louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01591161: Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Inflammation
Surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 369
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 this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

* Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
* Presence of active external ocular disease: infection or inflammation of the study eye.
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
timeFrame: 8 days
measure: Percentage of Participants With Grade 0 Pain
timeFrame: 8 days
Secondary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
timeFrame: 15 days
measure: Percentage of Participants With Grade 0 Pain
timeFrame: 15 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
timeFrame: 15 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.
timeFrame: 15 days
measure: Change From Baseline Anterior Chamber (AC) Cells and Flare Combined
timeFrame: 15 days
measure: Percentage of Treatment Failures
timeFrame: 8 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Quintus Ngumah, OD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05920161: Influence of Stress on Encoding and Prediction
Official title: Neural Mechanisms of Stress Effects Across Hippocampal Encoding and Prediction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Learning, Spatial
Keywords: memory
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-06-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.

Detailed description: This study aims to assess the neural and behavioral mechanisms by which acute stress modulates episodic encoding (which involves the trisynaptic pathway: entorhinal cortex, dentate gyrus, cornu ammonis \[CA\] 3, and CA 1) and statistical learning (monosynaptic pathway: entorhinal cortex, CA1) in humans.

Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* Fluent in English
* BMI 18-35

Exclusion Criteria:

* Meeting current DSM-V criteria for any substance use disorder (except caffeine)
* Having current significant medical conditions or psychiatric symptoms requiring medication
* Current use of medications/drugs that interfere with physiological stress responses
* Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
* Metal in body (for MRI safety) history will be assessed for female participants.

Primary outcomes:
measure: Changes in fMRI signal
timeFrame: 1-2 hours
measure: Statistical learning
timeFrame: 1-2 hours
measure: Retention of statistical learning
timeFrame: 1 hour
measure: Episodic memory
timeFrame: 1 hour
Secondary outcomes:
measure: Cortisol reactivity
timeFrame: 1-2 hours
measure: Alpha-amylase reactivity
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth V Goldfarb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037661: Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye
Official title: Double-Masked, Randomized, Placebo-Controlled Study of Efficacy Parameter Following Administration of INS365 Ophthalmic Solution or Placebo in a Controlled Adverse Environment (CAE) Chamber in Subjects With Non-Sjogren's Associated Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Keywords: dry eye
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-20
Enrollment: 222
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: Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.


Eligibility criteria: Inclusion Criteria:

* have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months
* had intermittent or regular artificial tear use within past 3 months

Exclusion Criteria:

* had LASIK surgery
* had punctal occlusion or cauterization within last 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05982561: Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Official title: Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Early is Good Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.

Brief summary: BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.

Detailed description: BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.

Eligibility criteria: Inclusion Criteria:

* Patients 18 Years and older
* Patients who have been diagnosed with incident or recurrent NMIBC within the past 2 years and undergoing standard of care/routine monitoring cystoscopy.
* Patients who are able to provide legally effective informed consent.
* Patients who are able to provide minimum 30mL of voided urine.

Exclusion Criteria:

* Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.

Primary outcomes:
measure: Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)
timeFrame: Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology Research Center
state: Arkansas
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT03746561: Automatic Diagnosis of Spinal Stenosis on CT
Official title: Automatic Diagnosis of Spinal Stenosis on CT With Deep Learning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Stenosis
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Shanghai East Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2018-11-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal stenosis is a narrowing of the spaces within the spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the back, the neck, and sometimes the thoracic spine.

Some people with spinal stenosis may not have symptoms. Others may experience pain, tingling, numbness and muscle weakness. Symptoms can worsen over time.

Brief summary: MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis.

Detailed description: MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis. It would be a time-saving workflow if the software can assist the radiologists to detect and locate the suspected lesion.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* with radiologists' CT reports on cervical, thoracic and lumbar stenosis

Exclusion Criteria:

* not applicable (only specific levels with extensive infections, fractures, tumor, high-grade spondylolisthesis would be excluded for analysis).

Primary outcomes:
measure: diagnostic accuracy of deep learning
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic Performance of deep learning
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02810561: Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)
Official title: Time Course and the Significance of Troponin Leaks in Emergency Department Patients Presenting With Supraventricular Tachycardia (SVT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraventricular Tachycardia
Keywords: Troponin
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the Emergency Department with Supraventricular Tachycardia and elevated troponin. All sexs, races and ages will be included.

Brief summary: The goal of this study is twofold. First the investigators would like to determine the trajectory of troponin leaks; if it can be shown that the participants who have only minimal elevations of their repeat troponin universally decrease on the 3rd level then future patients may see significantly improved length of stay. Second, given conflicting results in the literature, the investigators would like to determine if elevated troponin levels correlate to later cardiovascular complications. These complications will be defined as Death, Myocardial Infarction, Cardiovascular intervention (such as coronary artery stenting or bypass). As the investigator is a single hospital system in this county it is uniquely positioned to be able to review this retrospectively.

Detailed description: The investigators therefore propose retrospectively studying participants diagnosed with Supraventricular Tachycardia who had troponin(s) checked in the ED between January 1, 2012 and May 31, 2016 to allow a minimum of a year follow-up for our combined endpoint. The investigators will record the participants troponin value(s) in addition to the age, sex, race, heart rate, creatinine value. The investigators will compare the participants with positive troponins (and hopefully participants with strongly positive troponins) with those who are negative for troponin for presence of the combined end point via chart review.

Eligibility criteria: Inclusion Criteria:

* Supraventricular Tachycardia with troponin elevation

Exclusion Criteria:

* Other cardiac arrhythmias or conditions with increased troponin

Primary outcomes:
measure: Troponin-I Level
timeFrame: 6 hours after initial EKG
Secondary outcomes:
measure: Death/ Need for Cardiac Stent Placement or Coronary Bypass Artery Graft
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Lakeland Health Emergency Department
name: Matthew Hysell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01710761: Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
Official title: Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: nitric oxide
cycling performance
lactate
VO2
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Neogenis Laboratories
First posted: 2012-10-19
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance


Eligibility criteria: Inclusion Criteria:

* Regular commuter cyclist or spin class participant
* Male (VO2max \< 50) or Female (VO2max \< 45)
* Healthy
* Blood pressure below 140/90
* Non-smoker

Exclusion Criteria:

* Does not cycle 2-3 times/week
* Regular consumption of performance-enhancing substances
* Type I or Type II diabetes
* Renal, hepatic or cardiac disease
* Current infectious disease

Primary outcomes:
measure: Improved Time Trial Performance
timeFrame: After 20 min steady-state cycling
Secondary outcomes:
measure: Improved work efficiency
timeFrame: During 20 min steady-state cycling
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Lynne Kammer-Kerwick, MSE, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785961: Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)
Official title: Healing Assessment of External Inflammatory Root Resorption After Revascularization Technique of Avulsed Permanent Central Incisor (Case Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Avulsion
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 4
Sex: MALE
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the healing of external root resorption of replanted avulsed permanent maxillary central incisor after revascularization.

Detailed description: Healing assessment of external inflammatory Root Resorption after Revascularization Technique of Avulsed permanent Central Incisor (Case study)

Eligibility criteria: Inclusion Criteria:

* traumatic teeth
* external inflammatory root resorption

Exclusion Criteria:

-

Primary outcomes:
measure: Measure amount of bone healing and root formation by using cone beam computed tomography (CBCT)
timeFrame: 18 months
Secondary outcomes:
measure: Measuring pain by using the numeric pain rating scale
timeFrame: 18 months
measure: Pulp test to assess the vitality or health of the dental pulp
timeFrame: Every 6 months
Other outcomes:
Locations:
city: Badr
country: Egypt
facility: Badr university in Cairo
state: Cairo
Study officials:
References:
Clinical trial NCT06025461: Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions
Official title: Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Disease
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 85
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected.

Brief summary: Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.


Eligibility criteria: Inclusion Criteria:

* Perform ultrasound examination at our hospital before surgery or puncture biopsy; Complete histopathological data; Two ultrasound physicians with more than 5 years of experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on preoperative ultrasound images.

Exclusion Criteria:

* Poor image quality; Incomplete clinical data.

Primary outcomes:
measure: elasticity imaging/B-mode ratio
timeFrame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
measure: shear wave velocity
timeFrame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
measure: strain ratio
timeFrame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
Secondary outcomes:
Other outcomes:
Locations:
city: Shandong
country: China
facility: QianfoshanH
Study officials:
References:
Clinical trial NCT06902961: The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals
Official title: The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Keywords: pain
exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical activity is a significant factor that greatly affects human health. However, with the development of technology, there has been a significant decrease in the physical activity levels of individuals in their daily lives, leading to the emergence of a sedentary society.

Detailed description: Technological advancements, such as electronic devices and machines that replace human labor, push individuals toward laziness, encouraging them to adopt a more inactive lifestyle.

Eligibility criteria: Inclusion Criteria

* Accepting to participate in the study
* Between the ages of 18 and 45
* Physical activity level according to the International Physical Activity Questionnaire (short form) between 600 MET- 1500 MET min/week
* Having an appropriate cognitive level (not having a cognitive level that would make it difficult to understand the study or to perform the exercise) Exclusion Criteria
* Physical activity level \>1500 MET-min/week according to the International Physical Activity Questionnaire (short form)
* Having cancer and malignant tumours
* Presence of cognitive problems
* Severe vision problems (colour blindness, blindness, etc.)

Primary outcomes:
measure: Single Leg Stance Test
timeFrame: 6 weeks
measure: Libra Swivel Balance Board
timeFrame: 6 weeks
measure: International Physical Activity Questionnaire
timeFrame: 6 weeks
measure: Tampa Kinesiophobia Scale
timeFrame: 6 weeks
measure: Fatigue Severity Scale
timeFrame: 6 weeks
measure: McGill Pain Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahceşehir University Health Center
Study officials:
References: