cyrilzakka/clinical-trials huggingface dataset:
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

The goal is to conduct a 5-year prospective, randomized controlled trial to test an innovative, community-based intervention using posterior and anterior fundus photography of the optic nerve and macula and intraocular eye pressure measurements to improve access and utilization of eye care to detect, treat, and manage high-risk patients with previously undiagnosed glaucoma and other eye diseases. Research shows that subject failure to attend follow-up eye care appointments diminishes any previous benefits of community screenings for glaucoma. Greater adherence to follow-up visits can reduce glaucomatous blindness.

The project will be divided into following parts:

* Phase 1 will consist of recruiting patients from primary care offices and federally qualified health centers across Philadelphia and Chester counties. Using fundus photography of optic nerve and macula via telemedicine and measurement of intraocular pressure, eye disease will be detected at Visit 1, followed by a comprehensive eye exam by a glaucoma specialist in the primary care setting to confirm the diagnosis (Visit 2) of qualifying participants requiring further evaluation. Predictive accuracy of optic nerve images to detect glaucoma, glaucoma suspect and other eye diseases as confirmed by the comprehensive eye exam will be evaluated.
* Phase 2 will involve consenting, enrolling, and randomizing the qualifying participants confirmed by diagnosis at Visit 2 to either the Usual Care group or the Enhanced Intervention group and scheduling follow-up eye exams with a local, general ophthalmologist in an office-based setting (Visit 3). Enhanced intervention will use patient navigators and a social worker to reduce barriers to follow-up eye care.
* Phase 3 will involve monitoring the randomized participants attendance of proximal (1-2 months) and distal (3 years) follow-up care appointments (Visits 3-8) with a local ophthalmologist. Adherence to recommendations for follow-up eye care will be the primary outcome measure. A comprehensive estimation of intervention costs and cost-effectiveness of detecting eye diseases and vision impairment in a high-risk population will also be conducted. Protocols, materials, and results will be disseminated to other organizations, stakeholders and communities in order to expand detection of glaucoma, other eye diseases, and visual impairment, and to further refine these approaches.

Eligibility Criteria:
Inclusion Criteria:

* African-American, Hispanic, or Asian individuals over age 40
* Caucasian individuals over age 65
* Individuals of any ethnicity, over age 40 with a family history of glaucoma
* Individuals of any ethnicity, over age 40 with diabetes
* Individuals who meet one of the above criteria who have not seen an ophthalmologist in the past year

Exclusion Criteria:

Any patient with previously diagnosed glaucoma, glaucoma suspect, or eye diseases who is currently being followed by an ophthalmologist

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Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS.

Phase I study divided into 3 parts written as belows.

Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers


Eligibility Criteria:
Inclusion Criteria:

age: 20-55 years body weight: greater than 50kg written informed consent

Exclusion Criteria:

known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study
Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS

The goal of this non-interventional, observational study is to learn if cortical plexus enhancement in patients with primary progressive multiple sclerosis occurs in response to the autoimmune inflammatory process.

To study the effect of ocrelizumab on choroid plexus changes in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study

Eligibility Criteria:
Inclusion Criteria:

* Patient participating in the ORATORIO study
* MRI scans available at baseline
* Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 3D T1-WI at baseline

Exclusion Criteria:

- None
HIV Resilience Qualitative Study Hong Kong

This qualitative study aims to explore lived experiences of older adults living with HIV in Hong Kong. Twenty older Chinese adults of age 50 or above will be recruited from an HIV specialist clinic providing HIV care in the public service. Qualitative, semi-structured interview will be conducted to explore risk factors contributing to life stress and adversity, and protective factors associated with resilience. The qualitative data will be delineated to propose a typology of older adults living with HIV as characterized by their unmet needs, barriers and facilitators of resilience-building.

Objectives: The intersection of HIV and ageing has important implications for health and psychosocial wellbeing, which are complex in nature. In a setting with growing number of older adults living with HIV in Hong Kong, as in many other regions in the world, addressing their unmet healthcare needs is paramount. Failure to understand and recognise their needs will impede healthy ageing. This study aims to explore lived experiences of older adults living with HIV in regards their complex needs and resilience-building, with the specific objectives of examining associated factors of resilience development at individual-social- and structural level.

Design: A qualitative study targeting 20 older Chinese adults of age 50 or above who are living with HIV who are divided under the following groups: Group A: Chinese men who have sex with men and Group B: Chinese heterosexual males and females

Settings: Clinic providing HIV care in the public service

Methods: Participants will be recruited through purposive sampling based on their age (50-64; 65 and above of age), gender and sexual orientation. Qualitative, semi-structured interview will be conducted to explore: (1) risk factors contributing to life stress and adversity, and (2) protective factors associated with resilience. Interviews will be digitally recorded, transcribed verbatim and managed using "NVivo" software. Themes will be developed, constantly compared within and between targeted groups, using Grounded Theory approach.

Anticipated outcomes:

The qualitative data will be delineated to propose a typology of older adults living with HIV as characterized by their (1) unmet needs, (2) barriers of resilience-building, and (3) facilitators of resilience-building.

Eligibility Criteria:
Inclusion Criteria:

* Known and confirmed HIV infection
* age of 50 or above
* normally living in Hong Kong
* permanent residents of Hong Kong
* able to communicate in Cantonese

Exclusion Criteria:

* Active psychiatric disorder
* prisoners or under institutionalized care
* unable to give consent
Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial

This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.

Outcome measurements:

The frequency of bowel movement; The bristol stool scale; SF-36 evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
2. Age between 18 and 65 years old;
3. Did not take any medicine for bowel symptoms and attend other clinical research;
4. Have inform consent signed.

Exclusion Criteria:

1. Diarrhea caused by diseases such as infection, etc.
2. Patients can't express himself clearly or with mental diseases;
3. Tumor and other infectious diseases;
4. With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.
Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT

TO Compare The Clinical And Radiographic Outcomes of DCI VS ACDF For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD)

Anterior cervical discectomy and fusion (ACDF) is an effective and safe treatment for patients with radiculopathy and myelopathy. However, in the untreated levels adjacent to a fusion, increased motion and elevated intradiscal pressures have been reported. Some investigators have postulated that these changes may lead to an increased risk of adjacent segment degeneration (ASD). Limitations and problems with ACDF have led some investigators to explore the motion-preserving surgeries, such as cervical total disk replacement (TDR). Although TDR has been shown to reduce adjacent-level intra discal pressures and provide a more physiological overall cervical but also index- and adjacent-level range of motion (ROM) while maintaining sagittal alignment. Recent studies have also highlighted the potential limitations of TDR. Dynamic cervical implant (DCI) is a type of anterior decompression and cervical non-fusion implant that was initially conceived as a method to combine the potential advantages of fusion and TDR. The DCI is intended to provide controlled, limited flexion and extension-the primary motions in the sub axial cervical spine-that is greater than that seen with fusion, but less than that achieved with TDR .

Eligibility Criteria:
Inclusion Criteria:

* Single or multiple symptomatic cervical DDD with radiculopathy and\\or mylopathy not responding to non-surgical management
* Age older than 18 years

Exclusion Criteria:

1. ossification of posterior longitudinal ligament
2. facet arthritis
3. lack of motion or instability at the level of surgery
4. fracture
5. infection
6. tumors
7. osteoprosis
Self-help Treatment for Insomnia in Breast Cancer Patients

The main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. It is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). It is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.


Eligibility Criteria:
Inclusion Criteria:

* To be receiving treatment for a diagnosis of breast or gynaecological cancer
* To obtain a score of 8 or higher on the Insomnia Severity Index (ISI) or to be using a hypnotic medication ≥ 1 night per week

Exclusion Criteria:

* To have received a diagnosis or being treated for :

  * a sleep disorder other than insomnia (e.g., sleep apnea)
  * a severe psychiatric disorder (e.g., psychotic disorder)
  * a severe cognitive disorder (e.g., dementia)
Ultrasonography-guided Real-time Modular Systems for Hand Therapy

This study aimed to develop an ultrasonography-guided real-time modular system and try to apply it to clinical hand therapy using.

This study was divided into two parts. The first part is an observational study design. The ultrasonography-guided real-time modular system will be developed and integrated, and its overall reliability and validity will be tested in this part. Once the software and hardware of the modular system has been established, numerous hand-related ultrasonography data will be collected for building an artificial intelligence model for detecting the anatomic structures in hand, evaluating the status of the tissues in hand.

The second part is an interventional study design. The clinical application of the modular system on hand injured patients is conducted, and the biofeedback mechanics will also be defined in the second part. The patients will be recruited into the research to receive both traditional rehabilitation and the one which combines with biofeedback training via the modular system. The effect of the traditional and biofeedback-added rehabilitation will be compared.


Eligibility Criteria:
【Patients】

Inclusion Criteria:

* Traumatic hand injury (distal from wrist joint above 8 weeks and within one year)
* Able to do active motion and resistive activities
* Understand and cooperate the experiment

Exclusion Criteria:

* Burn, amputees or has history of arthritis
* Combined with other central or peripheral nerve deficits which cause difficulty in movements

【Healthy subjects】

Inclusion Criteria:

* No history of traumatic hand injury and other hand related conditions
* Understand and cooperate the experiment

Exclusion Criteria:

* Burn, amputees or has history of arthritis
* Combined with other central or peripheral nerve deficits which cause difficulty in movements
Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.

This study aims to investigate the characteristics of gut microbiome and metabolome in non-CF bronchiectasis patients, hoping to explore the underlying mechanisms as well as the influence of gut microbiota composition on bronchiectasis.

Non-cystic fibrosis bronchiectasis is a chronic airway disease characterized by irreversible and progressive dilation of the large airways, bronchi and bronchioles, which severely impairs the life quality of patients and increases the social and economic burden. It is also a heterogenous disease affected by multiple factors such as geography and ethnicity. The incidence of bronchiectasis among the Chinese population is about 1.2%, which has clearly been underestimated. However, due to the lack of awareness, the research of bronchiectasis in China is still in its infancy. Colonization and recurrent infection of pathogen is the primary unsolved problem in clinical practice. With the proposition of "gut-lung axis" theory, the role of gut microbiota in the pathogenesis of respiratory diseases has been gradually revealed. Evidences have shown that gut microbiota regulates respiratory immunity via releasing soluble bacterial components and its metabolites into the circulation, as well as facilitating the migration of immune cells directly to the lung. In the 1980s, a patient after a colectomy has been reported to generate bronchiectasis. The most common clinical manifestation of pulmonary involved IBD patients is also bronchiectasis, suggesting that the "gut-lung axis" may be involved in the pathogenesis of bronchiectasis. Therefore, clarifying the role and mechanism of gut microbiota in bronchiectasis and its gut microbiome is expected to provide new theoretical basis and ideas for its diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Regular bowel movement: every 2 days - 3 times/ day
* The diagnose of bronchiectasis should refer to "BTS guideline 2010"

Exclusion Criteria:

* Diagnosis of ABPA
* Pregnancy or lactation
* Active smoking or alcohol using within last 6 months
* HIV infection
* Previous abdominal or rectal surgery
* Diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal insufficiency (GFR \< 30ml/min) or immunodeficiency
* Regular use of the following types of medications (\> 2 times per week) within last 2 months: opium, loperamide antidiarrheal, systemic antihistaminic, metoclopramide, proton pump inhibitor
* Poor compliance or inability to cooperate as judged by the doctor
Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis

The goal of this study is to investigate the encapsulation of fluid collections in patients with ANP using serial MRI.

The main questions it aims to answer are:

* Evaluating the timing of encapsulation of necrotic fluid collection using serial non-enhanced MRI.
* Identifying the factors that affect the timing of encapsulation of necrotic fluid collections Participants will undergo serial MRI scans (all with the same protocol) performed starting at day 15. Subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen or patients are excluded from the protocol due to intervention.

Consecutive patients with ANP presenting to the hospital within 2 weeks from the pain onset will be recruited. They will undergo serial non-contrast MRI starting at day 15 and every 5 days thereafter, till complete encapsulation of PFC. Ultrasound evaluation of the collection will be performed on the day of MRI by a radiologist not involved in evaluation of MRI. The site and volume of collection as well as thickness and completeness of the capsule and solid content within the collection will be recorded independently by two radiologists. The timing of clinically significant (\>50% of PFC show capsule) and complete encapsulation will be recorded. The proportion of collections encapsulating in each week after 2nd week of illness will be recorded. The association between timing of encapsulation and clinical/biochemical parameters will be assessed. The correlation between the degree of encapsulation and percentage of solid components will also be documented. Multivariate analysis will be performed to identify factors associated with timing of encapsulation.

Eligibility Criteria:
Inclusion Criteria:

1. Acute necrotizing pancreatitis
2. Presentation to hospital within 2 weeks of pain onset

2. Willing to give informed consent

Exclusion Criteria:

1. Contraindications to non- enhanced MRI (Claustrophobia, cardiac pacemaker, cochlear implant).
2. Acute on chronic pancreatitis
3. Mechanical ventilation, ionotropic support (precluding safe environment in MRI).
4. Drainage or aspiration of a collection prior to recruitment
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer

This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.

PRIMARY OBJECTIVES:

I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.

SECONDARY OBJECTIVES:

I. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.

II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.

III. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \[QLQ-CIPN20\]) in the same TIPN patients.

IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.

TERTIARY OBJECTIVES:

I. To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.

II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.

OUTLINE:

Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.

After completion of study, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer (any stage)
* Previously or currently receiving taxane-based chemotherapy
* Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
* Ability and willingness to understand and sign an informed consent

Exclusion Criteria:

* Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
* Unable to provide history
Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older.
* Diagnosed with primary degenerative osteoarthritis.
* Complaining of knee pains
* Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination
* Patient signed ICF

Exclusion Criteria:

* Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM.
* Claustrophobic or failing cooperativity assessment of laying still during long MRI scans
* Pregnancy or pregnancy suspicion
* Enrolled in concurrent studies that may confound the results of this study
* Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.
A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis

This Phase 3 study (Study 305) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas).
4. Subject has moderate to severe plaque psoriasis.
5. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
6. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
3. Subject has palmar/plantar psoriasis.
4. Subject is pregnant, lactating, or is planning to become pregnant during the study.
5. Subject is currently enrolled in an investigational drug or device study.
6. Subject has been previously enrolled in this study and treated with a test article.

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.