louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05364996: Alveolar and Serum sRAGE in Severe Asthma in Children
Official title: Cross-sectional Pilot Study of the Alveolar and Serum sRAGE Biomarker in Severe Asthma in Children.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma in Children
Keywords: soluble receptor for advanced glycation end products
inflammation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child from 0 to 16 years old, eligible for bronchial endoscopy with bronchoalveolar lavage (BAL) for assessment of severe asthma. The diagnosis of asthma being established by a pneumo-pediatrician in the presence of a history of respiratory symptoms such as wheezing, shortness of breath, chest tightness and coughing variable in time and intensity, associated with a variable limitation expiratory flows.

Brief summary: sRAGE is a recognized marker of alveolar injury in acute respiratory distress syndrome (ARDS). More recently, it seems to be an interesting marker in asthma. It is the soluble form of the pro-inflammatory RAGE receptor overexpressed in the lungs and in particular the bronchi. It acts as a decoy to its ligands, and thus blocks the pro-inflammatory axis of RAGE.

Few studies are available in asthma, especially in children. A local study showed low levels of serum sRAGE in the context of acute bronchiolitis. The same finding emerges from the few studies available in asthma, with rates all the lower when the asthma is poorly controlled. A study carried out in the animal model in 2012 found an absence of inflammatory infiltrate, the absence of increased expression of mucin and the absence of mucus goblet cell hyperplasia within the respiratory epithelium in the absence of RAGE receptor in sensitized mice dust mites, after exposure to their allergen. One could imagine in the long term a potential therapeutic avenue by a substitution in sRAGE in this pathology.

The objective of this study is to study the ability of the alveolar sRAGE level measured on broncho-alveolar lavage for assessment, to discriminate the clinical degrees of control of severe asthma in children.


Eligibility criteria: Inclusion Criteria:

* severe asthma
* Weight greater than or equal to 5 kg

Exclusion Criteria:

* Current respiratory infection
* Bronchopulmonary dysplasia or prematurity \< 34 weeks
* Diffuse infiltrative pneumonia
* Cystic fibrosis, primary ciliary dyskinesia
* Known immune deficiencies;
* Congenital heart disease;
* Cardiomyopathy;
* Ongoing pericarditis, myopericarditis, endocarditis;
* Chronic valvular pathology;
* Known autoimmune disease;
* Neuromuscular pathology;

Primary outcomes:
measure: alveolar sRAGE level
timeFrame: at inclusion
Secondary outcomes:
measure: plasma sRAGE level
timeFrame: at inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
References:
Clinical trial NCT04430296: Cyclophotocoagulation in Primary Open Angle Glaucoma
Official title: Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of Cyclodestruction procedures has been extended to patients with non-refractory glaucoma and good vision. Our aim is to compare the safety and efﬁcacy of three cyclodestructive treatments; High Intensity Focused Ultrasound (HIFU) Cyclocoagulation versus micropulse cyclophotocoagulation (MP-CPC) versus transscleral continuous wave cyclophotocoagulation (CW-CPC) for the treatment of Primary open angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* medically uncontrolled, primary open angle glaucoma attending glaucoma clinic

Exclusion Criteria:

* patients with history of previous laser or surgical intervention

Primary outcomes:
measure: Success rate.
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02231996: Chronic Granulomatous Disease Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Granulomatous Disease, Chronic
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CGD patients

Brief summary: CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine, including clinical feature, laboratory data and genetic information. we aim to find out clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus further improving the level of diagnosis and treatment for CGD.


Eligibility criteria: Inclusion Criteria:

* x-linked and AR-linked Chronic Granulomatous Disease
* history of life-threatening severe infections
* A functional assay demonstrating abnormal NADPH oxidase function or clinical history consistent with CGD

Exclusion Criteria:

* Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD.

Primary outcomes:
measure: times of pneumonia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medical center
state: Shanghai
Study officials:
References:
Clinical trial NCT01882296: Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects
Official title: A Block-randomized, Open-Label, Multiple Oral Dosing, Phase I Study to Explore Comparability of the Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in healthy male subjects

Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare each dose-response


Eligibility criteria: Inclusion Criteria:

* Adult healthy males 20 to 45 years at screening
* BMI : 19kg/m2 \~ 26 kg/m2
* Blood Pressure : "140 mmHg ≥ sitting SBP ≥ 90 mmHg, 95 mmHg ≥ sitting DBP ≥ 50 mmHg"

Exclusion Criteria:

* Have history of significant hepatic, renal gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
* Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery (except for Appendectomy, hernia repair) affected the absorption of medications
* Have history of GERD, Gastric ulcer, Duodenal ulcer and H.pylori positive
* Hypersensitivity reactions to drugs of clinically significant hypersensitivity reactions in the history of benzimidazole (ex: pantoprazole, NSAID, antibiotic)
* Have a history of drug abuse
* unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
* Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who have taken habitually caffeine (caffeine \> 5 units/day)
* Subject who have drunken habitually (alcohol \> 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker
* Subjects deemed ineligible by investigator based on other reasons

Primary outcomes:
measure: 24h pH
timeFrame: 24 hours
Secondary outcomes:
measure: %Time pH>6
timeFrame: 24 hours
measure: % inhibition time gastric pH≤4
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00686296: Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
Official title: Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: soft tissue abscess requiring incision and drainage
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 56
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: To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry dressing in the treatment of open wounds after incision and drainage.


Eligibility criteria: Inclusion Criteria:

* Inpatients with soft tissue abscess that will result in an open surgical wounds greater than or equal to 4 cms in any dimension
* Wound will require serial dressing changes
* Greater than or equal to 18 years of age
* Ability to obtain informed consent

Exclusion Criteria:

* Inability to obtain informed consent
* Pregnancy
* Prisoner

Primary outcomes:
measure: The primary endpoint of this study will be rate of wound healing (judged as per cent complete wound closure) at the two (2) and three (3) week follow-up visits.
timeFrame: two and three weeks
Secondary outcomes:
measure: occurence of wound infection
timeFrame: two and three weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: John G Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514396: Skin Incision Adhesive in Pediatrics
Official title: Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: Pediatric
Wounds
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).

Detailed description: Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 5 and 18 years of age, inclusive
* Candidate for use of a topical surgical skin adhesive
* Informed consent by a parental guardian

Exclusion Criteria:

* A wound with evidence of active infection or gangrene or wounds of decubitus etiology
* Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to body fluids or dense natural hair
* Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Primary outcomes:
measure: Number of Participants With Wound Closure
timeFrame: baseline to 14 days
Secondary outcomes:
measure: Adverse Events Related to Wound Closure
timeFrame: 14 days
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital Emergency Department
state: Ohio
Study officials:
affiliation: Medline Industries
name: Ed Drower, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02107716: Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Official title: Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needlestick Injuries
Keywords: Pain
Injections
Lidocaine
Healthy volunteers
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the influence of adjusting the pH of lidocaine on pain during subcutaneous injection. Each participant will receive two injections on the abdomen with different pH. After each injection, the subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing pH. The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility criteria: Inclusion Criteria: fyll inn

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes

Primary outcomes:
measure: Pain
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Vilhjalmur Finsen, Prof md
role: STUDY_DIRECTOR
References:
citation: Skarsvag TI, Wago KJ, Tangen LF, Lundbom JS, Hjelseng T, Ballo S, Finsen V. Does adjusting the pH of lidocaine reduce pain during injection? J Plast Surg Hand Surg. 2015 Oct;49(5):265-267. doi: 10.3109/2000656X.2015.1047780. Epub 2015 May 19.
Clinical trial NCT00259116: A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Official title: A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure, Congestive
Keywords: Congestive heart failure
Relaxin
Cardiac hemodynamics
Lead sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.

Detailed description: Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.

Eligibility criteria: Inclusion Criteria:

* Male and female patients over the age of 18
* New York Heart Association (NYHA) Class II-III CHF
* Left Ventricular Ejection Fraction (LVEF) of \< 35%

Exclusion Criteria:

* Acute coronary syndrome
* Acute decompensated CHF
* Hypotension
* Recent significant arrhythmia
* Recent stroke
* Significant renal or hepatic impairment
* Pregnancy or child-bearing potential

Primary outcomes:
measure: Cardiac hemodynamics including PCWP, CO/CI, SVR
Secondary outcomes:
measure: Safety and tolerability
measure: Tolerability
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Hospital
Study officials:
affiliation: BAS Medical - Sponsor
name: Sam Teichman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02783716: Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
Official title: Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.


Eligibility criteria: Inclusion Criteria:

* CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)\<35%, Left Bundle Branch Block (LBBB)\>120 ms, New York Heart Association (NYHA) Class II-III).
* Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks

Exclusion Criteria:

* Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.

Primary outcomes:
measure: Change in vascular endothelial function
timeFrame: baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hon-Chi Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05008016: Procalcitonin Level and the High Risk of Mortality in 30 Days in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patient , Cases Series.
Official title: Procalcitonin Level and the High Risk of Mortality in 30 Days , in Critically Ill Patients Infected by SARS-CoV-2, Experience of a North African Hospital University , Cases Series.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Relationship Between Procalcitonin and 30-day Mortality in COVID Patients
Keywords: COVID
Procalcitonine
Mortality
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 582
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -582 patient with the SARS COV 2 virus, in the Resuscitation Service of the Mohammed VI University Hospital Center oujda, MAroc

Brief summary: Background:

Procalcitonin (PCT) is a biomarker that has been proposed as a helpful tool in inflammatory Clinique cases specially patient with pulmonary bacterienne infection .

Materials and methods the investigatore had retrospectively reviewed the electronic records and lists of all 582 COVID-19 patients admitted on the ICU of Hospital university Mohammed VI , Oujda. Between 01 juin 2020 and 31juanary 2021 , and analyzed the relation of PCT value and mortality at 30 days until we can defined a cut off Procalcitonine to use as a marker of severity and high mortality .

Detailed description: Our objective is to assess the relationship between Procalcitonin and 30-day mortality in patients admitted to the resuscitation department of the Mohammed VI University Hospital Center, Oujda, Morocco, infected by the SARS COV 2 Virus .

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of SARS COV2 infection needed admission in ICU .

Exclusion Criteria:

* patient under 15 ans

Primary outcomes:
measure: Procalcitonin is a marker of mortality
timeFrame: through study completion, an average of 8 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Berkane
country: Morocco
facility: younes Oujidi
Study officials:
References:
Clinical trial NCT02762916: CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies
Official title: Randomized Trial of CONTECI Program: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Personal Satisfaction
Telemedicine
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current increase in chronic diseases calls for changes to the health system. It is necessary to promote expert patient in chronic disease. The expansion of new technologies gives us new tools to face new challenges, providing efficiency, expertise and autonomy. The characteristics of peripheral arterial disease make possible to promote expert patient and the self-management. In order to bring these concepts together the telemedicine program was created to promote expert patient for increasing the quality of life and satisfaction of patients and improving the efficiency of the health system.

Methods: Randomized clinical trial on patients with peripheral arterial disease in intermittent claudication grade. They were randomized into two groups: intervention arm (IA) using CONTECI program for self-managing and control arm (CA), followed as usual vascular visits.


Eligibility criteria: Inclusion Criteria:

* Patient with confirmed PAD
* Over 18 years old
* Informed Consent
* Internet Access (patient or family)
* Spanish or Catalan fluidity

Exclusion Criteria:

* Cognitive impairment
* Previous patency arterial surgery
* Sever chronic obstructive pulmonary disease (GOLD III/ IV)
* Patients with decreased survival of 12 months

Primary outcomes:
measure: satisfaction. Analogical scale 0-100. To compare the satisfaction in the new model control and the model before
timeFrame: 12 months
Secondary outcomes:
measure: Clinical features. Pateint who turned to grade 3 or 4 of Le Fontaine classification, number of surgeries.
timeFrame: 6 and 12 months
measure: Health resources consumption: rate of Emergency visits, scheduled visits, extra visits, Mail per participant
timeFrame: 6 and 12 months
measure: Quality of life. EuroQol5D were used. Change from baseline Quality of line at 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: