louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01057628: A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients
Official title: Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Blood glucose
ASP1941
Diabetes mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients for at least 12 weeks
* HbA1c value between 7.0 and 10.0%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2
* Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases

Primary outcomes:
measure: change from baseline in HbA1c
timeFrame: 16 weeks
Secondary outcomes:
measure: change from baseline in fasting plasma glucose
timeFrame: 16 weeks
measure: change from baseline in fasting serum insulin
timeFrame: 16 weeks
measure: safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
timeFrame: During treatment
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
Clinical trial NCT03258528: Effect of Right Lateral Position on Ventilated Preterm Neonates
Official title: Effect of Right Lateral Position With Head Elevation on Tracheal Aspirate Pepsin in Ventilated Preterm Neonates: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 60
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2
Primary purpose: PREVENTION

Brief summary: Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured.

Detailed description: Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates \< 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured. Ventilatory settings were observed before and during the intervention and neonates were followed up for development of bronchopulmpnary dysplasia (BPD).

Eligibility criteria: Inclusion Criteria:

* A total of 60 preterm neonates \< 35 weeks gestational age were enrolled in the study, Inclusion criteria were tracheal intubated mechanically ventilated neonates for more than 72 hours, feeding \>30ml/kg/day via nasogastric tube.

Exclusion Criteria:

* Neonates with perinatal asphyxia, intracranial hemorrhage grade 3 or 4, periventricular leukomalacia, major congenital anomalies, gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedatives were excluded.

Primary outcomes:
measure: tracheal aspirate pepsin
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04349228: Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
Official title: Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID19
Sars-CoV2
Hydroxychloroquine
Prophylaxis
Healthcare Worker
Keywords: HCQ
prophylaxie
Healthcare Worker
Hydroxychloroquine
COVID19
Lead sponsor: Abderrahmane Mami Hospital
Sponsor class: OTHER
Collaborators: name: Eshmoun Clinical Research Center
name: Datametrix
First posted: 2020-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm1:Hydroxychloroquine (HCQ) (200 mg / day) for at least 2 months or until potential contamination\*\*.

Arm2:Placebo (1 tablet/day) for at least 2 months or until potential contamination\*\*.

\*\* If the participant is contaminated (COVID19+), he or she will be followed up by telephone according to the study schedule.
Primary purpose: PREVENTION

Brief summary: Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study

Detailed description: Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COVID-19 (-)
* Works in a medical intensive care unit exposed to COVID-19 infection
* 18 years old \< age \< 65 years old
* Having given written consent for their participation in the study.

Exclusion Criteria:

* Diagnosis of COVID-19+
* Retinopathies,
* Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study.
* Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug,
* Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance \< 30 ml/min.
* Inability to be monitored during the trial period
* Pregnancy and breastfeeding
* Psoriasis

Primary outcomes:
measure: Symptomatic COVID(+) infection rate
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Study officials:
affiliation: Hopital Abderrahmane Mami
name: Jalila Ben Khelil, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04744428: Trial of Autism Parent Navigator Program
Official title: Test of an Innovative, Scalable Support Program for Parents With a Young Child Recently Diagnosed With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: Family Connections
First posted: 2021-02-09
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.


Eligibility criteria: Inclusion Criteria:

* Parents of children who have been newly diagnosed with Autism Spectrum Disorder (ASD).
* The child will be age 2-6 years and been diagnosed with ASD in the past four months.
* The child is the first child in the family to be diagnosed with ASD.
* Parents are not already involved in a parent mentoring relationship.
* Parents are currently involved in a couple relationship, including same-sex partners, dating couples, adoptive parents and step-parent families.

Exclusion Criteria:

None

Primary outcomes:
measure: Weekly Count of Service Navigation Behaviors
timeFrame: 12 month
measure: Parenting Scale (Arnold)
timeFrame: 12 month
measure: CES-Depression
timeFrame: 12 month
Secondary outcomes:
measure: Coparenting Relationship Scale (Feinberg, Brown, & Kan, 2012)
timeFrame: 12 month
measure: Family Empowerment Scale - FES
timeFrame: 12 month
measure: PDD-BI
timeFrame: 12 month
Other outcomes:
Locations:
city: Columbia
country: United States
facility: USC
state: South Carolina
Study officials:
affiliation: Penn State
name: Mark Feinberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02660593: Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes
Official title: SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Chinese medicine
exercise
diet
Lead sponsor: Shidaihuajing Institute for Diabetic Research
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MedlinePlus related topics: Blood Sugar

Primary Outcome Measures:

* Fast glucose and HbA1c change between the baseline and end of study \[ Time Frame: From baseline to 30 and 100 days\]
* \[ Designated as safety issue: No \]
* Successful rate of blood glucose control (the proportion of patients with HbA1c \<7%) \[ Time Frame: From baseline to 30 days and 100 days\] \[ Designated as safety issue: No \]

Secondary Outcome Measures:

• To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36 \[ Time Frame: From baseline to month 1 \] \[ Designated as safety issue: No \]

Detailed description: This study is aimed to evaluate the safety and efficacy of Sangrow Decotion, diet and exercise for the treatment of type 2 diabetes. Previous study has shown that this therapeutic regimen is safe and effective.

Eligibility criteria: Inclusion Criteria:

* Type II diabetes mellitus patients who have received medical treatment for more than 3 months
* Patients willing to sign written informed consent form

Exclusion Criteria:

* Patients unable or unwilling to comply with the requirements of the protocol
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.

Primary outcomes:
measure: Blood Sugar level
timeFrame: From baseline to 30 and 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jiuhua Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Shidaihuajing Institute
name: Shizhan CHi, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00308893: BDNF Gene Polymorphism and Antidepressants Treatment
Official title: Brain Derived Neurotrophic Factor (BDNF) Gene Polymorphism and Response to Antidepressants Treatment in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Antidepressants
escitalopram
Genetic polymorphism
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2006-03-30
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main hypothesis is that the therapeutic response and pharmacological resistance to ADs in depressed patients can be associated with a polymorphism for the BDNF gene. The research of allelic forms associated to lesser efficiency or inefficiency of ADs could add to the body of evidence that BDNF mediates the mechanism of action of ADs, and could have important practical implications. We propose to compare in a group of patients with major depression, the allelic variability of the BDNF gene between responders and non-responders after a 3-week period and a 6-week period of SSRI treatment.

Detailed description: * The main objective is to research an association between polymorphism for the BDNF gene and the 3-week and 6-week response to a SSRI treatment (escitalopram) in major depression.
* A case control pilot study without any direct individual benefit (200 patients).
* Study period: 24 months.
* Scores from reliable and validated psychometric scales (Montgomery and Asberg Depression Scale, Mini International Neuropsychiatric Interview) specifically analysing depression dimension at the time of inclusion, after three and six weeks of antidepressant treatment.
* Genetic analysis researching a polymorphism of the BDNF gene is done by a blood sample at the baseline.

Eligibility criteria: Inclusion Criteria:

* Patient suffering a severe depressive episode (according to DSM-IV), evolving since at least 2 weeks before entering the study
* Age superior to 18 years
* Caucasian type
* In absence of any medicinal treatment that could enhance depression: methyldopa, beta-blockers, reserpine,
* In absence of hypothyroidia or anaemia
* Without comorbidity that could affect therapy response : e.g. food disorder, substance abuse or dependence syndrome

Exclusion Criteria:

- Will be excluded from the study the patients for which a modification of the depression diagnosis (according to the DSM-IV criteria) takes place during the period of study

Primary outcomes:
measure: Score on Montgomery and Asberg Depression Rating Scale (MADRS)
timeFrame: At 3 weeks and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CPU CHRU de Tours
Study officials:
affiliation: UNIVERSITY HOSPITAL OF TOURS
name: Wissam EL HAGE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05046093: Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study
Official title: Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Nodule
Keywords: Cryobiopsy
Pulmonary nodule
Radial EBUS
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.

Detailed description: This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.

Eligibility criteria: Inclusion Criteria:

* Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
* Age ≥ 18
* Written informed consent after participant's information

Exclusion Criteria:

* Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
* Pure GGO lesion
* Patients at increased risk of bleeding

  1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy
  2. Coagulopathy: Thrombocytopenia (\< 100,000/mm3) or prolonged PT (INR \> 1.5)
* Patient with existing or risk of pulmonary and cardiovascular decompensation
* Intolerance to sedation
* Vulnerable groups such as pregnant woman, breast feeding, etc.
* Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility

Primary outcomes:
measure: Diagnostic yield based on pathologic diagnosis
timeFrame: up to 6 months
Secondary outcomes:
measure: Diagnostic yield based on clinical diagnosis
timeFrame: up to 6 months
measure: Adverse events
timeFrame: up to 1 week
Other outcomes:
measure: Type of bronchoscope
timeFrame: up to 1 day
measure: Guide sheath use
timeFrame: up to 1 day
measure: Radial endobronchial ultrasound probe orientation
timeFrame: up to 1 day
measure: Procedure time in minutes and seconds
timeFrame: up to 1 day
measure: Diameter of cryoprobe
timeFrame: up to 1 day
measure: Number of biopsy
timeFrame: up to 1 day
measure: Freezing time of cryoprobe in seconds
timeFrame: up to 1 day
measure: Biopsy size in millimeter
timeFrame: up to 1 month
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jung Seop Eom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01719393: Pulse Spectrum Analysis in Adult Asthmatics: Correlation With Lung Function, Asthma Control Exhaled Nitric Oxide and Metabolites in Exhaled Breath Condensate
Official title: Pulse Spectrum Analysis in Adult Asthmatics: Correlation With Lung Function, Asthma Control Exhaled Nitric Oxide and Metabolites in Exhaled Breath
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulse Spectrum Analysis
Pulmonary Function
FeNO
Metabolites
Keywords: Asthma
Pulse spectrum analysis
lung function
exhaled nitric oxide
metabolites
exhaled breath condensate
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthma paitients

Brief summary: Our hypothesis is that radial arterial pulse may reflect the severity and airway function in asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with airy inflammation an lung funtion in asthmatics.

Detailed description: The microcirculation is directly involved in the cellular matabolism and homeostasis. Our hypothesis is that radial arterial pulse spectrum may reflect the airway condition in asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with lung function, asthma control status,exhaled nitric oxide, and metabolites in the exhaed breath condensates.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria of GINA guideline asthma patients

Exclusion Criteria:

* Cancer or immune impaired patients;
* pack-year smoking\> 5;
* long-term ventilator-dependent patients
* Control group: 30 age matched healthy controls

Primary outcomes:
measure: Pulse spectral analysis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ping-Hung Kuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382693: Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia
Official title: Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia in Long-term Care: a Cluster-randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Behavioral symptoms
Long-term care
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project, a small-scale pilot study, will attempt to determine if involvement in a group-based creative expression program may correlate with a reduction in use of psychotropic drugs for persons with dementia.

Detailed description: The study site has two skilled-nursing dementia Special Care Units. One unit will serve as a control with residents receiving the standard care activity program. The other unit will receive the standard care activity program as well as the TimeSlips storytelling program (two hour-long sessions per week for six weeks). The behavioral symptoms and psychotropic drug usage for both cohorts will be studied for eight months, the first four months with no intervention and the last four months with or without the six-week TimeSlips intervention.

Eligibility criteria: Inclusion Criteria:

* residence in one of two dementia special-care skilled nursing units at the study site
* clinical diagnosis of dementia

Primary outcomes:
measure: Rates of psychotropic drug prescriptions for study participants.
timeFrame: eight months
Secondary outcomes:
measure: Mood and behavior patterns
timeFrame: eight months
Other outcomes:
Locations:
city: Lititz
country: United States
facility: Landis Homes
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Winona S Houser, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
name: Daniel R George, PhD
role: STUDY_DIRECTOR
References: