louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04588493: Secondary Lymphedema Due to Human Adjuvant Disease
Official title: Human Adjuvant Disease as a Cause of Secondary Lower Extremity Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema, Secondary
Lymphedema of Leg
Granuloma, Foreign-Body
Keywords: human adjuvant disease
Lead sponsor: Hospital Angeles del Pedregal
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with history of injection of modeling substances for cosmetic purposes (non Federal Drug Administration-approved substances) in buttocks and presenting lower limb edema

Brief summary: This observational, descriptive, retrospective study the clinical and imaging findings of 10 lower legs of 5 patients with previous history of injection of modeling substances for cosmetic purposes at buttocks and hips ande developed lower limb edema. Lower limb lymphedema index and lymphoscintigraphy findings were evaluated and reported.

Detailed description: Lymphoscintigraphy findings were reported with the Transport index (TI), were any value over 5 will represent abnormalities in lymphatic function.

Eligibility criteria: Inclusion Criteria:

* Both sex
* Over 18 years old
* History of injection of modelling substances for cosmetic purposes
* History of lower limb edema

Exclusion Criteria:

* History of primary lower limb lymphedema
* Reject to participate
* Confirmed other causes of edema

Primary outcomes:
measure: Transport Index
timeFrame: 4 months
Secondary outcomes:
measure: Lower extremity lymphedema index
timeFrame: 4 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Angeles Pedregal
state: Cdmx
Study officials:
References:
Clinical trial NCT03980093: The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Official title: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-10
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot trial compares two online interventions to improve adherence to anti-hormonal medication among women with the most common form of breast cancer (estrogen receptor-positive).


Eligibility criteria: Inclusion Criteria include:

1. Women in Colorado treated for Stage 0 to III estrogen receptor-positive breast cancer who have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) and within the past 2.5 years, have been prescribed anti-hormonal therapy
2. Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription
3. Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult
4. Have internet access

Primary outcomes:
measure: Medication adherence assessed by electronic pillbox (Wisepill box)
timeFrame: Change from baseline through 6 month follow-up
Secondary outcomes:
measure: Self-reported medication adherence
timeFrame: Change from baseline to 3 and 6 month follow-up
measure: Positive and negative emotional associations with taking anti-hormonal medication
timeFrame: Change from baseline through 6 month follow-up
measure: Intentions to adhere to anti-hormonal medication in the next year and next several years
timeFrame: Change from baseline through 6 month follow up
measure: Medication nonpersistence assessed by electronic pillbox (Wisepill box)
timeFrame: Baseline through 6 month follow-up
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Joanna J Arch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05451693: Outreach-ER: A Dementia Care Intervention Program
Official title: Outreach-ER: A Dementia Care Intervention Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dementia
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population includes people living with dementia (PLWD) who are treated at the Regions Hospital Emergency Department in Saint Paul, MN.

Brief summary: This is a feasibility/pilot, prospective cohort study to determine how to implement and refine Outreach-ER intervention for a larger clinical study. A key feature of Outreach-ER is to reach out to people living with dementia (PLWD) and their families following an emergency room visit or hospitalization. The outcome of this study will help in the overall goal of studying the impact of Outreach-ER in a larger clinical study and focus on outcomes relevant to PLWD and their care partners.


Eligibility criteria: Inclusion Criteria:

* PLWD with a recent Emergency department visit or admission at Regions Hospital
* Diagnosis of dementia based on international classification of diseases (ICD) Codes in the medical record
* Provides informed consent prior to participation
* Must be able to read and speak English
* PLWD Living at Home
* Age \>=18 years for PLWD and their care partner

Exclusion Criteria:

* PLWD living in a nursing home/Long term care - Assisted living facility
* Current involvement in another clinical research study/trial for care partners
* PLWD medical record number (MRN) on the HealthPartners (HP) exclusion list

Primary outcomes:
measure: Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER
timeFrame: 4 months
measure: Recruitment Rate for Feasibility and Acceptability of Outreach-ER
timeFrame: 4 months
measure: Participant Rate for Feasibility and Acceptability of Outreach-ER
timeFrame: First day of intervention
measure: Completion Rate for Feasibility and Acceptability of Outreach-ER
timeFrame: about 4 months
measure: Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER
timeFrame: about 4 months
measure: Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER
timeFrame: about 4 months
Secondary outcomes:
measure: Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER
timeFrame: about 4 months
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neuroscience Research
name: Bhavani Kashyap, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners Neuroscience Research
name: Leah R Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389593: Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology As Reference
Official title: Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology As Reference
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Liver Fibroses
Liver Inflammation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2020-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with known or suspected NASH

Brief summary: This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.

Detailed description: This prospective pilot study evaluates the comparative and additive diagnostic performance of Magnetic Resonance Elastography (MRE) and corrected-T1 (cT1) for the detection and staging of fibrosis and inflammation in Nonalcoholic Steatohepatitis (NASH), using histology as the reference standard.

Eligibility criteria: Inclusion Criteria:

* Adult subjects of any gender and any ethnic group with known or suspected NASH
* Subject is willing and able to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, and research MRI exam), and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images and clinical or research biopsy results
* Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents
* Subject has had or is expected to have a clinical or research biopsy within 150 days of the MR exam

Exclusion Criteria:

* VA subject
* \< 18 years of age
* Subject does not have a physician and does not wish to be contacted about possible incidental findings
* MRI contraindication(s)
* Subject knows that she is pregnant or states she is trying to become pregnant

Primary outcomes:
measure: Accuracy of MRE and c-T1 to assess disease progress
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Claude B Sirlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06294093: Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure
Official title: Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure, Muscle Strength, Proprioception and Balance Performance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achilles Tendon Injury
Keywords: Achilles tendon
running
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Zinman College of Physical Education and Sports Sciences
First posted: 2024-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy runners who run on a regular basis, without injuries or pain during the last 6 months

Brief summary: this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.

Detailed description: Healthy runners (road and treadmill runners) who run regularly at least twice a week for half an hour, over 80% of the training on the treadmill or road, will be recruited for the study.

All subjects will fill out a demographic questionnaire for personal details (age, sex, height, weight, past injuries, training). Each participant will undergo functional tests in random order: 1. Examination of the morphology of the Achilles tendon - will be examined by ultrasound tissue characterized (UTC) 2. Balance test - Y Balance Test 3. Proprioception test - AMEDA device 4. Muscle strength test - manual dynamometer for testing gastrocnemius muscle strength. 5. Gastrocnemius muscle endurance test - single leg heel raise test until fatigue.

A comparison will be made between the two study groups.

Eligibility criteria: Inclusion Criteria:

* run regularly at least twice a week for half an hour,
* over 80% of the training on a treadmill or road

Exclusion Criteria:

* pain or injury to Achilles tendon during the 6 months, preventing running for at least 3 days.
* past Achilles tendon surgeries,
* sprained ankle in the last six months,
* lower limb and back pain while running
* participants who report running with minimalist shoes.

Primary outcomes:
measure: ultrasound tissue characterized
timeFrame: baseline
measure: Balance test
timeFrame: baseline
measure: Proprioception test
timeFrame: baseline
measure: muscle strength test
timeFrame: baseline
measure: endurance test gastrocnemius muscle
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: The Academic College at Wingate
Study officials:
affiliation: University of Haifa
name: Gali Dar, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dar G, Waddington G, Stern M, Dotan N, Steinberg N. Differences Between Long Distance Road Runners and Trail Runners in Achilles Tendon Structure and Jumping and Balance Performance. PM R. 2020 Aug;12(8):794-804. doi: 10.1002/pmrj.12296. Epub 2020 Jan 18.
Clinical trial NCT03976193: Improving Physical Activity Maintenance of Cancer Survivors
Official title: Improving Physical Activity Maintenance Following an Exercise Program for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: active treatment
Recent treatment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-05
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants enrolled in the BfitBwell Cancer Exercise Program at the University of Colorado Cancer Center will be randomized 1:1 to receive the current BfitBwell program, or BfitBwell plus six, group-based behavior change counseling sessions adapted from BEAT Cancer. We will stratify the randomization based on sex.


Eligibility criteria: Inclusion Criteria:

1. current patient at the University of Colorado Cancer Center
2. signed physician clearance to participate in a supervised exercise program
3. participant is actively receiving medical cancer treatment (chemotherapy, radiation or surgery) OR within 6 months of receiving medical cancer treatment.
4. Willingness to be randomized to receive six, PA behavior change counseling sessions as part of the BfitBwell program, and able to attend five out of six of these sessions

Primary outcomes:
measure: Examine the effects of six, group-based physical activity (PA) behavior change counseling sessions PA change from post-program, to 3-months following completion of the BfitBwell program.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCD Anschutz Health and Wellness Center
state: Colorado
Study officials:
References:
Clinical trial NCT04834193: Wet-suction Versus Slow-pull for EUS-FNB of Solid Lesions
Official title: Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Ultrasound
Fine-needle Aspiration
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.


Eligibility criteria: Inclusion Criteria:

* Solid pancreatic lesions 3 1cm
* Peri-GI tract lymph nodes 3 1cm
* Peri-GI tract masses
* Lesions of the GI wall
* Signed informed consent

Exclusion Criteria:

* Pancreatic cystic lesions (more than 50% of the volume)
* Diameter of lesion ≤ 1 cm
* Lesion not seen at EUS
* Pregnancy
* Coagulopathy (platelet count \<50.000/mm3 and/or international normalized ratio \>1.5);
* Severe cardiorespiratory dysfunction precluding endoscopy;
* Failure to provide informed consent

Primary outcomes:
measure: Histologic yield
timeFrame: 6 months
Secondary outcomes:
measure: Tissue integrity
timeFrame: 6 months
measure: Blood contamination
timeFrame: 6 months
measure: Tumor fraction
timeFrame: 6 months
measure: Diagnostic accuracy
timeFrame: 6 months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Integrata Verona
Study officials:
References:
citation: Crino SF, Conti Bellocchi MC, Di Mitri R, Inzani F, Rimbas M, Lisotti A, Manfredi G, Teoh AYB, Mangiavillano B, Sendino O, Bernardoni L, Manfrin E, Scimeca D, Unti E, Carlino A, Voiosu T, Mateescu RB, Fusaroli P, Lega S, Buscarini E, Pergola L, Chan SM, Lamonaca L, Gines A, Fernandez-Esparrach G, Facciorusso A, Larghi A. Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial. Endoscopy. 2023 Mar;55(3):225-234. doi: 10.1055/a-1915-1812. Epub 2022 Aug 1.
Clinical trial NCT04578093: Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
Official title: Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contraception Behavior
Keywords: teen pregnancy, adolescent contraception
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case-control
Primary purpose: PREVENTION

Brief summary: Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.


Eligibility criteria: Inclusion Criteria:

female, never used LARC, attending high school, less than 20 yo

Exclusion Criteria:

used LARC

Primary outcomes:
measure: Inquiries made of provider
timeFrame: 6 months
Secondary outcomes:
measure: LARC uptake
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: UTMB
name: Pooja R Patel, MD, MPH, MMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233193: The Effect of Pharmacist Intervention on Blood Pressure Control
Official title: Pharmacist Intervention Effect on the Medication Adherence and Blood Pressure Control in Treated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Home blood pressure measurement
Pharmaceutical Services
Medication adherence
hypertension management
Blood Pressure
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting.

Detailed description: Hypertension is a major health concern worldwide due to its deleterious impact on the population in terms of excessive morbidity and mortality, especially when there is insufficient hypertension control and prevention at the community level.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders between the ages of 18 and 80 years, who access the pharmacy to fill their own prescription for hypertension.

Exclusion criteria:

* Patient living with an other Hypertensive patient treated with the same medications
* Pregnant women
* Hypertensive patients with levels of systolic/diastolic blood pressure ≥ 180mmHg/110mmHg
* Patient with secondary hypertension, kidney or liver failure
* Patients already included in a care program for hypertensive patients
* Patients with a new treatment for hypertension (less than 1 month)

Primary outcomes:
measure: blood pressure control
timeFrame: At 6 months
Secondary outcomes:
measure: Adherence
timeFrame: At 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Community Pharmacies
state: Andalucia
city: Jaén
country: Spain
facility: Community Pharmacies
state: Andalucia
Study officials:
affiliation: Universidad de Granada
name: Maria Jose Faus, PhD
role: STUDY_DIRECTOR
References: