louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02988284: Gait Variability in Healthy Youngs
Official title: Investigating the Gait Variability in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Gait variability
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals

Brief summary: Three hundred healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait trainer Biodex 2, at participant's preferred speed.

Detailed description: Three hundred healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, year, side and level of limb loss will be recorded. Gait parameters (step length, variation of step length) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 4nd and 6th minutes at walk.

Eligibility criteria: Inclusion Criteria:

Want to participate

Exclusion Criteria:

Have passive joint limitation at extremities Surgery at last 5 year Systemic problems such as neurologic disorders, rheumatoid disorders... Another orthopedic anomalies

Primary outcomes:
measure: Step length variability assesment while walking.
timeFrame: Initially evaluation at first minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00535184: Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
Official title: A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Mammography
mammogram
breast
Abnormal and normal breast tissue
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic

Brief summary: Comparison of the ability of DBT and FFDM to detect breast cancer.

Detailed description: Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.

Eligibility criteria: Inclusion Criteria:

* Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
* Able and willing to comply with study procedures, and have signed and dated the informed consent form
* Surgically sterile or postmenopausal

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Has signs or symptoms of breast cancer
* Has been previously included in this study
* Has breast implants
* Has a history of breast cancer and is in active treatment
* Has breasts too large to be adequately positioned for the DBT examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GE Healthcare
name: Amy Longcore
role: STUDY_DIRECTOR
References:
Clinical trial NCT03222284: The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
Official title: The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
type 2 diabetes
type ii diabetes
insulin
mobile applications
Diabetes Mellitus
Diabetes Mellitus, Type 2
smartphone application
health application
Lead sponsor: Healthcare Innovation Technology Lab
Sponsor class: INDUSTRY
Collaborators: name: Novo Nordisk A/S
First posted: 2017-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. Participants will have either two or three visits at HITLAB during the 28-day study period.

Detailed description: The purpose of this study is to evaluate the utility and user experience of a mobile application, called Cornerstones4Care Powered by Glooko App (C4C), for persons diagnosed with diabetes type 2.Subjects will be asked to use the Cornerstones4Care Powered by Glooko App for an approximately 20 minute monitored demonstration session, followed by a 28-day period of daily engagement with the application.The Cornerstones4Care Powered by Glooko App lets users input nutrition, medication, exercise and other daily information to assist in the management of diabetes type 2. It also has the ability to sync with connected devices, such as blood glucose monitors. Additionally, the application offers a library of educational content for users.

Eligibility criteria: Inclusion Criteria:

1. Be diagnosed with type 2 diabetes
2. Live in the New York Metropolitan area
3. Be at least 18 years of age
4. Able to read, write, and speak in English
5. Have an iPhone or Android phone
6. Use a blood glucose meter
7. Regularly take insulin by injection
8. Be willing to follow study requirements for a 28-day period

Exclusion Criteria:

1. Not be diagnosed with type 2 diabetes
2. Not living in the New York Metropolitan area
3. Be less than 18 years of age
4. Be unable to read, write, and speak in English
5. Not have an iPhone or Android phone
6. Not use a blood glucose meter
7. Not regularly take insulin by injection
8. Be unwilling to follow study requirements for a 28-day period

Primary outcomes:
measure: Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report
timeFrame: 28 days
measure: Device usability as assessed by the System Usability Scale (SUS)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Healthcare Innovation and Technology Lab
state: New York
Study officials:
affiliation: Healthcare Innovation Technology Lab
name: Stan Kachnowski, PhD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03998384: A New Treatment of Retinitis Pigmentosa
Official title: Retrobulbar Injection of Autoserum in the Treatment of Retinitis Pigmentosa: A Prospective, Non-randomized Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two eyes of one patient with RP will be divided into two groups. One eye with more serious retinal atrophy will receive retrobulbar injection of autoserum, and the other eye will receive retrobulbar injection of saline solution.
Primary purpose: TREATMENT

Brief summary: This study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

Detailed description: The retinitis pigmentosa(RP) is an hereditary disease which causes visual deficiency leading to blindness. The methods of treatment include gene therapy, stem cell therapy and visual prothesis, etc. But all these methods own limitations can not be conquered in a short period. It was proved that vascular endothelial growth factor (VEGF) and pigment epithelium derived factor (PEDF) decreased in the aqueous humor of patients of RP. But the traditional exogenous nerve growth factors (NGFs) were immunogenic proteins and may cause inflammation. Autoserum contain a large amount of active factors and will not cause exclusive reaction. In this study we aim to assess and to evaluate the therapeutic effect and the safety of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of retinitis pigmentosa

Exclusion Criteria:

* Suspected glaucoma, suspected optic nerve disease, blindness due to other ocular disease
* Combined with serious systemic disease
* Can not cooperate with the interventions and examinations.

Primary outcomes:
measure: Change of the visual acuity
timeFrame: one day before injection, one day, one month, three months and six months after surgery
measure: Change of the contrast sensitivity
timeFrame: one day before injection, one month, three months and six months after surgery
measure: Change of the electrophysiological detection (flash electroretinogram)
timeFrame: one day before injection, three months and six months after surgery
measure: Change of the electrophysiological detection (electro-oculogram)
timeFrame: one day before injection, three months and six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01065584: An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
Official title: An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Keywords: liver transplantation
Patients undergoing liver transplantation
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver transplantation

Brief summary: In experimental and clinical settings it has been shown that transplant tolerance is possible. It has been suggested that regulatory T cells play a beneficial role in the establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance has not been studied in patients undergoing liver transplantation. Currently the investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor free immunosuppression in patients undergoing liver transplantation. In this study measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be performed. In parallel these measurements should be compared to a group of patients undergoing standard immunosuppression including calcineurin inhibitors.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary liver transplantation
* Patients of age 18 years and older
* Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation

Exclusion Criteria:

* Multiple organ graft recipients
* Patients receiving ABO incompatible grafts
* Patients with positive cross match
* Pregnancy
* Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
* Patients under guardianship (e.g. individuals who are not able to freely give their informed consent)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: University Medical Center Goettingen
state: Niedersachsen
Study officials:
affiliation: University Medical Center Goettingen
name: Aiman Obed, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Medical Center Goettingen
name: Armin Goralczyk, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01935284: Evaluation of Blood Gas Syringes
Official title: Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Gas Analyte Values
Lead sponsor: Smiths Medical, ASD, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bionostics
First posted: 2013-09-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.

Detailed description: This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Willing and able to independently sign an English Informed Consent
3. Have adequate veins for sampling blood from both right and left upper extremities

Exclusion Criteria:

1. Currently taking anti-coagulation medication
2. Have a known bloodborne disease or bleeding tendency
3. Have a known fear or adverse reaction to needles or blood
4. Women who are pregnant or nursing

Primary outcomes:
measure: Differences in analyte values obtained from three different blood gas syringes for each analyzer tested
timeFrame: Blood analysis within 30 minutes of draw
Secondary outcomes:
Other outcomes:
Locations:
city: Devens
country: United States
facility: Bionostics
state: Massachusetts
Study officials:
affiliation: Smiths Medical
name: Lisa Cifaldi, BS, RRT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00067184: Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Official title: Methadone, Buprenorphine and Fetal Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-Related Disorders
Keywords: methadone
fetus
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2003-08-13
Enrollment: 157
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: Methadone exposed pregnancies

Brief summary: The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.

Detailed description: This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

Eligibility criteria: Actively enrolled pregnant patients in CAP SA treatment.

Inclusion Criteria:

* Maternal age 18-40 years
* Single intrauterine fetus
* Estimated gestational age of 32 weeks
* DSMIV criteria for opioid dependence according to e-module of the SCID
* Daily methadone maintenance at a stable dose for greater than a week

Exclusion Criteria:

* Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence)
* Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation
* Evidence of preterm labor
* Evidence of prescription drug use (e.g., antidepressants, tranquilizers)
* Presence of major congenital fetal malformation
* Recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions
* Split methadone dosing schedule

Primary outcomes:
measure: fetal heart rate
timeFrame: 120 minutes
measure: fetal movement
timeFrame: 120 minutes
Secondary outcomes:
measure: neonatal abstinence syndrome
timeFrame: 4 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Addiction and Pregnancy
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lauren M. Jansson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansson LM, Dipietro J, Elko A. Fetal response to maternal methadone administration. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):611-7. doi: 10.1016/j.ajog.2005.02.075.
Clinical trial NCT00626184: A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Official title: A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Celiac Disease
Keywords: Celiac Disease
Lead sponsor: Alvine Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess safety and tolerability of ALV003 in healthy volunteers and patients with Celiac Disease

Detailed description: A Phase 1, Two Stage, Single Dose, Single-Blind, Placebo Controlled, Dose Escalation, Crossover Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease

Eligibility criteria: INCLUSION

* Health Status

  1. Healthy volunteers must be in good health
  2. Celiac Disease must be well controlled and in good health
* Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.
* Body Mass Index (BMI) of \< 30 kg/m2,

EXCLUSION

* A positive urine test for alcohol or illegal drugs at screening.
* The subject has received an experimental drug within 30 days of the present study.
* History of substance abuse, within the last 5 years
* Clinically significant abnormal lab values, as determined by the PI
* Alcohol consumption of \> 2 standard drinks equivalents per day12. Positive pregnancy test within 7 days prior to study drug administration.
* history of any medically significant condition considered by the PI to adversely affect participation in the trial

Primary outcomes:
measure: safety and tolerability
timeFrame: Throughout
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Applications Laboratories Inc.
state: California
Study officials:
affiliation: Clinical Applications Laboratory Inc.
name: Vijaya Pratha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702584: Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms
Official title: Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stent Embolisation
Keywords: stent
intracranial aneurysm
embolization
adverse event
Lead sponsor: Kobe City General Hospital
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stent assisted embolization of intracranial aneurysm

Brief summary: Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.

Detailed description: To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.

Eligibility criteria: Inclusion Criteria:

* stent assisted embolization of intracranial aneurysm
* 20 or more year old

Exclusion Criteria:

* not determined

Primary outcomes:
measure: any death, stroke and major hemorrhagic event
timeFrame: 2 years after treatment
Secondary outcomes:
measure: any adverse event
timeFrame: 2 years
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Nobuyuki Sakai, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: