louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03665792: The Correlation Between Sevoflurane and qNOX
Official title: The Prospective Observational Research of the Analgesic Effect of Sevoflurane and the Correlation Between Sevoflurane and qNOX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesic Adverse Reaction
Nociceptive Pain
Inhalation; Vapor
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: only elective thoracoscope surgery patients were enrolled

Brief summary: This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the correlation between the sevoflurane and NOX index.

Detailed description: This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the analgesia effect of the sevoflurane.

And test the correlation between the sevoflurane and NOX index.

Eligibility criteria: Inclusion Criteria:

1. Elective thoracoscope surgery patients
2. Age ranging from 25 to 85 years
3. American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4
4. a body mass index (BMI) ranging from 18.5 to 40 kg/m2.

Exclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease
2. implanted pacemaker
3. Clinical diagnosis of psychiatric diseases
4. Clinical diagnosis of epilepsy
5. Clinical diagnosis of autonomic nervous system disorders which might affect the EEG

Primary outcomes:
measure: The sevoflurane application correlated with the qNOX index
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bei Liu
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xiaohua Wang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05397392: Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
Official title: Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Kidney Diseases
Kidney Injury
Heart Valve Diseases
Dialysis; Complications
Coronary Heart Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from a tertiary hospital

Brief summary: To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes

Detailed description: Cardiorenal syndrome is a clinical syndrome caused by acute or chronic injury of one of the heart and kidney resulting to acute or chronic dysfunction of the other organ. In recent years, the morbidity of cardiorenal syndrome has increased rapidly in China. Its condition is complex and difficult to treat. Due to the lack of studies specifically targeting the cardiorenal syndrome population, there is no systematic in-depth understanding of the pathogenesis and risk factors of this kind of disease. In clinic, the course of various types of cardiorenal syndrome is complex and difficult to be summarized into a specific type. Therefore, we intend to conduct a clinical systematic observation and research on such patients so as to optimize a more reasonable treatment scheme.

Eligibility criteria: Inclusion Criteria:

Patients meet the diagnosis of various types of cardiorenal syndrome according to the classification standards of various types formulated by KDIGO and ADQI expert consensus. Different syndromes were identified and classified into five subtypes. Acute CRS (type 1): acute worsening of heart function (AHF-ACS) leading to kidney injury and/or dysfunction. Chronic cardio-renal syndrome (type 2): chronic abnormalities in heart function (CHF-CHD) leading to kidney injury and/or dysfunction. Acute reno-cardiac syndrome (type 3): acute worsening of kidney function (AKI) leading to heart injury and/or dysfunction. Chronic reno-cardiac syndrome (type 4): chronic kidney disease leading to heart injury, disease, and/or dysfunction. Secondary CRS (type 5): systemic conditions leading to simultaneous injury and/or dysfunction of heart and kidney.

Exclusion Criteria:

Pregnant or breastfeeding women; Female patients with recent birth plans; Patients who cannot follow up on medications.

Primary outcomes:
measure: Hospitalization due to worsening of renal or cardiac function
timeFrame: 1 year
measure: All-cause deaths
timeFrame: 1 year
Secondary outcomes:
measure: End-stage renal disease requires maintenance dialysis
timeFrame: 1 year
measure: Acute kidney injury
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
Study officials:
References:
Clinical trial NCT05347992: ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
Official title: ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Lead sponsor: DxTerity Diagnostics
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults diagnosed with SLE

Brief summary: To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information

Detailed description: Explore and demonstrate concordance between self-collected samples and traditional phlebotomist venous draw for DxTerity AIP module and biomarkers like C3, C4, anti dsDNA and CRP in SLE participants with self-reported outcomes and medical record data.

The study will collect blood samples and self-reported information for SLE subjects, up to 5000 participants in Phase I, with a subset of 1000 continuing to Phase II with Medical records. Study participants will be recruited using a combination of digital media (including social media, advertising, bloggers, emails). Enrollment and qualification will be done along with consented retrieval of medical records using a study specific mobile app.

Eligibility criteria: Inclusion Criteria: (PHASE I)

1. Individuals aged 18 years or older.
2. Must reside in United States
3. Have a clinical diagnosis of SLE
4. Willingness to consent to provide electronic medical records (EMR)
5. Provide written informed consent and comply with the study procedures.

(PHASE II)

1. Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE
2. Report one or more of the following (record all that apply):

   1. Worsening or changes in symptoms or flare
   2. Changes in treatment regimen
   3. On standard of care treatment
   4. On biologics

Exclusion Criteria:

1. Participants unable to complete study requirements

Primary outcomes:
measure: Concordance between self collected samples and traditional venous draws
timeFrame: 36 months
Secondary outcomes:
measure: Longitudinal monitoring
timeFrame: 36 months
Other outcomes:
Locations:
city: Compton
country: United States
facility: DxTerity Diagnostics, Inc.
state: California
Study officials:
affiliation: DxTerity Diagnostics
name: Robert Terbrueggen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05653492: Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease
Official title: Safety, Feasibility, and Tolerability of Sulforaphane in Children with CKD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pediatric Kidney Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Renal Research Institute
First posted: 2022-12-16
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic of kidney disease
* have eGFR 20-59 mL/min/1.73m2 at the time of enrollment
* parents must be able to provide consent

Exclusion Criteria:

* weight \<30 kg
* cancer or HIV diagnosis
* history of solid organ transplantation (including kidney transplant)
* structural heart disease
* currently pregnant or plan to become pregnant
* life expectancy is less than one year
* Patients will also be excluded if they are currently taking anticoagulants, immunosuppression, or chemotherapeutics

Primary outcomes:
measure: mean half life of drug in blood
timeFrame: 8 hours
measure: mean maximum concentration of drug in blood
timeFrame: 8 hours
measure: mean area under the curve of drug concentration in blood
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT03216889: Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
Official title: Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Multiple Sclerosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2017-07-13
Enrollment: 43
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 purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS by physician
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
* ≥10 on Insomnia Severity Index
* English speaking
* Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia

Exclusion Criteria:

* Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>4 on STOP BANG indicating high risk of sleep apnea
* Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
* Nervous system disorder other than MS
* Relapse and/or corticosteroid use in past 8 weeks

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Baseline to Week 7
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from Baseline to Week 7
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline to Week 7
measure: Fatigue Severity Scale (FSS)
timeFrame: Change from Baseline to Week 7
measure: Multiple Sclerosis Impact Scale (MSIS)
timeFrame: Change from Baseline to Week 7
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Katie Siengsukon, PT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05731089: IVI Aflibercept Before and After Phaco in DME.
Official title: Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Aflibercept; cataract; diabetic macular edema
Lead sponsor: Al Hadi Hospital
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective
Primary purpose: TREATMENT

Brief summary: To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).

Detailed description: A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.

Eligibility criteria: Inclusion Criteria:

- Diabetic patients with visually significant cataract

Exclusion Criteria:

* previous vitreoretinal surgery
* laser or intravitreal injections 6 months prior to the procedure
* intractable glaucom
* active intra-ocular inflammation
* retinal detachment
* vitreous hemorrhage
* epi-retinal membranes
* any other retinal vascular or neuroretinal disease.
* Patients with eventual cataract surgeries

Primary outcomes:
measure: resolving of macular edema
timeFrame: Sixth month
Secondary outcomes:
measure: Improvement of visual acuity
timeFrame: Sixth month
Other outcomes:
Locations:
city: Al Qādisīyah
country: Kuwait
facility: Ahady Hospital
state: Hawally
Study officials:
References:
Clinical trial NCT02903589: Knowledge Attitudes, Beliefs, and Practices Regarding HIV in Populations Living on the Maroni River
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 836
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general adult population living on the French bank of the maroni river

Brief summary: The HIV epidemic flared from 0 to over 1% prevalence in a decade on the Maroni river which lies between French Guiana and Surinameaim of the study is to determine the knowledge, attitudes, behaviours, and practices on HIV in the population living along the French bank of the Maroni border. Descriptive statistics are computed from the tabulation of answers to a structured questionnaire. Multivariate logistic models were computed to determine predictors of key outcomes. These data will help taylor prevention intervention in this very particular area.


Eligibility criteria: Inclusion Criteria:

* adult living on the maroni river

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: knowledge attitudes, beliefs, and practices regarding HIV and sexually transmitted diseases
timeFrame: when the interview was conducted
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References:
Clinical trial NCT00545389: Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
Official title: A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 38
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: Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).


Eligibility criteria: Inclusion Criteria:

* male \& female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
* general medical assessment satisfactory and no clinically significant and relevant abnormalities

Exclusion Criteria:

* severe ulcerative colitis
* subject in relapse for \> 6 weeks
* use of systemic or rectal steroids within last 4 weeks prior to baseline
* subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
* subjects hypersensitive to salicylates/aspirin
* subjects with moderate or severe renal impairment

Primary outcomes:
measure: % of subjects in remission (UC-DAI score)
timeFrame: Week 8
Secondary outcomes:
measure: Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology
timeFrame: 8 weeks
measure: Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA
timeFrame: 8 weeks
measure: Safety and tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda General Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: D'Haens G, Hommes D, Engels L, Baert F, van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1087-97. doi: 10.1111/j.1365-2036.2006.03082.x.
Clinical trial NCT04200989: Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy
Official title: Intra-lymphatic Immunotherapy for the Management of Peanut Allergy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Food Allergy Peanut
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: The Scripps Research Institute
First posted: 2019-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects receive the study intervention: Peanut ILIT.
Primary purpose: TREATMENT

Brief summary: Use of three intralymphatic injections of peanut allergen one month apart to induce tolerance to peanut in peanut allergic people.

Detailed description: Eligible subject undergo a baseline blinded oral peanut challenge. Then the peanut ILIT as described above. Pretreatment with antihistamines, leukotriene modifier and albuterol before each treatment.

Following the three ILIT peanut injections a repeat blinded oral peanut challenge is performed.

Blood is drawn at each of the 5 study visits for a variety of tests trying to elucidate the mechanism(s) of the induction of tolerance to peanut.

Eligibility criteria: Inclusion Criteria:

History of peanut allergy Positive prick skin tests or invitro IgE to peanut Positive blinded oral peanut challenge.

-

Exclusion Criteria:

History of

* life threatening anaphylaxis to peanut Uncontrolled asthma

Primary outcomes:
measure: Peanut tolerance
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic
state: California
Study officials:
affiliation: Scripps Health
name: Simon A Ronald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.
citation: Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.
citation: Lee SP, Choi SJ, Joe E, Lee SM, Lee MW, Shim JW, Kim YJ, Kyung SY, Park JW, Jeong SH, Jung JH. A Pilot Study of Intralymphatic Immunotherapy for House Dust Mite, Cat, and Dog Allergies. Allergy Asthma Immunol Res. 2017 May;9(3):272-277. doi: 10.4168/aair.2017.9.3.272.
Clinical trial NCT02651389: Evaluation of Tests Performance on a New Digital Orthoptic Platform
Official title: Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binocular Vision Disorder
Visual Impairment
Keywords: Digital Orthoptic Platform
Vision test
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People performing an orthoptic exam at ophthalmology department of Brest University Hospital.

Brief summary: This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.

Detailed description: The demography of ophthalmologists is becoming weaker, many tasks are now performed by orthoptists. To optimize the achievement of orthoptic exams and thus make reliable screening in a shorter time, digital tools are developed. They attempt to renew the orthoptic screening equipment that is still made up of numerous tests, often with old designs that must be handled and adapted to each patient which constitutes a significant loss of time.

It therefore appeared necessary for us to develop a platform of digital tools that integrates major tests used for diagnostic purposes, especially a visual acuity test, a stereoscopic vision test, a fusion test and a digital synoptophore enabling a detailed analysis of disorders of binocular vision.

The purpose of the study is to evaluate this new tool, avoiding the mobilization of patients , and quantify whether this platform is precise, reliable, fast, comfortable and allow the realization of a safe examination for the patient and for orthoptics.

Eligibility criteria: Inclusion Criteria:

* Patients with less than or equal to 16 ocular deviation prism diopters, without or with slight amblyopia (maximum difference of 2 logarithmic visual acuity lines) and performing an orthoptic exam at ophthalmology department of Brest University Hospital.

Exclusion Criteria:

* monophthalmic
* Medium and deep amblyopic patients
* Patients with not normal ocular motility
* Patient who underwent surgery at the head and neck during the previous three months
* Children under 7 years old.

Primary outcomes:
measure: Correlation of Ocular Convergence as Measured by the Two Machines
timeFrame: through study completion, an average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: University Hospital of Brest
name: Béatrice Cochener, Pr
role: PRINCIPAL_INVESTIGATOR
References: