louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02678728: Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Official title: Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Dissecting Aneurysm of Thoracic Aorta
Chronic Nontraumatic Dissection of Thoracic Aorta
Dissecting Aneurysm of the Thoracic Aorta
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. The investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with systemic inflammatory response, and oxidative stress.

Detailed description: Patients will be divided into 2 groups; dexmedetomidine group and control group. Dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery. And control group will receive the same amount of normal saline instead. Analyzing patients lung function and serum factors, which indicates the degree of systemic inflammatory responses and oxidative stress, The investigators will investigate the protective effect of dexmedetomidine on lung.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age

Exclusion Criteria:

* Unstable vital sign before surgery
* Severe pulmonary disease requiring consistent treatment
* Illiterate
* Pregnancy

Primary outcomes:
measure: Changes of lung oxygenation from baseline to 24 hr after reperfusion
timeFrame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
measure: Changes of lung compliance from baseline to 24 hr after reperfusion
timeFrame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT06080828: Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women
Official title: Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain Syndrome
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 35
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Chronic pelvic pain (CPP) significantly impacts the quality of life in women. This study investigated the effects of transdermal neuromodulation in females with CPP.

Trial Design: Parallel, randomized, single-blind, controlled trial The aim of the study will be to examine the effect of posterior tibial nerve stimulation on women with idiopathic chronic pelvic pain syndrome.

Methods: Thirty females with chronic pelvic pain will be randomly allocated 1:1 to receive either transdermal neuromodulation of the posterior tibial nerve (intervention group) or advice to control posture (control group) for 4 weeks at the Outpatient Physical Therapy Clinic at Kafrelsheikh University in Egypt. The primary outcome was pain intensity measured by visual analog scale (VAS). Secondary outcomes were serum cortisol level and quality of life (QOL) score. Assessments will be done at baseline and after 4 weeks.


Eligibility criteria: Inclusion Criteria:

* nulliparous, with a body mass index not exceeding 30 kg/m2 and complaining of idiopathic chronic pelvic pain syndrome (CPP).

Exclusion Criteria:

* chronic uterine prolapse, endometriosis, pelvic tumor, any sexual problems, an active genitourinary infection, heart diseases, kidney diseases, cognitive disorders or any physical or psychological condition that might impair the ability to provide written informed consent or adhere to the research procedure

Primary outcomes:
measure: VAS.
timeFrame: Before treatment and after 4 weeks of treatment
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: Before treatment and after 4 weeks of treatment
measure: serum cortisol
timeFrame: Before treatment and after 4 weeks of treatment
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelshaikh University
Study officials:
affiliation: Kafrelsheikh University
name: Ahmed M Kadry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06340828: Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
Official title: Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Gastroparesis
Diabetic Gastropathy
Diabetic Gastroenteropathy
Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:

* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
* The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.

Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
* Glycated hemoglobin (HbA1c) \< 11.0%.

Exclusion Criteria:

* Insulin dependent diabetes;
* Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
* Severe diabetic complications;
* Thyroid disease, malignancies, severe cognitive impairment and mental disease;
* Alcohol or substance abuse;
* Pregnancy or lactation.

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 0 days，weeks 1, 4, and 12 post-treatment
measure: Gut Microbiome Sequencing
timeFrame: 0 days，weeks 12 post-treatment
Secondary outcomes:
measure: Gastroparesis Cardinal Symptom Index
timeFrame: 0 days，weeks 1, 4, and 12 post-treatment
measure: Composite Autonomic Symptom Score 31
timeFrame: 0 days，weeks 1, 4, and 12 post-treatment
measure: Gastrointestinal Motility
timeFrame: 0 days，weeks 12 post-treatment
measure: Heart Rate Variability
timeFrame: 0 days，weeks 12 post-treatment
measure: Serum Metabolites
timeFrame: 0 days，weeks 12 post-treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00592228: Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent
Official title: Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Angiography
Drug-eluting Stents
Fractional Flow Reserve, Myocardial
Keywords: intermediate lesion
drug-eluting stent
fractional flow reserve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.


Eligibility criteria: Inclusion Criteria:

* Elective PCI
* Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion)
* Reference diameter \> 2.5mm, lesion length \< 60mm (cover by 2 stents)
* No documented evidence of ischemia by noninvasive tests

Exclusion Criteria:

* Acute ST elevation MI
* Left main disease
* Chronic renal failure (cr \>2 mg/dL)
* Expected survival \< 2yrs
* \> 1degree AV block

Primary outcomes:
measure: Clinical event: Cardiac death, myocardial infarction, target lesion revascularization
timeFrame: 9 months
Secondary outcomes:
measure: IVUS
timeFrame: at the time of procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SH, Jeon KH, Lee JM, Nam CW, Doh JH, Lee BK, Rha SW, Yoo KD, Jung KT, Cho YS, Lee HY, Youn TJ, Chung WY, Koo BK. Long-Term Clinical Outcomes of Fractional Flow Reserve-Guided Versus Routine Drug-Eluting Stent Implantation in Patients With Intermediate Coronary Stenosis: Five-Year Clinical Outcomes of DEFER-DES Trial. Circ Cardiovasc Interv. 2015 Dec;8(12):e002442. doi: 10.1161/CIRCINTERVENTIONS.115.002442.
Clinical trial NCT05276128: Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables
Official title: Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Type 2
Obesity
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy subjects
* Between 20 and 40 years old
* Body mass index between 19-28 kg / m2),
* Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations.

Exclusion Criteria:

* Fasting blood glucose concentration \>6.1 mmol/L
* Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results.
* Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin).
* Antibiotics or probiotics for at least four weeks before the start of the study,
* The use of tobacco products

Primary outcomes:
measure: glucose tolerance
timeFrame: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary outcomes:
measure: Insulin responses
timeFrame: 3 hours. Fasting (time =0 minutes), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
measure: Mood variables
timeFrame: 60 minutes after start of test product, after 120 minutes and after 180 minutes
measure: Appetite sensations
timeFrame: 3 hours. Fasting (time =0), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Other outcomes:
measure: Cognitive test variable
timeFrame: 60 minutes after start of breakfast, after 120 minutes, and after 180 minutes
Locations:
city: Lund
country: Sweden
facility: Anne Nilsson
state: Välj...
city: Lund
country: Sweden
facility: The Human Trial Facility, Food Technology engineering and Nutrition, Lund University
state: Välj...
Study officials:
References:
Clinical trial NCT05811728: Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement
Official title: Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Level Laser Therapy
Canine Retraction
Orthodontic Tooth Movement
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study is a randomized controlled clinical trial, involving the split-mouth design, with one side of the maxillary arch serving as the control group, and the other side serving as the experimental group.
Primary purpose: OTHER

Brief summary: Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement.


Eligibility criteria: Inclusion Criteria:

* Malocclusion that requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site, such as Class I bimaxillary protrusion, and Class II division 1 cases.
* Normal shape and structure of the maxillary canines, with no history of root canal treatment

Exclusion Criteria:

* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy, e.g. hormonal therapy and corticosteroids, as well as patients with chronic diseases.
* Pregnancy and lactation.

Primary outcomes:
measure: Measurement of alveolar bone density
timeFrame: 3 months
measure: Measurement of alveolar bone microstructure
timeFrame: 3 months
measure: Measurement of buccal bone thickness
timeFrame: 3 months
measure: Measurement of alveolar bone volume
timeFrame: 3 months
measure: Measurement of bone Microstructure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Farah Y Eid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425528: Study of Kuvan Treatment in Adults With GTPCH Deficiency
Official title: Pilot Study to Assess Impact of Kuvan® Supplementation as an Adjunct Treatment in Subjects With Dominantly-inherited GTPCH Deficiency on Mood, Behavioral and Motor Phenotypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: GTP Cyclohydrolase Deficiency
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2011-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH) deficiency and to asses the potential impact of oral Kuvan on mood and function in individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression, fatigue, trouble concentrating, or memory loss. This will be a phase one study. The investigators will monitor patients over a period of three to six months while on the medication. Medication levels will be monitored by measuring the BH4 levels in cerebral spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar punctures for this purpose. The investigators will also monitor emotional function and motor function.


Eligibility criteria: Inclusion Criteria:

* established diagnosis of GTPCH deficiency, supported by appropriate family history, CSF neurotransmitter studies, skin fibroblast enzyme assay and/or mutation analysis
* minimum age 18 years
* identified by self or others to have symptoms of anxiety, depression, fatigue, or other neurocognitive dysfunction (trouble concentrating, memory loss, etc)
* willingness to undergo at least 2 CSF evaluations for BH4 and neurotransmitter levels over an 8 to 12 week period

Exclusion Criteria:

* age \< 18 years old
* unwillingness to undergo repeated CSF analysis
* lack of supporting diagnostic criteria
* concomitant medical problems or medications which would increase risk of Kuvan®
* concomitant psychiatric state, such as severe depression with suicidal ideation that requires immediate referral and alternative treatment intervention
* prior history of back surgery, abnormality or chronic pain that in the opinion of the investigator would increase risks associated with lumbar puncture
* significant obesity that might increase difficulty or risk in performing lumbar puncture
* if female, unwillingness to use birth control during the period of study drug administration

Primary outcomes:
measure: Change in BH4 Levels in Cerebral Spinal Fluid
timeFrame: Baseline, 8 wks, 12 wks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Kathryn J Swoboda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02553928: Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer
Official title: Interventional, Randomised, Double-blind, Study to Evaluate the Safety and Tolerability of Once Daily Versus Twice Daily Memantine Treatment in Patients With Dementia of Alzheimer's Type and MMSE Range 5 - 18
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer Dementia (AD)
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 62
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: Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.


Eligibility criteria: Inclusion Criteria:

* The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
* The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
* The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
* The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

Exclusion Criteria:

* The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
* The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
* The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Adverse Events
timeFrame: baseline to week 16 (end of study)
Secondary outcomes:
measure: ADCS - CGIC Score at Week 12
timeFrame: ADCS - CGIC score at Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: CN001
city: Fujian
country: China
facility: CN006
city: Shandong
country: China
facility: CN004
city: Tianjin
country: China
facility: CN002
city: Xi'an
country: China
facility: CN007
city: Zhejiang
country: China
facility: CN003
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: