louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01496794: Endophthalmitis Cultures
Official title: Prospective Surveillance of Patients With Endophthalmitis for Multi-antibiotic Resistance (PROSPER) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endophthalmitis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vanderbilt Eye Institute

Brief summary: The intent of this surveillance study will be to obtain written permission from patients with bacterial endophthalmitis in order to compare sterilization rates of their cultured bacterial isolates to standard therapy (vancomycin and ceftazidime) versus combination therapy with vancomycin, ceftazidime, and moxifloxacin.

Research hypothesis:

1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to "standard therapy" with vancomycin and ceftazidime.
2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing rates of multi-antibiotic resistance.

Detailed description: Adult patients over 18 years of age presenting with endophthalmitis and able to sign consent.

Eligibility criteria: Inclusion Criteria:

* all adult patients age 18 or greater presenting with bacterial endophthalmitis to the Vanderbilt Eye Institute and who grow positive cultures

Exclusion Criteria:

* Patients \< 18 years of age or those patients without positive cultures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Stephen J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032694: Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
Official title: Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Community-Acquired Pneumonia
Keywords: Community-Acquired Pneumonia
Azithromycin SR
Amoxiclav
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Community-Acquired Pneumonia.

Brief summary: To compare compliance between patients with CAP treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of CAP in outpatient clinic practice.


Eligibility criteria: Inclusion Criteria:

* Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:

  1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
  2. Body temperature \>38 degrees C.

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin.
* Amoxiclav according to LPDs, pregnant or lactating women.

Primary outcomes:
measure: Percentage of Participants With Response of Very Convenient or Somewhat Convenient
timeFrame: Days 11-12
Secondary outcomes:
measure: Percent Compliance With the Prescribed Treatment Regimen
timeFrame: Days 11-12
measure: Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
timeFrame: Days 11-12
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06582394: Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
Official title: Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.

Detailed description: The study's main aim is to check virtual reality's effect on conservative treatment in hemiparetic stroke patients.

Eligibility criteria: Inclusion Criteria:

* Both ischemia and hemorrhagic stroke.
* Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.

Exclusion Criteria:

* Patient with the history of previous stroke attacks.
* Brainstem stroke
* Epilepsy
* Severely impaired communication and cognition
* Parkinson's disease and multiple sclerosis
* Other musculoskeletal and psychological disorder

Primary outcomes:
measure: Barthel index
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Depalpur
state: Punjab
Study officials:
References:
Clinical trial NCT02288494: Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
Official title: Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoalbuminemia
Adult ICU Patient
Stewart Approach for Acid Base Disorders
Human Albumin Perfusion
Keywords: hypoalbuminemia
-acid base balance
acid base disorders
critical ill
Stewart approach
human albumin infusion
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with severe hypoalbuminemia

Brief summary: The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion.

Detailed description: Prospective study, for ICU patient with severe hypoalbuminemia \< 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human albumin perfusion (the consensus conference ANAES of 1995 recommands to correct hypoalbuminemia below 20g/L).

Clinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.

Eligibility criteria: Inclusion Criteria:

* serum albuminemia \< 20g/L
* adult ICU patient
* Arterial line

Exclusion Criteria:

* albumin allergy
* pregnancy
* congestive heart failure

Primary outcomes:
measure: changes in pH and independent pH determinants using Stewart approach
timeFrame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
Secondary outcomes:
measure: changes in neurologic parameters
timeFrame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
measure: changes in hemodynamic parameters
timeFrame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
measure: changes in respiratory parameters
timeFrame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Julien PASCAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216694: The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy
Official title: The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oesophageal Cancer
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent oeosphagectomy at the Norfolk and Norwich Hospital between September 2011 to March 2017

Brief summary: A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.

Detailed description: The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.

Eligibility criteria: Inclusion Criteria:

i. male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test

Exclusion Criteria:

i. patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy

Primary outcomes:
measure: All cause postoperative morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Cardiopulmonary complications
timeFrame: 30 days
measure: Non-cardiopulmonary complications
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 90 days
measure: Pneumonia
timeFrame: 30 days
measure: Atrial fibrillation
timeFrame: 30 days
measure: Anastomotic leak
timeFrame: 30 days
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
Study officials:
References:
Clinical trial NCT07000994: Dobutamine During Major Abdominal Surgery
Official title: Dobutamine During Major Abdominal Surgery: A Randomized Pilot Trial (PUSH-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Myocardial Depression
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The PUSH-1 trial is a randomized, single-center pilot trial investigating whether dobutamine administration is feasible in patients having major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Consenting patients ≥18 years scheduled for elective major abdominal surgery under general anesthesia (expected surgery duration ≥ 120 minutes)
* Planned continuous intraarterial blood pressure monitoring using an arterial catheter for clinical indications not related to the trial

Exclusion Criteria:

* Emergency surgery
* Liver or kidney transplantation surgery
* Status of post transplantation of kidney, liver, heart, or lung
* Pregnancy
* Heart rhythms other than sinus rhythm

Primary outcomes:
measure: Feasibility of dobutamine administration
timeFrame: During surgery (incision-to-suture)
Secondary outcomes:
measure: Arterial hypotension
timeFrame: During surgery (incision-to-suture)
measure: Stroke volume index
timeFrame: During surgery (incision-to-suture)
measure: Heart rate
timeFrame: During surgery (incision-to-suture)
measure: Cardiac index
timeFrame: During surgery (incision-to-suture)
measure: Norepinephrine amount
timeFrame: During surgery (incision-to-suture)
Other outcomes:
measure: Severe tachyarrhythmias
timeFrame: During surgery (incision-to-suture)
measure: Blood loss
timeFrame: During surgery (incision-to-suture)
measure: Amount of fluids
timeFrame: During surgery (incision-to-suture)
measure: Red blood cell transfusion
timeFrame: During surgery (incision-to-suture)
measure: Urine output
timeFrame: During surgery (incision-to-suture)
measure: Hospital length of stay
timeFrame: Assessed up to 3 months
measure: Rehospitalization
timeFrame: Within 30 days after surgery
measure: Postoperative complications
timeFrame: Within 30 days after surgery
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Centre Hamburg-Eppendorf
name: Alina Bergholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756494: Ischemic Stroke in Chinese Young Adults
Official title: Some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults: a Protocol for a Case-control Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016. All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.

Brief summary: Stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of \<5% of all ischemic strokes.

Detailed description: Currently, stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of \<5% of all ischemic strokes. Our study aimed to evaluate some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016.
* All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.

Exclusion Criteria:

* The exclusion criteria will include patients with intracranial lesions or cerebrovascular disease (including cerebral venous sinus thrombosis)
* History that have caused sequelae, such as movement disorders, mood disorders, cognitive dysfunction or speech problems; or individuals who are pregnant or breast feeding.
* Patients with serious diseases that are related to the heart, liver, kidney or haematopoietic system will not be allowed to participate.

Primary outcomes:
measure: the incidence of Ischemic Stroke in Chinese Young Adults
timeFrame: every two months, up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01889394: Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision
Official title: Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision: Short-term Results of a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: pilonidal sinus
excision
primary wound closure
limberg flap
Lead sponsor: Kantonsspital Liestal
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.

Detailed description: Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).

Eligibility criteria: Inclusion Criteria:

* indication for excision of pilonidal sinus given

Exclusion Criteria:

* limberg flap not possible for surgical reasons

Primary outcomes:
measure: Inability to work
timeFrame: 1 year
Secondary outcomes:
measure: Pain perioperatively and after 3 weeks
timeFrame: 0 and 3 weeks
measure: Complication rate after 3 weeks
timeFrame: 3 weeks
measure: Patient satisfaction after 3 weeks & 1year
timeFrame: 3 weeks and 1 year
measure: Recurrence rate after 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Gesundheitszentrum Fricktal
state: AG
city: Liestal
country: Switzerland
facility: Kantonsspital Liest
state: BL
city: Visp
country: Switzerland
facility: Spitalzentrum Oberwallis
state: VS
Study officials:
affiliation: Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Liestal, Switzerland, affiliated with the University of Basel
name: Christoph A Maurer, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01199094: Clinical Assessment of Patients With High Bone Mass Due to Mutation in Lrp5
Official title: Clinical Assessment of Patients With High Bone Mass Due to Mutation in Low Density Lipoprotein l Receptor 5
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopetrosis
Keywords: low density lipoprotein receptor 5
high bone mass
autosomal dominant osteopetrosis type I
bone turnover markers
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 38
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case-control study on almost 40 individuals

Brief summary: The aim of the study is to describe patients with a high bone mass phenotype due to a mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age and sex matched controls. Moreover, bone density and microarchitecture as well as markers of bone metabolism are evaluated

Detailed description: Cases and controls are closely matched on age and sex and evaluated cross-sectionally.

Dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT) are used in order to evaluate bone density as well as microarchitecture. Bone turnover markers and body composition are also measured.

Eligibility criteria: Inclusion Criteria:

* Lrp5 mutation/ADOI

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Bone microarchitecture as assessed by high resolution quantitative computed tomography (HR-pQCT)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in bone turnover markers
timeFrame: 12 weeks
measure: Bone mineral density
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Osteoporosis Clinic
Study officials:
affiliation: Odense University Hospital
name: Kim Brixen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frost M, Andersen TE, Yadav V, Brixen K, Karsenty G, Kassem M. Patients with high-bone-mass phenotype owing to Lrp5-T253I mutation have low plasma levels of serotonin. J Bone Miner Res. 2010 Mar;25(3):673-5. doi: 10.1002/jbmr.44.
Clinical trial NCT03305094: The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery
Official title: The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Cardiopulmonary Bypass
Keywords: Remote ischemic preconditioning
Myocardial infarction
Cardiac surgery
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
First posted: 2017-10-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled prospective trial
Primary purpose: TREATMENT

Brief summary: The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Planned isolated aortic valve replacement (stenosis based)
* Age ≥ 18 years

Exclusion Criteria:

* Pregnancy
* Left ventricular dysfunction (LVEF\< 50%)
* Myocardial Infarct (\< 7days)
* Coronary artery disease (documented with \>50% stenosis)
* Coronary artery bypass grafting
* Chronic renal insufficiency (creatinine \>175 mmol/L or dialysis)
* Endocarditis
* Sternotomy redo
* Deep vein thrombosis to the compressed limb
* Emergency procedure
* TAVI procedure
* Planned off pump coronary artery bypass
* MAZE procedure

Primary outcomes:
measure: Change in biochemical markers of myocardial ischemia
timeFrame: 6, 12, 24 and 48 hours post-operatively
Secondary outcomes:
measure: Post-operative complications
timeFrame: post-operatively until 30 days
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Hôpital Laval
state: Quebec
Study officials:
affiliation: University Laval
name: Pierre Voisine, MD
role: PRINCIPAL_INVESTIGATOR
References: