cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)

This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.

Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV aimed to reduce or prevent relapse is very challenge. Although many medications have been used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has been proved to be effect in treatment of SLE) has not been studied yet. One study tested the efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as remission-induction treatment, no relapse was observed. However, the sample size of this study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on APRIL.

Many experiences have been accumulated about the efficacy and safety of Telitacicept in Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in the reduction of the relapse of AAV in China. In this study, we take Telitacicept as maintain treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify the effectiveness of Telitacicept in maintenance therapy of AAV.

Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by using from remission-induction treatment combined with Rituximab to maintenance treatment of AAV.

Study Design: This is a prospective, randomized, open-label, control, pilot study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 to 65 years, both genders can be included.
2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
3. Patients have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.

Exclusion Criteria:

1. Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.
2. Patients who had other autoimmune diseases.
3. Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD (eGFR\<30ml/min).
4. Patients who are pregnant or have planned for pregnancy in next 2 years.
5. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.
6. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.
7. Patients with malignancy.
8. Patients who are not eligible according to the judge of the principal investigators.
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome

The purpose of the study is to map regions of brain activation following rectal stimulation in children with irritable bowel syndrome (IBS) and healthy controls.

Our first aim is to compare the brain areas activated rectal stimulation in boys and girls with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain activated during rectal stimulation in pre and post-pubertal male and female subjects between 10-18 yrs of age.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 10 years to 18 years who provide written assent and whose parents provide written permission for participation
* English-speaking
* Subjects in the IBS group will meet Rome III criteria for IBS as determined by a pediatric gastroenterologist.

Exclusion Criteria:

* Other pain-related diseases, functional gastrointestinal disorders, or somatization disorder
* Mental retardation or pervasive developmental disorder or epilepsy
* Psychosis
* Genetic or chromosomal disorders
* Currently receiving psychoactive drug treatment
* Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning
* Inability to lie still in the scanner
* Claustrophobia (Inability to lie still in the scanner)
* Pregnancy
* Subjects who admit to substance abuse during screening
* Orthodontic braces
Distribution of Neutrophils in Bronchial Mucosal Tissue in Asthma Patients Before and After 4 Weeks Treatment With AZD 5069

Distribution of neutrophils in bronchial mucosal tissue in asthma patients before and after 4 wk treatment with AZD 5069

The purpose is to investigate the bronchial tissue neutrophil counts and distribution in asthma patients after 4 week oral treatment with AZD 5069

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients of Caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained.
2. Physician based (according to GINA 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the CSP
3. Morning prebronchodilator (ie, after abstinence from short-acting and long-acting ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) FEV1 of ≥70% of predicted normal (PN) for age, sex and height at enrolment
4. Increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50% of total sputum cell count
5. Physician prescribed daily use of medium or high dose ICS (≥ fluticasone 250 μg to ≤ 1.000 µg or the equivalent daily, as defined in GINA 2011; see CSP Appendix E) plus LABA.

Exclusion Criteria:

1. History of clinically relevant allergies or idiosyncrasies to AZD5069 or other investigational CXCR2 antagonists, or any inactive ingredient(s) of the IMP, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study
2. History of severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
3. Asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening.
4. Moderate to severe airflow limitation (FEV1 \<70% PN)
5. Any chronic lower respiratory disease other than asthma (see CSP for details) that, as judged by the Investigator or Medical Monitor, would interfere with the evaluation of the IMP or interpretation of patient safety or study results.

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Use of Echocardiography in the Evaluation of Chest Pain in the Emergency Department

Chest pain is one of the most common complaints that brings a patient to the emergency department (ED). The differential diagnosis of chest pain is broad and includes cardiac as well as non-cardiac diseases. One of the initial goals in the ED evaluation of a patient presenting with chest pain is to rapidly and accurately diagnose the presence or absence of acute coronary syndrome. The diagnostic accuracy of the initial routine evaluation is often limited and results in frequent admissions for patients presenting with chest pain for further diagnostic testing.

Echocardiography has a high sensitivity and specificity for the diagnosis of acute myocardial infarction. Tissue Doppler imaging with strain and strain rate (SR) measurement is a new echocardiographic technique, which enables accurate assessment of regional left ventricular systolic and diastolic function. Prior studies have shown that abnormal strain and SR are highly sensitive markers of ischemia. Acute ischemia induces early systolic thinning and a delay in the onset of systolic thickening, a progressive decrease in the rate and degree of maximal systolic thickening, and an abnormal ischemia-related thickening which occurs after aortic valve closure. A major obstacle to the routine use of echocardiography in the ED is the need for portable studies, using heavy, bulky portable echo machines. There are currently available portable hand-held echo machines (GE-Vivid I) that produce high quality images and offer an opportunity to incorporate echocardiography into routine practice in the ED.

This study will use of early, portable echocardiography, with detailed assessment of wall motion and left ventricular function by strain and strain rate measurements, for the evaluation of chest pain in the ED. It is hypothesized that an early with detailed left ventricular function assessment will be highly sensitive and specific for the diagnosis of myocardial ischemia, and will enable rapid triage of patients who present to the ED with chest pain.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Chief complaint on presentation to ED: chest pain
3. Differential diagnosis includes acute coronary syndrome as determined by the Emergency physician or admitting attending.
4. Admission to the hospital required for further cardiac work up.

Exclusion Criteria:

1. Obvious noncardiac cause of the chest pain
2. Patient requires urgent intervention before echo can be obtained
3. Failure to obtain informed consent
Breathing Performance of Healthy Young Adult

The study will recruit subject of healthy adult, COPD-like patient and patient with COPD to investigate the difference of respiratory performance. We will measure the body composition, respiratory muscle force, pulmonary function and performance of voluntary cough. The muscle thickness of abdominal muscle and diaphragm, assessment of diaphragm during different breathing pattern and the muscle activation during voluntary cough will also being determined. We hypothesized that there will be a significantly different between three group on the performance of voluntary cough, and the correlation between each variable will be further investigated.

The specific aims of the study are:

1. difference of respiratory muscle performance between three groups
2. the correlation between respiratory symptom and pulmonary functional test
3. difference of functional respiratory performance (peak cough flow of voluntary cough) between three groups
4. muscle activation of abdominal muscle and diaphragm during performing voluntary force
5. performance of diaphragm under different breathing load

Eligibility Criteria:
1. Health subject

   Inclusion Criteria:
   * aged 20 years or above
   * currently not being diagnosis as COPD
   * less than 4 times/week of aerobic exercise
2. COPD-like subject

   Inclusion Criteria:
   * aged 20 years or above
   * currently not being diagnosis as COPD
   * presented of COPD symptoms (coughing, sputum production and dyspnea), last for 3 months and more than 2 years
   * score more than 1 on modified Medical Research Council (mMRC) or COPD Assessment Test (CAT)
3. COPD subject

Inclusion Criteria:

* aged 20 years or above
* currently being diagnosis as COPD
* haven't participated in any pulmonary rehabilitation program in the past three months

Exclusion Criteria:

* Untreated comorbidities for COPD
* Postural asymmetries (Scoliosis, length discrepancy of the lower limbs or other previous surgical history of spine)
* Chronic nonspecific lumbopelvic pain
* Gynecological or abdominal surgery in the previous year
* Pregnancy or post-delivery in the previous 6 months
* Neurological or inflammatory disorders
* Any conditions that may interfere with the data collection
Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT

The purpose of this study is to assess the cut-off value of GM/G test in Chinese patients after hematopoietic stem cell transplantation, and evaluate GM/G test and real-time PCR for diagnosis of IFI in Chinese patients.

Invasive fungal infection is one of the major complications of HSCT recipients, and the incidence is increased rapidly in recent years. IFI also commonly occurs in Chinese HSCT recipients, and there is no formal report on the mortality and morbidity of IFI in Chinese patients, so this study could supply these data.

Galactomannan(GM) is a cell wall component of aspergillus only, which is released to the blood stream when the aspergillus grows. While the β-D-glucan(BG) is in the most fungal cell wall, and the high level of BG in body fluid is also an evidence of fungal infection. In this study, the serum level of GM and BG would be detected by the commercial available kit.

We will assess the cut-off value of GM/G test by proven/probable IFI patients and negative controls. Then, we could calculate the sensitivity, specificity, positive and negative predict value of the GM/G test. Meanwhile, we may find out the genus of the fungus by comparison of the two methods. For example, both positive of GM and G-test may suggest that the pathogen is Aspergillus, while the positive G-test and negative GM-test implies the Candida may be the pathogen.

RT-PCR is also a helpful method for the IFI diagnosis, which is more sensitive than GM and G-test and encompassing multiple fungal genera. The small-subunit rRNA gene sequence is relatively conserved among members of fungal kingdom, including the Aspergillus and Candida species, the dimorphic fungi, the agents of zygomycosis, and Pneumocystis. So we will amplify that part of DNA and using gene specific probe to detect whether the sample is positive for fungus or not. Until now, there is no report about real-time PCR assay for diagnosis of IFI in Chinese HSCT recipients, so we want to carry out this study. At the same time, the result of real-time PCR assay could help us to estimate the coincidence of GM and G-test with the IFI patients.

After performing the above three diagnostic test, we could identify the HSCT recipients whether they have the IFI more accurately, so that we could evaluate the antifungal therapy and find out the risk factors for IFI in those patients more accurately.

Eligibility Criteria:
Inclusion Criteria:

* Persistent fever(\>38.0℃) after three days broad-spectrum anti-bacteria or virus therapy
* Chinese patients after hematopoietic stem cell transplantation

Exclusion Criteria:

* Severe hemolysis patients
Substance Use Treatment and Its Role in Supporting Social Cognition

This study aims to assess changes in empathy levels before and after residential treatment among individuals with substance use disorders.

Despite the lack of a consensus on the conceptualization of empathy among researchers and practitioners, psychologists generally agree that empathy and valuable interpersonal relations are contingent upon the willingness to understand another's perspective as well as share feelings and experiences. Adults with a variety of substance use disorders (SUDs) experience impairments in various facets of empathetic processing compared to healthy controls. Impairments in empathy could lead to a weak therapeutic alliance, lower adherence to treatment, and higher relapse rate. Furthermore, the therapeutic relationship has been described as one of the strongest predictors of treatment drop-out for patients with SUDs. In addition, an impaired ability to relate to and understand the affective and mental state of others may contribute to key typologies of patients with SUDs including, impulsivity, aggression, and antisocial behavior. Review of literature emphasizes a need for research into an understudied, yet modifiable factor of empathy in the trajectory of SUDs. Particularly, identifying specific psychotherapeutic techniques capable of improving the expression of empathy in these patients. Given the importance of empathetic ability in optimal social functioning, understanding whether empathetic impairments improve with treatment is important to achieve the best treatment outcomes for individuals struggling with SUDs.This study will help improve the knowledge and understanding of how substance use treatment affects empathy, as measured by gains in empathetic ability in treatment seeking individuals. To date, there are no reported studies that examined the impact of residential SU treatment on empathy. The study will be an observational quasi-experimental design that utilizes a pre-test and post-test to examine change in empathy for recently detoxed substance use patients and a follow-up assessment to monitor long term outcomes. The results of this study will further our understanding of treatment's potential role in cultivating a fundamental interpersonal skill, empathy.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for a substance Use Disorder, receiving treatment at Recovery Unplugged Addiction Treatment Center, at least 18 years of age.

Exclusion Criteria:

* Neurological disorder, severe cognitive impairment, comorbid thought disorder such as schizophrenia, failure to complete detox period,
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.


Eligibility Criteria:
Inclusion Criteria:

* For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:

  1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR
  2. Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy
* For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
* Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol

Exclusion Criteria:

* Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
* Patients who are being treated with any investigational agents and/or approved biologics other than Humira.
Effect of Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on Dysphagia Patients After Stroke

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Dysphagia in patients after stroke continues to be a challenge. To avoid the wound caused by gastrostomy, nasogastric tube feeding has been the mainstay of palliation, but potential side effects exist this choice. Intermittent Oro-esophageal tube feeding is an established modality that can be used with comprehensive rehabilitation therapy. This study reports the outcomes of Intermittent Oro-esophageal tube feeding and comparison with nasogastric tube feeding, including nutritional status, dysphagia, quality of life, depression, and follow-up in patients receiving comprehensive rehabilitation therapy.This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage

The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

Consequently, use of PSMA PET-CT in patients with suspicious PSA changes may improve our knowledge whether the prostate tumor is clinically significant or not (for the development of PSMA PET-CT with 68 Ga ligand allows to visualize prostate cancer with aggressive patterns), and improve clinical decision making for performing prostate biopsy or selecting patients for observation only.

In light of the above, we are of the opinion that this proposed study has the potential to significantly alter the medical practice of how prostate cancer is diagnosed, which even today suffers from real clinical dilemma.

Eligibility Criteria:
Inclusion Criteria:

1. Men aged 40-75
2. With or without suspicious DRE,
3. Were referred by their treating physicians for prostate cancer biopsy based on either an elevated PSA result, a suspicious DRE exam, or both
4. 4 \< PSA ≤ 10 ng/ml

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   Exclusion Criteria:
5. A previous diagnosis of prostate cancer
6. Underwent previous prostate biopsy
7. Previous radiation to pelvis for any reason

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The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder

A pilot study to examine the effects of Non-Invasive Brain stimulation on impulsive behaviour in patients diagnosed with Borderline Personality Disorder. patients who received the neurostimulation sessions will be enrolled in short term psychotherapy (3-month)


Eligibility Criteria:
Inclusion Criteria

* Clinical Diagnosis of Borderline Personality Disorder (DSM-V)
* Resident of Great Montreal
* Ability to make decision
* Clinical score is equal or more than 17 in Borderline Personality Disorder Severity Index (BPDSI)

resident of greater Montreal Area,

Exclusion Criteria:

* material Metal in the brain
* History of seizure or epilepsy
* severe scalp irritation or eczema
* recent scares, cut wounds, tattoo on the scalp
* severe substance use disorder
* clinical diagnosis of severe mood disorders o
* Active psychotic episode
* Pregnancy