louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00824395: The Genetics of Diabetes in Southern California Chinese Americans
Official title: Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 1 Diabetes
Type 2 Diabetes
Metabolic Syndrome
Keywords: diabetes
type 1
type 2
metabolic syndrome
mitochondria
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2009-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are currently recruiting Chinese Americans living in Southern California, espcially in Orange and Los Angeles Counties. We are particularly in need of Chinese American men and women with diabetes as well as healthy male controls. We can arrange for offsite weekend trips to cities within LA or Orange Counties for eligible groups of 10 or more people.

Brief summary: The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.

Detailed description: Since our laboratory's initial linkage of Type 2 diabetes to a mtDNA rearrangement in a three generation maternal pedigree 13 years ago, there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus (DM) and the overlapping Metabolic Syndrome (MS). With this study we are planning an extensive investigation of defects in mitochondrial oxidative phosphorylation (OXPHOS) caused potentially by deleterious sequence variants in the mitochondrial DNA (mtDNA). As the primary objective we are trying to further substantiate 2 hypotheses: 1) that these diabetogenic mtDNA variants, which are proposed to range from recent, relatively severe, mutations will result in substantial OXPHOS defects with familial DM \& MS and 2) that ancient, relatively mild polymorphisms result in partial OXPHOS defects and an increase in the risk to develop DM \& MS.

Eligibility criteria: Inclusion Criteria:

* Chinese or Taiwanese ancestry
* Resident of Southern California
* Age between 40 and 65
* Both people with and without diabetes are welcome to enroll.

Exclusion Criteria:

* Younger than 40 years or older than 65 years
* Ancestry is not Chinese or Taiwanese
* Not a resident of Southern California

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine General Clinical Research Center
state: California
Study officials:
affiliation: UC Irvine Center for Mitochondrial Medicine
name: Douglas C Wallace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03805295: Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Official title: Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Physical Activity
Quality of Life
Fitness
Executive Function
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Council on Exercise
name: BOKS
First posted: 2019-01-15
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the BOKS program
* Participating school
* Age 5-14

Exclusion Criteria:

* No valid consent
* Not enrolled in BOKS

Primary outcomes:
measure: Change in Body Mass Index (kg/m^2)
timeFrame: Baseline, Follow-up for each session (12 weeks)
Secondary outcomes:
measure: Change in Executive Function
timeFrame: Baseline, Follow-up for each session (12 weeks)
measure: Change in Quality of life PedsQL
timeFrame: Baseline, Follow-up for each session (12 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Elsie Taveras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05376995: Effect of Graston Technique Versus MET on Improving Hamstring Flexibility and ADLS in Knee Osteoarthritis
Official title: Effect of Graston Technique Versus Muscle Energy Technique on Improving Hamstring Flexibility and ADLS in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of Graston technique versus muscle energy technique among patient of knee osteoarthritis
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to determine the comparison of Graston technique versus muscle energy technique to improve hamstring flexibility and ADL among patient of knee O.A.


Eligibility criteria: Inclusion Criteria:

* Knee osteoarthritis patient with bilateral (but tested only severe side) or unilateral limb involvement.(13)
* Knee osteoarthritis patient already diagnosed by orthopedic surgeon with x ray findings showing grade I or II in kellgren and Lawrence criteria for knee OA will be selected. (16)
* Ambulate independently with or without assistive devices and ascend and descend at least a flight of stairs.(13)
* Both male and female will be included in study.
* Age above 40 to 55years.(13)

Exclusion Criteria:

* Patient with history of any known neurological, cardio or respiratory conditions.
* Patient present with history of open wound, Skin infection or tumors in the area of treatment.
* Any other orthopedic condition or fracture in the area of treatment limb.
* Patient will be excluded if they have low back pain, sciatica or deformities related to his spine and knee.
* Patient with history of recent lower limb or spinal surgeries.

Primary outcomes:
measure: knee osteoarthritis
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00681395: Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adverse Events
Pharmacokinetic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.


Eligibility criteria: Inclusion Criteria:

* General good health
* BMI 19 to 29

Exclusion Criteria:

* Currently enrolled in another study
* Females who are pregnant or breastfeeding

Primary outcomes:
measure: Adverse event and safety laboratory assessments
timeFrame: 7 days
measure: Pharmacokinetic parameters
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 8089
state: Florida
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01556295: Gesture Behavior and Knowledge on Low Back Pain Among Nurses
Official title: Assessment of Gesture Behavior and Knowledge on Low Back Pain Among Nurses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: Nurses
Low back pain
Gesture behavior
Knowlegde
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nurses with non-specific low back pain and healthy nurses

Brief summary: The aim of the proposed study is to evaluate knowledge on low back pain and gesture behavior among nurses with low back pain using validated measures and compare the findings to those from nurses without back pain.

Detailed description: A controlled, cross-sectional study will be carried out with 100 nurses (50 with low back pain and 50 without low back pain). The following assessment measures will be employed: Visual analogue scale (VAS) for pain, Gesture Behavior Test (GBT), Low Back Pain Knowledge Questionnaire (LKQ), Roland Morris Questionnaire and the SF-36.

Eligibility criteria: Inclusion Criteria:

* Non-specific chronic low back pain,
* Performance in the hospital sector (hospitals, emergency rooms and/or intensive care units,
* Hourly load of at least 6 hours per day,
* Low back pain on most days in the last three months,
* Pain greater than 3 cm in visual analog scale (VAS).

Exclusion Criteria:

* Dispute,
* Previous surgery of the spine,
* Pregnant.

Primary outcomes:
measure: Gesture behavior
timeFrame: One week
Secondary outcomes:
measure: Knowledge among low back pain
timeFrame: One week
measure: Roland Morris Questionnaire
timeFrame: One week
measure: SF-36
timeFrame: One week
measure: Visual analogue scale (VAS) for pain
timeFrame: One week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: HIsa Costa Morimoto
Study officials:
affiliation: Federal University of São Paulo
name: Hisa Morimoto, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Anamaria Jones, PT, PHD
role: STUDY_DIRECTOR
affiliation: Division of Rheumatology, Federal University of Sao Paulo
name: Jamil Natour, MD, PHD
role: STUDY_CHAIR
References:
citation: Furtado R, Jones A, Furtado RN, Jennings F, Natour J. Validation of the Brazilian-Portuguese version of the Gesture Behavior Test for patients with non-specific chronic low back pain. Clinics (Sao Paulo). 2009;64(2):83-90. doi: 10.1590/s1807-59322009000200004.
citation: Morimoto HC, Jones A, Natour J. Assessment of gesture behavior and knowledge on low back pain among nurses. Adv Rheumatol. 2018 Sep 7;58(1):27. doi: 10.1186/s42358-018-0029-5.
Clinical trial NCT02887495: The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)
Official title: The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma
Keywords: scleroderma
biorepository
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with scleroderma, raynauds, or with positive autoantibodies

Brief summary: The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers use clinical data and human biospecimens to investigate why scleroderma patients develop certain complications from their disease. Patients with confirmed scleroderma, raynauds or positive autoantibodies are invited to participate. This research may help us understand how to prevent and treat scleroderma and other diseases.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Able to give informed consent.
* Diagnosed with scleroderma or with positive autoantibodies

Exclusion Criteria:

* \< 18 years old

Primary outcomes:
measure: Modified Rodnan Skin Score
timeFrame: 10 years
Secondary outcomes:
measure: Medsger Severity Score
timeFrame: 10 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Victoria K Shanmugam
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Victoria K Shanmugam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03581695: Inflammatory Biomarkers of Pediatric Pulmonary Hypertension
Official title: Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension, Pulmonary
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.

Brief summary: To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.


Eligibility criteria: Inclusion Criteria:

-patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart.

Exclusion Criteria:

* active systemic infection
* current active cancer
* active cancer treatment
* prior bone marrow transplant
* prior solid organ transplant

Primary outcomes:
measure: Measurement of HGMB1
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Katherine Taylor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04171895: Communication Training for Caregivers In Advanced Care Planning
Official title: Communication Training for Caregivers to Promote Advanced Care Planning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Malignant Brain Tumors
Advanced Care Planning
Keywords: Communication training
19-398
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For Part 1 and 2 participants will be recruited from the MSK Brain Tumor Center (BTC), a multidisciplinary center comprised of faculty from Neurology, Neurosurgery, Radiation Oncology, Radiology and Psychiatry. The study team may also conduct approaches and recruitment over the phone, in situations where clinic recruitment may not be possible. After screening medical records for eligibility, study staff will email the treating clinician for approach approval, and will only proceed to reach out over phone if the clinician provides explicit permission.

Brief summary: The purpose of this research study is to develop and test a new communication training to help caregivers communicate more effectively with their loved ones and healthcare professionals about advanced care planning.


Eligibility criteria: Inclusion Criteria:

Part 1:

Informal caregivers:

* Current self-reported informal cancer caregivers (IC) to a patient with a primary malignant brain tumor as per clinician judgment or as per EMR
* English fluency: Self-report by participant identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
* age ≥ 18
* has access to a computer or smartphone with a webcam and internet connection

Patients:

* English-speaking as per EMR
* Able to provide informed consent, a determination that will be made in assistance with the patient's medical team.

Part II:

Informal caregivers:

* Current self-reported IC to an MSK patient with a (1) primary malignant brain tumor or (2) leptomeningeal metastasis of a solid tumor, as per clinician judgment or as per EMR.
* English fluency: Self-report by identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
* Age \>18 as per self report
* Access to a computer or smartphone with a webcam and internet connection as per self report

Exclusion Criteria:

* None

Primary outcomes:
measure: preliminary efficacy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Allison Applebaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01913795: Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
Official title: Environmental Intervention to Reduce Allergens in Urban Schools and Childhood Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 29
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to pilot the role of school based intervention consisting of enhanced integrated pest management, classroom air purifiers and cleaning improves asthma morbidity.

Detailed description: By piloting this school based intervention, the investigators hope to learn from this study the best way to design and implement more cost and time efficient large-based school-based environmental interventions that may potentially help a community of children with asthma, allergic diseases, and its associated morbidity.

Eligibility criteria: Inclusion Criteria:

* grades K-8 with asthma attending sampling/intervention schools

Exclusion Criteria:

* moving schools

Primary outcomes:
measure: Asthma Symptoms
timeFrame: over a two week period at Baseline and Months 3, 6, 9 and 12
Secondary outcomes:
measure: Lung Function
timeFrame: measured at baseline and months 6 and 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01110395: Phosphorous Magnetic Resonance Spectroscopy of Heart
Official title: 31P Magnetic Resonance Spectroscopy of Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Dysfunction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Heart needs constant supply of energy to continue working. Phosphorus magnetic resonance spectroscopy allows us to measure energy produced in the heart. The purpose of this study is to determine if the energy production is reduced in failing heart.

Detailed description: We will use non-invasive phosphorus magnetic resonance spectroscopy technique to measure creatine kinase (CK) flux in failing heart. The studies will be done on Siemens 3.0T human system. We will recruit subjects with LV dysfunction due to prior anterior wall myocardial infarction.

Eligibility criteria: Inclusion Criteria:

* Individuals with left ventricular dysfunction

Exclusion Criteria:

* Age \< 18, pregnant, history of excessive alcohol use, or any condition (e.g. claustrophobia, a pacemaker) that would prevent him/her from completing the magnetic resonance spectroscopy study

Primary outcomes:
measure: An MR Spectroscopy Showing Signal to Noise Ratio to Determine the Level of Heart Failure
timeFrame: 1-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Adil Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lipskaya TY. Mitochondrial creatine kinase: properties and function. Biochemistry (Mosc). 2001 Oct;66(10):1098-111. doi: 10.1023/a:1012428812780.
citation: Nascimben L, Ingwall JS, Pauletto P, Friedrich J, Gwathmey JK, Saks V, Pessina AC, Allen PD. Creatine kinase system in failing and nonfailing human myocardium. Circulation. 1996 Oct 15;94(8):1894-901. doi: 10.1161/01.cir.94.8.1894.
citation: De Sousa E, Veksler V, Minajeva A, Kaasik A, Mateo P, Mayoux E, Hoerter J, Bigard X, Serrurier B, Ventura-Clapier R. Subcellular creatine kinase alterations. Implications in heart failure. Circ Res. 1999 Jul 9;85(1):68-76. doi: 10.1161/01.res.85.1.68.
citation: Nascimben L, Friedrich J, Liao R, Pauletto P, Pessina AC, Ingwall JS. Enalapril treatment increases cardiac performance and energy reserve via the creatine kinase reaction in myocardium of Syrian myopathic hamsters with advanced heart failure. Circulation. 1995 Mar 15;91(6):1824-33. doi: 10.1161/01.cir.91.6.1824.
Clinical trial NCT02710695: Pain in America: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Orthopaedic Related Pain (Musculoskeletal Pain)
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 50
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: Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.


Eligibility criteria: Inclusion Criteria:

* Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers

Exclusion Criteria:

* Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.

Primary outcomes:
measure: The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"
timeFrame: 15 minutes
Secondary outcomes:
measure: Surveys
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: UMKC Department of Orthopaedic Surgery
state: Missouri
Study officials:
affiliation: UMKC Department of Orthopaedic Surgery
name: Nkem Egekeze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMKC Department of Orthopaedic Surgery
name: Charles Rhoades, MD
role: STUDY_DIRECTOR
affiliation: UMKC Department of Orthopaedic Surgery
name: Mark Bernhardt, MD
role: STUDY_DIRECTOR
affiliation: UMKC Department of Orthopaedic Surgery
name: Karen Williams, PhD
role: STUDY_DIRECTOR
References: