louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04396782: Effectiveness of Immersive Virtual Reality in Functional Rehabilitation in Older People With Knee Arthroplasty
Official title: Effectiveness of Immersive Virtual Reality in Functional Rehabilitation in Older People With Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Carmen Ruiz Vergara
name: Rocío Martín Valero
First posted: 2020-05-21
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The number of knee arthroplasties performed each year is constantly increasing. Although the outcome is generally favourable, 10-20% do not achieve a satisfactory clinical result. This study evaluates the effectiveness of immersive virtual reality rehabilitation in older people who have undergone knee arthroplasty surgery. The 6 Meter Walking Test is used to determine the improvement of patients after the procedure.


Eligibility criteria: Inclusion Criteria:

* people who are admitted to one of the two chosen residences on the Costa del Sol who have had, or will have, a total knee arthroplasty recently.
* People between 60-75, who want to receive rehabilitation treatment.

Exclusion Criteria:

* Patients who refuse to participate or who suffer serious post-operative complications.
* patients with neurological or cognitive impairment that could interfere with the performance of the rehabilitative treatment will be excluded.
* Those with any severe cardiovascular or pulmonary disease that would prevent them from exercising and also those who are not allowed physical activity for any reason.
* Those with poor visual acuity who are unable to see the visual characteristics of the screen.
* Patients with severe contralateral knee osteoarthritis (\>5/10 pain when climbing stairs) or other orthopaedic conditions that limited function and required an alternative simultaneous operation, e.g. severe lumbar spinal stenosis, severe OA of the hip or ankle...
* Those who are scheduled for other lower limb surgery in the next 6 months.

Primary outcomes:
measure: Changes in six meter walking test (6-MWT) score
timeFrame: Baseline, up to three an six months.
Secondary outcomes:
measure: Sit to Stand Test
timeFrame: Baseline, up to three an six months.
measure: The range of motion
timeFrame: Baseline, up to three an six months.
measure: The Oxford Knee Score (OKS)
timeFrame: Baseline, up to three an six months.
measure: The BERG scale
timeFrame: Baseline, up to three an six months.
measure: The McMaster Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline, up to three an six months.
measure: The User Satisfaction Evaluation Questionnaire
timeFrame: up to six months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: University of Málaga
Study officials:
References:
Clinical trial NCT03805282: Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence
Official title: Intravenous Lidocaine Continuous-infusion to Supress of Cough Reflex During Anesthesia Emergence: Dose-finding Adaptive Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cough
Keywords: general anesthesia
cough
anesthesia emergence
lidocaine
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four parallel groups will be studied:

* Female \> 60 years old
* Male \> 60 years old
* Female 18 to 60 years old
* Male 18 to 60 years old
Primary purpose: PREVENTION

Brief summary: Introduction: Although inflating tracheal cuff using lidocaine is effective for cough suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during anesthesia emergence is not determined yet. Objective: the objectives of this study are to determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during extubation by sex and age group.

Detailed description: Ideal patient weight in kg will be considered.

Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on the incidence of emergence cough in the previous patient of the same group:

* It will increase if coughed in a probability of 95%
* It will decrease if not coughed in a probability of 5%.
* It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will receive remifentanil 0.025mcg/kg.min continuous infusion until extubation.

Patients groups will be determined by sex and age group (18-60 or \>60 years old), therefore, four independent groups will be studied:

* Female 18 to 60 years old
* Male 18 to 60 years old
* Female \> 60 years old
* Male \> 60 years old

Eligibility criteria: Inclusion Criteria:

* Understands study risks and benefits, signs informed consent.
* Not pregnant.
* Not an airway surgery
* No acute or chronic respiratory disease.
* Non smoker
* No chronic cough

Exclusion Criteria:

* Any protocol violation.

Primary outcomes:
measure: Cough during anesthesia emergence
timeFrame: Anytime during anesthesia emergence, before extubation.
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Universitario de Brasilia
state: Distrito Federal
Study officials:
References:
Clinical trial NCT03317782: NoL Index Variations Before and After a Stellate Ganglion Block
Official title: Evaluation of NoL Index Variations After a Painful Stimulus Before and After a Stellate Ganglion Block in Patients With Upper Extremity Complex Regional Pain Syndrome: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain Syndrome
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with upper extremity complex regional pain syndrome treated at the pain clinic of the Maisonneuve-Rosemont Hospital

Brief summary: To evaluate and compare the NoL index variations after a painful physiotherapy exercise in patients with upper limb CRPS, before and after a stellate ganglion block.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of upper limb CRPS according to the Budapest criteria12, for more than 6 months;
* Significant pain relief from stellate ganglion block;
* Undergoing physical therapy;
* 18 years and older.

Exclusion Criteria:

* Patients taking beta blockers

  * Bilateral/generalized CRPS
  * Patients needing sedation for the procedure
  * Inability to understand a Numeric Pain rating Scale due to cognitive dysfunction or linguistic barrier
  * Movement disorder making a person unable to lie still for the duration of the evaluation period.
  * Patient refusal

Primary outcomes:
measure: Change in NoL index from baseline
timeFrame: 20 minutes
Secondary outcomes:
measure: Change in peak NoL index values before and after a stellate ganglion block
timeFrame: 20 minutes
measure: change in Numeric Rating Scale (NRS) pain intensity score (from 0-10) before and after a stellate ganglion block
timeFrame: 20 minutes
measure: correlation between change in NoL index and change in the Numeric Rating Scale (NRS) pain score (from 0-10) from baseline
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Maisonneuve Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Veronique Brulotte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260982: Cognitive Disorders in Hereditary Spastic Paraplegia Type 4
Official title: Cognitive Disorders and Metabolism in 18-FDG- PET in Hereditary Spastic Paraplegia Type 4 (SPG4)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spastic Paraplegia
Keywords: Hereditary Spastic Paraplegia type 4
18-FDG-PET
cognitive disorders
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed in the Grand Est region for type 4 spastic paraplegia with identification of a pathogenic or probably pathogenic variant in the SPAST gene.

Brief summary: Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized.

Detailed description: Our primary objective is to describe a pattern of cognitive impairment in Hereditary Spastic Paraplegia type 4 using 18-FDG-PET metabolic imaging.

As secondary objectives, we wish to study the presence of correlations between neuropsychological tests, clinical examination, 18-FDG-PET data and general and genetic data of the pathology. We also wish to investigate correlations between genotype and phenotype.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age, living in the Grand Est region (France)
* Patient with a pathogenic or probably pathogenic variant (class 4 or 5) in the SPAST gene.

Exclusion Criteria:

* dementia comorbidities or cognitive disorders unrelated to the pathology that may affect neuropsychological tests.

Primary outcomes:
measure: cognitive testing
timeFrame: baseline
Secondary outcomes:
measure: Correlations between neuropsychological tests, clinical examination, PET and general data.
timeFrame: baseline
measure: Genotype/Phenotype correlations
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre hospitalier régional universitaire
Study officials:
affiliation: Central Hospital Nancy
name: Mathilde Renaud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01298882: Diacerein on Insulin Secretion in Diabetes
Official title: Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Overweight
Obesity
Keywords: Type 2 diabetes mellitus
Overweight
Obesity
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2011-02-18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα) inhibition with diacerein administration on insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

Hypothesis. Diacerein administration improves insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial. Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed rank and Mann-Whitney U test.


Eligibility criteria: Inclusion Criteria:

* Fasting glucose levels between 7.0 and 11.1 mmol/L
* A1C levels between 7 and 9%
* Same residential area and socioeconomic status
* Excessively sedentary or participated in heavy physical activity
* Nonsmokers
* Body weight was stable for at least 3 months before the study
* Blood pressure was \<130/80 mm Hg

Exclusion Criteria:

* Personal history of hepatic, renal or coronary artery disease
* Medications known to affect metabolism during the previous 6 months.

Primary outcomes:
measure: Fasting insulin concentration
timeFrame: 2 mo
measure: Fasting glucose concentration
timeFrame: 2 mo
measure: A1C concentration
timeFrame: 2 mo
measure: First phase of insulin secretion
timeFrame: 2 mo
measure: Late phase of insulin secretion
timeFrame: 2 mo
measure: Total insulin secretion concentration
timeFrame: 2 mo
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Médica en Epidemiología Clínica
state: Jalisco
Study officials:
References:
citation: Ramos-Zavala MG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Gonzalez-Lopez R, Santiago-Hernandez NJ. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2011 Jul;34(7):1591-4. doi: 10.2337/dc11-0357. Epub 2011 May 24.
Clinical trial NCT04633382: ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
Official title: JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Stricture
Cholangiocarcinoma
Cholangitis; Choledocholithiasis
Keywords: Fast track, Enhanced recovery after surgery, biliary surgery
Lead sponsor: Vitebsk State Medical University
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to improve the immediate results after reconstructive and restorative operations on the biliary tract by substantiating the management of the perioperative period on the principles of "enhanced recovery after surgery".

Detailed description: A prospective randomized study on the effect of fast-track surgery on the immediate postoperative results after various reconstructive and restorative operations on the bile ducts. In the Department of Surgical Hepatology and Transplantation, a prospective randomized study will include patients (about 50) with planned reconstructive and restorative operations on the bile ducts for malignant and benign diseases of the bile ducts.

Eligibility criteria: Inclusion Criteria:

1. Patients with malignant diseases of the biliary tract (cholangiocarcinoma):

   1.1. tumor resectability 1.2. absence:
   * distant metastases
   * carcinomatosis
   * perforation of the tumor and peritonitis
   * sprouting into adjacent organs and tissues (locally advanced cancer)
   * total adhesion process in the abdominal cavity (after previous operations). 1.3. Planned reconstructive surgery on the biliary tract.
2. Patients with benign biliary tract pathology. 2.1. Planned reconstructive or restorative surgery on the biliary tract for the following diseases:

   * choledocholithiasis
   * Mirizzi syndrome
   * cysts of the common bile duct
   * strictures of the common bile duct
   * injuries to the bile ducts
   * adenoma and stricture of the OBD

Exclusion Criteria:

1. Scale ASA\> III (severe concomitant cardiovascular pathology).
2. Palliative reconstructive surgery.
3. Previously performed operations on the bile ducts (up to 1 month).
4. Cachexia.

Primary outcomes:
measure: Reduction of bed-days
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05504382: Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial
Official title: Effect of Electroacupuncture Versus Phonophoresis on Refractory Pain in Juvenile Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Rheumatoid Arthritis
Keywords: Refractory Pain Juvenile Rheumatoid Arthritis
Lead sponsor: Egyptian Chinese University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 42
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: the purpose of the study is to investigate the effect of Electrical Acupuncture Versus naproxen phonophoresis on Refractory pain in Juvenile Rheumatoid arthritis

Detailed description: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children and adolescents, affecting approximately one in 1000 children in North America. It is diagnosed in children younger than 16 years of age with arthritis in one or more joints for at least six weeks after other causes have been excluded. Arthritis in JIA is characterized by stiffness, pain and swelling of affected joints. The disease course of JIA may involve flares of increased disease activity or chronic persistent joint inflammation, even into adulthood. Various complications may arise secondary to ongoing disease activity or treatment, including joint damage and deformity, growth abnormalities and osteoporosis with fragility fractures The prevalence of refractory pain in children with arthritis is of particular concern because it often contributes to poor physical and psychosocial outcomes. Increased daily symptoms of pain predict considerable functional disability, including significantly reduced participation in school, social and physical activities, and augmented mood disturbance

Eligibility criteria: Inclusion Criteria:

* • Age ranges from 14 to 16 years.

  * All children will be assigned to the study are suffering from persistent oligoarthritis.
  * All children have regional knee pain complaint more than 6 weeks.
  * Pain and stiffness especially in the morning, and a joint that feels warm to the touch
  * Low grade fever at the onset of disease

Exclusion Criteria:

* • Neurological disorders.

  * Dermatological disorders.
  * Acute trauma prior to the study.
  * Other co- morbidities like diabetes and conditions associated with inflammation such as malegnancies.
  * Analgesic drugs or NSAIDs during the treatment period.

Primary outcomes:
measure: knee pain
timeFrame: 2 weeks
Secondary outcomes:
measure: knee joint range of motion
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed Abo-El-Ros, Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05607082: COVID-19 Bivalent Booster Megastudy
Official title: COVID-19 Bivalent Booster Megastudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19 vaccination
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 2600000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This megastudy is a massive randomized controlled trial. By randomizing participants to 10 different intervention conditions simultaneously, the investigators will be able to compare the effectiveness of different interventions to one another and to a control group (in which individuals will only receive the usual communications from their partner organization) to identify which interventions significantly increase vaccination rates. Pharmacy customers will be randomly assigned to receive one of the interventions designed by team scientists to encourage vaccination or to a control group. The baseline intervention will be based on the top-performing SMS intervention identified in the investigators previous megastudies on encouraging vaccination (Milkman et al., 2021b, 2022). Pharmacy customers will receive SMS messages conveying that a COVID booster vaccine is reserved or waiting for them at the pharmacy. Additional behavioral science messaging strategies will be tested by building off of this baseline intervention.


Eligibility criteria: Inclusion Criteria:

• Patient of a large retail pharmacy that has opted into receving SMS messages from the pharmacy and has received their primary COVID vaccination series.

Exclusion Criteria:

* The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
* The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Primary outcomes:
measure: Patient uptake of the COVID bivalent booster
timeFrame: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes:
measure: Patient uptake of the COVID bivalent booster
timeFrame: 60 days after receiving the SMS/MMS intervention
measure: Patient uptake of the COVID bivalent booster
timeFrame: 90 days after receiving the SMS/MMS intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: