louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04067700: CPET in Myocardial Ischemia
Official title: Accuracy of Cardiopulmonary Exercise Testing in the Diagnosis of Myocardial Ischemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Ischemia
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who receive invasive coronary treatment will undergo additional coronary perfusion PET/CT and CPET tests six months after the treatment.
Primary purpose: DIAGNOSTIC

Brief summary: The investigators goal is to determine whether cardiopulmonary exercise testing (CPET) can be utilized in the diagnosis of myocardial ischemia. For the study participants the investigators will recruit patients who have been referred to myocardial perfusion PET/CT scan in Kuopio University Hospital. The participants will perform the CPET on a cycle ergometer on separate day after the perfusion scan. The investigators will compare the results of the PET/CT scan and CPET and evaluate if the possible perfusion defects detected in PET/CT correlate with the gas exchange parameters in CPET.

The patients who receive invasive coronary treatment (coronary bypass surgery or percutaneous coronary intervention) will be invited to perform additional CPET ja PET/CT tests six months after the treatment. The goal will be to determine whether the recovery of myocardial perfusion can be assessed with gas exchange parameters in CPET.


Eligibility criteria: Inclusion Criteria:

* Referral to coronary perfusion PET/CT scan in Kuopio University Hospital

Exclusion Criteria:

* Age under 18 years
* Pregnancy or breastfeeding
* Handicap
* Imprisonment
* Care under forensic psychiatry

Primary outcomes:
measure: Presence of myocardial ischemia assessed by the myocardial perfusion positron emission tomography
timeFrame: 6 months
measure: Presence of myocardial ischemia assessed by the cardiopulmanary exercise test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Agreement in the detected myocardial ischemia between the myocardial perfusion positron emission tomography and the cardiopulmonary exercise testing
timeFrame: 6 months
Locations:
city: Kuopio
country: Finland
facility: Kuopio Univerity Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Tomi Laitinen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857400: Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)
Official title: Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: METASTATIC CANCER
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prospective, open label, randomized and multicentric study evaluating the efficacy of an organized consultation "return home" compared to a current standard of care in patient hospitalized due to metastatic solid tumor cancer.

Subject will be randomized (1:1) as described below :

• Arm A (standard) : current standard of care ; connection documentation faxed to GP ( General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard of care, organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP


Eligibility criteria: Inclusion Criteria:

1. Age \> or = 18 years old
2. Subject hospitalized in an oncology dedicated center for administration of the first chemotherapy cycle.
3. Subject with metastatic solid tumor whatever the organ
4. subject planned to be discharged home after chemotherapy administration
5. Affiliated to the French social security system.
6. Subjects must provide written informed consent prior to any study-specific procedure or assessment

Exclusion Criteria:

1. Subject included in another trial evaluating the pathways care
2. Pregnant or breastfeedings women
3. Subject law protected

Primary outcomes:
measure: Evaluation of an organized consultation "return home" of patients with a metastatic cancer
timeFrame: up to 12 months
Secondary outcomes:
measure: Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction
timeFrame: up to 12 months
measure: Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life
timeFrame: up to 12 months
measure: Identification of the conformity of the standard of care regarding the place of care
timeFrame: up to 12 months
measure: To quantify the caregiver burden in the 2 standard of care (current and CREDO)
timeFrame: up to 12 months
measure: To assess the medical and economic consequences of the 2 standard of care (current and CREDO)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Auch
country: France
facility: Centre Hospitalier Auch
city: Toulouse
country: France
facility: Hopital Rangueil
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Marie-Eve ROUGE BUGAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06825000: Scientific Information and Beliefs About Psychological Therapy
Official title: The Effects of Science Education on Beliefs and Wellness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anxiety
Keywords: beliefs
mindsets
exposure therapy
neuroscience education
psycho-education
neuro-education
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The success of psychological therapy can be impacted by patients' beliefs, such as their belief in their own ability to complete therapy and their belief that therapy will work. The goal of this clinical trial is to learn whether and when scientific information about distress and coping can affect beliefs about psychological therapy in adults who experience anxiety. This study will compare two different types of scientific information in a one-hour study. Participants will view educational videos for 30 minutes and complete surveys, including quiz questions about the videos and surveys about their beliefs about psychological therapy.


Eligibility criteria: Inclusion Criteria:

* Probable anxiety disorder based on the Overall Anxiety Severity and Impairment Scale (OASIS) score
* Fluent in English
* Willingness and ability to comply with the protocol
* Age 18-80
* The ability to enroll in the study through Prolific.com

Exclusion Criteria:

* Having previously seen the study's videos

Primary outcomes:
measure: Treatment Self-Efficacy
timeFrame: Immediately before and immediately after watching the videos
measure: Treatment Expectancy
timeFrame: Immediately before and immediately after watching the videos
Secondary outcomes:
measure: Treatment Acceptability
timeFrame: Immediately after watching the videos
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Irvine
name: Golnaz Tabibnia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03446300: Shanghai High Myopia Study for Adults
Official title: The Cohort Study of Early Visual Impairment Mechanism Caused by Change of Fundus Structure in Adults With High Myopia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Myopia
Keywords: High Myopia, fundus structure, early visual impairment
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: college student population; working population; aged more than 50 years old population.

Brief summary: High myopia retinopathy has become the first cause of irreversible blindness and severe visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused by high myopia retinopathy, it is very necessary to research the mechanism of early visual impairment to prevent and control damages. Our recent research found that the decreasing of macular retina vascular density and subfoveal choroidal thickness, the increasing of Beta Zone area in optic atrophy and the rising of glycosylated hemoglobin in high myopia patients were significantly related to visual impairment, which suggested that the source of visual impairment was the abnormal structure changes surrounding optic and fovea, but so far there is no related study. We will conduct a 5 years prospective cohort study in the population of 2420 high myopia and controls which have established in college student population, working population and aged more than 50 years old population, using the latest OCT-A and SS-OCT to measure macular retina vascular density, subfoveal choroidal thickness, Beta Zone area in optic atrophy, combined with the semiparametric mixed effects model, we will analysis the prediction index between fundus structure parameters, blood biochemical index and individual characteristics prediction to explore the public health management mode of early prevention and treatment during high myopia population.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old; spherical equivalent refraction ≤-6.00D;

Exclusion Criteria:

* a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology

Primary outcomes:
measure: Retina Vessel Density (RVD)
timeFrame: December 31, 2016
measure: tilted optic disc
timeFrame: December 31, 2016
measure: β-zone PPA
timeFrame: December 31, 2018
measure: glycosylated hemoglobin
timeFrame: December 31, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Shanghai
Study officials:
affiliation: Shanghai Eye Disease Prevention & Treatment Center
name: Jianfeng Zhu, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05861700: The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH
Official title: The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phosphorus Metabolism Disorders
Acid-Base Balance Disorder
Keywords: phosphorus
hemodialysis
bicarbonate
acidosis
alkalosis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: University of Warsaw
name: Polish Academy of Sciences
First posted: 2023-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Blood acid-base and uremic solute levels were measured in twenty chronic HD patients during 4-hour treatments with A) constant Dbic of 35 mmol/L; B) Dbic of 35 mmol/L for the first two hours and 30 mmol/L for the second two hours; and C) Dbic of 30 mmol/L for the first 2 hours and 35 mmol/L later. Treatment interventions were fixed during a given week, arterial blood samples were obtained predialysis and every hour during the treatment, during the second and third treatments of the week.
Primary purpose: TREATMENT

Brief summary: Hyperphosphatemia is still an unresolved problem among hemodialysis patients and significantly increases the risk of death from cardiovascular diseases. Research to date has not answered the question of whether dialysate bicarbonate concentration profiling can improve phosphate removal and its concentration without negative impact on the acid-base balance. This study addressed this issue.

Twenty stable hemodialysis patients will enroll to a four-week study during which different dialysate bicarbonate concentration profiles will be used each week. Each patient will undergo the following profiles (one-week periods): Treatment A - stable dialysate bicarbonate concentration Dbic 35 mmol/L during the whole HD session, Treatment B - Dbic 35 mmol/L for the first two hours and Dbic 30 mmol/L for the next two hours and Treatment C - the opposite mid-HD change Dbic from 30 to 35 mmol/L and one week wash-out period between Treatment B and C. We will collect blood samples each hour during the session and one hour after HD completion.


Eligibility criteria: Inclusion Criteria:

* stable general condition
* hemodialysis more than 3 months
* Dialysis 3 times a week/ 4 hours +/- 20 minutes
* Dialysis with arterio-venous fistulas
* bicarbonate titer before hemodialysis 22-24 mmol/l

Exclusion Criteria:

* diabetes mellitus
* cachexia
* inflamation processes
* usage of sevelamer last month
* utrafiltration during dialysis more than 2500 ml

Primary outcomes:
measure: The blood phosphorus concentration change in hemodialysis patient
timeFrame: 4 weeks
Secondary outcomes:
measure: The maintaining the acid-base balance in accordance with applicable recommendations.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Wieliczko Monika
Study officials:
References:
Clinical trial NCT03309800: A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bronchitis
Keywords: Acute Bronchitis
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 168
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients.

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen


Eligibility criteria: Inclusion Criteria:

1. Both gender, 19 years ≤ age ≤ 80 years
2. (Bronchitis Severity Score)\* ≥ 5point at Visit 2 (Randomized Visit)
3. Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
4. Those who can comply with the requirements of clinical trials
5. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with respiratory and systemic infections requiring systemic antibiotic therapy
2. Patients with bleeding tendency
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
5. Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2

Primary outcomes:
measure: Bronchitis Severity Total Score(BSS) Change
timeFrame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary outcomes:
measure: The improvement and improvement rate of the tester for the treatment response (Chi-square test or Fisher's Exact test)
timeFrame: Visit 3 (7 day)
measure: The satisfaction of the subject (Questionnaire)
timeFrame: Visit 3 (7 day)
measure: Total usage of Acetaminophen
timeFrame: Visit 3 (7 day)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Dongdaemun-gu
Study officials:
References:
Clinical trial NCT02635100: Multinight CPAP for Sleep Apnea Patients
Official title: Evaluation of a Multinight (MNT) CPAP Titration Algorithm in Patients With Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea
Sleep Disordered Breathing
Keywords: Sleep Disordered Breathing
Sleep Apnea
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2015-12-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Obstructive sleep apnea (OSA) is a prevalent disorders characterized by intermittent obstructions of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) has been shown to be the most efficacious treatment for OSA. It consists of a small device that provides positive airway pressure delivered by a mask attached to the patients nose/mouth.

Detailed description: The primary purpose of this study is to evaluate the multinight (MNT) algorithm on patients with Obstructive Sleep Apnea (OSA) over 45 nights while using a CPAP machine at home. The researchers are evaluating the performance of the existing algorithm as well as capturing the data to make enhancements.

Two main stages of this algorithm will be assessed:

i. Fast Track (FT) stage. In the FT stage the aim is to assess if the algorithm reliably and timely reaches approximate therapeutic pressure levels.

ii. Slow Titration (ST). In the Slow Titration stage the aim is to assess if data samples have been appropriately collected in a pressure range so that the therapeutic pressure can be inferred according to the algorithm proposed.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* No contradictions to Continuous Positive Airway Pressure (CPAP)
* Able to provide consent

Exclusion Criteria:

° Vulnerable subjects

Primary outcomes:
measure: Difference in number of residual events between high and low pressure levels
timeFrame: 45 days
measure: Pressure level obtained during the MNT Fast Track stage
timeFrame: 7 days
measure: Number of days required to reach Fast Track pressure
timeFrame: 7 days
measure: Number of times the algorithm returns to Slow Track from the Fast Track stage
timeFrame: 45 days
measure: Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)
timeFrame: 3 hours
measure: Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure
timeFrame: 45 days
measure: Difference between PMNT and sleep lab diagnosed CPAP pressure
timeFrame: 45 days
measure: Number of residual events while using the PMNT function
timeFrame: 45 days
Secondary outcomes:
measure: Average comfort rating using CPAP with multinight automated titration
timeFrame: 45 days
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Rapoport, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00274300: Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
Official title: A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HSV-2
Keywords: DNA vaccine
immunotherapy
Herpes Simplex Virus Type 2 (HSV2)
Particle Mediated Epidermal Delivery
Lead sponsor: PowderMed
Sponsor class: INDUSTRY
First posted: 2006-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks

Detailed description: Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )

Eligibility criteria: Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

Primary outcomes:
measure: Adverse Events at all visits
measure: vaccine site evaluations
measure: laboratory parameters pre and post vaccination
Secondary outcomes:
measure: HSV recurrences post vaccination
measure: immunogenicity of vaccine post vaccination
Other outcomes:
Locations:
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
Study officials:
affiliation: University of Texas
name: Larry Stanberry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: