louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03667248: Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
Official title: Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: PERCEVAL® sutureless aortic valve prosthesis
aortic valve stenosis
aortic valve replacement
preoperative CT scan of the heart
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with implantation of a Sorin Perceval ® sutureless valve at University Hospital Basel/ Switzerland

Brief summary: This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Detailed description: Patients with severe aortic stenosis undergo aortic valve replacement (AVR). One approach to reduce trauma and operation time is the implantation of a sutureless valve to reduce aortic cross-clamp time due to the missing necessity of suturing the valve. Until now, sizing of the valve was determined intraoperatively using the measuring devices provided by the product manufacturer. Due to the implantation mechanism, the valve has to be collapsed after determination of the size. This is consuming time and can seriously delay the procedure.

This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Eligibility criteria: Inclusion Criteria:

* Implantation of a Sorin Perceval ® sutureless valve
* availability of preoperative CT scan

Exclusion Criteria:

* denial of consent
* missing preoperative CT scan
* bad quality of preoperative CT scan

Primary outcomes:
measure: accuracy of aortic valve sizing by preoperative CT scan of the heart
timeFrame: during surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Oliver Reuthebuch, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03828448: Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
Official title: A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Follicular Lymphoma
Small Lymphocytic Lymphoma
Keywords: Treatment naïve
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

Detailed description: The study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve FL and SLL. Ublituximab will be administered through Cycle 12, while umbralisib will be administered through Cycle 24. After this time, participants will be followed for progression free survival (PFS).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of FL or SLL.
* Measurable disease that requires treatment
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

* Currently or previously received treatment for their lymphoma
* Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1
* Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 22 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 35 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
timeFrame: Up to approximately 35 months
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Saint Petersburg
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Nashville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
Study officials:
References:
Clinical trial NCT00790348: Effect of Januvia on Ghrelin and Other Gut Hormones in Patients With Diabetes
Official title: Effect of Januvia on Ghrelin and Other Gut Hormones in Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes on oral agent that require Metformin or Januvia only

Brief summary: The purpose of this study is to see the effect of Januvia on Ghrelin levels in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes

Exclusion Criteria:

* Renal failure
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References:
Clinical trial NCT02822248: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05801848: Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain
Official title: Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lower Back Pain Chronic
Keywords: NaF PET
Bone metabolism
Bone perfusion
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2023-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic lower back pain where the source could not be identified on MRI scans

Brief summary: The main goal of this study is to determine if static or dynamic \[18F\]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans.

Detailed description: Patients with chronic lower backpain are routinely scanned with MR and/or CT to diagnos the source of pain. Larger studies have reported that approximately 20% of patients are given a certain diagnosis from the scans and in the majority of cases the source of the pain is not determined. The use of \[18F\]NaF PET/CT to map bone perfusion and metabolism is a routine clinical scan that can potentially identify the source of lower backpain in MRI and CT negative patients.

Hypothesis: That \[18F\]NaF PET/CT bone metabolism and bone perfusion images would contain information that allow the correct diagnosis in at least 20% of patients where MRI and CT images did not reveal pathology.

Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Chronic lower back pain with no concrete diagnosis after MRI and/or CT
* Under the the care of Rigshospitalets centre for Rheumatology and Spine Disease

Exclusion Criteria:

* previous operation in the lower back area
* Known inflammatory related illness or progressive rheumatism

Primary outcomes:
measure: Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion
timeFrame: 1 hour examination
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet - Centre of Rheumatology and Spine Disease
Study officials:
affiliation: Rigshospitalet Centre of Rheumatology and Spine Disease
name: Rune Tønnesen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamie S, El-Maghraby T. The role of PET/CT in evaluation of Facet and Disc abnormalities in patients with low back pain using (18)F-Fluoride. Nucl Med Rev Cent East Eur. 2008;11(1):17-21.
citation: Kogan F, Broski SM, Yoon D, Gold GE. Applications of PET-MRI in musculoskeletal disease. J Magn Reson Imaging. 2018 Jul;48(1):27-47. doi: 10.1002/jmri.26183.
Clinical trial NCT06928948: Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study (RESIF)
Official title: Medium-term Results of the LPS™ System for Segmental Resection of the Distal Femur, a Multicenter Retrospective Study.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prosthesis Failure
Keywords: megaprosthesis
knee replacement
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The institutional databases of university hospitals belonging to the HugOrtho network (Hôpitaux Universitaires du Grand Ouest) will be examined to identify patients who will have undergone reconstruction using the Limb Preservation System™ (LPS™, DePuy Synthes; Warsaw, USA) for segmental resection of the distal femur, regardless of the indication.

Brief summary: The reconstruction of the distal femur using modular systems has become increasingly popular over the years, surpassing primary arthrodesis or amputation. Despite the significant advantages of using megaprostheses, complications are not uncommon. Although the Limb Preservation System™ (LPS™, DePuy Synthes; Warsaw, USA) is one of the most widely used megaprostheses in the French market, there is currently no national evaluation of this system, and only two studies have been conducted worldwide.

The aim of our study is to present the mid-term survival rates of the LPS™ implant in order to answer three main questions:

1. What are the overall outcomes of the LPS™ system in distal femur replacement?
2. What factors are associated with a reduced survival rate of the implant?
3. What is the cumulative risk of complications according to Henderson's classification?

The secondary objective is to analyze the occurrence of specific failures, providing insights for potential improvements in the design and use of the LPS™ implant.


Eligibility criteria: Inclusion Criteria:

- Patients who underwent distal femoral reconstruction using the LPS system.

Exclusion Criteria:

* Lost to follow-up before 3 months.
* Associated tibial reconstruction using the LPS system.
* Total femoral reconstruction using the LPS system.

Primary outcomes:
measure: LPS stent failure
timeFrame: From enrollment to last consultation
Secondary outcomes:
measure: complications of the LPS stent
timeFrame: From enrollment to last consultation
measure: Surgical revision of the LPS stent
timeFrame: From enrollment to last consultation
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT01409148: Radioimmunoimaging of AL Amyloidosis
Official title: Radioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AL Amyloidosis
Keywords: Radioimmunoimaging
AL Amyloidosis
PET/CT
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2011-08-04
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

Detailed description: To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 or 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of AL Amyloidosis

Exclusion Criteria:

* New York Heart Association class IV
* patient on renal dialysis
* serum antibodies to mouse protein

Primary outcomes:
measure: Radioimmunoimaging of AL amyloid deposits
timeFrame: 36 months
Secondary outcomes:
measure: Imaging of amyloid deposits as determined by PET/CT
timeFrame: 10-14 days
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT06070948: A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants
Official title: A Bioavailability and Food Effect Study of Venetoclax New High Drug Load Tablet Formulation in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Venetoclax
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the bioavailability of two different doses of venetoclax new high drug load formulation tablets relative to two tablets of the currently marketed venetoclax tablets under fed conditions.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal.
* A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Participant must be postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.

Exclusion Criteria:

- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
timeFrame: Up to Day 27
measure: Time to Cmax (Tmax) of Venetoclax
timeFrame: Up to Day 27
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUCt) of Venetoclax
timeFrame: Up to Day 27
measure: AUC from Time 0 to Infinity (AUCinf) of Venetoclax
timeFrame: Up to Day 27
measure: Apparent Terminal Phase Elimination Rate Constant (β, BETA) of Venetoclax
timeFrame: Up to Day 27
measure: Terminal Phase Elimination Half-life (t1/2) of Venetoclax
timeFrame: Up to Day 27
measure: Number of Adverse Events (AEs)
timeFrame: Baseline to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 259897
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02008448: Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-12-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. Results were assessed with the use of an implanted monitoring device (IMD).


Eligibility criteria: Inclusion Criteria:

* Persistent and longstanding persistent AF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm

Primary outcomes:
measure: freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
timeFrame: 1 year
Secondary outcomes:
measure: serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT01277848: PLAC1 in Reproduction
Official title: PLAC1 in Reproduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: PLAC1
pregnant
first prenatal visit
pre-eclampsia
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: March of Dimes
First posted: 2011-01-17
Enrollment: 500
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at USF coming in for their first prenatal appointment

Brief summary: The PLAC1 gene is a recently described X-linked gene that maps to a region of the X chromosome thought to be important for normal fetal and placental development. Elevated levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened pregnancy.

The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50 of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data. The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be determined.

1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained as part of the routine blood draw at the time of enrollment. Blood will only be collected when drawn as part of routine laboratory testing as determined by the primary care provider.

Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum of 5 samples will be collected through the pregnancy.

Maternal demographic data will be collected and patients will be followed longitudinally to the completion of pregnancy to ascertain their clinical status during pregnancy, onset of premature labor, premature rupture of membranes, delivery date, and gestational age at delivery.


Eligibility criteria: Inclusion Criteria:

* Pregnant, primigravid and multigravid women between the ages of 14 and 55, receiving prenatal care at USF Health, STC, Dept. of Obstetrics.

Exclusion Criteria:

* presence of significant cardiac disease
* renal disease
* chronic hypertension
* chromosomal abnormalities
* cancer

Primary outcomes:
measure: Anti-PLAC1 autoantibodies
timeFrame: During pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health OB/GYN Clinic
state: Florida
Study officials:
affiliation: University of South Florida
name: Michael Fant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: