cyrilzakka/clinical-trials huggingface dataset:
Development of an Optimal Algorithm for the Management of Patients With Retinal Pigment Epithelium Detachment in Neovascular Age-related Macular Degeneration Using Artificial Intelligence

The study involves the development of an algorithm for predicting anatomical and functional results of therapy with angiogenesis inhibitors in patients with retinal pigment epithelium detachments in neovascular age-related macular degeneration, based on primary optical coherence tomography of the macular zone and clinical data.

Patients were divided into 3 groups according to the results of therapy: adhesion of detachment, lack of adherence to detachment, rupture of detachment. For these groups, OCT images of the macular zone with maximum detachment before therapy are selected. These images, along with other clinical parameters, are input to the algorithm. The result is one of the 3 treatment outcomes listed above. The methods that will be used to develop the algorithm include methods for processing and transforming data, deep machine learning, metrics for calculating the accuracy of algorithms.

Eligibility Criteria:
Inclusion criteria:

* Linear B - scan through the macular area with the longest detachment
* Other pathologies

Exclusion criteria:

* Images without detachment
* Images on which it is possible to diagnose the need for therapy only in the presence of additional factors not considered in the study.
Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis

Chronic rhinosinusitis (CRS) is defined according to the French society of otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding infectious damage to the sinus structures. The duration of the chronic impairment must be at least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and anosmia. It is a poorly understood pathology that affects a large part of the population. Its prevalence has increased significantly over the past 30 years. It affects about 11% of the population in Europe. It has become one of ten high-cost medical conditions for employers. Initially, it was accepted that CRS was due to chronic nasal infection. It is very debilitating for patients leading to a major consultation with practitioners (general practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses treatments allow an improvement in the symptomatology but no treatment allows a stable result over time, making long-term treatments essential.

Today, it is recognized that CRS has a multifactorial etiology including inflammatory processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have demonstrated a modification in the diversity and abundance of the microbiota in patients with CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes group. .

Few studies have studied the modification of the microbiota with the treatment of CRS today. However, local treatments based on nosewashing with physiological saline associated with local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology for patients suffering from CRS. This study will describe the modification of endonasal microbiota in différent conditions, such medical and surgical treatments, that usually improve patients symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* patients without chronic rhinosinusitis who undergo a nasal surgery
* patients with chronic rhinosinusitis who undergo a medical or surgical treatment

Exclusion Criteria:

* minor patients
* pregnant or lactating women
* patients undergoing antibiotic therapy in the month preceding the start of the study
* patients with immunosuppression
* ENT cancer or other cancer in progress
* primary ciliary dyskinesia or cystic fibrosis
* Systemic vasculitis (Wegener, Gougerot-Sjögren ...)
* Refusal to participate in the study
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

Chronic physical conditions are deﬁned as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inﬂammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage.

After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Identified diagnosis of one of nine chronic conditions (Heart Failure, PBC, Digestive Disease, Cirrhosis, Cancer survivor, Post-transplant, Women who have experienced a cardiac event, Chronic Kidney Disease), or another general category for physical chronic conditions not captured by these nine
* English language proficiency to complete questionnaires and read the educational material
* Access to the Internet and a computer or smart device at home

Exclusion Criteria:

* Receiving compassionate care
* Inability to provide informed written consent
* Severe psychiatric disorders (presence of uncontrolled schizophrenia, post-traumatic stress disorder (PTSD), and/or bipolar disorder unless approved to participate by their physician/psychologist; suicidality nearly every day)
* No access to the internet
Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active.

To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older, regardless of gender;
2. Life expectancy (estimated by the treating doctor) ≥ 6 months;
3. Histological diagnosis confirmed solid neoplasm;
4. Under active treatment
5. Previous two doses of Pfizer anti-SARS-CoV-2 vaccine received (will be considered also patients who have completed the vaccination cycle with other mRNA vaccines - Modern-)
6. All participants subscribed and signed the informed consent form first of enlistment
7. Patients with a positive history of a previous diagnosis are also enrolled laboratory confirmed COVID-19
8. ECOG 0-2

Exclusion Criteria:

1. Inability to sign informed consent
Albuterol HFA MDI in Pediatric Participants With Asthma

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.

Exclusion Criteria:

* Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.
Study of Oral Treatments for Hepatitis C

Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

In Phase 1 of this study, consented patients were randomized to 1 of the following 3 HCV DAA treatments: 1) Harvoni® (SOF/LDV) 2) Viekira Pak™ (PrOD) 3) Zepatier™ (EBR/GZR) with the optional addition of Ribavirin (RBV) and the length of treatment determined by the individual provider.

In Phase 2 of this study, consented patients were randomized to 1 of 2 FDA approved HCV treatments: Harvoni® or Zepatier™. Both Phase 1 and Phase 2 subjects had up to 1 tablespoon of blood drawn for HCV resistance testing and future biorepository testing (following appropriate additional consent). The results of testing determined whether a genotype 1a subject randomized to Zepatier would be provided 12 or 16 wks of Zepatier.

Following enrollment/randomization, participants completed patient reported outcome questionnaires (PROs) via electronic device or telephone. Following baseline/randomization, participants were asked to complete surveys again at Wk 4 of treatment, End of Treatment, 1 and 3 year post treatment. Patients continued standard medical care throughout study. Data was abstracted from test results and medical records throughout treatment and for up to 3 years post treatment.

Eligibility Criteria:
Inclusion Criteria:

* HCV Genotype 1a or 1b
* Adult patients (age 18 years or older)
* Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or Zepatier (EBR/GZR))

Exclusion Criteria:

* Inability to provide written informed consent
* HARVONI® is not a covered drug on benefits formulary
* Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)
* Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)
* Pregnant or breastfeeding women
Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction.

The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.


Eligibility Criteria:
Inclusion Criteria:

* Veterans
* Active Duty Service Members
* History of TBI (confirmed by TBI interview)
* Self-reported cognitive complaints (as indicated on the NSI)
* Able to communicate by telephone

Exclusion Criteria:

* Active suicidal intent
* History of bipolar disorder
* History of psychotic disorder
* Decisionally impaired
* Non-English speaking
Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography

Development of lympho-proliferation reticulation quantification using CT.

It is known that fibrosis of the subcutaneous soft tissue progresses over time in the lymph edema, and this change progresses to reticulation pattern.

Authors will develop a digital subtraction technique for the extraction of lympho-proliferative reticulation using the Housfield unit of non-reticulation structure (bones, muscles, tendons, vessels, nerves) in the axial image of CT.

Based on the medical records, authors will develop an early diagnosing tool by checking the correlation of the values derived the new technique with circumference, multi-frequency bio-electric impedance analysis, ISO sub-stage, and lymphascintigraphy, and qualify the cut-off values showing high sensitivity and specificity through the receiver operating characteristics (ROC) curve analyses.

Eligibility Criteria:
Inclusion Criteria:

* In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

Exclusion Criteria:

* Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda)
* Lymph edema simultaneously involving both limbs
* Patients who undertook implantation of electrical devices such as cardic pacemakers
Boosting Chinese Healthcare Service Providers' Utilization of Smoking Cessation Interventions by 'WeChat WeQuit' Program

In this single-blind, randomized trial, undertaken in China with 8-week interventions and follow-up to 52 weeks, about 2,200 providers will be randomly allocated to the intervention or control group.

Previous studies have been showed that providing behavioral and pharmacotherapy interventions for cigarette smoking patients was effective but rare among Chinese healthcare service providers. In order to minimize the huge gap between the shortage and demand for smoking cessation training program and smoking cessation service, this 'WeChat WeQuit' smoking cessation training program has been designed to assess whether it will increase Chinese healthcare service providers' utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation or not.

In this single-blind, randomized trial, about 2200 HSPs will be randomly selected (by randomizeR, https://CRAN.R-project.org/package=randomizeR) to 8-week intervention (behavioral and pharmacotherapy interventions for cigarette smoking patients to help them quit smoking) group or control group that only communicates without any standard smoking cessation practices related messages, and follow-up to 52 weeks. The trial will be carried out in into two phases, the first phase is the pilot study (n=200, 8-week intervention and follow-up to 16 weeks) and the second is the main study (n=2000, 8-week intervention and follow-up to 52 weeks). It is hypothesized that 'WeChat WeQuit' training program will improve Chinese HSPs' utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation and increase quit rate for smoking patients.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese-speaking healthcare service providers
2. Know how to use WeChat
3. Use WeChat on a daily basis
4. Willing to provide informed consent to participate in the study -

Exclusion Criteria:

1. Non-Chinese speakers
2. Not healthcare service providers
3. Do not use WeChat
4. Unwilling to participate in the study -
Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Be able to walk without an assistive aid (i.e., walker, cane)
* Have the capacity the provide written informed consent
* Have previously diagnosed peripheral arterial disease (by self-report)

Exclusion Criteria:

* Lower extremity injury or fracture within the last 6 months
* Have a leg prosthesis
* Prisoners
* Individuals clearly lacking the capacity to provide informed consent
* Vestibular impairment
Vestibular Socket Therapy With and Without Bone Grafting

Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result.

22 patients were randomly assigned to Group 1: Had received implants with the vestibular socket technique accompanied with bone grafting the jumping gap between the implant and the labial membrane.

Group 2: Had received implants with the vestibular socket technique, but without bone grafting the jumping gap.

Facial bone thickness and height were evaluated using CBCT scans at baseline before tooth extraction and after 6 and 13 months

Eligibility Criteria:
Inclusion Criteria:

* presence of a hopeless tooth or teeth in the esthetic zone (maxillary anterior area)
* No active infection
* Adequate bone palatally and apically
* Presence of contralateral tooth for the tooth being replaced

Exclusion Criteria:

* Hopeless tooth with acute infection
* heavy smokers (more than 10 cigarettes per day)
* pregnant and patients received recent chemotherapy/radiotherapy (during the previous year)
The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.


Eligibility Criteria:
Inclusion Criteria:

* diabetic, at least 18 years old, patient at a participating health clinic
Connected Health to Decrease Opioid Use in Patients With Chronic Pain

The objective of this pilot study to evaluate if behavioral incentives applied at the VA Medical Center can appreciably increase participation in activities that promote mobility, and subsequently reduce pain severity and opioid use.

Chronic pain is a highly prevalent and costly condition in the US. An estimated 88.5 million adults suffer from daily pain, resulting in estimated cost of $500- 635 biJlion due to lost productivity, and $261-300 billion in health care expenditures. To manage their chronic pain, 5 to 8 million Americans take an opioid medication daily. Yet , the risks associated with ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic effects.

Opioids are not more effective in the treatment of chronic pain compared with non-opioid approaches. Current guidelines have adapted to the evidence, recommending opioid-sparing approaches for treating patients with chronic pain, and tapering for those on higher doses to safer levels of use. Tapering opioids, however, requires replacing them with effective non-opioid strategies. Improving mobility has been shown to improve pain and decrease medication use among patients chronically prescribed opiates. Concurrently, financial incentives and the use of behavioral incentives have been shown to promote mobility.

Appreciating the gains in health outcomes that can be made with "connected health" approaches, we propose a novel pilot study designed to evaluate if technology enabled care (TEC) strategies and financial incentives can improve patient mobility in our chronic pain population, reduce pain and decrease opioid use . Our primary aim is to determine if chronic pain patients who receive TEC-enhanced treatment with financial incentives demonstrate increased participation in activities that promote mobility (physical therapy, yoga, tai chi) in comparison to patients receiving usual care. Secondary outcomes will include whether increased activity participation also reduces pain severity and opioid use, and improves function and increases the number of daily steps taken. The results of this pilot will enable us to determine what strategies are effective at increasing mobility and if these gains translate into reduced pain and decreased opioid use.

Eligibility Criteria:
Inclusion Criteria:

* Chronic non-malignant pain
* High dose opioid therapy
* Possession of activated cell phone with text messaging capabilities
* Willingness to comply with study requirements

Exclusion Criteria:

* Pain of malignant origin
* Sensory impairments precluding use of text messaging and activity tracker
* Physical disability precluding improvements in physical activity
Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

* Emergency cases
* Myocardial infarction up to 7 days prior to enrollment
* Ejection fraction less than 30%
* Inability to give informed consent
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa

This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up Period.


Eligibility Criteria:
Inclusion Criteria:

* male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa

Exclusion Criteria:

* History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
* Infected with hepatitis B or hepatitis C viruses.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)