louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06171880: To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901
Official title: An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901

Detailed description: An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects

Eligibility criteria: Inclusion Criteria:

1. Healthy adults over 19 years of age and under 65 years of age at the time of screening test
2. Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
3. Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
4. Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.

Exclusion Criteria:

1. Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
2. Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
3. A subject who shows the following values as a result of a laboratory test:

   ☞ ALT or AST \> 2 times the upper limit of normal range
4. Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)

Primary outcomes:
measure: AUC over 24H of JLP-1901
timeFrame: 24 hours
measure: Cmax of JLP-1901
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Bundang CHA university global clinical trials center Institutional Review Board
state: Bundang-gu
Study officials:
References:
Clinical trial NCT02746380: A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official title: Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: Mochida Pharmaceutical Company, Ltd.
First posted: 2016-04-21
Enrollment: 383
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.


Eligibility criteria: Inclusion Criteria:

* Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
* Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 months prior to screening
* Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.

Exclusion Criteria:

* patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
* patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
* patients with any seropositive result for hepatitis B or hepatitis C or HIV
* patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis

Primary outcomes:
measure: DAS28-ESR
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational site
city: Seoul
country: Korea, Republic of
facility: LGLS Investigational site
Study officials:
References:
Clinical trial NCT00596180: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning
Official title: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuropsychiatric Sequelae of Carbon Monoxide Poisoning
Keywords: carbon monoxide poisoning
brain injury
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Harch Hyperbaric Research Foundation
First posted: 2008-01-16
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment. Retrospective chart review

Brief summary: That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing.

Detailed description: The study is a retrospective review of the PI's experience using SPECT brain imaging and hyperbaric oxygen therapy in the diagnosis and treatment of non-acute phases of carbon monoxide poisoning. The purpose is to see if the SPECT brain imaging is consistent with the clinical condition and cognitive testing on the patients.

Eligibility criteria: Inclusion Criteria:

* Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment

Exclusion Criteria:

* None.

Primary outcomes:
measure: SPECT brain imaging
timeFrame: after completion of HBOT
Secondary outcomes:
measure: clinical history and physical exam
timeFrame: after completion of HBOT
measure: Neuropsychological testing
timeFrame: After the final HBOT
Other outcomes:
Locations:
city: Marrero
country: United States
facility: Family Physicians Center
state: Louisiana
Study officials:
affiliation: LSU School of Medicine
name: Paul G Harch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02902380: The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.


Eligibility criteria: Inclusion Criteria:

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
* patient scheduled for major spine surgery

Exclusion Criteria:

* ASA physical status Ⅳ
* congestive heart failure
* severe hepatorenal disease
* insulin dependent DM(diabetes mellitus)
* cancer or metastasis
* pregnancy
* problem with communication

Primary outcomes:
measure: Stress hormone level
timeFrame: immediately after anesthetic induction
measure: Stress hormone level
timeFrame: 1 hour after start of surgery
measure: Stress hormone level
timeFrame: 2-hour after start of surgery
measure: Stress hormone level
timeFrame: 1 second after the end of surgery
measure: Stress hormone level
timeFrame: 1 hour after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00914680: Berlin Magnetic Seizure Therapy Depression Trial 01
Official title: Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unipolar Depression
Bipolar Depression
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.


Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with a severe major depressive episode
* Patient is in a chronic current MDE and/or has had a history of recurrent MDEs
* Patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode
* Patient has a score \> 20 on the HAMD24
* Patient is stable on current psychotropic medication for at least 4 weeks
* Patient is \> 25 and \< 80 years

Exclusion Criteria:

* Atypical Depression or psychotic depression (according to DSM IV)
* Other relevant psychiatric axis I or axis II diseases
* Relevant neurological diseases
* Relevant cardiac or pulmonary diseases with enhances anesthesiological risk (ASA Score \> 3)
* Patient is currently enrolled in another investigational study not associated with the current study
* Patient has a history of, or evidence of, significant brain malformation or significant head injury

Primary outcomes:
measure: Clinical Improvement (HAMD)
timeFrame: before, after treatment
Secondary outcomes:
measure: Neurocognitive performance
timeFrame: before/after treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry, CC15, CBF, Eschenallee 3
Study officials:
References:
Clinical trial NCT03526380: The OPT-IN Project
Official title: Translation of Opiate Overdose Prevention Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Drug overdose
Substance-Related Disorders
Chemically-Induced Disorders
Risk Reduction Behavior
Harm Reduction
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-05-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use.

The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.

Detailed description: Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.

Eligibility criteria: Inclusion Criteria:

* Speaks English Fluently
* Receiving services at one of the investigator's partner sites
* History of opioid use

Exclusion Criteria:

* Medically unstable
* Prisoners
* Inability to speak and understand English
* Inability to give informed, voluntary, written consent for any reason

Primary outcomes:
measure: Overdose Risk Behaviors (ORB)
timeFrame: 3 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT01534780: 3 Fixation Devices in Laparoscopic Ventral Herniotomy
Official title: A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
First posted: 2012-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.

Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.

Detailed description: see brief summary

Eligibility criteria: Inclusion Criteria:

* ventral hernia 2(1,5) \< dia \> 7 cm
* danish speaking
* of sound mind
* bmi \< 35
* ASA 3 or less, no contra indication against laparoscopy

Exclusion Criteria:

* other size hernias,
* no danish,
* bmi \> 35

Primary outcomes:
measure: Pain
timeFrame: 1 measurement, 2nd postoperative day
Secondary outcomes:
measure: hernia recurrence
timeFrame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
measure: quality of life
timeFrame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
measure: Pain
timeFrame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Regional Hospital Horsens
Study officials:
affiliation: Regionshospitalet Horsens
name: Sanne S Harsløf, MD
role: STUDY_CHAIR
affiliation: Randers Regional Hospital
name: Thorbjørn Sommer, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Harslof S, Krum-Moller P, Sommer T, Zinther N, Wara P, Friis-Andersen H. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg. 2018 Jun;403(4):529-537. doi: 10.1007/s00423-018-1676-z. Epub 2018 May 25.
Clinical trial NCT04886180: Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX
Official title: Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 40
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: The Oxiris membrane is an AN-69 membrane whose surface is treated with polyethyleneimine (PEI) grafted with heparin. This property allows the removal of lipopolysaccharide and cytokines from the blood. During septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). Moreover, the literature suggests that the use of the Oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. To our knowledge (Pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ECLS.

The research hypothesis is that the early addition of an Oxiris membrane to the ECLS circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.


Eligibility criteria: Inclusion Criteria:

* Trusted person or relative who has given oral consent or emergency consent
* Person of legal age
* Patient receiving ECLS for refractory cardiogenic shock requiring continuous renal replacement therapy
* Included within 12 hours of ECLS initiation

Exclusion Criteria:

* Person not affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Pregnant or breastfeeding woman
* Minor
* Severe hemorrhage under ECLS

Primary outcomes:
measure: Plasma concentration of lipopolysaccharides
timeFrame: 24 hours after addition of the membrane
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
citation: Andrei S, Nguyen M, Berthoud V, Morgant MC, Bouhemad B, Guinot PG; ECMORIX Study Group. Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 11;8:738496. doi: 10.3389/fcvm.2021.738496. eCollection 2021.
Clinical trial NCT01395680: Trajectories of Regenerating Family Resilience in Adolescents With Cancer
Official title: Trajectories of Regenerating Family Resilience in Adolescents With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: cancer adolescent
resilience
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer adolescent aged 12-20 years old

Brief summary: Family resilience is an important strength to help family to manage life challenge successfully, and to reorganize family function. However, few studies have showed the trajectory of family resilience in adolescents with cancer over time. The purposes of this study are to know the trend of family resilience in adolescents with cancer from previous 3 months to the first year of newly diagnosed, and to examine the relationships among family members' stress, family satisfaction, and family resilience in adolescents with cancer.

Detailed description: The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires. The study is designed as repeated measurement. Considering attrition rate may be more than 60%. Therefore, of necessity, the proposed sample size was set at 60 families.

Data will be collected by a structured questionnaire (a demographic questionnaire and 4 scales). The study consists of four times of data collection time point as follows: approximately 3 month (t1), 6 months (t2), 9 months (t3), and 12 months (t4) after the diagnosis of cancer in adolescents. Each participant may take 20-30 minutes to finish the structured questionnaire.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria of adolescents with cancer are: 1) 12-20 years of age, 2) newly diagnosed with cancer about 3 months, 3) willing and able to complete own report questionnaires.

Exclusion Criteria:

* terminal stage

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital,Taipei,Taiwan
name: Dong-Tsamm Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: