louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00715585: Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
Official title: Addressing The Role of Nutrition Education & Health Literacy in Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
education
health literacy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: American Association of Diabetes Educators
First posted: 2008-07-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the impact of certified diabetes education, and the role of different educational approaches to medical nutrition therapy. in addition the role of patient health literacy level is assessed

Detailed description: 150 patients with type 2 diabetes with most recent a1c\>7% will be enrolled. patients are randomized to three arms: arm 1 includes 3 individualized visits with an rd-cde focused on a modified plate method for nutrition therapy, arm 2 includes 3 individualized visits with an rd-cde focused on carb counting for nutrition therapy, and arm 3 focuses on general diabetes education and health promotion. education sessions will be administered over a 4-6 week period. patients will be assessed at baseline, 3 and 6 month follow-up. primary outcome is a1c.

Eligibility criteria: Inclusion Criteria:

* Most recent a1c \>7
* Type 2 diabetes
* Receiving primary care
* Not currently in the diabetes improvement program
* No plans to refer to diabetes improvement program in the next 6 mos

Exclusion Criteria:

* Significant dementia or psychosis

Primary outcomes:
measure: A1C
timeFrame: 6 months
Secondary outcomes:
measure: self-efficacy
timeFrame: 3 and 6 months
measure: satisfaction
timeFrame: 3 and 6 months
measure: dietary behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Russell Rothman, MD MPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02735785: Adapting the HOPE Social Media Intervention to Reduce Prescription Drug Abuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Cancer Chronic Pain
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Harnessing Online Peer Education (HOPE) intervention combines social media with a psychology-based interventions to change behavior. This intervention is being applied to reduce prescription drug abuse among patients with chronic pain.


Eligibility criteria: Inclusion Criteria:

* (a) UCLA health system patient,
* (b) ≥ 18 years of age,
* (c) on chronic opioid therapy (\> 3 and \< 12 months) for chronic non-cancer pain as reported by their physician who referred them.

Exclusion Criteria:

° Does not satisfy inclusion criteria

Primary outcomes:
measure: Reduction in Current Opioid Misuse Measure (COMM) Score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
Clinical trial NCT00512785: Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
Official title: An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Imidafenacin
KRP-197/ONO-8025
overactive bladder
antimuscarinic
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kyorin Pharmaceutical Co.,Ltd
First posted: 2007-08-08
Enrollment: 435
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.


Eligibility criteria: Inclusion Criteria:

* Men and Woman equal or \> 20 years old
* Patients with urgency, urinary frequency and urgency incontinence

Exclusion Criteria:

* Patients with genuine stress incontinence
* Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
* Patients suffering from complications contraindicating the use of antimuscarinic medication
* Patients with polyuria

Primary outcomes:
measure: Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume
timeFrame: 64 weeks
Secondary outcomes:
measure: Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
Study officials:
affiliation: Kyorin Pharmaceutical Co.,Ltd
name: Yoshifumi Hirahara
role: STUDY_DIRECTOR
affiliation: Ono Pharmaceutical Co. Ltd
name: Toshihiko Konomi
role: STUDY_CHAIR
References:
Clinical trial NCT06842485: Effectiveness of Telerehabilitation for Work-Related Musculoskeletal Disorders in Cardiac Sonographers
Official title: Effectiveness of Telerehabilitation in the Management of Work-Related Musculoskeletal Disorders in Cardiac Sonographers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Work Related Musculoskeletal Disorders
Keywords: work related musculoskeletal disorders
cardiac sonographers
tele rehabilitation
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Work-related musculoskeletal disorders(WRMDs) are common among cardiac sonographers due to their nature of work. This study aims to find out the effectiveness of the telerehabilitation method in the management of WRMDs among cardiac sonographers. 38 cardiac sonographers diagnosed with WRMDs will be randomly allocated into experimental and control groups with an allocation ratio1:1. The Experimental group will be receiving the telerehabilitation program along with an ergonomic awareness education program for 6 weeks, and the control group will receive an ergonomic awareness education alone. Pain, quality of life and work satisfaction are the outcome measures which will be measured at the baseline and after 6 weeks of the program


Eligibility criteria: Inclusion Criteria:

* Cardiac sonographers with work-related musculoskeletal pain.
* Cardiac sonographers practicing adult echocardiography predominantly working in public hospitals, private hospitals or/and private outpatient clinics in Saudi Arabia.

Exclusion Criteria:

* Systematic diseases as reported by the participants such as Diabetes Miletus and Fibromyalgia.
* Using cardiac medications or the pain killer as reported by the participants.
* Any biomechanical abnormalities based on the evaluation of a qualified physical therapist.
* Any other musculoskeletal disorders or injuries which is not related to WRMDs.
* Any recent surgery which may affect the ability to participate in the exercise program.
* Any other contraindications to participate in the exercise program.
* Pregnancy in female participants.

Primary outcomes:
measure: Pain measured by Numeric Pain Rating Scale
timeFrame: baseline and immediately after 6 weeks of the program
measure: Quality of life measured by Short Form (36) Health Survey questionnaire
timeFrame: baseline and immediately after 6 weeks of the program
measure: Work satisfaction
timeFrame: baseline and immediately after 6 weeks of the program
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03751852: Body-Mind-Spirit Intervention for Women With Early Psychosis
Official title: Body-Mind-Spirit Intervention for Women With Early Psychosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-labelled randomised controlled trial (RCT) that aims to examine the effectiveness of exercise coaching approach in improving the physical activity engagement in patients with psychosis.

Detailed description: Patients with psychosis will be recruited from the out-patient department (OPD) of the Kwai Chung Hospital (KCH). The patient with informed consent will be randomly assigned to exercise coaching or psychoeducation group to prevent decline in cognitive and functional outcomes known to be common in this group. This comprises locally-tested evidence-based intervention strategies such as exercise and Yoga intervention, combined with exercise coaching to consolidate the exercise habit. Each of the intervention includes 28 sessions spanning for16-week.

Eligibility criteria: Inclusion Criteria:

* Female
* Age from 18-64
* Based on the Fifth version of the Diagnostic and Statistical Manual of Mental Disorders diagnosis to have schizophrenia and related psychotic disorders
* Have the ability to understand Chinese
* Able to give informed consent
* Physically fit for participating in our study assessed by using the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria:

* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders.
* Comorbid substance dependence
* Unstable psychotic symptoms
* Any history of brain trauma or organic brain disease
* Known history of intellectual disability or special school attendance
* Other mental conditions that requires other treatment priorities, e.g., suicidal risk.
* Other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.

Primary outcomes:
measure: Physical Activity Engagement
timeFrame: Change from baseline to 6-month post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Eric Yu Hai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03289052: Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Official title: A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Volyme for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midface Volume Deficit
Keywords: Hyaluronic acid, midface
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Men or women aged 18 years of age or older of Chinese origin
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
4. Subjects seeking augmentation therapy for the midface
5. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
2. Previous surgery or tattoo in the area to be treated
3. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
4. Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 9 months before treatment.
5. Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
6. Other condition preventing the subject from entering the study in the Investigator's opinion.

Primary outcomes:
measure: Percentage of Responders
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Q-Med AB
Study officials:
References:
Clinical trial NCT06697652: Readmission After Adrenalectomy
Official title: Early Readmission After Adrenalectomy for PHEO.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenalectomy
Keywords: adrenalectomy
hospital
risk factors
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-11-20
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pheo

Brief summary: to evaluate early hospital enterance after pheo surg.


Eligibility criteria: Inclusion Criteria:

* patients with pheo

Exclusion Criteria:

* non reactive
* missed data

Primary outcomes:
measure: readmission rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01173952: Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy
Official title: Prospective Evaluation of Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Vs. Radical Retropubic Prostatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Quality of Life
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with prostate cancer

Brief summary: This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

Detailed description: Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function

At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again.

All will be enrolled at Samsung Medical Center

Eligibility criteria: Inclusion Criteria:

* Pathologic diagnosis of prostate adenocarcinoma
* Clinical stage: AJCC (VI) stage T1-T2 N0M0
* Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy

Exclusion Criteria:

* Clinical Stage: T3, T4, nodal or distant metastasis
* All kind of neoadjuvant, concurrent and adjuvant treatment
* poor health forced a patient into dropout

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Urology Samsung Medical Center
name: Sung Won Lee, M.D.& Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02986152: Cancer Distress Coach Mobile App Trial
Official title: Cancer Distress Coach Mobile App Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Cancer
Keywords: PTSD
anxiety
depression
distress
fear
coping
support
caregiver
oncology
app
mobile app
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Institute for Health Innovation
First posted: 2016-12-08
Enrollment: 569
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 Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic stress disorder (PTSD) in cancer patients and caregivers. Based largely on "PTSD Coach" from the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms and is tailored specifically to individuals impacted by cancer.

This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a randomized controlled trial (RCT) where subjects are placed into either the intervention group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a free download on the App Store® and on Google Play™.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with cancer or are/were a caregiver to someone with cancer
* Resident of the United States of America
* Able to read and write English
* Age ≥ 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)
timeFrame: Baseline, Week 4, Week 8
Secondary outcomes:
measure: Change in distress level as measured by the Distress Thermometer
timeFrame: Baseline, Week 4, Week 8
measure: Change in stress management self-efficacy as measured by the Self-efficacy questionnaire
timeFrame: Baseline, Week 4, Week 8
Other outcomes:
measure: Feasibility as measured by satisfaction with the Cancer Distress Coach mobile app, as measured by the Feedback questionnaire
timeFrame: Week 4, Week 8
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Sophia K Smith, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351052: Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
Official title: A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-12
Enrollment: 184
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* Outpatients aged 2 to \< 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
* responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion Criteria:

* Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

Primary outcomes:
measure: Corticoid-sparing effect of pimecrolimus cream 1%
Secondary outcomes:
measure: atopic dermatitis control
measure: safety of pimecrolimus cream 1%
measure: quality of life
Other outcomes:
Locations:
city: Investigational Site
country: Germany
Study officials:
affiliation: Novartis
name: Novartis AG
role: STUDY_CHAIR
References:
Clinical trial NCT01515852: General Anesthesia vs. Local Anesthesia in Stereotaxy
Official title: General Anesthesia vs. Local Anesthesia in Stereotaxy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Lesion, Stereotactic Biopsy
Keywords: stress level
stereotactic biopsy
brain lesion
general anesthesia
local anesthesia
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Examination of stress level in general anesthesia in comparison to local anesthesia in stereotactic biopsy

Detailed description: Stereotactic biopsy is routinely performed under local or general anesthesia. The advantage of local anesthesia might be reduction in cardiac and pulmonal complications, reduction of surgical time, and reduction of hospital stay. On the other hand it has been postulated that intraoperative seizures are avoided by general anesthesia and that brain tumor surgery is perceived in the public as psychological and physical stress.Therefor we postulate that patients undergoing stereotactic biopsies in local anesthesia show a higher stress level than patients operated under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* planned stereotactic biopsy
* age \> 18 years

Exclusion Criteria:

* pregnancy
* anxiety disorder
* impaired consciousness

Primary outcomes:
measure: PTSS-10
timeFrame: Three days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Neurosurgery, Johann Wolfgang Goethe University
Study officials:
References: