louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06959433: Lu-177 PSMA Treatment in Cell Renal Carcinoma
Official title: Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Metastatic Renal Cancer
Keywords: Renal Cell Carcinoma, Radionuclide treatment, efficacy, safety.
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single arm will be included patients with metastatic RCC treated with Lu-177 PSMA
Primary purpose: TREATMENT

Brief summary: Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.

PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies
* At least 3 years of life expectancy
* ECOG performance status ≤ 2
* Ability to sign informed consent

Exclusion Criteria:

* Age\<18
* Not having received any systemic therapies
* History of a secondary malignancy
* ECOG performance status \> 2
* Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression
* Previous history of any radionuclide therapies
* Inability to sign informed consent

Primary outcomes:
measure: toxicity analysis
timeFrame: 1-36 months
Secondary outcomes:
measure: efficacy analysis
timeFrame: 1-36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02965833: CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
Official title: Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Contact lens induced dryness
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 126
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.


Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent document;
* Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
* Near spectacle add of +0.50 or greater;
* Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
* Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;
* Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
* Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

* Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
* Prior refractive surgery;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pathological dry eye that precludes contact lens wear;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Participation in any clinical study within 30 days of Visit 1;
* Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
* Other protocol-specific exclusion criteria may apply.

Primary outcomes:
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
timeFrame: Day 30, each product
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Project Manager, CPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT01218633: Dose-response Study of Exendin-9,39 on Glucose Metabolism
Official title: A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.


Eligibility criteria: Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Primary outcomes:
measure: Insulin Secretion
timeFrame: over 360 minutes of study
Secondary outcomes:
measure: glucagon secretion
timeFrame: over 360 minutes of study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sathananthan M, Farrugia LP, Miles JM, Piccinini F, Dalla Man C, Zinsmeister AR, Cobelli C, Rizza RA, Vella A. Direct effects of exendin-(9,39) and GLP-1-(9,36)amide on insulin action, beta-cell function, and glucose metabolism in nondiabetic subjects. Diabetes. 2013 Aug;62(8):2752-6. doi: 10.2337/db13-0140. Epub 2013 Apr 1.
Clinical trial NCT03528733: Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Official title: Feasibility of Single Exposure Dual Energy Subtraction With a Multi-Energy Digital Radiography Detector for Lung Lesions Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Tumor
Solitary Pulmonary Nodule
Lead sponsor: KA Imaging Inc.
Sponsor class: INDUSTRY
Collaborators: name: Grand River Hospital
First posted: 2018-05-18
Enrollment: 30
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: A single-centre, industry sponsored, pilot study to assess the feasibility of Single Exposure Dual Energy Subtraction with a Multi-Energy digital radiography detector as an imaging platform for lung lesion detection.

Detailed description: A feasibility study is proposed to investigate the imaging characteristics captured by a Single Exposure Dual-Energy Subtraction digital radiography with KA Imaging's Multi-energy detector.

The acquisition of Dual-Energy Subtraction radiography will consist of using the Multi-Energy detector integrated into the X-ray system in Grand River Hospital. Patient will receive a Multi-Energy Chest radiography exam on the same day as their routine chest CT exam. Each Multi-Energy radiography exam will consist of one Chest PA image and one Chest LAT image. Duration of each procedure is 60 minutes. The Multi-Energy Detector will generate a General Radiography Image and Dual-Energy Subtracted Images.

Visualization of lung lesions by Multi-Energy detector will be compared to corresponding CT exam and general radiography results. Imaging data will be evaluated qualitatively by radiologists on data collection form to describe the findings on the images. Further comparison between general radiography, Dual-Energy Subtraction radiography and CT will be analyzed to determine the differences of imaging characteristics such as description of image quality and visibility of relevant anatomical structures and anomalies.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older.
* Patients with previously diagnosed carcinoma with lung metastases, or patients with previously detected lung nodule
* Subject is able to provide informed consent
* Study participant is scheduled to have a chest CT exam as part of their routine care.
* Study participant is able to stand and be still during the exams.

Exclusion Criteria:

* Not able or willing to provide Informed Consent, or consent is withdrawn.
* Study participant is pregnant
* Study participant is unable to perform standard radiography exam and CT exam

Primary outcomes:
measure: Multi-Energy images will be compared to baseline Chest CT images for visualizing lung lesions.
timeFrame: 3 months
Secondary outcomes:
measure: Multi-Energy images will be compared to standard radiography images for visualizing lung lesions.
timeFrame: 3 months
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00636233: Genetics of Spina Bifida and Anencephaly
Official title: The Hereditary Basis of Neural Tube Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anencephaly
Acrania
Keywords: anencephaly
acrania
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-03-14
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Any current pregnancy affected by anencephaly or acrania.

Brief summary: The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.


Eligibility criteria: Not currently enrolling new participants.

Primary outcomes:
measure: genetic factors associated with neural tube defects
timeFrame: end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Allison Ashley-Koch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00880633: Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective
Official title: EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periampullary Neoplasms
Keywords: EUS
periampullary neoplasms
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2009-04-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective review of patients who have already undergone an EUS at this institution.

Brief summary: The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.


Eligibility criteria: Inclusion Criteria:

* Patients will be identified retrospectively through an existing Indiana University Medical Center EUS database and pathology database.
* Patients with and without biliary stents will be included.

Exclusion Criteria:

* Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.

Primary outcomes:
measure: The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT00508833: Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Official title: Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis B Disease
Keywords: Adjuvants
HBsAg
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 200
Sex: ALL
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: This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 40 years of age
* Written informed consent obtained from subject
* Female of non-childbearing potential

Exclusion Criteria:

* Any hepatitis B vaccination.
* Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
* Pregnancy or lactating female
* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration

Primary outcomes:
measure: Intensity of the CTL response at Week 6
Secondary outcomes:
measure: Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00395733: Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Official title: A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Diseases
Keywords: Gadovist
Gadavist
MRI Imaging
vascular diseases
Chinese
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Chinese origin
* Known or suspected blood vessel diseases

Exclusion Criteria:

* Pregnancy
* Lactation
* Conditions interfering with MRI
* Allergy to any contrast agent or any drugs
* Participation in other trial
* Require emergency treatment
* Severely impaired liver and kidney functions

Primary outcomes:
measure: Number of Vessel Segments Visualized With Diagnostic Quality
timeFrame: 20-30 seconds after injection
Secondary outcomes:
measure: Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
timeFrame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
measure: Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
timeFrame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
measure: Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
timeFrame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
measure: Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
timeFrame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
measure: MRA Diagnosis by Investigators
timeFrame: 20-30 seconds after injection
measure: MRA Diagnosis by Blinded Reader 1
timeFrame: 20-30 seconds after injection
measure: MRA Diagnosis by Blinded Reader 2
timeFrame: 20-30 seconds after injection
measure: MRA Diagnosis by Blinded Reader 3
timeFrame: 20-30 seconds after injection
Other outcomes:
Locations:
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Shanghai
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00589433: Follow Up Study of Tear in the Rotator Culf
Official title: Follow Up Study of Tear in the Rotator Culf
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rotator Culf Tear
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Rotator culf tears are common in the aging population and are a significant morbidity source. The common knowledge is that the major tears do not heal and constantly expanding.Still since the majority of the patients are old the acceptable therapy is conservative treatment.

Our objective is to estimate the accuracy of rotator culf tear utilizing an ultrasound.


Eligibility criteria: Inclusion Criteria:

* Was diagnosed with shoulder tear
* Size of the tear till 2.5 cm
* The opposite tendon-normal

Exclusion Criteria:

* systematic Diseases .
* Injury to the shoulder after the previous US.
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Orthopedic Department
Study officials:
affiliation: Hadassah Medical Organization
name: Ori Safran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06773533: Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism
Official title: Establishment of a Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each breast cancer patient on adjuvant hormone blockade diagnosed and evaluated at the Endocrinology Operative Unit for Bone Mineral Metabolism as part of the 'Diagnostic Clinical Care Pathway (PDTA) of the Breast Cancer Patient' of IRCCS AOU of Bologna and referred/referred by Zamagni Oncology.

Brief summary: Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.

Detailed description: Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.

Inclusion in the registry will be proposed consecutively to every patient with adjuvant hormone-blockade breast cancer diagnosed and evaluated at the Endocrinology Operative Unit for Bone Mineral Metabolism as part of the 'Diagnostic Clinical-Assistance Pathway (PDTA) of the patient with breast cancer' of IRCCS AOU of Bologna and referred/referred by Zamagni Oncology. The registry will include patients seen from 01/01/2015 for a duration of 15 years. A maximum follow-up duration for each patient is expected to be 10 years with an end date of enrollment on 12/31/2029 and a registry update deadline on 12/31/2039.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient undergoing adjuvant hormone blockade therapy (aromatase inhibitors, GnRH analogs, tamoxifen) for breast cancer referred by UO Oncology Zamagni
* Performed densitometry at UO Radiology Lovato and performed hematochemical tests inherent to mineral metabolism
* Informed consent obtained

Exclusion Criteria:

* none

Primary outcomes:
measure: Establishment of a Registry for Patients Treated with Adjuvant Hormone Blockade for Breast Cancer: Evaluation of Bone Mass, Calcium Metabolism Indices, and Fracture Incidence
timeFrame: through study completion, an average of 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Uberto Pagotto, MD
role: PRINCIPAL_INVESTIGATOR
References: