louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04213742: Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury
Official title: Study on the Application of Gratitude Intervention in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients ； Spinal Cord Injury
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 400
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: SUPPORTIVE_CARE

Brief summary: To analyze the present situation and influencing factors of gratitude level and quality of life of patients with spinal cord injury, and to explore the methods of Thanksgiving intervention for patients with spinal cord injury so as to provide scientific basis for improving the quality of life of patients with spinal cord injury.

Investigation and research design and experimental research design

Detailed description: Effectiveness evaluation indicators: (1) main efficacy indicators: gratitude level scale (C-GQ-6) score, quality of life scale (WHOQOL-BREF) score; (2) secondary efficacy index: positive psychological capital scale (PPQ) score; trait coping style (TCSQ) score, perceived social support scale (PSSS) score.

Inclusion criteria: accorded with the 6th edition of neurological classification of spinal cord injury issued by the American Spinal Cord injury Society, and confirmed by CT or MRI imaging; sequelae such as limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study; Exclusion criteria: spinal cord injury caused by non-trauma (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those who were diagnosed with mental disorders; unwilling to participate in this researcher;

Eligibility criteria: Inclusion Criteria:

* Conformed to the 6th edition of neurological classification of spinal cord injury issued by the American Spinal Cord injury Society, and confirmed by CT or MRI imaging; sequelae such as different degrees of limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from the hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study;

Exclusion Criteria:

* Non-traumatic spinal cord injury (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those with definite diagnosis of mental disorders; unwilling to participate in this researcher;

Primary outcomes:
measure: Gratitude scale (GQ-6) ；
timeFrame: 5 minutes
measure: Quality of life scale (WHOQOL-BREF) ；
timeFrame: 5 minutes
measure: Positive psychological capital scale (PPQ)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: 第四军医大学
state: 陕西省
Study officials:
References:
Clinical trial NCT06105242: Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)
Official title: Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CTEPH
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with right ventricular failure

Brief summary: 1. To identify biological sex differences in baseline RV function in CTEPH
2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH
3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Detailed description: Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).

Eligibility criteria: Inclusion criteria

* Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42
* Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis
* Subject must have a right heart catheterization (RHC) at the time of diagnosis
* To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis

Exclusion criteria

* Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center
* Any subjects \<18 years of age
* Patients diagnosed during pregnancy
* Patients without a TTE and RHC at time of diagnosis

Primary outcomes:
measure: Biosphere
timeFrame: 1 year
measure: Biopshere
timeFrame: 1 year
measure: Biosphere
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References:
Clinical trial NCT02218242: Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
Official title: A Single-arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung
Cancer
Ultrasound
Staging
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph node dissection. After completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes in non-small cell lung cancer patients undergoing definitive surgical resection.


Eligibility criteria: Inclusion Criteria:

Age ≥18 years. Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%, see Appendix A).

Life expectancy of greater than 3 months

Patients be able to undergo VATS resection as defined below:

* Preoperative Forced Expiratory Volume at one second ≥ 40% predicted
* OR
* Post-operative predicted Forced Expiratory Volume at one second ≥ 0.8 l
* Hg ≥ 8.0
* No evidence of coronary ischemia on stress evaluation Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with surgery for a prior ipsilateral lung cancer

Patients with known brain metastases

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. (Patients with HIV are not excluded from this study)

Primary outcomes:
measure: Detection of Occult Pathologic N2 Lymph Nodes
timeFrame: At time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Joel Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880042: COMPARISON of EFFICACY and SAFETY of NARROWBAND UVB with 0.1% TACROLIMUS VS NARROWBAND UVB with 0.005% CALCIPOTRIOL in TREATMENT of VITILIGO
Official title: COMPARISON of EFFICACY and SAFETY of NARROWBAND UVB with 0.1% TACROLIMUS VS NARROWBAND UVB with 0.005% CALCIPOTRIOL in TREATMENT of VITILIGO
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Vitiligo - Macular Depigmentation
Tacrolimus
Keywords: Vitiligo
Lead sponsor: Lahore General Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed

Detailed description: Evaulation of efficacy and safety of narrowband uvb and tacrolimus and NBUVB and calcipotriol in patient if stable vitiligo with body surface area less than 20% It will be assessed by VASI score and VIisual analogie scale

Eligibility criteria: Inclusion Criteria:

- Localized vitiligo Age 15 to 70years Body surface upto 20% Stable more than 3 months

Exclusion Criteria:

* • Pregnant or lactating female patients.

  * Skin malignancy or any other malignant skin condition.
  * Photo induced or photo aggravated dermatosis like (SLE, photodermatitis, rosacea, psoriasis, pemphigus vulgaris) along with vitiligo.
  * Prior history of allergy to tacrolimus or calcipotriol.
  * Other form of treatment for vitiligo within at least 1 month.

Primary outcomes:
measure: VASI improvement upto 50%
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03310242: Comparison of Sunlight Exposure and Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels
Official title: Comparison of Sunlight Exposure and Oral Vitamin D Supplementation on Serum 25-hydroxyvitamin D Concentration and Metabolic Markers in Korean Young Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Cardiometabolic Risk Factors
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the effects between sunlight exposure and oral vitamin D supplementation on serum 25-hydroxyvitamin D concentration and metabolic markers in Korean young adults.


Eligibility criteria: Inclusion Criteria:

* Serum 25(OH)vitamin D \< 12ng/mL
* age between 18 and 39 years
* Korean men and women

Exclusion Criteria:

* Vitamin D supplementation within 2 months
* Photosensitivity or UV allergy
* History of hyperparathyroidism/hypercalciuria/kidney stone/skin cancer and other cancer
* Under medication for hypertension, dyslipidemia, and diabetes
* Intake of photosensitive medicine during study period
* Exposure of strong UV (e.g., beach, sun tanning) during study period
* Pregnant/breast-feeding women

Primary outcomes:
measure: Serum 25(OH)D
timeFrame: Baseline, 4 week, and 8 week
Secondary outcomes:
measure: BMI
timeFrame: Baseline, 4 week, and 8 week
measure: Systolic blood pressure
timeFrame: Baseline, 4 week, and 8 week
measure: Diastolic blood pressure
timeFrame: Baseline, 4 week, and 8 week
measure: Lipid panel
timeFrame: Baseline and 8 week
measure: Fasting glucose
timeFrame: Baseline and 8 week
measure: AST
timeFrame: Baseline and 8 week
measure: ALT
timeFrame: Baseline and 8 week
measure: GGT
timeFrame: Baseline and 8 week
measure: Intact PTH
timeFrame: Baseline and 8 week
measure: Whole body BMD and BMC
timeFrame: Baseline and 8 week
measure: Lean body mass, fat mass, and percent fat
timeFrame: Baseline and 8 week
measure: Lean body mass, muscle mass, skeletal muscle mass, fat mass, and percent fat
timeFrame: Baseline, 4 week, and 8 week
measure: EQ-5D-5L
timeFrame: Baseline, 4 week, and 8 week
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University College of Medicine/Seoul National University Hospital
name: Hee-Kyung Joh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joh HK, Hwang SS, Cho B, Lim CS, Jung SE. Effect of sun exposure versus oral vitamin D supplementation on serum 25-hydroxyvitamin D concentrations in young adults: A randomized clinical trial. Clin Nutr. 2020 Mar;39(3):727-736. doi: 10.1016/j.clnu.2019.03.021. Epub 2019 Mar 21.
Clinical trial NCT00572442: Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial
Official title: Magnetocardiography (MCG) in Asymptomatic Individuals - Pilot Trial
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: Non-invasive heart scan
MCG
Cardiac Risk Factors
healthy volunteers
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: CardioMag Imaging
First posted: 2007-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals without symptoms or history of heart disease

Brief summary: The purpose of this research study is to perform serial magnetocardiographs (MCG)and cardiovascular risk factor assessments on individuals with no symptoms or history of heart disease. This small sized study of MCG in healthy individuals will allow for data collection for power analysis for a larger prospective trial.

Volunteers are not compensated or paid.

Detailed description: The Magnetocardiography (MCG) has been approved by the U.S Food and Drug Administration (FDA) as a tool to measure the heart's magnetic field.However, it is not yet approved for the specific diagnosis of coronary artery disease.

The MCG scan is entirely non-invasive, rapid and no risk, since it does not require stress provocation, radiation, or use of medication or contrast.

In this study, the MCG will be used to compare the scans of normal, healthy volunteers to those which have been previously or are currently being collected in subjects with known heart disease.

Eligibility criteria: Inclusion Criteria:

* Subjects without chest pain and known heart diseases.
* Subjects \> or = 18 years of age.

Exclusion Criteria:

* Heart disease patients
* Patients with chest pain
* Subjects with magnetic metal fragments in the head or torso
* Subjects unable to consent
* Minors \< 18 years of age
* Subjects unable to lie flat for the examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Kirsten Tolstrup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00499642: Study Evaluating the Effect of Lecozotan SR on the QTc Interval
Official title: A Single-Dose, Double-Blind, Crossover, Placebo- and Moxifloxacin (Open-Label)-Controlled Study of the Effects of Lecozotan SR on Cardiac Repolarization in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Healthy
Keywords: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.


Eligibility criteria: Inclusion Criteria:

* Women and men aged 18 to 55 years inclusive.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of any clinically important drug allergy.
* Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).

Primary outcomes:
measure: To assess the effect of drug administration on QTc interval.
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
city: Rueil-Malmaison
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For France: infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160442: Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
Official title: Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Lead sponsor: Carevive Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared decision-making (SDM) model that employs an "encounter tool"1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.

Detailed description: This project is a single-arm pilot project conducted with 90 patients with newly diagnosed or recurrent DLBCL or FL and their providers at three medical oncology practices. Utilizing the PPSDM tool in the Carevive electronic platform, patients will report their needs, preferences, values and goal prior to the treatment decision-making focused clinical encounter. The treating provider will receive the patient results prior to the visit and can use these to facilitate SDM in treatment selection during the clinical encounter. Post-encounter, patients and providers will complete measures designed to assess feasibility and utility of SDM intervention. Patients will also complete measures to assess patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making and satisfaction with care.

Eligibility criteria: Inclusion Criteria:

* All participants must be 18 years of age or older.
* Patient participants must have a diagnosis of new or recurrent DLBCL or FL
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Primary outcomes:
measure: Satisfaction of using the Carevive treatment planning system in shared decision making will be collected from both patient and provider perspectives: questionnaires
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of patient satisfaction and perceived shared decision making utilizing surveys at each clinic visit
timeFrame: 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
affiliation: Carevive Systems, Inc.
name: Debbie Wujcik, PhD,RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05512442: Comparison of the Centric Relation Recorded by Two Methods Using Cone Beam Computed Tomography
Official title: Comparison of the Centric Relation Recorded by the Gothic Arch Methods and the Neuromuscular Method Using Cone Beam Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Cone-Beam computed tomography
the centric relation
the upper airway
mandibular position
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate and compare the variation in mandibular relation recorded by the gothic arch methods and the K7 method using cone beam computed tomography (CBCT)

Detailed description: ten asymptomatic participants were selected,the centric relation registrations were separately recorded according to the technique of the gothic arch method and the neuromuscular method,subsequent, they were instructed to perform CBCT wearing two bite registrations,thus using dophin software to calculate the tmj space and the upper airway and using exocad software to ananyse the mandibular position, Data were analysed with paired t-test

Eligibility criteria: Inclusion Criteria:

absence of the mandibular position Classified as ASA 1 or 2 (normal healthy patient or with mild systemic disease, according to the American Society of Anaesthesiologists Physical Status Classification System); Absence of the symptoms and signs of the temporomandibular joint; Willing to participate and to sign a written informed consent form.

Exclusion Criteria:

Cardiac pacemaker carriers and pregnant women; people with heart pace disorders and epilepsy; Temporomandibular or craniocervical disorders.

Primary outcomes:
measure: the temporomandibular joint space
timeFrame: immediately
Secondary outcomes:
measure: the upper airway
timeFrame: immediately
Other outcomes:
measure: the mandibular position
timeFrame: immediately
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University
state: Fujian
Study officials:
affiliation: Fujian Medical University
name: Hao Yu
role: PRINCIPAL_INVESTIGATOR
References: