louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02767622: Reversibility of Minimal Hepatic Encephalopathy Following Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimal Hepatic Encephalopathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation.

Brief summary: This study included 20 patients listed for liver transplantation in addition to 20 age- and sex- matched controls. Neurological, psychiatric, laboratory and radiological examinations were performed for both patients and controls before and 6 months after liver transplantation. Assessment of cognitive functions by Trail Making Test A (TMT A), TMT B, Digit Symbol Test (DST), and Serial Dotting Test (SDT) was done before and after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Right handed patients with biopsy-proven liver cirrhosis listed for liver transplantation

Exclusion Criteria:

* Overt hepatic encephalopathy.
* Significant cortical atrophy or other structural brain changes revealed by conventional neuro-imaging.
* Regular use of psychotropic drugs, such as benzodiazepines.
* Known major psychiatric disorder.
* Less than 6 months of complete alcohol abstinence.
* Post-transplant toxic levels of immunosuppressive drugs.
* Patients unable to perform the tests (Illiterate or upper limb motor handicaps).

Primary outcomes:
measure: Improvement of Psychometric tests.
timeFrame: 6 months following liver transplantation.
Secondary outcomes:
measure: Improvement of liver functions and MELD score following liver transplantation.
timeFrame: 6 months following liver transplantation.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05365022: Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System
Official title: Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Prosthetic Surgery
Robotic Assistance
Keywords: Knee prosthetic surgery robotic assistance
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.


Eligibility criteria: Inclusion Criteria:

* Knee osteoarthritis requiring PS Knee Prosthesis

Exclusion Criteria:

* Not meeting Inclusion Criteria
* Requiring Constrained Prosthesis
* Metal Allergy
* Neurological disorders.
* Cognitive impairment
* Not giving consent.

Primary outcomes:
measure: Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Mobility
timeFrame: 1 year after surgery
measure: Technique reproducibility between surgeons
timeFrame: Intraoperative
measure: Patient satisfaction
timeFrame: 1 year after surgery
measure: Time to Recovery
timeFrame: 1 year after surgery
measure: Time to home discharge
timeFrame: 1 month
measure: Pain Control
timeFrame: 1 year after surgery
measure: Technique Timing at Operating Room (OR)
timeFrame: Intraoperative
measure: Implant Stability
timeFrame: 1 year after surgery
measure: Complications
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Clinical Assistant
name: Borja Alcobia-Díaz, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02202122: Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures
Official title: Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Femoral Neck Fracture
Keywords: Femoral Neck Fractures
Obstructive Sleep Apnea
Perioperative Complications
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 0
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: All patients with femoral neck fractures

Brief summary: Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture.

Detailed description: * All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture
* Study between 15/09/2014 and 15/10/2015
* The four OSA predictive scores will be collected
* Evaluation of mortality at 1 month

Eligibility criteria: Inclusion Criteria:

* All patients with femoral neck fractures
* Incoming at the Saint-Luc Bouge Hospital
* Between 15/09/2014 and 15/10/2015

Exclusion Criteria:

* None

Primary outcomes:
measure: Impact OSA predictive scores on mortality prognosis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc de Bouge
Study officials:
affiliation: Astes
name: Eric P Deflandre, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02594722: Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: COPD
Functional Electrical Stimulation Cycling
Pulmonary Rehabilitation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.

The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.


Eligibility criteria: Inclusion Criteria:

* COPD (Stade II, III or IV)
* Inform consent

Exclusion Criteria:

* Pulmonary rehabilitation contraindication
* Patient with Pacemaker
* Patient in acute exacerbation
* Patient with neurologic comorbidity
* Anemiae

Primary outcomes:
measure: oxygen uptake (VO2)
timeFrame: during 30 minutes exercise
Secondary outcomes:
measure: Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
timeFrame: during 30 minutes exercise
measure: Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
timeFrame: during 30 minutes exercise
measure: cardiac output
timeFrame: during 30 minutes exercise
measure: Muscular fatigue
timeFrame: after 30 minutes exercise
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Medrinal
Study officials:
affiliation: Groupe Hospitalier du Havre
name: Clement Medrinal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Medrinal C, Prieur G, Combret Y, Quesada AR, Debeaumont D, Bonnevie T, Gravier FE, Dupuis Lozeron E, Quieffin J, Contal O, Lamia B. Functional Electrical Stimulation-A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1454-1461. doi: 10.1016/j.apmr.2018.02.002. Epub 2018 Mar 7.
citation: Medrinal C, Prieur G, Debeaumont D, Robledo Quesada A, Combret Y, Quieffin J, Contal O, Lamia B. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial. BMJ Open Respir Res. 2016 Apr 12;3(1):e000130. doi: 10.1136/bmjresp-2016-000130. eCollection 2016.
Clinical trial NCT05023122: The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
Official title: The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D
Spinal Fusion
Lumbar Spine Disease
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.However, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin D supplements in spinal fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 80 years
* Indicated of elective spine fusion surgery for spinal stenosis or degenerative spondylolisthesis at the study hospital from January 2016 to December 2017.

Exclusion Criteria:

* Spinal instability due to trauma, infection, or malignancy
* History of previous spine surgery
* Hemodialysis
* Long-term steroid use
* History of medical treatments for osteoporosis
* Postoperative follow-up for less than 12 months
* Newly-onset compression fracture after study procedure

Primary outcomes:
measure: fusion rate at postoperative 1 year
timeFrame: postoperative 1 year
Secondary outcomes:
measure: time to fusion
timeFrame: from postoperative day 1 to postoperative 1 year
measure: spine function at postoperative 3 months
timeFrame: postoperative 3 months
measure: spine function at postoperative 6 months
timeFrame: postoperative 6 months
measure: pain at postoperative 3 months
timeFrame: postoperative 3 months
measure: pain at postoperative 6 months
timeFrame: postoperative 6 months
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital, Changhua, Taiwan
name: Pei-Yuan Lee, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hu MH, Tseng YK, Chung YH, Wu NY, Li CH, Lee PY. The efficacy of oral vitamin D supplements on fusion outcome in patients receiving elective lumbar spinal fusion-a randomized control trial. BMC Musculoskelet Disord. 2022 Nov 18;23(1):996. doi: 10.1186/s12891-022-05948-9.
Clinical trial NCT04581122: A Multiple-center Study on the Effect of Different Ways of Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With More Than 50% Solid Components
Official title: Zhongshan Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Progression
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 1500
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: OTHER

Brief summary: A multiple-center study on the effect of different ways of lymph node dissection on the prognosis of less than 3cm ground glass nodules with more than solid components


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 75 years;
2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
3. The maximum diameter of the GGO is smaller than 3cm;
4. The maximum diameter of the solid component in the GGO is more than 50%;
5. The patient is able to undergo the lobectomy
6. The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

-

Patients meeting any of the following criteria are not eligible for this trial:

1. Patients with a history of using immunosuppressive or hormonal drugs;
2. Patients receiving radiotherapy or chemotherapy;
3. Patients who fail to comply with our follow-up strategy;
4. Other situations that are not in conformity with the standards and requirements of this trial.

Primary outcomes:
measure: overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jiang Wei
Study officials:
affiliation: Fudan University
name: Jiang Wei
role: STUDY_DIRECTOR
References:
Clinical trial NCT01488422: Neural Correlates of Stress Reduction
Official title: Structural and Functional Mechanisms of Stress Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Psychological Stress
Life Stress
Emotional Stress
Social Stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Right-handed
* Stressed

Exclusion Criteria:

* Lifetime history of schizophrenia or psychosis
* Psychiatric illness
* History of seizure or significant head trauma
* Use of psychotropic medications
* Metallic implants or devices contraindicating magnetic resonance imaging
* Claustrophobia
* Pregnancy

Primary outcomes:
measure: Changes in gray matter structure
timeFrame: 8 weeks
Secondary outcomes:
measure: Emotion regulation
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sevinc G, Holzel BK, Greenberg J, Gard T, Brunsch V, Hashmi JA, Vangel M, Orr SP, Milad MR, Lazar SW. Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training. Biol Psychiatry. 2019 Nov 1;86(9):693-702. doi: 10.1016/j.biopsych.2019.05.017. Epub 2019 May 30.
Clinical trial NCT00305422: Effect of Quetiapine on Negative Symptoms and Cognition
Official title: Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 45
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 purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* men and women aged 18 to 65 years with diagnosis of schizophrenia
* score of at least 4 CGI, PANSS negative subscale score \> 21
* fulfil the criterion to be right-handed for inclusion in the fMRI investigations

Exclusion Criteria:

* Substance or alcohol dependence
* female patients who are pregnant, lactating or at risk of pregnancy
* history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions
* risk of suicide or aggressive behaviour
* history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor

For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as:

* existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.

Primary outcomes:
measure: Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12
Secondary outcomes:
measure: Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex.
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06585722: Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU Population
Official title: The Association Between Venous Excess Ultrasound, the Lung Ultrasound Score and Acute Kidney Injury and Death in the Intensive Care Unit Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fluid Overload
Kidney Injury
Make-30
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 136
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: All cricitally ill patients who are expected to be admitted to the ICU for more than 24 hours and who do not meet the exclusion criteria

Brief summary: Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.

Detailed description: This study will investigate the association between the venous excess ultrasound grading system (VExUS) and patient relevant outcomes such as acute kidney injury, mortality and length of stay.

A secondary analysis is planned where the association between VExUS and the lung ultrasound score will be investigated

Eligibility criteria: Inclusion Criteria:

* all patients admitted to the ICU 18 years or older expected to stay in the ICU for more than 24 hours

Exclusion Criteria:

* any obstruction between the righ atrium and structures assessed by VExUS
* a medical history of: Major cardiac shunts (e.g. atrial septum defect), Tricuspid regurgitation, dialysis, portal hypertension, pulmonary hypertension, interstitial lung disease, recipients of a kidney of liver transplant.
* patients in whom an ultrasound assesment is unfeasible e.g. a BMI over 40

Primary outcomes:
measure: Rate of acute kidney injury
timeFrame: within 30 days of admission to the ICU
measure: Mortality
timeFrame: within 30 days of admission to the ICU
measure: Rate of MAKE-30
timeFrame: within 30 days of admission to the ICU
Secondary outcomes:
Other outcomes:
measure: Lung ultrasound score
timeFrame: maximum of 3 times during the first 7 days of admission
measure: Cardiac function as assed by ultrasound
timeFrame: maximum of 3 times during the first 7 days of admission
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
References:
Clinical trial NCT04484922: Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
Official title: The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 160
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.


Eligibility criteria: Inclusion Criteria:

* Neonates undergoing cardiac surgery
* Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)

Exclusion Criteria:

* History of hypersensitivity of any drug
* Presence of hypotension or bradycardia considering age Bradycardia (heart rate \< 80 beats/min) or hypotension (systolic blood pressure \< 70mmHg for infants, \< 60mmHg for neonates)
* Elevated liver enzyme levels (aspartate transaminase \>100unit/L, alanine aminostrasferase \> 50 unit/L)
* surgery with deep hypothermic circulatory arrest
* Presence of complex cardiac defect
* single ventricular physiology
* plan of additional operation within a year
* preoperative use of beta-agonists
* presence of history of any neurological disorder

Primary outcomes:
measure: Bayley scales of Infant development
timeFrame: 1 year after the surgery
Secondary outcomes:
measure: neurodevelopment biomarker
timeFrame: intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
measure: inflammation
timeFrame: 4 hours after end of surgery
measure: acute kidney injury
timeFrame: 2 hours after end of cardiopulmonary bypass
measure: myocardial injury
timeFrame: intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery
measure: anesthesia monitoring
timeFrame: intraoperative (from anesthetic induction to end of surgery)
measure: fluid management
timeFrame: intraoperative (from anesthetic induction to end of surgery)
measure: fluid management
timeFrame: intraoperative (from anesthetic induction to end of surgery)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
citation: Ji SH, Kang P, Song IS, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a prospective randomized controlled trial. Trials. 2022 Apr 8;23(1):271. doi: 10.1186/s13063-022-06217-9.