louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04356508: COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
Official title: COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
SARS-CoV-2
2019-nCoV
Pneumonia, Viral
Keywords: COVID-19
SARS-CoV-2
2019-nCoV
Coronavirus
Anti-PD1
Nivolumab
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2020-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, controlled, single-centre pilot study of nivolumab in adult patients with COVID-19. This clinical study aims to evaluate efficacy of anti-PD1 antibody in relation to viral clearance and its safety.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COVID-19 by RT-PCR for SARS-CoV-2
* Clinically stable with disease severity defined as mild or moderate (mild disease is defined as symptoms with or without lung infiltrates on chest X-Ray or CT imaging; moderate disease is defined as lung infiltrates with evidence of type 1 respiratory failure)
* Asymptomatic patients may be enrolled if patients have obvious radiographic changes on chest or CT radiography deemed to be related to COVID-19

Exclusion Criteria:

* Active cancer, rheumatological and autoimmune conditions
* Transplant recipients, or patients on active immunosuppressants
* Chronic organ impairment, or documented or suspected concomitant infections (including chronic viral hepatitis B and hepatitis C) other than SARS-CoV-2
* Lactating mothers and women who are pregnant or intending to become pregnant
* Acute respiratory distress syndrome, evidence of myocardial injury, disseminated intravascular coagulopathy, organ failure, hemophagocytosis, shock, respiratory distress, or need for mechanical ventilation, AICU admission, or high flow oxygen therapy

Primary outcomes:
measure: Viral clearance kinetics
timeFrame: From diagnosis to recovery, assessed up to 6 months
Secondary outcomes:
measure: Treatment-related adverse events of nivolumab (Intervention arm only)
timeFrame: Up to 1 year after nivolumab dosing
measure: Lymphocyte kinetics
timeFrame: On days 1, 4, 6, 8, 10 and 28 from study enrollment
measure: Cytokine kinetics
timeFrame: On days 1, 4, 6, 8 and 10 from study enrollment
measure: Length of inpatient stay due to COVID-19
timeFrame: From hospital admission to discharge, assessed up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Gerry Gin Wai Kwok, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355208: Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle
Official title: Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques in Restoration of Fractured Incisal Angle: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clincl trial will be conducted to compare theShade Evaluation of Monochromatic versus Polychromatic layering techniques in restoration of Fractured incisal angle

Detailed description: The use of enamel and dentin shades allow us to reproduce anatomical features such as incisal edge translucency, halo effect, other internal colors and pigments such as craze lines, white patches, white horizontal striations .

Anterior composites usually have small filler particles to increase smoothness, nanotechnology has enabled recent advances in dental composite restorations. As a result , a different category of composite resins has emerged, known as nanocomposites.

However polychromatic layering is considered to be technique sensitive, from detection of details to proper reproduction of such fine details.

The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.

The use of monochromatic layering with only body shade can serve as a substitute for enamel and dentin, since it has an intermediate opacity between enamel and dentin , and can serve as an easier option with less technique sensitivity than polychromatic layering.

Filtek universal as claimed by the company manufacturer to have A "NaturalMatch" which is a term that describes the combination of 3M technologies and features present within 3M™ Filtek™ Universal restorative.

it contains nanofillers, pigments and proprietary low-stress monomers which gives Filtek™ Universal Restorative a combination of esthetic and universal opacity which in turn allow shade blending and making the restoration more invisible with surrounding dentition.

Eligibility criteria: Inclusion Criteria:

1. Patients with fractured incisal angle.
2. Vital teeth.
3. Anterior Permanent teeth.
4. Good oral hygiene.
5. Co-operative patients approving to participate in the study.

Exclusion Criteria:

1. Non vital teeth.
2. Severe or active periodontal disease.
3. Severe medical complications.
4. Uncooperative patients

Primary outcomes:
measure: Shade matching
timeFrame: immediate after restoration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01332708: Cholinergic Status and the Metabolic Syndrome
Official title: Cholinergic Status and the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obese
Keywords: high complex carbohydrates
hypocaloric diet
cholinergic status
overweight
obese
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aims in the current study are to examine whether the cholinergic status should be considered as another risk factor for the metabolic syndrome and it's co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the cholinergic status of overweight and obese adults with and without the metabolic syndrome.

Detailed description: Intervention studies have demonstrated that the autonomic disturbances of the metabolic syndrome may be reversible. A reduction in body weight induced by a hypocaloric diet exerts a marked reduction in sympathetic activity in obese people with or without metabolic syndrome. Incorporation of regular, moderate intensity aerobic exercise training during a dietary weight loss program does not confer additional benefits on resting sympathetic neural activity, compared with weight loss by diet alone. A new method has been developed to examine the sympathetic-parasympathetic status of an individual - the cholinergic status. Cholinergic Status represents the total soluble circulation capacity for acetylcholine hydrolysis. Higher cholinergic status means the individual is more sympathetic .

A cross sectional study that took place in Tel Aviv Sorasky medical center and included 632 participants found that the cholinergic status is related to metabolic syndrome parameters in a dose response manner and that it correlates significantly with glucose,HbA1c, lipid profile and hs-CRP.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25kg/m2
* Stable weight (±1kg)in the previous six months
* Non smokers

Exclusion Criteria:

* Type II diabetes
* Hypertension pharmacologically treated
* Cardiovascular disease
* Renal disease
* Cirrhosis and end-stage liver failure
* Thyroid disease
* Cerebrovascular disease
* Cancer
* Autoimmune disease
* Chronic inflammatory disease
* Surgery or heart catheterization in the previous six months
* Use of drugs known to affect measured parameters

Primary outcomes:
measure: total soluble circulation capacity for acetylcholine hydrolysis
timeFrame: 8 weeks or more
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 8 weeks or more
measure: ROTEM - rotation thromboelastometry
timeFrame: 8 weeks or more
measure: Metabolic markers
timeFrame: 8 weeks or more
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01259908: Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease
Official title: Laparoscopic Aortic Surgery: Norwegian Experiance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aorto Iliac Occlusive Disease
Keywords: laparoscopic aortic surgery
aorto-iliac occlusive disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sykehuset Ostfold
name: Sorlandet Hospital HF
First posted: 2010-12-14
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aorto-iliac occlusive disease (Type D lesion according to the Trans Atlantic Intersociety Consensus TASC II)

Brief summary: Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

Detailed description: Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

Secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered.

Besides short form- 36 (SF-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively.

Early, midterm and long time results shall be followed.

Eligibility criteria: All patients with a TASC D lesion in the aorto-iliac segment not amenable to or previously unsuccessfully treated by endovascular approach.

Exclusion Criteria:

* Unsuitable for surgery due to general health status

Primary outcomes:
measure: Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)
timeFrame: 2005-2015
Secondary outcomes:
measure: Operative time, operative bleeding, length of hospital stay, quality of life
timeFrame: 2005-2015
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Kazmi SS, Jorgensen JJ, Sundhagen JO, Krog AH, Florenes TL, Kolleros D, Abdelnoor M. A comparative cohort study of totally laparoscopic and open aortobifemoral bypass for the treatment of advanced atherosclerosis. Vasc Health Risk Manag. 2015 Sep 18;11:541-7. doi: 10.2147/VHRM.S92671. eCollection 2015.
citation: Kazmi SS, Krog AH, Berge ST, Sundhagen JO, Sahba M, Falk RS. Patient-perceived health-related quality of life before and after laparoscopic aortobifemoral bypass. Vasc Health Risk Manag. 2017 May 12;13:169-176. doi: 10.2147/VHRM.S134669. eCollection 2017.
Clinical trial NCT03195608: Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease
Official title: Using Advanced Driver Assistance Systems (ADAS) as an Intervention Strategy for Drivers With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Driving Impaired
Keywords: In-vehicle technologies
Parkinson's disease
Driving performance
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Parkinson's disease (PD) impacts an individual's fitness to drive in a number of ways that increase the crash risk in this population. Current vehicle automation technologies are available, that although designed for the general public, may help drivers with PD stay on the roads longer and safer than currently possible. Using a driving simulator (a safe and cost-effective alternative with no impact on licensing for participants), this study will investigate the feasibility and preliminary efficacy of utilizing in-vehicle technology (i.e., a simulated lane change assistance system) to address critical driving errors in individuals with mild to moderate Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Participants must be 21 years of age or older (as a feasibility study, this study will provide the opportunity to participate to those diagnosed with early onset PD)
* Have been diagnosed with Parkinson's disease by a neurologist or movement disorder specialist
* Currently hold a valid G driver's license
* Meet provincial visual acuity (20/50 binocular) and visual field (120 continuous along the horizontal meridian with both eyes examined together) requirements for driving
* Be proficient in English reading and speaking (self-reported).

Exclusion Criteria:

* Have any other neurological or psychiatric conditions that would interfere with full participation in the study
* Be taking psychotropic medication(s) that affect their mental and/or physical functioning

Primary outcomes:
measure: Change in number of lane maintenance errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)
timeFrame: Baseline, 4 weeks, and 6 weeks
measure: Change in number of visual scanning errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)
timeFrame: Baseline, 4 weeks, and 6 weeks
measure: Change in number of signalling errors from baseline to post-test 1(4 weeks) and post-test 2 (6 weeks)
timeFrame: Baseline, 4 weeks, and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Liliana Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00680108: A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
Official title: A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 62
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Best corrected visual acuity 20/40 in each eye
* 2 out 5 specified symptoms
* Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion Criteria:

* Unable to stop concomitant medications
* Have had intraocular surgery in previous 90 days
* Have excluded systemic or ocular disease
* Wear contact lenses and are not willing to remove them
* Have intraocular pressure greater than 22 mg Hg

Primary outcomes:
measure: Evaluation of adverse events
measure: Ocular symptomatology
measure: Visual acuity
measure: Biomicroscopy
measure: Ophthalmoscopy
Secondary outcomes:
measure: Unanesthetized Schirmer test
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Clinical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00921908: Multihole or Epidural Catheter for Local Anesthetic in the Wound
Official title: Multihole or Epidural Catheter for Local Anesthetic in the Wound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Hip Arthroplasty
Keywords: total hip arthroplasty
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing total hip arthoplasty

Brief summary: Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined.

This study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* operation with total hip arthroplasty

Exclusion Criteria:

* allergies to drugs administered

Primary outcomes:
measure: wound spread area of radioactive isotope
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
Clinical trial NCT04987008: Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
Official title: Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (29BRC21.0082)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Foramen Ovale, Patent
Keywords: foramen ovale, patent
stroke
pulmonary embolism
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 53 of the 324 EPIC-FOP patients not followed in previous PE cohort

Brief summary: stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

Detailed description: 324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.

Eligibility criteria: Inclusion Criteria:

* patients included in EPIC-FOP study

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: stroke
timeFrame: pulmonary embolism (2009 to 2015) to 2021
Secondary outcomes:
measure: TIA or stroke
timeFrame: pulmonary embolism (2009 to 2015) to 2021
measure: death
timeFrame: pulmonary embolism (2009 to 2015) to 2021
measure: bleeding
timeFrame: pulmonary embolism (2009 to 2015) to 2021
measure: VTE
timeFrame: pulmonary embolism (2009 to 2015) to 2021
Other outcomes:
Locations:
city: Brest
country: France
facility: HIA
city: Brest
country: France
facility: CHRU de Brest
city: Quimper
country: France
facility: CHIC de Quimper
Study officials:
References:
Clinical trial NCT05114408: Trimodal Prehabilitation in Patients Undergoing Elective Surgery
Official title: The Influence of Prehabilitation on the Surgical Patients Condition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Complication
Perioperative Complication
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: University Clinical Centre, Gdansk
name: EIT Health
First posted: 2021-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients scheduled for elective surgery will undergo 4 week course of trimodal prehabilitation

Detailed description: Patients with high surgical risk will participate in 4 week prehabilitation that will consist of 4 stationary sessions - one per week - comprised of: physiotherapy session, psychological session and nutritional advice. During first session each patient will receive an activity monitor and dedicated mobile app that will record his daily performance.

Eligibility criteria: Inclusion Criteria:

* Age \> 70 and/or American Society of American Society of Anesthesiologists Physical Status Classification System (ASA) 3-4
* Unfit patients

Exclusion Criteria:

* physical condition that makes the patient is not able to perform rehabilitation exercises
* cardiac and respiratory instability or high risk of its occurrence
* inability to use electronic devices used in the study

Primary outcomes:
measure: 6 minute walk test
timeFrame: baseline and pre surgery
measure: Yale Physical Activity Survey (YPAS)
timeFrame: baseline and pre surgery
measure: self-perceived health status scale (36-Item Short Form Survey - SF36)
timeFrame: baseline and pre surgery
measure: Global Leadership Initiative on Malnutrition (GLIM) scale
timeFrame: baseline and pre surgery
measure: Hospital Anxiety and Depression (HAD) scale
timeFrame: baseline and pre surgery
measure: motivation questionaire (MQ)
timeFrame: baseline and pre surgery
measure: Perceives stress - Perceived Stress Questionaire (PSS)
timeFrame: baseline and pre surgery
Secondary outcomes:
measure: Number of Participants requiring reintervention during initial hospitalization
timeFrame: 3 months after surgery
measure: ICU length of stay
timeFrame: 3 months after surgery
measure: Total hospital length of stay
timeFrame: 3 months after surgery
measure: Number of Patients requiring Emergency room visits and hospital readmissions
timeFrame: at 30 days
measure: Number of Patients with postoperative complications
timeFrame: 3 month after surgery
Other outcomes:
measure: Patient concentration questionaire (P3CQ)
timeFrame: after prehabilitation course
measure: Staff engagement questionaire (ACT)
timeFrame: after recruitment
measure: cost analysis
timeFrame: 3 months after surgery
measure: Continuity of Care Questionaire (NCQ)
timeFrame: after prehabilitation course
Locations:
city: Gdansk
country: Poland
facility: University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre
Study officials:
References: