louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05719753: The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
Official title: A Pilot Study to Characterise the Effectiveness of a Bacteriophobic Coating in Preventing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Camstent Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization

Detailed description: The purpose of the study is to provide pilot information on the characteristics of the biofilm formed on the coated catheter compared to a standard catheter. The two objectives are;

1. to evaluate the catheter's on-label performance in customary clinical use.
2. to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.

Eligibility criteria: Inclusion Criteria:

1. All patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care.
2. Patients aged 18-85 years will be eligible for the study.
3. Able to give informed consent.

Exclusion Criteria:

1. Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection.
2. Pregnant patients.
3. Patients with a potentially immunocompromised condition (steroids, HIV)
4. Patients who are unable to give informed consent

Primary outcomes:
measure: An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.
timeFrame: 1 year
Secondary outcomes:
measure: catheter blockage
timeFrame: 1 year
measure: catheter associated infection
timeFrame: 1 year
measure: Ease of insertion and removal of the catheter since it creates a very smooth and slippery surface using the NHS staff standard clinical feedback form.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
References:
Clinical trial NCT00609453: Brain Imaging of Psychotherapy for Depression
Official title: Brain Imaging of Psychotherapy for Depression (Includes, "Reward System Recovery Following Behavioral Activation Therapy in Depression")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Control participants
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fMRI), and to compare results to those obtained from a nondepressed control group.


Eligibility criteria: Inclusion Criteria:

* For group 1: Diagnosis of current depression and no other current Axis I psychiatric disorder
* For group 1: Hamilton Depression Rating Scale score of 15 or greater

Exclusion Criteria:

* A history of serious head injury or neurological disease or psychosis
* Current use of psychoactive medications
* Factors that could affect MRI safety including current or planned pregnancy
* For group 2: current Axis I psychiatric disorder, as assessed by structured clinical interview

Primary outcomes:
measure: Hamilton Depression Inventory
timeFrame: three times over 12 weeks
measure: Functional Magnetic Resonance Imaging
timeFrame: twice in 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke-UNC Brain Imaging and Analysis Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gabriel S Dichter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05678153: Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study
Official title: Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking
Orofacial Dysfunction
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cooperative Egyptian children aged from (four to seven) years.

Brief summary: This study aims to investigate the orofacial dysfunction in children who are subjected to passive smoking and to correlate its results to their saliva cotinine levels

Detailed description: The participants will be recruited from the pedodontics outpatient clinic in the, Faculty of Oral and Dental Medicine, Ahram Canadian University, Egypt. The aim and the steps of the study will be explained to the guardian.

After obtaining the informed consent, the investigator will fill an administrative questionnaire, which includes parents and child's personal data, medical and dental history, a question inquiring if one of the parents smokes in the house, the frequency of smoking, smoking type, and number of cigarettes (if present).

Then, the examination of orofacial dysfunction will be evaluated by the investigator, using Nordic Orofacial Test - screen (NOT-S)

Eligibility criteria: Inclusion Criteria:

* Children who are free from any systematic disease, or genetic disorders that
* Children whose families accept to participate in this study.

Exclusion Criteria:

* Children whose parents quit smoking after the child was born.

Primary outcomes:
measure: Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen)
timeFrame: baseline record
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ahram Canadian University
name: Mennat Allah Abd-Elsabour, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01845753: Molecular Screening for Lynch Syndrome in Denmark
Official title: Molecular Screening for Lynch Syndrome in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lynch Syndrome
HNPCC
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All colorectal cancer patients in Denmark

Brief summary: A clinically applicably strategy for molecular screening for Lynch Syndrome is being implemented in Denmark.

Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling.

The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone.

Prospective data collection is performed using established clinical databases.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of colorectal adenocarcinoma
* Diagnosed at one of the departments of pathology in Denmark

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of Lynch Syndrome in a population of primary colorectal cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Pathology
city: Aarhus
country: Denmark
facility: Department of Clinical Genetics
city: Aarhus
country: Denmark
facility: Department of Pathology
city: Esbjerg
country: Denmark
facility: Department of Pathology
city: Hjørring
country: Denmark
facility: Department of Pathology
city: Odense
country: Denmark
facility: Department of Clinical Genetics
city: Odense
country: Denmark
facility: Department of Pathology
city: Sønderborg
country: Denmark
facility: Department of Pathology
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Vejle
country: Denmark
facility: Department of Clinical Genetics
city: Vejle
country: Denmark
facility: Department of Pathology
Study officials:
References:
Clinical trial NCT05155553: QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study
Official title: An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis/Encephalitis
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 1524
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects (adults and children) with signs and symptoms of meningitis and/or encephalitis

Brief summary: Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Detailed description: This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Eligibility criteria: Inclusion Criteria:

* Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.

Exclusion Criteria:

* Specimens not fitting criteria outlined above.
* CSF obtained from an external ventricular drain or shunt source.
* Lack of clear subject identification or label on residual banked CSF specimen.
* Specimen has been centrifuged.
* Obvious physical damage of banked residual specimen.
* Repeat specimens from the same subject.

Primary outcomes:
measure: PPA
timeFrame: 6 months
measure: NPA
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Qiagen
Study officials:
affiliation: QIAGEN Gaithersburg, Inc
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT01264653: Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery
Official title: Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.


Eligibility criteria: Inclusion Criteria:

* male and female
* can read and sign informed consent form；
* Clinical diagnosis of cataract
* Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

* sensitivity to adrenalin；
* sensitivity to topical mydriatics；
* any other ocular surgeries；
* iris abnormalities

Primary outcomes:
measure: Pupil size after intracameral adrenaline
timeFrame: 1day
Secondary outcomes:
measure: endothelial cell count
timeFrame: 1month
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Ayong Yu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01260753: Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge
Official title: Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Palau Pharma S.L.U.
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
* Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
* Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
* Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score \[TNSS\]) within one hour after last nasal allergen challenge
* Screening and baseline FEV1 \>80% predicted and FEV1/FVC \> 70% predicted

Exclusion Criteria:

* Symptoms of allergic rhinitis within 2 weeks prior to screening
* Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
* Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
* History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1\<80% of predicted at screening or baseline

Primary outcomes:
measure: Nasal and ocular symptoms scores after nasal allergen challenge
timeFrame: 24 hours
Secondary outcomes:
measure: Inflammatory parameters measured from nasal exudate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Parexel
name: Rainard Fuhr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04891653: A Phase I Study of BR790 in Subjects With Advanced Solid Tumors
Official title: A Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Monotherapy in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent voluntarily.
* Age ≥18 and ≤75 years old.
* Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
* Had at least one measurable lesion.
* ECOG≤1.
* Expected survival period ≥ 3 months.

Exclusion Criteria:

* Any previous treatment with SHP-2 inhibitor.
* Symptomatic brain metastases.
* Subjects with thoracic/ascites fluid that need drainage or intervention.
* Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN.
* With uncontrolled severe disease.

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: up to 32 day
measure: maximum tolerated dose (MTD)
timeFrame: up to 32 day
measure: recommended phase II clinical study dose (RP2D)
timeFrame: up to 32 day
Secondary outcomes:
measure: AUC
timeFrame: up to 32 day
measure: Cmax
timeFrame: up to 32 day
measure: t1/2
timeFrame: up to 32 day
measure: pERK
timeFrame: up to 32 day
measure: AE
timeFrame: through study completion, an average of 3 years
measure: ORR
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06246253: Bone Formed Labial to the Implant in Relation to the Horizontal Gap Dimension in Immediate Implant Placement.
Official title: Bone Formed Labial to the Implant in Relation to the Horizontal Gap Dimension in Immediate Implant Placement. A CBCT Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immediate Implant Placement
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immediate implant placement in anterior maxillary teeth

Brief summary: Palate implant placement in extraction sockets, with a minimum of 2 mm between the implant and the inner side of the facial socket wall, has been advised as a step towards a 3D restorative-driven posture. The buccal gap left by this palatal location is identified by the term "jumping gap" or "jumping distance," which describes the capacity of bone to fill the void and bridge the horizontal gap. The gap is made up of a vertical and horizontal component. Significantly, this gap denotes the future buccal bone that will directly contribute to the buccal contour and impact the soft tissue levels, thus influencing the implant's final appearance. Consequently, it is now considered desirable to have a bigger horizontal gap since more newly created buccal bone is predicted to occur in areas with larger horizontal gaps.


Eligibility criteria: Inclusion Criteria:

* anterior maxillary teeth
* Immediate implant placement

Exclusion Criteria:

* fractured apical part of the root
* teeth with apical resorption or displacement

Primary outcomes:
measure: labial gap dimension
timeFrame: pre and immediately after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Continuing Education (IDCE) centre
Study officials:
References:
Clinical trial NCT06545253: A New Diagnostic Paradigm for Retinitis Pigmentosa Secondary to USH2A Pathogenic Variants
Official title: A New Diagnostic Paradigm for Retinitis Pigmentosa Secondary to USH2A Pathogenic Variants
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: USH2A Variant Retinitis Pigmentosa
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 60 patients affected by genetically-confirmed USH2A-RP, both males and females, age \>18 years
* 10 healthy age- and gender- matched control subjects recruited among healthy patients undergoing general ophthalmological examinations in the outpatient departments

Brief summary: Aim of the study is to perform a non-invasive multimodal retinal imaging investigation in a cohort of patients affected by USH2A retinitis pigmentosa (USH2A-RP), in order to develop a new diagnostic paradigm to categorize clinically relevant subgroups. All the procedures will be performed according to normal clinical practice. In addition, a novel quantitative profiling of serum microRNAs will be carried out in order to analyze the clinical importance of microRNA biomarkers in the clinical setting of the disease.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* genetically confirmed diagnosis of USH2A-RP
* availability of genetic tests to assess the pathogenic variants

Exclusion Criteria:

* inability to understand and sign the written informed consent form
* any inflammatory, infectious or degenerative eye disease
* media opacities resulting incompatible with good imaging quality
* uncontrolled systemic, metabolic, autoimmune neuroinflammatory and neurodegenerative disease
* ophthalmologic surgery within the previous six months

Primary outcomes:
measure: Clinical relevance of microRNAs in USH2A-RP
timeFrame: 6 months period following the last follow-up visit
Secondary outcomes:
measure: To test the association between specific microRNAs profiles and the quantitative multimodal retinal imaging findings
timeFrame: 6 months period following the last follow-up visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02647853: Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
Official title: A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nasolabial Folds
Lipoatrophy
Lipodystrophy
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.


Eligibility criteria: Inclusion Criteria:

* Men and women 40-70 years old
* Healthy volunteers
* Provision of informed consent

Exclusion Criteria:

* History of skin hypersensitivity
* Abnormality on screening assessments

Primary outcomes:
measure: Adverse Event rates
timeFrame: 21 days
Secondary outcomes:
measure: Plasma pharmacokinetics (Cmax)
timeFrame: Days 1 and 13
measure: Plasma pharmacokinetics (Tmax)
timeFrame: Days 1 and 13
measure: Plasma pharmacokinetics (AUC0-24)
timeFrame: Day 1 and 13
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Topokine Clinical Site
state: California
Study officials:
References: