cyrilzakka/clinical-trials huggingface dataset:
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.


Eligibility Criteria:
Inclusion Criteria:

* Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
* In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
* Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Must be able to work with smartphones/tablets/computers

Exclusion Criteria:

* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
* Abnormal function of the immune system resulting from clinical conditions or medication
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
* Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults

This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues.

In the double-blind portion, subjects received a single administration of study drug (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg.

The double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2 telephone contacts and 2 functional magnetic resonance imaging (fMRI) scans.

The optional open-label extension included 2 visits approximately 1 month apart. Subjects who completed both phases participated in a total of 8 scheduled visits (including 2 fMRI scans and 2 telephone contacts) over a period of up to 14 weeks.

At screening, eligible, consenting subjects were given an Actiwatch®-Score device. They were instructed to record their alcohol craving using this device throughout the double-blind phase. The Actiwatch was programmed to beep every 3 hours ±20 minutes, thereby signaling the subjects to enter their craving or desire to use alcohol, at that exact moment, on a scale of 0 to 10 (with 0 being no craving at all and 10 being extreme craving). In addition, subjects entered any drug and/or alcohol use at the time of occurrence. The Actiwatch was not utilized in the open-label portion of the study.

Eligibility Criteria:
Primary Inclusion Criteria:

* Current diagnosis of alcohol dependence, meeting at least 3 criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV)
* Recently completed alcohol detoxification and seeking treatment for alcohol dependence
* Women of childbearing potential must agree to use an approved method of contraception for study duration

Primary Exclusion Criteria:

* Pregnancy or lactation
* Evidence of hepatic failure including: ascites, bilirubin \>10% above upper limit of normal (ULN) and/or esophageal variceal disease
* Current dependence (within the past year) to benzodiazepines or cocaine, or current or history of opioid dependence according to DSM-IV criteria
* Use of any opioids and/or methadone within 14 days prior to the screening visit, or likely to require opioid therapy during the study period
* Previous enrollment in a VIVITROL clinical trial or previous VIVITROL experience
* Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)
* Parole, probation, or pending legal proceedings having the potential for incarceration during the study period
Impact of Fatty Liver on Hepatitis B Therapy

The primary goal of treating chronic hepatitis B(CHB) is to achieve maximal suppression of HBV replication, thereby reducing hepatocyte inflammation, necrosis, and liver fibrosis. Among various treatment strategies, antiviral therapy plays a crucial role. The prevalence of fatty liver disease (FLD) has continued to increase in recent decades. This study aims to accurately diagnose the pathological state of patients through liver biopsy and conduct a five-year follow-up to explore the impact of FLD on the efficacy of CHB treatment and to identify factors influencing adverse outcomes.

Chronic hepatitis B (CHB) remains a serious threat to people's health. As of 2019, approximately 296 million people (3.9% of the world's population) were infected with the HBV virus. In the treatment of CHB, Antiviral drugs can not only achieve long-term viral suppression for most CHB patients, but also have a positive impact on other CHB treatment goals and improvement of prognosis, but can not eliminate the risk of adverse clinical outcomes completely, which are partly attributed to concomitant diseases such as fatty liver disease (FLD). Both diseases can cause chronic liver injure and increase the risk of cirrhosis and HCC.All patients included in this study underwent liver biopsy to determine their pathological status, ensuring the reliability and accuracy of disease diagnosis. And based on biopsy results, patients were categorized into two groups:fatty liver combined with hepatitis B and hepatitis B alone. The main antiviral treatments used in the study include first-line NAs, such as entecavir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), and interferons (IFN-α and Peg-IFN-α). They were followed for five years to thoroughly assess the long-term efficacy of antiviral treatment. Additionally, complications and liver fibrosis were evaluated using ultrasound and FibroScan to monitor the advancement of liver disease.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 and ≤75 years old, regardless of gender;
2. The patient had a positive hepatitis B marker and met the criteria for current hepatitis B virus infection (hepatitis B combined with fatty liver group);
3. Liver pathology indicated fatty liver (hepatitis B combined with fatty liver group);
4. All patients have complete medical history, B-ultrasound, FibroSan, hepatitis B five items, liver function and other laboratory test data.

Exclusion Criteria:

1. Aged \<18 or \>75 years old;
2. Patients diagnosed with or previously diagnosed with HCC;
3. Those who are co-infected with other hepatitis viruses (HAV, HCV, HDV, HEV) or HIV or syphilis;
4. The follow-up data of patients are seriously missing.
Evaluation of the Efficacy and Safety of Microwave Ablation of Uterine Adenomyosis Under Improved Ultrasound Guidance

This study aims to compare the safety and efficacy of segmental power adjustment combined with uterine cavity hydro-isolation in microwave ablation of adenomyosis


Eligibility Criteria:
Inclusion Criteria:

1. UFs or AM diagnosed by pathology and ultrasound；
2. Relevant symptoms such asabnormal uterine bleeding, secondary anemia, progressive dysmenorrhea and enlargement of the uterus；
3. Voluntarily undergo MWA；
4. a confirmed available safe transabdominal puncture path；

Exclusion Criteria:

1. Pregnancy or malignancy；
2. Severe and uncorrectable coagulation disorders；
3. Severe cardiac, liver, and renal dysfunction；
4. Anesthesia allergy.
Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake

This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. This iteration will consider individuals recruited from the Flint Registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in Flint, Michigan.

African Americans develop and die from SARS-CoV-2 infection more than any other racial group in the United States, including in majority African American cities such as Flint, Michigan. Addressing these disparities may be aided by SARS-CoV-2 antibody testing. However, African Americans may be reluctant to partake in conventional antibody testing programs due to medical mistrust and experiences with racism. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing. The central hypothesis is that African-Americans will be more receptive to antibody testing when benefits and limitations are communicated in a culturally effective manner. Our clinical trial aims are to 1) develop and compare effects of a general versus culturally-targeted video about antibody testing on African American and White Flint residents' antibody testing attitudes and uptake; 2) identify and compare effects of a general versus culturally-targeted video on activation of medical mistrust and racism-related cognition among African Americans when considering antibody testing. In collaboration with clinical and community partners, we have prepared and will evaluate general and culturally-targeted video tutorials about SARS-CoV-2 antibody testing. These brief videos will be distributed to the Flint community through the Flint Registry - a highly visible local health resource exchange. We will furnish an opportunity to engage salivary antibody screening and measure willingness to participate. In this study iteration, we will consider willingness to participate in a drive-up saliva sample collection that is taking place at a central location in Flint, Michigan.

Eligibility Criteria:
Inclusion Criteria:

* African American or White, 18 or older, and enrolled in the Flint Registry

Exclusion Criteria:

* All who do not meet inclusion criteria.
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients

This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be an adult \>= 19 years
* Subjects who are eligible to be treated with adalimumab for intestinal Behcet's disease in accordance with the approved label in Korea
* Subjects provide written authorization form for use/disclose of personal health data prior to participating in this study

Exclusion Criteria:

* Subjects who are contraindicated to any anti-TNF agent
* Female subjects who are pregnant or breast feeding
* Subjects who are participating in other interventional clinical trials
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle

The investigators hypothesized that circulating EMP is a useful surrogate marker of early stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP, from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were repeated.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals who have no coronary risk factors

Exclusion Criteria:

* hypertension
* dyslipidemia
* chronic kidney disease
* liver dysfunction
* obesity (BMI\>25.0)
* cerebrovascular disease
* other severe systemic diseases (cancer, inflammatory diseases, etc)
Study of Chronic Degenerative Diseases

The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is attributable to genetic factors, clinical (waist circumference, adiposity and physical condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation) risk, each of which represents an independent risk.

As has already studied and published in the investigators' group, the child population of Toluca has greater expression of cardiovascular risk factors than their counterparts in Bogota, Colombia. The metabolic characterization of the young population of Toluca and Bogota with new biomarkers such as homocysteine and leptin is an activity that aims to provide more metabolic data affecting young people.

Hypothesis:

After six months of follow-up there will be a greater relative risk in Mexican population to have identified another component of metabolic syndrome compared to the young population of Colombia.

Objective:

To compare the expression levels of cardiovascular risk markers in young people between 5 and 12 years of Toluca, Mexico and Bogota, Colombia.

Material and methods:

Type of study: prospective, descriptive, comparative, and longitudinal.

Sample Calculation:

For a cohort study and taking into account that in the investigators' previous publication in the Colombian population only 13% (sick rate in unexposed group) had an altered metabolic parameter; accepting an alpha risk of 0.05 and a beta of 0.2 on a risk bilateral contrast, 57 subjects were required in the exposed group (Mexican population) and 57 in unexposed to detect a minimum relative risk of 3 to find other alteration to metabolic syndrome after six months follow-up.

Measurements:

The International Physical Activity Questionnaire (IPAQ) will be applied to all children. Dietary history of three days and physical examination (height in cm , weight in kg and waist circumference in centimeters) and blood pressure (mmHg) data will be recorded. Blood samples will be taken to analyze glucose, cholesterol, HDL, triglycerides, homocysteine and leptin.

Statistics:

Variables will be tested for normality through the Kolmogorov-Smirnov and Shapiro-Wilk formulas. Variables related to the physiological and metabolic functions and anthropometric measurements will be reported in mean and standard deviation. The differences in the laboratorial and anthropometrical variables will be analyzed with the Student t test. A difference will be considered significant with a p value ≤ 0.05. The statistical program used is the Statistical Package for the Social Sciences (SPSS) version 19.

Eligibility Criteria:
Inclusion Criteria:

* Primary school students of medium-low income.

Exclusion Criteria:

* Children with disabilities or a known chronic disease.
A Multicenter Case-control Study of Risk Factors for Premature Ejaculation in China's Shaanxi Province

Through a multicenter case-control study on the risk factors of premature ejaculation in Shaanxi, to find out the related factors of the occurrence and development of premature ejaculation, to provide reference for personalized treatment, in order to improve the quality of sexual life of patients and partners.


Eligibility Criteria:
Inclusion Criteria:

* 1) case group

  1. 18-64 years old, regular sexual life \> 6 months;
  2. Self-report of premature ejaculation;
  3. Able to complete questionnaires and scale scores independently. 2) control group

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  1. 18-64 years old, regular sexual life \> 6 months;
  2. Both partners are satisfied with their sexual life;
  3. Able to complete questionnaires and scale scores independently.

Exclusion Criteria:

* 1) case group

  1. Those who are unable to have sex due to genital malformation;
  2. Patients with serious cardiovascular and cerebrovascular diseases;
  3. Severe mental disorders (history of epilepsy, mania, etc.);
  4. Have a history of brain trauma;
  5. People with a long history of substance abuse. 2) control group

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  1. Patients with a history of mental illness;
  2. Oral selective serotonin (5-ht) reuptake inhibitors, tricyclic antidepressants, triazolidine antidepressants, tramadol and sedatives
Beyond COVID-19: Supporting Resilience With a Trauma-informed Music Composition Program

This study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic.

This study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic. The pandemic introduced widespread trauma for patients facing hospitalization. Therapeutic music interventions have demonstrated positive psychological effects, but none have explored the specific trauma-informed aspects of a composition-mentor program, as well as the specific impact of music composition on resilience-related traits.

Researchers implemented an adapted version of the New York Philharmonic Very Young Composers program (VYC): trained composer-mentors guide participants through four web-based sessions to elicit and develop participants' unique musical ideas into finished compositions. Participants are then invited to view a string quartet performance of their compositions. The Brief Resilience Scale \[BRS\] and New General Self-Efficacy Scale \[NGSE\] are administered pre-intervention, post-intervention, and post-performance.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age
* Massachusetts residents
* exhibiting English fluency
* in care with an MGB provider
* admitted as an inpatient for at least 3 days to an MGB hospital between March 15, 2020 and July 21, 2022
* not hospitalized within the month before starting the study.

Exclusion Criteria:

* neuropsychiatric illness impeding participation in the study including suicidality, psychosis, active substance use, and dementia
Intestinal Microbiome Dynamics in Solid Organ and Stem Cell Transplant Recipients

This is a pilot study designed to investigate the alterations in the gut microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic hematopoietic stem cells and mesenchymal stem cells transplantation in association with the clinical outcomes.

This is a pilot study designed to investigate the dynamic changes in the intestinal microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic HSCs and mesenchymal stem cells transplantation. Four patient cohorts will be followed. Cohort A: patients receiving kidney transplantation. Cohort B: patients receiving hematopoietic stem cells transplantation. Cohort C: patients receiving mesenchymal stem cells transplantation. Cohort D: patients receiving liver transplantation. Included participants are defined as patients with at least three analyzable stool samples including a baseline sample before the transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled into kidney transplantation or HSCs transplantation or MSCs transplantation or liver transplantation programs with fecal samples collected over the course of their initial transplant hospitalization.
* Be willing and able to provide written informed consent for the study.

Exclusion Criteria:

* Patients were excluded from the study if their first sample was not collected prior to the start of transplantation procedure.
* Samples were excluded from the analysis if they were not aliquoted and stored frozen within 24 hours of collection.
An Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes

To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* ≥ 18 years old
* Has been already diagnosed with hypertension
* Has been already diagnosed with type 2 diabetes mellitus
* Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment
* Heart rate ≥70 beat per minute

Exclusion Criteria:

* Pregnant or breast feeding female
* Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
* Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker;
* Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination
* Is currently participating in another clinical or non-clinical study
Differential Metabolic Effects of Statins

The investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.


Eligibility Criteria:
Inclusion Criteria:

* Low-density lipoprotein cholesterol levels \> 130

Exclusion Criteria:

* Overt liver disease,
* Chronic renal failure
* Hypothyroidism
* Myopathy
* Uncontrolled diabetes
* Severe hypertension