louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05776563: Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
Official title: Reversibility of Brain Glucose Transport and Metabolism in T2DM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control.

The main question\[s\] it aims to answer are:

* To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control.
* Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport

Participants will have:

* A screening visit
* placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0
* Additional visits/phone calls for intensification of diabetes management and nutrition visits
* Second magnetic resonance spectroscopy (MRS) at week 12


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-60
* medical history for Type 2 diabetes
* HbA1c \> 7.5%, BMI ≥18 kg/m2
* Be willing to adhere to the intensification of their diabetes regimen

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL
* Hgb \< 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants
* ALT \>3 x ULN
* untreated thyroid disease,
* uncontrolled hypertension
* known neurological disorders
* untreated psychiatric disorders
* malignancy
* bleeding disorders
* current or recent steroid use in last 3 months
* illicit drug use
* for women: pregnancy, actively seeking pregnancy, or breastfeeding
* inability to enter MRI/MRS (as per standard MRI safety guidelines).

Primary outcomes:
measure: Brain glucose concentration in the occipital cortex week 0
timeFrame: week 0
measure: Brain glucose concentration in the occipital cortex week 12
timeFrame: week 12
Secondary outcomes:
measure: CGM metrics
timeFrame: weeks 12
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital (YNHH) Research Unit (HRU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth Sanchez Rangel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616663: Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work
Official title: SARS-COV-2 Infection Among Hospital Staff: Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: COVID-19
SARS-COV-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional rom the University Hospitals of Strasbourg (HUS) who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.

Brief summary: Started on January 9, 2020 with the announcement of the discovery of a new SARS-CoV-2 coronavirus, the Covid-19 pandemic is responsible as of June 21, 2020 for 160,377 confirmed cases in France, 29,640 deaths and 9,823 hospitalizations. The Grand Est region is one of the regions in France that was most precociously and strongly affected by the epidemic, in particular the Strasbourg University Hospital. Faced with the heavy use of the healthcare system, hospital staff of all categories are an essential resource to be preserved. Several studies have shown the significant impact of Covid-19 on doctors and caregivers. In order to better protect these personnel and avoid contamination that could be harmful to their health but also because of the consequences in terms of staff, it is necessary to better understand the risk factors for transmission of this infection, the means of protection, the evolution of the disease and the determinants of the return to work. Few studies have explored on such a large workforce and in detail the professional risk factors for developing Covid-19 within different groups of hospital professionals including also non-caregivers and the evolution when returning to work in an outpatient population.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Professionals from the University Hospitals of Strasbourg (HUS)
* Professionals who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.
* Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes

Exclusion criteria:

- Subject who expressed their opposition to participating in the study

Primary outcomes:
measure: positive RT-PCR test
timeFrame: one week after infection with Covid-19
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pathologie Professionnelle et Médecine du Travail - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01110863: Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects
Official title: Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2010-04-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Lymphocytic Luekemia

Brief summary: By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.

Detailed description: By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia (B-CLL) can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.

Eligibility criteria: Inclusion Criteria:

* 18 years of age,
* Patients must be willing to contribute the required amount of blood without compromising their well being,
* Participants must be willing to be contacted in the future.

Exclusion Criteria:

* Pregnancy,
* Patients who are known to be anemic, with a hemoglobin \< 8,
* Patients who are known to be infected with HIV.

Primary outcomes:
measure: Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Nicholas Chiorazzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01910363: Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
Official title: Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lower Limb Spasticity After Stroke
Keywords: poststroke spasticity
lower limb
botulinum toxin
A2
Lead sponsor: University of Tokushima
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2013-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.

* we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.
* we also assess the safety of A2NTX and compare it to that of BOTOX.


Eligibility criteria: Inclusion Criteria:

* patients with lower limb spasticity after stroke
* duration more than 6 months
* Modified Ashworth Scale of ankle joint more than 2

Exclusion Criteria:

* patients with previous botulinum toxin injections to lower limbs
* patients with serious hepatic, renal or cardiac dysfunction
* patients with respiratory failure
* patients who cannot understand the instructions

Primary outcomes:
measure: Change in Modified Ashworth Scale of the ankle joint
timeFrame: 30-60 days after injection
Secondary outcomes:
measure: Change in Functional Independence Measure (FIM)
timeFrame: 30 days after injection
Other outcomes:
measure: Walking Speed for 3m
timeFrame: 30 days after injection
measure: grasp power
timeFrame: 30 days after injection
Locations:
city: Tokushima
country: Japan
facility: Tokushima University Hospital
Study officials:
References:
citation: Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon. 2015 Dec 1;107(Pt A):85-8. doi: 10.1016/j.toxicon.2015.09.025. Epub 2015 Sep 21.
Clinical trial NCT03995563: The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
Official title: The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neuralgia,Postherpetic
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficiency of epidural steroid injection in patients who has postherpetic neuralgia is well known. In this study, the purpose is whether the continous epidural steroid injection is effective or not.

Detailed description: Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days.

Continous epidural injection will be done during 10 days N group will be injected a 0.19% ropivacaine 8mL only every other day during 10 days

Eligibility criteria: Inclusion Criteria:

* Patients who has herpes zoster
* Patients has a period (at least 1month) after onset of herpes zoster
* Patients has a definite symptom along dermatome
* ASA class I - II
* Age : 18 - 80 years

Exclusion Criteria:

* Patients who has a cancer
* Patients who has a neurologic, psychologic, renal, hepatic and hematologic disease
* Patients who has a other dermatologic disease
* Patients who has major operation \& procedure history
* Patients who has a other pain origin
* Patients who can not be inserted epidural catheter

Primary outcomes:
measure: VAS score
timeFrame: up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam sacred heart hospital
state: Yeongdeungpo-gu
Study officials:
References:
Clinical trial NCT06880263: VR Training for Nurses' Delirium Management
Official title: Using 360-Degree Immersive Virtual Reality to Enhance Nurses' Delirium Management Skills - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: ICU Nurses, Delirium, Virtual Reality
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background:

Delirium is an acute mental status change characterized by confusion, fluctuating symptoms, and inattention. It affects 11%-40% of hospitalized elderly patients and over 80% of mechanically ventilated ICU patients. Early detection and intervention are crucial in preventing adverse outcomes. The Confusion Assessment Method for the ICU (CAM-ICU) has been widely adopted in Taiwan for delirium screening. However, nurses' knowledge and skills in delirium assessment remain insufficient.

Objective:

This study aims to evaluate the effectiveness of a spherical video-based virtual reality (SVVR) training system in improving nurses' delirium assessment and management skills.

Methods:

A parallel-group randomized controlled trial will be conducted. Participants (nurses aged 20-65) will be recruited via social media and screened for eligibility. They will be randomly assigned to:

Intervention group: SVVR-based delirium training using a head-mounted display. Control group: Standard video-based training via YouTube. Pre- and post-intervention assessments will measure delirium knowledge, attitudes, assessment skills, learning motivation, and technology acceptance. Quantitative data will be analyzed using SPSS (Version 25) with t-tests, ANOVA, and chi-square tests. Qualitative data will be analyzed using thematic analysis.

Expected Outcome:

This study will determine whether immersive VR training enhances nurses' delirium management skills more effectively than conventional video training.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 65 years.
* Currently a licensed nurse and practicing.
* Willing to participate in this study and comply with the related procedures.
* Completed and signed the written informed consent form.

Exclusion Criteria:

* Nurse managers or nurses who do not directly care for patients, or nurses working in outpatient or community settings.
* Individuals with epilepsy, heart disease, or dizziness.
* Individuals with anxiety, panic disorder, or claustrophobia.
* Individuals with myopia greater than 600 degrees or those who have previously undergone eye surgery.

Primary outcomes:
measure: Chinese Version of Nurse's Assessment Ability Questionnaire in Delirium Subtypes
timeFrame: 20 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
Clinical trial NCT04341363: Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling
Official title: Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The intent of this study is to evaluate the efficacy of microneedling through use of a professional tattoo machine in hair regrowth in patients with androgenic alopecia (AGA) over up to 6 treatments (6 months).

Detailed description: Proposed is an open label trial of tattoo machine microneedling in ten patients with androgenic alopecia. Ten healthy male patients older than 18 years will undergo 6 microneedling sessions. Over the course of six months, subjects will undergo up to six treatment sessions (one session every 30 day). Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes.

Eligibility criteria: Inclusion Criteria:

* Symmetric hair loss from AGA
* Hamilton-Norwood IIIa, III, III vertex, IV, Iva, V with low density hair coverage over majority of alopecic areas
* No or minimal scalp hair regrowth on oral and/or topical minoxidil

Exclusion Criteria:

* Any male with hair loss for other reasons
* Unilateral or asymmetric hair loss
* Hamilton-Norwood I, II, IIa, Va, IV, VII x
* Patients without hair
* Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
* Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate

Primary outcomes:
measure: Total Area Hair Count
timeFrame: 6 months
Secondary outcomes:
measure: SALT Score
timeFrame: 6 months
measure: Hair Shaft Diameter
timeFrame: 6 months
measure: Number of Follicular Units
timeFrame: 6 months
measure: Vellus Hairs
timeFrame: 6 months
measure: Terminal Hairs
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Associate Professor of Dermatology, Yale University
name: Brett King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03001063: Mental Health in Adults and Children- Frugal Innovations (MAC-FI): Adult Depression Component
Official title: Mental Health in Adults and Children: Frugal Innovations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Ministry of Labour - Invalids and Social Affairs
First posted: 2016-12-22
Enrollment: 376
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 stepped wedge, randomized controlled trial will test the effectiveness of a Supported Self-Management intervention for depression among adults in Vietnam. The intervention will be delivered at the community level in 8 Vietnamese provinces by primary care providers and social workers. The intervention group will receive the Supported Self-Management intervention, while the control group will receive enhanced treatment as usual. The primary outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional ability and alcohol misuse.


Eligibility criteria: Inclusion Criteria:

* Score of \>7 on SRQ-20 indicating depression caseness
* Consent to participate and complete all measures

Exclusion Criteria:

* Cognitive disturbance
* Psychotic symptoms

Primary outcomes:
measure: Self-Reporting Questionnaire 20 (SRQ-20)
timeFrame: Two months
Secondary outcomes:
measure: World Health Organization's Disability Assessment Scale (WHODAS 2.0)
timeFrame: Two months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Institute of Population, Health and Development
Study officials:
affiliation: Simon Fraser University
name: John O'Neil, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Population, Health and Development
name: Vu Cong Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy JK, Xie H, Nguyen VC, Chau LW, Oanh PT, Nhu TK, O'Neil J, Goldsmith CH, Van Hoi N, Ma Y, Lou H, Jones W, Minas H. Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial. Int J Ment Health Syst. 2020 Feb 12;14:8. doi: 10.1186/s13033-020-00342-1. eCollection 2020.
citation: Murphy J, Goldsmith CH, Jones W, Oanh PT, Nguyen VC. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):209. doi: 10.1186/s13063-017-1924-5.
Clinical trial NCT00523263: Dacron vs Dardik for Fem-Pop Bypass
Official title: Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intermittent Claudication
Arterial Occlusive Diseases
Atheroslerosis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-08-31
Sex: ALL
Minimum age (years): 31
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.


Eligibility criteria: Inclusion Criteria:

* age 31 to 89
* intermittent claudication
* ABI below 0.8

Exclusion Criteria:

* non elective surgery
* life expectancy below 2 yrs
* contraindication for anticoagulant therapy

Primary outcomes:
measure: Primary and primary-assisted bypass patency
timeFrame: 1 - 5 yrs
Secondary outcomes:
measure: Secondary bypass patency
timeFrame: 1 - 5 yrs
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMCN, Dept Vascular Surgery
Study officials:
affiliation: Radboud University Medical Center Nijmegen
name: J. Adam van der Vliet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scharn DM, Oyen WJ, Klemm PL, Verhofstad AA, van der Vliet JA. Thrombogenicity and related biological properties of heparin bonded collagen coated polyester and human umbilical vein prosthetic vascular grafts. J Surg Res. 2006 Aug;134(2):182-9. doi: 10.1016/j.jss.2006.01.025. Epub 2006 Mar 20.
citation: Scharn DM, Oyen WJ, Klemm PL, Wijnen MH, vanderVliet JA. Assessment of prosthetic vascular graft thrombogenicity using the technetium-99m labeled glycoprotein IIb/IIIa receptor antagonist DMP444 in a dog model. Cardiovasc Surg. 2002 Dec;10(6):566-9. doi: 10.1016/s0967-2109(02)00077-7.
citation: Dirven M, Scharn DM, Blankensteijn JD, van der Vliet JA. Preservation for future use of the autologous saphenous vein during femoro-popliteal bypass surgery is inexpedient. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):420-3. doi: 10.1016/j.ejvs.2008.06.012.