louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04265105: Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
Official title: A Pilot Randomised Controlled Superiority Trial of Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: asthma
fluticasone
LABA
fluticasone-vilanterol
Long acting Beta agonist
Lead sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigators will compare the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study, there is a random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol single daily use for the relief of symptoms.
Primary purpose: TREATMENT

Brief summary: Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care

Detailed description: single centre randomised control trial with the aim of comparing the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study there is random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol daily single dose for the relief of symptoms.

Eligibility criteria: Inclusion Criteria:

* Adults between the ages of 18 and 75 years old with a diagnosis of mild asthma attending the participating primary health care centres in Bahrain, being managed with usual care (SABA or ICS and SABA combination) and no other medications

Exclusion Criteria:

* Health centre medical record or self-reported use of LABA, leukotriene receptor agonist, theophylline, anticholinergic agent, oral corticosteroids for regular maintenance therapy in 3 months before entry to the trial. \[NB. nasal corticosteroid is permitted

Primary outcomes:
measure: Number of asthma exacerbations
timeFrame: 32 weeks/8 months
measure: Change in Asthma Control Score
timeFrame: baseline, 8 months
Secondary outcomes:
measure: Change in Asthma Quality of life score
timeFrame: baseline, 8 months
Other outcomes:
Locations:
city: Muharraq
country: Bahrain
facility: RCSI Bahrain
state: Busaiteen
Study officials:
References:
Clinical trial NCT05106205: Phamacokinetics and Safety Profiles of DA-5213 10mg in Healthy Subjects
Official title: An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5213 10mg in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phamacokinetics and safety profiles of DA-5213 10mg in Healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI between 18.0 and 30.0 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: [Time Frame: pre-dose~48 hours post-dose]
measure: Cmax
timeFrame: [Time Frame: pre-dose~48 hours post-dose]
Secondary outcomes:
Other outcomes:
Locations:
city: Siheung-si
country: Korea, Republic of
facility: Central Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00566605: Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Official title: Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Keratoconus
Lead sponsor: Hospital Oftalmologico de Sorocaba
Sponsor class: OTHER
First posted: 2007-12-03
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: To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old, with keratoconus and corneal transplant indication

Exclusion Criteria:

* Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Pachimetry, Microscopy, Corneal topography
timeFrame: 1 year
Other outcomes:
Locations:
city: Sorocaba
country: Brazil
facility: Sorocaba Eye Bank - HOSBOS
state: Sao Paulo
Study officials:
affiliation: Hospital Oftalmologico de Sorocaba
name: Elissandro M Silva, Lindoso
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02589405: Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris
Official title: Benzaknen® 5% Gel in Combination With Dermotivin® Soft Liquid Soap and Non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the Treatment of Mild-to-moderate Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
Collaborators: name: Proinnovera GmbH
First posted: 2015-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.

Detailed description: The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with 2 cosmetic products including a foam soap, Dermotivin® Soft Liquid soap, and a non comedogenic moisturizer, Cetaphil® Dermacontrol Moisturizer SPF30, in patients with mild to moderate acne, after 12 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female subject of any ethnic background of 12 years or older.
* Subject with mild or moderate facial acne vulgaris defined as an Investigator Global Assessment (IGA) score at 2 or 3 on a 0-4 scale.
* Subject with any skin phototype according to T.B. Fitzpatrick skin phototype definitions.

Exclusion Criteria:

* Subject with severe acne (IGA\>3) with nodules, cysts, scars or extra-facial lesions,
* Female subject who is pregnant, lactating or planning a pregnancy during the study,
* Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,

Primary outcomes:
measure: Number of Participants Satisfied and Very Satisfied With Regimen
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: EGBERT Mi-Ran
Study officials:
affiliation: Proinnovera GmbH
name: Mi-Ran EGBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MR, Kerrouche N. Combination of benzoyl peroxide 5% gel with liquid cleanser and moisturizer SPF 30 in acne treatment results in high levels of subject satisfaction, good adherence and favorable tolerability. J Dermatolog Treat. 2018 Feb;29(1):49-54. doi: 10.1080/09546634.2017.1342758. Epub 2017 Jul 5.
Clinical trial NCT04660305: AT278 and NovoRapid® in Glucose Clamp Study
Official title: Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Arecor Limited
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of type 1 diabetes for at least 12 months
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. HbA1c concentration ≤8.5% at screening
4. Weight within the range 75kg - 100kg (both inclusive)

Exclusion Criteria:

1. Known or suspected hypersensitivity to Investigational Medicinal Products
2. Clinically significant concomitant disease or abnormal lab values
3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

Primary outcomes:
measure: Area under the glucose infusion-rate curve of insulin aspart
timeFrame: 0 - 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Trials Unit, Medical University of Graz
Study officials:
References:
Clinical trial NCT01815905: Effect of U-Health Service in Stroke Patients
Official title: U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: KT Corporation
First posted: 2013-03-21
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Provides mobile programs for occupational and speech therapy to patients with stroke.


Eligibility criteria: Inclusion Criteria:

* stroke confirmed by brain imaging study
* Impairment in upper extremity function or speech
* native speaker of Korean

Exclusion Criteria:

* previous history of aphasia
* psychiatric or psychotic problem
* severe cognitive dysfunction
* severe hearing or visual loss
* cannot sit with devices

Primary outcomes:
measure: Fugl-Meyer upper extremity scale
timeFrame: 4weeks
measure: short form K-FAST (Korean version of Frenchay Aphasia Screening)
timeFrame: 4weeks
Secondary outcomes:
measure: Hand grip strength
timeFrame: 4weeks
measure: K-WAB(Korean version-the Western Aphasia Battery)
timeFrame: 4weeks
Other outcomes:
measure: EuroQol(EQ-5D)
timeFrame: 4weeks
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nam-Jong Paik, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01554605: Gait Disturbances and Hips Bone Mineral Density
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difference in BMD Between Both Hips
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects will be recruited from the bone clinic

Brief summary: The objective of this study is to investigate the role of gait disturbance as a cause for difference in Bone Mineral Density (BMD) between both hips. Each subject will undergo the following tests: Functional Mobility Testing, Gait analysis, Motion Analysis, Assessments for Balance and Gait and Cognitive assessments.


Eligibility criteria: Inclusion Criteria:

1. differeneces in hips in Bone Mineral Density test in one group.
2. Age 40-80.

Exclusion Criteria:

1. bone disease,
2. arthritis,
3. congenital skeletal malformations,
4. pregnancy,
5. neurological disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01922505: Eradication Rates of Helicobacter Pylori and Its Affecting Factors
Official title: The Trend of Eradication Rates of First-line Triple Therapy for Helicobacter Pylori and Clinical Factors That Affect the Eradication in Korean: Single Center Experience for Recent Ten Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Infections
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 2500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: H. pylori positive patient

Brief summary: The purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect the eradication in Korean.

Detailed description: A PPI triple regimen combining a proton pump inhibitor(PPI) with two antibiotics (amoxicillin and clarithromycin) is currently considered the gold standard therapy for eradication of H. pylori. However, recently the eradication rate with first-line treatment has a tendency to decrease because of increasing antibiotics resistance. In addition, PPI is mainly metabolized by cytochrome p450 2C19 (CYP2C19) in the liver and several reports have suggested that differences in th CYP2C19 genotype are associated with H. pylori eradication failure. Thus, the first aim of this study is to investigate the trend of eradication rates of first-line triple therapy in recent ten years. And the second aim is to analyze the antibiotics resistance rate for H. pylori by using culture minimal inhibitory concentrations(MICs) result and to analyze the association between CYP2C19 genotype and eradication rate of H.pylori. And also investigate the other clinical factors (age, gender, underlying disease, cigarette smoking and alcohol use) that affect the eradication rate.

Eligibility criteria: Inclusion Criteria:

* Patients who proven H. pylori infection by invasive or non-invasive H. pylori test
* Patients treated with First-line triple therapy (PPI + Amoxicillin + Clarithromycin)

Exclusion Criteria:

* Previous eradication therapy for H. pylori
* Follow-up loss patients after eradication therapy
* Other treatment regimen
* Poor medication compliance (\<80%)

Primary outcomes:
measure: Eradication Rates of First-line Triple Therapy for Helicobacter pylori
timeFrame: Four weeks after completing eradication therapy
Secondary outcomes:
measure: Clinical Factors that Affect the Eradication
timeFrame: Four weeks after completing eradication therapy
Other outcomes:
Locations:
city: Bundang-gu, Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06503705: Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders
Official title: Qualitative Investigation Into the Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Disorders
Keywords: Mental Disorders
Behavior Disorders
Anxiety Syndrome
Depression Syndrome
Mental health difficulties
Policmen
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active major subjet, administrative police officer, or scientific and technical police officer of the national police in France for more than a year, or work for the Ministry of the Interior as support staff, or medical staff,

Brief summary: Police officers are subject to various professional risk factors that can contribute to the occurrence of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. In previous work, low use of specialized care structures was noted. Added to this is the carrying of a weapon which represents an element facilitating the passage to self-aggressive action.

The objective of the study is to identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.


Eligibility criteria: Inclusion Criteria:

* Be an active, administrative police officer, or scientific and technical police officer of the national police in France for more than a year,
* Or work for the Ministry of the Interior as support staff, or medical staff,
* Agree to participate in the study,
* Agree to talk about the problem without managerial or union preconceptions.

Exclusion Criteria:

* Be in post for the Ministry of the Interior for less than a year.
* Be stationed in the Bas Rhin department (France), where the principal investigator works.

Primary outcomes:
measure: To identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pathologie Professionnelle - Médecine du Travail - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03539705: Food Allergy Registry at a Single Site
Official title: Food Allergy Registry at a Single Site
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy and Asthma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Food Allergy Research & Education
First posted: 2018-05-29
Enrollment: 6000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any interested party from 0-100 yrs of age to enter their information in registry

Brief summary: This is a registry of participants who are interested in being screened for clinical trials at a single site.

Detailed description: This registry will be maintained on a secure database and will include name, gender, age, disease, medical information, other information (via questionnaires), and date of consent. It will be overseen by our regulatory manager at our site and will not be shared with others outside of our site-specific trained individuals.

Eligibility criteria: Inclusion Criteria:

* Any interested party from 0-100 yrs of age to enter their information in registry

Exclusion Criteria:

* Any individual who does not consent

Primary outcomes:
measure: Registry to provide a list of interested individuals in clinical trials at a single site
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sharon Chinthrajah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03518905: Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa
Official title: Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa - a Prospective Randomized Sham-controlled Trial - the RAGE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Disorder
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized sham-controlled
Primary purpose: TREATMENT

Brief summary: The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.


Eligibility criteria: Inclusion Criteria:

* Histological proven presence of heterotopic gastric mucosa,
* pathologic Reflux Symptom Index (\>25)
* age: 18-70
* presence of symptoms \> 6 months,
* no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment
* negative symptom correlation for symptoms with reflux events in ambulatory pH monitoring

Exclusion Criteria:

* Not willing to participate in this study
* pregnancy
* lactation period

Primary outcomes:
measure: Normalization of the Reflux Symptom Index
timeFrame: 6 months after first RFA treatment/or sham procedure
Secondary outcomes:
measure: Histological eradication rate after radiofrequency ablation or sham treatment
timeFrame: 6 months after first RFA treatment/or sham procedure
measure: SF-12 quality of life
timeFrame: At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment
measure: Reflux Finding Score
timeFrame: Evaluated at the first intervention at study completion after 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: