louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04118309: The Effects of High-intensity Interval Training on Mental Health and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depressive Symptoms
Inflammation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2019-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study investigated the effects of high-intensity interval exercise training and placebo-exercise on mental health and inflammation using a randomized control trial. The study also examined how anxiety symptoms prior to high-intensity interval training may influence improvements in fitness. Inactive young adults underwent nine weeks of either high-intensity interval training or their regular routine. Questionnaires, a blood draw and a maximal exercise test were conducted the week before and week after the intervention. It was hypothesized those who underwent high-intensity interval training would experience greater reductions in their depression, anxiety, and inflammation than those who were in the placebo control group. It was also hypothesized those who had high anxiety symptoms at the start of high-intensity interval training would experience smaller improvements in fitness than those who had low anxiety symptoms.


Eligibility criteria: Inclusion Criteria:

* Full-time student at McMaster University
* Speak, read and understand English

Exclusion Criteria:

* Exercising for more than 150 minutes of moderate-to-vigorous physical activity per week

Primary outcomes:
measure: Change in mental illness symptoms (anxiety, depression) from baseline to post-intervention
timeFrame: 11 weeks
measure: Change in concentration of circulating proinflammatory cytokines (Interleukin-6, Interleukin-1 beta, Tumour necrosis factor alpha) from baseline to post-intervention
timeFrame: 11 weeks
measure: Change in cardiorespiratory fitness from baseline to post-intervention
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Jennifer Heisz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.
citation: Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available.
citation: Stubbs B, Rosenbaum S, Vancampfort D, Ward PB, Schuch FB. Exercise improves cardiorespiratory fitness in people with depression: A meta-analysis of randomized control trials. J Affect Disord. 2016 Jan 15;190:249-253. doi: 10.1016/j.jad.2015.10.010. Epub 2015 Oct 23.
Clinical trial NCT06585709: OUD (Opioid Use Disorder) Target Trial
Official title: The Development and Validation of Neural Targets in Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2024-09-05
Enrollment: 80
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: In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids.

The investigators are trying to learn two things:

1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS?

In order to complete the study the investigators will ask participants to:

* Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later.
* Undergo study-treatment with 50-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks.
* Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older; all genders included.
2. Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
3. Meet DSM-5 criteria for moderate or severe OUD. Individuals may also meet criteria for another substance use disorder (with the exception of alcohol or sedative/hypnotic); but must identify opioids as their primary substance.
4. Starting buprenorphine and planning on opioid abstinence

Exclusion Criteria:

1. Pregnant, breast-feeding, or planning on getting pregnant.
2. Alcohol or sedative/hypnotic use disorders (seizure risk).
3. History of/or current psychotic disorder (e.g. schizophrenia).
4. Current or lifetime bipolar disorder.
5. Unstable Axis-I condition requiring starting a new medication.
6. Active suicidal ideation / suicide attempt within 90 days.
7. History of/or current dementia or other cognitive impairment.
8. Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
9. Unstable general medical conditions.

Primary outcomes:
measure: Number of participants with Relapse Free survival
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Weeks of opioid abstinance
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Gregory Sahlem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06193109: The Prognostic Impact of Right Ventricular Systolic Dysfunction on the Survival of Patients With Sepsis and Septic Shock
Official title: The Prognostic Impact of Right Ventricular Systolic Dysfunction on the Survival of Patients With Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis and Septic Shock
Keywords: right ventricular systolic dysfunction
Lead sponsor: Burapha University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective study was conducted at Burapha University Hospital, enrolling admitted patients diagnosed with sepsis and septic shock. Echocardiography was performed on these patients within 72 hours after admission

Brief summary: This study sought to evaluate the association of right ventricular systolic dysfunction and 28-day in-hospital mortality in patients with sepsis and septic shock. Prospective cohort study of adult patients admitted at Burapha university hospital from October 1, 2022 through June 30, 2023 for sepsis and septic shock, who had an echocardiogram within 72 hours after admission for evaluating right ventricular systolic function. Right ventricular systolic dysfunction was defned by the American Society of Echocardiography criteria. Outcomes included 28-day in-hospital mortality, maximal blood lactate, length of intensive care unit(ICU) stay and duration of mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* diagnosed with sepsis or septic shock according to Sepsis-3 criteria
* received an echocardiogram within 72 hours after admission

Exclusion Criteria:

* prior diagnosis of pulmonary hypertension,
* cor-pulmonale,
* significant valvular heart disease,
* acute coronary syndrome,
* aortic dissection,
* heart failure
* inability to follow up within 28 days

Primary outcomes:
measure: 28 days in-hospital mortality
timeFrame: October 1, 2022 and June 30, 2023
Secondary outcomes:
measure: The prevalence of right ventricular systolic dysfunction
timeFrame: October 1, 2022 and June 30, 2023
measure: Blood lactate levels
timeFrame: October 1, 2022 and June 30, 2023
measure: Lenght of ICU stay
timeFrame: October 1, 2022 and June 30, 2023
measure: Duration of mechanical ventilation
timeFrame: October 1, 2022 and June 30, 2023
Other outcomes:
Locations:
city: Muang Chonburi
country: Thailand
facility: Burapha University Hospital
state: Chonburi
Study officials:
References:
Clinical trial NCT02492685: Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gallbladder Polyp
Keywords: Quantitative analysis
contrast enhanced endoscopic ultrasonography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis.


Eligibility criteria: Inclusion Criteria:

* patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
* have a plan to evaluate by EUS
* 19 years of age or older

Exclusion Criteria:

* difficult undergo EUS,
* allergy for contrast agent,
* renal failure,
* acute coronary syndrome
* pulmonary hypertension, 6) pregnancy

Primary outcomes:
measure: Accuracy between visual assessment and quantificational analysis based on surgical pathology
timeFrame: 1day
Secondary outcomes:
measure: Sensitivity between visual assessment and quantificational analysis based on surgical pathology
timeFrame: 1 day
measure: Specificity between visual assessment and quantificational analysis based on surgical pathology
timeFrame: 1 day
measure: PPV between visual assessment and quantificational analysis based on surgical pathology
timeFrame: 1 day
measure: NPV between visual assessment and quantificational analysis based on surgical pathology
timeFrame: 1 day
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:
citation: Wildner D, Pfeifer L, Goertz RS, Bernatik T, Sturm J, Neurath MF, Strobel D. Dynamic contrast-enhanced ultrasound (DCE-US) for the characterization of hepatocellular carcinoma and cholangiocellular carcinoma. Ultraschall Med. 2014 Dec;35(6):522-7. doi: 10.1055/s-0034-1385170. Epub 2014 Sep 9.
citation: Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.
Clinical trial NCT04199585: Safety and Tolerability of Lu AF95245 in Healthy Young Men
Official title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cohort A: sequential, cohort B parallel
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug

Detailed description: The study is divided in two parts, Part A and Part B:

Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men.

Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3)

Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.

Eligibility criteria: Inclusion Criteria:

* Healthy, young, non-smoking men with a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events
timeFrame: From baseline to Day 14
measure: AUC(0-inf) Lu AF95245
timeFrame: From 0 to 96 hours
measure: Cmax Lu AF95245
timeFrame: From 0 to 96 hours
measure: CL/F Lu AF95245
timeFrame: From 0 to 96 hours
measure: Total recovery of the administered dose (% of dose in urine and faeces)
timeFrame: From 0 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS Netherlands BV
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT00982085: The Status of Asthma in the Korean Military Personnel
Official title: The Status of Asthma in the Korean Military Personnel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Allergic rhinitis
Military
Lead sponsor: Armed Forces Capital Hospital, Republic of Korea
Sponsor class: OTHER_GOV
First posted: 2009-09-22
Enrollment: 4000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean Military personnel who resign in South Korea.

Brief summary: The aim of this study is to evaluate the status of allergic diseases in the Korean military personnel.

Detailed description: ISAAC (International Study of Asthma and Allergies in CHildhood) questionnaires are sent to military personnel in the republic of Korea. Military personnel are randomly selected representative of the number of soldiers in each area. We perform methacholine provocation test and MAST for current wheezer after informed consents.

Eligibility criteria: Inclusion Criteria:

* Korean military personnel who can respond questionnaire

Exclusion Criteria:

* Person who refuse to participate in this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Armed Forces Capital Hospital
state: Gyeonggi-do
Study officials:
affiliation: Armed Forces Capital Hospital
name: Sang Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02657785: Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
Official title: Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.

Detailed description: The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Eligibility criteria: Inclusion criteria:

* Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Exclusion criteria:

* Involved sites other than the brain, meninges, CSF, or the eyes.
* Age less than 18 years or greater than 75 years.
* Inadequate bone marrow capacity (defined as neutrophils\<1.5 ×10\^9/L, platelets \<100 ×10\^9/L, and hemoglobin level\< 8 g/dL).
* Known cause of immunosuppression (ie, HIV type I infection).
* Any previous malignancy.
* Creatinine clearance below 60 mL/min.
* Heart insufficiency (NYHA IIIB or IV).
* Uncontrolled infection.
* Noncompensated active pulmonary or liver disease.
* Previously treated for PCNSL, except by corticosteroids.

Primary outcomes:
measure: Overall survival
timeFrame: 3 year Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04112485: Open Discectomy Versus Microscopic Discectomy for Lumbar Disc Herniation
Official title: Open Discectomy Versus Microscope Assisted Discectomy for Treatment of Symptomatic Lumbar Disc Herniation: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Lumbar disc herniation , Open Discectomy, Micrdiscectomy
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old

Detailed description: 60 patients involved were divided into two matched groups; Group A: 30 patients were treated with conventional fenestration laminectomy and discectomy and Group B: 30 patients were treated with microdiscectomy. The age of the patients involved in this study ranged from 19 years old to 46 years old. All the patient was suffering from symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients.

Eligibility criteria: Inclusion Criteria:

* Adults who are symptomatic lumbar disc herniation L4-5. Each patient was assessed clinically and MRI was done for all the patients to prove clinically, the symptomatic lumbar disc herniation which was present in all patients. Conservative treatment for 6weeks was failed

Exclusion Criteria:

* smoking, previous lumbar spine surgery, Diabetes Melitus (DM) and neuromuscular disorders.

Primary outcomes:
measure: Visual analogue score
timeFrame: Visua analogue score was assessed preoperatively and postoperatively to see how much change in pain can occurred after open discectomy and after Microdiscectomy for 1 year
measure: Oswestry disability index
timeFrame: Oswestry disability index was assessed preoperatively and postoperatively to assess how much changes can occur after open discectomy and Microdiscectomy for 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hamawandi SA, Sulaiman II, Al-Humairi AK. Open fenestration discectomy versus microscopic fenestration discectomy for lumbar disc herniation: a randomized controlled trial. BMC Musculoskelet Disord. 2020 Jun 15;21(1):384. doi: 10.1186/s12891-020-03396-x.