louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03156894: Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
Official title: Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Graft Dysfunction
Keywords: Graft Dysfunction
Primary Graft Dysfunction
heart transplant
heart failure
Hemodynamic parameters
Incidence of PDG
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.

Brief summary: Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure.

The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (\<30 days) of support appear to improve survival in the first year after transplantation.

The haemodynamic parameters revealing this DPG are not clearly described in the literature.

hypothesis of this research is that:

* DPG risk factors in strasbourg's hospital center are comparable to other European and international centers.
* Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly.


Eligibility criteria: Inclusion Criteria:

* All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.

Exclusion Criteria:

* multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.

Primary outcomes:
measure: Retrospective comparison of risk factors (incidence for ordinal and average variables for numerical variables) between patients suffering from severe primary dysfunction of the graft and those not suffering from severe primary dysfunction of the graft
timeFrame: 1 month after leaving the operating room
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Réanimation chirurgicale cardio-vasculaire - NHC
Study officials:
References:
Clinical trial NCT04905394: Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Official title: Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Edema
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 50
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: Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.


Eligibility criteria: Inclusion Criteria:

* Atraumatic knee pain for at least 3 months;
* Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);
* Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)
* BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)

Exclusion Criteria:

* Knee pain and functional limitation related to other causes like osteonecrosis
* Fractures or inflammatory arthritis
* Ligamentous instabilities
* Malalignment on the coronal axis greater than 10 degrees in varus/valgus
* Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)

Primary outcomes:
measure: Pain reduction
timeFrame: 6 months
Secondary outcomes:
measure: Radiological evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Gaetano Pini hospital
state: Lombardy
Study officials:
affiliation: University of Milan
name: pietro randelli, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01495494: A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
Official title: A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Nasal Strip
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety \& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Primary outcomes:
measure: Dermal response score of the application site of the nasal strip
timeFrame: Baseline through 7 days
Secondary outcomes:
measure: Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
timeFrame: 7 days
Other outcomes:
Locations:
city: Verona
country: United States
facility: Essex Testing Clinic, Inc
state: New Jersey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ward J, Ciesla R, Becker W, Shanga GM. Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Allergy Rhinol (Providence). 2018 Oct 5;9:2152656718796740. doi: 10.1177/2152656718796740. eCollection 2018 Jan-Dec.
Clinical trial NCT01569594: CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
Official title: CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 230 subjects may be enrolled from up to ten U.S. clinical sites

Brief summary: Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.

Detailed description: The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.

Eligibility criteria: Inclusion Criteria:

* Subjects must be undergoing carotid endarterectomy with patch angioplasty closure.
* Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use.
* The subject must possess the ability to provide written Informed Consent.
* The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol.

Exclusion Criteria:

* Subjects with a known sensitivity to porcine material.

Primary outcomes:
measure: Carotid Procedure and Device Related Adverse Events to Determine Device Performance
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons, P.C. Trinity
state: Alabama
city: Marietta
country: United States
facility: Vascular Surgical Associates P.C.
state: Georgia
city: Indianapolis
country: United States
facility: Cardiac Surgery Associates
state: Indiana
city: Kansas City
country: United States
facility: St Luke's Hospital
state: Missouri
city: Memphis
country: United States
facility: Cardiovascular Surgery Clinic, PLLC
state: Tennessee
city: Charlottesville
country: United States
facility: UVA Heart and Vascular Center
state: Virginia
Study officials:
References:
Clinical trial NCT02192294: Absolute Bioavailability Of Bosutinib
Official title: An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bosutinib
absolute bioavailability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects (of non-childbearing potential).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
* A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.

Primary outcomes:
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 96 hours
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 96 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 96 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 96 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 96 hours
measure: Systemic Clearance (CL)
timeFrame: 96 hours
measure: Volume of Distribution at Steady State (Vss)
timeFrame: 96 hours
Other outcomes:
Locations:
city: Ruddington Fields
country: United Kingdom
facility: Quotient Clinical
state: Nottingham
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hsyu PH, Pignataro DS, Matschke K. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study. Clin Pharmacol Drug Dev. 2018 May;7(4):373-381. doi: 10.1002/cpdd.396. Epub 2017 Oct 23.
Clinical trial NCT03241394: The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome
Official title: The Investigation of the Role of Inflammation in the Insulin Resistance Syndrome: The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Metabolic Syndrome
Keywords: Monocyte subsets
Obesity
Metabolic Syndrome
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the present study healthy lean volunteers and obese subjects were recruited. The obese patients attended the Endocrinology outpatient clinic of the University Hospital of Ioannina in Greece. The obese patients were either with metabolic syndrome (MS) or without MS.

Brief summary: Obesity is associated with a chronic low-grade inflammation characterized by macrophage infiltration in adipose tissue that induces insulin resistance and the appearance of metabolic syndrome (MS). The aim of the study was the investigation of whether circulating monocyte subsets are differentially regulated in MS.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

Age less than 18 years old, pregnancy, breast feeding, kidney disease, liver disease, gastrointestinal disease, malignancy, any endocrine disorder or metabolic disease, other than obesity or type 2 diabetes mellitus (T2DM), alteration of body weight (BW) by up of 5% of the initial BW during the last 3 months, any state of stress or systemic inflammation and taking any of the following drugs, within 3 weeks prior to the start of the study: hypolipidemic agents, antidiabetics, drugs for weight loss, nonsteroidal antiinflammatory drugs, glucocorticoids.

Primary outcomes:
measure: Monocyte subsets
timeFrame: Baseline measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: University Hospital of Ioannina
Study officials:
References:
citation: Christou KA, Christou GA, Karamoutsios A, Vartholomatos G, Gartzonika K, Tsatsoulis A, Tigas S. Metabolically Healthy Obesity Is Characterized by a Proinflammatory Phenotype of Circulating Monocyte Subsets. Metab Syndr Relat Disord. 2019 Jun;17(5):259-265. doi: 10.1089/met.2018.0132. Epub 2019 Mar 13.
Clinical trial NCT03085394: Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Official title: Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Intra-Operative Injury - Other
Post Operative Hemorrhage
Tranexamic Acid
Keywords: Morbid Obesity
Sleeve gastrectomy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-03-21
Enrollment: 152
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: Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

Detailed description: Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.

Eligibility criteria: Inclusion Criteria:

* Morbid obesity
* Approved and scheduled for laparoscopic sleeve gastrectomy

Exclusion Criteria:

* Previous bariatric surgery
* Platelet count under 100,000
* Concurrent anticoagulation treatment
* Previous venous/atrerial thromboembolic event
* Known allergy to tranexamic acid
* History of heparin induced thrombocytopenia
* Oral contraceptive use
* Female hormonal replacement therapy
* Active thromboembolic state
* Genetic hypercoagulable state

Primary outcomes:
measure: Treatment efficiency (lowering/preventing clinically significant bleeding)
timeFrame: 1 week
measure: Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
timeFrame: 2 months
Secondary outcomes:
measure: Need for reintervention
timeFrame: 1 week
measure: Procedure change
timeFrame: 1 day
measure: Blood/blood product requirement
timeFrame: 1 week
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT01563094: Bone Accrual and Hormones in Response to Lactation
Official title: Bone Accrual and Hormones in Response to Lactation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactation
Keywords: Bone Density
Lactation
Bone Turnover Markers
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2012-03-26
Enrollment: 141
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postpartum women from outpatient obstetrical/gynecology clinics.

Brief summary: This is a prospective observational trial of healthy postpartum women to investigate changes in bone density and markers of bone turnover during lactation. The study hypothesis is that women who breast-feed 5 months or more will lose bone density and subsequently regain the bone density after weaning. This study seeks to define determinants of the regain in bone density.

Detailed description: This is a prospective observational trial enrolling healthy postpartum women, ages 20 years and older with the intent to breast-feed from the UNC outpatient obstetrical clinics and the UVA outpatient obstetrical clinics. These women were studied at 3-5 visits in the year following their delivery to assess bone density, nutritional intake, exercise, and breast-feeding choices. The number of study visits depended on the timing of return of menses and interest in participating in the follow-up study (timepoints are: immediate postpartum, 3 months postpartum, return of menses, 6 months after return of menses and follow-up visit 6 months after final visit). Blood was taken for analysis of bone-related hormones, bone turnover and calcium homeostasis markers. The study focuses on women with extended lactation (at least 5 months of lactation) whereas women who cease lactation prior to 3 months will be the primary comparison group.

Eligibility criteria: Inclusion Criteria:

* age \>20 at the time of delivery
* singleton pregnancy and
* \<2 prior pregnancies that were \>20 weeks gestation.

Exclusion criteria:

* maternal rheumatologic disorders
* maternal anorexia nervosa
* maternal endocrinologic disorders,
* medications known to affect bone density such as corticosteroids, thyroid hormone use, anticonvulsant therapy, bisphosphonates, long-term GnRH agonists use and calcitonin.
* Subsequent pregnancy during the study

Primary outcomes:
measure: The association of change in bone density and change in IGF-1 axis hormones during lactation and weaning
timeFrame: ~Two Years
Secondary outcomes:
measure: The association of changes in bone density and change in bone turnover markers during lactation and weaning.
timeFrame: ~Two years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UVA
name: Sue Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901794: Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis
Official title: Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis Measured by Non-invasive Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis Complication
Hemodialysis-Induced Symptom
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: end-stage renal disease patients who were under regular hemodialysis

Brief summary: Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor

Detailed description: By applying non-invasive hemodynamic monitors (ex. ClearSight, I-COM), the trends of mean arterial pressure (MAP), stroke volume (SV), cardiac index (CI) and calculated systemic vascular resistance (SVR) were collected along with volume removal by hemodialysis on ESRD patients. All data were compared and analyzed to detect the sequential body volume status as well as the autonomic responses during hemodialysis.

Eligibility criteria: Inclusion criteria:

1. Patients who were schedured with regular hemodialysis for end-stage renal disease.

Exclusion criteria:

1. Emergent hemodialysis
2. Medical conditions with poor peripheral circulation such as Raynaud's disease or PAOD
3. Skin defects or wounds over area to be applied for measurement (Wrist and fingers)

Primary outcomes:
measure: fluid removed along with hemodialysis
timeFrame: 4 hours
measure: changes of mean arterial pressure along with hemodialysis
timeFrame: 4 hours
measure: changes of heart rate along with hemodialysis
timeFrame: 4 hours
measure: changes of stroke volume along with hemodialysis
timeFrame: 4 hours
measure: changes of cardiac output along with hemodialysis
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: ST Chen
role: STUDY_CHAIR
References:
citation: Lai CJ, Shih CC, Huang HH, Chien MH, Wu MS, Cheng YJ. Detecting Volemic, Cardiac, and Autonomic Responses From Hypervolemia to Normovolemia via Non-Invasive ClearSight Hemodynamic Monitoring During Hemodialysis: An Observational Investigation. Front Physiol. 2022 Apr 28;13:775631. doi: 10.3389/fphys.2022.775631. eCollection 2022.