louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05503641: Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults
Official title: Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function and in the Functional Capacity of Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging.


Eligibility criteria: Inclusion Criteria:

* Have a mild dependency according to the Barthel Index (score greater than 60 points).
* Not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors.
* Be able to understand each of the self-administered questionnaires and perform the tests.

Exclusion Criteria:

* Have vision problems.
* Be enrolled in a physical exercise program.

Primary outcomes:
measure: Tinetti Scale
timeFrame: Up to twelve weeks
measure: Handgrip Strength
timeFrame: Up to twelve weeks
measure: MMSE (mini-mental state examination)
timeFrame: Up to twelve weeks
measure: TUG test (Timed Up and Go test)
timeFrame: Up to twelve weeks
measure: The Lawton & Brody scale
timeFrame: Up to twelve weeks
measure: The Barthel Index
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: BMI (Body Mass Index)
timeFrame: Up to twelve weeks
measure: Body Weight
timeFrame: Up to twelve weeks
measure: Height
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: U.E.D. Virgen de la Capilla
Study officials:
References:
Clinical trial NCT00919841: Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies
Official title: Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: postpartum
involution
three-dimension sonography
size of the uterus
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who deliver a singleton vaginally will be invited to participate the study.

Brief summary: Women who naturally deliver a singleton will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. The pattern of involution will be analyzed.

Detailed description: Women who naturally deliver a singleton in the Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. Transabdominal or transvaginal approach will be at the examiner's discretion. Uterine volume will be measured with 3-dimensional sonographic technologies. Ovaries will also be assessed, along with Doppler flow in several vessels in the pelvis. The pattern of involution will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Women who deliver a singleton vaginally will be invited to participate the study.

Exclusion Criteria:

* Women who deliver multiple gestation.
* Women who deliver by Cesarean section
* Women who have puerperal complications eg. postpartum hemorrhage or infection

Primary outcomes:
measure: To create the uterine involution curve after vaginal delivery
timeFrame: 7 weeks
Secondary outcomes:
measure: To assess an alteration in Doppler parameters in arcuate, uterine and ovarian arteries after vaginal delivery
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Tuangsit Wataganara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wataganara T, Phithakwatchara N, Komoltri C, Tantisirin P, Pooliam J, Titapant V. Functional three-dimensional sonographic study of the postpartum uterus. J Matern Fetal Neonatal Med. 2015;28(18):2221-7. doi: 10.3109/14767058.2014.983063. Epub 2014 Nov 27.
Clinical trial NCT05888441: Obstacle Negotiation in Older People With and Without Vision Impairment
Official title: Impact of Stepping Over Obstacles of Different Contrast and Height on Gait and Eye Movements in Older Adults With and Without Vision Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Vision
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Falls are common among people with vision impairment and can lead to devastating health consequences. Understanding the functions of vision and how the visual characteristics of obstacles in the walking path impact the gait of people with vision impairment is necessary to create strategies to prevent falls in this population. The purpose of this study is to determine how adults with vision impairment change their gait behavior when stepping over obstacles that vary in height and contrast to the ground. We will then determine the mechanisms of gaze behavior that correlate to the gait behavior.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* Able to walk independently
* Either have normal vision, or impaired vision.

  * Impaired vision is defined as binocular visual acuity of 20/25 or worse with or without a central scotoma; and/or binocular visual field that is restricted to an average of 100 degrees in diameter or less
  * Control subjects will have visual acuity of 20/40 or better.

Exclusion Criteria:

* Not cleared by a medical provider for moderate physical activity
* Self-report or have a history of: vestibular disorder or deafness
* Medical history of any condition that affects the ability to walk for up to 2 hours with breaks, such as feeling dizzy or faint, chest pain, palpitations, pain or numbness in the legs, shortness of breath,
* Cognitive limitations either by self-report or a score on the Mini Mental State Exam below 24 (out of 30)
* Walking or gait abnormalities, such as those caused from an injury, surgery, severe arthritis, or neurological condition such as Parkinson's disease
* Unable to walk without any walking aids such as a walker, cane, guide dog, or oxygen tank.
* Does not speak English

Primary outcomes:
measure: Vertical foot clearance, lead limb
timeFrame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
measure: Foot placement variability
timeFrame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
measure: Obstacle crossing speed
timeFrame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
measure: Gaze sequencing
timeFrame: During a single intervention visit (Study Visit 2), up to 2-3 hours in duration.
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT03046641: Exercise Duration Models, in Middle-aged Men
Official title: The Study of Various Models of Exercise Duration on Weight Loss and Lipid Profile in Sedentary Overweight/Obese Middle-aged Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Caloric Restriction
Dietary Formulations
Exercise
Men
Lead sponsor: P.L.Shupik National Medical Academy of Post-Graduate Education
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 82
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Duration of exercise is an important factor among the medical guides for weight loss. However, there is still little knowledge about other its models in middle-aged and older men. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

Detailed description: Participants included sedentary men (age 45-75 years) with overweight or obesity (n= 82). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility criteria: Inclusion Criteria:

* Sedentary lifestyle
* Good Health
* Weight stability

Exclusion Criteria:

Abnormality or history of Disease

Primary outcomes:
measure: 4-item
timeFrame: 3 months
Secondary outcomes:
measure: 4-item
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Member of Scientific Board in Physical Education and Sport Sciences of Sistan and Baluchestan University
name: Mohammadreza Rezaeipour, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01211119: Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
Official title: Novel One-step Repair of Knee Meniscal Tear Using Platelet-rich Fibrin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscal Injuries
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, most knee meniscal tears are treated by partial or complete meniscectomy, or by suture repair when it is possible. Recently, the investigators have successfully developed and implanted a novel biomaterial, platelet-rich fibrin (PRF), to treat articular cartilage defect in pigs. The PRF is autogenesis as a natural fibrin-based biomaterial favorable to the development of microvascularization and enables local and progressive delivery of growth factors providing unique properties for tissue remodeling and wound healing. The advantages of using PRF implantation include no transplant rejection and no need to perform second operation. Knee meniscal repair using PRF has not been reported before. The aim of this study is to investigate whether PRF implantation can facilitate regeneration process of meniscectomized knee and T2-map MRI can monitor the process in those patients with meniscal tears.

A total of 18 adult patients with torn menisci (outer 1/3, posterior horn, medial meniscus) will be recruited and randomly divided into three groups: A (n=6), implantation of PRF after partial menisectomy; B (n=6), implantation of PRF after partial menisectomy and suture; C (n=6), partial menisectomy only. All studied knee will be scanned on a 1.5-T MRI with surface coil at baseline before surgery, 3 months and 6 months and 12 months after surgery.

The investigators believe that PRF enables to facilitate regeneration of meniscectomized knee, and T2-map MRI enables monitoring healing process of meniscal tears.


Eligibility criteria: Inclusion Criteria:

* 20 to 45 years old;
* time of injury to surgery within 8 weeks
* patients who will sign inform consent
* patients with clinical and MRI diagnosis of meniscal tears who will undergo arthroscopy
* patients who will make MRI diagnosis at 3, 6, 12 months

Exclusion Criteria:

* major trauma
* coexist ligamentous rupture
* knee dislocations

Primary outcomes:
measure: MRI T2-map values in healing menisci
timeFrame: one-month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Wing P. Chan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04411719: Outcome Prediction in Patients With Acute Disorders of Consciousness
Official title: Prognosis of Acute DOC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Consciousness Disorder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unresponsive patients after severe brain injury.

Brief summary: Prior research has indicated a link between outcomes in patients with disorders of consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree of uncertainty in acute situations, this study plans to record EEG responses and observe microexpressions in DOC patients during exposure to auditory stimuli, with the aim to identify more reliable prognostic indicators. The goal is to uncover potential patterns or signals that can contribute to a more comprehensive understanding of a patient's condition, and thereby provide more accurate prognostication.

Detailed description: This study intends to probe the potential of electroencephalography (EEG) and microexpression analysis for predicting the outcomes of acutely unresponsive patients within the intensive care unit (ICU). Previous research has illuminated a relationship between patients' emotional responses to auditory stimuli and their prognosis. However, the predictive utility of these responses in the context of acute conditions remains largely unexplored.

At the onset of the study, participants will undergo EEG monitoring while exposed to a pre-determined set of emotional auditory stimuli. Additionally, the patients' facial expressions will be captured via video for subsequent microexpression analysis.

Follow-up assessments of the patients' status will be conducted at three, six, and twelve-month intervals. Using cutting-edge analytical techniques, the goal is to decode these EEG and microexpression responses. This study aims to identify possible correlations between these findings, the patients' diagnoses, and their respective outcomes over time.

Eligibility criteria: Inclusion Criteria:

* Patients with acute brain injury (\<28 days) in ICU
* GCS ≤ 8
* ≥ 2 days after sedation
* Normal hearing, with auditory startle reflex

Exclusion Criteria:

• Children under 18

Primary outcomes:
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Month 1
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Month 3
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Month 6
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Benyan Luo, Prof, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371019: Proteomic Assessment of Preterm Birth
Official title: Proteomic Assessment of Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Preterm Birth, Proteomics
Lead sponsor: Sera Prognostics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 5500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who are receiving prenatal care.

Brief summary: The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older.
* Subject has a singleton pregnancy.
* Subject is able to provide consent.

Exclusion Criteria:

* Subject is pregnant with more than one fetus.
* There is a known or suspected fetal anomaly.

Primary outcomes:
measure: Spontaneous Preterm Birth
timeFrame: August 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
city: San Diego
country: United States
facility: San Diego Perinatal Clinic
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Regional Obstetrical Consultants
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street ,
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Sera Prognostics, Inc.
name: Durlin E Hickok, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Esplin MS, Merrell K, Goldenberg R, Lai Y, Iams JD, Mercer B, Spong CY, Miodovnik M, Simhan HN, van Dorsten P, Dombrowski M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth. Am J Obstet Gynecol. 2011 May;204(5):391.e1-8. doi: 10.1016/j.ajog.2010.09.021. Epub 2010 Nov 11.
Clinical trial NCT00897819: Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200
Official title: Evaluation of the Association Between DNA Methylation and Shortened Survival in Patients With Advanced Colorectal Cancer Treated With 5-FU/Oxaliplatin-Based Regimens in E3200
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer
recurrent rectal cancer
stage III colon cancer
stage III rectal cancer
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E3200

Brief summary: RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

Detailed description: OBJECTIVES:

* Determine the CpG island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.
* Compare the methylation results to clinicopathologic and molecular findings and survival.

OUTLINE: This is a multicenter study.

Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14, and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346, and D17S250.

PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of the colon or rectum

  * Advanced disease
* Enrolled on clinical trial E-3200 and received fluorouracil and oxaliplatin
* Tumor tissue blocks available
* Routine pathology specimens (i.e., blood, urine) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation of MSI and LOH to outcome and response
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Stanley Hamilton, MD
role: STUDY_CHAIR
References: