louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01061632: High(Deadlift) Versus Low Intensity Motor Control Exercises on Low Back Pain
Official title: Effects of High(Deadlift) Versus Low Intensity Motor Control Exercises on Patients With Peripherally Mediated Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: deadlift
motor control
exercises
pain
function
functional capacity
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
Collaborators: name: Umeå University
name: Norrlandskliniken
name: County Council of Norrbotten, Sweden
First posted: 2010-02-03
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain


Eligibility criteria: Inclusion Criteria:

* low back pain over 3 month
* the pain must originate locally from the lowe back and be nociceptive

Exclusion Criteria:

-

Primary outcomes:
measure: Selfrated function, symptoms and pain-rating
timeFrame: 8 weeks, 6 month, 12 month
Secondary outcomes:
measure: Functional capacity
timeFrame: 8 weeks, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Luleå Tekniska Universitet
name: Kerstin Öhrling, As professor
role: STUDY_DIRECTOR
References:
citation: Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.
citation: Berglund L, Aasa B, Hellqvist J, Michaelson P, Aasa U. Which Patients With Low Back Pain Benefit From Deadlift Training? J Strength Cond Res. 2015 Jul;29(7):1803-11. doi: 10.1519/JSC.0000000000000837.
Clinical trial NCT00688532: Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not
Official title: A Pharmacoepidemiological Study on the Association Between Bicalutamide Treated Prostate Cancer and Risk of Coronary Heart Disease (CHD) and Heart Failure (HF) in the General Practice Research Database (GPRD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
pharmacoepidemiology study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 5103
Sex: MALE
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: GPRD containing computerized information entered by general practitioners in the UK

Brief summary: A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.


Eligibility criteria: Inclusion Criteria:

* At least two years enrollment with the general practitioner

Exclusion Criteria:

* Patients with cancer before start date of the study

Primary outcomes:
measure: Coronary heart disease including acute myocardial infarction and death from CHD
timeFrame: From study start 1 Jan 1999 through 31December 2006
measure: Heart Failure
timeFrame: From study start 1 Jan 1999 through 31December 2006
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CEIFE (Centro Español de Investigación Farmacoepidemiológica -Spanish Centre for Pharmacoepidemiologic Research) Almirante
name: LA García Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06749132: Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study
Official title: Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Stenosis
Keywords: aortic stenosis
artificial intelligence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Kaiser Permanente School of Medicine
name: Icahn School of Medicine at Mount Sinai
First posted: 2024-12-27
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US adults aged 65 and older with an echocardiogram within the prior 2-3 years that showed aortic sclerosis without stenosis or mild aortic stenosis (AS).

Brief summary: This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.


Eligibility criteria: Inclusion Criteria:

1. Age 65 years or older
2. Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS

Exclusion Criteria:

1. Opted out of research studies
2. Non-English speaking
3. Any echocardiogram within 24 months of medical record review.
4. Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
5. Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
6. Prior heart transplant
7. History of dementia
8. Unable to attend study visit at echocardiogram lab within four years of most recent echocardiogram.
9. Documented life expectancy of \<1 year or current participation in hospice services

Primary outcomes:
measure: Annualized change in AV Vmax in m/sec/years
timeFrame: From baseline TTE to TTE performed at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Santa Clara Medical Center - Kaiser Permanente
state: California
city: New Haven
country: United States
facility: Yale New Haven Health System
state: Connecticut
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Yale University
name: Rohan Khera, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06512532: Fireworks Eye Injuries During Festivals in Upper Egypt
Official title: Fireworks Eye Injuries During Festivals in Upper Egypt: Cross- Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ocular Injury
Blast Injuries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients attending ocular emergency unit with eye injury during different festivals in 2024

Brief summary: The aim of this study is to explore and report the epidemiology and outcome of fireworks ocular injuries in Upper Egypt.

Primary outcome : type and severity of injury of fireworks eye trauma during festives.

Secondary outcome: demography, complications, and final visual outcome of fireworks eye injury.


Eligibility criteria: Inclusion Criteria:

* Patients attending ocular emergency unit with fireworks eye injury during different festivals in 2024

Exclusion Criteria:

* patients presented with non-fireworks ocular injuries

Primary outcomes:
measure: epidemiology and outcome of fireworks eye injury
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
Clinical trial NCT01720732: Lifeline-NET (Narrative Exposure Therapy): A Short-term Treatment for Traumatized Refugees and Asylum Seekers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma Treatment
Lifeline NET
Modification of Narrative Exposure Therapy
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of a short version of Narrative Exposure Therapy


Eligibility criteria: Inclusion Criteria:

* PTSD

Exclusion Criteria:

* Psychotic Disorder,
* Severe Substance Dependence

Primary outcomes:
measure: PTSD
timeFrame: 9 months follow up
Secondary outcomes:
measure: Other Symptoms following and related to Trauma, e.g. Depression, Dissociation
timeFrame: 9 months follow up
Other outcomes:
measure: Social functioning, Life Satisfaction, Aggression
timeFrame: 9 months follow up
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
Study officials:
References:
citation: Schauer M, Neuner F, Elbert T (2005/2011): Narrative Exposure Therapy. A Short-Term Intervention for Traumatic Stress Disorders. 2nd Ed. Cambridge/ Göttingen: Hogrefe & Huber Publishers.
Clinical trial NCT00704132: Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 57
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.


Eligibility criteria: Inclusion Criteria:

* Participant has type 2 diabetes mellitus
* Males
* Females who are highly unlikely to become pregnant
* Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion Criteria:

* Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
* Participant required insulin therapy within the prior 8 weeks
* Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

Primary outcomes:
measure: Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.
Clinical trial NCT03109132: Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
Official title: Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wearing Comfort
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Institute for Skin Research, Israel
First posted: 2017-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is randomnized crossover study. Every subject will assess all cannulas in randomized order.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.

Detailed description: This test compares 4 models for the duration of up to 3 days each and 2 models with duration of up to 24 hours. Each subject will tested the models and will provide feedback at predefined times during the test. During the test and according to initial result the team may decide to shorten the test duration.

The testing staff will include a dermatologist and a technical representative that will supervise the test in order to monitor and control the required performance of the subjects according to test protocol, and relevant outcomes. During the test the dermatologist will monitor any unexpected skin reaction or patient discomfort.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Men and Women
* Age 50-85
* Willingness to participate in the study

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects with sensitivity to any of the products or the its ingredient
* Subjects with sensitivity to preparation for testing bacterial plaque
* Subjects who are treated with anti inflammatory antihistamine corticosteroids treatment
* Subjects who are treated with Anti-thrombotic agents

Primary outcomes:
measure: Comfort evaluation using self introduction questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Comfort evaluation using self introduction questionnaire - calculations
timeFrame: 3 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Israeli Institute for skin reaserch
Study officials:
affiliation: The Israeli Institute for Skin Research
name: Sarah Brenner, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231632: The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
Official title: Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Poliomyelitis
Keywords: Poliomyelitis
Vaccine
Safety
efficacy
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Guangxi Center for Disease Control and Prevention
First posted: 2014-09-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)

Detailed description: Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .

Eligibility criteria: Inclusion Criteria:Only subjects fulfilling all of the following criteria will be eligible for the study:

* People aged from 2 months to 4 months old.
* The subjects or subjects' guardians are able to understand and sign the informed consent
* The subjects or subjects' guardians allow to comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting
* The subjects have signed informed consent already

Exclusion Criteria:The subjects have never been vaccinated with any Poliomyelitis Vaccine.

-

Primary outcomes:
measure: Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
timeFrame: up to 90 days
Secondary outcomes:
measure: The frequency of all the adverse events in vaccine group and placebo group
timeFrame: up to 30 days
measure: Change of seroconversion from baseline to 3 months
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Kunming
country: China
facility: Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118
state: Yunnan
Study officials:
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
name: Qihan Li, Ph.D
role: STUDY_CHAIR
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
name: Jingsi Yang
role: STUDY_DIRECTOR
affiliation: Guangxi Provincial Center for Disease Control and Prevention
name: Rongcheng Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763032: Psychosocial Intervention in Latino Patients with Advanced Cancer
Official title: Expanding the Reach of Palliative Care: Pilot Study of a Psychosocial Intervention in Latino Patients with Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: Palliative Care
Latino
Psychosocial Intervention
Patient Navigation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will be assigned a patient navigator, who will provide a psychosocial assessment and palliative counselling
Primary purpose: SUPPORTIVE_CARE

Brief summary: Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies examining the effectiveness of a navigation intervention to improve palliative care for patients. This study will examine the feasibility to implement patient navigator and psychosocial interventions.


Eligibility criteria: Inclusion Criteria:

* Adults ages \> or = 18 years of age
* Must self-identify as Latino/a
* Have stage III/IV cancer
* Seeking or In treatment for their cancer (ie: not in hospice care)
* Not incarcerated
* Have at least moderate baseline distress (\> 4 on the NCCN Distress Thermometer) or positive screen for depression (PHQ-2 score \>=3) or anxiety (GAD-2 score \>=3)

Exclusion Criteria:

-No exclusion criteria listed

Primary outcomes:
measure: Feasibility of Recruitment: number of patients that are eligible to participate
timeFrame: Start of study to end of study, up to 12 months
measure: Feasibility of Completion: number of patients that complete the study
timeFrame: Start of study to end of study, up to 12 months
Secondary outcomes:
measure: Process Measure Assessment
timeFrame: Start of study to end of study, up to 12 months
Other outcomes:
measure: FACT-G Quality of Life Assessment
timeFrame: Start of study to end of study, up to 12 months
measure: Depression Assessment
timeFrame: Start of study to end of study, up to 12 months
measure: Anxiety Assessment
timeFrame: Start of study to end of study, up to 12 months
measure: Pain Assessment: PEG questionnaire
timeFrame: Start of study to end of study, up to 12 months
measure: Symptom Severity Assessment
timeFrame: Start of study to end of study, up to 12 months
measure: Hospital Assessments
timeFrame: Start of study to end of study, up to 12 months
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stacy Fischer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: David Bekelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00401232: Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development
Official title: Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 955
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to collect blood from volunteers to assist in assay development.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers aged 18-64

Exclusion Criteria:

* Bleeding disorder

Primary outcomes:
measure: "No outcome measures". Blood collected for assay development.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
city: Hackensack
country: United States
facility: Frontage Clinical Services Inc
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: