louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03989804: Effects of Targeted Follow-up of New Fitness Center Members
Official title: Long-term Effects of Targeted Follow-up of New Fitness Center Members: a Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: New Members of Fitness Centers
Keywords: Fitness center
Physical activity
Follow-up
Members
Visits
Membership terminations
Training advisors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 356
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective: To investigate the long-term effects of targeted follow-up of new fitness center members compared to usual practice, on frequency of visits and membership terminations after four years.

Design and setting: A participant and provider blinded parallel group randomized controlled trial conducted at eight Fitness Centers in Trondheim, Central Norway.

Participants: The inclusion criteria were new members \>16 years who between September 1st to 9th 2014 signed up for an ordinary contract with a minimum duration of 12 months.

Intervention: The intervention consisted of two phone calls and one e-mail delivered over 6-8 weeks after enrollment, aiming to motivate members to get started using the fitness center and its services. Usual practice at the fitness center is self-directed use.


Eligibility criteria: Inclusion Criteria:

* The study included new members (16 years in 2014 or older) on ordinary contracts with a minimum duration of 12 months and monthly automatic membership renewal that enrolled independent of the study at one of eight 3T-Fitness Centers in Trondheim between September 1st and September 9th, 2014.

Exclusion Criteria:

* Exclusion criteria were members with free contracts, employee contracts, cash membership, shorter membership contracts (duration \<12 months) and loyalty contracts (indicates that the member is improving his old contract and is not a new member).

Primary outcomes:
measure: Number of days with visits at the fitness center chain
timeFrame: 4 years
measure: Rate of membership terminations
timeFrame: 4 years
Secondary outcomes:
measure: Number bookings to training advisors
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology NTNU
name: Siri Forsmo, PhD Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02129504: Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix
Official title: Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: root coverage
gingival recession
periodontal surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.


Eligibility criteria: Inclusion Criteria:

* ages 25 to 50 years old
* bilateral gingival recession type Miller class I or II
* with 3 mm in height and less than 3mm of keratinized tissue
* non-molar teeth

Exclusion Criteria:

* diabetics
* pregnant women
* chronic use of medication
* periodontitis

Primary outcomes:
measure: Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months
timeFrame: Change from Baseline at 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of dentistry of Ribeirão Preto
state: São Paulo
Study officials:
References:
citation: McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.
Clinical trial NCT01713504: Identification of New Markers in the Hypereosinophilic Syndrome
Official title: Identification of New Markers in the Hypereosinophilic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypereosinophilic Syndrome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose is to characterize new hypereosinophilic syndrome biomarkers more informative and more accessible compared to those that we have already thanks to a proteomic approach. This will help the investigators to diagnose the this disease.


Eligibility criteria: Inclusion Criteria:

* dated and signed informed consent
* virale serology negative or negative result less than 6 months
* virale serology negative for HBV or vaccinated patient
* insured
* virale serology negative or negative result less than 6 months
* negative pregnancy test or female menopause for at least 1 year

Exclusion Criteria:

* subject enable adult, under guardianship or under protective measures of justice
* Refusal or inability to give informed consent
* The hypereosinophilic syndrome explained origin other than than atopy, bullous pemphigoid, the Churg-Strauss syndrome and DRESS

Primary outcomes:
measure: The aim is to characterize, through an approach immunoprotéomique, new HES biomarkers more informative and easier access than those currently available to us. These biomarkers will help to the diagnosis of HES, compared with other causes of eosinophilia.
timeFrame: one month after patient inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
state: Nord
Study officials:
affiliation: University Hospital, Lille
name: Lionel Prin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04437004: Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
Official title: Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Dravet Syndrome
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-06-18
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

Detailed description: The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

Eligibility criteria: Inclusion Criteria:

* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
Clinical trial NCT04448704: Understanding the Mental Health of Migrant Workers During the COVID-19 Outbreak
Official title: Understanding the Mental Health of Migrant Workers During the COVID-19 Outbreak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Issue
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 1011
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migrant workers employed in manual labor jobs within Singapore

Brief summary: This study aims to evaluate the mental health impact of the COVID-19 pandemic on international migrant workers by (1) documenting mental health symptoms among migrant workers and (2) identifying risk and protective factors during the pandemic.

Detailed description: Worldwide, there are an estimated 164 million migrant workers. Although studies have documented how migrant workers have an increased risk of adverse mental health outcomes, little is known about their mental health burden during a large-scale health crisis.

In the current COVID-19 outbreak, migrant workers represent 9 in 10 of the COVID-19 cases in Singapore, with 25 dormitories gazetted to contain the spread of the virus. Correspondingly, these measures have placed a spotlight on the mental well-being of migrant workers.

In this research protocol, the investigators propose to administer a survey to understand the prevalence and predictors of mental health symptoms amongst migrant workers in Singapore. In particular, prior meta-analyses have identified COVID-19 health concerns, quarantine status, financial instability, exposure to news and misinformation and demographics (i.e., gender, age, education) as risk factors for poor mental health amongst the general population. By assessing these factors amongst the migrant worker population and documenting their impact on migrant workers' mental health, we hope to identify workers in greatest need of support during the ongoing pandemic and provide empirical evidence to guide public health policies.

Eligibility criteria: Inclusion Criteria:

* ≥21 years of age
* Hold a government-issued work permit identifying employment status

Primary outcomes:
measure: DASS-21 Scores
timeFrame: single measurement upon study enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: EXPO
Study officials:
References:
Clinical trial NCT01948804: The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.
Official title: The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Randomized-controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Poor Responders Undergoing IVF
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.


Eligibility criteria: Inclusion Criteria:

Criteria for definition of poor responders included at least one of the following

1. Anti müllerian hormone \<1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol).
2. Primary infertile patients
3. BMI≤30 kg/m2 were included this study.

Exclusion Criteria:

-

Primary outcomes:
measure: clinical pregnancy rates
timeFrame: 6 months
Secondary outcomes:
measure: total number of oocytes retrieved
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00416104: Postcesarean Section Pain: Possible Demographic and Medical Predictors
Official title: Postcesarean Section Pain: Possible Demographic and Medical Predictors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Cesarean Section
Keywords: analgesia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The aim of this retrospective study is to find out if one or more of the following parameters has an impact on postcesarean section pain:age,ethnic origin, parity,body habitus, smoking, breastfeeding, education,newborn in intensive care unit, primary/repeated operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during operation.

Detailed description: The medical records of 600 consecutive women with a cesarean section will be reviewed.We will analyse the correlations between postcesarean section pain levels,analgesic consumption and; age,ethnic origin, parity,body habitus, smoking, breastfeeding, education,newborn in intensive care unit, primary/repeated operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during operation.

Eligibility criteria: Inclusion Criteria:

* Women undergoing a cesarean section

Exclusion Criteria:

* Medical or psychological conditions not enabling reliable patients pain assessment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: director of obstetrics rambam medical center
name: etan z zimmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02775604: Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in Detection of Fall Hazards at Home
Official title: Comparison of Home-based Video, Paper/Print Checklist and Professional Home Assessment in the Detection of Fall Hazards for Older Adults Living at Home: A Pilot Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Identification of Home Fall Hazards
Keywords: fall risks at home
video technology
home assessment
distal radius fractures
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2016-05-17
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the feasibility and potential impact of video analysis of footage taken with a GoPro camera video in comparison to a homeowner checklist or gold standard home assessment as a means of detecting home fall hazards.

Investigators hypothesize that the assessment of homes for fall hazards with a GoPro camera will be better than a homeowner paper checklist in hazard identification.

Detailed description: 80 community-dwelling adults (50-75 years of age) will be recruited from clinics and the community through posters and advertising (n = 40 in the Healthy Group; n = 40 in the Distal Radius Fracture (DRF) Group (adults with 3-12 months post-DRF)).

Participants will be randomly allocated to a homeowner paper checklist or a GoPro video assessment and then cross-over to the opposite intervention.

To assess accuracy, a gold standard home assessment will be completed by a trained evaluator, after the homeowner checklist and GoPro video assessment.

Upon completion of the data collection, the evaluator will conduct their assessment (gold standard); review the findings from the GoPro "playback" with the participant, and conduct a semi-structured interview on their prior awareness of fall hazards, perceptions about the different methods of detecting fall hazards in their home; and intentions to remediate identified hazards.

Eligibility criteria: Inclusion Criteria:

* Healthy Group: community-dwelling adults
* DRF Group: adults with 3-12 months post DRF
* ability to read, understand and speak English

Exclusion Criteria:

* identified cognitive disorder
* major loss of vision or hearing
* other concurrent upper extremity injuries or neurological impairments
* any unhealed fractures

Primary outcomes:
measure: Evaluation Agreement
timeFrame: Within 1 week of completion of assessment
Secondary outcomes:
measure: Feasibility and Fidelity
timeFrame: Within 1 week of completion of assessment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
Clinical trial NCT03229304: Prediction of Postpartum Hemorrhage With Uterine Artery Doppler Measurement
Official title: The Role of Uterine Artery Doppler Measurement to Predict the Amount of Postpartum Hemorrhage in Low Risk Term Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 800
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: PROBABILITY_SAMPLE
Study population: The pregnant women that is term and have no risk factors for postpartum hemorrhage

Brief summary: The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies. And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values.


Eligibility criteria: Inclusion Criteria:

* singleton term pregnancies

Exclusion Criteria:the pregnant women who have

* polyhydramnios
* Large for gestational age fetuses
* multiple pregnancies
* preterm labour
* chorioamnionitis
* history of atonia or postpartum hemorrhage

Primary outcomes:
measure: To measure the uterine artery Pulsatility index in term pregnant women
timeFrame: 6-8 hour before the delivery
measure: To measure the uterine artery Resistant index (cm/s) in term pregnant women
timeFrame: 6-8 hour before the delivery
measure: To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women
timeFrame: 6-8 hour before the delivery
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kerem Doga Seckin
Study officials:
References:
citation: Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.
citation: Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.
Clinical trial NCT00676104: Discrete Hypothermia in the Management of Traumatic Brain Injury
Official title: Discrete Hypothermia in the Management of Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Trauma
Hypothermia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.


Eligibility criteria: Inclusion Criteria:

* Patient is treated for severe traumatic brain injury at Grady Health System, GCS \< 8
* Patient is \>18 years of age
* Patient requires an Intracranial Pressure (ICP) Probe (part of their routine treatment)
* Patient is able to receive Discrete Cerebral Hypothermia within 48-hours of hospital admission
* Patient and/or guardian must speak English (in order to ensure proper Informed Consent)
* Patient and/or guardian/family must sign an Informed Consent

Exclusion Criteria:

* Unwillingness or inability of patient and/or guardian/ family to sign an informed consent
* Physical placement of cooling cap impedes routine treatment
* Patient has a core body temperature of 36 degrees C or less at time of assessment

Primary outcomes:
measure: Perform a comparative analysis of outcome (Glasgow Outcome Score)
timeFrame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
Secondary outcomes:
measure: The effectiveness of the Discrete Cerebral Hypothermia System by CoolSystems in maintaining a significant gradient between the core and brain temperatures in study population.
timeFrame: within 3 days after injury
measure: Functional Independence Measure
timeFrame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
measure: Mortality
timeFrame: Day 1, day 2, day 3, day 7, day 14, day 21, day 28 and 1 month after injury
measure: Confirm the effectiveness of the Discrete Cerebral System in reducing internal brain temperature
timeFrame: within 3 days after injury
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine, Grady Health System campus
state: Georgia
Study officials:
affiliation: Emory University
name: Odette A Harris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000204: Buprenorphine Maintenance for Opioid Addicts - 3
Official title: Buprenorphine Maintenance for Opioid Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate buprenorphine in a medical maintenance model three times a week.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Withdrawal symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References: