cyrilzakka/clinical-trials huggingface dataset:
A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)

The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 2-weekly intervals to complete study assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).

Eligibility Criteria:
Inclusion Criteria:

* Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no \>25% decrease in Score from Screening to Baseline
* The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
* Suitable contraception use in line with protocol requirements
* Ability to swallow tablets

Exclusion Criteria:

* A period of less than 6 months since the index trauma event
* Current and ongoing exposure to the trauma that caused the PTSD
* Complex PTSD
* Severe depression as measured by a score of ≥ 35 on the Montgomery Asberg Depression Rating Scale (MADRS)
* Borderline personality disorder, bipolar disorder and other psychotic disorders
* Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening.
* Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD.
* Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening.
* Any moderate or severe substance use disorder in the past 12 months
* Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk
Heart Rate Variability (HRV) Among Children With Brain Damage

to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance.

40 children with brain damage (20 with post TBI and 20 with CP)and 40 typically developed children will be participate in this study. ECG signals during rest and walking (for 6 minute and during step climbing) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* able to walk independently

Exclusion Criteria:

* can not follow simple commands
Danlou Tablets to Prevent Left Ventricular Remodeling

Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. This pilot study was designed to determine whether Danlou tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI. Major end points were changes in LV volumes and ejection fractions as evaluated by serial echocardiography in addition to clinical outcomes were also determined.

This randomized, prospective, double-blind, placebo-controlled, parallel-group clinical trial was performed in two institutions (Guangdong Provincial Hospital of CM and Wuyi Hospital of CM). The study was conducted in accordance with the Declaration of Helsinki and its text revisions and all participants provided written informed consent before enrollment. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (B2011-41-01).

Once eligible candidates had undergone PCI, they were admitted to the coronary intensive care unit and received standard treatment according to the institutional protocol based on American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines.20 Simultaneously, patients were randomized assigned in a 1:1 ratio to receive Danlou tablets (4.5 g oral dose taken once daily) or matching placebo for 90 days according to a computer-generated site-stratified, block randomization schedule. Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).

Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction
* successfully underwent revascularization

Exclusion Criteria:

* previous myocardial infarction within 30 days
* malignant arrhythmia
* congenital heart disease
* cardiac shock
* documented or suspected history of heart failure or depressed LV ejection fraction \<15%
* planned coronary artery bypass grafting
* a life expectancy of \<1 year
* hepatic impairment
* glomerular filtration rate ≤30 mL/min per 1.73 m2
* autoimmune or connective tissue disease
* chronic substance abuse or psychiatric illness
* unable to complete 3 month clinical follow-up
Clinical Research on a Novel Deep-learning Based System in Mediastinal Endoscopic Ultrasound Scanning

The goal of this clinical trial is to develop and verify the auxiliary role of the artificial intelligence system in mediastinal ultrasound endoscopic scanning. The main questions it aims to answer are as follows: 1.The comparison of the image recognition accuracy between the artificial intelligence system and the ultrasound endoscopist; 2. Whether the artificial intelligence system can improve the integrity and efficiency of the mediastinum scanning for the ultrasound endoscopist. Participants will undergo mediastinal EUS with or without the assistance of the artificial intelligence system.

In this study, a total of 200 cases of mediastinal endoscopic ultrasound scanning videos will be collected. First of all, an artificial intelligence system based on deep learning for the navigation and quality control of mediastinal endoscopic ultrasonography will be established. Secondly, the artificial intelligence system will be used to identify the site and anatomical structure of the mediastinal ultrasound endoscope, and the results of the artificial intelligence system's station recognition will be compared with the results of the endoscopist's station recognition. Finally, the completeness of standard sites and scanning time of endoscopic-assisted and non-assisted AI systems were compared.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old, \<80 years old 2.Patients who need endoscopic ultrasonography; 3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

* Subjects who meet any of the following criteria cannot be selected for this trial:

First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:

1. Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
2. Anesthesia assessment failed
3. Pregnancy or breastfeeding
4. In the acute stage of chemical and corrosive injury, it is very easy to cause perforation
5. Recent acute coronary syndrome or clinically unstable ischemic heart attack
6. Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\> 90mmHg),patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.

Second. Disagree to participate in this study.

Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:

1. Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy;
2. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.
Lymphocyte Count, ATG Dose and Incidence and Severity of GVHD in Pediatric Recipients of HSCT

Despite increasing success rate in hematopoietic stem cell transplantation (HSCT) control of graft versus host disease (GVHD) remains a significative burden in mortality and morbidity. A lot of strategies could lower the incidence and gravity of the disease and immunosuppressive treatment as GVHD prophylaxis still represent the main method.

Although immunosuppressive treatment showed a good effect on GVHD mortality a lot of studies also highlight an increase of relapse and infection related mortality that jeopardize the effect on overall survival of HSCT recipient. Using anti thymocyte globulin (ATG) as GVHD prophylaxis shares the same double-edge effect as other immunosuppressive treatment although is still unclear how manage dose and timing of the infusion to minimize promoting effect on infections and maximize protective effect on GVHD. Biological effect of ATG lead to a dose- related delay in all class of T-cell reconstitution but our data are mostly from adult studies with high doses between 30 and 60 mg/kg due to the more important burden of GVHD in HSCT adult population. As for other treatment in HSCT conditioning we would like to study a personalized approach for ATG treatment: some studies focus on tuning of ATG dose for kilos but previous evidence showed that the same dose could made too little or too much immunosuppressive effect for different patients, even though same age and same stem cell source.


Eligibility Criteria:
Inclusion Criteria:

1. Age of the patients between 0 and 17
2. Diagnosis of hematological or oncological disease undergoing allogeneic bone marrow transplantation
3. Patients undergoing myeloablative conditioning
4. Patients that received ATG as GVHD prophylaxis
5. Patients whose consent has already been acquired for the processing of data for research purposes
6. Minimum follow-up of 12 months

Exclusion Criteria:

1. Bacterial and / or fungal infection present at the time of bone marrow transplantation
2. Use of Thymoglobulin in the 3 months prior to transplantation
3. Allergy and / or intolerance to the active substances or excipients contained in Thymoglobulin
Mother-caregivers of Children With Duchenne Muscular Dystrophy

The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns. During its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. Due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.

The Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. The mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. The responsibility and workload to care for the child is high. Because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. Moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.

Eligibility Criteria:
Inclusion Criteria:

* Mothers-caregivers of children and adolescents with DMD
* Mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome)

Exclusion Criteria:

* Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made
* Working mothers of nocturnal period
An Efficacy and Safety Profile of Inhaled TV48108 in Healthy Volunteers and COPD Patients

The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.


Eligibility Criteria:
Inclusion Criteria:

Stage 1 (Healthy Volunteers)

* Male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body mass index (BMI) of less than 30 kg/m\^2.
* In good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology.
* Other criteria apply, please contact the investigator for more information

Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)

* Male or female; 40 to 75 years of age, inclusive with a minimum body weight of 40 kg
* Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the screening visit
* Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
* Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

Stage 1 (Healthy Volunteers)

* History or current evidence of a clinically significant or uncontrolled disease
* Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs.
* History of severe allergy to milk protein
* Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded.
* Other criteria apply, please contact the investigator for more information

Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)

* Recent history of hospitalization due to an exacerbation of airway disease within 3 months
* Need for increased treatments of COPD within 6 weeks prior to the screening visit
* History of and/or current diagnosis of asthma
* Known α1 antitrypsin deficiency, active lung infections (such as tuberculosis or pneumonia), and lung cancer are absolute exclusionary conditions
* Other criteria apply, please contact the investigator for more information
Confirmation of Tube Placement in Newborns

Tracheal intubation remains a common procedure in the neonatal intensive care unit (NICU) and the delivery room (DR).

Current guidelines recommend Estimation of correct endotracheal tube (ETT) insertion Our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the "7-8-9 rule" when the endotracheal tube is placed orally. Using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip.

With the new 2015 guidelines, ETT depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm or by using the "initial endotracheal tube insertion depth" table. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.

However, studies using NTL reported that using this technique only resulted in correct ETT placement in 56% of cases.

Every ETT has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ETT into the trachea. There has been npc study to compare the vocal cord markings with the current approach of NTL.

The current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to NTL in preterm and term infants.


Eligibility Criteria:
Inclusion Criteria:

* All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or/and Neonatal Intensive Care Unit will be eligible.

Exclusion Criteria:

* Infants will be excluded if their parents refuse to give consent to this study.
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty

The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).

The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/ motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr \> 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score, WOMAC score and baseline Pain Management Questionnaire. When designated through randomization, local infiltration of analgesia will be placed intraoperatively by the surgeons, per usual protocol and patients in the LIA group will receive sham adductor canal catheter. All ACC's for both study groups will be placed postoperatively in the PACU. Those collecting data will be blinded from identifying patients in the control group, as both groups will have ACC placed with same technique. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC. All adductor canal catheters will remain in for 72 hours. Pt from LIA group will be discharged home with sham catheter with a saline infusion at 10 ml/hr via an ambulatory pump. Patients in ACC group will be discharged with continuous adductor canal catheter delivering ropivacaine 0.2% at 10 ml/hr via an ambulatory pump. Patients will be called daily for pain diary results. As well as at 6-8 weeks postoperatively to collect painDetect and WOMAC survey.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-85
* American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. • Undergoing Unilateral, Primary, Total Knee Arthroplasty
* English as native language

Exclusion Criteria:

* Patient refusal
* History of opioid dependence
* Contraindication to peripheral nerve block • Pre-existing significant neuropathy
Prone Positioning for Invasively Ventilated Patients With COVID-19 Registry

SARS-CoV-2 infection is characterized mainly by moderate/severe pneumonia associated with progressive endothelial damage and coagulopathy. Acute respiratory failure among COVID-19 occurs in 42% of patients with COVID-19 pneumonia, and 61-81% of patients requiring intensive care . Among the suggested treatments for the management of ARDS patients, prone position (PP) can be used as an adjuvant therapy for improving ventilation in these patients, as recommended in the Surviving Sepsis Campaign COVID-19 guidelines. Nevertheless, no data is currently available on application and feasibility of PP in invasively ventilated patients with COVID-19 on their outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed COVID-19 infection
* Prone positioning in patients admitted to ICU undergoing invasive Mechanical Ventilation

Exclusion Criteria:

* Bedsides contraindications to the Prone Positioning and patients in PP but undergoing Non- invasive ventilation should be excluded.
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19

This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.

This is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, PK profile, and efficacy of a single injection of COVI-AMG in outpatient subjects with COVID-19 but are not likely to require hospital admission within 24 hours. Subjects will receive one of the following treatments: 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo. Subjects will be followed for 60 days after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample such as nasopharyngeal \[NP\], nasal, oropharyngeal \[OP\], or salivary) ≤ 72 hours prior to randomization. A historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented.
* Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h) hospitalization.
* Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol.
* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.

Exclusion Criteria:

* Have a documented infection other than COVID-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study.
* Have any medical condition that, in the Investigator's opinion, could adversely impact safety.
* Be pregnant or lactating and breast feeding
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. Note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.
Oligosecretary Myeloma: Prevalence and Its Clinical Significance

In this study, the investigators aim to investigate the prevalence and clinical course of oligosecretary myeloma.

Oligosecretary myeloma is a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day). Patients with oligosecretary myeloma do not have established methods for disease monitoring and clinical informations regarding oligosecretary myeloma are still largely unknown.

In this study, we aimed to investigate the prevalence and clinical course of oligosecretary myeloma.

Eligibility Criteria:
Inclusion Criteria:

* a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day)
* available clinical data

Exclusion Criteria:

* patients without available clinical data