louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06656923: Analyze Previously Collected Biopsy Samples From Participants Who Completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" Study
Official title: PLLA-ADIPOGENESIS-IFA: Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lateral Gluteal Depression
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2024-10-24
Enrollment: 14
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 16 Females that were previously enrolled and biopsied in SPLASH study.

Brief summary: Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.

Detailed description: Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed all biopsies in the previous SPLASH trial "A Single Center, Double- Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell - Protocol Number Sculptra-Hip-Dell-2021-12" .

Exclusion Criteria:

* Subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.

Primary outcomes:
measure: Change in cell count per area between PLLA and saline-treated specimens.
timeFrame: Specimens are from 6 months post-treatment compared to pre-treatment / Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology/West Dermatology Research Center
state: California
Study officials:
References:
Clinical trial NCT05605223: Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France
Official title: Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France Between 2006 and 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Autoimmune Encephalitis
Keywords: Acute autoimmune encephalitis
encephalitis
autoimmune encephalitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject (≤17 years) diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis

Brief summary: The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.

It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.


Eligibility criteria: Inclusion criteria:

* Age between 0 and 17 years at diagnosis
* Patient diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis in one of the participating university hospitals (Besançon, Nancy, Strasbourg, Reims and Dijon)
* Presence of clinical criteria of clinical and/or radiographic encephalitis
* Presence of one or more antibodies in the blood or CSF
* Parental authority holders and their child of childbearing age having given their consent for the use of the child's data for this research

Exclusion criteria:

* Refusal to participate in the study
* Absence of consultation at any of the study centers
* Absence of clinical and/or radiographic criteria for encephalitis.
* Absence of antibodies found in blood or CSF

Primary outcomes:
measure: Retrospective description of autoimmune encephalitis in children
timeFrame: Files analysed retrospectively from January 01, 2006 to December 31, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01657123: Exercise Capacity and Recovery in Addison's Disease
Official title: Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addison's Disease
Keywords: exercise capacity
Addison's disease
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic nervous system, depending on the type and intensity of the stressor. Physical exercise represents a stress condition influencing many systems in the body. Given a workload of at least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal (HPA)-axis. The increased endogenous cortisol secretion results in important metabolic and cardiovascular effects to maintain cellular and organ homeostasis. Patients with Addison's disease are not able to meet the increased demand of adrenal steroids in case of physical exercise, which may result in an impaired exercise capacity and a prolonged post-exercise recovery. We hypothesize that a hydrocortisone stress dose increases exercise capacity and improves post-exercise recovery in patients with Addison's disease.


Eligibility criteria: Inclusion Criteria:

* Addison's disease
* 18-50 years
* stable glucocortiocid replacement therapy

Exclusion Criteria:

* Presence of intercurrent (acute) infectious disease
* Mental impairment (major depressive, anxiety, panic, adjustment, bipolar, psychotic, posttraumatic or borderline personality disorder)
* Presence of the following chronic diseases: diabetes mellitus, chronic obstructive pulmonary disease, renal failure, chronic anaemia, malignancy, rheumatoid arthritis
* Presence of the following cardiovascular conditions: unstable angina pectoris, history of myocardial infarction, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic (severe) aortic stenosis, uncontrolled symptomatic heart failure, acute myocarditis or pericarditis, left main coronary stenosis, moderate stenotic valvular heart disease, tachyarrhythmias or bradyarrhythmias, hypertrophic cardiomyopathy and other forms of outflow tract obstruction, high-degree atrioventricular block
* History of pulmonary embolus or pulmonary infarction
* Known aortic aneurysm
* Severe hypertension (\>170/100 mm Hg)
* Medication that affects cardiovascular function (beta-blocker, calcium antagonist, ACE-inhibitors, aldosterone-antagonists)

Primary outcomes:
measure: exercise capacity
timeFrame: 140 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
Clinical trial NCT05031923: Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy
Official title: Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Simvastatin
Photodynamic Therapy
Periodontal Diseases
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.


Eligibility criteria: Inclusion Criteria:

* Patients were all healthy and free from any systemic disease;
* no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
* patients were willing and able to return for multiple follow-up visits;
* good levels of oral hygiene

Exclusion Criteria:

* Pregnant and lactating female patients,
* smokers,
* alcoholics,
* those receiving any medication that could affect healing of soft or hard tissue

Primary outcomes:
measure: Clinical evaluation and measurements of the defect in millimeters
timeFrame: 9 months
measure: Radiographic evaluation and measurements of the defect in millimeters
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of Dentistry, Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Dalia R Issa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06169423: Simulation of Perinatal Grief. (SPG)
Official title: Simulation of Perinatal Grief. Assessment of Knowledge Acquisition, Support Skills, Self-awareness and Student Satisfaction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Death
Perinatal Grief
Teaching Innovation
Keywords: Perinatal Death
Grief
Teaching Innovation
Clinical simulation
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an activity for simulation-based learning.
Primary purpose: OTHER

Brief summary: A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals.

Detailed description: A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals. With the aim of improving this knowledge and the communication skills of the students who are taught, the objective is to introduce perinatal grief so that the level of knowledge on this topic increases and also increases their communication abilities in this aspect, being a very difficult topic to cover if you do not have training. To carry out teaching innovation, it is proposed, in addition to a master class to impart theoretical knowledge, to innovate by carrying out clinical simulation among students and through a questionnaire to evaluate whether this type of technique is effective for the acquisition of knowledge, skills to provide support. , improve self-awareness and also assess student satisfaction.

Eligibility criteria: Inclusion Criteria: The sample population will be nursing students. Specifically, the project will be proposed and offered to students who have taken the subject "Women's Care" in the third year.

-

Exclusion Criteria: Those students who did not come to class the day that the activity took place, were excluded.

-

Primary outcomes:
measure: Mesure if simulation techniques are effective in helping to acquire knowledge about perinatal grief in nursing degree students.
timeFrame: 3 months
measure: Mesure if simulation techniques are effective in acquiring support skills and improving self-awareness about perinatal grief in nursing degree students.
timeFrame: 3 months
measure: Determine the degree of satisfaction of nursing degree students with the simulation learning of how to approach perinatal grief.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Isabel Almodóvar Fernández
state: Castellón
Study officials:
References:
Clinical trial NCT05788523: Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study
Official title: Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: artificial intelligence
kalemia
dyskalemia
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
First posted: 2023-03-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients consulted in the emergency unit of the participating centre, with quality criteria for the EHCs; this cohort will validate the Artificial Intelligence method developed in partnership with the laboratory

Brief summary: Dyskalemia, hypo- and hyperkalemia are common in the emergency department and are associated with increased morbidity and mortality.

The potential seriousness of dyskalemia results from the potential alteration of intracardiac conduction and the increase in cardiac rhythm disorders, all associated with a lethal risk. Given the aspecific symptoms of dyskalemia and the complex causal links to be acquired, it is difficult to judge the severity of the disorders in front of an initial clinical presentation of a patient in the emergency room, as the patient may present a serious condition during his stay in the emergency room, related to the dyskalemia and not prejudged at first. The ECG is recommended to judge the severity of the disorder, in association with the level of kalemia, but the electrical changes of its pattern in the context of dyskalemia are sometimes so fine that even the eye of the practitioner is not able to detect them. To date and to our knowledge, there is no tool for predicting the risk of RTA or death in dyskalemia. The existing studies on the subject, including ECGs, seek to detect dyskalemia and not its complications, and the proposed tools only take into account the ECG and not the clinical context of the patient.


Eligibility criteria: Inclusion Criteria:

* Major patient consulting in an emergency department participating in the study
* who received at least a digital ECG AND an ionogram in the emergency department during the study period

Exclusion Criteria:

* Patient who has expressed opposition to the reuse of their data for the study

Primary outcomes:
measure: Number of participants with Cardiac arrest and/or rhythm disorder
timeFrame: within 48 hours
Secondary outcomes:
measure: Rate of Mortality
timeFrame: within 48 hours
measure: The type of received treatment for dyskalemia
timeFrame: within 48 hours
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Laure ABENSUR VUILLAUME, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05922423: Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
Official title: Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Patients
Keywords: Mindfulness-Based Stress Reduction
fear of cancer recurrence
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1. Through cross-sectional investigation and research, construct an fear of cancer recurrence warning model to identify and screen high fear of cancer recurrencecancer populations, in order to identify predictive factors for high fear of cancer recurrence, study how cancer patients develop susceptibility to fear of cancer recurrence during the diagnosis and treatment process, including which participating factors, explore the development trajectory of fear of cancer recurrence, and effectively prevent the occurrence of high-level fear of cancer recurrence.
2. Through randomized controlled trials, conduct a study on mindfulness and stress reduction psychosocial intervention for high-level fear of cancer recurrence patients, verify the effectiveness of psychosocial intervention measures targeting domestic cancer populations, and improve standardized intervention methods, intervention time, and treatment content.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 18 years old
* Consistent with pathological diagnosis of cancer
* Able to understand and comply with research protocols
* Written informed consent can be provided
* Own and know how to use smart ·terminals (such as smartphones, tablets, computers, etc.)

Exclusion Criteria:

* Patients with mental illness and consciousness disorders;
* Patients with cancer metastasis or recurrence
* End of life treatment for patients.

Primary outcomes:
measure: Fear of cancer recurrence
timeFrame: Baseline
measure: Fear of cancer recurrence
timeFrame: At the end of the 8-week intervention
measure: Fear of cancer recurrence
timeFrame: 1 mouth
measure: Fear of cancer recurrence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00925223: Brain-derived Neurotrophic Factor Participates in Visceral Hyperalgesia in Irritable Bowel Syndrome (IBS) Patients
Official title: Study of Brain-derived Neurotrophic Factor in Visceral Hyperalgesia in IBS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Keywords: IBS
BDNf
visceral hypersensitivity
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel habits in the absence of structural and biochemical abnormalities.

Brief summary: Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth factor family, has aroused attention as a modulator in visceral hyperalgesia recently. Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with irritable bowel syndrome.

Exclusion Criteria:

* Patients have similar clinical symptoms as IBS, yet there is morphologic changes in the intestine.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05901623: ASQ Scores of Transient Hypothyroxinemia of Prematurity
Official title: Neurodevelopmental Outcome of the Infants With Transient Hypothyroxinemia of Prematurity in Newborn Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Hypothyroxinemia of Prematurity
Neurodevelopmental Abnormality
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 70
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included newborn infants born at 28-36 gestational weeks, with a diagnosis of transient hypothyroxinemia of prematurity, and hospitalized in the neonatal intensive care unit. Healthy age-matched infants were included in the control group.

Brief summary: • Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).


Eligibility criteria: Inclusion Criteria:

* newborn infants who were born at 28-36 gestational weeks
* Infants who were hospitalized in the neonatal intensive care unit
* Infants with transient hypothyroxinemia of prematurity

Exclusion Criteria:

* Newborns with maternal thyroid disease,
* Severe intracranial issues,
* Chromosomal and congenital anomalies,
* Infants older than 36 gestational weeks

Primary outcomes:
measure: Long-term Neurodevelopment
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References: