louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05845736: The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Elderly
Official title: The Impact of Dementia and Neurocognitive Disorders on Hypertension Treatment in the Very Elderly: the TAHOC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Disorders
Dementia
Hypertension
Aged, 80 and Over
Keywords: Neurocognitive Disorders
Dementia
Hypertension
Aged, 80 and over
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 353
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 80 years or more and hypertensive who received a Comprehensive Geriatric Assessment (including a mini mental state examination) as part of a frailty, memory or oncogeriatric assessment, in day hospital in the geriatric department in University Hospital of Nancy in 2022.

Brief summary: Neurocognitive disorders and hypertension occur commonly with aging. While, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. However, studies have shown that in aging adults, high blood pressure helps prevent against cognitive decline, and low blood pressure on antihypertensive drugs could accelerate it. This study aims at investigating if pharmacological treatment of hypertension in the very elderly is influenced by presence and severity of neurocognitive disorders. Our research hypothesis is that the drug management of hypertension in patients 80 years of age or older more is all the less aggressive as the neurocognitive disorders are advanced.


Eligibility criteria: Inclusion Criteria:

* to be 80 years of age
* with history of hypertension and/or on hypertensive drug(s)

Exclusion Criteria:

* legal protection measure.

Primary outcomes:
measure: number of antihypertensive agents
timeFrame: during inclusion
Secondary outcomes:
measure: class of antihypertensive medications
timeFrame: during inclusion
measure: systolic and diastolic blood pressure
timeFrame: during inclusion
measure: orthostatic hypotension
timeFrame: during inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
References:
Clinical trial NCT00177736: Pharmacodynamic Parameters of Two Different Doses of Cefepime
Official title: Pharmacodynamic Parameters of Two Different Doses of Cefepime
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Bacteremia
Pneumonia
Keywords: ventilator associated pneumonia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Elan Pharmaceuticals
First posted: 2005-09-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. Mathematical models of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal inhibitory concentrations of the antibiotic. Based on these models, there has been speculation that the antibiotic cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the "susceptible" range. This study of patients treated with cefepime will involve the collection of blood to determine cefepime concentrations, and determine if those concentrations are effective in killing the bacteria at the site of infection.

Detailed description: This will be a non-interventional study in that the antibiotic and its dose will be chosen by the treating team not the investigators. Patients on cefepime who have ventilator-associated pneumonia or bacteremia will be invited to participate in the study. Blood samples will be taken to determine the pharmacokinetic profile of the drug. Blood cultures will be repeated in patients with bacteremia to determine clearance of infection. A mini-BAL will be repeated in patients with ventilator-associated pneumonia to determine clearance of pneumonia.

Eligibility criteria: Inclusion Criteria:

1. Adults of at least 18 years of age or older
2. Culture proven ventilator associated pneumonia (VAP) or bacteremia caused by a cefepime susceptible gram negative pathogen:

   * Bacteremia is defined as at least one positive blood culture
   * VAP is defined by at least 10,000 cfu/ml of an organism from a bronchoalveolar lavage sample
3. Cefepime therapy (1 or 2 grams intravenously \[IV\] every \[q\] 8 hours or q 12 hours) initiated as part of standard of care

Exclusion Criteria:

1. Concomitant VAP or bacteremia with a cefepime resistant organism
2. Concomitant therapy with an antimicrobial agent active against gram negative bacilli other than a single dose of aminoglycoside
3. Patients requiring surgical or interventional drainage of purulent collections
4. Pregnant or lactating women
5. Dialysis patients
6. Contraindication to blood sampling
7. Cystic fibrosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David L Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02249936: A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations
Official title: A Phase 1, Single-Center, Randomized, 3-Way Cross-Over, Open Label Study to Evaluate the Pharmacodynamics of Different Formulations of AZD1722 in Healthy Volunteers Taking Omeprazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2014-09-26
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: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.


Eligibility criteria: Inclusion Criteria:

* Healthy man or woman
* Body mass index between 18 and 29.9 kg/m2

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
* Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 8 days
Secondary outcomes:
measure: Sodium levels in stool and urine
timeFrame: 8 days
measure: Plasma drug concentration to calculate AUC
timeFrame: 8 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: ICON Development Solutions
state: Nebraska
Study officials:
affiliation: Ardelyx, Inc
name: David P Rosenbaum, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02343770: Biomarkers in Idiopathic Juvenile Arthritis
Official title: Usefulness of Protoarray®Microarray for Identifying Biomarkers in Idiopathic Juvenile Arthritis Antinuclear Antibodies Positive.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Juvenile Arthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular JIA with antinuclear antibodies affects about half of all children. There 's no specific markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human Protein Microarray allows rapid and efficient detection of protein interaction using a suitable protein or small molecule probe. The investigators hope so detect novel potential autoantigen biomarkers specific in JIA.

Detailed description: We select 10 patients with inclusion criteria and 10 controls. We analyse their blood sample (5ml). The ProtoArray® Microarray allows to detect novel protein-protein interactions, to rapidly perform serum profiling using a sensitive method to detect potential autoantigen biomarkers. The ProtoArray® Human Protein Microarray is a high-density protein microarray containing thousands of purified human proteins for protein interaction screening.

Eligibility criteria: Inclusion Criteria for experimental group :

* child age from 2 to 16 years
* Oligoarticular JIA with antinuclear antibodies
* with or without uveitis

Exclusion criteria for experimental group :

* immunosuppressive and biological therapy

Inclusion Criteria for control group :

* child age from 2 to 16 years

Primary outcomes:
measure: identification of specific autoantigen biomarkers
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Cardiology paediatric consultation, Arnaud de Villeneuve Hospital
Study officials:
References:
Clinical trial NCT03546270: The Effects of Swimming on Elderly Women With Stage-2 Hypertension
Official title: The Effects of Swimming Training on Arterial Function, Strength and Cardiorespiratory Capacity in Elderly Women With Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Hypertension
Keywords: Swimming
Arterial Stiffness
Blood Pressure
Muscular Strength
Cardiorespiratory Endurance
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Marymount University
name: Dong-Eui University
name: University of Nebraska
First posted: 2018-06-06
Enrollment: 100
Sex: FEMALE
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: Aging is associated with progressive decreases in arterial health and function as well as overall fitness. It is crucial to prevent or reduce the negative effects of aging on the vasculature and fitness components by implementing appropriate lifestyle interventions, such as exercise training. We examined the effects of a swimming (SWM) regimen on arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), wave reflection (AIx), muscle strength and aerobic capacity in elderly women with stage 2 hypertension.

Detailed description: Using a parallel experimental design, participants were randomly assigned to either SWM (n=52) or non-exercising control group (n=48) for 20 weeks. Participant in the SWM group trained 3-4 days/week, progressing in duration from 25 to 45 min. Participants' carotid to radial PWV (crPWV), systolic and diastolic BP, AIx, strength and VO2max were measured at baseline and after 20 weeks of their assigned intervention.

Eligibility criteria: Inclusion Criteria:

* systolic/diastolic BP: 140-179 over 90-119 mm Hg
* had experienced the absence of menstruation for at least 1 year
* body mass index \<30 kg/m2
* \<1 h of regular exercise per week in the previous year

Exclusion Criteria:

* Smoker
* Taking any medications or hormone therapy in previous year

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 20-weeks
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 20-weeks
measure: Pressure Wave Reflection
timeFrame: 20-weeks
measure: Muscular Strength
timeFrame: 20-weeks
measure: Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)
timeFrame: 20-weeks
measure: Diastolic Blood Pressure
timeFrame: 20 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Wong A, Kwak YS, Scott SD, Pekas EJ, Son WM, Kim JS, Park SY. The effects of swimming training on arterial function, muscular strength, and cardiorespiratory capacity in postmenopausal women with stage 2 hypertension. Menopause. 2018 Dec 17;26(6):653-658. doi: 10.1097/GME.0000000000001288.
Clinical trial NCT04647370: Remote Ischemic Preconditioning in Cardiac Surgery
Official title: Implications of Remote Ischemic Preconditioning on Liver Function in Adults Undergoing Cardiac Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia Reperfusion Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim of the work :

Evaluation of the role of Remote Ischemic Preconditioning (RIP) on liver function in patients undergoing on-pump cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. Being candidate for on-pump cardiac surgery.
2. Willing to participate in the study
3. Ages eligible for the study: 18 to 70 years.
4. Gender eligible for the study : both

Exclusion Criteria:

1. Patient refusal.
2. Known cause of possible liver function disturbances that includes right heart failure, acute inflammation of gallbladder or any other complication of gallstone disease.
3. Active viral and non viral hepatitis.
4. Pregnant women.
5. History of peripheral nerve disease or peripheral vascular disease of the extremities

Primary outcomes:
measure: liver function test
timeFrame: 3 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT04209270: Breathing Pattern, WOB and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial
Official title: Breathing Pattern, Work of Breathing and Gas Exchange in Patients With Acute Respiratory Distress Syndrome During the Spontaneous Breathing Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Work of Breathing
ARDS
Weaning Failure
Lead sponsor: Sanatorio de la Trinidad Mitre
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 37
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: The investigators will meassure adult, ARDS, Intensive Care Unit patients that are able to perform a Spontaneous Breathing Trial.

Brief summary: There is little evidence about the mechanical characteristics and muscular function in patients with Acute Respiratory Distress Syndrome (ARDS) at the time of weaning of the mechanical ventilation, as well as the behavior of the mechanical properties, breathing pattern, muscular effort, and gas exchange during a successful and failed spontaneous breathing trial.

Detailed description: The study of the respiratory system (RS) mechanics in patients with ARDS has been focused on the initial phase of ventilatory support, with few studies observing the weaning in mechanical ventilation.The RS in patients with ARDS is characterized by a greater or lesser degree of low functional residual capacity (FRC) in relation to normal.

At the time of performing a spontaneous breathing trial, these mechanical characteristics determine the need to develop a high transpulmonary pressure during each breath, with high work of breathing (WOB) to achieve adequate alveolar ventilation.

Inspiratory muscle weakness could alter the ability to generate the necessary transpulmonary pressure over time according to the loads imposed at the time of performing a spontaneous breathing trial, with the consequent development of fatigue and ventilatory failure.

This is why the investigators propose to evaluate the association between elastic WOB and the failure of the spontaneous breathing trial.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* requiring mechanical ventilation for more than 12 hours
* moderate/ severe ARDS according to Berlin Definition
* able to make a Spontaneous Breathing Trial according to the institution protocol

Exclusion Criteria:

* pregnant patients
* history of neuromuscular disease
* patients in palliative care
* bronchopleural fistula
* contraindication of measurement of esophageal pressure

Primary outcomes:
measure: Spontaneous breathing Trial
timeFrame: During 60 minutes after inclusion or until the patient fails to breathe spontaneously
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Mitre
Study officials:
affiliation: Sanatorio de la Trinidad Mitre
name: Sebastian Fredes, RT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04798170: Fetal Nasal Bone Length Nomogram at 11-13wk+6days in Upper Egyptian Pregnant Women
Official title: Fetal Nasal Bone Length Nomogram at 11-13wk+6 Days in Upper Egyptain Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasal Bone Length
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cross sectional study of pregnant women in Upper Egypt at 11-13wk of gestation

Brief summary: establish a reference values for the fetal nasal bone length (NBL) in upper egyptian pregnant women at 11-13wk+6 days

Detailed description: By using ultrasound measure fetal nasal bone length at 11-13wk+6days in Upper Egyptian pregnant women in mid-sagittal view in single pregnancy

Eligibility criteria: Inclusion Criteria:

Normal antenatal women of gestational age between 11 to 13week +6days. Single pregnancy. Viable fetus. No fetal malformation. No previous history of fetal malformation

Exclusion Criteria:

Medical diseased women . Multiple gestations . Fetal malformations . Missed abortion .

Primary outcomes:
measure: Fetal nasal bone length nomogram
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01926470: The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral Radicular Pain
Keywords: epidural injections, intravascular injection
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 TFESI between method in anteroposterior view and method in oblique view using Scotty dog, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.


Eligibility criteria: Inclusion Criteria:

* Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at our pain management clinic

Exclusion Criteria:

* pregnancy
* coagulopathy
* systemic infection
* any active infection at the injection site
* history of allergy to contrast media, local anesthetics, corticosteroid
* patients unable to communicate or patients with cognitive dysfunction

Primary outcomes:
measure: the incidence of intravascular injection
timeFrame: 5 seconds after injection of contrast media via block needle.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.