louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04196426: Nutrition Education to Promote Calcium Intake Among 30-65 Year-old Women in Vietnam
Official title: Nutrition Education Intervention to Promote Dietary Calcium Intake Among Vietnamese Women Aged 30-65 Years in Rural Areas in Hanoi, Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: nutrition education
nutrition intervention
calcium intake
calcium-rich foods
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Hanoi University of Pharmacy
name: Vietnam National Institute of Nutrition
First posted: 2019-12-12
Enrollment: 250
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three communities receive the nutrition intervention while three other communities do not. After 1 month, the first 3 communities do not receive the intervention while the later 3 communities receive the same nutrition intervention. Baseline, post intervention data are collected.
Primary purpose: PREVENTION

Brief summary: Osteoporosis is an important public health problem in Vietnam, with one in ten Vietnamese women suffering from it. There is enough evidence demonstrating that low calcium intake is one of the risk factors for osteoporosis among Asian women in general and Vietnamese women in specific. It is reported that the intake of calcium among Vietnamese women is under 400 mg/day, which is less than the daily recommendation of 1,000 mg/day by the Vietnam National Institute of Nutrition, even though calcium-rich foods are largely available in Vietnam. Therefore, the purpose of this study is to promote dietary calcium intake among Vietnamese women aged 30-65 years through implementing a nutrition education intervention.

Detailed description: Vietnamese women aged 30-65 years without medical problems that could interfere with the calcium consumption, such as kidney stone, kidney and liver diseases. The women will be excluded if they are blinded, deaf, or have general learning disability.

Outcomes of the study are dietary calcium intake, calcium knowledge, and osteoporosis health belief. A quantitative questionnaire is being used to collect these data.

Eligibility criteria: Inclusion Criteria:

* women aged 30 to 65 years

Exclusion Criteria:

* have medical conditions that can interfere with calcium intake, such as physician-diagnosed kidney stone, kidney and liver diseases, etc.
* blind, deaf, and have general learning disability

Primary outcomes:
measure: Dietary calcium intake
timeFrame: 5 weeks
Secondary outcomes:
measure: Nutrition knowledge related to osteoporosis and calcium
timeFrame: 5 weeks
measure: Osteoporosis health beliefs
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Thach That
country: Vietnam
facility: Preventive Medical Centers
state: Hanoi
Study officials:
affiliation: Texas Tech University
name: Mary Murimi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02243826: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial
Official title: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lumbar Puncture
Keywords: Lumbar puncture
Adults
Nitrous oxide
Procedural pain
Procedural anxiety
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.

Detailed description: Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has never been investigated properly.

Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period of time. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding).

The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.

Eligibility criteria: Inclusion Criteria:

* Patients coming in the neurology department for a scheduled lumbar puncture
* 18 to 60 years.
* no previous use of nitrous oxide

Exclusion Criteria:

* contra-indication to nitrous oxide use
* Body Mass Index\>35
* Mini Mental State Examination \<26/30
* Temperature \>38°C
* Confusion
* Patient unable to communicate verbaly

Primary outcomes:
measure: Maximal pain level during the procedure
timeFrame: at day 1
Secondary outcomes:
measure: Maximal anxiety level during the procedure
timeFrame: at day 1
measure: Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)
timeFrame: at day 1
measure: Proportion of patients presenting side effects
timeFrame: at day 1
measure: Total duration of the lumbar puncture
timeFrame: at day 1
measure: Proportion of patients that would accept another lumbar puncture in the same conditions
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Pierre CLAVELOU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06740526: Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Official title: A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.


Eligibility criteria: Inclusion Criteria:

1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
3. Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)

Exclusion Criteria:

1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
2. Participant has coexisting chronic kidney disease, other than IgAN.
3. Participant has a serum IgG value \<600 mg/dL at screening.
4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:

   topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
6. Participants who would be likely to require prohibited concomitant therapy during the trial.

Primary outcomes:
measure: Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52
timeFrame: From Baseline to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Clinical Research Site 330
state: Colorado
city: Boston
country: United States
facility: Clinical Research Site 369
state: Massachusetts
city: Dakota Dunes
country: United States
facility: Clinical Research Site 374
state: South Dakota
city: Houston
country: United States
facility: Clinical Research Site 324
state: Texas
city: Scarborough
country: Canada
facility: Clinical Research Site 305
state: Ontario
Study officials:
References:
Clinical trial NCT05658926: A Brief Intervention for Patients on Opioids for Acute Pain
Official title: A Brief Intervention for Patients on Opioids for Acute Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 60
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: This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.


Eligibility criteria: Inclusion Criteria:

* Patients who are admitted to Henry Ford Hospital
* Patients who have been evaluated by the Psychosomatic Medicine Service
* Patients who are prescribed at least one opioid for an acute pain condition

Exclusion Criteria:

* Patients taking an opioid for a chronic pain condition within the previous year
* History of an opioid use disorder.

Primary outcomes:
measure: Pain severity
timeFrame: Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart.
Secondary outcomes:
measure: Stress level
timeFrame: Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT00061126: ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body
Official title: A Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients With Hormone Resistant Prostate Cancer With or Without Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
PSA
Hormone refractory
Rising PSA
Lead sponsor: Abgenix
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2003-05-22
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body.

Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.


Eligibility criteria: Inclusion Criteria:

* Male 18 years of age or older
* Has tumor tissue available for diagnostics
* Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study
* ECOG score of 0 or 1

Exclusion Criteria:

* Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent)
* Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed)
* Known to be HIV positive
* Myocardial infarction within one year prior to entering the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Stanford
country: United States
facility: Stanford Medical Center
state: California
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute, Hillman Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT05470426: Viral Excretion Among COVID-19 Omicron Recurrence Patients
Official title: Viral Excretion and Its Influencing Factors Among COVID-19 Omicron Recurrence Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Recurrence
Surface Contamination
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 35
Sex: ALL
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 COVID-19 Omicron Recurrence

Brief summary: The study analyzes the viral nucleic acid excretion and its influencing factors of SARS-COV-2 Omicron recurrence patients.


Eligibility criteria: Inclusion Criteria:

* Patients with nucleic acid detection N gene and ORF gene Ct value \< 40 after discharge from hospital
* Being able to provide basic information, living habits, vaccination information, admission information

Exclusion Criteria:

* Single gene target positive
* Patients with incomplete baseline data

Primary outcomes:
measure: COVID-19 Omicron Recurrence
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References:
Clinical trial NCT04180826: STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND
Official title: Impact of Verticalization on Intracranial Hemodynamics Assessed by Continuous Transcranial Doppler Monitoring at the Acute Phase of Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Carotid Stenosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Hopital Lariboisière
First posted: 2019-11-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with ischemic stroke or transient ischemic attack of less than 48 hours with or without carotid stenosis greater than 50% NASCET or occlusion

Brief summary: Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Thus, the management of patients with Ischemic strokes is based on the preservation of an area that maintains sufficient intracranial hemodynamics (IH) and achieves the fastest possible recanalization. The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. In practice, variations in blood flow according to the positioning of the patient's body can be measured using a transcranial Doppler. It is a simple, non-invasive and painless examination that provides the patient's bed with data on the intracerebral hemodynamic profile of patients.

This study was implemented because there are no studies known to us that evaluate the effect of verticalization on intracerebral hemodynamics based on the presence of upstream arterial stenosis or occlusion and other multimodal evaluation data in transcranial Doppler.


Eligibility criteria: Inclusion criteria

* Patient over 18 years of age
* acute ischemic stroke or transient ischemic attack
* symptoms onset \< 48 hours
* Absence of homolateral or downstream intracranial stenosis or M1 occlusion
* Verticalization authorized by the referent clinician.
* Rankin's score before AIC/AIT ≤ 2
* Non-opposition to participation in the study

Criteria for inclusion of cases

- Carotid stenosis of more than 50% NASCET or an occlusion

Criteria for including witnesses - Absence of carotid stenosis greater than 50% NASCET or occlusion

Criteria for non-inclusion

- Disrupted vigilance

Primary outcomes:
measure: Change in the monitoring of patient care
timeFrame: 2 minutes after verticalization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Mikaël Mazighi
Study officials:
References:
Clinical trial NCT02717026: Multimodal Imaging of Retinal Vessels
Official title: Retinal Vessel Morphology in Multimodal Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Blood Vessels
Age-Related Macular Degeneration
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients scheduled for routine retinal assessment

Brief summary: Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable.

The present study aims to reveal and quantify differences in vessel morphology between fundus photography, fundus angiography, and optical coherence tomography in health and disease.

Detailed description: This is considered a pilot study and will pe performed on patients scheduled for routine fluorescein angiography.

During the study day the following procedures will be performed:

* Medical history and concomitant medication
* Blood pressure and heart rate
* Assessment of visual acuity using Snellen vision charts
* Biomicroscopy
* Intraocular pressure
* Funduscopy
* IOL-Master axial length measurement
* Fundusphotography
* Optical coherence tomography
* Fluorescein Angiography Fundus photography analysis will be performed with an automated software and analysis of both angiography and optical coherence tomography will be performed via the devices inbuilt software.

Eligibility criteria: Inclusion Criteria:

* written informed consent, clear media

Exclusion Criteria:

* any abnormality preventing reliable vessel measurement, pregnancy,

Primary outcomes:
measure: retinal vessel diameter
timeFrame: 5 minutes
Secondary outcomes:
measure: retinal vessel reflectivity
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Ophthalmology, Medical University of Graz
state: Styria
Study officials:
References:
Clinical trial NCT02076126: Determination of Lung Maturity and Prediction of RDS at Birth
Official title: Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RDS
Premature Birth
Keywords: Lung maturity
RDS
Prematurity
Lecithin-sphingomyelin ratio
Spectroscopy
Chemometrics
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Holbaek Sygehus
name: Aalborg University Hospital
name: Odense University Hospital
name: Aarhus University Hospital Skejby
name: Kolding Sygehus
name: Copenhagen University Hospital at Herlev
name: Rigshospitalet, Denmark
name: Hvidovre University Hospital
name: Naestved Hospital
name: University Hospital, Linkoeping
name: Skane University Hospital
First posted: 2014-03-03
Enrollment: 145
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 135 preterm infants with gestational age 24-32 weeks (24+0 to 31+6)

Brief summary: The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment.

We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

Detailed description: In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.

The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy.

The infants will be monitored for the first five days with regard to possible development of RDS.

Clinical and biochemical data will be compared retrospectively.

There a no intervention procedures.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
* Age \< ½ hour

Exclusion Criteria:

* Lack of informed consent
* lack of aspirate

Primary outcomes:
measure: RDS
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Holbaek Sygehus
Study officials:
affiliation: Holbaek Hospital
name: Henrik Verder, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: