louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05621993: An Observational, Ambispective Cohort Study of Azvudine in the Treatment of Patients With COVID-19 Pneumonia
Official title: Efficacy and Safety of Azvudine in the Treatment of Patients With Corona Virus Disease (COVID-19) Pneumonia in China: an Multi-center Observational, Ambispective Cohort, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients who were diagnosed as COVID-19 pneumonia will be included in the study.

Brief summary: This is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine treatment group after 48 hours after the first positive for nucleic acid, short course of Azvudine treatment without nucleic acid turning negative, and the control group) . This study aims to analyze the efficacy and safety of Azvudine in the treatment of patients with COVID-19.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of COVID-19 pneumonia
* Patients with the ability to take medication orally

Exclusion Criteria:

* Severe vomiting and difficulty in taking oral medication or ingestion of drugs after oral administration
* Suspected or confirmed active systemic infection other than COVID-19 pneumonia
* Pregnant or lactating women
* Patients with mental disorders
* Patients with severe liver damage
* Patients who are treated with small molecule drugs such as Nirmatrelvir Tablets/Ritonavir Tablets(co-packaged)
* Patients who are treated with RNA-dependent RNA polymerase (RDRP) inhibitors (Junshipharma VV116, Ascletis Pharma Inc. Asc10, Kexing biopharm Shen26, and Molnupiravir).

Primary outcomes:
measure: Time from positive nucleic acid to negative
timeFrame: every 3 days
Secondary outcomes:
measure: Proportion of patients with relapsed positive nucleic acid test within 28 days after negative
timeFrame: up tp 28 days
measure: Proportion of patients with adverse events
timeFrame: up tp 28 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
state: Shandong
Study officials:
References:
Clinical trial NCT02119793: Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study
Official title: A Multicenter, Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of YVOIRE contour injected into the anteromedial malar region in subjects who have completed the LG-HACL014 study.


Eligibility criteria: Inclusion Criteria:

* Eligible subjects who have completed the LG-HACL014 study
* Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study
* Accept the obligation not to receive any other mid facial procedures or treatments during the study
* Signed informed consent
* Those who fall under one of the following 3 cases

  1. Males or females who are surgically sterile
  2. Post-Menopausal females who are above 45 years of age and 2 years after the last menstruation
  3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the repeat treatment of the investigational device to avoid pregnancy

Exclusion Criteria:

* Have a history of hypertrophic scars or keloids
* Other criteria as identified in the protocol

Primary outcomes:
measure: Mid Face Aesthetic Scale (MFAS) score
timeFrame: 2, 26, and 52 weeks after repeat treatment
Secondary outcomes:
measure: Mid Face Aesthetic Scale (MFAS) score
timeFrame: 2, 26, and 52 weeks after repeat treatment
measure: Mid Face Aesthetic Scale (MFAS) Responder rate
timeFrame: 2, 26, and 52 weeks after repeat treatment
measure: Global Aesthetic Improvement Scale (GAIS) score
timeFrame: 2, 26, and 52 weeks after repeat treatment
measure: Global Aesthetic Improvement Scale (GAIS) Responder rate
timeFrame: 2, 26, and 52 weeks after repeat treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04233593: Neuroimmune Response to Lipopolysaccharide
Official title: Imaging the Neuroimmune Response to Lipopolysaccharide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PET TSPO Imaging
Microglia Activation/Proliferation
Lipopolysaccharide
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will complete one 120-minute \[11C\]PBR28 PET scan before and one scan 3-hours after lipopolysaccharide (LPS; 1.0ng/kg; IV) administration. A subset of subjects will complete a follow-up \[11C\]PBR28 PET scan 24+ hours after LPS.
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, healthy adult volunteers will undergo two positron emission tomography (PET) scans using the radiotracer \[11C\]PBR28 which binds to the 18kDa translocator protein (TSPO). Approximately 3 hours prior to the second \[11C\]PBR28 PET scan, lipopolysaccharide (LPS; endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral cytokine levels will be assayed periodically throughout the experimental session.

Specific aims: Quantify the magnitude of neuroimmune response after a classical immune stimulus.

Secondary aims: Quantify changes in cognitive function after a classical immune stimulus.

Hypothesis: Individuals will exhibit a robust whole-brain neuroimmune response and impaired cognitive function after LPS.


Eligibility criteria: Inclusion Criteria:

1) Medically-healthy male and female subjects able to read/write English

Exclusion Criteria:

1. Subjects cannot meet DSM criteria for substance use disorder
2. Any psychiatric symptoms that could put the subject at risk by participating in the study including but not limited to suicidal or homicidal ideation, or suicide attempt within the last year
3. Pregnancy or breastfeeding;
4. Any current medical illness that could put the subjects at risk during the PET scan, or interfere with the PET or immunologic measures
5. Significant hepatocellular injury (as evidenced by AST or ALT levels greater than 5 times normal or a history of cirrhosis) will be exclusionary in order to reduce the risks associated with alcohol consumption
6. Subjects taking corticosteroids or other immunosuppressant drugs
7. Subjects with disorders affecting the brain, including but not limited to multiple sclerosis, history of stroke, brain tumors, intracranial bleeding, infection, or abscess.

Primary outcomes:
measure: Baseline TSPO Availability
timeFrame: Before LPS administration (baseline)
Secondary outcomes:
measure: Alcohol Dependence Scale (ADS) - questionnaire
timeFrame: baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Kelly Cosgrove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323893: Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans
Official title: Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG, a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Positron Emission Tomography
Cancer Immunotherapy
Lead sponsor: CellSight Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to visualize biodistribution of a PET tracer called \[18F\]F-AraG through time in healthy human volunteers.

Detailed description: A positron emission tomography (PET) imaging tracer will be intravenously injected into healthy human volunteers who provide informed consent. Following injection of this tracer each volunteer will have four whole-body PET scans inside a PET scanner to obtain images of tracer biodistribution at four different time points. This will allow studying the kinetics of the tracer as well analysis of tracer dosimetry. Safety of the tracer will also be analyzed in each volunteer.

Eligibility criteria: Inclusion Criteria:

* Healthy human subjects without history of chronic disease or at present an acute disease will be included.
* Ability to abide by the study conditions is also a requirement for inclusion.

Exclusion Criteria:

* Individuals under the age of 18 years and pregnant women will be excluded from the \[18F\]F-AraG imaging studies.
* Women who are breast-feeding will be excluded from the study.
* Individuals unable to provide informed consent will be excluded.

Primary outcomes:
measure: Visualize biodistribution of the PET tracer [18F]F-AraG
timeFrame: 1 day
measure: Analyze human dosimetry of [18F]F-AraG
timeFrame: 1 day
measure: Assess acute safety of intravenously injected trace dose of [18F]F-AraG
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Imaging Center at China Basin
state: California
Study officials:
affiliation: University of California, San Francisco
name: Henry VanBrocklin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Namavari M, Chang YF, Kusler B, Yaghoubi S, Mitchell BS, Gambhir SS. Synthesis of 2'-deoxy-2'-[18F]fluoro-9-beta-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET. Mol Imaging Biol. 2011 Oct;13(5):812-8. doi: 10.1007/s11307-010-0414-x.
Clinical trial NCT02056093: Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
Official title: Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: NAVA - PAV- Breathing Variability - Asynchrony
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.


Eligibility criteria: Inclusion Criteria:

* Intubated patients.
* Mechanical ventilation for a respiratory reason.
* Expected duration of Mechanical ventilation \> 48 hrs.
* Spontaneous breathing.
* Sedations stopped for more than 24 hours.

Exclusion Criteria:

* - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
* Main contra indications to PAV: airway leak, body weight \<25 kg, neuromuscular diseases.
* Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
* Severe hypoxemia defined as PaO2/FiO2 ratio \<200.
* Decision to withhold life-sustaining treatment.
* Pregnant women.
* Minors \< 18 years.

Primary outcomes:
measure: Breathing pattern variability
timeFrame: February 2014
Secondary outcomes:
measure: Patient-ventilator asynchrony
timeFrame: February, 2014
Other outcomes:
measure: Electrical diaphragm activity Gas exchange
timeFrame: February 2014
Locations:
city: Paris
country: France
facility: Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere
state: Ile de France
Study officials:
affiliation: Association pour le Développement et l'Organisation de la Recherche en Pneumologie
name: Matthieu SCHMIDT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
Clinical trial NCT06988293: Quality of Life Effects of Laparoscopic and Open Surgery in Inguinal Hernia Treatment
Official title: The Evaluation of the Long-Term Quality of Life Effects of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Surgery in Inguinal Hernia Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: İnguinal Hernia
Keywords: inguinal hernia, short form-36, total extraperitoneal(TEP) hernia repair, Liechtenstein hernia repair
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had liechtenstein or TEP surgery due to inguinal hernia

Brief summary: Inguinal hernia is the most common type of hernia, presenting with swelling and pain in the groin area as clinical signs of abdominal wall hernias. The gold standard treatment for symptomatic inguinal hernias is surgery. There are various surgical methods for inguinal hernia repair. Tissue repair techniques such as Bassini, Shouldice, and McVay are no longer preferred due to their high recurrence rates, except in cases where mesh prosthetics are contraindicated. Tension-free mesh prosthesis-based anterior repairs and laparoscopic posterior repairs are the most frequently preferred methods in treatment. (1) In our study, we aimed to evaluate the quality of life index following laparoscopic extraperitoneal hernia repair using the most commonly preferred Lichtenstein technique. (2,3) The Short Form-36 (SF-36) scale is planned to be used for evaluating the quality of life index. SF-36 is one of the most commonly used generic measures for assessing quality of life. This scale examines eight dimensions of health, including physical function, social function, mental health, vitality (energy), pain, and general health perception, through 36 items. (4) Our study aims to determine which surgical method, based on long-term patient follow-up, stands out in improving the quality of life.


Eligibility criteria: Inclusion Criteria:

* open and laparoscopic hernia repair surgery being over 18 years old approve the work

Exclusion Criteria:

* Being under 18 years old Emergency operated patients Patients using surgical techniques other than the open Liechtenstein method and laparoscopic extraperitoneal methods Patients who do not consent

Primary outcomes:
measure: SF-36 index
timeFrame: at least 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sütçü İmam University
Study officials:
References:
Clinical trial NCT03228693: Gene Expression and Biomarker Profiling of Keloid Skin
Official title: Gene Expression and Biomarker Profiling of Keloid Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keloid
Keloid of Ear Lobe
Healthy Adults
Keywords: Keloid
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2017-07-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation.

Hypothesis:

1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids
2. Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity
3. Biomarker analysis will provide useful insights for future targeted therapies for keloid scars

Detailed description: Objectives:

1. Determine gene expression profiles of keloid scar tissue using samples collected longitudinally
2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects

Eligibility criteria: Inclusion Criteria:

* Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment
* Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)

Exclusion Criteria:

* Patients who have had treatment of their keloid scar within 6 months of date of enrollment

Primary outcomes:
measure: Keloid progression
timeFrame: One year
measure: Gene Expression
timeFrame: One year
measure: Keloid recurrence
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Roopal Kundu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801593: Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis
Official title: Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with JIA.

Brief summary: Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement.

Aim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs.


Eligibility criteria: Inclusion Criteria:

* Children with defined JIA.

Exclusion Criteria:

* Children without defined diagnosis of JIA.

Primary outcomes:
measure: TMJ arthritis on MRI
timeFrame: every three to six months from recruitment to end of study
Secondary outcomes:
measure: TMJ arthritis on ultrasound
timeFrame: every three to six months from recruitment to end of study
measure: Action of current medication on TMJ arthritis.
timeFrame: every three to six months from recruitment to end of study
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Children's Hospital
state: Baden-Wuerttemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Nikolay Tzaribachev, MD
role: PRINCIPAL_INVESTIGATOR
References: