louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06748586: The Effect of Hyperbaric Oxygen Therapy on Circulating Hematopoietic Stem Cell Population
Official title: The Effect of Hyperbaric Oxygen Therapy (HBOT) on Circulating Hematopoietic Stem Cell Population , a Prospective Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Circulating Hematopoietic Stem Cells
Keywords: hyperbaric oxygen therapy
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: hyperbaric oxygen therapy (2ATA, 100% oxygen)
Primary purpose: TREATMENT

Brief summary: Hematopoietic stem cells (HSCs), which govern the production of all blood lineages, transition through a series of functional states characterized by expansion during fetal development, functional quiescence in adulthood, and decline upon aging.

Although research on aging has for a long time been relatively descriptive, much progress has been made in the past decade to uncover the molecular drivers of biological aging. One such drivers relates to stem cell exhaustion.

The amount and the function of HSCs decline in humans along aging. This decline is characterized by different changes such as signaling, epigenetic, cell surface markers etc. Various studies have been conducted to identify HSCs surface markers using flow cytometry.

Exposure to HBOT induce stem cells proliferation mobilization of stem progenitor cells (SPCs) in both animal and humans studies, and the number of SPCs remain elevated in blood over the course of 20 HBOT .

Additionally, Heyboer et al have found dose response curve between the HBOT protocol and circulating CD34+ and CD45-dim (stem cells potential markers): increasing the treatment pressure from 2.0 ATA to 2.5 ATA increased the concentration of circulating stem cells.

The aim of the current study is to evaluate the effect of HBOT on circulating hematopoietic stem cells, in the peripheral blood of patients who are candidate for HBOT.


Eligibility criteria: Inclusion Criteria:

* The study will include patients aged 20-80 who are intendent to start HBOT for other indication that are willing to give blood samples for measurements of circulating stem cells.

Exclusion Criteria:

1. Active or recent infection within the last month
2. Active malignancy.
3. History of hematopoietic disease
4. Low B12 or iron levels
5. Inability to sign the informed consent form
6. Leucocytes ˂4000 or ˃10,000

Primary outcomes:
measure: hematopoietic stem cells evaluation
timeFrame: Change from Baseline immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Study officials:
References:
Clinical trial NCT03350386: Drug-drug Interaction Study of FYU-981 and Oxaprozin
Official title: Drug-drug Interaction Study to Evaluate the Pharmacokinetics and Safety of FYU-981 and Oxaprozin in Healthy Male Adults Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fuji Yakuhin Co., Ltd.
First posted: 2017-11-22
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Adult healthy subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 48 hours
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 48 hours
measure: Safety (Incidence of treatment-emergent adverse event)
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hachiōji
country: Japan
facility: P-One Clinic
state: Tokyo
Study officials:
affiliation: Clinical Research Department
name: Nagasawa Katsuaki
role: STUDY_DIRECTOR
References:
citation: Furihata K, Nagasawa K, Hagino A, Kumagai Y. A drug-drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):36-43. doi: 10.1007/s10157-020-01855-2. Epub 2020 Feb 19.
Clinical trial NCT00197886: Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid.

This study examines whether increasing the dose of norepinephrine leads to higher concentrations of lactic acid in the rectum and stomach in patients with life-threatening infection.


Eligibility criteria: Inclusion Criteria:

* Septic shock
* NE-dose \> 0.1 microg/kg/min
* CI \> 3.0 l/min/m2

Exclusion Criteria:

* Age \< 18, unable to obtain informed consent from relatives
* Untreated hypertension
* Pregnancy
* Pathology in the rectum or stomach
* Limitation of therapy

Primary outcomes:
measure: L-lactate concentration in the rectum and stomach.
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Dept. of Intensive Care, Herlev University Hospital
Study officials:
affiliation: Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
name: Anders Perner, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04338386: Detection and Pathogenesis of Novel Protein F
Official title: Detection and Pathogenesis of Novel Protein F
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Disease
Multiple Myeloma
Keywords: diagnosis
protein
cardiac disease
multiple myeloma
globulin
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with heart diesease

Brief summary: From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Preliminary studies have shown that this novel protein F have an obvious absorption peak at about 600nm. Placed at 2-8 degrees for 7 days, protein F will be isolated from heparin plasma. To the naked eye, protein F appear to be transparent jelly between the red blood cells and the plasma. The specific protein F, how it is produced, how it causes disease are still unknown. This study will explore how to detect protein F and how it is produced.

Detailed description: Protein F screening was performed on anticoagulant blood plasma with heparin Lithium or blood serum by in-house turbidimetric method in Automatic biochemical analyzer.

All patients were followed-up for 3 years by telephones, routine appointment out-patient clinic or returning visit.

Eligibility criteria: Inclusion Criteria:

* Testing total protein and albumin
* Testing routine blood test

Exclusion Criteria:

* high triglycerides (TG\>5.00 mmol/L)
* hyperbilirubinemia (TBIL\>170 mmol/L)
* fat emulsion used in past 3 days
* patients with hemolytic disease
* pregnant and lactating women

Primary outcomes:
measure: Concentration of plasma protein F content
timeFrame: six month
Secondary outcomes:
measure: Number of Participants with Multiple myeloma
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Zhenlu Zhang, MD，Ph,D
role: STUDY_CHAIR
References:
Clinical trial NCT03183986: Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
Official title: Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2017-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Infants are randomised to phototherapy with blue LED's with wavelength of 478 or 459 nm. The decrease of TSB between the groups is compared.
Primary purpose: TREATMENT

Brief summary: Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance \> 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.

Detailed description: This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age \> 33 weeks and birth weight \> 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes.

Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.

Eligibility criteria: Inclusion Criteria:

* Indication for phototherapy with single light
* Gestational age \> 33 weeks
* Birth weight \> 1800 grams
* Should be treatable in a cradle

Exclusion Criteria:

* Haemolytic disease
* Indication for double/triple phototherapy or exchange transfusion

Primary outcomes:
measure: Decrease of total serum bilirubin
timeFrame: 24 hours of phototherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Neonatal department, Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Mette Donneborg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamola AA. A Pharmacologic View of Phototherapy. Clin Perinatol. 2016 Jun;43(2):259-76. doi: 10.1016/j.clp.2016.01.004. Epub 2016 Feb 15.
Clinical trial NCT06383286: The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes
Official title: The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes Who Prepared for Paralympic Games
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paralympic Athletes
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: disabled athletes who prepared the Paralympic Games

Brief summary: It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time


Eligibility criteria: Inclusion Criteria:

* Being a physically disabled athlete
* Preparation for the Paralympic Games
* Volunteering to participate in the study

Exclusion Criteria:

* Serious psychiatric illness
* Regular use of sedatives or neuropsychiatric drugs
* presence of active alcohol or drug addiction
* Presence of a systemic or neurological problem that develops independent of disability pathology.

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 8 months
measure: The Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 8 months
measure: Fatigue Severity Scale
timeFrame: 8 months
measure: International Physical Activity Questionnaire short form
timeFrame: 8 months
measure: Perceived Stress Scale (PSS-14)
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt Univercity
Study officials:
References:
Clinical trial NCT04617886: The Effect of Mood Induction in Body Image Through Virtual Reality
Official title: The Effect of Mood Induction Procedure of Sadness (vs. Joy) in Body Image Through Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sadness
Happiness
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 42
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within subjects design. Each participant will be tested, in a counterbalanced way, through both (sadness vs. joy) conditions
Primary purpose: SCREENING

Brief summary: The effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality

Detailed description: The general objective of this study is to analyze the impact of emotional induction (sadness vs. joy) on the two dimensions (perceptive and affective) of body image with the help of virtual reality. Thus, it is hypothesized that a negative emotional induction may partially explain the change in body image measures.

Eligibility criteria: Inclusion Criteria for CLINICAL population:

* ED diagnosis: Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified
* BDI-II - depression symptomatology scores \<29 (for ethical reasons)
* Age between 13 and 18

Exclusion Criteria for CLINICAL population:

* suicide risk: the decision of the psychiatrist/psychologist
* present any medical illness or physical incapacity that could impede the experiment
* diagnosis of Binge Eating Disorder
* Body Mass Index \<14 or \> 28
* pregnancy

Primary outcomes:
measure: Change in the Body image dissatisfaction state
timeFrame: Baseline; inmediately after procedure
measure: Change in the Body image estimation
timeFrame: Baseline; inmediately after procedure
Secondary outcomes:
measure: Change in the Positive and negative affect
timeFrame: Baseline; inmediately after procedure
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References:
Clinical trial NCT04884386: Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy
Official title: Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Bilateral Spastic and Hemiplegic Cerebral Palsy: A Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spastic Hemiplegic Cerebral Palsy
Bilateral Spastic Cerebral Palsy
Gait Disorders, Neurologic
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In children with cerebral palsy, the quality of walking decreases due to a decrease in the ability to control limbs, including walking, and coordination among various activities of daily living due to a decrease in functional independence and quality of life. Gait disorder is one of the important therapeutic goals of children with cerebral palsy, and recently robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help improve gross motor control and coordination control.


Eligibility criteria: Inclusion Criteria:

* Patients aged 6-12 years or younger who have not received botulinum toxin or surgery within 3 months before the study
* Patients diagnosed with Bilateral Spastic Cerebral Palsy
* Patients diagnosed with Spastic Hemiplegic Cerebral Palsy

Exclusion Criteria:

* Children who cannot understand and follow orders
* Children with stiffness in the lower limbs corresponding to the Modified Ashworth Scale (MAS)\> 3
* Patients who wear a robot and walk without affecting contractures, deformities, or skin problems
* Infants with cardiovascular instability and mild scoliosis with a cobb's angle of 30 degrees or more

Primary outcomes:
measure: muscle activation
timeFrame: Change from baseline muscle activation at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Ez rehabilitation medical center
Study officials:
References:
Clinical trial NCT04502186: A Systems-Level Intervention for Rural Adults With Depression
Official title: A Systems-Level Intervention for Rural Adults With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-06
Enrollment: 70
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: This study aims to test the effectiveness of a computer-assisted cognitive behavioral therapy for depression among rural adults. The intervention, called Raising Our Spirits Together (ROST), was developed via a community-based participatory approach and will be delivered in small groups, facilitated by local pastors. Groups will be held virtually, or in-person at two churches in rural Michigan. Eighty-four individuals will be recruited from Hillsdale, Michigan, to test the effect of ROST on depressive symptoms, compared to an Enhanced Control Condition (ECC).


Eligibility criteria: Inclusion Criteria:

* Must live in Hillsdale, Lenawee, Jackson, or Calhoun County, Michigan
* Positive screen for at least mild depressive symptoms based on the the Patient Health Questionnaire-9 (PHQ-9\>=5)

Exclusion Criteria:

* Non-English speaking
* Currently receiving cognitive behavioral therapy (CBT) for depression
* Ever completed a course of cognitive behavioral therapy (CBT; \>=8 sessions)
* Diagnosis of a psychotic disorder
* Current use of opiates or freebase cocaine
* Prominent suicidal/homicidal ideation with imminent risk.

Primary outcomes:
measure: Change in Self-report Measure of Depressive Symptoms
timeFrame: Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), and 12-weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hillsdale
country: United States
facility: Trinity Lutheran Church
state: Michigan
city: Jonesville
country: United States
facility: Jonesville First Presbyterian Church
state: Michigan
Study officials:
affiliation: University of Michigan
name: Addie Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509586: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
Official title: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: smoking
smoking cessation
Potentially Reduced Exposure Products (PREPs)
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-13
Enrollment: 1236
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.

Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.


Eligibility criteria: Inclusion Criteria:

* age \>=19
* a daily cigarette smoker of \>=10 cigs/day
* English speaking
* live in the contiguous U.S.
* unmotivated to quit smoking in the next 30 days

Exclusion Criteria:

* no use of smokeless tobacco in past six months
* not breastfeeding, pregnant, or planning a pregnancy
* devoid of any recent (past 6 months) cardiovascular trauma
* no quit attempt of \>=1 week in past 6 months
* no use of pharmacotherapy to quit smoking in past 3 months

Primary outcomes:
measure: Quit Attempts and Abstinence
timeFrame: From study enrollment through end of one-year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Matthew J. Carpenter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpenter MJ, Wahlquist AE, Burris JL, Gray KM, Garrett-Mayer E, Cummings KM, Alberg AJ. Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. Tob Control. 2017 Mar;26(2):202-209. doi: 10.1136/tobaccocontrol-2015-052783. Epub 2016 Apr 12.