louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02487901: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
Official title: Randomized Controlled Trial: Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthrodesis
Keywords: arthrodesiss
cervical vertebra
laminoplasty
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. In the present study, the investigators are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Detailed description: Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. The tissue selectivity of ultrasonic osteotomy may enhance operative time and reduce tissue trauma. Moreover, bony fusion rate may be increased because of low thermal injury to the bone. In the present study, we are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Eligibility criteria: Inclusion Criteria:

1. cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL;
2. aged more than 20 years
3. with American Society of Anesthesiology physical status class 1 or 2

Exclusion Criteria:

1) concomitant neurological disease such as cerebral palsy or amyotrophic lateral sclerosis; 2) concurrent cancer or infection; 3) previous cervical spinal surgery; 4) a trauma-associated lesion; 5) inability to be followed up (i.e., foreign patients); 6) refusal to participate in the study

Primary outcomes:
measure: Number of Participants With Bone Fusion
timeFrame: 6 months
Secondary outcomes:
measure: Bleeding Amount
timeFrame: during operation
measure: Fracture of Laminar
timeFrame: during operation
measure: Neck Pain/Arm Pain
timeFrame: postop 1 year
measure: Functional Outcome
timeFrame: postop 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim CH, Chung CK, Choi Y, Kuo CC, Lee U, Yang SH, Lee CH, Jung JM, Hwang SH, Kim DH, Yoon JH, Paik S, Lee HJ, Jung S, Park SB, Kim KT, Park HP. The Efficacy of Ultrasonic Bone Scalpel for Unilateral Cervical Open-Door Laminoplasty: A Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):825-834. doi: 10.1093/neuros/nyz301.
Clinical trial NCT06484101: Functional Characterization of CD8+ T Cells After Supramaximal Exercise
Official title: Effekten av högintensiv träning på Vita Blodkroppar, Med Speciellt Fokus på Funktion Kopplad Till Att bekämpa Cancerceller
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Induced CD8+ T Cell Recruitment and Characterization of Function and Phenotype of These Cells
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout.

Detailed description: Healthy, human subjects perform 3 x 30 seconds of supramaximal exercise. Venous blood samples were obtained before and up to 60 minutes after the exercise bout. The blood was used for absolute count of lymphocytes and monocytes per volume blood, and for isolation of CD8+ T cells. It was also used for blood gas analysis. The CD8+ T cells were characterized using flow cytometry, and then cultured for 7 days with CD8+ activation beads. The cells were counted and analyzed for viability at day4 and day8. RNAseq was performed on CD8+ cells isolated before and directly after exercise. CD8+ T cells from Day 1 pre and post exercise and then after 7 days of culture, were analyzed for IFNgamma release using Elispot, and for cytotoxicity against HEK cancer cells in vitro. Flow cytometry of CD8+ T cells was performed on fresh CD8 T cells pre and post exercise, and then on day4 and day8 after culture. SeaHorse metabolic assay was done on Day1 CD8 T cells obtained pre and post exercise.

Eligibility criteria: Inclusion Criteria:

* Be used to physical exercise and be able to perform strenous exercise Be able to attend the experimental procedure for the 90 minute duration of the study

Exclusion Criteria:

* Smoking Pregnant Have any medical condition requiring medical treatment

Primary outcomes:
measure: CD8 T cell absolute nr after exercise
timeFrame: Before, directly after, 60 minutes after exercise
measure: CD8 T cell cytotoxicity against cancer cells
timeFrame: Cryopreserved CD8 cells from Day 1 and Day 8 of the experiment, obtained before and after exercise
measure: CD8 T cell pheontype after exercise
timeFrame: Before, directly after, 30 minutes and 60 minutes after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Sjukhuset Huddinge
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Helene Rundqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905501: Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial
Official title: Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microsurgical Free Flaps
Keywords: Balanced anesthesia
Inhalation anesthesia
Reperfusion injury
Microsurgical Free flap
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.


Eligibility criteria: Inclusion Criteria:

Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II

Exclusion Criteria:

Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease

Primary outcomes:
measure: continuous tissue oximetry (NIRS)
timeFrame: 20 hours
Secondary outcomes:
measure: Biochemical Markers
timeFrame: Preoperative and 24 hours post operative
measure: Lactate Clearance
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena CI
Study officials:
affiliation: Regina Elena CI
name: Ester Forastiere, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claroni C, Torregiani G, Covotta M, Sofra M, Scotto Di Uccio A, Marcelli ME, Naccarato A, Forastiere E. Protective effect of sevoflurane preconditioning on ischemia-reperfusion injury in patients undergoing reconstructive plastic surgery with microsurgical flap, a randomized controlled trial. BMC Anesthesiol. 2016 Aug 22;16(1):66. doi: 10.1186/s12871-016-0230-1.
Clinical trial NCT05858801: First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine
Official title: First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Salvia BioElectronics
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.


Eligibility criteria: Main Inclusion Criteria:

* Able and willing to provide informed consent
* Age ≥ 18 years and ≤ 84 years at time of consent
* Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year.
* Developed migraine before the age of 50
* Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A
* Have at least 1 headache free day per month
* Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment.
* Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study.
* MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
* Able and willing to complete a daily headache eDiary

Main Exclusion Criteria:

* Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms.
* Concomitant neuromodulation
* Previous failure to an implantable neuromodulation device for neurovascular headache
* Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, ...)
* Metal implants in the skull (e.g. skull plates, seeds) nearby the implant.
* Have a pacemaker of implantable cardioverter defibrillator (ICD)
* Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months.
* Use of botulinum toxin injections in the past 3 months.
* Women of childbearing age who are pregnant, nursing or not using contraception

Primary outcomes:
measure: Safety Evaluation
timeFrame: 30 days
measure: Safety Evaluation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
References:
Clinical trial NCT03617601: Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
Official title: Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Diseases
Lead sponsor: Triemli Hospital
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 296 patients who received an aortic repair with open or endovascular technique at Triemli Hospital from May 2009 till March 2016

Brief summary: Reliable prediction of the preoperative risk is of crucial importance for patients undergoing vascular operations. The assessment of the metabolic equivalent of task (MET) is an easy clinical evaluation of the functional capacity of an individual. A MET is defined as the resting metabolic rate, that is the amount of the consumed oxygen at rest. According to the MET concept a patient would be considered as "fit for surgery" when the stairs of two flights can be climbed and the housework can be fully managed by oneself.

Hypothesis: Patients with a functional capacity over 4 MET (fit for surgery) have less perioperative complications with the focus on cardiac pathology than patients with less than 4 MET during aortic operations.

Patients and Method: Retrospective analysis of a single center unit of 296 patients undergoing open or endovascular aortic repair.


Eligibility criteria: Inclusion Criteria:

* Data of all patients after open and endovascular aortic repair of the descending aorta from May 2009 till March 2016

Exclusion Criteria:

* Data of all patients with isolated operations on the ascending aorta or aortic arch

Primary outcomes:
measure: Survival
timeFrame: up to ten years
Secondary outcomes:
measure: Perioperative complications
timeFrame: up to 30 days postoperatively
measure: Coronary artery bypass grafting, percutaneous coronary intervention/Stenting
timeFrame: up to ten years
Other outcomes:
Locations:
Study officials:
affiliation: Triemli Hospital Zurich
name: Nicolas Attigah, MD
role: STUDY_CHAIR
References:
citation: Zientara A, Schwegler I, Dzemali O, Bruijnen H, Bernheim A, Dick F, Attigah N. Evaluation of metabolic equivalents of task (METs) in the preoperative assessment in aortic repair. BMC Surg. 2021 Mar 13;21(1):130. doi: 10.1186/s12893-021-01143-0.
Clinical trial NCT05372601: Prebiotics and Stress Reduction in Women
Official title: The Effect of Galacto-oligosaccharides (GOS) on Self-perceived Stress in Apparently Healthy But Stressed Dutch Women: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 124
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In modern life, many people state to experience stress. Women compared to men report more and higher levels of stress. Recent research found that supplementation of galactose-oligosaccharides (GOS) resulted in reduced anxiety levels in British female students with higher anxiety scores at baseline in self-reported trait anxiety. Moreover, supplementation of probiotics in germ-free rodents resulted in reduced levels of circulating corticosterone (cortisol in humans). These findings illustrate the potential of prebiotic supplementation, through the microbiota-gut-brain (MGB) axis, to improve mental health and wellbeing.

The present study aims to study the effect of oligosaccharides on self-perceived stress.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy women
* Moderate or high stress level; DASS42 stress sub-score ≥19
* Age between 25 and 45 years
* Body mass index (BMI) between 18.5 and 30 kg/m2
* Access to internet and a smart phone

Exclusion Criteria:

* Any metabolic, gastrointestinal, inflammatory or chronic disease
* History of gastro-intestinal surgery or having (serious) gastrointestinal discomfort
* Use of supplement to relief stress during or within 2 weeks prior to the start of the study
* Use of pre- and/or probiotics during the study (except for the study product) or within 4 weeks prior to the start of the study
* Use of medication that may influence the study results, such as laxatives
* Self-reported and/or clinical lactose intolerance
* Self-reported and/or active cow's milk protein allergy
* Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported)
* Having used antibiotics in the 6 months prior to the start of the study

Primary outcomes:
measure: Perceived stress
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: FrieslandCampina Research and Development
Study officials:
affiliation: FrieslandCampina
name: Reina S Tjoelker, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04023201: Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
Official title: Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS

Brief summary: This is a cross-sectional, retrospective clinical observation study focusing on the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease.

Detailed description: This study was a cross-sectional, retrospective clinical observation study investigating the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease through the Parkinson's disease sleep-related scale. At the same time, the effects of nocturnal symptoms on the quality of life of patients with Parkinson's disease were studied. About 1,500 Parkinson's patients will be recruited into the study who come from Shanghai, China.

Eligibility criteria: Inclusion Criteria:

1. Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
2. Signing informed consent

Exclusion Criteria:

1. clinically suspected Parkinson's disease, has not been diagnosed;
2. suspected or diagnosed as secondary Parkinson's syndrome (vascular, drug, traumatic, encephalitis, toxic, etc.);
3. suspected or diagnosed as atypical Parkinson's syndrome (progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, etc.);
4. There is a clear history of stroke, moderate to severe traumatic brain injury, hydrocephalus, brain surgery or history of brain tumors;
5. severe cognitive impairment or psychiatric symptoms;
6. Can not cooperate with the completion of the study.

Primary outcomes:
measure: nocturnal symptoms in patients with Parkinson's disease
timeFrame: January 31, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhenguo Liu, Doctor
role: STUDY_CHAIR
References:
citation: Grandas F, Iranzo A. Nocturnal problems occurring in Parkinson's disease. Neurology. 2004 Oct 26;63(8 Suppl 3):S8-11. doi: 10.1212/wnl.63.8_suppl_3.s8.
Clinical trial NCT01356901: Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients
Official title: Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHB Patients treated by Gastroenterologists/Hepatologists

Brief summary: The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.

Detailed description: Sampling Method: Probability Sample (consecutive patient sampling)

Eligibility criteria: Inclusion Criteria:

* Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
* Written informed consent

Exclusion Criteria:

* All relevant conditions according to Summary of product characteristics (SmPC)
* Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
* Patients currently included in any investigational trial on CHB

Primary outcomes:
measure: Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.
timeFrame: After 2 years
Secondary outcomes:
measure: Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS)
timeFrame: After 2 years
measure: Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)
timeFrame: After 2 years
measure: Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss
timeFrame: After 2 years
measure: Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs
timeFrame: After 2 years
measure: Number of participants with occuring resistances based on results from resistance tests
timeFrame: After 2 years
measure: Assessment of Health Status (SF-12® Health Survey)
timeFrame: Assessment of Health Status (SF-12 Health Survey) at year 1
measure: Assessment of Health Status (SF-12® Health Survey)
timeFrame: Assessment of Health Status (SF-12 Health Survey) at year 2
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01377701: The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor
Official title: The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Adenomas
Keywords: pituitary adenomas
recovery of vision
trans-sphenoidal surgery
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pituitary adenomas at Huashan Hospital will be screened. Patients with loss of visual field and receive trans-sphenoidal surgery will be included.

Brief summary: Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to damage of vision. This study aims to evaluate the predictive factors for recovery of vision in patients with pituitary adenomas following trans-sphenoidal surgery.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* patients with pituitary adenomas, loss of visual field
* patients receive trans-sphenoidal surgery

Exclusion Criteria:

* visual damage caused by other diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Yao Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: