cyrilzakka/clinical-trials huggingface dataset:
Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).

This study aims to evaluate safety and efficacy of tSMS in ALS patients and to obtain preliminary data about the effects of tSMS on cortical excitability.

To this purpose, 40 ALS patients will be recruited and randomized to real or sham tSMS. After at least 3 months follow-up, they will undergo tSMS, daily for 120 min, at home, for 6 consecutive months.

Clinical status will be tested before, during and after the stimulation period. Moreover, cortical excitability will be tested by transcranial magnetic stimulation (TMS) before and after the stimulation period.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years
* diagnosis of ALS according to revised El Escorial criteria and Awaji-Shima criteria
* disease duration \< 24 months
* ALSFRS-R \> 30 at the recruitment
* ALSFRS-R decline \> 1 in the at least 3-months period before the intervention
* normal respiratory functionality (FVC \> 80% and ALSFRS-R items 10,11,12 \> 4) at the recruitment
* treatment with riluzole 50 mg x 2/die

Exclusion Criteria:

* inclusion in other clinical trials
* presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
* contraindications to magnetic fields exposure
* pregnancy or breast-feeding
* history of epilepsy or seizures
* assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
* cognitive impairment
* lack of informed consent
Establishing a Cohort for Occupational Disease of Emergency Medical Workers

This study aims to understand the epidemiological characteristics, related factors , and current status of occupational diseases and damage that occur in emergency medical workers (doctors and nurses). A number of surveys were conducted on about 100 emergency medical workers for about a year with occupational factors, physical health, and mental health.

* Background :

  1. The importance and public role of emergency medical care

     * Emergency medical care is a public and essential medical service that is directly related to the lives of the public and plays a key role in the domestic medical delivery system.
  2. Health problems of domestic emergency medical staff

     * Emergency medical workers are at higher risk than the general population due to higher work intensity, lack of medical staff, unplanned patient occurrence, and congestion.
     * Most emergency medical workers in Korea are classified as high-risk medical staff and receive special medical checkups once or twice a year. On the other hand, these regular medical checkups are only an evaluation of the overall health status of medical staff, which does not lead to prevention before the deterioration of the health status of individual medical staff.
* Objective : The purpose of this study is to establish a cohort research system to develop prevention and health care solutions by identifying epidemiological characteristics, related factors for occupational diseases, and damage occurring in emergency medical workers (doctors and nurses).
* Design: Observational (Cohort study)
* Setting: In the Department of Emergency at the Samsung Medical Center and other hospitals
* Enrollment : About 100 Emergency medical workers (doctors and nurses)
* Methods: Questionnaire surveys on occupational, mental, physical factors during about 1 year.

Eligibility Criteria:
Inclusion criteria: The emergency medical workers

* who have heard the explanation of the study and agreed to participate
* aged 18 or older
* have no occupational disease or damage (within 4 weeks) at the time of cohort establishment.

Exclusion criteria:

* Those who disagree with this study
* A person who is not engaged in actual work, such as taking leave of absence, or who does not agree to participate
* Those with occupational diseases or damage at the time of cohort establishment (within 4 weeks)
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults

Mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. For general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. Medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. In this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.

Mask ventilation is a foundation of airway management after the initial induction of anesthesia. It allows for adequate oxygenation of the patient to buy enough time for intubation, during which the patient is not ventilated. However, in some patients mask ventilation may be difficult - older than 55 years, heavier (BMI \> 26 kg/m\^2), with no teeth, having a beard or sleep apnea. Inadequate ventilation, if not corrected, can result in decreasing oxygen saturation to dangerous levels - which could lead to devastating complications. As a result, the efficacy of mask ventilation is of critical importance to patient safety after the induction of anesthesia.

A recent study proposed that mask ventilation could be improved simply by turning a patient's head. The study showed that rotating a patient's head to a 45 degree angle significantly improved mask ventilation when compared with the head placed in a neutral position. However, this study was done in patients with a BMI lass than 35. As such, the effects of head rotation on the efficacy of mask ventilation has not been studied in patients with a BMI of 35 and greater.

Obesity (BMI ≥ 30 kg/m\^2) affects almost 40% of US adults and is one of the most prevalent health concerns in our society. It is a predictor of difficult mask ventilation because it is associated with increased upper airway obstruction, decreased airway patency, and decreased lung volumes such as functional residual capacity (FRC). If previous findings in regard to the effects of 45 degree head rotation on the efficacy of ventilation hold true in the obese patient, then this study will show that head rotation could be used as a simple way to improve the efficacy of mask ventilation for patients with a BMI of 35 and above.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ASA Physical Status Classification I-III
* Body Mass Index (BMI) ≥ 35 kg/m\^2

Exclusion Criteria:

* Inability to obtain written informed consent
* Pregnant or breastfeeding
* Limited head rotation or neck extension
* Subjects with expected or history difficult intubation
* Large beard
* Orogastric (OG)/nasogastric (NG) tube
* Gastroesophageal Reflux Disease (GERD)
Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange

Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. However, in many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. The aim of this study is to determine adipokine and cardiac biomarker removal during TPE therapy.

We performed a observational prospective single-centered study. Every patient received two consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system. Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange volume of every TPE treatment was 1.1-times the individual calculated total plasma volume, using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in every treatment. Blood samples for measurement of different adipokines (resistin, leptin, soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and second TPE session.

Eligibility Criteria:
Inclusion Criteria:

* indication for TPE
* age between 18 and 80 years
* written informed consent

Exclusion Criteria:

* need for fresh-frozen plasma as replacement fluid
* participation in another study
Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study

A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner. The goal of this study is to establish the hyperinsulinemic-hypoglycemic clamp procedure at Pennington Biomedical Research Center in order to apply the knowledge gained to future studies which will determine the efficacy of our biomarker for predicting susceptibility to hypoglycemia. Additionally, our use of continuous glucose monitoring (CGM) during the clamp procedure will provide novel data regarding the accuracy of CGM during hypoglycemic conditions in a controlled research setting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Ages 18-40 years
* BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
* Medically cleared for participation in the study

Exclusion Criteria:

* History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
* Average screening blood pressure \>140/90 mmHg
* History of cardiovascular disease
* Pregnant, planning to become pregnant, or breastfeeding
* Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
Evaluate the Accuracy of a COPD Screening Algorithm Model

Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases. Early detection and treatment are critical to prevent the deterioration of COPD. In this study, we have established an algorithm that can detect and infer the severity of COPD from physiological parameters and audio data collected by wearable devices, and in this stage, we aim to evaluate the accuracy of this algorithm.

The investigators have established an algorithm that can detect COPD from physiological parameters, coughing sounds, and forceful expiratory sounds collected by wearable devices. This study will test the accuracy of this algorithm.

In this study, 404 residents at high risk of COPD (COPD-PS score≥5) will be enrolled. Questionnaires related to COPD will be collected, subjects will undergo pulmonary function tests and electrocardiogram. Physiological parameters such as oxygen saturation and heart rate will be collected by a wearable device 3 times for 2 minutes each time, and coughing sound will be collected. As spirometry is the gold standard for the diagnosis of COPD, the accuracy of COPD diagnosis algorithm model by intelligent terminal devices will be verified.

The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2022-083). Any protocol modifications will be submitted for the IRB review and approval.

Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18, no gender restrictions.
2. Participants at high risk of COPD (COPD-PS score ≥5).
3. Able to carry out daily activities and wear wearable devices.
4. Willing to participate in the study, willing to comply with the study protocol, and have the ability to sign informed consent.
5. Possess mobile communication equipment, which can meet the requirement of installing wearable device applications and recording function.

Exclusion Criteria:

1. Diagnosed with chronic respiratory diseases other than COPD, such as asthma, lung cancer, active tuberculosis, bronchiectasis and diffuse lung diseases (interstitial pneumonia, occupational lung disease, sarcoidosis, etc.).
2. lobectomy and/or lung transplantation, pleural disease.
3. Complicated with serious underlying diseases, including severe mental illness, intellectually impaired diseases, neurological disease (resulting in limb movement disorder), malignant tumor (PS score \> 2), chronic liver disease (transaminase \> 3 times the upper limit of normal), heart failure (NYHA\> Grade 3), autoimmune disease, chronic kidney disease (CKD-5), unstable coronary artery disease, arrhythmia (atrial fibrillation, atrial flutter, severe ventricular arrhythmia), congenital heart disease, pulmonary hypertension, etc., or life expectancy of less than 6 months.
4. Malnutrition (BMI\<18 kg/m2).
5. Bilateral wrist and hand edema, wrist soft tissue injury, inability to wear a watch/bracelet due to incomplete skin.
6. Dual upper limb pigmentation or abnormal blood supply (occlusion, thrombosis, trauma, etc.).
Establish a Vegetable Signature Database From Human Metabolomics Responses

Vegetable is well known to prevent chronic disease,however, the mechanism of its nutrients and non-nutrients still remains to be discovered.We design a feeding study which provides plant foods to subjects one by another and monitoring metabolomic changes up to 7 hours.The goal of this study is to establish a protocol for documenting metabolomics response to plant foods and try to characterize plant foods in terms of their anti-hypertension potentials with metabolomic profiling information.


Eligibility Criteria:
Inclusion Criteria:

* Age :18-60 years
* Body Mass Index :18.5-30(kg/m2)
* Non-smoking,alcohol abusing,and other bad hobbies

Exclusion Criteria:

* With regular drug intake e.g. anti-hypertensive or antidiabetes drug or history of immune, hepatic and metabolic disease or other unsuitable disorders e.g. cancer.
* unwilling to stop regular food supplement e.g. vitamins, herb
* cannot cooperate with designed diet
* History of urinary tract infection or antibiotic use within the previous 3 month
Use of Midodrine in Septic Shock Patients

This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.


Eligibility Criteria:
Inclusion criteria:

Patients diagnosed with sepsis within 24 hours of meeting all of the following criteria will be eligible to participate in the study:

* Sepsis-3 criteria: acute hospital admission for suspected infection with new or worsening organ dysfunction measured by the increase in Sequential Organ failure Assessment (SOFA) score of 2 points or more.
* IV vasopressor use or persistent hypotension (MAP \< 65 mm Hg) after initial fluid resuscitation in the ED or ICU (30 mL/kg unless deemed excessive by the treating clinician).

Exclusion criteria:

* High-dose vasopressors (norepinephrine equivalent \> 0.3 µg/kg/min).
* Inadequately controlled source of infection.
* Cardiogenic or obstructive (massive pulmonary embolism) shock.
* Clinical suspicion or confirmed diagnosis of bowel obstruction, bowel ischemia, or ileus.
* Contraindication to enteral intake (ileus, vomiting, gastrointestinal bleeding, endoscopic procedures etc.).
* Recent myocardial infarction (within the past 3 months).
* Recent treatment for peripheral vascular disease (within the past 3 months).
* Current use of monoamine oxidase inhibitors.
* Recent stroke (within the past 3 months).
* Prior use of midodrine as a home medication.
* Known allergy to midodrine.
* Comfort care measures.
* Pregnancy.
* Fludrocortisone acetate as a current home medication.
* Bradycardia (heart rate \< 50 beats/min).
* Untreated pheochromocytoma.
* Untreated thyrotoxicosis.
* Open-angle glaucoma.
* Treating emergency or critical care physician unwilling to enroll patient in trial.
* Inability to give consent for participation and no representative or surrogate available to consent.
Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)

The objective of the preliminary study is:

1. To identify correlations between brain lesions and sensorimotor impairments in stroke.
2. To identify possible patterns between brain lesions and sensorimotor impairments that might increase our understanding in stroke recovery and guide further tailor-based neuro-rehabilitation

The purpose of this study is to investigate arm and hand function after stroke and how the location of the brain lesion affects arm and hand function. We are hoping to collect data in the form of assessments what you feel and how your arm moves, surveys about activities in daily life and well-being, and we will perform 1 Magnetic Resonance Imaging (MRI) scan. MRI scans are loud but painless; nothing is injected. With MRI, we collect images from the brain.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for healthy subjects are:

  * medically stable;
  * 18 - 99 years of age;
  * able to hear the instructions given during the study

Inclusion criteria for stroke patients are:

* at least 6 months post-stroke;
* medically stable;
* 18 - 99 years of age;
* subcortical or cortical infarct confirmed with MRI;
* Mini-mental State Exam \> 24/30 (Folstein et al., 1975);
* able to hear the instructions given during the study;
* able to comprehend the instructions given during the study;
* able to commit time to participate in a 6-12-weeks rehabilitation program

Exclusion Criteria:

Exclusion criteria for healthy subjects are:

* having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment;
* severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
* contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position;
* interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
* exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
* pregnant or nursing mother;
* adults lacking capacity to consent

Exclusion criteria for stroke patients are:

* insular or cerebellar infarcts/brain lesions;
* unilateral spatial neglect, identified by a standard neuropsychological assessment (Bell's test (score/35, Gauthier et al., 1989);
* aphasia;
* apraxia (TULIA, Vanbellingen et al., 2011);
* severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
* contractures in the hemiplegic arm that hinder patients from keeping the outstretched arm in a relaxed position;
* interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
* patients currently receiving therapy for their hemiplegic arm, the latter in order to avoid confounding treatment effects;
* exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
* pregnant or nursing mother;
* adults lacking capacity to consent
Adverse Drug Reactions to Cancer Therapies in Patients with Depression: Insights from VigiBase

Importance:

Depression is prevalent among oncology patients and may influence the perception, reporting, and severity of adverse events (AEs) related to cancer therapies. Understanding this association is crucial for optimizing treatment outcomes and improving patient quality of life.

Objective:

To evaluate the association between depression and the reporting and severity of AEs among oncology patients using data from VigiBase®, the World Health Organization's global pharmacovigilance database.

Design:

This pharmacovigilance study employed a case/non-case disproportionality analysis using Individual Case Safety Reports (ICSRs) from 1968 to 2024. Multivariable analyses were conducted to adjust for potential confounders, such as age and sex.

Setting:

The study utilized data from VigiBase®, a global pharmacovigilance database containing reports from over 120 countries.

Participants:

ICSRs involving antineoplastic or immunomodulating agents were included. Depression was identified through antidepressant use, yielding 428,102 reports for patients on antidepressants and 8,376,761 for those not on antidepressants.

Exposure:

Oncology patients receiving antidepressant therapy were compared to those not receiving such treatment.

Main Outcome and Measures:

The primary outcome was the reporting of serious AEs (e.g., hospitalization, life-threatening events). Secondary outcomes included the 20 most frequently reported AEs among oncology patients, with comparisons made between those treated with and without antidepressants.


Eligibility Criteria:
Inclusion Criteria:

* ICSRs were limited to those involving liable antineoplastic or immunomodulating agents (per the Anatomical Therapeutic Chemical (ATC) Classification code L; hereafter referred to as antineoplastics)

Exclusion Criteria:

* Suspect of duplication
Bone Loss in Posterior Mandible Postextraction Sockets

The aim of this study is to evaluate the bone loss after extraction. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 40 patients

Primary objective :

Estimate the percentage of bone volume loss o and the percentage thickness loss of the buccal and palatal cortical for patients who underwent natural healing in the mandibular molar and premolar areas.

Methods :

Before tooth extraction of a premolar or molar in mandibular area by flapless technique, a CBCT preoperative is performed to verify the integrity of cortical and measure the height and width of the residual cavity. Caliper measurements will also be performed during surgery in order to integrate also the thickness of the bone tables and gingival thickness.

After natural healing , the pre-implant scan performed at six months postoperatively will measure the height and width of the grafted cell, to compare measurements and evaluate the dynamics of alveolar resorption.

Eligibility Criteria:
Inclusion criteria

* patients requiring tooth extraction
* aged 18 to 80
* Patients showing no indication against-General to surgery

Exclusion criteria

* Patient with against-indication for surgical treatment.
* Patients with an important loss of vestibular cortical
* Patients requiring and accepting a bone graft
* Unstabilized periodontal disease or aesthetic indication.
* Inability to maintain a good level of oral hygiene and good cooperation.
* Higher tobacco consumption has 10cig / day
* Acute dental infection