louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05923931: Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Official title: Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heat Stroke
Keywords: heat stroke, cooling blanket, cooling rate, outcomes
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yiwu Central Hospital
name: Jinhua People&#39;s Hospital
name: Jinhua Municipal Central Hospital
name: Dongyang People's Hospital
name: Lanxi People's Hospital
name: Hangzhou Medical College
First posted: 2023-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the cooling effect of cooling blanket in patients with heat stroke. The main questions it aims to answer are:

* the cooling rate of cooling blanket in patients with heat stroke
* the relationship between cooling blanket and outcomes in patients with heat stroke

Participants will accept the cooling blanket or non-cooling blanket according to the randomization group.

Researchers will compare cooling rate and outcomes to see if the cooling blanket can accelerate the cooling speed and improve the prognosis of patients in heat stroke.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* diagnosed as heat stroke
* informed consent of patients or family members

Exclusion Criteria:

* need immediate cardiopulmonary resuscitation
* body temperature \&lt;39.5℃ on admission
* with the underlying disease of severe organ damage
* pregnant women

Primary outcomes:
measure: cooling rate at 0.5 hours
timeFrame: 0.5 hours
measure: Body temperature of 0.5 hours
timeFrame: 0.5 hours after admission to emergency department
Secondary outcomes:
measure: Body temperature of 2 hours
timeFrame: 2 hours
measure: incidence of organ damage
timeFrame: up to 90 days
measure: length of ICU stay
timeFrame: up to 90 days
measure: in-hospital mortality
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Yiwu
country: China
facility: Yiwu Central Hospital
state: Zhejiang
city: Yongkang
country: China
facility: Yongkang First People&#39;s Hospital
state: Zhejiang
city: Dongyang
country: China
facility: Dongyang People's Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Jinhua
country: China
facility: Jinhua People's Hospital
city: Lanxi
country: China
facility: Lanxi People's Hospital
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Lan Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01172431: Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
Official title: A Comparison of Indapamide SR 1.5 mg With Hydrochlorothiazide 25 mg, in Combination With an ACE-inhibitor, in Old Patients With Mild to Moderate Renal Insufficiency and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Renal Insufficiency
Keywords: hypertension
renal insufficiency
indapamide
hydrochlorothiazide
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2010-07-29
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of indapamide SR 1.5 mg on renal function, endothelial function, blood pressure variability by comparison with hydrochlorothiazide 25 mg, in patients with Mild to Moderate Renal Insufficiency and Hypertension.


Eligibility criteria: Inclusion Criteria:

* Creatinine clearance 30 to 90 mL/min/1.73 m2, with variations of less than 20 percent in the 2 weeks before the screening evaluation.
* Diagnosed hypertension according to guidelines or having taken anti-hypertension drugs.
* Aged between 65 and 85 years.
* Willingness to provide written, informed consent.
* Ability to adhere to study protocol.

Exclusion Criteria:

* Secondary hypertension.
* Diabetes mellitus.
* Atrial flutter/atrial fibrillation.
* Symptoms of congestive heart failure (NYHA III-IV) or there is evidence that left ventricular EF \< 40%.
* Recent (\< 6 months) myocardial infarction or cerebrovascular ischemic symptoms.
* Recent (\< 3 months) or planned coronary revascularization: PCI (percutaneous coronary intervention)/CABG (coronary artery by-pass graft).
* Severe valvular heart disease.
* History of hypersensitivity to indapamide, thiazides or to any of the components of the products.
* Any current condition or other disease known to interfere significantly with the absorption, distribution, metabolism or excretion of study drugs.
* Participation to another investigational study in the last 3 months.

Primary outcomes:
measure: renal function
timeFrame: 1 year
Secondary outcomes:
measure: endothelial function
timeFrame: 1 year
measure: blood pressure variability
timeFrame: 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Cardiology, West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xiao P Chen, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887131: Dynamic Imaging of the Subtalar Instability
Official title: Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subtalar Arthritis
Subtalar Instability
Keywords: Subtalar arthritis
Subtalar instability
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to describe normal dynamic computed tomography anatomy of hind foot in inversion/eversion movement, and to define diagnostic criteria for subtalar instability.

Detailed description: Dynamic CT (Aquilion One Toshiba) of the ankle during inversion and eversion movement will be performed in patients from three groups: healthy volunteers, patients with subtalar arthritis, and patients with suspicion of subtalar instability.

Eligibility criteria: Inclusion Criteria:

* Group Instability: suspicion of subtalar instability
* Group Arhtritis: subtalar stiffness
* Group Healthy volunteers: healthy volunteers
* conscious and cooperating
* written consent obtained after oral and written clear and intelligible information
* no pregnancy

Exclusion Criteria:

* pregnancy
* unable to understand information about this study
* unable to understand the movement of inversion / eversion of ankle
* absence of affiliation to social security

Primary outcomes:
measure: Talocalcaneal angle
timeFrame: baseline
measure: Maximum exposed distance on superolateral surface of calcaneum
timeFrame: baseline
measure: Minimum distance between sustentaculum tali and talus posteromedial tubercle
timeFrame: baseline
measure: Maximum distance between sustentaculum tali and talus posteromedial tubercle
timeFrame: baseline
measure: Maximum anterolateral talocalcaneal distance
timeFrame: baseline
measure: Maximum posterolateral talocalcaneal distance
timeFrame: baseline
measure: Minimum posterolateral talocalcaneal distance
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
Study officials:
References:
Clinical trial NCT01559831: Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination
Official title: Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Japanese Encephalitis
Keywords: Japanese Encephalitis
IXIARO
Japanese Encephalitis Vaccine
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

Detailed description: IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
* In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
* Written informed consent obtained from the subject prior to any study-related procedures

Exclusion Criteria:

* Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
* Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
* Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
* Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
* Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
* Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
* Persons who are committed to an institution
* At Day 0, upcoming scheduled travel to a JE endemic region

Primary outcomes:
measure: Seroconversion rate (SCR) at Day 28
timeFrame: at Day 28
Secondary outcomes:
measure: SCR at Day 0
timeFrame: Day 0
measure: Geometric Mean Titer at Day 0 and 28
timeFrame: Day 0 and Day 28
measure: Rate of Adverse Events up to Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCLH Foundation Trust
Study officials:
affiliation: Valneva Austria GmbH
name: Vera Kadlecek, Mag.
role: STUDY_CHAIR
References:
Clinical trial NCT06847776: Longitudinal Evaluation of a Fracture Liaison Service
Official title: Longitudinal Evaluation of a Fracture Liaison Service
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteoporosis
Keywords: osteoporosis
fractures
DXA
CT
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients included in the fracture liaison service

Brief summary: The major objective of this study is to evaluated osteoporosis prevalence, both on computed tomography (CT) and dual x ray absorptiometry (DXA) in patients included in a fracture liaison service (FLS).

The secondary objectives are to evaluate the prevalence of antiosteoporotic treatments indication, of new fractures or mortality; to identify the risk factor for osteoporosis; the study the treatment's observance; to identify the screening threshold to diagnose osteoporosis on CT.


Eligibility criteria: Inclusion Criteria:

* age \>= 50 years
* Bone fracture due to a fall

Exclusion Criteria:

* patient's opposition

Primary outcomes:
measure: Osteoporosis prevalence on DXA and CT
timeFrame: during the evaluation in the fracture liaison service FLS and evry year until 5 years
Secondary outcomes:
measure: prevalnce of treatment for osteoporosis
timeFrame: during the evaluation in FLS and every year until 5 years
measure: prevalence of new fractures at 1-3 and 5 years
timeFrame: during the evaluation in FLS and at 1, 3 and 5 years
measure: identification of osteoporosis risk factors
timeFrame: at the inclusion in FLS
measure: definition of the CT threshold for bone fragility in this population;
timeFrame: at the inclusion in FLS
measure: study of the correlation dual x ray absorptiometry and computed tomography bone fragility evaluation
timeFrame: at the inclusion in FLS
measure: study of the correlation between FRAX score and DXA
timeFrame: at the inclusion in FLS
measure: study of the correlation between FRAX score and Trabecular bone score TBS
timeFrame: at the inclusion in FLS
measure: study of the correlation between FRAX score and lean mass
timeFrame: at the inclusion in FLS
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT03504176: Pediatric Acute Respiratory Distress Syndrome Ventilation Bundle
Official title: Pediatric Acute Respiratory Distress Syndrome Bundle vs. Standard Care; a Before-and-After Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-04-20
Enrollment: 134
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children admitted to the PICU needing mechanical ventilation will be screened for eligibility. Those who fulfill the PALICC criteria for PARDS will be included.

Brief summary: Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations by the Pediatric Acute Lung Injury Consensus Conference (PALICC) are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high end expiratory pressure. A recent retrospective study of ventilation practices in Asia including Singapore showed that a majority of patients with PARDS were being ventilated with high tidal volume, high peak pressure and low end expiratory pressure, not in compliance with PALICC recommendations. We postulate that currently used ventilation strategies could have contributed to the high PARDS mortality rates in Asia. We aim to determine if implementing a ventilation bundle comprising PALICC recommendations lowers PARDS and pediatric intensive care unit (PICU) mortality rates.

Detailed description: We implement a PARDS ventilation bundle compliant with PALICC recommendations. The bundle contains a daily checklist for ventilation targets and reference tables listing targeted tidal volumes and end expiratory pressure-fraction of inspired oxygen titration. We will recruit mechanically ventilated patients who meet PARDS criteria. After a one-month implementation period, we will collect patient data over the subsequent 18 months, and compare them with the corresponding data in the 24 months prior to the implementation. The primary outcome is PARDS mortality, defined as number of deaths out of PARDS cases. Secondary outcomes are feasibility of ventilation bundle implementation, ventilator (VFD) and intensive care unit (IFD) free days and PICU mortality (number of deaths out of PICU admissions).

Eligibility criteria: Inclusion Criteria:

* fulfill criteria for PARDS
* mechanically ventilated

Exclusion Criteria:

* perinatal lung disease

Primary outcomes:
measure: mortality
timeFrame: up to 60 days
Secondary outcomes:
measure: ventilator free days
timeFrame: up to 28 days
measure: PICU free days
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
Clinical trial NCT03692676: Characteristics of Pts Initiating Spiriva Respimat in Asthma
Official title: Characteristics of Patients Initiating Spiriva Respimat in Asthma in the UK: a Cross-sectional Study Based on the Clinical Practice Research Datalink
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 116133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatic patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC from the previous ICS/LABA FDC in the UK during the study period (September, 2014-December 31, 2017)

Brief summary: This study is a cross-sectional, non-interventional study based on existing data (NISed).

Detailed description: The UK CPRD data will be used to assess the characteristics of asthma patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC in the UK during the study period (September 2014-December 2017) enabling to assess potential channeling of prescribing to different patient populations.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and above at the index date
* At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Database (CPRD)
* Had a diagnosis of asthma before the index date
* Being treated with Inhaled corticosteroids/Long-acting beta agonists (ICS LABA FDC) before the index date (at least one prescription within 3 months before the index date)
* Patients who were new users of Spiriva Respimat, or LTRA, or patients who were prescribed a higher dose of ICS/LABA FDC, or patients who switched to a new ICS/LABA FDC from the previous ICS/LABA FDC

Exclusion Criteria:

* Patients who were prescribed other Long-acting muscarinic antagonists (LAMA) any time before or on the index date
* In the primary analysis, patients who were diagnosed with COPD before or on the index date will be excluded from the study. In a sensitivity analysis, patients who had both asthma and COPD diagnoses will be included in the study

Primary outcomes:
measure: Number of Participants With Cardiac Arrhythmias
timeFrame: On the index date or in the year prior to the index date
Secondary outcomes:
measure: Number of Participants With Cardiac Failure
timeFrame: On the index date or in the year prior to the index date
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: Boehringer Ingelheim
Study officials:
References:
Clinical trial NCT01396876: The Effects of Medical Clowns in Children Undergoing Blood Tests
Official title: Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Medical clown
Pediatric emergency medicine
Emergency procedures
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.

Detailed description: Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.

Eligibility criteria: Inclusion Criteria:

* Children needing venous blood sampling or the insertion of an intravenous canula

Exclusion Criteria:

* Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
* Absence of a parent during the procedure
* Abnormal development according to parents

Primary outcomes:
measure: Pain score
timeFrame: at the end of the procedure
Secondary outcomes:
measure: Parental anxiety level
timeFrame: at the end of the procedure
measure: Procedure's success rate
timeFrame: at the end of the procedure
measure: Overall report of procedure's comfort
timeFrame: at the end of the procedure
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Ayelet Rimon, MD
role: PRINCIPAL_INVESTIGATOR
References: