louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02772328: A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression
Official title: Randomized Controlled Trial of a Social-network Oriented Mobile Health Based Intervention to Increase Access and Adherence to Hepatitis C Treatment and HIV Viral Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
HIV
Risk Reduction Behavior
Keywords: Testing
Access
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to test an intervention designed to train persons who inject drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1) promote new HCV treatment and care 2) risk reduction and 3) recruit their social network members for HIV and HCV testing and linkage to care.

Detailed description: The investigators propose recruiting 300 HIV/HCV co-infected PWID (i.e. Index participants). Half will be randomly assigned to the experimental condition and half to the equal attention comparison. The experimental intervention will include 8 group sessions that focus on communication to social network members, medical adherence and risk reduction skills, 2 dyad sessions with network members, monthly booster sessions for 6 months, and mHealth cuing of behavior for 6 months. These Index participants will be followed for 24 months (3, 6, 12, 18, \& 24 month assessments). Participants who test positive for HCV will be linked to the Johns Hopkins Viral Hepatitis clinic to assess liver function and HCV chronicity and if applicable offered HCV treatment. Additionally, 450 network members will be recruited and will be tested for HIV and HCV and followed longitudinally to examine the social diffusion and social network factors associated with adherence among the Index participants.

Eligibility criteria: Inclusion Criteria:

* HCV antibody positive
* HIV antibody positive
* lifetime history of injection drug use
* interrupted HIV care:\>3 months since HIV care or detectable viral load
* willingness to participate in group sessions and have conversations with social network members

Exclusion Criteria:

- participated in a behavioral intervention in prior 2 years

Primary outcomes:
measure: Continuity in HIV care scale
timeFrame: 24 months
measure: Access to HCV care scale
timeFrame: 24 months
Secondary outcomes:
measure: HIV medication adherence scale
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Lighhouse Studies @ Peer Point
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Carl A Latkin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Karin E Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010828: Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System
Official title: Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet Japan, Inc.
First posted: 2009-11-10
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.


Eligibility criteria: Inclusion Criteria:

* The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects.

Exclusion Criteria:

* Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)

Primary outcomes:
measure: Force from femoral and tibial side to retract and bring visual field into view
timeFrame: intraoperatively
Secondary outcomes:
measure: Incision length
timeFrame: intraoperatively
measure: Visual determination of the extension and flexion gap
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: National Hospital Organization, Osaka National Hospital
Study officials:
affiliation: Osaka Medical Center
name: Takashi Miyamoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02000128: Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.
Official title: A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Peritoneal Dialysis
fluid overload
bioimpedance analysis
Randomized Controlled Trial
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
2. Design: prospective,randomized,controlled,single center study
3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
4. Objects: incident and prevalent patients with overhydration status.

   1. anticipated cases:240
   2. arms: all the patients are randomized into two arms.(BIA group/clinical group)
   3. observational time:12 months
5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.


Eligibility criteria: Inclusion Criteria:

* patients who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
* 18 Years and older;
* ratio extracellular water (ECW)/total body water(TBW)≧0.4;
* signed the informed consent

Exclusion Criteria:

* patients who have mental graft;
* amputation;
* patients who is unable to accomplish the BIA measurement in standing position for 3 minutes;
* patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard;
* Patients who have acute complications within 30 days prior to study enrollment;
* patients whose life expectancy is within 6 months;
* patients who are pregnant;
* patients who are unable to give consent.

Primary outcomes:
measure: death
timeFrame: 12 months
Secondary outcomes:
measure: technique failure
timeFrame: 12 months
measure: cardiovascular events
timeFrame: 12 months
measure: clinical adverse events
timeFrame: 12 months
measure: residual renal function
timeFrame: 12 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xuqing Yu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03709628: A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
Official title: An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn Disease
Lead sponsor: Enterome
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, open-label
Primary purpose: TREATMENT

Brief summary: Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

Detailed description: This open-label, multicenter study will enroll 8 evaluable patients with active Crohn's disease and will consist of 2 parts. Part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. Part 2 will include the 6 remaining patients with multiple dosing only. This Phase 1b study will investigate the PK, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of EB8018 following 13 days of consecutive BID oral dosing in patients with Crohn's disease.

Part 1 of this study will demonstrate a single oral dose of EB8018 that is safe and tolerable in patients with Crohn's disease and Part 2 of this study will characterize the PK profile when administered as multiple oral doses.

Eligibility criteria: Selection Criteria:

* Male and female patients of nonchildbearing potential ≥18 years of age at screening and Day -1
* Active Crohn's disease based on an elevated calprotectin at baseline.

Primary outcomes:
measure: Cmax
timeFrame: Day1, Day13
measure: Tmax
timeFrame: Day1
measure: AUC0-24
timeFrame: Day1; Day13
measure: T1/2
timeFrame: Day1; Day13
Secondary outcomes:
measure: AE
timeFrame: Up to Day22
measure: RR
timeFrame: Up to Day22
measure: QRS complex
timeFrame: Up to Day22
measure: QT
timeFrame: Up to Day22
measure: PR
timeFrame: Up to Day22
measure: HR
timeFrame: Up to Day22
measure: BP
timeFrame: Up to Day22
measure: RR
timeFrame: Up to Day22
measure: Temp
timeFrame: Up to Day22
Other outcomes:
measure: Gut Microbiome
timeFrame: Up to Day22
measure: Inflammatory Biomarkers
timeFrame: Up to Day22
measure: Inflammatory Biomarkers
timeFrame: Up to Day22
measure: CDAI score
timeFrame: Up to Day22
Locations:
city: Wien
country: Austria
facility: Medical University Vienna
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Nice
country: France
facility: Hôpital de l'Archet 2
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
Study officials:
References:
Clinical trial NCT05706428: Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
Official title: Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Lung; Newborn
Hemodynamic Instability
Echocardiography
Keywords: Premature infants
Echocardiography
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:

I. Primary outcomes:

* Duration of the non- invasive respiratory support.
* Need of invasive ventilation in the first 72 hours.
* Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma.

II. Secondary outcomes:

* Need for surfactant administration.
* Days on invasive mechanical ventilation.
* Days on supplemental oxygen.
* Duration of hospital stay.
* Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.


Eligibility criteria: Inclusion Criteria:

Moderate and late preterm infants born between 32+0 to 36+6 weeks gestation(according to WHO definitions of preterm birth) admitted to the neonatal intensive care unit with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).

Exclusion criteria:

* Any baby intubated for resuscitation or for other reasons.
* Obvious major congenital malformations or known complex congenital heart disease.
* Pulmonary hemorrhage.
* Cardiopulmonary arrest needing prolonged resuscitation.

Primary outcomes:
measure: Superior vena cava blood flow in ml/kg/min
timeFrame: first 3 days of life
measure: Right ventricular output in ml /kg/min
timeFrame: first 3 days of life
measure: left ventricular output in ml/kg/min
timeFrame: first 3 days of life
measure: peak systolic velocity in anterior cerebral artery in cm/sec
timeFrame: first 3 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Nader Abdelminem Fasseh
role: STUDY_DIRECTOR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Mohamed Amen Hassan, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00271128: NT-proBNP for Evaluation of the Dyspneic Patient in the Emergency Room and the Medical Ward
Official title: NT-proBNP for Evaluation of the Dyspneic Patient in the Emergency Room and the Medical Ward (BNP4EVER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shortness of Breath
Acute Exacerbation
Keywords: NT-proBNP
Heart failure
Dyspnea
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

Detailed description: The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

Patients will be consented and randomized to open or blinded NT-proBNP test performed within 90 minutes in a venous blood sample.

Evaluation of the ER diagnosis and final discharge diagnosis in admitted patients will be carried out in light of the NT-proBNP results.

Eligibility criteria: Inclusion Criteria:

1. Acute shortness of breath of unknown etiology as presentation to the emergency room
2. Possible acute exacerbation of known heart failure

Exclusion Criteria:

None -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Simcha R Meisel, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meisel SR, Januzzi JL, Medvedovski M, Sharist M, Shochat M, Ashkar J, Peschansky P, Haim SB, Blondheim DS, Glikson M, Shotan A. Pre-admission NT-proBNP improves diagnostic yield and risk stratification - the NT-proBNP for EValuation of dyspnoeic patients in the Emergency Room and hospital (BNP4EVER) study. Eur Heart J Acute Cardiovasc Care. 2012 Jun;1(2):99-108. doi: 10.1177/2048872612447049.
Clinical trial NCT06600828: Study's Care of Acute Pancreatitis at Saint-Etienne University Hospital.
Official title: Study's Care of Acute Pancreatitis at Saint-Etienne University Hospital.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pancreatitis
Keywords: Internal Medicine Unit efficiency
Retrospective observational study
Acute Pancreatitis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients hospitalized from January 1, 2022, to December 31, 2023 in the University Hospital of Saint Etienne with a primary diagnosis of acute pancreatitis in Internal Medicine and gastroenterology will be included.

Brief summary: Internal medicine units treat patients with undifferentiated or multisystem diseases, with a non-specific organ approach.

In some cases, patients with single-organ disease may be admitted to internal medicine wards. Acute pancreatitis is the most common gastrointestinal illness requiring acute admission to hospital. It is characterised by local and systemic inflammation of the pancreas corresponding to single-organ disease.

For patients with single-organ disease such as acute pancreatitis, it is not known whether admission to internal medicine is as effective as admission to a unit specialising in a specific organ, such as hepato-gastro-enterology.


Eligibility criteria: Inclusion Criteria:

* adult patient
* primary diagnosis of acute pancreatitis in Internal Medicine and gastroenterology.

Exclusion Criteria:

-

Primary outcomes:
measure: Performance Stay Length Index
timeFrame: From the date of inclusion to the date of discharge from hospital, assessed for up to 100 months
Secondary outcomes:
measure: Rate of complications at 1 year
timeFrame: During one year from diagnosis
measure: Rate of rehospitalization at 1 year
timeFrame: During one year from diagnosis
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Kyria REGALADE, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04407728: Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart Disease
Official title: Early Detection of Severe Heart Disease in Fetuses at High Risk of Heart
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the work is to evaluate, in the French health care system, the performance of early ultrasound screening for severe heart disease between 11 and 14SA in high-risk populations.

Detailed description: Numerous studies have shown a link between increased nuchal translucency and heart disease. Although high-risk fetal populations are identified between 11 and 13 SA on clinical and biological criteria and by screening ultrasound (Echo T1), cardiac morphology analysis is routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22 SA (EchoMorpho-T2) inducing a difficult wait for the couple.

The development of increasingly efficient ultrasound probes has made it possible to explore the foetal heart at an earlier stage. International learned societies recommend an early morphological examination with heart-centered slices before 14 weeks in high-risk situations. This practice is not systematic in France and no study has evaluated its feasibility and impact in a French care network.

Eligibility criteria: Inclusion Criteria:

Pregnant women whose fetus is at high risk for congenital heart disease:

* Nuchal translucency measurement on T1 echo ≥3.5mm
* Cardiac or extra-cardiac morphological abnormality suspected on the T1 screening echo
* First degree family history for the fetus (patient, spouse, 1st children of the couple) of significant congenital cardiopathy (excluding AIC, muscular VIC or persistent CA).

Exclusion Criteria:

* Multiple Pregnancies
* non-emancipated minors, persons unable to express their consent.
* Lack of affiliation to a social security scheme.
* Subject in a period of exclusion from another study,
* Subject under administrative or judicial supervision
* Subject cannot be contacted in case of emergency

Primary outcomes:
measure: early ultrasound screening
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04263428: The Effects of Sleep Variability in Youth
Official title: The Effects of Sleep Variability on Sleep Quality, Daytime Functioning and Cardiometabolic Regulation in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Variability
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Daily sleep variability is prevalent in the young populations, yet its effects remain less clear. The experimental study aims to examine the impacts of intraindividual daily sleep variability on sleep characteristics, cardiometabolic regulations and daytime functioning in college students.


Eligibility criteria: Inclusion Criteria:

* Habitual sleep duration \> 7 h/day.

Exclusion Criteria:

* Extreme morning- nor extreme evening-chronotype
* With sleep problems
* With mood and anxiety problems
* With excessive daytime sleepiness
* Have history of any chronic medical condition and on regular medication.

Primary outcomes:
measure: Subjective sleepiness
timeFrame: 7 days (every morning and evening)
measure: Mood
timeFrame: 7 days (every morning and evening)
measure: Cognitive functioning - Sustained attention
timeFrame: 7 days (every morning and evening)
measure: Cognitive functioning - processing speed
timeFrame: 7 days
measure: Cognitive functioning - inhibition
timeFrame: 7 days
measure: Cognitive functioning - working memory
timeFrame: 7 days
Secondary outcomes:
measure: Sleep quality
timeFrame: 7 days
measure: Sleep architecture
timeFrame: 7 days
measure: Heart rate variability
timeFrame: 7 days
measure: Cortisol awakening response
timeFrame: baseline, post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Dr. Shirley X. Li
role: PRINCIPAL_INVESTIGATOR
References: