louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04200976: Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)
Official title: Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Posttraumatic Stress Disorder
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2019-12-16
Enrollment: 94
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: Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction.

The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.


Eligibility criteria: Inclusion Criteria:

* Veterans
* Active Duty Service Members
* History of TBI (confirmed by TBI interview)
* Self-reported cognitive complaints (as indicated on the NSI)
* Able to communicate by telephone

Exclusion Criteria:

* Active suicidal intent
* History of bipolar disorder
* History of psychotic disorder
* Decisionally impaired
* Non-English speaking

Primary outcomes:
measure: Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest
timeFrame: Baseline; 12 weeks; and 6 months after baseline
measure: Change in the Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline; 12 weeks; and 6 months after baseline
measure: Change in the Satisfaction with Life Scale (SWLS)
timeFrame: Baseline; 12 weeks; and 6 months after baseline
Secondary outcomes:
measure: Change in the PTSD Checklist-5 (PCL 5)
timeFrame: Baseline; after 12 weeks; and 6 months after baseline
measure: Change in the Memory Compensation Questionnaire (MCQ)
timeFrame: Baseline; after 12 weeks; and 6 months after baseline
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
References:
Clinical trial NCT05747976: Genetic Disorders of Obesity Program Database
Official title: Genetic Disorders of Obesity Program Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Childhood
Genetic Disease
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with early-onset, severe obesity.

Brief summary: This study collects data on children with severe, early-onset obesity.

Detailed description: Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical/family history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.

Eligibility criteria: Inclusion Criteria:

* For individuals 2 years and older, BMI \> 97 percentile
* For individuals \< 2 years old, weight-to-length ratio \> 95th percentile

Exclusion Criteria:

* No other exclusion criteria

Primary outcomes:
measure: Prevalence of genetic causes of severe, early-onset obesity
timeFrame: through study completion, an average of 10 years
Secondary outcomes:
measure: Change in BMI over time
timeFrame: through participant completion, an average of 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT04089176: Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH
Official title: Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Postpartum Hemorrhage
Cesarean Section
High Risk Pregnancy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2019-09-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section

Detailed description: Randomized controlled clinical trial. Defined patient in two group. Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level

Eligibility criteria: Inclusion Criteria:

* previous history of postpartum hemorrhage
* polyhydramnios
* fetal macrosomia
* previous cesarean section
* grand multiparity
* intramural myoma
* chorioamnionitis
* prolonged premature rupture of membrane
* augmentation of labour

Exclusion Criteria:

* pregnancy induce hypertension
* on anticoagulant
* placenta previa or placenta percreta

Primary outcomes:
measure: Additional drug use
timeFrame: during intra-operation
Secondary outcomes:
measure: Estimate blood loss
timeFrame: During intra-opeartion and acute post operation period as 24 hours post operation
measure: Side effect
timeFrame: During intra-opeartion and acute post operation period as 24 hours post operation
measure: Hemoglobin level
timeFrame: Pre-operation and 24 hours post operation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT02625376: Resveratrol for Exudative Age-Related Macular Degeneration
Official title: Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: AMD
Age-related Macular Degeneration
Choroidal Neovascularisation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

Detailed description: Interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

Comparison of incidence of choroidal neaovascularization between each study group will be performed.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 55 or more with unilateral exudative AMD
* Visual acuity less or equal to 20/25 in the most affected eye

Exclusion Criteria:

* Allergy to an investigational product
* atrophic Age-Related Macular Degeneration or age related maculopathy
* significant media opacities
* Other retinal pathology (diabetic retinopathy, high myopia, retinal dystrophy)
* Recent Cataract surgery
* Previous history of vitrectomy
* Acute or chronic severe organ failure
* Present participation in other clinical research study

Primary outcomes:
measure: Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers - Ophtalmology
Study officials:
affiliation: Dpt of Ophthalmology, University Hospital of Poitiers, France
name: Nicolas LEVEZIEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818176: To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.
Official title: To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiofrequency Ablation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasonic-guided radiofrequency ablation is the most common minimally invasive treatment for liver cancer. This study will use my country's self-developed intelligent ultrasonic navigation tool (NAVIRFA® Navigation System) to assist in the puncture of the needle during ablation, to observe the operation time, Whether the needle accuracy, ablation effect and complications are different from the traditional free-hand ultrasonic guidance technology.


Eligibility criteria: Inclusion Criteria:

1. Patients with malignant liver tumors less than three centimeters in size who are expected to suffer radiofrequency tumor ablation in the hospital.
2. At least 20 years old.

Exclusion Criteria:

1. Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host.
2. Those who are unable to accept computerized tomography and MRI examinations, such as poor renal function or contrast agent allergy, are not suitable for examination after the evaluation of the test host.

Primary outcomes:
measure: required scan time
timeFrame: Before ablation treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03666676: Hearing Study: Sensitivity to Features of Speech Sounds
Official title: Auditory Processing of Complex Sounds - Sensitivity to Chirps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-09-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.

Detailed description: The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these "chirps" are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.

Eligibility criteria: Inclusion Criteria:

* Normal hearing, mild or moderate symmetric sensorineural hearing loss.

Exclusion Criteria:

* Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
* Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).

Primary outcomes:
measure: Pure-tone Average Thresholds
timeFrame: 6 months
measure: F1 Discrimination Threshold
timeFrame: 6 months
measure: F2 Discrimination Threshold
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Laurel H Carney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carney LH, Cameron DA, Kinast KB, Feld CE, Schwarz DM, Leong UC, McDonough JM. Effects of sensorineural hearing loss on formant-frequency discrimination: Measurements and models. Hear Res. 2023 Aug;435:108788. doi: 10.1016/j.heares.2023.108788. Epub 2023 May 8.
Clinical trial NCT00232076: Verification Study of Ciclosporin for Atopic Dermatitis
Official title: Verification Study of Ciclosporin for Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Atopic Dermatitis
Keywords: Atopic Dermatitis, Ciclosporin,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8 weeks to patients with severe adult atopic dermatitis.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility criteria: Inclusion Criteria:

* Appropriate the definition/diagnosis criteria of atopic dermatitis of the Japanese Dermatological Association
* Patients with severest atopic dermatitis \[according to the "Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment\].

Exclusion Criteria:

* - Patients who received oral preparations, injections, inhaled preparations and suppositories of steroids or immunosuppressants other than tacrolimus hydrate ointments within 14 days of subject enrollment
* Patients who might receive the oral/injection drugs which are known to enhance nephrotoxicity, increase serum potassium levels, HMG-CoA reductase inhibitors or theophylline during the treatment period.
* Patients who received or are receiving an ultraviolet therapy (PUVA therapy, etc.)
* Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References:
Clinical trial NCT06470776: Chatbot Counselling for Smoking Cessation in Youths
Official title: Development of a Chatbot for Smoking Cessation Counselling for Youth Smokers Enrolled in the Youth Quitline: a Pilot Randomised Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use
Smoking Cessation
Keywords: conversational agent
virtual assistant
digital health
artificial intelligence
large language model
ChatGPT
adolescent
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-06-24
Enrollment: 154
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot trial is to develop and examine the trial feasibility and acceptability of a chatbot for smoking cessation in youth smokers. Specific aims include:

1. To assess how many youth smokers accept the invitation to participate in the trial
2. To assess the retention of the participants through 6 months after treatment initiation
3. To assess the acceptability of the chatbot in terms of participants' compliance and usability rating of the chatbot.
4. To estimate the intervention effect on abstinence outcomes
5. To explore the participants' perception and experiences in the chatbot


Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents aged 25 years or younger
2. Used a tobacco product in the past 30 days, including cigarettes, electronic cigarettes, heated tobacco products, etc.
3. Able to communicate in Chinese
4. Own a smartphone with internet access

Exclusion Criteria:

1. Diagnosed with a mental disease or on regular psychotropic drugs, or
2. Participating in other ongoing smoking cessation studies.

Primary outcomes:
measure: Biochemically-validated tobacco abstinence
timeFrame: 6 months after randomisation
measure: Recruitment rate
timeFrame: Through recruitment completion, about 9 months
measure: Retention rate
timeFrame: 6 months
Secondary outcomes:
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: 3 months after randomisation
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: 6 months after randomisation
measure: Self-reported 30-day point-prevalence tobacco abstinence
timeFrame: 3 months after randomisation
measure: Self-reported 30-day point-prevalence tobacco abstinence
timeFrame: 6 months after randomisation
measure: Self-reported 24-hour quit attempt
timeFrame: 3 months after randomisation
measure: Self-reported 24-hour quit attempt
timeFrame: 6 months after randomisation
measure: Self-reported 50% smoking reduction
timeFrame: 3 months after randomisation
measure: Self-reported 50% smoking reduction
timeFrame: 6 months after randomisation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: HKU Youth Quitline
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05794776: Effect of Spinal Cord Stimulation (SCS) on Insulin Secretion in Humans
Official title: Effect of BurstDR and Tonic Spinal Cord Stimulation (SCS) on Glucose Metabolism in Patients With Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Stimulation
Insulin Secretion
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain.

Detailed description: This study investigates the effect of spinal cord stimulation (BurstDR stimulation versus tonic stimulation versus no stimulation) on glucose metabolism, insulin secretion and heart rate variability in patients with neuropathic pain. To assess insulin secretion, hyperglycaemic clamps are performed in 10 patients. Three different stimulation conditions (BurstDR, tonic and no stimulation) are tested in 10 hyperglycaemic clamps each. A total of 30 clamps are carried out.

Eligibility criteria: Inclusion Criteria:

* implanted BurstDR spinal cord stimulating system
* body mass index 18-25 kg/m2

Exclusion Criteria:

* neurological and psychatric diseases
* decompensated diabetes mellitus
* hemoglobin \< 13 g/dl
* thrombocytopenia

Primary outcomes:
measure: First and second phase of insulin secretion
timeFrame: Insulinsecretion during clamp (2 hours)
Secondary outcomes:
measure: Root Mean Square of Successive Differences (RMSSD)
timeFrame: Heart rate variablity during stimulation (10 minutes)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: Universitaetsklinikum Tuebingen
name: Matthias Morgalla, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612976: Symbicort in Chronic Obstruktive Pulmonary Disease
Official title: Symbicort in Chronic Obstruktive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: treatment of COPD
documentation of relevant data
related to the budesonide/formoterole therapy in patients with COPD.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 18014
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: general practitioners and internists

Brief summary: Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e.general practitioners and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

* limitiations; possible risks; warnings; contraindications mentioned in the SPC.

Primary outcomes:
measure: efficacy and tolerability of budesonide /formoterole in subjects with COPD who are treated by general practitioners and internists.
timeFrame: change of a quality of life score compared to baseline by using CRQ, stratified by present therapy and severity of COPD; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE under outpatient medical care conditions
Secondary outcomes:
measure: to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population
Other outcomes:
Locations:
Study officials:
affiliation: Medical Department AstraZeneca Germany
name: Kai Richter, MD
role: STUDY_CHAIR
References: