louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06176703: Mobile Application for Self-Management of Type 2 Diabetes Mellitus
Official title: Mobile Application for Self-Management of Type 2 Diabetes Mellitus: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this Randomized Controlled Trial is to study the effect of mobile Application on glycemic control of type2 diabetes mellitus. The main questions aim to answer are:

* The effect of mobile application on glycemic control and quality of life of diabetes mellitus patients
* The satisfaction of mobile application of diabetes mellitus patients who used it Participants will be received education about diabetes mellitus and separated into two groups, intervention group(using mobile application) and control group(not using mobile application but also receive standard treatment of diabetes mellitus.

Researchers will compare intervention group to control group about glycemic control including HbA1c, complications of diabetes mellitus etc. and quality of life.


Eligibility criteria: Inclusion Criteria:

* Type2 diabetes mellitus who have HbA1c above 7%
* Can use application on smartphone
* age 18 years old or more (relatives are accept if participants have age more than 65 years old and cannot use smartphone)
* consent to participate the research

Exclusion Criteria:

* refuse to participate the research
* pregnancy
* using continuous glucose monitoring system or insulin pump
* disability in sight or hearing
* have been using the mobile application(RAMAdiabetes) in the past

Primary outcomes:
measure: Glycemic control
timeFrame: 3-6 months
measure: Glycemic control
timeFrame: 3-6 months
Secondary outcomes:
measure: self-diabetes management
timeFrame: 3-6 months
measure: Quality of life
timeFrame: 3-6 months
Other outcomes:
Locations:
city: ฺBangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital
name: Chutintorn Sriphrapradang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01620203: Observational Study in Preterm Infants With Intracranial Hemorrhage
Official title: Observational Study in Preterm Infants With and Without Intracranial Hemorrhage: Longitudinal Assessment of Cerebral Oxygenation, Perfusion and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hemorrhage
Intraventricular Hemorrhage
Cerebral Hypoxia
Keywords: Premature infants
Intracranial hemorrhage
Intraventricular hemorrhage
Cerebral oxygenation
Brain function
Cerebral perfusion
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants admitted to the newborn intensive care unit at Holtz Children's Hospital of the Jackson Memorial Hospital/University of Miami Medical Center.

Brief summary: Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome.

The investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown.

This longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.


Eligibility criteria: Inclusion Criteria:

* Preterm infants born between 23 and 28 weeks of gestation
* Diagnosed with ICH grades II or higher during the first week after birth
* Matched control infants without ICH.

Exclusion Criteria:

* Major congenital malformations
* Birth asphyxia
* Not expected to survive

Primary outcomes:
measure: Change in cerebral oxygenation
timeFrame: postnatal weeks 4 and 8
Secondary outcomes:
measure: Change in cerebral perfusion and function
timeFrame: post natal weeks 4 and 8
Other outcomes:
Locations:
city: Miami
country: United States
facility: Holtz Children's Hospital, Jackson Memorial Hospital/University of Miami Medical Center
state: Florida
Study officials:
affiliation: University of Miami
name: Nelson Claure, M.Sc.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Eduardo Bancalari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Deepak Jain, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Sethuraman Swaminathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03041103: Acceptability and Tolerance of a Protein and Micronutrient Fortified Food
Official title: Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Nutrition
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single arm not blind
Primary purpose: OTHER

Brief summary: Acceptability and tolerance of a new food product in adults and children.

Detailed description: Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. The participants will record amount of daily intake, and will be given an entry and exit surveys. These surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. Acceptability will be measured as the number of servings and portion of serving completed each day over the trial period.

In adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.

Eligibility criteria: ° Inclusion Criteria:

* Male, 40-60 years old
* Male or Female 9-13 years old
* Subject is willing and able to comply with the study protocols
* Subject is willing to consume the test products

Exclusion Criteria:

* Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
* Under current medical supervision
* Non-English speaking
* Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
* Currently taking prescription drugs or supplements
* Daily use of aspirin and or non-steroidal anti-inflammatory medicines.
* Indications of substance or alcohol abuse within the last 3 years
* Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
* Self-reported malabsorption
* Current enrollee in a clinical research study.

Primary outcomes:
measure: GI function
timeFrame: at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Department of Nutrition
state: California
Study officials:
affiliation: University of California, Davis
name: Carl L Keen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01195103: Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery
Official title: A Prospective Randomized Study to Assess the Efficacy and Safety of Bolus-dose Lusedra (Fospropofol Disodium) 6.5 mg/kg or 10 mg/kg Versus a Placebo (With Midazolam Rescue) for Minimal-to-moderate Sedation in Patients Undergoing Procedural Sedation for Regional Anesthesia Blocks Prior to Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Procedural Sedation
Regional Anesthesia Block
Orthopedic Surgery
Keywords: Procedural sedation
Regional Anesthesia block
Orthopedic surgery
Lusedra
Fospropofol disodium
Midazolam
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2010-09-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?

Detailed description: The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a superior recovery profile compared to midazolam when used as a rescue comparator. While this study will only enroll patients undergoing regional blocks prior to orthopedic surgery, the clinical utility and value of the larger initial intravenous dosing for Lusedra may be evident for many different monitored anesthesia care anesthetic management situations requiring rapid and effective onset of effects.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective orthopedic surgery
* With a regional block prior to surgery
* Able to consent and complete the assessments and procedures
* If female, must be surgically sterile, postmenopausal, or not pregnant or lactating and using an acceptable method of birth control for at least 1 month prior to surgery with a negative urine pregnancy test at screening
* American Society of Anesthesiologists Physical Classification System status category P1 to P4

Exclusion Criteria:

* History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
* Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated

Primary outcomes:
measure: Percentage of Participants Achieving Sedation Within 4 Minutes
timeFrame: approximately 4 minutes after administration of first bolus of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: John B Leslie, MD MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04100603: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Clostridium Difficile
Clostridium Difficile Infection
Microbiome
CDI
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with C. difficile infection

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with C. diff.

Eligibility criteria: Inclusion Criteria:

* Willingness to sign informed consent
* Diagnosis of C. difficile infection
* Age of 18 and older

Exclusion Criteria:

* Refusal by patient to sign informed consent form
* Treatment with antibiotics 2 weeks prior to screening
* Treatment with probiotics 6 weeks prior to screening
* History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
* Postoperative stoma, ostomy, or ileoanal pouch
* Participation in any experimental drug protocol within the past 12 weeks
* Treatment with total parenteral nutrition
* Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
* Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850403: Social Media Impact on Patients' Regarding Aesthetic Dental Treatments
Official title: Social Media Impact on Patients' Decision-Making Regarding Aesthetic Dental Treatments: A Web-Based Questionnaire Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Media
Dentist-Patient Relations
Keywords: Social Media
Dentist-Patient Relations
Aesthetic dentistry
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergraduate students meeting the eligibility criteria

Brief summary: The aim of this observational study was to describe dental patients the use of social media related to aesthetic dental treatments. The main questions it aims to answer were:

* Describe the use of social media before undergoing an aesthetic treatment.
* To assess the influence of social media prior to undergoing aesthetic treatment

Participants answered a web-base questionnaire.

Detailed description: In recent years, an increased use of social media has been observed. Therefore, the aim of this observational study is to describe the use of social media in dental patients in relation to aesthetic dental treatments, as well as, its possible influence. A 25-question questionnaire was designed with the following 4 sections: (i) informed consent; (ii) demographic characteristics; (iii) cosmetic dental treatments; and (iv) social media use.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old that use social media

Exclusion Criteria:

* Not having undergone any aesthetic dental treatment

Primary outcomes:
measure: Use of social media
timeFrame: 3 minutes
Secondary outcomes:
measure: Influence of social media
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Universidad Europea de Madrid
state: Comunidad De Madrid
Study officials:
References:
Clinical trial NCT02280603: Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
Official title: A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia

Design : Randomized, double-blind, active-controlled study

Investigational Product : Finasteride, minoxidil


Eligibility criteria: Inclusion Criteria:

* Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2

Exclusion Criteria:

* Evidence of hair loss other than androgenetic alopecia
* Use of finasteride, dutasteride within previous 12 months
* Use of minoxidil within previous 6 months
* Use of androgenic or anti-androgenic agents within previous 6 months
* Use of steroid agents for local application to scalp or systemic application within previous 1 month
* History of hair transplantation, scalp reduction
* Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris

Primary outcomes:
measure: Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
timeFrame: baseline and week 24
Secondary outcomes:
measure: Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram
timeFrame: Baseline and week 16
measure: Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram
timeFrame: Baseline, week 16,and week24
measure: Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram
timeFrame: Baseline, week 16, and week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic Medical Center
state: Dongdaemun-gu
Study officials:
affiliation: The catholic univ. of korea, St.Paul's hospital
name: Hoon Kang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01625403: Recombinant BNP on Heart and Renal Function in Acute Heart Failure
Official title: Effect of Recombinant BNP on Heart and Renal Function in Acute Decompensated Heart Failure Patients With Acute Renal Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Heart Failure
Acute Renal Failure
Keywords: Recombinant BNP
Diuretics
Acute decompensated heart failure
Acute renal injury
Heart function
Renal function
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI).

Detailed description: Patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI) will be randomized to receive standard of care with or without additional rhBNP.

Clinical heart function, LVEF, SCr, GFR and other laboratory parameters will be evaluated.

Eligibility criteria: Inclusion Criteria:

* acute heart failure with acute renal injury

Exclusion Criteria:

* not tolerate to rhBNP

Primary outcomes:
measure: left ventricular systolic function
timeFrame: 90 days
Secondary outcomes:
measure: serum creatinine
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Fang Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768403: Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
Official title: Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Cardiovascular Disease
Hypertension
Diabetes
Coronary Heart Disease
Peripheral Arterial Disease
Keywords: Hypercholesterolemia
Cardiovascular disease
Hypertension
Coronary Heart disease
Peripheral Arterial disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 1236
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Subject must be 19 years of age or older of either gender or race.
* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks

Brief summary: Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population.

Detailed description: Centralised Pan-Algerian Survey on the undertreatment of hypercholesterolemia.

Eligibility criteria: Inclusion Criteria:

* Subject must provide informed consent and comply with the survey procedures.
* Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

- Subjects who are unwilling or unable to provide informed consent.

Primary outcomes:
measure: Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force (TJETF) guidelines.
timeFrame: 24 weeks
Secondary outcomes:
measure: Number and percentage of subjects achieving LDL-C goals according to the TJETF guidelines.
timeFrame: 24 weeks
measure: Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III/2004 updated NCEP ATP III and to the 2005 AFSSAPS guidelines
timeFrame: 24 weeks
measure: Number and percentage of subjects achieving LDL-C goals according to the : TJETF / NCEP ATP III and 2004 updated NCEP ATP III guidelines.
timeFrame: 24 weeks
measure: The association between achievement of LDL-C goals, according to the Third Joint European Task Force / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables, assessed by multivariate logistic regression models
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Habib BENNACEUR, MD
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Nawel BOUTEKDJIRET, MD
role: STUDY_DIRECTOR
affiliation: Cardiology department /Mustapha Bacha Hospital
name: Yassin BOUHOUITA-GUERMECH, Professor
role: PRINCIPAL_INVESTIGATOR
References: