louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04350957: Low-dose Imaging Technique (LITE)
Official title: Low-dose Imaging Technique (LITE) MRI Gadavist® (Gadobutrol)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This clinical trial has a single arm. All subjects will receive a low dose and standard dose on two separate days
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.

Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18-80
* Women with a suspected or biopsy proven enhancing lesion

Exclusion Criteria:

* Women with a history of adverse reactions to contrast media
* Women with GFR below 30 mL/min/1.73m2
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Low-dose Lesion Enhancement
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Deepa Sheth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Gregory S Karczmar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01186757: Multiple Dose Healthy Volunteer Study of PF-03715455.
Official title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Detailed description: Healthy volunteer PK study

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Standard healthy volunteer criteria

Primary outcomes:
measure: Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).
timeFrame: 17 days
Secondary outcomes:
measure: Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
timeFrame: 28 Days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04939857: Effect of Trimetazidine on Radiotherapy-induced Heart Damage.
Official title: Effect of Trimetazidine on Radiotherapy-induced Heart Damage in Lung Tumor Patients Treated With Stereotactic Body Radiotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cardiotoxicity
Keywords: Trimetazidine, Radiation-induced heart damage, GLS
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 80
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: TREATMENT

Brief summary: This is a randomized controlled trial. 80 patients with thoracic radiotherapy will be included. Participants will be randomly divided into experimental group or control group. Before radiotherapy, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, electrocardiogram (ECG), and hs-CRP will be detected. During subsequent follow-up, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, ECG, and hs-CRP will be collected at every follow-up time.

Detailed description: This is a randomized controlled trial. 80 patients with thoracic radiotherapy will be included in Peking University Third Hospital from May 15, 2021 to August 31, 2022. Participants will be randomly divided into experimental group or control group. Before radiotherapy, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, electrocardiogram (ECG), and hs-CRP will be detected. All participants will be followed up after completion of RT, 3 months after RT, 6 months after RT, and 12 months after RT. During subsequent follow-up, echocardiography, 2D STE, CK, CK-MB, cTnT, NT-proBNP, ECG, and hs-CRP will be collected at every follow-up time.

Eligibility criteria: Inclusion Criteria:

* lung tumor patients; 18-80 years old; will be treated by stereotactic body radiotherapy

Exclusion Criteria:

* Prior radiotherapy; ACS; heart failure (NYHA III-IV); arrhythmia requiring intervention; echocardiographic images that could not be satisfactorily obtained; significant valvular heart disease (defined as more than mild valvular regurgitation or stenosis).

Primary outcomes:
measure: global longitudinal strain-A parameter of two dimensional speckle tracking echocardiography
timeFrame: pre-radiotherapy, 12 months after radiotherapy
Secondary outcomes:
measure: Rate of major adverse cardiovascular events
timeFrame: pre-radiotherapy, after completion of radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, and 12 months after radiotherapy
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Dan Zhu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02623257: EGFR Mutations on ctDNA in Patients With Advanced NSCLC
Official title: A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer Stage III
Non-Small-Cell Lung Cancer Metastatic
Keywords: Non-small Cell Lung Cancer
circulating tumor DNA
amplification refractory mutation system
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 1055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Non-small cell lung cancer (NSCLC)

Brief summary: The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC;
* Patient had received ≤ 1 prior systemic chemotherapy regimens;
* Provision of blood (plasma) sample for ctDNA testing;
* Patient must be able to comply with the protocol;

Exclusion Criteria:

* Prior received ≥2 systemic chemotherapy regimens;
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
* Histologically confirmed small cell lung cancer or other metastatic tumors;
* Patient with no histologic or cytological diagnosis;

Primary outcomes:
measure: Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
timeFrame: up to 2 years
Secondary outcomes:
measure: Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics
timeFrame: up to 2 years
measure: Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
timeFrame: up to 2 years
measure: Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT06979557: RLE Outcomes With Bilateral Implantation of Odyssey IOLs
Official title: Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractive Lens Exchange
Lead sponsor: Mann Eye Institute
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2025-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be aged 40 years and older who underwent bilateral implantation with the Odyssey IOL.

Brief summary: This study is a single center, ambispective study of visual outcomes after successful bilateral implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS questionnaire, as well as measurement of visual acuities at distance, intermediate, and near, monocular (right eye) and binocular defocus curve, and refractive outcomes.


Eligibility criteria: Inclusion Criteria:

* Participants will include 40 patients aged 40 years and older who have a measurable Potential Acuity Meter (PAM) of 20/20 electing to undergo bilateral refractive lensectomy surgery with IOL implantation.

Exclusion Criteria:

* Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.

Primary outcomes:
measure: Binocular Photopic Visual Acuity
timeFrame: 2 months posoperatively
measure: Monocular Photopic Visual Acuity
timeFrame: 2 months posoperatively
measure: Monocular Defocus Curve (right eye only)
timeFrame: 2 months posoperatively
measure: Binocular Defocus Curve
timeFrame: 2 months posoperatively
Secondary outcomes:
measure: Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
timeFrame: 2 months posoperatively
Other outcomes:
measure: Percentage of patients within ± 0.5 D MRSE
timeFrame: 2 months posoperatively
measure: Percentage of eyes requiring additional corneal refractive procedures
timeFrame: 2 months postoperative
Locations:
city: Houston
country: United States
facility: Mann Eye Institute
state: Texas
Study officials:
affiliation: Mann Eye Institute
name: Phillip Brunson, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03400657: MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer
Official title: A Prospective, Multicenter, Prospective, Non-intervention, Controlled Trial of MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer in Realistic Medical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multi-disciplinary Treatment
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 484
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: recurrent / metastatic gastric or colorectal cancer

Brief summary: This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.


Eligibility criteria: Inclusion Criteria:

1. Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
2. Participate in formal MDT discussions at the Research Center.
3. MDT decision-making at least two subjects involved in treatment.
4. Patient informed consent and signed written consent.

Exclusion Criteria:

1. Early or locally advanced gastric cancer or colorectal cancer.
2. Accept informal MDT discussions.
3. MDT decisions recommend only a single subject for treatment of patients.
4. MDT decisions recommend only palliative patients.

Primary outcomes:
measure: overall survival
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: Differences in overall survival after performing MDT at center
timeFrame: 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05704348: Sleeve-pex: A Randomized Trial to Reduce Reflux After Sleeve Gastrectomy
Official title: A Clinical Intervention Study Exploring Gastropexy as a Measure to Reduce Gastro-oesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: Helse Forde
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 550
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: The goal of this clinical trial is to test gastropexy as a measure to reduce reflux in morbidly obese patients being submitted to sleeve gastrectomy. The main questions it aims to answer are:

Does gastropexy reduce reflux symptoms? Does gastropexy reduce objective evidence of reflux? Participants will be randomized to gastropexy or no gastropexy, and researchers will compare these groups to see if reflux (symptoms / objective evidence of) is different in the two groups.

Detailed description: Laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric procedure worldwide. LSG consists of a longitudinal resection of the stomach leaving the intestines intact, thereby lowering the risk for side-effects due to rerouting of the small bowel. However, gastro-esopageal reflux disease (GERD) has been reported to increase after LSG. Our hypothesis is that GERD is mainly due to intrathoracic migration of the gastric remnant. The aim of this study is to explore if suturing the gastric remnant to the gastrocolic ligament (gastropexy) will prevent intrathoracic migration and thereby reduce the development of reflux.

Patients planned for a sleeve gastrectomy will be invited to participate, and participating patients will be randomized to pexi or no pexi. According to power calculations a total of 550 patients will be randomized in the study. Follow-up will be at six weeks, one-, two- and five years.

Eligibility criteria: Inclusion Criteria:

* Patients planned for bariatric surgery with primary LSG

Exclusion Criteria:

* Age below 18 yrs
* Use of ARM for other reasons than reflux
* Previous antireflux surgery
* Inability to comprehend and respon to patient related outcome (PRO) questionnaire

Primary outcomes:
measure: Number of participants using acid-reducing medication (ARM) or having had reoperations due to GERD
timeFrame: Two years
Secondary outcomes:
measure: Endoscopic findings
timeFrame: Two years
measure: Patient related outcome
timeFrame: Two years
measure: pH-metry
timeFrame: Two years
Other outcomes:
Locations:
city: Førde
country: Norway
facility: Helse Forde
city: Oslo
country: Norway
facility: Aleris Oslo
city: Volda
country: Norway
facility: Volda sjukehus
city: Voss
country: Norway
facility: Voss sjukehus
Study officials:
affiliation: Helse Forde
name: Villy Vage, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04211948: Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer
Official title: Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Minimally Invasive Surgery
Keywords: Robotic assisted surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2019-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.


Eligibility criteria: Inclusion Criteria:

* Diagnosed pancreatic ductal adenocarcinoma
* Patients and their families volunteered to test and signed informed consent.

Exclusion Criteria:

* Preoperative exclusion:

  1. Patients with metastasis (M1)
  2. Patients with tumor recurrence
  3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
  4. Patients with poor cardiopulmonary function cannot tolerate surgery;
  5. receive neoadjuvant radiotherapy and chemotherapy before surgery;
  6. The patient or family member refuses to join the group;
  7. Pregnant patients
* Intraoperative exclusion:

  1. Intraoperative exploration of metastases in other parts besides the primary lesion
  2. Other organs malignant tumors metastasize to the pancreas
* Postoperative exclusion:

  1. pathology confirmed non-pancreatic ductal adenocarcinoma

Primary outcomes:
measure: 1 year overall survival rate
timeFrame: 1 year post-operation
measure: 3 years overall survival rate
timeFrame: 3 years post-operation
Secondary outcomes:
measure: Postoperative Complications
timeFrame: Within 90 days or before discharge
measure: 1, 3years disease free survival rate
timeFrame: 1,3years post-operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Kai Qin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228448: In-Room PET in Proton Radiation Therapy
Official title: Pilot Study of In-Room PET in Proton Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Head and Neck Tumor
Skull Base Tumor
Keywords: external beam proton radiotherapy
PET
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-10-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigational part of this study is using a mobile PET/CT scanner to take images of the participants tumor immediately after they are treated with proton radiation. This allows the participant to be treated and imaged on the same bed. The information obtained may improve the accuracy of treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.

Detailed description: For all participants, right after one regular treatment fraction, NeuroPET or NeuroPET II will be wheeled into the patient room. The patient bed will be moved directly into the scan position and a PET scan will be acquired in list-mode for 15 to 20 minutes followed by a CT scan for \~5 minutes. After undergoing their first PET scan, participants will have the option to undergo 1-2 additional scans throughout radiation treatment in the same manner as the first scan.

Eligibility criteria: Inclusion Criteria:

* Adult subjects with brain, head and neck, and skull base tumors receiving external beam proton radiotherapy at the Francis H. Burr Proton Therapy Center at MGH
* Age 18 or over
* ECOG Performance status 0, 1 or 2

Exclusion Criteria:

* Uncontrolled intercurrent illness that, in the opinion of the investigator, would limit the participant's compliance with study requirements.

Primary outcomes:
measure: Effectiveness
timeFrame: 2 years
Secondary outcomes:
measure: Optimize the in-room PET acquisition length
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Helen A. Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04954248: Pilot Study for PET/MR Imaging of Covid-19
Official title: Pilot Study for Simultaneous PET-MR Imaging of Covid-19 Associated Neurological Complications Using a Brain Dedicated PET Insert
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Diseases
Covid19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a pilot study for establishing an imaging protocol for combined PET and MR derived functional information as well as MRI acquired anatomical information.

Detailed description: This study is a non-randomized non-treatment study. The intention of this work is an assessment of the PET insert technology, and not, for example, to perform a treatment assessment or drug assessment. This work will actively recruit 10 individuals (5 Covid-19 negative and 5 Covid-19 previously positive in the last 180 days) to perform imaging of the brain with an FDA-approved radiotracer.

Eligibility criteria: Inclusion Criteria:

1. Whole body radiation dose in the last year of less than 5000 mrem determined via subject verbal history reporting
2. Must be at least 21 years of age
3. Deemed healthy to endure duration of imaging study as confirmed via study PI
4. Proof of COVID-19 viral or antibody testing within the timeframe of \>20 days but \<=180 days prior to scan.

Exclusion Criteria:

1. History of non-MRI compatible surgeries, implants, or activities
2. Pregnant or nursing
3. History of allergic reactions to PET radiotracers (via patient verbal report and /or medical record review.

Primary outcomes:
measure: PET/MR
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: