louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04558528: Innovation Platform
Official title: Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 640
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms suggestive of malaria seeking clinical care in health facilities

Brief summary: In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR\~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.


Eligibility criteria: Inclusion Criteria:

* Aged 5 years or older
* Presenting at the study site with symptoms and signs suggestive of malaria
* Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
* Willing to provide sample at enrolment

Exclusion Criteria:

* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Primary outcomes:
measure: Clinical performance assessment
timeFrame: up to 6 months
measure: Concordance
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Eijkman Institute for Molecular Biology
city: Kigali
country: Rwanda
facility: Stansile
Study officials:
References:
Clinical trial NCT05703828: Impact of Chronic Ankle Instability on Gait Loading Strategy
Official title: Impact of Chronic Ankle Instability on Gait Loading Strategy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Sprains
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: use G power soft were

Brief summary: compare the dynamic foot print outcomes in subjects suffering from chronic ankle sprain to heathy subjects


Eligibility criteria: Inclusion Criteria:

* subjects were suffering from chronic ankle sprain.
* age ranged from 20-30 years old.
* Normal BMI (ranged from 18 to 24.9 Kg/m2)

Exclusion Criteria:

* not suffering from any neuromuscular disorders , deformities

Primary outcomes:
measure: loading force
timeFrame: through study completion, an average of 3 months
measure: foot print parameter - ankle rocker
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Amira Hussin Mohammed
Study officials:
References:
Clinical trial NCT01667328: Preoperative Massage in Breast Surgery Patients
Official title: Utility of Preoperative Massage in Breast Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Presurgical Anxiety
Breast Cancer
Keywords: Anxiety
Presurgical anxiety
Breast Cancer
Lead sponsor: Vassar Brothers Medical Center
Sponsor class: OTHER
Collaborators: name: Health Quest Systems
name: Dyson Center for Cancer Care
First posted: 2012-08-17
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Must speak English
* Able to give consent
* 18 years of age or older
* Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers Medical Center

Exclusion Criteria:

* Anxiolytics or antidepressants medications during the previous 24 hours
* Any condition that would prohibit receiving a massage
* IV medications prior to presurgical holding VAS assessment

Primary outcomes:
measure: Anxiety level
timeFrame: Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
Study officials:
affiliation: Vassar Brothers Medical Center
name: Angela Keleher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04357028: Measles Vaccine in HCW
Official title: Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Covid19
Keywords: MMR vaccine, Respiratory failure,
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that cross-protective antibodies against measles vaccine ( MV). In mice susceptible to measles virus, recombinant MV induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with SARS-CoV,

The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19.

We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness


Eligibility criteria: Inclusion Criteria:

* Age 18-50 years old
* Subjects who are willing to comply with the requirements of the study protocol and scheduled visits (for example, completion of the subject diary, return for follow-up visits) and who are willing to make themselves available for the duration of the study with access to a consistent means of telephone contact

Exclusion Criteria:

* acute severe illness
* recent receipt of a blood product
* history of thrombocytopenia
* Pregnant females
* any chronic medical condition
* Any participant receiving any immune suppressive medication
* Immunocompromised staff
* Participants who have egg allergy
* Participants who care for immune compromised hosts
* Participants who test positive for COVID-19 serology prior to randomization

Primary outcomes:
measure: COVID-19 disease incidence
timeFrame: Time Frame: Measured over the 6 months following randomization
Secondary outcomes:
measure: SARS-CoV-2 pneumonia
timeFrame: Time Frame: Measured over the 6 months following randomization
measure: Critical care admission duration with SARS-CoV-2
timeFrame: Time Frame: Measured over the 6 months following randomization
measure: Oxygen therapy with SARS-CoV-2
timeFrame: Time Frame: Measured over the 6 months following randomization
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospital
Study officials:
References:
Clinical trial NCT00947128: To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
Official title: A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nausea
Vomiting
Keywords: Antiemetic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680728: Venous Congestion and Organ Dysfunction.
Official title: Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Congestion
Organ Dysfunction Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 185
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: patient admitted to intensive care for less than 24 hours

Brief summary: Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.


Eligibility criteria: Inclusion Criteria:

* Adult
* Patient who has expressed his or her non-opposition to the collection of data (or the health care proxy, or a close relative if the patien is unable to receive the information)
* Patient admitted to intensive care for less than 24 hours.

Exclusion Criteria:

* Person not affiliated to the national health insurance
* Minor, protected major
* Pregnant or breastfeeding women
* Anechogenicity confirmed by the operator
* Chronic atrial fibrillation
* Mechanical cardiac assistance
* Uncontrolled blood pressure (MAP \< 65 mmHg)

Primary outcomes:
measure: the presence of venous congestion
timeFrame: From date of inclusion until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00219128: A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.
Official title: An Eight-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, placebo
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 671
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: Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 8 weeks
measure: Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks
measure: Blood pressure <140/90 mmHg after 4 weeks and 8 weeks
measure: Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks
measure: Evaluate high and low level drug effect using 24 hour blood pressure monitoring
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03037528: Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
Official title: Examination of Psychological Tools and Tracking in an Online Intervention for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-01-31
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.

Detailed description: The core of the program, administered to all participants, includes recommendations to follow a very low carbohydrate, ketogenic diet. The researchers will test whether adding the following experimental components will enhance the intervention's ability to improve health outcomes: (1) active vs. periodic self-monitoring of dietary intake using an "app"; (2) training vs. no training in positive affect; and (3) training vs. no training in mindfulness and mindful eating.

Eligibility criteria: Inclusion Criteria:

* Weight: Body Mass Index of 25-45 kg/m2 or greater.
* Current HbA1c of 6.5% or higher
* Regular access to the internet

Exclusion Criteria:

* Taking glucose lowering medications other than metformin
* Being pregnant or breastfeeding
* Currently undergoing cancer treatments
* Active use of a weight loss program or medications
* Self-reported impaired renal or hepatic function
* Self-reported untreated thyroid condition
* Vegetarian or vegan
* Weight loss surgery within the past year
* Medical concerns that prevent participants from following the assigned protocol

Primary outcomes:
measure: Glycemic Control
timeFrame: 12 months
Secondary outcomes:
measure: Weight Loss
timeFrame: 12 months
measure: Depressive Symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT03717428: Preventing Age-Related Weight Gain in the Workplace With Daily Weighing
Official title: Preventing Age-Related Weight Gain in the Workplace With Daily Weighing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Effect of self-weighing to prevent age-related weight gain
Primary purpose: PREVENTION

Brief summary: To examine the effectiveness of daily weighing to prevent age-related weight gain.

Detailed description: Cornell employee's were recruited for a two-year weight gain prevention study. Height and weights were taken in our metabolic center. They were randomized into two group. The experimental group was given an internet based scale and asked to weigh themselves every morning immediately after rising. The other group was asked to return at the end of the study when they height and weight will again be measured.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-diabetic

Exclusion Criteria:

* History of eating disorders

Primary outcomes:
measure: Weight Change
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cornell University
name: Patrick Stover
role: STUDY_DIRECTOR
References:
Clinical trial NCT04906928: Evaluation of New MRI Sequences Including 3D-FGAPSIR for the Optimization of Inflammatory Spinal Cord Lesions Research
Official title: Evaluation of the Performance of a 3D FGAPSIR Sequence by MRI in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-05-28
Enrollment: 200
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 study will be offered prospectively to patients presenting to the imaging department for a 3T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax

Brief summary: * verification of inclusion and non-inclusion criteria
* information and collection of consent
* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
* 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Detailed description: * verification of inclusion and non-inclusion criteria
* information and collection of consent
* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
* 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* To benefit from a medullary exploration planned by 3T MRI as part of a first evaluation or a reassessment of inflammatory involvement of the nevrax
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant, parturient or breastfeeding woman
* Absolute or relative contraindication to MRI

Primary outcomes:
measure: estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence.
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Study officials:
References:
Clinical trial NCT00199628: Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization
Official title: Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glomerulonephritis, Membranous
Neonatal Diseases and Abnormalities
Hemochromatosis
Keywords: fetomaternal tissular alloimmunization
Mothers having a child suffering from:
neonatal membranous glomerulonephritis
unexplained neonatal tubular defect
unexplained thrombotic microangiopathy
neonatal hemochromatosis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant woman

Brief summary: Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus.

The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism.

The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.


Eligibility criteria: Inclusion Criteria:

Mothers having a child suffering from:

* Neonatal membranous glomerulonephritis
* Unexplained neonatal tubular defect
* Unexplained thrombotic microangiopathy
* Neonatal hemochromatosis

Exclusion Criteria:

* Any cause explaining the child's disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
affiliation: Department of Pediatrics, Limoges University Hospital
name: Vincent Guigonis, MD
role: PRINCIPAL_INVESTIGATOR
References: