louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00464997: The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate
Official title: The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: methotrexate aspirin pharmacokinetics
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: High dose aspirin have been shown to increase the level of Methotrexat in patients with Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the purpose of this study is to assess the effect of low dose aspirin on the levels of methotrexate.

Detailed description: Thirty Rheumatoid Arthritis patients currently treated with low dose methotrexate (MTX) will participate in this study. On the day of intake of methotrexate, the patients will receive 10 mg of MTX. Serum levels of MTX will be measured at time 0,30 ,90, 120 minutes, and after 12 and 24 hours.

Two weeks later, the patients will be recommended to take 100 mg aspirin/d during a week. The levels of MTX will be measured after a week of treatment in a way similar to a week before.

Eligibility criteria: Inclusion Criteria:

* RApatients treated with Methotrexate

Exclusion Criteria:

* Contraindication to aspirin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Ori Elkayam, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706297: Effect of Breathıng Exercıse Applıed to Indıvıduals Wıth Copd on Respıratory Functıon, Dyspnea and Qualıty of Lıfe
Official title: Effect of Breathıng Exercıse Applıed to Indıvıduals Wıth Copd on Respıratory Functıon, Dyspnea and Qualıty of Lıfe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Dyspnea
COPD
Breathing Exercise
Pranayama
Respiratory Function
Quality of Life.
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was planned as a prospective, randomized controlled, experimental type study with pretest-posttest measurements to determine the effect of breathing exercise on dyspnea, respiratory function and quality of life in patients with COPD.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of the research This research was designed to determine the effect of breathing exercise applied to individuals diagnosed with COPD on respiratory function, dyspnea and quality of life.

Hypotheses of the Research H0a: Breathing exercise applied to individuals diagnosed with COPD has no effect on the respiratory function test FEV1/FVC.

H1a: Breathing exercise applied to individuals diagnosed with COPD has an effect on the respiratory function test FEV1/FVC.

H0b: Breathing exercise applied to individuals diagnosed with COPD has no effect on dyspnea.

H1b: Breathing exercise applied to individuals diagnosed with COPD has an effect on dyspnea.

H0c: Breathing exercise applied to individuals diagnosed with COPD has no effect on quality of life.

H1c: Breathing exercise applied to individuals diagnosed with COPD has an effect on the quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD for at least 1 year, confirmed by pulmonary function test
* Those who voluntarily accepted to participate in the research
* Those aged 18 and over,
* Individuals who have access to the hospital

Exclusion Criteria:

* In COPD exacerbation period,
* Having a neurological or psychiatric diagnosis,
* Those with obesity,
* Those with physical disabilities (vision, hearing, walking, etc.),
* Those who are pregnant,
* Illiterate
* Diagnosed with another disease that significantly affects the respiratory system (scoliosis, lung cancer, abdominal tumor, etc.).
* Patients who have previously participated in an exercise program will be excluded from the study.

Primary outcomes:
measure: pulmonary function test
timeFrame: 6 weeks
measure: Dyspnea severity
timeFrame: 6 weeks
measure: Saint George's Solunum Anket
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
affiliation: Ondokuz Mayıs University
name: Aybike KÖSE, 1
role: STUDY_CHAIR
affiliation: Ondokuz Mayıs University
name: Afitap ÖZDELİKARA, 2
role: STUDY_DIRECTOR
References:
Clinical trial NCT04223297: Blue Protocol Assessment
Official title: Interest Assessment of the Blue Protocol in Improving Diagnosis of Dyspneic Patients in Pre- and Intra-hospital Emergency Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Emergencies
Keywords: dyspnea
lung ultrasound
emergency medicine
blue protocol
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Clermont
name: Centre Hospitalier de Montreuil sur Mer
name: Centre Hospitalier de Beauvais
name: Centre Hospitalier de Compiègne
name: Centre Hospitalier de Doullens
name: Centre Hospitalier de Abbeville
First posted: 2020-01-10
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each dyspneic patient meeting the inclusion criteria and admitted in emergency room will be included in the protocol.

Brief summary: Acute dyspnea is a common disease in emergency medicine. Mortality remains high is estimated at 15%. One third of initial diagnoses before paraclinical examination are estimated to be inaccurate. Lung ultrasound is a quick and immediate examination. Also, it is provided and performed at the bedside. The " Blue protocol " was designed by Daniel A. Lichtenstein as a diagnostic aid in dyspneic patients. It allows to obtain a diagnostic in more than 90% of acute dyspnea. However there is no validation in emergency medicine.

The main purpose is to evaluate the interest of the " Blue protocol "in the management and orientation of the dyspneic patient


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* dyspneic patient requiring management by an emergency physician
* information given and no patient opposition.

Exclusion Criteria:

* patient under a legal protection measure
* lack of social security

Primary outcomes:
measure: concordance between the clinical diagnosis and the final diagnosis
timeFrame: day of arrival in emergency
measure: concordance between the diagnosis establishes after the ultrasonography and the final diagnosis
timeFrame: day of arrival in emergency
Secondary outcomes:
measure: Change of proportion of examinations leading to a change in the therapeutic hypothesis
timeFrame: 8 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03356197: Epidemiology of Conjunctivitis in the Emergency Department
Official title: Epidemiology of Conjunctivitis in the Emergency Department of a Reference Ophthalmological Hospital in Goiânia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Conjunctivitis
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 783
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were submitted to a initial care in the Emergency Department performed by the Ophthalmology First Year Resident (R1) .

Brief summary: Epidemiology of Conjunctivitis in the Emergency Department of a Reference Ophthalmological Hospital in Goiânia.

Detailed description: The purpose of this study was to determine the epidemiology of ocular emergencies in a Reference Ophthalmological Hospital in Goiânia, with emphasis on acute infectious conjunctivitis, morbidity with a higher incidence in this Service. It aims to delineate the main etiologies found among infectious conjunctivitis and to compare them with those found in several other reference services in Ophthalmology.

Eligibility criteria: Inclusion Criteria:

* All those patients who were submitted to a initial care performed by the First Year Resident (R1) of the Hospital and who were admitted during the period described.

Exclusion Criteria:

* The patients who were admitted in the Emergency Department outside this period
* The patients who were not attended by a First Year Resident (R1)
* The patients who did not have all the data filled in the medical record
* The patients who needed to return, being attended in the hospital more than once.

Primary outcomes:
measure: Evaluation of the main etiologies of acute infectious conjunctivitis in the Emergency Department of a Reference Hospital in Goiânia.
timeFrame: 126 days
Secondary outcomes:
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto de Olhos de Goiania
state: Goiás
Study officials:
References:
Clinical trial NCT02804997: Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery
Official title: Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thoracic Surgery
Keywords: non-invasive ventilation
cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV, hemodynamic stability, prior consent, spontaneous ventilation, social security coverage

Brief summary: The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV,
* hemodynamic stability
* prior consent
* spontaneous ventilation
* social security coverage.

Exclusion Criteria:

* Under-18 patients
* complex cardiac surgery
* pregnancy
* pre-existing chronic obstructive respiratory disease (COPD \> stage II)
* legal guardianship
* incarceration

Primary outcomes:
measure: Quantitative evaluation by thoracic CT scan
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Elie ZOGHEIB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01936597: Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage
Official title: Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage During Training in Non-hospital Cardiac Cases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: external cardiac massage, medical hotline,
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer.

The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010)

* frequency
* depth of chest compressions.

This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).


Eligibility criteria: Inclusion Criteria:

- Healthy volunteers from the general population understanding the French language.

Exclusion Criteria:

* major physical disability;
* do not speak French
* first aid training under one year

Primary outcomes:
measure: frequency and depth of chest compressions
timeFrame: at the end of the simulation (10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU - Hôptaux de Rouen (Hôpital Charles Nicolle)
Study officials:
affiliation: CHU - Hôpitaux de Rouen
name: Cédric DAMM, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04795297: Observational Study of Correlation Between Recurrent Basal Cell Carcinoma and Localisation
Official title: Observational Study of Basal Cell Carcinoma Operated at Montpellier University Hospital and Millau Hospital From February 2020 to February 2021 - Study of Correlation Between Localisation and Recurrence, and Other Criterias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Keywords: Resection of BCC (Basal Cell Carcinoma)
Recurrence of BCC (Basal Cell Carcinoma)
Localisation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 804
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort :

All the resected BCC during one year in Montpellier University Hospital and Millau Hospital (both analyzed in anatomopathology unit in Montpellier University Hospital).

Cases :

All the cases of recurrent BCC, found after research in medical records or histopathology request form.

Brief summary: .During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).

From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.

The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.


Eligibility criteria: Cohort :

Inclusion criteria:

- Patients with resected BCC

Exclusion criteria:

* Biopsies of BCC,
* revised surgery of incomplete resection.

Cases :

Inclusion criteria:

-Recurrent BCC with complete first resection

Exclusion criteria:

- Recurrent BCC with incomplete first resection, Patients with Gorlin syndrome (a genetic disease that increase risk of BCC)

Primary outcomes:
measure: - Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
timeFrame: 1 day
Secondary outcomes:
measure: Analysis of correlation between localisation and histology characteristics
timeFrame: 1 day
measure: Analysis of correlation between histological type and recurrence risk
timeFrame: 1 day
measure: Analysis if there is a difference between first resection histological type and the recurrent histological type
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Sophie Pons, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536497: Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.
Official title: A 2 Part Open-label, Randomised, Crossover Study to Compare the Effects of Formulation, Food and Particle Size on the Pharmacokinetic Profiles of a Single 175mg Dose of GW842166X in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: GW842166,
Healthy volunteers,
Inflammatory Pain.
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.


Eligibility criteria: Inclusion Criteria:

* Body weight \>50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
* Healthy as judged by a responsible physician.

Exclusion Criteria:

* Positive pre-study urine screen for drugs of abuse or alcohol breath test.

Primary outcomes:
measure: Plasma GW842166 Cmax and AUC (O-Infinity)
timeFrame: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)
Secondary outcomes:
measure: Plasma GW842166 AUC (0-t), tlag,tmax and t1/2
timeFrame: Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03141697: The Use of CO2 in Routine-Colonoscopy
Official title: Is CO2 Insufflation an Amelioration of Routine Colonoscopy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Carbon Dioxide
Coloboscopy
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.

Detailed description: Between April 2012 and August 2014 150 patients referred to the University Hospital of Leipzig for colonoscopy were randomly assigned to either CO2 or air insufflation.

All examinations were performed by one of four experienced endoscopists. The patients usually received sedation. For sedation midazolam and propofol was used. At the beginning of the examination the patients usually received between 3-5 mg of midazolam and 20-40 mg propofol. During endoscopy propofol was titrated by administration of 20 mg at the time according to and pain reaction of the patient and required depth of sedation.

All patients had nasal insufflation of oxygen with 2 litres per minute. All sedated patients were monitored for pulse, blood pressure and blood oxygen saturation.

For bowel cleansing a solution of Macrogol 3350 (Moviprep®, Norgine) was administered orally according to the manufacturer.

All colonoscopies were performed using Fujifilm Endoscopes (EC 590 Series). For examinations with use of carbon dioxide the Fujifilm CO2 Insufflator GW-1 was used with appropriate water bottle and endoscope valve. The air pump of the light source Fujifilm System 4400 was deactivated according to the manufacturer.

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* informed consent

Exclusion Criteria:

* former colonic resections
* severe heart or lung disease (NYHA III or IV)
* Pregnancy
* Patients with planned gastroscopy within 24 hours

Primary outcomes:
measure: Post-procedural pain
timeFrame: 0 - 24 hrs after colonoscopy
Secondary outcomes:
measure: Abdominal bloating
timeFrame: 0 - 24 hrs after colonoscopy
measure: flatulence
timeFrame: 0 - 24 hrs after colonoscopy
measure: procedure time
timeFrame: duration of colonoscopy
measure: Used amount of sedative drugs
timeFrame: during endoscopy
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
References: