louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02263118: A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala
Official title: A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala, in the Context of Exclusive Breastfeeding Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exclusive Breastfeeding
Co-production of Health in Communities
Keywords: breastfeeding
rural
m-health
mHealth
Patojitos
Guatemala
exclusive breastfeeding
mobile
eHealth
e-health
Lead sponsor: Universidad Francisco Marroquín
Sponsor class: OTHER
Collaborators: name: Ecole Polytechnique, France
name: The SHM Foundation, UK
First posted: 2014-10-13
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to determine whether exposure to m-health platforms promoting recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding message to participant mothers, and in improving weight evolution of infants.


Eligibility criteria: Inclusion Criteria:

* Can read
* Has a baby of less than 4 months of age OR is in her 8th month of pregnancy

Exclusion Criteria:

* Cannot read
* Does not have a newborn

Primary outcomes:
measure: Number of Participants With Changes in Knowledge
timeFrame: December 2013 - May 2014, 23 weeks
Secondary outcomes:
measure: Qualitative Nature of Health-related Text-messages
timeFrame: December 2013 - May 2014, 23 weeks
measure: Number of Text-messages Exchanged in Virtual Communities
timeFrame: December 2013 - May 2014, 23 weeks
measure: Mean Change in Weight-for-Age Z-score
timeFrame: Baseline at December 2013 and 23 weeks later in May 2014
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Francisco Marroquin, Guatemala
name: Jorge Tulio Rodriguez, MD
role: STUDY_CHAIR
affiliation: Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala
name: Jose Tomas Prieto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174018: Validity and Reliability in Measuring the Subacromial Space by Using Ultrasound
Official title: Validity and Reliability in Measuring the Subacromial Space by Using Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Impingement
Keywords: subacrominal space
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To investigate validity and reliability in measuring the subacrominal space by using ultrasound


Eligibility criteria: Inclusion Criteria:

* Healthy subjects age range 19-35 years

Exclusion Criteria:

* With any pain in the upper extremities and back

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, NTU, Taiwan
Study officials:
affiliation: School and Graduate institute of Physical Therapy, National Taiwan University
name: Hsing-Kuo Wang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02625818: The Genetic and Affective Prediction Study
Official title: The Genetic and Affective Prediction Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Keywords: Emergency Services, Psychiatric
Prognosis
Biological markers
Anxiety
Panic
Psychomotor Agitation
Self-injurious Behavior
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2015-12-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the psychiatric acute department for central Norway, St Olavs University Hospital, Trondheim. The department has a catchment area of approximately 240000 inhabitants ≥ 18 years. The hospital has close to 2000 admittances each year

Brief summary: A major proportion of patients admitted to psychiatric acute and emergency departments have symptoms, behaviors or function influenced by implicit or explicit suicidal intention (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in the acute phase during in-patient stay and after discharge. At present there is no satisfactory tool to predict post-discharge suicide risk.

Multidimensional rating is expected to have better predictive properties than one-dimensional rating for suicidal behavior during in -patient stay and two years after discharge. Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations, as well as therapist's reactions during interviews. In the present study the predictive properties of two rating scales for suicidal behavior during in-patient stay and two years after will be compared. One of these is a multidimensional scale: "Multidimensional Assessment of Suicide Risk" (MARIS).


Eligibility criteria: Inclusion Criteria:

* acute agitated condition
* informed consent

Exclusion Criteria:

* Drug abuse
* in-patient stay for a fixed time at regular intervals

Primary outcomes:
measure: self-inflicted, potentially injurious behavior with intention to die defined as acts needing attendance by physician
timeFrame: 2 weeks
Secondary outcomes:
measure: suicide
timeFrame: 2 years after discharge
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Østmarka psychiatric department
Study officials:
affiliation: St Olavs Hospital, Division of Mental Health Care
name: Randolf Terje Vågen
role: STUDY_DIRECTOR
affiliation: Department of Mental Health, Faculty of Medicine and Health, NTNU
name: Nanna Sønnichsen Kayed
role: STUDY_DIRECTOR
References:
Clinical trial NCT00768118: A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants
Official title: A Pilot Study of Biomarker Alterations By Nutritional Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy, no Evidence of Disease
Keywords: healthy, no evidence of disease
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-10-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: RATIONALE: Studying samples of blood and urine from healthy participants receiving antioxidant nutritional supplements may help doctors identify changes in biomarkers related to oxidative stress.

PURPOSE: This clinical trial is studying how well a nutritional supplement capsule containing curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract works in healthy participants.

Detailed description: OBJECTIVES:

Primary

* To assess the effect of a specific combination nutritional capsule containing curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract on a specific biomarker of relevance to oxidative stress (NF-κB).
* To estimate the mean change in blood lymphocyte NF-κB level before and after 2 weeks of consumption of the nutritional agent under study.

OUTLINE: Participants receive oral curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule twice daily for 2 weeks. Participants are asked to keep a pill diary to track compliance.

Blood and urine samples are collected from participants at baseline and after completion of study. Lymphocytes and serum from the blood samples are isolated and analyzed for NF-κB biomarker levels. Urine samples are also tested for oxidative stress marker levels. Samples are analyzed using an electrophoretic mobility shift assay (EMSA).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Healthy volunteers who are employees of Karmanos Cancer Institute, Wayne State University, or Detroit Medical Center

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: The Magnitude of Change in Blood Lymphocyte NF-kB Level
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Fazlul H. Sarkar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914118: Modafinil to Prevent Postoperative Cognitive Decline
Official title: An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 137
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class I or II
* Elective surgery
* Surgery requiring general anesthesia

  4.) Control Group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.

Exclusion Criteria:

* Neurosurgery
* Cardiac surgery
* Narcotic or illicit drug abuse
* Chronic opioid use
* Chronic use of anxiolytics
* History of pulmonary disease
* C02 retention
* Sleep apnea
* Obesity

Primary outcomes:
measure: Rey Auditory Verbal Learning Test (RAVLT) scores
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00865618: Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
Official title: Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fed Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed 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 according to US FDA guidelines
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allied Research International Inc.
name: Deepen Patel, M.D., CCFP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06411418: Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm
Official title: Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysms
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Jacobs institute
First posted: 2024-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: OTHER

Brief summary: The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

Detailed description: The Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio \< 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

Eligibility criteria: Inclusion Criteria:

* Adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

Exclusion Criteria:

* Cannot provide consent or legally authorized representative not available to provide consent

Primary outcomes:
measure: Occurrence of thromboembolic event(s)
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery
state: New York
Study officials:
affiliation: University at Buffalo Neurosurgery
name: Elad LEvy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05315518: Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations
Official title: Effect of Using Shade Blocker Versus Chameleon Effect on Shade Matching of Two Single-shade Resin Composite Materials in Class IV Restorations: A One Year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Discoloration, Tooth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period

Detailed description: The color matching of both groups will be evaluated visually using modified USPH criteria

Eligibility criteria: Inclusion Criteria:

moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients

-

Exclusion Criteria:

* tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking

Primary outcomes:
measure: shade matching
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: sarah ahmed, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668018: Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
Official title: An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Male Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 887
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: Assess efficacy of vardenafil within 6 hours after intake


Eligibility criteria: Inclusion Criteria:

* Age: 18 years and older
* Males with erectile dysfunction
* Stable heterosexual relationship

Exclusion Criteria:

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use

Primary outcomes:
measure: Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
timeFrame: 12 weeks
Secondary outcomes:
measure: International Index of Erectile Function
timeFrame: 12 weeks
measure: Global Assessment Question (GAQ)
timeFrame: 12 weeks
measure: Other diary responses
timeFrame: 12 weeks
measure: General Safety
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01136018: A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Who Needs Epidural Block
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 24

Brief summary: Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigators hypothesize that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.


Eligibility criteria: Inclusion Criteria:

* patients with unilateral radiculopathy

Exclusion Criteria:

* patients with sepsis
* chronic infection
* coagulopathy
* local infection near the sacral hiatus
* the allergy of the contrast
* history of spine surgery, scoliosis and kyphosis

Primary outcomes:
measure: A prospective evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
timeFrame: during 10 seconds after obtaining the caudal epidurogram
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06264518: An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury
Official title: Exploration of Traumatic Brain Injury Clinical Trials: Unveiling Patient Participation Patterns
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Quantity of participants in traumatic brain injury study who sustain participation until study completion

Brief summary: Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with traumatic brain injury
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of patients who decide to enroll in a traumatic brain injury clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in traumatic brain injury clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Giner J, Mesa Galan L, Yus Teruel S, Guallar Espallargas MC, Perez Lopez C, Isla Guerrero A, Roda Frade J. Traumatic brain injury in the new millennium: new population and new management. Neurologia (Engl Ed). 2022 Jun;37(5):383-389. doi: 10.1016/j.nrleng.2019.03.024. Epub 2021 Apr 29.
citation: Hagos A, Tedla F, Tadele A, Zewdie A. Pattern and Outcome of Traumatic Brain Injury, Addis Ababa, Ethiopia: A Cross-sectional Hospital-based Study. Ethiop J Health Sci. 2022 Mar;32(2):343-350. doi: 10.4314/ejhs.v32i2.15.
citation: Shrestha A, Paudel N, Adhikari G, Shrestha S, Lamichhane S, Subedi S, Jaishwal N. Traumatic Brain Injury among Patients Admitted in Neurosurgical Unit in a Tertiary Care Centre: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2023 Jun 1;61(262):514-518. doi: 10.31729/jnma.8197.