cyrilzakka/clinical-trials huggingface dataset:
Telemedicine-based Model of Care for the Management of Hepatitis C Infected Patients

To achieve World Health Organization 2030 goals of hepatitis C elimination it is mandatory to document after treatment sustained virological response (SVR). Currently, patients after completing treatment do not show up for SVR assessment. The main objective of this study is to evaluate the effectiveness of a telemedicine-based model of care associated with dried blood spot testing at home to assess hepatitis C sustained virological response after treatment compared to the traditional model of care.

This is a prospective, randomized study in which hepatitis C (VHC) infected patients will be randomized to two strategies for HCV care.

All HCV infected patients will be evaluated in a first face-to-face consultation with the hepatologist for fibrosis evaluation and treatment prescription the same day. Patients will be invited to participate if they are: 1) 18 years or older 2) have contact telephone number 3) sing the informed consent 4) have not advanced fibrosis (F3) or cirrhosis (F4) 5) are not under surveillance by another specialist or drug addiction centre.

Participants will be randomized into two strategies to assess sustained virological response (SVR) during follow-up:

1. The traditional model of care: one appointment for venipuncture for RNA testing to assess SVR (undetectable RNA 12 weeks after treatment cessation), and an appointment with the specialist for result communication.
2. Telemedicine-based model of care: The patient will be provided with a home kit to perform the dried blood spot (DBS) testing for HCV RNA at 12 weeks (SVR), and an appointment for teleconsultation and communicate the results.

Demographic, clinical and laboratory data will be collected to evaluate the characteristics of included patients and to study predictive factors of adherence.

A satisfaction questionnaire will be conducted to compare patients´ satisfaction with both health care models.

The hypothesis of the study is that the adherence and SVR determination record will increase using the telemedicine-based model of care.

For the present study, a 20% improvement in the adherence (SVR record) was hypothesized in the group of patients randomized to the telemedicine-based model of care compared to the traditional model of care. Taking into account power of 80%, alpha error of 5% and losses of 10% will require 68 patients per group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* have contact telephone number
* sing the informed consent

Exclusion Criteria:

* have advanced fibrosis (F3) or cirrhosis (F4)
* are under surveillance by another specialist or drug addition center.
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Subfoveal CNV secondary to AMD.
* Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
* ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)

Exclusion Criteria:

* No prior treatment with the following in the study eye:

  * Subfoveal thermal laser therapy;
  * Submacular surgery or other surgical intervention for the treatment of AMD;
  * Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1 (Visit 2);
  * PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
  * Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
  * Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
  * Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
  * Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
* History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
* Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet \[YAG\] capsulotomy).
* Significant subfoveal atrophy or scarring.
* Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
Navigation and Free Recall in Chronically Implanted Humans

This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.


Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* 18 years of age or older
* Diagnosis of epilepsy
* Implanted RNS® device and receiving therapeutic stimulation for epilepsy.
* Capable of completing experimental tasks in the judgment of the Principal Investigator

Exclusion Criteria:

* RNS® Neurostimulator implanted within 3 months of experimental tasks.
Two-site Intradermal Influenza Vaccination in Elderly

One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.

The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. Check for HA Antibody

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female volunteer aged at least 60 years old
* willing to participate in this study

Exclusion Criteria:

* previous influenza vaccination within 6 months
* systemic ypersensitivity to egg or chicken proteins or any of the vaccine components
* history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents.
* ongoing acute febrile illness (oral temperature, ≥37.5 c )
* congenital or acquired immunodeficiency
* treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months
* long-term treatment with systemic corticosteroids
* receipt of blood or blood-derived products in the previous 3 months
* history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The investigators will assess the viscoelastic properties of the pharyngeal airway and its role in PEN.

In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

The investigators will test how the viscoelastic properties of the airway influence PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients using a thin endoscope and will induce central apneas during sleep. Pharyngeal cross-sectional area will be recorded during incremental changes in pharyngeal pressure during central apneas.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects or patients with OSA

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline hydrochloride
* For women: Pregnancy
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy

The purpose of this observational study is to evaluate the safety and performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the ascending colon. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility Criteria:
Inclusion Criteria:

* Age at study entry is at least 18 years.
* Patient must sign and date the informed consent form prior to the index-procedure.
* Patient has a tumor in the ascending colon.

Exclusion Criteria:

* Patient is pregnant.
* Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease).
* Patient has symptomatic diverticulitis.
* Patient has bowel trauma.
* Patient has peritoneal carcinomatosis.
* Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
Study to Evaluate the Safety and Efficacy of HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens

Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable contact lens (hexafocon b) test when worn on a daily wear basis in the correction of myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.

Subjects who meet all eligible requirements for entry into the study will be instructed to insert the Hi-Brite Large Diameter Rigid Gas Permeable contact lens in daily wear basis for clinical evaluation purposes.

Treatment period: 6 months

Eligibility Criteria:
Inclusion criteria:

* Ametropic or irregular cornea subjects who need to wear spectacle lens or contact lens in their daily life.
* Is of age at least 20 years old and no older than 65 years old capacity to volunteer.
* Has read and signed the Informed Consent Form or waiver. (4) Has myopia or hyperopia -20.00D～+20.00D, astigmatism -0.25\~-4.00D, or presbyopia +1.00D～+3.50D.
* Irregular cornea subjects include keratoconus, high astigmatism (\>-4.00D) or post-refractive surgery patients.
* No active ocular disease, infection or any disorder of eyelids and conjunctiva.
* Has reasonable expectation of improvement in visual acuity with the test lenses.
* Is willing and able to follow subject instructions and meet the protocol -specified visit schedule. (If subjects missed any visit, they must be discontinued from the study.) (9) Agrees to wear the test lenses at a daily wear basis. (10) Willing to adapt wearing GP contact lens.

Exclusion criteria:

The subject is ineligible for entry into the study if the subject

* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will, in the Investigator's opinion. Affect ocular physiology or lens performance within one (1) week before entering this study.
* Has an active ocular disease or has ever used systemic steroid or any other medicine that may affect significant on vision or healing.
* Has any Grade 2 or greater finding listed in the Quantification of Slit Lamp Observations Form. Subjects with corneal infiltrates, however, of ANY GRADE, are not eligible.
* Has any "Present" finding listed in the Quantification of Slit Lamp Observations that, in the Investigators' judgment, interferes with contact lens wear.
* Has any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
* Severe dry eye (Schirmer Test\<5mm/5min)
* Corneal keratitis
* Is aphakic
* Had undertaken the following surgery: Retina, Glaucoma, Cataract surgery.
* Is amblyopic, BSCVA can't achieve (include) 20/40(0.5) when wear trial lenses.
* Allergy to contact lens solution.
* ls participating in any other clinical research study.
* Pregnancy or Breast-feeding.
Shadows Edge Mobile Developing Resilience in Adolescent and Young Adult Cancer Survivors

This study evaluates the efficacy of an interactive mobile game, Shadow's Edge, on enhancing resilience, promoting identity development, and decreasing somatic symptoms among adolescent and young adult survivors of cancer.

Approximately 80% of youth treated for cancer during childhood will survive long-term; however, the majority of adolescent and young adult cancer survivors (AYACS) report at least one chronic health condition. These medical and cognitive-psychological late effects can disrupt or interfere with continual adaptation to post-treatment life, thereby negatively impacting identity formation and inhibiting AYACS from seeking fulfilling academic, career, and social relationship experiences. The Shadow's Edge mobile app was created for adolescent and young adults with complex medical conditions as an enjoyable and engaging digital, first-person perspective game that uses principles of narrative and creative arts therapies to encourage youth to reflect on, and create brief, developmentally-relevant narratives about, their life experiences. In this trial, investigators will conduct a two-arm, waitlist randomized controlled trial to evaluate the effectiveness of the Shadow's Edge game in promoting resilience and identify formation among AYACS. Participants will be 175 AYACS who receive clinical care in a large, pediatric cancer survivorship program. Data will be collected from medical records, mobile game play statistics, participant narratives and art created in the game platform, and participant responses to standardized assessments. Information gathered through this study will be used to establish initial game efficacy and to lead to Shadow's Edge game enhancements that will further improve acceptability and effectiveness of the game. The ultimate goal of this project is to provide a freely accessible, enjoyable and engaging self-led game that may bolster resilience resources, improve quality of life, and promote identity formation among adolescents and young adults with complex medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent/young adults 13-24 years of age
* Adolescent/young adult English-speaking at a second grade level
* Parent/guardian English- or Spanish-speaking at a second grade level (for participants younger than 18 years of age)
* Patients with history of hematological malignancies (e.g., acute lymphoblastic leukemia) at maintenance phase of treatment or beyond or solid tumor patients (e.g., osteosarcoma) who have completed active treatment or cancer survivors with any form of malignancy history (excluding brain tumors) and are at least 2 years post-diagnosis of the malignancy
* Consistent access to a mobile phone and/or internet service

Exclusion Criteria:

* Brain tumor history
* History of moderate to severe neurodevelopmental disorder (e.g., autism spectrum disorder)
Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM

Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. The primary aim of this study was to determine prognostic factors for the survival outcomes associated with LLR for CRLM.

LLR was defined as pure LLR, including conversions to OLR. In case of missing data, additional details were retrieved from the individual patient file. Data on patient demographics, timing of diagnosis, neoadjuvant chemotherapy (NAC), tumor characteristics (both primary tumor and CRLM), histopathology, molecular characteristics, operative technique (including classification into anatomically major/technically major/minor LR), intra- and postoperative course, adjuvant chemotherapy (AC) as well as oncological outcomes (OS and DFS) were gathered and analyzed. Postoperative complications were graded according to the Clavien-Dindo classification. Complications were classified as major in case of Clavien-Dindo ≥ 3A.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with colorectal liver metastases
* Patients who received laparoscopic liver resection for colorectal liver metastases
* Patients who received the laparoscopic liver resection between September 2011 and mid-March 2020

Exclusion Criteria:

* Patients with contraindication for laparoscopic liver resection
* Refusal to participate in the study
A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement

The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility Criteria:
Inclusion Criteria:

Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment

Exclusion Criteria:

i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete
Ruxolitinib for Polycythemia Vera in Patients Resistant to or Intolerant of Hydroxyurea.

This was an analytical and descriptive, non-interventional, retrospective cohort study of PV patients aged ≥ 18 years in the US using a secondary data source, Optum EHR database.

The Optum EHR database was current up to 30-Jun-2020.

Identification period: From 01-Apr-2007 to 30-Jun-2019

Study period: From 01-Jan-2007 to 30-Jun-2020

Index date:

First evidence of resistance to or intolerance of HU treatment in patients with PV according to modified European Leukemia Net (ELN) criteria and defined as:

1. HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) Or
2. Platelet count \> 400 x 109/L and presence of palpable splenomegaly (palpable spleen up to 3 months after platelet count)

Pre-index period:

Patients had a minimum of 3 months pre-index data available. Pre-index data availability was determined using the reported 'first month active' field.

Post-index period:

There was no minimum post-index period required. Each patient had a 'first month active' and 'last month active' reported within the database. As the 'last month active' was based on any activity in the database, including encounters such as letters and emails which occurred several months after the 'death_date' of the patient, using the 'last month active' can overestimate the follow-up for a given patient. For this reason, the end of follow-up for each patient was defined as the date of the last activity within the diagnosis, observations, prescriptions, laboratories, procedures tables or discharge date from the last visit within the visit table (whichever of these activities occurs latest). This underestimated the follow-up for some patients where they were not actively using healthcare resources.

Eligibility Criteria:
Inclusion Criteria:

Included patients:

* With at least one International Classification of Diseases, 9th Revision, Clinical Modification/International Classification of Diseases,10th Revision, Clinical Modification code for PV in the identification period (01-Apr-2007 until 30-Jun-2019) that had non-missing sex and year of birth data and who were treated as part of the Integrated Delivery Network
* That were ≥ 18 years old at PV diagnosis
* With ≥ 2 prescriptions of HU
* That were classified as resistant to or intolerant of HU after a minimum of 3 months HU treatment (index date), defined as:

HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) or Platelet count \> 400 x 109/L and presence of palpable splenomegaly (palpable spleen up to 3 months after platelet count).

To identify patients in the RUX group:

- With ≥ 2 prescriptions of RUX in the post-index period.

Exclusion Criteria:

Excluded patients:

- With a MF or AML diagnosis prior to a PV diagnosis.
A Transformational Teaching Intervention: Adolescents in Motion (AIM) Trial

The purpose of this Randomized Controlled Tria (RCT) is to evaluate the effects of a transformational teaching intervention in comparison to 'standard educational practices' within school-based physical education classes (within three Canadian provinces; British Columbia, Ontario and Nova Scotia) across 5 months.

Physical inactivity among adolescents has been linked to a vast array of physical and mental health problems. One potential vehicle to foster adolescent involvement in physical activity relates to physical education in schools.

A potentially important framework, that has recently been applied to educational and health promotion contexts, relates to transformational leadership theory. Transformational leadership involves the demonstration of behaviors that empower and inspire others to achieve higher levels of functioning, and has been consistently found to be associated with greater motivation, self-efficacy, well-being, and performance in those being led. From an applied perspective, a growing body of evidence also suggests that transformational behaviors can be developed in leaders through short-term interventions (e.g., one-day workshops), which subsequently result in positive changes in followers' attitudinal and behavioral responses.

With this in mind, the overall goal of this Randomized Controlled Trial (RCT) is to test the efficacy of a theory-driven evidence-based transformational teaching intervention for use within school-based physical activity settings. In this 5-month trial, physical education teachers from 36 schools from three provinces across Canada (British Columbia, Ontario and Nova Scotia) will be provided with (through a one day work shop and follow-up support program) the resources they need to implement transformational teaching behaviours in their day-to-day teaching practices. The primary hypothesis for this RCT is that students taught by teachers in the intervention condition will display greater adoption and maintenance of moderate-to-vigorous physical activity (MVPA) behaviors outside of school hours in comparison to control students, after controlling for baseline levels. A process evaluation will also be conducted with teachers to evaluate the procedures embedded within the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Grade 9 (aged 14 (+/- 1 year))

Exclusion Criteria:

* Do not have basic working knowledge of English