louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01767324: Site Selection for Intracutaneous Saline Delivery
Official title: Exploratory Evaluation of Injection Sites in Healthy Subjects Receiving Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracutaneous Drug Delivery
Keywords: microneedle-based array
hollow microneedle
intracutaneous
drug delivery
vaccine delivery
Lead sponsor: FluGen Inc
Sponsor class: INDUSTRY
Collaborators: name: Accelovance
First posted: 2013-01-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this exploratory study is to select the optimal body site for intracutaneous delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.

Detailed description: Test ability to inject saline into various sites on body.

Eligibility criteria: Inclusion Criteria:

* Able to read and/or understand and sign the Informed Consent Form

Exclusion Criteria:

* Medical history of acute or chronic skin disease
* Active skin allergy or acute skin infection, tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site
* Hirsute at any prospective injection site
* Diabetes
* High levels of anxiety or depression or history of psychosis
* Abuse of alcohol or use of other drugs of abuse including tobacco
* Pregnant or breastfeeding women
* Any medical condition that may interfere with study protocol adherence including completion of study activities
* Foreseeable inability to complete the study as scheduled.

Primary outcomes:
measure: The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.
timeFrame: 30 minutes, 24 hours, 1 week
Secondary outcomes:
measure: A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Accelovance Inc
state: Florida
Study officials:
affiliation: FluGen Inc
name: Renee Herber
role: STUDY_DIRECTOR
affiliation: Accelovance
name: Murray A Kimmel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01119924: A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain
Official title: Phase IV Study for Evaluation the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Pain
Keywords: Mirtazapine
Smilon
Depression
Pain
Lead sponsor: Nang Kuang Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Buddhist Tzu Chi General Hospital
First posted: 2010-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Efficacy and Safety of Smilon® in the Depression Patients with pain. Eligible patients will be randomly assigned to 1 of 2 arms, either Smilon® or placebo, and will receive the treatment for 8 weeks in this study.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 20-65 years
* Diagnosis of at least one chronic pain syndrome and the diagnosis of concomitant depression according to DSM-IV criteria
* Have a mean weekly pain score of at least 30 mm on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) before study entry

Exclusion Criteria:

* Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives
* Known hypersensitivity to Mirtazapine or any of its components
* Subjects who have a clinically significant or unstable medical or psychiatric condition
* Subjects who have received nerve blocks or acupuncture for pain relief

Primary outcomes:
measure: Evaluation of pain intensity using the visual analog scale (VAS)
timeFrame: 8-week treatment
Secondary outcomes:
measure: Evaluation of Severity of depressive symptom using the Depression and Somatic Symptoms Scale (DSSS)
timeFrame: 8-week treatment
measure: Evaluation of Severity of depressive and anxious symptom using the Hamilton depression scale (HAM-D) and Hamilton anxiety scale (HAM-A)
timeFrame: 8-week treatment
measure: Evaluation of quality of life assessed by a 28-item WHOQoL self-administered questionnaire
timeFrame: 8-week treatment
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Nang Kuang Pharmaceutical Co., LTD
state: Xinhua Township
Study officials:
affiliation: Buddhist Tzu Chi General Hospitsl
name: Tsai Hsin Chi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04659824: Study of Iron Accumulation Measured in MRI in Non-pathological Aging
Official title: Study of Iron Accumulation Measured in MRI in Non-pathological Aging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Aging
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects from 18 to 95 years old stratified by sex and age groups

Brief summary: To study the correlation between the iron load in brain, measured in MRI, and the age of healthy subjects Secondary objectives are to study the correlations between the iron load in cortical brain regions and (i) the cognitive performances, (ii) markers of aging (MRI, EEG, OCT, biology),and (iii) demographical factors involved in iron load.


Eligibility criteria: Inclusion Criteria:

* Men or women between 18 and 95 years old
* French speaker with capability to understand the instructions
* Health insurance

Exclusion Criteria:

* Pregnancy
* minor subject
* no informed consent agreement
* subject enrolled in pharmaceutic study or exclusion period
* MRI contra-indications
* Neurological or psychiatric disorders
* MOCA \< 26
* Psychotropic drugs
* More than 3 MRI exams
* More than 1 neuropsychological assessment (same cognitive tests) in the last 12 months
* Unable to follow the entire protocol according to the investigator

Primary outcomes:
measure: Correlation coefficient between iron load in MRI and age
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Grégory KUCHCINSKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05764824: Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults
Official title: Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Nutrition, Healthy
Brain Injuries
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 67
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: This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.

Detailed description: In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.

Eligibility criteria: Inclusion Criteria:

* Adults aged 65-99 years
* Able to travel to Brigham and Women's Hospital for 4 clinic visits

Exclusion Criteria:

* Known allergies to blueberries
* Unable to abstain from blueberry consumption during the study period
* Inability to provide informed consent
* Planned major surgery during study period or recent major surgery up to 3 months before recruitment
* Organ transplant
* Plan to move out of greater Boston area during the study period
* Diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.

Primary outcomes:
measure: Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks
timeFrame: Baseline and at 24 weeks after the intervention
measure: Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks
timeFrame: Baseline and at 24 weeks post intervention
Secondary outcomes:
measure: Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks
timeFrame: Baseline and at 24 weeks post intervention
measure: Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks
timeFrame: Baseline and 24 weeks post intervention
measure: Change in cognitive battery test score between baseline and 24 weeks post intervention
timeFrame: Baseline and at 24 weeks post intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
References:
Clinical trial NCT06359834: Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography
Official title: Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography.


Eligibility criteria: Inclusion Criteria:

* Patients (age 19\~80 yrs, ASA Class I\~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph

Exclusion Criteria:

* Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr \>2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP \<90mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure

Primary outcomes:
measure: Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
timeFrame: Evaluation begins after sedative administration until the end of endoscopic procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01376934: Clinical Trial of Hysteroscopy in Postmenopausal Women to Compare Techniques
Official title: Phase 1 Study of Two Techniques in Hysteroscopy That Compare Carbon Dioxide Versus Saline Solution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Women
Hysteroscopy
Keywords: hysteroscopy
saline solution
carbon dioxide
compare two techniques in office hysteroscopy co2 and saline solution
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 140
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nowadays,hysteroscopy is a golden standard procedure to describe the morphology of uterine cavity and investigate of abnormal uterine bleeding . The success of the procedure is based on the distension of the cavity . It can cause pain and discomfort and sometimes the procedure fails. . There are two techniques to make the procedure , one with gas and the other with saline solution. Objective: to compare two techniques concerning pain , procedure duration and image quality

Detailed description: The objective of this study is to compare two techniques in office hysteroscopy.In this clinical trial postmenopausal women will undergo a diagnostic hysteroscopy using carbon dioxide or saline solution to uterine cavity distension.

There will be two groups of 70 women each. The objective is to determine which technique provides better image,time of procedure and less discomfort.

Eligibility criteria: Inclusion Criteria:

* Women post-menopausal with abnormal uterine bleeding, ultrasound with thick endometrial distorted

Exclusion Criteria:

* Women with uterine malformations
* Women with mental retardation
* Women underwent pelvic radiotherapy

Primary outcomes:
measure: Evaluation of the comfort in office hysteroscopy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Departamento de Tocoginecologia FCM UNICAMP
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Valter Fausto Santos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189434: Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery
Official title: A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytoreductive Surgery
Lead sponsor: Eastern Regional Medical Center
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 20
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: Cancer patients having undergone cytoreductive surgery with or without HIPEC

Brief summary: Serum procalcitonin levels will be considerably higher, for a longer period of time, in patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU methods.


Eligibility criteria: Inclusion Criteria:

* Female or male person ≥ 18 years of age
* Biopsy proven carcinoma
* Scheduled for cytoreductive surgery, with or without HIPEC
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
* Able to give informed consent for protocol participation

Exclusion Criteria:

* Participants are not able to understand or provide written informed consent
* Pre-operative anti-inflammatory medication use within 72 hours of their baseline blood draw
* Pre-operative infection treatment with corticosteroids within 72 hours of their baseline blood draw
* Immunosuppressive illness other than neoplasm
* Pregnant or lactating female

Primary outcomes:
measure: The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC.
timeFrame: end of study
Secondary outcomes:
measure: Observe the patient's post-operative course with regards to serum procalcitonin levels and development of sepsis in patients previously treated with cytoreductive surgery with or without HIPEC.
timeFrame: end of study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
Study officials:
affiliation: Eastern Regional Medical Center
name: Rod Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01657734: Multimodal MR Imaging in Patients With Glioblastoma Treated With Dendritic Cell Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Gliomas
Keywords: therapy-induced inflammatory response with
magnetic resonance imaging
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 30
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 treated with glioblastoma treated with dendritic cell therapy

Brief summary: Malignant gliomas are aggressive tumours with poor prognosis despite the current multimodal treatment. Hence, there is a clear need for new, effective therapies, among which immune therapy has emerged as a promising treatment option.

When interpreting follow-up magnetic resonance (MR) examinations, the radiologist is often confronted with images that are difficult to interpret with the conventional anatomical imaging techniques. The difference between tumour relapse and therapy-mediated changes is not always distinctive.

In this project, the investigators attempt to characterize the inflammatory response with parameters from advanced MRI techniques like MR spectroscopy, MR perfusion imaging and MR-diffusion imaging. These techniques allow characterization of cellular properties like metabolism and tissue structure respectively. Doing so, the investigators will monitor disease evolution in order to timely detect treatment failure, thereby allowing appropriate switch in patient management.


Eligibility criteria: Inclusion Criteria:

\*\*\*\* patients enrolled in the HGG 2003 HGG-IMMUNO 2003 trial

Patients, older than 3 and younger than 60 years with relapse of high-grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma multiforme WHO grade IV), histologically diagnosed in the first stage of the disease as well as after relapse or relapse of glioma which was grade II in the First phase but grade III or IV upon relapse are treated with dendritic cell therapy (immunotherapy) as single treatment approach (No radiotherapy and/or chemotherapy).

\*\*\*\* patients enrolled in the HGG 2010 HGG-IMMUNO 2010 trial

* prospective double blind placebo controlled randomised clinical trial HGG-2010 for patients with newly diagnosed glioblastoma in which immunotherapy is integrated in the current standard of care (concommitant radiochemotherapy).

Exclusion Criteria:

minor age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
city: Leuven
country: Belgium
facility: University Hospitals of Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT00104234: Study of rhASB in Patients With Mucopolysaccharidosis VI
Official title: A Multicenter, Multinational Open-Label Extension Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With Mucopolysaccharidosis VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mucopolysaccharidosis VI
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-02-25
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.


Eligibility criteria: Inclusion Criteria:

* Patient consent
* Patient must have successfully completed study ASB-03-05, including having received at least 20 of 24 scheduled weekly infusions and having missed no more then two consecutive infusions
* If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria:

* Pregnant or lactating patient
* Patient has received an investigational drug within 30 days prior to study enrollment
* Patient is unwilling or unable to travel to the primary site for periodic assessments

Primary outcomes:
measure: 12-Minute Walk Test
timeFrame: Baseline of ASB-03-05 through week 96 of ASB-03-06
Secondary outcomes:
measure: 3-Minute Stair Climb
timeFrame: Baseline ASB-03-05 through week 96 of ASB-03-06.
measure: Change in Urinary Glycosaminoglycans (GAG) Level
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Novato
country: United States
facility: BioMarin Pharmaceutical Inc.
state: California
Study officials:
References:
citation: Tandon PK, Kakkis ED. The multi-domain responder index: a novel analysis tool to capture a broader assessment of clinical benefit in heterogeneous complex rare diseases. Orphanet J Rare Dis. 2021 Apr 19;16(1):183. doi: 10.1186/s13023-021-01805-5.