louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00991536: Impact of Non Invasive Ventilation on Quality of Sleep
Official title: Impact of Non Invasive Ventilation on Quality of Sleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restrictive Pulmonary Disorders
Non Invasive Ventilation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 95
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with respiratory failure due to predominantly restrictive disorders submitted to NIV in preparation for long-term home ventilation and assessed between 1987 and 2008 at the Sleep laboratory.

Brief summary: Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but may also have a favorable impact on sleep structure. The investigators reviewed polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with restrictive pulmonary disorders, before and after implementing non-invasive ventilatory support.

Detailed description: Chart review of all patients with predominantly restrictive pulmonary disorders treated for respiratory failure by NIV at our institution between 1987 and 2008.

Data systematically recorded included pulmonary function tests, diurnal arterial blood gases, and polysomnography before and after implementation of nocturnal NIV.

Eligibility criteria: Inclusion Criteria:

* Patients with restrictive pulmonary disorders (neuro-muscular diseases, chest wall disorders, sequellae of tuberculosis) leading to hypercapnic respiratory failure requiring non invasive ventilation (NIV), investigated according to clinical standards in our institution by polysomnography before and after implementation of NIV

Exclusion Criteria:

* Patients fulfilling inclusion criteria for whom diagnostic polysomnography and/or polysomnography under NIV were not performed

Primary outcomes:
measure: Daytime arterial blood gases and Polysomnography before and after non invasive ventilation
timeFrame: Average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Daniel Rodenstein, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04959136: Feasibility Study Of Ambulatory Monitoring System
Official title: Feasibility Study Of Ambulatory Monitoring System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Monitoring
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2021-07-13
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.

Detailed description: This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.

Participation is expected to last no more than 72 hours.

Eligibility criteria: Inclusion Criteria:

1. Are able to provide written informed consent or have a legally designated representative provide written informed consent;
2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
3. Are an adult 18 years or older, or pediatric or neonate subject.

Exclusion Criteria:

1. Are known to be pregnant;
2. Are breastfeeding; OR
3. Are suffering from infections that require isolation.

Primary outcomes:
measure: User feedback
timeFrame: through study completion, average of one day per subject
measure: Collection of electronic parameter data
timeFrame: 2 hours up to 3 days
Secondary outcomes:
measure: Safety information
timeFrame: through study completion and issues resolved, average of one day per subject
Other outcomes:
Locations:
Study officials:
affiliation: Hospital District of Helsinki and Uusimaa
name: Rita Linko
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005736: Interventions to Improve Asthma Management/Prevention at School
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE

Brief summary: To design, develop, implement, and test the effectiveness of a three component health services and health education intervention for primarily Hispanic inner-city elementary school students at high risk for asthma morbidity and mortality.

Detailed description: BACKGROUND:

The study was part of an initiative "Interventions to Improve Asthma Management and Prevention at School". The Broad Agency Announcement was released in June, 1994.

DESIGN NARRATIVE:

The study used a randomized intervention trial to test the effectiveness of a comprehensive school-based asthma program to increase linkages with primary care physicians, to increase self-management activities, and to reduce morbidity associated with asthma. The study used a nested design in which the schools were the unit of design, allocation, and analysis. Effects were measured from aggregate data about students and data from school measures to control asthma. There were three components to the intervention. First, case finding for asthma through screening in both intervention and control schools. Second, a linkage management system that connected the child with a source of primary care and enhanced communication among the school nurse, the primary care physician, and parents. Third, the development and implementation of interactive multimedia and decision support system techniques to tailor individualized learning opportunities for children with asthma. The interventions occurred in the school setting and included tailored feedback for children, teachers, nurses, primary care providers, and the family. Assessments were made of the potential for diffusion of the components to target audiences.

Eligibility criteria: Inclusion:

School-aged children enrolled at participating schools

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Guy Parcel
References:
citation: Tortolero SR, Bartholomew LK, Tyrrell S, Abramson SL, Sockrider MM, Markham CM, Whitehead LW, Parcel GS. Environmental allergens and irritants in schools: a focus on asthma. J Sch Health. 2002 Jan;72(1):33-8. doi: 10.1111/j.1746-1561.2002.tb06509.x.
Clinical trial NCT00541736: Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Official title: Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hemiplegic Migraine
Keywords: Familial Hemiplegic Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
Collaborators: name: EUROHEAD
First posted: 2007-10-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to explore the importance of migraine genes on the headache/migraine responses after GTN in FHM-patients and healthy volunteers.

Detailed description: Glyceryl trinitrate (GTN) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. After systemic administration GTN is transformed to nitric oxide (NO). Treatment of spontaneous migraine attacks with an inhibitor of NO is effective in 60% of patients. These data show that NO is involved in both initiation and maintenance of migraine attack.

The importance of migraine genes is disputed. Evidence from FHM patients with known mutations indicates that migraine pathways in FHM may be different from normal migraine. The aim of the present study is to examine whether this difference also exists in FHM patients without known mutations. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of familial hemiplegic migraine (IHS-classification criteria)

Exclusion Criteria:

Patients and controls:

* A history of cerebrovascular disease and other CNS- disease
* A history of serious somatic and mental disease
* A history suggesting ischaemic heart disease
* A history of hypo- or hypertension
* Daily intake of medication apart from oral contraceptives
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

On the study day:

* No intake of a simple analgesic in the previous 48 hours
* No headache in the previous 48 hours

Primary outcomes:
measure: Migraine and associated symptoms
timeFrame: 0-14 h
measure: Migraine aura
timeFrame: 0 - 14 h
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
Study officials:
affiliation: Danish Headache Center
name: Jakob Møller Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04535336: Vitality Acupunch Exercise Program for Older Adults With Sarcopenia
Official title: Effects of the Vitality Acupunch Exercise Program on the Muscle Mass, Muscle Strength, and Sleep Quality of Older Adults With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Mass
Muscle Strength
Sleep Quality
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project was aimed to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia.

Detailed description: A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a VA experimental or a control group. The experimental group received the VA program led by certified instructors 3 times per week and 40 minutes per session for 6 months; the control group continued with their regular daily activities. One pre-test and two post-tests, 3 months apart, were conducted.

Eligibility criteria: Inclusion Criteria:

* age ≥ 65 years old
* have been living in the facility for at least 3 months
* intact cognitive function with the Short Portable Mental Status Questionnaire score ≥ 8
* hand-grip strength \< 28 kg for men and \< 18 kg for women
* calf circumference \< 34 cm for men and \< 33 cm for women

Exclusion Criteria:

* have spinal cord injury
* have severe cardiovascular or pulmonary diseases
* have musculoskeletal diseases

Primary outcomes:
measure: Muscle mass
timeFrame: 6 months
measure: Muscle strength
timeFrame: 6 months
Secondary outcomes:
measure: Sleep quality
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Kuei-Min Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214136: Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
Official title: A Phase II Prostate Cancer Trial Treating Pelvic Lymph Nodes to High Dose Using Intensity Modulated Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
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 examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).


Eligibility criteria: Inclusion Criteria:

* Prostate cancer stage T-T3
* Predicted risk of lymph node involvement \> 15%
* Gleason \> 7

Exclusion Criteria:

* Distance metastases
* Use of anti-coagulant therapy

Primary outcomes:
measure: Number of Participants Experiencing Expected Toxicities
timeFrame: Up to 5 years
Secondary outcomes:
measure: To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University Of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mark Ritter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741336: Electrophysiologic Changes in Blacks Treated With CBT for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2016-04-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is a highly prevalent, often debilitating, and economically burdensome condition. Reviews of the literature indicate that there are ethnic differences in sleep behavior, with African Americans objectively and subjectively reporting more disordered sleep than Caucasian Americans.Chronic insomnia can have a significant impact on mental and physical health outcomes and has been associated with impaired cognitive performance, particularly, in areas of speed, attention, working memory, and executive function. In order to understand the brain mechanisms in sleep disorder both during resting state as well as during cognitive processing, the investigators will assess resting state EEG (during eyes-closed and eyes-open conditions) as well as ERP tasks for assessing decision-making and reward processing. The primary objective of the study is to evaluate the effect of a tailored, telephone-delivered cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms of insomnia and its neurodynamic correlates.

Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to the tailored, telephone-delivered CBT-I, compared with those randomized to the self-monitoring control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia as measured by the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic improvement (ERP, ERO) in the intervention condition in response to laboratory paradigms Hyp 3: Greater improvement in psychosocial functioning including reduction in depression and increase in quality of life.


Eligibility criteria: Inclusion Criteria:

* A positive endorsement of insomnia items on the Sleep Disorders Questionnaire
* Self- reported race/ethnicity as black (men and women)
* Ages 30 to 50 years
* Accessible by telephone
* No plans to move away from the region within the year following enrollment
* Consent to participate.

Exclusion Criteria:

* Documented co-existing sleep apnea
* Self-reported use of sleep medication
* Impaired cognitive or functional ability precluding meaningful participation
* Stated intention to move within the same year of enrollment.

Primary outcomes:
measure: Sleep Diary
timeFrame: 2 months after enrollment
Secondary outcomes:
measure: QEEG tests of cognition
timeFrame: 2 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05583136: Restoring Neural Oscillatory Communication in Developmental Dyslexia
Official title: Restoring Neural Oscillatory Communication Between Dorsal and Ventral Visual Streams in Developmental Dyslexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Dyslexia
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Developmental dyslexia (DD) is a multifactorial disorder that hampers the education of about 10% of individuals across cultures and is associated to both phonological and visual deficits. The latter have been linked to a deficit in the magnocellular-dorsal (M-D) visual stream, that has a critical role in guiding the activity of ventral visual stream areas where letters identity is extracted. Here, we will test the efficacy of transcranial alternate current stimulation (tACS) of the M-D stream combined with reading trainings in adult participants with DD, assessing the neurophysiological underpinnings of these new trainings with EEG and fMRI/DTI.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age between 18 and 35)
* Official Diagnosis of Developmental Dyslexia (DD)
* Normal or corrected-to-normal vision and hearing
* Normal motor skills

Exclusion Criteria:

* Participants that cannot sign the consent form
* Participants unable to read or understand and correctly complete the procedures foreseen by the study
* Participants with a diagnosis or personal history of epilepsy or patients with a positive family history of epilepsy
* Pregnant or breastfeeding patients
* Participants with major psychiatric or neurological disorders and/or currently in psychopharmacological treatments.
* Participants with metal implants in the brain, pacemakers, brain stimulators, cochlear implants.
* Participants with claustrophobia (only for fMRI)

Primary outcomes:
measure: Reading score
timeFrame: Pre-training, 1-7 days post-training, follow-up at 1 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Luca Ronconi
Study officials:
References:
Clinical trial NCT05634213: Feasibility of Transepicardial Atrial Injection
Official title: Feasibility of Transepicardial Atrial Injection of Saline at the Time Open Chest Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Cardiac Surgery
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Single blind feasibility trial using a binary 'traffic light' design to evaluate the feasibility of injecting normal physiological saline into the atria of patients at the time of clinically indicated open chest cardiac surgery.

Detailed description: In this project, The investigators will see if patients can undergo successful transepicardial injection of saline at the time of cardiac surgery as compared to no injection. Patients will be randomised in a 1:1 allocation ratio using a parallel two-arm design. The study is designed to meet the following 3 feasibility objectives before proceeding: reasonable recruitment uptake, successful transepicardial injection of saline into the atria, and adequate retention of patients at follow-up.

Eligibility criteria: Inclusion Criteria:

Undergoing non-emergent open chest cardiac surgery for coronary artery bypass graft (CABG) and/or valve disease.

Exclusion Criteria:

1. Age less than or equal to 18 years of age.
2. Pregnant or breast feeding.
3. Patient is unable or unwilling to provide informed consent.
4. Patient is included in another randomized clinical trial.
5. A history of complex congenital heart disease.
6. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years.
7. Underwent ineligible procedures during or prior to operation (including atrial ﬁbrillation ablation, heart transplantation, pulmonary thromboendarterectomy, isolated thoracic aorta procedures, ventricular assist device insertion, extracorporeal membrane oxygenator insertion, and percutaneous valve replacement).
8. Patients for whom the investigator believes that the trial is not in the interest of the patient.

Primary outcomes:
measure: Recruitment uptake
timeFrame: 1 year
measure: Treatment fidelity
timeFrame: 1 year
measure: Participant retention (follow up)
timeFrame: 30 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Insitute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Darryl Davis
role: PRINCIPAL_INVESTIGATOR
References: