louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04700605: Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.
Official title: Intra-rater Reliability and Agreement Between Static Balance Test Using Nintendo Wii Balance Board and Gait Test Under Dual Task Conditions in Community-dwelling Older Adults.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Balance; Distorted
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minimum 65 year-old community dwelling citizens at activity centers.

Brief summary: Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults.

Detailed description: Participants:

Investigators aim to recruit a minimum of 30 participants aged 65 years or above through convenience sampling at an senior activity centre in the Municipality of Aalborg. Participants inclusion critiria is age about 65, the ability to stand for 30 seconds unaided and the ability to walk 8 meters. Exclusion critiria is severe cognitive impairment (e.g., dementia).

Procedure:

Each participant will undergo two testdays separated by approximately two weeks. Both testdays have the same number and order of tests and are placed approximately the same time of the day. At the first testday descriptive information for each participant is collected.

Measuring device:

The Nintendo Wii Balance Board (Nintendo, Kyoto, Japan) is a small portable force plate measuring sway ellipse area and sway speed.

Analysis:

Will include intra-rater reliability for each test and agreement between the two. Calculations of balance/gait costs will be made to unify the unit and to compare the two tests to each other. Results shown by intraclass correlation coeffients and Bland Altman plots.

Eligibility criteria: Inclusion Criteria:

* Minimum 65 years old.
* Community dwelling

Exclusion Criteria:

* Unable to stand unsupported for 30 seconds
* Unable to walk 8 meters unsupported

Primary outcomes:
measure: Intra-rater reliability for the gait test and the WBB test.
timeFrame: Through study completion, app. 8 months.
Secondary outcomes:
measure: Agreement between the gait test and the WBB test as dual task measurements.
timeFrame: Through study completion, app. 8 months.
measure: Descriptive data.
timeFrame: Through study completion, app. 8 months.
Other outcomes:
Locations:
city: Vodskov
country: Denmark
facility: Liselund Aktivitets Center
state: Aalborg
Study officials:
affiliation: Aalborg University Hospital
name: Martin Eriksen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145105: Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
Official title: Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Sciatica
Keywords: Low back pain
Sciatica
Pain
Physiotherapy
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain.

It has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg.

Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.

Detailed description: Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. The treated individuals and the referring physician will also be blinded to the treatment allocation;

Eligibility criteria: Inclusion Criteria:

* Written consent
* LBP with radiation to one leg, that lasts more than 6 weeks
* Abnormal response to SLR test
* With or without neurological signs

Exclusion Criteria:

* History of spinal surgery
* Patient with FUO
* History of malignancies
* Patient with saddle anesthesia

Primary outcomes:
measure: Efficacy of neural dynamics technique
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit Health Services, Haifa and Western Galilee District
Study officials:
affiliation: clinical research unit, Clalit health services, Haifa and western Galilee district.
name: Noga Roguin Maor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: clinical research unit, Clalit health services, Haifa and western Galilee district.
name: Uzi Milman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03767205: The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Official title: The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Keywords: gait function
Metabolic energy expenditure
ankle assist robot
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing

1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)


Eligibility criteria: Inclusion Criteria:

* Stroke patients with hemiplegia over 19 years old
* Ischemic or hemorrhagic stroke patients over 3 months of onset
* Functional Ambulation Category Scale with 3 or more scales

Exclusion Criteria:

* Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures
* Stroke patients with walking difficulty due to serious cognitive problems
* Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot
* Stroke patients at risk of falling when walking with severe dizziness
* Modified ashworth scale (MAS) Stroke patients over 3
* Pregnant woman
* People with mental illness and psychiatric medication

Primary outcomes:
measure: Change on gait speed in different three conditions
timeFrame: 20minutes
Secondary outcomes:
measure: Change on gait function in different three conditions (kinematic)
timeFrame: 20minutes
measure: Change on gait function in different three conditions (kinetic)
timeFrame: 20minutes
measure: Change on gait function in different three conditions (muscle activation)
timeFrame: 20minutes
measure: Change on metabolic energy expenditure in different three conditions
timeFrame: 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: YunHee Kim, Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06017505: Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals
Official title: Integrating the Electronic Self-administered Gerocognitive Examination (eSAGE) With Electronic Health Records (EHR) Data Using Machine Learning (ML) for the Early Detection and Monitoring of Cognitive Impairment in Individuals
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dementia
Alzheimer Disease
Mild Cognitive Impairment
Worried Well
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 1486
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include males and females 50 years of age and over who complete the eSAGE as part of their office visit at the Center for Cognitive and Memory Disorders.

Brief summary: The goal of this observational trial is to leverage the electronic Self-Administered Gerocognitive Examination (eSAGE), a variety of metadata (a set of data that describes and gives information about other data) collected during eSAGE testing, electronic health records (EHR) information, and advanced machine learning (ML) techniques to develop a new tool that can aid in early-stage prediction of individuals with cognitive impairments.

Detailed description: This is a retrospective and prospective record review trial for patients who are followed at the Center for Cognitive and Memory Disorders.

eSAGE assessment data (including cognitive data, behavioral data, timing data and other metadata) as well as varying amount of electronic health records (EHR) data will be collected on all eligible subjects. Machine learning techniques with feature selection will identify important EHR variables to determine what may be useful for the prediction of cognitive impairment.

Based on the EHR analysis additional questions will be added to the eSAGE to make an enhanced eSAGE version (eSAGE+). The goal of the eSAGE+ is to facilitate the identification of cognition impairment, and ultimately have a translational impact on Alzheimer's disease (AD) identification and management.

Eligibility criteria: Inclusion Criteria:

* 1. Males and females 50 years of age and over who complete the eSAGE as part of their office visit at the Center for Cognitive and Memory Disorders.

Exclusion Criteria:

* None

Primary outcomes:
measure: Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects.
timeFrame: 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nicole Vrettos
state: Ohio
Study officials:
affiliation: Ohio State University
name: Douglas Scharre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00337805: Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
Official title: A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiac Surgery
Keywords: colloid
crystalloid
hemodynamics
flow-directed
resuscitation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-06-16
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.


Eligibility criteria: Inclusion Criteria:

* status post cardiac surgery
* pulmonary artery occlusion catheter in place
* informed consent
* morning case (must be out of OR by 2:00 PM

Exclusion Criteria:

* excessive bleeding (\> 200 cc/hr)
* intraaortic balloon pump
* refusal by treating team
* emergency cases
* patients with known adverse reactions to starch solutions

Primary outcomes:
measure: Use of catecholamines at 8:00 the morning after surgery
timeFrame: first post operative day
Secondary outcomes:
measure: Total use of catecholamines
timeFrame: Time in ICU
measure: Time in the ICU
timeFrame: Time in ICU
measure: Post-operative complications
timeFrame: Hospital stay or 28 days
measure: Bleeding
timeFrame: Hospital stay or 28 days
measure: Renal failure
timeFrame: Hospital stay or 28 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: sheldon magder, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Potter BJ, Deverenne B, Doucette S, Fergusson D, Magder S; Canadian Critical Care Trials Group. Cardiac output responses in a flow-driven protocol of resuscitation following cardiac surgery. J Crit Care. 2013 Jun;28(3):265-9. doi: 10.1016/j.jcrc.2012.09.008. Epub 2012 Nov 14.
Clinical trial NCT06932705: A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mixed Dyslipidemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-17
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

Detailed description: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied

Primary outcomes:
measure: Maximum concentration of drug in plasma (Cmax)
timeFrame: pre-dose (0hour) to 72hours
measure: Area under the plasma concentration-time curve during dosing interval (AUCt)
timeFrame: pre-dose (0hour) to 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT00768105: To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin
Official title: A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.


Eligibility criteria: Inclusion Criteria:

* Female with non child-bearing potential
* Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
* HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Primary outcomes:
measure: Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D MÃ¶lndal
name: Klas Malmberg, MD, PhD
role: STUDY_DIRECTOR
affiliation: Profil Institut for Clinical Research Inc.
name: Marcus Hompesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06908005: RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer
Official title: Development and Prognostic Validation of RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer - Non Small Cell
Keywords: NSCLC
radiomics
PFS
fibrosis
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Jinling Hospital, China

Brief summary: Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results, CT images and pathological sections were collected. The investigators also collected the disease-free survival and overall survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and PyRadiomics was used to extract the radiomic features. Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software. The investigators developed RaFIST, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (NSCLC) using contrast-enhanced CT imaging. And it was further tested on the held-out external test cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC).


Eligibility criteria: Inclusion Criteria:

* Solid pulmonary nodule detected on CECT within 3 weeks pre-resection
* No history of previous treatment such as chemotherapy, or radiotherapy

Exclusion Criteria:

* Unavailable pathological sections
* Missing CT images or hard-to-annotate CT images
* Undergone anticancer therapy before CT
* Loss to follow-up
* Concurrent other malignant tumors

Primary outcomes:
measure: DFS (Disease-free survival)
timeFrame: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.
Secondary outcomes:
measure: OS (overall survival）
timeFrame: Record from the date of surgery to the date of death from any cause，whichever comes first, and assess up to a maximum of 5 years.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01271205: Red Cell Distribution Width and Mortality in Adult Pneumonia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia
Keywords: pneumonia
RDW
mortality
prognostic factor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with pneumonia

Brief summary: Abstract Pneumonia is a leading cause of severe morbidity and mortality among adults. During the last two decades, several scores were developed to evaluate the probability of morbidity and mortality among patients with community acquired pneumonia (CAP), such as the PORT score and the CURB65. Recently, several studies showed that elevated Red Cell Distribution Width (RDW) could be used as a prognostic tool for predicting severe morbidity and mortality among patients with cardiac diseases.

RDW is a quantitative measure for red blood cell (RBC) size variability. Recent studies have suggested that high levels of RDW are in association with higher mortality among cardiovascular patients.

RDW has not yet been studied as a prognostic sign in CAP. The goal of this study is to examine the role of RDW as a prognostic factor for severe morbidity and mortality among patients who were hospitalized with CAP , independently to Hemoglobin levels, renal function and inflammatory markers.


Eligibility criteria: Inclusion Criteria:

patients 18 years and older, hospitalized due to pneumonia between 2005-2010. All patients must have RDW values.

-

Exclusion Criteria:

* under 18 no RDW value The primary cause of hospitalization was not pneumonia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: