cyrilzakka/clinical-trials huggingface dataset:
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder

This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.

This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.

Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
* Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5

Exclusion Criteria:

* Do not want to participate in the study
* Ongoing intoxication (e.g. severe alcohol intoxication)
* Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
* Not oriented
* Not having a memory ot the tramatic event
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension

This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
* Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and \< 180 mmHg at the randomization visit (Visit 201) and msSBP ≥140 mmHg \< 180 mmHg at the visit immediately proceeding Visit 201 (Visit 102 or 103).
* Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and \< 180 mmHg at both Visit 1 and Visit 201.
* Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit;

Exclusion Criteria:

* Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg).
* History of angioedema, drug-related or otherwise, as reported by the patient.
* History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol-defined inclusion/exclusion criteria may apply.
HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia

The population of inpatients is large in Zambia; however, because of poor linkages between hospitals and community HIV care, there are few data to analyze their engagement in HIV care before and after hospitalization. The goal of the study is to learn more about Zambian adults who are HIV-infected and get hospitalized. The purpose of this study is to gather formative, preliminary data, to be used in future grant applications to improve linkage and engagement in HIV care in Zambia.

The main objective of this study is to generate preliminary data on the outcomes of Zambian HIV-infected individuals after discharge from University Teaching Hospital (UTH) Internal Medicine wards which can inform development of a linkage intervention. Our central hypothesis is that in Sub-Saharan African settings like Zambia hospitalizations among HIV-infected individuals are driven by suboptimal linkage and initiation of ART following HIV diagnosis. Specific Aims: (a) Characterize the distribution of hospitalized 300 HIV-infected adults across the HIV care continuum. (b) Identify structural, psychosocial, clinic, and medical factors that predict suboptimal linkage to care and ART initiation after 90 days of hospital discharge among HIV-infected Zambians.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* HIV-infected as documented in the UTH file
* Admitted to Internal Medicine Ward at UTH

Exclusion Criteria:

* Unable to provide informed consent
* Not planning to remain in Lusaka province for 3 months after discharge
Smoking Interventions in the General Population

The study takes up two problems: 1) Little research exists about general population interventions for smokers not ready to quit within the foreseeable future. 2) There is little evidence for smoking reduction as a behavioural goal in interventions. Interventions based on the Transtheoretical Model of Behavior Change (TTM) using computer expert-system technology yield delayed and smaller effects in smokers in the precontemplation stage of change compared to smokers in more advanced stages of change. Reducing the number of cigarettes smoked per day is currently discussed as an intermediate goal for this subgroup. Epidemiological and clinical studies revealed that smokers are able to maintain a substantial reduction. No undermining effects with respect to smoking cessation have been found. However, there are no studies that test the efficacy of behavioural interventions for smoking reduction using population based recruitment. Objectives: Testing the efficacy of TTM based interventions for general population smokers not intending to quit smoking, i.e. a smoking-reduction and a smoking-cessation tailored intervention using computerized expert-system technology.


Eligibility Criteria:
Inclusion Criteria:

* Daily smoking of 10 or more cigarettes
* No intention to quit within the next six month
* Age of 18 years and older
* valid telephone number

Exclusion Criteria:

- Insufficient german language and cognitive capabilities to complete the assessment
Cancer Patients' Medication Knowledge in the Emergency Center

The goal of the study is to learn about patients' knowledge of their medications in an outpatient acute care setting (such as the M. D. Anderson Emergency Center) and to learn about any clinical factors that affect patients' knowledge of their medications.

You will be asked to list your prescription medicines, over-the-counter medicines, herbal preparations and vitamins, minerals and supplements that you take. Information about you (such as age or gender), the status of the disease (such as cancer diagnosis and extent of disease), and your Emergency Center visit (such as your reason for visit and discharge diagnosis) will be collected from your medical record.

To find out if your answers on the questionnaire are correct regarding the medications you take, researchers will check the pharmacy database for medications you fill at the M. D. Anderson pharmacy, your medical record, and contact any outside pharmacy that you may use to fill your medicines, with your permission. In order for outside pharmacies to release the requested medication information, you will need to sign an Authorization for Disclosure of Health Information from Pharmacy Records.

Your information will be kept confidential. All patient data will be reported and published as a group. You will not be individually identified. Data will be stored with patient codes so that your identity will be protected. In addition, the study database will be password protected.

You may be contacted in the future for more information; however, you are not obligated to answer any future questions just because you agreed to participate in this study.

This is an investigational study. About 350 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the Emergency Center
2. Patients must be able to read and write English
3. Patients must agree to participate and sign informed consent
4. Patients 16 years or above. (Age limit explained below)
5. Patients must be able to complete the survey tool. They may have help from a caregiver in transcribing the information but the caregiver can not fill the tool independent of the patient. A research assistant will be trained to discriminate whether a caregiver is acting as a scriber or independently completing the tool. If the caregiver completes the tool independently, the patient will be excluded from the study.

Exclusion Criteria:

1. Patients with altered mental status and those with an acute, emergent illness and hemodynamic instability (Examples: status epileptics, sepsis, and cardiac arrest)
2. Employees of the institution with work-related injuries
3. Visitors who are non-cancer patients
4. Patients transferred directly from another hospital
5. Patients will be excluded after their first enrollment during the study period. (Can only be enrolled once though may have multiple Emergency Center visits during study time frame).
6. Patients will be excluded if all prescribed medications are filled at an external pharmacy and this pharmacy is not accessible.
Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study

The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD).

The main question\[s\] it aims to answer are:

\[question 1\] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? \[question 2\] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?

Background Inflammation is related to the occurrence and development of fatty liver. Our research aimed to investigate the link between an inflammatory indicator, high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD).

Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the NHANES database, respectively. The relationship between hsCAR and MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same methodology.

Eligibility Criteria:
Inclusion Criteria:

* Total participants from NHANES 2017-2020
* Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver disease (MAFLD) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.

  1. Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥ 6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); (4) 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L (200 mg/dL).
  2. Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
  3. If presence of at least two metabolic risk abnormalities:

     * Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in Asian men and women)
     * Blood pressure≥130/85 mmHg or specific drug treatment
     * Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment
     * Plasma HDL-cholesterol \<40 mg/dl (\<1.0 mmol/L) for men and \<50 mg/dl (\<1.3 mmol/L) for women or specific drug treatment
     * Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl \[5.6 to 6.9 mmol/L\], or 2-hour post-load glucose levels 140 to 199 mg/dl \[7.8 to 11.0 mmol\] or HbA1c 5.7% to 6.4% \[39 to 47 mmol/mol\])
     * Homeostasis model assessment of insulin resistance score≥2.5
     * Plasma high-sensitivity C-reactive protein level \>2 mg/L

Exclusion Criteria:

* Liver ultrasound data not available
* participants without complete clinical data
* participants under 18 years old
* participants with cancer.
Virtual World Training for Community Health Workers (CHW)

Standard, effective, and scalable training models are needed to help equip community health workers in their community-based diabetes prevention awareness efforts. This study will tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to remotely deliver a diabetes prevention awareness training program to community health workers.

Standard, effective, and scalable training models are needed to help equip community health workers in their community-based diabetes prevention awareness efforts. This study will tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to remotely deliver a diabetes prevention awareness training program to community health workers. A sequential mixed-methods design is used to address these specific aims: 1. Use community-based participatory research methods to guide the overall study and inform tailoring and adaptation of our virtual world model to deliver the CHW training program; 2. Conduct a randomized pilot study to compare change in primary outcomes (0, 12 weeks) after the in-person versus virtual world delivery of the program; and 3. Conduct summative focus groups to gather information to refine the program and study methodology.

Eligibility Criteria:
Inclusion Criteria:

* community health worker
* 18-65 years old
* Female
* Of African American/Black/African ancestry
* not getting 150 minutes of physical activity weekly and/or overweight
* residing in Chicago/driving distance to Chicago study site
* regular access to internet and computer

Exclusion Criteria:

• does not meet inclusion criteria
Translating ECHOS2 Into an mHealth Platform

Childhood cancer survivors are at an increased risk of cardiac toxicity due to prior anti-cancer therapy. However, adherence to cardiac screening in this population remains low. This study aims to assess the feasibility of an mHealth motivational interviewing platform called Computerized Authoring Intervention Software (CIAS) in childhood cancer survivors. Participants will be recruited from the Childhood Cancer Survivorship Study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed with cancer at age 17 or younger
* 2 or more years after completion of cancer therapy
* Receipt of cardiotoxic therapy (Any dose of anthracycline or 15 Gy chest radiation involving cardiac structures)
* No history of cardiomyopathy
* Have not received an echocardiogram in the past 5 years
Way to Cure HCV Adherence

This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.

This 3-arm trial will field test the efficacy of "Way to Cure" intervention on medication adherence in Hepatitis C for 12 weeks. As part of routine clinical care all patients will receive medication counseling regarding proper use and side effects by trained nurses or pharmacists depending on the clinical site.

Arm 1: Control (n=20) - Monitoring pill box will be set into "quiet mode". This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill bottle, however, does not remind the participant to take the medication. In the event no electronic signal is received by the platform for 96 hours, the RA will call the participant to assess any usability or connectivity issues.

Arm 2: Intervention - Reminders/Feedback (n=20) - Patients will receive tailored text message reminders to take the medication if in case the interval from last box opening is \>30 hours (greater than 6 hours overdue). Patients will receive weekly text messages with summary cumulative adherence scores.

Arm 3: Intervention - Reminders/Feedback and Financial Incentives (n=20) - In addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a financial incentive each week they demonstrate perfect \>85% adherence. The weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.

Eligibility Criteria:
Inclusion Criteria:

a) age 50 older, b) prescribed a fixed dose combination HCV regimen containing sofosbuvir/ledipasvir for 12 weeks, and 3) willing to receive text message communications.

Exclusion Criteria:

a) non-English speaking, b) have severe vision, hearing impairment precluding study participation, c) no text messaging capability, d) decompensated cirrhosis requiring hospitalization in the past 30 days, e) medication primarily given by a caregiver/facility
Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis

A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.

Multiple sclerosis (MS) is a debilitating and incurable chronic disease. Patients might benefit from peer support provided by patients entitled to give advice on daily life management with MS. Studies have shown that peer support can enhance chronic patients' quality of life in Psychiatry and Oncology.

This pilot study aims at assessing the impact of peer support on therapeutic adherence and quality of life in patients with MS, but also to appraise the project feasibility and acceptability among the healthcare team, with large-scale implementation in mind.

This mixed methods pilot study consists in a monocentric open-label randomized controlled trial. It is located in Nantes, France, and aims to recruit 60 patients with relapsing-remitting MS undergoing drug therapy from the Nantes University Hospital Neurology Department. Patients will be randomized 1:1 to receive either usual care only or usual care combined with peer support (3 individual sessions at 1, 3 and 5 months with a peer support specialist).

Primary outcome is enhanced therapeutic adherence 6 months after baseline, secondary outcomes include therapeutic compliance, quality of life, anxiety and depression, social support. All dimensions will be assessed using validated health questionnaires at baseline and at 6 months.

Interventions acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and 2 focus-groups, one with the peer support specialists and the other with the healthcare team.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* With relapsing-remitting MS according to 2017 revised Mc Donald criteria
* Attending medical consultation at Nantes University Hospital Neurology Department
* For whom background drug therapy is needed (oral or injectable)
* Who gave consent to participate in trial

Exclusion Criteria:

* Primary-progressive or secondary-progressive MS patients
* Patients under protection of vulnerable adults measure or convicted
* Patients not fluent in French
* Patients with severe cognitive impairment, who may find difficult filling out questionnaires properly
* Patients with a risk of follow-up interruption (move, nomadism...)
Human Papilloma Virus Awareness Intervention

Intervention aimed at increasing knowledge of the human papillomavirus in homosexual men as a means of preventing sexually transmitted diseases and controlling complications associated with the pathology.

Introduction: The World Health Organization reports a 21% prevalence of Human Papillomavirus (HPV) in men, with rates reaching 93% among homosexual men. This group exhibits specific characteristics, such as high rates of sexually transmitted infections (STIs) due to multiple partners and inconsistent condom use, along with limited knowledge about HPV. The intervention "Safe and Protected Sex", using a horizontal methodology, aims to address this health issue.

Objective: To evaluate the effect of the "Safe and Protected Sex" program on HPV knowledge among homosexual men.

Methodology: A quasi-experimental study with a test-retest design and convenience sampling. The sample size was calculated using n'Query Advisor 4.0, resulting in 20 homosexual men per group (n=40).

Eligibility Criteria:
Inclusion Criteria:

* Males who self-identify as homosexual and/or bisexual.
* Engage in sexual relationships with individuals of the same sex.
* Willing to voluntarily participate in the study.
* Have provided informed consent.

Exclusion Criteria:

* Homosexual and/or bisexual males with a profession related to the healthcare field.
A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial

This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential should have a negative urine pregnancy test prior to Screening and Day -2 of the trial
* All subjects of childbearing potential must practice a highly effective method of birth control excluding oral contraceptives for the duration of the trial and up to 3 months after the last dose of investigational product. Oral contraceptives are not allowed, based on the precaution listed in the Zanaflex package insert.
* Have a body mass index (BMI) ranging between 19 and 30 kg/m2
* Comprehend and be able to provide written informed consent
* Be willing and able to comply with all trial requirements

Exclusion Criteria:

* Female who is either pregnant, breastfeeding or planning to become pregnant
* History of hypersensitivity or allergic reaction to tizanidine or moxifloxacin or any of the tablet components
* Any condition possibly affecting drug absorption, metabolism or excretion including previous surgery for removal of parts of stomach, bowel, liver, gall bladder, or pancreas
* History of Long QT Syndrome or a first-generation relative with this condition
* Evidence or history of clinically significant allergies except for untreated, asymptomatic, seasonal allergies at time of dosing, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease. Determination of clinical significance is to be made at the Investigator's discretion
* History or presence of any malignant or benign neoplasm considered by the investigator to be clinically significant
* History of drug or alcohol abuse or dependence within the last year
* Have an active infectious disease