louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00946582: The Therapeutic Effects of Barkley's Parenting Management Program for Taiwanese School-Aged Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Official title: The Therapeutic Effects of Barkley's Parenting Management Program for Taiwanese School-aged Children With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: parenting management program
ADHD
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the therapeutic effects of Barkley's parenting management program for Taiwanese school-aged children with ADHD. The investigators hypothesized that Barkley's parenting management program might empower the parents' competence to manage their school-aged children's ADHD-related disturbing behaviors as its previously-proven effects for parents and their preschool-aged children with ADHD.

Detailed description: Participants will be recruited from the child psychiatric clinics of NTUH-Yunlin branch and will include 30 school children with ADHD, their parents and teachers. The Kiddie-Schedule for Affective Disorders and Schizophrenia-epidemiology version will be adopted to confirm the diagnosis of ADHD. The child participants will received assessments of the Conner's Continuous Performance Test, and the Wechsler Intelligence Scale for Children-4th edition. We use ADHD symptoms, children't wellbeing, parent-child relationship, parent's competence and parenting stress as the outcome indices of therapeutic effects.Research instruments employed include CBCL, SNAP-IV, Parental Bonding Instrument, The Family Adaptability and Cohesion Evaluation Scale, Chinese Health Questionnaire, Parenting Stress Index, Short Form, Multidimensional student's life satisfaction scale and Nowicki-Strickland Locus of Control Scale for Children.

Eligibility criteria: Inclusion Criteria:

* Parents of 7-12 year-old aged children with ADHD and overall normal intelligence

Exclusion Criteria:

* Parents of children with comorbid autism spectrum disorders

Primary outcomes:
measure: SNAP-IV
timeFrame: pretest, before session 4, before session 8, posttest, 3 months after the program finished
Secondary outcomes:
measure: Parenting Stress Index, Short Form
timeFrame: pretest, posttest, 3 months after the program finished
Other outcomes:
Locations:
city: Douliou City
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
state: Yunlin County
Study officials:
affiliation: Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch
name: Shu-Tsen Liu, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04295382: Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts
Official title: An Open-Label, Study of the Feasibility and the Usability of a Software Application to Deliver Targeted Interactive Exercises, in Addition to Treatment as Usual, to Patients Recently Hospitalized for Suicidal Ideation or Suicide Attempts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Lead sponsor: Oui Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 15
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: DEVICE_FEASIBILITY

Brief summary: The primary objective of this feasibility study is to assess the feasibility, and usability of a software application to deliver targeted interactive exercises to patients recently hospitalized for suicidal ideation or suicide attempts.


Eligibility criteria: Inclusion Criteria:

* English speaking male or female patients, 18-70 years
* Patients who have attempted suicide and voluntarily admitted themselves to an inpatient psychiatric unit or have clinically significant suicidal ideation and intent to harm themselves and are still on the inpatient psychiatric unit.
* Understand written and spoken English
* Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
* Willing and able to complete enrollment procedures
* Able to understand the nature of the study and provide written informed consent
* Able and willing to provide at least two verifiable contacts for emergency or tracking purposes.

Exclusion Criteria:

* Patients with active psychosis
* Patients who are acutely intoxicated at the time of enrollment
* Currently enrolled in other treatment studies for the symptoms and behaviors targeted
* Patients who are cognitively impaired
* Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit (e.g. critically ill patients) profile with respect to the software application that delivers interactive exercises.

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: 16 weeks
measure: User Feedback Interview Questions
timeFrame: 16 weeks
Secondary outcomes:
measure: Suicidal ideation
timeFrame: 16 weeks
measure: Suicide attempts and other behaviors
timeFrame: 16 weeks
measure: Diagnostic interview
timeFrame: 1 week
measure: Adverse events
timeFrame: 16 weeks
measure: Depressive symptoms
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Sam Wilkinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04284982: Periodized Resistance Training for Persistent Non-specific Low Back Pain
Official title: Periodized Resistance Training for Persistent Non-specific Low Back Pain: A Mixed Methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Exercise therapy
Resistance training
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the feasibility is investigated of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain.


Eligibility criteria: Inclusion Criteria:

* persistent non-specific low back pain with a duration \>3 months
* average low back pain intensity last two weeks \>= 4 on numerical pain rating scale (0-10 scale)
* no experience with heavy resistance training.

Exclusion Criteria:

* previous surgery of the low back
* radiculopathy
* structural spinal changes and/or specific spinal conditions that limit function (spinal stenosis, ankylosing spondylitis, spondylolisthesis/spondylolysis, protrusion, structural scoliosis)
* autoimmune and systemic inflammatory diseases
* cardiovascular disease
* neurological diseases
* severe osteoporosis.

Primary outcomes:
measure: Low back pain intensity on 0-10 Numerical Pain Rating Scale
timeFrame: 8 weeks
measure: Low back pain intensity on 0-10 Numerical Pain Rating Scale
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
Study officials:
affiliation: Dept Neuromedicine and Movement Science, Fac MH, NTNU
name: Jorunn Helbostad, prof
role: STUDY_DIRECTOR
References:
citation: Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.
Clinical trial NCT04911582: Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Acute Substudy)
Official title: Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? Acute and Longer-term Metabolic Effects of Cafestol. (Acute Substudy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2021-06-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.

Detailed description: The study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with abdominal obesity at high risk of developing T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6 or 12mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 2 hours blood samples are collected at time points 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the different dosage of cafestol or placebo. The process is repeated for three weeks until every subject has undergone both interventions and the placebo.

Eligibility criteria: Inclusion Criteria:

25 \< BMI \< 40 kg/m2 Waist circumference \> 102 cm (men) / 88 cm (women)

Exclusion Criteria:

* Type 2 diabetes (HbA1c \> 48 mmol/mol) or in treatment with antidiabetic drugs
* Pregnancy
* Planned pregnancy
* Breastfeeding
* Significant comorbidity expected to unable the subject from completing visits

Primary outcomes:
measure: Area under the curve for glucose
timeFrame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Secondary outcomes:
measure: Area under the curve for insulin-response
timeFrame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
measure: Area under the curve for cafestol
timeFrame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
measure: Area under the curve for GLP-1 (glucagon-like peptide-1)
timeFrame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
measure: Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide)
timeFrame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Steno Diabetes Center Aarhus
state: Aarhus N
Study officials:
References:
Clinical trial NCT05639582: Fractal Analysis Method in Periodontal Disease
Official title: Evaluation of Trabecular Bone Changes in Individuals With Periodontal Disease Using Fractal Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Digital Radiography
Fractal Analysis
Periodontitis
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the effects of periodontal disease on alveolar bone were investigated using fractal analysis method.

Detailed description: Background: It is very difficult to objectively evaluate the negative changes in bone structure due to periodontitis. The present study was aimed to evaluate the trabecular bone changes between healthy individuals and periodontitis patients by fractal dimension analysis on digital panoramic radiographs.

Method: The study included 50 periodontally healthy individuals (control group), 50 individuals with Stage 1 periodontitis (S1-P group), 50 individuals with Stage 2 periodontitis (S2-P), and 50 individuals with Stage 3 periodontitis (S3-P), a total of 200 individuals were included. The fractal dimension (FD) value of the trabecular bone in the interproximal space between mandibular first molar and second premolar tooth roots was evaluated using Image J program. The mean fractal dimension values of the two regions were calculated by box counting method.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Getting a diagnosis of stage 1,2 and 3 periodontitis
* Be diagnosed as periodontally healthy
* Have no barriers to obtaining radiographs
* Not having any systemic disease that may affect periodontal status
* Not smoking and alcohol use
* Volunteer to participate in the study

Exclusion Criteria:

* Those who use drugs that can affect bone metabolism
* Radiographs with poor diagnostic quality
* Root canal treatment or teeth with periapical lesions in the area of interest
* Individuals who have suffered a fracture or trauma that affects the anatomy or integrity

Primary outcomes:
measure: Evaluation of the effect of periodontal disease on alveolar bone by fractal analysis
timeFrame: baseline
Secondary outcomes:
measure: Probing pocket depth
timeFrame: baseline
measure: gingival index
timeFrame: baseline
measure: plaque index
timeFrame: baseline
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References:
Clinical trial NCT05985382: Comparing the Effects of Upper and Lower Body Resistance Training on Pain Sensitivity
Official title: Comparing the Effects of Upper and Lower Body Resistance Training on Pain Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Resistance exercise may immediately lessen the perception of pain. The purpose of this study is compare the effects of an upper body exercise to a lower body exercise on the perception of pain (pressure pain threshold).


Eligibility criteria: Inclusion Criteria:

* pain free

Exclusion Criteria:

* non-English speaking
* regular use of prescription pain medications
* current or history of chronic pain condition
* currently taking blood-thinning medication
* any blood clotting disorder
* medical conditions known to affect sensation, such as: uncontrolled diabetes or neurological conditions
* any contraindication to the application of ice, including: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* surgery, injury, or fracture within the past 6 months
* unable to perform exercise portions of the study
* unable to attend three sessions
* pregnant

Primary outcomes:
measure: Lower Body Resistance Exercise
timeFrame: Pressure pain threshold will be applied to the quadriceps immediately after each exercise.
Secondary outcomes:
measure: Heat Pain Threshold
timeFrame: Heat Pain Threshold will be applied over the quadriceps before and after the exercise.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Abigail Wilson, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06098482: An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Official title: A Prospective, Repeated-measures Investigation to Validate Digital Speech Perception Endpoints in Adult Cochlear Implant Recipients Using the Mobile Research App: a Master Umbrella Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older.
* Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s).
* Fluent speaker in the language used to assess clinical performance as judged by the investigator.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
* Women who are pregnant.

Primary outcomes:
measure: Percent correct performance for the test and retest runs of speech perception ability
timeFrame: 1 day - immediately post screening.
Secondary outcomes:
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Denver Research and Technology Labs
state: Colorado
city: Melbourne
country: Australia
facility: HEARnet Clinical Studies
state: Victoria
city: Wommelgem
country: Belgium
facility: Hoorzorg van Looveren
state: Antwerp
city: Antwerp
country: Belgium
facility: European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp
Study officials:
References:
Clinical trial NCT06332482: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration
Official title: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration :occlusal Accuracy of Different Techniques Used to Record Maxillo-mandibular Relationship(Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year
Primary purpose: TREATMENT

Brief summary: This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration.


Eligibility criteria: Inclusion Criteria:

* • Inclusion criteria: i- complete maxillary and mandibular edentulous arches ii- residual alveolar ridges covered with healthy firmly attached mucosa. iii- Angel's class I maxillo-mandibular relationship and iv- Adequate bone height and width for placement of standard diameter implants.

Exclusion Criteria:

* History of drug administration that interfere with bone quality ii- Surgical contraindication (patients under anticoagulant ,immunosuppressive drugs, chemotherapy and irradiation therapy) iv- tempromandibular or myoneurological disorders.

Primary outcomes:
measure: measurement of occlusal prematurity
timeFrame: one year
measure: prosthestic complications
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University ,Faculty of dentistry
Study officials:
References:
Clinical trial NCT05912582: Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Stage IVa Nasopharyngeal Carcinoma
Official title: Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Stage IVa Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stage IVA Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Biomarker
Spatial Transcriptomics
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma

Brief summary: This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in stage IVa nasopharyngeal carcinoma.

Detailed description: Primary endpoint: Evaluation of the major pathological response of stage IVa nasopharyngeal carcinoma patients.

Secondary endpoint: Evaluation of failure-free survival and overall survival of stage IVa nasopharyngeal carcinoma patients.

Outline: This is a prospective observational study. Patients of stage IVa nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression. The samples are analyzed for biomarkers and spatial transcriptomics. The biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).

The analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in stage IVa nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help in precision medicine of stage IVa nasopharyngeal carcinoma.

Eligibility criteria: Inclusion Criteria:

1. Patients with newly histologically confirmed stage IVa nasopharyngeal carcinoma
2. No evidence of distant metastasis (M0)
3. Written informed consent

Exclusion Criteria:

Treatment with palliative intent

Primary outcomes:
measure: major pathological response
timeFrame: 3 months after radiation therapy
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 2 years after radiation therapy
measure: Overall Survival
timeFrame: 2 years after radiation therapy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
Study officials:
References: