louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06243094: Antibiotic Therapy Practices for Ventilator-Associated Pneumonia (PETUNIA)
Official title: Survey on Antibiotic Therapy Practices for Ventilator-Associated Pneumonia in ICU Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventilator Associated Pneumonia
Keywords: antibiotic
intensive care
guidelines
outcome
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 1060
Sex: ALL
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: Participants in this study will be ICU patients, undergoing invasive mechanical ventilation \> 48h, for whom antibiotic therapy is initiated to treat a suspicion of Ventilator-Associated Pneumonia (VAP).

Brief summary: The French Society of Intensive Care conducts a comprehensive assessment of current antibiotic therapy practices in critically ill patients suspected of Ventilator-Associated Pneumonia (VAP).

Detailed description: This prospective observational multicenter study will be conducted in intensive care units (ICU) across France and French-speaking regions. The primary objective of this study is to delineate the characteristics of antibiotic treatments administered for a first episode of suspected VAP. Secondary objectives include describing the outcomes of enrolled patients, assessing adherence to European guidelines regarding empirical antibiotic treatment, and identifying factors associated with mortality in patients with microbiologically confirmed VAP.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Admission to the ICU
* Intubation and duration of invasive mechanical ventilation \> 48 hours
* Initiation of new antibiotic therapy to treat a first suspicion of Ventilator-Associated Pneumonia (VAP)

Exclusion Criteria:

* Presence of a decision to limit active therapeutic measures at the time of initiating antibiotic therapy
* Organ donor
* Prior inclusion in the study during a previous stay in the intensive care unit (a patient cannot be included multiple times)
* Participation in an interventional study focusing on the management of VAP and directly impacting antibiotic therapy practices
* Patient and/or family opposition to participation
* Lack of affiliation with a social security system

Primary outcomes:
measure: Characteristics of Initial Antibiotic Treatment
timeFrame: 3 days
measure: Characteristics of Definitive Antibiotic Treatment (for patients alive at Day 3 only)
timeFrame: 7 days
measure: Total Duration of Appropriate Treatment
timeFrame: ICU stay (up to 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille university hospital
state: Haut De France
Study officials:
affiliation: French Intensive Care Society
name: Anahita Rouzé, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00441194: To Compare the Octopus 311 and the Humphrey Field Analyzer 700 Series
Official title: To Compare the Octopus 311 and the Humphrey Field Analyzer 700 Series With Respect to Reliability, Reproducibility, Test Duration, Patient Preference, Technician Preference.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Visual Field
Keywords: Perimetry
Visual Field
Octopus
Lead sponsor: Haag Streit USA
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects

Brief summary: To compare the Octopus 311 and the HFA 700 series

Detailed description: To compare the Octopus 311 and the HFA 700 series to evaluate reliability, reproducibility, test duration, patient preference and technician preference.

Eligibility criteria: Inclusion Criteria:

* Prior Visual Field

Exclusion Criteria:

* Scotopic pupil less than 3 mm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Capital Eye Consultants
state: Virginia
Study officials:
affiliation: American, Virginia and Northern Virginia Optometric Associations
name: James Powers, O.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937494: Bronchial Hyperreactivity During Histamine Passive Exposure
Official title: Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Bronchial Hyperresponsiveness
Keywords: asthma
bronchial hyperresponsiveness
histamine challenge test
spirometry
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.Bronchial challenge test is used to confirm/exclude asthma (metacholine or histamine).Protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction even if they suffer from BHR.The purpose of the study is to determine if patients with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are developing a bronchoconstriction, when placed in the same conditions that the technicians performing these tests.

Detailed description: Bronchial hyperresponsiveness (BHR) consists in excessive response to bronchial stimuli.Bronchial challenge test is used to confirm/exclude asthma.BHR is also present in other diseases such as allergic rhinitis, Chronic Obstructive pulmonary disease,heart failure..

Thes test is performed with metacholine or histamine with spirometric documented response to incremental doses.Protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction if they suffer from BHR.

The purpose of the study is to determine if patients, newly diagnosed with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are reacting to histamine when placed in the same conditions that the technicians performing these tests.

Eligibility criteria: Inclusion Criteria:

* adult patients with positive histamine challenge test (first dose)

Exclusion Criteria:

* other active respiratory disease

Primary outcomes:
measure: spirometric values in patients exposed passively to histamine during BHR challenge
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: service de pneumologie, CHU St Pierre
Study officials:
affiliation: CHU ST Pierre
name: Marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02188394: Anesthetic Blockades and Migraine
Official title: Effects of Anesthetic Blockades on Pain Modulation in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Migraine
Pain
Keywords: migraine,
pressure pain,
anesthetic blocks
patients
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 36
Sex: FEMALE
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: Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.


Eligibility criteria: Inclusion Criteria:

* Chronic migraine

Exclusion Criteria:

* Other primary headaches
* Other secondary headaches
* Co-morbid medical diseases

Primary outcomes:
measure: Changes in the number of days with moderate/intense migraine
timeFrame: Baseline (1 week before) and 1 week after intervention
Secondary outcomes:
measure: Changes in the number of days with mild/moderate migraine
timeFrame: Baseline (1 week before) and 1 week after intervention
measure: Changes in the number of symptomatic medication drugs
timeFrame: Baseline (1 week before) and 1 week after intervention
measure: Changes in pressure pain thresholds
timeFrame: Baseline, 1 hour after and 1 week after intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid
Study officials:
affiliation: Hospital Clinico San Carlos-Universidad Complutense de Madrid
name: Maria Luz Cuadrado, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.
Clinical trial NCT06789094: Validating the Ain Shams Cognitive Assessment Tool
Official title: Validating the Ain Shams Cognitive Assessment (ASCA) for Diagnosing Mild Cognitive Impairment and Dementia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mild Cognitive Impairment (MCI)
Dementia
Keywords: Mild cognitive impairment
Dementia
cognitive assessment
Arabic cognitive assessment tools
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community dwelling elderly participants (caregivers of inpatients, attendants of primary care , elderly clubs and other community gatherings).

Brief summary: The diagnosis of cognitive impairment, including dementia and mild cognitive impairment (MCI), is crucial for timely intervention and management. Various screening tools are available for assessing cognitive function, among which the Mini-Mental State Examination (MMSE), the Addenbrooke's Cognitive Examination (ACE), and the Montreal Cognitive Assessment (MoCA) are widely used. However, the recently developed Ain Shams University Cognitive Assessment (ASCA) has shown promise in detecting early cognitive decline. This study aims to assess the performance of ASCA in diagnosing cognitive impairment against DSM5 criteria.


Eligibility criteria: Inclusion Criteria: older adult participants 60 years old and above who are native Arabic speakers

-

Exclusion Criteria:

* severe dementia, delirium, major mental disorders, aphasia, and those with severe visual or hearing impairment that interfere with the assessment.

Primary outcomes:
measure: ASCA cut off points
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05214794: An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Official title: An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Sclerosis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
* Systemic Sclerosis patients with moderate to sever skin sclerosis

Exclusion Criteria:

* Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
* Patients with a diseases that could interfere with assessment of Systemic Scleorosis
* Patients with body weight less than 30.0kg
* Pregnant or lactating women.

Primary outcomes:
measure: Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
Study officials:
affiliation: Tokyo University
name: Ayumi Yoshizaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00287794: Quality of Sleep in Patients With Rheumatoid Arthritis
Official title: Study on the Quality of Sleep in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
sleep disturbance
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with rheumatoid arthritis with or without sleep disturbance.

Brief summary: As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. The investigators hypothesized that this unique character might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. The investigators test (1) the sleep quality of the patients and draw some characteristic features, and (2) investigated the connection between unique biochemical changes such as the increase of c-fos or wee-1.

Detailed description: Under the hypothesis the unique character of patients might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. We do following studies; The study of sleep quality of the patients; The number of patients expected to be included in the study is 1,000. Inclusion criteria is the ACR criteria, and exclusion criteria is any defined disease conditions of sleep disorders in ICSD. The method includes questionnaire using the Pittsburgh Sleep Quality Index (PSQI) scoring and Epworth scoring, and actigraphy measurement for more than 3 days. In a portion of the patients, we measure clinical arthritis activities in conjunction with western blot for c-fos and wee-1 as well as routine clinical laboratory tests. Also in a portion of the patients, we do the polysomnography study; expected number of participants would be 100. We also plan to test the effect of good sloop on arthritis in a portion of the patients.

Eligibility criteria: Inclusion Criteria:

* Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis

Exclusion Criteria:

* Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kakogawa
country: Japan
facility: Konan Kakogawa Hospital
state: Hyogo
Study officials:
affiliation: Faculty of Heath Science, Kobe University School of Medicine
name: Shunichi Shiozawa, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01895894: Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
Official title: A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrotic Syndrome
Keywords: Mycophenolate mofetil
Immunosuppressive Agents
Nephrosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Chong Kun Dang Pharmaceutical
First posted: 2013-07-11
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.

Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.


Eligibility criteria: Inclusion Criteria:

* Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
* in complete remission

Exclusion Criteria:

* Hereditary or secondary nephrotic syndrome
* Estimated glomerular filtration rate (GFR) \< 60 mg/min/1.73 m\^2
* Body weight \<16 kg
* leukocytopenia (absolute neutrophil count \< 2000/mm\^3) or anemia(Hct \< 25%)
* Severe gastrointestinal disease
* chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
* prior live vaccine inoculation within 6 weeks (from the study enrollment)
* GOT/GPT elevation or hyperbilirubinemia
* malignant disease
* Pregnant or Breast feeding
* Previous history of mycophenolate mofetil use
* Participation to other therapeutic trial within recent 3 months
* Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase

Primary outcomes:
measure: relapse free time
timeFrame: 1 year
Secondary outcomes:
measure: adverse effect
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Gyung Aurea Kang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03194594: Dexamethasone and Ketamine on Change of Postoperative Mood
Official title: The Effects of Combination of Intravenous Dexamethasone and Ketamine on Change of Postoperative Mood in Patients Undergoing Laparoscopically Assisted Gynecologic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Symptoms
Keywords: Ketamine, dexamethasone, mood
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketamine and dexamethasone have been known to be effective postoperative pain. Many studies also have reported these two drugs might change mood such as depression. This study aimed to investigate the effect of each drug individually with their combination on perioperative change of mood in patients undergoing gynecologic surgery

Detailed description: After receiving by IRB approval and obtaining informed consent from patients, 93 patients who are aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II.

Afterward, the patients will be randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receive dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receive ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.

Eligibility criteria: A total of 93 patients

Inclusion Criteria:

* patients who were scheduled for laparoscopic gynecologic surgery

Exclusion Criteria:

* Patients with hepatic and renal insufficiency, history of allergy to the study drugs, previous gastric ulcer, diabetes mellitus, and receiving analgesic, antiemetic, antihistamine, steroids or psychiatric drugs within 24 hours before surgery steroids

Primary outcomes:
measure: The change of patient health questionnaire (PHQ)-9 scores
timeFrame: at the 1st day after surgery
Secondary outcomes:
measure: postoperative visual analog scale (VAS) for pain
timeFrame: for 48 h after surgery
measure: patient controlled analgesia (PCA) consumption
timeFrame: for 24 h after surgery
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: WonwangUH
state: Jeonbuk
Study officials:
affiliation: Wonkwang UH
name: Cheol Lee, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105494: An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia
Official title: Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 6000
Sex: ALL
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: Dialysis patients with end-stage kidney disease on treatment with epoetin beta \[Neorecormon\]

Brief summary: This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta \[Neorecormon\] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/=18 years of age
* Dialysis patients with chronic renal anemia
* Written informed consent

Exclusion Criteria:

* Red blood cell transfusion in the previous 2 months
* Severe neuropsychological disorder
* Diabetic patients with serious complications

This trial is being conducted in Morocco.

Primary outcomes:
measure: Quality of life assessment: Kidney Disease Quality of Life Questionnaire
timeFrame: Throughout study: 6 months
Secondary outcomes:
measure: Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life
timeFrame: Throughout study: 6 months
Other outcomes:
Locations:
city: Casablanca
country: Morocco
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: