louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01204047: Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury
Official title: Wheelchair Propulsion Function and Physical Capacity in Persons With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 62
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: Community sample

Brief summary: The specific aims of this study are: 1) to assess the test-retest reliability of a modification of an existing wheelchair propulsion assessment and 2) validate the modification against traditional measures of physical strength, power, and endurance in a group of persons with spinal cord injury (SCI).

Detailed description: The ability to independently self-propel and transfer oneself is a crucial component of daily life for individuals with a spinal cord injury. This ability is related in part to an individual's strength, power, and endurance, but it is unknown which of these measures is most important to achieve a high level of wheelchair function. Identification of which physical performance parameters are best related to wheeled mobility performance is essential in developing interventions to improve said performance. Currently, clinic-friendly assessments of a person's wheeled mobility ability do not exist. We have developed a modified, clinic-friendly version of validated wheelchair mobility assessment that can be completed in most clinics. Before it can be implemented by clinicians its reliability must be established. Crossvalidating it against standard measures of physical performance will allow for the identification of the most appropriate exercise interventions to improve independent wheeled mobility.

Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury
* American Spinal Injury Association Impairment Scale (AIS) A-D
* Self-reported ability to self-propel themselves in a manual wheelchair
* Age 18 or older

Exclusion Criteria:

* surgery within 6 months
* pressure ulcer within 3 months
* upper limb pain that limits completion of exercise
* recurrent acute infection or illness requiring hospitalization or IV antibiotics
* pregnancy
* previous myocardial infarction or cardiac surgery

Primary outcomes:
measure: Ability Score
timeFrame: within a 14 day period
Secondary outcomes:
measure: Muscular strength
timeFrame: 1 day
measure: Anaerobic power
timeFrame: 1 day
measure: Cardiovascular endurance
timeFrame: 1 day
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03919747: Oral Contraceptives in Reproductive Age Women
Official title: The Awareness About Oral Contraceptives in Reproductive Age Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contraception Behavior
Keywords: oral contraceptives
knowledge
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive aged women

Brief summary: Contraception is an important issue in public health; especially when maternal risks and morbidities are considered. There is a need for consciousness about the contraceptive choices. The reproductive age women in Turkey may be stubborn or may choose to believe heath information. The oral contraceptive drugs are not used because of wrong beliefs. This survey study aims to investigate the consciousness and knowledge about the oral contraceptives in 3 different areas in Turkey.

Detailed description: In this study; surveys will be given to reproductive age women admitting to the obstetrics and gynecology departments in 3 different cities of Turkey. Survey questions start with the education and socioeconomical status of the participants. Mainly the questions include the knowledge, ever use about oral contraceptives.

Eligibility criteria: Inclusion Criteria: The women admitting to the clinics -

Exclusion Criteria:

-

Primary outcomes:
measure: Knowledge about oral contraceptives
timeFrame: 6 months of survey study
measure: Contraindications of OC pills
timeFrame: 6 months of survey study
Secondary outcomes:
measure: Knowledge difference in between different regions
timeFrame: 6 months of survey study
measure: Oral contraceptive use
timeFrame: 6 months of survey study
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University Hospital
city: Kayseri
country: Turkey
facility: Acıbadem Private Hospital
city: Ankara
country: Turkey
facility: Ufuk University Dr Ridvan Ege Hospital
state: Çankaya
Study officials:
affiliation: The Turkish Reproductive Medicine Association
name: Recai Pabuccu, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06011447: Laser Speckle Imaging in Ischaemic Tissue Loss
Official title: The Use of Laser Speckle Imaging in the Evaluation of Successful Revascularisation of Patients With Ischemic Tissue Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with vascular ulcers

Brief summary: Peripheral arterial disease is a condition in which the arteries become narrowed due to a build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and this can compromise the parts of the body supplied by these arteries. In its most severe form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading to ulcers or gangrene. Patients with peripheral arterial disease undergo procedures to improve blood flow.

However, there are often multiple arteries to treat and each intervention carries risk. It therefore can be difficult to judge how much treatment is sufficient to promote healing. Laser Speckle Imaging is a technique used to demonstrate blood flow in the skin. It is hoped that changes in skin blood flow, as measured by LSI, immediately after a procedure to improve blood flow, may help in the decision making as to whether further intervention is necessary. An LSI scan will be performed before a procedure for tissue loss and immediately after it is performed. The patient's clinical records will then be checked to see whether the wound has improved and whether the difference in LSI scans correlated with this.


Eligibility criteria: Inclusion Criteria:

Patients with diabetes Patients with a foot ulcer or open wound Patients aged over 18 Patients able to given consent Patients undergoing femoropopliteal bypass or superficial femoral / popliteal artery angioplasty

Exclusion Criteria:

nability to consent Planned major limb amputation for the affected limb

Primary outcomes:
measure: fail to heal wounds
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds NHS Teaching Hospitals
Study officials:
References:
Clinical trial NCT00825747: Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
Official title: Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Keywords: Cataract
Cataract surgery
intraocular lens
Aspheric lens
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.

Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.

Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.

Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Senile Cataract
* Age \>18 years
* Cataract extraction using phacoemulsification
* Corneal incision less than 1.5 mm

Exclusion Criteria:

* Allergy/sensitivity to eye drops used during and after cataract surgery
* Amblyopia/ strabismus
* Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
* previous ocular surgery or ocular trauma in the investigated eye
* Ocular anomaly, such as microphthalmos
* Keratometry values less than 40 diopters or more than 47 diopters.
* Ocular axial length less than 21.0 mm or longer than 25.0 mm
* Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.
* posterior capsular scar
* visual acuity in the fellow eye less than 20/200

Primary outcomes:
measure: Best corrected visual acuity 3 months after SeeLens AF implantation
timeFrame: 3 months
Secondary outcomes:
measure: Complications related to SeeLens AF implantation during cataract surgery.
timeFrame: 3 months
measure: Postoperative severe intra-ocular inflammation or infection
timeFrame: 3 months
measure: Prediction of ocular refraction after cataract surgery with Seelens AF implantation
timeFrame: 3 months
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel
name: Yokrat Ton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00970047: Development of a Fetal Sex Assay From Maternal Whole Blood
Official title: Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Sex Determination
Keywords: pregnant
fetal sex determination
gender determination
noninvasive test
fetal DNA
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women between 6 and 16 weeks of gestation.

Brief summary: Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.

Detailed description: This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.

Eligibility criteria: Inclusion Criteria:

* Subject is 18-64 years of age
* Subject is female
* Subject is pregnant and between 6 and 16 weeks of gestation
* Subject provides a signed and dated informed consent
* If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
* If subject undergoes an invasive procedure, she agrees to provide the fetal sex results

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: NCOG Medical Group
state: California
city: San Diego
country: United States
facility: IGO
state: California
city: San Diego
country: United States
facility: Scripps Clinic Medial Group
state: California
Study officials:
affiliation: Sequenom, Inc.
name: Allan Bombard, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00144547: Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 241
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA012JP.


Eligibility criteria: Inclusion criteria

* Patients must suffer from RA, and must have participated in the preceding study.
* Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

* Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
* Patients who have not been registered by 3 months after week 52 of the preceding study

Primary outcomes:
measure: Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
timeFrame: 0W,4W,8W,12W,LOBS
measure: Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria
timeFrame: 0W,4W,8W,12W,LOBS
Secondary outcomes:
measure: Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
timeFrame: 0W,4W,8W,12W,LOBS
measure: Frequency, severity, and seriousness of adverse events and adverse drug reactions
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT04777747: The Role of Lactate in Viral and Bacterial Infection
Official title: The Role of Lactate From Viral to Bacterial Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Infection
Bacterial Infections
Lactate Blood Increase
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-03-02
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The age of a child ranged from 0 to 18 is included in the present study, especially the first viral infection.

Brief summary: Acute upper respiratory tract infection(AURI) is common in children, and viral infection is the main cause. However, several children with viral infection are easy to suffer from secondary bacterial infection, and the mechanism is unclear.

Detailed description: Lactate is an important molecule in the spread and metastasis of tumor by suppressing the innate immune response. As is known, the immune system is not mature in children and it is reverse related to the age of children. An reasonable hypothesis is that the lactate is a independent risk factor in the children with viral infection progress to bacterial infection. Here, our aim is to test the hypothesis.

Eligibility criteria: Inclusion Criteria:

* child's age is from 0 to 18 years
* a child is at least diagnosed with viral infection

Exclusion Criteria:

one of the following conditions appeared:

* congenital heart disease or other abnormalities
* respiratory failure
* hereditary and/or metabolic disease

Primary outcomes:
measure: level of lactate
timeFrame: three days after admission
measure: the level of lactate dehydrogenase(LDH)
timeFrame: three days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chen
state: Chongqing
Study officials:
References:
Clinical trial NCT01487447: Customized Acoustic Stimulation for the Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 31
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 the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Male or female
* Tinnitus present for 6 months or more
* Adequate command of English

Exclusion Criteria:

* Active illicit drug use, alcohol dependence
* Treatable cause of tinnitus
* History of psychosis
* Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.

Primary outcomes:
measure: Change in score of tinnitus loudness
timeFrame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months
measure: Change in score of tinnitus annoyance
timeFrame: 0, 1 minute; 1 hour; 1, 2, 4 and 6 months
measure: Change in residual inhibition
timeFrame: 1 minute; 1 hour; 1, 2, 4 and 6 months
measure: Change in score of Tinnitus Handicap Inventory (THI)
timeFrame: 0, 1, 2, 4 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
References:
Clinical trial NCT05876247: Articulatory Adaptation Following Oral Cancer Treatment
Official title: Speech Flexibility in Adulthood Following Oral Cancer Treatment: Acoustic and Kinematic Explorations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Cavity Squamous Cell Carcinoma
Speech Disorders
Keywords: Articulation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with and without oral cancer who speak Dutch as their native language

Brief summary: The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies.

Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with T1 or T2 tumor in the oral cavity
2. At least 18 years old and able to provide informed consent
3. Native speaker of Dutch
4. Has nog been treated for oral cancer before

Exclusion Criteria:

1a. Recurrence of disease (for patients)

1b. Treated for oral cancer (for healthy controls) 2. Speech problems (e.g., stuttering) 3. Problems with sight or hearing that impede reading or understanding instructions. When glasses or a hearing aid resolve these problems, then participants are not excluded.

4. Neurological or psychological disorders (e.g., stroke) 5. Non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. Self-reported signs of depression

Primary outcomes:
measure: Articulatory gestures
timeFrame: 2022-2025
measure: Acoustic outcomes
timeFrame: 2022-2025
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Faculty of Arts, University of Groningen
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University of Groningen
name: Max Witjes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448247: A Study of SPY001-001 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY001-001 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Spyre Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Altasciences Company Inc.
First posted: 2024-06-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose, first in human safety, tolerability, and pharmacokinetic study of SPY001-001 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits

Exclusion Criteria:

* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
* History of severe allergic reactions or hypersensitivity
* Donation or loss of \>1 unit of whole blood within 1 month prior to dosing

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: Up to 64 weeks
Secondary outcomes:
measure: Cmax
timeFrame: Up to 64 weeks
measure: Tmax
timeFrame: Up to 64 weeks
measure: t1/2
timeFrame: Up to 64 weeks
measure: AUC
timeFrame: Up to 64 weeks
measure: ADA
timeFrame: Up to 64 weeks
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Spyre Site 2
state: California
city: Montréal
country: Canada
facility: Spyre Site 1
state: Quebec
Study officials:
affiliation: Spyre Therapeutics
name: Deanna Nguyen, MD
role: STUDY_CHAIR
References: