louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00888966: Oxidative Stress and Cardiac Arrest
Official title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Keywords: heart arrest
oxidative stress
lactic acid
outcome
Lead sponsor: Institut d'Anesthesiologie des Alpes Maritimes
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.

Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.

The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.


Eligibility criteria: Inclusion Criteria:

* Out of hospital cardiac arrest

Exclusion Criteria:

* refractory shock
* moribund patient
* resuscitation \> 60 minutes
* hypothermia \< 30 degrees

Primary outcomes:
measure: Oxidative stress markers and antioxidants after out of hospital cardiac arrest
timeFrame: 4 days
Secondary outcomes:
measure: Lactate after out of hospital cardiac arrest
timeFrame: 4 days
measure: Outcome after out of hospital cardiac arrest
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Carole Ichai, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04751266: Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)
Official title: Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Funnel Chest
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Friedrich-Alexander-Universität Erlangen-Nürnberg
First posted: 2021-02-12
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.


Eligibility criteria: Inclusion Criteria:

* MIRPE

Exclusion Criteria:

* none

Primary outcomes:
measure: change of mean chromium values in blood (µg/l)
timeFrame: 4 years
measure: change of mean chromium values in urine (µg/l)
timeFrame: 4 years
measure: change of mean chromium values in tissue (µg/g)
timeFrame: 3 years
measure: change of mean nickel values in blood (µg/l)
timeFrame: 4 years
measure: change of mean nickel values in urine (µg/l)
timeFrame: 4 years
measure: change of mean nickel values in tissue (µg/g)
timeFrame: 3 years
Secondary outcomes:
measure: Observation of clinical reactions in correlation with elevated metal values
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatric Surgery
name: Caroline Fortmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594666: Visual Training for Improving Intermittent Exotropia Visual Function
Official title: Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intermittent Exotropia
Visual Functions
Keywords: visual training
visual function
intermittent exotropia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia.

The main question it aims to answer is :

Does the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia.

Researchers will compare intervention group to control group to see if VR/AR visual training could enhance stereoscopic vision function in children with intermittent exotropia.

Participants will:

The intervention group will receive 20 minutes of VR/AR visual training once a day for a period of one year.

Follow up check ups at the hospital every 3 months. Keep a diary of the values of stereoscopic vision function and Newcastle Control Score.


Eligibility criteria: Inclusion Criteria:

Aged 6 to 14 years. Intermittent exotropia meeting all of the following criteria: Exodeviation at least 10Δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10Δby prism and alternate cover test, mean distance Newcastle Control Score (NCS)≥2 points (mean of 3 assessments during the examination).

Refractive error between -5.00 D \< spherical equivalents (SEs) ≤ -1.00 D, astigmatism ≤1.50D, anisometropia ≤1.5D, best visual acuity in each eye of 1.0.

Not receiving any other form of strabismus or myopia treatment within 3 months. Willing to follow the research plan and participate in the entire research process.

Participants and guardians agree to be randomly assigned and sign an informed consent form.

Exclusion Criteria:

Vertical strabismus; Diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; Existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; Unable to cooperate with eye examination and follow-up work.

Primary outcomes:
measure: changes in stereoscopic vision function after 6 month
timeFrame: 6 months after baseline
measure: changes in stereoscopic vision function after 12 month
timeFrame: 12 month after baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05115266: Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
Official title: Efficacy of Animal-assisted Therapy in Patients With Borderline Personality Disorder and Addictions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnosis, Dual (Psychiatry)
Keywords: Animal-assisted therapy
Borderline personality disorder
substance abuse
Dual pathology
Residential treatment
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Animal-assisted therapy (AAT) is a complementary intervention of therapy that has shown positive results in the treatment of various pathologies. This study assesses the viability of the implementation and the effectiveness of an AAT program in patients diagnosed with borderline personality disorder and substance abuse disorder.

Our hypotheses are that participation in the TAA program will reduce negative symptoms, improve the quality of life of people with dual pathology, whose mental illness is schizophrenia, and increase adherence to treatment for people with dual pathology, whose mental disorder it's schizophrenia.

Detailed description: Animal assisted therapy (AAT) is a complementary intervention to therapy that presents positive results in the treatment of different pathologies. The study assesses the implementation and effectiveness of a TAA program in patients diagnosed with borderline personality disorder and substance abuse disorder.

Eligibility criteria: Inclusion Criteria:

* Meeting DSM-5 criteria for substance abuse disorder and the presence of borderline personality disorder.
* Voluntary participant in the study and having signed the informed consent

Exclusion Criteria:

* Patients whose functioning could be altered by factors not specifically related to addictive pathology or mental disorder (severe cognitive impairment, intellectual deficiency or language barrier)
* Animal-specific phobia

Primary outcomes:
measure: The Life Skills Profile questionnaire (LSP)
timeFrame: Change from Life Skills at 3-6-9 months (12 minutes)
measure: Barrat impulsiveness scale (BIS-11)
timeFrame: Change from impulsiveness at 3-6-9 months (12 minutes)
measure: Calgary Depresión Scale for Schizophrenia (CDSS)
timeFrame: Change from Depresión at 3-6-9 months (12 minutes)
measure: Rosenberg Self-Esteem Scale
timeFrame: Change from self-esteem at 3-6-9 months (12 minutes)
measure: Positive and negative symptom scale (PANSS)
timeFrame: Change from Positive and negative symptom at 3-6-9 months (12 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04326166: Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.
Official title: Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 1971
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 DM patients

Brief summary: Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes


Eligibility criteria: Inclusion Criteria:

1. The subject is aged ≥19 years
2. The subject has type 2 diabetes mellitus

Exclusion Criteria:

1. The subject has a contraindication

Primary outcomes:
measure: Change in HbA1c
timeFrame: at 12 weeks
Secondary outcomes:
measure: Change in HbA1c
timeFrame: at 24 weeks
measure: The percentage of patients with HbA1c <7.0% and <6.5%
timeFrame: at 12 and 24 weeks
measure: Change in FPG
timeFrame: at 12 and 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanggye paik pospital
state: Nowon-gu
Study officials:
References:
Clinical trial NCT02039466: The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Respiratory Complication
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification
* patients scheduled for laparoscopic colectomy

Exclusion Criteria:

* severe cardiopulmonary disease
* patients who cannot understand Korean

Primary outcomes:
measure: peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation
timeFrame: 40 minutes after pneumoperitoneum
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT00862966: Central Venous Catheter Lock Solution
Official title: Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacteremia
Lead sponsor: University Medical Center, Tuzla
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of end stage renal disease

Exclusion Criteria:

* Patients refusing randomization

Primary outcomes:
measure: lower incidence of infection
timeFrame: 1 year
Secondary outcomes:
measure: lower incidence of thrombosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Tuzla
country: Bosnia and Herzegovina
facility: Department of Dialysis
state: TK
Study officials:
References:
Clinical trial NCT01278966: Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
Official title: Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Diet
the Modified Atkins Diet
Ketogenic diet
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.

Detailed description: The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.

Eligibility criteria: Inclusion Criteria:

* age: 2-18 years
* At least 3 epileptic seizures per week
* Tried at least two anti-epileptic drugs without satisfactory seizure control
* Willing to try diet treatment for 6 months

Exclusion Criteria:

* Too difficult for the family to adhere to a strict diet
* Not able to fill in a seizure calendar
* Local authorities will not approve the treatment
* VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months
* Other disease where a diet high in fat is contra indicated
* Diet treatment is not possible because of poor intake of food or fluids
* Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month
* Patient has the last month used alternative medicine which may influence the diet
* Patient has tried the ketogenic fiet og Modified Atkins diet the last three years
* pregnancy

Primary outcomes:
measure: Seizure frequency
timeFrame: 6 months
Secondary outcomes:
measure: Ambulatory EEG
timeFrame: After 6 months
measure: Body Weight
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Ketosis
timeFrame: 6 months
measure: Dietary records
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Pb. 53
country: Norway
facility: The National Centre for Child Epilepsy
state: Bærum Postterminal
Study officials:
affiliation: Oslo University Hospital
name: Morten Lossius, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT04241666: Sonographic Examination of Renal Function in Individuals With Long-term Spinal Cord Injury
Official title: Comparison of Sonographic Examination of Renal Function With Gold-standard Examination in Individuals With Long-term Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Renal Insufficiency
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
Collaborators: name: Lotte und Adolf Hotz-Sprenger Stiftung
First posted: 2020-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with long-term lower urinary tract dysfunction due to spinal cord injury

Brief summary: Patients with long-term lower urinary tract dysfunction due to spinal cord injury presenting for a routine urodynamic control will be screened for inclusion and exclusion criteria. Suitable individuals providing written informed consent will undergo renal Doppler sonography and renal scintigraphy in addition to the routine examinations. Conclusions regarding renal function based on the clearance rate determined by scintigraphy (gold standard) will be compared with the conclusions based on Doppler sonography and Cystatin C clearance.


Eligibility criteria: Inclusion Criteria:

* long-term spinal cord injury (≥10 years)
* age ≥30 years
* written informed consent

Exclusion Criteria:

* dementia or severe intellectual impairment
* serious internal illness
* previous or current tumor disease
* known allergy to the radioactive marker (Technetium)
* pregnancy or breastfeeding
* withdrawal of informed consent

Primary outcomes:
measure: renal clearance
timeFrame: at the time of inclusion into study
Secondary outcomes:
measure: Cystatin C concentration
timeFrame: at the time of inclusion into study
measure: Cystatin C clearance
timeFrame: at the time of inclusion into study
measure: renal peak systolic velocity
timeFrame: at the time of inclusion into study
measure: renal peak enddiastolic velocity
timeFrame: at the time of inclusion into study
measure: renal resistive index
timeFrame: at the time of inclusion into study
Other outcomes:
measure: size of kidneys
timeFrame: at the time of inclusion into study
measure: renal tissue echogenicity
timeFrame: at the time of inclusion into study
measure: bladder evacuation method
timeFrame: at the time of inclusion into study
measure: lesion level
timeFrame: 1 year after spinal cord injury
measure: lesion severity
timeFrame: 1 year after spinal cord injury
measure: duration of spinal cord injury
timeFrame: at the time of inclusion into study
measure: age
timeFrame: at the time of inclusion into study
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Centre
name: Jens Wöllner, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04306666: Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain?
Official title: Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? Study Walant " Wide Awake Local Anesthesia No Tourniquet " Versus Axillary Brachial Plexus Block.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand Surgery
Wrist Surgery
Keywords: Regional anesthesia
Walant block
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults patients scheduled for hand or wrist ambulatory surgery

Brief summary: The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery.

The main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request.

The secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.

Detailed description: data will be collected on patient records and will be compared between groups of regional anesthesia.

Data will be :

* time to first analgesic request
* sensory block
* rescue analgesia during the first 24 hours after surgery
* maximal pain score during the first 24 hours after surgery
* patient satisfaction of managing care

Eligibility criteria: Inclusion Criteria:

- All adults patients scheduled for hand or wrist ambulatory surgery since 2016

Exclusion criteria:

- NA

Primary outcomes:
measure: duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: maximal pain score during the first 24 hours after surgery
timeFrame: 24 hours
measure: total rescue analgesia amounts the first 24 hours after surgery
timeFrame: 24 hours
measure: duration of sensory block
timeFrame: 24 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: olivier CHOQUET, PhD
role: STUDY_DIRECTOR
References: