cyrilzakka/clinical-trials huggingface dataset:
Retisert and Cataract Surgery in Patients With Severe Uveitis

To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis.

Cataracts are common in eyes with uveitis. It results from inflammation or the use of topical or systemic steroids. Cataract surgery can cause an unusually severe inflammatory response, abnormal or excessive bleeding, and unexpected postoperative IOP responses such as hypertension or hypotony. Previous studies showed that successful outcome is preoperative and postoperative control of intraocular inflammation by topical, periocular, and systemic steroidal or immunosuppressive agents. In patients with severe posterior uveitis, periocular and intravitreal injections often provide only transient effects and are associated with complications such as hemorrhage, retinal detachment and endophthalmitis. Oral corticosteroid therapy are also associated with side effects to multiple organ systems in the body. A novel technology that delivers corticosteroid therapy linearly via an intravitreal, polymer-coated, sustained release implant has been developed and FDA approved to treat severe posterior segment uveitis. FA implantation effectively controls inflammation over an extended period of time in a complicated group of patients with posterior and/or panuveitis and allows reduced immunosuppression. We hope to determined whether this implant, a fluocinolone acetonide sustained drug delivery system (FA), can safely suppress postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis. We hypothesize that combining the implant with cataract surgery will provide better surgical outcomes by suppressing inflammation during the postoperative period. By reviewing our own surgical data at the Duke Eye Center, we intend to primarily focus on the safety and effectiveness of this surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* A visually significant cataract
* A history of recurrent noninfectious posterior uveitis or intermediate uveitis with or without iridocyclitis
* incomplete therapeutic response or treatment-limiting side effects to oral, periocular corticosteroid, and/or immunosuppressive agents
* VA of at least light perception; and
* Ability to comprehend informed consent and comply with follow-up examinations

Exclusion Criteria:

* An allergy to fluocinolone acetonide or any component of the delivery system
* A toxoplasmosis scar was present in the study eye,
* A peripheral retinal detachment (RD) in the area of the planned fluocinolone acetonide implant placement
* Required chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to treat non-ocular disease or if they tested positive for human immunodeficiency virus.
* Also excluded were female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar

A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared to control clusters over 2 years. 24 clusters (selected as high incidence during previous years) will be randomly allocated to intervention or control. Following health education, and with informed consent, all households in intervention villages will receive free Permanets (from September 2006). Net usage will be monitored and new nets provided if required. Control villages will not be given untreated nets, as - although commonly used in this region - their effectiveness against sandflies has not been proven. Pre-intervention infection status of villagers (\>2 yrs) will be evaluated serologically from finger-prick blood (and past/current disease status noted). Incident infections will be recorded by 3-monthly active search for clinical cases, and by annual serological diagnoses to detect subclinical infections. All villagers (\>2yrs) will be leishmanin skin tested at the end of the trial for further subclinical infection detection, and sera from a sub-sample will be tested for antibodies to sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given free treatment. Free Permanets will be provided to control villages after the trial. Complementary studies involve entomological surveillance by light traps in a sample of houses and social/economic questionnaire surveys. The entomological surveys will test whether community-wide use of LLINs provides any mass effect, which could protect those in the community who fail to use LLIN for any reason.


Eligibility Criteria:
Inclusion criteria (Clusters):

1. at least have seen 1 case per year in each of the last 3 years
2. An average of at least 1% Incidence rate over the period of past 3 years.

Exclusion criteria (Clusters):

1. Minimum 500 people
2. Maximum 2000 people
3. Distance between clusters 2000 meters (distance between borders)
4. Houses in tola/ward not sprayed (DDT, other) in 2006
5. Accessibility
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer

A registry-based randomized phase II trial. A total of 46 patients with metastatic head and neck cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Biopsy proven HNSCC (oropharynx, oral cavity, nasopharynx, sinonasal, larynx or hypopharynx)
* Metastatic HNSCC, with pathological or radiological proof of metastasis
* Ability to provide written informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
* Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
* All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
* Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
* Presence of spinal cord compression
* Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel
Phase II Exploratory Clinical Study of KUX-1151

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.


Eligibility Criteria:
Inclusion Criteria:

* Japanese HU patients (Outpatient)
* Patients who meet the following criteria concerning serum uric acid levels at the screening \[1) Gout: \> 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL\]

Exclusion Criteria:

* Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration
Conjoint Analysis of Patient Preferences in Joint Interventions

This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. This study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient age criteria for each condition is listed below:

  1. Hip arthritis: 50-80 years
  2. Knee arthritis: 50-80 years
  3. Hip labral tears and FAI: 18-65
  4. Osteochondritis dissecans: parents with children between the ages of 8-18
  5. Achilles tendon rupture: 25-60 years
  6. Patellofemoral dislocation: parents with children between the ages of 8-18 and adults between 18-50 years of age
  7. Distal radius fracture: 18-80 years
  8. Hip fracture: 50-85 years
  9. Ankle fracture: 18-80 years
  10. Tibia fracture: 18-80 years
  11. Proximal humerus fracture: 18-80 years
  12. Ankle Arthritis: 40-80 years

      Exclusion Criteria:
* Inability to read, understand and give effective English consent
Impact of Anticipated Regret Incorporation Into Patient Decision Aids

The purpose of this study is to investigate the impact of incorporating "anticipated regret " into standard patient decision aids. Participants in the Wharton Behavioral Lab will be administered a standard patient decision aid and an "anticipated regret" augmented decision aid. Participants will complete a computerized survey about their experiences with each version, and their answers will be assessed for potential differences associated with the incorporation of "Anticipated Regret."

Participants will be recruited through the Wharton Behavioral Lab. Upon arrival males will be provided with two decision aids focusing on prostate cancer, while females will be provided with two decision aids focusing on early breast cancer. One of these decision aids will be a standard version, and one of these will be the anticipated regret-augmented version. Participants will be randomized to which version they receive first to minimize the effect of presentation order. After reviewing the materials, participants will immediately complete a computerized survey at their work stations that will ask them to answer questions based on the materials presented as well as how any hypothetical treatment decisions they would be asked to make would have been influenced by them. Because these are healthy subjects participating in a hypothetical decision-making process for sole purpose of research, the intervention can neither be categorized as experimental or as the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Healthy females ages 18 years or older

Exclusion Criteria:

* Under age 18 years
ESP Block, CNP and QoL After VATS

The Erector Spinae Plane Block (ESPB) is an adequate alternative for pain management after video-assisted thoracoscopy surgery (VATS). The incidence of postoperative chronic neuropathic pain (CNP) and the quality of life (QoL) in patients with ESPB after VATS remain unknown. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and would report a good QoL up to three months after VATS.

We, therefore, performed this prospective observational study. The a priori primary outcome was incidence of CNP three months postoperatively (POP) in patients undergoing VATS surgery with ESPB as the regional anaesthesia technique. The secondary outcome was to describe pain control at PACU, 12 and 24 hours POP and QoL reported up to three months after surgery. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and report a good QoL.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent VATS and required at least one day of hospital stay after surgery

Exclusion Criteria:

* patients with mental or physical limitation to answer the questionnaires.
* patients who required mechanical ventilation.
* patients who required surgery conversion to thoracotomy.
* patients who declined consent.
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.

Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) for the: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.

Real world evidence from routine clinical practice using edoxaban up to 2 years will be collected and evaluated in approximately 200 patients, treated by specialized as well as non-specialized physicians in hospital centers.

Eligibility Criteria:
Inclusion Criteria:

* Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information
* Has provided written informed consent to participate in the study

Exclusion Criteria:

* Is participating in an interventional study
Pilot Trial of Spiritual Care Interventions for Patients With Cancer

This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of spiritual care into outpatient oncology care on patient outcomes.

This will be a pilot, stratified block randomized controlled trial of the effects of healthcare chaplain services on spiritual well-being and advance care planning (ACP) among black advanced cancer patients (N=64) in outpatient settings at two medical institutions: NYP/Brooklyn Methodist Hospital (BMH) and the University of Texas Medical Branch (UTMB). The investigators will randomly assign patients in a 1:1 ratio to either the Spiritual Care Intervention #1 or Spiritual Care Intervention #2 arm of the trial. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Trial outcomes will be assessed at the primary endpoint, 2 months after the onset of the spiritual care intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with a life-limiting, advanced cancer.
2. Identifies racially as black or African American.
3. Is fluent in English.

Exclusion Criteria:

1. Have received medical system-based spiritual care within the past 2 months.
2. Have already completed a DNR order.
3. Are too weak or cognitively impaired to engage in study activities
Online Self-Compassion Course for pALS (Compassion pALS)

This study is designed to be a pragmatic, single-arm trial to evaluate the efficacy, implementation, and feasibility of an online ALS-specific self-compassion training program to enhance self-compassion and improve quality of life.

Optimizing quality of life for people with ALS is a primary goal of ALS multidisciplinary care, Therefore, it is especially important to conduct research into interventions to address the psychological needs and well-being of people with ALS.

Recent studies have shown that mindfulness-based interventions promote improved quality of life for people with ALS. It is essential that such strategies as mindfulness-based interventions consider the specific needs of the ALS population and potential barriers to participation.

Very few studies have evaluated mindfulness-based interventions in the ALS population and no studies to date have evaluated self-compassion people with ALS. Self-compassion has been linked to increased emotional resilience, psychological well-being, and quality of life in multiple populations.

The intervention will include a 2-part workshop entitled 'Introduction to Mindful Self-Compassion for Persons Living with Amyotrophic Lateral Sclerosis.' Experience and feedback gained from the workshop will be incorporated into the format for an 8-week course in Cultivating Self-Compassion for persons living with ALS (Compassion pALS). Compassion pALS will be adapted from the Mindful Self-Compassion (MSC) Program to accommodate ALS clinical features and limit potential barriers to participation.

The primary outcome will be quality of life assessed with the Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSA-5). Participants will be assessed at the 2-part workshop (T0, baseline), start of the 8 week Compassion pALS course (T1 = pre-intervention); after completing the intervention (T2, post-intervention). Secondary outcomes will include Secondary outcome measures the Self-Compassion Scale Short Form (SCS-SF), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Amyotrophic Lateral Sclerosis Functional Rating Scale-R (ALSFRS-R), Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS within the last 18 months.
* 18 years or older
* Access to and the physical ability to use a computer with internet access with and/or without adaptive devices.
* Ability to communicate and understand tasks.
* A caregiver available to provide assistance.
* Ability to provide informed consent

Exclusion Criteria:

* More than one neuropsychological impairment such as (frontotemporal dementia) which may interfere with the study procedures.
* Severe medical condition that would reduce life expectancy to less than 6-12 months.
* No access to a computer with internet access
* Unsuitable for the study as determined by the Investigator.
The Norwegian "iCanCope With Pain" App

Background: Research evidence shows that prevalence of pain in adolescents is increasing and is therefore recognized as a growing health problem. Psychological interventions delivered remotely through the internet may reduce intensity or severity of pain among children and adolescents with chronic pain. The iCanCope with Pain program is an existing web- and mobile-based self-management program, which is developed as a multi-center study funded by the Canadian Institutes of Health Research and is based on identified health care needs and current best practices for pain self-management.

Objectives: The primary objectives are to describe the translation and cultural adaptation of the Norwegian version of the iCanCope with Pain mobile application and evaluate the effect in an upcoming randomized controlled trail with adolescents with chronic pain.

Study sample: 16-19-year-old adolescents with self-declared persistent and/or chronic pain. Recruited from high schools in Southern Norway.

Theoretical framework: Cognitive behavioral therapy (CBT) is explained by an integration of behavioral and cognitive theories of human behavior and psychopathology and is often the preferred treatment of choice for adolescents with different health disorders. The theoretical framework of CBT is integrated in the iCanCope with Pain app in terms of five components. The intervention group will receive the app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education. The control group will receive the app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.

Methods: Both qualitative and quantitative data will be gathered for evaluating the Norwegian version of the iCanCope with Pain app. Usability testing are assessed in both laboratory settings and in field using observation, interviews and questionnaires, which provide necessary information for an upcoming randomized controlled trail (RCT). Outcomes will in the RCT be measured at baseline (mid-April) and after an 8 weeks intervention (mid-June).

The study is part of a PhD project.


Eligibility Criteria:
Inclusion Criteria:

1. 16-19-year-old adolescents
2. with persistent and/or chronic pain, weekly suffered and lasting 3 months or more based on subjective reporting
3. be able to read and understand Norwegian
4. have their own smartphone.

Exclusion Criteria:

1. Adolescents with cognitive disability or diseases, because of the risk of not correctly understanding the iCanCope with Pain program via self-report, goal setting and/or library reading.
2. Adolescents that have participated in the usability testing of the Norwegian iCanCope with Pain app
3. Adolescents with diagnoses from a pathological or medical origin (e.g hematology/oncology patients) will also be excluded because the program was not specifically designed for these pain groups.