louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04496427: Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
Official title: A Single-center, Long-term, Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penile Enhancement
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 13
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.

Brief summary: This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement.

The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.


Eligibility criteria: Inclusion Criteria:

* Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.

Exclusion Criteria:

* Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation.
* Subjects deemed as ineligible to participate by the investigator

Primary outcomes:
measure: Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline
timeFrame: 18 months
measure: Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
state: Gangdong-gu
Study officials:
References:
Clinical trial NCT00470327: A Study of the Natural Progression of Interstitial Lung Disease (ILD)
Official title: A Study of the Natural Progression of Interstitial Lung Disease (ILD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Diseases
Idiopathic Pulmonary Fibrosis
Sarcoidosis
Connective Tissue Disorder
Keywords: Interstitial lung diseases
idiopathic pulmonary fibrosis
Sarcoidosis
mRNA and cytokine expression
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Idiopathic Pulmonary Fibrosis Clinical Research Network
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2007-05-07
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects cared for in the ILD (Interstitial Lung Disease)clinic

Brief summary: We propose to acquire data and blood samples on all patients being cared for by the Interstitial Lung Disease (ILD) program. Additionally, we will collect data and blood samples from a control group for comparator purposes. In doing so, we will be able to describe the "phenotypic" expression of these diseases.


Eligibility criteria: Inclusion Criteria:

* Interstitial lung disease

Exclusion Criteria:

* Does not have Interstitial lung disease

Primary outcomes:
measure: Natural history of course of disease in patients with Interstitial lung disease (ILD)
timeFrame: Yearly
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mary E Strek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00271427: Selenium Treatment in Autoimmune Thyroiditis (AIT)
Official title: Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Thyroiditis
Hashimotos Thyroiditis
Keywords: Thyroiditis
Autoimmune
Hashimoto's
TPOAb
Selenium
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2006-01-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.


Eligibility criteria: Inclusion Criteria:

* Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.

Exclusion Criteria:

* Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.

Primary outcomes:
measure: statistically important change in serum TPOAb titers.
Secondary outcomes:
measure: Observe the long term effects to 9th mo.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dep. of Nuc. Med., Ege University Faculty of Medicine.
Study officials:
affiliation: Dep. of Nuc. Med., Gulhane Military Academy of Medicine
name: Omer Turker, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Nuc. Med., Ege University Faculty of Medicine.
name: Kamil Kumanlioglu, Prof.
role: STUDY_DIRECTOR
References:
citation: Turker O, Kumanlioglu K, Karapolat I, Dogan I. Selenium treatment in autoimmune thyroiditis: 9-month follow-up with variable doses. J Endocrinol. 2006 Jul;190(1):151-6. doi: 10.1677/joe.1.06661.
Clinical trial NCT01224327: Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients
Official title: The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Radiology
Mesenchymal Stem Cells
Umbilical Cord
Keywords: Liver cirrhosis
Radiology
Mesenchymal Stem Cells
Umbilical Cord
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.

Detailed description: To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.

Eligibility criteria: Inclusion Criteria:

* Aged 18\~70 years.
* Liver cirrhosis
* written consent

Exclusion Criteria:

* The end-stage of liver cirrhosis.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Hepatocellular carcinoma or other malignancies
* Pregnancy
* sepsis
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* Cardiac, renal or respiratory failure
* Active thrombosis of the portal or hepatic veins

Primary outcomes:
measure: The result of liver function and liver histological improvement.
timeFrame: every 4 weeks
Secondary outcomes:
measure: The disappearance or reduction of abdominal dropsy
timeFrame: every 4 weeks
measure: The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )
timeFrame: every 4 weeks
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Stem Cell Research Center of Medical School Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Zibin Tian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04723927: Development of Fall Prediction Model for Older Adults Based on Multi-faceted Data
Official title: Development of Fall Prediction Model for Older Adults by Analysis of Walking Patterns Based on Multi-faceted Biosignal Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait
Keywords: Fall prediction model
Gait Pattern
Muscle activity
Brain activity
Cardiopulmonary metabolic cost
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community seniors aged 65 to 84 years

Brief summary: This study aimed to develop a fall prediction model for older adults by measuring the multi-faceted biosignal data to classify the walking patterns and by identifying causal relationships with the variables that affect the fall.

Detailed description: This study aimed to develop a fall prediction model by measuring the multi-paceted biosignal data for the elderly's physical function and walking to classify the walking patterns of the elderly, and by identifying causal relationships and influences with the variables that affect the fall.

Eligibility criteria: Inclusion Criteria:

* Community seniors aged 65 to 84 years
* A person who has no history of central nervous system disease

Exclusion Criteria:

* Older adults who are unable to walk independently due to vision loss, fractures, etc.
* An elderly person who had musculoskeletal history that could cause problems in the function of the lower extremities, such as fractures, within three months before recruitment;
* In case it is difficult to understand the task due to severe cognitive impairment (Korean simplified mental health examination, K-MMSE score 10 or less)
* In the event of a serious mental illness, such as schizophrenia or bipolar disorder;
* In case of severe dizziness and difficulty in pedestrian inspection
* Persons not eligible for examination

Primary outcomes:
measure: Gait analysis
timeFrame: 1 hour
Secondary outcomes:
measure: Change on metabolic energy expenditure
timeFrame: 15 minutes
measure: Change on muscle activity
timeFrame: 30 minutes
measure: Change on brain activity
timeFrame: 30 minutes
measure: Short Physical Performance Battery (SPPB)
timeFrame: 5 minutes
measure: Four Square Step Test (FSST)
timeFrame: 5 minutes
measure: The Timed Up and Go test (TUG)
timeFrame: 5 minutes
measure: 10 meter walk test (10MWT)
timeFrame: 5 minutes
measure: Modified Bathel index (MBI)
timeFrame: 5 minutes
measure: 6 minutes walking test (6MWT)
timeFrame: 6 minutes
measure: Fall Efficacy Scale (FES)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663127: Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial
Official title: Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: gamma-aminobutyric acid
blood pressure
clinical trial
angiotensin converting enzyme
Beauty Drink
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Overall, "Beauty Drink" consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of ACE linked to downstream suppression of angiotensin II formation, which further decreases the sympathetic outflow leads to hypertension.

Detailed description: This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Fifty subjects with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized to ingest 2 bottles of "Beauty Drink" or placebo per day for 8 weeks of a stage. In addition, anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every four weeks.

Eligibility criteria: Inclusion Criteria:

* Eligible subjects were untreated hypertensive men or women aged between 20 and 70 years old with SBP between 120 and 159 mmHg and/or DBP between 80 and 99 mmHg as measured in a sitting position

Exclusion Criteria:

* Subjects were excluded if they had a history of major cardiovascular disease or severe liver dysfunction; Diastolic blood pressure ≥ 100 mmHg or Systolic blood pressure ≥ 160 mmHg;
* Alcoholic;
* US-controlled diabetics;
* Stoke in past one year;
* Mental diseases or melancholia;
* Pregnancy or breast-feeding a child;
* Renal dysfunction;

Primary outcomes:
measure: The changes of blood pressure of the subjects (SBP and DBP)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: You-Cheng Mr Shen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01932827: Attidutes and Understanding of Oat Fibre Claims on Food Labels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consumer Research
General Population
Keywords: Attitudes and understanding of oat fibre claims
Food labels
General Canadian population
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Advance Foods and Materials Network
First posted: 2013-08-30
Enrollment: 1002
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A subsection of the Canadian Consumer Monitor Panel - a national representative online consumer panel comprised of 30,000 Canadians

Brief summary: Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for heart health. Oat and fibre claims on food labels should help people find heart healthy food choices; however consumer attitudes and understanding of such claims are unknown.

The objective of this study was to evaluate the attitudes and understanding to different types of permitted oat fibre claims.


Eligibility criteria: Inclusion Criteria:

* Primary grocery shoppers
* Canadian adults between the ages 20 to 69 years

Exclusion Criteria:

* Did not have an email address or have access to internet

Primary outcomes:
measure: Response to survey questions measuring attitudes towards sodium claims using 5-point likert rating scales
timeFrame: On average the survey took 25 minutes to complete
measure: Response to survey questions evaluating participants understanding of oat fibre claims
timeFrame: On average the survey took 25 minutes to complete
Secondary outcomes:
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
References:
Clinical trial NCT02981927: Bed Rest, Inactivity and Early Responses
Official title: Bed Rest, Inactivity and Early Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Responses to Inactivity
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet


Eligibility criteria: Inclusion Criteria:

* Healthy and aged 18-40 y
* BMI between 18 and 30

Exclusion Criteria:

* On medication
* Family history of metabolic disease
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30

Primary outcomes:
measure: Glucose tolerance
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences
state: Devon
Study officials:
References:
Clinical trial NCT02769260: Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Official title: Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Biofilm
Dental Plaque
Keywords: pyrosequencing
16S DNA gene
Confocal Laser Scanning Microscope
bacterial viability
bacterial diversity
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.

Detailed description: * To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.
* Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
* Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.

Eligibility criteria: Inclusion Criteria:

* systemically healthy
* good oral health status

Exclusion Criteria:

* smoker or former smoker,
* presence of dental prostheses or orthodontic devices,
* antibiotic treatment or routine use of oral antiseptics in the previous 3 months,
* presence of any systemic disease that could alter the production or composition of saliva

Primary outcomes:
measure: Bacterial viability
timeFrame: Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity
measure: Bacterial diversity
timeFrame: Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity
Secondary outcomes:
measure: Biofilm thickness
timeFrame: Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Univeristy of Santiago de Compostela, Faculty of Dentistry
state: Galicia/ A Coruña
Study officials:
affiliation: Univeristy of Santiago de Compostela
name: Inmaculada Tomás Carmona, S Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02562560: Neuropsycholgy and Neuroimaging in Transient Global Amnesia
Official title: Neuropsycholgy and Neuroimaging in Transient Global Amnesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transient Global Amnesia (TGA)
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish a diagnosis in transient global amnesia (TGA) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). Secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in TGA.


Eligibility criteria: Inclusion Criteria:

* All the participants

  * Minimum of 7 years of education
  * French native speaker
* Healthy subjects : Non pathological Dementia rating scale score
* Patients : Clinical diagnosis of TGA according to Hodges and Warlow's criterion

Exclusion Criteria:

* Chronic neurological disease
* Encephalitis
* Endocrinal disease
* Hepatic disease
* Case history of head injury with loss of consciousness of more than one hour
* Case history of stroke
* Case history of cancer during the five last years except squamous cell carcinomas
* Alcoholism or drug addiction
* Major psychiatric disorders according the Diagnostic and Statistical Manual of -Mental Disorders

Primary outcomes:
measure: Episodic memory scores
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Fausto Viader, PUPH
role: PRINCIPAL_INVESTIGATOR
References: