cyrilzakka/clinical-trials huggingface dataset:
Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition

The PANDA trial is a multicenter prospective observational study designed to analyze various ICP derived parameters and clinical status in neurosurgical critical patients through a new big data acquisition system.

Nowadays, intracranial pressure (ICP) monitoring is widely used as a way to evaluate intracranial status in neurosurgery department especially in neurosurgical critical patients. Most of us focus only on the mean ICP value while ignoring other ICP derived parameters, such ICP waveform, AMP, RAP, PRx, IAAC and so on. However, it is reported that these parameters can reflect the status of intracerebral circulation, cerebrospinal compensatory reserve and brain compliance and can often be indicative of impending neurological deterioration and even outcome of patients. The PANDA trial is a multicenter prospective observational study designed to investigate the relationship between these ICP derived parameters and clinical status and to uncover the mechanism behind it. We will use a brand-new automatic big data collecting and storing system to continuously acquire patients' physiological information such as blood pressure, ICP, ETCO2，EEG etc. before analysis. Hopefully, this trial will reveal what is happening in the cranial cavity through the natural history of different kinds of intracranial lesion.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* Intracranial lesion underwent ICP sensor implantation
* Informed consent obtained

Exclusion Criteria:

* No consent
* A life-threatening injury to an organ other than the brain
* Known pregnancy
Monitoring Antiplatelet Drugs in Cardiac Arrest Patients

Dual Antiplatelet Therapy (DAPT) with acetylsalicylic acid (ASA) and oral P2Y12 inhibitor (Clopidogrel, Ticagrelor or Prasugrel) is recommended in STEMI or NSTEMI patients undergoing primary Percutaneous Coronary Intervention (PCI). There is evidence for an increased risk of stent thrombosis after PCI despite administration of DAPT in patients resuscitated from a cardiac arrest with STEMI/NSTEMI who undergo primary PCI, in particular for those treated with hypothermia. Point of Care Aggregometry represents an emerging tool to measure platelet reactivity in patient treated with antiplatelets drugs. Among patients with Acute Coronary Syndrome (ACS), those requiring Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory Cardiogenic Shock or Cardiac Arrest represent a growing population burdened by more profound metabolic, pharmacokinetic, hemostatic and physiological alterations due to increased clinical severity and ECMO itself. In addition, profound platelet inhibition can result in a higher risk of bleeding complication, since these patients have to be simultaneously anticoagulated with unfractioned heparin (UFH) and ECMO itself can cause coagulopathy. We aimed to perform an observational prospective cohort study to investigate platelet reactivity in a population of ACS patients with different clinical severity.


Eligibility Criteria:
Inclusion Criteria:

* Patients P2Y12 naive
* Suffering from Acute Coronary Syndrome needing primary percutaneous coronary intervention (PCI) and treated with oral antiP2Y12 drugs

Exclusion Criteria:

* Known liver or hematological disease
* Anticoagulant therapy
* Active bleeding needing blood transfusions.
the Impact of a Digital Game-based Learning Activity on Nursing Students' Understanding of Surgical Site Infections

The aim of this randomized controlled trial was to evaluate the effect of a digital game-based learning activity on students' learning of interventions to prevent surgical site infections.This study will seek answers to the following questions:

Is digital game-based learning activity effective in students' learning process? Is the traditional method of theoretical lecturing effective in the learning process? What is the effect of students' learning methods on their motivation? The researchers will compare the group with the theoretical lecture to see the effectiveness of the digital game-based learning activity.

Participants will be divided into 3 groups. In the first group, the level of learning interventions to prevent surgical site infections with digital game-based learning activity will be evaluated with pre-test and post-test In the second group, the level of learning the theoretical course and interventions to prevent surgical site infections will be evaluated with pre-test and post-test.

The control group will be evaluated only with the pre-test post-test without any intervention.


Eligibility Criteria:
Inclusion Criteria:

* Having a cell phone, computer or tablet device.

  * To have internet access on one of the cell phone, computer or tablet devices.
  * To have taken the Surgical Diseases Nursing course.
  * To be a 4th year student of Van Yüzüncü Yıl University Faculty of Health Sciences, Department of Nursing
  * Volunteering to participate in the research

Exclusion Criteria:

* - Graduating from a health vocational high school or coming from a health-related department with vertical transfer
* Limited ability to read and write in Turkish.
* Not having a software infrastructure suitable for opening digital game activities on mobile phones, computers or tablet devices
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy.
* A RET gene fusion in tumor and/or blood from a qualified laboratory.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Adequate hematologic, hepatic and renal function.
* Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of treatment and for 6 months after.
* Ability to swallow capsules.

Exclusion Criteria:

* Additional validated oncogenic drivers in NSCLC if known.
* Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization.
* Major surgery within 3 weeks prior to planned start of selpercatinib.
* Radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung.
* Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression.
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds.
* Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
* Pregnancy or lactation.
* Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active.
* Uncontrolled, disease related pericardial effusion or pleural effusion.
* Requiring chronic treatment with steroids.

Exclusion Criteria for Participants Receiving Pembrolizumab:

* History of interstitial lung disease or interstitial pneumonitis.
* Active autoimmune disease or any illness or treatment that could compromise the immune system.
Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene

Interactions between genes and environment, are likely to be crucial in the development of the common diseases such as type 2 diabetes. It was recently shown that FADS1 and FADS 2 genotypes are the strongest genes in a genome-wide analysis regulating serum fatty acid profile.The aim of this study is to test if subjects with the CC and TT genotypes of the FADS1 gene (rs174547) respond differentially to a diet supplemented with linoleic acid (substrate for FADS). We hypothesize that subjects with the TT genotype with more active desaturases will be more sensitive to dietary modification leading to more robust differences in serum FA profile, tissue inflammation and serum lipids.

Lean and overweight subjects (BMI \>20kg/m2 \<29kg/m2 ) with CC and TT genotypes of FADS1 polymorphism (rs174547) were recruited from the METSIM study (METabolic Syndrome in Men, currently \>10000 men included from the population living in Kuopio). The potential participants were asked to contact study nurse if willing to participate. Twenty six subjects with CC genotype were selected after matching with thirty six subjects with the TT genotype for age, BMI and medication.

Study diet were isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower oil daily depending on body weight. Thus, approximately 16-28 g (6 E%) LA daily were provided on top of the average intake of approximately 10-12 g (4.5 E%). This dose of sunflower oil is not known to cause any side effects or adverse events and even higher doses have been safe.

Food records were collected at the beginning (4 days) and during the third week of the study (7 days) to estimate daily intake of macronutrients and specifically of different fatty acids.

Eligibility Criteria:
Inclusion Criteria:

Participant of Metabolic syndrome in men (METSIM) cohort BMI 20-30 kg/m2 Healthy CC/TT genotype (rs 174547)

Exclusion Criteria:

Type 2 diabetes Other chronic disease
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère

Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.


Eligibility Criteria:
Inclusion Criteria:

* Dystophinopathy (Duchenne or severe Becker)
* \>8yo
* with social insurance
* informed consent

Exclusion Criteria:

* arythmia
* impossibility to undergo an MRI (pacemaker, ....)
Micro-environment Involvement in Muscle Alteration Induced

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strengh and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. During exacerbation, some studies have suggested an association between muscle dysfunction and modifications of inflammatory circulating factors such as CRP, TNF-alpha, IL- 6, IL8, but no exhaustive study has identified precisely one (or more) biomarker(s) that can induce this muscle wasting during the exacerbation of COPD. Our hypothesis is that the serum of exacerbated COPD patients represents a deleterious microenvironment for the muscle cells which would amplify the mechanisms of atrophy linked to hospitalization. Our team has already developed a cell culture model to study the effects of the plasma microenvironment on atrophy of cultured myotubes. The investigators have shown that the serum of COPD patients can induce muscle atrophy.

The objectives of this study are : 1/ to evaluate the effects of circulating pro-inflammatory factors on atrophy and the myogenic capacities of muscle cells; and 2/ to identify one (or more) circulating biomarker (s) that may be responsible for the muscle damage induced by the microenvironment of hospitalized patients for exacerbation of COPD. First, myotubes and myoblasts of healthy subjects will be cultivated with 9 exacerbation copd patient serum or 9 copd patient serum or 9 healthy subject serum. Myotube diameters, atrophy, inflammatory and oxidative stress markers and alteration of the myogenic capacity of satellite cells will be compared between three groups. Second, the differential expression of circulating proinflammatory molecules will be compared in the serum of the three groups. Identifying circulating factors associated with muscle weakness is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.

.


Eligibility Criteria:
Inclusion criteria 1/ for COPD patients hospitalized for exacerbation:

* Hospitalization for COPD exacerbation 2/ for COPD patients
* COPD patients GOLD II à IV
* Not having followed respiratory réhabilitation stay for at least one year 3/ for Healthy subjects
* healthy and sedentary (Voorips score \<9)

Exclusion criteria:

1. for COPD patients hospitalized for exacerbation:

   * concomitant acute cardiac évent
   * trachéal intubation with mechanical ventilation
   * chronic respiratory disease other than COPD
   * locomotor, neurologic or psychiatric comorbidities
2. for COPD patients

   * Exacerbation with récent hospitalization (\<4 weeks)
   * Neurologic comorbidity
3. for Healthy subjects - long term drug treatment with proven central effects
Evaluation of Novel Lung Function Parameters in Patients With Interstitial Lung Disease (ILD)

Current diagnostic tools used in interstitial lung disease (ILD) do not meet the challenges set by the complex pathophysiology of this heterogenous group. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various ILDs.


Eligibility Criteria:
Inclusion Criteria:

* known or suspected interstitial lung disease

Exclusion Criteria:

* pregnancy
* inability to participate
Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure

Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing. Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF). This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate.


Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years old who were hospitalised for acute heart failure were included (either new-onset acute heart failure or ADHF).

Exclusion Criteria:

* Patients with septic shock or pulmonary infarction were excluded.
Assessment of Remote Approaches for Identification of Autonomic Dysfunction Among Survivors of Leukemia and Lymphoma

This study seeks to determine if diagnosing cardiac autonomic dysfunction (AD) can be done remotely with the same accuracy as in-person testing. If so, the identification of AD could happen sooner, facilitating remote studies of the condition and potentially reducing the risk of illness. Childhood cancer survivors, particularly survivors of acute lymphoblastic leukemia (ALL) and Hodgkins's lymphoma (HL), appear to be at increased risk for AD.

Primary Objectives:

* To determine the sensitivity and specificity of heart rate variability (HRV), measured remotely with biosensor technology (Actigraph LEAP), compared to in-person assessment using the Ewing battery as the reference standard to identify cardiac autonomic dysfunction (AD) among survivors of leukemia and lymphoma.
* To determine the sensitivity and specificity of the Composite Autonomic Symptom Scale 31 (COMPASS31) compared to the Ewing battery to identify AD among leukemia and lymphoma survivors.

Each participant will complete an in-person standardized clinical assessment for AD, called the Ewing battery. during the participants' Human Performance Lab during their SJLIFE functional exam. It is estimated it will take 60-90-minutes to complete the Ewing battery. The tests include monitoring heart rate variations during deep breathing and lying down to standing, as well as monitoring blood pressure variations when standing and maintaining hand grip. Participants will be asked to not consume aspirin, ibuprofen or acetaminophen 24-hours before the assessment. Additionally, participants will be asked to avoid alcohol or caffeine within 6-hours, and smoking 3-hours, before testing.

After the in-person assessment, each participant will be given a wrist biosensor to remotely monitor heart rate variability for 7 days after they return home. Participants will also complete an AD symptom questionnaire, COMPASS31. The AD symptom questionnaire will be completed either before or after the in-person assessment. This questionnaire will take about 20-30 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in St. Jude Lifetime Cohort (SJLIFE) \>18 years of age.
* Primary diagnosis of acute lymphoblastic leukemia (ALL), Hodgkin's Lymphoma (HL), or Non-Hodgkin's Lymphoma (Non-HL).
* Not currently taking beta-blocker medication.

Exclusion Criteria:

* Individuals who cannot speak, read, and/or understand English.
* Individuals who are unable to follow directions/instructions in order to complete the Ewing battery.
* Individuals with acute heart failure (new or worsening signs and symptoms of heart failure, including a combination of the following: dyspnea, orthopnea, lower limb swelling, elevated jugular venous pressure, and pulmonary congestion).
* Women who are currently pregnant.
DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

Recently, DPP-IV inhibitors are used as a novel way to augment the incretin system and one of the newest classes of medications in the treatment of type 2 diabetes mellitus (T2DM). Since the DPP-IV inhibitor was first used, about 5 years have passed in USA. However, there were no major side effects including occurrence of cancers. The main mechanism for DPP-IV inhibitors is due to suppress the function of DPP-IV activity. As it is known that the suppressed DPP-IV activity is a marker for early diagnosis of cancers, the reason of disassociation is not clear.

Activation of receptor for advanced glycation endproduct (AGE) is related to sideration of cancers. Meanwhile, the DPP-IV inhibitors may be related to inhibit the activation of receptor for AGE (RAGE). Therefore, DPP-IV inhibitors may work as a cancer protective agent in diabetes by blocking the AGE-RAGE axis.

However, it is not demonstrated why DPP-IV inhibitors have no side effect of occurrence of cancer via blocking the activation of AGE-RAGE.

The investigators examined effect of DPP-IV inhibitors on frequency of cancers and the underlying mechanism using AGE and RAGE before and 5 years after administration of DPP-IV inhibitors in Japanese patients with T2DM.

The AGE and RAGE are measured using ELISA method in the laboratory of Department of Pathophysiology and Therapeutics of Diabetes Vascular Complications, Kurume University, School of Medicine, Japan before and for 5 years after administration of DPP-IV inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients with or without cancer

  * Patients who have no treatment with DPP-IV inhibitors.
  * Outpatients regularly visiting hospital
  * Patients 20 years old (gender is disregarded)

Exclusion Criteria:

* Patients with a serious complication in the heart, liver or kidney

  * Pregnant or possibly pregnant patients, or lactating patients
  * Patients participating in other clinical study.
  * Other than the above, patients judged inappropriate as the subjects of this study by the investigator
Texting to Reduce Alcohol Misuse Pilot Trial

The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.


Eligibility Criteria:
Inclusion Criteria:

* English reader
* Owns a mobile phone with SMS
* Hazardous alcohol consumption as measured by: "How many times in the past year have you had X or more drinks in a day?", where X is 5 for men and 4 for women, and a response of 1 or greater is considered at-risk
* At least in contemplative stage of change for reducing alcohol consumption

Exclusion Criteria:

* Currently enrolled or past enrollment in a 4-year college
* Pregnant or pregnancy plans in the next 3-months
* Current or planned treatment for alcohol or substance use disorder in next 3-months
The Doctors for Coronavirus Prevention Project Thanksgiving / Christmas Messaging Campaign

Facebook ads with physician-delivered videos were shown before the Thanksgiving and Christmas holidays and focused on staying safe during the COVID pandemic by limiting travel and mask-wearing.

The investigators used Facebook ads to show a 20 second video clip recorded by Massachusetts General Hospital, Harvard and Lynn Community health center doctors (6 people in all) to approximately 20,000,000 Facebook users. The ads will be shown before the Thanksgiving and Christmas holiday and will focus on staying safe - limiting travel and mask-wearing. The investigators will randomize exposure to the ad campaign at the ZIP code or county level to ask:

Do the videos change mobility and Thanksgiving and Christmas holiday travel? Do they reduce the spread of COVID-19?

Are there spillover impacts from the video messages? For example, if individuals decide to stay home, then do the geographical regions that tend to be visited by people from treated areas experience any effects, either through information spillovers or through a reduction in travel?

Eligibility Criteria:
Inclusion Criteria:

- Individuals viewing the ads must be Facebook users, 18 years and older. Facebook will decide specifically which users receive the messages within a target geographical area (zip or county).

Exclusion Criteria:

-
Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy

The aim of this prospective randomized trial is to compare the efficacy ultrasound guided thoracolumbar interfascial plane block versus bilateral ultrasound guided erector spinae plane block for post-operative pain management after lumbar laminectomy


Eligibility Criteria:
Inclusion Criteria:

* Seventy cases with herniated lumbar disc scheduled for lumbar single-level or multiple-level lumbar discectomy with American Society of Anesthesiologists physical status (ASA) I or II aged between 21 and 60 years of both genders.

Exclusion Criteria:

1. Body mass index \>32
2. History of relevant allergy to any of the drugs used in the procedure
3. Previous lumbar spine surgery or back surgery with planed spinal fixation