cyrilzakka/clinical-trials huggingface dataset:
Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery

The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.

Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.

Eligibility Criteria:
Inclusion Criteria:

* children undergoing elective strabismus surgery under sevoflurane anesthesia

Exclusion Criteria:

* children who experienced postoperative retching or vomiting
* children who have taken anti-emetic medications within 24 hours before surgery
* children who experienced motion sickness
Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Primary Outcome Measure:

1. AUClast and Cmax of tegaprazan
2. Gastric pH

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males aged ≥ 19 years and ≤ 50 years
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
* Helicobacter pylori negative

Exclusion Criteria:

* Presence or history of clinically significant diseases
* Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
* Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Serologic test positive
* Abnormal obstacle to insertion and maintenance of pH meter catheter
* History of drug abuse
* Excessive caffeine intake or persistent alcohol intake
* Not use of a medically acceptable method of contraception
MitoQ for Fatigue in Multiple Sclerosis (MS)

The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.

Recruitment of subjects on hold due to COVID-19 pandemic

MitoQ is a potent antioxidant dietary supplement with potentially significant immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal energy depletion may be an important contributor to fatigue in MS.

This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It will also explore the effects of MitoQ on cognitive function, quality of life and mood. If enrolled in the study, patients will take two capsules of the study drug or placebo at the same time every day for twelve weeks. There will be 4 study visits where the participant will undergo medical and nervous system examinations, questionnaires, and blood draws. Because it is a placebo-controlled trial, participants will have a 33% chance of receiving either placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study, meaning neither the participant nor the investigator will know who received the placebo or study drug.

Eligibility Criteria:
Inclusion Criteria:

* MS (any clinical subtype) as diagnosed by the 2017 McDonald criteria
* EDSS score of 2 to 8
* complaint of fatigue that has been persistent for at least two months
* Modified Fatigue Impact Scale (MFIS) score of 38 or greater

Exclusion Criteria:

* treatment with systemic glucocorticoids in the prior six weeks
* Beck Depression Inventory (BDI) \>31 or BDI-FS\>10 (severe depression)
* significant MS exacerbation in prior 30 days
* previous use of MitoQ or Coenzyme Q10 (CoQ10) within thirty days of screening appointment
* other significant health problem that might increase risk of patient experiencing Adverse Events (AEs), e.g.:

  * active coronary heart disease
  * liver disease
  * pulmonary disease
  * diabetes mellitus
* pregnancy or intending to become pregnant or breastfeeding
* unable to complete the self-report forms
* unable to give informed consent
* prisoners
* any condition which would make the patient in the opinion of the investigator unsuitable for the study
Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes

Our study is the first multicenter study in Vietnam on clinical phenotypes of heart failure with preserved ejection fraction (HFpEF) in patients with concurrent type 2 diabetes (T2DM) and hypertension (HTN). The purpose of this study is to identify different phenotypes of the Vietnamese HFpEF-HTN-T2DM population, as well as the association of these phenotypes with long-term outcomes.

The study is expected to provide further understanding on the characteristics, risk profiles and treatment patterns of an emergingly common and high-risk population. At baseline, patients will be grouped into phenotypes. During the 12 month follow up, investigators will collect information on predefined outcomes, especially the all cause mortality and hospitalization for heart failure, thereby establishing the association between phenotypes and outcomes.

The knowledge gained from the study is supposed to add valuable information on the feasibility of phenotype-guided approach for heart failure with preserved ejection fraction in patients with hypertension and diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years at screening
* Preexisting or newly diagnosed hypertension, diabetes
* Preexisting or newly diagnosed heart failure with preserved ejection fraction using 2016 European Society of Cardiology's guideline on heart failure.

  * Signs and symptoms of heart failure
  * N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 in acute setting, and ≥125 in chronic setting
  * Echocardiography with left ventricular ejection fraction (LVEF) ≥50% and at least one of these following criteria:

    * Structural changes indicated by either left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m\*2 in male and ≥95 g/m\*2 in female), or left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥34 ml/m\*2, or or LA diameter \>40 mm)
* Further inclusion criteria apply

Exclusion Criteria:

* Listed for heart transplant
* Primary stage D valvular heart disease requiring surgery or intervention, prosthetic or mechanical valve.
* Severe, unrepaired pericardiac disease
* Complex, unrepaired congenital heart disease
* Takotsubo disease, peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, cardiac sarcoidosis/amyloidosis.
* End stage renal dysfunction, defined as persistent estimated glomerular filtration rate (eGFR)\<15 ml/min (CKD-EPI Chronic Kidney Disease Epidemiology Collaboration Equation) or requiring renal replacement therapy.
* Child-Pugh-Turcotte C.
* Life expectancy \<1 year due to non-cardiac etiology, as per investigator judgement
* Severe pulmonary disease requiring continuous home oxygen
* Pregnancy or lactation.
* Concurrent enrolment in another interventional device or drug trial
* Further exclusion criteria may apply
Illness Management and Recovery (IMR) in Danish Community Mental Health Centres

The aim of this trial is to evaluate the effectiveness of the Illness Management and Recovery program for people diagnosed with schizophrenia or bipolar disorder in according to their level of functioning.

Background: Illness Management and Recovery (IMR) is a curriculum-based psychosocial intervention designed as structured program with a recovery-oriented approach. The aim of IMR is to rehabilitate people with severe mental illnesses by helping them acquire knowledge and skills in managing their illness and achieve personal recovery goals. Previous randomised clinical trials indicate that IMR can be implemented with a good effect and a high fidelity though further trials are crucial to demonstrate the potential effectiveness of IMR.

Methods/Design: The trial design is a randomised, assessor-blinded, multi-centre, clinical trial of the IMR program compared with treatment as usual for 200 participants diagnosed with schizophrenia or bipolar disorder under the care of two community mental health centres in the Capital Region of Denmark. The primary outcome is level of functioning at the end of treatment and at follow-up 21 months after baseline. The secondary outcomes are disease symptoms; use of alcohol/drugs; individual meaning of recovery; hope; hospital admissions and out-patient psychiatric treatment at the end of treatment and at follow-up 21 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* adults (age 18+)
* both sexes
* associated with one of the two participating community mental health centres
* diagnosed following the ICD-10 criteria of schizophrenia or bipolar disorder
* able to speak and understand Danish
* giving informed consent verbally and in writing

Exclusion Criteria:

* have a guardian or a forensic psychiatric arrangement
* comorbidity with the ICD-10 criteria of the diagnoses of dementia or mental retardation
* a large-scale substance abuse - if later on the abuse is under control inclusion in the trial will be possible
* a current home of supported housing - since the treatment as usual given to this group of patients is significant different from patients living independently
* a current involvement in a psycho-educational course - patients are eligible for participation in the trial after the psycho-educational course has ended if they meet the inclusion criteria at this point
* not given informed consent.
Risk Factors for Aneurysm Rebleeding

The purpose of this study is to examine the risk factors for aneurysm rebleeding.

To investigate risk factors for spontaneous aneurysm rebleeding during hospitalization and to reach conclusions if any,of clinical signs for predicting rebleeding.

Eligibility Criteria:
Inclusion Criteria:

* Individual whose clinical course was clear enough to be traced back and whose conservative treatment duration was shorter than 6 weeks was included

Exclusion Criteria:

* Rebleeding patients with certain inducing factors such as:

  * severe emotional episode,
  * severe coughing,
  * constipation,
  * excessive activities, or
  * with coagulation disorder,or
  * with other intracranial vascular malformations,such as:

    * moyamoya disease,
    * arteriovenous malformation were excluded.
* Also patients who rebled while angiography were excluded.
Effect of Cricoid Pressure on Macintosh, McGrath X-Blade and Glidescope Videolaryngoscopes in Rapid Sequence Induction Intubation

Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.

The investigators fecidedir to enroll the ASA I-II 120 patients and divided them into three groups ( Macintosh / McGarth X-Blade / Glidescope). The investigators recorded the patients' airway data and demographic variables. All patients were premeditated with midazolam. Standard monitoring including electrocardiogram, non invasive blood pressure, pulse oximetry, heart rate were recorded before induction , after induction, after the device insertion and every 1 minutes after intubation. Cormac-Lehan grades with these video laryngoscope were recorded also. We recorded the optimization maneuvers ( like handling force, reinserting, cricoid pressure). Bloodstaining on the devices after removal were recorded as mucosal damage. Teeth, tongue, lip damage were also recorded. Sore throat, bronchospasm, wheezing were recored at recovery unit.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* BMI\< 30
* 18-65 years of age

Exclusion Criteria:

* known difficult airway
* BMI \> 30
* \< 18 years of age
* \> 65 years of age
* known respiratory tract infection in 10 days
* pregnant
An Observational Study on the Relationship Between Tear Metabolomics and POD

To explore the correlation between tear metabolomics and POD. The purpose of this study was to compare the results of tear metabolomics between POD and non-POD elderly patients undergoing abdominal surgery, to clarify the correlation between tear metabolomics and POD, and to find tear markers related to POD.


Eligibility Criteria:
Inclusion Criteria:

* age 65-90 years old;
* ASA I-III;
* patients who plan to undergo elective abdominal surgery under general anesthesia;
* Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

* patients with known mental illness or lack of communication or cognitive impairment before operation;
* severe vision, hearing, language impairment or other reasons unable to communicate with visitors;
* severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;
* long-term use of sedatives, antidepressants or alcoholism;
* patients with severe postoperative complications and admitted to intensive care unit;
* patients who refused or failed to complete the cognitive function test.
* patients who could not cooperate with the study for any other reason
The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice

The study explore the relationship between COVID-19 and the induction of autoimmune diseases.

This study comprises both retrospective and prospective components. The retrospective arm (2016-2019) was conducted to establish baseline incidence rates of autoimmune diseases (AIDs) prior to the COVID-19 pandemic. The prospective arm (2020-2024) involves the identification and longitudinal follow-up of newly diagnosed AID cases to evaluate disease progression, therapeutic response, and recurrence. Based on these data, the study will yield four distinct analyses:

1. trends in AID incidence before and after the COVID-19 pandemic,
2. the demographic and clinical profile of AID patients in the post-COVID-19 era,
3. the association between COVID-19 vaccine status and the development of AIDs, and
4. the clinical course, response to therapy, and long-term outcomes of AIDs in post-COVID patients compared to pre-pandemic cases.

It has been suggested that the shared pathogenetic mechanisms and clinical-radiological aspects between the hyper-inflammatory diseases and Covid-19 may suggest that SARS-CoV-2 could act as a triggering factor for the development of a rapid autoimmune and/or autoinflammatory dysregulation, leading to the severe interstitial pneumonia, in genetic predisposed individuals.

The study is designed to investigate four primary objectives:

1. the incidence and trends of autoimmune diseases (AIDs) before and after the COVID-19 pandemic,
2. the association between COVID-19 vaccine status and the development of AIDs,
3. the clinical progression, treatment response, and recurrence of AIDs in post-COVID patients, and
4. the demographic and clinical profile, contributing factors, and spectrum of AID types identified during the post-pandemic period.

Retrospective data from 2016 to 2019 will be analyzed to establish baseline incidence rates, while prospective data from 2020 to 2024 will focus on new cases, vaccine exposure, clinical course, and patient characteristics.

The investigators hypothesize that:

1. the incidence of AIDs has increased in the post-COVID-19 era compared to the pre-pandemic period,
2. there is a positive association between COVID-19 vaccination and the onset of AIDs,
3. the clinical course and therapeutic response of AIDs in post-COVID patients differ from historical cases, and
4. unique demographic and clinical patterns characterize AID cases arising during the post-COVID period.

Accordingly, the study will yield four distinct analyses, each to be reported in a separate manuscript corresponding to the above objectives.

Eligibility Criteria:
Inclusion Criteria:

* all gender
* all age

Exclusion Criteria:

* Those who refused to participate
Message Testing in Aging African American Smokers

The goal of this study is to examine different messages to motivate smokers who self-identify as an African American current smoker, between the ages of 50-80 years old to quit smoking. Participants will be asked to complete a survey and look at two messages.


Eligibility Criteria:
Inclusion Criteria:

* Current smoker (smoking at least some days per week)
* Ability to read and write English
* Between the ages of 50 and 80 years old
* Self identify as African American.

Exclusion Criteria:

* History of Mild Cognitive Impairment or dementia
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.


Eligibility Criteria:
Inclusion Criteria:

* Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
* Migraine attacks have been persisting for more than 1 year
* 2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
* 2 to 6 migraine attacks of at least moderate severity during the screening period

Exclusion Criteria:

* Non-migraine headaches such as tension-type headaches
* Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
* Onset of migraine is after age of 50
* Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse
Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients

A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients

This is a dose-escalation study of Low-dose Radiation in combination with CS1001 in relapsed SCLC patients. Patients are assigned to 3 treatment groups received from 3 Gy to 15Gy, to determine the safety, tolerability and the maximal tolerant dose. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed LS-SCLC or ES-SCLC and experienced progression since first-line standard platinum containing dual-drug chemotherapy.
2. Patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons
3. At least one extracranial measurable lesion (RECIST v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed.
4. Patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months.
5. No radiotherapy contraindications were judged by the radiologist
6. ECOG performance status of 0 or 1.
7. Patients with life expectancy ≥ 3 months.
8. Patients must have adequate organ function.
9. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 6 months after last study drug administration.

Exclusion Criteria:

1. Subjects known to have primary CNS tumors or meningeal metastases or unstable CNS metastases.
2. Patients with active autoimmune diseases or history of autoimmune diseases should be excluded.
3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
4. Known history of HIV infection.
5. Subjects with active chronic hepatitis B or active hepatitis C .
6. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
7. Known history of alcoholism or drugs abuse.
8. Subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.
Induction of Labor in Oligohydramnios

When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.

The study will be a prospective randomised trial.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* normal pregnancy, well dated, at term
* un ripened cervix

Exclusion Criteria:

* previous cesarean section
* multiple pregnancy
* intra uterine growth restricted fetus