louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02270437: Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty
Official title: Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: total knee arthroplasty
cocktail analgesia
morphine consumption
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 55
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.

Detailed description: It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty.

A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.

Eligibility criteria: Inclusion Criteria:

* patients with tricompartmental knee disease undergoing simultaneous bilateral TKA

Exclusion Criteria:

* diabetes mellitus
* neuromuscular deficit
* a known allergy to one of the drugs being injected
* a history of cardiac disease or arrhythmia requiring special monitoring

Primary outcomes:
measure: To evaluate the Morphine consumption and PCIA duration
timeFrame: 12 hours to 3 days after the surgery
Secondary outcomes:
measure: To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty
timeFrame: 4 hours to 5 days after the surgery
measure: Function recovery evaluation for patients received surgery
timeFrame: 1, 3 and 5 days after the surgery
Other outcomes:
measure: Testing of body temperature,routine blood examination
timeFrame: hospital admission and 1, 3, 5 days after the surgery
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wu Zhihong, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01620437: Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects
Official title: A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* BMI (body mass index) between 19-29 kg/m\^2 (both inclusive)
* Fasting blood glucose between 3.8-6.0 mmol/L (both inclusive)
* Non-smokers

Exclusion Criteria:

* Subjects with a first-degree relative with diabetes mellitus
* Subjects smoke 5 cigarettes or more per day

Primary outcomes:
measure: Area under the insulin aspart curve in the interval from 0-16 hours
measure: Cmax, maximum insulin aspart concentration
Secondary outcomes:
measure: tmax, time to maximum insulin aspart concentration
measure: Area under the insulin aspart curve
measure: Mean residence time (MRT)
measure: t½, terminal half-life
measure: Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02834715: Metabolic Effects of Stevia in Type 2 Diabetic Patients
Official title: Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Stevia
insulin secretion
insulin sensitivity
Sweetener
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2016-07-15
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.

Detailed description: This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.

The intervention is made of two phases including

1. A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
2. An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects

Eligibility criteria: Inclusion Criteria:

* Known type 2 diabetes
* Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion
* No acute complication of diabetes
* HbA1C≤ 8%

Exclusion Criteria:

* Infection up to 10 days prior to inclusion
* Serum ALAT \>3N,
* MDRD estimated creatinine clearance \<60ml/min
* Tobacco smoking

Primary outcomes:
measure: Glycaemic profile in response to mixed meal test
timeFrame: 1 month
Secondary outcomes:
measure: insulin secretion in response to mixed meal test
timeFrame: 1 month
measure: Serum lipids
timeFrame: 1 month
measure: Insulin sensitivity
timeFrame: 1 month
measure: Liver enzymes
timeFrame: 1 month
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: National Obesity Centre
Study officials:
affiliation: University of Yaoundé 1 and Yaoundé Central Hospital
name: Eugene Sobngwi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02240615: The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora
Official title: The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Epiphora
Keywords: Epiphora
Lacrimal Stent
Lacrimal System
Lead sponsor: Sinopsys Surgical
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.

Detailed description: Up to 10 patients will be enrolled and followed for six months. The primary objective is to demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular pathologies in this patient population. The primary outcome measure for performance is the relief of epiphora determined by both investigator assessment of stent patency and patient self-assessment of epiphora symptom improvement compared to baseline.

Eligibility criteria: Inclusion Criteria:

* Clinically significant functional epiphora for at least three months
* Keros classification 1 or 2 skull base anatomy

Exclusion Criteria:

* Active infection
* Craniofacial deformity
* Severe inflammatory disease

Primary outcomes:
measure: Relief of epiphora, determined by both 1) the Investigator assessment of the patency/function of the Sinopsys Lacrimal Stent ( and 2) the subject's self-assessment of tearing.
timeFrame: Six Months
Secondary outcomes:
measure: Measurement of device insertion success
timeFrame: Procedural
measure: Evaluation of all safety
timeFrame: Six Months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
Study officials:
affiliation: Sinopsys Surgical Inc.
name: Harry Ross, MD
role: STUDY_DIRECTOR
affiliation: Sinopsys Surgical Inc.
name: Teena Augostino
role: STUDY_DIRECTOR
References:
Clinical trial NCT01874015: Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease
Official title: Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Crohn's Disease
Keywords: Crohn's disease
mesenchymal stem cell
fistula
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-06-10
Enrollment: 10
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: This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.

Detailed description: In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A receives only autologous MSCs suspended in fibrin glue, group B receives autologous MSCs+ Fibroblasts. Both groups receive 4 injections inside the wall and lumen of the fistula. Injections will be repeated every month.

Eligibility criteria: Inclusion Criteria:

* 1- Poor response to routine treatments in refractory Crohn's disease with fistula.

  2- CDAI\>220 3- Age 18 to 60 years 4- GFR\>30, Cr\<2 5- The presence of perinea fistula.

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: fistula closure
timeFrame: 4months
Secondary outcomes:
measure: CDAI
timeFrame: 4months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan department of degenerative medicine,Head of Royan celltherapy center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: TUMS DDRI
name: Mahdi Mohammad Nejhad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04216615: Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.
Official title: Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Anxiety
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 290
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 290 elderly patients undergoing elective orthopaedic surgery in the Affiliated Hospital of Xuzhou Medical University.

Brief summary: Postoperative delirium is a common and important complication in patients. The aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in elderly patients undergoing orthopaedic surgery, so as to help develop preventive approaches.


Eligibility criteria: Inclusion Criteria:

* aged 65 or older
* patients undergoing elective orthopaedic surgery
* ASA I-III

Exclusion Criteria:

* history of craniocerebral trauma surgery or severe central nervous system disease
* inability to read or understand the informed consent documents
* too physically or psychologically ill

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: 5-day postoperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01998815: Role and Mechanisms of Obesity Surgery
Official title: Role and Mechanisms of Obesity Surgery - Physical Activity and Other Predictors of Hospital Stay, Recovery and Complications After Obesity Surgery
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Obesity
Bariatric Surgery
Physical Activity
Post-operative Complications
Quality of Life
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2013-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All obese patients undergoing laparoscopic Roux-en-Y gastric bypass surgery at Sahlgrenska University Hospital in Gothenburg and Kärnssjukhuset in Skövde, Sweden.

Brief summary: The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery.

The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure.

The investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea.

First aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of QoL and normal physical function.

The second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.


Eligibility criteria: Inclusion Criteria:

* \>18 y of age
* BMI \>35

Exclusion Criteria:

* non-knowledgeable in Swedish language

Primary outcomes:
measure: Post-operative recovery and complications
timeFrame: 30 days
Secondary outcomes:
measure: Post-operative well-being and late complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahglrenska University Hospital
Study officials:
References:
Clinical trial NCT01580215: Long Term Follow up Investigation of Endobronchial Valves in Emphysema
Official title: Long Term Follow up Investigation of Endobronchial Valves in Emphysema
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Emphysema
Keywords: Valves
Endobronchial
Endoscopic lung volume reduction
Pulmonx
Zephyr
Chartis
Emphysema
COPD
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 628
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: Patient participation is entirely voluntary. Patients must meet the inclusion/exlusion criteria to be eligible for the study.

Brief summary: This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Detailed description: Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders of at least 18 years of age
* Understand and voluntarily sign an informed consent form.
* FEV1 \> 15% predicted and \< 45% predicted
* RV \>180% predicted
* Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System

Exclusion Criteria:

• Active pulmonary infection

Primary outcomes:
measure: FEV1
timeFrame: 2 years
Secondary outcomes:
measure: Modified Medical Research Council (mMRC) Questionnaire
timeFrame: 5 years
measure: COPD Assessment Test (CAT)
timeFrame: 5 years
measure: Survival over 5 years
timeFrame: 5 years
Other outcomes:
measure: Adverse Events
timeFrame: 5 years
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg Hospital
Study officials:
affiliation: Medizinische Fakultät Heidelberg
name: Felix JF Herth, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04308915: Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
Official title: Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: digital intervention
serious games
Lead sponsor: Indian Institute of Technology Kanpur
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. Several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. A meta-analysis of the studies aimed at evaluating working memory (WM) in autistic population suggested deficits in visual and verbal aspects of WM. Working memory training has also been studied in other neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD). The study includes development of mobile-based games for training WM and other cognitive skills in patients and the evaluation of such training in reducing symptoms of ASD. These games may also be useful for other neurodevelopmental disorders.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD

Exclusion Criteria:

* Inability to use smartphones/tablets
* Serious intellectual disabilities.
* Sensory impairment

Primary outcomes:
measure: Corsi Task Block Span
timeFrame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
measure: Corsi Task Total Score
timeFrame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
Secondary outcomes:
measure: Autism Treatment Evaluation Checklist Total Score
timeFrame: change from baseline to program completion or last usage (up to 30 days of usage within 56-day trial period from the first day of data collection)
Other outcomes:
Locations:
city: Kanpur
country: India
facility: Indian Institute of Technology Kanpur
state: Uttar Pradesh
Study officials:
References:
citation: de Vries M, Prins PJ, Schmand BA, Geurts HM. Working memory and cognitive flexibility-training for children with an autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2015 May;56(5):566-76. doi: 10.1111/jcpp.12324. Epub 2014 Sep 26.