louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00204984: Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation
Official title: The Effect of Aortic Impedance on Myocardial Relaxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: arterial stiffness
echocardiography
nesiritide
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2005-09-20
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?

Detailed description: 60 subjects, 30 with hypertension and 30 without will attend two visits to the GCRC. At each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and Doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication. At the first visit, each patient will receive an oral dose of the vasodilator hydralazine (does not effect aortic stiffness), and at the second visit each patient will receive intravenous nesiritide (does effect aortic stiffness). The relationship between timing of the reflected pulse wave and myocardial relaxation velocity will be studied at baseline and following administration of each vasodilator to determine if changing aortic stiffness has an impact on myocardial relaxation.

Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 65

Exclusion Criteria:

* Have known or suspected coronary artery disease
* Have known or suspected left ventricular dysfunction
* Have significant valvular, infiltrative, pericardial, or congenital heart disease
* Have a resting systolic blood pressure \< 100 mmHg
* Have had an adverse reaction to nesiritide or hydralazine
* Have a serum creatinine \> 2 mg/dl at Visit 1

Primary outcomes:
measure: heart myocardium relaxation (diastole)
timeFrame: before and after administration of vasodilator medication
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Nancy K Sweitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sweitzer NK, Hetzel SJ, Skalski J, Velez M, Eggleston K, Mitchell GF. Left ventricular responses to acute changes in late systolic pressure augmentation in older adults. Am J Hypertens. 2013 Jul;26(7):866-71. doi: 10.1093/ajh/hpt043. Epub 2013 Mar 28.
Clinical trial NCT04904484: A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients
Official title: A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aerosol Disease
Covid19
Noninvasive Ventilation
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Mercedes AMG PETRONAS Formula One Team
name: Imperial College London
First posted: 2021-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Environmental contamination of SARS Co-V2 (air and surface) will be tested around COVID patients receiving Non-invasive ventilation or high flow oxygen therapy before using the iZephyr hood and then with the iZephyr hood in place, to determine if the hood changes the amount of environmental contamination
Primary purpose: PREVENTION

Brief summary: This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.

Detailed description: Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT).

Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT.

Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.

Eligibility criteria: Inclusion Criteria:

Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II)

Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III)

Exclusion Criteria:

Patients under the age of 18 years or those lacking capacity

Primary outcomes:
measure: Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
timeFrame: 3 month
measure: Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
timeFrame: 12 months
measure: Impact of iZephyr hood on environmental SARS Co-V2 contamination
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04299984: Italian Multicenter Database for Open Conversions After EVAR
Official title: Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Enlargement
Keywords: Abdominal aortic aneurysm
Open surgical conversion
Endovascular repair
EVAR explantation
Failed EVAR
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 500
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 who underwent EVAR for abdominal aortic aneurysm exclusion, who developed complications not amenable to endovascular repair.

Brief summary: Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).

LOC is defined as a total or partial endograft explantation \>30 days after the initial EVAR.

SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.

The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.


Eligibility criteria: Inclusion Criteria:

* open or laparoscopic surgery for EVAR complications, with or without endograft explantation

Exclusion Criteria:

* endovascular reinterventions
* extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery

Primary outcomes:
measure: Early Mortality
timeFrame: 30 days
measure: In-hospital Mortality
timeFrame: 90 days
measure: Long-term survival
timeFrame: 4 years
Secondary outcomes:
measure: Early Morbidity
timeFrame: 30 days
measure: Related complications
timeFrame: 4 years
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
Study officials:
affiliation: Parma University Hospital
name: Paolo Perini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00094484: Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Disease
Chronic Kidney Disease
Keywords: Sensipar®
Mimpara®
Cinacalcet
Calcimimetic
Chronic Kidney Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-10-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).


Eligibility criteria: Inclusion Criteria: Chronic Kidney Disease patients not receiving dialysis with: - An iPTH greater than 100 pg/mL \[10.6 pmol/L\] for subjects with stage 3 CKD or greater than or equal to 160 pg/mL \[17.0 pmol/L\] for subjects with stage 4 CKD; - A serum calcium greater than 9.0 mg/dL \[2.25 mmol/L\]; - An estimated GFR less than or equal to 59 mL/min and greater than or equal to 15 mL/min. Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. - Experienced a myocardial infarction (MI) within 3 months before day 1. - Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. - Received active vitamin D therapy (i.e., 1-hydroxylated metabolites of vitamin D) for less than 30 days before day 1 or required a change in active vitamin D brand or dose level within 30 days before day 1 (for patients prescribed active vitamin D).

Primary outcomes:
measure: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
Secondary outcomes:
measure: Changes in iPTH at 32 weeks.
measure: Safety and tolerability of cinacalcet at 32 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Chonchol M, Locatelli F, Abboud HE, Charytan C, de Francisco AL, Jolly S, Kaplan M, Roger SD, Sarkar S, Albizem MB, Mix TC, Kubo Y, Block GA. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in participants with CKD not receiving dialysis. Am J Kidney Dis. 2009 Feb;53(2):197-207. doi: 10.1053/j.ajkd.2008.09.021. Epub 2008 Dec 24.
Clinical trial NCT01203384: Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
Official title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: CERESPIR
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.

Exclusion Criteria:

* Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
* Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
* Significant allergic conditions that require medical treatment
* Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
* Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

Primary outcomes:
measure: Adverse Events
timeFrame: from Screening through Day 18
Secondary outcomes:
measure: Dose linearity of CHF5074 plasma levels (Cmax)
timeFrame: Day -1 through Day 18
measure: Dose linearity of CHF5074 plasma levels (AUC 0-t)
timeFrame: Day -1 through Day 18
Other outcomes:
Locations:
city: Eatontown
country: United States
facility: Iberica Clinical Research Center
state: New Jersey
Study officials:
affiliation: Iberica Clinical Research Center
name: Magdy L Shenouda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05299684: Smartphone Addiction and Muscular Disorder
Official title: The Effect of Smartphone Addiction on the Musculoskeletal System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofascial Trigger Point
Keywords: Smartphone
mobile phone addiction
myofascial trigger point
forward head
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants of this study included 136 healthy students between the ages of 18 - 25 years. The study group consisted of 84 females and 52 males.

Brief summary: Background and aim: The use of smartphones, which has reached the level of addiction causes some physical and psychological health problems. The aim was to examine the musculoskeletal disorders of the neck and upper extremities of mobile phone addiction in a population of young adults.

Methods: The study is a cross sectional research conducted on students of a university in İstanbul between December 2018-October 2020. The level of addiction was assessed with the Smartphone Addiction Scale Short Form (SAS-SF). The posture of participants was evaluated by New York Posture Rating Chart (NYPRC), mostly usage smartphone posture, forward head and myofascial trigger points were questioned according to Simon and Travel criteria. Mann-Whitney U test Pearson's chi-squared test were used for analyzing the data.


Eligibility criteria: Inclusion Criteria:

* used smartphones
* volunteered to participate in the study.

Exclusion Criteria:

* having any history of trauma at the neck region within the last six months,
* taking any treatment for trigger points within the last 3 months
* having a history of neck surgery.

Primary outcomes:
measure: Smartphone Addiction
timeFrame: Baseline
measure: Posture
timeFrame: Baseline
measure: myofascial trigger point
timeFrame: Baseline
measure: Forward head posture
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Arel University
Study officials:
References:
Clinical trial NCT00409084: Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
Official title: Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Esophageal Varices
Keywords: varices
band ligation
portal hypertension
primary prophylaxis
cirrhosis
beta blockers
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.


Eligibility criteria: Inclusion Criteria:

* cirrhosis
* medium to large varices

Exclusion Criteria:

* contraindications to beta blockers
* refusal to give consent
* prior history of variceal hemorrhage
* creatinine \> 1.5 mg/dl

Primary outcomes:
measure: first variceal bleed
timeFrame: 2 years
Secondary outcomes:
measure: survival
timeFrame: 2 years
measure: liver function
timeFrame: 1 year
measure: encephalopathy
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
measure: frequency of other complications of cirrhosis
timeFrame: 2 years
measure: cost utility
timeFrame: 1 year
measure: patient preference
timeFrame: 1 year
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Division of Gastroenterology, Virginia Commonwealth University
name: Arun J Sanyal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03857984: Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study
Official title: Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Acid Metabolism
Erythrocytes
Lipidomics
Hemodialysis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the dialyzer / hemofilter arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during hemodialysis and thus act as potential candidate products for the result of hypotonic phases in the Dialysis.

We will determine differences in RBC fatty acids profiling in hemodialysis patients before and after dialysis intervention. Furthermore a matched control group of healthy individuals will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.

It is believed that during hemodialysis / HLM / CVVH there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.

Detailed description: Differences in Erythrocyte Fatty-Acid Status Profiling in:

* before and after hemodialysis intervention
* in hemodialysis patients and healthy individuals Venous blood will be collected from each subject in the sitting position

Eligibility criteria: Inclusion Criteria for hemodialysis patients:

* Patients who have a history of renal failure and undergo hemodialysis / hemofiltration
* Age over 18 years
* Ability to consent
* There is a written consent of the study participant

Exclusion Criteria for healthy control group:

* chronic illness requiring any medication
* pregnancy
* limitations regarding functioning in the hypoxic chamber
* inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination

Primary outcomes:
measure: Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, using LC-MS / MS.
timeFrame: 4-5 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Experimental & Clinical Research Center
Study officials:
References:
Clinical trial NCT03321084: Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
Official title: Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthrosis
Exercise Movement Techniques
Pilates
Elderly
Physiotherapy
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: a MatPilates group (MG) and a Control group (CG).
Primary purpose: TREATMENT

Brief summary: Introduction: The osteoarthrosis is incurable, one of the most incapacitating disease around the world and your prevalence is increasing every year. The main consequences of this disease is pain and loss of functionality as a result of biomechanical limitations coming from articular inflammation. Among the variability of therapeutic resources, we propose MatPilates like a no drug intervention, that probably will contribute for a decrease in the symptoms of this disease.

Objective: It is hypothesized that MatPilates is a method capable of decrease pain and increase functionality in elderly woman with osteoarthrosis.

Methods: This study is a randomized double blind clinical trial, in which the volunteer need be in between 60 and 69 years old. Will be formed of two groups: MatPilates Group (MG) and Control Group (CG), and the ideal "n" will be calculated in a pilot study.


Eligibility criteria: Inclusion Criteria:

* Bilateral osteoarthritis
* Body mass index (BMI) between 25 and 34,9 (WHO, 2000)
* Mini mental state examination score, with cutoff score of 18 (illiterate) and 24 (literate) (BRUCKI et al. 2003; LOURENÇO e VERAS, 2006)
* Unassisted gait (no wheelchair, no walking stick, no crutches or no walker)
* No history of neurologic disease
* No other physical activity
* Never practiced Pilates

Exclusion Criteria:

* Change in habitual drug's program during the study
* Join in other physical activity during the study
* Refuse to wear suitable clothing

Primary outcomes:
measure: Pain.
timeFrame: 7 weeks.
Secondary outcomes:
measure: Pain
timeFrame: 7 weeks.
measure: Pain
timeFrame: 7 weeks.
measure: Functionality.
timeFrame: 7 weeks.
measure: Functionality.
timeFrame: 7 weeks.
measure: Stiffness.
timeFrame: 7 weeks.
measure: Balance.
timeFrame: 7 weeks.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
state: Pernambuco
Study officials:
References: