cyrilzakka/clinical-trials huggingface dataset:
Factors Associated to the Instability of the INR (International Normalized Ratio ) in the Prevention of Thromboembolism AVK (Anti Vitamin K) in Atrial Fibrillation in the Elderly: Instead of Comorbidities

Atrial fibrillation (AF) is a common condition whose prevalence increases with advancing age . One of the main complications of this arrhythmia is the occurrence of systemic thromboembolism, the first of which the occurrence of cerebrovascular accident (CVA) . The advanced age itself is an independent risk factor for occurrence of stroke in the context of AF , evidenced by the score awarded to the age over 75 years in the risk estimate thromboembolism in the score CHA2DS2-Vasc . Making the elderly a priority target for the prevention of thromboembolism, both because of the increased thromboembolic risk and prevalence of AF in this population. For many years, vitamin K antagonists (VKA) have proven their effectiveness in this context . But the effectiveness and safety of thromboembolism prevention by anti-vitamin K treatment involves maintaining the INR (International Normalized Ratio) in the therapeutic range. Indeed occurred of a thromboembolic or haemorrhagic adverse event directly correlates to having an INR outside the therapeutic range and maintaining the INR in the therapeutic range is subject to many variations inter- and intra-individual. They include, genetic factors , food , drug interactions , as well as disease processes . Or one of the elderly characteristics is the coexistence of multiple pathological processes or comorbidities . The supposed interaction between comorbidities and variability of INR has been little studied: Only a few studies have examined the factors associated with the stability of the INR and unstable . The identification of patients at risk of instability INR yet allow clinicians greater vigilance and better identification of patients for whom the initiation of treatment with vitamin K does not appear the best therapeutic strategy.

Our study seeks to determine whether comorbidity, assessed by the Charlson comorbidity index, are associated with instability of the INR, among more than 80 years for patients treated with AVK atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 80 years or more;
* Patients present in geriatric structure June 21, 2011 ( short geriatric , SSR , LTC or nursing homes ) ;
* Patients with AVK June 21, 2011 or having received warfarin in the previous 7 days ;
* Patients with AVK under thromboembolism prevention in atrial fibrillation .

Exclusion Criteria:

* - Patients receiving AVK for another reason thromboembolism prevention for atrial fibrillation : treatment of venous thromboembolism , pulmonary embolism, mechanical heart valve , etc
Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD

Study Summary: This study is being conducted in order to rigorously evaluate the real-world effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk for FASD, as delivered under routine practice conditions.

Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list control group receiving standard services, the treatment group receiving COS will show greater improvement in caregiver behaviour, as well as child emotional and behavioural outcomes.

See Arms and Intervention

Eligibility Criteria:
Inclusion Criteria:

* Two criteria must be present for a family (caregiver-child dyad) to be included in the COS component of the FASD Outreach Program and its evaluation:

  * the child was exposed to alcohol prenatally and has been clinically evaluated using the Canadian FASD diagnostic guidelines as having Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), Alcohol Related Neurodevelopmental Disorder (ARND), or is considered "at risk" for FASD based on their confirmed history of prenatal alcohol exposure and clinical multidisciplinary assessment; and
  * evidence of disrupted caregiver behaviours or problems in the caregiver-child interaction as identified through a screening process consisting of clinical judgment and the SBSH procedure.

Exclusion Criteria:

* children from foster families who have experienced more than 2 placements in the last six months,
* children who have an Autism diagnosis,
* children with a developmental quotient less than 50,
* children with sensory impairments (hearing or sight impaired), and
* children who are already involved in New Directions' 'Self Regulation Therapy Project'.

Children who have parents who are clinically depressed, whose parents have substance abuse or domestic violence issues, or whose parents display a narcissistic devaluation personality trait based on initial clinical evaluation, will also be excluded from study eligibility.
Anxiolytic Effectiveness of Virtual Reality Glasses in Surgery

Regional anesthesia allows surgery without affecting the patient's level of consciousness.However, this may cause anxiety in some patients.In previous research, scientists have tried to prevent anxiety with non-pharmacological interventions such as music and cognitive therapies.Virtual reality is thought to offer an immersive experience that can alter the mind's perception of pain. Scientists have found in previous preliminary studies that virtual reality is safe and effective as an adjunct to standard sedative/analgesic protocols for reducing patients' pain and anxiety during endoscopy, colonoscopy, dental treatments, burn dressings, and labor. In this study, it is expected that anxiety scores, postoperative analgesic need and intraoperative sedation need will decrease, recovery quality will improve and patient satisfaction will increase in patients who will undergo upper extremity surgery under regional anesthesia and watch videos through VR glasses.


Eligibility Criteria:
Inclusion Criteria:

* who will undergo upper extremity surgery under regional anesthesia

Exclusion Criteria:

* being under 18 years old
* Those who do not have the ability to read, understand and sign the consent form
* An active infection or open wound in the face or eye area
* History of seizures due to an epileptic condition or any other reason
* Planning to wear a hearing aid during the surgical procedure
* Having a pacemaker or other implanted medical device
* Migraine
* Having an infectious condition that is transmitted through droplets or airborne
* not knowing Turkish
* Not deemed suitable for the approach by the surgeon
* History of psychosis or claustrophobia
* Being visually and/or hearing impaired
Molecular and Genetic Analysis of Lung Cancer

Investigators use a genome-wide approach within a case-control design to identify SNPs that show evidence of association with lung cancer risk and survival.

Investigators also investigate how genetic variants may affect cancer treatment, at various stages of disease development, in order to determine prognostic and predictive factors for survival.

Eligibility Criteria:
Inclusion Criteria:

* healthy controls: participants without evidence of any cancer
* cases: pathology proven primary lung cancer

Exclusion Criteria:

* younger than 18 years old
Response Evaluation in Malignant Pleural Mesothelioma

Recently, a few small trials have shown promising results on value of fluoro-2-deoxy-D-glucose and positron emission tomography imaging in response assessment in Malignant Pleural Mesothelioma. These studies considered different parameters in Positron Emission Tomography (PET) analysis, mainly the standardized uptake value and volume-based parameters such as total glycolytic volume.

This is a retrospective analysis of two consecutive and homogeneous series of Malignant Pleural Mesothelioma patients treated with first-line pemetrexed-based chemotherapy and evaluated by CT scan and FDG-PET.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven MALIGNANT PLEURAL MESOTHELIOMA
* Patients not candidate to radical surgery
* Unidimensionally and/or bidimensionally CT-measurable disease and Candidate to first-line pemetrexed-based chemotherapy

Exclusion Criteria:

* Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA
A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.


Eligibility Criteria:
Inclusion Criteria

* Healthy female participants without, in the opinion of the investigator, clinically significant deviation from normal in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations.
* Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. Given participants are postpartum, BMI accommodation up to 35.0 kg/m2 may be expected.
* Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.
* Is willing to exclusively pump breast milk for the 72-hour post dose period of milk collection during CRU confinement, and not to breastfeed or provide milk to infant until after CRU discharge (72 hours post dose).

Exclusion Criteria

* Presence or history of any clinically relevant abnormality, condition, or disease (such as liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study intervention, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if she were to participate in the study.
* Current or recent (within 3 months of study intervention administration) clinically significant gastrointestinal disease that, in the opinion of the investigator, could impact upon the absorption of study intervention.
* Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which are considered clinically significant by the investigator and/or, in the investigator's opinion, may significantly impact breastfeeding or collection of milk from one or both breasts.
* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease, except for isolated gallbladder issues, which are not by themselves exclusionary.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Doxycycline Prophylaxis at Vacuum Aspiration Trial

This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.


Eligibility Criteria:
Inclusion Criteria.

1. Women seeking elective surgical abortion
2. Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.
3. Willing and able to sign an informed consent.
4. Willing to comply with the study protocol.
5. Age at enrollment of 18 years or more.

Exclusion criteria

1. Allergy to doxycycline or any tetracycline
2. Evidence of current pelvic infection
3. Breastfeeding
4. Current or recent use (within the past 7 days) of any other antibiotic.
5. Prior cardiac valve surgery or cardiac valve replacement.
6. Active use of alcohol, heroin, or cocaine.

Post-enrollment Exclusion criteria

1) Abortion procedure not performed
Studying Impact of Religiosity and Spirituality on Depression and Anxiety

The aim of the study is to detect correlation between religiosity/spirituality and severity of depression and anxiety as well as finding impact on quality of life in patients, suffering from one of those disorders or both, who are attending the Psychiatric Clinic and Ward of Assiut University Hospitals. Given the centrality of religious activities in Egyptian society and the Arab population as a whole, finding such correlation may be beneficial in terms of analysing factors that may lead to depression and/or anxiety as well as factors that may reduce their severities.

Religiosity and spirituality are fundamental aspects of the human experience, shaping beliefs, values, and how individuals navigate life's challenges. Religiosity refers to the degree to which individuals identify with, and participate in the practices and beliefs of, a particular religion. It encompasses behaviors like prayer, attending religious services, and following religious teachings. Spirituality, on the other hand, is a broader concept that reflects a sense of connection to something larger than oneself, a search for meaning and purpose in life. This connection can be expressed through religious beliefs, but it can also be independent of religion, encompassing a connection to nature, humanity, or a sense of purpose. Research has increasingly explored the complex interplay between these constructs and mental health. The relationship between religiosity/spirituality and mental health is multifaceted. Religious involvement can provide individuals with social support, a sense of belonging, and a framework for coping with stress. Spiritual beliefs can offer comfort, hope, and a sense of purpose, potentially promoting resilience in the face of challenges. However, the relationship is not always straightforward. Certain religious beliefs or practices could contribute to feelings of guilt, shame, or isolation, potentially impacting mental health. Additionally, negative religious coping styles, such as feeling angry or abandoned by God, might exacerbate mental health problems. Given the centrality of religion in the Arab world, including Egypt, a deeper look into the associations between religiosity/spirituality and psychiatric disorders such as depression and anxiety is warranted.

Eligibility Criteria:
* Inclusion Criteria:

  1. Age above 18 years old.
  2. Diagnosed with Depression and/or Anxiety disorders according to the DSM-5 criteria.
* Exclusion Criteria:

  1. Severe psychiatric disorders including schizophrenia, personality disorders and drug-use disorders.
  2. Patients with cognitive impairment.
  3. Severe comorbid medical condition or disabilities including metabolic diseases and neurological disabilities.
Artificial Intelligence for Real-time Detection and Monitoring of Colorectal Polyps

The investigators hypothesize that the clinical implementation of a deep learning AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps and other anatomical landmarks during colonoscopy. The objectives of this study are to generate preliminary data to evaluate the effectiveness of AI-assisted colonoscopy on: a) the rate of detection of adenomas; b) the automatic detection of the anatomical landmarks (i.e., ileocecal valve and appendiceal orifice).

In this trial, the investigators aim to evaluate the followings:

1. the accuracy of automatic detection of important anatomical landmarks (i.e., ileocecal valve, appendiceal orifice);
2. the accuracy of automatic detection of polyps/adenomas (PDR/ADR);

Eligibility Criteria:
Inclusion Criteria :

* Signed informed consent
* Age 45-80 years
* Indication to undergo a lower GI endoscopy.

Exclusion Criteria :

* Coagulopathy
* Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class \>3
* Emergency colonoscopies
* Hospitalized patients
* Known inflammatory bowel disease (IBD)
* Patients currently in the emergency room
Do PA Interventions Increase Acute Medical Inpatients PA Levels

Physical activity (PA) can help treat and prevent many physical and mental health conditions. However, many of the United Kingdom population do not meet the Department of Health's PA recommendations which is contributing to the high chronic disease burden in the UK population. Many patients who are admitted to acute medical wards have at least one co- morbidity. Inpatients on acute hospital wards do not routinely receive PA advice from healthcare staff. The investigators believe that patients could be encouraged to increase their PA level (PAL) during an admission to hospital.

The investigators have undertaken two previous qualitative studies that proceed this work. The first study found that patients were open to discussing PA during admission to an acute medical unit (AMU). In the second study patients thought motivational interviews focused on PA helped them increase their PAL. Although patients have reported that motivational interviews were beneficial in helping them increase their PA, this has so far not been assessed quantitatively.

The investigators plan to recruit 50-100 patients and randomise them into two groups. One group will receive a short PA intervention and the other a long intervention. The investigators will use the moving medicine online resource to structure both PA intervention. The 'one minute' conversation will be used for the short PA intervention and the 'more minutes' conversation for the long PA intervention. The investigators will measure the PAL of both groups at baseline and at two follow-up points (4 weeks and 12 weeks). The Global Physical Activity Questionnaire will be used to assess participants self-reported PAL. The data collected will be used to describe participants baseline PAL and the treatment effect of the two PA interventions. The investigators will also calculate estimated recruitment and retention rates. The results of this feasibility study will be used to plan a similarly designed powered randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent.
* Patients equal or greater than 18 years of age.
* Patients identified by ward staff as being about to be discharged from hospital over the coming day(s).
* Patients identified by ward staff as being able to walk 10m on flat ground, with or without a walking aid.

Exclusion Criteria:

* Patients who do not understand verbal and written English.
* Patients who currently meet the Department of Health's current aerobic physical activity recommendations as assessed by the GPAQ.
Advocates for All Youth

Advocates for ALLY Youth (ALLY) is a universal, school-based, multicomponent positive psychology program aimed to increase youth's well-being and reduce symptoms of psychological distress including depression, anxiety, and stress.


Eligibility Criteria:
Inclusion Criteria:

* students enrolled at participating schools

Exclusion Criteria:

* none
A Randomized Phase 1 of of MZE001 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.

Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered MZE001 in healthy subjects, in fasted and fed states. Each SAD and MAD cohort will enroll 8 subjects randomized 6 active: 2 placebo to receive single or multiple doses of MZE001.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects, ages 18 - 55 years, inclusive;
2. Must provide written informed consent prior to any study assessments and be willing and able to comply with all study procedures;
3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;
4. Healthy as determined by the Investigator based on pre-study medical history, physical examination, and baseline safety laboratory studies.
5. Able to complete exercise treadmill test with no cardiac abnormalities detected
6. Females of childbearing potential who are sexually active with a non-sterilized partner must use a highly effective method of contraception during study participation and for 30 days after last administration of study drug.
7. Males of childbearing potential must use a highly effective method of birth control during study participation and for 90 days after last administration of study drug.

Exclusion Criteria:

1. Any concurrent condition that in the opinion of the Investigator would interfere with the evaluation of the investigational product or lead to increased risk of harm;
2. Any history of coronary artery disease or cardiovascular disease;
3. History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
4. History of cancer within past 5 years, with the exception of non-melanoma skin cancer and treated / excised melanoma;
5. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to the Screening visit;
6. Fridericia's corrected QT (QTcF) \> 450 ms for male participants and \> 470 ms for female participants or history of QT interval prolongation;
7. History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion
8. Resting seated blood pressure \< 90/40 mmHg or \> 140/90 mmHg
9. Resting seated heart rate \< 45 bpm or \> 99 bpm
10. Poor peripheral venous access;
11. Have a history of drug hypersensitivity or anaphylaxis;
12. Current smoker or recent history of smoking within the last 3 months prior to the Screening visit;
13. Have a history of alcoholism or drug abuse or positive drug screen
14. Have used any prescription or non-prescription medicines or have been administered a vaccine within 14 days of admission,
15. Have received any investigational drug within 30 days or \< 5 half-lives, whichever is longer, prior to the Screening visit;
16. Have donated or received any blood or blood products within the 3 months prior to the Screening visit.