louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06133127: Is There an Association Between Quadriceps Strength and Different Markers of Fragility in Patients With Cirrhosis?
Official title: Is There an Association Between Quadriceps Strength and Different Markers of Fragility in Patients With Cirrhosis?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis
Keywords: Frailty markers
Quadriceps strength
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Physical frailty and malnutrition are important factors in morbidity and mortality in patients with cirrhosis. No study has assessed the validity of Liver Frailty Index (LFI) against reference measures such as maximal lower limb strength.

Main objective: To assess the association between LFI score and isometric maximal lower limb strength (quadriceps) in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

SUBJECT :

* with a diagnosis of liver cirrhosis (regardless of cirrhosis stage and etiology)
* under the care of a physician practising in the University Hospital Estaing in Clermont-Ferrand
* affiliated to the french social security system

Exclusion Criteria:

SUBJECT:

* with hepatocellular carcinoma
* with HIV infection
* with hepatic encephalopathy grade ≥ 2
* with cognitive dysfunction
* with contraindication for physical activity
* with knee pain/knee disorders
* pregnant or breastfeeding
* under protective supervision (guardianship, curatorship, protection of the court)

Primary outcomes:
measure: Isometric quadriceps strength
timeFrame: once, at inclusion
Secondary outcomes:
measure: Malnutrition: Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT)
timeFrame: once, at inclusion
measure: Malnutrition: Mini Nutritional Assessment (MNA))
timeFrame: once, at inclusion
measure: Body composition by circumference and triceps skinfold
timeFrame: once, at inclusion
measure: Frailty by LFI
timeFrame: once, at inclusion
measure: Frailty by Short Physical Performance Battery (SPPB)
timeFrame: once, at inclusion
measure: Muscle cramps by Cramp questionnaire
timeFrame: once, at inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: aabergel@chu-clermontferrand.fr
name: Armando ABERGEL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04874727: Comparison of Standing Versus Supine 3D Cone Beam Computed Tomography in Patient With Obstructive Sleep Apnea
Official title: Reduction of Volumetric and AP Measurements of the Airway in Pseudo-sleep Supine Position vs Standard 3D Cone Beam Computed Tomography on Patients With Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OSA
Sleep Apnea
Keywords: tomography
CBCT
Cone-beam computerized tomography
obstructive sleep apnea
airway volume
anterior-posterior measurement
Lead sponsor: Manhattan Beach Orthodontics
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population was selected from the patient pool of Dr. Maryam Bakhtiyari. They are individuals with diagnoses of OSA and consented to taking two x-rays and enrolling into this study.

Brief summary: The anatomical changes of the upper airway in a standing vs pseudo-supine position using Carestream Orthodontic Imaging (Volumetric) and Carestream Orthodontic Imaging module (AP measurements) of the patient's airway respectively, have been taken and the obtained results compared. In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.


Eligibility criteria: Inclusion Criteria:

* Participant must be a patient of Dr. Maryam Bakhtiyari's orthodontic practice
* Participant must have a diagnosis of obstructive sleep apnea
* Participant must have an invitation to join research study from Dr. Bakhtiyari

Exclusion Criteria:

* Participant cannot have a history of serious dental trauma

Primary outcomes:
measure: 3D volumetric airway measurement
timeFrame: through study completion, an average of 1 year
measure: 2D Anterior-Posterior airway Measurement
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan Beach
country: United States
facility: Manhattan Beach Orthodontics
state: California
Study officials:
References:
Clinical trial NCT01208727: Post Cond No Reflow
Official title: The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Reperfusion Injury
Keywords: Myocardial infarction
Postconditioning
Microvascular obstruction
No reflow
MRI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 44
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: After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old,
* Male or female,
* Presenting first myocardial infarction, with the beginning of pains \< 12 hours,
* Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on IVA or RCA (not CA).
* Artery guilty with TIMI flow = 0

Exclusion Criteria:

* cardiac arrest before the angioplasty,
* Cardiogenic shock
* Occlusion of the artery circumflex responsible for the infarction
* Magnetic resonance imaging: contre indication

Primary outcomes:
measure: Extent of the area of microvascular obstruction
timeFrame: 5 days
Secondary outcomes:
measure: Size of the myocardial infarction
timeFrame: 5 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre CROISILLE, MD
role: STUDY_DIRECTOR
References:
citation: Thuny F, Lairez O, Roubille F, Mewton N, Rioufol G, Sportouch C, Sanchez I, Bergerot C, Thibault H, Cung TT, Finet G, Argaud L, Revel D, Derumeaux G, Bonnefoy-Cudraz E, Elbaz M, Piot C, Ovize M, Croisille P. Post-conditioning reduces infarct size and edema in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2012 Jun 12;59(24):2175-81. doi: 10.1016/j.jacc.2012.03.026.
Clinical trial NCT03639727: Cough in Eastern and Central Finland
Official title: Cough in Eastern and Central Finland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cough
Keywords: cough
cough provocation test
mannitol
citric acid
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2018-08-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study compares citric acid and mannitol bronchial challenges in their ability to separate chronic cough subjects from healthy subjects. There are no therapeutic interventions.
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.

Detailed description: 35 subjects with chronic cough plus 25 subjects without any cough will be asked to participate. The study consists of two visits in the outpatient clinic of Kuopio University Hospital, department of respiratory medicine, 2 - 7 days apart. They will fill in the Leicester Cough Questionnaire and undergo two different cough provocation tests, in random order: Mannitol test and citric acid test. If a chest x-ray has not been taken within 6 months, it will be taken.

Eligibility criteria: Inclusion Criteria, Chronic cough patients:

(both criteria must be fulfilled)

* presence of current chronic cough (\> 8 weeks)
* Leicester Cough Questionnaire total score \< 17

Inclusion criteria, healthy volunteers

* absence of any form of cough

Exclusion Criteria:

* age \< 18 years
* any disability which would challenge the subject's ability to understand the purpose and methods of the study
* pregnancy
* breastfeeding
* current smoking or ex smoking more than 10 pack years
* any thoracic x-ray finding indicating urgent mediacal interventions

Primary outcomes:
measure: Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges
timeFrame: Within one week from the start of the study in each individual
Secondary outcomes:
measure: Leicester Cough Questionnaire total score
timeFrame: The first study day
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Heikki O Koskela, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02757027: Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for CABG Surgery
Official title: Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During CABG Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CABG Surgery
Keywords: CABG surgery
blood viscosity
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing CABG surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number).

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 30th patient's discharge and data acquisition


Eligibility criteria: Inclusion Criteria:

* Patients undergoing CABG Surgery
* Patients provided a written informed consent.
* Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female)
* Patients with PaO2/FiO2 ratio \>150

Exclusion Criteria:

* Patients with history of anemia, dyspnea, active infection.
* Patients with endocrine disease

Primary outcomes:
measure: whole blood viscosity
timeFrame: with 1 hour after the completion of procedure
Secondary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: with 1 hour after the completion of procedure
measure: hematocrit
timeFrame: with 1 hour after the completion of procedure
measure: glucose
timeFrame: with 1 hour after the completion of procedure
measure: osmolarity
timeFrame: with 1 hour after the completion of procedure
measure: urine output
timeFrame: with 1 hour after the completion of procedure
measure: Maximum clot formation
timeFrame: with 1 hour after the completion of procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02835027: Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014
Official title: Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemia of Lower Limb
Keywords: Acute limb ischaemia(ALI)
Acute ischaemia of the lower extremity
Thrombosis
Emboli
Endovascular surgery
Surgery
Amputation free survival
Long time survival
Demographics
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 16287
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: The entire Swedish population, thus no sampling.

Brief summary: Study of acute lower ischemia therapies based on data collected from the Swedish Vascular Surgery Registry between 1994 and 2014.

Primary endpoint is long term amputation-free survival and secondary end-points are 30 days and 1 year amputation-free survival as well as different revascularization techniques results and time trends.

Detailed description: The prospective Swedish Vascular Registry (Swedvasc) started in 1987 and since 1994 it has included more than 95 percent of the vascular surgical procedures performed nationwide. The registry has received extensive high internal and external validation. Roughly 16000 open surgical and endovascular revascularisation procedures for acute limb ischemia have been performed during this period of time.

The fact that every Swedish citizen has a unique personal identification number makes it possible to obtain 100 percent accurate survival and amputation data. Survival data were obtained through crosschecking the personal identification number with the national population registry in June 2016.

This offers a unique opportunity to study a large population-based cohort of unselected patients.

Eligibility criteria: Inclusion Criteria:

* Patients with acute limb ischemia
* Surgical procedure performed between 1 January 1994 and 31 December 2014 in Sweden and registered in the Swedvasc registry
* Infrainguinal occlusions

Exclusion Criteria:

* Acute limb ischemia secondary to trauma, bleedings, dissection or graft infections.
* Suprainguinal occlusions.

Primary outcomes:
measure: Amputation-free survival
timeFrame: 1-22 years
Secondary outcomes:
measure: Amputation
timeFrame: 1-22 years
measure: Survival
timeFrame: 1-22 years
measure: Complications 30 days after surgery
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University
name: Martin Björck, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02894827: The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years
Official title: The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Status
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit

Brief summary: Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a medication and digestive tolerance are ensured, the medication can be taken a long time from meals to reduce its side-effects. Despite numerous studies that have investigated links between medication and malnutrition, none have assessed the influence of the time the drug is taken on the evolution of the nutritional status of elderly hospitalized persons. So as to identify the best nutritional criterion in hospitalized persons, a retrospective pilot study will be conducted in about thirty patients. Their medication will be recorded and their nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI), albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form.

This preliminary study will allow us to choose the best nutritional criterion to compare the impact of two strategies for taking medication (post prandial versus pre-prandial) on improving the nutritional status of malnourished elderly hospitalized patients taking multiple drugs.


Eligibility criteria: Inclusion Criteria:

* patients aged 65 years or more.
* patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit.
* patients whose life expectancy is greater than 30 days.
* patients able to eat food normally.
* patients able to swallow their medication.
* patients with at least 3 drugs to be taken orally per day, not including oral nutritional supplements.

Exclusion Criteria:

* patients at the end of life.
* patients whose drugs must be taken before meals like Non-steroid anti-inflammatory drugs (NSAIDs), glinides, oral antidiabetic agents (OAD).
* patients with parenteral and/or enteral nutrition in the period preceding admission to the geriatric unit.
* patients with indications for parental and/or enteral nutrition.

Primary outcomes:
measure: MNA short form
timeFrame: 30 days
Secondary outcomes:
measure: Geriatric Nutritional risk form
timeFrame: 30 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04280627: Changes in the Microbiome Associated With Transplantation
Official title: Changes in the Microbiome Associated With Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microbiota
Keywords: microbiome
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
First posted: 2020-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney and Transplant Recipients

Brief summary: To study the effects of organ transplantation and immunosuppression on the human microbiome, and to understand the interlinkage of changes in the microbiome with clinical events surrounding transplantation, and graft and patient clinical outcomes.

Detailed description: This study will involve the collection of oral swabs, saliva, urine and rectal swabs, blood and skin scrapings from patients before and after kidney and pancreas transplantation. At Day 0 and day 1, week 1, and at 3, 6, and 12 months.

These samples will be collected longitudinally over a period of one year after transplantation and will be analysed using 16s rRNA gene sequencing in order to capture the dynamics of the microbiome after exposure to surgery, immunosuppression and the specific medication necessary during the process of transplantation.

Two groups of recipients will be recruited, the first one includes kidney and/or pancreas transplant recipients from both deceased and living donors.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.
* Under 75 years
* Participants must be able to receive and understand English verbal and written information regarding the study and give written, informed consent.
* Participants will be recipients of pancreas or kidney allografts

Exclusion Criteria:

* Outside of stated age range.
* Unable to give informed consent

Primary outcomes:
measure: Changes in the Microbiome following transplantation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundationn Trust
state: Greater Manchester
Study officials:
affiliation: Consultant Transplant Surgeon
name: Titus Augustine, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Fellow
name: Oana Piscoran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00927927: First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
* Aged between 18 and 75 years (both inclusive)
* Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
* Use of highly effective contraception during the trial (both males and females)

Exclusion Criteria:

* A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
* An active or latent tuberculosis
* Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
* A known significant cardio-vascular disease
* Vaccination against live virus or bacteria within 4 weeks prior to randomization
* The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
* A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
* Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Secondary outcomes:
measure: Area Under the Concentration-time Curve (AUC)
timeFrame: Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Britta Væver Bysted, DVM, PhD
role: STUDY_DIRECTOR
References: