louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00130429: Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease
Official title: Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: dementia
memory
Hopkins verbal learning test
paired associated learning
Lead sponsor: Phytopharm
Sponsor class: INDUSTRY
First posted: 2005-08-15
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* At least 50 years of age
* Diagnosis of possible or probable Alzheimer's disease
* Mini mental state examination score at least 16
* Good understanding of both written and verbal English
* A recent head scan that is consistent with the diagnosis of Alzheimer's disease

Exclusion Criteria:

* Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
* Known to have another condition that is associated with dementia
* Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
* Hormone replacement therapy started or changed within the previous 6 months
* Received any investigational drugs within the previous 12 weeks

Primary outcomes:
measure: Hopkins verbal learning test (revised) total word recall after 12 weeks
measure: Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
Secondary outcomes:
measure: Mini mental state examination score
measure: Clinical dementia rating (overall and sum of boxes)
measure: CANTAB rapid visual information processing (RVIP) mean latency
measure: CANTAB RVIP total correct hits
measure: CANTAB spatial working memory within error, between error and strategy scores
measure: Clinicians global impression of change
measure: Disability assessment for dementia score
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Project to Investigate Memory and Ageing
state: Oxfordshire
Study officials:
affiliation: University of Oxford, UK
name: Robin Jacoby, FRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04155229: EMR Defaults to Nudge Opioid Prescribing
Official title: Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Opioid Use, Unspecified
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-11-07
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Each of two sites underwent block randomization of four treatment assignments.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (EMR) affect opioid prescriptions for patients discharged from emergency departments (EDs).

Detailed description: In two large, urban emergency departments, we randomly altered the pre-populated dispense quantities of discharge prescriptions for commonly-prescribed opioids over a series of five 4-week blocks. These changes were made without announcement, and providers were not informed of the study itself.

Eligibility criteria: Inclusion Criteria:

* Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.

Exclusion Criteria:

* none

Primary outcomes:
measure: Dispense quantity of prescribed opioids
timeFrame: Through study completion, approximately 340 days
Secondary outcomes:
measure: Proportion ≤12
timeFrame: Through study completion, approximately 340 days
measure: Proportion at default setting
timeFrame: Through study completion, approximately 340 days
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Juan Carlos Montoy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montoy JCC, Coralic Z, Herring AA, Clattenburg EJ, Raven MC. Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study. JAMA Intern Med. 2020 Apr 1;180(4):487-493. doi: 10.1001/jamainternmed.2019.6544.
Clinical trial NCT02885480: Courses Emergency Psychiatric Strasbourg
Official title: ROUTE PATIENT CONSULTANT in OUTPATIENT CARE PSYCHIATRIC EMERGENCY SERVICES AND PUBLIC OF EUROMETROPOLE STRASBOURG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Emergency
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 500
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated in psychiatric emergencies

Brief summary: Describe and analyze routes and modes of care for patients in emergency consultant in various emergency care and public psychiatric outpatient devices to provide useful information to optimize trajectories taken into psychiatric load on the Eurométropole territory upstream and downstream of where they viewed urgently.


Eligibility criteria: Inclusion Criteria:

* All patients, men and women, adults and minors of 11 years and more, seen for psychiatric consultation request emergency (unscheduled and requiring specialized psychiatric consultation within 72 hours)

Exclusion Criteria:

* Will not be included in the study psychiatric consultations requested by internal hospital services other than emergency services, patients with psychiatric emergencies revised for post-emergency consultations

Primary outcomes:
measure: management of emergency patients consulting
timeFrame: follow-up of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Pierre VIDAILHET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02403180: DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Official title: Comparative Assessment of Visual Performance Between DAILIES® AquaComfort Plus® (DACP) Multifocal (MF) and PROCLEAR 1 Day Multifocal (PROCLEAR 1D MF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Visual Performance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 41
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.


Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent;
* Adapted soft contact lens wearer;
* Vision correctable to 20/30 \[(0.2 logMAR (logarithm of the minimum angle of resolution)\] or better in each eye at distance;
* Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing multifocal contact lenses;
* Currently wearing monovision;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications which could contraindicate contact lens wear;
* Eye injury or surgery within 12 weeks prior to enrollment;
* Prior refractive surgery;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear
timeFrame: Day 5, each product
Secondary outcomes:
measure: Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear
timeFrame: Day 5, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, Spain
name: Clinical Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT06392880: Comparison of Floss Band Application and Mulligan Mobilization
Official title: Comparison of the Effects of Floss Taping and Mulligan Mobilization on Ankle Joint Movement, Vertical Jump, Gait and Balance in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health, Subjective
Keywords: ankle motion
gait
vertical jump
balance
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study features a balanced cross-over design.
Primary purpose: OTHER

Brief summary: This study will investigate the effects of Floss band application and Mulligan mobilization on ankle range of motion, vertical jump, gait and balance in active healthy young adults.

Detailed description: The effects of floss band application and mulligan mobilization on ankle range of motion, vertical jump, gait, and balance in active healthy young adults are unclear or limited due to a lack of studies. There are also no other studies comparing the two interventions in healthy young adults. Therefore, this study will investigate the effects of Floss band application and Mulligan mobilization on ankle range of motion, vertical jump, gait, and balance in active healthy young adults.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-24 years,
* Not having any known disease
* Being recreationally active
* Body mass index between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* Presence of cardiovascular, rheumatic, dermatologic, orthopedic or neurologic diseases
* History of injury or trauma in the last 6 months

Primary outcomes:
measure: Passive ankle joint range of motion
timeFrame: The assessment will be conducted before and immediately after the interventions.
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: EMEL TAŞVURAN HORATA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06612580: 68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
Official title: 68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer (Adenocarcinoma)
Keywords: PSMA
Prostate cancer
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-AAZTA-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in patients with prostate cancer.

Detailed description: Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-NI-093 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in prostate cancer patients.

Eligibility criteria: Inclusion Criteria:

* confirmed treated or untreated prostate cancer patients;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Adverse events
timeFrame: Within 7 days following PET/CT
Secondary outcomes:
measure: Dosimetry data
timeFrame: through study completion, an average of 3 months
Other outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 3 months
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00471380: A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
Official title: A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension
* Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM
* Stable visual field in last 6 months
* 6 weeks wash out from previous topical medications

Exclusion Criteria:

* Age

Primary outcomes:
measure: Intra Ocular Pressure (IOP)
timeFrame: Baseline, end of each period (week 8, week 16, week 24)
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Catania
Study officials:
affiliation: Alcon Research
name: Marcello Fornoni
role: STUDY_DIRECTOR
References:
Clinical trial NCT06699680: Phase 1 Study of PRX019 in Healthy Adult Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending and Multiple Doses of PRX019 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants Study
Lead sponsor: Prothena Biosciences Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period
* Participant is willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted
* Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer)

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 6 months
measure: Number of participants with clinical laboratory assessment abnormalities
timeFrame: Up to 6 months
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 6 months
measure: Time to the maximum measured plasma concentration (Tmax)
timeFrame: Up to 6 months
measure: Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)
timeFrame: Up to 6 months
measure: Terminal elimination half-life in plasma (t1/2)
timeFrame: Up to 6 months
measure: Maximum observed plasma concentration at steady state (Cmax,ss)
timeFrame: Up to 6 months
measure: Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Local Institution
state: California
Study officials:
affiliation: Prothena Biosciences
name: Chad Swanson
role: STUDY_DIRECTOR
References:
Clinical trial NCT05261880: Comparative Effect of Scaphoid, Hamate Mobilization and Neural Mobilization in Patients With Carpal Tunnel Syndrome
Official title: Comparison of the Effects of Scaphoid and Hamate Mobilization and Neural Mobilization on Patients With Carpal Tunnel Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To rule out the effects bone mobilization and neural mobilization in Carpal Tunnel Syndrome.

Detailed description: A Randomized control study of 3 month period will be conducted at Riphah International University Faisalabad. Patients will be enrolled by purposive sampling based on pre-defined inclusion and exclusion criteria. Patients were randomly allocated into groups. The Patients of group A will receive scaphoid, hamate mobilization with kinesio taping and group B will receive neural mobilization with kinesiotaping. Group A will receive neural mobilization and Group B will receive scaphoid and hamate moilization. The Patient's outcome will be distinguished by Visual Analogue scale and the data of the patients will be noted pre-treatment and post-treatment. Informed consent will be taken from each patient. Data entry and analysis will prepare through Statistical Package of Social Sciences Version 20.

Eligibility criteria: Inclusion Criteria:

* At median nerve distribution, felt pain and parasthesia Phalen sign positive Tinel sign positive Increase symptoms throughout the night Symptoms that continue for at least 3 weeks

Exclusion Criteria:

* Pregnancy Diabetes Thyroid disease Rheumatoid arthritis Thenar muscle atrophy Weakness of thenar muscle Hand surgery/ bone fracture

Primary outcomes:
measure: Visual analogue scale
timeFrame: 12th Week
measure: Dynamometer
timeFrame: 12th Week
measure: Boston questionnaire
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT05861180: Neck Joint Position Error Among Taibah Students University; Saudi Arabia; Cross Section Design
Official title: Neck Joint Position Error Among Taibah Students University; Saudi Arabia; Cross Section Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proprioception
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All four groups were recruited from the college of medical rehabilitation sciences, Applied Medical Sciences, and Business administration faculty through posters, word of mouth, and by WhatsApp groups.

Brief summary: this study was done to answer the following: Is there a difference between students without and with varying degrees of text neck in cervical proprioception defect? Is there a correlation between JPE and severity of text neck among Taibah students University?


Eligibility criteria: Inclusion Criteria:

* A convenient sample of 68 female students
* the age was between 18-25 years

Exclusion Criteria:

* Any students with neck pain or previous neck or back surgery or a history of a previous accident were excluded
* Also, we excluded any student with a history of fracture injury of the cervical column, scoliosis, severe thoracic kyphosis, rheumatic disease, torticollis, loss of standing balance, use of hearing aid, and persistent respiratory problems.

Primary outcomes:
measure: neck proprioception error
timeFrame: one day
Secondary outcomes:
measure: joint position error
timeFrame: one day
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Taibah University
Study officials:
affiliation: Taibah University
name: walaa ragab, phd
role: PRINCIPAL_INVESTIGATOR
References: