louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05753319: Physiotherapist in the Emergency Department
Official title: Physiotherapist in the Emergency Department : What Impact Does the Intervention of the Physiotherapist Have on the Care Pathway of the Elderly Person Who Falls?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Fall
Keywords: Emergency department
Elderly person
Physiotherapist
Fall
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Laboratoire Motricité, Interactions, Performance (UR 4334) of Nantes University
First posted: 2023-03-03
Enrollment: 155
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People aged 75 and over admitted to emergency for falls

Brief summary: This study aims to evaluate the impact of assessment and early physiotherapy management on the care pathway of the elderly person who falls, their length of stay in hospital and their fall recurrence rate.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 75 and over
2. Patients admitted to emergency for falls.
3. Clinically stable patient who may benefit from a gait assessment or fall risk assessment
4. Patients able to understand the protocol and not verbally object to participation.

Exclusion Criteria:

1. Patients with limb fractures requiring surgical treatment
2. Patients under guardianship or curatorship.
3. Patients already included in an interventional research protocol.

Primary outcomes:
measure: Patient orientation (return home, short-term hospitalization unit, hospitalization) at discharge from the emergency department
timeFrame: up to 48 hours
Secondary outcomes:
measure: Length of stay in emergency departments and in the short stay hospital unit
timeFrame: up to 48 hours
measure: Total duration of hospitalization for each stay, all services combined
timeFrame: 1 week
measure: Number of recurrence of emergency admission for the same reason (fall)
timeFrame: up to 9 days
measure: Satisfaction of doctors in emergency services
timeFrame: 0 day
measure: Emergency discharge referral before and after assessment by the physical therapist.
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital of Nantes
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Marie Blandin
role: PRINCIPAL_INVESTIGATOR
affiliation: marie.gallet@chu-nantes.fr
name: Marie Gallet
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratoire Motricité, Interactions, Performance (UR 4334)
name: Guillaume LE SANT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04519619: Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
Official title: Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neovascular Glaucoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-19
Enrollment: 480
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: Participants with a diagnosis of NVG will be enrolled after the decision for treatment with Aflibercept (AFL) has been made by the investigator.

Participants who have been prescribed AFL for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.

Brief summary: This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.

The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NVG
* Patients who have received IVT-AFL treatment according to Japanese labeling.

Exclusion Criteria:

* Patients who are contraindicated based on approved label
* Diagnosis of other indication

Primary outcomes:
measure: The number of participants with adverse events (AEs)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Intraocular Pressure (IOP) value after study drug administration
timeFrame: Up to 6 months
measure: Mean changes in Visual Acuity
timeFrame: Up to 6 months
measure: Proportion of participants with improvement of anterior neovascularization
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many locations
Study officials:
References:
Clinical trial NCT00737841: Effect of Bifidobacterium on Irritable Bowel Syndrome
Official title: Effect of Bifidobacterium on Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: stress
brain-gut interactions
visceral perception
gastrointestinal motility
emotion
Lead sponsor: Tohoku University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients.

Detailed description: There has been no data on effect of Bifidobacterium breve on symptoms of patients with irritable bowel syndrome (IBS). We hypothesized that Bifidobacterium breve is effective on symptoms of IBS patients. IBS patients will be enrolled via advertisement. Any IBS subtypes will not be rejected. They will take either 1.0 g of Bifidobacterium breve 3 times a day or same amount of placebo for 8 weeks. IBS symptoms and allied markers will be checked before, during, and after the administration.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBS with Rome II definition

Exclusion Criteria:

* Diagnosis of serious diseases (both physically and mentally)

Primary outcomes:
measure: Adequate relief and SIBSQ
timeFrame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Secondary outcomes:
measure: Psychometric test, bowel gas, blood, and feces.
timeFrame: 2, 0, 2, 4, 8 weeks during treatment and 4 weeks after treatment
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Tohoku University Graduate School of Medicine
state: Miyagi
Study officials:
affiliation: Tohoku University
name: Shin Fukudo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096341: A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001
Official title: A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Malignant Solid Tumor
Lymphomas
Lead sponsor: EpicentRx, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 2
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: To investigate the dosage of RRx-001 by the subcutaneous route.

Detailed description: This is a phase I, open-label, dose-escalation study of RRx-001. Subjects will receive RRx-001 administered as subcutaneous injections twice weekly for at least 8 weeks. At least three subjects must complete 2 weeks of treatment with RRx-001 at each dose level, before escalation to the next higher RRx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested.

The purpose of the study is to extend the dosage options for RRx-001 since faster subcutaneous (SC) administration may increase convenience versus the traditional IV method. The study also will also measure the mean concentrations of an RRx-001 metabolite in the blood (pharmacokinetics; PK) versus the IV formulation.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old.
* ECOG (performance) status of 0, 1 or 2.
* Histologically or cytologically confirmed primary or metastatic advanced solid tumors or lymphoma. Subjects with curative treatment options are not eligible for the protocol.
* No active ongoing cancer treatment (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and anti-androgens such as; Flutamide, Dutasteride, and Finasteride).
* Adequate organ and bone marrow function.
* Male and female subjects of childbearing potential must agree to use contraception.

Exclusion Criteria:

* Pregnant or breast-feeding.
* Use of anti-coagulant therapy.

Primary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 10 weeks
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of RRx-001-glutathione conjugate
timeFrame: 1 day
measure: Peak Plasma Concentration (Cmax) of RRx-001-glutathione conjugate
timeFrame: 1 day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Jeffrey Infante, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454141: Cognitive Control Training for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depressed mood
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative thinking styles; these patterns themselves are thought to result from a combination of decreased attentional control, decreased executive functioning, and increased negative affect. Specifically, the dorsolateral prefrontal cortex has been hypothesized to play a central role in emotion regulation by recruiting resources necessary for executive control. Recent advances have been made in neurobehavioral training strategies as interventions for emotional disorders such as depression. Cognitive control training (CCT) uses computer-based exercises to recruit and activate prefrontal neural networks via repeated behavioral exercises, with the aim of strengthening cognitive and emotional functions. A previous study found that severely depressed participants who received CCT exhibited reduced negative affect and rumination as well as improved focus and concentration. The present study aimed to extend this line of research by employing a more stringent control group and testing the efficacy of three sessions of CCT over a two-week period in a community population with depressed mood. Forty-eight participants with high BDI-II scores were randomized to CCT or a comparison condition (Peripheral Vision Training; PVT). The investigators hypothesized that relative to a control condition (PVT), CCT would be associated with less self-reported negative mood and emotional reactivity.


Eligibility criteria: Inclusion Criteria:

* BU students and local community members.
* At least 18 years of age.
* Familiarity with a computer keyboard.
* BDI-II score ≥ 17

Exclusion Criteria:

* BDI-II score \< 17, or \> 35

Primary outcomes:
measure: Change in Beck Depression Inventory
timeFrame: two weeks
Secondary outcomes:
measure: Change in Positive and Negative Affective Scale (PANAS)
timeFrame: two weeks
measure: Emotional Response and Recovery Task
timeFrame: two weeks
measure: Changes in Visual Analog Scales
timeFrame: two weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References:
Clinical trial NCT04591041: HoloSIM: Mixed Reality Medical Student Training in Complex Crisis Scenarios
Official title: HoloSIM: The Way Forward in Complex Crisis Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simulation of Physical Illness
Educational Problems
Keywords: Mixed Reality
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students.


Eligibility criteria: Inclusion Criteria:

* University of Toronto Medical student volunteers

Exclusion Criteria:

* Unwilling to enter the study
* Deficit of vision or hearing incompatible with Microsoft Hololens 2 use

Primary outcomes:
measure: Anaphylaxis Checklist of Core Decision Making Steps
timeFrame: one week post exposure
Secondary outcomes:
measure: Usability Score
timeFrame: Immediately after exposure
measure: Learning Satisfaction Score
timeFrame: Immediately after exposure
measure: Time required to complete critical crisis related tasks
timeFrame: one week post exposure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT03961841: Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma
Official title: A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Esophagogastric Junction Disorder
Neoplasms
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 900
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: Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.


Eligibility criteria: Inclusion Criteria:

* informed consensus of the enrolled patients
* from 18 to 75 years old
* proven to be primary adenocarcinoma of EGJ
* pre-operative staging cT3-4N+M0
* no prior other chemotherapy and/or radiation against the disease
* normal function of all other vital organs including heart,liver ,kidney and so on
* Eastern Cooperative Oncology Group performance status: 0\~2

Exclusion Criteria:

* history of other malignancy
* allergic reaction to capecitabine or oxaliplatin
* enrolled in other clinical trials
* abnormal GI tract function
* dysfunction of other organs
* pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
* other situations judged as not adaptive to the study by investigators

Primary outcomes:
measure: 3 year of disease free survival
timeFrame: 3 year
Secondary outcomes:
measure: 5 year of overall survival
timeFrame: 5 year
measure: Rate of pathological complete remission
timeFrame: 1 year
measure: Anastomosis leak rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02663141: Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Farabi Eye Hospital
First posted: 2016-01-26
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).


Eligibility criteria: Inclusion Criteria:

All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria

Exclusion Criteria:

1. Patients with Uncontrolled hypertension
2. Patients with Proliferative diabetic retinopathy
3. Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
4. Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
5. media opacities
6. evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,)
7. Pathologic myopia \> 6 Diopter
8. Patients with poor fixation or cooperation
9. Patients with renal or cardiac disease

Primary outcomes:
measure: difference in ETDRS best-corrected visual acuity (BCVA) between arms
timeFrame: Within 6 months from therapy
measure: Difference in frequency of intravitreal Bevacizumab injection between arms
timeFrame: Within 6 months from therapy
Secondary outcomes:
measure: change in central macular thickness(measured by spectral domain optical coherence tomography)
timeFrame: Within 6 months from therapy
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Farabi Eye Hospital
Study officials:
References:
Clinical trial NCT05148741: Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT
Official title: Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Cataract
Keywords: SS-OCT
capsule bag
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were divided into 2 groups according to the different intraocular lenses implanted: 39 eyes were implanted with the C-loop haptic intraocular lens (Acrysof) while the other 41 eyes were implanted with plate haptic intraocular lenses (CT ASPHINA 509 M).

Brief summary: Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT.

Detailed description: Eighty patients (80 eyes) with simple age-related cataracts were treated from December 2019 to December 2020 in the Wenzhou Medical University. Investigators specifically included patients who were bodily healthy and underwent a successful implantation of an IOL. Inclusion criteria for this study were patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

Eligibility criteria: Inclusion Criteria:

-patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

Exclusion Criteria:

* people cannot cooperate with the check， corneal opacity, glaucoma, and other eye diseases
* any other previous intraocular surgery, and intraoperative complications including anterior or posterior capsulartears
* Continuous circular capsulorhexis is not centered and Mydriasis is less than 7mm.

Primary outcomes:
measure: Capsular bend index (CBI)
timeFrame: 2020.12.1
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Ophthalmology and Optometry Hospital
name: Yune Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT03111641: The Role of Lung Ultrasound During Perioperative Evaluation
Official title: Comparison of Lung Ultrasound Assessment and Chest Radiography During Perioperative Evaluation: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia plan. Until now, chest X-ray is considered the standard of care for lung assessment during perioperative evaluation. However, lung ultrasound is a rapid, simple, non-invasive, radiation-free imaging modality and can be used as an alternative to chest radiography for the diagnosis and follow-up of various lung diseases. Moreover, the decreased radiation exposure represents a considerable improvement in patient safety. Consequently, we decided to compare the data obtained from the lung ultrasound and the chest X-ray.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing elective general surgery;
* age \>18 years;
* ability to provide written consent;
* use of Chest radiography during the preoperative evaluation.

Exclusion Criteria:

* age \< than 18 year;
* pregnant patients;
* not use of Chest radiography during the preoperative evaluation.

Primary outcomes:
measure: Performance comparison of lung ultrasonography and chest x-ray in the detection of pleural effusion, consolidation, alveolar- interstitial syndrome.
timeFrame: during preoperative anaesthesia consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
References: