louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04103463: Interactive Stepping Exercise on Memory
Official title: Effects of Interactive Stepping Exercise on Memory in Adults With Amnestic Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amnestic Mild Cognitive Impairment
Interactive Stepping Exercise
Memory
Cognitive Function
Executive Function
Keywords: square stepping exercise
Amnestic mild cognitive impairment
Interactive stepping exercise
memory
cognitive function
executive function
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A \& B (TMT-A \& B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.


Eligibility criteria: Inclusion Criteria:

* Age≥50 years
* Complained of memory impairment
* Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words
* MMSE score≥24 and CDR score=0.5
* Activities of daily living are intact
* DSM-IV criteria for the diagnosis of dementia is not met

Exclusion Criteria:

* Any significant neurologic disease other than suspected incipient Alzheimer's disease
* Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol

Primary outcomes:
measure: Chinese version verbal learning test
timeFrame: Change from baseline at 12 week
measure: Selective reminding test
timeFrame: Change from baseline at 12 week
measure: Wechsler Memory Scale-III
timeFrame: Change from baseline at 12 week
measure: Logic memory test
timeFrame: Change from baseline at 12 week
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Change from baseline at 12 week
measure: Trail making test
timeFrame: Change from baseline at 12 week
measure: Stroop test
timeFrame: Change from baseline at 12 week
measure: Executive Interview
timeFrame: Change from baseline at 12 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06269263: Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF)
Official title: Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of home-based cardiac rehabilitation
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, the investigators will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, the investigators will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Chronic heart failure irrespective of the ejection fraction
* Recent history of acute cardiac decompensation leading to hospitalization

Exclusion Criteria:

* Patients not willing to participate
* Patients with orthopedic diseases limiting their mobility
* Cognitive diseases that hinder adequate participation in the opinion of the investigator
* Inpatient rehabilitation.

Primary outcomes:
measure: Percentage of patients completing the program
timeFrame: After 12 weeks
Secondary outcomes:
measure: Quality of life by KCCQ
timeFrame: After 12 weeks
measure: Exercise capacity
timeFrame: After 12 weeks
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Saxony
Study officials:
References:
Clinical trial NCT02028663: Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Official title: A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erosive Esophagitis
GERD
Keywords: P-CAB
APA(Acid Pump Antagonist)
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 206
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.


Eligibility criteria: Inclusion Criteria:

* Aged between 20-70
* Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment

Exclusion Criteria:

* Patients who cannot undergo EGD
* Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
* Patients who took PPIs within 2 weeks prior to study drug administration
* Long-term use of nonsteroidal anti-inﬂammatory drugs throughout the study
* Clinically significant abnormal laboratory values during screening

Primary outcomes:
measure: Cumulative healing rate of erosive esophagitis at 8-week
timeFrame: 8 week
Secondary outcomes:
measure: Healing rate of erosive esophagitis at 4-week
timeFrame: 4 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital and 11 others
Study officials:
affiliation: Seoul National University Hospital
name: Hyun-Chae Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161263: Quality of Vision and Quality of Life With LASIK
Official title: Patient Quality of Vision and Quality of Life With LASIK Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Astigmatism
Quality of Lifte
Keywords: LASIK
Satisfaction
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 49
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults over the age of 21 with healthy eyes and nearsightedness, farsightedness and/or astigmatism

Brief summary: The investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery

Detailed description: The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.

Eligibility criteria: Inclusion Criteria:

* Are aged 21 years or older.
* Have the ability to give informed consent.
* Speak and read English fluently.
* Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
* May benefit from increased spectacle independence.
* Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
* Have a treatment target of bilateral emmetropia.
* Express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator.
* Are not enrolled in any other research study.

Exclusion Criteria:

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectactic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.

Primary outcomes:
measure: Quality of Vision and Quality of Life Questionnaires after LASIK Surgery
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Eye Laser Center
state: California
Study officials:
affiliation: Stanford University
name: Edward E Manche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01715363: Feasibility of an Immediate Preoperative Chemotherapy Before Resection fo Colorectal Cancer
Official title: Feasibility of an Immediate Preoperative Chemotherapy Before Resection of Colorectal Cancer and Research of Gene Expressions Changes Induced in the Tumor, Predictive of Chemotherapy Efficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Patients With Colorectal Cancer With Unresectable Synchronous Metastasis in Whom Resection of the Primitive Tumour is Indicated
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the clinical tolerance of immediate preoperative chemotherapy in terms of toxicity and perioperative morbidity and mortality


Eligibility criteria: Inclusion Criteria:

* colorectal metastatic adenocarcinoma (stage IV) with unresectables, measurables and visibles secondary lesions
* primitive tumor must be operate
* patient age between 18 and 70
* OMS status performance \< 2
* life expectancy \> 12 weeks
* hematologic function : PNN \>/= 1.5x10\^9/L, platelets \>/= 100x10\^9/L
* hepatic function : bilirubin \</= 1.5xLSN, AST and ALT \</= 3xLSN, alcalin phosphatasis \</= 3xLSN
* plasmatimic creatin \</= 1.25xLSN
* No previous chemotherapy or pelvic radiotherapy
* men and women in age of procreate agreeing to use a contraception until 4 months after the end of treatment for women and until 6 months for men

Exclusion Criteria:

* nonmetastatic forms
* Colorectal tumor which requires preoperative radiotherapy
* nonmeasurable metastasis based on RECIST criteria
* previous chemotherapy for colorectal cancer
* previous irradiation of the primitive tumour
* specific indication against the treatment studied
* Patient considered as inoperable for physiological or carcinologic reasons
* Pregnant or breast feeding women

Primary outcomes:
measure: Clinical tolerance of immediate preoperative chemotherapy
timeFrame: Assess up to 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val de Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Diane GOERE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03839563: Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
Official title: Temporal Relations and Exercise Interventions of Various Gait and Cognitive Domains in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fallers
Mild Cognitive Impairment
Keywords: Biomarker
Cognitive impairment
Gait abnormality
Older Adults
Exercise
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2019-02-15
Enrollment: 189
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic, single-blinded, randomized controlled trial with three arms will be conducted to investigate the effectiveness of conventional exercise and tai chi chuan, compared to health education/usual physical activity.
Primary purpose: PREVENTION

Brief summary: The effectiveness of conventional exercise, tai chi chuan and health education/usual physical activity over a 6-month intervention period in improving primary outcomes and secondary outcomes in older mild cognitive impairment adults will be compared. Third, whether changes in serum levels of the brain-derived neurotrophic factor (BDNF), insulin-like growth factor (IGF)-1, and vascular endothelial growth factor (VEGF) and expression of the apolipoprotein E (APOE) ε4 allele parallel changes in gait characteristics and cognitive functions after the intervention will be examined.


Eligibility criteria: Inclusion Criteria:

* At least 65 years old
* Had an emergency department visit due to a fall at least 3 months prior to the baseline assessment (assuming a full recovery time from a fall to be 3 months)
* Can ambulate independently
* Has mild cognitive impairment

Exclusion Criteria:

* Do not live in a community setting
* Cannot ambulate independently and communicate with researchers
* Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
* Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)

Primary outcomes:
measure: Gait characteristics
timeFrame: 12 months
measure: Global cognition
timeFrame: 12 months
measure: Serum levels of BDNF
timeFrame: 12 months
measure: Serum levels of IGF-1
timeFrame: 12 months
measure: Serum levels of VEGF
timeFrame: 12 months
Secondary outcomes:
measure: Tinetti balance
timeFrame: 12 months
measure: Mobility
timeFrame: 12 months
measure: Muscle strength
timeFrame: 12 months
measure: Falls
timeFrame: 12 months
measure: Depressive symptoms
timeFrame: 12 months
measure: Fear of falling
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Mau-Roung Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576263: Autologous Blood Transfusion After Local Infiltration
Official title: Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Total Knee Arthroplasty
Keywords: Anaesthesia
Infiltration
Blood transfusion
Autologous
Arthroplasty
Replacement
Ropivacaine
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic.

Brief summary: Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges.

To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis for hip arthroplasty
* Clinical diagnosis for knee arthroplasty

Exclusion Criteria:

* Patients \< 18 years
* Lack of informed consent
* Inability to read/understand Danish
* Bilateral diagnosis
* Cancer diagnosis

Primary outcomes:
measure: Concentrations of ropivacaine in serum
timeFrame: 6 hours
Secondary outcomes:
measure: Analysis of ECG and pulse rate
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University
Study officials:
affiliation: Northern Orthopaedic Department, Aalborg University Hospital, Denmark
name: Ole Simonsen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Orthopaedic Division, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology, Aalborg University Hospital, Denmark
name: Bjarne B. Dencker, M.D.
role: STUDY_CHAIR
affiliation: Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark
name: Torben Breindahl, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02612363: Early Goal Directed Sedation on Microcirculation in Septic Shock
Official title: The Effect of Early Goal Directed Sedation on Microcirculation in Septic Shock Patients With Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Septic Shock
Keywords: septic shock
sedation
microcirculation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients.

Detailed description: Recent studies suggest that early goal directed sedation might improve the outcome of critically ill patients. The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients with relative stable hemodynamics.

Eligibility criteria: Inclusion Criteria:

* Septic shock patients despite early goal directed therapy
* Required sedation

Exclusion Criteria:

* Age\< 18
* Pregnancy
* Bradycardia (HR\<55bpm)
* Systolic blood pressure \< 80 mmHg / mean arterial pressure \< 50 mmHg on maximal support
* Death imminent
* Unlikely to survive 90 days
* Acute liver failure
* Dementia
* High-grade block in the absence of a functioning pacemaker.

Primary outcomes:
measure: Microcirculatory function as assessed by perfused vessel density
timeFrame: one hour
Secondary outcomes:
measure: Dose of sedatives and analgesic agents
timeFrame: 14 days
measure: Oxygen metabolic: lactate clearance time
timeFrame: six hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Yi Yang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05268263: Feasibility of AI-based Classification of Normal, Wheeze and Crackle Sounds From Stethoscope in Clinical Settings
Official title: Evaluating the Feasibility of Artificial Intelligence Algorithms in Clinical Settings for Classification of Normal, Wheeze and Crackle Sounds Acquired From a Digital Stethoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory
Lung
Lead sponsor: Innova Smart Technologies (Pvt.) Ltd
Sponsor class: OTHER
Collaborators: name: Lady Reading Hospital, Pakistan
name: NOABIO LLC
First posted: 2022-03-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assessing the feasibility and testing the accuracy of the developed artificial intelligence algorithms for detection of wheezes and crackles in patients with lung pathologies in clinical settings on unseen local patient data acquired through three digital stethoscopes.


Eligibility criteria: Inclusion Criteria:

* Ages all
* Written consent provided

Exclusion Criteria:

* Subject condition unstable
* Chest wall deformity or wounds in adhesive application areas
* Written consent not provided

Primary outcomes:
measure: Testing the accuracy of artificial intelligence models for detection of wheeze, crackles, and normal lung sounds by measuring the sensitivity and specificity
timeFrame: 2 months
measure: Clinical validation of AI models for detection of wheeze, crackles, and normal lung sounds by comparison with gold standard
timeFrame: 2 months
Secondary outcomes:
measure: Performance analysis of three digital stethoscopes: Littmann, NoaScope, and eSteth
timeFrame: 2 months
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital, Pakistan
Study officials:
References: