louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03184896: Services Mapping Among Older Adults With Hip Fracture
Official title: Multicenter Prospective Observational Study in Hip Fracture Among Older Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Beijing Anzhen Hospital
name: Beijing Friendship Hospital
name: Beijing Shuyi Hospital
name: Beijing Fangshan District Liangxiang Hospital
name: Beijing Changping District Hospital
name: Beijing Jishuitan Hospital
First posted: 2017-06-14
Enrollment: 2500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a history of an acute injury that occurred within 21 days, and diagosed by X-ray will be recruited in this study.

Brief summary: Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public health issue in China. The British Orthopedic Association and the British Geriatric Society have published the UK Blue Book, which summarizes current evidence and best practice in the hip fracture care and secondary prevention, but this kind of standardized practice in hip fracture care is not yet existed in China. The Blue Book standards will be used as the most contemporary evidence-based guidelines for management of hip fracture.This study is to prospectively examine the barriers and facilitators in the current management of hospital in China by comparing the Blue Book standards.


Eligibility criteria: Inclusion Criteria:

* Adults aged 65 years old or over;
* Hip fracture with X-ray-confirmed femoral neck, trochanteric or sub-trochanteric fracture;
* Within 21 days of a hip fracture;
* Willingness to sign informed consent form;

Exclusion Criteria:

* Patients with pathological fractures;
* With terminal malignancies.

Primary outcomes:
measure: Operative administration within 48 hours
timeFrame: One year
Secondary outcomes:
measure: A&E Admission within 4 hours
timeFrame: One year
measure: The Incidence of Pressure Ulcer
timeFrame: One year
measure: The Proportion of Patients Who Receive Geriatrician Assessment
timeFrame: One year
measure: The Proportion of Patients Who Receive Osteoporosis Assessment and Treatment
timeFrame: One year
measure: The Proportion of Patients Who Receive Specialist Falls Assessment
timeFrame: One year
Other outcomes:
measure: Mortality Rate in One Month, Four-Month, and One Year
timeFrame: One month, four-month, and one year
measure: The Incidence of Complications in One Month, Four-Month, and One year
timeFrame: One month, four-month, and one year
Locations:
city: Beijing
country: China
facility: The George Institute
Study officials:
References:
Clinical trial NCT01675596: The SOLACE-AU Clinical Trial
Official title: A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe, Symptomatic Aortic Stenosis
Keywords: Aortic Stenosis
Transfemoral
Transcatheter Heart Valve
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: Pacific Clinical Research Group
First posted: 2012-08-30
Enrollment: 199
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Detailed description: This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial \[NCT01314313\].

Eligibility criteria: Inclusion Criteria:

* Age \> 70 years
* STS Score \> 4
* Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate

Exclusion Criteria:

* Age \<70 years
* Evidence of an acute myocardial infarction ≤ 30 days
* Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
* Stroke or transient ischemic attack (TIA) within 6 months of the procedure

Primary outcomes:
measure: VARC-2 Composite Safety Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 30 days
measure: All Cause Mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie Unversity Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital - MELBOURNE
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital/Fiona Stanley Hospital
state: Western Australia
Study officials:
affiliation: The Prince Charles Hospital
name: Dr. Owen Christopher Raffel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04161196: Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
Official title: Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post - Tonsillectomy Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 and over.
2. patients with tonsillectomy indication due to chronic Tonsillitis.

Exclusion Criteria:

1. patients with tonsillectomy indication without chronic tonsillitis ( due to other causes).
2. chronic disease, chronic neurology disease.
3. chronic psychology disease.
4. bleeding tendency.

Primary outcomes:
measure: Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03365596: Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients
Official title: Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Brain connectivity
Magnetic resonance imaging
Recovery prediction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First-ever stroke patients at subacute stage.

Brief summary: Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.


Eligibility criteria: Inclusion Criteria:

* First-ever stroke patients
* Unilateral stroke
* Subacute stage (less than 4 weeks)

Exclusion Criteria:

* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain

Primary outcomes:
measure: Fugl-Meyer Assessment score at 3 months after stroke onset
timeFrame: 3 months after stroke onset
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02616796: Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Official title: Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fragile X Syndrome
Intellectual Disability
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 71
Sex: MALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.


Eligibility criteria: Inclusion Criteria:

1. Boys diagnosed with fragile X syndrome
2. Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
3. Age 8 to 18 years inclusive
4. Ability to travel to Stanford
5. Vineland Adaptive Behavior Scales standard score between 50 and 75 points

Exclusion Criteria:

1. Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
2. Materials in body that would preclude an MRI scan (e.g., dental braces).

Primary outcomes:
measure: Percentage of social gaze aversion recorded during the social challenge
timeFrame: 3 days
measure: Heart rate recorded during the social challenge
timeFrame: 3 days
measure: Total t-score on the Social Responsiveness Scale (SRS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Verbal responses and pauses in conversation observed during the social challenge
timeFrame: 3 days
measure: Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex
timeFrame: 3 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
citation: Gannon CE, Britton TC, Wilkinson EH, Hall SS. Improving social gaze behavior in fragile X syndrome using a behavioral skills training approach: a proof of concept study. J Neurodev Disord. 2018 Aug 28;10(1):25. doi: 10.1186/s11689-018-9243-z.
Clinical trial NCT04130958: Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Official title: Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Episode
Borderline Personality Disorder
Suicide
Keywords: Transcranial Magnetic Stimulation
Intermittent Theta Burst
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).

Detailed description: This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Diagnosed with BPD or MDE
* Chief complaint of suicidal thoughts and behaviors

Exclusion Criteria:

* Neurological conditions with known structural brain lesion
* Prior neurosurgical procedure
* Metal in the body that is ferromagnetic or metal injury to the eyes
* Epilepsy
* Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
* Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
* Current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report
* Inability to meet the safety criteria for MRI scanning according to the protocols of the MGH Department of Radiology
* Current pregnancy

Primary outcomes:
measure: Changes in Functional Connectivity of Key Nodes
timeFrame: Through Treatment Completion, Average of 3 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: 6177265348
name: Joan Camprodon, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05783258: Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage
Official title: Comparative Evaluation of the Coronally Advanced Flap (CAF) Using a Connective Tissue Graft From the Tuberosity (tCTG) or L-PRF Membranes: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Root coverage
Periodontal plastic surgery
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 30
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 aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.

A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.


Eligibility criteria: Inclusion Criteria:

* Presence of a class RT1 recession;
* age \> 18 years;
* systemic health conditions that do not affect the periodontium;
* Non smoker;
* FMPS and FMBS values \< 20% before the surgical procedure;
* absence of implants or subgingival restorations in the sites to be treated;
* presence of adequate tissue distal to the last maxillary molar.

Primary outcomes:
measure: Gingival thickness
timeFrame: 12 months
Secondary outcomes:
measure: Keratinized tissue height
timeFrame: 12 months
measure: Gingival recession
timeFrame: 12 months
measure: Complete root coverage
timeFrame: 12 months
measure: Clinical attachment level
timeFrame: 12 months
measure: Pocket depth
timeFrame: 12 months
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Michele Paolantonio
Study officials:
References:
Clinical trial NCT03764358: AUSTrian Randomized Interventional Study on Dialysis Accesses
Official title: Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Catheter Infection
Shunt Malfunction
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index \>6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.


Eligibility criteria: Inclusion Criteria:

* Age of 60 and higher
* CCI Score \>6 when under 60 years
* Patients with CKD G5 A1-3 with indication for hemodialysis
* Stable clinical condition
* Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
* Availability for follow-up.
* Written informed consent.

Exclusion Criteria:

* Uncontrolled infection at screening and/or CRP \>5 mg/dl (normal \<0.5 mg/dl) at screening.
* Poor general condition of health or malignancy not in remission at screening
* Major surgery within 12 weeks before screening.
* Pre-existent vascular access.
* Patient not eligible for any one of the vascular access options.

Primary outcomes:
measure: Composite primary end-point of any access related complication
timeFrame: From placement of vascular access through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis
name: Guerkan Sengoelge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04658758: The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors
Official title: Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vein Infusion Phlebitis
Keywords: vein infusion phlebitis
proton pump inhibitor therapy
intravenous infusion
ulcer bleeding
aging
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients aged \> 70 years.

Brief summary: Intermittent or continuous proton pump inhibitor (PPI) therapy are recommended for high-risk bleeding ulcers according to the French Society of Gastroenterology. The prevalence of incidence of vein infusion phlebitis after PPI intravenous infusion is high in geriatric acute ward (about 10% of severe vein infusion phlebitis).

The primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after PPI intravenous infusion in aging people.

The secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.

Detailed description: This is a multicenter observational study. 5 centers will participate to the study. Aging patients undergoing PPI intravenous infusion therapy will be proposed to be enrolled in the study. Paramedical observation will be performed during 5 days for each enrolled patients.

Eligibility criteria: Inclusion Criteria:

* Patients aged \> 70 years;
* Undergo intravenous continuous or intermittent proton pump inhibitor therapy;
* Patients being informed and not opposed to the study.

Exclusion Criteria:

* Existing vein infusion phlebitis before the PPI infusion by intravenous route;
* Under guardianship or curators;
* Covered by french AME health system.

Primary outcomes:
measure: Occurence of infusion phlebitis
timeFrame: at day-5
Secondary outcomes:
measure: Factors of risk of vein infusion phlebitis
timeFrame: Throughout of the study, an average of 1 year
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Geriatric Department, Ambroise Paré Hospital, APHP
Study officials:
affiliation: Geriatric Department, Ambroise Paré Hospital, APHP
name: Marion PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: