cyrilzakka/clinical-trials huggingface dataset:
Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive patients meeting the standard criteria for CRT are included in a prospective, double-blinded, randomized trial to LV lead positioning either 1) guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and visualization of cardiac venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at the site of latest mechanical activation without scar tissue or 2) using standard LV lead placement.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
* ECG with QRS ≥ 120 milliseconds and left bundle branch block (LBBB) or paced QRS ≥ 180 milliseconds.
* LV systolic dysfunction (Ejection Fraction ≤ 35%).
* written informed consent.

Exclusion Criteria:

* Expected lifetime \< 6 months.
* Recent myocardial infarction (\< 3 months).
* Pregnant or lactating.
* Inadequate echocardiographic images for determination of site with latest mechanical activation
* No written informed consent.
Lenalidomide and Dexamethasone for Rosai-Dorfman Disease

Rosai-Dorfman Disease (RDD) is a rare, heterogeneous histiocytic disorder. Because of the rarity of RDD and a lack of prospective randomized trials, the treatment strategy for RDD is mostly based on retrospective study. Steroid was suggested as frontline treatment as RDD with only lymph nodes involvement. Studies showed thalidomide or lenalidomide showed some effect in recurrent/refractory skin RDD. The investigators want to analyze the efficacy and toxicity of lenalidomide combined with dexamethasone regimens in the treatment of RDD among adult patients at our hospital.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of RDD
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Patients must have adequate renal, liver, and bone marrow function as defined by the following criteria:

Absolute neutrophil count ≥1500 cells per mm3 Platelet count ≥100000 cells per mm3 Creatinine clearance \[according to Cockcroft formula\] ≥60 mL/min. Aspartate aminotransferase and alanine aminotransferase ≤2·5×upper limit of normal \[ULN\], and total bilirubin ≤2·5×ULN; or ≤10×ULN in the case of known liver involvement by RDD.

* No active or untreated infection.
* No cardiac abnormalities.
* Subject provide written informed consent.
* A female is eligible to enter and participate in this study if she is of:

Non-childbearing potential including ω Any female who has had a surgical procedure rendering her incapable of becoming pregnant.

ω Subjects have experienced total cessation of menses for more than 1 year and be greater than 45 years in age.

⎫ Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, and agrees to use adequate contraception.

• Male subjects must use an effective barrier method of contraception during the study and for 90 days following the last course of MA if sexually active with a childbearing potential

Exclusion Criteria:

* Patients had concurrent malignancies.
* History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
* Women who were pregnant or of childbearing potential.
* Known HIV seropositive, active hepatitis C infection, and/or hepatitis B (defined as HCV RNA≥1000 copies or HBV DNA ≥1000 copies at screening).
* Major surgical procedure within 28 days prior to the first dose of study treatment.
* Presence of uncontrolled infection.
* Evidence of active bleeding or bleeding diathesis.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
Journey of Transformation Curriculum for Native American Adolescents

The investigators will conduct a waitlist control trial to test the efficacy of the Journey of Transformation-Native Youth Health Leadership Program (JOT) in terms of delaying or reducing tobacco and other substance use and improving sexual health.

This study assesses a new curriculum that will be available to students in the ninth grade. The lessons will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making, field trips), as well as Traditional Ecological Knowledge (TEK) activities. This study also assesses how well the curriculum explains leadership skills, Native American cultural arts, the natural environment, and promotes healthy decision-making around health and relationships.

Participants are randomly assigned to a health class that starts the curriculum in the fall or to a health class that will start the curriculum in the winter. Participants will:

Week 1. Take a 30-40 minute online survey about healthy relationships, drug use, youth leadership skills and connecting with Native communities.

Weeks 1-3. Meet with a counselor up to two times to set goals around health, healthy relationships and how to reduce or avoid alcohol, tobacco, or other drug use.

Weeks 1 - 8 (months 1-2). As part of the health class, attend about 16 health sessions on healthy behaviors and health promotion. Learn new skills around youth leadership, storytelling, and traditional health practices. The sessions will highlight connecting to tribal traditions.

Month 3. Take an online check-in survey via a link sent to participants' email address.

Month 6. Take an online check-in survey via a link sent to participants' email address.

Month 12. Take an online check-in survey via a link sent to participants' email address.

Optional after school activities Week 9-16 (months 3-4). Attend a once-a-month activity to help build leadership skills. Activities are between 1-2 hours after school and include drum making, film making, creating a storytelling vest that incorporates cultural symbols, and up to two outdoor field trips. The field trips are to places of cultural significance near the school and involve a 30-45 minute hike.

Week 16 (month 4). Meet with the study counselor for a session to revise goals for health and community leadership.

Week 9-24 (months 3 - 6). Attend a 2-hour digital storytelling training and three-monthly planning sessions to prepare for an optional digital storytelling leadership night. The story can be about what has been learned about health promotion, traditional health practices, and to celebrate participants' health leadership journey.

Week 25 (month 6). Attend the leadership night and present digital stories.

Eligibility Criteria:
Inclusion Criteria:

* Between 13 years of age and 16 years of age
* Attending an off-reservation boarding school in the ninth grade at time of enrollment

Exclusion Criteria:

* Under 13 years old, or over 16 years old
* Does not attend an off-reservation boarding school in the ninth grade at time of enrollment
A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GAD (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
* Subjects must have a HAM-A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of \>9 and a Raskin Depression Scale score \<7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
* Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder, Obsessive compulsive disorder, Panic disorder; Agoraphobia, Posttraumatic stress disorder, Anorexia, Bulimia, Caffeine-induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
* Any of the following past or current DSM IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
* Antisocial or borderline personality disorder.
* Serious suicidal risk per the clinical investigator's judgment.
A Pilot Study of an Online HIV Stigma Training for Nursing Students in Iran

In this study, the investigators will assess the feasibility, acceptability, and preliminary efficacy of online HIV stigma training in reducing stigmatizing attitudes and behaviors of nursing students in simulated clinical visits of patients living with HIV compared to an online HIV epidemiology training with no specific content on stigma.

Iran has the highest burden of HIV in the Middle East. However, only 42% of Iranians living with HIV are diagnosed and 28% on antiretroviral therapy. The largest gap in the continuum of HIV care is diagnosis. Due to sociocultural and religious beliefs, HIV- associated stigma and drug use stigma are exceedingly high, and sex outside of marriage, or sex of man with another man are considered to be "sinful" behaviors. These intersectional stigmas (stigma towards drug use, sexism, and homophobia) in addition to HIV stigma are major barriers for many people at risk for or living with HIV to engage in HIV testing or treatment. Our prior studies found that health providers have limited clinical encounters with people living with HIV (PLWH) and have no HIV stigma training. This lack of training can lead to stigmatizing attitudes and behaviors towards people at risk for HIV or PLWH. The highest HIV stigmatizing behaviors was reported in nurses and physician assistants. These data, coupled with the extreme marginalization of key populations at high risk for HIV in Iran, call for the development of new ways to train nurses to reduce HIV-related stigma in clinical settings. The investigators propose to develop, and field test an HIV stigma online training including simulated patients living with HIV for nursing school students. In a randomized controlled trial, the investigators will assess the feasibility, acceptability, and preliminary efficacy of the online HIV stigma training in reducing stigmatizing attitudes and behaviors of nursing students in simulated clinical visits of patients living with HIV compared to an online HIV epidemiology training with no specific content on stigma. Successful development of the HIV stigma training and simulated patients at risk for or living with HIV will set the stage for developing a larger trial of nurses and other health providers which can lead to an effective and scalable training program to reduce HIV-related stigma in clinical settings and improve engagement in HIV testing and care services. The investigators from the University of California San Francisco (UCSF), will lead and co-investigate the project, respectively. They will collaborate with teams from Kerman University of Medical Sciences (KMU), Iran, and Ponce Health Sciences University (PHSU) in the USA.

Eligibility Criteria:
Inclusion Criteria:

* Currently nursing students in their year 3 or 4 of training
* Kerman Medical University (KMU) nursing schools

Exclusion Criteria:

* Nursing student in their year 1 and 2
* Students of other fields and other universities
Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention

Individuals with Cystic Fibrosis (CF) are at high risk for depression and anxiety, with negative consequences for quality of life, ability to carry out daily CF treatments, and health. CF Foundation and European CF Society guidelines recommend routine screening, treatment, and preventative efforts for depression and anxiety. Cognitive-behavioral therapy (CBT) interventions focused on teaching coping skills have a large evidence-base for prevention and treatment of depression and anxiety, but there are barriers to accessing these interventions for individuals with CF. Drs. Friedman and Georgiopoulos at Massachusetts General Hospital (MGH) have developed a CF-specific CBT-based preventive intervention for depression and anxiety with input from adults with CF and CF healthcare team members, called CF-CBT: A cognitive-behavioral skills-based program to promote emotional well-being for adults with CF, along with a training and supervision program for CF team interventionists. CF-CBT consists of 8 45-minute modules that can be flexibly delivered in the outpatient CF clinic, on the inpatient unit, or by telephone, by multidisciplinary members of the CF care team, minimizing additional cost and burden of care to patients. The goal of this study is to test CF-CBT in 60 adults screening in the mild range on measures of depression and anxiety at 4 CF centers, in a prospective randomized clinical trial comparing the intervention to usual treatment. Participants will be randomized to receive the CF-CBT intervention immediately, or to a 3-month waitlist control followed by intervention. The study will measure depression, anxiety, quality of life, stress, and coping self-efficacy before and after the CF-CBT intervention, and also 3 and 6 months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CF
* depression and anxiety scores on the PHQ-9 and/or GAD-7 screening measures in the mild but not moderate or severe range (scores are \> 4 and ≤ 9)
* Able to speak and read English

Exclusion Criteria:

* Presenting an acute safety risk to self or others despite self-reporting of mild (subclinical) depression or anxiety scores on routine screening at baseline. Those reporting suicidal intent with or without specific plan will be excluded from the study. These individuals will be referred for urgent/emergent further assessment and treatment as clinically indicated.
* Participation in concomitant formal cognitive-behavioral therapy at baseline
Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Had a 10-second 12-lead ECG done at Mayo Clinic
* Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3

Exclusion Criteria:

* Diagnosed atrial fibrillation or atrial flutter
* Missing date of birth or sex in the electronic health record (EHR)
* A history of intracranial bleeding
* A history of end-stage kidney disease
* Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
* Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.

The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit
* Negative result from Serum Helicobacter pylori antibody at the time of screening visit

Exclusion Criteria:

* Patients with trouble performing pH monitor catheter
Scapular Motor Control for Chronic Mechanical Neck Pain

The purpose of this study is to investigate the effect of motor control training using scapular PNF exercise on neck pain, function, proprioception, and scapular muscle strength in patients with chronic mechanical neck pain.

Chronic mechanical neck pain (CMNP) is defined as generalized neck and/ or shoulder pain for more than 3 months with symptoms provoked by neck movement, neck postures, or palpation of the cervical muscles .

regional interdependence (RI) is defined as the concept that a patient's primary musculoskeletal symptom(s) may be directly or indirectly related or influenced by impairments from various body regions and systems regardless of proximity to the primary symptom(s)'.

Changes in scapular posture and alteration of muscle activation patterns of scapulothoracic muscles are cited as potential risk factors for neck pain the structural connectivity of the cervical spine and scaopulothorathic muscles . The bones and muscles of the cervical spine and the shoulders are connected to each other mechanically, thus a continuously applied mechanical load on the shoulders directly increases the load on the cervical region, which may cause joint and ligament pain Scapular malalignment can contribute to prolonged compressive loading of the posterior cervical structures .

It has been suggested that abnormal joint stress affects the firing of cervical afferents, leading to changes in proprioceptive function. Moreover, pain leads to changes in motor control . we believe that scapular motor control exercises using PNF technique may help to restore normal alignment and reverse this vicious circle PNF Technique is based on movement patterns to facilitate and correct sensory-motor function it has been suggested that PNF correct the impaired impulses emerging from proprioceptive receptors in the muscle. Therefore, it decreases pain and desires to improve the strength of muscles. PNF position renders a greater amount of sensory input coming from the periphery than that in the neutral position .The purpose of this study is to investigate the effect of motor control training using scapular PNF exercise on neck pain, function, proprioception, and scapular muscle strength in patients with chronic mechanical neck pain.

Eligibility Criteria:
Inclusion Criteria:

* -The subject will be referred from orthopedic surgeon with diagnosis of CMNP.
* Subjects with CMNP of more than 3 months with age range between 18 and 45 years
* Subjects having a baseline NDI score of at least 20% (10 points)
* At least 3/10 pain intensity on VAS

Exclusion Criteria:

* Spinal canal stenosis.
* Traumatic injury to the cervical spine.
* Previous surgery related to cervical spine.
* Hypermobility of the cervical spine,
* Any red flags e.g. cervical instability, history of cancer, long use of corticosteroids.
* Presence of an inflammatory rheumatologic disease,
Evaluation of Prognostic Factors in Tympanoplasty

Tympanoplasty is the surgical operation performed for the reconstruction of the eardrum and/or the ossicles. Tympanoplasty is classified into five different types, originally described by Horst Ludwig Wullstein. 1,2 Type 1 involves repair of the tympanic membrane alone, when the middle ear is normal. A type 1 tympanoplasty is synonymous to myringoplasty, Type 2 involves repair of the tympanic membrane and middle ear in spite of slight defects in the middle ear ossicles, Type 3 when mallus and incus are absent graft place directly on stapes head., Type 4 describes a repair when the stapes foot plate is movable, but the crura are missing. The resulting middle ear will only consist of the Eustachian tube and hypotympanum, Type 5 is a repair involving a fixed stapes footplate.

There are various prognostic factors reported in the literature that may influence the surgical success of tympanoplasty.

Some studies report significance for some of these factors whereas others report the contrary. The reported incidence of surgical success of tympanoplasty ranges from 60% to 99% in adults Belluci described four separate stages for prognosis of tympanoplasty 4 according to otorrhea

. Austin proposed a prognostic stratification according to disease categories, stage categories, and disease descriptors.

Black introduced the surgical, prosthetic, infection, tissues, and eustachian tube system (SPITE), and more recently Kartush developed middle ear risk index (MERI).

Smoking is added as a middle ear risk. Furthermore, cholesteatoma and granulation tissue or effusion risk value has been increased in MERI 2001.

Prognostic factors such as age, sex, presence of systemic diseases, location and size of perforation, duration of dry period, presence of myringosclerosis, presence of septal and conchal pathology, operation type, and status of the opposite ear and middle ear risk index were investigated. 9

Eligibility Criteria:
Inclusion Criteria:

* patients of the age group 18-60 years with Chronic suppurative otitis media (CSOM) planned for tympanoplasty.

Exclusion Criteria:

* Patients with otomycosis, septic foci such as sinusitis which can influence the outcome of tympanoplasty were excluded from the study
The Effect of 6 Week Hamstring Exercise Programs on Hamstring Muscle Strength

This study aims to compare the effect of two hamstring strengthening programs on hamstring muscle strength in university students. 60 participants will be recruited for this study. They will be randomly assigned to one of two 6-week hamstring strengthening programs, namely the single leg bridge exercise and the Nordic hamstring exercise protocol, and one control group. Eccentric and isometric hamstring strength, gluteal strength and will sprint speed will be measured before and after the intervention.

Participants will be recruited from the local university sports clubs. Club chairpersons will be asked to send an email to club players. Players interested in participating in the study will be asked to attend a meeting where the study will be explained to them. Those who were interested will then be assessed for inclusion and exclusion criteria.

Group allocation:

A four block randomization method will be used to allocate participants to the Nordic hamstring exercise protocol or the single leg bridge protocol.

Interventions:

The Nordic hamstring exercise program or the single leg bridge program.

Testing procedure:

The eccentric strength of the participants' hamstrings will be recorded before and after the exercise intervention.

A 10 point visual analogue scale will be used to record the level of muscle soreness experienced after each training session.

Eligibility Criteria:
Inclusion Criteria:

* free from hamstring injury in the 6 months prior to the study
* currently competing in team sports at least three occasions per week

Exclusion Criteria:

* history of a hip or knee injury in the 3 months prior to the study
* a history of anterior cruciate ligament rupture
* a history of involvement in a hamstring strengthening, injury prevention programme in the 3 months prior to the study.