date, a pathophysiological link between LV diastolic dysfunction associated with septic shock and the water balance (reflecting volume overload) remains to establish. In addition, small size studies reported an excess of mortality in patients with septic shock who were diagnosed with a high cardiac output. However, no large cohort has yet confirmed the negative prognostic role of a hyperkinetic hemodynamic profile at the initial phase of septic shock.

Consecutive patients diagnosed with septic shock will be followed daily using echocardiography from Day1 (first echocardiography performed within 12h after the diagnosis of septic shock) to Day3, after vasopressor discontinuation (Day end), and on Day28 or at hospital discharge (if occurs before Day28). Echocardiographic data will be anonymized and stored in DICOM format in a dedicated database for independent measurements by an expert in echocardiography blinded from the clinical data of the patients including vital status. Vital and biological parameters usually monitored for the management of septic shock will be collected at the time of each echocardiographic assessment. Patients' vital status will be collected on Day28. The potential influence of LV diastolic dysfunction and LV hyperkinesia on prognosis will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in ICU for septic shock:

  * Documented or highly suspected infection (clinically or microbiologically)
  * Causing an organ failure defined as an acute change in total SOFA score ≥ 2 points (baseline SOFA score can be assumed to be zero in the absence of pre-existing organ dysfunction)
  * And low blood pressure (sBP \< 90 mmHg or a decrease of more than 40 mmHg compared to baseline, or mBP \< 65 mmHg) despite a fluid loading of 30 mL/kg (except if clinical or radiological sign of pulmonary fluid overload) requiring vasopressor infusion to maintain mBP \> 65 mmHg
  * And lactate level \> 2 mmol/L
* Patient older than 18 years old affiliated to the French Social Security
* Non-opposition of the patient (or of its next-of-kin) to participate in the study

Exclusion Criteria:

* Ongoing dobutamine or epinephrine infusion
* Severe left valvular disease (severe stenosis, severe regurgitation ≥ grade 3)
* Constrictive pericarditis (invalidate the mitral tissue Doppler imaging)
* Pregnant women
* Patient with estimated life expectancy \< 24h.
Effect of Synapse Medicine Decision Support on Inpatient Pharmacist Efficacy and Efficiency

Adverse drug events (ADE) are common and dangerous in the hospital and following discharge to the ambulatory setting. One cause of ADEs in both settings is medication regimen inappropriateness, including polypharmacy, drug-drug interactions, and medications that are inappropriate or inappropriately dosed given patients' age, renal, and hepatic function. Hospitalization provides a good opportunity to investigate medication appropriateness given new or worsening conditions and available expertise. Inpatient pharmacists are medication experts and often round with medical teams, but they may not always have all the information available at their fingertips to make optimal recommendations regarding medication appropriateness for each patient. Clinical decision support to pharmacists at the point of care has potential to improve the speed, quantity, and quality of medication recommendations to inpatient teams; any subsequent improvements to medication regimen appropriateness have the potential to reduce ADEs in the hospital and after discharge.

Specific Aims and Objectives

Aim 1: Implement real-time decision support regarding medication regimen appropriateness among pharmacists who round with inpatient medical teams.

Aim 2: Determine the effects of this intervention on the number of medication regimen recommendations and time spent per recommendation

Aim 3: Evaluate the use and usability of the decision support tool and develop strategies to mitigate barriers and promote facilitators of implementation using mixed methods implementation science approaches.

This will be a prospective pre-post mixed methods hybrid type 2 effectiveness-implementation study. The study will take place at BWH and at Vanderbilt University Medical Center (VUMC). The direct subjects will be the inpatient pharmacists (4 at each site) who round with general medicine teams. Patients will be indirect subjects as pharmacists provide medication recommendations regarding these patients to the clinicians on each team with or without the Synapse software. We estimate this number of patients to be 3 new admitted patients per day per team x 56 days x 8 teams = 1344 patients (672 at MGB sites). Patients can be any patients admitted to these general medicine service teams at BWH and VUMC. The pharmacists are trained hospital pharmacists who round with general medicine service teams and approve inpatient medication orders. There are no local site restrictions. VUMC will cede IRB approval to the MGB IRB.

Eligibility Criteria:
Inclusion Criteria:

* any patient that the inpatient pharmacists care for on the inpatient medical team they round with

Exclusion Criteria:

* N/A
Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas

The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.

Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ:

1. Baseline within 2 weeks before initiation of RT/TMZ
2. At the end of RT/TMZ approximately week 6
3. Before adjuvant TMZ approximately week 10
4. After 2 cycle of TMZ approximately week 18
5. After 4 cycle of TMZ approximately week 26
6. Three month after last cycle of TMZ

Secondary Endpoints

1. Changes in serial T cell subtypes and cytokines levels
2. Incidence of lymphopenia related infections
3. Changes in T-cell numbers and subtypes with TMZ administration
4. Overall survival

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be at least 18 years of age.
2. Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV).
3. Patients proposed post-operative treatment plan must include standard radiation and temozolomide.
4. Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
5. Patients must be able to provide written informed consent.
6. Steroid use is allowed.

Exclusion Criteria:

1. Patients with HIV are excluded.
TAPSE/PASP Anesthesia

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction.

Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. 18-75 years old
3. ASA Physical Status 1-3;
4. Patients planned for pulmonary resection surgery

Exclusion Criteria:

1. The patient is pregnant
2. After cardiac surgery
3. Severe pulmonary hypertension
4. Severe valve disease
5. Hypertrophic or dilated cardiomyopathy
6. Presence of acute myocardial infarction
7. Patients with severe visual or hearing impairment/disability
8. ASA physical status IV or V
9. Ischemic heart disease, conduction disorder.
10. History of long-term use of certain medications (β-blockers, angiotensin converting enzyme inhibitors, analgesics, sedatives or tricyclic antidepressants)
Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx

The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci robotic system to reduce scarring, while respecting patient safety.

Feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.

Secondary objectives include the following:

A. Describe certain technical variables: surgical time, extent of blood loss, need for conversion to open surgery, anesthesia procedure used, the level of difficulty and speed associated with each surgical step, length of stay, B. Describe the pathological findings for each patient, C. Evaluate neurological complications (function of cranial nerve pairs X, XI, XII, brachial plexus, cervical sympathetic) D. Identify specific complications, E. Evaluate post-operative pain, F. Evaluate the scar outcome at 6 and 12 months G. Describe the oncological results at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Cancer of the epi-larynx: (i) ranked T1 or T2 in the TNM classification, (ii) supraglottic or glotto-supraglottic location, (iii) CN0 nodal status
* Absence of distant metastasis (M0)
* Decision for unilateral endoscopic axillary neck dissection at lymph node levels IIa, III and IV of the Robins classification is retained in a multidisciplinary meeting
* The patient is available for 12 months of follow-up
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan

Exclusion Criteria:

* Patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study
* Adult under judicial protection or any kind of guardianship
* Refusal to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Preoperative diagnosis of a second location of cancerous disease
* Body Mass Index \> 25
* History of cervical spine surgery
* History of instability of the cervical spine
* History of surgery in the shoulder or pre-pectoral region
* History of ipsilateral neck surgery
* History of cervical radiotherapy
* History of breast implants
Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes

the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.


Eligibility Criteria:
Inclusion Criteria:

* adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication

Exclusion Criteria:

* smokers during 10 last years
Endotoxin in Gram-negative Septic Shock

The purpose of this observational study is to determine whether endotoxin levels and/or their trends can be considered predictive of morbility or mortality in septic shock caused by gram-negative bacteria, searching also for a possible correlation with Simplified Acute Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells (WBC) and Platelets (PLT).

Medical literature states that Endotoxin (a structural molecule of the Gram-negative bacteria extracellular membrane) is able to activate target cells such as macrophages and neutrophils, inducing them to produce and release cytokine, nitric oxide and other mediators that cause a systemic inflammatory response that can evolve until to endothelial damage, shock and multi-organ failure (MOF).

Since 2004 it has been possible to better determine the concentration and the activity of endotoxin in plasma, thanks to a reliable and quick to implement method: the EAA (Endotoxin Activity Assay) test, which is an alternative technique for detecting endotoxin in whole blood based on the detection of enhanced respiratory burst activity in neutrophils following their priming by complexes of endotoxin and a specific anti-endotoxin antibody. The EAA shows excellent performance characteristics in recovering endotoxin from spiked samples and can be performed within 30 min, using less than 100µl whole blood.

Participants of this study (all affected by gram-negative septic shock) will show different values of endotoxin in their blood samples during their stay in Intensive Care Unit (ICU), and the investigators will try to figure out if these values and their trends can be somehow predictive of morbility and/or mortality, despite the small number of septic patients and the heterogeneity of their clinical picture.

So, if endotoxin induces sepsis, can the investigators also state that high values and/or trends of endotoxin can be correlated to severity of disease?

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe sepsis or septic shock
* acquisition of informed consent
* age over 18 years old

Exclusion Criteria:

* any diagnosis different from severe sepsis or septic shock
* rejection of informed consent by participant
* age under 18 years old
* any clinic condition considered not suitable by researcher
Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

Sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths. Early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. At present, there is no epidemiological investigation report on sepsis in ICU in China.

Although great progress has been made in maternal care in China in recent years, the maternal mortality rate in China has remained high in the past three years, fluctuating from 19.6-20.1/100000, and there is still a large gap between China and developed countries (12.1/100000). Sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths; Early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. At present, there is no epidemiological investigation report on sepsis in ICU in China. A total of 160 cases of maternal sepsis with ICU admission in any trimester of pregnancy or within 42 days of delivery were reviewed between January 1, 2008, and December 31, 2019. The demographic data including age and gestational age, mode of delivery, the maximal SOFA score, invasive operation before sepsis, sepsis focuses, intervention, microbial culture results, body temperature and blood routine were reviewed to investigate the incidence and mortality of maternal sepsis in intensive care unit, as well as the incidence of multidrug-resistant bacteria and the risk factors of multidrug resistance.

Eligibility Criteria:
Inclusion Criteria: Obstetrics with sepsis in any trimester of pregnancy or within 42 days of delivery -

Exclusion Criteria: The electronic medical record is lost. Patients with incomplete infection data: if the temperature sheet is ambiguous and the temperature data is not recorded in the medical record.

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