louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06814756: Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection
Official title: Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prosthetic Joint Infections of Hip
Keywords: Bacteriophage
Periprosthetic joint infection
Phage therapy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Qeen BioTechnologies
First posted: 2025-02-07
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single patient
Primary purpose: TREATMENT

Brief summary: This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage drug product to treat and prevent the recurrence of a Morganella morganii prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of active chronic prosthetic joint infection
* Causative bacteria is susceptible to bacteriophage therapy in vitro
* History of multiple failed antibiotic and surgical interventions

Exclusion Criteria:

* Stage 5 chronic kidney disease
* Cirrhosis
* A known allergy to phage products
* Fever
* Involvement in another clinical trial
* Pregnancy

Primary outcomes:
measure: Clinical response to phage therapy as determined by participant's absence of physical symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events
timeFrame: 29 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre, University of Calgary
Study officials:
References:
Clinical trial NCT00628056: Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
Official title: Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Cardiomyopathy
Keywords: Perhexiline
diabetes
diabetic cardiomyopathy
high energy phosphate kinetics
magnetic resonance spectroscopy
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2008-03-04
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus(WHO definition)
* HbA1C \<9
* No history of chest pain
* No evidence of Coronary Artery Disease or peripheral vascular disease
* Left ventricular ejection fraction over 50%
* No evidence of respiratory disease

Exclusion Criteria:

* Patients \< 16years or who cannot provide informed consent
* Evidence of significant epicardial coronary artery disease
* Evidence of peripheral vascular disease
* Abnormal liver function tests
* Clinically apparent peripheral neuropathy
* Severe chronic renal failure (creatinine \>250) or diabetic nephropathy
* Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
* Patients on statin therapy for primary dyslipidemia.
* Patients with recurrent hypoglycaemia
* Women of child bearing age who are not using effective contraception (or if pregnancy test positive)

Primary outcomes:
measure: The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: Westmidlands
Study officials:
affiliation: University of Birmingham
name: Michael Frenneaux, MD FRCP FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01844037: OneShot Renal Denervation Registry
Official title: Renal Denervation Using the OneShot Ablation System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Heart Failure
Diabetes Mellitus
Sleep Apnea
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.


Eligibility criteria: Inclusion Criteria:

* Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
* Patient is ≥ 18 years old.
* Patient provided written informed consent.

Exclusion Criteria:

* Patients who are pregnant, nursing, or planning to become pregnant.
* Patients who have only one functioning kidney.
* Allergy to contrast or known hypersensitivity to device materials
* Patients with renal arteries \< 4 mm in diameter.
* Patients whose life expectancy is less than the planned period of study involvement.

Primary outcomes:
measure: Change in office systolic blood pressure (SBP) from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.
timeFrame: One Week
measure: Change in office diastolic blood pressure (DBP)
timeFrame: 6 and 12 months post procedure
measure: Change in office SBP
timeFrame: 6 and 12 months post procedure
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Hospital San Raffaele
Study officials:
References:
Clinical trial NCT06332937: Breast Reconstruction
Official title: Complication Following Postmastectomy Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Implant; Complications
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 5000
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: Immediate implant-based breast reconstruction following mastectomy

Brief summary: Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction


Eligibility criteria: Inclusion Criteria:

* Patients who received implant-based breast reconstruction following mastectomy between 2015 and 2020 in Seoul National University Hospital

Exclusion Criteria:

* Patients who received flap surgery simultaneously with implant insertion

Primary outcomes:
measure: Infection
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01728415: Effects of High-intensity Interval Training in Patients in Hemodialysis
Official title: Effects of High-intensity Interval Training in Patients in Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Renal Disease
Keywords: Exercise
Hemodialysis
Physical therapy
high-intensity
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2012-11-19
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of high intensity interval training compared to moderate exercise training and a control group on exercise capacity and quality of life in patients with end stage renal disease on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Patients on hemodialysis ≥ 3 months

Exclusion Criteria:

* Acute infection
* Systolic BP\>180 mmHG or diabolic BP\>105 mmHG
* Unstable angina pectoris
* Serious rhythm disturbances
* Hyperkalemic (\> 6 mmol/L),
* Unstable diabetes mellitus
* Wheelchair
* Dialyses access on lower extremities
* Haemoglobin \< 9 g/dl

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: baseline, 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
state: Postboks 4950 Nydalen
Study officials:
References:
citation: Nilsson BB, Bunaes-Naess H, Edvardsen E, Stenehjem AE. High-intensity interval training in haemodialysis patients: a pilot randomised controlled trial. BMJ Open Sport Exerc Med. 2019 Nov 10;5(1):e000617. doi: 10.1136/bmjsem-2019-000617. eCollection 2019.
Clinical trial NCT00410215: A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
Official title: A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 315
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: Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate the preparation. Pico-salax has recently been introduced in Canada as an alternative agent and is being used more and more widely despite an almost complete lack of clinical data supporting efficacy and safety. This study will establish the relative efficacy and patient tolerability of this agent and its safety profile. This is a very important, practical issue which continues to challenge gastroenterologists, surgeons, internists, family doctors and thousands of their patients in Canada on a daily basis.

Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.

Detailed description: This is a randomized, investigator blinded clinical trial assessing the cleansing efficacy (using the Ottawa Bowel Preparation scale) and tolerance of three bowel cleansing regimens, two of which involve pico-salax.

Eligibility criteria: Inclusion Criteria:

* Consecutive male and non-pregnant female patients
* ≥ 18 years old
* who require outpatient colonoscopy will be approached to consider participation in the study.

Exclusion Criteria:

* ileus or bowel obstruction;
* previous colorectal surgery;
* renal impairment;
* pregnancy;
* recent (\<6 months) myocardial infarction or unstable angina.

Primary outcomes:
measure: Ottawa Bowel Preparation scale
timeFrame: At Colonoscopy.
Secondary outcomes:
measure: Tolerance-Likert scale questionnaire
timeFrame: After Preparation.
measure: Safety Hemodynamics, Blood Chemistry
timeFrame: After Preparation.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence C Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991015: Goals of Care Discussions for Hospitalized Patients With Advanced Cancer
Official title: Gender Differences in Inpatient Goals of Care Discussions in Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-11-25
Enrollment: 43
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: Patients must be hospitalized at Northwestern Memorial Hospital and be having a goals of care discussion with their physician. In addition, eligible patients must be greater than the age of 18 years, speak English fluently, be able to physically and cognitively complete the informed consent process, and have metastatic cancer that has progressed despite treatment.

Brief summary: The goal of this study is to better understand gender differences in end-of-life communication between physicians and patients with advanced cancer in the hospital.


Eligibility criteria: Inclusion Criteria:

* English speaking, have metastatic cancer that has progressed despite treatment

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: Quality of end-of-life communication
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Rashmi K Sharma, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777815: Safety and Performance Study of the NeoChord Device
Official title: Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: NeoChord
DS1000
Mitral Valve
Mitral Valve Regurgitation
MR
Mitral Valve Repair
Mitral Valve Prolapse
Artificial Chordae
Lead sponsor: NeoChord
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 and \< 80 years
* Candidate for surgical mitral valve repair or replacement
* Isolated posterior leaflet prolapse
* Moderate to severe or severe mitral valve regurgitation that is degenerative in nature

Exclusion Criteria:

* Anterior or bi-leaflet prolapse
* Functional or ischemic MR
* NYHA Class IV
* Complex mechanism of MR (leaflet perforation, etc)
* Significant tethering of leaflets toward LV apex
* Severely calcified mitral valve annulus
* Inflammatory valve disease
* Severe LV dilation

Primary outcomes:
measure: Procedural Success
timeFrame: 30 days
Secondary outcomes:
measure: Procedural Safety
timeFrame: 30 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Neustadt
country: Germany
facility: Herz und Gefäß-Klinik
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Munich
country: Germany
facility: Klinik für Herz-und Gefäßchirurgie
city: Milan
country: Italy
facility: San Raffaele
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista "Molinette"
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto ligonines Santariskiu
Study officials:
affiliation: Herz und Gefäß-Klinik
name: Anno Diegeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seeburger J, Rinaldi M, Nielsen SL, Salizzoni S, Lange R, Schoenburg M, Alfieri O, Borger MA, Mohr FW, Aidietis A. Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept. J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24.
Clinical trial NCT00255515: Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia
Official title: An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
* Clinically stable and in an outpatient setting before entering the study (visit 1).

Exclusion Criteria:

* Use of clozapine and quetiapine within two months prior to visit 1.
* If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.

Primary outcomes:
measure: Social outcome measured by Strauss-Carpenter scale
timeFrame: change from baseline to last visit and end of CRT
Secondary outcomes:
measure: Change in PANSS total score
timeFrame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
measure: Change in PANSS positive, negative and general psychopathology symptom subscales
timeFrame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit
measure: Change in cognition as measured by a Cognitive Battery of Tests
timeFrame: change from baseline to end of CRT and from baseline to last visit
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Hisingsbacka
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Lidingö
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Norsborg
country: Sweden
facility: Research Site
city: Nyköping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
Study officials:
affiliation: Västerås
name: Leif Lindström,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004815: Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Werner's Syndrome
Keywords: Werner's syndrome
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: University of Texas
First posted: 2000-02-25
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werner's syndrome and osteoporosis.

Detailed description: PROTOCOL OUTLINE: The patient receives subcutaneous recombinant human insulin-like growth factor 1 daily for 7 months. The dose is adjusted according to the serum hormone level and biological markers of bone turnover.

Concurrent therapy includes a metabolic diet, calcium citrate, and estradiol.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Werner's syndrome with osteoporosis and low serum insulin-like growth factor 1 level Patient treated on protocol 04-9215300 "Metabolic and Skeletal Effects of Exogenous Recombinant Human Insulin-Like Growth Factor"

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Craig D. Rubin
role: STUDY_CHAIR
References: