louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01717365: Psychometric / Validation Study
Official title: SCOPE: A Psychometric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Determine the Psychometric Properties of the Short Child Occupational Profile
Keywords: SCOPE
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 499
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity.

Brief summary: Data for the study will be collected from therapist across the world. The therapists will share data they have already compiled from their caseload. Data will be stripped of all personal identifiers and personal health information. The TWU SCOPE research team has no contact with clients whose assessment data is being shared for secondary analysis or clinical data repository. For educational and training purposes clients can be videotaped by the therapist who will obtain consent and/or assent from the client. Not every client will be videotaped. The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity. The total amount of data collected from all participating therapists will be 500 pieces.

Detailed description: Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who wish to participate will send a data sharing letter to the PI of the study. Once the TWU SCOPE research team has received the data sharing letter, a clinical data packet will then be distributed to the therapist through the U.S. mail or an email will be sent containing a web address link to http://www.myweb.twu.edu/\~ttioseco for access to the clinical data packet via the internet. Those therapists who collect ten pieces or more of de-identified data and send them to the TWU SCOPE research team will receive an incentive in the form of a gift card.

Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank (new de-identified data input) → data analysis (analysis of new and old de-identified data) → publication/presentation

No risks are involved because data collected is without any personal identifiers.

Eligibility criteria: Inclusion Criteria:

Subjects receiving therapy from participating therapists.

Exclusion Criteria:

Age over 21.

Primary outcomes:
measure: To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
References:
Clinical trial NCT05612165: Effectiveness and Safety of tDCS for Pain
Official title: Effectiveness and Safety of Transcranial Direct Current Stimulation for Pain Changes in Patients With Central Post-Stroke Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the effectiveness and safety of transcranial direct current stimulation in patients with central post-stroke pain.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 to 90 years old
2. Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis
3. A person whose stroke lesions are cortex or subcortex
4. A person who satisfies 'Mandatory criteria'
5. Those with cognitive ability to understand and follow the researcher's instructions
6. Those who voluntarily agree to participate in this clinical trial and signed the agreement

Exclusion Criteria:

1. Those who have a fracture or have undergone orthopedic surgery
2. In case of accompanying serious neurological diseases
3. In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
4. Those with complex part pain syndrome by Budapest Criteria
5. If there is a cause of other pain in the relevant area, such as peripheral nerve damage
6. Persons included in the exclusion of transcranial direct current stimulation
7. If the researcher is judged to be judged that the participation in this study is not appropriate

Primary outcomes:
measure: Change of pain score in Brief Pain Inventory(BPI)
timeFrame: Baseline, after 2 weeks(after the end of intervention)
Secondary outcomes:
measure: Change of pain score in Neuropathic Pain Scale(NPS)
timeFrame: Baseline, after 2 weeks(after the end of intervention)
measure: Change of depression score in Beck Depression Inventory-II(BDI-II)
timeFrame: Baseline, after 2 weeks(after the end of intervention)
measure: Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)
timeFrame: Baseline, after 2 weeks(after the end of intervention)
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
References:
Clinical trial NCT05604365: FearLess in Cognitively Intact Patients With Glioma
Official title: FearLess in Cognitively Intact Patients With Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioma
Fear of Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will assess the preliminary feasibility and acceptability of FearLess, a newly-developed psychological intervention for fear of cancer recurrence (FCR) among cognitively-intact patients with glioma.


Eligibility criteria: Inclusion Criteria:

Patient inclusion:

* Confirmed glioma diagnosis (grade II-IV) via histopathology
* Be a minimum of 2 weeks post surgical repair or biopsy (if applicable)
* Elevated FCR \[\> 13 on Fear of Cancer Recurrence Inventory\]
* Primarily English speaking

Caregiver Inclusion:

* Loved one, or non-paid care partner to a patient with a confirmed glioma diagnosis (grade II-IV) via histopathology
* Elevated FCR \[\> 13 on Fear of Cancer Recurrence Inventory\]
* Primarily English speaking
* Age 18+

Exclusion Criteria:

Patient:

* Cognitive impairment \[\< or equal to 31 on the Telephone Interview for Cognitive Status (TICS)\]
* Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
* Inability to understand and provide informed consent.

Caregiver:

* Inability to attend virtual sessions (e.g. due to lack of stable internet connection, difficulty using technology)
* Inability to understand and provide informed consent.

Primary outcomes:
measure: Determine feasibility of FearLess recruitment
timeFrame: 1 Day
measure: Determine the feasibility of FearLess intervention- Data collection procedures
timeFrame: 12 Weeks
measure: Determine the acceptability of FearLess intervention- Attendance
timeFrame: 12 Weeks
measure: Determine the acceptability of FearLess intervention- Retention Rate
timeFrame: 12 Weeks
measure: Determine the acceptability of FearLess intervention- Satisfaction
timeFrame: 12 Weeks
measure: Determine the acceptability of FearLess intervention- Satisfaction- Recommendation
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
measure: Determine the efficacy of FearLess intervention- Baseline to post intervention - fear scale
timeFrame: 12 Weeks
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee Loughan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06371365: Adverse Events for Free Flap Surgery in Head and Neck Cancer
Official title: Prescription Pattern and Adverse Events of Postoperative Antithrombotic Regimes for Free Flap Surgery in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Flaps
Flap Failure Risk Factors
Hematoma Risk Factors
Thrombosis Risk Factors
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University Chung-Ho Memorial Hospital
First posted: 2024-04-17
Enrollment: 540
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient greater than or equal to 20 years old who had free flap surgery following cancer ablation for head and neck cancer.

Brief summary: This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022.

Detailed description: Patient information are collected from the electronic medical records retrospectively:

Head and Neck cancer diagnosis: The International Classification of Diseases, Tenth Revision (ICD-10), which included C00-C14, C31, C32, C73, C75.0, C75.4 and C41.1.

The cancer stage, alcohol use, betel nut, and smoking, and baseline comorbidities.

Surgical characteristics including flap history, ablation time, reconstruction time, donor sites, recipient sites, neck dissection, flap size, anastomosis, artery types, vein types, intraoperative sealants used, and intravenous calcium channel blocker nicardipine to control hypertension after surgery.

Eligibility criteria: Inclusion Criteria:

* Age greater and equal to 20 years old
* Underwent free flap surgery
* Had head and neck cancer

Exclusion Criteria:

* HIV positive
* Pregnant, breast feeing women
* Missing surgical charts

Primary outcomes:
measure: Number of participants with flap failure
timeFrame: 30 days post-operation
Secondary outcomes:
measure: Number of participants with hematoma
timeFrame: 30 days post-operation
measure: Number of participants with thrombosis
timeFrame: 30 days post-operation
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Ying-Chi Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687865: Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)
Official title: Biological Material Bank for Studies Related to Organ Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Organ Transplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients that received a solid organ transplant at the transplantation department of Lyon University Hospital

Brief summary: This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :

i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)


Eligibility criteria: Inclusion Criteria:

* Male or Female patient ≥18 years old
* Recipient of an organ transplant
* Written informed consent

Exclusion Criteria:

* Non-affiliation to a social security system.
* Subjects deprived of liberties
* Pregnant or breastfeeding woman

Primary outcomes:
measure: the biological samples
timeFrame: At inclusion
measure: Change Biological Samples
timeFrame: Month 1
measure: Change Biological Samples
timeFrame: Month 3
measure: Change Biological Samples
timeFrame: Month 6
measure: Change Biological Samples
timeFrame: Month 12
measure: Change Biological Samples
timeFrame: Month 60
measure: Change Biological Samples
timeFrame: Month 120
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
state: Rhône
Study officials:
affiliation: Edouard Herriot Hospital - Transplantation department
name: Olivier Thaunat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203565: Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy
Official title: Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Skin Reactions Secondary to Radiation Therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's solution may help reduce dermatitis caused by radiation therapy.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for breast cancer compared to historical experience using standard skin care.

SECONDARY OBJECTIVES:

I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's solution), and to assess levels of pain during radiotherapy treatment.

OUTLINE:

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

After completion of study treatment, patients are followed up at 4-6 weeks.

Eligibility criteria: Inclusion Criteria:

* Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Women with scleroderma or discoid lupus
* Women with inflammatory breast cancer as evidenced by clinical assessment
* Women with breast cancer involving the skin
* Women who have undergone prior radiotherapy to the chest wall and/or breast

Primary outcomes:
measure: Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy
timeFrame: Baseline to up to 6 weeks after completion of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Kathleen Horst
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06155565: Understanding Patient Engagement Trends in Anxiety Disorder Clinical Research
Official title: Investigating Patterns in Enrollment and Engagement Among Individuals Coping With Anxiety Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anxiety Disorder
Keywords: anxiety disorder
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with anxiety disorder who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials, specifically focused on anxiety disorder, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosis of anxiety disorder
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Number of anxiety disorder patients who decide to enroll in a clinical research
timeFrame: 3 months
measure: Rate of anxiety disorder patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Szuhany KL, Simon NM. Anxiety Disorders: A Review. JAMA. 2022 Dec 27;328(24):2431-2445. doi: 10.1001/jama.2022.22744.
citation: Yee A, Ng CG, Seng LH. Vortioxetine Treatment for Anxiety Disorder: A Meta-Analysis Study. Curr Drug Targets. 2018;19(12):1412-1423. doi: 10.2174/1389450118666171117131151.
citation: Liao J, Kang J, Li F, Li Q, Wang J, Tang Q, Mao N, Li S, Xie X. A cross-sectional study on the association of anxiety and depression with the disease activity of systemic lupus erythematosus. BMC Psychiatry. 2022 Sep 5;22(1):591. doi: 10.1186/s12888-022-04236-z.
Clinical trial NCT00946465: To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions
Official title: A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cetero Research, San Antonio
name: Steven Herrmann, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264965: Non-cancer Pain and Cognitive Impairment: A Disabling Relationship
Official title: Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthritis
Pain
Cognitive Impairment
Keywords: Pain
Analgesia
Cognitive impairment
Randomized controlled trial
Physical function
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.


Eligibility criteria: Inclusion Criteria:

1. age over 65
2. Pain at least 3 months duration
3. Pain greater in lower extremity than other anatomical site with ambulation
4. Pain self-report of moderate intensity of higher on an average day
5. Community-dwelling
6. Ambulatory
7. Physician states participants have decision-making capacity to enroll into the trial
8. Participants with cognitive impairment have a reliable caregiver
9. Inadequate pain relief from NSAIDS and/or acetaminophen in the past

Exclusion Criteria:

1. Current cancer requiring chemotherapy
2. History of addiction to opioids or other controlled substance
3. Consumes more than 2 alcoholic drinks a day
4. Severe balance disturbance
5. Intra-articular steroid injection in the past 6 weeks

Primary outcomes:
measure: Pain Self-report on the Brief Pain Inventory and WOMAC
timeFrame: 14 days
Secondary outcomes:
measure: Discontinuation of Study Drug, Short Physical Performance Battery
timeFrame: 14 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center Outpatient Senior Health Center South Shore
state: Illinois
Study officials:
References: