louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02364661: The Influence of Short-term Starvation on Hepatitis B Virus Load
Official title: The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Starvation
Infection
Keywords: Hepatitis B virus
Metabolovirus
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. Specifically, starvation induces HBV gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. In this study we are going to recruit HBV patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. Our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.


Eligibility criteria: Inclusion Criteria:

* Hepatitis B virus patients with detectable viremia
* \>18 years old
* signed a consent form

Exclusion Criteria:

* patients with malignancy
* Patients with diabetes mellitus
* Alcohol consumption of more than 140grams a week
* Advanced liver disease
* HCV or HIV infection
* Pregnancy
* Mental retardation or unable to understand basic explanation about the study -

Primary outcomes:
measure: A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states
timeFrame: Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center, Beilinson hospital
name: Amir Shlomai, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shlomai A, Paran N, Shaul Y. PGC-1alpha controls hepatitis B virus through nutritional signals. Proc Natl Acad Sci U S A. 2006 Oct 24;103(43):16003-8. doi: 10.1073/pnas.0607837103. Epub 2006 Oct 16.
citation: Shlomai A, Shaul Y. The "metabolovirus" model of hepatitis B virus suggests nutritional therapy as an effective anti-viral weapon. Med Hypotheses. 2008;71(1):53-7. doi: 10.1016/j.mehy.2007.08.032. Epub 2008 Mar 10.
Clinical trial NCT05183061: Factors Associated With Post-induction Hypotension in iNPH Patient Undergoing VP and LP Shunt
Official title: Factors Associated With Post-induction Hypotension in Idiopathic Normal Pressure Hydrocephalus (iNPH) Patient Undergoing Ventriculoperitoneal (VP) and Lumbar Peritoneal (LP) Shunt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The iNPH Patients Scheduled for VP or LP Shunt Procedures
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Elective cases of iNPH scheduled for VP and LP shunt whose medical records were acquired from the hospital's central database.

Brief summary: This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. The incidence of post-induction hypotension according to our institution's pilot study November 2019-January 2020) was 47%. With 10% addition for missing data and other possible reasons, the sample size was 426. The primary objective of the study is to report the factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures. Our secondary objective is to determine the incidence of post-induction hypotension in these patients.


Eligibility criteria: Inclusion Criteria:

* Elective cases of iNPH scheduled for VP and LP shunt
* Patients aged \> 18 years old

Exclusion Criteria:

* Emergency cases

Primary outcomes:
measure: Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology Department
Study officials:
References:
Clinical trial NCT04336761: Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France
Official title: Prevalence of Covid-19 in Children Admitted to Paediatric Emergency Departments During the Pandemic Period in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
COVID
Infection Viral
Keywords: pediatric emergencies
pandemia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 901
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children admitted to hospital pediatric emergencies in France during the pandemic period.

Brief summary: Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.


Eligibility criteria: Inclusion Criteria:

* 1st Line Consultation in Pediatric Emergencies
* All reasons for consultation during working hours
* Informed and written consent of a parent holder (only 1 authorized companion) and a child of understanding age

Exclusion Criteria:

* Refusal of participation by parents/child of decision age
* No membership of a social security scheme (beneficiary or entitled)
* No understanding of French

Primary outcomes:
measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR
timeFrame: At 28 days
Secondary outcomes:
measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients
timeFrame: at the end an average 28 days
measure: Respiratory signs of children tested within 28 day
timeFrame: through study completion, an average 28 days
measure: Percentage of children hospitalized tested within 28 day
timeFrame: through study completion, an average 28 days
measure: Contact frequency
timeFrame: At inclusion
measure: Prevalence of positivity of other respiratory viruses measured by rt-PCR
timeFrame: at 28 days
Other outcomes:
Locations:
city: Colombes
country: France
facility: CH Louis MOURIER
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
city: Nantes
country: France
facility: Hôpital Mère Enfant CHU
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
city: Toulouse
country: France
facility: Hôpital des enfants - CHU
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: University Hospital, Lille
name: François Dubos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456961: Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin
Official title: Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Collagen crosslinking (CXL)
Standard corneal crosslinking (CXL)
Transepithelial CXL
Iontophoresis
Riboflavin
Lead sponsor: Ufa Eye Research Institute
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation.

In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.


Eligibility criteria: Inclusion Criteria:

* Documented progressive KC (by Pentacam and/or corneal topography imaging).
* A clear central cornea.
* A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
* Minimal Snellen corrected distance visual acuity of ≥ 0.4.
* Patient age of ≥ 18 years.

Exclusion Criteria:

* Corneal scarring.
* History of epithelial healing problems.
* History or presence of ocular infection (such as herpes keratitis)
* Pregnancy and/or breastfeeding.

Primary outcomes:
measure: Kmax, D
timeFrame: 2 years
Secondary outcomes:
measure: Corneal thickness, μm, as measured by OCT tomography
timeFrame: 2 years
measure: Visual acuity as assessed by Decimal system
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Ufa Eye Research Institute
name: Mukharram Bikbov, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04159961: Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
Official title: A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adult aged between 19 and 65 at screening
* Those whose BMI is less than 40kg/m2
* Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)
* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* History of any intervention to treat Submental fat or abdominal fat
* History or current symptoms of dysphagia
* History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment

Primary outcomes:
measure: Cmax
timeFrame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
measure: Tmax
timeFrame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
measure: AUCt
timeFrame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03697161: A Study of OV101 in Individuals With Fragile X Syndrome
Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fragile X Syndrome (FXS)
Lead sponsor: Ovid Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-05
Enrollment: 36
Sex: MALE
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.


Eligibility criteria: Inclusion Criteria:

* Is male and 13 to 22 years old (inclusive) at the time of informed consent.
* Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).

Exclusion Criteria:

* Concomitant disease or condition that are clinically significant and would limit study participation
* Clinically significant lab abnormalities or vital signs at the time of screening
* History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
* Unable or does not have a caregiver able to comply with study requirements.
* Enrolled in any clinical trial within the 30 days before screening.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
measure: Clinical Global Impressions- Improvement (CGI-I)
timeFrame: Week 12
Locations:
city: Sacramento
country: United States
facility: Ovid Therapeutics Investigative Site
state: California
city: Aurora
country: United States
facility: Ovid Therapeutics Investigative Site
state: Colorado
city: Chicago
country: United States
facility: Ovid Therapeutics Investigative Site
state: Illinois
city: Baltimore
country: United States
facility: Ovid Therapeutics Investigative Site
state: Maryland
city: Cincinnati
country: United States
facility: Ovid Therapeutics Investigative Site
state: Ohio
city: Nashville
country: United States
facility: Ovid Therapeutics Investigative Site
state: Tennessee
Study officials:
affiliation: Ovid Therapeutics Inc.
name: Amit Rakhit, MD
role: STUDY_DIRECTOR
References:
citation: Budimirovic DB, Dominick KC, Gabis LV, Adams M, Adera M, Huang L, Ventola P, Tartaglia NR, Berry-Kravis E. Gaboxadol in Fragile X Syndrome: A 12-Week Randomized, Double-Blind, Parallel-Group, Phase 2a Study. Front Pharmacol. 2021 Oct 8;12:757825. doi: 10.3389/fphar.2021.757825. eCollection 2021.
Clinical trial NCT04756661: Uterotonics for Severe Preeclampsia
Official title: Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia Severe
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia


Eligibility criteria: Inclusion Criteria:

* Pregnant women which diagnosed with severe pre-eclampsia.
* Singleton pregnancy.
* Termination of pregnancy by Cesarean section after 28 weeks of gestation.

Exclusion Criteria:

* Suspected or proven placental abruption.
* Known placenta Previa or acreata.
* Multiple pregnancies.
* Obesity (BMI \>35).
* Anemia (\<9 g/dl).
* Retained placental tissues.
* Big baby (\> 4 kg).
* Presence of coagulopathy.
* Polyhydramnios.
* Presence of Uterine fibroids.
* Medical diseases as; cardiac, liver, renal or endocrine diseases.
* General anesthesia.

Primary outcomes:
measure: The rate of postpartum hemorrhage more than 1000 ml
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT06555861: Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT) (Retros MUMOFRAT)
Official title: Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Identify FDG PET/CT Parameters Predictive of Local Control
Keywords: PET/CT
Radiomics
Early-stage NSCLC
Stereotactic radiotherapy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 87
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: Eighty-seven patients with NSCLC stage I-II and tumours diameters below 5 cm according to the 8th American Joint Committee on Cancer classification, treated with definitive curative SBRT from January 2012 to December 2016 at 4 French institutions (Rennes, Tours, Brest and Nantes) were retrospectively included.

Brief summary: The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT).


Eligibility criteria: Inclusion Criteria:

* NSCLC stage I-II treated by SBRT
* PET/CT imaging performed within 60 days of SBRT

Exclusion Criteria:

* Lack of follow-up
* Refusal of consent

Primary outcomes:
measure: Local Recurrence
timeFrame: Time-to-Event measures up to 5 years
Secondary outcomes:
measure: Cancer specific survival
timeFrame: Time-to-Event measures up to 5 years
measure: Distant metastasis free survival
timeFrame: Time-to-Event measures up to 5 years
measure: Recurrence free survival
timeFrame: Time-to-Event measures up to 5 years
measure: Overall survival
timeFrame: Time-to-Event measures up to 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: ICO
state: Saint Herblain
city: Brest
country: France
facility: CHRU de Brest
city: Rennes
country: France
facility: Centre Eugènes Marquis
city: Tours
country: France
facility: CHU de Tours
Study officials:
References:
Clinical trial NCT01881061: Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Keywords: Sonography
ICU
PEEP
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU population

Brief summary: The purpose of this study is to evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS.

Detailed description: Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in critically ill patients.

Patients with ARDS invariably require mechanical ventilation to improve oxygen transport. An improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (PEEP).

In critically ill patients with ARDS, lung imaging is been held by the use of chest radiography and the "gold standard" technique, Computed Tomography (CT).

We designed an observational study in which we included patients under mechanical ventilation admitted in our ICU. In all patients PEEP changes were applied and lung sonography was performed.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients with ARDS admitted in ICU of Evangelismos Hospital
* length of stay \> 48 hours

Exclusion Criteria:

* age \< 18 years
* emphysema fractures or skin lesions that do not allow the implementation of lung sonography
* BMI \> 35 kg/m2
* length of stay \< 48 hours

Primary outcomes:
measure: Non aerated lung area changes
timeFrame: 20 min after PEEP trial
Secondary outcomes:
measure: Arterial oxygen and carbon dioxide partial pressure
timeFrame: 20 min after PEEP trial
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens
state: Attiki
Study officials:
affiliation: University of Athens
name: Serafim Nanas, MD
role: STUDY_CHAIR
References:
citation: Stefanidis K, Dimopoulos S, Tripodaki ES, Vitzilaios K, Politis P, Piperopoulos P, Nanas S. Lung sonography and recruitment in patients with early acute respiratory distress syndrome: a pilot study. Crit Care. 2011 Aug 4;15(4):R185. doi: 10.1186/cc10338.
Clinical trial NCT00982761: Metabolic Syndrome of Occupational Drivers
Official title: Analysis of Health Status of Occupational Driver
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: occupational drivers
health status
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is to understand the health status of occupational status. Occupational drivers work in a sitting position for long durations, facing traffic stress, irregular mealtimes and lack of exercise etc, and may impede their health. For passengers, their safety is related to the occupational drivers' health status and should pay attention to the health condition of the occupational drivers.

Brief summary: The purpose of this study is to discover the health status of occupational drivers. The health status includes data collection of body mass index, blood pressure, central obesity, anxiety scale scores, smoking habit and related cessation therapy, etc.

Detailed description: Occupational drivers' health is essential for passengers' safety. However, occupational drivers' health is damaged by long-term sitting and driving, lack of exercise, stress from traffic, and irregular diet. The objectives of this study were to assess the health status of occupational drivers in Taiwan. The measures included blood pressure, central obesity, fasting blood sugar, triglyceride, body mass index (BMI), anxiety scale scores, and metabolic syndrome, etc.

Eligibility criteria: Inclusion Criteria:

* metabolic syndrome
* hypertension
* anxiety scale scores

Exclusion Criteria:

* hyperuricemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chung Yin Wu
name: Chung Yin Wu, MD
role: STUDY_CHAIR
References: