louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03587545: Study of Probiotic Potential of Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
Official title: Study of Probiotic Potential of Nasopharyngeal Lactobacillus Strains in the Upper Respiratory Tract After Nasal Spray Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Chronic Rhinosinusitis (Diagnosis)
Probiotics
Sprays
Nasal Disease
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Probiotics are defined as "live micro-organisms that, when administered in adequate amounts, confer a health benefit to the host" (Hill et al, 2014). These microbes are generally applied in the gastrointestinal tract via fermented food products or capsules. In previous research, the investigators isolated bacterial strains with potential probiotic properties for the upper respiratory tract based on in vitro laboratory tests, in vivo mice experiments and genome sequencing.

In this study, the investigators want to deliver the Proof-of-Concept that the most promising isolated strain, Lactobacillus casei AMBR2 (LAMBR2) and the well-documented probiotic strain Lactobacillus rhamnosus GG (LGG) also have interesting properties in humans, i.e. that these strains are able to -temporarily- persist in the upper respiratory tract of healthy volunteers and CRS patients after daily nasal application via a nasal spray for 2 weeks. In addition, the investigators aim to explore whether the application of these strains has an impact on the nasopharyngeal microbiome via 16S rRNA amplicon sequencing and dedicated qPCR analysis.

Therefore, bacterial DNA from nasal swabs will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of the Lactobacillus and specific pathogens will be monitored via qPCR.


Eligibility criteria: Inclusion Criteria:

* CRS patient group: CRS diagnosed

Exclusion Criteria:

* no patients with trisomy 21
* no pregnant women
* no breastfeeding women
* no acute or chronic airway infections (except for CRS patients in CRS patient group)
* no cancer
* no autoimmune diseases

Primary outcomes:
measure: Nasal persistence of lactobacilli
timeFrame: 3 years
Secondary outcomes:
measure: Microbiome differences
timeFrame: 3 years
measure: Therapeutic potential: chronic rhinosinusitis
timeFrame: 3 years
measure: Therapeutic potential: nasal hyperreactivity
timeFrame: 3 years
measure: Therapeutic potential: SNOT-22 score
timeFrame: 3 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Sarah Lebeer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01876745: A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
Official title: A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Glanzmann's Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with GT, who are enrolled in this study and to whom activated recombinant human factor VII (NovoSeven®) is administered in the study period, shall be included.

Brief summary: This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol).
* All-treated patients in the registration period

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria \[The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied\]
* Patients with a history of hypersensitivity to any of the product components

Primary outcomes:
measure: Therapy-related thrombosis
timeFrame: From onset of treatment until 6 hours after treatment onset
Secondary outcomes:
measure: Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
timeFrame: Within 30 days of end of treatment for bleeding episodes
measure: Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
timeFrame: Within 24 hours after surgery for surgery/delivery
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04758845: Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults
Official title: A Randomized, 5 Arm, Parallel, Placebo Controlled Clinical Study to Evaluate Safety and Efficacy of New Probiotic Strains in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Health
Respiratory Health
Safety
Keywords: Probiotics
Gastrointestinal Health
Respiratory Health
Immunomodulation
Antioxidant
Chelation of heavy metals
Lead sponsor: Deerland Enzymes
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form. Healthy adults aged 18-65.

Exclusion Criteria:

* Presence of a pre-existing adverse events monitored in the study. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major GI surgery, chronic GI illness, abnormal intestinal anatomy or significant abdominal disorder. Severe chronic illness. Known immunodeficiency. Use of immunosuppressive agents. Presence of severe immunodeficient family members. Pregnancy, 6 months postpartum period or currently breastfeeding. Women of child bearing age planning pregnancy during the course of the study. Participation in another study. Not able to understand and comply with requirements of the study.

Primary outcomes:
measure: Safety
timeFrame: 45 days
Secondary outcomes:
measure: Immunomodulation
timeFrame: 45 days
measure: Regularity
timeFrame: 45 days
measure: GI Health
timeFrame: 45 days
measure: Respiratory Health
timeFrame: 45 days
Other outcomes:
measure: Heart Health
timeFrame: 45 days
measure: Inflammation
timeFrame: 45 days
Locations:
city: Šempeter Pri Gorici
country: Slovenia
facility: Health Center Nova Gorica
Study officials:
affiliation: Health Center Nova Gorica
name: Lilijana K Besednjak, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02924545: Evaluation of Osteoporosis Support After a Severe Osteoporotic Fracture in Women Over 50 Years in University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients over 50 years (\> 50 years) hospitalized at the CHU de Nîmes all services (rheumatology , orthopedic surgery, emergency medicine versatile , physical medicine and rehabilitation, etc.) taken into charge between 1 January 2014 and 31 December 2014 for a wrist fracture , femoral neck or spine osteoporotic fracture.

Patients supported for a fracture may be osteoporotic, will be identified using the PMSI (Programme de Médicalisation des Systèmes d'Information) data.

Brief summary: Evaluate the support of osteoporosis in women over 50 years with severe osteoporotic fractures (hip, vertebral, rib, Humeral, pelvic fractures) in the Nîmes University Hospital taking prediction of treatment of osteoporosis as criterion.


Eligibility criteria: Inclusion Criteria:

* patients over 50 years (\> 50 years) with severe osteoporotic fractures (hip, vertebral, rib, Humeral, pelvic fractures) hospitalized in the Nîmes University Hospital

Exclusion Criteria:

* patient under 50 years
* Non osteoporotic fractures

Primary outcomes:
measure: Is the treatment of osteoporosis scheduled according to the hospital report? yes/no
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02411045: Dress for Success: Can Just Dressing for the Gym Help Going to the Gym?
Official title: Dress for Success: Can Just Dressing for the Gym Help Going to the Gym?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Indirect incentives
Exercise more
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2015-04-08
Enrollment: 1310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators ask the question: can incentivizing smaller, less costly behaviors-like just getting yourself dressed to go to the gym-be more effective (and palatable) than incentivizing the larger goal directly?

Detailed description: To test this hypothesis, the investigators will randomly assign participants to one of three experimental conditions: (1) control, (2) dress for success (low effort), and (2) exercise for success (high effort). The investigators' hypothesis is that incentivizing a low effort, indirect/workout-related behavior (i.e., "dressing for success") will be more effective in motivating workouts than the control, despite a lack of economic incentive for the workout itself. Additionally, the investigators will compare workout levels for groups 2 and 3; if there is no difference between the two groups (or if 2 has higher exercise rates than 3), this would suggest that indirect incentives may be as effective as direct ones.

Eligibility criteria: Inclusion Criteria:

* those who opt-in to the recruitment email to all of the investigators' corporate partner's users.

Exclusion Criteria:

Primary outcomes:
measure: number of steps taken
timeFrame: 1-2 weeks before and after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L. Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Bradford Tuckfield
role: PRINCIPAL_INVESTIGATOR
affiliation: HBS
name: Katherine Barasz
role: PRINCIPAL_INVESTIGATOR
affiliation: HBS
name: Leslie K. John, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03929445: Bougie Assisted Endotracheal Intubation in Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask
Official title: A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Keywords: Bougie
Air Q
Fastrach
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate.

Detailed description: The investigators hypothesis that using bougie with its smaller caliber or lesser size can facilitate intubation and improve success rate when blind intubation through both devices fails.

Study objectives

* To make a comparison between Air-Q intubating laryngeal mask and Fastrach intubating laryngeal mask by using bougie assisted endotracheal intubation through both devices in patients undergoing elective surgeries in Suez Canal Hospitals.
* To assess the first trial success rate, the total success rate, time to tracheal intubation, the number of attempts, hemodynamics and adverse events.

Eligibility criteria: Inclusion Criteria:

* Patient aged \>18 years old.
* Gender both male and female.
* Patients are ASA I (American Society of Anesthesiologists' physical status Grade I) normal healthy patients or ASA II patients with mild systemic disease and no functional limitations

Exclusion Criteria:

* Any disorder of the cardiovascular, pulmonary, hepatic, renal, or gastrointestinal systems known from history or general examination.
* Patients with unstable cervical spine
* Any medical disease that may affect airway as Rheumatoid arthritis.
* Patient refusal to participate in the study.

Primary outcomes:
measure: success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach
timeFrame: 180 seconds after anethesia induction
measure: The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)
timeFrame: !80 seconds after anesthesia induction
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Intraoperative and in the first 48 postoperative hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ghada A.Kamhawy
Study officials:
affiliation: Suez Canal University
name: Ghada A. Kamhawy, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06213545: Diagnostic Accuracy of Teledermatology in Patch Test Interpretation
Official title: Diagnostic Accuracy of Teledermatology in Patch Test Interpretation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teledermatology
Keywords: teledermatology
patch test
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to learn about accuracy of teledermatology in patch test interpretation in patch test\&amp;#39;s patients population. The main question\[s\] it aims to answer are:

* Accuracy of teledermatology in patch test interpretation by dermatologist
* Accuracy of teledermatology in patch test interpretation by Residency
* Accuracy of teledermatology in patch test interpretation by Scitentist
* The factors influencing the interpretation of remote dermatologic patch test results from photographs of patients.

Participants will

* do patch test in Siriraj hospital and come to follow up at 48 hr and 72 hr for interpretation of patch test
* take a photo at home and sent the photo to contact clinic via online application or email on the day of 48 hr, 72 hr and 7 days following the interpretation of patch test

Researchers will compare in-clinic group and telephoto group to see if the accuracy of patch test interpretation is more or less.


Eligibility criteria: Inclusion Criteria:

* Participants in the study must be 18 years of age or older.
* Participants in the study must have undergone patch testing for contact allergies.
* Participants in the study should be able to take photos of test results on their back and/or arms using a mobile phone or personal camera, and send them to the researcher through the Line application and/or email within 48 hours, 96 hours, and on the 7th day.
* Participants in the study should be able to read and comprehend the questionnaire in Thai and respond to the questionnaire independently.
* Participants in the study must have at least one positive result in the patch testing.
* Participants in the study must provide consent to participate in the study by signing the informed consent document.

Exclusion Criteria:

* Participants in the study who are unable to attend follow-up appointments for result assessments.

Primary outcomes:
measure: grading of patch test
timeFrame: 48 hours, 72 hours and 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of medicine, Siriraj hospital, Mahidol university
state: Bangkok
Study officials:
References:
Clinical trial NCT00163345: Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
Official title: Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Small Airways
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent
* History of bronchial asthma
* FEV1 more than or equal to 60% of predicted
* Stable asthma
* Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS
* COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* Use of ICS 4 weeks before entry into the baseline period
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Use of other drugs not allowed
* Current smokers and ex-smokers with more than or equal to 10 pack-years

Primary outcomes:
measure: variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
measure: FVC% at PC20 AMP, SVC% at PC20 AMP
measure: regional air trapping
measure: bronchial and alveolar exhaled NO
measure: lung function variables
measure: non-cellular inflammatory markers.
Secondary outcomes:
measure: safety and tolerability.
Other outcomes:
Locations:
city: RB Groningen
country: Netherlands
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: Cohen J, Douma WR, ten Hacken NH, Vonk JM, Oudkerk M, Postma DS. Ciclesonide improves measures of small airway involvement in asthma. Eur Respir J. 2008 Jun;31(6):1213-20. doi: 10.1183/09031936.00082407. Epub 2008 Feb 20.
Clinical trial NCT04936945: Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases
Official title: Comparative Study Between the Outcome of Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Arthroscopic Management of Temporomandibular Degenerative Joint Diseases: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of intra-articular injection of platelet rich plasma versus hyaluronic acid following diagnostic arthroscopy in the management of patients suffering from degenerative temporomandibular joint (TMJ).

This is a prospective randomized study of 20 patients with TMJ degenerative joint diseases Wilkes IV, V.

Patients will be divided into two groups; Group A: will be treated with operative arthroscopy plus intra-articular platelet rich plasma.

Group B: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.


Eligibility criteria: Inclusion Criteria:

* - All patients with reduced mouth opening and/or painful maximum mouth opening.
* Joint pain.
* Patients with radiological evidence of degenerative joint disease.
* Patients with unsuccessful medical conservative treatment for at least two months.
* Unilateral or bilateral temporomandibular joint involvement.
* Wilkes stages IV and V

Exclusion Criteria:

* - Patients with bony ankylosis .
* Patients with advanced resorption of the glenoid fossa.
* Patients with infection or tumors around joint area
* Patients unfit for intervention medically.
* Patients who refused to share in the study

Primary outcomes:
measure: Maximum Interincisal Opening (MIO) Measurements
timeFrame: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
measure: Pain Intensity Measurements
timeFrame: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Professor
name: Samia M Saied, MD
role: STUDY_CHAIR
References: