louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06030843: The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Official title: The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Empagliflozin in Cardiorenal Syndrome Type 1
Keywords: Empagliflozin
SGLT2i
Cardiorenal syndrome
ADHF
AKI
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 200
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: Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.


Eligibility criteria: Inclusion criteria

* Age 18 years or more
* Hospitalized for the primary diagnosis of acute denovo or decompensated chronic heart regardless of ejection fraction
* AKI KDIGO any stage or urine NGAL ≥ 150 ng/mL
* Must be able to be enrolled into the trial ≤ 12 hours of diagnosis of AKI or elevated urine NGAL

Exclusion criteria

* Denied to participate in the study
* Cardiogenic shock or unstable hemodynamic (systolic blood pressure of at least 100 mmHg or required inotropic support within last 24 hours)
* Cardiac mechanical support (i.e. extracorporeal membrane oxygenation and intra-aortic balloon pump)
* Acute coronary syndrome
* Diagnosed with cause of AKI other than cardiorenal syndrome (eg. sepsis, nephrotoxic, dehydration)
* Anuria or requiring dialysis or expected to required dialysis within 24 hr
* Baseline eGFR ≤ 20 ml/min/1.73m2 with or without dialysis initiated
* Heart or kidney transplanted
* Previously received any SGLT2i in the last 3 months before admission
* Allergic to any SGLT2i
* Type 1 diabetes mellitus
* History of ketoacidosis, including diabetic ketoacidosis
* Pregnancy
* Comorbid conditions with an expected survival of less than 1 months such as end-stage liver or heart disease, or uncurable malignancy

Primary outcomes:
measure: MAKE30
timeFrame: 30 days
Secondary outcomes:
measure: In-hospital mortality rate
timeFrame: During admission
measure: 30-days mortality rate
timeFrame: 30 days
measure: Initiation of Renal Replacement therapy
timeFrame: 30 days
measure: Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
timeFrame: 30 days
measure: Recurrent heart failure
timeFrame: 30 days
measure: Vasoactive drug
timeFrame: 30 days
measure: Mechanical ventilation
timeFrame: 30 days
measure: Ventricular tachycardia or ventricular fibrillation
timeFrame: 30 days
measure: Resuscitation following a cardiac arrest
timeFrame: 30 days
measure: Reduction of prespecified renal biomarkers
timeFrame: 30 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
state: Pathumwan
Study officials:
affiliation: Chulalongkorn University
name: Nattachai Srisawat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06084143: Analysis of Suicide Dynamics in Link to the COVID-19 Pandemic
Official title: Analysis of Suicide Dynamics in Link to the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: Covid-19
Suicide
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient died between 01/01/2018 and 12/31/2021

Brief summary: Covid is a virus that first appeared in China in 2019 and was quickly described as a pandemic virus by its globalized nature. The unprecedented occurrence of the virus has led to several health and restrictive government measures. The Covid-19 pandemic and health measures have been able to contribute to the deterioration of the mental health of citizens as it has already been observed during the former pandemic context (Sars covid in 2003 in China or the Spanish flu).

Among the consequences of a negative impact on mental health, investigators assume that there is an increase in transitions to the completed suicidal act. However, current studies and observations tend to note that there has been no major change in the dynamics of successful suicides during the Covid period.

However, there are biases in the studies conducted: some suicide deaths may have been hidden and not reported as such, due to several factors. For example, the measure of the evolution of suicide attempts that was most often made by the measure of the evolution of the number of hospitalizations for this reason can be a source ofestimate whether people who did this gesture were not hospitalized after a visit to the emergency room or if they gave up attending because of the pandemic. Moreover, suicide deaths are more difficult to report as such when they occur at home than after hospitalization.

It is therefore interesting to study the dynamics of suicide during this health crisis retrospectively based on data from the Strasbourg Institute of Forensic Medicine containing the census of the Alsace region, which was hit hard by the pandemic.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Died between 01/01/2018 and 12/31/2021
* Absence of opposition from the patient expressed in writing during his lifetime to the reuse of his personal data for scientific research purposes.

Exclusion Criteria:

* Presence of opposition by the patient expressed in writing during his lifetime to the reuse of his personal data for scientific research purposes.

Primary outcomes:
measure: Suicide rates before and after the Covid-19 pandemic
timeFrame: from January 1, 2018 to December 31, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01733043: Sedative Effects in Obstructive Sleep Apnea
Official title: Dexmedetomidine for Sedation in Individuals With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnea
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the effect of dexmedetomidine infusion on the Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with obstructive sleep apnea (OSA).


Eligibility criteria: Inclusion Criteria:

* All individuals who have previously undergone diagnostic polysomnography in the Sleep Lab which documented significant OSA, and who have not undergone any changes that are likely to alter the severity of their condition since the time of their diagnostic sleep study (loss of weight; surgical therapy for OSA; removal of tonsils; discontinuation of medications likely to affect arousal or respiratory function, etc.) are eligible to participate. Subjects will be identified as they complete outpatient sleep studies or from records of previous sleep studies performed in the Duke Sleep Laboratory. After obtaining informed consent, subjects will be screened by history and physical examination, 12-lead electrocardiogram, and comprehensive metabolic profile.

Exclusion Criteria:

* Exclusion criteria will include a history of illicit drug or alcohol dependence, impaired hepatic (aspartate aminotransferase or alanine aminotransferase \> 2x upper limit of normal range) or renal function (receiving dialysis or serum creatinine \> 1.5 mg/dL), high-grade (\> 1st degree) heart block, or known allergy to dexmedetomidine.

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 8 hour sleep study
Secondary outcomes:
measure: Sleep Architecture
timeFrame: During 8 hour sleep study
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Brian Colin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00797303: The Effect of Bevacizumab on Corneal Neovascularization
Official title: The Effect of Bevacizumab on Corneal Neovascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Neovascularization
Keywords: bevacizumab
cornea
neovascularization
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.

Detailed description: To evaluate the effect of repeated subconjunctival bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) on inflammatory corneal neovascularization.

Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.

Eligibility criteria: Inclusion Criteria:

* Corneal Neovascularization
* Stable lesion

Exclusion Criteria:

* Diabetes
* Autoimmune diseases

Primary outcomes:
measure: The Effect of Bevacizumab on Corneal Neovascularization
timeFrame: Compare the results
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Olhos de Goiânia
name: Belquiz A Nassaralla, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05519943: Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
Official title: Effectiveness of Group CBT on Internalizing and Externalizing Symptoms in Children With Mixed Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Keywords: children
group cognitive behavioral therapy
cognitive behavioral therapy
internalizing symptoms
externalizing symptoms
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 103
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the immediate and longer-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in reducing internalizing and externalizing symptoms in children treated for mixed psychiatric disorders in naturalistic clinical settings. Further, the effectiveness of GCBT is compared to a treatment-as-usual condition (TAU). Within this study, it is hypothesized that children with mixed psychiatric disorders will exhibit improvements in parent-rated internalizing problem behavior and parent- and teacher-rated externalizing problem behavior following GCBT.


Eligibility criteria: Inclusion Criteria:

* Helsinki University Hospital child psychiatric outpatient clinic patients with symptoms of anxiety or depression, deficiencies in emotional and behavioral skills impairing functioning, and sufficient social and cognitive skills to participate in group work.

Exclusion Criteria:

* Helsinki University Hospital child psychiatric outpatient clinic patients with excessive physical aggression, excessive physical restlessness to enable skill training, or whose severity of psychiatric symptoms required individual psychotherapy (e.g., acute suicidality or psychosis).

Primary outcomes:
measure: Change in parent- and teacher rated internalizing and externalizing symptoms
timeFrame: From referral to GCBT to 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02240043: Growth Hormone Evaluation in the Elderly People
Official title: Growth Hormone Evaluation in the Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the growth hormone (GH) and adrenocorticotrophic hormone (ACTH) secretion in elderly without hypothalamic-pituitary disease using the glucagon stimulation test (using Glucagen® Hypokit, Novo Nordisk A/S, Denmark) and evaluate some parameters such as sarcopenia, nutritional state, bone mineral density, frailty criteria with secretion of GH.

Detailed description: subjects over 65 years old were recruited from the geriatric ambulatory unit of our hospital to voluntarily participate in a research study concerning the GH and ACTH axis in the elderly, which included the realization of the glucagon stimulation test as the first phase of the study.

The GST (Glucagen® Hypokit, Novo Nordisk A/S, Denmark) was the chosen test to assess both ACTH and GH release because of its few known contraindications and mild side effects. It is a provocative test to evaluate GH and ACTH axis, i.e, a diagnostic test, without therapeutic effects.

Eligibility criteria: Inclusion Criteria:

* elderly people above 65 years old with comorbidities peculiar to their age (such as hypertension, diabetes, dyslipidemia, parkinson disease) or without comorbidities

Exclusion Criteria:

* pituitary disease, severe acute disease, terminal renal chronic disease, active malignant cancer, the presence of any other disease that could interfere with the somatotrophic axis evaluation, and the contraindications for glucagon administration (pheochromocytoma, insulinoma and malnourishment).

Primary outcomes:
measure: Growth Hormone Secretion in the elderly people using glucagon stimulation test (GST)
timeFrame: up to one week
Secondary outcomes:
measure: ACTH release in the elderly people using GST
timeFrame: up to one week
Other outcomes:
measure: Body composition in the elderly people according with GH secretion
timeFrame: up to 3 months
Locations:
Study officials:
affiliation: Hospital Universitário Clementino Fraga Filho - UFRJ
name: Flávia L Conceição, PhD
role: STUDY_DIRECTOR
References:
citation: Tavares AB, Seixas-da-Silva IA, Silvestre DH, Paixao CM Jr, Vaisman M, Conceicao FL. Potential risks of glucagon stimulation test in elderly people. Growth Horm IGF Res. 2015 Feb;25(1):53-6. doi: 10.1016/j.ghir.2014.11.002. Epub 2014 Nov 29.
Clinical trial NCT01301443: Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)
Official title: A Phase I Dose Escalation Safety Study of Subretinally Injected RetinoStat, a Lentiviral Vector Expressing Endostatin and Angiostatin, in Patients With Advanced Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age Related Macular Degeneration
Keywords: Age Related Macular Degeneration
Lead sponsor: Oxford BioMedica
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.

Detailed description: There are two parts to the study. A dose-escalation phase looking at three doses of RetinoStat starting with the lowest dose, three patients will be recruited at each dose level. The escalation phase will be followed by a dose confirmation phase where the highest dose that is safe and well tolerated will be examined in 9 patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AMD with active CNV that shows evidence of leakage.
* BCVA less than or equal to 20/200 in the study eye for dose escalation phase.
* BCVA less than or equal to 20/80 in the study eye for maximum tolerated dose phase.

Exclusion Criteria:

* Significant ocular abnormalities that prevent retinal assessment.
* Treatment with steroids within three months of screening.
* Treatment with anti-VEGF therapy to either eye within one month of screening.
* Clinically significant intercurrent illnesses, laboratory, ECG or chest XRay abnormalities.

Primary outcomes:
measure: The incidence of adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in subretinal and intraretinal fluid as measured by OCT
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Portland
country: United States
facility: Dr Andreas Lauer - Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Johns Hopkins University Hospital
name: Peter A Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campochiaro PA, Lauer AK, Sohn EH, Mir TA, Naylor S, Anderton MC, Kelleher M, Harrop R, Ellis S, Mitrophanous KA. Lentiviral Vector Gene Transfer of Endostatin/Angiostatin for Macular Degeneration (GEM) Study. Hum Gene Ther. 2017 Jan;28(1):99-111. doi: 10.1089/hum.2016.117. Epub 2016 Sep 26.
Clinical trial NCT02645643: Medical Education Intervention for Medical Students
Official title: Intervention to Promote Medical Students Empathy, Well-being and Study emotion-a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mental Health
Keywords: medical students
professionalism
medical education
study emotion
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2016-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The doctor-patient relationship was becoming worse. More and more work-related violence has happened to physicians and nurses. A portion of medical students felt depressed and thought that the career future was gloomy. The study was designed to measure the empathy, an vital element of professionalism, well-being of mental and study emotion. Furthermore, the investigators explored an intervention of group study to promote medical students' professionalism, mental health and study emotion.

Detailed description: A total number of 200 junior medical students are going to be enrolled according to inclusive criteria. They are divided into two groups, one group is given education about medical humanities when the other group is not given any intervention but the same room and time.The outcomes including empathy, depression, quality of life, burnout and self-efficiency are measured before, during and after the trial.

Eligibility criteria: Inclusion Criteria:

* 1 age 18 to 25 years
* 2 junior students majoring in clinical medicine
* 3 no mental diseases previously

Exclusion Criteria:

* Did not meet inclusion criteria

Primary outcomes:
measure: Medical students' empathy
timeFrame: 3 months
Secondary outcomes:
measure: Medical students' burnout
timeFrame: 3 months
measure: Quality of life of Medical students
timeFrame: 3 months
measure: Medical students' self-efficiency
timeFrame: 3 months
measure: Medical students' depression
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Schwenk TL, Davis L, Wimsatt LA. Depression, stigma, and suicidal ideation in medical students. JAMA. 2010 Sep 15;304(11):1181-90. doi: 10.1001/jama.2010.1300.
citation: Reed DA, Shanafelt TD, Satele DW, Power DV, Eacker A, Harper W, Moutier C, Durning S, Massie FS Jr, Thomas MR, Sloan JA, Dyrbye LN. Relationship of pass/fail grading and curriculum structure with well-being among preclinical medical students: a multi-institutional study. Acad Med. 2011 Nov;86(11):1367-73. doi: 10.1097/ACM.0b013e3182305d81.
citation: Chen D, Lew R, Hershman W, Orlander J. A cross-sectional measurement of medical student empathy. J Gen Intern Med. 2007 Oct;22(10):1434-8. doi: 10.1007/s11606-007-0298-x. Epub 2007 Jul 26.
citation: Rong R, Chen W, Dai Z, Gu J, Chen W, Zhou Y, Kuang M, Xiao H. Improvement of the management of mental well-being and empathy in Chinese medical students: a randomized controlled study. BMC Med Educ. 2021 Jul 10;21(1):378. doi: 10.1186/s12909-021-02813-6.
Clinical trial NCT04719143: Effects of Insomnia Treatment on Metabolism in Patients With Depression
Official title: Effects of Insomnia Treatment on Metabolism in Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Insomnia
Insomnia, Primary
Depression
Depressive Symptoms
Keywords: Metabolism
Metabolomics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2021-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.


Eligibility criteria: Inclusion Criteria:

* Insomnia Severity Index \> 14
* Meet diagnostic criteria for Insomnia
* Meet diagnostic criteria for Major Depressive Disorder
* Either currently taking an SSRI/SNRI or no antidepressant

Exclusion Criteria:

* BMI \> 30
* Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months
* Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder)
* Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia
* Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)

Primary outcomes:
measure: Metabolomic Assays
timeFrame: Baseline (week 0)
measure: Metabolomic Assays
timeFrame: 2 weeks post-treatment (week 10 on average)
measure: Insomnia Severity Index
timeFrame: Baseline (week 0)
measure: Insomnia Severity Index
timeFrame: 2 weeks post-treatment (week 10 on average)
measure: Insomnia Severity Index
timeFrame: 3 months post-treatment (week 20 on average)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The University of Pennsylvania
state: Pennsylvania
Study officials:
References: