louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06660290: A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
Official title: A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: Dry Eyes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the proportion of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and Refresh® Classic.

Detailed description: This is a 1-visit study (Screening, Enrollment, Assessments).

Eligibility criteria: Key Inclusion Criteria:

* Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
* Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
* Capable of giving signed informed consent.

Key Exclusion Criteria:

* Current evidence of other clinically significant ophthalmic disease other than dry eye;
* History of ocular surgery within 1 year of the Study Visit;
* Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
* Positive pregnancy test or currently breastfeeding.

Primary outcomes:
measure: Percentage of Ocular Adverse Events
timeFrame: Day 1 post drop instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research, LLC
state: Tennessee
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT00402090: DHPLC Determination of TPMT Polymorphisms.
Official title: Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia
Keywords: thiopurines
thiopurine methyl transferase
toxicity
pharmacogenomics
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2006-11-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

Detailed description: Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia.

* To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity.
* Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age \> 18 years, who attend to the National Institute of Cancerologia.
* Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up.
* Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).

Eligibility criteria: Inclusion Criteria:

* Healthy and patientes with acute lymphoblastic leukemia.
* Age: older than 18 years.
* Attend to the National Institute of Cancerologia

Exclusion Criteria:

* Foreign patients with an irregular attendance to the National Institute of Cancerologia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: MExico city
country: Mexico
facility: National Institute of Cancerologia
state: DF
Study officials:
affiliation: National Institute of Cancerologia
name: Myrna Candelaria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03145090: Bone Scintigraphy and Unicompartimental Knee Arthroplasty
Official title: Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Scintigraphy and Knee Arthroplasty
Keywords: bone scintigraphy
knee arthroplasty
spect-ct
quantification
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient over 18 years old undergoing unicompartmental knee arthroplasty (1 or 2 knee) and who accept the study

Brief summary: Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty

Detailed description: Knee osteoarthritis is a very common disease with significant functional consequences. Surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments.

Consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (PUC) is considered.

The scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment.

This study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy

Eligibility criteria: Inclusion Criteria:

* patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition

Exclusion Criteria:

* Under 18 years old/ contraindications for bone scintigraphy/ refusal to participate

Primary outcomes:
measure: modification in surgical strategy according to bone scintigraphy results
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: Clinique de La Baie
Study officials:
References:
Clinical trial NCT04936490: Crocin Supplementation in CSCR
Official title: Efficacy and Safety of Crocin Supplementation in Patients With Central Serous Chorioretinopathy (CSCR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chorioretinopathy, Central Serous
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (CSCR). They involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. It also showed that crocin has a protective effect on the retinal pigmented epithelium (RPE) layer. Based on the mentioned evidence the study designed to evaluate the efficacy and safety of 2-month crocin supplementation (15 mg/d) in 40 patients with CSCR in a randomized controlled blinded clinical trial.


Eligibility criteria: Inclusion Criteria:

* age of 18-60 years old
* The diagnosis of CSCR based on clinical and imagining evaluation
* informed consent

Exclusion Criteria:

* Chronic CSCR
* Laser treatment (6 months prior to enrollment)
* IVB treatment (3 months prior to enrollment)
* Other retinal diseases
* History of eye diseases
* Diabetes Mellitus
* Renal or hepatic diseases
* Allergy to saffron or crocin
* Pregnancy or lactation
* Beta-blocker, diuretic, or corticosteroid (1 week prior to enrollment) Bleeding tendency or any coagulation disorder

Primary outcomes:
measure: Best-corrected visual acuity (BCVA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Foveal thickness (μm)
timeFrame: 8 weeks
measure: Subretinal fluid height (μm)
timeFrame: 8 weeks
measure: Subfoveal choroidal thickness (μm)
timeFrame: 8 weeks
measure: Number of participants need to laser therapy
timeFrame: 8 weeks
measure: Total number of reported adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
References:
Clinical trial NCT05187390: Incidence of Chronic Pain After Video-Assisted Thoracic Surgery
Official title: Incidence of Chronic Pain After Video-Assisted Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Postoperative Pain, Acute
Postoperative Pain, Chronic
VATS
Keywords: Postoperative Pain
Postoperative Pain, Acute
Postoperative Pain, Chronic
VATS
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-65 years, in the ASA I-II-III risk group, with a BMI between 18-35 kg/m2 and undergoing VATS will be included in our study.

Patients under the age of 18 years and over the age of 65 years, with an ASA score of IV and above, with a BMI below 18 kg/m2 and above 35 kg/m2, who were operated under emergency conditions, and who received chronic pain treatment will be excluded from the study.

Brief summary: Video-assisted thoracic surgery (VATS) is frequently performed in thoracic surgery. It is widely accepted that VATS causes acute pain. Many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. This acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic pain in the later period, and may adversely affect the quality of life of the patients.

This study, it was aimed to analyze the symptoms of chronic pain in the 1st and 3rd months postoperatively in patients who had undergone VATS.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-35 kg/m2
* Patients undergoing elective VATS

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* Patients with previous thoracic surgery
* Patients who were operated under emergency conditions

Primary outcomes:
measure: Pain scores at 1st months.
timeFrame: Chronic pain symptoms at 1st months
measure: Pain scores at 3rd months
timeFrame: Chronic pain symptoms at 3rd months
Secondary outcomes:
Other outcomes:
Locations:
city: Keçiören
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Oya Kaybal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524290: Multinational Study of Acinetobacter Bloodstream Infection: Clinical Outcomes and Global Epidemiology-PITT Protocol
Official title: Multinational Study of Acinetobacter Bloodstream Infection: Clinical Outcomes and Global Epidemiology-PITT Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acinetobacter Infections
Keywords: Acinetobacter
infection
isolate
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acinetobacter infections

Brief summary: The objectives of this multinational study are to assess the clinical outcomes of patients with Acinetobacter bloodstream infection and to further assess the predictors of mortality in this patient population. We also aim to characterize the molecular epidemiology of this remarkable organism in an attempt to further understand its transmission dynamics on a global level and to determine whether increased pathogenicity is geographically dependent.

Detailed description: Medical records will be reviewed and information collected to assess the clinical outcomes of patients with Acinetobacter bloodstream infection and to further assess the predictors of mortality in this patient population.

Eligibility criteria: Inclusion Criteria:

* Patients with Acinetobacter infections

Exclusion Criteria:

* Those that do not meet entry criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: David Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05967390: Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE)
Official title: Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE): A Project of MRI-informed Computational Head Model
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aging
Dementia Alzheimers
Parkinson Disease
Dementia Frontotemporal
Depression in Old Age
Keywords: Aging
Scalp-to-cortex distance
Transcranial brain stimulation
Parkinson disease
Simulation
Predictor
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 488
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal ageing adults and adults with neurocognitive disorders

Brief summary: Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has been highlighted in the guidelines of non-invasive brain stimulation. However, in the context of age-related brain changes, the region-specific SCD and its impact on stimulation-induced electric field in different types of neurodegenerative diseases remain unclear.

Detailed description: Objective: This study aimed to investigate the region-specific SCD and its relationship with morphometric features and cognitive function in age- and disease-specific populations. Methods: The SCD and cortical thickness (CT) of left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) were measured in cognitively normal adults and dementia patients. CT-adjusted SCD was used to control the influence of CT on SCD. Head model was developed to simulate the impact of SCD on the electric field induced by transcranial electrical stimulation.

Eligibility criteria: Inclusion Criteria:

* Right-handed as assessed by the Edinburgh Inventory
* Able to attend TMS interventions
* Consent
* Independent in daily life activities

Exclusion Criteria:

* Uncorrected visual or auditive deficits not allowing the realization of the test
* Evolutive disease (such as cancer)
* Neurological or psychiatric antecedent
* Counter-indication to MRI

Primary outcomes:
measure: Scalp-to-cortex distance will be measured using geometric brain model
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tai Po Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Hanna LU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05743790: The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption
Official title: The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We originally enrolled 196 participants and collected saliva samples for screening to participate in the intervention. Then we enrolled 76 participants in the intervention study. These participants were randomly assigned to one of two parallel arms in the intervention study.
Primary purpose: OTHER

Brief summary: Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.


Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Willing to consume the supplements provided throughout the duration of the study

Exclusion Criteria:

* History of diabetes, prediabetes or impaired glucose tolerance.
* Existing, UNTREATED, thyroid condition.
* Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study.
* Acute disease at the time of enrollment.
* Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
* History of active UNTREATED gastrointestinal disorders or diseases including:

  i. Inflammatory bowel disease (IBD) ii. Ulcerative colitis (mild-moderate-severe) iii. Crohn's disease (mild- moderate-severe) iv. Indeterminate colitis v. Irritable bowel syndrome (IBS) (moderate-severe) vi. Persistent, infectious gastroenteritis, colitis or gastritis vii. Persistent or chronic diarrhea of unknown etiology viii. Clostridium difficile infection (recurrent) ix. Chronic constipation
* Suspected state of immunosuppression or immunodeficiency including HIV.
* History of bariatric surgery.
* Pregnant or lactating women.

Primary outcomes:
measure: Gut microbiome
timeFrame: 7 weeks
measure: Fecal short-chain fatty acid concentration
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
References:
Clinical trial NCT00231790: A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 848
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.

Detailed description: Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes.
* Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards.

Exclusion Criteria:

* Patients must not suffer from diabetes insipidus
* Hyperglycemia
* Hypercalcemia
* Orthostatic hypotension
* Active/recurrent urinary tract infections (\>6 episodes per year)
* Patients must be willing to discontinue their current OAB medication therapy.

Primary outcomes:
measure: Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)
timeFrame: Baseline and Week 8
measure: Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
timeFrame: Day 1 of Follow-up
measure: Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
timeFrame: Day 1 of Follow-up
Secondary outcomes:
measure: Change from baseline in the number of total incontinence episodes
timeFrame: Baseline and Week 8
measure: Number of urge-incontinence episodes
timeFrame: Up to 8 weeks
measure: Number of urgency episodes per day averaged over a diary card week (4 to 10 days)
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: