louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06150274: Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy
Official title: Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Heart Disease
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
First posted: 2023-11-29
Enrollment: 20
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 goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.

Detailed description: Background: Rheumatic valvular disease, a chronic sequela of acute rheumatic fever, is a leading cause of cardiovascular mortality in developing countries. The available options of management include surgical treatment and balloon valvulotomy. Among various forms of rheumatic valvular lesions, severe mitral stenosis with favorable morphology can be successfully treated by balloon valvulotomy.

Methods: The study is a randomized controlled trial with intervention in both arms.

The objective of this study is to compare procedural time as a primary end point.

Eligibility criteria: Inclusion Criteria:

* significant mitral stenosis
* low Wilkins score (\< 10)
* mitral regurgitation grade not more than 2

Exclusion Criteria:

* high Wilkins score (\>10)
* unfavourable anatomy
* presence of left appendage thrombus
* non-conclusive periprocedural trans oesophageal echocardiography imaging

Primary outcomes:
measure: Reduction in procedure duration
timeFrame: day 1
Secondary outcomes:
measure: procedure failure
timeFrame: day 1
Other outcomes:
measure: mortality
timeFrame: 30 days
measure: mortality
timeFrame: 3 months
measure: Hospitalization for heart failure
timeFrame: 2 year
measure: Procedure related neurological events
timeFrame: day 1
measure: Procedure related neurological events
timeFrame: 30 days
measure: Vascular complications requiring intervention
timeFrame: day 1
measure: new arrythmia
timeFrame: day 1
measure: new bradyarrythmia
timeFrame: day 1
Locations:
city: Addis Ababa
country: Ethiopia
facility: Tikur Anbessa Specialized Hospital
state: Addis Abeba
Study officials:
affiliation: Haukeland University Hospital, Bergen, Norway
name: Nigussie Bogale, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02640274: Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction.
Official title: Self-management Behaviour After an Individual Nurse-led Counselling Programme for Patients Early Discharged After Myocardial Infarction: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Disease
Myocardial Infarction
Keywords: Practise Patterns, Nurses'
Directive Counseling
Self Care
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The European guidelines of cardiovascular disease prevention recommend treatment modalities, such as lifestyle changes in order to minimize the risk of further cardiac event after a myocardial infarction (MI). However, a considerable gap exists between guidelines and their implementation in clinical practise. Further, less is known about the impact of different interventions on patient's knowledge, skills and confidence necessary for self-management after MI.

Aim: To evaluate and compare the short- and long-term effects of an individual nurse-led counselling programme together with usual care for patients early discharged after MI on self-management behaviour.


Eligibility criteria: Inclusion Criteria:Patients with documented evidence of myocardial infarction during hospitalisation will be considered for inclusion.

* patients over 18 years old
* living at home in the local hospital area after hospital discharge
* able to receive telephone calls, fill in questionnaire and communicate in Norwegian.

Exclusion Criteria:

* cognitive impaired/dementia
* planning for coronary artery bypass graft surgery

Primary outcomes:
measure: Changes in self-management
timeFrame: from baseline to 6 and 12 months of follow-up
Secondary outcomes:
measure: changes in health behaviour
timeFrame: from baseline to 6 and 12 months of follow-up
Other outcomes:
Locations:
city: Namsos
country: Norway
facility: Medical Clinic
Study officials:
affiliation: Leangen Hospital HNT
name: Liv Heidi Skotnes, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04275674: Inflammasome Activation and Cortisol Metabolism in Obese Women With Recurrent Miscarriage
Official title: Dr. Pao-Lin Kuo (Department of Obstetrics and Gynecology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Inflammation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases were referred for 200 women who have experienced at least two consecutive miscarriages are recruited from outpatient clinics of our hospital, including at least 50 obese women

Brief summary: The prevalence of obesity among women of reproductive age is increasing. Obesity represents a chronic low-grade inflammatory state and NLRP3 inflammasome plays a pivotal role in obesity-induced inflammation. Obesity is associated with an increased risk of recurrent miscarriage (RM), but the underlying mechanisms are unclear. Abnormal inflammasome activation was also identified in the endometrium of women who experienced RM. Given inflammasome activation has emerged as common pathophysiology in obesity-related disorder and RM, the investigators wonder whether inflammasome activation occurs in the uterine macrophages of obese women, and result in early reproductive failure.

Detailed description: pending

Eligibility criteria: Inclusion Criteria:

All women have conceived naturally without the aid of assisted reproductive technologies

Exclusion Criteria:

N/A

Primary outcomes:
measure: Validity of inflammatory markers
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, National Cheng Kung University Hospital
name: Pao-Lin Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03831074: Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses
Official title: Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Capsule Opacification
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-02-05
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary.

As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 40 and older
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.)
* Uncontrolled systemic or ocular disease

Primary outcomes:
measure: Posterior capsule opacification
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Katharina Kriechbaum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520974: Effect of an Oral Probiotic Tablet on Oral Bacteria and Clinical Measurements (ProBiora3)
Official title: ProBiora3 Oral Care Probiotics Usage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Health
Lead sponsor: Oragenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2012-01-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if an oral probiotic tablet taken once a day for twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and gum disease in a dentally healthy, young adult population.

Detailed description: There are over 500 types of bacteria in the mouth. Most of these bacteria do not cause disease. However, some mouth bacteria can cause tooth decay and gum disease. The purpose of a probiotic tablet for the mouth is to put known healthy bacteria in the mouth. This study will compare the effect of the probiotic tablet on the levels of harmful or disease causing bacteria in the mouth to a placebo tablet that does not contain any probiotic bacteria.

Eligibility criteria: Inclusion Criteria:

* minimum of 20 teeth, with only a few fillings
* good general health
* willing to use an appropriate method of birth control during the study
* measurable levels of Streptococcus mutans and one or more of the selected periodontal pathogens

Exclusion Criteria:

* chronic or acute illness such as heart disease, diabetes, cancer, hepatitis (liver disease) or HIV positive
* radiation therapy or systemic cancer treatment (chemotherapy)
* require antibiotics for dental treatment
* pregnant or planning to become pregnant during the study period

Primary outcomes:
measure: Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque
timeFrame: 12 weeks
Secondary outcomes:
measure: Breath odor
timeFrame: 12 weeks
measure: Teeth whiteness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center
state: Washington
Study officials:
affiliation: University of Washington
name: Whasun O Chung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zahradnik RT, Magnusson I, Walker C, McDonell E, Hillman CH, Hillman JD. Preliminary assessment of safety and effectiveness in humans of ProBiora3, a probiotic mouthwash. J Appl Microbiol. 2009 Aug;107(2):682-90. doi: 10.1111/j.1365-2672.2009.04243.x. Epub 2009 Mar 30.
Clinical trial NCT04724174: Pancreaticogastrostomy for High-Risk Pancreas
Official title: Double Purse-String Telescoped Pancreaticogastrostomy for High Risk Anastomosis: A 6-Year Single Center Case-Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomosis; Complications
Pancreatic Fistula
Keywords: High Risk Pancreatic Anastomosis
Clinically Relevant Pancreatic Fistula
Pancreaticogastrostomy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with pancreatic tumor who underwent pancreatoduodenectomy

Brief summary: In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.

Detailed description: From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) \>20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).

Eligibility criteria: Inclusion Criteria:

* Pancreatoduodenectomy
* High updated alternative -Fistula Risk Score which was defined \> 20%, as the higher-risk category of the alternative-Fistula Risk Score

Exclusion Criteria:

* Explorative laparotomy
* Hard pancreatic parenchyma

Primary outcomes:
measure: Incidence of clinically relevant post operative pancreatic fistula
timeFrame: at hospital discharge assessed up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Paoli-Calmettes- (IPC)
name: Olivier Turrini, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356574: Long-term Survival After Single-ventricle Palliation
Official title: Long-term Survival After Single-ventricle Palliation: A Swedish Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Defects, Congenital
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Queen Silvia Children's Hospital, Gothenburg, Sweden
name: Lund University Hospital
First posted: 2017-11-29
Enrollment: 800
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.

Brief summary: A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively. Patients born with a functionally single ventricle but not undergoing surgery will not be included. Data regarding preoperative clinical characteristics and operative details will be obtained by medical records review and from The Swedish Registry of Congenital Heart Disease (SWEDCON). Using unique personal identity numbers assigned to all residents of Sweden, data from SWEDCON will be linked with dates of death.


Eligibility criteria: Inclusion Criteria:

* Operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Survival
timeFrame: Until death or end of follow-up (December 31st 2017)
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Pediatric Heart Center, Queen Silvia Children's Hospital
city: Lund
country: Sweden
facility: Pediatric Heart Center, Lund University Hospital
Study officials:
References:
Clinical trial NCT04522674: Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine
Official title: A Pilot Trial Evaluating the Feasibility of Using Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Osteoarthritis of the Lumbar Facet Joint(s) of the Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Platelet-Rich Plasma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
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 investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.


Eligibility criteria: Inclusion Criteria:

* Suspicion of z-joint mediated low back pain
* Pain rating of ≥4/10 on a VAS scale
* Symptom duration of 3 or more months
* Failed conservative therapy (minimum of PT and pain medications)
* Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.

Exclusion Criteria:

* Inability to undergo fluoroscopically guided procedures
* Current pregnancy
* Prior spinal surgery with hardware
* Intolerance to local anesthesia, contrast medium, or blood derivatives
* Local or systemic infection or spinal infection
* Irreversible coagulopathy
* Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week
* Less than 18 years of age
* Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.
* Patients with workman compensation related back pain
* Patients with rheumatic cause of lumbar facet arthritis.
* Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year

Primary outcomes:
measure: Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.
timeFrame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
measure: PROMIS Survey for Low Back Pain Function (PROMIS-29)
timeFrame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
Secondary outcomes:
measure: Length of enrollment of 10 patients and attrition rate
timeFrame: 3 months
measure: Safety as measured by number of subjects with at least one adverse event
timeFrame: 3 months
measure: Degree of improvement in pain and function based on severity of lumbar facet OA.
timeFrame: 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine Spine Center
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Venu R Akuthota, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053074: Nasal High Flow (NHF) in COPD - Effects on Ventilation in Wakefulness
Official title: Nasal High Flow (NHF) Bei COPD - Effekte Auf Die Ventilation im Wachzustand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Nasal High Flow
PaCO2
Tidal Volume
Washout Effect
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
First posted: 2021-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Controlled randomized crossover trial in patients with chronic obstructive respiratory disease (COPD), who are treated with Nasal High Flow (NHF) therapy during wakefulness with a small amount of CO2 added to the inhaled air to keep the patients' PaCO2 stable despite the washout effect. Aim of the study is to examine respiratory rate, tidal volume and work of breathing under NHF without the CO2 washout effect.

Detailed description: In this controlled randomized crossover trial, 10 stable patients with chronic obstructive respiratory disease (COPD) are treated with Nasal High Flow (NHF) therapy during wakefulness. NHF treatment will inevitably result in increased upper airway washout and thus in a slight reduction of PaCO2 of approximately 2 mmHg. For compensation, a small amount of CO2 is added to the inhaled air during this experimental situation, which keeps the patients' PaCO2 stable. This will allow to examine the effects of NHF therapy on respiratory rate, tidal volume and work of breathing, that are not attributable to the CO2 washout effect.

Eligibility criteria: Inclusion Criteria:

* Hospitalized COPD patients GOLD (3 and 4) in stable phase after an acute exacerbation.
* Written informed consent is required for participation.

Exclusion Criteria:

* Acute respiratory failure with clinical instability or respiratory acidosis defined by pH\<7.35
* Severe acute physical illness that does not allow the subject to participate in a clinical trial
* Unable to give consent
* Language, cognitive, or other impairments that may prevent independent completion of questionnaires

Primary outcomes:
measure: Minute Ventilation
timeFrame: up to 1 hour
Secondary outcomes:
measure: Tidal Volume
timeFrame: up to 1 hour
measure: Respiratory Rate
timeFrame: up to 1 hour
measure: Transcutaneous pCO2
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte gGmbH
state: NRW
Study officials:
affiliation: Evang. Kliniken Essen-Mitte gGmbH
name: Georg Nilius, Professor
role: PRINCIPAL_INVESTIGATOR
References: