louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436861: the Health Crisis at the Healthcare Professionals, Careers and Non-careers, a Month After the Containment Period
Official title: Demonstration of the Level of Anxiety / Depression of Healthcare Professionals and Non-healthcare Professionals One Month After the Confinement Period
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Psychology, Social
Lead sponsor: Clinique Medipole Garonne
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are not basing the study size on statistical arguments for this observational study. The study will be offered to all healthcare professionals in order to limit bias. However, we expect a minimum of 200 responses

Brief summary: The investigator wish to study, at a distance from the lifting of confinement (1 month), whether the psychological impact on professionals in nursing and non-nursing care establishments is associated with their living context (professional and personal situation) during confinement.

Detailed description: The context of confinement and of the global pandemic is a major source of stress for the entire population: separation of loved ones, loss of freedom, uncertainty about the infectious status, boredom. All of these factors can cause negative mental health consequences. Having little social contact was one of the factors increasing the negative psychological impact of confinement.

People suffering from psychological disorders are particularly vulnerable during quarantine periods. On March 17, 2020, the French government implemented national containment measures due to the Covid-19 epidemic.

Although the effects of containment have been studied for fragile populations, no study to date has focused on the specific population of healthcare facility staff. These caregivers have for the most part continued their professional activity, but they have been confronted with the fear of contracting or causing patients to contract Covid-19.

At a distance from the lifting of confinement (1 month), the investigator wish to study whether the highlighting of anxiety or depression in these healthcare professionals is associated with their context of life (professional and personal situation) during confinement

Eligibility criteria: Inclusion Criteria:

* Nursing and non-nursing care professionals

Exclusion Criteria:

* Refusal to participate
* Subject included in an interventional study

Primary outcomes:
measure: Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01442961: Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
Official title: Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: pain, postoperative
hysterectomy, vaginal
surgery, gynecological
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.


Eligibility criteria: Inclusion Criteria:

* Age 18 -69 years
* Gender . female
* ASA status 1-3
* Vaginal hysterectomy or laparoscopic hysterectomy

Exclusion Criteria:

* Body mass Index over 35
* Diabetes Mellitus
* Liver disease
* Allergies to pharmaceuticals used in the Study
* Present use of opioids
* Vaginal prolapse

Primary outcomes:
measure: Postoperative consumption of an opioid (oxycodone)
timeFrame: 20 hours
Secondary outcomes:
measure: NRS (numeral rating scale) of pain
timeFrame: 20 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
Clinical trial NCT01650961: The Effect of Palonosetron on the QTc Interval During Perioperative Period
Official title: The Effect of Palonosetron on the QTc Interval During Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Palonosetron
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Elective abdominal surgery under general anesthesia

Exclusion Criteria:

* Cardiac valvular disease
* Clinically significant arrhythmias including atrial fibrillation
* Anti-emetics within 24 hours before surgery
* Steroids within 1 week before surgery
* Cancer chemotherapy or radiotherapy within 4 weeks before surgery
* Diabetes mellitus
* Pregnancy
* Patients receives a QT-prolonging drug

Primary outcomes:
measure: corrected QT interval (QTc interval)
timeFrame: up to 90 minutes after induction of general anesthesia
Secondary outcomes:
measure: proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female
timeFrame: up to 2 hours after induction of general anesthesia
measure: corrected QT interval (QTc interval) at Postanesthetic care unit
timeFrame: up to 1 hour after arrival on postanesthetic care unit
measure: Incidence of postoperative nausea and vomiting
timeFrame: for 24 hours after surgery
measure: proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)
timeFrame: up to 2 hours after induction of general anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014 Mar;112(3):460-8. doi: 10.1093/bja/aet335. Epub 2013 Oct 14.
Clinical trial NCT00136461: A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Official title: A Randomized Phase II Trial of All-Trans Retinoic Acid and One of Two Schedules of Bryostatin 1 in Patients With Refractory Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Keywords: AML
acute myelogenous leukemia
MDS
myelodysplastic syndrome
bryostatin 1
all-trans retinoic acid
ATRA
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-08-29
Enrollment: 40
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 purpose of this study is to assess the effects of the combination of all-trans retinoic acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia and acute myelogenous leukemia.

Detailed description: All patients receive all-trans retinoic acid at a dose of 150 mg/m2/day and patients are randomized to one of two schedules of Bryostatin 1.

Arm 1: Bryostatin 1 is administered at a dose of 60 mcg/m2 as a 30 minute intravenous (IV) infusion on days 8 and 22.

Arm 2: Bryostatin 1 is administered at a dose of 40 mcg/m2 as a 72 hour IV infusion starting on days 8 and 22.

Patients are assessed for response on day +50 with a bone marrow examination and patients with either a clinical response or stable disease receive further therapy.

Bryostatin 1 pharmacokinetic samples are to be drawn on days 1, 8 and 50 of each cycle.

Eligibility criteria: Inclusion Criteria:

* Patients with AML who have failed induction chemotherapy.
* Patients with secondary AML
* Patients with AML over age 60 who are deemed not to be a candidate for chemotherapy.
* Patients with any subtype of MDS.
* Age 18 or greater.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Satisfactory liver and kidney function.
* Greater than 4 weeks from prior chemotherapy or radiation therapy.

Exclusion Criteria:

* Central nervous system abnormality.
* Uncontrolled active infection.

Primary outcomes:
measure: This study is designed to test the therapeutic effect of combining Bryostatin 1 with the known maximum tolerated dose of all-trans retinoic acid in patients with either MDS or AML.
Secondary outcomes:
measure: This study will also determine the ability of Bryostatin 1 in combination with ATRA in humans to induce differentiation of human leukemic cells and to cause changes in the levels of protein kinase C isoenzymes in these cells.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Richard M. Stone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02702661: PRCT of FICB vs LAI for Hip Arthroscopy
Official title: Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement
Keywords: Fascia Iliaca Block
Local Anaesthetic Infiltration
Hip Arthroscopy
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective randomised controlled trial involving patients undergoing hip arthroscopy. Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 years
* Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology
* Able to read, write and communicate in English

Exclusion Criteria:

* Patients who did not want to be involved in the Trial
* Unable to give informed consent
* Previous hip surgery
* Patients younger than 18 years of age
* Chronic opioids users
* Patients known to have an allergy or intolerance to local anaesthetic agents or none steroidal anti-inflammatory medications

Primary outcomes:
measure: Level of pain as assessed by Numeric Pain Score
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Frequency of morphine consumed
timeFrame: 1 and 24 hours after surgery
measure: Total dose of morphine consumed
timeFrame: 1 and 24 hours after surgery
measure: Total dose of codeine consumed
timeFrame: 1 and 24 hours after surgery
measure: Nausea and Vomiting
timeFrame: 1 and 24 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Vikas Khanduja, MA, FRCS (Orth)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05693961: An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter
Official title: An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Oxygen Saturation
Lead sponsor: Sky Labs
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 20-50 years2
* COHb \< 3 %
* MetHb \< 2 %
* ctHb \> 10 g/dl
* Non-smoker
* An individual deemed fit by the investigators to be included in the clinical trial

Exclusion Criteria:

* History of respiratory disease
* History of cardiovascular disease
* Smoker
* Pregnant
* History of fainting
* History of diabetes
* Obesity (defined as BMI \> 30 kg/m2)
* Allen's test positive (poor collateral blood supply of hand)
* An individual who is judged to be difficult for the collection of normal PPG signals because CART-I is loose when being worn on fingers other than the thumb and little finger

Primary outcomes:
measure: Accuracy of SpO2
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Sky Labs
state: Pangyo
Study officials:
affiliation: Asan Medical Center
name: Byung-Moon Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luks AM, Swenson ER. Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance. Ann Am Thorac Soc. 2020 Sep;17(9):1040-1046. doi: 10.1513/AnnalsATS.202005-418FR.
citation: Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
citation: Andres-Blanco AM, Alvarez D, Crespo A, Arroyo CA, Cerezo-Hernandez A, Gutierrez-Tobal GC, Hornero R, Del Campo F. Assessment of automated analysis of portable oximetry as a screening test for moderate-to-severe sleep apnea in patients with chronic obstructive pulmonary disease. PLoS One. 2017 Nov 27;12(11):e0188094. doi: 10.1371/journal.pone.0188094. eCollection 2017.
citation: Shiao SY, Ou CN. Validation of oxygen saturation monitoring in neonates. Am J Crit Care. 2007 Mar;16(2):168-78.
Clinical trial NCT04105361: Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study
Official title: Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis :A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Polyps
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 20
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: The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis

Detailed description: Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate

Eligibility criteria: Inclusion Criteria:

* all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis

Exclusion Criteria:

* refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome

Primary outcomes:
measure: Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mengeling WL. Anamnestic immune response of pigs to pseudorabies virus: latent virus reactivation versus direct oronasal and parenteral exposure to virus. J Vet Diagn Invest. 1991 Apr;3(2):133-6. doi: 10.1177/104063879100300205.
Clinical trial NCT05660161: This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions
Official title: A Pilot Study to Evaluate the Functional Outcome of Nanofractures for the Treatment of Cartilage Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cartilage Damage
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Articular cartilage lesions, with their inherent limited healing potential, remain a challenging problem for orthopaedic surgeons. Various techniques, both palliative and reparative, have been used to treat this injury with variable success rates. If not adequately treated, they may even lead to the development of early-onset osteoarthritis. Among all the available techniques, microfractures are used in restoring the cartilage tissue, especially in the deep and extended lesions.

More recently, the need for minor bone trauma with still adequate bleeding resulted in the development of nanofractures. Nanofracturing means creating perforations with a smaller diameter that go deeper into the bone while damaging it less. This is supposed to reduce the injury to the subchondral bone and increase the amount of bone marrow-derived mesenchymal stromal cells at the bone surface.

Thus, the aim of this pilot study is to evaluate the efficacy of nanofractures for the treatment of cartilage lesions of the knee, specifically focusing on the chondral healing that will be addressed with magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Patients with cartilage lesions of the knee scheduled for surgery
* Age 16-50
* BMI between 18.5 and 30 points
* Ability to give informed consent

Exclusion Criteria:

* Uncorrected knee instability
* Meniscectomy \> 50%
* Uncorrected knee misalignment
* Uncontrolled metabolic diseases
* Inability to give informed consent

Primary outcomes:
measure: Functional outcomes measured by International Knee Documentation Committee subjective score
timeFrame: 12 months
Secondary outcomes:
measure: Functional outcomes measured by International Knee Documentation Committee subjective score
timeFrame: 6 months, 24 months
measure: Activity level measured by Tegner score
timeFrame: 6 months, 12 months, 24 months
measure: Knee pain on the Visual Analogic Scale
timeFrame: 6 months, 12 months, 24 months
measure: Activity level measured by Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 months, 12 months, 24 months
measure: Cartilage Repair Tissue measured by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) 2.0 score
timeFrame: 12 months
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: EOC
Study officials:
affiliation: Service of Orthopaedics and Traumatology, Department of Surgery, EOC, Lugano, Switzerland
name: Luca Deabate, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02251561: Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan
Official title: Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Staining
Keywords: contact lenses
contact lens solution
corneal staining
fluorescein
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.


Eligibility criteria: Inclusion Criteria:

* Soft contact lenses habitual wearer, both eyes.
* Voluntarily sign Informed Consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
* Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
* Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
* Corneal staining greater than Grade 1 at baseline.
* Pregnant, lactating, or intend to become pregnant during study period.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
timeFrame: Day 1, after 2 hours of wear
Secondary outcomes:
measure: Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein
timeFrame: Day 1, after 2 hours of wear
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Japan, Ltd.
name: Tsunemitsu Senta
role: STUDY_DIRECTOR
References: