louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05842408: Clinical Trial of DA-5212 in Patients with Functional Dyspepsia
Official title: A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients with Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 384
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia


Eligibility criteria: Inclusion Criteria:

* Men or women ≥ 19 years of age
* Patients who diagnosed with functional dyspepsia
* Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit

Exclusion Criteria:

* Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit
* Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit
* Patients with hypersensitivity to investigational drugs and similar drugs
* Pregnant or breastfeeding women

Primary outcomes:
measure: Change in NDI-K functional dyspepsia score
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Change in overall treatment score of patients
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Muwangro 895
Study officials:
References:
Clinical trial NCT06583408: The REgistry of Very Early Estrogen and AnovuLation
Official title: The REgistry of Very Early Estrogen and AnovuLation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypothalamic Amenorrhea, Functional
Hypothalamic Amenorrhea
Functional Hypogonadotropic Hypogonadism
Keywords: Anovulation
Estrogen Loss
Hypoestrogenemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 100000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects are women aged 18-40 years old with a diagnosis of Functional Hypothalamic Amenorrhea (FHA) or lab results that are within the inclusion criteria. To ensure accurate case ascertainment before enrollment into the study, volunteers must have a diagnosis of FHA from a provider with previously performed lab tests, which will be reviewed and adjudicated by a women's health expert to confirm a diagnosis of FHA. If the potential participant doesn't have access or cannot obtain the required lab results, they can contact the study team to receive an at-home finger-stick hormone test (U.S. Specialty Labs) paid for by the study.

Brief summary: The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.


Eligibility criteria: Inclusion Criteria:

* 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to:

  * Estradiol: \< 50pg/mL
  * LH: \< 10 IU/mL
  * FSH: \< 10 IU
  * Testosterone: 2 - 45 ng/dL
  * Free Testosterone: 0.1 - 6.4 pg/mL
  * FT4: 0.93 - 1.70 ng/dL
  * Prolactin: \< 20 ng/mL
  * AMH: \> 1 ng/mL
  * Urine or serum human chorionic gonadotropin: Negative
* LH:FSH Ratio \<1
* No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back
* Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
* Premenopausal status determined by WISE criteria
* Able to give informed consent
* Able to read English

Exclusion Criteria:

* Parturition/lactating in the last 6-12 months
* Lack of consent

Primary outcomes:
measure: Study Participants
timeFrame: 5 years
Secondary outcomes:
measure: Assessing the Impact of Amenorrhea on Women's Health: Symptoms, Care Experiences, and Work Productivity
timeFrame: 5 years
measure: Impact of Social, Early Life, and Pregnancy Factors on Functional Hypothalamic Amenorrhea
timeFrame: 5 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Chrisandra Shufelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06466408: Effect of Vegetable and Fruit Enzyme Supplementation on Muscle Activation, Aerobic Capacity, and Blood Biochemical Parameters After High-Intensity Interval Exercise: Feasibility Study of Exercise Design With Exergaming
Official title: Exploring the Impact of Fruit and Vegetable Enzyme Supplementation on Aerobic Performance and Lactate Response in the Elderly Following High-Intensity Interval Exercise Combine Exergaming: Randomized Experimental Matched-Pair Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overtraining Syndrome
Lead sponsor: Tainan University of Technology
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: groups -enzyme and -placebo
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study explores the effectiveness of fruit and vegetable enzyme supplementation in reducing fatigue and enhancing aerobic capacity in elderly individuals after engaging in high-intensity interval exercise (HIIE) through exergaming. Sixteen elderly female participants were divided into two groups based on pre-test lactate levels: an enzyme group and a placebo group, to ensure comparability. They performed HIIE using Nintendo Switch Ring Fit Adventure, completing eight sets of 20-second high-effort exercises with 30-second rest intervals, totaling 370 seconds of activity. The primary metrics evaluated were blood lactate levels, heart rate (HR), rating of perceived exertion (RPE), and training impulse (TRIMP). Participants in the enzyme group received a fruit and vegetable enzyme supplement in a 30 c.c. dose twice daily for 14 days. The study aimed to determine if enzyme supplementation could effectively mitigate the physiological stress of HIIE and improve exercise outcomes in the elderly.


Eligibility criteria: Inclusion Criteria:

1. Aged 65 and above
2. healthy elderly participants
3. regular exercise habit (3 times per week within the past year)
4. Those who can move their upper and lower limbs normally

Exclusion Criteria:

1. no history of upper limb skeletal muscle injury or major injury
2. No heart-related diseases such as high blood pressure
3. No related chronic diseases, such as diabetes

Primary outcomes:
measure: Lactate
timeFrame: pre and after-intervention: measurements taken before the test, during the 2 and 4 minute of the test, and 5 and 10 minutes after the test.
measure: Heart rate (bpm)
timeFrame: Collect the heart rate at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
measure: Borg 0-10 score rating of perceived exertion (RPE)
timeFrame: Collect the RPE at 20, 50, 80, 110, 140, 170, 200 and 220 seconds in the HIIE test
Secondary outcomes:
measure: Training Impulse
timeFrame: During Exergaming HIIE
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Tainan University of Technology
Study officials:
References:
Clinical trial NCT04205708: Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Official title: Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silicosis
Pneumoconiosis; Silica
Keywords: silica
public health
early prevention
silicosis
screening
Oklahoma
lung disease
pulmonology
Pneumoconiosis
lung
dust exposure
occupational health
community health
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 183
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, community sample

Participants will be recruited from waiting rooms or other common spaces at participating community health clinics.

Brief summary: Silicosis, a preventable yet irreversible occupational lung disease, has an insidious onset with a latency period for diagnosis extending beyond 10 years from the initial exposure. The central hypothesis of this study is that silicosis cases may currently be going undetected. The long-term goal of this research is to determine the current prevalence and forecast the future prevalence of silicosis and other pneumoconiosis among working populations in Oklahoma and to assist the public health and the healthcare system in planning for a potential resurgence of silicosis.


Eligibility criteria: Inclusion Criteria:

* Male 30 years or older
* Past or present employment in dusty environment, exposed to dust at work
* Ability to consent and answer the questionnaire

Exclusion Criteria:

* Female
* Never exposed to dusty environment or never exposed to dust at work
* Inability to consent and answer the questionnaire
* Age 29 years or younger

Primary outcomes:
measure: Estimate of average cumulative respirable crystalline silica exposure (semi-quantitative)
timeFrame: Single point assessment at baseline survey
measure: Percentage of participants who report any exposure to silica
timeFrame: Single point assessment at baseline survey
measure: Prevalence of silicosis among study group
timeFrame: Single point assessment at clinic visit
Secondary outcomes:
measure: Analysis to determine if any demographic, work history, or other trait correlates with increased silica exposure
timeFrame: Single point assessment at baseline survey
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Jad Kebbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00182208: Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Official title: Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postphlebitic Syndrome
Keywords: PTS
Post phlebitic Syndrome
Activities of Daily Living
Quality of Life
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2005-09-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.

Detailed description: Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}

Eligibility criteria: Inclusion Criteria:

* Past History of objectively documented deep vein thrombosis
* Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
* Over 18 years of age (and of either gender).
* Villalta score of greater than 14(i.e.severe post phlebitic syndrome)

Exclusion Criteria:

* Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
* Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
* Active venous ulceration
* Baseline leg circumference greater than 50 cm (cuff will not fit subject)
* Symptomatic peripheral arterial disease Peripheral neuropathy

Primary outcomes:
measure: Clinical Success measured with the Global Rating Instrument
Secondary outcomes:
measure: PTS-CCS questionnaire
measure: Villalta Scale
measure: Veines Quality of Life Questionnaire
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Henderson Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Martin O'Donnell, MB MRCPI
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine McGill University
name: Susan R Kahn, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201408: DPBRN Longitudinal Study of Dental Restorations Placed on Previously Un-restored Surfaces
Official title: Longitudinal Study of Dental Restorations Placed on Previously Un-restored Surfaces
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Dental Caries
Assessments
dental materials
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
name: University of Alabama at Birmingham
name: University of Copenhagen
name: University of Florida
First posted: 2010-09-14
Enrollment: 9291
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants directly involved in this study are the participants who have sought dental treatment in the practitioner-investigators' practices and particpated in the DPBRN "Reasons for placing the first restoration on permanent tooth surfaces" study.

Brief summary: The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN "Reasons for placing the first restoration on permanent tooth surfaces" study, and the factors affecting how long the fillings last.

Detailed description: This study is an observational follow-up of previously placed dental restorations (fillings) and is conducted during routine dental care visits.

Eligibility criteria: Inclusion Criteria:

* participant in the DPBRN "Reasons for placing the first restoration on permanent tooth surfaces" study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gainesville
country: United States
facility: University of Florida College of Dentistry
state: Florida
city: Minneapolis
country: United States
facility: Health Partners Dental Group
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Research Foundation
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: Permanente Denrtal Associates
state: Oregon
city: Copenhagen
country: Denmark
facility: University of Copenhagen Royal Dental College
Study officials:
affiliation: University of Florida
name: Valeria V Gordan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184808: Ambulatory Assessment of Motor State in Patients With Parkinson's Disease in Real Daily Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Patients with Parkinson's disease (PD) suffer from motor fluctuations and levodopa induced dyskinesia. The prupose of this study is to evaluate the effect of an automatic system to assess the motor state of PD patients in real daily life. Movements and postures are assessed using 6 accelerometers attached to the the most affected wrist, trunk, both upper legs and both upper arms. Patients wear the system for two days and keep an own diary of their motor state


Eligibility criteria: Inclusion Criteria:

Patients with parkinson's disease with motor fluctuations and dyskinesias

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university Nijmegen
Study officials:
affiliation: Radboud University Medical Center
name: Stan Gielen, Prof
role: STUDY_CHAIR
affiliation: Radboud university Nijmegen medical center
name: Martin Horstink, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05149508: Intraperitoneal Pressure Measurements in Children
Official title: Intraperitoneal Pressure Measurements in Children: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis
Keywords: Peritoneal Dialysis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 21
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor subject (\<18 years old) in stable peritoneal dialysis for more than 3 months and having had at least 3 IPP measurements

Brief summary: Pediatric peritoneal dialysis is prescribed according to the type of dialysis, the volume infused and the dialysis time. The measurement of intraperitoneal pressure (IPP) is an important and easy indicator to perform. A IPP greater than 18 cmH20 has been correlated with pain and dyspnea, a IPP greater than 14 has been correlated with a higher risk of peritonitis and a IPP greater than 13 was correlated with higher mortality and a switch on hemodialysis. These data suggest the importance of routine IPP measurement. Few data are available in the pediatric population.


Eligibility criteria: Inclusion criteria:

* Minor subject (\<18 years old)
* In stable peritoneal dialysis for more than 3 months
* Subject having had at least 3 IPP measurements
* At least 3 months after surgery to insert a peritoneal dialysis catheter
* Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

- -Subject (or his parents) having expressed his (their) opposition to participating in the stud

Primary outcomes:
measure: Study of good prescribing practices in children followed by peritoneal dialysis at Strasbourg University Hospital, by intraperitoneal pressure measurements
timeFrame: Files analysed retrospectively from January 01, 2001 to August 31, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service : Pédiatrie 1 - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT04450108: Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
Official title: Clinical Study of the Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients Responding to Inhaled Corticosteroid (ICS) Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Asthma in Children
Lead sponsor: Bosch Healthcare Solutions GmbH
Sponsor class: INDUSTRY
Collaborators: name: Global BioClinical
First posted: 2020-06-29
Enrollment: 122
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Detailed description: Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro

Eligibility criteria: Inclusion Criteria:

1. Subject is 7 to 80 years of age.
2. Has asthma
3. Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
4. Is willing and able to perform Vivatmo pro™ testing

Exclusion Criteria:

1. Subject has used corticosteroids prior to enrollment.
2. Subject has other current serious medical conditions
3. Subject has not been clinically stable for at least 2 weeks prior to the study
4. Subject is unwilling or unable to perform Vivatmo pro testing

Primary outcomes:
measure: Change in FeNO Value
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Bakersfield
country: United States
facility: Kern Research, Inc.
state: California
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Saint Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
Study officials:
affiliation: Bosch Healthcare
name: Klaus Mueller
role: STUDY_DIRECTOR
References: