louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01631071: Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Virosomal influenza vaccine
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy female and male adults aged ≥18 on Day 1
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
* Investigational medicinal product received in the past 3 months (90 days) starting from the first day of the month following the last visit in a previous study
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative of the investigator
* Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Primary outcomes:
measure: Seroprotection
timeFrame: Day 22 +/- 2 days
measure: Seroconversion
timeFrame: Day 22 +/- 2 days
measure: Geometric Mean Titer
timeFrame: Day 22 +/- 2 days
Secondary outcomes:
measure: Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
timeFrame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)
Other outcomes:
Locations:
city: Arzo
country: Switzerland
facility: CROSS-Research SA
Study officials:
affiliation: CROSS-Research SA
name: Milko Radicioni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202071: A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
Official title: A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Rabeprazole
proton pump inhibitor
pharmacokinetics
pharmacodynamics
healthy adult male Japanese subjects
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.


Eligibility criteria: Inclusion Criteria:

* healthy adult Japanese male between the age of 20-40
* body mass index between 18.5-25

Exclusion Criteria:

* clinically significant abnormal physical examination, vital signs or electrocardiogram
* use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
* use of any non-prescription medication within the previous 1 week
* history of drug or alcohol abuse

Primary outcomes:
measure: Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
timeFrame: Day 5 of administration during Period I-IV
Secondary outcomes:
measure: Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
timeFrame: Day 1 and Day 5 of administration during Period I-IV
measure: Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
timeFrame: Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)
Other outcomes:
Locations:
city: Toshima-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section
name: Masahiro Munesue
role: STUDY_DIRECTOR
References:
citation: Hayato S, Hasegawa S, Hojo S, Okawa H, Abe H, Sugisaki N, Munesue M, Horai Y, Ohnishi A. Dose-response relationships of rabeprazole 5, 10, 20, and 40 mg once daily on suppression of gastric acid secretion through the night in healthy Japanese individuals with different CYP2C19 genotypes. Eur J Clin Pharmacol. 2012 May;68(5):579-88. doi: 10.1007/s00228-011-1164-7. Epub 2011 Nov 23.
Clinical trial NCT06840171: The Effect of Mandala Coloring on Depression, Anxiety and Quality of Life of Inpatients in a Psychiatric Clinic
Official title: The Effect of Mandala Coloring on Depression, Anxiety and Quality of Life of Inpatients in a Psychiatric Clinic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effects of mandala coloring activity applied to individuals hospitalized in a psychiatric clinic with a diagnosis of anxiety and depression disorder on quality of life, psychological resilience and depression, anxiety and stress levels.

Detailed description: Introduction: It is stated that healthcare professional-patient interaction and patient activity improve clinical outcomes for patients with mental illness. When compared to psychosocial interventions, the most commonly used method in 49% of clinics was found to be artistic practices. It is stated that mandala painting has a calming and healing effect on the individual, facilitating psychological integration and personal meaning in life.

Objective: The aim of this study is to examine the effects of mandala coloring activity applied to individuals hospitalized in a psychiatric clinic with a diagnosis of anxiety and depression disorder on quality of life, psychological resilience and depression, anxiety and stress levels.

Method: The research will be conducted using a randomized controlled experimental research design. The research sample will consist of 50 patients in a university hospital psychiatry clinic. Research data will be collected using the Introductory Information Form, Depression-Anxiety-Stress Scale Short Form, Quality of Life Scale (SF-12), and Brief Resilience Scale. Patients diagnosed with anxiety and depression will undergo 8 sessions of mandala application. Data will be collected in two time periods before starting the mandala application and at the end of the 8-session application.

Eligibility criteria: Inclusion Criteria:

* Agreeing to participate in the study
* Being 18 years of age or older
* Diagnosed with anxiety and depression disorder

Exclusion Criteria:

* Those who gave incomplete answers to the scales used in the study
* Those with serious psychiatric symptoms (e.g. harming themselves or others, sedation)
* Those who did not participate in the mandala coloring session
* Those who did not agree to participate in the study

Primary outcomes:
measure: Depression-Anxiety-Stress Scale
timeFrame: 3 week
measure: Quality of Life Scale
timeFrame: 3 week
measure: Brief Psychological Resilience Scale
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yıldırım Beyazıt U
name: Reyhan Eskiyurt
role: STUDY_DIRECTOR
References:
Clinical trial NCT06017271: Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Official title: Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Embolism
Lung Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted on patients with a confirmed diagnosis of Lung Cancer who were admitted to the First Affiliated Hospital of Xi'an Jiaotong University from 1 January 2012 to 31 December 2021. Patients who did not meet any of the inclusion criteria or met any of the exclusion criteria were excluded. The subjects were divided into PE group and control group according to the results of CTPA examination, and the patients in the two groups were matched by gender and age 1:1 tendency score.

Brief summary: The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT). Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory cytokines and adipokines, participating in the formation of local inflammation, promoting the formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients with lung cancer have increased inflammatory response and are more prone to suffer thrombosis. However, in lung cancer patients, the clinical correlation between EAT and pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density, as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer patients, half with pulmonary embolism and half without. The incidence of adverse prognosis and related factors were followed up by telephone.


Eligibility criteria: Inclusion Criteria:

* The pathological diagnosis was lung cancer
* Pulmonary artery was evaluated by CTA during hospitalization.

Exclusion Criteria:

* Patients with incomplete clinical data
* Patients with no follow-up data
* Patients with a history of PE before diagnosis of lung cancer

Primary outcomes:
measure: EAT volume
timeFrame: May, 20, 2023
measure: EAT density
timeFrame: May, 20, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Haichen Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02658071: Measurement of Ocular Tensional Fluctuation by Triggerfish Lens Before and After Cataract Surgery in Patients With Exfoliative Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Exfoliative Glaucoma
Keywords: exfoliative glaucoma
cataract
ocular pressure
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Sensimed AG
First posted: 2016-01-18
Enrollment: 10
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: Patient with exfoliative glaucoma and cataract

Brief summary: Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and their axons slowly die with visible changes at the optic nerve head (cupping). Without early diagnosis and effective treatment or with delayed treatment decrease of visual acuity or blindness become.

In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise. The exfoliation material is found on the surface of the lens capsule with frequent developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP) decrease.

Some recent study have found decreasing ocular volume variation associated to IOP fluctuation in night after cataract surgery in normal pressure glaucoma patients. In our study we want see if it's the same thing in pseudoexfoliation glaucoma patients.


Eligibility criteria: Inclusion Criteria:

* Adult
* Exfoliative glaucoma
* Patient who need cataract surgery
* Patient agree with study

Exclusion Criteria:

* Monophtalm patient
* Patient with bleb after glaucoma surgery
* Terminal glaucoma
* Herpes
* One year control impossible

Primary outcomes:
measure: Measurement of ocular tensional fluctuation by Triggerfish lens before and after cataract surgery in patients with exfoliative glaucoma.
timeFrame: During 24H00 before and after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: University Hospital of Brest
name: Catherine COCHARD, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01048671: Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)
Official title: Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant Infected With HIV-1

Brief summary: To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.


Eligibility criteria: Inclusion Criteria:

* Participant Infected With HIV-1.
* Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
* Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.

Exclusion Criteria:

* Participant taking part in a clinical trial to assess raltegravir.
* Participant in whom raltegravir treatment was started more than 30 days ago.

Primary outcomes:
measure: Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
timeFrame: Up to 25 months after start of raltegravir treatment
measure: Percentage of Participants Responding to Treatment: All Treated Participants
timeFrame: 24 months after start of raltegravir treatment
measure: Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
timeFrame: 24 months after start of raltegravir treatment
measure: Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
timeFrame: Baseline and 24 months after start of raltegravir treatment
measure: Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
timeFrame: Baseline and 24 months after start of raltegravir treatment
Secondary outcomes:
measure: Number of Participants With at Least One Adverse Event
timeFrame: Up to 25 months after start of raltegravir treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00446771: A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study has an open-label, randomized, crossover design, in which each subject will receive mannitol powder for inhalation using a dry powder inhaler with and without premedication with a bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.


Eligibility criteria: Inclusion Criteria:

* Subject has signed a written informed consent form.
* Subject is a normal male volunteer between 18 and 65 years of age.
* Subject is willing to comply with the procedures of the study and to remain in the clinical unit for the scheduled visits.
* Subject is willing to abstain from chewing gum for the duration of the study.

Exclusion Criteria:

* Subject has asthma or other disease affecting the lungs or airways.
* Subject has a history indicating possible airway hyperresponsiveness.
* Subject is allergic to mannitol or gelatin or a known intolerance to intravenous mannitol.
* Subject uses inhaled drugs (legal or illegal).
* Subject uses oral bronchodilator drugs.
* Subject has celiac disease, Crohn's disease or other disease affecting intestinal absorption.
* Subject has renal impairment or other condition that would affect urine collection.
* Subject's weight deviates by more than 15% from the ideal weight listed for his height in the Metropolitan Life table.
* Subject is a smoker.
* Subject has participated in another clinical trial within the past 30 days.
* Subject has used chewing gum within the past 72 hours.
* Subject needs to use bisphosphonates, non-steroidal anti-inflammatory agents, or other drugs known to affect intestinal permeability on a chronic basis.
* Subject has used non-steroidal anti-inflammatory agents within the past 72 hours

Primary outcomes:
measure: To determine the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously.
measure: To determine the relative bioavailability of mannitol powder for inhalation by comparison to orally administered mannitol.
measure: To determine the pharmacokinetic parameters of systemically available mannitol after administration of mannitol powder by inhalation.
Secondary outcomes:
measure: A secondary objective of the study is to provide information on the urinary excretion of mannitol after each of the routes of administration.
Other outcomes:
Locations:
Study officials:
affiliation: Nucleus Networks
name: Andrew Humberstone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184171: Treatment of Microscopic Colitis
Official title: Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colitis
Keywords: Microscopic colitis
Drug treatment
Diarrhoea
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 105
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 study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

Detailed description: This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).

Eligibility criteria: Inclusion Criteria:

* Microscopic colitis verified with biopsies from the colon
* Symptoms to such an extent that treatment is indicated
* Age \> 17 years
* Informed consent

Exclusion Criteria:

* Previous treatment with any of the investigational drugs
* Patients treated with ketoconazole
* Pregnant and breast-feeding females

Primary outcomes:
measure: Symptoms: Stool frequency and consistency
timeFrame: 2001 - 2011
Secondary outcomes:
measure: Histological findings in biopsies from colon
timeFrame: 2001 - 2011
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Aust-Agder Sentralsjukehus
city: Gjovik
country: Norway
facility: Sykehuset Innlandet HF, Gjøvik
city: Hamar
country: Norway
facility: Sykehuset Innlandet, HF, Hamar
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet HF, Lillehammer
city: Molde
country: Norway
facility: Helse NordMøre og Romsdal
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Aker sykehus
city: Oslo
country: Norway
facility: Rikshopitalet
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Per G Farup, PhD
role: STUDY_CHAIR
References: