louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02180308: Lymph Node Assessment Using Simultaneous 18F-FDG-PET and MRI
Official title: Lymph Node Assessment Using Simultaneous 18F-FDG-PET and MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Head cancer
Neck cancer
MRI
PET
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and neck cancer who are scheduled for node dissection surgeries at NYU Langone Medical Center or Bellevue hospital.

Brief summary: The overarching goal of this study is to develop PET/MR techniques to accurately detect nodal metastases for surgical planning and assessment of treatment response.

Detailed description: Patients (n = 30) with head and neck cancer who are scheduled for node dissection surgery are eligible. Enrolled subjects will undergo one research PET/MR scan at the Center for Biomedical Imaging (660 First Avenue) within one week prior to the planned surgery. During the dissection, the locations of removed lymph nodes will be noted in terms of conventional neck lymph node levels. PET/MR data will be used for development of a combined kinetic model analysis of PET and MRI data (Aim 1). The final PET/MR findings will be compared with pathological evaluation results in order to assess the accuracy of PET/MR for detection of nodal metastases (Aim 2).

Eligibility criteria: Inclusion Criteria:

Patients with head and neck cancer who are scheduled for node dissection surgeries at NYU Langone Medical Center or Bellevue hospital are eligible.

Exclusion Criteria:

Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.

* Electrical implants such as cardiac pacemakers or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
* Ferromagnetic objects such as jewelry or metal clips in clothing
* Claustrophobia
* History of seizures
* Diabetes In addition, patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.

Primary outcomes:
measure: Accuracy of simultaneous FDG-PET/MRI for detection of nodal metastases
timeFrame: 2 years after beginning of study (July 2014 - June 2016)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Sungheon Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966108: SENSIMED Triggerfish Discomfort During IOP Monitoring
Official title: Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects and glaucoma patients

Brief summary: Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens


Eligibility criteria: Inclusion Criteria:

* Patient is able to comply with the study procedure
* Patient is 18-80 years old
* Healthy subject or glaucoma patient
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Cylinder refraction of no more than +/- 2 diopters in the study eye
* Visual acuity of 20/80 or better in the study eye
* Ability of subject to understand the character and individual consequences of the study
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects wearing contact lenses within the last two years
* Subjects with contraindications for wearing contact lenses
* History of refractive surgery
* History of intraocular surgery in the last three months
* Severe dry eye syndrome
* Keratoconus or other corneal abnormalities
* Conjunctival or intraocular inflammation
* Pregnancy and lactation
* Simultaneous participation in other clinical trials

Primary outcomes:
measure: ocular discomfort on a visual analogue scale
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Universitätsmedizin Mainz
name: Norbert Pfeiffer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03274908: Real-world Clinical Study and Medical Machine Intelligence Study for Traditional Chinese Internal Medicine
Official title: Real-world Clinical Study and Medical Machine Intelligence Study for Traditional Chinese Internal Medicine by Using Medical Big Data and Artificial Intelligence Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Internal Disorders
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Puer Hospital of Chinese Medicine
name: Dangyang Hospital of Chinese Medicine
name: Changde Hospital affiliated to Hunan University of Chinese Medicine
name: Ruikang Hospital affiliated to Guanxi University of Chinese Medicine
name: Jining First People's Hospital
name: People's Hospital of Dangyang
First posted: 2017-09-07
Enrollment: 2000000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: all patients of internal medicine in hospital to include hospital of Chinese medicine and morden hospital in China

Brief summary: This real-world study aimed at 1. exploring the relationships of traditional Chinese medicine (TCM) syndrome and internal diseases, 2. investigating the relationships of TCM treatment and internal diseases, and 3. creating medical machine intelligence to help internal physician in clinical practice. Big data methods and artificial intelligence algorithms are used to assess the associations based on electronic case files of patients.


Eligibility criteria: Inclusion Criteria:

* all patient records of internal medicine in hospital

Exclusion Criteria:

* subjects with major missing data

Primary outcomes:
measure: internal diseases
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huasha Hospital
state: Shanghai
Study officials:
References:
citation: Liu J, Xu F, Mohammadtursun N, Lv Y, Tang Z, Dong J. The Analysis of Constitutions of Traditional Chinese Medicine in Relation to Cerebral Infarction in a Chinese Sample. J Altern Complement Med. 2018 May;24(5):458-462. doi: 10.1089/acm.2017.0027. Epub 2017 Aug 18.
citation: Li X, Lei T, Tang Z, Dong J. Analyzing the association between fish consumption and osteoporosis in a sample of Chinese men. J Health Popul Nutr. 2017 Apr 19;36(1):13. doi: 10.1186/s41043-017-0088-y.
citation: Geng W, Qin X, Yang T, Cong Z, Wang Z, Kong Q, Tang Z, Jiang L. Model-Based Reasoning of Clinical Diagnosis in Integrative Medicine: Real-World Methodological Study of Electronic Medical Records and Natural Language Processing Methods. JMIR Med Inform. 2020 Dec 21;8(12):e23082. doi: 10.2196/23082.
Clinical trial NCT06549608: A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
Official title: Patient Characteristics and Treatment Duration of Mavacamten Obstructive HCM Patient Support Program in Canada: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic cardiomyopathy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants in Canada diagnosed with hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment as part of the BMS-sponsored CAMZYOS Patient Support Program

Brief summary: This real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the Bristol-Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program in Canada.


Eligibility criteria: Inclusion Criteria:

* Participants ≥18 years of age.
* Participants who have initiated mavacamten as part of routine clinical care, through the BMS-sponsored CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
* Participants who consented to the use of their de-identified data, generated from information collected in the course of the program.

Exclusion Criteria:

• There are no exclusion criteria.

Primary outcomes:
measure: Participant demographics
timeFrame: Baseline
measure: Participant clinical characteristics
timeFrame: Baseline
Secondary outcomes:
measure: Dose regimen of mavacamten treatment
timeFrame: Every 3-months up to 14 months
measure: Titration patterns of mavacamten treatment
timeFrame: Up to 14 months
measure: Mavacamten treatment duration
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05184608: Cycling Dual-task in Parkinson's Disease
Official title: Effects of a Cycling Dual-task Intervention on Cognition and Functionality in Parkinson's Disease: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.


Eligibility criteria: Inclusion Criteria:

* Parkinson disease
* Hoehn and Yahr 1 and 2

Exclusion Criteria:

* Hoehn and Yahr \>2

Primary outcomes:
measure: Timed Up and Go
timeFrame: Change from Baseline Timed Up and Go at 7 weeks
measure: Sit to Stand test
timeFrame: Change from Baseline Sit to Stan Test at 7 weeks
measure: Movement Disorder Society - Unified Parkinson's Disease Rating Scale
timeFrame: Change from Baseline Unified Parkinson's Disease Rating Scale at 7 weeks (0-159, better lower values)
measure: Parkinson's Disease Questionnaire - 39
timeFrame: Change from Baseline Parkinson's Disease Questionnaire - 39 at 7 weeks (0-100, better lower values)
Secondary outcomes:
measure: Trail Making Test A & B
timeFrame: Change from Baseline Trail Making Test A & B at 7 weeks
measure: Stroop test
timeFrame: Change from Baseline Stroop Test at 7 weeks
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: University of Vigo
Study officials:
References:
Clinical trial NCT02852408: Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy
Official title: Unintentional Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy: A Prospective Controlled Blinded Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Cholecystectomy
Postoperative Pain
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-08-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have scheduled for laparoscopic cholecystectomy

Brief summary: Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. Although it has low morbidity, postoperative pain is challenging situation like every other operation.

Detailed description: Postoperative pain after laparoscopic cholecystectomy has a three component: parietal, visceral and referring (shoulder) pain. Although intensities of them can be various, all of them affects the total pain together. Unintentional liver cauterization during laparoscopic cholecystectomy is unwanted, but sometimes unavoidable complication/process. However its effect on postoperative pain is not studied with detail in literature.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II
* Presumptive diagnosis of benign gallbladder disease

Exclusion Criteria:

* The patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease

Primary outcomes:
measure: Visual analog scale (VAS) abdominal pain scores
timeFrame: Postoperative 2nd hour
measure: Visual analog scale (VAS) abdominal pain scores
timeFrame: Postoperative 24th hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05916508: A Bleeding-Model Clinical Study
Official title: A One-Month Bleeding-Model Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with ≥10 % bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.

Primary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Baseline
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research Group
state: Nevada
Study officials:
References:
Clinical trial NCT02090608: Paricalcitol in Fabry Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fabry Disease
Proteinuria
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Proteinuria is the predominant risk factor for renal disease progression in Fabry disease (FD). When urine protein excretion is controlled to \<0.50 g/24 hr, the rate loss of glomerular filtration rate (GFR) is not significantly different from 0. However, enzyme replacement therapy (ERT) alone does not decrease proteinuria and it has been recommended that patients receiving ERT also receive anti Renin-Angiotensin-System (RAS) therapy. Emerging evidences show that paricalcitol (PCT) reduces proteinuria in presence of intensified inhibition of RAS; however, there is no evidence in FD. The aim of this study is to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria \>0.50 g/24 hr persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.


Eligibility criteria: Inclusion Criteria:

* genetically proven FD
* stable dose of ERT for at least 12 months
* stable dose of ACEi or ARB titrated to maximum tolerated dosage for at least 6 months
* persistent proteinuria \>0.50 g/24 h despite the use of ERT and ACEi/ARBs in 2 consecutive samples within 12 weeks

Exclusion Criteria:

* steroid/immunosuppressive treatment or glomerular filtration rate change \>30% in the past 3 months
* PTH levels \<20 pg/mL
* serum phosphorus \>5.0 mg/dL
* serum calcium (adjusted for albumin) \>10.0 mg/dL
* active malignancy.

Primary outcomes:
measure: Effect of paricalcitol on proteinuria reduction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: federico II university, department of nephrology
Study officials:
affiliation: Federico II University
name: eleonora riccio, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01584908: Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients
Official title: Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients(AdVEnTR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: kidney transplant recipients
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult kidney tranplant recipients

Brief summary: Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.


Eligibility criteria: Inclusion Criteria:

Adult kidney transplant recipients Greater than 3 months post-transplant

Exclusion Criteria:

Has already received influenza vaccination for 2012-2013 season Egg allergy Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks Unable to provide informed consent Unable to comply with study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01106508: A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
Official title: A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Recurrent or Refractory Medulloblastoma
Locally Advanced or Metastatic Basal Cell Carcinoma
Keywords: Advanced solid tumors
recurrent or refractory medulloblastoma
locally advanced or metastatic basal cell carcinoma
hedgehog pathway inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 57
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: This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
* Protocol defined laboratory parameters
* Performance status ≤ 2
* Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy

Exclusion Criteria:

* History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
* Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
* Impairment of cardiac function or significant cardiac disease
* Pregnant or lactating women
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
timeFrame: 21 day cycles
Secondary outcomes:
measure: To characterize the safety and tolerability of LEQ506 treatment
timeFrame: 21 day cycles
measure: To characterize the pharmacokinetics of LEQ506
timeFrame: 21 day cycles
measure: To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
timeFrame: 21 day cycles
measure: Tumor response
timeFrame: every 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles UCLA LeConte Location
state: California
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Zürich
country: Switzerland
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: