louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05448391: A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF)
Official title: An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Familial Mediterranean Fever
Lead sponsor: Aristea Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 12-week Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects with Familial Mediterranean Fever followed by an additional Open-label Extension Phase.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 FMF disease but no active flare at the time of screening according to Tel Hashomer criteria or EUROFEVER/Paediatric Rheumatology International Trials Organization (PRINTO) criteria for FMF
* Documented to be heterozygous or homozygous for at least one of the known clearly pathogenic MEFV gene exon 10 mutations
* Males and females must be willing to use birth control as indicated

Exclusion Criteria:

* Breastfeeding or pregnant
* Known immunodeficiency or subject is immunocompromised
* Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Proportion of responders who achieve resolution of their index flare after initiating study treatment and do not experience a new flare from the time of resolution of the index flare until Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01774591: Effect of Azilsartan on Aldosterone in Postmenopausal Females
Official title: Effect of Azilsartan on Aldosterone in Postmenopausal Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Post Menopause
Female
Obese
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2013-01-24
Enrollment: 21
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.

Detailed description: The study is a randomized, placebo-controlled trial of post-menopausal females with stage 1 hypertension. The goal is to randomize 40 post-menopausal females with stage 1 hypertension and assess whether azilsartan reduces urinary aldosterone levels. We will compare subjects having azilsartan medoximil (treatment group) with placebo group. Additionally, a small sub-study comparing pre-menopausal and post-menopausal female aldosterone levels was performed as well as the presence of aldosterone production in fat cell cultures of a subset of 3 patients in the randomized trial.

Eligibility criteria: Inclusion Criteria:

* Female
* Ages 45-70
* Post-menopause: have not had a menstrual period for one year or more
* Diagnosed with Stage 1 hypertension
* Body Mass Index (BMI) greater than or equal to 28

Exclusion Criteria:

* Male
* Diagnosed with Stage 2 hypertension
* Stage 1 hypertension requiring more than one agent
* Pregnancy or attempting pregnancy
* Use of oral contraceptive pills
* Use of hormone replacement therapy
* Use of steroids
* Stage 3 or greater kidney disease
* Diabetes mellitus
* untreated hypothyroidism or hyperthyroidism
* primary hyperaldosteronism
* Cushing's disease
* obstructive sleep apnea
* chronic illness, e.g. chronic liver disease
* NYHA class III or greater heart failure
* moderate to severe lung disease

Primary outcomes:
measure: 24-hour BP (Systolic)
timeFrame: 26 weeks
measure: 24-hour BP (Diastolic)
timeFrame: 26 weeks
Secondary outcomes:
measure: Difference in 24-hour Urine Aldosterone Change From Baseline
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: George Bakris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997591: Upper Limb Reeducation Across Life Span
Official title: Effect of Ready2E.A.T. in Risk Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Extremity Dysfunction
Dementia
Cerebral Palsy
Cognitive Decline
Eating Disorders
Keywords: eating
upper limb
reeducation
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Old people and children dependent in feeding activity.

Brief summary: Program Ready2E.A.T. was developed to be tested in the upper limb reeducation on population at risk, such as:

* Children with dysfunction
* Cognitive impaired elderly
* Dementia people

Detailed description: Program Ready2E.A.T. consists on the training of specific upper limb tasks, including:

* reaching during attention tasks
* reaching during memory tasks
* reaching during sequential motor tasks
* reaching during fine hand movements

This program has been tested as a measure of functional status (cognitive and motor habilities) in population with different risks; It also has been tested as an effective program for reeducation in cognitive affected population.

Eligibility criteria: Inclusion Criteria:

* people with 60years old with cognitive decline
* children aging 6-10 years old with cognitive and motor dysfunction
* dysfunction in feeding participation

Exclusion Criteria:

* participants that do not understand 2 simnultaneous verbal commands

Primary outcomes:
measure: Video analysis of feeding performance
timeFrame: 6 weeks
Secondary outcomes:
measure: Frontal assessment battery
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leiria
country: Portugal
facility: Instituto Politécnico de Leiria
Study officials:
References:
Clinical trial NCT02620891: Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome
Official title: Study on the Effect of Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome Parallel Synchronized Intermittent Mandatory Ventilation; Synchronous Maudatory Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Meconium Aspiration
Keywords: helium oxygen mixture
Meconium aspiration syndrome
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 37
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome in previous studies，but the evidence was limited．The aim of the study was to assess the effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70% helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in meconium aspiration syndrome.


Eligibility criteria: Inclusion Criteria:

* Subject has the diagnosis of neonatal meconium aspiration syndrome
* Subject has Synchronous instruction ventilation

Exclusion Criteria:

* History of congenital or hereditary disease

Primary outcomes:
measure: blood gas analysis
timeFrame: 2 hour
measure: blood gas analysis
timeFrame: 6 hour
measure: blood gas analysis
timeFrame: 12 hour
measure: blood gas analysis
timeFrame: 24 hour
measure: blood gas analysis
timeFrame: 48 hour
Secondary outcomes:
measure: Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
timeFrame: 0 hour
measure: Inflammatory response index (IL-6,IL-8, TNF-a,CRP)
timeFrame: 6 hour
Other outcomes:
measure: Amplitude integrated electroencephalogram
timeFrame: 28and 100 days
measure: Amplitude integrated electroencephalogram
timeFrame: 100 days
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT06091891: Tranexamic Acid in Pediatric Scoliosis Surgery
Official title: Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid.


Eligibility criteria: Inclusion Criteria:

* Children undergoing scoliosis surgery under the age of 18

Exclusion Criteria:

* Patients with coagulation disorders
* Patients at an increased risk of thrombosis
* Patients with a history of epilepsy or brain surgery
* Patients with a previous allergic reaction or anaphylaxis history to tranexamic acid
* Severe liver or kidney impairment
* Other cases deemed inappropriate by the researcher

Primary outcomes:
measure: intraoperative bleeding loss
timeFrame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Secondary outcomes:
measure: RBC blood transfusion
timeFrame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
measure: urine output
timeFrame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
measure: Other blood transfusion
timeFrame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
measure: postoperative viscoelastic whole blood profile
timeFrame: 1 hours from the end of surgery
measure: JP drain
timeFrame: 24 hours from the end of surgery
measure: IL-6
timeFrame: 1 hours from the end of surgery
measure: total tranexamic acid dose
timeFrame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
measure: postoperative complications
timeFrame: 2 weeks from the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Bin Park
role: STUDY_DIRECTOR
References:
Clinical trial NCT03491891: Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China
Official title: Correlates and Mehcanisms Underlying Very Late Stent Thrombosis After Implantation of New Generation DES in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stent Thrombosis
Keywords: Very Late Stent Thrombosis
New generation DES
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Shantou University Medical College
First posted: 2018-04-09
Enrollment: 8476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients\>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent were included.Patients' expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al),and with a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued, refusing to sign informed consent, died prior to discharge, unable to participate in regular follow-up were excluded.

Brief summary: The investigators sought to identify and verify the potential correlates and mechanisms of Very Late Stent Thrombosis (VLST) after the implantation of new generation drug eluting steng in China from an analysis of multicenter registries.

Detailed description: This study represents a patient-level pooled analysis of patients undergoing percutaneous coronary intervention with stent implantation for acute coronary syndrome. Multiple aspects including clinical, angiographic, procedural characteristics , intravascular imaging results and blood samples were collected at index PCI and the time of VLST or CAG during follow-up, in order to reveal the potential mechanisms or risk factors that contribute to the development of VLST.

Eligibility criteria: Inclusion Criteria:

* Patients\>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent.

Exclusion Criteria:

* Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.

Primary outcomes:
measure: Very Late Stent Thrombosis
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin University 1st Hospital
state: Jilin
Study officials:
affiliation: Jilin University 1st Hospital Cardiovascular Center
name: yang zheng
role: STUDY_DIRECTOR
References:
Clinical trial NCT06349291: Venous Thrombosis After Removal of Central Venous Catheter
Official title: Venous Thrombosis After Removal of Central Venous Catheter-prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombosis, Venous
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were admitted to the intensive care unit and had a central catheter inserted during their stay in the unit for any reason, and whose central catheter was removed during their stay in the general intensive care unit.

-

Brief summary: Insertion of intravenous catheter is a very common operation in patients in the general intensive care unit. These catheters are used for a variety of purposes - administration of inotropics/pressors, intravenous nutrition, concentrated electrolytes and performing dialysis.There are several known complications of central venous catheter insertion, such as thrombosis and pulmonary embolism. In a literature review, there are no clear data regarding the rate of intravenous thrombosis in patients after removal of a central venous catheter. These findings are often discovered randomly, when the patient undergoes imaging for a different indication. There is no recommendation for an active search for intravenous thrombi at the catheter insertion sites in these patients, and it is not entirely clear whether it is mandatory to administer anticoagulant treatment in these patients if thrombi are randomly discovered at the catheter insertion sites.

In this study, we aim to check the proportion of patients who developed thrombosis at the central catheter insertion sites after its removal, to check whether there are catheter insertion sites that are at a higher risk of developing thrombosis than other sites, and to check whether there are predictive characteristics for the development of this type of thrombosis.


Eligibility criteria: Inclusion Criteria: Patients who were admitted to the intensive care unit and had a central catheter inserted during their stay in the unit for any reason, and whose central catheter was removed during their stay in the general intensive care unit.

-

Exclusion Criteria:Patients whose insertion or removal of the central catheter did not occur during the hospitalization in the intensive care unit, patients who were treated with full anticoagulation in the intensive care unit.

-

Primary outcomes:
measure: Rate of DVT after removal of central venous catheter
timeFrame: 1-3 days after removal of central venous catheter
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT03044691: The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care
Official title: The OneFlorida Cancer Control Alliance: Implementing the 6As in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 84
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary purpose of our study is to conduct a pilot, practice-based intervention focused on increasing adherence to the 6As for youth ages 11 through 17 years. The 6As are: (1) "Anticipate" (future use), (2) "Ask" (about tobacco use), (3) "Advise" (advise the patient to quit using tobacco), (4) "Assess" (the patient's readiness to quit using tobacco), (5) "Assist" (by setting a quit date, providing materials on quitting tobacco, providing tobacco cessation medications, and referring the patient for additional services and/or counseling) , and (6) "Arrange" (by re-contacting the patient after their quit date and arranging a follow-up visit).

Detailed description: Investigators will incorporate American Academy of Pediatrics (AAP) best practice recommendations to screen and counsel parents. The specific aims of this study are to: (1) Develop and deploy an electronic short screening tool for tobacco and nicotine product use into pediatric primary care workflow in conjunction with clinician and office staff training on the 6As and parent screening through the use of trained Clinical Practice Facilitators, clinician-engaged adaptations of the intervention to fit their practice workflow, and support for Maintenance of Certification (MOC) to engage pediatricians in implementing the best practices; (2) Gather pilot data about the effectiveness of the intervention on clinician adherence to best practices and changes in practice capacity for change, adaptive reserve, and clinician self-efficacy; and (3) Examine the congruence between documentation of the intervention in the electronic health record (EHR) and youth report of the intervention.

Eligibility criteria: Inclusion Criteria:

* 11-17 years old

Exclusion Criteria:

* 18 years and older

Primary outcomes:
measure: Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Clinics
state: Florida
city: Jacksonville
country: United States
facility: UF Health Family Medicine and Pediatrics-Blanding
state: Florida
city: Jacksonville
country: United States
facility: UF Health Family Medicine and Pediatrics-Baymeadows
state: Florida
Study officials:
affiliation: University of Florida
name: Elizabeth Shenkman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Ramzi Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04426994: Hypomagnesemia Associated With Proton-Pump Inhibitor Use
Official title: Hypomagnesemia Associated With Proton-Pump Inhibitor Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proton Pump Inhibitor Adverse Reaction
Hypomagnesemia
Arrhythmias, Cardiac
Seizures
Hypocalcemia
Hypokalemia
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 211672
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients managed at a referral centre from 2013 - 2016. Cases were admitted to the referral centre and had documentation hypomagnesemia. Controls were prescribed a course of proton pump inhibitor during the same period

Brief summary: Use of proton pump inhibitors has been associated with hypomagnesemia. However, various case-control or prospective studies have found conflicting results with regards to proton pump inhibitors use and development of hypomagnesemia. Our aim was to evaluate the likelihood that proton pump inhibitors contributed to severe hypomagnesemia in a retrospective cohort of patients admitted with severe hypomagenesemia. We also aimed to look for risk factors leading to development of hypomagnesemia amongst users of proton pump inhibitors


Eligibility criteria: Inclusion Criteria:

* Patients admitted with hypomagnesemia (cases)
* Patients prescribed with proton pump inhibitors (controls)

Exclusion Criteria:

* Patients prescribed with less than three months duration of proton pump inhibitors (controls)

Primary outcomes:
measure: Hypomagnesemia due to use with proton pump inhibitor
timeFrame: 2013 to 2016
Secondary outcomes:
measure: Risk factors for Hypomagnesemia
timeFrame: 2013 to 2016
measure: Hypocalcaemia
timeFrame: 2013 to 2016
measure: Hypokalemia
timeFrame: 2013 to 2016
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Troy H Puar, MRCP
role: PRINCIPAL_INVESTIGATOR
References: