louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00784095: Outlook Quality of Life Intervention
Official title: Outlook: An Intervention to Improve Quality of Life in Serious Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-11-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.

Detailed description: This is a pilot randomized control trial to evaluate the feasibility of the Outlook intervention. 36 veterans with advanced cancer, congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures. Subjects in the first group ("treatment") will meet with a facilitator three times for a period of 45 min-1 hour. In the first session, subjects will be asked to discuss issues related to life review. In the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, In the final session, subjects will focus on heritage and legacy. The subjects in the second group ("attention control") will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation compact disk (CD). The third group of participants ("true control") will be exposed to no intervention or attention control. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

Eligibility criteria: Inclusion Criteria:

Patients with advanced cancer, CHF or COPD.

Exclusion Criteria:

Cognitive impairment, inability to speak, non-English speaking

Primary outcomes:
measure: Quality of Life - Preparation
timeFrame: Baseline, 6 and 8 week follow up
measure: QUAL-E Completion Sub-scale
timeFrame: Baseline, 6 and 8 week follow up
Secondary outcomes:
measure: Functional Status ADL
timeFrame: Baseline, 6 and 8 week follow ups
measure: Center for Epidemiology Studies - Depression Scale (CES-D)
timeFrame: Baseline, 6 and 8 week follow up
measure: POMS Anxiety Sub-scale
timeFrame: Baseline, 6 and 8 week follow ups
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center HSR&D COE
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center HSR&D COE
name: Karen E. Steinhauser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. J Am Geriatr Soc. 2014 Jun;62(6):1082-90. doi: 10.1111/jgs.12841. Epub 2014 May 6.
Clinical trial NCT06619795: Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease
Official title: Combined Effect of tDCS and Motor or Cognitive Activity in Patients With Alzheimer's Disease: A Proof-of-Concept Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease (AD)
Keywords: Transcranial Direct Current Stimulation
Motor Activity
Cognitive Stimulation
Alzheimer's disease
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of combining tDCS with motor or cognitive activities on cognitive functions in patients with AD. Second aim is to investigate if tDCS has a different impact if it is combined with motor or cognitive activities.


Eligibility criteria: Inclusion Criteria:

* Mini Mental State Examination (MMSE) major or equal to 15;
* good level of compliance;
* acetylcholinesterase inhibitor treatment (e.g., donepezil, rivastigmine);
* no modifications of medication during the last four months.

Exclusion Criteria:

* behavioral disorders (e.g., aggressiveness);
* alcohol abuse;
* orthopedic pathology with risk of falls to the ground;
* respiratory pathology;
* severe auditory or visual deficits uncorrected;
* history of epileptic fits;
* anti-epileptic medication;
* metallic body implants; pacemaker;
* psychiatric, neurologic, systemic or metabolic disorders.

Primary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: From enrollment to the end of treatment at two weeks
Secondary outcomes:
measure: Picture Recognition (PR)
timeFrame: From enrollment to the end of treatment at two weeks
measure: Digit Span Test- Forward (DSF)
timeFrame: From enrollment to the end of treatment at two weeks
measure: Digit Span Test- Backward (DSB)
timeFrame: From enrollment to the end of treatment at two weeks
measure: Phonemic Fluency Test (PFT)
timeFrame: From enrollment to the end of treatment at two weeks
measure: Visual Search Test (VST)
timeFrame: From enrollment to the end of treatment at two weeks
measure: Sustained Attention to Response Test (SART)
timeFrame: From enrollment to the end of treatment at two weeks
measure: Neuropsychiatric Inventory (NPI)
timeFrame: From enrollment to the end of treatment at two weeks
Other outcomes:
Locations:
city: Mantova
country: Italy
facility: Mons. A. Mazzali Foundation
Study officials:
References:
Clinical trial NCT00664495: Reduction of Abdominal Obesity and Insulin Resistance in Women
Official title: Reduction of Abdominal Obesity and Insulin Resistance in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity, exercise, diet, insulin resistance
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-04-23
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to assess the effects of equivalent diet- or exercise-induced weight loss and related insulin resistance in abdominally obese women.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women

Exclusion Criteria:

* Smokers and diabetics

Primary outcomes:
measure: Abdominal Obesity
timeFrame: 4 months
measure: Insulin Resistance
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross R, Janssen I, Dawson J, Kungl AM, Kuk JL, Wong SL, Nguyen-Duy TB, Lee S, Kilpatrick K, Hudson R. Exercise-induced reduction in obesity and insulin resistance in women: a randomized controlled trial. Obes Res. 2004 May;12(5):789-98. doi: 10.1038/oby.2004.95.
Clinical trial NCT05837195: Diastolic Deceleration Area in Late-onset FGR
Official title: Diastolic Deceleration Area (DDA) in Late-onset Fetal Growth Restriction (FGR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxia
Anemia
Lead sponsor: Orthogyn Medical Center, Bulgaria
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant subjects only

Brief summary: DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Late-onset FGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an essential role in detecting hypoxia, anemia, and other adverse neonatal outcomes.


Eligibility criteria: Inclusion Criteria:

* absence of fetal abnormalities and/or genetic conditions;
* single pregnancy;
* fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms, appearing after 32nd week of gestation

Exclusion Criteria:

* documented fetal abnormalities and/or genetic conditions in the course of the pregnancy;
* multiple pregnancy;
* absence of fetal growth restriction (FGR) \< 10%, according to the INTERGROWTH 21st nomograms after 32nd week of gestation

Primary outcomes:
measure: Hypoxia in the newborn
timeFrame: immediately after delivery
measure: Anemia in the newborn
timeFrame: immediately after delivery
measure: Occurence of hypoxic-ischemic encephalopathy
timeFrame: first 72 hours after delivery
Secondary outcomes:
measure: Apgar score at 1st minute
timeFrame: 1 minute after delivery
measure: Apgar score at 5th minute
timeFrame: 5 minutes after delivery
measure: Apgar score at 10th minute
timeFrame: 10 minutes after delivery
measure: Admissions to a NICU
timeFrame: first 72 hours after delivery
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Orthogyn Medical and Dental Center
Study officials:
affiliation: Orthogyn Medical Center
name: Petar N Ignatov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059395: Mastery Learning Versus Time-based Education: Skill Acquisition and Retention of Basic Life Support in Laypeople
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basic Life Support
Cardiac Arrest
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background:

In cardiac arrest survival rates dramatically increase when bystanders are present and initiate Basic Life Support (BLS). However, even though serious efforts have been made, skill retention after a traditional time-based BLS course for laypeople remains suboptimal. In contrast, a mastery learning-based educational approach was shown to be efficacious and might be promising even for laypersons. Therefore the investigators aim to evaluate the impact of a mastery learning-based BLS course on skills retention of BLS in laypeople.

Methods:

Forty laypeople without previous BLS experiences will be randomized into the traditional time-based BLS course group (Control - TB group) or mastery learning-based group (Intervention - ML group).

Both groups will receive BLS training consisting of 6 successive stations including diagnosis of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer BLS and AED use. In the ML group, subjects will deliberately practice and receive feedback at each station until a pre-set target level is reached. Subjects will be allowed to proceed to the next station only when they achieve the required target level of performance. In contrast, participants of the TB group will be taught the same 6 stations in two hours, according to standard American Heart Association BLS criteria. All subjects will have an assessment of knowledge and skills immediately after teaching (immediate post-test) and at four months (retention post-test).

Implications:

Previous research has shown that mastery learning-based education improves learners' procedural skill performance. The investigators study will determine the impact of a mastery learning-based BLS course on skill retention in laypeople.


Eligibility criteria: Inclusion Criteria:

* University students in Ottawa

Exclusion Criteria:

* Students of the Faculty of Medicine
* Previous Basic Life Support Training Certificate

Primary outcomes:
measure: Skill Retention Estimated From the Change of AHA Heartsaver Total Score From Immediate Post-test to Retention Test
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Skills and Simulation Centre
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Sylvain Boet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00500695: Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
Official title: Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.

Detailed description: See Brief Summary above.

Eligibility criteria: Inclusion Criteria:

* Current smokers must be over the age of 18,
* Must have a diagnosis of schizophrenia or schizoaffective disorder
* Must smoke at least 10 cigarettes per day
* Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22

Exclusion Criteria:

•Those unable to give informed consent.

Primary outcomes:
measure: Attendance at first smoking cessation session
timeFrame: one month
Secondary outcomes:
measure: Cigarettes per day
timeFrame: 1-Month Follow Up
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ- Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Marc L. Steinberg, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06246695: A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
Official title: A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers aged between 18 and 45 years old;
* Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);
* The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;

Exclusion Criteria:

* The participant were deemed unsuitable for participating in the study by the investigator for any reason.

Primary outcomes:
measure: Cmax
timeFrame: Up to 32 Days
measure: AUC
timeFrame: Up to 32 Days
measure: Adverse Events
timeFrame: Up to 32 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT06873295: Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Unit in Subjects Over and Under 75 Years
Official title: Evaluation of the Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Intraoperative Unit in Subjects Over and Under 75 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 424
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the digestive surgery department and geriatric perioperative unit of the CHU de Nîmes with a diagnosis of acute cholecystitis.

Brief summary: The management of these often frail elderly patients, with more comorbidities and declining functional capacities, is more complex and justifies a specific, tailored approach.

Age is also associated with an increasing prevalence of gallstones. The disadvantages of "cold" surgery (longer hospital stay, higher cost, risk of disease recurrence in the interim, difficult surgery with more scar tissue due to repeated inflammation) have to be weighed against the high operative risk in the case of emergency surgery, leading to strict criteria for early cholecystectomy.

These criteria are rarely met in geriatric patients, who thus enter a hospital cycle whose impact on morbidity and mortality, as well as on loss of autonomy, has been demonstrated in this population. What's more, the deteriorating general condition of frail elderly patients means that a number of them end up being definitively rejected for surgery, despite an initial strategy of cold cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age.
* Diagnosis of acute cholecystitis.
* Hospitalization in the digestive surgery department and geriatric perioperative unit of Nîmes University Hospital.

Exclusion Criteria:

* Patients under 18 years of age.
* Opposition of the patient to his inclusion in the study after sending the letter of information and non-opposition.

Primary outcomes:
measure: Rate of patients with an initial cold cholecystectomy strategy who did not undergo surgery, died or underwent emergency surgery
timeFrame: Up to 6 months, from date of first collection to date of end of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Simonet Anne Clarisse
Study officials:
References:
Clinical trial NCT00715195: Improving Quality of Life of Fibromyalgia Patients
Official title: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Cognitive behavioral
Long-term study
Education
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2008-07-15
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in "Plurifocal educational group" than in control group

Detailed description: Comparing two forms of non-drug treatment of fibromyalgia: "Information" (an information group session on the fibromyalgia management modalities) versus "Plurifocal educational program " (intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy).

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia Patients according to the criteria of the American College of Rheumatology defined by:

  * diffuse pain evolving for over three months
  * pain on palpation of at least 11 of the 18 sites listed
* age between 18 and 65
* FIQ Score higher than 35/100 at inclusion
* Ability to respond to questionnaires
* monitoring possibility for at least a year
* Affiliation to the French Health System (social security)

Exclusion Criteria:

* Association with chronic pain from other sources which can interfere with fibromyalgia assessment
* Inability to follow the full educational program
* previous participation in an educational program of same nature
* psychological disorder (personality disorder or behaviour, schizophrenia), preventing participation in the program group

Primary outcomes:
measure: Score of the Fibromyalgia Impact Questionnaire, at one month and twelve months after program end
timeFrame: one month and twelve months after program end
Secondary outcomes:
measure: Pain Numeric scale,Number of tender points, Sleep quality numeric scale,Pain Impact Questionnaire ANAES,STAI-Y anxiety questionnaire,Beck Depression Index II,Coping Strategy Questionnaire,Multidimensional self-assessment(SF36, PSOCQ)
timeFrame: one , six and twelve months after program end
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guy COICHARD, MD Ph
role: PRINCIPAL_INVESTIGATOR
References: