louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06024967: A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
Official title: The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: GHD
Keywords: GHD
growth hormone deficiency
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Detailed description: The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Eligibility criteria: Inclusion Criteria:

1. Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy
2. Participant must be 6 months to 17 years old
3. Tanner stage \<5 at Visit 1
4. Open epiphyses
5. Normal fundoscopy at Screening
6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant

Exclusion Criteria:

1. History or presence of malignant disease
2. Children with diabetes mellitus
3. Major medical conditions and/or presence of contraindications to GH treatment
4. Pregnancy
5. Participation in any other study of an investigational agent within three months prior to Visit 1
6. Prior exposure to investigational drug or any other long-acting growth hormone
7. Any other reason per investigator's discretion

Primary outcomes:
measure: Adverse Events of once-weekly GenSci004 in children with GHD
timeFrame: 108 weeks
Secondary outcomes:
measure: Annualized Height Velocity (AHV)
timeFrame: 104 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Morristown Medical Center
name: Lawrence Silverman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04609267: Interactive Voice-Based Administration of the PHQ-9
Official title: Interactive Voice-Based Administration of the PHQ-9
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Oral Roberts University
First posted: 2020-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be a repeated measure, mixed methods design (i.e., it will contain both qualitative and quantitative components). Newly admitted patients will be asked to complete the questionnaires (i.e., PHQ-9 and the UEQ) at two different time points (i.e., Baseline and 1-month follow-up). In order to reduce or control for order effects, the procedure will be counterbalanced.
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates a new delivery method for the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The new tool records auditory responses to the assesment and the study will examine if the instrument is effective at capturing participant depression levels. If proven effective, future studies may investigate if the new format can be used to improve at home clinical care.

Detailed description: This study is an investigation of a new delivery system of the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The purpose of the study is to examine if the new delivery system of the PHQ-9 is effective at capturing participant depression levels. The new version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9 through Amazon Alexa. We will be comparing the responses from the Mirror device to those given on the clinically established paper format. If proven effective at capturing depression levels of patients, future studies may investigate if the new format can be used to improve at home clinical care.

Eligibility criteria: Inclusion Criteria:

* Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic

Exclusion Criteria:

* Vulnerable populations, such as children (i.e., minors or individuals under the legal age of consent) and individuals who are incarcerated (i.e., prisoners), will be excluded.
* Individuals who are not their own guardian (i.e., those suffering from severe disabilities) will also be excluded.

Primary outcomes:
measure: PHQ-9 Total Scores
timeFrame: Immediate
measure: User Experience Survey
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: OSU Behavioral Health Clinic
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Jason Beaman, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905267: Mindfulness Intervention to Study the Neurobiology of Depression
Official title: Mindfulness Intervention to Study the Neurobiology of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: mindfulness
relapse prevention
recovery
depression
adolescents
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a research study examining how mindfulness can help teenagers stay healthy and prevent depression relapse.

Detailed description: Study involves:

* Brain scan using fMRI technology
* Questions about mood and behavior
* Meeting with a clinician
* Possibility of 8 weekly treatment sessions using mindfulness
* Ongoing assessment of depression for next 2 years

Eligible participants will be compensated for their time.

Eligibility criteria: Inclusion Criteria:

* between the ages of 12 and 18
* history of major depressive disorder

Exclusion Criteria:

* braces
* afraid of small spaces

Primary outcomes:
measure: Change in Children's Depression Rating Scale - Revised
timeFrame: Baseline, 8 week
Secondary outcomes:
measure: Change in Reynolds Adolescent Depression Scale
timeFrame: Baseline, 8 week
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago Pediatric Mood Disorders Program
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Rachel H Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bessette KL, Jacobs RH, Heleniak C, Peters AT, Welsh RC, Watkins ER, Langenecker SA. Malleability of rumination: An exploratory model of CBT-based plasticity and long-term reduced risk for depressive relapse among youth from a pilot randomized clinical trial. PLoS One. 2020 Jun 17;15(6):e0233539. doi: 10.1371/journal.pone.0233539. eCollection 2020.
citation: Jacobs RH, Watkins ER, Peters AT, Feldhaus CG, Barba A, Carbray J, Langenecker SA. Targeting Ruminative Thinking in Adolescents at Risk for Depressive Relapse: Rumination-Focused Cognitive Behavior Therapy in a Pilot Randomized Controlled Trial with Resting State fMRI. PLoS One. 2016 Nov 23;11(11):e0163952. doi: 10.1371/journal.pone.0163952. eCollection 2016.
Clinical trial NCT01529567: Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 311
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: Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.


Eligibility criteria: Inclusion Criteria:

* Fluency in Swedish
* IBS-diagnosis established by physician
* Fulfillment of Rome III criteria for IBS

Exclusion Criteria:

* Diarrhea predominance with no colonoscopy performed
* Blood in stool without benign medical explanation
* Rapid weight loss without benign medical explanation
* Ongoing alcohol or drug abuse
* Suicidal ideation

Primary outcomes:
measure: Gastrointestinal symptom rating scale
timeFrame: 1 week before randomization
measure: Gastrointestinal symptom rating scale
timeFrame: 10 weeks after randomization (i.e. after conclusion of treatment)
measure: Gastrointestinal symptom rating scale
timeFrame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Secondary outcomes:
measure: Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
timeFrame: 1 week before randomization
measure: Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
timeFrame: 10 weeks after randomization (i.e. after conclusion of treatment)
measure: Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
timeFrame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
measure: Visceral Sensitivity Index (VSI)
timeFrame: 1 week before randomization
measure: Visceral Sensitivity Index (VSI)
timeFrame: 10 weeks after randomization (i.e. after conclusion of treatment)
measure: Visceral Sensitivity Index (VSI)
timeFrame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Brjánn Ljótsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.
Clinical trial NCT06557967: Study on Prevalence and Impact of Brain Metastases on Survival in Lung Cancer by Line of Treatment
Official title: Prevalence of Brain Metastases and Impact on Survival in Metastatic Non-small Cell Lung Cancer by Line of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lung Cancer
Metastatic Cancer
Brain and Central Nervous System Cancer
Keywords: Real World Evidence
NSCLC
Brain metastases
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 22517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with metastatic NSCLC between 2015-2023 treated with systemic therapy.

Brief summary: This study will use real-world data to assess prevalence of brain metastases in metastatic non-small cell lung cancer (mNSCLC) patients and its impact on associated clinical outcomes.

Detailed description: This retrospective cohort database study will generate real-world evidence describing prevalence of brain metastases at metastatic diagnosis and by line of therapy, patient characteristics, treatment patterns, and clinical outcomes in metastatic non-small cell lung cancer (mNSCLC) patients

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of mNSCLC in study period (01/01/2015-06/30/2023) including newly diagnosed at metastatic stage or progression from advanced stage NSCLC
2. Age 18+ years at the time of diagnosis of mNSCLC

   Additional inclusion criteria for 1st Line of Therapy cohort:
3. Treated with systemic anti-cancer therapy in 1L setting

   Additional inclusion criteria for 2nd Line of Therapy and 3rd Line of Therapy cohorts:
4. Treated with systemic anti-cancer therapy in 2L setting treated with systemic anti-cancer therapy in 3L setting

Exclusion Criteria:

1. Evidence of other primary malignancy in the 365-day baseline period immediately prior to the first mNSCLC diagnosis in the study period
2. Evidence of stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT), or whole brain radiotherapy (WBRT) in the baseline period

Primary outcomes:
measure: Overall Survival (OS) of (AGA+/-) mNSCLC Participant With And Without Brain Metastases by Line of Therapy
timeFrame: From baseline to end of follow-up or death, whichever comes first, up to approximately 40 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: ConcertAI Database
state: Massachusetts
Study officials:
References:
Clinical trial NCT05793567: A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)
Official title: Assessment of Microcirculatory Function in Type 2 Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocardial Infarction
Coronary Microvascular Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receiving care at Mayo Clinic in Rochester, MN identified with T2MI and controls with atypical chest pain with indication for CMD testing will be enrolled in this study. Both groups will have no epicardial coronary stenosis \>50% or obstructive disease.

Brief summary: The purpose of this research is to find out if patients with Type 2 Myocardial Infarction (T2MI) without significant epicardial coronary artery disease (CAD) have a greater chance of having coronary microvascular disease (CMD).


Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Structurally normal heart (normal LV and RV function, no more than mild valvular heart disease)
* For controls: atypical chest pain with indication for CMD testing
* For T2MI: meet criteria for T2MI according to the 4th Universal definition of MI (rise/fall of troponin with at least 1 value \>99th centile+ evidence of symptoms or signs of myocardial ischemia)

Exclusion Criteria:

* Acute coronary event (evidence of plaque rupture, fissure or dissection on coronary angiogram)
* Known to have angiographically significant CAD/pressure wire positive for epicardial CAD
* Inability to receive heparin products
* Allergy/contraindication to acetylcholine/adenosine/nitroglycerine products
* Prior coronary artery bypass grafting
* Pregnancy (if sexually active woman of reproductive age, need negative pregnancy test prior to proceeding with coronary angiography - this is standard of care in cath lab)
* Asthma with prior ICU admission due to bronchospasm/need for invasive ventilation

Primary outcomes:
measure: Coronary Flow Reserve (CFR)
timeFrame: Baseline
Secondary outcomes:
measure: Backward Compression Wave (BCW)
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Claire Raphael, MBBS, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313467: Topical PDT Cream Without Irradiation Source in the Acne Treatment
Official title: Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne, Photodynamic Therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.


Eligibility criteria: Inclusion Criteria:

* mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.

Exclusion Criteria:

* known pregnancy
* lactation
* any medical illness that might influence the results of the study
* a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment
* use of topical acne medication within 4 weeks of study enrollment.

Primary outcomes:
measure: Percent change of inflammatory acne lesions compared with baseline
timeFrame: 12 week
Secondary outcomes:
measure: Percent change of non-inflammatory acne lesions compared with baseline
timeFrame: 12 week
measure: Percent change of overall severity of acne lesions compared with baseline
timeFrame: 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Unviersity
state: Seoul Metropolitan
Study officials:
affiliation: Seoul National University Department of Dermatology
name: Dae Hun Suh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547467: TOADS Study: TO Assess Death From Septic Shock.
Official title: Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: mortality
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Laboratoire français de Fractionnement et de Biotechnologies
First posted: 2015-09-11
Enrollment: 340
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: Consecutive patients who had died of septic shock

Brief summary: The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .

Detailed description: The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Died of septic shock in the intensive care unit (ICU)
* At least 6 hours of vasopressors

Exclusion Criteria:

* Legally protected adult patient.
* Less than 6 hours of vasopressors
* Opposition to participation in the study expressed by the patient, family or person of trust

Primary outcomes:
measure: The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire.
timeFrame: Patients will be followed during their hospital stay, with a maximal follow up of 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University hospital, Angers, FRANCE
name: Pierre ASFAR, MD-PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02156167: Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
Official title: Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe to Profound Mixed Hearing Loss
Keywords: Otosclerosis, cochlear implant, acoustic stimulation
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810 Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability of the Codacs™ Test System.


Eligibility criteria: Inclusion Criteria:

* Subjects implanted with a Cochlear C-DACS investigational device

Exclusion Criteria:

* Participation in another medical device study
* Unwillingness or inability of the subject to comply with the study requirements

Primary outcomes:
measure: Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test
timeFrame: 3 months after initial upgraded fitting
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Niedersachsen
Study officials:
affiliation: Cochlear
name: Ernst von Wallenberg, PhD
role: STUDY_DIRECTOR
References:
citation: Lenarz T, Zwartenkot JW, Stieger C, Schwab B, Mylanus EA, Caversaccio M, Kompis M, Snik AF, D'hondt C, Mojallal H. Multicenter study with a direct acoustic cochlear implant. Otol Neurotol. 2013 Sep;34(7):1215-25. doi: 10.1097/MAO.0b013e318298aa76.
citation: Lenarz T, Verhaert N, Desloovere C, Desmet J, D'hondt C, Gonzalez JC, Kludt E, Macias AR, Skarzynski H, Van de Heyning P, Vyncke C, Wasowski A. A comparative study on speech in noise understanding with a direct acoustic cochlear implant in subjects with severe to profound mixed hearing loss. Audiol Neurootol. 2014;19(3):164-74. doi: 10.1159/000358004. Epub 2014 Feb 18.