cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder

The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior.

The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder.

Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.

Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group.

Study design: Clinical evaluation of a medical device without CE mark; Parallel study design


Eligibility Criteria:
Inclusion Criteria:

* Written consent of the participant after clarification
* Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group)
* Age between 18 and 70 years
* Knowledge about using a smartphone

Exclusion Criteria:

* Rejection of participation
* Lack of knowledge about how to deal with a smartphone
* Congenital / early-childhood intelligence reduction
* Moderate / severe dementia
Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis

This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.


Eligibility Criteria:
Inclusion Criteria:

* With atopic dermatis.
* Voluntarily sign the informed consent form.

Exclusion Criteria:

* Any major surgery planned during the research period.
* With intestinal parasitic infection within the first 6 months of screening.
* With any previous malignant tumors prior to screening.
* With any circumstance that is not suitable to participate in this study.
Logistic Regression and Elastic Net Regularization for the Diagnosis of Fibromyalgia

This study will utilize ultrasound image texture variables to construct an elastic net regularized, logistic regression model to differentiate between healthy and Fibromyalgia patients. The collected ultrasound data will be from participants who are healthy, and from participants who have Fibromyalgia. The predicted performance accuracy of the diagnostic model will be validated and this will confirm or deny the hypothesis that differentiation between the two cohorts is possible.

Fibromyalgia (FM) diagnosis remains a challenge for clinicians due to a lack of objective diagnostic tools. One proposed solution is the use of quantitative ultrasound (US) techniques, such as image texture analysis, which has demonstrated discriminatory capabilities with other chronic pain conditions. The investigators propose the use of US image texture variables to construct an elastic net regularized, logistic regression model, for differentiating between the trapezius muscle in the healthy and FM patients. 162 Ultrasound videos of the right and left trapezius muscle were acquired from healthy participants and participants with FM. The videos will then be put through a mutli-step processing pipe including converting them into skeletal muscle regions of interest (ROI). The ROI's will be then filtered by an algorithm utilizing the complex wavelet structural similarity index (CW-SSIM), which removes ROI's that are too similar to one another. Eighty-eight texture variables will be extracted from the ROI's, which will be used in nested cross-validation to construct a logistic regression model with and without elastic net regularization. The generalized performance accuracy of both models will be estimated and confirmed with a final validation on a holdout test set. Depending on the predicted, generalized performance accuracy it will be validated or not by the final, holdout test set (confirming the model construction is accurate). These models should then confirm or deny the hypothesis that a regularized logistic regression model built on ultrasound texture features can accurately differentiate between healthy trapezius muscle and that of patients with FM.

Eligibility Criteria:
Inclusion Criteria:

* gender independent; chronic widespread pain, fitting the 2016 FM criteria, absence of myofascial pain syndrome trigger points and between the ages of 20 and 65 years (44.3 ± 13.9 years).
* Healthy asymptomatic volunteers who were age matched (n = 17) with no physical complaints or abnormality on physical examination also participated.

Exclusion Criteria:

* Participants were excluded if they demonstrated clinical evidence of another cause for widespread pain, such as polymyositis, dermatomyositis, endocrine disorders, etc. None of the participants had performed any physical exercise during the two to three days prior to entry into the study.
Phone Outreach Nudges Among Individuals Losing Medicaid Coverage

In May 2023, Covered California, California's ACA marketplace, implemented its automatic enrollment program for individuals losing Medicaid coverage, as defined by Senate Bill 260. If individuals are found eligible for subsidized marketplace coverage, individuals will be automatically enrolled in the lowest cost silver plan available to them, but individuals must still take action to confirm their plan or pay their first month's premium. To identify whether the phone outreach is the effective outreach strategy to increase take-up in this population, Covered California implemented this intervention. The results of this evaluation will inform operational and budgeting decisions.


Eligibility Criteria:
Inclusion Criteria:

* Lost Medi-Cal (California's Medicaid coverage) in July 2023-June 2024
* Auto-enrolled into lowest cost silver plan with Covered California as per Senate Bill 260 and have not opted-in (effectuated) into the coverage
* Have a valid phone number on the health insurance application
* Do not have a delegated agent to their case
* Still have Covered California Program eligibility, not reverted back to Medi-Cal coverage
* Have English or Spanish as preferred speaking language
A Comparison the Intubation of a Left Sided Double Lumen Tube and Uniblocker

One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the commonly used device for OLV.The objective of our study was to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image.

One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Bronchial blockers (BBs) are the commonly used device for OLV.The objective of this study is to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image(the operator count the number of CT slices (slice thickness is 5mm) from vocal cord slice to carina slice to calculate the distance between vocal cord and carina) then measure a distance on the DLT or Uniblocker from the upper edge of the cuff to the mouth side and made a marker on the DLT or Uniblocker.During the intubation the operator insert the DLT or Uniblocker into the trachea via video laryngoscope, after passing the glottis the DLT or Uniblocker are advanced toward the left main-stem bronchus, once the anesthesiologist see the marker on the DLT or the Uniblocker just above the vocal cord stop the insertion.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing left side thoracic surgery

Exclusion Criteria:

* 1.Age\>70 or \<18 years 2.ASA classifications \>III 3.BMI \>35kg/m2 4.Modified Mallampati classification ≥III 5.Thoracic surgery within the last one month 6.Severe cardiopulmonary disease
Patients Who Underwent Surgical Procedures State of Readiness for Discharge

In this study, it was aimed to evaluate the readiness status of patients who are planned to be discharged after the surgical procedure.

Objective: In this study, it was aimed to evaluate the readiness status of patients who are planned to be discharged after the surgical procedure.

Method: Explanatory sequential mixed design will be used in accordance with the purpose of the study. The purpose of the exploratory sequential design is to clarify the relationships obtained with the quantitative data by applying the qualitative step.

This pattern is applied in two stages. The first phase begins with the collection of quantitative data that will essentially answer the research question. In the second stage, qualitative data are collected and the collected data is interpreted to help explain the quantitative results.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Willingness and willingness to participate in the study,
* Having undergone a surgical procedure,
* Healing / discharge as it is,
* Not having difficulties in understanding
* Patients who do not feel ready for discharge according to quantitative data and also agree to participate in the qualitative study

Exclusion Criteria:

* Be under the age of 18,
* Being discharged without surgical procedure,
* Transfer to another department
Families Coping Together With Alzheimer's Disease

Two remote phone/zoom calls are required to assess experiences as a family coping with dementia.

Using a combination of paper or online surveys in addition to interactive visits with blood pressure monitoring, participants are observed interacting with each other. Blood pressure devices are mailed to their homes and only worn for six minute intervals. The first visit generally lasts one hour and the second visit 90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Parent must be 55 plus with symptoms or a diagnosis of dementia
* Adult child must be over 18 and involved in some way with assisting parent.

Exclusion Criteria:

-
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty

This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation,
* able to give consent
* able to perform a exercise protocol

Exclusion Criteria:

* Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH
* ongoing PAH-specific vasodilator therapy
* known contraindication to riociguat
* a physical limitation to completing an exercise protocol
Assessment of Cancer Related Brain Fog Using the Test of Strategic Learning

The Inova research team will ask people who have had an experience of breast cancer and related changes to their cognition to complete some scales that researchers have established describe brain fog (called patient reported outcomes) and compare those results to the TOSL results. This will be done twice to see if changes are detected similarly on both types of measures.

Current brain fog research struggles to clearly define and measure brain fog because the changes are more subtle than typically show up on "objective" tests. These subtle changes on the tests, may not appear subtle in everyday life. This disconnect can lead to people managing cancer feeling unheard or unbelieved about their experience with brain fog. However, cognitive research outside of the cancer population has developed and tested tests that are more sensitive to cognitive changes and improvements. The goal of this initial research project is to test a more sensitive test, called the Test of Strategic Learning (TOSL), to see if it is sensitive enough to objectively measure brain fog.

One other problem with previous brain fog research is that it has not included a diverse population. Therefore, what we think we know about brain fog may not be true for everyone with brain fog. The diverse population in the DMV area that Inova serves deserves to have their experiences represented in the research.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* ECOG performance status ≤ 2
* Patients diagnosed or with a history of breast cancer within the last 5 years.
* Life expectancy of at least 3 months
* Subject reports experiencing brain fog or cognitive impairment that the subject attributes to cancer or cancer therapy
* Able to sit for one hour and attend and respond to verbal and written instructions.
* Able to use a computer

Exclusion Criteria:

* Brain metastases from breast cancer
* Severe hearing or visual impairment
* Unable to give informed consent
* Unable to read and write in English
* Those diagnosed with history of neurologic injuries or disorders (e.g. seizures, strokes, traumatic brain injury, brain surgery, neurodegenerative disorders) other than those attributable to cancer or cancer therapy.
Using A Gelatin-Based Model In USG-Guided Jugular Venous Catheter Placement Training

An education model with a homemade jugular venous catheterization model will be compared to the conventional training model for ultrasound-guided central jugular line catheterization.

The study will include 60 residents to be divided into two groups with stratified random sampling.

Training session for the control group (Group 2) will include a lecture about the subject, a demo video presentation, and practice of visualization of right jugular vein on a real human subject.

Training session for the model group (Group 1) will include the same as GControl with the addition of the puncture practice on the homemade jugular venous catheterization model(HJVCM) with ultrasound guidance.

Both groups will be tested with another HJVCM individually and the results of the success and fail parameters will be compared.

According to the latest guidelines, ultrasound guidance has become the golden standard in Jugular Central Venous Catheter applications. This reveals the necessity of theoretical and practical training on USG for jugular central venous catheter training. Models for jugular venous catheterization training are few in number and also expensive. Thus, the investigators built an Homemade Jugular Venous Catheterization Model which meant to be cheap and easy to make and transport. With this study, the investigators will test whether this model will provide any benefit to the success of the training on USG Guided Jugular Venous Catheterization.

Two different training sessions are planned as one will include the training model and the other will not. The study will be conducted with resident physicians without any experience on jugular venous catheterization or ultrasound-guided interventions of any kind. Participants will be divided into two groups with stratified random sampling (According to specialties and years of residency) and the both will attend to a 30 minutes lecture on jugular venous catheterization with US guidance and basic ultrasound principles including a demo video illustrating the procedure. Later, the participants will practice ultrasound imaging of right jugular vein on a real human subject. The model training group will be named Group 1 and control group will be named Group 2. Group 1 will also practice jugular vein puncture on the training model. After training sessions, each participant will be tested with a different model placed in a manikin. The assessment session will include successful visualization of the jugular vein, puncture of the jugular vein, and insertion of the guide wire. Evaluation of the success and fail parameters (explained in outcome parameters) will be monitored by four educated supervisors. The sessions for both of the groups are planned to take 120 minutes in total and the assessment will be limited to five minutes individually.

Eligibility Criteria:
Inclusion Criteria:

* Residents

Exclusion Criteria:

* Any experience on jugular venous catheterization
* Experience of ultrasound guided interventions of any kind.
SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study

This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).

This PMCF study is designed to further evaluate the safety and performance of the POUNCE Venous Thrombectomy system in the treatment of patients with symptomatic peripheral vascular thrombus through removal of thrombus. The study will collect both qualitative and quantitative data recorded by the investigators during the procedure to further evaluate safety and performance of the device.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18 years or older
2. Patients with peripheral vascular thrombus (e.g., iliofemoral) as confirmed by Doppler Ultrasonography (DUS)
3. Voluntary informed written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care
4. Patients who would likely experience benefit from mechanical thrombus removal

Exclusion Criteria:

1. Presence of a stent in the target vein
2. Known aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C/S Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V Leiden
3. Limb-threatening circulatory compromise
4. Known symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunction
5. Patients with a positive COVID test result at the time of the procedure
6. Patients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infection
7. History of, or active heparin induced thrombocytopenia (HIT)
8. Inability to withstand endovascular procedures
9. Life expectancy \< 1 year
10. Participation in any other drug or device studies that have not reached the primary endpoint follow up, which could compromise the results of either trial
11. Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
12. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
13. Known or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinion
14. Inability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)
Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product

The goal of this study is to test the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in youth (aged 18-25 years) with elevated depressive symptoms who are overweight/obese and/or self-report parental history of overweight/obesity.

Eligible participants will be randomly assigned to one of two groups: one group will use the Vira mobile app intervention with support from a health coach, and the other group will use the Vira mobile app intervention without coaching. Both groups will use the app for 12 weeks.

The primary aim of this project is to examine the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in a 2 x 2 (gender x condition) designed pilot study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (PHQ-8 score ≥10) and (2) overweight/obesity (BMI ≥ 25 and/or reporting a parental history of overweight/obesity). The study will examine the feasibility and utilization of the mobile app intervention with coaching compared to that of the mobile app intervention without coaching.

This is an exploratory pilot study; therefore, no formal sample size calculation was conducted. It is anticipated that 1,000 individuals will be screened, of which 20% will be eligible, and that 50% of those eligible will agree to participate (final N = 100, 50 per arm).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* Live in the United States
* English fluency and literacy
* Have access to an Android or iOS device
* Elevated depressive symptoms (PHQ-8 score of 10 or above)
* Overweight (BMI of 25 or above) OR reporting a parental history of overweight or obesity

Exclusion Criteria:

* Previous participation in this study
* Major mental or physical illness that will interfere with completing intervention and/or assessment activities.
Examining the Effects of Virtual Reality Exercise on Mental Health

The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-64
* Living in the Greater Victoria area
* Have a stable Wi-Fi connection at home
* Experience no health constraints that limit moderate-to-vigorous physical activity participation as identified by the Physical Activity Readiness Questionnaire (PARQ+).
* Currently participating in less than 75 minutes of vigorous physical activity per week (as per Canadian physical activity guidelines)
* Be willing to travel into the Behavioural Medicine Lab on the UVic campus
* Be the only member of their household to participate in the study, past or present

Exclusion Criteria:

* If participant is flagged by the PARQ+ and is not cleared to participate in physical activity by their physician they are ineligible to participate
* Does not meet any of the above inclusion criteria