louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03804723: Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
Official title: Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Glucocorticoids
Therapy Withdrawal
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
Primary purpose: TREATMENT

Brief summary: This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
* Aged 18 to 75 years old, inclusive, at the time of informed consent
* Documented diagnosis of SLE according to the current ACR criteria
* Stable immunosuppressive treatment for SLE for a minimum of one year/six months
* Stable treatment with antimalarials for a minimum of 3 months
* stable (lasting for at least 6 months) low disease activity

Exclusion Criteria:

* Disease activity (non LLDAS) within 6 months prior to screening
* Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
* Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
* Nursing mothers, pregnant women or women planning to become pregnant during the study.

Primary outcomes:
measure: disease flare
timeFrame: 35 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02287623: Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study
Official title: Subcostal TAP Block With Liposomal Bupivacaine vs Bupivacaine in Donor Nephrectomy Patients: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 60
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: The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

Detailed description: The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. These two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a TAP block. A TAP block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. This layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen.

Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.

Eligibility criteria: Inclusion Criteria:

* presenting for donor nephrectomy

Exclusion Criteria:

* non english speaking
* chronic pain condition
* taking chronic opioids

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 48-72 hours after injection
Secondary outcomes:
measure: Post Operative Opioid Use
timeFrame: 48-72 hours
measure: Number of Patients With Post Operative Nausea/Vomiting
timeFrame: 0-72 hours
measure: Post Operative Length of Stay
timeFrame: up to 30 days after surgery
measure: Postoperative Opioid Use
timeFrame: 24-48 hours
measure: Post Operative Opioid Use
timeFrame: 0-24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04159623: Clinical Applicability of the Device Belk in the Rehabilitation Process
Official title: Clinical Applicability of the Device Belk in the Rehabilitation Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Application Site Atrophy
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2019-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot, interventional, randomized of parallel groups and multicenter clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes.
* Patients aged between 18 and 85 years.
* Patients with knee arthroplasty in the immediate postoperative period.
* Sign in informed consent.

Exclusion Criteria:

* Physical or psychological pathologies that prevent patient participation.
* Tumor arthroplasty.
* Knee replacement prosthesis.
* Impossibility of holding the device.
* Patients with a pacemaker.

Primary outcomes:
measure: Number of sessions until recovery
timeFrame: An average of 12 weeks
Secondary outcomes:
measure: March in 10 meters
timeFrame: An average of 12 weeks
measure: UP&Go test
timeFrame: An average of 12 weeks
measure: Number of falls during rehabilitation sessions
timeFrame: An average of 12 weeks
Other outcomes:
Locations:
city: Baracaldo
country: Spain
facility: IIS Biocruces Bizkaia
state: Bizkaia
Study officials:
References:
Clinical trial NCT06434623: Federal Learning Algorithm for an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients
Official title: A Multicenter Federal Learning Algorithm to Build an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 30100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetes who

Brief summary: Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

Detailed description: Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes inpatients receiving insulin therapy

Exclusion Criteria:

* use of insulin pumps or glucocorticoids during hospitalisation
* less than two days of insulin therapy

Primary outcomes:
measure: the accuracy of AI models
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Xiaoying Li, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03964623: Impact of Nicotine on Retinal Vascularization
Official title: Impact of Nicotine on Retinal Vascularization (Tabaret)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tabagism
Keywords: OCT-A
smokers
vapers
non-smokers/non-vapers
nicotine
retinal micro-vascularization
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: smokers, non-smokers/non-vapers or vapers if they meet the inclusion and non-inclusion criteria

Brief summary: The main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization.

Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption via cigarette or e-cigarette data will be collected.

The objective is to seek an association between retinal vascular density and inhaled nicotine intake.


Eligibility criteria: Inclusion criteria

* For group of smokers: Patient reporting active smoking for at least 3 months and at least 1 cigarette per day on average over a week
* For group of vapers : Patient using exclusively the electronic cigarette with a nicotine level of more than 6mg/ml for at least 3 months and at least 1 times per day on average over a week.
* For group of no-smokers no-vapersNon-smoking and no vaping, for more than 6 months

Non-inclusion criteria:

* Caffeine intake within 2 hours prior to the OCT-A exam
* ametropia greater than + 3 dioptres of hyperopia or-3 dioptres of myopia
* astigmatism greater than 2 dioptres
* Known retinal or retina vascular pathology

Primary outcomes:
measure: Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.
timeFrame: At the inclusion consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
References:
Clinical trial NCT04227223: Oxidative Balance in Opioid Therapy
Official title: Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Opioids
Keywords: neurological condition
opioids
oxidative balance
pain
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The serum measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. I
Primary purpose: DIAGNOSTIC

Brief summary: The oxidative - antioxidative balance is the crucial mechanism of opioid-induced immunomodulation. Additionally, impairement of cognitive function during opioid therapy is another important side- effect. This phenomenon was clearly described in opioids abuse. This is interesting to evaluate the importance of this subjects in chronic pain patients. The aim of the study was to investigate the oxidative - antioxidative homeostasis and cognitive functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC) tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain treated with opioids.

Detailed description: The project was approved in Ethical Committee and supported by Medical University of Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. In Study Group anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx, PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.

Eligibility criteria: Inclusion Criteria:

* minimally, 6 months opioid therapy in chronic Low- Back Pain

Exclusion Criteria:

* depression, steroids- local or systemic administration

Primary outcomes:
measure: oxidative balance
timeFrame: 6 months of opioids therapy
measure: cognitive state
timeFrame: 6 months of opioids therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Urszula Kosciuczuk
Study officials:
affiliation: Medical University in Bialystok
name: Urszula Kosciuczuk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03955250: Mobile After-Care Support App: Pilot RCT
Official title: Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization: Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorder
Keywords: schizophrenia
psychosis
mHealth
psychiatric hospitalization
treatment adherence
transitions of care
coping skills
psychosocial intervention
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-05-20
Enrollment: 42
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: The overall aim of this program of research is to refine and test the feasibility and acceptability of a newly developed mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder. The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of the app. To achieve the specific aims, the investigators will conduct a pilot randomized clinical trial (n = 60), with two treatment arms: MACS vs. a mobile app attention control condition.


Eligibility criteria: Inclusion Criteria:

* recently hospitalized
* DSM-5 criteria for psychotic-spectrum disorder based on structured clinical interview
* 18 years or older
* prescribed antipsychotic medication upon discharge
* ability to speak and read English

Exclusion Criteria:

* substance use disorders at severe level
* planned discharge to supervised living setting or participation in formal outpatient adherence programs
* pregnancy or other medical condition contraindicating use of antipsychotic medications

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 month
Secondary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline, 4 month
measure: Brief Adherence Rating Scale (BARS)
timeFrame: Baseline, 4 month
measure: Brief Cope Inventory (Brief COPE)
timeFrame: Baseline, 4 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Ethan Moitra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294450: Feasibility Study of a New Fistula Pouching System
Official title: Pouching of Fistula - a Non-comparative, Multi-center Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cutaneous Fistula
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 22
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 purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Capable of giving informed consent
* Have to be hospitalized
* Have a fistula with the opening on the skin in the abdominal area

Exclusion Criteria:

* Pregnant and/or breast-feeding
* Receiving radiation- or chemotherapy during the investigation period

Primary outcomes:
measure: Nurse's preference to use the test product in the future
timeFrame: Up to 18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: Clearwarter
country: United States
facility: Morton Plant Hospital
state: Florida
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview - Riverside
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
Study officials:
affiliation: Coloplast A/S
name: Thais Benjamin N. Christensen, M.Sc. (BME)
role: STUDY_CHAIR
References:
Clinical trial NCT04320550: Frequency of Functional Gastrointestinal Disorders in Children
Official title: Frequency of Functional Gastrointestinal Disorders Among School Aged Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Abdominal Pain Syndrome
Keywords: abdominal pain
recurrent
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 246
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with recurrent abdominal pain will be subjected to medical history , detailed examination and some investigations

Brief summary: cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain

Detailed description: school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of recurrent abdominal pain
* the child can express and locate site of the pain

Exclusion Criteria:

* children less than 5 and adolescents more than 14
* mentally retarded children

Primary outcomes:
measure: no structural or biochemical abnormality
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
measure: structural or biochemical abnormalities
timeFrame: 1 week
Locations:
Study officials:
References:
citation: Reust CE, Williams A. Recurrent Abdominal Pain in Children. Am Fam Physician. 2018 Jun 15;97(12):785-793.
citation: Chopra J, Patel N, Basude D, Gil-Zaragozano E, Paul SP. Abdominal pain-related functional gastrointestinal disorders in children. Br J Nurs. 2017 Jun 8;26(11):624-631. doi: 10.12968/bjon.2017.26.11.624.
Clinical trial NCT01473550: Mental Health Engagement Network (MHEN)
Official title: Mental Health Engagement Network (MHEN): Connecting Clients With Their Health Team
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorder
Psychotic Disorder
Keywords: Mental Health
Smart Technology
Mood disorder
Psychotic disorder
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
name: Canadian Mental Health Association
name: St. Joseph's Health Care London
First posted: 2011-11-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with mood disorder or psychotic disorder will be given handheld devices with personal health records to educate, monitor and deliver customizable healthcare tools based on their personal needs. The use of technology has great potential to deliver care more effectively and efficiently. No actual information is on the handheld device - it is accessed from a secure site behind hospital firewalls.


Eligibility criteria: Inclusion Criteria:

* Must be diagnosed with mood disorder or psychotic disorder for a minimum one year
* Able to make informed consent to participate in the study
* Able to understand and speak English to the degree necessary to participate in interviews/focus groups

Exclusion Criteria:

* Younger than 18 or older than 80

Primary outcomes:
measure: Lehman Quality of Life - Brief Version
timeFrame: Every 6 months for total of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Canadian Mental Health Association (London-Middlesex Branch)
state: Ontario
city: London
country: Canada
facility: Regional Mental Health Care
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Western Ontario Therapeutic Community Hostel
state: Ontario
Study officials:
affiliation: Lawson Health Research Institute; University of Western Ontario
name: Cheryl Forchuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forchuk C, Donelle L, Ethridge P, Warner L. Client Perceptions of the Mental Health Engagement Network: A Secondary Analysis of an Intervention Using Smartphones and Desktop Devices for Individuals Experiencing Mood or Psychotic Disorders in Canada. JMIR Ment Health. 2015 Jan 21;2(1):e1. doi: 10.2196/mental.3926. eCollection 2015 Jan-Mar.