louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06410885: Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
Official title: Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).


Eligibility criteria: Inclusion criteria

1. Existing ventricular cerebrospinal fluid shunt
2. Age ≥ 2 years old
3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device
4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

Exclusion criteria

1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
2. Presence of more than one distal shunt catheter in the study device measurement region
3. Presence of an interfering open wound or edema in the study device measurement region
4. Subject-reported history of adverse skin reactions to silicone adhesives
5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
6. Subject not available for seven-day follow-up

Primary outcomes:
measure: Study device negative predictive value (NPV)
timeFrame: Up to 7 days
Secondary outcomes:
measure: Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT05688085: Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of Irbesartan High/Amlodipine Fixed Dose Combination in Comparison With Co-administration of Mono Compounds in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applied

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied

Primary outcomes:
measure: AUCt of Irbesartan High and Amlodipine
timeFrame: 72 hours
measure: Cmax of Irbesartan High and Amlodipine
timeFrame: 72 hours
Secondary outcomes:
measure: AUCinf of Irbesartan High and Amlodipine
timeFrame: 72 hours
measure: AUCt/AUCinf of Irbesartan High and Amlodipine
timeFrame: 72 hours
measure: tmax of Irbesartan High and Amlodipine
timeFrame: 72 hours
measure: half-life of Irbesartan High and Amlodipine
timeFrame: 72 hours
measure: CL/F of Irbesartan High and Amlodipine
timeFrame: 72 hours
measure: Vz/F of Irbesartan High and Amlodipine
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT01291485: Electronic Intervention for HIV Medication Adherence
Official title: Randomized Clinical Trial Examining the Efficacy of an Electronic Intervention for HIV Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Medication adherence
computer-based intervention
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and examine the feasibility and initial efficacy of a computer-based intervention to improve medication adherence among people living with HIV.


Eligibility criteria: Inclusion Criteria:

* infected with HIV
* over age 18
* currently prescribed a Highly Active Antiretroviral Therapy (HAART) regimen
* prescribed a regimen for the first time, changing regimens, or report adherence below 95% agree to brief follow-up interviews

Exclusion Criteria:

* physical impairment that would prevent them from successfully completing the computer-based program (e.g., blind, deaf, severe neuropsychological impairment)
* Actively psychotic
* Not fluent in English

Primary outcomes:
measure: HIV medication adherence
timeFrame: up to 6 months
Secondary outcomes:
measure: HIV Treatment Adherence Self-Efficacy
timeFrame: Baseline, 1-month, 3 months, and 6-months
measure: Quality of Life
timeFrame: Baseline, 1-month, 3-months, and 6-months
measure: Viral Load
timeFrame: Baseline, 1 month, 3 months, and 6 months
measure: CD4 cell count
timeFrame: Baseline, 1 month, 3 months, and 6 months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Internal Medicine Specialty Services
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: Thad R Leffingwell, Ph.D.
role: STUDY_DIRECTOR
affiliation: Oklahoma State University
name: Kasey R Claborn, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma State University Center for Health Sciences
name: Johnny Stephens, Pharm.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06663085: Using NIRS to Evaluate Splanchnic Oxygenation During Blood Transfusion in Preterm Infant
Official title: The Effect of Enteral Feeding on Splanchnic Oxygenation During Blood Transfusion in Preterm Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Splanchnic Oxygenation
NIRS
PreTerm Neonate
Enteral Feeds
Keywords: transfusion
nirs
splanchnic oxygenation
preterm neonate
enteral feeds
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: control group: not received enteral feeding during transfusion intervention group: received enteral feeding
Primary purpose: PREVENTION

Brief summary: To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.

Detailed description: using NIRS to evaluate splanchnic oxygenation

Eligibility criteria: Inclusion Criteria:

* Infant with gestational age \< 37 weeks
* Planned to receive blood transfusion
* Had received minimum 25 ml/kg/day enteral feeding
* in stable condition

Exclusion Criteria:

* Infant with multiple congenital anomalies
* Infant with suspected/confirmed genetic anomalies
* Parents or family did not sign the informed consent

Primary outcomes:
measure: cerebral splanchnic oxygenation ratio using nirs
timeFrame: from enrollment to 48 hours after transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Dr Sardjito General Hospital
Study officials:
References:
Clinical trial NCT00831285: Barley Tortillas Study in Healthy Volunteers
Official title: A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.

Detailed description: Specifically, we wish to examine the glycemic response of barley tortillas containing different ratios of amylose and amylopectin and different amounts of soluble and insoluble fibre with an appropriate control during acute phase testing in healthy volunteers. Possible relationships between composition of the barley tortillas and the degree of physiological response will also be investigated as the secondary objective.

Eligibility criteria: Inclusion Criteria:

* male or female age 18 to 40 years
* normal glycated hemoglobin of \<6%
* BMI of 20 to 30
* must read the consent form
* must comply with the protocol requirements

Exclusion Criteria:

* allergies to barley flour
* presence of chronic conditions such as cardiovascular disease, hypertension, disorders affecting the gastrointestinal tract, thyroid disease, and requiring medication for these conditions
* requiring medication for glycemic control
* consumption of supplements which have an effect on blood glucose response

Primary outcomes:
measure: Calculation of area under the curve for glucose and insulin
timeFrame: 6 weeks
Secondary outcomes:
measure: comparison of food groups using ANOVA
timeFrame: 6 weeks
measure: measurement of incretins
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital Research Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Carla Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makelainen H, Anttila H, Sihvonen J, Hietanen RM, Tahvonen R, Salminen E, Mikola M, Sontag-Strohm T. The effect of beta-glucan on the glycemic and insulin index. Eur J Clin Nutr. 2007 Jun;61(6):779-85. doi: 10.1038/sj.ejcn.1602561. Epub 2006 Dec 6.
Clinical trial NCT00042185: Eating Disorder Prevention Programs
Official title: Austin Body Acceptance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Adolescence
Prevention and Control
Bulimia
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-07-26
Enrollment: 450
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated 2 eating disorder prevention programs designed to increase body satisfaction among adolescent females with body image concerns.

Detailed description: Adolescent girls with body dissatisfaction (N=481; SD=1.4) were randomized to a dissonance-based thin-ideal internalization reduction program, healthy weight control program, expressive-writing control condition, or assessment-only control condition. Dissonance participants showed significantly greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, and lower risk for eating pathology onset through 2-3 year follow-up than assessment-only controls. Dissonance participants showed greater decreases in thin-ideal internalization, body dissatisfaction, and psychosocial impairment than expressive-writing controls. Healthy weight participants showed greater decreases in thin-ideal internalization, body dissatisfaction, negative affect, eating disorder symptoms, and psychosocial impairment, less increases in weight, and lower risk for eating pathology and obesity onset through 2-3 year follow-up than assessment-only controls. Healthy weight participants showed greater decreases in thin-ideal internalization and weight than expressive writing controls. Dissonance participants showed a 60% reduction in risk for eating pathology onset and healthy weight participants showed a 61% reduction in risk for eating pathology onset and a 55% reduction in risk for obesity onset relative to assessment-only controls through 3-year follow-up, implying that the effects are clinically important and enduring.

Eligibility criteria: Inclusion criteria:

* Self-reported body image concerns

Primary outcomes:
measure: Eating Disorder Diagnostic Interview
timeFrame: 1 year
Secondary outcomes:
measure: The Ideal-Body Stereotype Scale-Revised, Satisfaction and Dissatisfaction with Body Parts Scale, Positive Affect and Negative Affect Scale-Revised
timeFrame: 1 year
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
citation: Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.
citation: Stice E, Fisher M, Martinez E. Eating disorder diagnostic scale: additional evidence of reliability and validity. Psychol Assess. 2004 Mar;16(1):60-71. doi: 10.1037/1040-3590.16.1.60.
Clinical trial NCT02685085: Combined Method for Induction of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Induced Labor
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.


Eligibility criteria: Inclusion Criteria:

* females presenting for induction of labor

Exclusion Criteria:

* previous cesarean section
* previous uterine scars e.g. myomectomy
* refusal to participate in the study

Primary outcomes:
measure: Duration of induction of labor
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248885: Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)
Official title: Peri-Operative Morbidity and Quality of Life After CABG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery
Keywords: Coronary artery bypass graft surgery
Perioperative complications
Neurocognitive function
Quality of life
Blood pressure
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-11-04
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.

Detailed description: The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.

Eligibility criteria: Inclusion Criteria:

1. Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
2. Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.

Exclusion Criteria:

1. Patients who refused to participate in the study.
2. Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
3. Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
4. Patients who were unable to complete the neuropsychologic test.
5. Patient who were part of another CABG study.

Primary outcomes:
measure: Cardiac morbidity
timeFrame: 6-months after surgery
measure: Neurologic morbidity
timeFrame: 6-months after surgery
measure: Mortality
timeFrame: 6-months after surgery
measure: Functional status
timeFrame: 6-months after surgery
measure: Neurocognitive function
timeFrame: 6-months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04100785: A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients
Official title: A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients in an Outpatient Hospital Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to explore the efficacy and acceptability of a clinician-guided internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression, in Singapore.

Detailed description: All outpatients, from the Institute of Mental Health, Singapore, who are diagnosed with a primary diagosis of mild to moderate depression and were referred to the Psychology Department for therapy were invited to take part in this research. Participants were randomised into two groups: iCBT Intervention Group and Delayed Waitlist-Control Group. The four-week iCBT programme comprised of three face to face 30-minute sessions with a clinician and six online modules).The treatment group is hypothesised to exhibit pre-post improvements in depressive symptoms, compared to the control group.

Eligibility criteria: Inclusion Criteria:

* 21 to 65 years old
* Not currently seeing a therapist for any form of invidual or group therapy
* Diagnosed with a primary diagnosis of depression by IMH psychiatrist
* A total score of above 9 on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001), indicating at least mild symptoms
* If using medication for depression then on a stable dose for at least 1 month,
* Provides informed consent
* Able to read and speak at least Primary 6 level English
* Adequate IT skills to operate iCBT programme

Exclusion Criteria:

* Severe depression (i.e. score = 23 on PHQ-9)
* Strong suicidal ideation (i.e. score \> 2 on Question 9 of the PHQ-9)
* Current active suicidal intention or plan
* Presenting problem is not depression
* Does not meet the minimum English language requirements stated above
* Participants who are concurrently attending other forms of group/individual psychotherapy

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ9)
timeFrame: week 1, week 3, week 4 and 3-month follow-up
Secondary outcomes:
measure: Change in Generalised Anxiety Disorder-7 (GAD-7)
timeFrame: week 1, week 3, week 4 and 3-month follow-up
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: week 1, week 3, week 4 and 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Sharon HX Lu, DPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570385: Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Official title: Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Neuritis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric
Primary purpose: OTHER

Brief summary: Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?


Eligibility criteria: Inclusion Criteria:

* Age from 18 to 55 years old
* Clinically suspected optic neuritis defined as a sudden decrease of the visual acuity and/or a damage to the field of vision and/or a defect of the colour vision and/or retro-orbital pain with a relative afferent pupillary defect (except if the optic neuropathy is bilateral or symmetrical), in the absence of a severe retinal macular pathology, and in the absence of a toxic or iatrogenic intake (ethambutol, vfend)
* Clinical optic neuritis duration \< 15 days
* First episode of an inflammatory ON
* No corticosteroids in the month before
* Indication to a corticosteroid therapy at high dose to cure the felt symptomatology
* Retinal nerve fibre layer (RNFL) thickness upper 75 µm at initial stage
* Isolated ON, multiple sclerosis or NMO (Neuro Myelitis Optica) - SD (Spectrum Disorder) context
* Having signed informed consent for participating in the study

Exclusion Criteria:

* Contra-indication to MRI

  * Cardiac pacemaker or defibrillator implant
  * Neurosurgical clips
  * Cochlear implants
  * Intra-orbital or encephalic foreign bodies
  * Stents implanted since less than 4 weeks and osteosynthesis equipment implanted since less than 6 weeks
  * Claustrophobia
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
* Eye examination suggests a pre-existing eye abnormality that could affect the visual function (amblyopia, strong myopia...)
* Pregnant or breastfeeding women

Primary outcomes:
measure: Study of DTI markers in the assessment of the visual prognosis at 6 months of an inflammatory NO based on RNFL thickness (< ou > 75 µm)
timeFrame: Month 6
Secondary outcomes:
measure: Study of DTI markers in the assessment of the visual prognosis at 6 months of an inflammatory NO based on visual acuity and/or sensible damage to the field of vision
timeFrame: Month 6
measure: Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON
timeFrame: Month 6
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: