louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02083666: Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI002 Following Subcutaneous and Intravenous Administration. A Double-blind, Placebo-controlled, Randomized Within Dose Cohort, Single and Repeated Dose-escalation Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Dose cohorts
Escalating dose
Single dose
Multiple dose
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
volunteers
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Richmond Pharmacology Limited
First posted: 2014-03-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.

Detailed description: This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.

Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.

Eligibility criteria: Inclusion Criteria:

* Females of non-childbearing potential or males
* 18 to 45 years of age
* Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments.

Exclusion Criteria:

* Females of childbearing potential
* Clinically significant disease
* Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.

Primary outcomes:
measure: To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Assessment of pharmacokinetics of SOBI002 through analysis of serum samples
timeFrame: Up to 13 weeks
measure: Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity
timeFrame: Up to 13 weeks
measure: Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology Ltd.
state: St George's University of London
Study officials:
affiliation: Swedish Orphan Biovitrum AB (publ)
name: Erik Brouwer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02278666: Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry
Official title: Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Surgery
Lead sponsor: Maria Cecilia Hospital
Sponsor class: OTHER
Collaborators: name: Ettore Sansavini Health Science Foundation
First posted: 2014-10-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing isolated aortic valve surgery

Brief summary: The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

Detailed description: The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing isolated aortic valve surgery
* Written Informed consent to the use of personal data

Exclusion Criteria:

* other associated cardiac surgery
* emergency surgery

Primary outcomes:
measure: Cardiopulmonary bypass time
timeFrame: during surgery
measure: Total duration of Intensive Care Unit stay
timeFrame: during hospital stay, usually lasting one to two weeks
measure: Blood transfusions
timeFrame: during hospital stay, usually lasting one to two weeks
Secondary outcomes:
measure: renal insufficiency
timeFrame: during hospital stay, usually lasting one to two weeks
measure: Prolonged ventilation
timeFrame: during hospital stay
measure: Re-exploration for bleeding
timeFrame: during hospital stay, usually lasting one to two weeks
measure: sepsis
timeFrame: during hospital stay, usually lasting one to two weeks
measure: Neurological complications
timeFrame: during hospital stay, usually lasting one to two weeks
measure: in-hospital mortality
timeFrame: during hospital stay, usually lasting one to two weeks
measure: 30-day mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
Study officials:
affiliation: Maria Cecilia Hospital
name: Elisa Mikus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05621226: Message Communicating Latest Data on COVID-19 Transmission in Patient's Area
Official title: Message Communicating Latest Data on COVID-19 Transmission in Patient's Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 520000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be randomly assigned to the different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. The focal comparison in this experiment is between a message encouraging vaccination by communicating to patients that they live in an area with significant COVID transmission and a control message telling patients that an updated COVID booster vaccine is waiting for them.


Eligibility criteria: Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Primary outcomes:
measure: Patient uptake of COVID bivalent booster
timeFrame: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes:
measure: Patient uptake of COVID bivalent booster
timeFrame: 60 days after receiving the SMS/MMS intervention
measure: Patient uptake of COVID bivalent booster
timeFrame: 90 days after receiving the SMS/MMS intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06487026: Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study
Official title: An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Metastases
Lead sponsor: EpiSonica
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 25
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: An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases

Detailed description: Pain palliation of bone metastasis through localized denervation by thermal ablation.

Eligibility criteria: Inclusion Criteria:

1. Male or female, who randomized into Sham control group and withdrew from CTP-BM-22-01 Study (i.e. main study) due to lack of efficacy.
2. Completed 14-day evaluation in main study.
3. Will provide completed and signed written informed consents.

Exclusion Criteria:

1. Pregnant women.
2. Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
3. Determined by the investigator to be not suitable for the conduct of the study for any other reasons.

Primary outcomes:
measure: Unanticipated adverse device effects (UADEs) from Day 0 to 90.
timeFrame: from Day 0 to 90
Secondary outcomes:
measure: Solicited events from Day 0 to 30
timeFrame: from Day 0 to 30
measure: Unsolicited adverse events from Day 0 to 90
timeFrame: from Day 0 to 90
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
Study officials:
References:
Clinical trial NCT00642226: Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Official title: A Randomized Study Comparing Combined Vitrectomy and Triamcinolone to Laser Grid in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Branch Retinal Vein Occlusion
Macular Edema
Keywords: Branch Retinal Vein Occlusion
BRVO
Macular Edema
Triamcinolone
Vitrectomy
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2008-03-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* Macular edema secondary to BRVO
* Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
* Duration no shorter than 3 months
* Duration no longer than 12 months

Exclusion Criteria:

* Proliferations in study eye
* Blod in vitreous cavity
* Previous fundus laser treatment
* BRVO with over 180˚ of ischemia on FA
* Age under 18
* Other eye condition which contribute to relevant loss of visual acuity

Primary outcomes:
measure: Visual acuity (ETDRS)
timeFrame: 12 and 36 Months
Secondary outcomes:
measure: Retinal thickening measured on OCT.
timeFrame: 12 and 36 Months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
affiliation: Helse Stavanger HF
name: Johan Seland, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00603226: Slow Coronary Artery Flow: Influence on Morbidity and Mortality
Official title: Slow Coronary Artery Flow: Influence on Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Keywords: Coronary slow flow phenomenon
Coronary angiography
Acute coronary syndrome
Chest pain
Unstable angina
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent coronary angiography in the Hillel Yaffe Medical Center

Brief summary: To compare patients with Slow Coronary Artery Flow to patients with normal flow and to determine whether there is a difference in their future incidence of heart disease.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent coronary angiography

Exclusion Criteria:

* Patients with coronary occulsion above 50%
* Patients with severe valve disorder

Primary outcomes:
measure: How many hospitalizations for major coronary events in patients with or without slow coronary artery flow.
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yaniv Levi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00609726: Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography
Official title: Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder Disease
Pancreatitis
Keywords: Endoscopic Ultrasonography
Pancreatitis
EUS
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 199
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women diagnosed with unexplained pancreatitis.

Brief summary: The purpose of the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis.

Detailed description: The study evaluates the role of endoscopic ultrasonography, given that the minimally invasive procedures can diagnosis gallbladder disease as well as pancreatitis abnormalities.

Eligibility criteria: Inclusion Criteria:

* All patients referred to the principal investigator for unexplained pancreatitis will be enrolled.

Exclusion Criteria:

* There are no gender nor racial exclusion.

Primary outcomes:
measure: Evaluation of current clinical practice for patients with idiopathic pancreatitis
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Charles M Wilcox, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilcox CM, Seay T, Kim H, Varadarajulu S. Prospective Endoscopic Ultrasound-Based Approach to the Evaluation of Idiopathic Pancreatitis: Causes, Response to Therapy, and Long-term Outcome. Am J Gastroenterol. 2016 Sep;111(9):1339-48. doi: 10.1038/ajg.2016.240. Epub 2016 Jun 21.
Clinical trial NCT02481726: 68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Lung Tuberculosis
Keywords: 68Ga
Alfatide II
RGD
αvβ3
PET/CT
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.


Eligibility criteria: Inclusion Criteria:

* Must be able to provide a written informed consent
* Males and females, ≥18 years old.
* The definite diagnosis of lung cancer was established by pre-operational bronchoscopic or puncture biopsy or the definite diagnosis of lung tuberculomas was established on the basis of positive sputum culture examinations and confirmed by follow-up.
* Without any treatment or resection surgury.
* All the biopsies are done at least 10 days before PET/CT scans.
* Evaluation of cardiac function.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential；
* Known severe allergy or hypersensitivity to IV radiographic contrast；
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Primary outcomes:
measure: Quantitative measurement of standardized uptake values (SUVs) of lesions.
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04418726: Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF
Official title: The Clinical Value of Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF: a Random Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Malfunction
Vascular Access Complication
Vascular Access Site Occlusion
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 200
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: SUPPORTIVE_CARE

Brief summary: Whether intensive monitoring and preemptive intervention has an positive clinical effect on arterio-venous fistula (AVF) maintenance is a new issue in hemodialysis (HD) patient management. This study aims to explore the clinical value of intensive monitoring and preemptive intervention on AVF, so to decide the best follow-up items and frequency.


Eligibility criteria: Inclusion Criteria:

* patients on HD with AVF in Zhongshan Hospital, Fudan University

Exclusion Criteria:

* with malignancies

Primary outcomes:
measure: AVF patency rate
timeFrame: 6 months
Secondary outcomes:
measure: AVF complication
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02380326: Innovation in Endobronchial Sampling
Official title: Innovation in Endobronchial Sampling : Integration of Virtual Bronchoscopic Navigation in the Current Diagnostic Algorithm and the Use of Micro-CT for Tissue Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Interstitial Lung Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 20
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: Lung transplant recipients and diffuse interstitial lung disease without certain diagnosis

Brief summary: Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB), confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic path of pulmonary lesions in the non-oncological patient.

Detailed description: The region(s) of interest that has/have to be sampled, will be selected upfront. Guided by the endobronchial pathway that is created by virtual bronchoscopy, the flexible bronchoscope will be navigated to the regions of interest and an optical biopsy of the region will be obtained using pCLE. One biopsy sample will be processed in the endoscopy suite to be able to prepare it for micro-CT analysis.

Eligibility criteria: Inclusion Criteria:

* Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation.
* Informed consent available
* Age \> 18
* FVC \> 50%pred
* DLCO \> 35%pred
* PaO2 \> 55 mmHg, pCO2 \< 45 mmHg (ambient air)
* No exclusion criteria

Exclusion Criteria:

* Age \> 75
* Systolic arterial pressure in the pulmonary artery : PAPS \>40mmHg
* Platelet count \<100000/µl
* INR \> 1.4
* BMI \>30
* Diffuse bullous lung disease
* Active anti-platelet or anticoagulant treatment
* Active heart failure or unstable coronary heart disease

Primary outcomes:
measure: Diagnostic yield
timeFrame: postprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jonas Yserbyt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794026: Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients
Official title: Use of Diffusion Weighted Magnetic Resonance Imaging to Stage Gastric Adenocarcinoma Patients Preoperatively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastric Adenocarcinoma
Keywords: diffusion weighted
magnetic resonance imaging
surgery
histopathology
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Preoperative staging for gastric adenocarcinoma is an important procedure to detect advanced disease stateS for the patients in which the surgery may be unnecessary to perform. Although there are many imaging techniques for this purpose, sensitivity and specificity of these techniques still remains to be low.Preoperative detection of peritoneal carcinomatosis and involvement of lymph nodes beyond D2 may prevent surgical procedures.

Removal of the determined lymph nodes according to the type of the surgery is the accepted surgical method. However, accurate determination of malignant lymph nodes may prevent dissection of some groups of the lymph nodes. These findings may cause a new definition of gastric lymph node dissection.

Detailed description: 1. proven endoscopic diagnosis of gastric adenocarcinoma
2. for staging purposes, computed tomography for all patients
3. evaluation of benign and malignant lymph nodes according to computed tomography findings and mapping of the lymph nodes
4. to state precisely resectable patients according to computed tomography and anesthetic evaluation
5. evaluation of benign and malignant lymph nodes according to diffusion weighted magnetic resonance imaging findings and mapping of the lymph nodes
6. standard gastrectomy and D2 lymph node dissection
7. mapping of the lymph nodes after taking the specimen out
8. histopathological diagnosis of the lymph nodes and mapping
9. comparison of the results taken from computed tomography, diffusion weighted magnetic resonance imaging and histopathological analysis

Eligibility criteria: Inclusion Criteria:

* gastric adenocarcinoma proven by endoscopic biopsy;
* application of both computed tomography and diffusion weighted magnetic resonance imaging;
* standard gastrectomy and a D2 lymph node dissection;
* desire to attend the study protocol

Exclusion Criteria:

* preoperative neoadjuvant therapy;
* metastatic disease;
* undesired reaction to attend the study protocol

Primary outcomes:
measure: efficacy of diffusion weighted magnetic resonance imaging to detect benign and malignant lymph nodes
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Faculty of Medicine Dept of General Surgery
Study officials:
References: