cyrilzakka/clinical-trials huggingface dataset:
Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings

The purpose of this study is to conduct preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in care and to determine whether a similar intervention structure can be used across various sexual risk groups and cultural settings.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years of age (Note: Pregnant and breast feeding women are allowed to enroll into the study)
* Documented evidence of HIV infection (HIV diagnosis performed outside of the trial is acceptable so long as local/country guidelines were followed in the testing)
* Receiving HIV/AIDS care (defined as at least two visits within 9 months of enrollment) in a formal health care setting (clinic or hospital)
* Reported history of sexual risk behavior in the previous 12 months, including: acquisition of a sexually transmitted infection, vaginal or anal intercourse without a condom, difficulty negotiating condom use, or non-disclosure of HIV status to an HIV-uninfected partner or partner of unknown HIV serostatus.
* NOTE: For the MSM population, we will enroll men who have sex with men, regardless of whether or not they also have sex with women

Exclusion Criteria:

* Anyone currently enrolled in another study that involves protocolized HIV risk reduction counseling (e.g. ACTG 5175 or HPTN 052) or any other prevention study
* Anyone having unprotected (i.e. without a condom) sex for the expressed purpose of conceiving
* Planning to relocate out of the area in the next year
* Any condition that, in the opinion of the Investigator of Record or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Creating a Zone of Openness to Increase Patient-Centered Care

This study implements a simple evidence-based patient activation intervention - "Ask 3 Questions"- augmented by a novel theory-based intervention - "Open Communication" - aimed at activating patients and healthcare providers. The goal of this project is to increase patient and physician's preparedness for more having more questions, expressing differing opinions, and working collaboratively in making medical decisions that are both informed and responsive to patients' needs and preferences.

Conduct a pilot randomized controlled trial (RCT) to compare two interventions, "Ask 3 Questions," "Open Communication," a combination of both "Ask 3 Questions" and "Open Communication," to a usual care control condition. These data will inform a potential future large scale evaluation of the interventions in clinical practice. Consistent with a patient-centered approach, outcome measures are selected in collaboration with a group of patient stakeholders and will include measures of patient satisfaction. The study aims to collect 75 post-visit surveys and 10 appointment audio-recordings from patients at each of 4 participating sites (a total of 300 post-visit surveys and 40 audio-recordings).

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a scheduled appointment with the participating family medicine and internal medicine physicians during the study period.

Exclusion Criteria:

* Non-English speakers
* Patients younger than 18
Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma

The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* ECOG performance status 0-2
* Hepatocellular carcinoma diagnosed histologically or clinically
* Tumor numbers of 5 or less
* No history of treatment for hepatocellular carcinoma
* Patients with informed consent

Exclusion Criteria:

* Extrahepatic metastasis
* Rupture of hepatocellular carcinoma
* Infiltrative hepatocellular carcinoma
* Malignancy other than hepatocellular carcinoma
Comparing the Effectiveness of Different Appointment Reminder Methods

Penn Medicine is continually trying to optimize operations and decrease number of patients who do not show up for their appointments. This has included new changes to text message reminders, implemented as usual care. At a baseline, less than 75% of scheduled outpatient appointments are actually completed. This results in longer wait times and decreased access for patients and operational inefficiencies. The goal of the project is to test whether supplementing standard text message appointment reminders with targeted outreach using an automated phone call to patients with increased risk of not showing up for their appointment (\>15% per Epic's Risk of Patient No-Show Model) reduces no show rate (the study's primary outcome) and increases patient appointment completion rate (% of appointments that were completed during scheduled appointment time, a secondary outcome). Participants will be randomized in a 1:1 ratio to receive either the standard text message or standard text message plus the automated caller. Eligible patients have already consented to receiving text message reminders from Penn Medicine and must have an in-person appointment scheduled during the study period. The Access Optimization Group at Penn will be monitoring the randomization and outcomes reporting of whether a patient confirmed, cancelled, or no showed at the scheduled appointment. All eligible outpatient appointments over a two week period will be included in this operational evaluation. The Access Optimization Group will then make a decision on which approach to implement as usual care based on the results of this operational evaluation.


Eligibility Criteria:
Inclusion Criteria:

* in-person appointments
* English or Spanish speakers
* 18 years old or older
Back Pain Prevalence in Wheelchair Users and Associated Risk Factors

The primary purpose of this study is to determine the prevalence of back pain in permanent wheelchair users (excludes transitory users) in different regions of Spain. Another study objective is the identification of risk factors for back pain in this population. Data collection will be by means of a structured questionnaire which will be validated in a previous pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Adults with established disability;
* Permanent wheelchair users;
* Having physical and intellectual ability to answer questionnaire.

Exclusion Criteria:

* Transitory wheelchair users;
* Diagnosis of inflammatory rheumatic disease, cancer, systemic infection;
* Red flags for systemic disease.
Axillary Reverse Mapping for Invasive Carcinoma of the Breast

Primary Objectives:

* To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing axillary lymph node dissection for breast cancer therapy.
* To determine the incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by axillary reverse mapping.
* To determine the safety of axillary reverse mapping.

Lymphazurin is a blue dye used usually in breast cancer surgery to trace the drainage pathway that flows to lymph nodes. The dye will travel to the lymph system and will end up in the lymph nodes that are draining the arm.

In this study, lymphazurin will be used to find the drainage routes from your arm, rather than your breast.

AXILLARY REVERSE MAPPING:

Before axillary lymph node surgery, your surgeon will inject lymphazurin into your arm. Your surgeon will watch how the dye flows and find the channels and nodes draining the arm. You will then have standard axillary lymph node (lymph nodes found under the arm) surgery. Any lymph nodes found that are dyed blue (lymph nodes that have traveled down the drainage pathways) that would normally be removed will be removed and sent to the pathology department. Pathologists will check the nodes to see if they have breast cancer cells in them. Also as part of routine care, all other axillary lymph nodes draining the breast will be removed and checked for breast cancer cells.

This is an investigational study. Lymphazurin is FDA approved and commercially available. The use of lymphazurin with axillary reverse mapping is investigational.

Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Patients with invasive carcinoma of the breast planning to undergo axillary lymph node dissection at M. D. Anderson Cancer Center.
* Eastern Cooperative Oncology Group (ECOG) performance status of equal to or less than 3.

Exclusion Criteria:

* Patients with known allergies to blue dye or other contraindications to Lymphazurin.
A Study Comparing Two Treatments for Infants With Hydrocephalus

The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.

TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection.

TVH is currently treated through one of the following two approaches:

* Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully.
* Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic TVH requiring treatment.
* No previous treatment for TVH
* Under 24 months of age at time of surgery
* Full-term pregnancy (\>36 weeks)
* Mandatory pre-operative MRI that includes mid-sagittal T1 \& T2 scans which show: Tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of CSF collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete Dandy Walker Syndrome excluded); questionable flow in aqueduct acceptable as long as TVH exists
* History or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity).
* Ability to participate in followup for at least 5 years

Exclusion Criteria:

* Open Spina Bifida
* Complete Dandy Walker syndrome (vermian agenesis / dysgenesis)
* Prematurity
* Perinatal asphyxia
* Severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts)
* intracranial tumor
PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru

This study is an evaluation of an intervention (nicknamed "PASEO") that aims to facilitate the transition to adult HIV care for adolescents living with HIV in Lima, Peru. The intervention consists of health systems navigation and accompaniment, monthly check-ins with a lay health worker, enhanced social support provided through peer support groups, education sessions, mental health screening and referral, resolution of acute needs, and individualized adherence support.

The study is a two-arm 1:1 randomized evaluation to determine the short- and long-term (i.e., post-intervention) efficacy of the PASEO intervention with regard to retention with viral load suppression as well as other indicators of well-being. The cumulative incidence of unsuccessful transition at 12- and 24-months will be compared. The cost and cost-effectiveness of the study intervention in terms of cost per additional successful transition achieved will be estimated. Data on implementation considerations essential for uptake, sustainability, and successful adoption by the public sector will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent or young person living with HIV and aware of diagnosis
* 14 to 21 years of age (may be increased to 23 to meet recruitment targets)
* Currently taking or eligible for ART at a participating facility
* Scheduled to transition to adult care or previous unsuccessful transition to adult care
* Willing to participate regardless of the study arm to which they will be assigned
* Able and willing to provide written informed consent

Exclusion Criteria:

* Living outside of Lima province
* Participation in the PASEO pilot study
* Current enrollment in another research study
* Having any condition (social or medical) which the study team considers would make participation unsafe
US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.

Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced emphysema
* Limited exercise capacity and persistent symptoms despite medical therapy
* Age between 18 and 75
* No significant heart, kidney or liver disease
* Willingness and ability to tolerate bronchoscopy
* No prior Lung Volume Reduction Surgery or Lung Transplantation
* Screening test results indicating that the procedure is appropriate
Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder

This research examines the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD).

This project aims to evaluate the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD). The project includes three subject groups: patients with BPD undergoing the DBT program (BPD-DBT), control patients with BPD on the waiting list for the program (BPD-control), and healthy controls (HC). Patients in the BPD-DBT group undergo a 24-week DBT program in an outpatient setting. All participants undergo a test battery comprising of self-report measures, clinical evaluation and fMRI and EEG measurement in the week before the DBT program beginning (T1), after 24 weeks (follow-up, T3), and at 24 weeks after T3 (follow-up, T4). The BPD-DBT group undergoes another assessment at T2 (after 12 weeks) to monitor selected symptoms during the DBT program by a short set of questionnaires.

Eligibility Criteria:
BPD-DBT group:

Inclusion Criteria:

* diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
* minimum age 16, informed consent of the patient
* informed consent of patient's legal representative in case of patients under age 18
* more than one self-injury incident and/or suicidal attempt in the past six months

Exclusion Criteria:

* neurological disorder
* comorbid affective disorder or schizophrenia-related disorder
* intelligence quotient\<70
* contraindications for MRI measurement
* pregnancy
* body mass index under 15

BPD-C group:

Inclusion Criteria:

* diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
* minimum age 16, informed consent of the patient
* informed consent of patient's legal representative in case of patients under age 18
* more than one self-injury incident and/or suicidal attempt in the past six months

Exclusion Criteria:

* completing a DBT program or attending DBT-based therapy
* neurological disorder
* comorbid affective disorder or schizophrenia-related disorder
* intelligence quotient\<70
* contraindications for MRI measurement
* pregnancy
* body mass index under 15

HC group:

Inclusion criteria:

* minimum age 16, informed consent of the patient
* informed consent of patient's legal representative in case of patients under age 18

Exclusion criteria:

* mental health problems
* history of self-injury or/and suicidal attempt
* neurological disorder
* intelligence quotient\<70
* contraindications for MRI measurement
* pregnancy
* body mass index under 15
Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers

To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers

Neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation. A reduction In corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing epithelial keratopathy, ulceration and perforation.

Because decreased corneal sensitivity is the hallmark sign of neurotrophic keratitis (NK), corneal sensitivity testing should be performed as soon as It is suspected

There are 2 common ways to test-one qualitative, the other quantitative:

The qualitative method is most commonly used In clinic and often achieved with a cotton tipped applicator because It is easily accessible.

The most common quantitative method is the handheld esthesiometer (Cochet-Bonnet).

Standard treatment of neurotrophic corneal ulcer involves aggressive lubrication of the corneal surface, therapeutic contact lenses, amniotic membrane grafts and tarsorrhaphy . Refractory neurotrophic corneal ulcers occur when treatment response is incomplete and are potentially blinding.

Insulin is a widely available, relatively safe, and familiar medication that has been shown to improve corneal epithelial healing In vitro and in diabetic animal models. However, clinical experience with topical insulin in patients with non-healing corneal wounds is minimal.

Insulin-like growth factor-1 (IGF-1) has been shown to be an important modulator of corneal wound healing.

Topical insulin may be a simple and effective treatment for neurotrophic corneal ulcers.

The main outcome measurements for improvement are the decrease of ulcer size by fluroscien stain,the increase in visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neurotrophic corneal ulcers caused by:

  * Herpes simplex or Herpes zoster viral infection
  * Topical anesthetics abuse
  * Chemical and physical burn
  * Chronic CL wear
  * Following LASIK,PRK,CXL
  * Following vitrectomy and endophotocoagulation for retinal detachment
  * Diabetes mellitus
  * Leprosy
  * Trigeminal neuralgia surgery

Exclusion Criteria:

* Non compliant patients with the study protocol
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.

The investigators will conduct a pilot hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) wherein 100 pregnant women with DSM-5 insomnia disorder and comorbid depression (Edinburgh Postnatal Depression Scale ≥ 10) are randomized to a mindfulness-based intervention--Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)--or Cognitive Behavioral Therapy for Insomnia (CBTI). Patients will be recruited from women's health clinics across Henry Ford Health in Metro Detroit including underserved women, serving as real-world implementation. Per clinic operations since the pandemic, therapies will be via telemedicine to meet patient expectations. Study outcomes will be assessed before and after treatment, then across the first postpartum year.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy, gestational week 14-31.
2. DSM-5 Insomnia Disorder (acute or chronic).
3. Insomnia Severity Index (ISI) score ≥ 11.
4. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
5. Ensure adequate sleep opportunity.
6. Age ≥ 18, English-speaking.
7. Reliable internet access (treatment, assessments)

Exclusion Criteria:

1. High risk pregnancy (age \>40y, pre-eclampsia, any condition deemed serious risk to mother/fetus; hypertension and diabetes allowed).
2. Active suicidal intent (ideation is allowed).
3. Night or rotating shift work.
4. Epworth Sleepiness Scale\>15 (Excessive sleepiness)
5. Health condition unsafe for sleep restriction (bipolar, epilepsy, etc.).