cyrilzakka/clinical-trials huggingface dataset:
Maintenance of Efficacy With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.

This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Required long-term antipsychotic therapy at the time of recruitment
* Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)
* Patients or their legal representatives provided their written informed consent prior to enrollment in the study

Exclusion Criteria:

* Patients who had received clozapine during the previous 3 months
* Participated in an investigational drug trial in the previous 30 days
* Previously been shown to be either intolerant or non-responsive to risperidone therapy
* Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome
* Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception
Testing Educational Videos on Conservative Kidney Management

This study aims to test the efficacy of a series of just-in-time educational videos on topics related to CKM (CKM-EMPOWER) in improving nephrology providers ability to provide CKM.

Conservative kidney management (CKM) is an important therapeutic alternative for patients who do not wish to pursue dialysis for their advanced chronic kidney disease (CKD). Despite a growing body of evidence and clinical services to support patients who do not wish to pursue dialysis, nephrologists receive very limited training in CKM. This is a randomized trial of nephrology fellows that utilizes surveys to assess their change in knowledge, confidence and practice of providing CKM with receipt of CKM-EMPOWER. The investigators hypothesize that the CKM-EMPOWER will improve nephrology fellows' knowledge and confidence with delivering key elements of CKM. Investigators will recruit 126 nephrology fellows from US fellowship programs and randomize participants in a 1:1 fashion to either receipt of the CKM-EMPOWER or non-receipt. Participants will complete web-based surveys to assess knowledge and confidence with providing CKM between groups.

Eligibility Criteria:
Inclusion Criteria:

* nephrology fellow enrolled in US nephrology fellowship training program

Exclusion Criteria:

* none
Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance

necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so prophylactic measures at this stage may help to prevent its progression and its complications.

N-acetyl cysteine is an FDA- approved drug and has many uses in different diseases and in different age groups including neonates, it has a mucolytic and anti-inflammatory and anti-oxidant effects that are believed to break the bacterial biofilm which enables it to stick to the intestinal wall and also decrease the intestinal wall inflammation, therefore enhance the intestinal barrier and decrease the chance of bacterial invasion.


Eligibility Criteria:
Inclusion Criteria:

* preterm neonates (less than or = 36 weeks gestational age )
* feeding intolerance

Exclusion Criteria:

* active gastro-intestinal tract bleeding
* Gastro- intestinal tract surgical problem
* Congenital gastro-intestinal tract anomalies
* evidence of allergy to NAC
* use of prebiotics or probiotics
Antiplatelet Therapy for AIS Patients With Thrombocytopenia

The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

Antiplatelet therapy is widely used in non-cardiogenic AIS patients for secondary prevention. However, it may also increase the risk of bleeding complications, especially in patients with thrombocytopenia. The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Acute ischemic stroke or transient ischemic attack with onset \< 7 days
* The last blood routine test before enrollment indicates platelet count \< 100 x 10\^9 and \> 30 x 10\^9

Exclusion Criteria:

* Chronic renal dysfunction (GFR \< 30ml/min) or severe hepatic injury
* Indications for anticoagulation therapy, e.g. atrial fibrillation
* Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
* Have or plan to receive CEA or CAS in the following 3 months
* Life expectancy less than 1 year
* Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
* Pregnant or lactating women
* Individuals identified by researchers as unsuitable for participation in the study due to other reasons.
Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients.

To investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam

It is intended to recruit 240 insomnia outpatients in this study, 120 patients receiving Brotizolam + Estazolam placebo (Test Group) and 120 patients given Estazolam + Brotizolam placebo (Control Group).

Study Hypothesis:

Brotizolam can be safely used in insomnia patients in China. And Brotizolam 0.25mg is non-inferior with Estazolam 1-2mg in treatment of insomnia patients in China

Comparison(s):

Estazolam 1-2mg

Eligibility Criteria:
Inclusion_Criteria:

Patients will be eligible for enrollment of this study if they meet all of the following criteria:

* Willing and able to provide written informed consent
* Male or female, aged 18 - 65 (including 18 and 65)
* Diagnosed as insomnia by the criteria of CCMD-3:

Exclusion_Criteria:

* Who received any central nervous system drugs within one week before visit 2(baseline)
* Continuous use of hypnotic agents for more than 3 months recently
* History of inefficiency with benzodiazepine-type hypnotics
* Who have a history of obvious hypersensitivity
* Hamilton Depression Rating Scale (HAMD)18
* Who was diagnosed with other mental illness
* With serious diseases of heart, liver and kidney, etc
* Who had sleep apnoea syndrome
* Who had epileptic seizures within one year
* With angle closure glaucoma that is acute or easy to occurred
* Whose AST or ALT values are 2 times of normal upper limit
* Whose Cr or BUN values are 2 times of normal upper limit
* Who are known to be prone to the abuse of alcohol (i.e. history of evidence of acute or chronic abuse), or any other addictive agents
* Who is participating in other clinical trial, or have participated in a clinical study of any other drug in one month prior to visit 2 (baseline). In addition, patients who has been randomized in this trial and then withdrew can not be enrolled again.
* All pregnant, lactational women and women who have the plan of pregnancy.
* Who are unwilling to or not able to complete the whole clinical trial
* Other patients who are unsuitable to be included in the trial judged by investigator
Long Term Results of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury

Mild traumatic brain injury (mTBI) accounts for 70-90% of brain injuries, with 600 cases of mTBI per 100 000 people in the united states, but only 100-300 mTBI patients per 100 000 people receive hospital-based care. Symptoms reported immediately after injury tend to diminish over the following 10 days and are generally resolved by 3 months. However, in 15-25% of cases , problems persist, and may even worsen, at 3 months. Physical, emotional, and behavioral factors can be affected. Physical disorders include pain and fatigue. Sleep disorders are also common. Persistent symptoms can affect patient outcomes (affecting all aspects of life) and increase public healthcare costs .In a previous study (NCT03811626, Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. The investigators were able to demonstrate that early multidisciplinary management improved the outcome and prognosis of patients by statistically significantly reducing the percentage of patients with Post traumatic syndrome distress at six months (6% for the treated group versus 52% for the control group, p \< 0.001).

It seems important to verify that if this short-term improvement (6 months after the trauma) persists in the long term, and therefore at a distance from the end of the initially proposed rehabilitation.

80 mTBI patients included in the previous study (NCT03811626) will be contacted by phone and an assessment consisting of questionnaires (QOLIBRI, SF-36, Posttraumatic stress disorder Checklist Scale (PCLS ) , ProQol) will be offered to them.

Eligibility Criteria:
Inclusion Criteria:

* all patients from our previous study NCT03811626 and included by our center
* Patient informed and willing to participate

Exclusion Criteria:

* Patient without social security
Role of Comorbidities in Chronic Heart Failure Study

This study aims to create a database of patients with stable and chronic heart failure with comprehensive assessment of bone, skeletal and vascular status. RoC-HF will facilitate cross-sectional and, eventually, longitudinal mechanistic epidemiological analyses to disentangle the role of the bone- vascular axis in chronic heart failure. Blood and urine samples will be stored to facilitate future biomarker analyses.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18
2. NYHA (New York Heart Association) class II-IV symptoms
3. Left ventricular ejection fraction \< 50% at Visit 1.
4. Treatment according to current Heart Failure Guidelines of the European Society of Cardiology
5. Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures
6. Previous diagnosis of heart failure with reduced ejection fraction defined as symptomatic left ventricular ejection \< 40% requiring optimization of heart failure therapy

Exclusion Criteria:

1. Unplanned hospitalization within 1 month prior to the Baseline Visit.
2. Discontinuation or initiation of a pharmacologic or device treatment for HFrEF within 1 month prior to the baseline visit.
3. Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
4. Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
5. Any acute illness
6. Disease reducing life expectancy to \< 1 year, except HFrEF
7. Recipient of any organ transplant
8. Primary significant valve disease (at least moderate to severe valve disease)
Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery

Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years
2. programmed cardiac surgery
3. Central venous catheter placed in territory SVC
4. Affiliation to a social security system
5. Hemoglobin \<9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)

Exclusion Criteria:

1. Patient minor or under court protection
2. Pregnant or lactating women
3. severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
4. Installation of an external or internal circulatory support
5. emergency surgery (\<24 hours from admission)
6. Complex Aortic Surgery
7. Sepsis
8. Patient Refusal of transfusion (religious belief)
9. Patient under guardianship
10. Renal failure with dialysis treatment
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis

The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

Group 1 (Healthy Participants):

Subjects without present or history of any kind of atopy.

Group 2 (Atopic Dermatitis Participants):

Subjects with diagnosed atopic dermatitis.

All study subjects:

1. Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.
2. Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
3. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination.
4. Lab values without clinically significant findings.
5. Electrocardiogram (ECG) without clinically significant findings.

Exclusion Criteria:

1. Pregnant or breast-feeding women.
2. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
3. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
4. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
5. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
6. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
7. History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.
8. Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
9. History of anaphylaxis or severe allergic reaction.
10. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
11. Administration of immunomodulatory substances.
Comparison of Drug Eluting Balloon and Drug Eluting Stent

The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).

A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.

We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.

Eligibility Criteria:
Inclusion Criteria:

* De novo lesion
* 2.5mm =\< Reference diameter =\< 4mm
* Lesion length =\< 28mm
* Type A, B1/B2 lesion

Exclusion Criteria:

* ST-segment elevation MI
* Reference diameter \< 2.5mm or \> 4mm
* Bifurcation lesion
* Type C lesion
* history of AMI or stroke within 1 year F. chronic renal disease (Cr \> 2mg/dL)
Multimodal Model Predicts Recurrence

This study focuses on developing an advanced model that combines clinical information, imaging, and pathology data to predict the likelihood of cancer returning after surgery in patients with locally advanced gastric cancer. By using artificial intelligence (AI), this model analyzes various data sources to create a more accurate prediction of recurrence risk, which can help doctors, patients, and families better understand the chances of recurrence. This AI-driven approach allows healthcare providers to make more informed decisions about personalized follow-up care and potential additional treatments to improve patient outcomes.


Eligibility Criteria:
\*\*Inclusion Criteria:\*\*

* Patients diagnosed with locally advanced gastric cancer (Stage II or III).
* Patients who have undergone surgical resection for gastric cancer.
* Patients with complete clinical, imaging, and pathology data available for analysis.
* Age 18 years or older.
* Patients who provide informed consent to participate in the study.

\*\*Exclusion Criteria:\*\*

* Patients with distant metastasis (Stage IV) at the time of diagnosis.
* Patients with incomplete or missing clinical, imaging, or pathology data.
* Patients who have received prior treatment for gastric cancer other than surgical resection.
* Patients with other concurrent malignancies.
* Patients who are unable or unwilling to comply with the study follow-up requirements.
A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience

The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.

The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants. This study will assess the relative abuse potential of soticlestat compared to alprazolam and placebo in healthy adult, nondependent recreational drug users with CNS depressant experience. The study will enroll approximately 110 participants. Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the study.

Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This single center trial will be conducted in the United States. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 11 weeks.

Eligibility Criteria:
Inclusion Criteria

1. Healthy as determined by the investigator.
2. Current CNS depressant user who has used CNS depressants (example, benzodiazepines, barbiturates, zolpidem, eszopiclone, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate) for recreational, nontherapeutic reasons at least 10 times in their lifetime and at least once in the 12 weeks prior to screening. Participant must also have recreational experience with at least 1 other drug class associated with abuse (example, opioids, stimulants, cannabinoids, hallucinogens, dissociatives) at least 10 times in their lifetime.
3. Body mass index (BMI) of 18.5 to 35.0 kilogram per square meter (kg/m\^2), inclusive, and a minimum body weight of 50.0 Kilogram (kg) at screening.

Exclusion Criteria

1. Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit).
2. Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC).
3. Heavy smoker or user of other types of nicotine products (greater than \[\>\] 20 cigarettes equivalent per day).
4. Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing.
5. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.