cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis

The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.

Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose autoimmune pancreatitis (AIP) and exclude malignancy. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Previous studies suggest 19-gauge fine needle aspiration (FNA) needle provides a reliable specimen for diagnosis of AIP. However tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, the superiority of histology over cytology in EUS-guided tissue sampling for diagnosis of AIP has not been proven yet. In this study, we aim to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for EUS-guided tissue acquisition because of clinical suspicion of AIP
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
* Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5
* Previous inclusion in the current study
* Pregnancy
Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy

The purpose of this prospective work is to study the consequences of obstetrical brachial plexus paralysis on the rotator muscles of the shoulder. The hypothesis is that shoulder stiffness of these children is due to an impairment of the shoulder rotator muscles. The investigators want to test the regenerative capacities of these muscles. The development of a cellular model of this pathology will allow to test new therapeutic perspectives and to validate our hypothesis.

During delivery, there can be a lesion of the nerve roots of the brachial plexus (cervical C5-C8 and/or thoracic T1 roots). The newborn presents at birth a paralysis of the arm (Obstetrical Brachial Plexus Paralysis: OBPP). One third of children with OBPP will have sequelae despite daily rehabilitation. The most frequent disability is shoulder stiffness. The current hypothesis is that this stiffness is due to a permanent imbalance between the affected shoulder muscles (lateral rotators) and the muscles less affected by the paralysis (medial rotators). Because of this imbalance, the injured shoulder is spontaneously positioned in medial rotation. This position would lead to retractions at the front of the joint despite rehabilitation. In case of incomplete recovery, growth disorders of the shoulder joint (dysplasia) appear as well as a functional handicap.

The management, from the age of 2 years, in case of shoulder stiffness and dysplasia, is surgery (arthrolysis) to regain mobility. During this operation, a muscle transfer can also be performed to strengthen the lateral rotator muscles.

However, despite surgery, mobility deficits often recur within a few years. To understand the origin of the lateral and medial rotation deficits, the investigators conducted an anatomopathological study of the rotator muscles in these children. The preliminary results show a significant damage of the rotator muscles with the presence of fibrosis which could explain the rotational stiffness and the functional impairment. To better understand the pathophysiological mechanisms, the investigatorswill set up an OBPP model in cell culture to understand the regenerative capacities and to test new pharmacological approaches.

Eligibility Criteria:
Inclusion Criteria:

* OBPP children with a planned shoulder surgery (arthrolysis and/or muscle transfer).

Exclusion Criteria:

* other neurological disorders, post-traumatic shoulder stiffness
Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond

The COVID-19 pandemic has had detrimental effects on mental health. Individuals with eating disorders (EDs) are no exception, exhibiting increased symptoms and exacerbated feelings of isolation and anxiety. Across Canada, in-person outpatient services have been quickly replaced with virtual care, yet practitioners and patients have noted substantial challenges in adapting ED-related care virtually. Given the success of our previous research on Family-Based Treatment (FBT) for EDs, as well as the rapid transition to virtual care during COVID-19, there is an urgent need to adapt FBT to virtual formats and adopt it in the ED network. Using a multi-site case study with a mixed method pre/post design, this study aims to examine the implementation of virtual FBT (vFBT) as well as its impact within six ED programs in Ontario, building on the investigator's previous work, and further developing capacity in the system. The investigator will develop implementation teams at each site and provide a virtual training workshop on vFBT, with ongoing consultation during initial implementation. The investigator proposes to examine implementation success by studying fidelity to vFBT, as well as team and patient/family experience with virtual care, and patient outcomes. These findings for virtual care will not only be important in the COVID-19 context but are also vital in the North, where access to specialized services is extremely limited.


Eligibility Criteria:
Inclusion Criteria:

* Youth must be under 18 years of age in order to participate
* Youth must have a diagnosis of Anorexia Nervosa in order to participate
* Must have the capacity to write, speak, and understand English
* Must have access to a computer and the internet.

Exclusion Criteria:

* Individuals 18 years of age and older are unable to participate
* Youth without a diagnosis of Anorexia Nervosa are unable to participate
* Individuals who cannot write, speak and understand English are unable to participate
* Individuals who do not have access to a computer and the internet are unable to participate
The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications

This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design studies to optimize anticoagulation and anti-platelet therapies in the hybrid setting.

The aim of this study is to test the association of DNA polymorphisms linked to the level of αβ1 integrin expression on platelets with clinical outcome in terms of bleeding or thrombotic complications. The association of polymorphisms in other genes such as GPVI, PAR-1, and COX-2, as well as PLA ½ status, will also be examined and considered in the context of other factors such as medications including IIb/IIIa inhibitors, anticoagulants, type of procedure, obesity smoking status, etc.

Lower levels of platelet surface expression of the α2β1 integrin are associated with an increased risk of bleeding complications following hybrid procedures, especially when the low level of integrin expression is associated with other risk factors that may exacerbate bleeding such as vigorous anti-coagulation, aggressive anti-platelet therapy and other genetic risk factors that contribute to a hemorrhagic phenotype. Conversely, higher level expression of the α2β1 integrin is likely associated with a greater tendency to thrombotic complication that is again modified by other coexisting risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited to the study who are to undergo elective hybrid procedures \[percutaneous coronary intervention (PCI) followed by minimally invasive coronary artery bypass graft (CABG) surgery or valve surgery\].
* Both male and females will be enrolled in this study.
* The age of the population is 18-70 years old.
* No one ethnic group or gender will be targeted or excluded.
Effect of One-lung Ventilation on BIS Values

In this observational study, all enrolled patients having a thoracic surgical procedure requiring lung isolation will have a bispectral index (BIS) monitor placed at time of induction. BIS monitors are used to assist in determining depth of anesthesia. This study will evaluate changes in BIS before, during and after lung isolation.


Eligibility Criteria:
Inclusion Criteria:

* Patients coming for thoracic surgery with anticipated need for lung isolation

Exclusion Criteria:

* None
Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis

The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Have a clinical diagnosis of cystic fibrosis with an FEV1 \>40% of predicted normal
* Be able to comply with induced sputum procedure
* post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy)

Exclusion Criteria:

* Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
* Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
* Known to be infected with Burkholderia cepacia
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism

The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in children with autism.

Autistic GI Dysfunction (AGID) is a term that describes a constellation of GI signs and symptoms often found in children with autistic disorder, including abdominal pain, constipation, chronic diarrhea, alternating constipation and diarrhea, gaseousness, bloating, and reflux.

The objective of this study is to assess the potential efficacy of oral immunoglobulin in reducing a wide range of GI symptoms in children and adolescents diagnosed with autistic disorder.

Eligibility Criteria:
Inclusion Criteria:

* Male or female from 2 years to 18 years of age (up to, but not inclusive of the 18th birthday)
* Diagnosis of autistic disorder corroborated by an Autism Diagnostic Interview - Revised (ADI-R) assessment performed by a certified investigator
* Physician Clinical Global Impression of Severity (of Autistic Disorder)
* History of chronic, persistent gastrointestinal disturbance
* No elective changes in medication, diet intervention, or behavioral therapy during the study (18 weeks total)

Exclusion Criteria:

* Evidence of a gastrointestinal infection or GI abnormality
* A known diagnosis of other gastrointestinal pathology
* Antibiotic and/or antifungal (e.g. nystatin) medication
* Chelation therapy
* Medication affecting gastrointestinal transit
* Planned use of prohibited drugs or agents that could affect GI transit
* Changes in diet intervention within 30 days prior to the screening visit
* Changes in alternative medical therapies or dietary supplements within 30 days prior to the screening visit
* Adding and/or changing behavior modification or psychotherapy during participation in the study
* Adding or changing psychotropic medication during participation in the study
* DSM-IV diagnosis of a pervasive developmental disorder other than autistic disorder
* Evidence of a seizure disorder, diagnosis of fragile X syndrome, tuberous sclerosis complex, liver disease, pancreatic disease, cystic fibrosis, or chronic infection
* Previous gastrointestinal surgery
* Pregnancy
* Participation in another investigational study
* Significant deviation from normal laboratory test values at baseline
* IgA deficiency (serum IgA \< 5 mg/dL)
* A history of severe hypersensitivity to human immunoglobulin
* Treatment with any human immunoglobulin and/or immunoglobulin products
* Any concurrent medication that would compromise subject's tolerance of drug or compliance with the protocol
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.

Eligible subjects will receive 1.0×10\^8 CAR gdT, 2.0×10\^8 CAR gdT, 4.0×10\^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age≥ 18 years old, gender is not limited;
* (2) expected survival time≥ 3 months;
* (3) ECOG score 0-1 points;
* (4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression;
* (5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods.
* (6) Coagulation function, liver and kidney function, cardiopulmonary function meet requirements.
* (7) Be able to understand the trial and have signed the informed consent form.

Exclusion Criteria:

* (1) Malignant tumors other than acute myeloid leukemia within 5 years before screening;
* (2) Those who test positive for virus and syphilis;
* (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \[NYHA\] classification≥ grade III), severe arrhythmia;
* (4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
* (5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening;
* (6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion;
* (7) Subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use);
* (8) Have participated in other clinical studies within 1 month before screening;
* (9) There was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration;
* (10) Those who have graft-versus-host response and need to use immunosuppressants;
* (11) Those with a history of epilepsy or other central nervous system diseases;
* (12) Patients with primary immunodeficiency diseases;
* (13) situations that other investigators consider unsuitable for enrollment.
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban New York City population.

All patients, at least 18 years of age, with a chief complaint of dyspepsia and documented treatment-naïve HP infection diagnosed on UBT, esophagogastroduodenoscopy (EGD) with HP biopsy, or SAT were recruited for the study. Dyspepsia was defined as persistent or recurrent abdominal pain for at least one month. All subjects who met inclusion criteria were randomly assigned by a computerized system to one of two treatment groups: standard triple therapy (STT) or high-dose dual therapy (HDDT). After patient randomization, all potential side effects were discussed. Education regarding the importance of adherence to complete the full 14 day regimen was provided. Patients were provided an electronic prescription for the respective assigned regimen along with a medication log to self-report drug compliance. The patients were asked to record medication compliance and report any adverse events to research personnel.

After completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. During this period, patients were asked to abstain from taking PPI's to avoid false negative eradication testing. At the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Treatment-naïve
* Clinical diagnosis of helicobacter pylori infection based on urea breath test, endoscopy or stool antigen test
* Subject willing to participate and able to provide informed consent.

Exclusion Criteria:

* Prior helicobacter pylori treatment failure
* Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis
* Pregnancy or breastfeeding
* Penicillin allergy
* History of active or non-gastric malignancy
* Severe illness requiring hospitalization during treatment period
* Starting additional antibiotic while on treatment
Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG 24-02

RATIONALE: Learning about the long-term effects of adjuvant tamoxifen (T), adjuvant tamoxifen with ovarian function suppression (T+OFS), and exemestane with ovarian function suppression (E+ OFS) on brain function may help doctors plan cancer treatment.

PURPOSE: This study is looking at brain function in premenopausal women who are receiving adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS) for early-stage breast cancer on clinical trial IBCSG-2402.

OBJECTIVES:

Primary:

\* To evaluate and compare the changes in cognitive function over one year in premenopausal breast cancer patients who receive adjuvant tamoxifen (T) alone against those receive adjuvant tamoxifen (T+OFS) or exemestane (E+OFS) with ovarian function suppression (OFS).

OUTLINE: This is a multicenter study.

Objective cognitive function was measured with the CogState computerized test battery. The CogState battery consists of seven tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT), and ISLT-Delayed Recall. Performance speed is measured for the Detection, Identification and Monitoring tasks and performance accuracy is measured for the Memory, Learning, ISLT, and ISLT-Delayed Recall. Measures of performance speed are normalized using measures of performance accuracy (%) are normalized using arcsine transformation. The main outcome measure is a composite score which is the average of these task scores (after transformation and standardization by age-specific norms). Patients complete these assessments at baseline (i.e. before start of protocol hormonal therapy) and approximately one year after randomization to the parent IBCSG 24-02 (SOFT) study.

Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Completely resected disease
* Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy

  * Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:

    * Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist
    * Ovarian irradiation
    * Bilateral oophorectomy
* Hormone receptor status:

  * Estrogen and/or progesterone receptor positive

    * Each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

* Premenopausal
* Can speak and read the local language(s) fluently

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery

Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients undergoing major abdominal surgery

Exclusion Criteria:

* Patients with solid organ dysfunction
* Patients who receive opioid or corticosteroid medication prior to surgery
* Patients with bleeding diathesis
* Patients with psychiatric disorders
* Patients who can not be contacted after surgery