cyrilzakka/clinical-trials huggingface dataset:
Promoting Alcohol Treatment Engagement Post-hospitalization

This study is a 3-arm randomized clinical trial to evaluate the effectiveness of hospital-initiated Alcohol Use Disorder treatment, involving a Brief Negotiated Interview (with referral and telephone booster) alone, BNI+facilitated provision of MAUD, BNI+facilitated provision of MAUD+CBT4CBT on AUD treatment engagement, alcohol use and healthcare utilization.

The proposed 3-arm randomized clinical trial will initiate interventions during hospitalization and evaluate outcomes at 34- and 90-days following hospital discharge to compare the effectiveness of 1) BNI, 2) BNI+facilitated provision of MAUD, and 3) BNI+facilitated provision of MAUD+CBT4CBT on AUD treatment engagement, alcohol consumption, and healthcare utilization among 450 racially and ethnically diverse hospitalized individuals with AUD.

Using a hybrid type 1 effectiveness-implementation design the investigators will also conduct an implementation- focused process evaluation to yield relevant data to inform future implementation, including process measures, clinician and staff (n=150) perspectives and cost effectiveness.

This proposed study is directly informed by rigorous prior research by this group and others demonstrating: 1) a need for new strategies to engage patients, particularly Black and Hispanic individuals, with AUD in treatment; 2) benefits of engaging patients in addiction treatment during acute care;3) benefits of MAUD and the potential to integrate its provision in general medical settings; and 4) benefits of CBT as an adjunct to MAUD with strong support for CBT4CBT across diverse populations

Eligibility Criteria:
Inclusion Criteria:

* hospitalized at Yale New Haven Hospital (YNHH)
* meet Diagnostic and Statistical Manual (DSM-5) criteria for a moderate to severe AUD (regardless of primary reason for hospitalization) consistent with clinical guidelines for MAUD initiation
* \>1 heavy drinking day by TLFB in 30 days prior to hospitalization
* willing to consider MAUD
* willing and able to be contacted for follow-up
* provide written informed consent

Exclusion Criteria:

* have been engaged in formal AUD treatment in the past 30 days (i.e., excluding mutual help groups, such as Alcoholics Anonymous)
* meet DSM-5 criteria for untreated moderate to severe opioid use disorder
* self-reported or urine testing confirming pregnancy, nursing, or trying to conceive
* life-threatening or unstable medical, surgical, or psychiatric condition that prohibits study participation
* inability to provide \>1 collateral contact for a friend or family member
* anticipate being unable to return for follow-up assessments for any reason, such as travel, incarceration, planned procedure
* inability to understand English or Spanish.
A Study to Evaluate Intramuscular ASP7374

The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy or medically stable, as judged on the basis of history and concurrent diseases.
* Subject understands procedure of the protocol and is willing to comply with the protocol.
* Written informed consent has been obtained.

Exclusion Criteria:

* Scheduled to receive another vaccine during the study.
* Received influenza HA vaccine within 180 days prior to screening.
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
* Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* History of seizures, except for febrile seizures in childhood
The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.

Women being treated at the Women \& Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.

The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.


Eligibility Criteria:
Inclusion Criteria:

* Patient at the Women and Infants Triage/Women's Emergency Department
* Vital signs are stable
* Ages 18 and older
* Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
* Estimated gestational age up to 10 weeks
* Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
* Able to read English or Spanish
* Able to give informed consent for involvement in the study

Exclusion Criteria:

* Allergic to lidocaine, iodine or betadine
* Known sensitivity to any component of the lidocaine or placebo gel.
* In acute distress
* Unable to give informed consent
* Unable to read English or Spanish
Sexuality Education: Knowledge of Women Aged 18 to 25

Information, education and communication concerning sexual health are essential for enable to do informed and responsible decisions about it.

In France, education for sexuality in schools still remains unequal and is considered as unsuited to the realities of young people. This observation led to the development of a national sexual health strategy. One of the challenges is to promote and enhance the implementation of interdisciplinary sexuality education. Midwives are and should be involved in the issue of sexuality.

The aim of the study is to describe knowledge concerning sexuality of young women aged 18 to 25.

Eligibility Criteria:
Inclusion Criteria:

* female
* aged 18 to 25 years old
* with or without sexual activity
* agreeing to participate in the study

Exclusion Criteria:

- none
Nutrilite Memory Builder on the Improvement of Cognitive Function

Its a randomized controlled trial, to evaluate the effect of NUTRILITE Memory Builder on the improvement of cognitive function in middle-aged and elderly people.

The study center will recruit 100 male or female subjects aged 40-75 years as needed. Enrolled subjects will be divided into 2 groups, with 50 subjects in each group.

Study subjects will be administrated with either the Amway product or a placebo for three months (12 weeks). At least 42 subjects in each group (84 in total) are required to complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, 40-75 years old (with age groups of 40-60 years and 61-75 years as close as possible to a 1:1 ratio);
* Healthy subjects with no underlying diseases and no drug treatment at the time of screening;
* Meet the requirements of MMSE scores of 24-29;
* Be willing to comply with all study requirements and procedures;
* Agree to sign the informed consent form.

Exclusion Criteria:

* Participated in similar clinical trials in the last 6 months;
* Have mental illness or disorders of consciousness and behavior;
* Have severe chronic diseases and are currently under treatment with drugs;
* Have taken drugs that can affect cognitive function (such as first-generation antihistamines, benzodiazepines, sedatives, opiates, stabilizers, antidepressants, cholinergic drugs, anticholinergic drugs, prescription anti-inflammatory drugs) and any other regularly influential agents.
* Had flu/virus symptoms within 3 months before screening;
* Received within 3 months before screening or currently receiving medical or nutritional treatments, including protein supplementation or substances that provide exercise capacity;
* Had weight gain or weight loss of more than 5kg within 3 months before screening;
* Have a history of hospitalization within 3 months before screening;
* Have any of the following medical history or have been clinically diagnosed with any of the following diseases: obvious gastrointestinal disorders; liver, kidney, endocrine, blood, respiratory and cardiovascular diseases. These may affect the assessment of product efficacies.
* Have high daily alcohol consumption, i.e. more than 14 bottles of beer (350 ml/bottle) or wine (180 ml/bottle) per week;
* The PI believes that the subjects cannot fully cooperate with the trial arrangement.
A Safety Study of Brentuximab Vedotin in Participants With HIV

This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment. It will also see if brentuximab vedotin raises CD4+ counts. It will study the side effects of this drug as well. A side effect is anything a drug does to the body besides treating the disease.

In this study participants will be assigned randomly to a group. Participants will get either brentuximab vedotin or placebo. A placebo looks like the drug but does not contain any medicine in it. All participants will keep getting ART during the study.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 seropositive with documentation of infection
* Immunological nonresponder, defined as:

  * Has been on ART with an HIV viral load \<50 copies/mL for at least 24 months
  * Has a CD4+ T-cell lymphocyte count between 51 to 200 cells/µL
* Life expectancy of \>9 months.
* Participant is negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy
* Participants with a history of hepatitis C virus (HCV) are eligible if they have completed therapy for HCV and show sustained virologic remission (12 weeks or more)

Exclusion Criteria:

* Any currently active AIDS-defining illness per Category C conditions according to the CDC Classification System for HIV Infection, with the following exceptions:

  * Limited cutaneous Kaposi's sarcoma not currently requiring systemic therapy
  * Wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications
* Acute liver disease or any other active infection secondary to HIV requiring acute therapy
* History of progressive multifocal leukoencephalopathy (PML)
* Prior clinical John Cunningham virus (JCV) infection, history of JCV identified in cerebrospinal fluid, or presence of JCV antibodies at screening
* Cirrhosis secondary to any cause
* Any immunomodulating therapy (excluding premedication steroid) within 4 weeks prior to the screening visit
* Prior malignancy within 2 years other than cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, anal intraepithelial neoplasia, or cutaneous Kaposi's sarcoma
Reshaping Food Choice at University of Michigan

Nearly a quarter of global greenhouse gas emissions originate from agriculture. Consumer demand for food, especially carbon-intensive red meats, largely underlies these emissions. Therefore, reducing consumption of red meat has the potential for transformative impacts on climate change. Our interdisciplinary team of researchers and dining staff aims to determine the carbon impact of evidence-based behavior change interventions to reduce red meat consumption at University of Michigan dining halls. Using an experimental design, we will evaluate the impacts of three "nudge" interventions (i.e., modifying environmental cues and incentives) to reduce red meat consumption in three randomly assigned treatment dining halls vis-à-vis three paired control dining halls. Nudges will include changing default food items and altering food labels. We will: 1) collect data on meals served during each intervention periods to assess the separate and combined effects of the interventions on red meat consumption; 2) conduct e-mail interviews with students to understand treatment effect heterogeneity and sociodemographic determinants of food choice; and, 3) conduct focus group discussions and interviews, respectively, with students and dining staff to assess implementation feasibility. We expect that this research will generate scalable, replicable solutions for reducing greenhouse gas emissions through dietary change at universities and similar institutions, will significantly advance the food choice literature, and will influence sustainability strategies at university dining operations nationally given the proposed team's close partnership with regional and national dining programs.


Eligibility Criteria:
Student Survey:

* An individual must have been a frequent diner at one of the six project dining halls during the first three weeks of the academic term
* An individual must have attended only treatment or only control dining halls for 90% or more of their dining hall visits during the first three weeks of the academic term

Student Focus Group:

* Must have participated in the student survey
* We will stratify the sample by selecting respondents whose red meat consumption either increased, decreased or remained the same (based on baseline to endline comparisons of data in the student survey)

Dining Staff Interviews:

- Must have been a non-student member of the Michigan Dining staff at one of the six project dining halls during the relevant intervention period.
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health
* Is confirmed human immunodeficiency virus (HIV)-uninfected
* Is at low risk of HIV infection
* For males, uses contraception in accordance with local regulations regarding contraception use for those participating in clinical trials
* For females, is not pregnant or breastfeeding and one of the following applies:
* Is not a participant of childbearing potential (POCBP)
* Is a POCBP and uses an acceptable contraception method or is abstinent

Exclusion Criteria:

* Has an active diagnosis of hepatitis (B or C) due to any cause
* Has a history of malignancy ≤5 years before signing informed consent
* Has a history or current evidence of any condition that might confound study results or interfere with study participation
* Has a history of keloid in upper arm or presence of tattoo, scar, or other physical finding that could interfere with implant placement (the contralateral arm may be used if the findings are limited to 1 arm)
* Is taking or is expected to take immunosuppressants during the study
Lactoferrin Prophylaxis in VLBW and Regulator T-cells

The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.


Eligibility Criteria:
Inclusion Criteria:

* Inborn infants
* Gestational age \< 32 weeks
* Birth weight \< 1500 g
* Parental consent

Exclusion Criteria:

* Congenital abnormalities
* Severe perinatal asphyxia
The Prevalence of Rheumatic Heart Disease in School Children in Fiji

This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School children will be enrolled after informed consent has been obtained. A standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician. All children with or without murmur will have a screening echocardiogram performed at a subsequent visit. Children found to have possible, probable or definite RHD or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit. They will all also be referred to a paediatric cardiologist for further investigation and management and monitoring . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at CWMH in Suva.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent will be obtained for all participants
* All children between the ages of 5-14 Years are eligible for the study.

Exclusion Criteria:

* None
Candesartan Effect in Second Stage Arterial Hypertension

To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen


Eligibility Criteria:
Inclusion Criteria:

* Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

Exclusion Criteria:

* Current serum-creatinine \>3 mg/dL, Current serum-potassium \>5.5 mmol/L, 16.
* Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study

This activity will have the objective of testing the validity of the integrated in-game assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders in youth.


Eligibility Criteria:
Inclusion Criteria:

* children and adolescents between 8 and 16 years old
* provided written parental consent
* able to access mobile/internet applications on their device

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder
Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea \>30/min or dyspnea at rest).
* Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection.

Exclusion Criteria:

* Hypercapnia (above 47 mmHg)
* Chronic respiratory failure
* Previous mechanical ventilation in the days before admission
* Need of immediate NIV or intubation
* Refusal
* Pregnancy
Urinary Retention After Removing Urinary Catheter at 24 Hour Versus 48 Hour in Patients With Vaginal Surgery

Comparison incident of urinary retention in patients with vaginal surgery of pelvic organ prolapse, who removed urinary catheter at 24 hours versus 48 hours after surgery

Vaginal surgery of pelvic organ prolapse needs to insert urinary catheter for monitoring post-operative complication, hemodynamic status, and prevention post-operative urinary retention. Urinary retention occur 2.4 - 43% after pelvic organ prolapse surgery, whereas retaining urinary catheter is common cause of urinary tract infection, often hospital-acquired infection. At Rajavithi hospital always remove urinary catheter at 48 hour after surgery. Accordingly, appropriated time for removing urinary catheter in patients with vaginal surgery of pelvic organ prolapse is unclear. This study aims to reduce timing for removing urinary catheter after vaginal surgery, not increase urinary retention and re-catheterization and reduce urinary tract infection and day of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Woman with pelvic organ prolapse, who undergoing vaginal surgery and agrees to participate in this study
* Able to understand and communicate Thai language

Exclusion Criteria:

* Woman with diabetes mellitus with HbA1C \> 10.9%
* Woman with stroke
* Woman with urinary tract infection before surgery
* Woman with urinary retention before surgery
* Woman, who experienced surgery for urinary incontinence
* Woman, with operative complication including of hemorrhagic shock (Blood pressure \< 90/60 mmHg, Heart rate \> 120 beats per minute, Intra-operative blood loss \> or = 750 ml), urinary tract injury, bowel injury