cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. A minimum of 24 participants (12 participants per sequence) will complete the study. Participants will be randomly assigned to 2 possible sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. The study is expected to last approximately 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers between 18 and 55 years of age, inclusive
* Body mass index between 18.5 to 32.0 kg/m2, inclusive;
* Adequate renal, liver, and hematologic function
* Participants who are in good health as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator)
Overal Survival After TAVI According to Sarcopenia

The goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans.

The main question it aims to answer is:

• Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?

The patients suffering from aortic valve stenosis, that are not eligible for cardiosurgery were indicated to miniinvasive transcatheter aortic valve implantation (TAVI). The follow up of 930 patients were done in time interval from 1 to 11 years. In every patient the preprocedural CT scans were done. From these CT scans the L3 cross sections will be used for sarcopenia evaluation. Then we will statisticaly evaluate the overal survival after TAVI procedure in the relation with sarcopenia status. We will answer the main question: Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?

Eligibility Criteria:
Inclusion Criteria:

* patients udergone TAVI procedure

Exclusion Criteria:

* patients with incomplete TAVI procedure, patients without clinical follow up
Positive Steps to Enhance Problem Solving Skills

This randomized control trial is to test the efficacy of a stepped-care "adaptive" Antiretroviral Therapy (ART) adherence intervention ("Positive STEPS") for HIV infected adolescents and young adults, ages 16 to 29. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention.

HIV infected adolescents and young adults will be recruited from Providence, Rhode Island, Boston, Massachusetts and Chicago, Illinois. Participants will be equally randomized to:

1. "Positive STEPS" - a stepped care, adherence intervention with integrated technology (2-way daily text messaging aimed at improving ART adherence). If text messaging is not sufficient to overcome the barriers to ART adherence;these individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy.
2. Standard of Care comparison group including a brief adherence educational session. This will consist of a review of medications and recommended dosing (i.e., to understand regimen), adherence expectations, toxicity expectations and medication misperceptions.The participant will then view a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Between 16 and 29 years of age
* HIV-infected (perinatally, transfusion, or behaviorally-acquired)
* Currently taking or prescribed antiretroviral therapy and: 1) Began taking ART \< 3 months ago, OR 2) Has been taking ART for \>3 AND has missed one or more doses in the past week or more than 3 doses in the past month.
* Daily access to a cell phone
* Has lived in the greater Providence, Boston, or Chicago area greater than three months
* Self-reports \< 90% ART medication adherence in the past month (i.e., missed one or more doses in the past week or more than 3 doses in the past month) at screening
* Able to speak and understand English
* Not currently enrolled in another ART-adherence intervention study
* Willing and able to complete all study visits in person or remotely via video conferencing platform

Exclusion Criteria:

* Unable to give informed consent due to severe mental or physical illness, cognitive limitation, or substance intoxication at baseline visit
* HIV-uninfected
* Not currently on antiretroviral therapy
* Does not own a cell phone
* Has lived in the greater Providence, Boston, or Chicago area for less than three months or is planning to move outside the area within the next year
* Self-reports \> 90% ART medication adherence in the past month AND has been taking ART for more than 3 months
* Unable to speak and understand English
* Currently enrolled in another ART-adherence intervention study
* Not willing to and able to complete all study visits in person or remotely via video conferencing platform
Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care

The purpose of this study is to prospectively explore the impact from the different cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients with type 2 diabetes.

CARDIPP (Cardiovascular Risk factors in Patients with Diabetes - a Prospective study in Primary care) was launched in 2005 with the aim of identifying markers for cardiovascular disease to facilitate earlier and individually adjusted intervention in middle aged patients with type 2 diabetes. The patients in CARDIPP were consecutively recruited from primary health care centres in the counties of Östergötland and Jönköping, Sweden from November 2005 through December 2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years and the participation in the study was performed as an extended annual follow up. Blood pressure was measured as the average of three seated measurements taken 1 minute apart and standard anthropometric and clinic evaluations were performed including measurement of waist circumference and sagittal abdominal diameter which is a new and promising measurement of abdominal obesity that may serve as a surrogate marker of insulin sensitivity. We also obtained a recording of 24-hour ambulatory blood pressure. The patients filled out a detailed questionnaire for evaluation of life style factors and exercise habits. Pedometer-determined ambulatory activity for three consecutive days in combination with the questionnaires was used for quantification of daily physical activity.

The cardiovascular investigations were performed at the Department of Physiology, Linköping University Hospital and at County Hospital Ryhov, Jönköping, Sweden. The patients were subjected to cardiac ultrasonography for calculation of left ventricular mass and ejection fraction as well as diastolic cardiac function. Measurement of the carotid, femoral and radial pulse pressure wave form is performed by aid of tonometry, with pressure wave analysis and calculation of central blood pressure. Furthermore, pulse wave velocity in both central elastic and muscular peripheral arteries is defined as an index of arterial wall stiffness. The intima-media thickness (IMT) and the lumen diameter (LD) of the carotid arteries were evaluated using a B-mode ultrasound.

CARDIPP-R comprises a re-investigation of the cohort four years after the completion of the baseline examination and will thus start in November 2009 and will be completed by 2012. In CARDIPP-R, all participants from the baseline study will be invited to the re-investigation. The CARDIPP-R study protocol for the cardiac ultrasonography, the carotid ultrasonographic investigations and tonometry for measurements of the carotid, femoral and radial pulse pressure wave form and pulse wave velocity will follow the CARDIPP baseline protocol.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

* Not able to understand Swedish
Effect of a Single Dose of Cranberry Beverage on Inflammation and Oxidative Stress

The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.

Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.

Eligibility Criteria:
Inclusion Criteria:

* Men \& women; aged 18-35 years
* BMI: 19-25 kg/m2

Exclusion Criteria:

* Any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness
* Had major gastrointestinal surgery or on prescription or surgical treatment
* Any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients
* Regularly smoked in the previous 6 months
* On medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment
* Risk factors for AIDS or known HIV positive status
* Pregnant or lactating
* High intake of chocolate or similar high polyphenol foods
* Regular intake of vitamin and polyphenol supplements
* Drug and alcohol misuse
* Currently participating or had participated in another clinical study during the previous 3 weeks
* Donated blood in the previous 3 weeks
* Exercise more than 3 times/week for longer than 45 min each time
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.

At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Ability to exercise
* Ability to computer mouse to provide ratings
* \> 10 pack-years smoking
* Baseline dyspnea index \< 9

Exclusion Criteria:

* Clinically significant comorbidities
Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

One of the most serious complications of treatment in patients with hemophilia A or hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. The ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem

Eligibility Criteria:
Inclusion Criteria:

* Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher

Exclusion Criteria:

* Severe Hemophilia A with a negative inhibitor
Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas

To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.


Eligibility Criteria:
Inclusion Criteria:

At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥ 3000.

Subjects who meet all of the following specific criteria will be considered for participation in the study:

1. Male or female with age ≥ 45 years inclusive;
2. Able to read, understand and sign informed consent;
3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures.

Exclusion Criteria:

Subjects who meet any of the following specific criteria will be refused to participate in the study:

1. have a history of drug or alcohol abuse or psychological disorders within the last 5 years;
2. Pregnant or lactating women;
3. Patients with known multiple polyp syndrome;
4. patients with known inflammatory bowel disease;
5. known intestinal stenosis or space-occupying tumor;
6. known colon obstruction or perforation;
7. patients with a history of colorectal surgery;
8. Patients with previous history of allergy to pre-used spasmolysis;
9. Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
10. High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
A Study of LY3832479 (LY-CoV016) in Healthy Participants 1

The purpose of this study is to test the safety and tolerability of LY3832479 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3832479 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history and physical examination
* Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected
* Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to less than (\<)35 kilograms per square meter (kg/m²)
* Male participants must agree to adhere to contraception restrictions
* Female participants must be of non-childbearing potential

Exclusion Criteria:

* Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
* Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of

  * Significantly altering the absorption, metabolism, or elimination of drugs
  * Constituting a risk while taking the investigational product, or
  * Interfering with the interpretation of data
* Have significant allergies to humanized monoclonal antibodies (mAbs)
* Have any of the following that are clinically significant:

  * Multiple or severe drug allergies, or
  * Intolerance to topical corticosteroids, or
  * Severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
* Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Have had breast cancer within the past 10 years
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus \[HCV\] ribonucleic acid \[RNA\])
Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients

An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. A recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients. It is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician. The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.

An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Several indices have been used to assess disease activity in patients with UC. Mayo score is the most widely used index for UC activity measurement. Meanwhile, recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. SCCAI is consisted of only clinical items and includes items such as nocturnal diarrhea and urgent defecation which are more closely related to the quality of life of patients. In this regard, a recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients.

Since SCCAI is composed of only clinical parameters, it can be evaluated by the patients themselves. According to recent research, the self-administered SCCAI was reported to have a high correlation with the SCCAI assessed by physician (correlation coefficient = 0.79). Moreover, it is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician (Spearman's correlation = 0.79). These results suggest that the patient's self-reported SCCAI can be applied to actual clinical practice, and it will enable remote monitoring and flexible follow-up depending on the patient's disease activity. If self-administered SCCAI is to be applied as a more valid disease activity assessment tools, it also properly reflects patient's quality of life status. However, it is not yet known whether the self-administered SCCAI using web-based tools reflects the quality of life of patients.

The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the health-related quality of life of UC patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of UC for \>3 months
* familiarity with online communication (e.g., use of the Internet)
* Consent for study participation

Exclusion Criteria:

* Previous colon resection or other UC related bowel surgery
* Psychiatric or intellectual disability
* Lack of ability for access or use online tools
Developing a Virtual Reality Training Tool for Exposure Therapy: Simulated Exposure Trainer (SET)

The goal of this study is to develop a targeted virtual training program (Simulated Exposure Trainer; SET) for exposure therapy. Two platforms with differing levels of immersion (low - mobile device; high - head mounted display) will be evaluated based on their usability and engagement of an empirically-derived training target (i.e., therapist negative beliefs). Target engagement will be evaluated by applying an experimental therapeutics framework during a brief training trial.

Despite the existence of numerous, well-established evidence-based practices (EBPs) for mental disorders, it has been difficult to disseminate these practices in community settings. Exposure therapy for anxiety disorders represents one of the most glaring examples of this research-to-practice gap. Just as patients are anxious about approaching their fears, therapists are often reluctant to use exposure therapy due to their own anxious beliefs that it may be dangerous and/or intolerable for patients, even after receiving specialized exposure training. Emerging training research suggests the inclusion of targeted behavioral strategies (i.e., role play, self-exposure) can reduce anxious beliefs above and beyond standard didactic training sessions. By leveraging the same behavior change principles that reduce patient anxiety (i.e., exposure), behavioral strategies can be tailored to target therapists' anxious beliefs about the treatment (i.e., conduct training as "exposure to exposure"). Unfortunately, current experiential training tasks have failed to closely replicate commonly feared clinical contexts, and as a result lack the necessary potency to potentially overcome therapist-level barriers for uptake and quality treatment delivery following training. Virtual reality (VR) has demonstrated utility as a potent and cost-effective approach for delivering exposure. We plan to investigate the application of VR as a tailored training tool (i.e., virtual "exposure to exposure" for therapists) capable of enhancing the quantity and quality of experiential learning that is lacking in current exposure training initiatives. This study will test the implementation of a VR training program on both a low-immersion (i.e., mobile device) and high-immersion (i.e., head mounted display) platform to assess which platform provides the ideal balance of immersion, usability, target engagement, and scalability. The study involves a clinical training trial to establish target engagement. Usability and target engagement information from this pilot trial will support a Phase II project aimed at building out and broadly disseminating the VR-enhanced training approach.

Eligibility Criteria:
Inclusion Criteria:

* Bachelor's level of education (or higher)
* Able to come to study site in-person for experiential training
* Has the ability to provide some sort of clinical care to patients

Exclusion Criteria:

* Found study procedures to be unacceptable during the consent process