cyrilzakka/clinical-trials huggingface dataset:
Trauma Screening/Referral and Interpersonal Violence Prevention for Women with Substance Use Disorders

The purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist delivered violence prevention program for women in substance use treatment. The program entails a posttraumatic stress disorder (PTSD) screening, resource referral, and two session interpersonal violence prevention protocol for 60 participants. In this single arm trial, women are recruited from three substance use treatment facilities. Participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. Self-report surveys assess trauma exposure, knowledge and behaviors related to interpersonal violence, and intervention engagement.

The majority of women entering substance use treatment have a trauma history, placing them at risk for revictimization and substance use relapse. The purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist-delivered violence prevention program for women in substance use treatment. The program entails a posttraumatic stress disorder (PTSD) screening, trauma-focused resource referral, and two session interpersonal violence prevention protocol for 60 participants. In this single arm trial, women are recruited from three substance use treatment facilities. Participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. Self-report surveys assess demographics, trauma and sexual assault experiences, knowledge and attitudes towards sexual and intimate partner violence, protective behavioral strategies, and intervention satisfaction and engagement.

Eligibility Criteria:
Inclusion Criteria:

1) Age 18 or higher;2) female gender identity; 3) currently engaged in substance use treatment or care (behavioral, peer support, pharmacological, medical)

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Exclusion Criteria:

1) Non-English-speaking; 2) acute physical and medical conditions that interfere with participation in educational sessions (e.g., active psychosis, suicidality).

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Physiological Effects of Lung Impedance Tomography-Guided and Plat Pressure-Guided Phigh During APRV in Patients With ARDS

This study aims to investigate the effects of EIT-guided and Pplat-guided Phigh settings on regional ventilation and perfusion in ARDS patients during APRV, while also examining the impact of different Phigh settings on gas exchange, respiratory mechanics, and hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ARDS according to the 2023 global new definition of ARDS.
* Age ≥ 18 years.

Exclusion Criteria:

* Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bullae, pneumothorax, subcutaneous emphysema, mediastinal emphysema, etc. · Contraindications for EIT, such as chest wound dressing, pacemaker implantation, defibrillator use, etc.
* Pulmonary interstitial disease.
* Uncorrected shock of various types.
* Intracranial hypertension.
* Pregnant and postpartum women.
Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19)

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.

ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.

In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.

Part B of this study was not conducted.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization.
* Must have \>= 1 symptom associated with COVID-19 with an onset of \<= 8 days prior to randomization.
* Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study

Exclusion Criteria:

* Have an oxygen saturation (SpO2) \< 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<= 200 mmHg at randomization.
* Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
* Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.
A Comparison of Two Psycho-educational Group Interventions for Tinnitus Patients

participants will be randomized into one of three groups: 3-session CET intervention, 3-session ACT intervention, or Waiting List group. Each weekly session will last up to 2 hours and 10 participants will be assigned to each group. There will be two cohorts, with 30 participants in each cohort. The Waiting List group will receive the CET intervention after the groups have completed theirs.


Eligibility Criteria:
Inclusion Criteria:

* Tinnitus lasting more than 3 months
* Hebrew speaking
* Use hearing aids if needed
* Signed informed consent

Exclusion Criteria:

* None
A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical Practice

This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy type 2C (LGMD2C/R5), or Limb-girdle muscular dystrophy type 2A (LGMD2A/R1).

These enrolled participants will be followed to evaluate mobility and pulmonary function for up to 5 years after enrollment for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a North Star Assessment for Dysferlinopathy (NSAD) ≥ 25 at Baseline, up to 3 years for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a NSAD \< 25 at Baseline, and up to 3 years for participants with LGMD2A/R1. Additional participant data will be collected from the time the individual began experiencing LGMD symptoms to the present.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participant ≥ 4 years of age who demonstrate symptoms of LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, or LGMD2A/R1 in the opinion of the investigator (eg, muscle weakness, loss of function, delayed milestones).
* Confirmed clinical and genetic diagnosis of LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, or LGMD2A/R1.

Exclusion Criteria:

* Demonstrates cognitive delay or impairment that could confound motor development, in the opinion of the Investigator.
* Has a medical condition, in the opinion of the Investigator, that might compromise participants ability to comply with study requirements.
* Is participating in other interventional study(ies) at the time of enrollment in this study.
Reveal Transition - A Mechanistic Study in Transition / Stabilized Phase of CAD

Longterm oral anticoagulation with very low dose rivaroxaban (2.5mg bid) in combination with aspirin has been shown superior over standard aspirin monotherapy in patients with stable coronary artery disease (CAD) in the COMPASS trial. To date, there are no data comparing these - antithrombotic strategies and to provide insights about mechanistic effects of very low dose rivaroxaban on top of aspirin for longterm treatment.

Thus, the goal of the planned pilot study will be to identify effects of rivaroxaban on platelet function, platelet-mediated vascular inflammation and particularly, platelet-mediated thrombin generation as well as the underlying mechanisms and to reveal differences in mechanistic effects during longterm treatment with combined novel antiplatelet/anticoagulant strategies. This study is planned as descriptive study.


Eligibility Criteria:
Inclusion Criteria:

1. patients≥ 18 years.
2. troponin-positive acute coronary syndrome (NSTEMI/STEMI) with planned dual antiplatelet therapy (DAPT, ASA + ticagrelor) for 12 months or stable CAD with previous PCI and drug eluting-stent (DES) + pre-existing PAD under treatment with DAPT (ASA + clopidogrel).
3. Patients with coronary artery disease who are younger than 65 years of age are required to have documentation of atherosclerosis involving at least two vascular beds or to have at least two additional risk factors (current smoking, diabetes mellitus, an estimated glomerular filtration rate \[GFR\] \<60 ml per minute, heart failure, or nonlacunar ischemic stroke ≥1 month earlier).
4. informed written consent.

Exclusion Criteria:

1. any condition that requires longterm or already ongoing full oral anticoagulation (e.g. recent systemic embolism, prosthetic heart valves or chronic atrial fibrillation).
2. patients with increased bleeding risk preventing guideline adherent dual antiplatelet therapy
Phenotypic Characteristics of Inflammatory Bowel Disease in Southeast Asian Population - A Multi-centered US Study

This is a retrospective, case control study of inflammatory bowel disease. This study will analyze the phenotypic characteristics of inflammatory bowel disease in the Southeast Asian population and will help describe clinical characteristics and serologic profiles in Southeast Asians with inflammatory bowel disease, comparing the phenotype differences to historical Caucasian controls. The data from this study will help identify the phenotype characteristics of different ethnic groups and study the epidemiological patterns of the disease.

This study is a retrospective, case control study of inflammatory bowel disease characteristics in patients with origins from the Indian sub-continent. Patients will be selected from the IBD registry maintained at respective institutions. Subjects from the Indian sub-continent will be identified using their country of birth, parents' ethnicity, number of years since leaving the country of birth, and number of years residing in the United States.

Using both electronic and paper databases, demographic information regarding age, gender, body mass index, smoking history, dietary habits; medical history such as type of IBD, IBD symptoms, location and behavior, medication use (past and current), history of other autoimmune disorders; surgical history (IBD and non-IBD related); laboratory indices such as IBD serology, Thiopurinemethyltransferase (TPMT), and infliximab levels will be collected.

Demographics will be compared between groups using descriptive statistics. Using univariate analysis, variables that are significantly different will be identified. Conditional logistic regression will then be performed to identify those clinical variables that are statistically significant.

The study duration will be one year from IRB approval.

Eligibility Criteria:
Inclusion Criteria:

* Patients with origins from the Indian sub-continent
* Patients will be selected from the IBD registry maintained at respective institutions.
Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections

Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI.

The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.


Eligibility Criteria:
Inclusion Criteria:

* patients having had an osteo-articular infection with Staphylococci

Exclusion Criteria:

-
SD01 Master Study (Safety and Efficacy Study)

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for an ICD/CRT-D therapy
* Signed informed consent form
* Patient is willing and able to participate for the whole study duration
* Patient is willing and able to activate and use the CardioMessenger
* Legal capacity and ability to consent.

Exclusion Criteria:

* Standard contraindication for an ICD/CRT-D therapy
* Age \<18 years.
* Pregnant or breastfeeding
* Cardiac surgery is planned within the next six months
* Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Dexamethasone acetate intolerance
Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients

The study team performed a randomized controlled trial to evaluate the efficacy of a care coordination intervention composed of proactive symptom monitoring and algorithm-based triggers to improve patient reported outcomes (PROs) and healthcare expenditures for high-risk patients with IBD. Enrolled patients with IBD were randomized to proactive symptom monitoring with the support of a care coordinator or usual care.


Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of IBD (with at least 3 office visits)
* followed in GI clinic within 1 year of enrollment
* in top 20th percentile of predicted risk for subsequent healthcare utilization (previously validated model)

Exclusion Criteria:

* non-IBD driver for high utilization (e.g., active cancer undergoing treatment
* A life expectancy of less than one year, were excluded from participation.
Garlic in Patients With Febrile Neutropenia

To determine the clinical effects of garlic in preventing and treatment of patients with chemotherapy related febrile neutropenia.These patients have a very high incidence of infections which are not routinely covered by the standard empiric therapy. Adding a non- toxic and possibly effective therapy may reduce the risk for infections, synergize the empiric antibiotic treatment and may lessen the need for broader spectrum and more severe side effects.

Patients eligible are randomized to receive placebo or garlic capsules after chemotherapy course and until leukocyte recovery.

Eligibility Criteria:
Inclusion Criteria:

FN patients expected to have at least 5 days or more of neutropenia will be eligible for treatment with garlic compounds AST/ALT ≤ 3 times the upper limit of institutional laboratory normal.

Total bilirubin ≤ 2 times the upper limit of institutional laboratory normal.

BUN and creatinine should be ≤ 3 times the upper limit of institutional laboratory normal.

Newly diagnosed as well as previously treated patients will be eligible.

Exclusion Criteria:

History of clinically significant liver or kidney disease.

Patients on anti-coagulation therapy with Coumadin will be excluded because of the potential garlic interference with metabolism.

Patients receiving concomitant chemotherapeutic treatment
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases

The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

RATIONAL Inflammatory Bowel Disease (IBD) affects more than 200,000 people in France and 1.5 million in Europe. Difficulties in the management of IBD are related to the need for invasive tests for the diagnosis of IBD (endoscopy), partly explaining the delay in diagnosis, and the inability to distinguish early colonic Crohn's disease of ulcerative colitis (UC) in 10-30% of cases.

Recently, we identified real-time polymerase chain reaction (PCR), from healthy colonic mucosa of IBD patients, a molecular signature of IBD involving 10 microRNA (miRNA) Common (miR26a, miR29a, miR29b, miR126 \* miR15a, miR127-3p, miR324 -3p, miR30c, miR185, miR196a) and 15 colic chronic disease (MC) and ulcerative colitis (RCH) discriminating microRNA (miR-142-3p, miR-142-5p, miR-146a, miR-146b-5p, miR150, miR-181d, miR-182, miR199a -3p, miR199a-5p, miR199b-5p, miR-203, miR223, miR-299-5p, miR320a, miR-328).

TYPE OF STUDY : multicenter diagnostic evaluation Study

MAIN PURPOSE OF THE STUDY : To evaluate the diagnostic value of microRNA in colonic IBD (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

SECONDARY OBJECTIVES :

* assess the ability of microRNA to discriminate a colic chronic disease (MC) of ulcerative colitis (RCH) in adults
* evaluate the diagnostic value of microRNA in inflammatory colitis child
* explore the possibility of measuring miRNA of interest in the stool

PRODUCTS OF THE STUDY diagnostic kit of IBD in quantitative polymerase chain reaction (qPCR)

NUMBER OF PATIENTS : 6 groups of 50 patients each will be included

* Group 1: Crohn adult colic
* Group 2: ulcerative colitis (RCH) adults
* Group 3: Witnesses healthy adults
* Group 4: Witnesses adults with non-IBD inflammation
* Group 5: Children with colitis
* Group 6 : Witnesses healthy children

INCLUSION LENGTH 30 months

DURATION OF THE STUDY 30 months

Eligibility Criteria:
Inclusion criteria :

* Target Population : Patients (children and adults), man or woman, suffering from Crohn's disease with colonic involvement or ulcerative colitis according to the criteria of the European consensus (ECCO 2010)
* Control population: healthy subjects and any non-Crohn's colitis or ulcerative colitis
* Having a colonoscopy examination indication,
* Who signed the consent form (for adults and signed parental consent obtained for patients minors)

Exclusion Criteria:

* No health insurance ,
* mental disability,
* pregnancy
Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm

This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).


Eligibility Criteria:
A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.
A Pilot Study for the Brain Health Support Program

Prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. To address this, investigators have developed the CAN-THUMBS UP program to conduct studies that target lifestyle risk and focus on dementia prevention. An online Brain Health Support Program (BHSP) has been developed. The BHSP is an educational program designed to teach about dementia. Before the full BHSP is offered to a large group, we are conducting an initial pilot study to help assess the usability of the program.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for No Dementia and one of the following (according to CCNA criteria):

Cognitively Intact (CI) Cognitively Intact plus Subjective Cognitive Impairment (CI + SCI) Mild Cognitive Impairment (MCI)

• AND Classified as being at increased risk of dementia based on at least one of the following: First-degree family history of dementia

Self-Reported or documented current and/or history at midlife (45-60) on any of the following risk factors:

* Hypertension (documented Systolic Blood Pressure \> 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise))
* Hypercholesterolemia (documented total cholesterol \> 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise))
* Body Mass Index \> 30 kg/m2 (derived from NIH Metric BMI Calculator)
* Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)
Food Patterns, Inflammation Markers of Cardiovascular Disease Risk and Incidence of CVD

Health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. To examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in Malmö, Sweden, and after 13 years of follow-up food pattern associations with CVD incidence.


Eligibility Criteria:
Inclusion Criteria:

* The "cardiovascular sub-cohort" is a random sample (i.e., 50 percent) of those who joined from November 1991 to February 1994. This group underwent additional examinations to assess carotid arteriosclerosis by ultrasound (n = 6103) and donated blood after fasting (n = 5533).

Exclusion Criteria:

* Subjects were excluded, either because they were using medication for diabetes mellitus or had previously been diagnosed as having diabetes mellitus.