louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00539799: Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis
Official title: Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: systemic lupus erythematosus
lupus nephritis
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2007-10-05
Enrollment: 15
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: There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.


Eligibility criteria: Inclusion Criteria:

* age at least 18 years
* diagnosis of SLE by ACR criteria
* diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV)
* currently on prednisolone (5 to 20 mg/day)
* in partial or complete remission for at least 3 months

Exclusion Criteria:

* currently pregnant
* in end-stage renal failure
* receiving corticosteroids for an indication other than lupus nephritis

Primary outcomes:
measure: Feasibility (recruitment rate and protocol adherence)
timeFrame: 12 months
Secondary outcomes:
measure: 1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function
timeFrame: 24 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: David Jayne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Michael Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00654199: Ventricular Asynchrony in Cardiac Surgery Patients
Official title: Ventricular Asynchrony in Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Asynchrony in Cardiac Surgery Patients
Keywords: CABG
Ventricular Asynchrony
Normal Sinus Rhythm
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-04-07
Enrollment: 20
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: Inpatient population

Brief summary: The purpose of this study is to:

1. assess the existence of inter-ventricular and intra-ventricular asynchrony in cardiac surgery patients before (PRE) and after cardiopulmonary bypass surgery (POST)
2. investigate whether a modification of usual pacing practices (RA-LV pacing) can achieve inter- and intra-ventricular synchrony and improve heart function, as evaluated by hemodynamic and echocardiographic indexes, when compared with the patient's native rhythm (normal sinus rhythm (SR), or conventional pacing modes


Eligibility criteria: Inclusion Criteria:

* scheduled for cardiac surgery, in normal sinus rhythm

Exclusion Criteria:

* atrial fibrillation, abnormal hearth rhythms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
References:
Clinical trial NCT01514799: Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
Official title: Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Weight Loss
Keywords: gastric bypass
morbid obesity
gut function
weight loss
Lead sponsor: Aleris Obesity
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
Primary purpose: TREATMENT

Brief summary: Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.

The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.

Endpoints are quality of life, gastrointestinal function, and weight development.

Detailed description: Two variations of gastric bypass are compared:

Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.

Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.

FU time is set at 5 years.

Eligibility criteria: Inclusion Criteria:

* BMI 50-65
* Age 18-55
* Conservative attempts at weight reduction failed

Exclusion Criteria:

* Inability to speak and understand the Swedish language
* Residence outside the county of Skåne
* Psychotic disease
* Inflammatory bowel disease

Primary outcomes:
measure: body weight reduction
timeFrame: 5 years
Secondary outcomes:
measure: gastrointestinal function
timeFrame: 5 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Aleris Obesity Skåne
Study officials:
affiliation: Lunds Universitets Diabetescentrum
name: Jan L Hedenbro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nergard BJ, Leifson BG, Gislason H, Hedenbro JL. Effect of different limb lengths on quality of life, eating patterns and gastrointestinal symptoms after Roux-en-Y gastric bypass in superobese patients: randomized study. BJS Open. 2020 Sep 15;4(6):1109-16. doi: 10.1002/bjs5.50334. Online ahead of print.
citation: Nergard BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2.
Clinical trial NCT06064799: GCF miRNA-223 , -214 Levels in Smokers and Nonsmokers Periodontitis Patients
Official title: Expression of microRNA-223 and microRNA-214 in Gingival Crevicular Fluid of Smoker and Nonsmoker Periodontitis Patients, an Observational Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis, Adult
Keywords: Periodontitis
microRNA
smoking
GCF
biofluids
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: individuals were recruited from the outpatient clinic of the department of periodontology

Brief summary: Objective: Periodontitis is a multifactorial disease that affects a wide range of populations. However, its pathogenesis remains unclear. miRNAs are now considered potential diagnostic markers for many inflammatory diseases. Thus, the aim of this study was to assess the expression of microRNA-223(miRNA-223) and microRNA-214 (miRNA-214) in gingival crevicular fluid (GCF) of smoker and nonsmoker with periodontitis.

Materials and Methods: We conducted a prospective study among 42 participants: 14 healthy controls, 14 nonsmoker periodontitis participants, and 14 smoker with periodontitis. Eligibility criteria for inclusion were consecutive adults, aged 20-60 years, with stage III periodontitis grade B/C and no systemic diseases. All consenting participants had gingival crevicular fluid samples collected after diagnosis to assess miRNA-214 and -223 by quantitative real-time polymerase chain reaction assay.


Eligibility criteria: Inclusion Criteria:

* both genders
* age from 20 to 60 years
* no more than 4 teeth lost due to periodontitis
* systemically free participants

Exclusion Criteria:

* Pregnant or lactating female
* participants with a history of an inflammatory or immunological disease
* history of any current medication

Primary outcomes:
measure: assessment of miRNA-223 & -214 levels in GCF samples in all groups
timeFrame: level of miR-223 & -214 are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: faculty of dentistry, Fayoum university
Study officials:
References:
Clinical trial NCT02782299: Shared Decision Making in Older Adults With Distal Radius Fractures
Official title: Shared Decision Making in Older Adults With Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radius Fracture
Keywords: Decision aid
Shared decision making
Older adult patients
Distal radius fracture
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the use of a Decision Aid for shared decision making in older adults with distal radius fractures. The goal is to improve patient decisions making, and improve patient knowledge through the use of a validated decision aid.

Detailed description: Shared decision making has become a increasingly important with the goal of helping patients make decisions that more align with patients values and goals. Decision aids are validated instruments that provide unbiased information and guide patients through questions that allow patients to clarify patients goals.

Older adults with distal radius fractures have increasing evidence of ability to tolerate residual deformity with little to no functional deficits, which has called into question the indications for surgery. In situations where the operative indications are not clear, it is important to engage the patient in the risk and benefits of the decision.

This trial is a prospective trial with two groups, one standard of care, and one with the decision aid.

Eligibility criteria: Inclusion Criteria:

* Distal radius fracture within the past 2 weeks
* Initial appointment seeing Attending
* Age 65+

Exclusion Criteria:

* Non english speaker
* Dementia or other mental limitation preventing ability to complete survey
* Other traumatic injuries in extremity that would affect surgical decision

Primary outcomes:
measure: Decision Conflict Score
timeFrame: Immediate post appointment
Secondary outcomes:
measure: Decision regret scale
timeFrame: 6 weeks and 6 months post appointment
measure: Patient knowledge
timeFrame: immediate post appointment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University-St Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan Calfee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00673699: The Role of Narrow-Band Imaging Endoscopy in Diagnosing Gastric Intestinal Metaplasia
Official title: Observational: Studies in Human Beings Health Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspepsia
Keywords: NBI
gastroscopy
biopsy
intestinal metaplasia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hundred consecutive dyspeptic patients

Brief summary: The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia

Detailed description: To detect intestinal metaplasia which consider pre malignant condition and use a targeting biopsy in case of suspected intestinal metaplasia which allowed us to better follow-up those patients.

Eligibility criteria: Inclusion Criteria:

* Dyspepsia

Exclusion Criteria:

* Pregnancy,
* Upper gastrointestinal bleeding,
* Previous gastric operation,
* Known gastric malignancy'
* Non cooperative patients

Primary outcomes:
measure: To determine if endoscope with NBI can detect intestinal metaplasia
timeFrame: In one week (the time from biopsy till the histology assement)
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Med Ctr
Study officials:
affiliation: Hillel Yaffe Med Ctr
name: Zvi Fireman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirata M, Tanaka S, Oka S, Kaneko I, Yoshida S, Yoshihara M, Chayama K. Evaluation of microvessels in colorectal tumors by narrow band imaging magnification. Gastrointest Endosc. 2007 Nov;66(5):945-52. doi: 10.1016/j.gie.2007.05.053.
Clinical trial NCT03922399: Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
Official title: Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Major Burn Injury in Formosa FunCost Explosion
Keywords: burn scar
laser
ultrapulse
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with major burn scar, after lasers treatment for three years Evaluation tool: questionnaires, sonography, HRV
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Protocol title： Outcome evaluation for burn scar therapy-laser and surgery in patients in Formosa Fun Coast Explosion

Objectives： The goal of this study is to evaluate the effectiveness of both lasers and operations on patients with major burn scar(\>20% TBSA).

Detailed description: Background： There is no gold standard treatment for burn scar treatment, especially for those with major burn scar. In the Formosa Fun-Coast Dust Explosion in 2015, lots of patients with major burn scar suffer from severe pathologic burn scar syndromes. The gold of the study is to evaluate the efficacy of both lasers and operations on major burn scars treatment in the past two years.

Study Design： To take the assessment of scar into account, the investigators use both objectives and subjective methods to evaluate the scar condition. In addition to the scale of scar, the investigators also use both sonography and HRV system to evaluate the expressions of scar. All evaluated tools used are the same as those used in 20160201R and 20160202R. The investigators also used previous records to check the patient's scar condition before these treatments.

Hypothesis： After treatment, scar conditions should get better than before. However, the investigators need more scientific statistics to evaluate the improve rate.

Key words： Burn scar, burn scar syndromes. Scar laser treatment

Eligibility criteria: Inclusion Criteria:

1. \>20% major burn scar, for 3 years
2. patients in Formosa FunCost Explosion
3. offering medical records, including laser and treatments
4. available for questionnaire evaluation and others' evaluation
5. those are willing to receive both sonography on scars and HRV evaluation

Exclusion Criteria:

1. those aren't willing to offer medical records
2. those aren't willing to fill questionnaire
3. those aren't willing to receive sonography on scars

Primary outcomes:
measure: Patients objective questionnaire
timeFrame: Week 0
measure: Burn assessment by researchers
timeFrame: Week 0
Secondary outcomes:
measure: Scar evaluation by sonography (selective)
timeFrame: Week 0
measure: Autonomic nervous system analysis (selective)
timeFrame: Week 0
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho Su Memorial Hospital
Study officials:
References:
Clinical trial NCT00157599: MDA D-Dimer / Recurrent DVT Study
Official title: A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: deep vein thrombosis
DVT
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Currently suspected for recurrent DVT
* Has a prior history of objectively documented DVT or PE

Exclusion Criteria:

* Comorbid condition limiting survival to less than 3 months
* History of hypersensitivity to contrast medium
* Renal dysfunction with a creatinine of \> 150 mcmol/L
* Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
* Pregnancy or lactation
* Symptomatic for pulmonary embolism
* Absence of symptoms within five days prior to presentation
* Participation in another trial precluding the use of the diagnostic algorithm in this study
* Geographically inaccessible for follow-up
* Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment

Primary outcomes:
measure: Suspected DVT during follow-up
measure: Suspected PE during follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Henderson Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General
state: Quebec
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
Study officials:
affiliation: McMaster University
name: Shannon Bates, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06224699: Toothpaste With Sodium Carbonate in Patients With Gingivitis
Official title: Clinical and Antimicrobial Effectiveness of a Toothpaste With Sodium Carbonate in Patients With Gingivitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingivitis
Periodontal Diseases
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals with gingivitis
Primary purpose: TREATMENT

Brief summary: Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in gingivitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing Sodium carbonate 67% and fluoride toothpaste that contains no bicarbonate on patients with gengivitis.

Detailed description: Sodium carbonate has several properties that may be beneficial in the management of bacterial biofilm in both gingivitis and periodontitis patients. The aim of this RCT study is to clinically evaluate the clinical properties of two toothpaste containing sodium carbonate at 67% or no sodium carbonate at 67% at 6-month follow-up in patients with gingivits. The study was designed as a double-blind randomized controlled trial (RCT) with 2 parallel groups of individuals.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with gingivitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Systemic diseases.

Primary outcomes:
measure: Gingival index (1-4)
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico Catania
Study officials:
References: