cyrilzakka/clinical-trials huggingface dataset:
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

This randomized, partially masked, controlled, Phase 3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 gene therapy relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of ABBV-RGX-314 relative to aflibercept. Approximately 660 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years and ≤ 89 years
2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF
4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
5. Willing and able to provide written, signed informed consent for this study
6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to any causes other than AMD
2. Subfoveal fibrosis or atrophy in the study eye
3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
5. Advanced glaucoma or history of secondary glaucoma in the study eye
6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
7. History of intraocular surgery in the study eye within 12 weeks prior to randomization
8. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
9. Prior treatment with gene therapy.
Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality

To construct and evaluate an immersive 3D simulation to familiarize patients with the pre-operative experience, and investigate whether A) immersive 3D virtual reality video can reduce pre-operative anxiety, and B) how this approach compares to current practice of viewing traditional educational videos.

The prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical populations. Physiologically, this may result in higher cortisol levels, which may slow down the healing and recovery process. A multitude of perioperative clinical trials have revealed that pre-operative anxiety is associated with reduced short-term postoperative recovery, increased pain scores, nause \& vomiting, sleep disturbances, surgical wound infections, increased length of stay, and cardiac complications. It has also been linked with worse functional outcomes and quality of life up to one-year after surgery.

Literature looking at factors associated with preoperative anxiety outline a general theme of the fear of the unknown that is distressing. Specifically, the most distressing events seem to be waiting to be collected for surgery, waiting outside the operating room (OR), being transferred to the OR bed and having monitors and oxygen mask applied. These moments prior to surgery are when patients are most likely to continuously ruminate over 'what comes next' and the fact of not knowing - leading to anxiety. One survey of 161 patients presenting for elective surgery inquired about factors that led to being calm prior to their procedure and found that being well informed of the pre-operative process was a critical aspect of anxiety relief. Approaches such as implementation of the pre-anesthetic clinic (PAC) and the use of videos of what to expect leading up to surgery have been implemented to address this issue but have been costly or have had mixed effects.

Virtual reality (VR) technology presents a new educational opportunity for patients in an effort to reduce pre-operative anxiety. Through immersive 3D simulation, patients can experience the journey of being prepped for surgery and transferred to the OR. A patient can learn about their pre-operative experience in a more engaging manner as opposed to passively reading, watching video or being verbally taught about it by the healthcare provider. A patient is educated by having the perception of being physically present in the pre-operative experience days or weeks prior to their OR date.

Eligibility Criteria:
Inclusion Criteria:

* All participants less than 80 years old presenting to the pre-assessment clinic at Sunnybrook Health Sciences Centre
* Planned surgical procedure is 7-14 days after pre-assessment clinic visit

Exclusion Criteria:

* Inability to provide informed consent
* Unable to complete study assessments (ie: visually impaired)
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
* Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

  * CDAI score greater than 220
  * Stool samples not required
  * C-reactive protein levels are not an exclusion criterion

Exclusion Criteria:

* Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

  * Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery

Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.

Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing thoracic surgery including resection of lung parenchyma.
* To have given signed consent to enter in the study.

Exclusion Criteria:

Weaning in the first 4h after the intervention end.

* Suspected bronchopleural fistula at the admission to the surgical ICU.
* Patients with facial problems or a history of intolerance to CPAP masks.
* Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae \<2cm or the existence of a pulmonary bulla\> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.
* Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.
* Immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)
Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates

The overall goal of this project is to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in this setting.

Parents of hospitalized neonates experience high stress levels and feelings of helplessness in the neonatal ward and often concern for the health and well being of their fragile infant. Parental stress associated with admission to the neonatal ward of infants has been extensively studied in developed countries for many years, but rarely have epidemiological and intervention studies been reported in Chinese parents of hospitalized neonates. The aim of the present study was to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in a Chinese hospital.

Eligibility Criteria:
Inclusion Criteria:

* Speaks and reads Chinese
* No severe handicapping conditions or mental diseases
* Informed consent, no medical dispute
* Infants born within 28 days to be cared in the neonatal ward for at least 24 hours

Exclusion Criteria:

* Significant mental health history
* Newborns died within a week after hospitalization
Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device

Aim: To determine the impact of wireless transmission of prehospital ECGs to a hand-held computer on time to treatment and myocardial salvage in acute MI patients.

Background: The TIME-1 investigators documented a 27% (109 to 80 minutes) reduction of time from EMT arrival at the scene to successful primary PCI implementing pre-hospital ECG transmission to the ED. ECG transmission directly to a physician's cellular phone/PDA through a wireless modem has only recently become an option. The recently completed TIME-NorthEast (NE) study tested the Welch Allyn version of this system and the results show a reduction in time to reperfusion for acute MI patients by 66 minutes (116 to 50).

Methods: This study will involve approximately 20 sites around the country. The study will be divided into two phases: a consecutive control data collection phase (Phase I) and an intervention with concurrent control phase (Phase II). Phase II will begin after installation of Welch Allyn ECG transmission equipment. The primary end-point will be time to reperfusion and secondary end-points will include myocardial salvage, aborted infarction and hospital mortality. ECG measurements will be made at a central ECG core lab by a blinded investigator.

Data Analysis: Patient characteristics for the three periods were compared with the chi-square statistic for categorical variables and one-way analysis of variance for age. The Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and study periods as well as in the Group 1 post-study period. Comparisons were performed separately for EMS and self-transport groups.


Eligibility Criteria:
Inclusion Criteria:

All patients with a diagnosis of acute STEMI defined as 1 mm ST segment elevation in two spatially contiguous leads were included. There were two major subgroups: emergency medical services (EMS) and self-transport patients. Self-transport patients, who did not have PH-ECG transmission, served as a comparison group.

Exclusion Criteria:

* Less than age 18
* No intent to undergo reperfusion therapy (PCI or thrombolytics)
Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)

The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase of physical activity are recommended as an effective approach for the prevention and treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In the present study we aim to compare the effect of intensive and conventional exercise interventions on NAFLD.


Eligibility Criteria:
1. Subjects with NAFLD determined by MRS ;
2. Age 40-65 years old;
3. Waist circumference\> 90cm for men and \> 85cm for women.
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers

This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.

This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of VTP-43742 in healthy volunteers conducted at a single, study center in the United States (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40 healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1 of the study only; Part 2 is reported separately.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, 18 to 45 years of age, inclusive.
* Body weight of at least 55 kg and body mass index of 18-32 kg/m2, inclusive.
* Medically healthy with clinically insignificant screening results.
* Women of child-bearing potential (WOCBP) AND men with partners who are WOCBP must agree that they and/or their partner will use two reliable forms of contraception as per study requirements
* WOCBP must have a negative serum β-hCG pregnancy test at the Screening and Baseline visit.
* Voluntarily consent to participate in the trial

Exclusion Criteria:

* Unwilling or unable to provide written informed consent
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, coagulation, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, clinical laboratory determinations or ECG
* Any major surgery within 3 months of Screening
* Positive urine drug/alcohol testing at Screening or Baseline visit
* Use of tobacco and/or nicotine-containing products within 3 months prior to the start of dosing of the trial
* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at Screening
* History or presence of alcoholism or drug abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse
* History of hypersensitivity or idiosyncratic reaction to drugs from multiple drug classes
* Any previous gastrointestinal surgery or recent (within 3 months) history of gastrointestinal disease that could impact the absorption of the study drug
* Blood donation or significant blood loss within 8 weeks prior to Day 1 of the trial
* Plasma donation within 7 days prior to Day 1 of the trial
* Blood transfusion within 4 weeks of Screening
* Positive serum pregnancy test (WOCBP) at the Screening or Baseline visit
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease) must not be enrolled into this study
* Any other medical, psychiatric, and/or social reason as determined by the Investigator
The Role of Pyruvate Kinase M2 in Growth, Invasion and Drug Resistance in Human Urothelial Carcinoma

Bladder urothelial carcinoma (UC) is a common malignancy and the incidence is increasing by years in Taiwan. Chemoresistance was inevitable in treatment of metastatic disease and lead to the ominous outcomes. To develop novel therapeutic strategies to overcome chemoresistance is imperative. Cancer cells uptake glucose at higher rates than normal tissue but use most of glucose for glycolysis even under normoxia condition, which is known as the Warburg effect. Pyruvate kinase (PK) catalyzes the last step in the process of glycolysis, and one of it isoform--PKM2 has been reported to be associated with tumor progression and some specific tissues and promotes the Warburg effect in cancer cells.

Regulation of PKM2 can be a novel target of cancer therapy. Meanwhile, PKM2 may play a critical role in the development of drug resistance and can be a promising target to overcome drug resistance.

In this study, our specific aims are as follows:

1. To prove the differentia expression levels of PKM2 in UC cells and drug-resistant UC cells, as well as in human UC tissues and drug-resistant UC tissues.
2. To examine the effect of PKM2 regulations（PKM2 siRNA and shikonin）on invasiveness and metastatic ability of UC cells and clarify the role of PKM2 in human UC cells.
3. To investigate the combinatory effect of PKM2 regulations（PKM2 siRNA and shikonin）and currently used chemotherapeutic agents (cisplatin，gemcitabine ,doxorubicin). Do PKM2 regulations enhance the cytotoxic effect of chemotherapy and overcome the chemoresistance？
4. To further prove the in vitro findings in the nude mice xenograft model。

Eligibility Criteria:
Inclusion Criteria:

* patients with age between 20-80 years old and had taken Radical Cystectomy or nephrectomy between 2008-2012

Exclusion Criteria:

* patients with age not located in the interval of 20-80 years old.
Monitoring Of Scratch Via Accelerometry In Children

Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. The overall aim of this research is to validate the use of sensor technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients, and specifically in this study in children ages 2 to 11 years. To evaluate this experimental paradigm, the investigators propose using wearable accelerometers, a sleep sensor, PSG, videography and associated traditional patient-reported outcome measures/clinical outcome assessments (PRO/COA) in patients/caregivers with AD in a well-controlled in-laboratory and at-home study.

To assess the feasibility of quantifying scratch and sleep in children with Atopic Dermatitis (AD), children, age 2 to 11 years, with AD will be recruited. The subjects will complete specific questionnaires related to itch, sleeping habits and AD and continuously wear two wrist worn accelerometry devices. The EarlySense Sleep Monitor will also be placed underneath the mattress to measure additional sleep related activities.

The study will be comprised of two overnight sleep laboratory site visits. The clinic visits will be followed by a continuous \~48 hour in-home environment assessment period (defined as the subject's daily routine environment). During the sleep lab site visit, the subject and accompanying parent(s)/guardian(s) will sleep overnight at the facility. The subject will be video-recorded during the in-sleep lab visit, wear the wrist accelerometry devices, use the sleep sensor and complete assessments (Depending on age, parent/guardian may complete some assessments). Upon the completion of sleep lab activities the subjects will then continue to wear the wrist accelerometry devices, utilize the sleep sensor and complete Patient Reported Outcome/Clinical Outcome Assessments (PRO/COA) assessments during the 48 hour in-home assessment. At the conclusion of the in-home portion of the assessment, the subject will return the device/s and assessments to the facility and undergo brief assessments/interview.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥2 years of age and \<12 years of age at Day 1.
2. Written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable).
3. Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s)).
4. Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).

Exclusion Criteria:

1. AD affected surface areas are in a location of device placement.
2. Has unstable AD (Total BSA\>40%).
3. Has any planned surgical or medical procedure that would overlap with study participation.
A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who:

* Have taken PAXLOVID PACK and have no history of using this medicine.
* Are 12 years and older

All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed.

We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective.

Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.

This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are administered PAXLOVID PACK and have no history of using this drug.

Exclusion Criteria:

* There are no exclusion criteria for this study.
eKISS: Electronic KIOSK Intervention for Safer-Sex

This study is a randomized controlled trial to test acceptability, feasibility and preliminary efficacy of an interactive computer-based intervention with individualized feedback to promote sexual health in adolescents and young adults with assessment of behavioral and biomarker outcomes.

This study is a randomized controlled trial to test acceptability, feasibility and preliminary efficacy of an interactive computer-based intervention (ICBI) with individualized feedback to promote sexual health in adolescents and young adults. The intervention uses physician avatars and uses elements of motivational interviewing to elicit sexual risk behaviors and motivation to change risky behavior. Feedback includes instructive video modules. Participants were asked to identify one behavior to change and were reassessed at 3-month follow-up for interim sexual behavior including condom and birth control use. Participants were tested for chlamydia, gonorrhea, and pregnancy(females) at baseline and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* English speaking and reading
* Report at least one episode of unprotected vaginal sex (no condom OR no birth control) in the last 2 months
* Not currently pregnant or actively seeking pregnancy in self or partner

Exclusion Criteria:

* Currently pregnant or actively seeking pregnancy in self or partner