louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05369325: Non-invasive Hemoglobin Monitoring in Outpatient Total Joint Arthroplasty
Official title: Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Joint Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing total joint arthroplasty at Mayo Clinic

Brief summary: This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Adult patients age ≥ 18.
* Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.

Exclusion Criteria:

- Individuals \< 18 years of age.

Primary outcomes:
measure: Concordance between non-invasive Hgb and serum Hgb
timeFrame: 1 hour
measure: Patient satisfaction with non-invasive Hgb
timeFrame: 1 day
measure: Nurse satisfaction with non-invasive Hgb
timeFrame: 1 day
measure: Cost comparison between non-invasive and serum Hgb
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Abdel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04515225: COVID-19 Prevalence in HIV-infected Patients
Official title: Seroprevalence of SARS-CoV-2 Antibodies Among Adult Patients Living With HIV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Keywords: HIV-infection
AIDS
antiretroviral treatment
CD4 cell count
plasma HIV
RNA
SARS-CoV-2
antibodies
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected patients on follow-up in a single University Hospital

Brief summary: North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.


Eligibility criteria: Inclusion Criteria:

* adults (\> 18 years)
* HIV-infected patients
* subjects with social insurance
* subjects able to understand study purposes, and to give a written and informed consent

Exclusion Criteria :

* subjects unable to understand informations on the study, and to provide informed consent
* subjects under guardianship or curatorship
* subjects under judicial protection

Primary outcomes:
measure: Seroprevalence of SARS-CoV-2
timeFrame: From baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT00173225: Sputum and Plasma Levels of Nociceptin and Substance P in Patients With Asthma, COPD and Chronic Cough
Official title: Association Between Sputum and Plasma Levels of Nociceptin and Substance P With Cough Severity and Airway Hyperreactivity in Patients With Asthma, COPD and Chronic Cough
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
COPD
Cough
Keywords: nociceptin
sunstance P
asthma
COPD
cough
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough.

Detailed description: Recent animal studies have found that nociceptin can inhibit cough responses induced by capsaicin. We hypothesize that sputum and plasma levels of these peptides may reflect some neurochemical alterations in airway cough reflex or neurogenic inflammation in asthma or COPD. The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough. We will enroll 260 patients (100 patients with asthma, 60 with COPD and 100 with chronic cough) as well as 40 healthy subjects for this study. Sputum and peripheral blood will be collected and concentrations of nociceptin and substance P will be measured by ELISA. These levels will be correlated with cough severity (symptom scores), and airway hyperresponsiveness to inhaled methacholine as measured by PC20. Sputum and plasma concentrations of both peptides will be rechecked after clinical improvements in cough or airway symptoms are achieved after therapy.

Eligibility criteria: Inclusion Criteria:patients with asthma, COPD, chronic cough

-

Exclusion Criteria:patients refusing blood sampling

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ping-Hung Kuo
Study officials:
affiliation: Department of Internal Medicine, National Taiwan University Hospital
name: Ping-Hung Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03798925: mNGS for Detection of Pathogens for Pulmonary Infection
Official title: Microbiological Diagnostic Performance of Metagenomic Next-generation Sequencing for Pulmonary Infection in Clinical Settings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Infection
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained

Brief summary: Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.


Eligibility criteria: Inclusion Criteria:

* Pulmonary infection as the primary diagnosis
* Bronchoalveolar lavage fluid can be obtained

Exclusion Criteria:

* when the primary diagnosis is tumor or connective tissue diseases
* microbiological diagnosis is confirmed before bronchoalveolar lavage
* not enough bronchoalveolar lavage fluid for mNGS

Primary outcomes:
measure: microbiological diagnosis (pathogen of pulmonary infection)
timeFrame: through study completion, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03037125: The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)
Official title: The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without PRF In Conjunction With Simultaneous Implant Placement In Narrow Alveolar Ridges: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Deficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis

The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.


Eligibility criteria: Inclusion Criteria:

1. Patients with at least one missing tooth in the maxillary region
2. All the selected patients have a bucco-palatal width of the edentulous alveolar ridge from 3.5-5.5mm.
3. All the selected patients have at least 12 mm residual bone height at the edentulous area
4. The recipient site of the implant should be free from any pathological conditions.
5. No diagnosed bone disease or medication known to affect bone metabolism.
6. Patients who are cooperative, motivated, and hygiene conscious.

Exclusion Criteria:

1. Patients unable to undergo minor oral surgical procedures.
2. Patients with a history of drug abuse or catabolic drugs.
3. Patients with a history of psychiatric disorder.
4. Patients with unrealistic expectations about the esthetic outcome of implant therapy.
5. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.
6. Patients in the growth stage with partially erupted teeth.
7. Patients who have any systemic condition that may contraindicate implant therapy.
8. Patients who have any habits that might jeopardize the osseointegration process, such as smoking and alcoholism.
9. Patients with parafunctional habits that produce overload on the implant, such as bruxism and clenching.

Primary outcomes:
measure: Bone width gain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine, Cairo university
Study officials:
References:
Clinical trial NCT03202225: Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors
Official title: Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constrained Insert in Knee Arthroplasty
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients underwent primary total knee arthroplasty at our institution

Brief summary: While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary TKA.


Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis
* primary total knee replacement

Exclusion Criteria:

* secondary knee osteoarthritis
* revision total knee replacement
* previous knee surgery
* post-traumatic knee
* history of previously infection
* comorbidity;rheumatoid arthritis, connective tissue disease, neuromuscular disease, lumbar spinal stenosis, neuropathy
* severe osteoporosis

Primary outcomes:
measure: prevalence to use constrained insert in primary total knee arthroplasty
timeFrame: intraoperative
measure: risk factors to use constrained insert in primary total knee arthroplasty
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05729425: Evaluating the Accuracy of Microvessel Ultrasound Imaging for Detecting Extent of Disease in Patients With Angiosarcoma of the Skin
Official title: Microvessel Ultrasound Imaging of Cutaneous Angiosarcoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Skin Angiosarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 21 with new diagnosis of cutaneous angiosarcoma of the breast or scalp.

Brief summary: This study evaluates the accuracy of a new ultrasound technology called microvessel imaging for detecting the extent of disease among patients with angiosarcoma of the skin. Microvessel ultrasound imaging uses high frequency waves to visualize vessels in the skin that are not easily seen using other imaging tests.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the accuracy of depicting extent of disease of cutaneous angiosarcoma before and after neoadjuvant treatment compared to clinical photographs, magnetic resonance imaging (MR) or positron emission tomography (PET)/computed tomography (CT) imaging and surgical pathology both on skin biopsies and surgical excision.

OUTLINE:

Patients undergo microvessel ultrasound imaging on study.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosed with cutaneous angiosarcoma of the breast or scalp and scheduled for trimodality therapy
* Twenty one years of age or older

Exclusion Criteria:

* Unwilling to consent to microvessel ultrasound imaging
* Younger than 21 years of age

Primary outcomes:
measure: Accuracy of microvessel ultrasound imaging
timeFrame: Through to study completion up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Tiffany M Sae-Kho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812825: A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
Official title: A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety Tolerability Pharmacokinetics/pharmacodynamics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy males between 18 and 55 years, inclusive.
* Healthy females between 18 and 44 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant disease;
* Post-menopausal women;
* History of intolerance or significant adverse effects with glucocorticoids. therapy.

Primary outcomes:
measure: Safety and tolerability of multiple doses of PF-04171327
timeFrame: 14 days
measure: Determination of pharmacokinetic parameters of PF-04171327 after multiple doses
timeFrame: 14 days
measure: Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers
timeFrame: 14 days
measure: Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet
timeFrame: 1 day
Secondary outcomes:
measure: To characterize the pharmacodynamic effects of prednisolone
timeFrame: 14 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02001025: Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bioresorbable Scaffolds
Keywords: coronary vessels
coronary stenosis
percutaneous transluminal angioplasty
stents
drug-eluting stents
bioresorbable scaffolds
optical coherence tomography
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease

Brief summary: The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.


Eligibility criteria: Inclusion Criteria for implanting an Absorb scaffold:

* age \< 55 years OR
* lesion length \> 24mm OR
* multiple lesions to be treated

Primary outcomes:
measure: adverse post-stenting results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02358525: Effects of a Rehabilitation Program on Immune Activation and Mood in Heart Failure Patients
Official title: Effects of a Multi-Modality Rehabilitation Program on Immune Activation, Depressive Symptoms and Quality of Life in Heart Failure Patients. A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Depressive Symptoms
Lead sponsor: Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients, EF ≤ 45%, NYHA I - III; ACC/AHA stage C

Brief summary: The aim of this descriptive study is to examine potential changes regarding inflammatory cytokine levels, depressive symptoms and quality of life over the course of the 4-week inpatient rehabilitation program which includes a cassette of modalities including counseling, psychosocial education and supervised exercise training as a main pillar, and to further investigate if there are correlations between changes in immune regulation, depressive symptoms and quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of heart failure with reduced ejection fraction (HFREF) with an EF ≤ 45%, NYHA (New York Heart Association) I - III; ACC/AHA (American College of Cariology/ American Heart Association) stage C, irrespective of etiology
* Clinically stable patients without deterioration or hospitalization due to heart failure within the last 4 weeks
* Neuro-hormonal medication according to the ESC (European Society of Cardiology) guidelines for the treatment of chronic heart failure consisting of antagonists of the Renin-Angiotensin-Aldosterone System (RAAS) and beta-blockers as indicated.
* Ability to fully understand all elements of and sign the written informed consent before initiation of the study

Exclusion Criteria:

* Fluid retention of cardiac decompensation, necessitating i.v. diuretic therapy
* Myocardial infarction within the last 2 months
* Surgery including cardiovascular or valvular surgery within 3 Months
* Uncontrolled proinflammatory comorbidities (e.g. Diabetes mellitus HbA1c \>9%, COPD ( chronic obstructive pulmonary disease) \>II, active rheumatic diseases and autoimmune disorders)
* Current infectious diseases ( e.g. pneumonia, COPD exacerbations or urinary tract infections)
* Morbid obesity: BMI \> 40
* Alcohol or drug abuse
* psychiatric disorders

Primary outcomes:
measure: inflammatory activity
timeFrame: 8 weeks
Secondary outcomes:
measure: physical fitness
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 8 weeks
measure: Depressive Symptoms
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Grossgmain
country: Austria
facility: Ska Rz Grossgmain
state: Salzburg
city: Salzburg
country: Austria
facility: SALK, 2.Medizin, HI-Ambulanz
Study officials:
affiliation: Ludwig Boltzmann IRBR
name: katherine wachmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References: