cyrilzakka/clinical-trials huggingface dataset:
Vicente Ferrer HIV Cohort Study

The VFHCS is a long-term prospective cohort study of HIV infected patients from a resource-poor rural setting in India. The aim of the study is to use data collected from routine clinical care in order to describe the epidemiology of HIV and its related conditions in the investigators area, and to study the effectiveness of health interventions in a "real-world" setting (implementation and operational research).

Andhra Pradesh is the state with highest burden of HIV in India. Anantapur is a district situated in the South border of Andhra Pradesh with 72% rural population and adult literacy rate of 74.1% in men and 54.3% in women. In Anantapur, the HIV epidemic is largely driven by heterosexual transmission and it is characterized by poor socioeconomic conditions and high levels of illiteracy.

Rural Development Trust (RDT) is a nongovernmental organization, which provides medical care to people living with HIV free of charge, including medicines, consultation and admission charges. In Bathalapalli Hospital, outpatient clinics and 71 beds are allocated exclusively for HIV or tuberculosis infected patients.

The Vicente Ferrer HIV Cohort Study (VFHCS) is a prospective open cohort study of all HIV infected patients who have attended Bathalapalli RDT Hospital. Routine clinical data from patients are collected prospectively since September 2009 and entered in a SQL-server database using C# as front end. Details of route of transmission, HIV associated risk factors and socio-demographic data are collected at enrolment. Data collected include medical treatment (antiretroviral treatment and other medications), laboratory investigations (haemogram, renal function tests, liver function tests, CD4 lymphocyte count, bacterial infections), and standardized diagnoses.

The objective of the VFHCS is to describe social and medical aspects related to HIV in the investigators setting, including:

1. Epidemiology: trends in HIV incidence, transmission mechanisms, socioeconomic risk factors associated with HIV.
2. Incidence and prevalence of opportunistic infections, especially tuberculosis and cryptococcosis.
3. Life expectancy and factors associated with mortality
4. Describe the retention across the continuum of care and investigate factors associated with loss to follow-up.
5. Toxicity and effectiveness of antiretroviral therapy.
6. Effectiveness of programmes to prevent mother to child transmission.
7. Incidence and prevalence of non-communicable diseases such as cancer or cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Positive serology for HIV

Exclusion Criteria:

* Refuse to consent
Serotonin and Everyday Social Interaction

Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor serotonin function may also contribute to MDD. Recent research suggests that serotonin plays a role in regulating human social behaviour. Therefore it would be intriguing to investigate the role of serotonin in regulating the quality of everyday social interactions in a population at risk for MDD. Human social behaviour can be reliably assessed in everyday life using Ecological Momentary Assessment (EMA).

Objective: This study aims to investigate how an experimental increase in serotonin influences social functioning in healthy adults with a first-degree family member diagnosed with MDD. The primary goal is to investigate the role of serotonin in regulating everyday social behaviour, measured using EMA. This will be done using oral supplementation with tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this experimental manipulation influences people's feelings as well as their perceptions of other's social behaviour following interpersonal events, and social cognitions at the end of the day. An exploratory goal is to investigate if these effects are moderated by genes thought to be involved in MDD.

The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* At least one first-degree family member with MDD
* Willingness to cooperate; to sign written informed consent

Exclusion Criteria:

* Any current or past MDD or other mood disorder as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)
* Any current anxiety disorder, psychotic disorder, substance use disorder, eating disorder, or somatoform disorder as determined by SCID
* Any contraindication for the use of tryptophan, i.e. pregnancy, diabetes, cancer or a history of cancer, a history of any scleroderma-like condition, evidence of achlorhydria, upper bowel malabsorption, or irritation of the urinary bladder
* Current use of psychotropic medications including medications for psychiatric problems (e.g., antidepressants such as Mono Amine Oxidase inhibitors and fluoxetine) or migraines
* Not speaking Dutch fluently
Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections

The insertion of peripheral vascular catheters (PVCs) is the most often invasive procedure performed in hospital settings. During hospitalization, the majority of patients need to have a PVC inserted. These devices are not risk-free, affecting patients' safety and well-being. In clinical settings, health professionals must deal with difficult venous accesses due to the patient's age, physical characteristics, clinical status, and medication, which hinder the PVC insertion. When veins are not visible or palpable, this may lead to successive puncture attempts, causing pain to the patient and discomfort to the nurse, which results in increased costs.

Guidelines state that puncture should be attempted only twice per professional, to a maximum of four attempts; against this recommendation and due to the patient's therapeutic needs and clinical situation, health professionals attempt to puncture multiple times in a single scenario. In this regard, health professionals should consider using specific technologies that help to select the vein and reduce the number of puncture attempts and catheter-related mechanical complications. Taking into account the multiplicity of existing technologies in the international market that assist health professionals in peripheral venous catheterization, ultrasound and infrared devices emerge in the literature as two of the most commonly used during this procedure.

These technologies were developed with the purpose of improving peripheral intravenous catheterization success rate and thus reducing the number and extent of the negative effects of multiple or unsuccessful attempts, with the additional purpose of avoiding the frustrations of health professionals in these scenarios. However, such technologies are still underused in clinical practice, since health professionals are not familiar with the use of these devices. Moreover, the costs associated with their purchase and maintenance may be considered as excessive in relation to the traditional method.

The project investigators aim to determine whether the use of either ultrasound or near-infrared vascular imaging will significantly improve the success rate of peripheral intravenous catheterization in adults on first attempt by nurses compared with the standard approach, reduce immediate related complications and improve patient and provider satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Participants who require peripheral intravenous catheterization as part of routine care;
* Participants whose primary nurse agrees to participate in the study;
* Participants who are able to give written assent or oral assent.

Exclusion Criteria:

* Confused and/or disoriented participants;
* Participants who are unable to communicate orally and/or in writing.
The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula

The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula

Recently, the use of biomaterial for the treatment of anal fistula has drawn great interest. The advantages of this technique include simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and the ability for subsequent surgical options if needed. Champagne et al reported using a biologic absorbable anal fistula plug which is made from lyophilized porcine small intestinal submucosa (Surgisis®). In their series of 46 patients treated with the anal fistula plug, a success rate of 83 percent was achieved at a median follow-up of 12 months. In addition, evaluation of the functional outcome after fistula closure showed no impairment of continence with significant improvement in quality of life showed. However, the long term success rates of Surgisis® are variable according to other studies.

Human acellular dermal matrix (ADM) is a biologic material consists of dermis without its cellular components. Early and rapid revascularization of the implanted ADM, as was shown in our previous experimental study, is thought to enhance resistance to infection and contamination. These properties make ADM an attractive alternative for the treatment of anal fistula. The ability of ADM to become vascularized and remodeled by autologous cells may be advantageous for anal fistulas healing.

The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula.

Eligibility Criteria:
Inclusion Criteria:

* complex anal fistula

Exclusion Criteria:

* pregnancy or lactation
* with operation contraindication
* allergic constitution to heterogeneous protein
* complicated with tumor
* complicated with acute infection
Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health

Exposure to electromagnetic field (EMF) emitted by mobile phones and devices with WIFI is on the rise and so is the EMF effects on sleep quality and well-being of individuals with high exposures to EMF. Some studies have shown poor sleep quality among individuals with long-term occupational exposure to EMF, and some have shown association between EMF long-term exposure and neuropsychiatric disorders including depression. This study aims to investigate a commercially available EMF- blocker blanket, called Sleepgift, that claims helping people to have a better sleep and improved health. We will investigate the Sleepgift efficacy on adults' quality of sleep and their vital signals as a measure of their well-being in a placebo-controlled single- blind cross-over designed study. Participants will sleep in our sleep lab at baseline and then 10 days later with the Sleepgift blanket after using it every night for the past 10 consecutive days. Participants will be given two blankets for each cycle of the study as it is a cross-over designed study: one Sleepgift and one regular blanket; they will not know which one is real or sham. There will be one-month washout period between the two cycles of the cross-over study. We aim to enroll 30 adults for the study. Participants' sleep quality will be measured by the established device called Prodogy; their vital signals will also be measured and monitored through the night. The collected data will be analyzed statistically for any significant effect of the Sleepgift blanket on sleep quality and vital signals such as heart's rhythm and heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* 18 y\<age\<70 years
* Being generally healthy (cognitively and psychologically)
* ability to read, write and speak English fluently.

Exclusion Criteria:

* Being diagnosed with any neurological, intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder.
* Inability to adequately communicate in English
* Current substance abuse disorder
* Currently participating in another therapeutic study
* Being on a regular pain killer, sleeping or depression pill.
Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery

The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months.

The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65
* Clinical - radiological presence of hip fracture

Exclusion Criteria:

* Age \<65
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Completion of all required visits of a qualifying Phase 3 core protocol
* Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

Exclusion Criteria:

* Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function

The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image.

This is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan.

The presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function.

The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire.

The anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.


Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18 years
* dutch-speaking
* ongoing pregnancy before 14 weeks GA
* intending to deliver in UZ Leuven
* ICF

Exclusion Criteria:

* age \< 18 years
* not dutch-speaking
* non evolutive pregnancy
* pregnancy over 14 weeks GA
* intention to deliver elsewhere
Twins MR Imaging Study

This study aims to create a comprehensive Magnetic Resonance Imaging data resource in twins aged 18 years and older. The data will be used alone or in conjunction with existing data to explore organ-specific ageing and twin-pair differences related to ageing and disease.

BACKGROUND Diverse interactions between environmental, genetic, and epigenetic factors shape individual paths of ageing and disease. In young adulthood, twins are highly similar in most organ structures, but their similarity decreases over time as they are progressively exposed to different environments. Twin studies provide an ideal way to investigate how the body ages and how age-related diseases (such as Alzheimer's disease, heart failure, fatty liver disease, and cancer) develop. Magnetic Resonance Imaging (MRI) is a type of scan that produces detailed images of the inside of the body. MRI enables non-invasive and safe visualisation of age and disease-related changes in the body, often long before clinical symptoms are perceived. MRI-derived biological features/biomarkers can be used to understand the influence of environmental exposures on ageing and disease.

PARTICIPANTS 2500 adult (age 18 and older) volunteers of TwinsUK, the UK's largest adult twin Biobank and the most clinically detailed globally, will be invited to participate. Interested individuals will complete screening to confirm study eligibility and their safety for MRI scanning. Eligible participants will complete informed consent prior to undertaking research MRI scans of their brain, spine, heart, abdomen and parts of their skeleton and muscles. 350 twins with differences in their data will be invited to repeat the MRI scans about two years later to explore longitudinal multi-organ imaging correlates of key environmental exposures based on cross-sectional signals and existing literature.

PROCEDURES Two 45-minute MRI scans of (1) the head and spine and (2) the abdomen to the upper thigh.

OUTCOMES Imaging-derived measures of morphology and function of the brain, spine, abdominal organs and musculoskeletal tissue. These measures will be used to identify twin pair differences related to ageing and disease. A comprehensive repository of MRI data will be created using protocols harmonised with the UK biobank. This will facilitate subsequent linkage with concurrently acquired samples and historic exposome data in longitudinal twin cohort.

Eligibility Criteria:
Inclusion Criteria:

* Identical or non-identical twins
* Gender: Male or Female
* Age: 18 years or above at the time of recruitment
* Must be able to understand the study information and provide informed consent
* Participation in the TwinsUK Biobank

Exclusion Criteria:

* Pregnancy
* Unable to tolerate MRI Procedures, e.g., claustrophobia, severe anxiety
* Contraindication to MRI Scanning, e.g., presence of non-MR conditional implants
* Any additional condition declared voluntarily by the participant that the principal investigator (PI) deems likely to affect the study's outcome.
MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.

This is a multicenter, open-label study of maralixibat in subjects diagnosed with cholestatic liver disease (including, but not limited to ALGS, PFIC or Biliary Atresia) who have previously participated in a maralixibat clinical study. All subjects will receive maralixibat in this study.

Eligibility Criteria:
Inclusion Criteria Subjects will need to meet all criteria below to be considered eligible for the study.

1. Provide informed consent and assent (as applicable) per the Institutional Review Board/Ethics Committee (IRB/EC).
2. Previously participated in a maralixibat study and with approval of the Medical Monitor. Previous participation is defined as:

   * Having completed the EOT Visit, for subjects coming from the maralixibat Phase 2 studies.
   * Having completed the entire duration of the study (i.e., core and extension, if applicable), for subjects coming from the maralixibat Phase 3 studies.
3. At least 1 year of age
4. Males, and females of non-childbearing potential. Males and non-pregnant, non-lactating females of childbearing potential who are sexually active must agree to use acceptable contraception during the study and 30 days following the last dose of the study medication. Females of childbearing potential must have a negative pregnancy test.
5. Caregivers (and/or age appropriate subjects) must have access to email or phone for scheduled remote visits if applicable.
6. Subject and caregiver willingness to comply with all study visits and requirements.

Exclusion Criteria

A subject will be excluded from the study if any of the following exclusion criteria are met:

1. Experienced an AE or SAE related to maralixibat during the lead-in protocol that led to permanent discontinuation of the subject from maralixibat.
2. Any conditions or abnormalities (including laboratory abnormalities) which, in the opinion of the Investigator or Medical Monitor may compromise the safety of the subject or interfere with the subject participating in or completing the study.
3. History of non-adherence to medical regimens, unreliability, medical condition, mental instability or cognitive impairment that, in the opinion of the Investigator or Sponsor medical monitor, could compromise the validity of informed consent, compromise the safety of the subject, or lead to non-adherence with the study protocol or inability to conduct the study procedures.
Adult Trauma Centers RE-AIM at Gun Safety

The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:

1. (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;
2. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers.


Eligibility Criteria:
Electronic Medical Record (EMR) Participants:

Inclusion Criteria:

* trauma patients admitted to adult trauma inpatient services at participating institutions

Exclusion Criteria:

* none

Patient participants

Inclusion Criteria:

* at least 18 years of age;
* admitted to a participating trauma service for an injury;
* fluent in English or Spanish;
* able to provide informed consent.

Exclusion Criteria:

* prisoner or in police custody;
* admitted due to suicide attempt
* any acute conditions that would preclude provision of informed consent or assent (i.e., acute psychosis, altered mental status, cognitive impairment).

Staff participants

Inclusion Criteria:

* trauma service physician, physician assistant, nurse practitioner, nurse or social worker at participating pediatric trauma center

Exclusion Criteria:

* none
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS

Primary objective:

* to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions.

Secondary objectives:

* to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population.
* to document SSR149744C plasma level during the study.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia OR implanted with an ICD and with at least one appropriate ICD therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year.
* Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months.

Exclusion Criteria:

MAIN CRITERIA (non-exhaustive list):

* Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.