louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04647266: Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions
Official title: Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyp of Colon
Keywords: Endoscopic Submucosal Dissection
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient, more than 18 years old with no contra indication of the general anesthesia suffering of lesion relevant of endoscopic submucosal dissection treatment.

Brief summary: The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.

Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.

There is currently no score established for the colo-rectal endoscopic submucosal dissection.

* To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
* Allow to obtain an estimation of number of patients required for a larger study.


Eligibility criteria: Inclusion Criteria:

* Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
* Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
* Mucosal tumors with submucosal fibrosis
* Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
* Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
* Male or female patients aged ≥ 18 years old
* Patients able to fill in questionnaires written in French

Exclusion Criteria:

* Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)

Primary outcomes:
measure: To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
timeFrame: From 2016 to 2020
Secondary outcomes:
measure: Allow to obtain an estimation of number of patients required for a larger study
timeFrame: From 2016 to 2020
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Brabois
state: Meurthe ET Moselle
Study officials:
affiliation: Doctor
name: Jean Baptiste CHEVAUX
role: STUDY_DIRECTOR
References:
Clinical trial NCT01962766: Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Official title: Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Breathing
Atypic Swallowing
Low Resting Position of Tongue
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.

Detailed description: The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes, such as: 1) Is treating a low tongue position and lip closure at rest sufficient for orthodontic short and long-term outcomes? 2) Does treating atypical swallowing along with an incorrect tongue position help achieve and maintain higher outcomes of the myofucntional and orthodontic treatments?

Eligibility criteria: Inclusion Criteria:

* Between 6 and 14 years old
* Atypical or immature swallowing pattern and lower position of the tongue at rest
* Be an orthodontic patient treated at the Faculty of Dentistry, Université de Montreal
* Speak and understand French without assistance
* Be in good health (without neurological or psychiatric syndrome)
* Agree to participate and sign the consent form research

Exclusion Criteria:

* Non compliance to clinical visits (eg too many missed visits)
* Patients who had previous orthodontic treatments
* Syndrome or known systemic disease (chronic cardiopulmonary or neuromuscular disease, dysmorphia, major craniofacial abnormalities)

Primary outcomes:
measure: respiration mode
timeFrame: 6 months following therapy
Secondary outcomes:
measure: tongue resting position
timeFrame: 6 months following therapy
Other outcomes:
measure: swallowing pattern
timeFrame: 6 months following therapy
Locations:
city: Montreal
country: Canada
facility: Clinique d'orthodontie - Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT03893266: Diabetic Patients Needs in Therapeutic Education About Work. TE-DIW (Therapeutic Education of DIabetic Working People)
Official title: Exploratory Study of the Needs of Type 1 Diabetic Patients in Therapeutic Education in Order to Reconcile Diabetes and Work.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult person with a type 1 diabetes and having paid employment

Brief summary: Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* To be diagnosed with type 1 diabetes according to the criteria of the French High Authority of Health and confirmed by an endocrinologist
* To have paid employment with an employment contract during the study
* to be informed and having no opposition to the study

Exclusion Criteria:

* self-employed person
* to be unemployed
* To be diagnosed with an other disease wich could damage cognition or motricity and could interfere with work (cancer, neurodegenerative disorder, etc)
* To have legal guardian.

Primary outcomes:
measure: Collection of the needs of type 1 diabetic patients in therapeutic education in order to reconcile diabetes and work.
timeFrame: Expected duration of interviews is around 1 hour, when no new idea appear in an interview.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Médecine et santé au travail - Hôpital Cardiologique Louis Pradel - Groupement hospitalier Est
Study officials:
References:
Clinical trial NCT03969966: Citrate Anticoagulation for Postdilution Hemofiltration
Official title: Citrate Anticoagulation for Postdilution Hemofiltration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Critical Illness
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Diamed GmbH, Cologne, Germany
First posted: 2019-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients at ICU with acute kidney injury

Brief summary: This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.

Detailed description: Acute kidney injury (AKI) requiring continuous renal replacement therapy (CCRT occurs in approx. 15 % of all intensive care patients. A sustained and prolonged filter running time is required to deliver an effective dialysis dose. This requires effective anticoagulation. Today, regional citrate anticoagulation (RCA) is preferred over systemic anticoagulation because of prolonged filter lifetimes and less adverse effects.

We here study prospectively patients with AKI who are treated with continuous veno-venous haemofiltration using an RCA protocol.

We will evaluate all parameters of CRRT including filter running times, delivered dialysis dose, causes for treatment interruption and control of pH and electrolytes.

Eligibility criteria: Inclusion Criteria:

* acute kidney injury
* critical illness and treatment at ICU

Exclusion Criteria:

* age \< 18 years
* pregnancy or breast feeding
* severe lactate acidosis ( \> 10 mmol/l) for longer than 6 hours and pH \< 7.2

Primary outcomes:
measure: Filter running time
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
Study officials:
References:
Clinical trial NCT06021366: Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study
Official title: Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 2089
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief summary: REALIZE was a single-arm retrospective cohort study which described treatment patterns with brolucizumab, including treatment intervals between anti-vascular endothelial growth factor (VEGF) injections before and after a switch to brolucizumab.

This study was conducted using German patient-level prescription data and the prescription date was used as a proxy for anti-VEGF injection date.

The study period was defined from the date of the first available anti-VEGF injection in the dataset to 30 November 2021. The index date for each patient was the date of the first brolucizumab injection, which could be anytime between 01 March 2020 (since brolucizumab became available in Germany for use outside of clinical trials in March 2020) and 30 November 2021. The date of the patient's first neovascular age-related macular degeneration (nAMD) diagnosis was assumed to be the date of the first anti-VEGF prescription in the database for that patient, from January 2015 onwards.


Eligibility criteria: Inclusion Criteria:

• Patients aged ≥50 years with a nAMD diagnosis, who received ≥1 brolucizumab prescription regardless of prior anti-VEGF treatment, and had a minimum of 12-month follow-up from index date.

Exclusion Criteria:

* Patients without a record of prescription of any drug in the six months before the index date (pre-index period).
* Patients with evidence of bilateral treatment with brolucizumab.

Primary outcomes:
measure: Number of brolucizumab injections
timeFrame: Up to 12 months
Secondary outcomes:
measure: Time difference between the last anti-VEGF treatment interval before switch to brolucizumab and the last brolucizumab treatment interval at 12 months
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Porto Salvo
country: Portugal
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00937066: Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
Official title: Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Cost-effectiveness analysis
Symbicort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

Brief summary: This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and reliever therapy (SMART) versus its competitive alternatives.

The aims of this study are:

* To estimate the relative effectiveness of each one of the alternatives in the management of patients with moderate to severe asthma through a systematic review for the following outcomes:

  * Cumulative incidence of asthma severe exacerbations symptoms
  * Safety of each alternative (frequency of adverse events and complications due to the medications)
* To estimate the direct medical costs of treating with each pharmacologic alternative: Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting inhaled beta 2 agonist plus inhaled corticosteroids.
* To create a decision analysis model (decision tree) that allows comparisons between the alternatives on expected values and costs.
* To calculate the average and incremental cost-effectiveness ratios.
* To carry out a sensitivity analysis to test de robustness of the cost-effectiveness results allowing for reasonable changes in expected values and costs.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe asthma.

Primary outcomes:
measure: Estimate incremental cost-effectiveness ratio using Symbicort as Maintenance and Reliever Therapy in the pharmacologic management of patients when compared with competitive alternatives
timeFrame: 12 months
measure: Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Research Site
Study officials:
affiliation: Pontificia Universidad Javeriana
name: Rodolfo Dennis, M.D.
role: STUDY_DIRECTOR
affiliation: Pontificia Universidad Javeriana
name: MARÍA XIMENA ROJAS, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156766: Metaphyseal Distal Radius Fractures
Official title: Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)
Keywords: Fracture
Radius
Osteosynthesis
Metaphyseal
Pinning
Locking anterior plate
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Stryker SA
name: Polyclinique du Parc Rambot
First posted: 2010-07-05
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.

The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.

Detailed description: Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.

The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.

These clinical facts need of course to be validated.

Eligibility criteria: Inclusion Criteria:

* - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
* age 60 years or older

Exclusion Criteria:

* open fracture
* fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
* polytraumatized patient
* fractures older than 15 days
* infection of the operating site
* previous osseous disease

Primary outcomes:
measure: - X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
timeFrame: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths
Secondary outcomes:
measure: PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)
timeFrame: 2 weeks, 5 weeks, 3, 6 and 12 months
measure: Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)
timeFrame: 5 weeks, 3, 6 and 12 months
measure: Grip and pinch strength (5 weeks, 3, 6 and 12 months)
timeFrame: 5 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stéphane DESCAMPS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03933566: US-Guided Superficial Cervical Plexus Block
Official title: Comparison Between Ultrasound-Guided and Landmark-Based Superficial Cervical Plexus Block：A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nerve Block
Keywords: Ultrasound-Guided Superficial Cervical Plexus Block
Landmark-Based Superficial Cervical Plexus Block
Lead sponsor: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200

Brief summary: This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block

Detailed description: Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.

Eligibility criteria: Inclusion Criteria:

* Undergoing surgery of the shoulder and clavicle
* Urgent or planned surgery

Exclusion Criteria:

* Refused to sign informed consent
* Pregnant women
* Allergic to the local anesthetic

Primary outcomes:
measure: Success rate
timeFrame: At 15 mins after nerve block
Secondary outcomes:
Other outcomes:
Locations:
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
state: Hebei
Study officials:
affiliation: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
name: Ruizhao Lv, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04271566: Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
Official title: Drug Utilization and Quality of Life Study in Coronary Artery Disease Patients in a North Indian Tertiary Care Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: KR Mangalam University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study has two parts: A drug utilization study and a Health-related quality of life study.

Detailed description: This study has two parts: A drug utilization study and a Health-related quality of life study.

Drug utilisation study is an open label, cross sectional, descriptive drug utilization analysis of the primary cardiovascular drug classes prescribed to coronary artery disease patients attending cardiology OPD of a North India hospital.

Quality of life study intended to evaluate impact of a mobile based patient education program on the health related quality of life, physical activity and body mass index of coronary artery disease patients. It is a two arm study.

Eligibility criteria: Inclusion Criteria:

* Male or female adults 18 - 75 years of age
* Diagnosed cased of coronary artery disease
* Agreeing after informed consent to participate

Exclusion Criteria:

* High risk cardiac patients
* Systemic, orthopedic and/or neurological problems restricting physical activity

Primary outcomes:
measure: HRQOL measured by RAND-Short form (SF)- 36 questionnaire
timeFrame: 9 months
Secondary outcomes:
measure: Physical activity measured by International Physical Activity Questionnaire (IPAQ)- Short Form
timeFrame: 9 months
Other outcomes:
measure: Body mass index
timeFrame: 9 months
Locations:
city: Gurgaon
country: India
facility: Paras Hospital
state: Haryana
Study officials:
affiliation: KR Mangalam University
name: Yojna Jain, Masters
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.