louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03354949: Base Positioning Wheelchair Hemiplegic
Official title: Postural Wheelchair Control in Hemiplegic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wheelchair
Keywords: Wheelchair
Hemiplegia
Stroke
Postural control
Pain
Lead sponsor: Groupement Hospitalier Intercommunal du Vexin
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Positioning of all hemiplegics by stroke requiring a wheelchair even punctual at the exit of the SSR compared to patients with hemiplegic sequelae.

Brief summary: The investigators looked at the population of hemiplegic stroke participants hospitalized with GHIV : the investigators assessed the postural control of the participants of the chair using MCPAA, and assessed the pain of the participants while sitting in a wheelchair. The investigators then had to the participants try positioning equipment and then prescribed it once the choice was made. The investigators then reassessed postural control and wheelchair pain with this positioning equipment.

Detailed description: For each hemiplegic participants with wheelchair user stroke, the investigators collect : date of birth, date of stroke, side of hemiplegia. The wheelchair propulsion mode, the degree of autonomy (FAC and Enjalber scales), the way bed - wheelchair transfers are made. Assessment of wheelchair pain in the spine and Ischia with EVA. Time to travel 10 meters in a wheelchair. Postural control of the wheelchair is evaluated by the MCPAA. The investigators then carry out tests of positioning equipment : backrest, cushion, form elements and belt. This material is tried for several days. If it is appropriate (improvement on the postural control and on the pains), otherwise another material is tried.

When the choice is made, the material is prescribed. The participant is seen again 3 months after the delivery of his personal material, and the same evaluation is redone.

Eligibility criteria: Inclusion Criteria:

* Hemiplegia by stroke
* Wheelchair user

Exclusion Criteria:

* Two-handed propulsion of the wheelchair
* Cognitive impairment preventing clinical examination

Primary outcomes:
measure: Study the improvement of the basin retroversion.
timeFrame: Through study completion, an average of one year.
Secondary outcomes:
measure: The tilt.
timeFrame: Through study completion, an average of one year.
measure: Propulsion speed.
timeFrame: Through study completion, an average of one year.
Other outcomes:
Locations:
Study officials:
affiliation: Groupe Hospitalier Intercommunal du Vexin
name: Nadine PELLIGRINI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943149: E-MAX 2nd Gen Vit E Poly On BIOLOX Delta Ceramic Heads
Official title: E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: In Need of a Total Hip Arthroplasty
Lead sponsor: Renovis Surgical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be patients of specified doctors specialized in orthopedic medicine with a specialty in joint replacement.

Brief summary: The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.


Eligibility criteria: Inclusion Criteria:

* Patient is under 65 years of age
* Patient's health status qualifies as ASA 1 or ASA 2
* Patient is willing to commit to long term follow (study duration is 10 yrs)

Exclusion Criteria:

* Allergy to any materials used in hip implant
* Unwillingness to participate in long term follow-up
* Diagnosis of inflammatory arthritis
* Simultaneous bilateral total hip arthroplasty is recommended.
* Patient's health status qualifies as ASA 3 or greater.
* Patient is over the age of 65 of age

Primary outcomes:
measure: E-Max liner wear rate
timeFrame: Change from baseline to 10 years post-operative
Secondary outcomes:
measure: Patient Function and Mobility
timeFrame: Change from Pre-operative to 10 years post-operative
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Cornerstone Orthopedics
state: Colorado
Study officials:
References:
Clinical trial NCT04458649: Continuous Glucose Monitoring in Infants
Official title: Continuous Glucose Monitoring in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Hypoglycemia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2020-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.

Brief summary: The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.

Detailed description: We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.

Eligibility criteria: Inclusion Criteria:

* Mother at least 18 years of age
* Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)
* Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers

Exclusion Criteria:

* Infants born small for gestational age (SGA)
* Infant birth weight \<2.5 kg
* Infant BMI \<10th percentile on Olsen chart
* Infants born \<38 weeks gestation
* Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound
* Mother is non-English speaking

Primary outcomes:
measure: Time spent with glucose <40 mg/dL
timeFrame: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: University of California San Diego/Rady Children's Hospital
name: Jane Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
citation: Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319.
citation: Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061.
Clinical trial NCT00484549: Fabry : National Initiative of Screening
Official title: National, Multicenter, Prospective Study of Screening of Fabry Disease in a Population of Men Over 28 Days Old and Less Than 55 Years, Hospitalized for an Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke Hospitalized
Keywords: Fabry disease, Screening, Ischemic stroke
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 889
Sex: MALE
Minimum age (years): 28
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke.

The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke.

This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.


Eligibility criteria: Inclusion Criteria:

* Hospitalized ischemic stroke
* Written and signed informed consent from patient or legal representative

Exclusion Criteria:

* Patients belonging to a family which has a Fabry disease's diagnosis confirmed

Primary outcomes:
measure: Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
timeFrame: Positive microdosage confirmed by a macrodosage
Secondary outcomes:
measure: Describe and compare the characteristics of patients affected by Fabry disease and patients who are not affected Identify clinical and neuroradiological predictive elements of Fabry disease
timeFrame: patients affected by Fabry disease
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
Study officials:
affiliation: Unaffilliated
name: Pierre Clavelou, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clavelou P, Besson G, Elziere C, Ferrier A, Pinard JM, Hermier M, Artigou JY, Germain DP. [Neurological aspects of Fabry's disease]. Rev Neurol (Paris). 2006 May;162(5):569-80. doi: 10.1016/s0035-3787(06)75051-2. French.
Clinical trial NCT01544049: Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study
Official title: Patients Salpingectomy as a Method of Ovarian Cancer Prevention: A Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: fallopian tube removal
salpingectomy
ovarian cancer prevention
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have had their fallopian tubes removed as a method of ovarian cancer prevention.

Brief summary: The purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. The investigators hope to gain information that will allow us to better counsel women about ovarian cancer prevention.

Detailed description: Women will be found eligible for this study after an eligibility questionnaire given over the phone. If one is found eligible, she will be sent a consent and paper survey to fill out and send back to the research coordinator. Once that is completed, she will be given a phone interview in order answer additional questions of interest. Lastly, the study participant will be contacted once a year over the phone to obtain follow-up information.

Eligibility criteria: Inclusion Criteria:

* Female of at least 18 years of age
* Must speak English fluently
* Have had fallopian tubes removed as a method of ovarian cancer prevention

Exclusion Criteria:

* Males
* Females under the age of 18

Primary outcomes:
measure: Describe subject experience in undergoing Salpingectomy as a means of riks reduction
timeFrame: At conclusion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Elizabeth Swisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01004549: An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakia
Keywords: Patients who have previously undergone bilateral intraocular lens implantation
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 and older
* Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:

  * Crystalens
  * Crysalens HD
  * Tecnis One monofocal
* Patients must have a healthy cornea and macula
* Patients must have 20/25 or better best corrected vision
* Able to provide written informed consent

Exclusion Criteria:

* BCVA of less than 20/25
* On oral medications that could potentially block accommodation:

  * First generation antihistamines
  * Anticholinergic agents
  * Anti-psychotic medications
  * Antidepressant medications

Primary outcomes:
measure: Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading
timeFrame: one study visit
Secondary outcomes:
measure: Amplitude of accommodation on pushdown test - and how it compares to the COAS test results
timeFrame: one study visit
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
Study officials:
affiliation: The Center for Excellence in Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03828149: Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Official title: Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: Novus Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2019-02-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Detailed description: Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Eligibility criteria: Inclusion Criteria includes but is not limited to:

1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
2. No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
3. Negative urine pregnancy test at screening and baseline for females of childbearing potential
4. Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
5. Physiologic tympanogram type A (normal) or type C at screening visit

Exclusion Criteria includes but is not limited to:

1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
2. Positive urine drug screen at screening visit
3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit
4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
7. Clinically significant findings on ear nose and throat exam
8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
9. Current diagnosis of sleep apnea
10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

Primary outcomes:
measure: Safety (Evaluation of Adverse Events)
timeFrame: Days 1-9
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Cologne University Hospital
Study officials:
References:
Clinical trial NCT00860249: Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening
Official title: Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-study 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Keywords: education
preventive service
screening
Colorectal Cancer Screening
Prevention & Control
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2009-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.


Eligibility criteria: Inclusion Criteria:

* Patient of Northwestern Medical Faculty Foundation General Internal Medicine
* Patient has a scheduled appointment with a GIM physician in the next several weeks
* Patient will be 50 years old at the time of this appointment
* Patient is male or female

Exclusion Criteria:

* This is the first time the patient is seen in the NMFF GIM clinic
* There is a prior completion of CRC screening noted in EHR.
* There is a prior order placed for CRC screening in EHR.
* Patient has a history of CRC
* Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.

Primary outcomes:
measure: Completion of CRC Screening
timeFrame: 6 months from initial contact
Secondary outcomes:
measure: The Secondary Outcome for the Study is the Time to Screening Completion.
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation General Internal Medicine Clinic
state: Illinois
Study officials:
affiliation: Northwestern University, Department of General Internal Medicine
name: Kenzie Cameron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830049: Differential Plasma MicroRNA Profiles in ED and Normal Erectile Function in Older Males
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Group I: older males came to our clinic for diagnosis and treatment of ED. Group II: older males came to our clinic for physical examination and the erectile function was normal.

Group III: young males came to our clinic for physical examination and the erectile function was normal.

Brief summary: Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ED is expected in the years to come. Currently, the mechanism of ED is not fully understood. MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression post-transcriptionally. It has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ED. This research was designed to investigate the differential plasma MiRNA profiles in ED and normal erectile function in older males. The results might tell us which MiRNA and how did it involved in the process of ED in aging.


Eligibility criteria: Inclusion Criteria:

* older males with erectile dysfunction

Exclusion Criteria:

* have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.

Primary outcomes:
measure: Gene chips
timeFrame: 30 days
Secondary outcomes:
measure: RT-PCR
timeFrame: 15 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Gulou Hospital affiliated to Nanjing University, Medical School
state: Jiangsu
Study officials:
References: