louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04127253: Evaluation of the Hypoalgesic Effects of Transcranial Direct Current (tDCS) in Healthy Subjects
Official title: Evaluation of the Hypoalgesic Effects of Transcranial Direct Current (tDCS) in Combination With Motion Representation Tools in Healthy Subjects: a Double-blind Randomized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Modulation
Keywords: Motor imagery
Transcranial direct current stimulation
Action observation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2019-10-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this research is to evaluate and quantify hypoalgesic effects caused by imagination and observation with or without the presence of transcranial direct current (tDCS) in healthy participants. The secondary objective of this research is to evaluate the possible relationships between hypoalgesic effects and different physical and cognitive variables such as the ability to generate motor mental images, mental chronometry and levels of physical activity.


Eligibility criteria: Inclusion Criteria:

* asymptomatic participants
* men and women aged 18 to 65 years

Exclusion Criteria:

* insomnia
* nausea
* headache
* pregnant woman
* use of painkillers in the last twenty four hours
* presence of metal inside the head
* pacemaker
* wound on the area of electrodes' application
* drugs consumer
* recent application of transcranial direct stimulation
* psychiatric disease who lead the subject to a misunderstand of the study

Primary outcomes:
measure: Pressure pain threshold
timeFrame: Change in Pressure pain threshold just before the start of the intervention, immediately at the end of the intervention and 15 minutes after the end of the intervention
Secondary outcomes:
measure: Ability to generate motor images
timeFrame: Just before the start of the intervention
measure: Mental Chronometry
timeFrame: Just before the start of the intervention
measure: The degree of physical activity
timeFrame: Just before the start of the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT00822653: The Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life With Adults on Hemodialysis
Official title: the Effects of Plantar Stimulation on Hypotension, Treatment Efficacy and Quality of Life
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypotension
Keywords: hemodialysis treatment
pump stimulation
reduce hypotensive episodes
Lead sponsor: Binghamton University
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: For the end stage renal disease (ESRD) patients undergoing hemodialysis treatment, specifically, reflex mediated calf muscle pump stimulation has the potential to significantly reduce the number and magnitude of hypotensive episodes thus enhancing the effectiveness of the dialysis process. Fewer hemodialysis complications during the patient's hemodialysis treatment, would allow treatment sessions to continue to the prescribed volume removal, with much reduced patient recovery time, and the costs associated with this recovery.

Detailed description: Recruit individuals who consistently miss their dialysis goal. Maintain the goal over a six week period of time. Utilize exogenous calf muscle pump stimulation during each dialysis session to enhance fluid return from the lower limbs with the objective of assisting the patient in reaching ultrafiltration goal.

Track number of hypotensive events during dialysis, as well as goal success.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older;
2. alert and oriented to time, place, and self;
3. able to read and speak the English language;
4. currently receiving hemodialysis treatment approximately 3-4 hour sessions, 3 times a week;
5. received hemodialysis treatments continuously for the several previous months; AND
6. consistently exhibits hypotensive symptoms during dialysis.

Exclusion Criteria:

1. receiving hemodialysis as a temporary treatment following a peritoneal dialysis complication or an episode of transplant rejection;
2. receiving hemodialysis at home; OR
3. if they have a Medical History of any the following conditions: deep venous thrombosis, uncontrolled hypertension, pulmonary embolus

Primary outcomes:
measure: Achievement of ultrafiltration goal
timeFrame: 6 weeks
Secondary outcomes:
measure: Hypotensive events
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Science and Engineering Research Center
name: Kenneth J. McLeod, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03144453: Recovery From Anesthesia After Robotic Assisted Radical Cystectomy
Official title: Recovery From Anesthesia After Robotic Assisted Radical Cystectomy. Two Different Reversal of Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesiology Management
Keywords: Curare
Robotic surgery
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 50
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: Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. The aim of this study was to evaluate the quality of awakening in two groups of patients undergoing different combinations of curarization/reversal.


Eligibility criteria: Inclusion Criteria:

* ASA (american society of anesthesiologists) score ≤ III
* Patients underwent robotic assisted cystectomy

Exclusion Criteria:

* Cerebrovascular disease
* BMI (body mass index) ≥ 30

Primary outcomes:
measure: Time to discharge from recovery room
timeFrame: Up to 240 Minutes After recovery
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ester Forastiere
state: RM
city: Rome
country: Italy
facility: Regina Elena Cancer Institute
state: RM
Study officials:
References:
Clinical trial NCT00682253: Use of Bone Scintigraphy, CT and MRI in Breast Cancer
Official title: Use og Bone Scintigraphy, CT and MRI for Detection of Metastases in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: SPECT/CT
MRI
Breast neoplasms
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women aged 18-80 years with suspicision of disseminated breast cancer seen at Dept. of Oncology, Aarhus University Hospital

Brief summary: A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled the combination of functional and anatomical imaging. Its use in cancer patients has not yet been evaluated or validated against a relative gold stand or clinical follow up. The purposes of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in breast cancer patients


Eligibility criteria: Inclusion Criteria:

* Histological verified breast cancer
* Age 18-80 years
* Investigation for metastases using imaging modality/modalities planned
* Written consent to participate in trial

Exclusion Criteria:

* Overweight limiting the use of MRI
* Metal parts in body
* Claustrophobia
* Allergy to contrast agents used in trial
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT03565653: The Effects of Dietary Salt on Post-exercise Hypotension
Official title: The Effects of Dietary Salt on Post-exercise Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Post-Exercise Hypotension
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The new American Heart Association (AHA) blood pressure guidelines are expected to raise the prevalence of high blood pressure to \~46% in the United States. One recommendation for lowering blood pressure is aerobic exercise, which produces a period of lowered blood pressure (post-exercise hypotension; PEH) that lasts up to 24 hours. It is believed that PEH may be responsible for the observations of lowered blood pressure following initiation of exercise. However, most Americans eat too much salt, which expands plasma volume and may prevent PEH, rending aerobic exercise ineffective in improving blood pressure status.

Detailed description: Recently released blood pressure guidelines from the American Heart Association and American College of Cardiology are expected to raise the prevalence of hypertension in America from \~33% to \~46%. A single bout of aerobic exercise produces a prolonged period (up to 24 hours) of lowered blood pressure (post-exercise hypotension; PEH). Repeated bouts of aerobic exercise results in maintenance of lowered blood pressure, leading to recommendations of aerobic exercise for improvement of blood pressure status. However, more than 90% of Americans consume more sodium in their diets than is recommended. This is alarming, as excess dietary sodium intake expands plasma fluid volume, which may in turn attenuate the reduction in BP following exercise. Therefore, the objective of this project is to determine the effects of high dietary sodium intake on PEH. The investigators hypothesize that, compared to a recommended sodium diet, a high salt diet will attenuate post-exercise hypotension.

Eligibility criteria: Inclusion Criteria:

* Recreationally active

Exclusion Criteria:

* high blood pressure (\>140/90 mmHg)
* history of cardiovascular disease
* history of cancer
* history of diabetes
* history of kidney disease
* obesity (BMI \> 30 kg/m2)
* smoking or tobacco use
* current pregnancy
* nursing mothers
* communication barriers

Primary outcomes:
measure: Post-exercise hypotension
timeFrame: 24 hours following exercise
Secondary outcomes:
measure: Blood pressure reactivity
timeFrame: 10th day of high salt diet
Other outcomes:
Locations:
city: Newark
country: United States
facility: Department of Kinesiology and Applied Physiology, University of Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT01297153: Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
Official title: Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congenital Cataract
Keywords: Congenital Cataract
Children younger than 2 years
Aphakia
Primary IOL Implantation
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 100
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.

Detailed description: The use of IOLs in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. The refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2 years remains controversial. Exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of IOLs in the first two years of life. Further more, there is concern about the unknown risks of an IOL over the long life span.

Currently, there are 3 methods of optical rehabilitation following congenital cataract surgery :

1. Primary IOL implantation.
2. Aphakic glasses.
3. Contact lenses.

At present, there is no randomized clinical trial reported to document the safety and efficacy of IOL implantation in children less than 2 years.

Aim : To compare the technical outcome (safety) and functional outcome (benefits) following primary IOL implantation and aphakia in children less than 2 years.

Eligibility criteria: Inclusion Criteria:

* Children less than 2 years
* Congenital cataract
* Bilateral cataracts
* IOL fixation - Bag/Ciliary fixated

Exclusion Criteria:

* Microphthalmos (Mean axial length 2 SDs less than normal for age)
* Microcornea (Horizontal corneal diameter \<9.5 mm-asper that particular age)
* Iris coloboma
* PHPV
* Aniridia
* \*Glaucoma - IOP more than or equal to 25 mmHg

  * One eyed
  * Cataract surgery already performed in fellow eye

Primary outcomes:
measure: Visual axis obscuration
timeFrame: 4 years
measure: Glaucoma
timeFrame: 4 years
measure: Central Corneal Thickness
timeFrame: 4 Years
Secondary outcomes:
measure: Visual Acuity
timeFrame: 4 years .
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Iladevi Cataract & IOL Research Centre
Study officials:
affiliation: Iladevi Cataract And IOL Research Centre
name: Abhay R Vasavada, MS,FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742453: Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis
Official title: Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: CEUS
gadoxetic acid
MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Bracco Corporate
First posted: 2018-11-15
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).


Eligibility criteria: Inclusion Criteria:

* High risk group of developing HCC
* hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
* newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
* scheduled for gadoxetic acid-enhanced liver MRI
* signed informed consent

Exclusion Criteria:

* hypersensitivity for ultrasound contrast media
* pregnancy
* history of recent treatment for HCC in a year
* standard of reference is not available
* severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)

Primary outcomes:
measure: Diagnostic performance of CEUS for diagnosing HCC
timeFrame: 3 months after CEUS
Secondary outcomes:
measure: Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018
timeFrame: 3 months after MRI
measure: Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018
timeFrame: 3 months after MRI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976053: Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
Official title: Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Myocardial perfusion imaging
Single photon emission computed tomography
Positron emission tomography
Lead sponsor: Aspire Foundation
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
name: Cardiovascular Imaging Technologies
name: Saint Luke's Cardiovascular Consultants
name: Mid America Heart Institute
First posted: 2009-09-14
Enrollment: 330
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.


Eligibility criteria: Inclusion Criteria:

* History of coronary artery disease
* New or worsening symptoms
* Out-patients and in-hospital patients

Exclusion Criteria:

* Creatinine above 2.5 mg%
* PCI within prior 6 months
* Pregnant females
* Cardiomyopathy (LVEF below 40%)
* Significant valvular heart disease
* Body mass index greater than 38

Primary outcomes:
measure: Diagnostic failure of SPECT vs PET
timeFrame: 60 days
Secondary outcomes:
measure: Composite of diagnostic or clinical failure
timeFrame: 12 months
measure: Each of individual components of clinical failure
timeFrame: 12 months
measure: Relative effect on quality of life
timeFrame: 3 months, 6 months
measure: Relative direct and downstream costs
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Cardiovascular Consultants
state: Missouri
Study officials:
affiliation: Aspire Foundation
name: Timothy M Bateman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel KK, Al Badarin F, Chan PS, Spertus JA, Courter S, Kennedy KF, Case JA, McGhie AI, Heller GV, Bateman TM. Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients. JACC Cardiovasc Imaging. 2019 Sep;12(9):1821-1831. doi: 10.1016/j.jcmg.2019.04.020. Epub 2019 Jul 17.
Clinical trial NCT04941053: Seroprevalence of COVID-19
Official title: Seroprevalence of COVID19 in Sohag Governorate Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: group 1 patients coming to hemodialysis unit group 2 relative to patients coming to hemodialysis unit, medical staff

Brief summary: Coronavirus disease pandemic has been started in late 2019. Since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 September, 2020. . Herd immunity is achieved when enough people become immune to a virus to stop its spread. Around 70% to 90% of a population needs to be immune to protect the uninfected. In A Spanish study of more than 30,000 people estimates that around just 5% of the Spanish population has developed antibodies

Detailed description: Aims of work:

A cross-sectional study to detect the seroprevalence to COVID 19 in chronic hemodialysis patients and compare it with the COVID 19 seroprevalence in healthy control in Sohag governorate Egypt

Methods:

After taken informed consent according to Sohag University Ethical Committee A questionnaire on coronavirus symptoms will be asked including epidemiological characters and history of previous COVID 19 infection and infection control measures to prevent it

5 ml of the blood sample will be taken for IgG antibodies testing with a chemiluminescent microparticle immunoassay.

Eligibility criteria: Inclusion Criteria:

* patient accept to participate

Exclusion Criteria:

* vaccinated people

Primary outcomes:
measure: seroprevalnce
timeFrame: 3-6-2021 to 30-8-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: N S shafik, lecturer
role: PRINCIPAL_INVESTIGATOR
References: