louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05370495: Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Official title: A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Seinda Pharmaceutical Guangzhou Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked, parallel, randomized
Primary purpose: TREATMENT

Brief summary: This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).


Eligibility criteria: * Inclusion Criteria

  1. Provide written informed consent prior to any study-related procedures.
  2. Are 18 years of age or older.
  3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
  4. Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.

Exclusion Criteria:

1. Unanesthetized Schirmer test score in either eye \<2 mm/5 minutes at Visit 1.
2. Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
3. Have corneal erosive disease (e.g., confluent staining \[National Eye Institute (NEI) grade 4\], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
4. Have a history of glaucoma or intraocular pressure (IOP) \>25 mmHg at Visit 1 or a history of elevated IOP (\>25 mmHg) in either eye.
5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.

Primary outcomes:
measure: Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
timeFrame: 60 days
measure: Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60
timeFrame: 60 days
Secondary outcomes:
measure: Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60
timeFrame: 60 days
measure: Change From Baseline in Symptom Severity Score (Subscale) at Day 60
timeFrame: 60 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Lexitas
state: North Carolina
Study officials:
References:
Clinical trial NCT04498195: Walking on Cognitive Function in Individuals With Mild Cognitive Impairment: A Pilot Project
Official title: Effect of a Walking Intervention on Cognitive Function in Individuals With Mild Cognitive Impairment: A Knowledge Translation to Practice Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment, Mild
Lead sponsor: Samuel Merritt University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background: Many studies suggest physical activity reduces risk of dementia and improves global cognitive function in individuals with mild cognitive impairment (MCI). Using commercial wearable technology to measure daily steps is feasible in this population.

Objectives: The purpose of this pilot study was to explore whether 12 weeks of increased physical activity improved cognitive function in individuals with MCI. A wearable activity tracker was used to measure participants' daily steps as a quantifiable measure of daily activity level.

Design: This was a one-group pretest-posttest study.

Setting: Established memory clinic patients within a neurology department in Northern California during 2019.

Participants: 17 enrolled and 14 included for data analysis. There were 7 females and 7 males whose mean age was 76.21 (SD 2.69). 12 participants were White, which reflected the clinic population.

Intervention: Participants were asked to wear an activity tracker for approximately 12 hours a day for 12 weeks and to increase their physical activity as much as possible. They were provided twice a month telephone support.

Measurements: The Montreal Cognitive Assessment (MoCA) was used to measure pretest-posttest cognitive function. Timed Up and Go (TUG) was used to assess fall risk at enrollment. Cumulative step count for the study period was measured with an activity tracker.


Eligibility criteria: Inclusion Criteria:

* Participants had a score of 0.5 on the Clinical Dementia Rating and are on a stable medication regimen for 3 months prior to enrollment.

Exclusion Criteria:

* a diagnosis of dementia; receiving chemotherapy; unstable chronic diseases; surgery with general anesthesia in the prior 3 months; MRI-confirmed brain damage from trauma, stroke, or other neurological disorder; a myocardial infarction \< 1 year; a serious or non-healing wound, ulcer, or bone fracture; TUG ≥ 12 seconds; MoCA score \>26 or \<16; already using a wearable activity tracker; lacked access to the internet; or non-English speaking.

Primary outcomes:
measure: Whether increasing the number of daily steps among older adults with mild cognitive impairment would improve their cognitive functioning.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Medical Neuroscience
state: California
Study officials:
References:
Clinical trial NCT01103895: Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.
Official title: Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Output
Keywords: cardiac output
cardiopulmonary bypass
ultrasound dilution
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-04-15
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.

Brief summary: Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."


Eligibility criteria: Inclusion Criteria:

* Patients aged \> 21 years
* Patients undergoing surgery involving cardiopulmonary bypass
* Patients instrumented with a thermodilution catheter

Exclusion Criteria:

* Patients aged \< 21 years
* Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)

Primary outcomes:
measure: Cardiac output after cardiopulmonary bypass
timeFrame: Less than 10 minutes
Secondary outcomes:
measure: Cardiac output before cardiopulmonary bypass
timeFrame: Less than 10 minutes
Other outcomes:
Locations:
city: Elmira
country: United States
facility: Arnot Ogden Medical Center
state: New York
Study officials:
affiliation: Transonic Systems Inc.
name: Nikolai Krivitski, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Arnot Ogden Medical Center
name: Edward P Nast, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00197795: Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neisseria Meningitidis
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.


Eligibility criteria: Inclusion Criteria:

* Informed written consent given for three immunizations with MenBVac and five blood tests
* Between the ages of 18 and 55 years inclusive at recruitment

Exclusion Criteria:

* Previous history of bacteriologically confirmed meningococcal disease
* History of clinically significant allergic sensitivity to any vaccine received in the past
* Immunodeficiency
* Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol
* Language difficulties sufficient to preclude adequate comprehension of the study information
* Possibility of pregnancy
* Receipt of any other vaccine in the previous 4 weeks
* Receipt of any group B vaccine in the past
* Current participation in any other clinical trial
* Generalized acute systemic illness and/or temp \>38C on day of vaccination deferral

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Public Health England
name: Elizabeth Miller, MBBS FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
citation: Findlow J, Taylor S, Aase A, Horton R, Heyderman R, Southern J, Andrews N, Barchha R, Harrison E, Lowe A, Boxer E, Heaton C, Balmer P, Kaczmarski E, Oster P, Gorringe A, Borrow R, Miller E. Comparison and correlation of neisseria meningitidis serogroup B immunologic assay results and human antibody responses following three doses of the Norwegian meningococcal outer membrane vesicle vaccine MenBvac. Infect Immun. 2006 Aug;74(8):4557-65. doi: 10.1128/IAI.00466-06.
Clinical trial NCT04790695: Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
Official title: Single Patient Protocol for an NRG1 Fusion Positive Metastatic Pancreatic Cancer Patient Using Seribantumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: NRG1 gene fusions are extremely rare across solid tumours (estimate 0.3-0.5%). However, it is felt to be an actionable and potentially major growth pathway for those tumours that harbour this gene rearrangement. Tumours that harbour NRG1 fusions are driven by HER3 overactivation. Seribantumab is a mono-clonal antibody against HER3, it binds HER3 and inhibits NRG1-dependent activation and HER2 dimerization.


Eligibility criteria: Inclusion Criteria:

* Serious, life-threatening condition

  * Not eligible for, or exhausted all other treatment options or causing significant toxicity
  * No other way to access treatment

Exclusion Criteria:

-

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT05408195: E-Care Acceptability for Older People Undergoing Chemotherapy
Official title: Evaluate E-Care Acceptability for Older People Undergoing Chemotherapy at Home
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Keywords: older adults
nurses
smartphones
chemotherapy
geriatric oncology.
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this pilot study is to evaluate the acceptability of clinical data collection using a semi-automated e-solution based on the use of text messaging among older adults undergoing chemotherapy treatment at home.

Detailed description: Most cancer diagnosis are made among the 70 years and over population. In this population, negative consequences of cancer treatments are of great concern, especially for those who are socially isolated or live in rural areas. International oncology societies recommend personalized treatments to reduce adverse events. However, few tools have been validated in this population to monitor compliance and risks of outpatient treatments. In addition, health professionals continue to manage unplanned patient calls which could disrupt effectiveness of their work. Our hypothesis is that the semi-automated collection of health data (text message questionnaires) during outpatient chemotherapy secures the patient's care pathway and optimizes care time, in particular for patients' education and support. Therefore, patients (and/or their caregivers) who benefit from calls follow-up (usual care), would have the possibility of receiving an additional weekly remote questionnaire (by email or SMS) via a CHATBOT on any terminal. This automated questionnaire collects data on tolerance and compliance with care plan.

Eligibility criteria: Inclusion Criteria:

* Subjects of 70 years of age or older;
* Subjects undergoing chemotherapy treatment after a cancer diagnosis;
* Subjects managed by the oncogeriatrics team at the Toulouse University Hospital as part of an outpatient follow-up and followed by conventional telephone calls and CHATBOT support.

Exclusion Criteria:

* Patient's refusal to participate.
* Patient does not have sufficient equipment for downloading and using the CHATBOT tool
* Participant under guardianship, curatorship or safeguard of justice.

Primary outcomes:
measure: Acceptance of semi-automated follow-up
timeFrame: 6 months of CHATBOT use
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine PIAU, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02297295: Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning
Official title: Impact of Exercise Medicine on Lower Limb Amputees According to the Three Domains of the International Classification of Functioning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Amputees
Keywords: Sequelae of; Amputation, Traumatic, Limb, Lower
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.

Detailed description: Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF).

The investigators want to determine benefits of exercise medicine on all of these domains.

Eligibility criteria: Inclusion Criteria:

* unilateral lower limb amputation
* amputees with prothesis
* after learning how to walk with the prothesis
* walking with or without technical aids

Exclusion Criteria:

* previous exercise training

Primary outcomes:
measure: Change in 6 minutes walk test
timeFrame: at -1, 0, 2 and 4 mounths
Secondary outcomes:
measure: Change in Timed Up and Go
timeFrame: at -1, 0, 2 and 4 mounths
measure: Change in Satisfaction towards prothesis questionnaire (SAT-PRO)
timeFrame: at -1, 0, 2 and 4 mounths
measure: Change in Flexibility test
timeFrame: at -1, 0, 2 and 4 mounths
measure: Change in Isokinetic strength testing
timeFrame: at -1, 0, 2 and 4 mounths
measure: Change in Prosthetic Profile of the Amputee
timeFrame: at -1, 0, 2 and 4 mounths
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gilles Caty
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05895695: Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
Official title: Levator Muscle Resection for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Ptosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.

Detailed description: Blepharotosis is one of the most encountered oculoplastic problems. Blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position.

It can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. It can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). Surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.

Eligibility criteria: Inclusion Criteria:

* mild to moderate simple unilateral congenital ptosis with good to fair levator function

Exclusion Criteria:

1. severe ptosis
2. poor levator function
3. poor Bell's phenomenon
4. lagophthalmos
5. diminished corneal sensation
6. completed congenital or acquired ptosis
7. history of previous lid surgery

Primary outcomes:
measure: Comparison of outcome of levator muscle resection and plication in mild to moderate congenital ptosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: SooHoo JR, Davies BW, Allard FD, Durairaj VD. Congenital ptosis. Surv Ophthalmol. 2014 Sep-Oct;59(5):483-92. doi: 10.1016/j.survophthal.2014.01.005. Epub 2014 Feb 5.
citation: Nemet AY. Accuracy of Marginal Reflex Distance Measurements in Eyelid Surgery. J Craniofac Surg. 2015 Oct;26(7):e569-71. doi: 10.1097/SCS.0000000000001304.
citation: Hwang K. Surgical anatomy of the upper eyelid relating to upper blepharoplasty or blepharoptosis surgery. Anat Cell Biol. 2013 Jun;46(2):93-100. doi: 10.5115/acb.2013.46.2.93. Epub 2013 Jun 30.
citation: Baldwin HC, Manners RM. Congenital blepharoptosis: a literature review of the histology of levator palpebrae superioris muscle. Ophthalmic Plast Reconstr Surg. 2002 Jul;18(4):301-7. doi: 10.1097/01.IOP.0000021973.72318.07.
Clinical trial NCT00143195: Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina
Official title: Open Label Study Comparing Amlodipine vs Long-acting Nitrates in Patients With Chronic Stable Angina.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Ischemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 200
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 objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia


Eligibility criteria: Inclusion Criteria:

* Outpatients \> =18 years of age with diagnosed clinically stable angina pectoris

Exclusion Criteria:

* Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG

Primary outcomes:
measure: Evaluate the time to 1mm ST depression
Secondary outcomes:
measure: The number of patients experiencing angina attacks The frequency of hospitalizations due to angina attacks Time to onset of 1mm ST segment depression Total external workload performed Safety
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Attika
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Holargos/Athens
country: Greece
facility: Pfizer Investigational Site
city: Loannina
country: Greece
facility: Pfizer Investigational Site
city: N. Ionia
country: Greece
facility: Pfizer Investigational Site
city: Patra
country: Greece
facility: Pfizer Investigational Site
city: Rio, Patra
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Voula/Athens
country: Greece
facility: Pfizer Investigational Site
city: Zakynthos
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: