louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05292430: B2RAD Translational Medicine Study
Official title: B2RAD Translational Medicine Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Specimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow Draw
Lead sponsor: DHR Health Institute for Research and Development
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included.

Brief summary: Recent advances in understanding the molecular and cellular pathology of many diseases have resulted in direct benefit to today's patients. The translational research studies that have led to these advances relied on an integrated model of clinical and non-clinical laboratory investigations based on the analysis of human biospecimens that lead directly to drug discovery, drug validation, novel detection assays, and prognostic marker discovery. Translational research provides a unique mechanism to address questions specific to particular tumor or other disease types, biological modifiers and/or mechanisms of action that are essential for the advancement of healthcare. Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included


Eligibility criteria: Inclusion Criteria:

1. Any subject choosing to give consent for participation will be included.
2. Any subject in which the primary diagnosis of cancer was made at the DHR Health System.

Exclusion Criteria:

1. Any subject deemed unable to provide legally effective consent.
2. Any pediatric subject where the subject does not freely give his or her assent or where his or her parent/guardian does not give consent.

Primary outcomes:
measure: Collection of diseased and non-diseased tissue, blood, and other body fluids
timeFrame: once
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development
state: Texas
city: Edinburg
country: United States
facility: DHR Health
state: Texas
Study officials:
affiliation: DHR Heath Institute for Research and Development
name: Sohail Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427930: Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial
Official title: Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this follow-up study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Participants of Jointstem Phase 3 Clinical Trial
* Participates who signed informed consent document of this study

Exclusion Criteria:

* No applicable

Primary outcomes:
measure: Adverse Events
timeFrame: 5 Years
Secondary outcomes:
measure: Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
timeFrame: 5 Years
measure: WOMAC 3 subscale score
timeFrame: 5 Years
measure: SF-36
timeFrame: 5 Years
measure: Measuring of Kellgren-Lawrence grade
timeFrame: 1, 2, 3, 4, 5 Years
measure: Measuring of Femoro-tibial anatomical angle(FTA)
timeFrame: 1, 2, 3, 4, 5 Years
measure: Measuring of Hip-Knee-Ankle angle(HKA)
timeFrame: 1, 2, 3, 4, 5 Years
measure: Measuring of Joint Space Width
timeFrame: 1, 2, 3, 4, 5 Years
measure: MRI scan
timeFrame: 1, 2, 3, 4, 5 Years
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: KyungHee University Gangdong Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: KyungHee University Gangdong Hospital
name: KANGIL KIM
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Severance Hospital
name: WOOSUK LEE
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: KICHEOR BAE
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: YONG IN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00530530: ASP8825 - Study in Patients With Restless Legs Syndrome
Official title: ASP8825 Phase ⅡStudy-A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP8825 in Patients With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Keywords: ASP8825
Restless legs Syndrome
XP13512
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 474
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

Detailed description: Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome

Eligibility criteria: Inclusion Criteria:

* Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
* History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period

Exclusion Criteria:

* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
* A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
* Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias

Primary outcomes:
measure: The change of the International Restless Legs Syndrome rating scale score
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigator-related Clinical Global Impression of Improvement
timeFrame: 12 weeks
measure: Patient- related Clinical Global Impression of Improvement
timeFrame: 12 weeks
measure: The Pittsburgh sleep quality index
timeFrame: 12 weeks
measure: The SF-36 Health Survey
timeFrame: 12 weeks
measure: The Restless Legs Syndrome QOL Questionnaire
timeFrame: 12 weeks
measure: The Medical Outcomes Study sleep scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyusyu
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
citation: Inoue Y, Hirata K, Uchimura N, Kuroda K, Hattori N, Takeuchi M. Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Curr Med Res Opin. 2013 Jan;29(1):13-21. doi: 10.1185/03007995.2012.746217. Epub 2012 Nov 30.
Clinical trial NCT06202430: Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery
Official title: Comparison of Ultrasound Guided High Thoracic Erector Spinae Plane Block With Shoulder Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery.

Primary outcome:

• 24-hour analgesic consumption.

Secondary outcomes:

* Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
* Time to first rescue analgesia and total postoperative consumption of analgesia.
* Effect of the block on Hemodynamics.
* Adverse effects in the form of postoperative nausea and vomiting (PONV).
* Patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* All patients within the age range ≥ 21 to ≤ 70 years old.
* Body mass index (BMI) ≤ 35kg m2.
* ASA I, II of both sex

Exclusion Criteria:

* Refusal of the patient to the study.
* Infection at the site of injection.
* Previous known allergy to any drug used in the study by history.
* Renal disease \[Creatinine. \>3mg/dl.\].
* Hepatic disease. \[ALT\>50U/L, AST \>50U/L\].
* Un cooperative or psychological unstable patients.
* Coagulopathy or anticoagulant therapy.
* Pregnancy.

Primary outcomes:
measure: 24-hour analgesic consumption.
timeFrame: 24 hours.
Secondary outcomes:
measure: Visual Analogue Scale.
timeFrame: ● Every 0.5 hour for next 2 hours. ● Every 2 hours for next 6 hours. ● Every 6 hours for remaining 24 hours post-operatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: MenoufiaU
Study officials:
References:
Clinical trial NCT01694030: Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study
Official title: Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Unipolar Depression
Keywords: Attachment security priming
depressed mood
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore whether asking participants to visualise a secure attachment figure or a neutral event leads to differences in self-reported felt security or depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep a secure prime activated over 3 days via text message visualisation tasks.


Eligibility criteria: Inclusion Criteria:

-Anxiety and depressive symptoms

Exclusion Criteria:

-Bipolar disorder

Primary outcomes:
measure: Depressed Mood 1
timeFrame: Depressed mood will be measured on day 7 of the study (immediately after lab primes)
Secondary outcomes:
measure: Felt Security 1
timeFrame: Felt security will be measured on day 7 of the study (after initial lab primes)
measure: Depressed Mood 2
timeFrame: Depressed mood will be measured on day 7 of the study (after 3 days of text primes)
measure: Depressed Mood 3
timeFrame: Depressed mood will be measured on day 11 of the study (24 hours after the last text prime).
measure: Felt Security 2
timeFrame: Felt security will be measured on day 10 of the study (after 3 days of text primes)
measure: Felt Security 3
timeFrame: Felt security will be measured on day 11 of the study (24 hours after last text prime)
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: College Keep
state: Hants
Study officials:
affiliation: University of Southampton
name: Professor Baldwin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06244030: The Effect of Core Stabilization Exercises in Female Wrestlers
Official title: The Effect of Core Stabilization Exercises on Trunk Muscle Strength, Upper Extremity Performance and Spinal Stability in Female Wrestlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Addiction
Trunk Muscle Strength
Upper Extremity
Wrestling
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned to investigate the effect of core stabilization exercise program on trunk muscle strength, spinal stability and upper extremity performance in elite wrestling athletes.


Eligibility criteria: Inclusion Criteria:

* Being between 14 and 21 years old and interested in wrestling
* Actively pursuing a life of wrestling
* Participate in training at least 4 days a week
* Wrestling in freestyle style.
* To confirm that there is no injury problem
* Being a licensed athlete

Exclusion Criteria:

* Experiencing any serious injury problems

Primary outcomes:
measure: Assessment of muscle strength
timeFrame: ''6 weeks''
measure: Medicine Ball Throwing Test
timeFrame: ''6 weeks''
measure: Closed Kinetic Chain Upper Limb Test
timeFrame: ''6 weeks''
measure: Upper extremity Y balance test
timeFrame: ''6 weeks''
Secondary outcomes:
measure: Functional Reach Test
timeFrame: ''6 weeks''
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT03138330: Validation of a Food Frequency Questionnaire
Official title: Validation of Dietary Patterns and Inflammatory Salivary Biomarkers Among Healthy Toddlers of 15-36 Months Old in Singapore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 95
Sex: ALL
Minimum age (years): 15
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children who are aged 15-36 months and of Chinese, Indian or Malay ethnicity

Brief summary: The purpose of this study is to collect nutritional information from young children aged 15-36 months to validate a newly developed food frequency questionnaire.

Detailed description: The primary purpose of this study is to validate a semi-quantitative food frequency questionnaire (FFQ) against a reference method (2-day weighed food records) in a sample of young children aged 15-36 months.

In addition to dietary data, the investigators also collected information on parental demographics, toddler health with regards to allergies and intolerance, parental feeding practices, parent and child weight and height and lastly, saliva samples to study inflammatory markers.

Therefore, in addition to the validation of the FFQ- the data will also be used to study associations between dietary patterns, food and nutrient intake and (i) parental feeding practices and (ii) inflammatory biomarkers from saliva

Eligibility criteria: Inclusion Criteria:

1. 15-36 months old boys and girls who are healthy
2. Toddlers who are from either Chinese, Malay or Indian ethnic group

Exclusion Criteria:

1. Toddlers with any acute or chronic illness, such as chronic inflammatory bowel disease, or illness that negatively affects food intake (e.g. Crohn's disease or ulcerative colitis).
2. Toddlers with history of antibiotics used in the last 1 week before the study.
3. Toddlers with history of vaccination in the last 2 weeks before the study
4. Toddlers with one or both parents of Caucasian origin.

Primary outcomes:
measure: Validated Food Frequency Questionnaire
timeFrame: up to 1 month
Secondary outcomes:
measure: Salivary Inflammatory Biomarkers
timeFrame: up to 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Danone Nutricia Early Life Nutrition
name: Elena Sandalova, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danone Nutricia Early Life Nutrition
name: Smita Nambiar-Mann, PhD
role: STUDY_CHAIR
References:
citation: Allan C, Abdul Kader UH, Ang JYY, Muhardi L, Nambiar S. Relative validity of a semi-quantitative food frequency questionnaire for Singaporean toddlers aged 15-36 months. BMC Nutr. 2018 Dec 11;4:42. doi: 10.1186/s40795-018-0252-9. eCollection 2018.
Clinical trial NCT01444625: Flavanols and Skin Photo Protection: a Clinical Trial
Official title: Flavanols and Skin Photo Protection: a Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solar Skin Damage
Keywords: UV radiation
photoprotection
flavanols rich chocolate
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 78
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may increase microcirculation in skin, the purpose of the study is to investigate the chronic effect of flavanol-rich chocolate as an effective strategy to protect against the harmful effect of ultraviolet (UV) radiation.

Detailed description: Recent data suggested that chronic ingestion of high flavanols cocoa might be a promising agent for dietary photo protection against UV light. Moreover, flavanols-rich cocoa intake has been shown to increase microcirculation in human skin.

Eligibility criteria: Inclusion Criteria:

* Non-smoking women between the ages of 20 and 65 years.
* Normal skin of type I and II as decried by Fitzpatrick classification.

Exclusion Criteria:

* Pregnancy and breast feeding.
* Photo sensibility: history of skin cancers, photosensitizing medication.
* Sun bed use or sunbathing in the previous 3 months.
* Use of supplements or natural health products (fish oils, coenzyme Q10, garlic, lycopene, beta carotene).
* Allergy or intolerance to nuts or chocolate.

Primary outcomes:
measure: Change in Minimal erythema dose
timeFrame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Secondary outcomes:
measure: Change in Skin elasticity
timeFrame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
measure: Change in Skin moisture
timeFrame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
measure: Change in levels of Vitamin D and polyphenols
timeFrame: within the first 12 weeks of chocolate intake and 3 weeks later after end of chocolate consumption
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
state: Quebec
Study officials:
affiliation: Laval University
name: Sylvie Dodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mogollon JA, Boivin C, Lemieux S, Blanchet C, Claveau J, Dodin S. Chocolate flavanols and skin photoprotection: a parallel, double-blind, randomized clinical trial. Nutr J. 2014 Jun 27;13:66. doi: 10.1186/1475-2891-13-66.
Clinical trial NCT05826925: Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
Official title: Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension, Pregnancy Induced
Hypertension Complicating Pregnancy
Preeclampsia
Cardiovascular Diseases
Patient Engagement
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

Detailed description: Current evidence demonstrates that women with hypertensive disorders of pregnancy have 2-fold higher risk for the later development of cardiovascular disease (CVD) compared to women with healthy pregnancies. CVD prevention is a high priority for women's health, as it is the leading cause of death among women in the United States. In order to improve women's cardiovascular health, interventions for cardiovascular prevention could be initiated shortly after a pregnancy complicated by a hypertensive disorder. However, patient-centered interventions to promote preventive care engagement among postpartum women are lacking. Our objective is to address current gaps in knowledge regarding needs, values, and barriers regarding cardiovascular prevention among postpartum women with hypertensive disorders of pregnancy, and to remedy the lack of available evidence-based interventions for this at-risk population. To this end, we will conduct a pilot study to demonstrate feasibility and preliminary efficacy of a patient decision aid to improve patient knowledge and self-efficacy regarding CVD prevention during the postpartum period

Eligibility criteria: Inclusion Criteria:

* Delivered a pregnancy complicated by a hypertensive disorder of pregnancy at the University of Utah during the current hospital admission
* Ability to speak and read English or Spanish
* Written informed consent obtained

Exclusion Criteria:

* Cardiovascular disease diagnosis (history of peripheral artery disease, stroke, or myocardial infarction)
* Impairment of cognitive function or vision that prohibits communication and/or reading the decision aid.

Primary outcomes:
measure: Decisional conflict
timeFrame: 6-8 weeks postpartum
Secondary outcomes:
measure: Decisional conflict
timeFrame: One month after the initial assessment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
References: