louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06514521: Post Marketing Study on Pluvicto in Korea
Official title: A Post Marketing Surveillance on PluvictoTM (Lutetium(177Lu) Vipivotide Tetraxetan) in South Korea; An Open-label, Non-interventional, Primary Data Collection, Multi-center, Non-comparative, Non-randomized Observational Study to Assess Safety and Effectiveness of Pluvicto in Real World Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: Metastatic castration-resistant prostate cancer
mCRPC
PMS
RMP
Pluvicto
Korea
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 278
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been using or going to receive Pluvicto per clinical judgment under routine medical practice are eligible for the study

Brief summary: Post marketing study on Pluvicto in Korea

Detailed description: This is open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Pluvicto in patients with mCRPC in the real-world setting in South Korea.

Eligibility criteria: Inclusion criteria

Study participants eligible for inclusion in this study must meet all of the following criteria:

1. Male adult patient age ≥ 18
2. Subject who are being treated with Pluvicto or whose treatment plan is finalized and scheduled to be administered at the time of consent by physician in accordance with the approved indication in South Korea
3. Subject who provided the written informed consent prior to the study enrollment

Exclusion criteria

Study participants meeting any of the following criteria are not eligible for inclusion in this study:

1. Subject whose medical record is not accessible
2. Subject who is not willing to provide the informed consent

Primary outcomes:
measure: Incidence of Adverse Events, Serious Adverse Events, unexpected Adverse Events, Adverse Drug Reactions, Serious Adverse Drug Reactions and unexpected Adverse Drug Reactions
timeFrame: Until 30 days after the last dose of Pluvicto, up to 33 months
Secondary outcomes:
measure: Objective response rate (ORR) as assessed by investigator
timeFrame: 4th±1 week from the last dose
measure: Radiographic progression-free survival (rPFS)
timeFrame: Up to 33 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00082121: Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Ischemia
Coronary Arteriosclerosis
Aortic Valve Insufficiency
Mitral Valve Insufficiency
Keywords: cardiac bypass
CABG
complement activation
Lead sponsor: Avant Immunotherapeutics
Sponsor class: INDUSTRY
First posted: 2004-05-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.

Detailed description: During cardiac surgery, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.

Eligibility criteria: Inclusion Criteria:

* Female
* To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
* CABG alone or with valve surgery

Exclusion Criteria:

* Acute myocardial infarction (heart attack) within a 3 days of entering the study
* Conditions that may interfere with interpretation of electrocardiogram data
* History of immune deficiency syndrome
* Planned supplemental cardiac surgery or other surgery
* Pregnancy or lactation

Primary outcomes:
measure: Reduction in death & myocardial infarction (MI)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Towson
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Cincinnati
country: United States
state: Ohio
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Danville
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References:
Clinical trial NCT05917821: New Antigens Against Glioblastoma
Official title: Identification of New Antigens Against Glioblastoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma Multiforme
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: National monocentric study, enrolling approximately 120 patients with glioblastoma, males and females, no pedriatic age.

Brief summary: In this study the investigators will select and develop potential therapeutic monoclonal antibodies (mAbs) for glioblastoma (GB). Activities include tissue microarray (TMA) to test monoclonal antibodies specificity and target distribution, selection of glioblastoma specific functional monoclonal antibodies, identification of candidate targets.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years;
* Written informed consent

Exclusion Criteria:

* Not-availability of informed consent

Primary outcomes:
measure: Validation of the tumour specificity of the identified monoclonal antibodies
timeFrame: 4 years
Secondary outcomes:
measure: Generate the single chain Fab antibody fragments (scFv) and then develop the Chimeric Antigen Receptor (CAR) T cells
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05711121: Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
Official title: Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbosacral Radiculopathy
Keywords: epidural injection
radicular pain
disc herniation
lumbosacral radiculopathy
transforaminal injection
caudal injection
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2023-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients having radicular pain were randomized to either caudal or transforaminal epidural injection group
Primary purpose: TREATMENT

Brief summary: To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy.

Detailed description: Epidural steroid injections are commonly performed for the treatment of radicular pain resulting from a disc herniation. There are 3 different methods to deliver steroids to epidural area which are caudal, interlaminar and transforaminal routes. Lower lumbar and sacral radiculopathies can be managed with caudal epidural steroid injection which is generally quite easier to perform in comparison to transforaminal injection. Transforaminal epidural injection provides injectate to reach anterior epidural area and is the most target specific technique among others. In the present study investigators aim is to compare the success rates of these two different procedures regarding unilateral S1 radiculopathy. The patients referring to the pain medicine outpatient clinic of a university hospital for unilateral radicular pain and diagnosed S1 radiculopathy were planned to be randomized into these two different intervention groups.

Eligibility criteria: Inclusion Criteria:

* Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression.

Exclusion Criteria:

* History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases

Primary outcomes:
measure: 50 percent pain relief
timeFrame: 3 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Procedure time
timeFrame: during procedure
measure: Radiation exposure
timeFrame: during procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Pendik
Study officials:
affiliation: Marmara University
name: Osman Hakan Gunduz, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02931721: Treatment of Severe Male Infertility - Predictive Factors (Imaging)
Official title: Treatment of Severe Male Infertility - Predictive Factors (Imaging)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility
Keywords: Azospermia
Micro Dissection Testicular Sperm Extraction
Male infertility
Testis
MRI
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-10-13
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Azoospermic men scheduled for MD-TESE

Brief summary: Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential differences depending on the outcome, ie. sperm recovery in consequent microdissection testicular sperm extraction (MD-TESE).

Detailed description: Sperm recovery rate in non-obstructive azoospermia (NOA) men is 43% in Turku University Hospital, depending on the diagnosis leading to NOA. To date, there are no known parameters known to differentiate between successful and unsuccessful sperm recovery.

MRI is performed on men prior to the operation, and the objective is to compare the functional parameters assessed by magnetic resonance imaging between the group of men with positive and the men with negative sperm recovery in testicular microdissection sperm extraction (MD-TESE).

Eligibility criteria: Inclusion Criteria:

* non obstructive azospermia

Exclusion Criteria:

* malignancy
* contraindication for fertility treatment

Primary outcomes:
measure: Functional difference in testicular MRI depending on MD-TESE outcome (=sperm recovery)
timeFrame: Baseline/ pre-invention
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Dept of Obst and Gyn
city: Turku
country: Finland
facility: Dept of Obst and Gyn
Study officials:
affiliation: Turku University Hospital
name: Antti Perheentupa, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01529021: Reducing Children's Distress Towards Flu Vaccinations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children's Distress During Flu Vaccination
Keywords: Pain management
vaccination
immunization
pediatric
robotics
human-robot interaction
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 57
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children in the general public and from hospital ages 5-9 years

Brief summary: Millions of children in North America receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. Children frequently use technologically advanced devices such as computers and cell phones. Based on this familiarity, the investigators introduced another sophisticated device - a humanoid robot to- interact with children during their vaccination. The investigators hypothesized that these children would experience less distress than children who did not have this interaction.

Detailed description: 57 children (30 male; age, mean + SD: 6.87 + 1.34 years) were randomly assigned to a vaccination session with a nurse who used standard administration procedures, or with a robot who was programmed to use cognitive-behavioral strategies with them while a nurse administered the vaccination. Measures of distress were completed by children, parents, nurses, and researchers.

Eligibility criteria: Inclusion Criteria:

* ages 5-9 years,
* boys and girls

Exclusion Criteria:

* children with pervasive developmental disability

Primary outcomes:
measure: Faces Pain Scale-Revised
timeFrame: 5 mins before and immediate after vaccination
Secondary outcomes:
measure: Behavioral Approach-Avoidance Distress Scale
timeFrame: one week after vaccination was administered
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Tanya Beran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beran TN, Ramirez-Serrano A, Vanderkooi OG, Kuhn S. Reducing children's pain and distress towards flu vaccinations: a novel and effective application of humanoid robotics. Vaccine. 2013 Jun 7;31(25):2772-7. doi: 10.1016/j.vaccine.2013.03.056. Epub 2013 Apr 24.
Clinical trial NCT00711321: Long-term Safety and Tolerability of AFFITOPE AD02
Official title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer
Morbus Alzheimer
Vaccine
Alzheimer Vaccine
A-beta immunotherapy
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects having participated in AFFiRiS 002

Brief summary: The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002


Eligibility criteria: Inclusion Criteria:

* Written informed consent signed and dated by patient and caregiver
* Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
* Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits

Exclusion Criteria:

* Patients having received no vaccination with AFFITOPE AD02
* History of questionable compliance to visit schedule, patients not expected to finish the clinical trial

Primary outcomes:
measure: Long-term tolerability
timeFrame: 1 year
Secondary outcomes:
measure: Clinical and immunological efficacy (evaluated in an explorative manner only)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ordination Schmitz
Study officials:
affiliation: Ordination Schmitz
name: Margot Schmitz, MD Univ. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519921: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Official title: An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-65 years of age
* HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
* Detectable hepatitis B virus (HBV) DNA (\>100,000 copies/mL)

Exclusion Criteria:

* Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* A medical condition associated with chronic liver disease other than viral hepatitis

Primary outcomes:
measure: Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
timeFrame: Week 72
measure: Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants With ALT Normalization At Week 48 and Week 72
timeFrame: Week 48 and Week 72
measure: Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72
timeFrame: Week 48 and Week 72
measure: Percentage of Participants With a Combined Response At Week 48 and Week 72
timeFrame: Week 48 and Week 72
measure: Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion
timeFrame: Week 48 and Week 72
measure: Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72
timeFrame: Week 48 and Week 72
measure: Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72
timeFrame: Week 48 and Week 72
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: Up to Week 72
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT06053021: Antiplatelet Therapy for AIS Patients With Thrombocytopenia
Official title: Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Thrombocytopenia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

Detailed description: Antiplatelet therapy is widely used in non-cardiogenic AIS patients for secondary prevention. However, it may also increase the risk of bleeding complications, especially in patients with thrombocytopenia. The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Acute ischemic stroke or transient ischemic attack with onset \< 7 days
* The last blood routine test before enrollment indicates platelet count \< 100 x 10\^9 and \> 30 x 10\^9

Exclusion Criteria:

* Chronic renal dysfunction (GFR \< 30ml/min) or severe hepatic injury
* Indications for anticoagulation therapy, e.g. atrial fibrillation
* Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
* Have or plan to receive CEA or CAS in the following 3 months
* Life expectancy less than 1 year
* Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
* Pregnant or lactating women
* Individuals identified by researchers as unsuitable for participation in the study due to other reasons.

Primary outcomes:
measure: 90-day Composite events
timeFrame: 90 days
Secondary outcomes:
measure: 90-day ischemic stroke
timeFrame: 90 days
measure: 90-day hemorrhagic stroke
timeFrame: 90 days
measure: 90-day myocardial infarction
timeFrame: 90 days
measure: 90-day major extracranial hemorrhage
timeFrame: 90 days
measure: 90-day non-major bleeding
timeFrame: 90 days
measure: 90-day vascular death
timeFrame: 90 days
measure: 90-day all-cause death
timeFrame: 90 days
measure: Discharge mRS
timeFrame: Through hospitalization, an average of 7 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
Study officials:
References: