louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05448430: iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.
Official title: iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Aim: 1. To confirm that patients with predominant negative symptoms in schizophrenia have deficits in frontal cortical dopamine release when compared with healthy control and patients with positive symptoms.

2. Our previous study found patients with negative symptoms have more possibilities to have disorders in glucose metabolism, we wonder whether dopamine release, negative symptoms or glucose metabolism can be improved by iTBS.

Study design: Case control study.

Detailed description: Eligibility Criteria: Predominant negative symptoms for Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or more, and score of 4 or more on at least two of three core negative PANSS items, PANSS for positive symptoms of 19 or less, HAMD depression scale of 16 or less. Predominant positive symptoms for PANSS for positive symptoms of 20 or more. Healthy control will be recruited matching the age and sex of patient groups, Outcome Measures: Oral glucose tolerance test (OGTT), PET dopamine imaging.

Eligibility criteria: Inclusion Criteria for negative group

* diagnosed with schizophrenia according to ICD-10 or DSM-V
* Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or moreand score of 4 or more on at least two of three core negative PANSS items
* PANSS for positive symptoms of 19 or less, and HAMD depression scale of 16 or less.
* drug-naive Inclusion Criteria for positive group
* PANSS for positive symptoms of 20 or more
* drug-naive

Exclusion Criteria:

* drug or alcohol addiction
* diagnosed with other major mental disorders according to ICD-10 or DSM-V

Primary outcomes:
measure: PET dopamine imaging and OGTT
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT03163030: Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
Official title: Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart Failure
Preserved Ejection Fraction
VNS
Vagus Nerve
Autonomic Regulation Therapy
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and mid-range ejection fraction.

Detailed description: Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.

Eligibility criteria: Inclusion Criteria:

Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).

Exclusion Criteria:

-

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Cardiac Size (LAVI)
timeFrame: 12 months
measure: Functional Status (6MWD)
timeFrame: 12 months
measure: Quality of Life Score
timeFrame: 12 months
measure: Functional Status (NYHA Class)
timeFrame: 12 months
measure: Cardiac Function (E/E')
timeFrame: 12 months
measure: Cardiac Size (LV mass index)
timeFrame: 12 months
measure: Autonomic Function (HRV)
timeFrame: 12 months
measure: Blood Biomarkers
timeFrame: 12 months
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Krishna Institute of Medical Science
Study officials:
affiliation: Cyberonics, Inc.
name: Imad Libbus, Ph.D
role: STUDY_DIRECTOR
References:
citation: Kumar HU, Nearing BD, Mittal S, Premchand RK, Libbus I, DiCarlo LA, Amurthur B, KenKnight BH, Anand IS, Verrier RL. Autonomic regulation therapy in chronic heart failure with preserved/mildly reduced ejection fraction: ANTHEM-HFpEF study results. Int J Cardiol. 2023 Jun 15;381:37-44. doi: 10.1016/j.ijcard.2023.03.030. Epub 2023 Mar 17.
Clinical trial NCT01358630: Vascular and Periodontal Disease - Microbial, Genetic and Histological Causalities
Official title: Periodontal-, Cardiovascular- and Aneurysmal Diseases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Vascular Disease
Keywords: Periodontitis
Vascular disease
Proinflammatory cytokines
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2011-05-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing vascular surgery at Oslo University Hospital, Aker, previously randomly collected patients with periodontitis, and randomly selected blood donors at Oslo University Hospital, Ullevål.

Brief summary: The purpose of this study is to analyze genetic polymorphisms in genes encoding pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The investigators will also try to identify oral bacteria in atherosclerotic plaques and aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and aneurysmal wall will be performed.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing vascular surgery at Oslo University Hospital, Aker, previously randomly collected patients with periodontitis,

Exclusion Criteria:

* patients whom undergone antibiotic treatment the past month.
* patients whom undergone periodontal treatment the past 6 months.
* patients with no teeth

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dental and Medical Faculty, University of Oslo
Study officials:
References:
Clinical trial NCT06908330: Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health
Official title: Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health: A Pilot Test of the Strengthening Social-Emotional Skills for Relating and Thriving at School (SSTRS) Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parenting Behavior
Social Emotional Competence
Internalizing Behavior
Externalizing Behavior
Lead sponsor: Oregon Social Learning Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if the Social-emotional Skills for Thriving and Relating at School (SSTRS) Program can help children entering kindergarten and their families. The main questions it aims to answer are: 1) Do children who participate in SSTRS have better social-emotional skills and mental health? and 2) Do parents who participate in SSTRS have more positive parenting skills and involvement in their children's learning?

Researchers will compare the SSTRS Program to the regular kindergarten curriculum without SSTRS to see if being in SSTRS helps children to have better mental health and parents to have better parenting skills.

Kindergarteners will have daily SSTRS lessons in their kindergarten classes for 8 weeks.

Their parents will watch videos and attend group meetings with other parents and answer questions about their own and their children's behaviors and mental health


Eligibility criteria: Inclusion Criteria:

* child entering kindergarten in school that is participiating in the study

Exclusion Criteria:

* being in a classroom in which the teacher or EA was previously trained in another closely-related treatment protocol

Primary outcomes:
measure: Strengths & Difficulties Questionnaire
timeFrame: Parents will complete the measure at baseline, 2 months post-baseline at the end of the intervention and 9 months post-baseline. Teachers will complete the measure at 9 months post-baseline.
measure: Office discipline referrals
timeFrame: These will be collected at 9 months post-baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Social Learning Center
state: Oregon
Study officials:
affiliation: Oregon Social Learning Center
name: Katherine Pears, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05436730: "Escape" Phenomenon of the Antihypertensive Therapy Efficacy
Official title: The Role of Ambulatory Blood Pressure Characteristics, Features of the Structural and Functional Vascular Wall State, the Presence and Severity of Obstructive Sleep Apnea Syndrome in Predicting the "Escape" Phenomenon of the Antihypertensive Therapy Efficacy.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arterial Hypertension
Lead sponsor: Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADE
Sponsor class: OTHER_GOV
First posted: 2022-06-29
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women aged 18-90 years with arterial hypertension grade 1-3, stage I-II and initially achieved target BP levels while taking 2-3-component AHT.

Brief summary: A little attention is paid to the AHT efficacy escaping problem, which can be explained by the AHT correction simplicity and rapid achievement of the target BP level. Nevertheless, modern statistic data on the effective AH treatment described above let us assume that AHT correction is either totally absent or is untimely in case of the "escape" phenomenon development. This could be one of the main reasons for the high prevalence of ineffective AH treatment. The aim of this study is to determine AHT efficacy "escape" phenomenon timeline and its predictors in hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Arterial hypertension (AH) grade 1-3, stage I-II
* High compliance during the follow-up period (≥ 85%)
* Initially achieved target office BP levels while taking 2-3-component AHT

Exclusion Criteria:

* Secondary AH
* Resistant AH,
* AH III stage,
* PAP- therapy,
* type 2 diabetes mellitus,
* pregnancy
* history of low adherence to treatment

Primary outcomes:
measure: Assessment of BP increasing higher the target level when taking the same therapy
timeFrame: 1-6 months
Secondary outcomes:
measure: Disease course: assessment of major CVE and death occurrence
timeFrame: 10 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Oksana Mikhailova
Study officials:
References:
Clinical trial NCT01267630: The Validity of the Thai Version of the Confusion Assessment Method
Official title: The Validity and Reliability of Thai Version of the Confusion Assessment Method for the Intensive Care Unit (CAM -ICU)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Keywords: Delirium of Mixed Origin
Subacute Delirium
Mental Disorders, Organic
Organic Brain Syndrome, Nonpsychotic
Organic Mental Disorders
Organic Mental Disorders, Psychotic
Psychoses, Traumatic
Cognition Disorder
Confusion state
Disorientation
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours.

Brief summary: The purpose of this study is to determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly.

Detailed description: The incidence of delirium in intensive care unit varied between 20 and 80% depending on many factors such as types of study, diagnostic tools, severity of patients.The occurrence of delirium is common in elderly patients. However, the prevalence of delirium in the intensive care has not been reported in Thailand. There is no common tool used for detecting delirium in Thai ICU. Currently, CAM-ICU has been developed for nonpsychiatric physician and other health care professionals to detect delirium. The sensitivity and specificity of CAM-ICU was 91-93% and 89-100% respectively. In addition, it has been translated to many version to diagnose deliriums for all over the world. In Thailand, there is no common tool used for detecting delirium in ICU. The use of CAM-ICU may be useful in Thai ICU settings.

Eligibility criteria: Inclusion Criteria:

* age ≥ 55 years old

Exclusion Criteria:

* Severe visual or auditory impairment
* Comatose or moribund patients
* Unable to communicate with Thai language

Primary outcomes:
measure: Sensitivity and Specificity of Thai version of the CAM-ICU for diagnosis of ICU delirium
timeFrame: within 48 hours after admission
Secondary outcomes:
measure: The prevalence of elderly delirium patients in intensive care unit
timeFrame: within 48 hours after ICU admission
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Chiang Mai University Hospital
state: Chiang Mai
city: Maung
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine
state: Chiang Mai
city: Muang
country: Thailand
facility: Chiang Mai University Hospital
state: Chiang Mai
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
name: Tanyong Pipanmekaporn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02428530: Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors
Official title: Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Smoking
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2015-04-28
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.

Brief summary: This study assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy.

Detailed description: Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included. Demographic and health information was collected. A composite support score for each woman was generated from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. Support scores were evaluated with women's current smoking and drinking status using ANOVA and Student's t-test.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.

Exclusion Criteria:

* Non-English speaking.

Primary outcomes:
measure: A composite support score for each woman from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Brett Worly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06778330: The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients with Secondary Pulmonary Hypertension
Official title: The Effect of Combination of Dapagliflozin and Sildenafil in Treatment of Heart Failure Patients with Secondary Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure NYHA Class II
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 100
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 study aims to determine the efficacy of sildenafil (improve PAH) as an add-on therapy to dapagliflozin in the treatment of heart failure patients with secondary pulmonary arterial hypertension and compare the result with monotherapy dapagliflozin


Eligibility criteria: Inclusion Criteria:

patients with established heart failure with secondary pulmonary hypertension seen by a primary care provider to diagnose a heart disease, the patient's symptoms which may experience:

* Dizziness or fainting
* Heart palpitations, which may feel like your heart fluttering or skipping beats
* Shortness of breath

Exclusion Criteria:

* Patients with a history of severe allergic reactions or hypersensitivity to sildenafil, dapagliflozin, or related medications.
* Individuals with contraindications to the use of sildenafil or dapagliflozin.
* Patients with pulmonary arterial hypertension (PAH) due to conditions other than heart failure (e.g., idiopathic PAH).
* severe hepatic impairment
* aged less than 18 years.
* valvular heart disease .
* Patients with a known or suspected history of non-compliance with medical treatment or inability to adhere to study procedures.
* life expectancy of less than 6 months .
* Pregnant or breastfeeding women

Primary outcomes:
measure: change in ejection fraction
timeFrame: 12 weeks after treatment
measure: change in systolic pulmonary artery pressure
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT06270030: Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Presbyopia
Keywords: Presbyopia
LNZ100
LNZ101
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: LENZ Therapeutics, Inc
First posted: 2024-02-21
Enrollment: 21
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia

Detailed description: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia

Eligibility criteria: Inclusion Criteria

1. Be able and willing to provide written informed consent prior to any study procedure being performed.
2. Be able to and willing to use investigational products per study requirements and attend all study assessments, including admission to and stay in the CRU on required study days.
3. Be Chinese healthy male or female subjects aged 45-75 years (inclusive) at screening.
4. Be diagnosed and documented to have presbyopia by the investigator at the screening visit.

Exclusion Criteria:

1. Have known contraindications or sensitivity to the use of any of the investigational products or its components, or any other medications required by the protocol.
2. Have any active systemic or ocular disorder that has a potential risk to or impact on subject safety, study process or study results other than refractive disorder.
3. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the investigator's opinion could affect ophthalmic solution absorption in either eye.
4. Have prior (within 14 days of the first dose), current or anticipated use of any contact lenses during study participation.
5. Be ineligible for this trial in the opinion of the investigator.

Primary outcomes:
measure: Cmax
timeFrame: Day 1 and Day 8
measure: Tmax
timeFrame: Day 1 and Day 8
measure: AUC0-t
timeFrame: Day 1 and Day 8
measure: AUC0-∞
timeFrame: Day 1 and Day 8
measure: T1/2
timeFrame: Day 1 and Day 8
measure: Safety: adverse event reporting
timeFrame: up to 23 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Corxel Pharmaceuticals
name: Larry Li, Doctor
role: STUDY_DIRECTOR
References: