cyrilzakka/clinical-trials huggingface dataset:
Treatment -Resistant Neovascular Age-Related Macular Degeneration

The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective. To address this issue, investigators propose a clinical trial in which patients with late stage disease, poor vision and who have failed treatment by conventional means will receive rituximab by direct injection into the affected eye and will be followed for improvement in the structure of their retina. Age Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with routine care involving injections in the eye to improve and to prevent worsening of vision. However, some patients do not respond to the medications that we currently have and as such an alternative medication is needed. One potential medication is rituximab, which has been injected into the eye for primary eye cancer, and has been tolerated well and led to patient improvement. Investigators will obtain baseline eye tests then plan on injecting this medication in to the eye of our patients with late stage AMD, by first placing numbing drops into the eye, then injecting the medication directly into the eye using sterile techniques. Investigators will then follow the patient and repeat eye tests to monitor for improvements.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 40
* Patients who have a diagnosis of wet age-related macular degeneration
* Patients who have a central visual acuity ,20/200
* Patients who have been deemed "treatment-resistant" at the discreation of the treating physician

Exclusion Criteria:

* Patients with treatment failure for neovascular AMD
* Patients who have tried multiple anti-vegf medication without anatomical or objective improvement
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System

This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.

This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT.

The WHT will consist of:

* AppleWatch and iPhone
* Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph)
* Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training

Subjects will use the WHT 20 hours per day, every day for a period of 12 months.

Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.

Outcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the MPP
* Completion of the 3-day MPP training
* Ability to understand and complete the informed consent form prior to the initiation of any study procedures
* Adequate motor skills needed to utilize WHT
* Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process
* Ability to understand spoken and written English

Exclusion Criteria:

* Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease
* Hospitalization \>30 days during the 12 months prior to Index Date
* Nursing home or hospice care during the 12 months prior to Index Date
* Presence of an EHR Diagnosis description "OPT-OUT CENTER RESEARCH" which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research
* Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence
Virtual Reality For Shoulder Dysfunction Post Neck Dissection Surgeries

The goal of this clinical trial study: is to determine the effect of Virtual reality on pain and function for shoulder dysfunction post neck dissection surgeries. The main question is: Can Virtual reality technique affect the dysfunction of shoulder joint post neck dissection surgeries? Participants will receive the treatment for 2 times per week for 2 months. Assessment will be done before and after treatment.

1. Subjects: sixty eight patients from both genders, suffering from shoulder dysfunction post neck dissection surgery, their ages ranges from 40-60 years.
2. Design of the study:

In this study the patients will be randomly assigned into two equal groups (34 patients for each group):

1. Group A (Study group):

   This group includes 34 patients suffering from pain and loss of shoulder flexion, abduction and external rotation ROM, patients will be treated with active ROM exercise, stretching exercise for shoulder extensors, adductors and internal rotators muscles and strengthening exercise for shoulder muscles, and with fully immersive Head-Mounted Display virtual reality (Oculus Quest virtual reality (VR) headset with hand controller) for 30 min. 2 times per week for 2 months.
2. Group B (Control group):

This group includes 34 patients suffering from pain and loss of shoulder flexion, abduction and external rotation ROM, patients will be treated with traditional physical therapy: active ROM exercise, stretching exercise for shoulder extensors, adductors and internal rotators muscles and strengthening exercise for shoulder muscles, 2 times per week for 2 months.

- Equipments:

Measuring tools:

* Measuring and assessment of pain by: Smart phone version of visual analogue scale (VAS).
* Measuring range of motion (ROM) by: Mobile application Goniometer.
* Measuring upper limb function by: The Arabic Version of Modified QuickDASH-9 Questionnaire.

Therapeutic equipment:

* Oculus Quest virtual reality (VR) headset with hand controller.

Each patient will play 3 games 10 min. for each with 1 min. rest in between. First game is Dance loop gameplay, there are throwing balls moving toward the patient in all directions, and the patient tries to catch all of them by the arm controllers, so it promote the movement of the arm toward flexion, abduction and external rotation directions.

Second game is Tennis ball, which promote the arm to move toward flexion, abduction and external rotation directions.

Third game is Boxing, which promote the arm to move toward flexion and abduction directions.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 40-60 years
* Both genders will participate in the study
* All patients have undergone neck dissection surgery
* All patients enrolled to the study will have their informed consent

Exclusion Criteria:

* Age more than 60 years or less than 40 years
* Subjects who have hearing problems
* Subjects who have visual problems
* Patients have acute viral diseases, acute tuberculosis, mental disorders or those with pace makers
The Hypotensive Effect of Metformin in Hypertensive Patients.

The proposed study is to evaluate the possible effect of metformin on arterial pressure by 24h-ambulatory blood pressure monitory (24h-ABPM).

The primary outcome was the difference in mean 24-hour blood pressure variation between the two groups after the intervention. The difference in mean of blood pressure during daytime and nighttime in 24h ambulatory blood pressure monitory, as well as the office BP and laboratory differences were considered secondary outcomes.

This randomized, double-blind parallel study was conducted in the Hypertension Clinic of the Department of Cardiology, Hospital de Clínicas de Porto Alegre (Porto Alegre, Brazil).

We selected hypertensive individuals (controlled or not) without diabetes aged 18-70 years.

Exclusion criteria: metformin intolerance, creatinine \> 1,5 mg/dl Risks: adverse effects related to metformin use, mainly diarrhea and nausea Benefits: possible lower effect on arterial pressure Statistical analysis: sample size was calculated on the basis of a standard deviation of 8 mm Hg and effect size of 5 mm Hg in 24-h systolic ABPM and a two-sided significance level of 5%. A sample size of 42 patients per group was estimated to provide a power of 80% to reject the null hypothesis. Considering possible 10% of losses, the final calculated sample was 92 patients.

The baseline comparison between groups was performed using the Student t test for continuous variables and x2 for categorical variables. In each group, the change in BP by ABPM -24 h, daytime and nighttime, and laboratory tests was calculated by subtracting baseline values measured after the intervention period. The difference between groups was calculated by subtracting the variation observed between them (δ-values). The differences in BP variation and laboratory tests were analyzed by analysis of variance for repeated measures (MANOVA). For differences in pressure variation adjustment was considered for the baseline BP values (analysis of covariance). All tests were two-tailed and significance level was 5%. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 13.0.

Eligibility Criteria:
Inclusion Criteria:

* hypertensive patients,
* aged 18-75 years

Exclusion Criteria:

* diabetes
* metformin intolerance
* creatinine level above 1.5 mg/dL
Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients with Lung Cancer

The study aims to evaluate the Plasma-SeqSensei™ Solid Cancer IVD Kit NGS diagnostic test (Sysmex) before its introduction into routine diagnostics. This is a test for research of EGFR mutations in cfDNA that needs to be evaluated in a patient population with lung adenocarcinoma already characterized for EGFR mutations by a molecular test of reference. The proposed study does not present any risk to participants.


Eligibility Criteria:
Inclusion Criteria:

* Males or Females aged at least 18 years;
* Patients with advanced or metastatic non-small cell lung cancer at diagnosis or progression who have previously had the cobas® EGFR Mutation Test v2 (Roche) performed on a liquid biopsy with a valid result (positive or negative);
* Availability of 6 mL of plasma.

Exclusion Criteria:

* Plasma not available in sufficient quantities to perform both tests;
* Cobas test with invalid result.
Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
* Age 18 to 80.

Exclusion Criteria:

* Subjects lacking capacity to consent
* Subjects with unreliable ultrasound or MRE measurements.
* Pregnant women.
Gastrectomy Plus Prophylactic Cholecystectomy in Gastric Cancer Surgery

The patients will be divided into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group will be submitted to standard gastric surgery only.

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing standard gastric surgery for cancer

Exclusion Criteria:

* gallbladder disease
Surfactant Administration During Spontaneous Breathing

Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.

In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing. In the control group infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. The procedures were compared for short-term efficacy and possible complications.

Eligibility Criteria:
Inclusion Criteria:

* All infants who presented with clinical anl laboratory signs of RDS

Exclusion Criteria:

* infants who required intubation or PPV right after birth
Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting

Performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus. Recovery has been difficult to measure for people with substance use disorders, and is more challenging in the context of opioid use disorders (OUD) and treatment medications. This study will examine a recovery patient-reported outcome measure to determine if patients and clinicians find it useful and acceptable in the clinical context, and if it leads to improved outcomes.

The pilot clinical trial will test the newly developed Recovery Patient-Reported Outcome Measure ("Recovery PROM") and approach with patients and clinicians in an office-based opioid medication treatment program (known as office-based opioid treatment (OBOT), medication-assisted treatment (MAT) or medications for OUD (MOUD)), in the specific context of buprenorphine treatment.

Aims

This is a pilot study to assess the feasibility of implementing the Recovery PROM into the workflow of a clinical setting, assess its initial effectiveness, and evaluate its value to patients and clinicians. The aims are as follows:

1. Work with a clinical partner to assess and refine the draft Recovery PROM, and examine feasibility and implementation (e.g., workflow, data transfer issues) related to its use in a clinical setting.
2. Determine initial effectiveness of the Recovery PROM for improving patient outcomes (self-efficacy, health-related quality of life, patient-provider relationship, social determinants of health, substance use) and facilitating self-directed care and patient-centered shared decision-making.
3. Evaluate and update (if needed) the Recovery PROM in terms of recovery while on OUD medication treatment, patient characteristics, and clinical workflow.

Hypotheses Although this pilot study is primarily for information gathering, and ultimately refinement of the Recovery PROM and approach, the study has two broad hypotheses.

H1. Patients and clinicians will find the Recovery PROM to be a useful tool for patient recovery.

H2. Patient self-efficacy, shared decision-making, patient-provider relationship, and health-related quality of life will improve and substance use will decrease with the use of the Recovery PROM.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Taking buprenorphine for OUD treatment, in current episode of care at clinical partner site, for at least 6 weeks but less than 3 years.
* Able and willing to provide informed consent.
* Able to read English, to provide informed consent and complete study instruments.
* Able to use a smart phone to complete study instruments \[phones with data plan will be provided for those without\].

Exclusion Criteria:

• Patients who do not meet inclusion criteria.
A Randomized Pilot Trial Investigating a Novel Mobile Application for Practicing Exercises from ACT

Mindfulness-related skills are associated with positive mental health outcomes and can be effectively taught through mobile apps. However, further research is needed to determine how best to support skill acquisition through the delivery of mindfulness exercises via smartphone apps. ACTaide is a novel mobile app designed to support home practice of mindfulness-related skills through exercises presented as stepwise annotated image sequences. The primary objective of this pilot and feasibility trial is to evaluate the feasibility of a prototype version of ACTaide. This two-arm parallel single-blinded (blinded participants) pilot trial will be conducted virtually with distressed Canadian adults. Participants (N = 60) will be recruited through the online platform Prolific. The intervention group will receive an Acceptance and Commitment Therapy (ACT) psychoeducational workshop and access to ACTaide for two weeks to support home practice of a mindfulness exercise from ACT: dropping anchor. The control group will receive the same psychoeducational workshop and access to a reminders-only mobile app to support their practice of the dropping anchor exercise. The main outcome measures will assess intervention feasibility, including adherence to the intervention, acceptability of the app, and retention rates. In addition, measures related to mindfulness-related skills and psychological distress will be collected. Prespecified progression criteria will be used to determine whether and how to proceed to a future trial designed to investigate the efficacy of ACTaide.


Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years old;
2. be fluent in English;
3. own a smartphone with a data plan;
4. report at least moderate psychological distress as measured by the 21-item Depression Anxiety Stress Scales (DASS-21; i.e., overall score of at least 43); and
5. report at least moderate motivation to learn a new psychotherapeutic exercise for navigating psychological distress (i.e., at least 6 out of 10).

Exclusion Criteria:

Due to the limited psychotherapeutic scope of the intervention, individuals were ineligible if they self-reported extremely severe psychological distress (i.e., an overall score of 82 or higher on the DASS-21) or a diagnosis of a severe mental illness (i.e., bipolar disorder, psychosis, schizophrenia, borderline personality disorder).
Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study

This observational study aims to establish a prospective nationwide cohort of venous thromboembolism. The main questions it mains to answer are:

* Which patients with venous thromboembolism should accept long-term anticoagulation therapy?
* Mechanism and prognosis of venous thromboembolism. Participants will receive yearly follow-ups through telephone, hospitalization, or outpatient care.

Venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, is a class of diseases with strong occultation, high mortality, and a high recurrence rate.Long-term anticoagulant therapy can reduce the risk of recurrence. Although long-term anticoagulation can reduce the risk of VTE recurrence, it will also increase the risk of major bleeding and the economic burden of long-term anticoagulation. Therefore, stratifying the risk of VTE recurrence and preventing recurrence with accurate anticoagulant therapy is an urgent problem in VTE management.

Investigators will establish a prospective nationwide cohort of VTE, develop a unified follow-up plan, and conduct whole-life follow-up management for patients. Demographic, clinical, imaging, laboratory indicators, gene, and other information of patients will be collected. A VTE patient database with complete clinical phenotype data, genetic data, and biological samples will be established.

Investigators will construct a VTE recurrence risk prediction model based on Chinese data to provide clinical decision suggestions for clinicians to select appropriate individualized anticoagulant duration according to risk stratification. VTE patients with low recurrence risk could avoid long-term anticoagulant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 18.
* Patients diagnosed with venous thromboembolism.

Exclusion Criteria:

* Pregnant or lactating women
* Patients with active tumor
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.

PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients. The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices
* Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit
* Patients who are in sinus rhythm at the time of implant
* Patients who remain in the clinical care of the enrolling physician in approved centers
* Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy

Exclusion Criteria:

* Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing \[DDD or DDDR\]) and respective lower rate limits
* Patients with permanent atrial fibrillation or atrial flutter
* Patients who are in complete heart block
* Patients who have previously had a pacemaker, ICD, or CRT device
* Patients whose life expectancy is less than 12 months due to other medical conditions
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have other cardiac surgeries or procedures planned but not yet performed
* Patients who currently have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study.
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
* Patients who are or become pregnant