louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06975085: Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Administrative Supplement Study
Official title: Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer Female
Keywords: breast cancer risk
risk perceptions
screening intentions
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-05-16
Enrollment: 781
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

Detailed description: The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by testing hypotheses about why women reject their risk estimate and the influence of rejection on screening intentions.

The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's breast cancer risk. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. Participants will be required to complete a survey in which they receive their BCRAT model risk estimate and respond to that risk estimate.

Eligibility criteria: Inclusion Criteria:

1. Female sex
2. Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
3. English literacy
4. Black or African American race

Exclusion Criteria:

1. Prior diagnosis of

1. breast cancer
2. Ductal carcinoma in situ (DCIS)
3. Lobular carcinoma in situ (LCIS)
4. Known BRCA1/2 gene mutation
5. Cowan syndrome
6. Li-Fraumeni syndrome
7. Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Primary outcomes:
measure: Risk rejection as measured by a numeric estimate
timeFrame: at baseline survey
measure: Risk-concordant information seeking
timeFrame: at baseline survey
measure: Screening intentions
timeFrame: at baseline survey
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Laura D Scherer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Erika Waters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04801485: D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
Official title: D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Quzhou Maternal and Child Health Care Hospital
First posted: 2021-03-17
Enrollment: 291
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.


Eligibility criteria: Inclusion Criteria:

* During 12-16 weeks gestation
* Meet any of the following: prepregnancy BMI \> 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth;
* Willing to participate

Exclusion Criteria:

* Type 1 or type 2 diabetes mellitus diagnosed before pregnancy
* Multiple gestation
* Mental or cognitive impairment cannot complete the study

Primary outcomes:
measure: the incidence of gestational diabetes
timeFrame: 24-28th weeks gestation
Secondary outcomes:
measure: the perinatal outcomes-1
timeFrame: Delivery
measure: the perinatal outcomes-2
timeFrame: Delivery
measure: the perinatal outcomes-3
timeFrame: Delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xinning Chen
state: Zhejiang
Study officials:
References:
citation: Chen X, Du Z, Zhang Z, Chen D. D-Chiro Inositol Supplementation and the Occurrence of Gestational Diabetes: A Randomized Controlled Trial in China. Food Sci Nutr. 2024 Dec 5;13(1):e4601. doi: 10.1002/fsn3.4601. eCollection 2025 Jan.
Clinical trial NCT04082156: The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Fatigue
Keywords: TENS, DOMS, soreness, fatigue
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Western Michigan University
First posted: 2019-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.


Eligibility criteria: Inclusion Criteria:

* No phobia of electrical stimulation
* No pain or anti-inflammatory medication will be taken during study
* English speaking

Exclusion Criteria:

* Pregnancy
* Diabetes Mellitus
* Neuropathy
* Smoker
* Uncontrolled Hypertension
* Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
* Rhumatoid Arthritis (RA) in the area to be treated by TENS
* Allergic to tape/electrodes
* Dementia
* History of knee joint replacement or tibial osteotomy
* Undergoing physical therapy
* Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
* Contraindications to TENS such as having a pacemakers, dermatological conditions, and abnormal sensation of the lower extremity.

Primary outcomes:
measure: VAS(Visual Analog Scale score) for soreness or pain
timeFrame: 2weeks
measure: FI (Fatugue Index)
timeFrame: 2weeks
Secondary outcomes:
measure: sleep quality measurement
timeFrame: 2weeks
measure: POMS (Profile of Mood States)
timeFrame: 2weeks
Other outcomes:
Locations:
city: Muko
country: Japan
facility: Omron healthcare Co.,Ltd.
Study officials:
References:
Clinical trial NCT05526456: Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma
Official title: Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: National Cancer Center/Cancer Hospital
Lead sponsor: National Cancer Center, China
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 207
Sex: ALL
Minimum age (years): 44
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the 207 patients, 22 were in the T1a stage, whereas 185 were in the T1b stage. The invasion depth was EP in 2, LPM in 1, MM in 17, SM1 in 37, SM2 in 39 and SM3 in 97 patients

Brief summary: With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.


Eligibility criteria: Inclusion Criteria:

* Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.

Exclusion Criteria:

* The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.

Primary outcomes:
measure: LNM rates of the 207 thoracic T1N+ ESCC patients.
timeFrame: 2012.2-2022.4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06338956: Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI
Official title: Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Hyperlipidemias
Keywords: Percutaneous coronary intervention
Statin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 135877
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease undergoing PCI

Brief summary: For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI.

Detailed description: To investigate the Optimal Attained LDL-C Levels in Patients Who Achieved ≥50% LDL-C Reduction After PCI.

Eligibility criteria: Inclusion Criteria:

* Patients receiving PCI with health check up before and after PCI within 3 years

Exclusion Criteria:

* Patients receiving statin before PCI
* Patients with liver cirrhosis
* Patients with cancer
* Patients without prescription of statin
* Patients with LDL-C \<55 mg/dL before PCI

Primary outcomes:
measure: MACCE
timeFrame: 10 years after PCI
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 10 years after PCI
measure: Spontaneous myocardial infarction
timeFrame: 10 years after PCI
measure: Repeat revascularization
timeFrame: 10 years after PCI
measure: Ischemic stroke
timeFrame: 10 years after PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02107456: Effect of Dry Needling on Myofascial Trigger Point
Official title: The Long Term Effect of Dry Needling on Myofascial Trigger Point in the Upper Trapezius Muscle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Dry Needling, Myofascial trigger point, Upper trapezius
Lead sponsor: University of Social Welfare and Rehabilitation Science
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Myofascial trigger point is one of the most common causes of musculoskeletal disorders. Myofascial trigger point in upper trapezius has been reported as a symptom in patients with neck and upper thoracic pain. The purpose of this study was to investigate the prolonged effect of dry needling on myofascial trigger point in upper trapezius muscle.

Detailed description: Pain intensity and Disability of arm, hand and shoulder (DASH) were collected at base line and at the end of treatment sessions, two weeks and three months follow up in both groups.

Eligibility criteria: Inclusion Criteria:

* 1. Presence of a palpable taut band in muscle.
* 2. Presence of a hypersensitive tender spot in the taut band.
* 3. Reproduction of the typical referred pain pattern of the MTP in response to compression. To detect active TrPs, TrP pressure tolerance was assessed using a mechanical pressure algometer. The investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2.
* 4. Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar.
* 5- Pain of at least 30 mm on a visual analogue scale (VAS). The selected MTP of the UT muscle was located in the middle of the more nearly horizontal fibers of the UT 40.

Exclusion Criteria:

* had a history of fibromyalgia syndrome, whiplash injury, cervical spine surgery and fracture, cervical radiculopathy, having therapy within the past month before the study
* any systematic disease such as rheumatism and tuberculosis or cervical myelopathy, multiple sclerosis
* local infection,
* pregnancy
* taking anticoagulants (e.g. warfarin)
* long-term steroid using

Primary outcomes:
measure: Pain intensity
timeFrame: One year
Secondary outcomes:
measure: Disability
timeFrame: One year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: University of Social Welfare and Rehabilitation Sciences
Study officials:
affiliation: University of Social Welfare and Rehabilitation Sciences
name: Amir M Arab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05389956: Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study
Official title: Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Malignancy
Risk Factor
Keywords: Cardiovascular disease
Malignancy
Risk factor
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 510000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Health screening participants aged 19 years and older from community and workplace

Brief summary: Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.

Detailed description: This is a single center, observational, prospective cohort study. The primary outcomes include the incidence of MACE (major adverse cardiovascular events) and the incidence of any malignancy. We plan to collect the baseline information at enrollment and the occurrence of clinical endpoint events will be followed for at least 10 years. The study will enroll 510,000 subjects aged ≥19 years who underwent a general health screening in Korea.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)
* Subjects have to agree to participate by signing a consent

Exclusion Criteria:

* Subjects who cannot or reject to sign the consent form.

Primary outcomes:
measure: Major adverse cardiovascular event (MACE)
timeFrame: 10 year
measure: Incidence of malignancy
timeFrame: 10 year
Secondary outcomes:
measure: All-cause death
timeFrame: 10 year
measure: Cardiovascular death
timeFrame: 10 year
measure: Myocardial infarction
timeFrame: 10 year
measure: Stroke
timeFrame: 10 year
measure: Cancer related mortality
timeFrame: 10 year
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Sangwoo Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05438056: The Effect of the Mobile Application Developed for Home Care of Preterm
Official title: The Effect of the Mobile Application Developed for Home Care of the Premature Baby on the Mother's Baby Care Skills, Self-efficacy and Mother-infant Bonding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mother
Premature
Education
Home Care
Mobile Application
Keywords: Mothers, premature, mobile application, education, home care
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled interventional research
Primary purpose: SUPPORTIVE_CARE

Brief summary: mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated.

Detailed description: This research aims to examine the effect of the mobile application developed for the home care of the babies of the mothers of premature babies on their baby care knowledge and skills, mother-infant attachment and mother self-efficacy. A mobile application will be developed to support mothers who care for their premature babies at home after discharge. The application will be installed on the phones of mothers whose babies are discharged from the neonatal intensive care unit. After the babies are discharged, mothers will be trained at home with a mobile application. Maternal self-efficacy and mother-infant supplementation will be measured when infants admitted the NICU and one month after discharge the NICU.

Eligibility criteria: Inclusion Criteria:

For mothers;

* Being over the age of 18,
* Having a premature baby
* At least primary school graduate,
* Smart mobile app can be installed have a phone,
* Being able to understand and speak Turkish,
* Residing in Ankara

For babies;

* 32-37 weeks of gestation of the baby (middle and borderline premature)
* Baby in neonatal intensive care unit to stay
* Not having undergone a surgical operation,
* Absence of physical anomalies

Exclusion Criteria:

For Mothers;

* Diagnosed with postpartum depression
* unwillingness to participate in the study

For babies;

- Very small preterm (born below 28 weeks of gestation) and small preterm (between 28 and 31 weeks of gestation)

Primary outcomes:
measure: parent self-efficacy scale
timeFrame: up to 10 months
measure: parent self-efficacy scale
timeFrame: up to 14 months
Secondary outcomes:
measure: maternal attachment scale
timeFrame: up to 10 months
measure: maternal attachment scale
timeFrame: up to 14 months
Other outcomes:
measure: baby care knowledge and skills form
timeFrame: up to 14 months
Locations:
Study officials:
References:
Clinical trial NCT05928156: Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT
Official title: Blood Cancer Symptom Management App Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Chronic Lymphocytic Leukemia
Keywords: MM
CLL
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effectiveness of evidence-informed mobile apps, Myeloma Coach and CLL Coach. These apps have been developed to help manage the physical and emotional symptoms experienced by multiple myeloma and chronic lymphocytic leukemia survivors. This study hopes to determine if a mobile app is a useful tool to help people manage commonly reported symptoms related to Multiple Myeloma (MM) and chronic lymphocytic leukemia (CLL).


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Be a resident of the United States of America;
* Be able to read and write English
* Consistent access to the internet via a smartphone, tablet or computer
* Have a diagnosis of multiple myeloma or chronic lymphocytic leukemia

Primary outcomes:
measure: Change in Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in NCCN Distress Thermometer
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form Global Health
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in severity of PTSD related symptoms as measured by PTSD Checklist (PCL5)
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT03631056: Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Vascular Diseases
Vascular System Injuries
End Stage Renal Disease on Dialysis
Lead sponsor: Humacyte, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-15
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study

Detailed description: Procedure for Requesting Expanded Access:

The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.

General Criteria:

We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.

Anticipated Timing:

If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: