louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03200158: Study on Correlated Factors of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)
Official title: Study on Changes of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Related Mucosal Disease
Keywords: Stress related mucosal disease (SRMD)
APACHEII score
C-reactive protein
Malondialdehyde (MDA)
transforming growth factor (TGF)
interleukin (IL)
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2017-06-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).

Detailed description: 38 patients admitted to ICU and 15 healthy volunteers were successively enrolled in this study.The healthy volunteers were treated with endoscopy and biopsy .The 38 patients were treated with bedside gastroscopy and diagnosed with SRMD due to illness. The acute physiology and chronic health evaluation（APACHE）II score were evaluated, malondialdehyde (MDA) as an index of oxygen radical-lipid peroxidation was assessed in the serum. Transforming growth factor(TGF)β1,claudin3, interleukin (IL) 1 and interleukin（IL）10 levels in the gastric mucosa and plasma level of superoxide dismutase(SOD)，Ischemic modified albumin(IMA)and C-reactive protein（CRP）were evaluated.

Eligibility criteria: Inclusion Criteria:

* Occurrence time: ≤72h.
* With complete clinical data.
* Patients admitted to ICU were treated with bedside endoscopy and diagnosed with SRMD.

Exclusion Criteria:

* Primary digestive tract diseases included stomach cancer, gastric ulcer, cirrhosis with esophagus fundus ventricularis varices and esophageal cancer.
* Patients were complicated with gastric perforation.
* Nonsteroidal anti-inflammatory drugs and antiplatelet agents had been used recently, or with the history of major surgery.

Primary outcomes:
measure: malondialdehyde (MDA)（nmol/mL）
timeFrame: Month 1
measure: superoxide dismutase(SOD)(u/mL)
timeFrame: Month 1
measure: claudin3
timeFrame: Month 1
measure: TGFβ1
timeFrame: Month 2
measure: Acute physiology and chronic health evaluation（APACHE）II score
timeFrame: Month 3
measure: interleukin（IL）1β
timeFrame: month 4
measure: interleukin（IL）10
timeFrame: Month 5
measure: Nitric oxide synthasei（iNOS）
timeFrame: Month 6
Secondary outcomes:
measure: Ischemic modified albumin（IMA）(u/ml)
timeFrame: Month 7
measure: C-reactive protein（CRP）
timeFrame: Month 8
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598258: Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Official title: Hemodynamic Effects of Dry Sauna Followed by Cold Water Immersion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Arrhythmias
Keywords: Sauna
Cold water bath
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the Montreal Heart Institute Prevention and Cardiac Rehabilitation centre.

Detailed description: To determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the Montreal Heart Institute Prevention and Cardiac Rehabilitation centre. A recent complete evaluation will have excluded any cardiac condition. Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after , subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.

Principal goal of study: to determine the safety of this practice. Secondary goals of study: to measure the blood pressure response, heart rate, presence of arrythmyas, cardiac output and cerebral perfusion during both conditions.

Primary endpoint: Change in systolic blood pressure from sauna (after 10 minutes ) to cold water (after one minute).

Physiologic measurements: continuous ECG monitoring, BP measurements at every 3 minutes during sauna and at one minute in the cold bath, gaz exchange with a portable equipment (Cosmed K4), bioimpedance and cerebral perfusion with a single frontal NIRS electrode.

Eligibility criteria: Inclusion Criteria:

* Healthy women and men aged 40 and older with a recent complete medical evaluation including a normal resting ECG and a normal symptom-limited treadmill exercise test.

Exclusion Criteria:

* Any cardiac condition, abnormal exercise test, hypertension, type I diabetes and presence of any medications that may affect blood pressure.

Primary outcomes:
measure: Blood pressure
timeFrame: Difference between baseline and 11 minutes of intervention.
Secondary outcomes:
measure: Arrhytmias
timeFrame: Number of arrhytmias during all 25 minutes of the intervention.
measure: Blood pressure
timeFrame: Measured at 10 minutes after the end of the intervention (recovery period).
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cardiovascular Prevention and Rehabilitation Center
state: Quebec
Study officials:
affiliation: EPIC Centrer - Montreal Heart Institute
name: Martin Juneau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00186758: Transcranial Magnetic Stimulation in Bipolar Depression
Official title: A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Affective Disorder
Keywords: Transcranial Magnetic Stimulation
TMS
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Queen's University, Kingston, Ontario
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)

to determine if non-responders can become responders if treated on the other side of the hemisphere

(rTMS)

Detailed description: Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.

Eligibility criteria: Inclusion Criteria:

* Bipolar Depression
* no physical health problems

Exclusion Criteria:

* Metal in head/neck or skull
* History of Epilepsy
* Pregnancy
* Pacemaker

Primary outcomes:
measure: To compare antidepressant efficacy of right, left to sham
timeFrame: within 9 weeks
Secondary outcomes:
measure: To determine if QEEG activity correlates with antidepressant response to rTMS
timeFrame: within 9 weeks
measure: To determine if non-responders can become responders if treating the opposite hemisphere
timeFrame: within 9 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street
state: Ontario
Study officials:
affiliation: McMaster University
name: Gary Hasey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03600558: Efficacy of FLAG Regimen for the Treatment of Patients With AML
Official title: Efficacy of Fludarabine, Cytarabine and G-CSF (FLAG Regimen) for the Treatment of Patients With Acute Myeloid Leukemia (AML)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Keywords: FLAG
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective cohort, using medical charts of AML patients treated with the FLAG regimen from January 2007 to May 2018

Brief summary: The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.


Eligibility criteria: Inclusion Criteria:

* Patient more than 18 year old
* De novo or secondary leukemia.
* Treated with FLAG regimen

Exclusion Criteria:

* Acute promyelocytic leukemia (APL)

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Relapse-free survival
timeFrame: 2 years
measure: Severe adverse events
timeFrame: 45 days
measure: Complete Remission Rate
timeFrame: 2 months
measure: Event-Free Survival Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT05495958: The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
Official title: The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized clinical trial, patients with Meibomian gland dysfunction aged 50 year and more will be enrolled. The Meibomian gland dysfunction diagnosis will confirmed by a cornea specialist. The enrolled patients will be randomly allocated to the treatment and placebo group. The patients in treatment group will receive topical vitamin D every 6 hours daily (25 Microgram/cc or 1000 IU). The control group will receive the same-shape packed drop without vitamin D. The patients in both group will receive the conventional treatment including hot compress and shampoo scrub.

The primary outcome is the change in Ocular surface disease index and 5-Item Dry Eye Questionnaire score assessed before the topical treatment and every one-months until 3 months. The secondary outcome measures are Tear breakup time, Schirmer test, Corneal fluorescein staining, Meibomian gland expressibility.

The grader and the patients will blind to the study group.


Eligibility criteria: Inclusion Criteria:

* patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.

Exclusion Criteria:

* Patients with Vitamin D deficiency
* Patients taking Vitamin D systemic Supplementation
* Patient with prior ocular surgeries within previous 6 months.
* Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease

Primary outcomes:
measure: Ocular Surface Disease Index score
timeFrame: 3 months
Secondary outcomes:
measure: Tear breakup time (TBUT)
timeFrame: 3 months
measure: schirmer1
timeFrame: 3 months
measure: Fluorescein staining test
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research center
Study officials:
References:
Clinical trial NCT04119258: Therapist Adherence to Cognitive-behavioral Therapy
Official title: Therapist Adherence to Evidence-based Cognitive-behavioral Therapy in a Patient Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psychiatric outpatient care sample

Brief summary: An observational web-based survey on therapist adherence to evidence-based cognitive-behavioral therapy (CBT) in the perspective of their patients with depression or anxiety disorders in psychiatric outpatient care in Stockholm, Sweden. Following completion of CBT, participants respond to questions including their age, gender, education, whether they have improved, whether they considered treatment helpful, and an instrument measuring therapist adherence to CBT procedures (e.g., setting agenda, follow up on home assignments) and CBT techniques (e.g., exposure, cognitive restructuring). The purpose of the study is to contribute to quality assurance of CBT in Stockholm Health Care Services.


Eligibility criteria: Inclusion Criteria:

* A primary diagnosis of major depressive disorder, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or illness anxiety disorder
* 18 years of age or older
* Just completed individual cognitive-behavioral therapy in psychiatric outpatient care in Stockholm, Sweden

Exclusion Criteria:

* None

Primary outcomes:
measure: Adherence to Cognitive-Behavioral Therapy Scale - Patient Version
timeFrame: Up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: WeMind Psykiatri AB
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118558: Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Total Knee Replacement
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-04-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.


Eligibility criteria: Inclusion Criteria:

* Ages: 18 to 80
* Males- not involved in active military duty.
* Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.

Exclusion Criteria:

* Active systemic or local infection.
* History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
* Active autoimmune disease.
* Any past or present immunosuppressive treatment.
* Current treatment with chemotherapeutic agents
* History of metabolic bone disease (primary or secondary).
* Chronic renal insufficiency (defined by 50% increase of normal levels).

Primary outcomes:
measure: The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
timeFrame: six weeks
Secondary outcomes:
measure: 1. To assess the proportion on infections at two weeks and 6 weeks of follow-up.
timeFrame: two weeks and six weeks
measure: The number of patients recommended to undergo further procedural intervention because of the infection.
timeFrame: 12 MONTHS
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04437758: Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance
Official title: Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Collagen Synthesis
Rate of Force (RFD) Development
Keywords: exercise
performance
athletes
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50 mg vitamin C, along with a power training exercise program, increases rate of force development (RFD) and performance in athletes


Eligibility criteria: Inclusion Criteria:

1. Healthy male athletes between 18-30 years of age
2. Currently participating in sport
3. \<3 musculoskeletal injuries in the past year
4. No health or dietary restriction that would be affected by the supplementation protocol

Exclusion Criteria:

1. History of more than 3 musculoskeletal injuries within the past 12 months
2. Health, dietary restriction or diet that would be affected by the supplementation protocol
3. Willing to eat similar dietary pattern the day before baseline testing and each exercise testing/intervention day

Primary outcomes:
measure: Maximal rate of force development (RFD) of isometric squat (MIS)
timeFrame: % change from baseline to week 1, week 2 and week 3
measure: Counter-movement jump (CMJ) rate of force development (RFD)
timeFrame: % change from baseline to week 1, week 2 and week 3
measure: Squat jump height rate of force development (RFD)
timeFrame: % change from baseline to week 1, week 2 and week 3
Secondary outcomes:
Other outcomes:
measure: Maximum peak force of maximal isometric squat (MIS)
timeFrame: % change from baseline to week 1, week 2 and week 3
measure: Counter-movement jump (CMJ) net eccentric impulse
timeFrame: % change from baseline to week 1, week 2 and week 3
measure: Counter-movement jump (CMJ) net concentric impulse
timeFrame: % change from baseline to week 1, week 2 and week 3
measure: Leg stiffness assessment
timeFrame: % change from baseline to week 1, week 2 and week 3
Locations:
city: Davis
country: United States
facility: UC Davis Functional Molecular Biology Laboratory and Human Performance Laboratory
state: California
Study officials:
affiliation: University of California, Davis
name: Keith Baar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04960358: Surface Electromyography in Stratifying Chronic Low Back Pain.
Official title: The Application Of Surface Electromyography (SEMG) In Stratifying Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with low back pain who were being referred to the rehabilitation outpatient in University Malaya Medical Centre between November 2019 until July 2020.

Brief summary: Surface Electromyography can be utilised to detect normal muscle electrical activity during maximum forward flexion termed Flexion Relaxation Response (FRR)

Detailed description: In this study, our primary objective is to assess FRR and disability (ODI) correlation protocol as an objective tool in stratifying Chronic LBP. We also would like to evaluate the relationship between FRR with pain intensity and lumbar range of motion as our secondary objective.

Eligibility criteria: Inclusion Criteria:

* Participants aged between 20 - 70 years old
* Mechanical LBP \> 6 weeks (not acute LBP)
* Not received any specific exercise spinal manipulation or surgery to improve LBP within the last 3 months.

Exclusion Criteria:

* Pregnancy
* Radicular LBP patients or specific-spinal pathology / "red-flags".
* Surgical intervention for the current LBP complaint (includes traumatic causes of LBP with surgical intervention)
* Cognitive or communication difficulty preventing active participation in exercises or communicating pain scores

Primary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 1 YEAR
measure: Flexion Relaxation Response (FRR) ratio
timeFrame: 1 YEAR
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 1 YEAR
measure: Gross Range of Motion
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: University of Malaya
name: ANWAR SUHAIMI, MBBS
role: PRINCIPAL_INVESTIGATOR
References: