louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01151241: Early Discharge in Patients Undergoing Elbow Arthroscopy
Official title: Outpatient Versus Inpatient Continuous Brachial Plexus Block for Complex Arthroscopic Elbow Surgery: Safety and Functional Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Arthroscopy Surgery
Keywords: elbow surgery
infraclavicular nerve block
continuous passive motion
ultrasound guided regional anesthesia
early discharge
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 40
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: Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia (infraclavicular nerve block combined with general anesthesia for surgery; continuous infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group will be discharged home after one day, with infraclavicular catheter in place; patients in the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study will compare range of motion as the primary endpoint, in a non-inferiority design, to see if early discharge is feasible while providing similar recovery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective complex arthroscopic elbow surgery requiring postoperative CPM - synovectomy, capsulectomy, extensive debridement, contracture release, osteocapsular arthroplasty.
* ASA I-III

Exclusion Criteria:

* Age\>65
* Cognitively challenged patients
* Severe COPD
* Patients who, on their own or with the assistance of a caregiver, are not confident of being able to remove the local anesthetic infusion catheter at home
* Psychiatric history
* Allergy to ropivacaine.
* Opioid tolerance (\>60mg oral morphine or equivalent/day)

Primary outcomes:
measure: Range of Motion
timeFrame: 1 year
Secondary outcomes:
measure: Post-operative analgesia
timeFrame: 3 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anahi Perlas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03621241: Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes
Official title: Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelodysplastic Syndromes
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MDS

Brief summary: Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly


Eligibility criteria: Inclusion Criteria:

1. Patient who have been orally informed, and given a short written information notice about the study
2. Adult patient\>18 years
3. For whom a blood sample analysis is routinely prescribed
4. Presenting cytopenia on at least one lineage according to the 2016 WHO classification (Hemoglobin level\<100 g/L and/or platelets \<150 G/L and/or Neutrophils\<1G/L).
5. For whom a bone marrow analysis for morphology assessment and cytogenetics have to be performed, because of suspicion of MDS.t The results of this bone marrow evaluation will classify the patients in Group 1 (MDS diagnosis) and Group 2 (no MDS according to the 2016 WHO criteria), defining the two populations of this validation cohort for whom the FC score will be calculated.

Exclusion Criteria:

1. Transfused patients (less than 3 months) in RBC or platelets units

Primary outcomes:
measure: identification of the most relevant combination of FC markers
timeFrame: 0 days
Secondary outcomes:
measure: prospective validation of a diagnostic score using pre-identified markers
timeFrame: 0 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Lille
country: France
facility: CHRU Lille
city: Rouen
country: France
facility: CHU Rouen
Study officials:
References:
Clinical trial NCT06404541: A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface
Official title: A Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Ocular Surface Disease
Dry Eye Syndromes
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.

Detailed description: 60 eyes of will be included in this study.

* 20 eyes will receive regular Tobradex 0.1mg/ml BAK 5 times per day (Group 1).
* 20 eyes will receive Dexathalm multidose 0.05mg/ml BAK 5 times per day (Group 2).
* 20 eyes will receive single dose unit Dexathalm NO BAK 5 times per day (Group 3).

Preoperative assessment:

All selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients.

Tear break up time (TBUT) will be measured non-invasively by Ocular Surface analyzer.

Ocular Surface disease index will be calculated by filling a questionnaire. 12-item questionnaire provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.

Postoperative:

1. All patients will be examined at day1, 1 week and 3 week postoperative.
2. At 3 weeks re-evaluate I. TBUT by non-invasive ocular surface analyzer II. OSDI by filling the questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing uncomplicated cataract surgery
* Cataract grade: (LOCSIII): NO2NC2,C3,P2

Exclusion Criteria:

Preoperative non-invasive TBUT\<10 seconds. Patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface.

Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.

Primary outcomes:
measure: NBUT
timeFrame: preoperative and 1 month postoperative
measure: TMH
timeFrame: preoperative and 1 month postoperative
measure: OSDI
timeFrame: preoperative and 1 month postoperative
measure: MG loss
timeFrame: preoperative and 1 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: KasrAl Ainy Hospital
state: Giza
Study officials:
References:
Clinical trial NCT03781141: Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery
Official title: Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Trigger Finger
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

Detailed description: The study will involve randomizing patients to wound closure with absorbable or non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different between the two types of closures as determined by the patient and observer scar assessment scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between absorbable and non-absorbable suture for wound closure of open carpal tunnel release and trigger finger pulley release.

Eligibility criteria: Inclusion Criteria:

* Any patient greater than or equal to 18 years of age.
* Any patient undergoing primary open carpal tunnel release or primary trigger finger pulley release

Exclusion Criteria:

* Any patient identified outside of the proposed study time period.
* Any patient receiving revision surgery
* Patients who have had prior ipsilateral palmar or finger surgery
* Patients with Dupuytren's disease

Primary outcomes:
measure: Scar formation with the Patient and Observer Scare Assessment Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Peter C Rhee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04723641: Effect of Functional Training on Motor Performance
Official title: Effect of Functional Strength Training From Plantigrade Foot Position on Motor Performance in Children With Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegia
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
Primary purpose: TREATMENT

Brief summary: The functional strength training is mainly dealt with anti-gravity muscles and aiming at maximal carry over in day to day activities. The functional strength training can be given using resistance and it may be gravity, body weight, resistance bands and free weights. The exercises are specific to the muscle or muscle groups recruited during the functional activities


Eligibility criteria: Inclusion Criteria:

1. Age ranged from 7 to 10 years old.
2. The degree of spasticity ranged from grade 1 to 2 hypertonia according to Modified Ashwarth Scale (MAS)
3. Level II and III on GMFCS-ER
4. They were able to understand and follow verbal instructions

Exclusion Criteria:

* 1- visual or auditory problems. 2- Orthopedic surgery in the lower limb in the last 12 months before the study. 3- Fixed deformities in joints and bones of lower limbs. 4- Botox injection in the last six months before the study. 5- Children with any special medications affecting muscle functions (anti-spastic drugs).

Primary outcomes:
measure: Gross motor functional measurement
timeFrame: pre and after 3 months of intervention,, the higer score will represent the improvement
Secondary outcomes:
measure: Isometric muscle strength measurements
timeFrame: pre and after 3 months of intervention,, increase in muscle will represent the improvement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa
Study officials:
References:
Clinical trial NCT05311241: Teleconsultation in Ambulatory Care in France
Official title: Observational Study of the Use of the Service Giving Access to Teleconsultation in France by Telemedicine Companies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telehealth
Telemedicine
Teleconsultation
Lead sponsor: Les Entreprises de Télémédecine
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 84000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients registered with a teleconsultation company member of the LET participating to the study with at least one teleconsultation during the study period.

Brief summary: Teleconsultation is a telemedicine medical act carried out remotely via information and communication technologies. This medical procedure has been legal in France since 2010 and reimbursed by the National Health Insurance under certain conditions since 2018. In 2020, following the COVID-19 epidemic, the lockdowns and the extension of the scope of financial coverage, 17 million teleconsultations have been reimbursed.

To date, few scientific studies have been published in France to precisely describe the use of the service giving access to outpatient teleconsultation, in particular since the major increase in activity linked to the COVID-19 epidemic.

The objective is to describe the use of the service giving access to outpatient teleconsultation carried out in France by teleconsultation companies and compare the use of the teleconsultation service according to the medical density of the territory.


Eligibility criteria: Inclusion Criteria:

* Patient who used the teleconsultation access service with one of the telemedicine companies member of the LET participating in the study
* Patient residing in France according to the written information (address and or postal code) given at registration to the telemedicine company
* Teleconsultation service used between August 1, 2021 and November 30, 2021
* Teleconsultation service used in the context of outpatient care (hospitals excluded)
* Teleconsultation service used for a teleconsultation with a doctor registered with the Medical Doctors Council in France

Primary outcomes:
measure: Rate of patients without a treating doctor
timeFrame: Through the study completion at the time of the teleconsultation, average 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Les Entreprises de Télémédecine
Study officials:
affiliation: Qare
name: Julie Salomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04106141: Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases
Official title: Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leveling and Alignment of Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged (18\~33)
* CVMI = 6
* Moderate crowding (4-8) as described by Laura mitchel
* No extractions required

Exclusion Criteria:

* Growing patients
* Previous orthodontic treatment
* Missing teeth other than the wisdoms

Primary outcomes:
measure: Degree of alignment of teeth
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06533241: Trends of Renal Biopsy in Pediatric Patients at Tanta University Hospital for 10 Years From 2012 to 2022.
Official title: Trends of Renal Biopsy in Pediatric Patients at Tanta University Hospital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients less than 18 years' old who underwent renal biopsy.

Brief summary: This study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at Tanta University Hospital from 2012 to 2022.

Detailed description: This study will be conducted on pediatric patients less than 18 years' old who underwent renal biopsy at Tanta University Hospital from 2012 to 2022.

The data will be collected from records:

1. History taking including age and sex.
2. Indications for renal biopsy.
3. Methods of renal biopsy
4. Complications of renal biopsy
5. Adequacy of samples
6. The results obtained by light microscopy
7. The results obtained by electron microscopy, immunofluorescence when indicated

Eligibility criteria: Inclusion Criteria:

* All pediatric patients less than 18 years' old who underwent renal biopsy.

Exclusion Criteria:

* no exclusions

Primary outcomes:
measure: the indications of renal biopsy
timeFrame: 3 months
Secondary outcomes:
measure: light , electron microscope and immunofluorescence results of renal biopsy
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sara Mabrouk Mohamed Elghoul
state: Tanta, Qism 1
Study officials:
affiliation: Tanta University
name: Sara Mabrouk Mohamed Elghoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03567941: To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen
Official title: A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects 18 to 55 years of age.
2. Opioid users who have used opioids for recreational purposes and or is an avid opioid user.

Exclusion Criteria:

1. Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
2. Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
3. Difficulty swallowing large number of pills.
4. Subjects who have had a tattoo or body piercing.

Primary outcomes:
measure: Drug Liking
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: SPARC Site 1
state: Ontario
Study officials:
References:
Clinical trial NCT00891241: A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Official title: A Multi-Center, Single Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Keywords: Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)


Eligibility criteria: Cohort 1 Inclusion:

* Healthy, age 18-40

Cohort 1 Exclusion:

* Significant or chronic medical illness
* Pregnant females
* Smoking within one month of enrollment
* Use of any prescription drugs within 4 weeks prior to dosing

Cohort 2 Inclusion:

* 30-70 year old subjects with a diagnosis of NYHA Class II-III heart failure
* Ejection fraction less than or equal to 35%
* Rest SPECT imaging within 90 days prior to enrollment

Cohort 2 Exclusion:

* Significant or chronic medical illness
* Pregnant females
* Known history of arrhythmogenic disorder or rhythm disorder

Primary outcomes:
measure: Safety of LMI 1195 in terms of treatment-related adverse events
timeFrame: 14 days
Secondary outcomes:
measure: Radiation Dosimetry of a single dose of LMI 1195
timeFrame: 2 days
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University Medical Center
state: Connecticut
Study officials:
affiliation: Medical Monitor - Lantheus Medical Imaging
name: L. Veronica Lee, M.D.
role: STUDY_DIRECTOR
References: