louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06003686: Spinal Cord Injury Model Systems (SCIMS) - Education Module
Official title: A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Obesity
Cardiometabolic Syndrome
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2023-08-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.


Eligibility criteria: Inclusion Criteria:

1. Men and Women with SCI/D aged 18-70 years.
2. Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
3. Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.

Exclusion Criteria:

1. Pregnancy determined by urine testing in sexually active females.
2. Cognitive impairment that compromises the legitimacy of consent.
3. Grade 3-4 pressure injury at the time of study entry.
4. Prisoners

Primary outcomes:
measure: Change in Effectiveness of education modules as determined in the Knowledge Test
timeFrame: baseline, up to 6 months
Secondary outcomes:
measure: Change in Body Weight as determined by kilograms (kg)
timeFrame: baseline, up to 6 months
measure: Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
timeFrame: baseline, up to 6 months
measure: Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
timeFrame: baseline, up to 6 months
measure: Change in sugar metabolism as determined by Insulin resistance (IR)
timeFrame: baseline, up to 6 months
measure: Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
timeFrame: baseline, up to 6 months
measure: Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
timeFrame: baseline, up to 6 months
measure: Change in heart disease risk as determined by cholesterol
timeFrame: baseline, up to 6 months.
measure: Change in heart disease risk as determined by blood pressure (BP)
timeFrame: baseline, up to 6 months.
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Network
state: District of Columbia
city: Miami
country: United States
facility: University of Miami - Miami Project to Cure Paralysis
state: Florida
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Research
state: Texas
Study officials:
affiliation: University of Miami
name: Gary Farkas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01653886: Palatability (Energy I Pilot)
Official title: Palatability of Meals That Vary in Fat and Energy Density. A Pilot Study to the Behavioral Response to Short-Term (Two Day) Positive Energy Balance Through Overfeeding (ENERGY I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Density
Keywords: Palatability
Taste
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A pilot study was conducted to develop the study menus that were similar in appearance, aroma, and taste.

Detailed description: The aim of the pilot study was to test for differences in palatability ratings of the four menus that will be administered during the ENERGY I project. During the pilot study, palatability ratings were collected for each meal (breakfast, lunch, and dinner) from four different menus that were served to participants during the main ENERGY I trial. The menus consist of three diets that vary in dietary fat and energy density: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. In addition to these three menus, the menu from the baseline period of the trial will also be tested for palatability.

Eligibility criteria: Inclusion Criteria:

* You are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female.
* your body mass index (BMI) is between 25 and 30 kg/m2, inclusive
* For females, if you have regular menstrual periods, with no less than 28 day cycles.

Exclusion Criteria:

* you have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease.
* You use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat).
* You have symptoms of depression or excessive dietary restraint.
* You have an allergy to one or more of the test foods.

Primary outcomes:
measure: Palatability
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: Apolzan JW, Bray GA, Hamilton MT, Zderic TW, Han H, Champagne CM, Shepard D, Martin CK. Short-term overeating results in incomplete energy intake compensation regardless of energy density or macronutrient composition. Obesity (Silver Spring). 2014 Jan;22(1):119-30. doi: 10.1002/oby.20587. Epub 2013 Sep 10.
Clinical trial NCT03081286: Treatment of Postmastectomy Pain Syndrome With Fat Grafting
Official title: Treatment of Postmastectomy Pain Syndrome With Fat Grafting: A Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Mastectomy Chronic Pain Syndrome (Disorder)
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the possible beneficial effect of fat grafting for post mastectomy pain syndrome. Half of patients will receive fat grafting and the other half of patients will receive sham.

Detailed description: Several studies have suggested that fat grafting can alleviate pain in post mastectomy pain syndrome. These studies however have either been in the form of case series or unblinded studies with great risk of bias.

It is believed that fat grafting with its content of adipose-derived stem cells can modulate the scar tissue upon grafting and hereby decrease pain.

In this study patients will be randomized to either fat grafting or a sham procedure where they undergo the same liposuction but no fat grafting, only injection of saline instead of fat.

Eligibility criteria: Inclusion Criteria:

* Treated for breast cancer
* Pain in the breast cancer treated area on the breast or axilla.
* Pain present at least 4 days a week with an intensity above 3 on VAS.
* Duration longer than 3 months
* Recurrence free for minimum 6 months
* Understand the nature of the study and can give informed consent

Exclusion Criteria:

* Psychiatric condition that can affect participation.
* Recurrence of breast cancer at any time.
* Other indication for fat grafting other than pain treatment.
* Breast reconstruction with flap

Primary outcomes:
measure: Pain on visual analog scale (VAS) 0-10
timeFrame: 6 months
Secondary outcomes:
measure: Neuropathic Pain Symptom Inventory
timeFrame: 3 and 6 months
measure: Use of pain medication
timeFrame: 3 and 6 months
measure: Pain on visual analog scale (VAS) 0-10
timeFrame: 3 months
Other outcomes:
measure: Complications
timeFrame: 3 months
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jens A Sørensen, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06977386: The Application Value of Spectral CT in the Accurate Staging of Gastric Cancer
Official title: The Application Value of Spectral CT in the Accurate Staging of Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Spectral CT was used to prospectively collect medical images and clinical data related to gastric cancer, evaluate the effect of image quality in the diagnosis of gastric cancer, and evaluate the application value in the accurate staging of gastric cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* (a)Patients with pathologically confirmed gastric cancer;
* (b) aged ≥ 18 years old;
* (c) have not received chemoradiotherapy or surgery.

Exclusion Criteria:

* (a)Combined with other primary tumors;
* (b) The image quality does not meet the diagnostic criteria;
* (c)Those who cannot tolerate CT examination.

Primary outcomes:
measure: Pathological TNM staging
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming City
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT02688686: Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases
Official title: Safety and Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases: a Phase I/II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Non-Small-Cell Lung Cancer With Bone Metastases
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed diagnosis of non-small cell lung cancer
* Age \>18 years at time of consent
* Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* No severe viral or bacterial infections
* Predicted survival \>3 months

Exclusion Criteria:

* Clinically relevant diseases or infections (HBV, HCV, HIV)
* Females who are pregnant or nursing
* Immunosuppressant treatment
* Currently participating in another clinical trial

Primary outcomes:
measure: objective response rate (CR+PR) as measured by RECIST criteria
timeFrame: one month after DC/CIK treatment
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: 3 days during DC/CIK treatment]
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital to Academy of Military Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT05444686: Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT
Official title: Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 99mTc-FAPI-positive Gastrointestinal Tumor
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.

Detailed description: 5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.

Eligibility criteria: Inclusion Criteria:

* patients with gastrointestinal tumors: diagnosed by pathological needle biopsy

Exclusion Criteria:

* refuse or cannot endure surgery pregnant women

Primary outcomes:
measure: SUV of primary and metastases lesions
timeFrame: 2 hours after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05824286: HbA1c Prediction Model in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Blood Glucose Self-Monitoring
HbA1c Prediction Model
Ridge Regression
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
* Have HbA1c results within 4 weeks, and the range was 7.5-11%;
* Willing and able to conduct self-glucose monitoring;
* Have not participated in any other research program in the past 4 weeks.

Exclusion Criteria:

* Type 1 diabetes mellitus;
* Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
* Diabetic ketosis in the last 1 week;
* Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
* Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
* Pregnancy or breastfeeding;
* Receiving chemotherapy or radiation therapy;
* Have a severe mental illness and cannot complete the trial.

Primary outcomes:
measure: Change in measured HbA1c from baseline to 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in measured HbA1c from baseline to 12 weeks
timeFrame: 12 weeks
measure: The percentages of participants with HbA1c less than 7.0% at 12 weeks
timeFrame: 12 weeks
measure: The percentages of participants with HbA1c less than 7.0% at 24 weeks
timeFrame: 24 weeks
measure: Change in weight from baseline to 24 weeks
timeFrame: 24 weeks
measure: The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT05484986: Nursing Students' Personality Traits and Competence in Workplace Violence Management
Official title: Relationship Between Nursing Students' Personality Traits and Competence in Workplace Violence Management in Turkey: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Violent Event
Nursing Student
Personality
Violence
Workplace Bullying
Keywords: exposure to violence
nursing student
personality
violence
workplace
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 321
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing students

Brief summary: Aim: The aim of this study was to determine the relationship between nursing students' personality traits and competence in workplace violence management.

Background: Violence against nursing students is a growing concern in nursing education, clinical practice, and professional development and needs to be managed.

Design: A cross-sectional study. Methods: This study was conducted with 321 nursing students in the summer of 2022.


Eligibility criteria: Inclusion Criteria:

* Being in the nursing students at the research university,
* Being in the \>18 years age,
* Agree to participate in the study

Exclusion Criteria:

* Being in the \<18 years age,
* Disagree to participate in the study

Primary outcomes:
measure: To determine nursing students' personality traits
timeFrame: 1 month
measure: To determine nursing students' competence in workplace violence management
timeFrame: 1 month
measure: To determine the relationship between nursing students' personality traits and competence in workplace violence management
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University
Study officials:
References:
Clinical trial NCT00268086: Constrictive Pericarditis in the Adult Congenital Cardiac Population
Official title: Constrictive Pericarditis in the Adult Congenital Cardiac Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: constrictive pericarditis
adult congenital patients
pulmonary insufficiency
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis

The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.

Detailed description: Constrictive pericarditis is a notoriously difficult diagnosis to reach. There are no signs, symptoms or pathognomonic diagnostic tests for pericardial constriction. In the adult congenital patients, it is also difficult. In addition, with pulmonary insufficiency, constrictive pericarditis may mask the findings of progressive right sided ventricular dilation and heart failure.

The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis

The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.

Study Design and Methodology:

Retrospective chart review - approximately 15 patients

Preoperative data:

ECHO and cath findings

Operative data:

Operative findings

Postoperative data:

ECHO and cath findings

Eligibility criteria: Inclusion Criteria:

* patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis

Exclusion Criteria:

* those who do not meet the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta
name: Brian E Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111786: Finger Hardness Measure in Scleroderma
Official title: Durometer Skin Assessment in Scleroderma: a Study to Validate This New Tool in the Digital Tufts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma
Keywords: scleroderma
skin
tightness
durometer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scleroderma and controls without tight skin attending our rheumatology clinic for a regularly schedualled visit

Brief summary: Thirty subjects with systemic sclerosis and 30 age and sex matched controls without any known condition that should cause increased skin hardness in the fingers with undergo examination by manual palpation and durometer measured hardness of their digital tuft skin by 2 observers on 2 separate occasions. There will be 1 hour between individual observer's scorings. Observers will be blinded from the observer's scores and from their previous scores. Results will be tabulated and compared for manual scores versus durometer measurements, intra-observer scores by both methods and inter-observer scores by both methods.

Detailed description: It is pretty straightforward. We will measure and record the hardness of the digital tufts on ten digits by palpation and the hardness in the same area by using a durometer. We will repeat this one hour later. Scores will be compared as a measure of how consistent and precise they are.

Eligibility criteria: Inclusion Criteria:

* Scleroderm
* Rheumatologic condition not effecting the skin tightness

Primary outcomes:
measure: Fingertip hardness in patients with scleroderma and controls: comparing manual assessment(scale0 - 3) with durometer assessment(scale 0- 100).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas Osborn, MD
role: PRINCIPAL_INVESTIGATOR
References: