louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03708627: Bimatoprost as a Treatment for Graves' Orbitopathy
Official title: The Role of Bimatoprost in Graves' Periorbitopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Graves Ophthalmopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing whether Bimatoprost, a topical eye drop used for glaucoma, can be used to induce periorbital fat atrophy in patients with Graves' disease


Eligibility criteria: Inclusion Criteria: Graves' Ophthalmopathy with Exophthalmos/Proptosis -

Exclusion Criteria: Active Graves Disease, Currently pregnant, Taking Steroids

-

Primary outcomes:
measure: Reduction in periorbital fat causing improvement in proptosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Emily Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113827: Effects of Water-soluble Olive Extract Supplementation
Official title: Effects of Water-soluble Olive Extract on Antioxidant Status, Exercise Performance, Muscle Metabolism, Muscle Damage and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Olive
antioxidant
exercise
inflammation
recovery
Healthy men
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2010-04-30
Enrollment: 61
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Six weeks of supplementation of an olive extract will:

* Improve antioxidant status
* Reduce inflammation
* Reduce muscle damage
* Improve exercise performance
* Improve exercise recovery as compared to a placebo.


Eligibility criteria: Inclusion Criteria:

* Recreational exerciser
* BMI \<= 30
* Non-smoker

Exclusion Criteria:

* Blood pressure over 140/90
* Type I or Type II diabetes
* Renal, hepatic or cardiac disease
* Current infectious disease

Primary outcomes:
measure: Improved Antioxidant Status
timeFrame: 6 weeks
Secondary outcomes:
measure: Reduced Inflammation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: John Ivy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886427: Implementation of a Multidimensional Quality Model
Official title: Implementation of a Multidimensional Quality Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Management Systems
Quality Improvement
Public Health
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Sint-Trudo Hospital
First posted: 2021-05-14
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treated or working in the hospital

Brief summary: The aim of this study is to measure the experiences about the current care of the patients, their kin and staff by a quickscan based on a multidimensional quality model. Further more we want to define the psychometric characteristics of the quickscan.


Eligibility criteria: Inclusion Criteria:

* 18 years old
* Treated/working in the hospital

Exclusion Criteria:

* Do not understand Dutch

Primary outcomes:
measure: Perception of the organisation of care
timeFrame: During their treatment or work experience in the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Sint-Truiden
country: Belgium
facility: Sint-Trudo Ziekenhuis
city: Tienen
country: Belgium
facility: RZ Heilig Hart
Study officials:
References:
Clinical trial NCT00380627: Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)
Official title: Quality of Life With Arcoxia in Women With Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 337
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.


Eligibility criteria: Inclusion Criteria:

* Healthy women older than 18 years old and younger than 25 years old
* Voluntary agreement to participate in the study and signature of informed consent
* Women with clinical diagnosis of dysmenorrhea

Exclusion Criteria:

* Diagnosis of secondary dysmenorrhea due to: endometriosis, adenomyosis, malformations of Muller's conducts, uterine fibromyomas, ovarian cystic, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical channel stenosis, etc.
* Patients with diagnosis of acute inflammatory abdomen
* Patients with diagnosis of congestive heart disease, stroke (1 year), unstable angina, and history of myocardial infarction
* Women auto prescribing rescue medication for dysmenorrheal pain during the study
* Women with a diagnosis of mild dysmenorrhea

Primary outcomes:
measure: Perception of menstrual pain, through the analog verbal scale during three days.
Secondary outcomes:
measure: Quality of life measures during three days.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03556527: Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch
Official title: Long-term Radiographic and Clinic Outcomes of Ulnar Shortening Osteotomy in Patients With Ulnar Impaction Syndrome and Reverse Oblique Sigmoid Notch
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Distal Radioulnar Joint
Keywords: osteotomy
reverse oblique sigmoid notch
ulnar impaction syndrome
ulnar shortening
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vertebral impingement due to wrist ulnar pain, patients who have undergone ulnar shortening surgery.

Brief summary: Patients with ulnar impingement are often coexisting with patients with distal ulnar and ulnar joints with a type of sigmoid notch, and ulnar shortening surgery is one of the most useful and long-lasting treatments for the treatment of ulnar impingement. Some theories point out that if ulnar shortening surgery is performed on patients with distal oblique ulnar incisional ulnar joints, it may lead to accelerated degeneration of distal ulna and ulna articular joints, resulting in worse wrist function. Some theories have pointed out this Instead, surgery will cause joint remodeling and adaptation, but no long-term studies have confirmed this. Therefore, this study plans to evaluate the long-term radiological and clinical outcomes of ulnar shortening surgery performed on patients with preexisting inverted sigmoid notch to determine whether this surgery will cause accelerated distal degeneration of the phalangeal joints or Reshaping of joints and clinically corresponding changes in results.


Eligibility criteria: Inclusion Criteria:

* The distal ulnar joint of the wrist contains a patient with an inverted sigmoid notch of the sacrum, and the ulnar impaction causes ulnar wrist pain. Therefore, the ulnar shortening surgery is accepted.

Exclusion Criteria:

* Patients with diagnosed diseases of immune rheumatism, patients with ischemic necrosis of the carpus, patients with this lesion caused by infection or tumor.

Primary outcomes:
measure: 4-Item Pain intensity Measure
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT01018927: Detecting Early Myocardial Infiltration w/Amyloid & Light Chain Deposition Disease in Multiple Myeloma Subjects
Official title: Role of Cardiac MR (CMR) In Detecting Features of Early Myocardial Infiltration With Amyloid and Light Chain Deposition Disease in Subjects With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Keywords: Cardiac MR (CMR)
Early Myocardial Infiltration
Amyloid
Light Chain Deposition Disease
Multiple Myeloma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Siemens Molecular Imaging
First posted: 2009-11-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Myeloma subjects

Brief summary: The purpose of this study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac amyloidosis is a medical disorder that decreases heart function.

Detailed description: The purpose is to investigate the use of multiple newer CMR techniques for early evaluation of cardiac amyloidosis in multiple myeloma.

Eligibility criteria: Inclusion Criteria:

* All races and ethnic groups
* Male and female ages 18-80 years of age
* History of multiple myeloma
* CMR study for evaluation for cardiac amyloidosis

Exclusion Criteria:

* Pregnant women
* Subject with a metallic or electronic or other device that could be affected by the magnet

Primary outcomes:
measure: This study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma.
timeFrame: The time frame is five additional minutes & three additional images during and MRI.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University or Arkansas for Medical Sciences (UAMS)
state: Arkansas
Study officials:
affiliation: University of Arkansas for Medical Sciences (UAMS)
name: Tarun Pandey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04183127: Exploring Advanced Clinical Practitioner's Experience Developing Clinical Competence and Opinions on Role Identity
Official title: Exploring Advanced Clinical Practitioner's Experience Developing Clinical Competence and Opinions on Role Identity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACP
Nurse's Role
Development, Consensus
Keywords: ACP
Competence
Role identity
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: South Yorkshire and Bassetlaw Faculty of Advanced Clinical Practice
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2019-12-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be NHS staff working in the Yorkshire and Bassetlaw region as ACPs (qualified or in training).

Brief summary: In the United Kingdom, there is an urgent need to reshape the National Health Service (NHS) workforce to equip it to meet the changing demands of the population it serves and deliver the vision set out in the Next Steps on the NHS Five Year Forward View (2017) and recently published NHS Plan (2019). One of the key elements to this is the continuing development, support and utilisation of Advanced Clinical Practice (ACP) roles.

Advanced Clinical Practitioners are educated to Masters Level in clinical practice and assessed as competent in practice using their expert clinical knowledge and skills. They have the freedom and authority to act, making their own decisions in the assessment, diagnosis and treatment of patients.

Although the level of education and assessment of competence are common for ACPs working in all areas, training and supervision varies between primary and secondary care, specialties and sites.

The proposed research will explore ACP experiences of how they develop clinical competence and their opinions on role identity, specifically:

* Factors that have influenced their clinical competency achievements.
* Training experience (clinical and external education opportunities)
* Experience of educational/ clinical supervision and its benefits.
* Self-identified knowledge gaps, with a focus on mental health.
* Future ACP role identity


Eligibility criteria: Inclusion Criteria:

* Qualified ACP or trainee ACP who has completed at least 1 years (FTE) of ACP clinical training
* Currently working in this role within either Primary or Secondary Care and based in South Yorkshire and Bassetlaw.

Exclusion Criteria:

* Unable to communicate in English

Primary outcomes:
measure: Experiences and views of ACPs regarding their experience of developing clinical competence and opinions on role identity [Time frame: 120 minutes]
timeFrame: Jan-Dec 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
Study officials:
References:
Clinical trial NCT00556127: Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Official title: Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
POOR PROGNOSIS
Keywords: Large B-cell Lymphoma
Rituximab
ASCT
Lead sponsor: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Sponsor class: OTHER
First posted: 2007-11-09
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score


Eligibility criteria: Inclusion Criteria:

* previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,
* Primary Mediastinal,
* Follicular grade III b Lymphoma);
* age 18 to 60;
* III-IV Ann Arbor stage;
* 0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS);
* intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI).
* Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease.

Exclusion Criteria:

* HIV,
* hepatitis B or C virus seropositivity;
* CNS involvement at diagnosis;
* abnormal renal, pulmonary and hepatic function;
* left ventricular ejection fraction less than 45%;
* pregnancy.

Primary outcomes:
measure: Failure-free survival
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
city: Aosta
country: Italy
facility: Ospedale Regionale, Divisione di Oncologia,
city: Bari
country: Italy
facility: Azienda Ospedaliera Ospedale Policlinico Consorziale
city: Biella
country: Italy
facility: Osp. degli Infermi
city: Brescia
country: Italy
facility: Spedali Civili
city: Cagliari
country: Italy
facility: Centro Trapianti Midollo Osseo, P.O. Businco
city: Monza
country: Italy
facility: Ospedale S. Gerardo
city: Novara
country: Italy
facility: Osp. maggiore della Carità
city: Perugia
country: Italy
facility: Università degli Studi Policlinico Monteluce
city: Torino
country: Italy
facility: Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo
city: Torino
country: Italy
facility: Istituto per la Ricerca e la Cura del Cancro, Candiolo
city: Torino
country: Italy
facility: Osp. S. Giovanni Battista "Molinette"
city: Torino
country: Italy
facility: Ospedale di Chivasso e Ivrea
city: Torino
country: Italy
facility: Stabilimento Ospedaliero Ciriè -
Study officials:
affiliation: S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -
name: Umberto Vitolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04057027: The Effect of Delayed Cord Clamping and Milking on the Amount of Stem Cells In Preterm
Official title: The Effect of Delayed Cord Clamping and Milking on the Amount of Endogenous Stem Cells In Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Umbilical Cord; Clamping Time
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Turkish Neonatology Society
First posted: 2019-08-14
Enrollment: 90
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. Although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no obvious recommendations for the type of stem cells, dosage or the route of administration the cells. The usage of exogenous stem cells can be difficult due to technical issues in preterm infants.

In the presence of these data, the amount of endogenous stem cells passing through the cord to the infant may show differences in terms of delayed cord clamping and milking. Therefore the aim of this prospective randomized study is to determine the quantity of the stem cells according to delayed cord clamping or cord milking. We also aimed to evaluate the association between the number of stem cells and neonatal morbidities.


Eligibility criteria: Inclusion Criteria:

* Infants born under 32 weeks of gestation
* Accepted to participate with informed consent
* History of healthy pregnancy
* Infants born and will be followed up at the study hospital

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal abnormalities
* Declined to participate

Primary outcomes:
measure: Concentration of Stem cells
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants with Neonatal Morbidities
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
affiliation: Kanuni Sultan Süleyman Eah
name: Seda Yilmaz Semerci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00823927: Alveolar Macrophage Proteomics in HIV-associated Emphysema
Official title: Alveolar Macrophage Proteomics in HIV-associated Emphysema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Emphysema
HIV Infections
Keywords: lung damage
cigarette smoking
HIV-seropositive
emphysema
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-01-16
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: This study is being done to examine lung function changes in individuals with HIV infection and to understand why individuals with HIV have increased risk of lung damage from cigarette smoking.

Detailed description: To delineate the natural history of HIV associated emphysema in the HAART era. To compare the alveolar macrophage proteomes from HIV-seropositive smokers with emphysema to the alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.

To establish whether coinfection with HIV and Hepatitis C results in accelerated lung disease manifested by decrements in forced expiratory volume and carbon monoxide diffusing capacity.

Eligibility criteria: Inclusion Criteria:

* Clinically stable HIV-seropositive (and HIV-seronegative) individuals
* Ages 18 years and older
* Female subjects on no oral contraception with a negative pregnancy test
* Subjects capable of giving written consent

Exclusion Criteria:

* Known medical illness that would preclude bronchoscopy/BAL (e.g. unstable angina, new cardiac arrhythmia). This only pertains to subjects involved in the bronchoscopy phase of the study.
* Pregnant females
* Prisoners

Primary outcomes:
measure: examine the natural history of smoking related lung damage in patients with HIV
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Philip T Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06278727: Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy
Official title: Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Heart Failure
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 270
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: Chinese

Brief summary: This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* ≥2+ FMR
* Receiving GDMT

Exclusion Criteria:

* degenerative mitral regurgitation
* myocardial infarction, percutaneous coronary intervention, coronary bypass grafting surgery, cardiac resynchronization therapy, or stroke within three months prior to this study
* ≥2+ aortic stenosis or regurgitation
* previous surgical mitral valve repair or replacement
* restrictive cardiomyopthy, hypertrophic cardiomyopathy, or constrictive pericarditis
* severe heart failure (NYHA class IV) or left ventricular ejection fraction \< 20%
* symptomatic hypotension affecting GDMT prescription
* severe hepatic or renal insufficiency
* life expectancy \< 12 months
* Pregnancy

Primary outcomes:
measure: FMR regression rate
timeFrame: 3 months
Secondary outcomes:
measure: FMR regression rate
timeFrame: 6 months
measure: composite endpoint
timeFrame: one year
Other outcomes:
Locations:
city: Canton
country: China
facility: Sun-Yatsen Memorial Hospital
state: Guangdong
Study officials:
References: