louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06445478: Effectiveness of Blood Flow Restricting Exercises and Isokinetic Exercises in Female Football Players
Official title: Comparison of Blood Flow Restrictive Exercises and Isokinetic Exercises in Female Football Players: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Football Players
Keywords: Resistance exercise
Isokinetic exercise
Female football player
Blood flow restrictive exercise
Athlete rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim in the study is; Comparison of blood flow restrictive exercises and isokinetic exercises in female football players. 30 female football players between the ages of 18-30 who came to DOIT Health \& Sports clinic to receive rehabilitation will be included in the study. Participants will be randomized into 2 groups. Resistant exercise with blood flow restrictive exercise (BFR-RE) will be applied to one group, and resistant exercise with isokinetic device (ID-RE) will be applied to the other group. An 8-week exercise protocol will be created for both groups and exercise training will be given twice a week. Demographic data form, Kineo Intelligent Load Isokinetic Device to measure muscle strength, tape measure to measure circumference, universal goniometer for joint range of motion, Illinois Agility Test for agility and quality of life; World Health Organization Quality of Life Scale-Short Form Turkish Version will be administered before exercise, at the 4th week and at the 8th week. The effectiveness of the applications for female football players and their advantages over each other will be examined. The 4-week and 8-week effects of 2 types of exercise will be examined.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-30
* Becoming a female football player
* Volunteering to participate in the study

Exclusion Criteria:

* Deep vein thrombosis
* Pregnancy
* Hypertension
* Anti-inflammatory use
* Unexplained chest pain
* Congenital heart disease
* Participants with a history of contraindications to exercise
* There is another study conducted at the same time as the study.

Primary outcomes:
measure: Kineo Intelligent Load Isokinetic Device
timeFrame: 10 weeks
measure: Thigh and Leg Circumference Measurement
timeFrame: 10 weeks
measure: Universal Goniometer
timeFrame: 10 weeks
measure: Illinois Agility Test
timeFrame: 10 weeks
measure: World Health Organization Quality of Life Scale - Short Form Turkish Version
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: DOIT Health & Sports Clinic
state: Ataşehir
Study officials:
References:
Clinical trial NCT05146778: A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
Official title: A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Mastectomy
Pain, Chronic
Pain, Post Operative
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 230
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Control arm: Conventional Anesthesia with opioid
2. Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
Primary purpose: PREVENTION

Brief summary: In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.

Detailed description: Study population

1. All of patients will undergo mastectomy with or without immediate breast reconstruction.
2. 230 patients will be enrolled.

Intervention

1. OFA group will be sedated using dexmedetomidine and lidocaine.
2. Conventional opioid anesthesia group will be sedated using remifentanil.

Pain screening

1. Breast Cancer Pain Questionnaire (BCPQ)
2. Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A\&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)

Eligibility criteria: Inclusion Criteria:

* All of patients will undergo mastectomy with or without immediate breast reconstruction.

Exclusion Criteria:

* Previous history of breast surgery
* Allergy to drug
* Other cancer history
* Underlying psychologic disorder
* Patients with chronic pain requiring pain killers
* Baseline SpO2 \<95%
* Left ventricular EF \<40%
* Bradycardia as HR \<50 bpm
* BMI \>35kg/m2
* Pregnant woman

Primary outcomes:
measure: Presence of chronic breast pain at 1 year after mastectomy
timeFrame: 1 year after mastectomy
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year after mastectomy
measure: Pain Sensitivity
timeFrame: 1 year after mastectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Sung Gwe G Ahn, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956978: Shared Decision Making to Address Racial Disparities in Oral Anticoagulation in NVAF
Official title: Shared Decision Making to Address Racial Disparities in Oral Anticoagulation Use in Patients With Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Oral Anticoagulation
Health Disparities
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a pilot analysis using a decision on the risk and benefits of oral anticoagulation for stroke reduction for patients with non-valvular atrial fibrillation. This study is a feasibility and acceptability analysis but will also measure preliminary effectiveness measures.

The investigator hypothesizes that a patient decision support tool will increase decision quality and secondarily increase the use of oral anticoagulation in Black patients with non-valvular atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Black and White adults greater than or equal to 18 years of age
* Clinical diagnosis of NVAF
* CHA2DS2-VASc score greater than or equal to 2
* New patient visit for initiation of oral anticoagulation at primary care and cardiology clinics

Exclusion Criteria:

* Unable to speak English
* Unable to provide informed consent

Primary outcomes:
measure: Proportion of patients willing to consent as measured by enrollment log
timeFrame: End of Study, 12 months
measure: Proportion of patients willing to participate as measured by enrollment log
timeFrame: End of Study, 12 months
measure: Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP)
timeFrame: End of Study, 12 months
measure: Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture
timeFrame: End of Study, 12 months
measure: Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.
timeFrame: 1 week post clinic visit
Secondary outcomes:
measure: Decision Quality measured by use of the decision conflict scale
timeFrame: Clinical Day, up to 1 day
measure: Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.
timeFrame: Clinical Day, up to 1 day
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Larry Jackson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686178: Countering Young Adult Tobacco Marketing in Bars
Official title: Countering Young Adult Tobacco Marketing in Bars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
Smoking Cessation
Tobacco Use Cessation
Social Networks
Social Control, Informal
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-09-17
Enrollment: 17422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of the study is to implement and evaluate interventions to decrease smoking among young adults attending bars and nightclubs. It is believed that the proportion of young adult current smokers during and after the intervention will be significantly less than the proportion of young adult smokers before the intervention in each of the study cities.


Eligibility criteria: Inclusion Criteria:

* Participants are healthy volunteers 18-26 years old currently living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, or Los Angeles who attend bars or nightclubs
* Able to read, speak, and understand English
* NOTE: PARTICIPANTS CAN ONLY TAKE PART IN THE STUDY BY ENCOUNTERING STUDY SURVEY TEAMS OUT AT BARS OR NIGHTCLUBS IN ONE OF THE STUDY CITIES LISTED ABOVE. PARTICIPANTS CANNOT SIGN UP FOR THE STUDY BY CALLING OR EMAILING.

Exclusion Criteria:

* Out of age range (18-26 years old)
* Not living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, Los Angeles or New York City, or currently attending college outside of the target cities.
* Unable to read, speak, or understand English.
* Unwillingness or inability to participate or give informed consent.

Primary outcomes:
measure: Self-Reported Tobacco Smoking in past 30 days
timeFrame: Between baseline and follow-up at 1,2, & 3 years post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pamela M Ling, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ling PM, Glantz SA. Using tobacco-industry marketing research to design more effective tobacco-control campaigns. JAMA. 2002 Jun 12;287(22):2983-9. doi: 10.1001/jama.287.22.2983.
citation: Ling PM, Lisha NE, Neilands TB, Jordan JW. Join the Commune: A Controlled Study of Social Branding Influencers to Decrease Smoking Among Young Adult Hipsters. Am J Health Promot. 2020 Sep;34(7):754-761. doi: 10.1177/0890117120904917. Epub 2020 Feb 20.
citation: Lisha NE, Jordan JW, Ling PM. Peer crowd affiliation as a segmentation tool for young adult tobacco use. Tob Control. 2016 Oct;25(Suppl 1):i83-i89. doi: 10.1136/tobaccocontrol-2016-053086.
Clinical trial NCT05188378: A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Detailed description: Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth

Exclusion Criteria:

* A medical history and/or condition that is considered significant
* Clinically significant allergic reactions, hypersensitivity
* History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous exposure to tocilizumab or any drug that targets IL-6

Primary outcomes:
measure: Primary objective
timeFrame: up to Day 43
measure: Primary objective
timeFrame: up to Day 43
measure: Primary objective
timeFrame: up to Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: KyungSang Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: JaeYong Chung
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: HyeWon Chung
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: DongSeong Shin
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: MinKyu Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeonbuk National University Hospital
name: MinGul Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: JongLyul Ghim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090478: The Effect of Dietary Sugar Consumption on Sweet Taste Perception
Official title: The Effect of Dietary Sugar Consumption on Sweet Taste Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sweet Taste Perception
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
First posted: 2014-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine how reducing the amount of simple sugars in the diet affects sweet taste perception. Healthy adult subjects will be assigned to either follow their usual diet, or to replace sugar calories with fats or starch.

The investigators hypothesize that eating less sugar will:

1. cause foods and drinks with a given amount of sugar to taste sweeter
2. cause people to prefer lower levels of sugar in foods and drinks


Eligibility criteria: Inclusion Criteria:

* Good general heath (by self report)
* Consume at least 2 sugar-containing soft drinks/day on average)
* Able to control diet (select their own foods)

Exclusion Criteria:

* Major illness of any kind within the last six months, or any chronic illness
* Daily use of medication, except for birth control, vitamins, and aspirin
* Regularly consume non-nutritive sweeteners
* Pregnant women
* Gained or lost 10% or more of their body weight in the last 3 months

Primary outcomes:
measure: Change in Sweet Taste Intensity over Five Months
timeFrame: Monthly (for five months)
measure: Change in Pleasantness Over Five Months
timeFrame: Monthly (five month participation duration total)
Secondary outcomes:
measure: Sucrose detection thresholds
timeFrame: Every month (for five months)
measure: Body mass index
timeFrame: Every month (five months total)
measure: Diet records
timeFrame: Every month (five month total)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Paul M Wise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wise PM, Nattress L, Flammer LJ, Beauchamp GK. Reduced dietary intake of simple sugars alters perceived sweet taste intensity but not perceived pleasantness. Am J Clin Nutr. 2016 Jan;103(1):50-60. doi: 10.3945/ajcn.115.112300. Epub 2015 Nov 25.
Clinical trial NCT04832178: Sumor as Adjuvant Therapy in Treatment-resistant Major Depression
Official title: Use of Sumor in the Antidepressant Therapy of Subjects With Major Depression: a Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sumor is a food supplement that combines the main coenzymes of the S-Adenosyl methionine (SAMe) cycle, namely vitamins B6, B12 and folate, with SAMe and betaine. Sumor also contains vitamin C, a molecule that has shown promise in the treatment of depression in experimental models, and selenium, an antioxidant agent whose blood deficiency has been associated with depressive symptoms in some preliminary studies. There are no studies in the literature on the efficacy of this combination in the adjuvant therapy of depression. The purpose of this study is to compare the effects of Sumor in co-therapy with an SSRI antidepressant versus co-therapy with placebo in patients with treatment-resistant Major Depressive Disorder.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Major Depressive Disorder according to DSM-5 criteria
* Treatment-resistant status, assessed by clinical interview, after four weeks after SSRI therapy prescription as per NICE guidelines (National Institute for Health and Care Excellence, 2009)
* Age between 18 and 65 years
* Signature of informed consent

Exclusion Criteria:

* Presence of intellectual disability or illiteracy
* Diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychotic disorders according to DSM-5
* Diagnosis of a disorder belonging to the bipolar spectrum according to DSM-5
* Concomitant intake of therapy with other antidepressants, antipsychotics or mood stabilizers at the time of evaluation or in the previous 4 weeks
* State of pregnancy

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: Baseline, 2 weeks, 4 weeks and 8 weeks
measure: SIDE
timeFrame: Baseline, 2 weeks, 4 weeks and 8 weeks
measure: Depressive symptoms remission
timeFrame: Baseline, 2 weeks, 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Careggi
name: Francesco Rotella, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01801878: Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Official title: Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Neoplasms
Skin Abnormalities
Keywords: breast cancer
loss of elasticity in irradiated breast skin
Other Reconstructive Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.

Detailed description: 10 participants who taken conservative mastectomy will be enrolled

1. Process

   * adipose tissue is obtained from the subject's thigh or abdomen
   * adipose-drived stromal vascular fraction(SVF)cell isolation using automatic centrifuge system
   * adipose-drived stromal vascular fraction(SVF)cell graft into the irradiated breast.
2. Duration of study

   * entire duration: approximate 30weeks
   * Follow-up period: 12 weeks
   * Enrollment period: 12 weeks
3. Study design - Randomized, prospective, pilot study

Eligibility criteria: Inclusion Criteria:

* Female aged between 40 and 60
* Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0, negative resection margin of below 2mm in histopathologic examination
* Subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy
* Subjects who understand the study contents and sign the informed consent

Exclusion Criteria:

* Subjects who have radiodermatitis
* Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse Rectus Abdominis Muscle flap)
* Subjects who have a history of smoking within 3months recently
* Subjects who participated in other clinical trial within 30 days recently
* Pregnant or lactating subjects
* Subjects who have a active infectious disease
* Subjects who are not eligible for this study at the discretion of the investigator

Primary outcomes:
measure: The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
timeFrame: change in the breast skin thickness from baseline at 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Bundang,Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chanyeong Heo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: