louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06455761: 68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
Official title: 68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Tumor
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Detailed description: Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Eligibility criteria: Inclusion Criteria:

Various solid tumors with available histopathological findings; Signed informed consent.

Exclusion Criteria:

pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: SUV of tumors
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Weibing, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05458661: Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort
Official title: Feasibility Investigation of Biometry and Tomography Measurements in a Heterogeneous Patient Cohort (BioBase)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lens Opacities
Artificial Lens Implant
Corneal Astigmatism
Corneal Defect
Corneal Deformity
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all suitable/eligible subjects will undergo a series of biometry measurements
Primary purpose: OTHER

Brief summary: The planned clinical investigation will be conducted to acquire raw data for the development of the algorithm. The data acquisition is intended to obtain first impressions of the potential performance of the changed hardware and software components and to confirm the safety profile assessed by risk analysis.


Eligibility criteria: Inclusion Criteria:

* Male or female 21 years of age and older
* Able and willing to make the required study visit
* Able and willing to provide consent and follow study instructions
* Patients must have understood and signed the informed consent

Exclusion Criteria:

* Any performed contact measurements or examinations in which the eye is touched on the same day prior to the investigation measurement
* Physical inability to be positioned at the study devices (e.g. torticollis, head tremor, injuries at forehead or chin, etc.)
* Principal Investigator's determination that the subject is not suitable due to other medical condition (reasons to be listed on eCRF)
* Known Pregnancy

Primary outcomes:
measure: Data collection for algorithm development - Cornea to retina Scan
timeFrame: day 1
measure: Data collection for algorithm development - Corneal topography
timeFrame: day 1
measure: Data collection for algorithm development - - Anterior-segment OCT data
timeFrame: day 1
measure: Data collection for algorithm development - Extended retina-scan
timeFrame: day1
measure: Data collection for algorithm development - Reference pictures for markerless alignment of toric IOL (sclera images)
timeFrame: day 1
measure: Data collection for algorithm development - White-to-white determination
timeFrame: day 1
measure: Data collection for algorithm development - IOL Imaging pictures
timeFrame: day 1
measure: Affected measurements - OCT measurements
timeFrame: day 1
measure: Affected measurements - Keratometry and Topography measurements
timeFrame: day 1
measure: Affected measurements - - WTW measurements
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02789761: The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
Official title: The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Flow-mediated dilatation (FMD)
Vascular function
cognitive function
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.


Eligibility criteria: Inclusion Criteria

* Body Mass Index 18.5-27.5 kg/m2
* Normal Blood pressure (\< 150/90)
* Non-smoker
* Regular exercise routine
* Signed consent form

Exclusion Criteria:

* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Total Cholesterol \> 6.5 mmol/l
* Suffered a myocardial infarction or stroke in the last 12 months
* Suffers from any cardiovascular or metabolic disorders
* Suffers from any blood-clotting disorder, and/or takes supporting medication
* Any dietary restrictions or on a weight reducing diet
* On any lipid-modifying or blood pressure lowering medication
* Consuming any specific vitamin/ herbal supplements or fish oils

Primary outcomes:
measure: Flow-mediated Dilation (FMD)
timeFrame: Change from baseline at 14 days
Secondary outcomes:
measure: Blood pressure (BP)
timeFrame: Change from baseline at 14 days
measure: Executive Function
timeFrame: Change from baseline at 14 days
measure: Endothelial progenitor cells and Microparticles
timeFrame: Change from baseline at 14 days
measure: Plasma flavanol metabolite analysis
timeFrame: Change from baseline at 14 days
measure: Plasma Nitrite & Nitrate analysis
timeFrame: Change from baseline at 14 days
measure: Serum analysis of cardivascular-related blood marker(s) concentration
timeFrame: Change from baseline at 14 days
measure: Serum analysis of insulin
timeFrame: Change from baseline at 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Univerisity of Reading
name: Jeremy P Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02338661: Clinical Observation Study With the SBG Stem
Official title: Clinical Observation Study With the SBG Stem
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Hip Replacement
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 148
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: Primary care clinic

Brief summary: This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.


Eligibility criteria: Inclusion Criteria:

* patients requiring the implantation of the SBG hip stem

Exclusion Criteria:

* general medical contraindications to surgery
* acute or recent infection of joint
* atrophy or deformation of upper femur
* muscular atrophy or neuromuscular disease
* pathologic fractures
* per- and subtrochanteric fractures
* revision of failed hip endoprosthesis
* hypersensitivity to used materials
* any conditions preventing stable anchoring of the hip prosthesis

Primary outcomes:
measure: Harris Hip Score
timeFrame: Baseline and 10 years post surgery
Secondary outcomes:
measure: Assessment of position of hip stem
timeFrame: Baseline and 10 years post surgery
measure: Radiographic Analysis: classification of osseointegration of hip stem
timeFrame: 10 years post surgery
measure: Radiographic Analysis: radiolucent lines around hip stem
timeFrame: 10 years post surgery
measure: Radiographic Analysis: number of participants with femoral osteolysis around hip stem
timeFrame: 10 years post surgery
measure: Radiographic Analysis: bone atrophy around hip stem
timeFrame: 10 years post surgery
measure: Radiographic Analysis: bone hypertrophy around hip stem
timeFrame: 10 years post surgery
Other outcomes:
Locations:
city: Buchs
country: Switzerland
facility: Praxis Klinik Gut Buchs
Study officials:
affiliation: Praxis Klinik Gut Buchs
name: Beat Schmid, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520761: The Effect of Injectable PRF Vs LLL on Orthodontic Tooth Movement
Official title: The Effect of Injectable Platelet Rich Fibrin Versus Low-Level LASER Therapy on The Rate of Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rate of Canine Retraction
Root Resorption
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2024-07-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the present study is to compare the effect of injectable platelet fibrin and Low Level LASER therapy on the rate of upper canine retraction, and on root resorption of the canine

Detailed description: the study involves two groups the first group received low level laser at the upper right canine, while the upper left canine act as a control. The second group received injectable platelet rich fibrin at the upper right canine, while the upper left canine act as a control. in each group we will compare rate of canine retraction between both sides, and amount of root resorption also we will compare both groups regarding rate of canine retraction and amount of root resorption

Eligibility criteria: Inclusion Criteria:

1. Patients with age 18 years or older.
2. Presence of all permanent teeth except for the third molar.
3. Presence of malocclusion requiring maxillary first premolar extraction such as (class II division 1 or bimaxillary dentoalveolar protrusion).

Exclusion Criteria:

1. Patient with a history of previous orthodontic treatment.
2. Medical problems may interfere with orthodontic treatment.
3. Bad oral hygiene.

Primary outcomes:
measure: Rate of canine retraction
timeFrame: 4 month
Secondary outcomes:
measure: Root resorption of upper canine
timeFrame: 4 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine for Girls Al Azhar university
state: Naser City
Study officials:
affiliation: Head of orthodontic department at faculty of Dental Medicine for Girls Al-Azhar university
name: Samir A Ebrahim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
Clinical trial NCT04681261: Occupational Balance, Fear and Agoraphobia
Official title: Evaluation of Occupational Balance, Fear and Agoraphobia in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 699
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult individuals

Brief summary: This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic.

Detailed description: During the Covid-19 pandemic, the occupational balance of individuals change and the sedentary activities preferences, that pose a risk for health, increase.The outbreak also produced effects such as fear of sickness and death in addition to changing daily life and work routines, occupational balance and social participation. This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic.

Eligibility criteria: Inclusion Criteria:

between 19-65 years of age

Exclusion Criteria:

\<19 years and \>65 years old

Primary outcomes:
measure: Occupational Balance Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Özgü İnal
state: Merkez
Study officials:
affiliation: Trakya University
name: Özgü İnal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968161: Investigator Initiated Study - Asenapine Early Psychosis
Official title: An Open-label Switch Study to Asenapine in the Early Stage of Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia and Disorders With Psychotic Features
Disorders
Lead sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 12
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: We propose a use of a unique facility, the databank at the CNDV, to examine the impact of switching subjects to asenapine in an open-label naturalistic setting. This offers the following advantages: i) providing data on a particularly important population, i.e., subjects who are at the inception of treatment for a psychotic disorder and who are likely to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting, with a clinical team dedicated to provide innovative interventions; iii) its naturalistic design, that will allow to obtain data that will be applicable to "real-life" clinical settings; indeed, subjects who will be switched to asenapine within the current project are those we would switch to this drug in our daily practice.


Eligibility criteria: Inclusion Criteria:

* Meeting DSM-IV criteria for schizophrenia (SZ) or related SZ spectrum psychotic disorders
* having provided a consent to include data on our databank,and being able to provide informed consent
* willingness to participate to the assessments
* being over 18 years of age
* being in a clinical situation that warrants switch to asenapine

Exclusion Criteria:

* suffering from a primary drug-induced psychosis
* being at significant risk for suicide or assault
* unstable medical condition
* persistence of psychotic symptoms despite adequate treatment to an extent that clozapine would be required
* being treated with antipsychotic for 5 years or more
* having contraindications(allergy to asenapine)
* being pregnant or lactating

Primary outcomes:
measure: Impact of switching to asenapine
timeFrame: 3 months
Secondary outcomes:
measure: Predictors of successful switch to asenapine
timeFrame: 3 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Clinique Notre-Dame des Victoires
Study officials:
affiliation: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
name: Marc-André Roy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073461: Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
Official title: A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 236
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.


Eligibility criteria: Inclusion Criteria:

* Men and women at the age of 12 or older at the Screening visit.
* Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

* Those with more than two nodular acne lesions or any cysts.
* Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
* Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

Primary outcomes:
measure: Percent Changes From Baseline in Total Lesion Counts
timeFrame: Baseline - Week 12
Secondary outcomes:
measure: Percent of Subjects With Adverse Events
timeFrame: up to 12 weeks
measure: Local Tolerability (Erythema)
timeFrame: 12 weeks
measure: Local Tolerability (Scaling)
timeFrame: 12 weeks
measure: Local Tolerability (Dryness)
timeFrame: 12 weeks
measure: Local Tolerability (Pruritus)
timeFrame: 12 weeks
measure: Local Tolerability (Stinging/Burning)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Galderma investigational site
state: Hyogo
city: Kobe
country: Japan
facility: Galderma investigational site
state: Hyogo
city: Nakano
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Shibuya
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Shinjuku
country: Japan
facility: Galderma investigational site
state: Tokyo
city: Fukuoka
country: Japan
facility: Galderma investigational site
Study officials:
References:
Clinical trial NCT05501028: NLP to Aid in the Evaluation and Diagnosis of FGIDs
Official title: Using Natural Language Processing of Novel Biopsychosocial Disease Constructs to Aid in the Evaluation and Diagnosis of Functional Gastrointestinal Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2022-08-15
Enrollment: 700
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: Group 1: Patients who are scheduled for a consult in the MGH Gastroenterology Unit

Group 2: Patients who are scheduled for a diagnostic endoscopy in the MGH Gastroenterology Unit

Brief summary: The study has two arms, where the same natural language processing (NLP) and probabilistic graphical modeling technology will be utilized on patients' report of symptoms in both arms. The clinical arm is focused on patients presenting for consultation with a gastroenterologist. The endoscopy arm is focused generally on patients presenting for a diagnostic endoscopy, with the goal of capturing Functional Gastrointestinal Disorder (FGID) patients prior to diagnosis.


Eligibility criteria: Inclusion Criteria:

* Scheduled for consult in the Motility Clinic in the MGH Gastroenterology Unit or for diagnostic endoscopy in the MGH Gastroenterology Unit
* Patient must agree to have their interactions audio-recorded
* Informed consent form signed by the subjects

Exclusion Criteria:

* Non-native English speaker
* Patients unable to communicate their own symptoms

Primary outcomes:
measure: Latent themes present in patient descriptions of FGIDs symptoms
timeFrame: 08/09/2018-08/09/2023
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03281928: Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
Official title: Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Stone
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function.


Eligibility criteria: Inclusion Criteria:

* age 18 - 70, approximately equal numbers of men and women
* studied by endoscopy with complete papillary mapping and grading
* stone formers

Exclusion Criteria:

* Patients with primary renal diseases or renal impairment (eGFR \< 90), or medical conditions such as diabetes, or systemic diseases or medications that alter calcium metabolism
* Patients with known bladder voiding problems

Primary outcomes:
measure: Urine Calcium levels
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References: