cyrilzakka/clinical-trials huggingface dataset:
Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation

The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

One lung ventilation (OLV) is a mechanical ventilation method used during thoracic surgery to collapse the non-ventilated lung and secure the surgical field. During one lung ventilation, the pulmonary artery of the collapsed lung undergoes vasoconstriction in response to hypoxia, which increases the blood flow of the normally ventilated lung as a compensatory physiological response. This is known as hypoxic pulmonary vasoconstriction (HPV). Therefore, by using HPV, arterial blood oxygenation can be maintained and pulmonary shunting can be reduced, preventing hypoxemia during one lung ventilation.

The two most commonly used anesthetics in thoracic surgery are sevoflurane, an inhaled anesthetic, and propofol, an intravenous anesthetic. Previous studies have shown that there were no significant differences between two anesthetics on arterial oxygenation during one lung ventilation because sevoflurane administered in clinical concentrations of 1 minimum alveolar concentration (MAC) resulted in similar changes in shunt fraction as did propofol.

However, the effect of remimazolam on arterial blood oxygenation and intrapulmonary shunt during one lung ventilation has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and sevoflurane anesthesia on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing video-assisted thoracoscopic surgery
* 19 years of age or older, less than 80 years old
* The American Society of Anesthesiologists (ASA) classification I-Ⅲ physical status

Exclusion Criteria:

* Patients with known allergy to benzodiazepine, propofol
* Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Patients with hypersensitivity to Dextran40
* Patients with end stage renal disease requiring hemodialysis
* Patients with history of acute angle glaucoma
* Emergency operation
* Patients with unstable hemodynamics requiring inotropics
* Patients with preoperative oxygen supplement
* Preoperative forced expiratory volume (FEV1) less than 40% of predicted
* Preoperative ejection fraction less than 50%
Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis

The aim of the study was to assess the effect of nitazoxanide delivered subgingivally as thermosensitive hydrogel on the clinical and biochemical outcomes of SRP in patients with moderate periodontitis.

A randomized, controlled clinical trial in a split-mouth design was conducted on forty patients equally divided between two groups: a control group treated with full mouth scaling and root planing (SRP) and a test group treated with SRP combined with subgingivally delivered 0.01% NTZ sustained release Poloxamer 407/hyaluronic acid thermosensitive hydrogel.

Eligibility Criteria:
Inclusion Criteria:

* Patients having probing depth (PD) ≥5 mm.
* Patients having bleeding on probing (BOP) in proximal tooth surface.
* Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study.

Exclusion Criteria:

* Patients having any systemic disease that may affect the treatment outcomes.
* Smokers.
* Pregnant females.
* Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.
Seal, Stopping Eczema and Allergy Study

This is a randomized, controlled trial designed for children who are have already developed atopic dermatitis (AD or eczema) by 12 weeks of age. The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

This is a randomized, controlled, parallel design, open-label phase 2 clinical study to compare the efficacy of a proactive treatment arm versus the reactive arm, for the prevention of atopic dermatitis in children at high risk of food allergy. We will recruit 312 infants who have signs of dry skin or atopic dermatitis between 0-12 weeks of life.

The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone propionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).

Eligibility Criteria:
Inclusion Criteria:

1. Participants who develop early onset visible dry skin or atopic dermatitis up to and equal to 12 weeks of age.
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. In good general health as evidenced by medical history
4. No known adverse reaction to any of the study medications, their components or excipients

Exclusion Criteria:

1. Infants \<3kg body weight
2. Infants with a chronic disease requiring therapy (e.g. heart disease, diabetes, serious neurological defects, immunodeficiency)
3. Known moderate to severe cutaneous skin disorder other than AD, including but not limited to cutaneous mastocytosis, bullous skin disease, pustular skin disease, neonatal HSV, aplasia, and albinism
4. Parents or guardians unwilling to sign consent
5. Current participant or participation since birth in any interventional study
6. Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)
7. A course of antibiotics in infant within 7 days of enrollment
8. Any known food allergies
Group Advanced Care Planning Pilot for Veterans

The proposed research aims to engage participants with an advanced stage cancer diagnosis in group educational sessions to facilitate learning of topics related to advanced care planning. The investigators also hope to learn if conducting educational sessions in a group setting helps to create a more supportive environment amongst patients, caregivers, etc.

The purpose of this study is to compare usual care against a group advanced care planning intervention comprised of two sessions led by trained community health workers or health educators from VA Palo Alto. A total of 50 participants will be randomly assigned to either usual care (n=25) or usual care + group advanced care planning intervention (n=25). Those in usual care will be mailed some educational materials about advanced care planning that they may review independently. Those in the group advanced care planning arm will participate in two 1-hour educational sessions led by the community health worker/educator that will be on site, by VA-approved video conference, or a hybrid model. Topics will include an introduction to advanced care planning, goals of care topics, advance directives, and physicians order of life sustaining treatment. Both usual care and the group advanced care planning arms will also participate in pre/post surveys and/or interviews.

Eligibility Criteria:
Inclusion Criteria:

1. All patients \>18 years old with newly diagnosed advanced cancer are eligible.
2. Patients must have the ability to understand and willingness to provide verbal consent
3. Participants must speak English

Exclusion Criteria:

1. Inability to consent to the study
2. Plans to change oncologist within 4 months
3. Employed by the practice site
4. Patients who anticipate moving from the area within 4 months
ISIS 1 Therapeutic Effectiveness

The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.

Precisely, the study was designed to :

* evaluate the therapeutic efficacy of the CPAP/autoCPAP Sandman device in improving sleep quality and normalozing respiratory events
* determine the sensitivity and specificity of the device in adequately detecting respiratroy events
* compare effective pressure Peff determined by the device and during manual titration
* compare the impact of the two-speed descent pressure algorithm

During the study, each patient underwent one night of full polysomnography with two consecutives therapeutic sequences during the same night, after randomization of the passage order:

* autotitrating pressure phase: sleep parameters and respiratory events vs results of the polysomnographic registration,
* manual titration phase: concordance between events respiratory analyzed on the polysomnographic recordings and the events detected by the CPAP / auto-CPAP.

Eligibility Criteria:
Inclusion Criteria:

* patient male or female, aged 18 to 75 years
* weight \> 30kg
* patient with a newly diagnosed OSAS, under treatment with CPAP
* patient in stable condition
* patient affiliated to a social security insurance
* having given its written informed consent to participate to the study

Exclusion Criteria:

* pneumothorax or pneumomediastin history
* massive epistaxis (current or previous)
* decompensated heart failure or hypotension
* pneumoencephal history, recent trauma or surgery sequel with cranio-nasopharyngeal fistula
* acute sinusitis history, middle ear infection or perforation of the tympanic membrane
* respiratory insufficiency or severe respiratory illness with the possibility of residual hypoxemia
* severe bullous emphysema or previously complicated pneumothorax
* severe claustrophobia
Periodic Limb Movement and Genetic Generalized Epilepsy

The study aimed to study the correlation between periodic limb movement occurring during sleep and the different parameters of genetic generalized epilepsy

Although periodic limb movements are prevalent among patients with epilepsy, the exact relationship between these movements and epilepsy remains elusive. Objective: The aim of this work was to study the periodic limb movements among patients with genetic generalized epilepsy in relation to different clinical characteristics and seizure recurrence. Methods: Sixty individuals participated in this study: thirty of them were newly diagnosed with genetic generalized epilepsy and thirty were healthy individuals. Sleep quality was assessed using the Pittsburgh Sleep Quality Index questionnaire, and a standard polysomnographic study was conducted to all subjects. All patients then received sodium valproate in therapeutic doses and were followed up for six months. Electroencephalogram (EEG) was done after the follow-up period and seizure recurrence was assessed. Accordingly, patients were classified into three groups according to clinical seizure recurrence and follow-up EEG findings.

Periodic limb movement index and frequency were compared among the patients' groups and were correlated with different clinical characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria
* did not previously receive AEDs.
* The clinical seizures were either eyewitnessed by physicians or video-recorded to ensure they were true epileptic seizures.
* At least two unprovoked seizures occurring \>24 hours apart

Exclusion Criteria:

* Patients with pre-existing psychiatric illnesses
* Patients with seizures due to toxic or metabolic causes (including glucose disturbance, uremia, and electrolytes disturbance), infections, or structural causes (such as neoplasms)
* Patients using hypnotic drugs
Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers

This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult aged between 19 and 45 at screening
* Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2
* Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria:

* Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Subjects who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple ppendectomy and herniotomy)
* Subjects who showed positive result for Helicobacter pylori test
* Subjects with serum AST (SGOT) or ALT (SGPT) level \>1.5 times the upper limit of the normal range at the time of the screening examination
* Subjects with a history of drug abuse or a positive urine screening for drug abuse
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
Protective Effect of EECP Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients with Stable angina pectoris, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiogenic shock;
* Patients chronic heart failure;
* Patients are ready to received cardiovascular surgery during this hospital admission.
* Patients agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Moderate to severe aortic insufficiency; 2. Dissection aneurysm; 3. Significant pulmonary hypertension; 4, A variety of bleeding diseases or bleeding tendencies, or use anticoagulants, INR\>2.0; 5, active phlebitis, venous thrombosis; 6. There is an infection in the counterpulsating limb; 7. Uncontrolled hyperhypertension (\>170/110mmHg); 8. Uncontrolled arrhythmias: frequent premature beats, rapid atrial fibrillation, etc.

9. Pregnancy.
Opp - a Universal Mental Health Promoting Mobile Application for Adolescents

The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.

The intervention "Opp" will be delivered through a mobile application. The overall goals of Opp are to 1) increase well-being and mental well-being, 2) increase knowledge about mental health, 3) increase coping skills to deal with stress, 4) increase help-seeking behavior, 5) increase self-esteem, 6) increase sleep quality and 7) reduce mental health problems.

To evaluate the mobile application two studies will be conducted: A user survey and an effectiveness study with a follow-up examination after about six weeks. The effectiveness study will be conducted as a randomized controlled trial with an intervention group and a waiting-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents under 16 years whose guardians have given consent

Exclusion Criteria:

* severe developmental or cognitive challenges
A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)

The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.


Eligibility Criteria:
Inclusion Criteria:

* Participants with age greater than or equal to (\>=) 18 years
* Participants with moderate to severe active RA (DAS28 \>=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (DMARDs), irrespective of whether they were of biological or synthetic nature
* Participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (SPC) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for RA in the past either
* Assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient.
* Pulmonologist's consent for chest X-ray and quantiferon test with commencement of biological treatment

Exclusion Criteria:

* Hepatitis B surface antigen (HBsAg,) hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positivity
* History of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies
* History of intestinal ulcerations or diverticulitis
* Active hepatopathy with more than threefold increase of alanine transaminase (ALT) or aspartate transaminase (AST)
* Thrombocytes \<100,000 per cubic milliliters (/mm\^3), less than (\<) 3,000 mm\^3, absolute neutrophil count \< 2,000 mm\^3
* Women of childbearing age (without medically confirmed sterility, e.g. following hysterectomy, ovariectomy, menopause lasting 2 years) who do not accept the use of a suitable form of contraception (e.g. barrier methods of contraception in the participant and partner, contraceptive pills or patches, hormonal implants, spermicidal agents in combination with barrier method of contraception, intrauterine device)
Kidney Information Network for Disease Research and Education

In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data. Investigators will utilize data from the cohort to test the independent relationship between biochemical and genetic markers and Fabry disease and other rare diseases.

KINDRED is a prospective observational cohort study that will enroll up to 5,000 dialysis patients throughout the United States with and without known diagnosis of Fabry disease but at risk for Fabry disease (e.g., unknown cause of renal disease, young male, initiating dialysis without a kidney biopsy, etc).This tissue repository will allow for genetic screening of a geographically diverse population, assist in identification of rare diseases in ESRD, and collect research-quality information on risk factors and outcomes from an ethnically heterogeneous population of dialysis patients. In this study, Investigators will use a novel method of performing research in this population by leveraging the internet to enhance and accelerate recruitment of potential subjects to participate in a genetic screening/tissue repository protocol.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 65 with ESRD undergoing dialysis.

Exclusion Criteria:

* Kidney biopsy unlikely to be Fabry disease; those with a diagnosis that is clinically or biochemically proven not to be Fabry disease.
Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases

The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of non-small cell lung cancer
* Age \>18 years at time of consent
* Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* No severe viral or bacterial infections
* Predicted survival \>3 months

Exclusion Criteria:

* Clinically relevant diseases or infections (HBV, HCV, HIV)
* Females who are pregnant or nursing
* Immunosuppressant treatment
* Currently participating in another clinical trial
Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.

This single-center, single ascending dose, phase I/IIa study was divided into 2 parts, involving both healthy subjects and patients with brain lesions:

* Study Part I included healthy subjects: double-blind, randomized, placebo control;
* Study Part II included patients with brain lesions: open-label.

In Part I, the following 6 dosing groups were investigated:

* Group 1: 0.025 mmol/kg
* Group 2: 0.05 mmol/kg
* Group 3: 0.075 mmol/kg
* Group 4: 0.1 mmol/kg
* Group 5: 0.2 mmol/kg
* Group 6: 0.3 mmol/kg

Healthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.

In Part II, the following 4 doses groups were investigated:

* Group 7: 0.05 mmol/kg
* Group 8: 0.075 mmol/kg
* Group 9: 0.1 mmol/kg
* Group 10: 0.2 mmol/kg

Patients with brain lesions were included and were then administered with P03277 and underwent MRI examination.

Eligibility Criteria:
Inclusion Criteria:

* Part I: Subjects between 18 and 45 years old (inclusive), with a body mass index (BMI) of 18 to 30 kg/m² (exclusive) and in a good health.
* Part II: Patients 18 years old and older and having at least one brain lesion with a disruption of the blood brain barrier (BBB) and/or with abnormal vascularity in the brain. This/these lesion(s) must have been detected by previous imaging evaluation (Computed Tomography or MRI).
Effective Use of Respiratory Patterns in the First Period of Labor in Control of Maternal Anxiety

The effectiveness of breathing exercise on anxiety in women during the first period of labor.

The groups will be randomized into intervention groups, which will be held ventilatory patterns while the control group will receive routine care service. The measurements will be made during the admission, and every 2 hours until the final phase of dilation.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* First stage of labor

Exclusion Criteria:

* Multiple gestation;
* Eclampsia;
* Pregnancy with a dead fetus;
* Use of analgesia;
* Pregnant women with clinical instability;
* Psychiatric disorders;