louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04409197: Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network
Official title: Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comorbidities
Confinement
Obesity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 4789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from patients enrolled in a Nutritional Psycho-Behavioural Re-education (RNPC) programme in one of the RNPC centres in France.

Brief summary: During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption.

The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).


Eligibility criteria: Inclusion Criteria:

* BMI \> 25 kg/m² and/or waist circumference \> 80 cm in women and 94 cm in men
* Persons registered in the RNPC program
* Be legally able to give consent after adequate information and submission of the information note
* Person affiliated to social security

Exclusion Criteria:

* Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.

Primary outcomes:
measure: Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France
timeFrame: 3 months
Secondary outcomes:
measure: Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight
timeFrame: 3 months
measure: Evolution of blood pressure before versus after confinement
timeFrame: 3 months
measure: Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement
timeFrame: 3 months
measure: Evaluate the impact of teleconsultation monitoring during containment on weight loss
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02927197: LearningRx Brain Training for Children 8-14
Official title: A Randomized, Controlled Study on the Effects of LearningRx Brain Training for Improving Cognitive Skills in Students Ages 8-14
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning Problems
Lead sponsor: Gibson Institute of Cognitive Research
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 39
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine changes in multiple cognitive skills after completing 60 hours of cognitive training with ThinkRx, a LearningRx program.

Detailed description: In a two-phase randomized controlled study, investigators will examine the effects of a one-on-one cognitive training program on memory, visual and auditory processing, processing speed, reasoning, attention, and General Intellectual Ability (GIA) score for students ages 8-14. In Phase 1, participants will be randomly assigned to either an experimental group to complete 60 hours of one-on-one cognitive training or to a wait-list control group. In Phase 2, the wait-list control group will complete the intervention using an alternative delivery model: 50% clinician delivered and 50% digital delivery.

Eligibility criteria: Inclusion Criteria:

* Between 8-14 years of age, living in the greater Colorado Springs area, screening GIA score between 70 and 130

Exclusion Criteria:

* None

Primary outcomes:
measure: Evidence of overall cognitive function improvement
timeFrame: within 14 days after completing the intervention
Secondary outcomes:
measure: Evidence of improvement in school performance
timeFrame: Within two years after completing the intervention
measure: Evidence of improvement in working memory
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in long-term memory
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in fluid reasoning
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in processing speed
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in visual processing
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in auditory processing
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in attention
timeFrame: within 14 days after completing the intervention
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Gibson Institute of Cognitive Research
state: Colorado
Study officials:
affiliation: University of Colorado, Colorado Springs
name: Dick M Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carpenter DM, Ledbetter C, Moore AL. LearningRx Cognitive Training Effects in Children Ages 8-14: A Randomized Controlled Trial. Appl Cogn Psychol. 2016 Sep-Oct;30(5):815-826. doi: 10.1002/acp.3257. Epub 2016 Aug 2.
Clinical trial NCT04727697: Augmented Reality Perioperative Training and Patient Satisfaction
Official title: Patient Reported Outcomes, Satisfaction, and Understanding Following Orthopaedic Ambulatory Procedures Using Augmented/Virtual Reality as an Education Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* All patients 18 years old or greater
* Patients who have a scheduled ambulatory procedure with University of Miami Orthopaedic providers.

Exclusion Criteria:

* Any patient not scheduled for procedures
* Minors
* Cognitively incapacitated
* Prisoners.
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Primary outcomes:
measure: Change in Anxiety as measured by the state-trait anxiety inventory (STAI)
timeFrame: Baseline, up to 14 days
Secondary outcomes:
measure: Change in comfort level as measured by perioperative comfort questionnaire
timeFrame: Baseline, up to 14 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lee Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04251897: Novel Support Surface to Alleviate Pressure Ulcer
Official title: Novel Support Surface Based on Smart Materials to Alleviate Pressure Ulcer Formation During the Rehabilitation of Immobile Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immobility Syndrome
Pressure Ulcer
Pressure Injury
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: A prototype support surface has been designed which aims to successfully redistributes the pressures exerted and provides sufficient support to human soft tissue

We want to prove the effectiveness of the prototype support surface by enlisting patients in a clinical trial, where we will assess the presence of pressure ulcers, and the ability of the patients to tolerate the support surface, and also measure the pressure over time and compare them to when the patients are using standard mattresses.


Eligibility criteria: Inclusion Criteria:

1. Patients must be immobile as assessed on the braden scale.
2. Patients must require 2 hourly turning
3. Age 21-85

Exclusion Criteria:

1. No existing pressure ulcers
2. No active infections, fever, or medical conditions that require constant medical attention.
3. They must also not have severe incontinence requiring the change of diapers more frequently than 4 hours
4. No significant cognitive impairment
5. Pregnant women will be excluded from the study

Primary outcomes:
measure: PTAUC
timeFrame: For a maximum of 14 days (duration of trial)
measure: Pressure sores - NPUAP (National Pressure Ulcer Advisory Panel) grade
timeFrame: For a maximum of 14 days (duration of trial)
Secondary outcomes:
measure: Patient's comfort
timeFrame: For a maximum of 14 days (duration of trial)
measure: Discomfort or pain
timeFrame: For a maximum of 14 days (duration of trial)
measure: Suggestions
timeFrame: For a maximum of 14 days (duration of trial)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital Rehabilitation Centre
Study officials:
affiliation: Tan Tock Seng Hospital
name: Chin Jung Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03168997: Memantine Treatment in Alzheimer's Disease Patients
Official title: Memantine Treatment in Alzheimer's Disease Patients Stratified With Behavioral and Psychological Symptoms of Dementia (BPSD) Symptoms and Cognitive Severity: A Multi-center, Open-label, Parallel-group and Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease Memantine
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 222
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether there will be any efficacy difference of Memantine treatment in different cognitive severity AD patients stratified with BPSD

Detailed description: Planed to enroll a total of 222 patients with mild, moderate or severe AD treated with Memantine in 2017-2018 from 15 centers.

Eligibility criteria: Inclusion Criteria:

1. Probable AD based on the diagnosis criteria of NIA-AA guideline (the U.S. National Institute on Aging and Alzheimer's Association guideline, McKhann et al, 2011\[8\];
2. Male or female, 50 years and older ;
3. All inpatients or outpatients recruited into this study must meet MMSE score ≤24 points, patients with MMSE score as 21-24 points will be enrolled into mild group, patients with MMSE score as 10-20 points will be enrolled into moderate group, patients with MMSE score less than 10 points will be enrolled into severe group.
4. Have a reliable caregiver who can accompany the patient to the site to complete the required study procedures;
5. Provide the informed consent.

Exclusion Criteria:

1. Patients with disturbance of consciousness of any causes;
2. Patients with severe aphasia or physical disability who were unable to complete neuropsychological examination;
3. Patients with mental illness;
4. Patients with a history of alcoholism and drug addiction, or traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus and other neurological disorders causing cognitive impairment;
5. Patients with systemic diseases causing dementia (e.g. liver and kidney insufficiency, endocrine disorders, vitamin deficiency);
6. Patients with a history of ischemic or hemorrhagic cerebrovascular diseases, and vascular diseases (stroke foci) as confirmed by imaging examination;
7. Subjects who are unwilling or unable to abide by the study requirement.

Primary outcomes:
measure: ADAS-cog change
timeFrame: ADAD-cog Change from baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02611297: Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Diseases
Interstitial Disease
Keywords: Cryoprobes
Cryobiopsy
Transbronchial lung biopsy
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Germans Trias i Pujol Hospital
First posted: 2015-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Patients with mechanical ventilation.
* Patients with diffuse lung disease of unknown etiology.
* Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
* Inform consent signed by family.

Exclusion Criteria:

* Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio \> 1.5).
* Comorbidities that could increase the risk of the TBLB.
* Bullous emphysema.
* Hemoptysis, pneumothorax.
* Severe respiratory insufficiency requiring PEEP \>12 cm H2O

Primary outcomes:
measure: Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
timeFrame: 27 months
Secondary outcomes:
measure: Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes
timeFrame: 27 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Tries i Pujol Hospital
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Virginia Pajares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965497: Escitalopram (Lexapro) for Depression MS or ALS
Official title: An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression
Multiple Sclerosis
Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
ALS
Multiple Sclerosis
MS
Major Depression
Depression
Major Depressive Disorder
antidepressants
Escitalopram
Lexapro
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

Detailed description: This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 70 years of age with documented ALS or MS,
* DSM-IV episode of non-psychotic Major Depression,
* ≥14 score on the 17-item HAM-D,
* Ability to give informed consent.

Exclusion Criteria:

* History of psychotic disorders,
* Psychotic depression,
* Bipolar depression,
* Suicide risk,
* History of substance abuse in the previous 6 months,
* History of unstable medical disorders,
* Pregnancy or planning for pregnancy,
* Severity of ALS or MS that limits participating in the study protocol.

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D 17).
timeFrame: 8 weeks
Secondary outcomes:
measure: McGill Quality of Life Scale (MQOL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina School of Medicine
state: South Carolina
Study officials:
affiliation: University of South Carolina School of Medicine
name: Meera Narasimhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19. doi: 10.1177/026921639500900306.
citation: Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. doi: 10.1212/wnl.52.7.1434.
Clinical trial NCT00721097: Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics
Official title: Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Chronic Inflammatory Diseases
Keywords: Severe asthma
exacerbation
predictive factors
Severe
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe asthma

Brief summary: Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. The aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.


Eligibility criteria: Inclusion criteria :

* Male or female adults aged ≥ 18 years, who have signed an Inform Consent Form prior to initiation of any study-related procedure
* Patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy

Exclusion criteria :

* Pregnant or nursing women
* Patients with other chronic inflammatory lung disease
* Current smoker or a smoking history of 10 pack years or more

Primary outcomes:
measure: Number of predictive factors for exacerbation outcome in severe asthmatics.
Secondary outcomes:
measure: Rate of predictive factors identified in the study, in order to prevent exacerbations.
Other outcomes:
Locations:
city: Nantes
country: France
facility: nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Antoine MAGNAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03115697: High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
Official title: High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Refractory Hepatic Encephalopathy
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .

Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)


Eligibility criteria: Inclusion Criteria:

* Cirrhotics
* Age between 18-70 years
* Hepatic encephalopathy -Grade 3-4
* Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4)

Exclusion Criteria:

* Concomitant participation in an other clinical trial
* Patient receiving sedatives(propofol,etc) 24 hours prior.
* Patients with severe cardiopulmonary disease
* Pregnancy
* Human Immunodeficiency Virus
* Hepatocellular Carcinoma or extrahepatic malignancy
* Active uncontrolled sepsis with hemodynamic instability
* Chronic renal insufficiency on treatment with haemodialysis
* Uncontrolled bleed or patients in DIC
* Extremely moribund patients with expected survival of less than 48 hours on high vasopressor support
* Patients with moderate-severe Acute Respiratory Distress Syndrome (ARDS).
* Patients with Non Hepatic Coma.

Primary outcomes:
measure: Resolution in Hepatic Encephalopathy by 2 grades in both groups
timeFrame: Day 5
Secondary outcomes:
measure: Improvement in Hepatic Encephalopathy in both groups
timeFrame: 2 years
measure: Number of days of mechanical ventilation in both groups
timeFrame: 2 years
measure: Survival in both groups
timeFrame: 28 days
measure: Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.
timeFrame: 2 years
measure: Proportion of patients with failure of standard medical therapy in both groups.
timeFrame: 48 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: