louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01297075: Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Official title: Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Health Services Research
Chronic Care
Outreach Visits
Primary care
chronic disease management
Lead sponsor: Research Unit Of General Practice, Copenhagen
Sponsor class: OTHER
Collaborators: name: Region Capital Denmark
First posted: 2011-02-16
Enrollment: 189
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice.

The Facilitator Project is funded by The Danish Ministry of Interior and Health.

Detailed description: In a cluster randomized trial the investigators will explore the efficacy of up to three outreach visits by specially trained GPs. Efficacy data are obtained by means of questionnaires at regional databases.

Eligibility criteria: Inclusion Criteria:

General Practices working in the capital region in Denmark

Exclusion Criteria:

General Practices where the facilitator works.

Primary outcomes:
measure: Change from baseline at 12 month in Annual systematic chronic disease follow up consultations
timeFrame: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)
Secondary outcomes:
measure: ICPC diagnosis coding
timeFrame: 12 months
measure: Sentinel Data Capture
timeFrame: 12 months
measure: Stratification
timeFrame: 12 months
measure: Change from baseline and at 12 month in practices with low performance on annual systematic chronic disease follow up consultations.
timeFrame: Month 4, 3, 2 before baseline and month 13,14,15 after baseline (after intervention)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Frans Boch Waldorff
state: Capital Area
city: Copenhagen
country: Denmark
facility: Research Unit of General Practice
state: Capital
Study officials:
affiliation: Research Unit of General Practice
name: Frans B Waldorff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Due TD, Thorsen T, Kousgaard MB, Siersma VD, Waldorff FB. The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial. BMC Fam Pract. 2014 Apr 9;15:65. doi: 10.1186/1471-2296-15-65.
Clinical trial NCT00433875: Phase 2 AMG 714 in Rheumatoid Arthritis
Official title: A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a 3 month observational period.


Eligibility criteria: Inclusion Criteria: Diagnosis of RA -

Exclusion Criteria: No prior biologic treatment for RA

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01882075: Closed-loop Fluid Administration System: Pilot Study to Evaluate Feasibility
Official title: Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Anesthesia
Fluid administration
Closed-loop
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.

Detailed description: The optimization of the cardiac output is an important goal during anesthesia to decrease the postoperative morbidity, mortality and the care costs.

We want to test if the closed-loop fluid administration is feasible.

Two groups will be compared. In all cases:

* anesthesia will be provided by a closed-loop which aim is to maintain bispectral index between 40 and 60 using propofol and remifentanil. This method permits to have similar depths of anesthesia in all cases.
* cardiac output will be continuously monitored by LidCO. In one group, fluid replacement is decided by the physician; in the other, fluid replacement is automated using a closed-loop system.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18-75 years
* Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
* Consenting to participate in the study

Exclusion Criteria:

* Pregnant, breast feeding women
* Allergy
* Pacemaker
* Psychiatric disease, dementia, brain disease
* Contraindication to hydroxyethyl starch
* Inability to measure pulse pressure variability : arrhythmia, spontaneous breathing, or tidal volume \< 7 ml/Kg

Primary outcomes:
measure: Mean cardiac output index during the surgery
timeFrame: One day after anesthesia
Secondary outcomes:
measure: Time before reaching maximizing cardiac output
timeFrame: One day after anesthesia
measure: Volume of fluid replacement during surgery
timeFrame: One day after anesthesia
measure: cardiac index during the surgery
timeFrame: One day after anesthesia
measure: arterial hypertension
timeFrame: One day after anesthesia
measure: Dysfunction of the closed-loop fluid device
timeFrame: One day after anesthesia
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
Clinical trial NCT06585475: Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map
Official title: The Effectiveness of Structured Training According to the Premenstrual Syndrome Symptom Map
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndromes
Education
Menstrual Cycle Disorder
Keywords: life satisfaction
pain
depression
stress
anxiety
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.


Eligibility criteria: Inclusion Criteria:

Meeting ACOG's PMS diagnostic criteria Being over 18 years of age, Not using psychotherapeutic medications, Not having a mental illness, Not being pregnant, Agreeing to participate in the study

Exclusion Criteria:

Not having regular menstruation in the last 3 months, Using analgesics during menstruation while participating in the study.

Primary outcomes:
measure: Premenstrual syndrome assessment scale
timeFrame: pre-intervention, 2 month after intervention
measure: premenstrual syndrome specific life satisfaction scale
timeFrame: pre-intervention, 2 month after intervention
measure: DAS depression stress anxiety assessment scale
timeFrame: pre-intervention, 2 month after intervention
measure: VAS pain score
timeFrame: pre-intervention, 2 month after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
References:
Clinical trial NCT05124275: Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Keywords: Pilocarpine
Refractive errors
Loss of near vision
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 123
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.


Eligibility criteria: Inclusion Criteria:

* Presbyopic male or female 40-55 years of age
* Willing and able to provide written informed consent on the IRB/IEC approved informed consent form

Exclusion Criteria:

* Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
* History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products
* History of, or active, iritis or uveitis in either eye
* Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment

Primary outcomes:
measure: Binocular Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: Day 28
Secondary outcomes:
measure: Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.
timeFrame: Day 28
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Glaukos Investigator
state: Arizona
city: Sun City
country: United States
facility: Glaukos Investigator
state: Arizona
city: Glendale
country: United States
facility: Glaukos Investigator
state: California
city: Newport Beach
country: United States
facility: Glaukos Investigator
state: California
city: Petaluma
country: United States
facility: Glaukos Investigator
state: California
city: Louisville
country: United States
facility: Glaukos Investigator
state: Kentucky
city: Rochester
country: United States
facility: Glaukos Investigator
state: New York
city: Memphis
country: United States
facility: Glaukos Investigator
state: Tennessee
city: Houston
country: United States
facility: Glaukos Investigator
state: Texas
city: San Antonio
country: United States
facility: Glaukos Investigator
state: Texas
Study officials:
References:
Clinical trial NCT05337475: Feeding and Swallowing Problems in Infants With Laryngomalacia
Official title: Feeding and Swallowing Problems in Infants With Laryngomalacia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding Disorders
Swallowing Disorder
Laryngomalacia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Infants with suspected laryngomalacia referred to phoniatrics unit, Sohag University Hospitals.

Brief summary: Observational cross-sectional study Infants with laryngomalacia Feeding and swallowing assessment

Detailed description: Identification of swallowing and feeding disorders in infants with laryngomalacia.

Identify if there is relation between severity of laryngomalacia and feeding and swallowing disorder.

Eligibility criteria: Inclusion criteria:

* Infants up to 2 years old diagnosed with laryngomalacia.
* Full term infants.

Exclusion criteria:

* Infants with other possible causes of dysphagia e.g., craniofacial anomalies, BDMH and neurological affection secondary to birth trauma, hypoxic ischemic encephalopathy and other brain insults.
* Infants who were lethargic and/or medically unstable and were generally unable to participate to protocol of assessment.
* Premature infants.

Primary outcomes:
measure: Mansoura Early Feeding Skills Assessment (MEFSA)
timeFrame: 2 years
measure: Fibreoptic Endoscopic Evaluation of swallowing (FEES)
timeFrame: 2 years
Secondary outcomes:
measure: The Functional Oral Intake Scale- Suckle Feeds and Transitional Feeds (FOIS-SFTF)
timeFrame: 2 years
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospitals
state: سوهاج
Study officials:
References:
Clinical trial NCT04034875: Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
Official title: SOCIALBI, a Rasch Questionnaire for the Evaluation of Anger, Hostility and Aggression After Acquired Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Lesion
Keywords: Acquired cerebral lesion
Anger
Aggression
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The incidence of aggression and violent behavior is usually reported to be high after acquired brain injury, around 54%. Behaviors with verbal agression and, less frequently, physical agressions, are described.

These behaviors may be linked to the dysfunction of the frontal lobes responsible for executive functions and complex social interactions, or to the dysfunction of the temporal structures that may also be responsible for increased aggression.

It is interesting to note that very few scales or specific questionnaires evaluate the factors and co-variables that could lead to aggressive behavior after an acquired brain injury. Such questionnaires are very rare, and none have been validated in French.

The objective of this study is to develop a questionnaire in French that aims to assess anger, hostility and aggression after acquired brain injury. The psychometric qualities of this questionnaire will be evaluated using the Rasch probabilistic model.

The development of such a tool will be of major interest for clinical practice and future clinical research.


Eligibility criteria: Inclusion Criteria:

* Patients of the CHU Brugmann Hospital
* Central neurological pathology of vascular or traumatic origin, acute or chronic (known since more than one year).

Exclusion Criteria:

* Pregnant or lactating women
* Presence or antecedents of psychiatric disease
* Degenerative pathology (ex: Parkinson...)
* Antecedents of other neurologic pathologies before the acquired lesion
* Oral or written comprehension dysfunctions.

Primary outcomes:
measure: Questionnaire evaluation by Rasch methodology
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brugmann University Hospital
city: Paris
country: France
facility: Hôpital Universitaire Pitié-Salpêtrière
city: Saint-Maurice
country: France
facility: Hôpitaux Saint Maurice
Study officials:
affiliation: CHU Brugmann
name: Eric Durand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05388175: LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
Official title: Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome in Preterm Infants
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia, and hemodynamic changes.

Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.

Detailed description: This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.

Eligibility criteria: Inclusion Criteria:

* Level III NICU consultants and residents will be eligible to participate in the study

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Total time of device (catheter) positioning
timeFrame: 5 minutes
Secondary outcomes:
measure: Success of device positioning at the first attempt
timeFrame: 1 minute
measure: Achievement of the correct depth of the catheter in the trachea
timeFrame: 5 minutes
measure: Participant's opinion regarding the procedure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Poliambulanza Breacia
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova, University of Padova
Study officials:
References:
Clinical trial NCT06919575: A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial
Official title: A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Frailty refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals.

We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months.

This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.


Eligibility criteria: The inclusion criteria were the following: (1)≥60-years old; (2) recognized as frailty by Fried scale.

The exclusion criteria were the following: (1) considered with life expectancy \< 1 year such as advanced cancer patients; (2) difficult to communicate with such as patients with severe cognitive impairment (Mini Mental State Examination score ≤ 17); (3) severe hearing disord.

Primary outcomes:
measure: Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals.
timeFrame: The GAS score was calculated according to a standardized formula and assessed at baseline, 3 months, and 24 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: