louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00666679: Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)
Official title: Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 134
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Detailed description: During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Eligibility criteria: Inclusion Criteria:

* Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
* Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator

Exclusion Criteria:

* Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
* Has required an oral corticosteroid rescue for worsening asthma during the screening period

Primary outcomes:
measure: Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change From Baseline in Daytime Asthma Symptom Score
timeFrame: Baseline and 2 weeks
measure: Change From Baseline in Nighttime Asthma Symptom Score
timeFrame: Baseline and 2 weeks
Other outcomes:
measure: Change From Baseline in Total Daily β-agonist Use
timeFrame: Baseline and 2 weeks
measure: Percentage of Days With Asthma Control
timeFrame: 2 weeks
measure: Percentage of Days With Asthma Exacerbations
timeFrame: 2 Weeks
measure: Change From Baseline in Total Peripheral Blood Eosinophils
timeFrame: Baseline and 2 weeks
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, Villaran C, Shah SR, Vandormael K, Smugar SS, Reiss TF. The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. J Asthma. 2011 Jun;48(5):495-502. doi: 10.3109/02770903.2011.573042. Epub 2011 May 5.
Clinical trial NCT05969379: Investigational Biomarkers for Neurological Immune-related Adverse Events
Official title: Genetic Predisposition, Inflammation, and Neurodegeneration Biomarkers in Patients With Neurological Adverse Events of Immune Checkpoint Inhibitors: Correlation With Clinical Phenotypes and Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurological Disease
Keywords: Biomarkers
autoimmunity
immunotherapy side-effects
immune checkpoint inhibitors
neuroimmunology
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 18 years-old with a diagnosis of n-irAE

Brief summary: Neurological immune-related adverse events (n-irAEs) are an emerging group of disorders of patients with cancer treated with immune checkpoint inhibitors, presenting with heterogeneous clinical manifestations and of uncertain outcome. Novel genetic, inflammatory, and neurogenerative biomarkers could be associated with distinct phenotypes and different outcomes. To test this hypothesis, the study will provide: a phenotypic characterization and outcome assessment of patients with n-irAEs; the analysis of biomarkers of genetic predisposition (HLA and other immunity-related genes), inflammation (serum and cerebrospinal fluid \[CSF\] cytokines and autoantibodies, peripheral blood and CSF lymphocytes and other immune cells, neuroimaging), neurodegeneration (serum and CSF neurofilaments, neuroimaging) and their correlation with clinical features and outcome.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of n-irAEs

Exclusion Criteria:

* Presence of an alternative diagnosis explaining the neurological syndrome

Primary outcomes:
measure: Analysis of neurofilaments
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer
Study officials:
References:
Clinical trial NCT01437579: Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions
Official title: Randomized Controlled Trial for Efficacy of Botulinum Toxin Type A in Treatment of Patients Suffering Bladder Pain Syndrome/Interstitial Cystitis With Hunners' Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Interstitial Cystitis
Keywords: interstitial cystitis
bladder pain syndrome
intratrigonal injection
botulinum toxin
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 60
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: The etiology of bladder pain syndrome is unknown. Therefore the management is directed to pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy of botox for treatment of painful bladder.

The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are suffering bladder pain syndrome with Hunner lesions during cystoscopy.


Eligibility criteria: Inclusion Criteria:

* longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy

Exclusion Criteria:

* Pregnancy
* neurologic diseases
* urinary tract infections
* bladder outlet obstruction
* previous pelvic radiotherapy

Primary outcomes:
measure: Change from baseline in pain intensity
timeFrame: 1 week followed by 1, 3, and 6 months after BoNTA injection
measure: Change from baseline of intensity of bladder bother symptoms
timeFrame: within 1 week, at 3 months and 6 months
measure: Change from baseline of quality of life
timeFrame: within 1 week, at 3 months and 6 months
Secondary outcomes:
measure: Postvoid residual urine volume
timeFrame: within 1 week, at 3months and 6 months after BoNTA injection
measure: Upper urinary tract retention
timeFrame: 1 week, 3 months and 6 months after BoNTA injection
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Urology department of moscow state university of medicine and dentistry
Study officials:
References:
citation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Clinical trial NCT02862379: Personalized Rehabilitation Program for Elderly Patients That Fall
Official title: Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Falls
Rehabilitation
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death.

The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.


Eligibility criteria: Inclusion Criteria:

* Persons who have fallen minimum twice the last year
* 60 years old or more
* Mini Mental State Examination (MMSE) equal or superior to 23/30
* Persons who gave consent to participate in the study
* Persons with severe visual or hearing impairment

Exclusion Criteria:

* Patients with severe disease that might interfere with walking or with program monitoring

Primary outcomes:
measure: Falls Efficacy Scale (FES-I)
timeFrame: Change from baseline at 6 months and 12 months
Secondary outcomes:
measure: Number of falls the previous year before inclusion
timeFrame: at baseline
measure: Life Space Assessment scale
timeFrame: Change from baseline at 6 months and 12 months
measure: Get up and go test
timeFrame: Change from baseline at 6 months and 12 months
measure: Walking and talking test
timeFrame: Change from baseline at 6 months and 12 months
measure: Tinetti test
timeFrame: Change from baseline at 6 months and 12 months
measure: Measure of the time that the patient is able to stay in station bipedal standing feet together followed by a monopodal support
timeFrame: Change from baseline at 6 months and 12 months
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: Change from baseline at 6 months and 12 months
measure: Incidence of falls during one year
timeFrame: through the study completion, an average of 12 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Esprad Chute, Ghicl
Study officials:
affiliation: ESPRAD CHUTE, GHICL
name: Brigitte Romagny
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02424279: Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
Official title: Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Pain
Keywords: pancreatic cancer
pain
splanchnicectomy
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 90
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: Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is made usually in the late stage of this condition. One of the treatment methods of pain accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a safe procedure with a small percentage of complications, nevertheless it is often use as the last stage in pain management what significantly decreases its effectiveness.

The aim of this study is to determinate the effect of invasive pain treatment (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT questionnaires), and suffering (measured with PRISM projection test), the use of painkillers during the disease and patients' overall survival. Moreover the investigators want to check if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is combined with better therapeutic effect of this treatment.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with pancreatic cancer
* Age over 18 years
* Signed informed consent to participate in the study

Exclusion Criteria:

* Age under 18 years
* Intellectual inability to fill the questionnaires
* Co-occurrence of a disease in which significant chronic pain exists, which was recognized before the onset of pancreatic cancer

Primary outcomes:
measure: Change from baseline pain intensity at 1 year (BPI questionnaires)
timeFrame: one year
Secondary outcomes:
measure: Quality of life and pain intensity measurement (measured with the QLQ- C30, FACIT and BPI questionnaires)
timeFrame: From date of randomization until the date of death from any cause,assessed up to 100 months
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Department of General, Endocrine and Transplant Surgery, Medical University of Gdansk.
Study officials:
References:
citation: Dobosz L, Stefaniak T, Dobrzycka M, Wieczorek J, Franczak P, Ptaszynska D, Zasada K, Kanyion P. Invasive treatment of pain associated with pancreatic cancer on different levels of WHO analgesic ladder. BMC Surg. 2016 Apr 18;16:20. doi: 10.1186/s12893-016-0136-3.
Clinical trial NCT04671979: Serum Lactate in Acute Mesenteric Ischemia
Official title: Lactate Dehydrogenase, Bowel Necrosis and Mortality in Acute Mesenteric Ischemia: Retrospective Cross-Sectional
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesenteric Ischemia
Keywords: Biomarker
L-Lactate
Mortality
Lead sponsor: Universidad del Rosario
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seventy-four cases were identified that met the study's criteria. The patients' average age was 73.5 (SD, 10.7) years, and 44 (60%) were men. The mean body mass index was 25 (SD, 2.9) kg/m2. Fifteen (20%) of the patients presented non-occlusive acute mesenteric ischemia.

Brief summary: Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Nevertheless, the association between them has been mildly studied. Our objective was to evaluate the association between serum lactate admission levels, bowel necrosis extension, and mortality. Additionally, we performed a mortality characterization.

Materials and Methods: A retrospective cross-sectional study was designed. We reviewed patients' clinical records with acute mesenteric ischemia that attended a hospital between 2012 and 2018. We compared serum lactate admission levels with bowel necrosis length and mortality. A receiver operating characteristic curve was performed on the last association. As post hoc analysis, a classification and regression tree on mortality was fitted.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Required urgent laparotomy with a postoperative diagnosis of acute mesenteric ischemia
* Attended the private academic hospital, between 2012 and 2018
* Had a registered serum lactate dehydrogenase at admission

Exclusion Criteria:

* Secondary causes of AMI
* Chronic intestinal ischemic
* Patient records with no description of the serum lactate dehydrogenase or extension of intestinal necrosis

Primary outcomes:
measure: Serum Lactate in mmol/l
timeFrame: 30 days
measure: Bowel necrosis length in cm
timeFrame: 30 days
measure: Percentage of patients that died between 30 postsurgical days, %
timeFrame: 30 days
Secondary outcomes:
measure: Cut value of lactate levels as a predictor of mortality, in mmol/l
timeFrame: 30 days
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Andres Isaza Restrepo
state: Cundinamarca
Study officials:
References:
Clinical trial NCT03293979: Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis
Official title: Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flu
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: each patient admitted in emergy service between february 2016 and april 2016

Brief summary: It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular biology available in emergency service in the economic field .


Eligibility criteria: Inclusion Criteria:

* respiratory symptoms
* fever \>38°C
* general symptoms of flu like pathology

Exclusion Criteria:

* cognitive disorders
* patient with guardianship
* patient already having a flu diagnosis in the last 7 days
* without social protection.

Primary outcomes:
measure: time to have the result of the biological test
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: GANANSIA Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01549379: Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer
Official title: Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and neck cancer
Radiation
Chemotherapy
Surgery
Dynamic contrast enhanced computed tomography
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: London Regional Cancer Program, Canada
First posted: 2012-03-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma (includes variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head and neck
* Tumor stage: Any (T1-T4)
* Nodal stage:

  * N2 or N3 (≥ 3 cm) on pre-treatment imaging for radiotherapy cohort (higher likelihood of requiring neck dissection);
  * N1-N3 for surgery cohort. N0 admissible for T4 tumors.
* Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon), with recommendation for definitive chemoradiation therapy (n=15) or surgery (n=15)

Exclusion Criteria:

* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Metastatic disease, or imaging findings suspicious for metastases
* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer.
* Pregnant or lactating women
* Contraindication to DCE-CT (e.g. contrast allergy)

Primary outcomes:
measure: Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy
timeFrame: 8-10 weeks post treatment
Secondary outcomes:
measure: Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery
timeFrame: Approximately 2-6 weeks after enrollment
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
Study officials:
affiliation: London Regional Cancer Program
name: David A Palma, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01441479: Strep A Fluorescent Immunoassay and Analyzer Field Study
Official title: Strep A Fluorescent Immunoassay and Analyzer Field Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strep Throat
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-27
Enrollment: 1282
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must be greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.

Brief summary: The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects three (3) years of age or older

Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis

* Extreme sore throat
* Redness of the posterior pharyngeal wall
* Difficulty Swallowing
* Fever, \>38.7C (100F) at presentation or within past 24 hours
* Pharyngeal exudate
* Tender cervical lymphadenopathy
* Absence of cough or other upper respiratory symptoms

Exclusion Criteria:

* Subjects currently under treatment with antibiotics are not to be included in this study.
* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Primary outcomes:
measure: Streptococcus Group B identification
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Best Medical Group
state: Arizona
city: Carlsbad
country: United States
facility: La Costa Pediatrics
state: California
city: San Diego
country: United States
facility: La Jolla Pediatrics
state: California
city: Tampa
country: United States
facility: Teena Hughes
state: Florida
city: Morris Plains
country: United States
facility: FastER Urgent Care
state: New Jersey
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
References: