louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04209907: the Effect of Retrolaminar Block on Postoperative Pain
Official title: the Effect of Retrolaminar Block on Post Operative Analgesia After Lumbar Vertebra Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In recent years, as a part of multimodal analgesia, paravertebral blocks are replacing epidural analgesia due to the less side effects. Although the risk of pneumothorax is the most feared complication in paravertebral blocks, retrolaminar block (RLB) -which is a paravertebral block- significantly reduces this risk due to the anatomical technique of procedure. The investigators aim to investigate the effect of retrolaminar block with ultrasound- guided on perioperative analgesia for patients undergoing lumbar vertebra surgery.

Detailed description: Retrolaminar block will applie before general anesthesia induction when patients will be awake and under midazolam (0.03 mg/kg) sedation and standardized monitoring at the preoperative block area in sitting position using in-plane approach. After sterilising the skin, the investigators will perform block by using 7-18 MHz convex ultrasound probe ( Esaote My Lab 6 US Machine, Florance, Italy) and a 22-gauge, 100-mm Stimuplex needle (B. Braun, Germany). The investigators will pass in a sagittal plane from medial to lateral at the mid-lomber level, and identified the hyperechoic laminae, transverse processes, ribs and pleura.

The L3 laminae will be identified approximately lateral of the spinous process. The needle will insert in-plane, cephalad to caudad. After lamina contact and negative aspiration, 20 ml bupivacaine 0.25% will be injected at low pressure with intermittent negative aspiration on each side and spread of local anesthetic between laminae and paraspinous muscles will be seen without pain or paresthesia. Then 30 minutes later, the patient will be taken to the operating room.

After general anesthesia prosedure, the patients will evaluate whether they have pain throughout 24 hours after the operation. The pain scores will be evaluated with visuel analogue scale.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old
2. ASA 1, 2, 3 patients
3. undergoing lumvar vertyebra surgery

Exclusion Criteria:

1. pregnant woman
2. child
3. patint wiht cognitive disfunction

Primary outcomes:
measure: change of pain throughout postoperative 24 hours
timeFrame: change in postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale Univercity Faculty of Medicine Hospital
Study officials:
affiliation: Kırıkkale University Faculty of Medicine
name: Kevser Peker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825407: Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity
Official title: Creation et Characterization of Two Groups of Elderly Subjects so as to Evaluate the Link Between the Characteristics of Oral Physiology, Sensory Sensitivity, the Release in Vivo Aromatic Compounds, and In-mouth Comfort During the Consumption of Foods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensitivity
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 260
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: There are few data on elderly people concerning mechanisms involved in the in vivo release and perception of aromatic compounds. Any knowledge on this point would be of great interest to the scientific community. Concerning the dimensions of sensory perception and in-mouth comfort, there is, to our knowledge, no methodology to describe them. These dimensions are truly original and innovative, and investigating them will lead to the development of foods adapted to elderly populations with chewing and salivation disorders.

The expected results are:

* to obtain two groups of subjects with differences in chewing abilities and saliva production
* the characterization of flavour release profiles in elderly subjects with regard to oral physiology (mastication and salivation) and saliva composition
* a sensory profile describing in-mouth comfort when food is eaten


Eligibility criteria: Inclusion Criteria:

* Persons who have provided written consent
* Age \>= 65 years
* Persons living at home or in an old-people's home (Etablissement Hébergement Personnes Agées Dépendantes : EHPAD)
* Persons able to move around independently

Exclusion Criteria:

* Persons without national health insurance cover
* Persons in hospital
* Persons whose MMSE (Mini-Mental State Examination) is \< 24
* Persons requiring enteral or parenteral feeding
* Persons who in the last 12 months have received € 4500 by participating in clinical studies, including the present study
* Persons in a period of exclusion following a previous study
* Food allergies
* Adults under guardianship

Primary outcomes:
measure: Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index
timeFrame: At inclusion
Secondary outcomes:
measure: Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI)
timeFrame: At inclusion
Other outcomes:
measure: Measure of salivary flows in the rest and in stimulation
timeFrame: Day 0 and month 9
measure: Measure of strength of compression between the tongue and palate with the IOPI system
timeFrame: month 9
measure: Volume of the oral cavity by acoustic reflectometry by means of a rhynopharyngometer
timeFrame: month 9
Locations:
city: Dijon
country: France
facility: Hôpital Champmaillot Geriatric Department
Study officials:
References:
Clinical trial NCT06237907: Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Official title: The Role of Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients as experimental group who has lymphedema and need to underwent surgery. Patients as control group who require surgery without lymphedema. Written informed consent was obtained from all patients.

Brief summary: The project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.

Detailed description: This project aims to investigate the expression of cell death through apoptosis and iron-dependent cell death in the subcutaneous adipose tissue of patients with lymphedema. The study also seeks to explore the roles of these processes among lymphatic endothelial cells, adipocytes, and macrophages, and their association with lymphedema, thus gaining insights into the pathophysiological mechanisms of lymphedema. Furthermore, the project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.

Eligibility criteria: Inclusion Criteria:

* Control Group: Patients who have not experienced lymphedema but require surgery due to other diseases such as cancer, trauma, chronic wounds, skin defects, etc.
* Experimental Group: Patients who have lymphedema and undergone lymphedema surgery.

Exclusion Criteria:

* 1. Individuals with venous thrombosis, chronic heart failure, and renal failure.
* 2. Vulnerable populations, individuals with limited mobility, pregnant women, and minors.
* 3. Those expected to be unable to attend follow-up visits or complete the study smoothly.
* 4. Participants who express doubts about the trial and cannot provide satisfactory answers.

Primary outcomes:
measure: The correlation between post-LVA volume reduction
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT04415307: The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department
Official title: The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dizziness
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed in patients with persistent dizziness as the chief complaint that is treated with acupuncture or/and far-infrared heat-patch attachment intervention over the acupoints for the purpose of dizziness symptoms treatment. The research hypothesis is that the treatment over acupoints in traditional Chinese medicine is effective in treating symptoms of dizziness.


Eligibility criteria: Inclusion Criteria:

1. Patients with age between 20 to 80-year-old who can cooperate to the whole treatment, testing and questionnaire.
2. The chief complaint is dizziness which diagnosed by the doctor in charge of the emergency department, in together to exclude the patients with severe unstable vital signs, and then consult for help with Chinese medicine.
3. Sign the clinical trial agreement sheet.

Exclusion Criteria:

1. Inacceptable to the research content
2. Unable to complete the study process
3. Unwilling to cooperate with acupuncture and other treatments
4. Abnormal blood clotting profile
5. With wound or allergy over the treated acupoint
6. Unstable vital sign
7. Post major trauma

Primary outcomes:
measure: Visual Analog Scale (VAS) of dizziness
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03602807: Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients.
Official title: Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients - a Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplant Dysfunction
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total.

The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA.

The safety of ESWT on the renal allograft will be assessed during and after treatments.


Eligibility criteria: Inclusion Criteria:

* Minimum 1 year ago since last kidney transplant
* P-Creatinin under 300, in the last 3 blood-samples
* U-Albumine/creatinine ratio over 100, in the last 3 urine-samples

Exclusion Criteria:

* Not Danish speaking.
* Obstructive uropathy
* Suspected autoimmune disease in the kidney graft
* Symptomatic urinal tract infection (UTI)
* Severe psychiatric disorder
* Pregnant or planning on becoming pregnant

Primary outcomes:
measure: Change in renal clearance (GFR)
timeFrame: At baseline and 3 months after treatment
Secondary outcomes:
measure: Change in albumin/creatine ratio in 24hour urine sample
timeFrame: At baseline, 1 month after treatment and 3 months after treatment
measure: Incidens of treatment-related adverse events
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Of Southern Denmark
Study officials:
References:
citation: Klomjit N, Lerman A, Lerman LO. It Comes As a Shock: Kidney Repair Using Shockwave Therapy. Hypertension. 2020 Dec;76(6):1696-1703. doi: 10.1161/HYPERTENSIONAHA.120.14595. Epub 2020 Nov 2.
Clinical trial NCT00616707: Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds
Official title: Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Keywords: Inflammation
Oxidative Stress
Microalbuminuria
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Children's Miracle Network
First posted: 2008-02-15
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric out-patient at UCDavis Medical Center clinic

Brief summary: The purpose of this study is to determine if there are signs of inflammation in one's blood and urine and to find out if one's body size or ethnicity has an effect on these substances.


Eligibility criteria: Inclusion Criteria:

* Adolescents between 12 to 18 years old
* Hispanic, African American or Caucasian ethnicity
* Have a Body Mass Index (BMI) between the 5th and 85th percentile or greater than the 95th percentile
* Must currently be attending a UC Davis Pediatric clinic

Exclusion Criteria:

* Chronic liver or kidney disease, known Diabetes or other chronic illnesses (such as Sickle Cell Disease or Cystic Fibrosis)
* Subjects can NOT be acutely febrile, smoke, chronically use prescription medications or oral contraceptive pills.

Primary outcomes:
measure: To compare plasma levels of inflammatory markers and urinary biomarkers of oxidative stress in adolescents of Hispanic, African-American and Caucasian ethnicity
timeFrame: at the end of study
Secondary outcomes:
measure: To determine if there is an independent correlation between these markers and urinary microalbumin excretion
timeFrame: at the end of study
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Lavjay Butani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745407: Effects of Fenofibrate on Adipocytokine Levels In Hypertriglyceridemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia
Keywords: adipocytokines
insulin sensitivity
hypertriglyceridemic patients
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2008-09-03
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Fenofibrate increases adiponectin levels, but reduces leptin levels


Eligibility criteria: Inclusion Criteria:

* hypertriglyceridemia

Exclusion Criteria:

* chronic liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
Clinical trial NCT05368207: Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient
Official title: Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Small Cell Carcinoma, Hypercalcaemic Type
Ovarian Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It is an open-label single patient Clinical Trial to be conducted at Princess Margaret Cancer Centre for a patient with Small Cell Carcinoma of Ovary - Hypercalcemic Type (SCCOHT) who has rare and aggressive malignancy with no current consensus on treatment approach and surveillance.
Primary purpose: TREATMENT

Brief summary: This is a study of pembrolizumab as consolidation therapy for a patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).

Detailed description: It is an open-label single patient Clinical Trial to be conducted at Princess Margaret Cancer Centre for a patient with Small Cell Carcinoma of Ovary - Hypercalcemic Type (SCCOHT) who has rare and aggressive malignancy with no current consensus on treatment approach and surveillance.

Eligibility criteria: Inclusion Criteria:

* Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: overall performance status
timeFrame: 2 years
measure: Objective evidence of response to treatment
timeFrame: 2 years
measure: Exploratory Endpoint
timeFrame: 2 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02452307: Peptide-specific Vaccination in HLA-A*02 Positive Patients With Biochemical Recurrence After Radical Prostatectomy
Official title: Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Recurrent Prostate Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 36
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the prostate-specific antigen (PSA) response in HLA-A\*02 positive patients with biochemical recurrence after radical prostatectomy treated with a prostate-specific peptide vaccine in combination with different immune-adjuvants.

Detailed description: Patients with a biochemical recurrence after initial therapy can be included.

Eligibility criteria: Inclusion Criteria:

* biochemical recurrence after Radical Prostatectomy
* no clinical metastases in CT or bone scan
* HLA-Type: HLA-A\*02 positive
* Karnofsky-Performance-Index \>70
* Age \>45 / \<80 years
* no prior or ongoing hormonal therapy
* no ongoing radiation therapy
* Serum-Creatinine \<2mg/dl; Bilirubin: \<2gm/dl
* no history of allergy or chronic obstructive lung disease (COLD)

Exclusion Criteria:

* Patients unable to consent
* Karnofsky-Performance-Index \<70
* known allergy or COLD
* presence of secondary malignancy
* prior or ongoing hormonal treatment
* ongoing radiotherapy
* immunosuppressive medication
* seizure

Primary outcomes:
measure: Change from Baseline in Immune Response at day 70
timeFrame: Days 0-70
Secondary outcomes:
measure: Tolerability
timeFrame: Days 0-420
measure: Treatment response
timeFrame: Months 0-60
Other outcomes:
Locations:
Study officials:
affiliation: Department of Urology, University of Tuebingen
name: Arnulf Stenzl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04674007: The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics
Official title: The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Landing Biomechanics
Fatigue
Keywords: landing
biomechanics
fatigue
dual task
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 16
Sex: MALE
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volleyball, basketball and handball players

Brief summary: In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

Detailed description: In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

Eligibility criteria: Inclusion Criteria:

* volleyball, basketball of handball players
* male

Exclusion Criteria:

* history or surgery of the lower extremities
* history of fractures of the lower extremities

Primary outcomes:
measure: Joint angles lower extremity
timeFrame: The same day/test moment, immediately after fatiguing exercises
measure: Joint moments lower extremity
timeFrame: The same day/test moment, immediately after fatiguing exercises
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Roel De Ridder
state: East Flanders
Study officials:
References: