louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03655769: fMRI Analysis of Aging and Awareness in Conditioning
Official title: Functional Magnetic Resonance Imaging (fMRI) Analysis of Aging and Awareness in Conditioning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-08-31
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cathodal Transcranial direct current stimulation (tDCS) was administered to the right parietal region in order to determine if this stimulation could disrupt awareness of the conditioned stimulus (CS) - unconditioned stimulus (US) relationship in a classical conditioning experiment.


Eligibility criteria: Inclusion Criteria:

* Educational attainment of at least eight years and English as the native language
* Mini-Mental State Examination (MMSE) score of 26
* Normal episodic memory (i.e., CERAD word List Recall \> 5)
* Informed consent; 5) age of 20-30

Exclusion Criteria:

* Disturbed consciousness
* Other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* Prior history of a major psychiatric disorder
* History of definite stroke
* Focal lesion on MRI exam
* Use of anxiolytic, antidepressant, neuroleptic, or sedative medication
* Predominately left-handed
* Has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).

Primary outcomes:
measure: CS-US Awareness
timeFrame: recorded immediately after the 20 minutes of tDCS stimulation
Secondary outcomes:
measure: Line bisection test of left-hemifield neglect
timeFrame: recorded immediately after primary awareness questionnaire
measure: Eyeblink conditioned responding
timeFrame: recorded during the tDCS administration
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: John Desmond
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687569: Glycaemic Responses to Cracker Snacks
Official title: Effects of Added Spice Flour on Glycaemic Responses to a Cracker Snack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycaemic Response Measurements
Keywords: Glycaemic Response
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Reading Scientific Services Ltd.
First posted: 2012-09-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.


Eligibility criteria: Inclusion Criteria:

* Male or female (not less than 40% Male)
* Aged 18 - 55 years
* Non Smokers
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Not allergic to wheat, mustard, dairy, or soy
* Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent

Primary outcomes:
measure: Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC)
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Reading,
country: United Kingdom
facility: Reading Scientific Services Limited (RSSL)
Study officials:
affiliation: Reading Scientific Services Limited
name: Rungano Munyuki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545569: Evaluation of New Custom Made Hearing Product Technology and Shell Modification
Official title: Evaluation of New Custom Made Hearing Product Technology and Shell Modification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss, Bilateral or Unilateral
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.

Detailed description: This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.

The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.

Eligibility criteria: Inclusion Criteria:

* Only adult participants between 18 and 99 years
* lnformed Consent as documented by signature (Appendix lnformed Consent Form)
* Ability to fill in a questionnaire conscientious
* Healthy outer ear (w/o previous surgical procedures)

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
* Massively limited dexterity
* Psychological problems
* Central hearing problems

Primary outcomes:
measure: Objective measurement of speech intelligibility related to the intervention.
timeFrame: 5 years
measure: Objective measurement of the transfer function related to the intervention.
timeFrame: 5 years
measure: Objective measurement from the position of the outer ear related to the test subject.
timeFrame: 5 years
measure: Objective measurement from the size of the outer ear related to the test subject.
timeFrame: 5 years
measure: Objective measurement of humidity in the ear canal related to the test subject and the intervention.
timeFrame: 5 years
measure: Objective measurement of temperature in the ear canal related to the test subject and the intervention.
timeFrame: 5 years
Secondary outcomes:
measure: Subjective rating of the intervention via questionnaire.
timeFrame: 5 years
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
affiliation: Switzerland, Sonova AG, CH-8712 Staefa, Zurich
name: Jana-Kosima Schwarzlos, B.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06925269: DMD Voice: Qualitative Interviews With Patients and Caregivers
Official title: Duchenne Muscular Dystrophy Quality of Life: Qualitative Interviews With Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: Duchenne
givinostat
Lead sponsor: Red Nucleus Enterprise Solutions, LLC
Sponsor class: INDUSTRY
Collaborators: name: Italfarmaco S.A
First posted: 2025-04-13
Enrollment: 68
Sex: MALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of individuals with Duchenne Muscular Dystrophy (DMD) and patients with DMD

Brief summary: The purpose of this study is to understand DMD functional losses or abilities and their association with independence and quality of life from the perspective of individuals with DMD and/or and their caregivers.

This is a qualitative interview study in which individuals with DMD and/or their caregivers will be asked to participate in a semi-structured, approximately 60- minute interview. Interviews will focus on functional abilities and independence. Caregivers and boys with DMD will be interviewed. This study includes no treatment nor intervention; however, some participants are being treated by a drug that is approved in the U.S. and the U.K. and under investigation in other geographies.


Eligibility criteria: Inclusion Criteria:

Subsample A - Patients

Eligible participants for Subsample A must:

* Have been treated with Givinostat for at least 2 years
* Be at least 10 years of age with signed consent of a parent or legal guardian
* Be currently taking givinostat
* Willing and able to participate in a video and/or audio recorded interview

Subsample A - Caregivers

Eligible caregivers for Subsample A must:

* Be a parent or legal guardian of an individual with DMD that has been taking givinostat for at least two years
* Willing and able to participate in a video and/or audio recorded interview

Subsample B - Caregivers

Eligible caregivers for Subsample B must:

* Provide care to an individual with DMD who is unable to raise their hands above their head as confirmed by the caregiver
* Reside in the United States or Canada
* Able to read, speak, and understand English
* Willing and able to participate in a video and/or audio recorded interview Have access to a stable internet connection

Exclusion Criteria:

-

Primary outcomes:
measure: Qualitative Interview
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yardley
country: United States
facility: Red Nucleus
state: Pennsylvania
Study officials:
affiliation: Red Nucleus Solutions
name: Mindy Leffler, M.Ed.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004669: Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Keywords: bronchopulmonary dysplasia
cardiovascular and respiratory diseases
neonatal disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Penn State University
First posted: 2000-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days of life for prevention of bronchopulmonary dysplasia.

II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal insufficiency.

III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations and on the ability of the adrenal gland to respond to ACTH.

IV. Determine the effect of this replacement therapy on markers of inflammation in lung lavage fluid and peripheral blood leukocytes.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Hydrocortisone therapy IV or placebo begins no later than 48 hours after birth and continues every 12 hours for 12 days. Hydrocortisone is given at 2-4 times the basal cortisol secretion rate.

Tracheal lavage on intubated babies is performed at start of study and on day 4 of life to assess concentrations of inflammatory markers.

If larger babies show appropriate response to ACTH by 15-17 days and the less mature babies show a decreased response, then a longer course of therapy is proposed for future studies.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* At risk for development of bronchopulmonary dysplasia

--Patient Characteristics--

* Hematopoietic: No congenital sepsis
* Hepatic: No structural defect of liver
* Renal: No agenesis or structural defect of a kidney
* Cardiovascular: No structural defect of the heart
* Metabolic: No diabetic mothers (e.g., preexisting insulin dependent, noninsulin dependent, and gestational diabetes)
* Pulmonary: No structural defect of the lung
* Other: Newborn birth weight must be 500 to 999 g and have endotracheal tubes in place at 12 hours of age Eligible if treatment can be given before 48 hours of postnatal life No major congenital anomaly causing significant defect in major organ system

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University
name: Kristi L. Watterberg
role: STUDY_CHAIR
References:
Clinical trial NCT04741269: ASYMMETRIC LACK OF KNEE FLEXION AS A SYMPTOM OF DLM IN CHILDREN
Official title: ASYMMETRIC LACK OF KNEE FLEXION AS A SYMPTOM OF DLM IN CHILDREN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Highlights a New Clinical Sign Which Point Out a Meniscus Posterior Luxation Because of a MCA-type DLM
Keywords: discoid lateral meniscus
children
instability
arthroscopy
repair
lack of flexion
flexion block knee
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 98
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with a discoid lateral meniscus symptomatic and surgical care.

Brief summary: Highlighted during the clinical examination of a knee flexion asymmetry, and related to the intraoperative meniscal observations on DLM.

Search for a link between asymmetric bending defect and posterior shift in MCA-type DLM.

Analysis of all patients with symptomatic DLM.


Eligibility criteria: Inclusion Criteria:

* \< 18 yo
* Symptomatic discoid lateral meniscus

Exclusion Criteria:

* Osteochondritis dissecans (OCD)
* Asymptomatic and partial DLM observed during arthroscopic exploration for other reasons
* Revision knee surgery

Primary outcomes:
measure: Meniscal posterior shift per-operative
timeFrame: During surgery for MCA-type DLM
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Paediatric orthopaedic - Femme Mère Enfant Hospital (HFME)
Study officials:
affiliation: Paediatric orthopaedic - Femme Mère Enfant Hospital (HFME)
name: Nicolas CANCE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508869: Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Erythema and Flushing Associated With Rosacea
Lead sponsor: Skin Laser & Surgery Specialists
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2018-04-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.

Detailed description: To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. 18 years of age or older
3. Clinical diagnosis of rosacea
4. Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1)
5. No known medical conditions that may interfere with study participation
6. Willingness to not use any products on their face for the duration of the study
7. Read, understand, and sign informed consent forms
8. Willingness to sign photography release form
9. Willing and able to comply with all follow-up requirements
10. Willingness to undergo treatment using Mirvaso® Gel and Dysport®

Exclusion Criteria:

1. Any significant skin disease at treatment area
2. Any medical condition which could interfere with the treatment
3. Inability or unwillingness to follow the treatment schedule
4. Inability or unwillingness to sign the informed consent
5. Pregnant or lactating
6. Allergy to cow's milk protein
7. Previous or current use of Mirvaso® Gel
8. Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients
9. Previous Dysport® treatment 6 months prior to the screening visit

Primary outcomes:
measure: Efficacy Assessments for Erythema
timeFrame: 6 months
measure: Efficacy Assessments for Flushing
timeFrame: 6 months
Secondary outcomes:
measure: Safety Assessments
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05118646: Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Official title: Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Early Fluid Resuscitation in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Keywords: Septic shock; Sublingual Microcirculation
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock

Detailed description: Objectives: Comparison of microcirculation indexes and hemodynamic indexes to guide resuscitation in patients with septic shock.

Intervention:

1. Microcirculation-oriented resuscitation group: When the system hemodynamics meets the standard of EDGT, the microcirculation-oriented resuscitation group will evaluate the organ perfusion level and adjust the hemodynamic therapy according to the sublingual microcirculation parameters (PPV \> 68%).
2. Control group: The standard treatment group will adjust the shock management scheme through systemic hemodynamic parameters.

Primary outcome:

(1)change in SOFA score at 72h (2)30-day mortality

Eligibility criteria: Inclusion Criteria:

* patients fulfilled the diagnostic criteria of septic shock.

Exclusion Criteria:

* declined to participate
* pregnant
* patients who were younger than 18 years old
* active bleeding
* septic shock is diagnosed for more than 4 hours
* patients are expected to be die within 24hours

Primary outcomes:
measure: change in SOFA score
timeFrame: 72h
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30d
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: XiangYa Hospital CentralSouth University
name: lina Zhang, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969846: Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects
Official title: Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HTN-Hypertension
Blood Pressure Management
Keywords: neuromodulation
hypertension
autonomic
electrode
implant
Lead sponsor: Cleveland VA Medical Research and Education Foundation
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Uncontrolled hypertension (HTN) is growing in incidence globally creating a critical need for alternative therapeutic strategies. Directly stimulating the carotid sinus nerve (CSN) is known to potentially reduce blood pressure (BP) but its clinical efficacy has not been consistently demonstrated with existing electrode technologies in humans.

We investigated the effect of acute direct CSN stimulation on BP and HR in anesthetized humans using an application-specific multi-contact electrode.


Eligibility criteria: Inclusion Criteria:

* . Eligible patients were those scheduled to undergo elective surgical procedure that therapeutically indicated exposure of the carotid bifurcation and vascular sheath (e.g. carotid endarterectomy, neck dissection, or carotid tumor Resection) regardless of a HTN diagnosis.

Exclusion Criteria:

* history of stroke
* prior ipsilateral neck surgery or radiation treatment
* Cardiovascular disease that precluded enrollment were diagnoses which independently increased surgical and anesthetic risk (American Society for Anesthesia Classification System).

Primary outcomes:
measure: Maximum drops and recovery in systolic blood pressure (SBP) as a result of carotid sinus nerve (CSN) stimulation
timeFrame: 1 hour
Secondary outcomes:
measure: The changes in blood pressure as a result of stimulation across all stimulation epochs
timeFrame: 1 hour
measure: The changes in heart rate as a result of stimulation across all stimulation epochs
timeFrame: 1 hour
measure: Cumulative drops in SBP throughout entire stimulation session
timeFrame: 1 hour
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: VA Northeast Ohio Healthcare System
state: Ohio
Study officials:
References: