louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00403676: Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Official title: Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: nurse practitioner
rheumatology care
outpatient clinic
patient satisfaction
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2006-11-27
Enrollment: 68
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 effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.

Detailed description: This study is part of a national multicenter study (NOR-DMARD) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. The Nor-Dmard study is a comparative, phase IV, longitudinal, observational study. All patients starting a DMARD regime are enrolled. Patients from two clinics (different parts of Norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist.

The primary outcome measure is patient satisfaction measured by Leeds Satisfaction Questionnaire.

The secondary outcome is effectiveness measured by Coping (CORS),Health related quality of life (SF-36) and Disease activity (MHAQ, DAS-28).

Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.

Primary outcomes:
measure: patient satisfaction
timeFrame: 12 mnths and 24 mnths
Secondary outcomes:
measure: Health related quality of life
timeFrame: 12 mnths and 24 mnths
measure: Disease activity
timeFrame: 12 mnths and 24 mnths
measure: coping
timeFrame: 12 mnths and 24 mnths
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Kåre Birger Hagen, PhD
role: STUDY_CHAIR
References:
citation: Koksvik HS, Hagen KB, Rodevand E, Mowinckel P, Kvien TK, Zangi HA. Patient satisfaction with nursing consultations in a rheumatology outpatient clinic: a 21-month randomised controlled trial in patients with inflammatory arthritides. Ann Rheum Dis. 2013 Jun;72(6):836-43. doi: 10.1136/annrheumdis-2012-202296. Epub 2013 Feb 7.
Clinical trial NCT03998176: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
Official title: A Phase 4, Single-Arm Study of the Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Patients With Active Illicit Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: Substance use
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2019-06-26
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected patients who actively use illicit substances. The study will also evaluate retention in care and adherence to B/F/TAF by self-report and pharmacokinetic analysis.

Detailed description: This is a single-center, single-arm, prospective, pilot study to evaluate the effectiveness and safety of B/F/TAF in viremic HIV-1 infected treatment naive or experienced patients with active illicit substance use outside of nicotine, alcohol, and marijuana use.

Eligibility criteria: Inclusion Criteria:

* Documented HIV-1 infection
* Treatment naive or experienced
* Self-reported illicit substance use or confirmed urine drug screen within past 6 months of any of the following: cocaine, heroin, methamphetamine, MDMA, phencyclidine, ketamine, gamma hydroxybutyrate, cathiniones, or inappropriate prescription opiate, benzodiazepine or stimulant use (excluding nicotine, alcohol, marijuana for criteria)
* HIV RNA \>1000 copies/mL
* Creatinine clearance \> 30 mL/min (Cockroft-Gault)
* ALT and AST \< 5 times the upper limit of normal
* Willing and able to provide written informed consent

Exclusion Criteria:

* History of integrase or tenofovir related HIV resistance mutations
* Pregnancy
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry

Primary outcomes:
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Grade 3 or Greater Adverse Events
timeFrame: Week 24
measure: Percentage of Participants With Grade 3 or Greater Adverse Events
timeFrame: Week 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
timeFrame: Week 48
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Joshua Havens, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053776: Clinical and Laboratory Predictors of Respiratory Morbidities in CP Children
Official title: Clinical and Laboratory Predictors of Respiratory Morbidities in Children With Cerebral Palsy at Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Respiratory Tract Infections
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Identification of different respiratory problems in children with cerebral palsy

Brief summary: Relationship between respiratory morbidities and cerebral palsy in children

Detailed description: Identification of symptoms,signs,severity and outcomes of respiratory morbidities in children with Cp

Eligibility criteria: Inclusion Criteria:

* children with CP from 1 month to 18 years

Exclusion Criteria:

* neonates with Cp CP patients more than 18 years old

Primary outcomes:
measure: Chest auscultation
timeFrame: Baseline
Secondary outcomes:
measure: Chest X-ray
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00516776: The Innate Immune System and Inflammatory Bowel Disease
Official title: The Innate Immune System and Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Crohn's Disease
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2007-08-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from endoscopy unit and outpatients clinic with ulcerative colitis, Crohn's disease and healthy controls

Brief summary: The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Colonic mucosal samples are examined to find gene expression patterns which may distinguish the two forms of disease from each other and from healthy controls.

The hypothesis is that the innate immune system has responses unique for the disease states, and that the diseases may be differentiated by examination of gene expression patterns in mucosal biopsies.


Eligibility criteria: Inclusion Criteria:

* Presence of ulcerative colitis
* Presence of Crohn's disease
* Healthy (no sign of inflammatory bowel disease)

Exclusion Criteria:

* Anticoagulation
* Cardiac valvular disease
* Intravascular prosthesis
* Coagulation disorders
* Gastrointestinal malignancy

Primary outcomes:
measure: gene expression patterns in mucosal biopsies
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept of Cancer Research and Molecular Medicine, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Arne K Sandvik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenna O, Bruland T, Furnes MW, Granlund Av, Drozdov I, Emgard J, Bronstad G, Kidd M, Sandvik AK, Gustafsson BI. The guanylate cyclase-C signaling pathway is down-regulated in inflammatory bowel disease. Scand J Gastroenterol. 2015;50(10):1241-52. doi: 10.3109/00365521.2015.1038849. Epub 2015 May 15.
citation: Ostvik AE, Granlund Av, Gustafsson BI, Torp SH, Espevik T, Mollnes TE, Damas JK, Sandvik AK. Mucosal toll-like receptor 3-dependent synthesis of complement factor B and systemic complement activation in inflammatory bowel disease. Inflamm Bowel Dis. 2014 Jun;20(6):995-1003. doi: 10.1097/MIB.0000000000000035.
citation: Ostvik AE, Granlund AV, Bugge M, Nilsen NJ, Torp SH, Waldum HL, Damas JK, Espevik T, Sandvik AK. Enhanced expression of CXCL10 in inflammatory bowel disease: potential role of mucosal Toll-like receptor 3 stimulation. Inflamm Bowel Dis. 2013 Feb;19(2):265-74. doi: 10.1002/ibd.23034.
Clinical trial NCT04416776: Validation of the Utility of Strabismus Intelligent Diagnostic System
Official title: Validation of the Utility of Strabismus Intelligent Diagnostic System: A Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmological Disorder
Strabismus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 323
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective study to validate the accuracy of the strabismus intelligent diagnostic system in the clinical practice.

Brief summary: Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients in the outpatient clinic of strabismus department.

Exclusion Criteria:

* Patients or their parents diagree to participate in the trial.
* Patients with blepharoptosis.
* Patients can't facing forward or lacking fixation.

Primary outcomes:
measure: The proportion of accurate, mistaken and miss detection of the diagnostic system.
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05744076: Analysis of Circulating Exosomes in Melanoma Patients
Official title: Analysis of Circulating Exosomes in Melanoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Georges Francois Leclerc
First posted: 2023-02-24
Enrollment: 150
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: Melanoma patients admitted in Besançon University Hospital

Brief summary: The hypothesis is that PD-L1\[Programmed Death-Ligand 1\] labeling in exosomes could be a biomarker of disease progression in melanoma. The rate of circulating exosomes, their size and the exosomal expression of PD-L1 could be correlated with the stage of the disease, the response to treatment and/or the prognosis of patients. In this study, blood samples (EDTA tubes taken as part of routine care at Besançon University Hospital) and associated clinical data are reused.


Eligibility criteria: Inclusion Criteria:

* Melanoma patients admitted in Besançon University Hospital
* exigible for immunotherapy such as anti PD-L1/PD-1
* Age ≥18 years
* Affiliation to a social security system,

Exclusion Criteria:

* Minor patients
* Patients who have expressed their opposition to the reuse of their data and biological samples

Primary outcomes:
measure: Quantification of circulating exosomes
timeFrame: Day 1
Secondary outcomes:
measure: PDL1 marking
timeFrame: Day 1
measure: Other proteins detection
timeFrame: Day 1
measure: Determine whether the initial exosome concentration (at T0) is associated with a response to treatment.
timeFrame: Day 1
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT01903876: A Web-based Bystander Education Program
Official title: Preventing Violence Against Women: A Web-based Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Violence
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-07-19
Enrollment: 743
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to determine whether a theoretically-driven web-based 3-hour intervention designed for male college students called RealConsent is effective in increasing prosocial intervening behaviors and in preventing sexual violence perpetration. Sexual violence programs for this population have been implemented for decades in the United States, but a program that is web-based and incorporates the bystander education model has never been implemented or tested. In this study, male college students will be recruited online, enrolled and randomly assigned to RealConsent or to a comparison condition. Prior to the intervention, investigators will ask questions about their intervening and sexually coercive behaviors and other theoretical and empirical factors related to the study outcomes. Investigators will survey the young men again at post-intervention, and at 6-months follow-up to determine whether young men in the RealConsent program intervened more often and engaged in less sexual violence compared to young men in the comparison condition. The main hypotheses are: (1) college men in the RealConsent program will report more instances of prosocial intervening; and (2) college men in the RealConsent program will report less sexual violence against women.


Eligibility criteria: Inclusion Criteria:

* Student matriculated at Georgia State University
* Male
* 18 to 24
* Undergraduate
* Self-identify as heterosexual or bisexual

Exclusion Criteria:

* Graduate student
* Self-identify as homosexual

Primary outcomes:
measure: Prosocial Intervening Behavior
timeFrame: 6 months
Secondary outcomes:
measure: Sexual Violence Perpetration
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Emory University
name: Laura F Salazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salazar LF, Vivolo-Kantor A, Hardin J, Berkowitz A. A web-based sexual violence bystander intervention for male college students: randomized controlled trial. J Med Internet Res. 2014 Sep 5;16(9):e203. doi: 10.2196/jmir.3426.
Clinical trial NCT00997776: Effect of Leg Strengthening Exercise After Hip Fracture
Official title: Effect of Leg Strengthening Exercise After Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hip Fractures
Keywords: Hip Fracture
Exercise
Rehabilitation
Functional Performance
Lead sponsor: Arcadia University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to examine the effectiveness of a short-term leg strengthening exercise program compared to attention control on improving leg strength, walking speed and endurance, physical performance, and physical function one year after hip fracture.

Detailed description: Poor functional outcomes are reported for the majority of older adults who sustain a hip fracture. The ability of hip fracture patients to make sustained functional improvements above and beyond natural recovery is unknown. It has been shown that gym-based programs can help old adults regain function after hip fracture. It is unclear if these results could be translated into the home setting that lacks the gym-based equipment, or if improvement would be sustainable. This program compares high intensity strength training performed in the home twice weekly for 10 weeks to an attention placebo control in which participants receive sensory electrical stimulation to leg muscles.

Eligibility criteria: Inclusion Criteria:

* Successful fixation (partial or total hip replacement or open reduction internal fixation) of a hip fracture within the last 6 months
* Were 65 years of age or older, were living at home prior to the fracture, had a physician referral and were discharged from physical therapy.

Exclusion Criteria:

* Medical history of unstable angina or uncompensated congestive heart failure, ongoing chemotherapy or renal dialysis, history of stroke with residual hemiplegia, Parkinson disease, absent sensation in the lower extremities due to sensory neuropathy, life expectancy of less than 6 months, and Folstein mental status scores \< 20.

Primary outcomes:
measure: lower extremity force production
timeFrame: one year after hip fracture
Secondary outcomes:
measure: six minute walk distance
timeFrame: one year post fracture
measure: free and fast gait speed
timeFrame: one year post fracture
measure: modified physical performance test
timeFrame: one year post fracture
measure: SF-36 physical function
timeFrame: one year post fracture
Other outcomes:
Locations:
city: Glenside
country: United States
facility: Arcadia University
state: Pennsylvania
Study officials:
affiliation: Arcadia University
name: Kathleen K Mangione, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02322476: Herpes Simplex Reactivation in Adult Critical Care Patients
Official title: Herpes Simplex Reactivation in Adult Critical Care Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Herpes Simplex I
Herpes Simplex II
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 140
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: Adult critically ill patients

Brief summary: Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill patients despite that clinical impact remains unknown.

Detailed description: Normally primary HSV infection is asymptomatic but can under certain circumstances cause manifestations such as encephalitis and bronchopneumonitis. Bruynseels showed that HSV was detectable in the throat of two percent of healthy volunteers and three percent of patients not admitted to the ICU, this provides a broad "recruitment-base" for either latent or lytic HSV infection in the ICU. Viral dissemination to the bloodstream is seen in neonates , immunocompromised patients, but also in patients with primary herpetic gingivostomatitis. Patients testing polymerase chain reaction (PCR) positive for herpes simplex DNA in blood, have a higher rate of systemic symptoms than those testing PCR negative for herpes simplex. Additionally it is known that HSV suppression in HIV patients has beneficial effects. PCR, now being available for more than a decade, has been shown to provide a more sensitive method for the detection of HSV than culture, but viral detection does not per se translate to viral disease thus the impact of disseminated HSV infection in ICU patients remains unclear.

The investigators would like to investigate the incidence of HSV reactivation in blood and tracheal secretions critically ill patients and its impact on clinical course.

Eligibility criteria: Inclusion Criteria:

* Admission to ICU
* Expected length of stay (LOS) \>72 hours
* Intubated \<24 hours prior to inclusion
* Informed consent by patient, relative or guardian

Exclusion Criteria:

* Ongoing antiviral treatment/prophylaxis
* Expected LOS \<72 hours
* Intubation \>24 hours prior to inclusion
* Withdrawal of informed consent

Primary outcomes:
measure: Incidence of HSV reactivation
timeFrame: Approximately 16 days
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Approximately 16 days
measure: ICU length of stay
timeFrame: Approximately 16 days
measure: 30/90 day mortality
timeFrame: 30/90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02274376: Non-Interventional Study of Xeloda (Capecitabine) in Patients With Gastric Cancer
Official title: NIS Xeloda in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced gastric cancer eligible for Xeloda (capecitabine)

Brief summary: This observational study will collect prospective data on the safety and tolerability of Xeloda in patients with advanced gastric cancer from every day clinical practice. Documentation of treatment for each patient is to continue until the end of treatment per oncologist's assessment.


Eligibility criteria: Inclusion Criteria:

* Patients aged \>/=18 years, with metastatic gastric cancer who are available for prospective documentation of their treatment (first-line chemotherapy)
* Informed consent

Exclusion Criteria:

* Contraindications to Xeloda per the Summary of Product Characteristics (SmPC)

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 4 years
measure: Safety and tolerability: incidence and nature of adverse drug reactions
timeFrame: Up to 4 years
Secondary outcomes:
measure: Proportion of patients with modifications in Xeloda dosing
timeFrame: Up to 4 years
measure: Average duration of treatment
timeFrame: Up to 4 years
measure: Number of modifications in chosen regimen combination therapy
timeFrame: Up to 4 years
measure: Incidence and nature of dose interruptions
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Mannheim
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: