louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00863551: Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elderly
Pharmacokinetics
Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.


Eligibility criteria: Inclusion Criteria:

* Male or female, 65-75 years of age without evidence of memory impairment
* Subject has overactive bladder symptoms but otherwise healthy
* Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
* Weight within normal range
* Ability to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* Residual urine within bladder greater than 4 ounces
* Moderate or severe memory impairment
* Bleeding disorder
* Blood-thinning agents
* Concurrent overactive bladder medication
* Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
* Chronic kidney failure
* Abdominal bypass surgery for obesity

Primary outcomes:
measure: Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
timeFrame: Day 10, Hour 5
Secondary outcomes:
measure: Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose
timeFrame: Day 10
measure: Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose
timeFrame: Day 10
measure: Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose
timeFrame: Day 10
measure: Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose
timeFrame: Day 10
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01989351: Predisposition to Persistent Pain After Orthopaedic Surgery: Genetic Aspects
Official title: LA PREDISPOSIZIONE AL DOLORE PERSISTENTE POST OPERATORIO IN AMBITO ORTOPEDICO: ASPETTI GENETICI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing total knee arthoplasty.

Brief summary: The study purpose is to examine polymorphism of genes associated to post-operative persistent pain and to verify the possible association between genotype phenotype and ADRB2 polymorphism in orthopaedic surgery. The primary aim is to evaluate the expression of ADBR2 in VAS\>4 patients and to compare it to those with VAS\<4.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* ASA I to III

Exclusion Criteria:

* Contraindications to regional anesthesia procedures
* Not stabilized neurological diseases
* Diabetes

Primary outcomes:
measure: Frequency of SNPs rs12654788 and rs1042713 of ADBR2 gene in patients who complain persistent pain 4 months postoperatively compared to chronic pain free patients.
timeFrame: 4 months after surgery
Secondary outcomes:
measure: Expression frequency of OPRM1, COMT, IL1Ra
timeFrame: 6, 12, 24, 48 hours
measure: Serum concentration of TNFα, TGFβ, IFNγ, IL-6 and IL-10 obtained with ELISA system
timeFrame: 6, 12, 24 and 48 hours postoperatively
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Ortopedico G. Pini
state: Milano
Study officials:
affiliation: ASST Gaetano Pini-CTO
name: Gianluca Cappelleri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Manuela de Gregori, Biologist
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Massimo Allegri, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05864651: Tele-Exercise for Male Elite Fencers
Official title: Tele-Exercise Programs Improves Physical Performance for Male Elite Fencers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Athletic Performance
Keywords: Sports Physical Therapy
Athletic Performance
Fencing
Tele-exercise
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Tele-exercise has been used to enhance athletic performance among athletes. Physical performance indicators such as lunge distance, speed, reaction time, coordination, and balance control during stationary jumps can be used to measure the effectiveness of tele-exercise programs for fencing athletes.

The objective of this study was to examine the effectiveness of tele-exercise programs on lunge distance, speed, reaction time, coordination, and balance control during stationary jumps among male elite fencers.


Eligibility criteria: Inclusion Criteria:

* who are registered to Elite Fencer to both Korean Sports \& Olympic Committee and Korean Fencing Federation;
* who does not have a history of musculoskeletal or neurological injuries in the past six months;
* who have no physical limitations.

Exclusion Criteria:

* Those who have the experience of participating in experiments in the past year
* who refuses to participate or provide written consent.

Primary outcomes:
measure: Lunge speed
timeFrame: changes from baseline after intervention at 4 weeks
measure: Lunge distance
timeFrame: changes from baseline after intervention at 4 weeks
measure: Reaction time
timeFrame: changes from baseline after intervention at 4 weeks
Secondary outcomes:
measure: Accurate repeatability of stationary hops
timeFrame: changes from baseline after intervention at 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Physicla Therapy, Sahmyook University
Study officials:
References:
Clinical trial NCT02510651: Effect of Procedural Variables on Outcome of Surgical Treatment of Vitiligo
Official title: Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Non-Segmental Stable Vitiligo: A Clinical and Immunohistochemical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vitiligo
Keywords: : non-segmental vitiligo
melanocyte-keratinocyte suspension
cryoblebbing
CO2 laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 40
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: ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.

Detailed description: Background: Melanocyte-keratinocyte suspension (M-K susp) is gaining popularity for vitiligo treatment. Few studies have addressed procedure-related variables.

Objective: To assess the effect of different M-K susp procedure-related variables on the clinical outcome in stable vitiligo.

Methods: This retrospective study included 40 cases with stable non-segmental vitiligo treated by M-K susp followed by narrow band- ultraviolet B phototherapy twice weekly. Donor site was either a skin graft in non-cultured epidermal cell suspension (NCECS) (34 cases) or hair follicle unit in Outer Root Sheath Hair Follicle Suspension (ORSHFS) (6 cases). Recipient site was prepared by either cryoblebbing (24 cases) or carbon dioxide (CO2)laser resurfacing (16 cases). Cell counts and viability were recorded in the cell suspensions, and tissue melanocytes and keratinocytes were examined by Melan A and Cytokeratin respectively. Assessment of repigmentation was done 18 months after the procedure.

Eligibility criteria: Inclusion Criteria:

* Stable non-segmental vitiligo

Exclusion Criteria:

* Active vitiligo

Primary outcomes:
measure: The number of patients with satisfactory response after the surgical procedure for vitiligo.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06951451: Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman
Official title: Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Cardiovascular Disease
Hypertension
Hyperlipidemia
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to:

1. Investigate the impact of MED-AD intervention on medication adherence among CVD patients, compared to patients receiving text message reminders or routine care alone at baseline, 6 months, and 12 months later.
2. Evaluate the effectiveness of MED-AD intervention on clinical outcomes among patients with CVD, compared to the outcomes of patients receiving text or routine care alone at baseline, 6 months, and 12 months later.

This study is a prospective randomized controlled clinical trial (RCT) with three arms:

1. MED-AD intervention: MED-AD is a smartphone application that will use the following strategies (pill reminders, Medication Adherence Report, medication intake confirmation, Medical Appointment Reminder, and educational notifications) to enhance medication adherence
2. Text message reminders: Participants will receive short text message (SMS) reminders to remind them to take medications as prescribed once daily
3. Routine care only: Participants will receive routine care that does not include text messages or reminders and education through an application.


Eligibility criteria: Inclusion Criteria:

1. diagnosed with at least one CVD (i.e., HTN, IHD, hyperlipidemia),
2. prescribed at least one medication for at least one year,
3. Omanis aged 18 years or older,
4. registered in the selected healthcare center, and 5) agreed to participate in the study

Exclusion Criteria:

1. have a severe cognitive impairment,
2. are unable to provide informed consent,
3. cannot read, and 4) do not have a smartphone with a compatible operating system (ios or Android).

Primary outcomes:
measure: Adherence to Refills and Medications Scale
timeFrame: BASELINE, AT 6 MONTHS, AT 12 MONTHS
measure: The Proportion of Days Covered
timeFrame: BASELINE, AT 6 MONTHS, AT 12 MONTHS
Secondary outcomes:
measure: Clinical outcomes
timeFrame: BASELINE, AT 6 MONTHS, AT 12 MONTHS
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Ministry of Health
Study officials:
References:
Clinical trial NCT06297551: Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)
Official title: Prospective Study of Leukemia Stem Cells Fractional Change in Peripheral Blood and Its Correlation With Therapeutic Outcome in Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 20
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: Adults diagnosed with acute myeloid leukemia, undergoing systemic chemotherapy (high or low intensity)

Brief summary: Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved.

Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming.

In this study investigators will study whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. A retrospective study found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment.

This pilot study will allow the investigators to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.


Eligibility criteria: Inclusion Criteria:

* diagnosis of acute myeloid leukemia
* ability to receive treatment for acute myeloid leukemia at the research center
* elevated values of CLL1A and CD45RA positive cells at the time of diagnosis

Primary outcomes:
measure: Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
Study officials:
affiliation: Stony Brook Medicine
name: Suhu Liu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04669951: Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer
Official title: Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagus Cancer, Adenocarcinoma
Keywords: urokinase plasminogen activator receptor
uPAR
Cardia
Adenocarcinoma
Immunohistochemistry
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patients will be drawn from the existing clinical biobank. The biobank is located at the department of pathology, Rigshospitalet. From this clinical biobank, a new temporary research biobank will be made. Supplementary sections from formalin-fixed paraffin embedded (FFPE) blocks containing tumor tissue will be cut and Haematoxylin and eosin (HE) and immunohistochemical (IHC) staining will be performed.
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate urokinase Plasminogen Activator Receptor (uPAR) microexpression in gastroesophageal cancer (adenocarcinomas) both qualitatively and semi-quantitatively and to evaluate if it offers a possibility for future imagining purposes.

Detailed description: * Sections of the tumor tissue will be HE stained.
* Sections of the tumor tissue will be stained with an uPAR antibody for immunohistochemistry.
* Immunohistochemical staining against cytokeratin which colors cancer cells will be made to assist the observer in the evaluation of uPAR microexpression pattern.
* A semiqualitative scale corresponding to the level of uPAR expression will be made.
* Quantitative polymerase chain reaction will be used to validate the immunohistochemistry uPAR expression pattern.
* An electronic scoring system (digital pathology) will be trained to access the expression of uPAR in both tumor- and normal tissue.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old.
* Patients who underwent curatively intended surgery for gastroesophageal cancer
* Patients who underwent surgery after 01-01-2016.

Exclusion Criteria:

* Patients who applied for an exception from medical research at the "National Registry of Tissue Use."
* Patients with other histological subtypes than adenocarcinoma.

Primary outcomes:
measure: uPAR microexpression
timeFrame: Up to 6 months
measure: Tumor-to-background ratio
timeFrame: Up to 6 months
Secondary outcomes:
measure: uPAR in patient groups
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Region Hovedstaden
Study officials:
affiliation: Rigshospitalet, Department of Surgical Gastroenterology
name: Michael Achiam, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842151: Optimizing the Assessment of Refractive Outcomes After Cataract Surgery
Official title: Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular Lens (IOL)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 162
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.

Detailed description: Subjects will be implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Standard clinical practice will be followed for pre-operative testing, IOL power estimation and IOL implantation. Only one eye will be enrolled in the study per surgeon determination. The eye will undergo both an automated and manual manifest refraction assessment at 3 months postoperative.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an Ethics Committee/Institutional Review Board approved Informed Consent;
* Willing and able to attend all scheduled study visits as required per protocol;
* Diagnosed with cataract in one or both eyes;
* Planned cataract removal by phacoemulsification with implantation of a monofocal IOL; laser refractive procedures for incisions (primary and sideport), capsulorhexis and lens fragmentation are allowed;
* Preoperative keratometric astigmatism ≤ 1.0 diopter (D);
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential, pregnant, or breast-feeding;
* History of ocular pathology, ocular inflammation, or ocular conditions, as specified in the protocol;
* Previous intraocular or corneal surgery;
* Use of systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk of complications to the subject;
* Any medical condition that, in the opinion of the Investigator, may confound the results of this study, prohibit the completion of the study assessments, or increase the risk for the subject;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: IOL A-constant at 3 Months at Each Site
timeFrame: Month 3 (Day 80-100) Post Study Eye Implantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT04854551: Opioid Modulation and Neural Reward Activation in Healthy Adults
Official title: Opioid Modulation and Neural Reward Activation in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcohol Drinking
Opioid Use, Unspecified
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be counterbalanced for the order they undergo placebo and medication.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a double blind study of the effects of opioid antagonism on the brain's reward response. The investigators will recruit participants to undergo two scans, one on active medication and one on placebo. During the scan, the investigators will assess reward.

Detailed description: The study will employ a crossover design. The study will use the monetary incentive delay task during functional MRI to assess reward. This task presents participants with cues indicating whether they are playing to win $5, win $0, or to avoid losing $5. This task has been well-validated to elicit activation in a key reward response area of the brain called the ventral striatum.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 35 years of age,
* Is a moderate drinker (i.e. consumes 1-14 drinks/week for males, or 1-7 drinks/week for females).

Exclusion Criteria:

* Non-drinker
* Positive result on urine drug screen or breathalyzer at the start of any study visit
* Inability to complete MRI (e.g. presence of ferromagnetic objects in body)
* Current use of medications that alter the hemodynamic response such as insulin
* History of trauma resulting in loss of consciousness longer than 15 minutes
* Currently taking opioid medications
* Pregnancy

Primary outcomes:
measure: Change in Brain Activation to Reward Between Placebo and Active Medication
timeFrame: one week
Secondary outcomes:
measure: Alcohol Value
timeFrame: one week
measure: Brain Activation to Emotion Regulation
timeFrame: one week
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Joshua Gowin, PhD
role: PRINCIPAL_INVESTIGATOR
References: