louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02748499: Healthy Beat Accupunch (HBA) Exercise Program for Community Older Adults
Official title: Evaluation of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceived Health Status
Sleep Quality
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2016-04-22
Enrollment: 232
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise program on the perceived health status and sleep quality of the community-dwelling older adults.

Detailed description: Phase I: A cluster randomized controlled trial was used to test the effects of a six-month, instructor-led Healthy Beat Accupunch (HBA) exercise program on the perceived health status and sleep quality of the community-dwelling older adults. Through the use of convenience sampling strategy, eight community care centers with 232 older adults in Kaohsiung were recruited and randomly assigned based on their community care centers to a HBA experimental group or a wait-list control group. Participants in the experimental group received the HBA exercise program led by trained and certified instructors, three times per week, 40 minutes per practice for six months; participants in the wait-list control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted. Phase II: Using the same method as in the phase I, participants from the phase I continued practicing the HBA exercise program, but guided by a DVD, for another six months. The feasibility, compliance, and effectiveness of the DVD-led HBA exercise program on the community-dwelling older adults were tested, and another two post-tests, three months apart, were conducted on the same outcome measurements as in the phase I.

Eligibility criteria: Inclusion Criteria:

* community-dwelling older adults aged 65 and over
* Mandarin or Taiwanese speakers
* able to stand and walk without assistive devices
* cognitive alert and able to verbally state their name, address, and answer questions

Exclusion Criteria:

* participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses

Primary outcomes:
measure: Perceived health status measured by SF-12 Health Survey
timeFrame: 12 months
Secondary outcomes:
measure: Sleep quality measured by Pittsburge Sleep Quality Index (PSQI)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University
name: Kuei-Min Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00608699: A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Official title: A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Dyslipidaemias
Keywords: Flushing
GSK256073A,
Dose Escalation,
Immediate Release Niacin,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.


Eligibility criteria: Inclusion Criteria:

* Adult males between 18 and 55 years of age, inclusive.
* Healthy subjects
* Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
* Subjects with QTc \< 450 msec at screening

Exclusion Criteria:

* History of significant cardiac arrhythmias
* Active peptic ulcer disease (PUD) and/or history of PUD
* History of gout and/or hyperuricemia
* History of Gilbert's syndrome
* History of recurrent indigestion, stomach upset or diarrhea
* History of other than rare (once yearly or less) flushing
* Recurrent skin rash or psoriasis
* History of kidney stones

Primary outcomes:
measure: Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
timeFrame: up to 8 hours post dose
measure: Safety and tolerability of GSK256073A and immediate release niacin
timeFrame: up to 36 hours post dose
Secondary outcomes:
measure: Standard and Secondary pharmacokinetic endpoints of interest
timeFrame: up to 36 hours post dose
measure: Pharmacodynamic response
timeFrame: up to 36 hours post dose
measure: Pharmacodynamic response
timeFrame: up to 24 hours post dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00188799: Xray Volume Imaging (Cone Beam CT) - Prostate Cancer
Official title: A Clinical Study of X-ray Volume Imaging to Evaluate the Daily Set-up Accuracy of Conformal Prostate Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: Canadian Association of Radiation Oncology
First posted: 2005-09-16
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH for intermediate risk patients with localised disease in 1997. This technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. One way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at PMH). However, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. This study will investigate and compare X-ray volume imaging to the gold standard imaging markers.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate
* Patient undergoing escalated dose conformal external beam radiotherapy.
* Patient has low or intermediate risk prognostic factors: all of PSA \<21, Gleason score \<8, clinical T category \<T3, clinical N category 0 or X, M category 0 or X.
* Informed consent

Exclusion Criteria:

* No diagnosis of adenocarcinoma of the prostate
* Patient not undergoing escalated dose conformal radiotherapy
* Patient does not have low or intermediate risk prognostic factors

Primary outcomes:
measure: To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy.
Secondary outcomes:
measure: To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Charles Catton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01640899: Insoles Effect on Pain and Daily Activities
Official title: The Effect of Shoe Insoles on Pain and Daily Activities and the Relation Between Satisfaction With Insoles and Use: A pre-and Post-intervention Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Pain in Lower Extremities
Keywords: Orthotic Devices
Activities of Daily Living
Pain Measurement
Lower Extremity
Foot
Personal Satisfaction
Lead sponsor: Centre for Rehabilitation Research, Örebro
Sponsor class: OTHER_GOV
Collaborators: name: Örebro County Council
First posted: 2012-07-16
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain.

Detailed description: Pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. This pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time.

One of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. Reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities.

Persons actual use of the insoles, is a prerequisite for any effect it may have. It can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.

Eligibility criteria: Inclusion Criteria:

* Pain in lower extremities
* Aged 18 years or older
* Able to speak Swedish.

Exclusion Criteria:

* Pain due to a systemic or progressive disease
* Use of orthosis of other type than insoles
* Earlier foot surgery or current use of prosthesis.

Primary outcomes:
measure: Shoe insoles effect on pain level in lower extremities.
timeFrame: Four-weeks follwo up period
measure: Shoe insoles effect on daily activities
timeFrame: Four-weeks follow up period
measure: Satisfaction with shoe insoles use
timeFrame: After four weeks of use
Secondary outcomes:
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Dept. of Prosthetics and Orthotics, Orebro University Hospital
state: Orebro County
Study officials:
affiliation: Centre for Rehabilitation Reserach, Örebro
name: Ahmed Amer, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro
name: Liselotte Norling-Hermansson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03572699: Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
Official title: Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Lead sponsor: Medios Technologies Pte. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Diacon Hospital
First posted: 2018-06-28
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with diabetes mellitus presenting to the outpatient for routine clinical care.

Brief summary: This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.


Eligibility criteria: Inclusion Criteria:

1. Patients with type 1 or type 2 diabetes mellitus
2. Ages 18 and above
3. Male and female

Exclusion Criteria:

1. Persistent visual impairment in one or both eyes;
2. Subjects with corneal opacities and advanced cataract.
3. History of retinal vascular (vein or artery) occlusion;
4. Subject is contraindicated for fundus photography (for example, has light sensitivity);
5. Subject is currently enrolled in an interventional study of an investigational device or drug;
6. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.

Primary outcomes:
measure: Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy
timeFrame: 3 months
Secondary outcomes:
measure: Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater)
timeFrame: 3 months
measure: Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Diacon Hospital
Study officials:
affiliation: Investigator
name: Srikanth Y N, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546299: Gas Usage for Those With COPD Who Experience Low Oxygen Levels During Activities Only
Official title: Ambulatory Gas Usage in Patients With COPD and Exertional Hypoxemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Ambulatory oxygen therapy
COPD
exertional hypoxemia
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: McMaster University
name: Ontario Ministry of Health and Long Term Care
First posted: 2007-10-18
Enrollment: 27
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. This report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with COPD who experience low oxygen levels during activities.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* dyspnea limiting daily activities
* desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test

Exclusion Criteria:

* less than or equal to 18 years old
* those who met criteria for mortality reduction with long-term oxygen
* those who received oxygen for palliative care or isolated nocturnal hypoxemia
* those unable to complete the questionnaires or provide informed consent

Primary outcomes:
measure: gas usage
timeFrame: 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Respiratory Rehabilitation, West Park Healthcare Centre
name: Roger Goldstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04772599: Measurement of Noradrenaline Concentrations Using Different Dilution Methods
Official title: Measurement of Noradrenaline Concentrations Using Different Dilution Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Hypertension
Keywords: Noradrenaline
Norepinephrine
Concentration of noradrenaline
Vasopressor
Baby-noradrenaline
Dilution of Noradrenaline
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Employee of the University Hospitals of Strasbourg accepting to participate in the study

Brief summary: Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline").

In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).


Eligibility criteria: Inclusion criteria:

* Adult person,
* Employee of Strasbourg University Hospitals,
* Likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, IADE, IADE student)

Exclusion criteria:

- Subject's refusal to participate in the study

Primary outcomes:
measure: Measurement of noradrenaline concentrations using different dilution methods
timeFrame: 1 hour after the preparation of the noradrenaline solutions
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Strasbourg University Hospitals - Anesthesia-intensive care unit
Study officials:
References:
Clinical trial NCT06270342: The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients
Official title: The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Dual Task
Dual Task Effect
Multiple Sclerosis
Upper Extremity
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having been diagnosed with MS and healthy volunteers

Brief summary: The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls.

Detailed description: The study was carried out at Kutahya Health Sciences University Evliya Çelebi Training and Research Hospital. 30 individuals with MS and 30 healthy controls, aged 18-65, were included in the study. In the evaluation, demographic and clinical data were recorded first. The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Multiple Sclerosis for at least 1 year
* Being between the ages of 18-65
* Being at least a primary school graduate
* Volunteering to participate in the study
* EDSS score between 1 and 6.5

Exclusion Criteria:

* Patients whose Multiple Sclerosis diagnosis is uncertain
* Having additional neurological disease that may affect clinical evaluation
* Having a neurological and/or psychiatric disease that may affect cognitive tests
* Having had an attack in the last 3 months

Primary outcomes:
measure: The Minnesota Manual Dexterity Test
timeFrame: 30 minutes
measure: Dual Task Questionnaire
timeFrame: 10 minutes
measure: Edinburgh Handedness Questionnaire
timeFrame: 10 minutes
measure: Expanded Disability Status Scale
timeFrame: 10 minutes
measure: Brief International Cognitive Assessment Battery for Multiple Sclerosis
timeFrame: 15 minutes
measure: Beck Depression Scale
timeFrame: 10 minutes
measure: Fatigue Impact Scale
timeFrame: 5 minutes
measure: Multiple Sclerosis Quality of Life Questionnaire-54
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References:
Clinical trial NCT00145236: Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension
Official title: A Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Nebivolol
Beta-Blocker
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 300
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 purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.

Detailed description: This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).

Eligibility criteria: Inclusion Criteria:

* Black adults with an average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline.

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindication to beta-blocker therapy

Primary outcomes:
measure: -Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline
Secondary outcomes:
measure: -Change in sitting systolic blood pressure (SBP)
measure: -Change in supine and standing DBP and SBP
measure: -Response rate
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00792649: Comparison Between HD+ Endoscopy and Standard Videoendoscopy in Screening Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polyps
Neoplasia
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 200
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: Consecutive patients scheduled for screening colonoscopy were examined using HD+ colonosccopes and standardendoscopes.

Brief summary: Colonoscopy is the accepted gold standard for screening of colorectal cancer. However, small and flat neoplastic lesions might be overlooked with standard video endoscopes. The new available EPKi system (Pentax, Japan) enables with HD+ imaging resolution above HDTV standard. Aim of the study was to test the efficacy of HD+ colonoscopy alone and in conjunction with I-Scan (newly developed post processing digital filter)in comparison to standard videoendoscopy


Eligibility criteria: Inclusion Criteria:

* Consecutive patients scheduled for screening colonoscopy

Exclusion Criteria:

* Inflammatory bowel disease
* Cancer
* Pregnancy
* Inability to obtain informed consent
* Prothrombin time \< 50% of control
* Partial thromboplastin time \> 50 seconds

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