louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04798157: Transcranial Doppler in Children With Hemoglobinopathies
Official title: Role of Transcranial Doppler (TCD) in Children With Hemoglobinopathies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemoglobinopathies
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Transcranial Doppler ultrasonography (TCD) is a noninvasive, portable technique for evaluating the intracranial vasculature.

TCD ultrasonography is performed placing a low frequency (≤ 2 MHz) transducer on the scalp of the patient, in order to visualize the intracranial arterial vessels through specific acoustic windows, where bone is thinner, and evaluate cerebral blood flow velocity (CBFV) .

Patients diagnosed to have hemoglobinopathy conditions with its most common forms thalassemia and sickle cell disease manifest both biochemical and clinical evidence of hypercoagulability conditions include deep venous thrombosis, pulmonary emboli and recurrent arterial occlusion .

Cerebrovascular accidents can be identified using transcranial Doppler ultrasonography which enables evaluation of cerebral artery blood flow velocity with a sensitivity of 90% and specificity of 100 % when compared with cerebral angiography .

According to the stroke prevention trial in sickle cell anemia (STOP) study ,TCDs were classified based on blood velocity in the circle of Willis, expressed as time averaged mean of the maximum velocity (TAMMV). Children with abnormal, high velocities (\>200cm/s) were at increased risk of stroke, which was reduced by 90% after starting regular blood transfusions. TAMMVs less than 170cm/s were classified as normal with annual TCD scanning recommended, whereas velocities between 170 and 200cm/s were called conditional, and followed up more closely without starting transfusion.


Eligibility criteria: Inclusion Criteria:

* children diagnosed with hemoglobinopathies

Exclusion Criteria:

* Children before two years old .
* Hemoglobinopathy patients more than 18 years .
* Uncooperative patients .

Primary outcomes:
measure: Changes in the blood flow velocities at the circle of Willis
timeFrame: At procedure exam time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of medicine Sohag university
name: Mohamed E. Mohamed, ass. teacher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560157: Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Official title: Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurological Diseases
Pneumopathy
Major Abdominal Surgery
Acute Pancreatitis
Keywords: ICU patients
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients


Eligibility criteria: Inclusion Criteria:

* 18\<age\<89, ASA score\<4 , SAPS II score\>10
* requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
* ICU patients hospitalized for:
* neurologic affections
* pneumopathy
* major abdominal surgery or serious acute pancreatitis
* written informed consent

Exclusion Criteria:

* pregnancy or breast feeding
* immunosuppressive therapy
* radiotherapy or chemotherapy in the last six month
* uncontrolled septic choc
* auto-immune disease
* hepatic,renal or digestive insufficiency
* hyperlipidemia
* diabetes mellitus type 1
* digestive malabsorption
* life threatening situation
* treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate

Primary outcomes:
measure: Variation of Glutamine after 90 min of enteral product administration
timeFrame: J5
Secondary outcomes:
measure: Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
timeFrame: J1, J5, J8
measure: Tolerance
timeFrame: Daily until J8
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hopital A. BECLERE
city: Paris
country: France
facility: Hopital Saint Antoine
Study officials:
affiliation: University PARIS V
name: Luc CYNOBER, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01007357: Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation
Official title: Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diffuse and Focal Abnormalities of the Liver and Pancreas
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
First posted: 2009-11-04
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project will facilitate the optimization of body MR imaging at 3 Tesla.

Detailed description: This project is meant to improve the image quality of multiple sequences at 3.0T applied to the abdominal and pelvic regions.

Eligibility criteria: Inclusion Criteria:

* Subjects between ages of 19 and 65
* Healthy volunteer subjects should not have any history of disease or symptoms - based on clinical history
* Subjects with an underlying disorder (diffuse and focal abnormalities of the liver and pancreas)

Exclusion Criteria:

* Inability to provide informed consent
* A medical or contraindications that will prevent subjects from having a MRI
* Subjects with severe renal dysfunction or patients on dialysis

Primary outcomes:
measure: Optimizing body MR imaging sequences
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Shahid Hussain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111357: Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis
Official title: Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Rheumatoid Arthritis according to ACR criteria of diagnosis
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2010-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Martinique with at least 3 African-Caribbean grandparents

Brief summary: Rheumatoid arthritis (RA), affects between 0.3% and 1.0% of the population, it can lead to progressive joint destruction and severe disability. To date, two RA genetic susceptibility factors have been identified: HLA-DRB1-SE (Shared epitope) and PTPN22 620W alleles. The predictive value of the alleles for diagnosis of RA was previously investigated in cohorts of caucasians patients with early unclassified arthritis that showed restrained association between RA and HLA-SE. Despite the contribution of HLA to the overall genetic risk has been estimated to range from 30% to 50%, it has never been studied in the French west-Indian population.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis according to ACR criteria
* Come from French West Indies (At least 3 grandparents are African-Caribbean)
* Sign written informed consent

Exclusion Criteria:

* Minor
* Patient with no Rheumatoid Arthritis according to ACR criteria
* Patient does not agree for a genetic study

For the control

Inclusion Criteria:

* Blood donor
* Sign written informed consent
* Patient with no Rheumatoid Arthritis according to ACR criteria
* Come from French West Indies (At least 3 grandparents are African-Caribbean)

Exclusion Criteria:

* Minor
* Patient does not agree for a genetic study

Primary outcomes:
measure: Difference of distribution of HLA alleles in patients and in healthy controls
timeFrame: 1 day
Secondary outcomes:
measure: The association between the different HLA alleles among French West-Indian RA patients and the autoantibodies production.
timeFrame: 1 day
measure: The association between the different HLA alleles among French West-Indian RA patients and the radiological damage.
timeFrame: 1 day
measure: The association between the different HLA alleles among French West-Indian RA patients and the response to therapy
timeFrame: 1 day
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: Service de rhumatologie CHU de Fort-de-France
Study officials:
affiliation: CHU de Fort-de-France
name: Georges JEAN-BAPTISTE, Professor of medecine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991157: Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
Official title: Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: cerebral vasospasm
nimodipine
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aneurysmal subarachnoid hemorrhage with cerebral vasospasm

Brief summary: This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.


Eligibility criteria: Inclusion Criteria:

* aneurysmal subarachnoid hemorrhage
* potential or actual cerebral vasospasm

Exclusion Criteria:

* non-aneurysmal subarachnoid hemorrhage
* outside the 4-21 day window after ictus
* peripheral deoxygenation
* contraindication for nimodipine administration

Primary outcomes:
measure: Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
timeFrame: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
Secondary outcomes:
measure: Change in the cardiac output measured using near NICOM technology after administration of nimodipine
timeFrame: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
measure: Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
timeFrame: Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: NIMHANS
Study officials:
References:
Clinical trial NCT00278057: STUDY OF GLUCOSE IN DIALYSIS WATER WITH REGARD TO BLOOD PRESSURE AND QUALITY OF LIFE
Official title: PHASE 4 STUDY OT THE EFFECT OF GLUCOSE ADDED TO THE DIALYSIS FLUID ON BLOOD PRESSURE, BLOOD GLUCOSE AND QUALITY OF LIFE IN HEMODIALYSIS PATIENTS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis
Keywords: Blood pressure;
chronic renal failure;
diabetes mellitus;
dialysis fluid; glucose;
hemodialysis;
hypertension;
uremia.
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: We wanted to test the hypotheses that blood pressure level was lower, that the variability of blood pressure and blood glucose was reduced, and that quality of life was improved when glucose was added to the dialysis fluid.

Detailed description: The purpose of the study was to determine the effect of glucose added to the dialysis fluid on 1.blood pressure and variation in blood pressure, 2.blood glucose and variation in blood glucose, and 3.quality of life in patients treated with chronic maintenance hemodialysis in a randomized, placebo-controlled, unblinded cross-over study.

Eligibility criteria: Inclusion Criteria:

* age more than 18 years, both men and women, and hemodialysis treatment for more than three months

Exclusion Criteria:

* treatment with hemodiafiltration, change to another dialysis modality, renal transplantation, alcohol abuse defined as more than 21 drinks a week for men and more than 14 drinks a week for women, and unwillingness to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
Study officials:
affiliation: Holstebro Hospital, 7500 Holstebro, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05699057: Tendency to Suicide as a Sequel of Computer Vision Syndrome
Official title: Prevalence and Associated Risk Factors of Tendency to Suicide as a Sequel of Computer Vision Syndrome Among Medical Students in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Computer Vision Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 3512
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: medical students or staff who are using screens in their medical studies or personal lives and how these screens affect their medical studies and the effect of mandated medical computer use if present on their screen-behaviour, tendency to suicide and associated risk factor

Brief summary: CVS-F4 questionnaire will be used as an instrument to survey prevalence of tendency to suicide among medical students in the Egyptian Universities and analyse associated risk factors and any correlated determents

Detailed description: CVS-F4 (30 questions) will be an online survey via the SurveyMonkey Company. We will collect the responses and analyze the results. Informed consent will be obtained from the participants as an item within the survey itself that he/she agrees to use his/her data in this research work. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. CVS-F4 questionnaire will be used as an instrument to survey prevalence of tendency to suicide among medical students in the Egyptian Universities and analyse associated risk factors and any correlated determents Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis.

Eligibility criteria: Inclusion Criteria:

* university students
* university staff members

Exclusion Criteria:

* hysteria
* ocular surgery
* amblyopia
* anisometropia
* strabismus
* systemic disease

Primary outcomes:
measure: Tendency to suicide
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Screen-time
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Professor of Ophthalmology
name: Mohammed Iqbal Iqbal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01332357: Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
Official title: Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: fluticasone/propionate salmeterol combination
hospitalization
emergency department
asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 6139
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study intends to identify subjects with asthma discharged from an emergency department that received fluticasone propionate/salmeterol from either an ED physician or from an outpatient physician

Brief summary: The objective of this study is to compare readmission to the emergency department for asthma in asthma patients who receive treatment with fluticasone propionate and salmeterol oral inhaler after an initial emergency department visit using a retrospective observational cohort study design.


Eligibility criteria: Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 12 years of age
* discharged from an initial Emergency Department visit within 12 months

Exclusion Criteria:

* Subjects with COPD or treatment for COPD

Primary outcomes:
measure: Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
timeFrame: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01698957: Maternal Uterine Artery Doppler Study
Official title: A Simple Technique to Modify Maternal Uterine Artery Perfusion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal-Fetal Exchange
Keywords: Pregnant women
Uterine Artery Doppler Velocimetry
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women greater than or equal to 18 weeks gestation and 18 years old eligible for an ultrasound without fetal or uterine anomalies

Brief summary: The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.

Detailed description: In the setting of uteroplacental insufficiency, there is little that can be done to increase blood flow through the uterus and placenta. Historically, women with growth restricted fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment modality has met with only limited success. Cardiologists have long recognized the simple act of making a fist or otherwise occluding blood flow through a limb dramatically increases a person's peripheral vascular resistance. If maternal peripheral resistance can be increased, perhaps the increased differential between the maternal peripheral vascular resistance and that of the uteroplacental unit will increase flow through the uterus and placenta.

Eligibility criteria: Inclusion Criteria:

* Pregnant women greater than or equal to 18 years old
* Able to speak and read English
* Have a singleton pregnancy greater than or equal to 18 weeks gestation

Exclusion Criteria:

* Multiple gestation
* Less than 18 weeks gestation
* Uterine anomalies
* Fetal anomalies
* Preeclampsia
* Hypertension
* Inability to have BP cuff on left arm

Primary outcomes:
measure: Uterine Artery Doppler
timeFrame: at time of routine ultrasound
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Phoenix Perinatal Associates
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Perinatal Associates
state: Arizona
Study officials:
affiliation: Obstetrix Medical Group
name: Thomas H Strong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02521857: A Water Consumption Study of ALKS 5461 in Healthy Volunteers
Official title: A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Alkermes
Samidorphan
ALKS 5461
Healthy Volunteer
Pharmacokinetics
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.


Eligibility criteria: Inclusion Criteria:

* Has a body mass index (BMI) of 18.0 - 30.0 kg/m\^2
* Is in good physical health
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Has a history of substance abuse disorder
* Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
* Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
* Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
* Has used alcohol within 72 hours prior to any inpatient period
* Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
* Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
* Additional criteria may apply

Primary outcomes:
measure: AUCinf
timeFrame: Up to 72 hours
measure: AUClast
timeFrame: Up to 72 hours
measure: Cmax
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Safety and tolerability will be measured by the incidence of Adverse Effects
timeFrame: Up to 46 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Arielle Stanford, MD
role: STUDY_DIRECTOR
References: