louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06475339: Predicting Responses to Exhausting, Prolonged, and Repeated Exercise Demands (PREPARED) for Heat
Official title: Predicting Responses to Exhausting, Prolonged, and Repeated Exercise Demands (PREPARED) for Heat
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperthermia
Fatigue; Heat
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to identify a work/rest cycle that allows for faster mission completion needed in emergency situations, compared to current Army heat guidance, while mitigating heat strain and neuromuscular fatigue. This project will determine the trade-off between faster mission completion and risk of heat strain and physical performance decrements. Completion of this project will allow military leaders to make informed decisions by understanding the impact of their choices on the magnitude of physical performance decrements and expected heat casualties, setting up hot weather missions for success.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Physically active

Exclusion Criteria:

* History of cardiovascular, metabolic (such as clinical thyroid disease), respiratory, neural, or renal disease
* Hypertensive (systolic blood pressure \> 139 mmHg, diastolic blood pressure \> 89 mmHg) or tachycardic (heart rate \> 100 bpm) during the screening visit
* Taking medications or supplements known to effect physiologic responses to exercise or thermoregulation (e.g., beta blockers, omega-3 fatty acids, statins, aspirin)
* Tobacco or nicotine use currently or in the past six months
* Musculoskeletal injury expected to impact exercise in the protocol
* A positive pregnancy test at any point in the study
* Study physician discretion based on any other medical condition or medication
* Inability to understand or follow instructions or the protocol
* Gastrointestinal disease or previous surgery prohibiting core temperature capsule use. Participants with a contraindication can opt to insert the pill rectally as a suppository.

Primary outcomes:
measure: Core temperature
timeFrame: 180 minutes of work
measure: Isometric mid-thigh pull strength
timeFrame: 180 minutes of work
Secondary outcomes:
measure: Metabolic cost
timeFrame: 180 minutes of work
measure: Heart rate
timeFrame: 180 minutes of work
measure: Mean skin temperature
timeFrame: 180 minutes of work
measure: Vastus lateralis electromyography
timeFrame: 180 minutes of work
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Education in Special Environments
state: New York
Study officials:
affiliation: University at Buffalo
name: Riana R Pryor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545139: Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth
Official title: Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Nonvital Tooth
Keywords: pulp revascularization
endodontic regeneration
NeoMTA
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
* Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.

Detailed description: The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth.

to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.

Eligibility criteria: Inclusion Criteria:

* Age of patients: 7-15years old.
* Free from any systemic diseases that may affect the normal healing process.
* Tooth with immature root apex.
* Traumatically or cariously exposed non vital permanent anterior tooth.
* Pulp space not needed for post and core for final restoration.
* Compliant patient/parent

Exclusion Criteria:

* Patients having allergy to medicaments and antibiotics necessary to complete procedure.
* Tooth with vital pulp or complete root formation.
* Teeth with internal or external root resorption.
* Un-cooperative patients.
* Luxative injuries.
* Teeth with a root fracture
* Alveolar fracture
* Subjects with chronic systemic illness.
* Subjects with poor oral hygiene.
* Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.

Primary outcomes:
measure: Discoloration/ Staining potential
timeFrame: 9 month
Secondary outcomes:
measure: Pain on biting
timeFrame: 9 month
measure: Pain on percussion
timeFrame: 9 month
measure: Sinus or fistula, recurrent swelling
timeFrame: 9 month
measure: Root lengthening
timeFrame: 9 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral & Dental Medicine Cairo University
Study officials:
References:
Clinical trial NCT06329739: Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes
Official title: Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes in Patients Undergoing Dopaminergic Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants clinically diagnosed with Parkinson's Disease (PD) undergoing genetic testing for mendelian forms of PD

Brief summary: The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.

The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.

Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.

Researchers will compare data collected from patients with genetic mutation versus patients without mutation.


Eligibility criteria: Inclusion Criteria:

* diagnosed with Parkinson's Disease (PD)
* in use of dopaminergic medication (L-Dopa and/or dopamine agonists)
* genetic testing for mendelian forms of PD
* able to provide informed consent to participate in the study

Exclusion Criteria:

* Patients underwent Deep Brain Stimulation (DBS) treatment

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Annual assessments up to 5 years
measure: Beck Depression Inventory
timeFrame: Annual assessments up to 5 years
measure: State-Trait Anxiety Inventory
timeFrame: Annual assessments up to 5 years
measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson
timeFrame: Annual assessments up to 5 years
measure: Pittsburgh Sleep Quality Index
timeFrame: Annual assessments up to 5 years
measure: Parkinson's Disease Questionnaire-8
timeFrame: Annual assessments up to 5 years
measure: Minnesota Multiphasic Personality Inventory 2-RF
timeFrame: Annual assessments up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Francesca Mameli, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05198739: Video Interaction Project in Brazil
Official title: Feasibility Study of the Pilot Implementation of the Video Interaction Project in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Early exposure to poverty is associated with adverse impacts on long-term educational achievement. Support of positive parenting is a key strategy to prevent emergence of socioeconomic disparities in child development. This study will assess the feasibility of the pilot implementation of an evidence-based parenting program designed to prevent disparities in child development, the Video Interaction Project (VIP), in Brazil, as an exemplar low- and middle-income country (LMIC), and explore changes in parenting and child outcomes after participation in the program.

Detailed description: This international study will be conducted in Southern Brazil. After translation and cultural adaptation of VIP materials (Aim 1), a qualitative investigation of VIP implementation feasibility (Aim 2) will be conducted using semi-structured interviews and observation of engagement for approximately 50 caregiver-child dyads with children 0-5 years who will participate in 3 VIP sessions. To explore changes in parenting and child outcomes (Aim 3), dyads enrolled in the study (for Aim 2) will complete assessments pre- and post-participation in 3 VIP sessions.

Eligibility criteria: Inclusion Criteria:

* Caregiver-child dyads with at least one child age 0 to 5 years;
* Caregiver can be contacted (has a working phone); and
* Caregiver is 18 years old or older.
* Child is 1 day to 5 years old

Exclusion Criteria:

* Caregiver is under 18 years old; and
* Child has a neurodevelopmental disability or known or suspected genetic syndrome

Primary outcomes:
measure: Change in the Percentage of Acceptance of the Video Interaction Project
timeFrame: Baseline Visit, Visit 4 (7 months)
measure: Change in Parenting practices in Cognitive stimulation
timeFrame: Baseline Visit, Visit 4 (7 months)
measure: Changes in Parent-child interactions during reading
timeFrame: Baseline Visit, Visit 4 (7 months)
measure: Change in Parent Reading Belief of their children
timeFrame: Baseline Visit, Visit 4 (7 months)
Secondary outcomes:
measure: Change in Depression in Caregivers
timeFrame: Baseline Visit, Visit 4 (7 months)
measure: Change in Stress in Caregivers
timeFrame: Baseline Visit, Visit 4 (7 months)
measure: Child Development (CS)
timeFrame: Baseline Visit, Visit 4 (7 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alan Mendelsohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05527886: Acute Effects of Dynamic Stretching, Plyometrics, and Loading on Achilles Tendon Properties and Performance Outcomes
Official title: Acute Effects of Dynamic Stretching, Plyometrics, and Loading on Achilles Tendon Properties and Performance Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injuries
Lead sponsor: University of South Dakota
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will be looking at acute changes in Achilles tendon properties and changes in a vertical single leg hop following an exercise intervention. The three exercise interventions will be randomized and take place on separate days 1 week apart. The three exercise interventions are AAROM, slow load, and plyometrics.

Detailed description: The purpose of the study is to determine if there are acute changes in Achilles tendon properties and changes in performance based on what tendon exercise intervention is being used. About 70 people will take part in this research.

Eligibility criteria: Inclusion Criteria:

* College student

Exclusion Criteria:

* Unable to complete interventions

Primary outcomes:
measure: Achilles Tendon Stiffness
timeFrame: immediately
measure: Achilles Tendon Natural Oscillation
timeFrame: immediately
measure: Achilles Tendon Logarithmic Decrement
timeFrame: immediately
measure: Achilles Tendon Mechanical Stress Relaxation Time
timeFrame: immediately
measure: Achilles Tendon Creep
timeFrame: immediately
Secondary outcomes:
measure: Single-leg drop jump vertical
timeFrame: immediately
measure: Reactive Strength Index
timeFrame: immediately
measure: Flight Time
timeFrame: immediately
measure: Contact Time
timeFrame: immediately
measure: Limb Stiffness
timeFrame: immediately
Other outcomes:
Locations:
city: Vermillion
country: United States
facility: Sanford Coyote Sport Center
state: South Dakota
Study officials:
References:
Clinical trial NCT05725122: Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
Official title: Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2023-02-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones


Eligibility criteria: Inclusion Criteria:

* single upper ureteric stone
* size ranging from 6-15 mm
* stones history less than 6 months

Exclusion Criteria:

* Patients with urinary tract infection
* multiple ureteric stones,
* presence of a ureteric stricture distal to the stone,
* previous unsuccessful ESWL,
* concomitant use of calcium channel blockers or alpha-adrenergic antagonists
* patients with abnormal coagulation profile

Primary outcomes:
measure: stone clearance
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: services Institute of Medical Sciences
state: Punjab
Study officials:
References:
Clinical trial NCT00220922: A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
Official title: An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Copaxone
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* 18 years of age or older
* Diagnosis of RRMS
* Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously

Exclusion Criteria:

* Unable to perform subcutaneous self-injection
* Pregnant, or trying to become pregnant, or breast feeding during the study

Primary outcomes:
measure: Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
timeFrame: four weeks of Period 1 and the four weeks of Period 2
Secondary outcomes:
measure: The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection
timeFrame: four weeks of Period 1 and the four weeks of Period 2
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: MerriKay Oleen-Burkey, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06966622: Comparison of Retinal Damage in ICL Implantation Using 3D Visualization System vs. Microscope
Official title: Comparison of Ngenuity and Traditional Microscopy in Assessing Retinal Function Recovery Post-ICL Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High Myopia
Lead sponsor: Fuzhou Eye Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2025-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of high myopic
* Aged 18-40 years
* Desire to improve their refractive status via ICL surgery
* Relatively stable refractive error (change ≤ 0.50 D per year for two consecutive years)
* Central anterior chamber depth ≥ 2.8 mm
* Open angles
* Corneal endothelial cell density ≥ 2000 cells/mm2.

Exclusion Criteria:

* Cataracts
* Corneal diseases,
* Glaucoma,
* Nystagmus,
* Strabismus,
* Lens subluxation,
* Severe vitreoretinal diseases,
* Other ocular diseases
* A history of ocular trauma
* A history of ocular surgery

Primary outcomes:
measure: b-wave amplitude
timeFrame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Secondary outcomes:
measure: a-wave amplitude
timeFrame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
measure: macular vessel density
timeFrame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
measure: Uncorrected visual acuity
timeFrame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
measure: Best-corrected visual acuity
timeFrame: 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op
Other outcomes:
measure: Intraoperative illumination intensity
timeFrame: surgery beginning
measure: Surgical time
timeFrame: Starting with the making of the surgical incision and ending with incision closure
Locations:
Study officials:
References:
Clinical trial NCT02493322: Efficacy and Safety of Olmesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
Official title: Efficacy and Safety Evaluation of the New Association on Fixed Dose of Olmesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Essential Arterial Hypertension
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 261
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: The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.

Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL /min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria in urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactating patients;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Efficacy of essential hypertension control based on the reduction of systolic blood pressure at the end of the study.
timeFrame: 60 days
Secondary outcomes:
measure: Safety will be evaluated by the occurrences of adverse events.
timeFrame: 9 weeks
Other outcomes:
Locations:
Study officials:
References: