louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05241639: Pentacam Study of the Cornea in RA Patients
Official title: Pentacam Study of Rheumatoid Arthritis Activity on Corneal Densitometry, Corneal Curvature, Corneal Thickness and Lens Densitometry.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: RA - Rheumatoid Arthritis
Keywords: Pentacam-RA-Corneal densitometry
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study subjects were divided into 3 groups, group 1 of 120 eyes of 60 RA patients with disease remission, group 2 of 120 eyes of 60 RA patients with disease activity and group 3 of 120 eyes of 60 healthy group 3 of similar age group.

Brief summary: To evaluate the effect of rheumatoid arthritis (RA) activity on the corneal densitometry, corneal curvature (CC), central corneal thickness (CCT), and lens densitometry by Pentacam and compared these parameters with those of age-matched healthy control subjects

Detailed description: Case - control observational study on RA patients which divided into 2 groups, each group 120 eyes of 60 patients, group 1 of RA in the remission state and group 2 of RA in the active state. Group 3 of 120 eyes of healthy controls. Pentacam was used to measure corneal densitometry, CC, CCT, and lens densitometry. The cornea was divided into 4 concentric zones (0-2, 2-6, 6-10, and 10-12) and anterior, central, and posterior layers according to the depth

Eligibility criteria: Inclusion Criteria:

* The included patients had aged more than 20 years with RA only without ocular manifestations with clinically clear cornea with normal anterior and posterior segment examinations with normal intraocular pressure (IOP)

Exclusion Criteria:

* We excluded patients with ocular problems as corneal opacity, cataract, glaucoma, errors of refraction, topical application of eye drops except for topical artificial tears. The presence of systemic diseases other than RA as DM, hypertension were also excluded

Primary outcomes:
measure: Corneal densitometry
timeFrame: through study completion, an average of 1 year".
measure: Corneal thickness
timeFrame: through study completion, an average of 1 year".
measure: lens densitometry
timeFrame: through study completion, an average of 1 year".
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia Faculty of medicine
city: Minya
country: Egypt
facility: Minia University hospital
Study officials:
affiliation: Minia faculty of medicine
name: mohamed Mahmoud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02155439: Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
Official title: Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keloidscars
Keywords: Prospective, randomized controlled trial - pilot study
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.


Eligibility criteria: Inclusion Criteria:

* Person who has a keloidscar which could be treated with injection treatment

Exclusion Criteria:

* Pregnancy, lactating, renal or liver failure

Primary outcomes:
measure: Symptoms (pain, itching) of keloids and appearance of keloid
timeFrame: baseline and one year
Secondary outcomes:
measure: Concentration change of hemoglobin and melanin
timeFrame: 0 week, 3 week, 6 week, 12 week, 1 year
Other outcomes:
measure: Inflammatory cells and their different populations, blood vessel density, fibroplast proliferation (KI67) and estrogenreseptor
timeFrame: 0 week, 3 week, 6 week, 12 week, 1 year
Locations:
city: Tampere
country: Finland
facility: Tampere university hospital
Study officials:
References:
Clinical trial NCT03006939: Fluid Balance During Surgery for Ovarian Cancer
Official title: Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Neoplasm
Fluid Therapy
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ovarian cancer

Brief summary: Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes survival in late-stage ovarian cancer patients. Little is known about the intraoperative fluid balance and its impact on morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for cytoreductive surgery in ovarian cancer

Exclusion Criteria:

* Age \< 18 years
* unability to give consent

Primary outcomes:
measure: fluid balance
timeFrame: at the end of surgery
Secondary outcomes:
measure: mechanical ventilation
timeFrame: at the timepoint of extubation
measure: mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Study officials:
affiliation: University Clinic Bonn
name: Martin Soehle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081339: Cohort Study of the Clinical Course of Macular Diseases in Japanese
Official title: Cohort Study of the Clinical Course of Macular Diseases in Japanese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macular Disease
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.

Brief summary: Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth.

Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Eligibility criteria: Inclusion Criteria:

* Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
* Patients who are agreed with the participation of this study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Initial factors associated with visual prognosis in each macular disease
timeFrame: Five years after the registration
Secondary outcomes:
measure: The difference in the visual prognosis depending on the treatments in each macular diseases
timeFrame: Five years after the registration
Other outcomes:
measure: The change in visual acuity in each macular diseases.
timeFrame: Five years after the registration.
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Nagahisa Yoshimura, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04609839: FOLLOW-UP OF PATIENTS WITH COVID-19.
Official title: TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Admitted to Intensive Care Unit for COVID-19
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to intensive care unit for COVID-19.

Brief summary: Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.

The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to intensive care unit for COVID-19
* Adult patient ≥ 18 years old
* Subject having expressed his non-opposition to the research
* Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme

Exclusion Criteria:

* Subject under safeguard of justice
* Patient under guardianship or curatorship

Primary outcomes:
measure: The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
timeFrame: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
Secondary outcomes:
measure: 1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months
timeFrame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
measure: 2) Number of re-hospitalizations at 3, 6 and 12 months
timeFrame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
measure: 3) Date of death
timeFrame: Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
measure: 4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months
timeFrame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
measure: 4.2) The Pittsburgh sleep quality index (PSQI questionnaire) at 3, 6 and 12 months
timeFrame: At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion
measure: 5) Cost of health expenditure
timeFrame: The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02938039: I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures
Official title: I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Keywords: laryngeal airways
infants
neonates
children
anesthetized
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 112
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.

This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.

Detailed description: Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic and intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation.

There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.

Eligibility criteria: Inclusion Criteria:

* Elective surgical procedures
* No muscle relaxant agents
* No other comorbidities

Exclusion Criteria:

* Emergency surgical procedures
* Full stomach
* Subjects with upper respiratory tract infection
* Failed caudal block

Primary outcomes:
measure: Airway Leak Pressure
timeFrame: 17 months
Secondary outcomes:
measure: Effective airway time
timeFrame: 18 months
measure: Ease of insertion
timeFrame: 18 months
measure: Success at first attempt
timeFrame: 18 months
measure: Oxygen Desaturation less than 90%
timeFrame: 18 months
measure: Gastric Insufflation
timeFrame: 18 months
measure: Manipulation of the Device
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: King Saud University
name: Abdulrahman M Alzahem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00083239: Study of Talabostat in Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Skin Cancer
Lead sponsor: Point Therapeutics
Sponsor class: INDUSTRY
First posted: 2004-05-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002)
* Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins
* ECOG Performance Status of 0, 1, or 2
* Expected survival ≥12 weeks
* Written informed consent

Exclusion Criteria:

* More than 1 prior chemotherapy or biotherapy regimen for Stage IV melanoma
* Radiation therapy to \>50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
* Clinically significant laboratory abnormalities
* CNS metastases
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
* Pregnant or lactating women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
References:
Clinical trial NCT02377739: Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
Official title: Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noninvasive Ventilation
Lung Diseases, Interstitial
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Weinmann Geräte für Medizin GmbH + Co. KG
First posted: 2015-03-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous studies. There is only a limited number of therapeutic options for patients with severely progressed interstitial lung disease (ILD). The question whether chronic hypercapnic ILD-patients are able to profit from nocturnal NIV and thus increase their performance in physical training has been left unknown. Therefore, this study aims to evaluate the feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary rehabilitation.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of Interstitial lung disease
* Hypercapnia defined as carbon dioxide partial pressure ≥45 mmHg (at rest, night or activity)
* already existing but not sufficient and regular use of non-invasive ventilation (≤3h/24h)
* patients consent to participate in this trial

Exclusion Criteria:

* acute pulmonary insufficiency (ph\<7.35)
* acute, clinically relevant heart disease
* already existing and sufficient use of non-invasive ventilation (≥3h/24h)
* Body-Mass-Index\>30
* obstructive sleep apnea
* Intolerance to perform non-invasive ventilation
* acute infection

Primary outcomes:
measure: timespan until sufficient use of noninvasive ventilation > 6h during night
timeFrame: day 4-16
Secondary outcomes:
measure: 6-minute walking test
timeFrame: day 1-3 and day 17-19
measure: arterial pressure of carbon dioxide during night
timeFrame: day 1-3 and day 17-19
measure: lung function measured by bodyplethysmograph
timeFrame: day 1-3 and 17-19
measure: energy expenditure during night assessed by Sensewear Armband
timeFrame: day 5 and 15
measure: quality of life
timeFrame: day 1-3 and 17-19
Other outcomes:
Locations:
city: Schoenau Am Koenigssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
state: Bayern
Study officials:
affiliation: Schoen Klinik Berchtesgadener Land
name: Klaus Kenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03274739: Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
Official title: Maternal Mediterranean Diet During Pregnancy in Association to Longitudinal Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiometabolic Risk
Growth
Childhood Obesity
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 2762
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included pregnant women recruited between 2003 and 2008 in the four Spanish regions of Asturias, Gipuzkoa, Sabadell and Valencia as part of the population-based INMA ("INfancia y Medio Ambiente") birth cohort study. The pregnant women were recruited during prenatal visits in the 1st trimester of pregnancy at public health care centers or hospitals. Mothers were afterwards followed at 3rd trimester, and their children later, and at ages 6 months, 1 and 4 years.

Brief summary: This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. This study is part of a secondary data analysis of the INMA (INfancia y Medio Ambiente-(Environment and Childhood)) Project.


Eligibility criteria: Inclusion Criteria:

* to be resident in one of the study areas
* to be at least 16 years old
* to have a singleton pregnancy
* to wish to deliver in the reference hospital

Exclusion Criteria:

* to not be fluent in Spanish or other regional languages.
* to have followed a programme of assisted reproduction

Primary outcomes:
measure: Offspring's body mass index z-score trajectories
timeFrame: From birth to 4 years of age
measure: Child cardiometabolic risk score
timeFrame: At 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Guxens M, Ballester F, Espada M, Fernandez MF, Grimalt JO, Ibarluzea J, Olea N, Rebagliato M, Tardon A, Torrent M, Vioque J, Vrijheid M, Sunyer J; INMA Project. Cohort Profile: the INMA--INfancia y Medio Ambiente--(Environment and Childhood) Project. Int J Epidemiol. 2012 Aug;41(4):930-40. doi: 10.1093/ije/dyr054. Epub 2011 Apr 5. No abstract available.