louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03065777: Postoperative Pain Associated With Three Endodontic Rotary Systems
Official title: Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pulpitis
Keywords: single file.
ONE ENDO.
F6 SkyTaper.
ProTaper Universal.
irreversible pulpitis.
postoperative pain.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of postoperative pain after root canal treatment using different rotary systems.

Detailed description: Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.

Eligibility criteria: Inclusion Criteria:

* Systematically healthy patients,
* maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.

Exclusion Criteria:

* Non-vital teeth,
* teeth with apical periodontitis,
* teeth requiring endodontic retreatment,
* root resorption,
* immature / open apex,
* root canals with radiographic evidence of calcification,
* presence of more than one symptomatic tooth in the same quadrant,
* pregnancy,
* medically compromised patients,
* patients receiving medication for chronic pain,
* patients who have taken analgesics in the last 12 hours before treatment.
* teeth that have initial apical size more than 20,
* teeth that could not be treated in a single session,
* if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.

Primary outcomes:
measure: postoperative pain
timeFrame: up to 72 hours after endodontic treatment
Secondary outcomes:
measure: Number of analgesics consumed
timeFrame: up to 72 hours after endodontic treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine - Cairo University
Study officials:
affiliation: Faculty of Oral and Dental Medicine - Cairo University
name: Ola A. Hafez, MD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Oral and Dental Medicine - Cairo University
name: Alaa El-Din H. Diab, Professor
role: STUDY_CHAIR
affiliation: Faculty of Oral and Dental Medicine - Cairo University
name: Kareem G. Abd El-Kader, Assistant Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04915677: Edentulous Sites Augmented With Collagen Matrix or CTG
Official title: Volumetric Changes at Edentulous Sites Augmented With Collagen Matrix or Connective Tissue Graft: a Randomized Clinical Trial With 6 Months Follow up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Alveolar Ridge
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ridge deformities can complicate prosthetic rehabilitation, especially in situations where optimal esthetic outcomes are desired. Simpler, less invasive and predictable treatments are needed in order to obtain soft tissue augmentation at edentulous ridges. Autogenous subepithelial connective tissue graft (SCTG) has always been regarded as the treatment of choice, but heterologous volume stable collagen matrix (VCMX) is emerging as a reliable alternative. The principal aim of the present RCT will be to compare the volumetric buccal soft tissue changes at edentulous areas after augmentation procedure using VCMX or SCTG. Parameters related to periodontal health at adjacent teeth and patient reported outcomes (PROMs) will be also assessed as secondary outcomes. Proving the non- inferiority of VCMX compared to SCTG would provide the specialists and general clinicians with an easier, less invasive and better tolerated technique for soft tissue augmentation at edentulous ridges and for improving aesthetic and cleansability of the prosthetic rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Intercalated mono-edentulous area ridge defects to be rehabilitated with fixed partial bridge
* At least 18 years old
* At least 6 months from tooth extraction at the study area.

Exclusion Criteria:

* Systemic diseases which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus);
* Smoking ≥ 10 cigarettes a day;
* Pregnant or nursing women;
* Chronic use of corticosteroids or other anti-inflammatory or immune-modulator drugs;
* Patients who need use of medications affecting bone metabolism or oral mucosa;
* Presence of a congruous FDP at the edentulous area;
* History of soft tissue augmentation surgery in the study area;
* Active periodontitis
* Uncompliant patients

Primary outcomes:
measure: Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
timeFrame: 6 months
Secondary outcomes:
measure: Change in Probing Pocket Depth (PD) at adjacent teeth (0-15 mm with higher values representing worse outcomes)
timeFrame: 6 months
measure: Mucosal recession at adjacent sites (0-15 mm with higher values indicating worse outcomes)
timeFrame: 6 months
measure: Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
Study officials:
References:
Clinical trial NCT05748977: Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients
Official title: Inhaled Fenotereol,Ipratroium Plus Beclomethasone Versus Salmeterol,Tiotropium Plus Fluticasone in Frequent Excerbator COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Copd
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 80
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: Chronic obstructive pulmonary disease is heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive ,airflow obstruction.

There are network meta analysis to compare the efficacy and safety of short acting bronchodilators Vs long acting agents in treatment of COPD

Detailed description: Aim of the work1.To compare efficacy of short acting beta 2 agonists ,short acting antimuscrinic agents and beclomethasone versus long acting beta 2 agonist,short acting antimuscurnic agents and fluticasone.- Type of the study: This study is a randomized controlled trail 2.4. 2- Study Setting: Present study will be conducted in chest outpatient clinic Chest department Assiut University hospital 2.4. 3- Study subjects: Frequent exacerbator COPD patients Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group).

Main outcome variable is difference in dyspnoea scores in frequent exacerbator COPD patients receiving long-acting steroids vs. short acting treatment. Based on previous systematic review we expected to find significant improvement in long-acting treatment group (large effect size). Data will be collected through: patients diagnosed COPD by different investigations (history, examinations spirometry) have recurrent exacerbations, some patients receiving short acting beta 2 agonists, short acting anti-muscurnic agents and beclomethasone versus long acting agents and fluticasone then all patients followed using dyspnea scores, CCQ, saint George questionnaire which assess heath related quality of life.

Eligibility criteria: Inclusion Criteria:

* All frequent exacerabator copd patients

Exclusion Criteria:

* patients less than 18

Primary outcomes:
measure: to assess improvement of symptoms mainly dyspnea
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Nermen Mohammed Abuelkassem
Study officials:
affiliation: MD
name: nermen M abuelkassem, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750177: Sedentary Screen Time Activities on Food Intake
Official title: Effect of Sedentary Screen Time Activities Before a Meal on Food Intake in Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exogenous Obesity
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Mount Saint Vincent University
First posted: 2012-12-17
Enrollment: 31
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose is to investigate the effect of sedentary screen time activities on food intake and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes increases subjective appetite and food intake at the next meal. Food intake will be measured immediately following screen-time exposure, and subjective appetite measured throughout the study period at 0, 15, 30, 45 and 75 minutes.


Eligibility criteria: Inclusion Criteria:

* healthy girls with no emotional, behavioral or learning problems

Exclusion Criteria:

* boys

Primary outcomes:
measure: Food Intake (kcal)
timeFrame: measured at 45 minutes after the treatment
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0-75 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Department of Applied Human Nutrition
state: Nova Scotia
city: Toronto
country: Canada
facility: School of Nutrition, Ryerson University
state: Ontario
Study officials:
References:
citation: Totosy de Zepetnek JO, Pollard D, Welch JM, Rossiter M, Faghih S, Bellissimo N. Pre-meal screen-time activities increase subjective emotions, but not food intake in young girls. Appetite. 2017 Apr 1;111:32-37. doi: 10.1016/j.appet.2016.12.025. Epub 2016 Dec 21.
Clinical trial NCT02329145: Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
Official title: Renal Denervation in Patients With Chronic Heart Failure and Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Keywords: renal denervation
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2014-12-31
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: Chronic heart failure is becoming more and more common disease and activation of sympathetic nervous system plays a crucial role in its development. There is some data allowing to suspect that one of the new treatment methods- renal denervation, also in patients with chronic heart failure may lead to decrease of systemic activity sympathetic nervous system and, as a consequence, to decrease of disease progression. The research hypothesis is whether renal denervation in case of symptomatic heart failure, even the optimal treatment therapy is used (including resynchronization therapy), is contributing to the improvement in parameters of neurohormonal activation, hemodynamics and clinical patient status. The aim of the study is to obtain a new knowledge concerning renal denervation in chronic heart failure, So far only very limited data- mostly case reports- are available in this study area.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 year
2. heart failure patients NYHA Class II - IV
3. implanted resynchronization pacemaker according to current european guidelines at least 6 months earlier
4. symptoms of heart failure even on optimal pharmacological therapy including resynchronization therapy (lack of improvement within dyspnoea and exercise tolerance after the procedure)
5. left ventricular ejection function ≤ 35%
6. glomerular filtration rate (eGFR according to MDRD formula ≥ 30 mL/min/1.73m2)
7. patient informed consent for participation in the study

Exclusion Criteria:

1. renal artery anatomy not eligible for denervation (at least 4 mm diameter, 20 mm in length)
2. history of prior renal artery intervention
3. single functioning kidney
4. clinic systolic BP \< 110mmHg
5. pregnancy
6. acute coronary syndrome or cerebrovascular event within last 3 months
7. serious medical conditions which may adversely affect safety- clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders (thrombocytopenia, hemophilia, or significant anemia)

Primary outcomes:
measure: Number of hospitalizations due to heart failure worsening.
timeFrame: one year
measure: Change in NYHA class.
timeFrame: one year
measure: Change in 6 minute walk test distance.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Ist Department of Cardiology, Interventional Electrocardiology and Hypertension
state: Malopolska
Study officials:
References:
Clinical trial NCT06014645: Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery
Official title: The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Disease
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted with volunteer patients who are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. The control group will receive post-operative exercise training and will be encouraged to move. The study group will receive a core stabilization program in addition to education via telerehabilitation. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Having undergone lumbar decompression surgery without fusion and 2 months of history
* Participate in all necessary follow-up assessments
* Being between 18-65 years old
* Understand simple commands
* Signing the consent form

Exclusion Criteria:

* Presence of a previous spinal fusion surgery
* Presence of malignancy
* Having undergone spine surgery before
* Have any other orthopedic or neurological problem that may affect treatment and assessments
* Situations that prevent communication
* Lack of cooperation during the study

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 8 weeks
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Change from Baseline TSK at 8 weeks
measure: Pain Catastrophising Scale (PCS)
timeFrame: Change from Baseline PCS at 8 weeks
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Change from Baseline RMDQ at 8 weeks
measure: Lumbar region flexibility in flexion extension lateral flexion directions
timeFrame: Change from Baseline flexibilty tests at 8 weeks
measure: Lumbar region endurance flexor and extensor
timeFrame: Change from Baseline endurance tests at 8 weeks
measure: Functional Reach Test (FRT)
timeFrame: Change from Baseline FRT at 8 weeks
measure: Stair Climbing Test (SCT)
timeFrame: Change from Baseline SCT at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Çekirge State Hospital
state: Osmangazi
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: STUDY_DIRECTOR
affiliation: Bursa Çekirge State Hospital
name: Mustafa Yalçın, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Baki Umut Tuğay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706445: Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
exercise
children
cardiorespiratory fitness
muscle strength
pulmonary function
quality of life
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
First posted: 2012-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To study the effects of an 8-week combined inspiratory muscle training and exercise (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak) (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in children with Cystic Fibrosis (CF) (secondary outcomes).

Detailed description: The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).

Eligibility criteria: Inclusion Criteria:

* boy/girl aged 6-17 years
* living in the Madrid area

Exclusion Criteria:

* severe lung deterioration \[forced expiratory volume (FEV1) \<50% of expected\]
* unstable clinical condition (hospitalization within the previous 3 months)
* Burkholderia cepacia infection
* any disorder (e.g. muscle-skeletal) impairing exercise.

Primary outcomes:
measure: cardiorespiratory fitness (VO2peak)
timeFrame: this outcome will be assessed up to 12 weeks
Secondary outcomes:
measure: quality of life
timeFrame: this outcome will be assessed up to 12 weeks
Other outcomes:
measure: Maximal inspiratory pressure (PImax)
timeFrame: september 2011-july 2012
Locations:
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
Study officials:
References:
Clinical trial NCT04712045: Rational Use of Personal Protective Equipment During COVID-19 Pandemic
Official title: Rational Use of Personal Protective Equipment: a Randomised Trial and Quality Improvement Intervention During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Personal Protective Equipment
Keywords: PPE
Multi-drug resistance organism
Cross-infection
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to improve the personal protective equipment (PPE) used while treating patients with COVID-19, to protect staff and avoid cross-infection of patients. Protecting staff from infection during the Covid pandemic is critical to maintaining health services. Mistakes in using protective equipment (PPE) are the commonest avoidable factor in staff becoming infected at work. Recently, intensive care doctors have also reported an increase in the spread of dangerous multi-resistant bacteria between patients, which appears likely to be transmitted between patients by Level 2 PPE worn by staff (specifically gown sleeves). This study therefore seeks to develop and test a new protocol to decrease cross-infection risks whilst using Level 2 PPE.


Eligibility criteria: Inclusion Criteria:

1. NHS staff and works in the Adult Intensive Care Unit, Neuro Intensive Care Unit or Cardio-thoracic Intensive Care Unit
2. Trained in the correct use of Level 2 PPE according to current guidance
3. Trained in ICU COVID19 Intubation and Proning protocols
4. Willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. taking any medication which can cause photosensitivity reactions in the preceding 3 months

Primary outcomes:
measure: Proportion of participants and simulated patients with contamination as assessed by ultraviolet light
timeFrame: immediately after simulations
Secondary outcomes:
measure: Participants' perception of personal comfort and safety and safety of the patients as assessed through structured questionnaire
timeFrame: immediately before simulations and immediately after simulations
measure: changes in participants perception of personal comfort and safety and safety of patients as assessed through a semi-structured questionnaire
timeFrame: immediately before training, immediately after training and immediately after simulation
measure: The difference in the area of contamination between New and Standard PPE as analyzed through python script
timeFrame: immediately after simulations
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Professor Peter McCulloch
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Peter McCulloch
role: PRINCIPAL_INVESTIGATOR
References: