louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00247910: Behavioural Treatment of Hypertension
Official title: Behavioural Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension, ambulatory BP, office resting BP, hydrochlorothiazide, stress reduction, self-help, psychotherapy, efficacy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine whether psychological therapy (self-help or individualized intense stress management) is different than a single drug treatment in terms of their effectiveness for lowering blood pressure.


Eligibility criteria: Inclusion Criteria:

* must be at least 19 years of age
* subjects can be male or female
* subjects must have an average resting blood pressure of \>140 systolic pressure an/ or \>90 diastolic pressure off anti-hypertensive medication

Exclusion Criteria:

* must not be on more than 2 blood pressure lowering drugs
* must not have known or suspected of having secondary hypertension on initial examination
* must not be pregnant or anticipating pregnancy during study period
* must not have history of allergy, hypersensitivity or intolerance to diuretics
* must not have medical condition that may result in an unacceptable risk of complications due to uncontrolled hypertension during time period of study
* must not have average resting BP readings that exceed 190 systolic, or 115 diastolic, or have two consecutive readings of 180 systolic or 110 diastolic

Primary outcomes:
measure: Day time ambulatory BP
timeFrame: See description
Secondary outcomes:
measure: 24 hour ambulatory BP, and office resting BP
timeFrame: See description
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Wolfgang Linden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04209010: Immediate Breast Reconstruction With Acellular Dermal Matrix
Official title: Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Carcinoma in Situ
Mammaplasty
Acellular Dermis
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: The Korning foundation
name: Foundation of the Kjaersgaard Family
name: King Christian X foundation
name: Foundation of architect Holger Hjortenberg
name: LifeCell Corporation (Branchburg, NJ, USA)
First posted: 2019-12-23
Enrollment: 44
Sex: FEMALE
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: Eligible patients were all women admitted for immediate, implant-based breast reconstruction following skin-sparing mastectomy at the Department of Plastic and Breast Surgery, Aarhus University Hospital, Denmark from September 2010 to January 2014.

Brief summary: The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.


Eligibility criteria: Inclusion Criteria:

* Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
* Mastectomy weight ≤ 600 g
* Patient older than 18 years
* Ability to complete the study questionnaire
* Only for the two-stage group no later than 2 years and 4 months from breast reconstruction

Exclusion Criteria:

- smokers

Primary outcomes:
measure: Postoperative complications
timeFrame: 3 months
measure: Postoperative complications
timeFrame: 3 months
Secondary outcomes:
measure: Patient assessed satisfaction with aesthetic result
timeFrame: 2 years
measure: Investigator assessed satisfaction with aesthetic result
timeFrame: 2 years
measure: Patient reported outcome measures
timeFrame: 2 years
measure: Cost
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital, Aarhus University, Denmark
name: Mette Eline Brunbjerg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunbjerg ME, Jensen TB, Overgaard J, Christiansen P, Damsgaard TE. Comparison of one-stage direct-to-implant with acellular dermal matrix and two-stage immediate implant-based breast reconstruction-a cohort study. Gland Surg. 2021 Jan;10(1):207-218. doi: 10.21037/gs-20-581.
Clinical trial NCT06842810: Fibroblast Growth Factor 21 in Systemic Lupus Erythematosus
Official title: Evaluation of Serum Fibroblast Growth Factor 21 Levels in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Systemic Lupus Erthematosus
Keywords: SLE
Fibroblast growth factor 21
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 95
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: * 50 SLE patients with lupus nephritis
* 25 SLE patients without lupus nephritis
* 20 healthy controls

Brief summary: Systemic lupus erythematosus (SLE) is a chronic disorder characterized by profound immune and metabolic disturbances. It emerges due to a complex interplay of genetic and environmental factors. Alteration in immune cell metabolism is another feature of SLE. Mitochondria, serving as the main regulator of cell metabolism, exhibits pronounced dysfunction in SLE patients.

Kidneys are among the most frequently affected organs in SLE, with 30-40% of patients developing lupus nephritis (LN) over the course of their disease. LN patients exhibit varying degrees of renal injury, significantly reducing their survival rate. Usually, LN originates from abnormal immune responses, resulting in the formation and deposition of immune complexes in the kidneys, triggering the release of pro-inflammatory cytokines, cell adhesion molecules, and chemokines, thereby inducing inflammation. Extensive glomerular mitochondrial damage has been reported in kidney biopsies obtained from patients with LN. So, identifying peripheral immune markers of mitochondrial dysfunction may be beneficial in assessing SLE activity and the extent of organ involvement.

Among these markers, fibroblast growth factor 21 (FGF-21) is one of the circulating immune markers which is expressed in response to mitochondrial stress. FGF-21 is known to be primarily produced in the liver, but under stress conditions, it can also be produced by the kidneys. In addition, it correlates with the degree of renal impairment in various kidney diseases.


Eligibility criteria: Inclusion Criteria:

- 1- Patients who will be diagnosed as SLE according to the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus.

2-SLE Patients \> 18 years old.

Exclusion Criteria:

* 1-SLE Patients \< 18 years old. 2- Patients with other rheumatic diseases or overlap syndromes. 3- Patients with malignancy. 4- Patients with liver diseases.

Primary outcomes:
measure: Assessment of serum FGF21 level in SLE patients with and without nephritis in comparison to healthy controls.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05900310: Linus Health CDS Retrospective Validation Study
Official title: Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Impairment
Motor Disorders
Dementia
Lead sponsor: Linus Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 55 and above, with or without cognitive symptoms, across all the healthcare organizations that Linus Health has been deployed in.

Brief summary: This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE.

Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.


Eligibility criteria: Inclusion Criteria:

* Age 55 and above
* Has already completed the Linus Health CCE

Exclusion Criteria:

* Incomplete CCEs
* CCEs that are flagged as "Requires clinician review"

Primary outcomes:
measure: Median rating of each CDS recommendation
timeFrame: 2-3 weeks
Secondary outcomes:
measure: Intraclass correlation coefficient (ICC) of each rating
timeFrame: 2-3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Linus Health, Inc.
state: Massachusetts
Study officials:
affiliation: Linus Health
name: Ali Jannati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131310: Managment of Cardiorespiratory Arrest
Official title: Managment of Cardiorespiratory Arrest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assess the Quality Ofmanagement of Children With Cardiorespiratory Arrest in Assuit University Children Hospital According to the( A H A)Guidelines
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: the present study is to assess the quality of care and management of children with cardiorespiratory arrest admitted to assuit university children hospital according to the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) (2015) and Emergency Cardiovascular Care (ECC) of Pediatric and Neonatal Patients searching for defect,obstacles,or need to improve health service. CPR will be done based on American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) (2015) and Emergency Cardiovascular Care (ECC) of Pediatric and Neonatal Patients.

Brief summary: CPR will be done based on American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.

Detailed description: the present study is to assess the quality of care and management of children with cardiorespiratory arrest admitted to assuit university children hospital according to the American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients searching for defect,obstacles,or need to improve health service.

CPR will be done based on American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.

Eligibility criteria: Inclusion Criteria:

* Seriously ill Patients who will be admitted with or will be developed cardiorespiratory arrest and undergo CPR.

Age2 month to 18 years. Both sex.

Exclusion Criteria:

* Traumatic cause (blunt, penetrating, burn) of arrest

Primary outcomes:
measure: managment of cardiorespiratory arrest in children
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05436210: Postural and Anthropometric Properties of Foot and Ankle of Patients With DMD
Official title: The Impact of Postural and Anthropometric Properties of Foot and Ankle on Physical Performance and Ambulation of Patients With Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Ambulation Difficulty
Posture Disorders in Children
Ambulation Disorder, Neurologic
Keywords: Duchenne Muscular Dystrophy
foot posture
performance
ambulation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Suleyman Demirel University
First posted: 2022-06-29
Enrollment: 48
Sex: MALE
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulated Duchenne Muscular Dystrophy patients aged of 5-18 years

Brief summary: Introduction: Progressive muscle weakness, joint contractures and body alignment disorders seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure of the patients.

Objective: The aim of this study is to examine the relationship between foot posture, performance and ambulation in patients with DMD.

Method: The patient with ambulatory DMD will be included in the study. The foot postures of the patients will be evaluated with the Foot Posture Index. Relationships between the Foot Posture Index and performance tests (6 minute walk test, timed performance tests (10m walking, Gower's, climb/descend 4 stair)) and the North Star Ambulation Evaluation, an ambulation evaluation, will be examined.


Eligibility criteria: Inclusion Criteria:

1.5 to 18 years old 2. Not to have lost his ambulation 3. Agreeing to participate in the research voluntarily

Exclusion Criteria:

1. Having serious mental and psychological problems,
2. Having lost his ambulation
3. Inability to cooperate adequately with the physiotherapist who made the evaluations,
4. Any injury and/or surgery to the lower extremities in the last 6 months.

Primary outcomes:
measure: foot posture index - 6
timeFrame: 10 minutes
measure: 6 min walk test (6MWT)
timeFrame: 6 minutes
measure: north star ambulation assessment
timeFrame: 10 minutes
measure: timed performance test
timeFrame: ten minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Güllü Aydın Yağcıoğlu
Study officials:
References:
Clinical trial NCT02069210: The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
Official title: The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection After Transfusion
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Wolf-Schleinzer-Stiftung
First posted: 2014-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent elective spine surgery

Brief summary: The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 - \< 60 years
* Patients underwent elective spine surgery
* ASA classification 1-3

Exclusion Criteria:

* Patients who have the concomitant condition
* Cancer
* History of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament.
* Serum creatinine \> 1.5 mg/dL
* Stroke, neurologic and mental deficits, epilepsy
* General or local infection (site of surgery),
* Coagulation disorders.
* Intraoperative massive bleeding
* Infection of the spine
* Rheumatoid arthritis
* Patients who had either of the following drug (aspirin, methotrexate, cyclosporine, qualaquin)

Primary outcomes:
measure: Immunologic parameters
timeFrame: 7 days
Secondary outcomes:
measure: To determine the effect of red cell transfusion on clinical relevant outcome parameters, such as myocardial infarction, infection rate, and length of hospital stay.
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sirilak Suksompong
Study officials:
affiliation: Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University
name: Sirilak Suksompong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01948310: Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Official title: Effects of Ranolazine and Exercise on Daily Physical Activity Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Stable Angina
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2013-09-23
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Documented CAD diagnosis
* Stable angina ≥ 3 months

Exclusion Criteria:

* Class III or IV heart failure
* Myocardial Infarction or coronary revascularization procedure within 2 months
* QT interval \> 500ms or prescribed medication known to prolong the QTc interval
* Contraindicated Medications
* Metformin dose \> 1700mg/day
* Class Ia, Ic and III anti-arrhythmics
* CYP3A inhibitors
* Simvastatin \>20mg/day
* Severe renal disease (\< 30ml/min creatinine clearance)
* Currently on dialysis
* Lack of transportation to the exercise and testing facilities
* Implanted pacemaker that is not rate responsive

Primary outcomes:
measure: Change in Peak Oxygen Consumption (VO2 Max)
timeFrame: Baseline, Week 2 and Week 14
Secondary outcomes:
measure: Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire
timeFrame: Baseline, Week 2 and Week 14
measure: Change in Total Daily Energy Expenditure
timeFrame: Week 1, Week 4 and Week 14
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Living
state: North Carolina
Study officials:
affiliation: Duke University
name: William E Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687410: Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs
Official title: Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Neoplasm
Pancreas Cancer
Keywords: fine needle aspiration
fine needle biopsy
solid pancreatic lesion
pancreatic neoplasm
pancreatic cancer
endoscopic ultrasound
EUS-FNA
EUS-FNB
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Gastro Unit, Endoscopy Section, Hvidovre Hospital, Denmark
name: Department of Gastroenterology, Ponderas Academic Hospital Bucharest, Romania
name: Endoscopy Unit, Odense Hospital, Denmark
First posted: 2020-12-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.

Exclusion Criteria:

* Patients with uncorrected coagulopathies (INR \>1.5 or platelet count \<50,000) or patients treated with anticoagulants that cannot be discontinued.
* Pregnant or lactating females.
* Interposed, large vessels between the transducer and the target lesion.

Primary outcomes:
measure: Amount of tissue micro-fragments
timeFrame: 1 month
measure: Diagnostic tissue area
timeFrame: 1 month
measure: Total tissue area
timeFrame: 1 month
Secondary outcomes:
measure: Diagnostic yield
timeFrame: 1 month
measure: Diagnostic performance
timeFrame: 12 month
measure: Adverse event rate
timeFrame: 1 month
measure: Mean DNA concentration
timeFrame: 6 months
measure: Suitability for molecular analyses
timeFrame: 6 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Gastro Unit, Division of Endoscopy
state: Danmark
Study officials:
References:
Clinical trial NCT01589510: A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 419
Sex: ALL
Minimum age (years): 16
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 POAG and OHT

Brief summary: A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG or OHT
* Prescribed Lumigan® 0.01%

Exclusion Criteria:

* None

Primary outcomes:
measure: Intraocular Pressure (IOP) at Baseline
timeFrame: Baseline
measure: IOP at Week 14
timeFrame: Week 14
Secondary outcomes:
measure: Physician Evaluation of IOP Lowering in the Study Eye(s)
timeFrame: Week 14
measure: Patient Assessment of Tolerability on a 4-Point Scale
timeFrame: Week 14
measure: Physician Assessment of Tolerability on a 4-Point Scale
timeFrame: Week 14
measure: Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment
timeFrame: 14 Weeks
measure: Percentage of Patients Who Continue Lumigan® 0.01% Treatment
timeFrame: Week 14
measure: Physician Assessment of Patient Compliance Compared to Previous Therapy
timeFrame: Week 14
Other outcomes:
Locations:
city: Vienna
country: Austria
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: