louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04755712: Comparison of Two Analgesic Strategies After Scheduled Caesarean
Official title: Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.

Detailed description: Interventional, comparative, randomized, controlled study versus reference therapeutic strategy, in 2 parallel groups, double-blind (patient and evaluator), single-center, aiming to demonstrate the superiority of ropivacaine in square lumbar block versus intrathecal morphine, on the efficacy of post-operative analgesia, following a scheduled caesarean.

Eligibility criteria: Inclusion Criteria:

* Patient to undergo a scheduled caesarean under spinal anesthesia, for the birth of a term baby with a Pfannenstiel-type incision;
* Patient in good health ;
* Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.

Exclusion Criteria:

* Pregnancy less than 37 weeks with amenorrhea;
* Multiple pregnancy;
* Fetal pathology known at the time of inclusion;
* Body mass index\> 45 kg / m²;
* History of scoliosis or spine surgery;
* History of chronic pain associated with taking opiates, neuropathic pain, neurological pathology;
* Preoperative anemia (blood hemoglobin \<9 g / dL);
* Hypersensitivity to ropivacaine or other local anesthetics with amide bond;
* Hypersensitivity to morphine or opioids;

Primary outcomes:
measure: Cumulative quantity of morphine received postoperatively via pump
timeFrame: 1 day
Secondary outcomes:
measure: Characteristics of postoperative pain using a visual analogic scale
timeFrame: 2 days
measure: Side effects of the two analgesic strategies
timeFrame: 2 days
measure: Cumulative quantity of morphine received postoperatively via pump
timeFrame: 2 days
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: MAUPAIN
Study officials:
References:
Clinical trial NCT03954912: Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty
Official title: Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Arthropathy of Knee
Keywords: MAKO
NAVIO
robotic surgery
UKA
surgical time
KSS
KFS
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Bhumibol Adulyadej Hospital
First posted: 2019-05-17
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective cohort study
Primary purpose: TREATMENT

Brief summary: This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty

Detailed description: this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

* patients were those deemed suitable for unicondylar knee arthroplasty surgery
* patients who could give informed consent
* patients who willing to attend the prescribed follow-up.

Exclusion Criteria:

* Patients who have medial osteoarthritis knee with following condition:

  1. Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).
  2. Inflammatory arthritis
  3. A deformity requiring augmentation
  4. Neurological movement disorders
  5. pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations
* Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.

Primary outcomes:
measure: operative time
timeFrame: 1 day
measure: calculated total blood loss
timeFrame: 1 day
Secondary outcomes:
measure: post operative complications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Leelasestaporn C, Tarnpichprasert T, Arirachakaran A, Kongtharvonskul J. Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Knee Surg Relat Res. 2020 Mar 12;32(1):13. doi: 10.1186/s43019-020-00030-x.
Clinical trial NCT04792112: Navigating the Grey Zone for Antenatal Corticosteroids
Official title: Improving Clinical Practice Guidelines for Antenatal Corticosteroids: Incorporating a Decision Support Tool to Tackle the Uncertain Balance of Harms and Benefits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decision Making, Shared
Pregnancy
Preterm Birth
Keywords: Antenatal corticosteroid
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-03-10
Enrollment: 460
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled before and after study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to find out if including a decision support tool in clinical practice guidelines will improve how doctors discuss the option of antenatal corticosteroid treatment with patients who might deliver at 34 to 36 weeks of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Age 18 year or older.
* Delivered a live neonate at 34+0 to 36+6 weeks of gestation.
* Speaks English.
* Agrees to participate in the questionnaire during their first week post-partum.
* Delivered at one of the six participating obstetrical hospitals.

Exclusion Criteria:

* None.

Primary outcomes:
measure: The change in frequency of clinical counselling about late preterm antenatal corticosteroids.
timeFrame: up to 8 months following implementation of the intervention.
Secondary outcomes:
measure: The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.
timeFrame: up to 8 months following implementation of the intervention.
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jessica Liauw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088212: Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor
Official title: Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor: the Cog-HF Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Cognitive Impairment
Dementia
Left Ventricular Dysfunction
Cognitive Change
Cognitive Decline
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.


Eligibility criteria: Inclusion Criteria:

1. Hospitalised with HF as primary or secondary diagnosis.
2. At least mild cognitive impairment (CI) based on Montreal Cognitive Assessment (MoCA) on hospital discharge.

Exclusion Criteria:

1. Unable to provide written consent; requiring palliative care; or participating in another RCT
2. Recovery of cognitive function shortly after hospital discharge: to ensure that we only include patients with "true" CI, any patients with a repeated MoCA\>25 at 2 weeks post-discharge will be excluded.
3. Terminal illness (eg. cancer) that may influence 12-month prognosis.

Primary outcomes:
measure: Change in MOCA score
timeFrame: 12 months
Secondary outcomes:
measure: Change in cardiac function
timeFrame: 12 months
measure: Change in 6-minute walk distance
timeFrame: 12 and 24 months
measure: Change in quality of life
timeFrame: 12 and 24 months
measure: Change in MOCA score
timeFrame: 24 months
measure: Change in brain volume via MRI measurement
timeFrame: 24 months
measure: Change in hand grip strength
timeFrame: 12 and 24 months
measure: Change in heart failure classification
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: Menzies Institute for Medical Research
state: Tasmania
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Thomas H Marwick, MBBS PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06452212: Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients
Official title: A Non-Interventional, Modified Delphi Study to Establish Consensus Recommendations on the Optimal Management of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Hormone-Sensitive Prostate Cancer
Keywords: mHSPC
Urological cancers
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target recruitment of 25 urologists will be recruited with an acceptable goal of 20 as panelists from university hospitals in South Korea.

Brief summary: The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making. There are no secondary objectives for this study.

Detailed description: Data collection for this study will be conducted through 2 rounds of web-based surveys of health care professionals (HCPs). A meeting with the panelists will be held as a 3rd round if a consensus for pre determined key questions is not achieved after the 2 rounds of the survey.

Eligibility criteria: Inclusion Criteria:

* Urologist from university hospitals in South Korea.
* Has a minimum 10 years of practice experience (experience as a military or public health doctor could be considered practice experience)
* Sees a minimum of 50 mHSPC patients in a year.
* At least 10 publications in SCIE (Science Citation Index Expanded) journals in the past 5 years.

Exclusion Criteria:

* Urologist in private practice.

Primary outcomes:
measure: Treatment plans for patients with mHSPC
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KR82001
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04929912: Electroporation for Cancer Treatment Real World Registry
Official title: Electroporation for Cancer Treatment Real World Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Cancer
Gastrointestinal Cancer
Keywords: Pulsed Electric Fields
Reversible Electroporation
Electrochemotherapy
Ca-Electroporation
Lead sponsor: Mirai Medical
Sponsor class: INDUSTRY
First posted: 2021-06-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a single arm, observational medical device registry designed to establish the efficacy and safety of treating solid tumours with reversible electroporation. ePORE, CUTIS and EndoVE are CE marked and are currently being used in the treatment of patients with solid tumours. This medical device registry will enable the collection of anonymised data which will enable the analysis and publication of high quality data to continuously support the efficacy and safety of these devices.

Brief summary: This registry aims to assess real-world long-term disease outcomes for patients treated using reversible electroporation and a chemotherapeutic or calcium; in particular tumour response rates and recurrence rates. The study also aims to characterise side effects and the occurrence of Adverse Events and their relationship to the treatment.


Eligibility criteria: Inclusion Criteria:

* Any patient who has been treated using Calcium Electroporation
* Any patient who has been treated using Electrochemotherapy
* Patients must be mentally capable of understanding the information given
* Patients must give written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (CTCAE)
timeFrame: 5 years
Secondary outcomes:
measure: Response Evaluation Criteria in Solid Tumours (RECIST)
timeFrame: 3 months, 12 months, 3 years, 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Mirai Medical
name: SEAN H Kinsella
role: STUDY_DIRECTOR
References:
Clinical trial NCT01035112: Magnetic Resonance Imaging of Breast Cancer
Official title: Magnetic Resonance Imaging of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Non-invasive Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-12-18
Enrollment: 445
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.


Eligibility criteria: INCLUSION CRITERIA

* Female
* Documented breast physical examination,
* Documented mammography within 3 months of the MR studies
* Palpable or mammographically-detected suspect breast lesions
* Women who have already undergone lumpectomy for breast cancer and have post-biopsy/post-radiation changes will be eligible if they have mammographically-detected or palpable breast abnormalities which are sufficiently suspicious to merit core needle or surgical biopsy.

EXCLUSION CRITERIA:

* Male by birth
* Able to complete the MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to
* MR contraindications including
* Pacemakers
* Metallic implants
* Severe claustrophobia
* Aneurysm clips
* Pregnancy
* Current lactation
* Other conditions precluding proximity to a strong magnetic field.
* Received an enhanced MR procedure within 48 hours,
* Iodinated contrast within six hours,
* Known sensitivity to MR contrast agents,
* Not likely to complete the study in full or
* Other clinical reason which would preclude participation in the protocol.

Primary outcomes:
measure: To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.
timeFrame: Length of one MRI scan
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Bruce L Daniel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03676712: The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
Official title: The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Scoliosis Idiopathic
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 17
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial


Eligibility criteria: Inclusion Criteria:

* who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray

Exclusion Criteria:

* Patients who underwent spinal surgery
* Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities
* Patients observed with Cobb's angle less than 20 degrees, over 45 degrees
* Patients complaining of acute low back pain
* Patients with cognitive impairment, severe mental illness, and inability to communicate

Primary outcomes:
measure: cobb angle
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT05794412: Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study
Official title: Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Influenza Viral Infections
Virus Shedding
Mucosal Immunity
RSV Infection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
name: ModernaTX, Inc.
First posted: 2023-04-03
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms:

* Cough
* Fever
* Tired
* Sore throat
* Difficulty breathing
* Respiratory distress
* Headache
* Loss (or alteration) of smell
* Loss (or alteration) of sense of taste
* Myalgias
* Chills
* Subjective fever
* Pink sputum (or coughing up blood)
* Thoracic pain
* Runny nose
* Abdominal pain
* Nausea
* Vomiting
* Diarrhea
* Constipation
* Irritated or watery eyes
* Rashes
* Other


Eligibility criteria: Inclusion Criteria:

* In general good health, as determined by study investigators
* All participants must be living in the canton of Geneva or working/studying in the canton of Geneva and living in neighboring communities that are within one hour travelling distance by car.

Exclusion Criteria:

* Inability to provide written consent.
* Severely immunocompromised subjects as determined by the study investigator
* Treated with inhaled drugs by nasal route within the last month

Primary outcomes:
measure: SARS-CoV-2 infectious viral load
timeFrame: up to 14 days post symptom onset
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University of Geneva
name: Benjamin Meyer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06495112: Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
Official title: Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ocular Surface Disease
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 69
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: "Comparison between Lathe Cut versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity" investigates the impact of two different manufacturing methods on the health and integrity of the ocular surface.

Detailed description: The study aims to determine which technique, lathe cutting or cast molding, produces soft contact lenses that are more biocompatible and less likely to cause adverse effects on the eye. The findings from our research could have significant implications for contact lens wearers and manufacturers, guiding the production of lenses that promote better ocular health and enhance wearer comfort. Ultimately, this research contributes valuable knowledge to optometry and ocular surface disease management.

Eligibility criteria: Inclusion Criteria:

* Patients who have never used contact lenses
* Age of participants would be 15 to 35 years
* Patients free of any ocular pathology

Exclusion Criteria:

* Patients having astigmatism of more than 0.75DC
* Subjects with a previous history of ocular surgery, eye pathology, or systemic disease.
* Patients with abysmal compliance.

Primary outcomes:
measure: Corneal epithelial integrity
timeFrame: 12 Months
measure: Ocular surface symptoms
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
state: Punjab
Study officials:
References: