louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03573284: Validity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
Official title: Evaluating the Efficacy of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough Variant Asthma
Keywords: cough variant asthma
chronic cough
fractional exhaled nitric oxide
impulse oscillometry
forced mid-expiratory flow
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the research is to evaluate the clinical value of fractional exhaled nitric oxide(FeNO) ,impulse oscillometry(IOS) and mid-expiratory flow (MEF) in patients with cough variant asthma.

Detailed description: The present study has the following objectives:

to evaluate the relationship between BHR and mid-expiratory flow, to assess the diagnostic accuracy of fractional exhaled nitric oxide，impulse oscillometry and mid-expiratory flow in CVA with special regard to its discriminating value between CVA and other causes of a chronic cough, to estimate prognostic value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment.

Eligibility criteria: Inclusion Criteria:

age 18-65 years old. Cough as the sole or predominant symptom lasting for at least 8 weeks, with no radiographic evidence of lung diseases.

Exclusion Criteria:

treatment of any oral corticosteroid in the last 4 weeks, and respiratory tract infection within 8 weeks.

smoking (min. 6 months) had asthma or other lung diseases, including obliterative bronchiolitis, bronchiectasis,and cystic fibrosis.

Primary outcomes:
measure: the value of fractional exhaled nitric oxide(FeNO) in patients with cough variant asthma
timeFrame: at least 4 weeks of treatment
measure: the value of impulse oscillometry(IOS) in patients with cough variant asthma
timeFrame: at least 4 weeks of treatment
Secondary outcomes:
measure: the value of forced mid-expiratory flow (MMEF) in patients with cough variant asthma
timeFrame: at least 4 weeks of treatment
measure: the value of BHR and fractional exhaled nitric oxide (FeNO) count in predicting response to asthma treatment
timeFrame: at least 4 weeks of treatment
measure: the relationship between BHR and mid-expiratory flow
timeFrame: at least 4 weeks of treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Huapeng Yu
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Yu Hupeng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398184: Motor Imagery and Action Observation in Patients With Knee Osteoarthritis
Official title: Motor Imagery and Action Observation in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term.


Eligibility criteria: Inclusion Criteria:

* diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)

Exclusion Criteria:

* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
* undergone another hip or knee joint replacement in the previous year
* any medical condition in which exercise was contraindicated or if they had participated in exercise programs or motor imagery/action observation intervention

Primary outcomes:
measure: Pain intensity (Visual analogue scale)
timeFrame: through study completion, 1 month
measure: Disability (WOMAC scale)
timeFrame: through study completion, 1 month
measure: Algometry
timeFrame: through study completion, 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04440384: Long Term Evaluation of Function and Quality of Life After Pollicisation
Official title: Long Term Evaluation of Function and Quality of Life After Pollicisation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patients That Had Pollicization Surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient that underwent pollicisation surgery more than 5 years before

Brief summary: The study aims at describing long term functional outcome of patients that underwent pollicisation surgery.

The hypothesis of the study is that there are prognostic factors of good function results of pollicisation (based on T-GAP classification for function) that will be searched on univariate and multivariate analysis.


Eligibility criteria: Inclusion Criteria:

* More than 7 years and less than 50 years
* Underwent unilateral or bilateral pollicisation surgery
* For children : non opposition of the parents
* For adults : non opposition

Exclusion Criteria:

- Patients able to understand the research and to answer to forms

Primary outcomes:
measure: T-GAP score
timeFrame: At baseline, Day 0 (>5 years post-surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital femme mère enfant
Study officials:
References:
Clinical trial NCT00202384: Gene Expression in MS Patients Before and During Treatment With Interferon-beta
Official title: Gene Expression in MS Patients Before and During Treatment With High-dose Interferon Beta: Prospective Study for the Identification of Predicting Factors of Therapeutic Response.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
microarrays
Lead sponsor: S. Andrea Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient MS centres

Brief summary: Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients.

Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time.

The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.


Eligibility criteria: Inclusion Criteria:

* diagnosis of relapsing-remitting MS (McDonald criteria)
* age between 18-55
* EDSS less or equal to 5.5

Exclusion Criteria:

* use of any other disease modifying drugs
* use of corticosteroids during 3 months before starting protocol
* clinical relapse during 1 month before starting protocol
* serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams

Primary outcomes:
measure: Gene Expression in MS Patients
timeFrame: baseline and 12 months after IFN beta 1a treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Study officials:
name: Marco Salvetti, MD
role: STUDY_DIRECTOR
References:
citation: Bomprezzi R, Ringner M, Kim S, Bittner ML, Khan J, Chen Y, Elkahloun A, Yu A, Bielekova B, Meltzer PS, Martin R, McFarland HF, Trent JM. Gene expression profile in multiple sclerosis patients and healthy controls: identifying pathways relevant to disease. Hum Mol Genet. 2003 Sep 1;12(17):2191-9. doi: 10.1093/hmg/ddg221. Epub 2003 Jul 8.
citation: Sturzebecher S, Wandinger KP, Rosenwald A, Sathyamoorthy M, Tzou A, Mattar P, Frank JA, Staudt L, Martin R, McFarland HF. Expression profiling identifies responder and non-responder phenotypes to interferon-beta in multiple sclerosis. Brain. 2003 Jun;126(Pt 6):1419-29. doi: 10.1093/brain/awg147.
citation: Weinstock-Guttman B, Badgett D, Patrick K, Hartrich L, Santos R, Hall D, Baier M, Feichter J, Ramanathan M. Genomic effects of IFN-beta in multiple sclerosis patients. J Immunol. 2003 Sep 1;171(5):2694-702. doi: 10.4049/jimmunol.171.5.2694.
citation: Waubant E, Vukusic S, Gignoux L, Dubief FD, Achiti I, Blanc S, Renoux C, Confavreux C. Clinical characteristics of responders to interferon therapy for relapsing MS. Neurology. 2003 Jul 22;61(2):184-9. doi: 10.1212/01.wnl.0000078888.07196.0b.
Clinical trial NCT05282784: Hyperthermia With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors
Official title: Exploratory, Open-labelled, Control Group-included, Single Institution Clinical Trial for Evaluating Immunogenic Effect of Hyperthermia Applied With Flexible Electrode-typed 2-MHz Device During Radiotherapy for Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor
Keywords: Radiotherapy
Hyperthermia
Lead sponsor: Yonsei Hyperthermia Study Group
Sponsor class: OTHER
Collaborators: name: Medicon, Inc.
First posted: 2022-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate immunogenic effect of hyperthermia applied with flexible electrode-typed 2-MHz device during radiotherapy for solid tumors.


Eligibility criteria: Inclusion Criteria:

* Solid tumor (primary, metastatic)
* Eastern Cooperative Oncology Group (ECOG) score 0-3
* Ability to understand and the willingness to sign a written informed consent documents

Exclusion Criteria:

* Myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia within 6 months
* Active infectious disease
* Pregnant or probability of pregnancy during treatment
* Obesity (BMI ≥35)
* Immunosuppressive drug after organ transplantation
* Autoimmune disease
* Skin injury on treatment area

Primary outcomes:
measure: Immunogenic effect
timeFrame: 1 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04188184: Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
Official title: Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures

Detailed description: Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and VIII. More than 95% of TXA intravenous administered dose eliminated unchanged through the urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .

Eligibility criteria: Inclusion Criteria:

* 18 - 60 years old
* ASA (I and II)
* Hb level \> 10 mg/dl
* elective ear exploratory tympanotomy surgery under general anesthesia.

Exclusion Criteria:

* Allergy to TXA
* bleeding/coagulation disorders
* psychiatric illness
* acute and chronic renal failure
* heparin use within 48 hrs or aspirin use within seven days before surgery,
* pregnancy
* liver cirrhosis
* color blindness
* cardiac stent.

Primary outcomes:
measure: State of surgical field categorized by surgeons based on Boezaart classification
timeFrame: 2 hour
Secondary outcomes:
measure: bleeding volume
timeFrame: 2 hour
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
city: Asyut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT03236584: Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir
Official title: Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
Lead sponsor: Uijeongbu St. Mary Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy


Eligibility criteria: Inclusion Criteria:

* HBsAg (+) for \> 6 months age \>19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels \<20 IU/ml on two consecutive tests of 3-month interval

Exclusion Criteria:

* Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Primary outcomes:
measure: SVR
timeFrame: 48 WEEK
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03560284: Marathon and Half Marathon Runners, Older Than 70 Years Old: Who Are They?
Official title: Marathon and Half Marathon Runners, Older Than 70 Years Old: Who Are They?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follow-up Care
Keywords: Marathon
Half Marathon
Runners
Ederly
Aging process
Sport Addiction
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Marathon and half marathon runners older than 70 years old

Brief summary: Through this study, the investigators intend to describe the profile of marathon and half marathon runners older than 70 years old, in terms of medical, social and psychological characteristics.

First, in order to acquire a better knowledge of these aged runners: who they are; on a medical, social and psychological point of view; to figure out their motivations; to assess the impact on their life, their health and aging process.

Then, in order to be able to offer them a better medical care, in terms of prevention, treatment and follow-up care.


Eligibility criteria: Inclusion Criteria:

* Older than 70 years old
* Marathon or Half marathon runner
* To give an agreement to use medical datas for research study

Exclusion Criteria:

- Refusal to give an agreement to participate

Primary outcomes:
measure: Evaluation of medical, social and psychological characteristics via a questionnare
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Geriatrie - Soins de Suite Et Readaptation
Study officials:
References:
Clinical trial NCT00449384: SIB-Norwegian Version, Validation and Reliability Study
Official title: Severe Impairment Study - Norwegian Version. A Validation and Reliability Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Diagnostic Tests, Routine
Keywords: Severe Impairment Battery
Clinical Dementia Rating
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB).

Detailed description: The study will include 60 persons with mild to severe dementia. To test the validation of SIB, we will interview the included persons with Severe Impairment Battery (SIB) and compare the results with Clinical Dementia Rating (CDV)reported by their nurses. To test interrater reliability 30 of the included persons will be interviewed with SIB by two different raters, and the two raters results will be compared.

Eligibility criteria: Inclusion Criteria:

* Dementia, mild to severe.
* Nursing Home resident

Exclusion Criteria:

* No ability to write or read.
* Physical handicapped, unable to use hands.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Sykehuset Innlandet HF - Sanderud
state: Oppland
Study officials:
affiliation: The Norwegian Centre for Dementia Research (NCDR), Norway
name: Knut Engedal, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04159584: Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD
Official title: Pilot Study: The Effects of Medical Music on Anxiety in Patients With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Neuralpositive
First posted: 2019-11-12
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an uncontrolled, interventional pilot study to determine feasibility
Primary purpose: TREATMENT

Brief summary: This is uncontrolled, interventional feasibility study for determining the effects medical music on anxiety levels in subjects with ILD. Enrolled subjects will be asked to complete questionnaires and undergo physiologic measurements prior to listening to medical music. The music intervention will be for approximately 30 minutes. Post intervention questionnaires and physiologic measurements will be done.

Detailed description: The Medical Music intervention includes playlists that contains songs specifically designed, recorded, and optimized through the provisionally-patented methods, to treat their co-morbid anxiety. The duration of the medical music playlist is 30 minutes.

Enrolled subjects will be asked to complete questionnaires to assess anxiety, a questionnaire related to their music preferences, and undergo physiological measurements (vital signs, galvanic skin response, and heart rate variability) before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Men and women age 50 to 80 years old
* Diagnosis of definite or probable interstitial lung disease (ILD)
* Willingness to participate and sign consent

Exclusion Criteria:

* Patients who are deaf
* Inability to provide informed consent
* Pregnant women

Primary outcomes:
measure: Feasibility of using a medical music intervention as a treatment for anxiety in subjects with ILD, as measured by descriptive evaluation.
timeFrame: Baseline to 30 minutes
Secondary outcomes:
measure: Change in State Anxiety Inventory scores before and after intervention
timeFrame: Baseline to 30 min
measure: Change in Visual Analogue Scale scores for Anxiety and Distress (VAS-A) before and after intervention
timeFrame: Baseline to 30 min
measure: Change in Borg Dyspnea Scale scores before and after intervention
timeFrame: Baseline to 30 min
measure: Change in heart rate variability before and after intervention
timeFrame: Baseline to 30 min
measure: Change in galvanic skin response before and after intervention
timeFrame: Baseline to 30 min
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Robert Kaner, MD
role: PRINCIPAL_INVESTIGATOR
References: