louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00860704: Goal Directed Fluid Therapy
Official title: Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Goal Directed Fluid Therapy
Keywords: goal directed fluid therapy
lean patients
obese patients
crystalloids
Esophageal Doppler
tissue oxygenation
Fluid management during surgery
Fluid management
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.

Detailed description: To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI \<25) vs. obese patients (BMI \>25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.

Eligibility criteria: Inclusion Criteria:

* female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)

Exclusion Criteria:

* cardiac insufficiency (EF\< 35%)
* renal insufficiency (creatinin clearance \<30ml/min, dialysis)
* insulin dependant diabetes mellitus
* coagulopathy
* NYHA IV
* infection
* sepsis
* history of suspect malignant hyperthermia
* porphyria

Primary outcomes:
measure: different hemodynamic fluid responses in the different groups
timeFrame: every 10 minutes during surgery
Secondary outcomes:
measure: Subcutaneous oxygen tension (PsqO2)
timeFrame: every 10 minutes during surgery and 2 hours postoperatively
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine
name: Andrea Holzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
Clinical trial NCT00187304: ACTION - Anticoagulation Treatment Influence on Post-operative Patients
Official title: Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heart Valve Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).


Eligibility criteria: Inclusion Criteria:

1. Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
2. Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
3. Patient is of legal age in the host country
4. The patient is in sinus rhythm before implantation

Exclusion Criteria:

1. Patient already has a prosthetic valve, other than the valve being replaced at this time.
2. Patient requires double valve implantation
3. Patient requires concomitant CABG
4. Patients requires intra aortic balloon pump at intervention
5. Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
6. Patient requires ASA or AVK therapy, i.e. not suitable for randomization
7. Patient is pregnant or nursing.
8. Patient is affected by active endocarditis.
9. Patient is affected by aortic dissection.
10. Patient has history of cerebral ischemia
11. Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
12. Patient is affected by peripheral vascular disease requiring treatment
13. Patient has previous chronic anticoagulation therapy
14. Patient is allergic to ASA and/or AVK

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Pontchaillou Rennes France
name: Jean-Phillippe Verhoye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01549704: Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty
Official title: Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain After Total Knee Arthroplasty
Keywords: Total knee arthroplasty
Adductor canal blockade (ACB)
High pain responders
US-guided nerve block
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS \> 60 during knee flexion the 1. or 2. day after surgery.

Detailed description: The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS \> 60 during active 45 degrees knee flexion will be asked to participate.

Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.

Eligibility criteria: Inclusion Criteria:

* TKA within 48 hours and VAS\>60 during active 45 degrees knee flexion despite conventional pain medication.
* Informed consent
* ASA 1-3
* BMI 18-40

Exclusion Criteria:

* Unable to communicate in Danish
* Allergic reactions toward drugs used in the
* Abuse of alcohol/drugs
* Unable to cooperate

Primary outcomes:
measure: Difference in VAS between ACB and placebo during active 45 degrees knee flexion
timeFrame: 45 minutes
Secondary outcomes:
measure: Difference in mean VAS between the groups during active knee flexion
timeFrame: 15, 30, 60, 75 and 90 minutes
measure: Difference in mean VAS between the groups at rest
timeFrame: 15, 30, 60, 75 and 90 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Ulrik Grevstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.
Clinical trial NCT04755504: The Development of an Algorithm to Detect Sleep Structure With a Wearable EEG Monitor in an Elderly Population
Official title: The Development of an Algorithm to Detect Sleep Structure With a Wearable EEG Monitor in an Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will be evaluated with routine polysomnography and additionally 2 EEG signals will be recorded behind each air.
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate whether it is able to perform sleep staging with EEG data recorded from 2 electrodes behind each ear.

Detailed description: The Sensor Dot wearable device measures electroencephalography (EEG). It records from 2 electrodes behind each ear. The device was designed as a wearable for seizure detection in epilepsy patients. The purpose of this study is to test its ability to capture the information necessary for sleep monitoring in elderly patients. Trained electrophysiologists are unable to stage sleep on data from novel wearable devices, since AASM sleep scoring rules are only defined for standardized recording positions on the head. Therefore, we need an automated algorithm to perform sleep staging with data from the Sensor Dot device. We will train this algorithm using manual annotations made with the polysomnography simultaneously acquired with the wearable EEG.

Eligibility criteria: Inclusion Criteria:

* Subjects planned to undergo a diagnostic polysomnography
* \> 60y old

Exclusion Criteria:

* Patients unable to provide informed consent

Primary outcomes:
measure: Sleep algorithm
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT06571604: Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
Official title: Preoperative Gluteal Muscle Atrophy: A Silent Predictor of THA Dislocation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dislocation
Total Hip Arthroplasty
Muscle Degeneration
Keywords: Total Hip Arthroplasty
Muscle Fatty Degeneration
CT
Gluteal Muscles
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients following THA at Nimes university hospital

Brief summary: This study looks at how fat buildup in hip muscles relates to hip osteoarthritis and less favorable recovery after hip replacement surgery. While it is known that weak gluteal muscles might cause problems, it is not yet proven if this specifically leads to hip dislocation after surgery. The goal of this study is to compare fat buildup in gluteal muscles between patients who had a hip dislocation soon after surgery and those who did not.


Eligibility criteria: Inclusion Criteria:

* primary THA with preoperative CT-scan

Exclusion Criteria:

* malposition of acetabular implants outside the Lewinneck safe zone,
* neurological or cognitive disorders,
* associated spinal pathologies (within the context of a hip-spine syndrome),
* chronic alcoholism,
* aseptic osteonecrosis,
* revision surgeries,
* late dislocations attributed to polyethylene wear,
* replacement following post-traumatic coxarthrosis due to acetabulum injuries.
* diameters of the prosthetic heads ≠ 32mm

Primary outcomes:
measure: Mean Attenuation Ratio
timeFrame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Secondary outcomes:
measure: Cross-Sectional Area
timeFrame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
measure: Intramuscular Fatty Fraction
timeFrame: The CT scan of the pelvis used to plan the operation is performed between one and two months before the surgery.
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nîmes
state: Gard
Study officials:
References:
Clinical trial NCT05360004: The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in HK to Prevent COVID-19
Official title: The Use of Chinese Herbal Medicine and Vitamin C by Hospital Care Workers in Hong Kong Mobile Cabin Hospital to Prevent COVID-19 Transmission: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: Chinese herbal medicine
Prevention
Health Care Worker
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-labelled, controlled trial
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized controlled trial study to explore whether the combination of Chinese herbal medicine and Vitamin C is effective and safe to prevent COVID-19 transmission among health care workers in Hong Kong Mobile Cabin Hospital governed by the Hong Kong Hospital Authority who have been caring for patients with COVID-19. A total of 652 adults will be enrolled. Eligible subjects who provide written informed consent will be assessed for inclusion/exclusion criteria.

All participants are asymptomatic and test negative for SARS-CoV-2 at the study's commencement. Subjects with major medical illness, renal insufficiency and hypersensitivity to Chinese herbal medicine will be excluded. All participants will receive Vitamin C (VC) supplementation and 28 packets of the herbal medicine free of charge and are advised to consume daily for 14 days. After written informed consent, the subjects will be included and randomly allocated to either CHM+VC group or VC treatment.


Eligibility criteria: Inclusion Criteria:

1. Health care workers in Hong Kong Mobile Cabin Hospital;
2. Asymptomatic and test negative for SARS-CoV-2;
3. Aged ≥18;
4. Voluntarily signing a written informed consent form;

Exclusion Criteria:

1. With major medical illness or renal insufficiency;
2. With hypersensitivity to Chinese herbal medicine;
3. Pregnancy or lactation.

Primary outcomes:
measure: Proportion of subjects who become SARS-CoV-2 positive
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of days of confirmed SARS-CoV-2 infection
timeFrame: 4 weeks
measure: Duration of COVID-19-related symptoms in confirmed SARS-CoV-2 infection cases
timeFrame: 4 weeks
measure: Safety endpoint
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02675504: Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years
Official title: Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fear
Keywords: scary scale
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 544
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participating in the study of children aged 4 to 12 years. In this study, participation of school children and hospitalized children

Brief summary: Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.


Eligibility criteria: Inclusion Criteria:

* Children aged 4 to 12 years.
* Enrolled in one of the participating institutions in the study (steps 1-5) or consultant pediatric emergencies at the Children of Limoges (step 6).
* Authorization of at least one person having parental authority for the child to participate in the study.
* Children affiliates or benefiting from a social security

Exclusion Criteria:

* Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions.
* Children in vital emergency

Primary outcomes:
measure: Percentage of children who validate the 6 faces expressing fear.
timeFrame: 5 minutes
Secondary outcomes:
measure: Percentage of children who properly fit the faces expressing fear in ascending and descending order.
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges hospital
Study officials:
References:
citation: Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.
Clinical trial NCT03896204: Effect of Telephone-supported Joint Protection Technique Training
Official title: Effect of Telephone-supported Joint Protection Technique Training on Pain and Functionality in Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Woman
Epicondylitis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.

Detailed description: There is limited evidence of the efficacy of joint protection principles in individuals diagnosed with lateral epicondylitis in the literature. The aim of this study was to investigate the effect of training of the telephone supported joint protection technique education on pain and upper extremity function in individuals with lateral epicondylitis. New information will be obtained according to the results.

Eligibility criteria: * unilateral lateral epicondylitis diagnosis
* Individuals between 18-40

Exclusion Criteria:

-individuals with a history of surgery

Primary outcomes:
measure: hand grip strength
timeFrame: first month
measure: pain and function
timeFrame: first month
measure: function
timeFrame: first month
measure: beahviour
timeFrame: first month
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Özgü İnal
Study officials:
affiliation: Trakya University
name: Özgü İnal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00936104: Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)
Official title: Prognostic and Therapeutic Relevance of the 'Side Population' in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm
Pancreas
Keywords: pancreas
cancer
stem cell
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SP cells will be identified through incubation with vital dye Hoechst 33342 of cell suspensions that are obtained from fresh human pancreatic cancer resection specimens.

Brief summary: In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results.


Eligibility criteria: Inclusion Criteria:

* Resected pancreatic ductal adenocarcinoma (PDAC)
* Informed consent

Exclusion Criteria:

* Age \< 18years
* Pregnancy
* Pre-operative radiotherapy
* Pre-operative chemotherapy
* IPMT

Primary outcomes:
measure: Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
Study officials:
References:
citation: Van den Broeck A, Gremeaux L, Topal B, Vankelecom H. Human pancreatic adenocarcinoma contains a side population resistant to gemcitabine. BMC Cancer. 2012 Aug 15;12:354. doi: 10.1186/1471-2407-12-354.