louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03878615: Inflammation and Organ Impact During Hepatic Surgery
Official title: Inflammation and Organ Impact During Hepatic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Surgery
Keywords: liver surgery
hepatic resection
inflammation
organ dysfunction
blood loss
IFABP
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for open liver resection, ASA class I-III.

Brief summary: Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.

Detailed description: During hepatic surgery, blood and urine samples will be obtained at 3 times during surgery, at 3 h after resection of liver, at 24 h after resection of liver and at post operative day 2, and subsequntly analyzed for the above mentioned substances. Routine labs will be monitored until patient is discharged from hospital. During surgery, hemodynamic parameters will be monitored by Picco calculations. Urine output and blood loss will be registred.

Eligibility criteria: Inclusion Criteria:

ASA I-III Patient has given informed consent to participate in study.

Exclusion Criteria:

preoperative kidney failure (E-GFR \>30), current infection treatment with corticosteroids coagulopathy surgical or anatomical conditions that makes patient unsuitable for participation (for example reoperation, need of vascular bypass, single tumor)

Primary outcomes:
measure: Ischemic Intestinal Damage
timeFrame: from day of surgery until 24-48 hours postoperatively
measure: Kidney injury
timeFrame: from day of surgery and approximately 1 week onwards
measure: Intestinal Bacterial Transloction
timeFrame: from day of surgery until 24-48 hours postoperatively
measure: Kidney injury
timeFrame: from day of surgery until 24-48 hours postoperatively
measure: Kidney injury
timeFrame: from day of surgery until 24-48 hours postoperatively
Secondary outcomes:
measure: Description of Inflammatory Response
timeFrame: from day of surgery and approximately 1 week onwards
Other outcomes:
measure: blood loss
timeFrame: from day of surgery and approximately 1 week onwards
Locations:
city: Gothenburg
country: Sweden
facility: SahlgrenskaUH
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Sven-Erik Ricksten, MD, PhD, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916915: Usage of Tramadol With Levobupivacaine for Pain Treatment After Cesarean Section
Official title: The Effect of Addition of Tramadol to Levobupivacaine in Continuous Wound Infusion for Postoperative Pain Treatment in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients experience considerable amount of pain after cesarean section. The aim of this study is to investigate the effect of tramadol (an opioid pain killer) added to levobupivacaine (a local anesthetic) in continuous wound infusion (which is done by placing a catheter in the incision) after cesarean sections.


Eligibility criteria: Inclusion Criteria:

* Planned cesarean section
* American Society of Anesthesiologists Class I-II

Exclusion Criteria:

* Patients refusing to enroll in the study
* Serious coagulopathy
* Serious systemic disease
* Story of allergy to drugs being used in the study
* Morbid obesity (Body mass index \> 30)

Primary outcomes:
measure: lowering of pain as measured by visual analogue scores
timeFrame: forty eight hours after the operation
Secondary outcomes:
measure: total additional analgesic consumption
timeFrame: forty eight hours after the operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Dr Rıdvan Ege Hospital
Study officials:
affiliation: Ufuk University Dr Rıdvan Ege Hospital Department of Anesthesiology and Reanimation
name: Perihan Ekmekçi, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05823415: Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession
Official title: Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recession, Gingival
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.


Eligibility criteria: Inclusion Criteria:

* Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket)
* Patients with good oral hygiene
* Medically free patients
* No signs of active periodontal disease (with no site showing probing depth \> 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth).
* Palate with sufficient thickness to accommodate soft tissue defect.

Exclusion Criteria:

* Smokers
* Pregnancy
* Severe gag reflex
* Non-carious cervical lesion
* History of mucogingival or periodontal surgery at the experimental site
* History of medication that can affect periodontal healing

Primary outcomes:
measure: Reduction in recession depth
timeFrame: 6 Months
Secondary outcomes:
measure: Post-operative pain assessed by VAS Scale
timeFrame: 2 week
measure: Probing Depth
timeFrame: 6 months
measure: Clinical Attachment Level
timeFrame: 6 months
measure: Width of Keratinized Tissue
timeFrame: 6 months
measure: Gingival Thickness
timeFrame: 6 months
measure: Percentage of complete root coverage by williams periodontal probe
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03293615: Exercise Capacity of Patients with Dermatomyosis
Official title: Exercise Capacity of Patients with Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dermatomyositis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown.

The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.


Eligibility criteria: Inclusion Criteria:

* Woman or man\> 18 years,
* Signature of informed consent,
* Muscle biopsy for suspicion of recent inflammatory myopathy (\<6 months) or for exclusion of neuromuscular pathology.

Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:

* "DM" group: DM according to the ENMC criteria;
* "other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
* Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.

Exclusion Criteria:

* - Taking an immunomodulatory treatment within 6 months before inclusion,
* Paraneoplastic form of the disease,
* Presence of associated interstitial pneumonitis,
* Neuromuscular pathology different from inflammatory myopathy,
* Unbalanced cardiovascular disease,
* Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
* Subject under safeguard of justice,
* Subject under tutelage or under curators,
* Pregnancy (positive pregnancy test)
* Breastfeeding.

Primary outcomes:
measure: Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Meyer
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Alain Meyer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03606915: Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease
Official title: Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: pain
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 131
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergo spinal anesthesia

Brief summary: Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.

Detailed description: The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.

Eligibility criteria: Inclusion Criteria:

* . Patients undergo spinal anesthesia
* . Over 20 years of age

  * Patients who are competent to understand the study and provide written informed consent.

Exclusion Criteria:

* Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis)
* Refuse participated in this study or pre-existent neurological disease.
* Patients with advanced tumor staging (stage 3 or 4).

Primary outcomes:
measure: cytokine measurement in cerebrospinal fluid
timeFrame: through study completion, an average of 1 year
measure: cytokine measurement in blood
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Yen-Chin Liu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431115: Physical Activity, Sedentary Behaviour and Physical Fitness Profile of Primary School Children in Lagos, Nigeria.
Official title: Levels, Patterns and Correlates of Physical Activity, Sedentary Behaviour and Physical Fitness Profile of Primary School Children in Lagos, Nigeria; Development of a Physical Activity Guideline.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 1038
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are primary school children(6-12 yrs) in public and private schools in Lagos state, Nigeria..

Brief summary: This research study intends to use a mixed method approach(both qualitative and quantitative) to describe and analyse the levels, patterns, and correlates of physical activity((PA), sedentary behaviour(SB), and physical fitness(PF) profiles of primary school children in Lagos state, Nigeria. The study is in four phases.

Detailed description: Phase1 is a scoping review of literature of the level of compliance of all the countries in sub-saharan Africa to the Global observatory on physical activity(GOPA) recommendation on the minimum level of daily physical activity to reduce incidence of non communicable chronic diseases e.g. hypertension, diabetes, obesity etc.

Phase2 is a concurrent mixed method which will explore parents and other stakeholders awareness, understanding and perspectives on PA,SB, and PF among primary school children in Lagos, Nigeria.

Phase 3 is a cross sectional study which will investigate levels, patterns and correlates among physical activity, sedentary behaviour and physical fitness profile of primary school children in Lagos, Nigeria.

Phase 4 is development of physical activity guideline for primary school children in Lagos, Nigeria.

Eligibility criteria: Inclusion Criteria: 1.Must be Primary school children between ages 6 and 12 years in Lagos, Nigeria.

-

Exclusion Criteria:

1. Obvious lower limb musculoskeletal diseases.
2. Normal gait impairment.

Primary outcomes:
measure: Youth activity profile(YAP)
timeFrame: About 5 days
measure: Children physical activity questionnaire(CPAQ)
timeFrame: for activities over the past seven days.
Secondary outcomes:
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Lagos state primary schools
Study officials:
affiliation: UKZN
name: Olusegun O Ojedoyin
role: PRINCIPAL_INVESTIGATOR
affiliation: UKZN
name: Pragashnie Govender
role: STUDY_CHAIR
affiliation: UKZN
name: Thayananthee Nadasan
role: STUDY_DIRECTOR
affiliation: UKZN
name: Michael O Olagbegi
role: STUDY_DIRECTOR
References:
Clinical trial NCT05347615: Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology
Official title: The Implantation Of Monofocal And Premium IOL Models - A Registry Study At The Kepler University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male and female patients with senile cataract undergoing surgery

Brief summary: Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a monofocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this "mix-and-match" is well established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens cohort and evaluate visual acuity and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patient age between 21-99 years
* signed consent form
* senile cataract LOCS III grading
* Cataract surgery with monofocal or premium lens implantation

Exclusion Criteria:

* missing signed consent form
* macular pathologies
* corneal pathologies
* irregular astigmatism
* pregnancy

Primary outcomes:
measure: uncorrected distance visual acuity
timeFrame: 24 months
measure: uncorrected intermediate distance visual acuity
timeFrame: 24 months
measure: uncorrected near visual acuity
timeFrame: 24 months
Secondary outcomes:
measure: Dysphotopsia
timeFrame: 24 months
measure: PRISQ-Questionnaire
timeFrame: 24 months
measure: Patient Satisfaction
timeFrame: 24 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Johannes Kepler University
Study officials:
References:
Clinical trial NCT04724915: Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
Official title: Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
Primary purpose: TREATMENT

Brief summary: The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.


Eligibility criteria: Inclusion Criteria:

* End stage osteoarthritis of the knee joint with failed conservative treatment

Exclusion Criteria:

* Previous ligament trauma of the MCL/LCL
* Previous fracture of femur or tibia
* Fixed flexion contracture \> 10°
* Flexion \< 110°
* Coronal deformity \> 15°
* Previous infection of the knee joint
* Ligament insufficiency
* Neurologic conditions

Primary outcomes:
measure: Knee Laxity
timeFrame: Preoperative and postoperatively at 1 year.
Secondary outcomes:
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Alignment
timeFrame: Preoperative and postoperatively at 6 weeks and 6 months.
measure: Knee laxity anteroposterior
timeFrame: Preoperative and postoperatively at 1 year.
measure: Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
timeFrame: Postoperatively at 1 year.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: UZ Ghent
name: Jan Victor, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03677115: Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine
Official title: Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Thoracic Paravertebral Blocks
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single-dose thoracic paravertebral analgesia for postoperative pain control after thoracoscopic lobectomy
Primary purpose: TREATMENT

Brief summary: The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration.

Detailed description: The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration. The effects of dexmedetomidine have only been compared at lower doses. This trial examined the effect of greater dose of dexmedetomidine on thoracic paravertebral block analgesia duration.

Eligibility criteria: Inclusion Criteria:

* Patients were included in the study if they were ethnic Chinese,
* American Society of Anesthesiologists (ASA) physical status I or II,
* candidates for general anesthesia undergoing thoracic surgery

Exclusion Criteria:

* Patients were excluded if they do not want to cooperate with the test,
* had a history of radial artery puncture or coronary artery bypass grafting,
* had acute vessel trauma,or had been diagnosed with Raynaud' disease,
* had suffered from mental or neurological disorders

Primary outcomes:
measure: Change of analgesia duration
timeFrame: Change from Baseline to 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References: