louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04753684: Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea
Official title: Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Harvard Medical School (HMS and HSDM)
name: Universiteit Antwerpen
First posted: 2021-02-15
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe OSA who underwent polysomnography and DISE at UZA in the last 3 years.

Brief summary: OBJECTIVES

To train and test a mathematical model to predict complete concentric collapse at the level of the palate (CCCp, primary) and other sites of upper airway collapse (secondary) during drug-induced sleep endoscopy (DISE) using the data captured during a diagnostic polysomnography (PSG).

HYPOTHESIS

The site, pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG.

STUDY DESIGN

Retrospective trial.

STUDY POPULATION

200 patients with moderate to severe obstructive sleep apnea (OSA, AHI ≥ 15/h) who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital (UZA) between January 2018 and December 2020.

OUTCOME MEASURES:

Raw data as captured during a diagnostic PSG, including electroencephalography (EEG), flow, electrocardiography (ECG), electromyography (EMG), oxygen desaturation and breathing effort.

SAMPLE SIZE / DATA ANALYSIS

Data of 200 patients will be retrospectively included into this study protocol. Different machine learning techniques will be adopted to select features, train the model and test the model.

TIME SCHEDULE

January 30, 2021 - November 30, 2021


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Diagnosis with symptomatic moderate to severe OSA (AHI ≥ 15/h).
* Underwent DISE at UZA as part of the clinical pathway for non-continuous positive airway pressure (CPAP) therapies
* Underwent a baseline diagnostic PSG at UZA max 2 years before DISE

Exclusion Criteria:

* Medication use related to sleeping disorders
* Central Sleep Apnea Syndrome.
* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, periodic leg movements, narcolepsy).
* Seizure disorder.
* Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
* Pregnancy
* \<4 h of data recording during the baseline PSG night

Primary outcomes:
measure: Airflow [l/s]
timeFrame: Retrospective, measured during the baseline polysomnography study
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
state: Antwerp
Study officials:
References:
Clinical trial NCT00173784: Development of an Instrumental Activities of Daily Living Scale
Official title: Development of an Instrumental Activities of Daily Living Scale for Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injury
Keywords: psychometrics
activities of daily living
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This study is to develop an IADL Scale for patients with SCI (IADL-SCI) and examine its psychometric properties in three years.

Detailed description: This study is to develop an IADL Scale for patients with SCI (IADL-SCI) and examine its psychometric properties in three years. In the first year, we will devote ourselves to the development of IADL-SCI - first version. About 150 patients will be recruited in this year.

In the second year, the study will be focused on investigating the psychometric properties of IADL-SCI in order to construct the formal version of IADL-SCI in about 120 patients with stable condition.

In the third year, we will be engaged in analyzing and comparing the psychometric properties of the three IADL scales (IADL-SCI, Frenchay Activities index, and Lawton IADL) to confirm that IADL-SCI is the best among the three. About 50 inpatients receiving rehabilitation will be recruited in this year.

Eligibility criteria: Inclusion Criteria:

patients with spinal cord injury

Exclusion Criteria:

patients with other major diseases (e.g., cancer)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School of Occupational Therapy, College of Medicine, National Taiwan University
Study officials:
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University
name: Jang Yuh, MPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389684: Clinical and Psycho-social Impact of COVID-19 Related Confinement on Patients With Digestive Tumors
Official title: Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemeotherapy
Immunotherapy
Treatment Mofidied
Coronavirus
Quality of Life
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 102
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: Patients under chemotherapy, immunotherapy or targeted therapy for a digestive tumor had their treatment modified during Coronavirus epidemia in France.

Brief summary: To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically proven digestive tumor
* Ongoing treatment from March,1st and April 30th

Exclusion Criteria:

* Patient refusal for enrollment in the study
* Patient not recognised legally competent

Primary outcomes:
measure: Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: MOULIN Valérie
city: Le Mans
country: France
facility: BOURGEOIS Hugues
city: Poitiers
country: France
facility: RANDRIAN Violaine
Study officials:
References:
Clinical trial NCT06216184: Adding Vortexing to the Maki Technique Provides no Benefit for the Diagnosis of Catheter-related Bacteremia
Official title: Adding Vortexing to the Maki Technique Provides no Benefit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter-related Bloodstream Infection
Lead sponsor: University Hospital of Canary Islands
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient recruitment was performed in the Intensive Care Unit

Brief summary: The investigators wanted to determine whether the combined use of vortexing and Maki techniques provides profitability versus the Maki technique for the diagnosis of catheter tip colonization and catheter-related bloodstream infection

Detailed description: BACKGROUND A previous study compared vortexing and Maki techniques for the diagnosis of catheter-related bloodstream infection (CRBSI), and concluded that vortexing was not superior to Maki method.

AIM To determine whether the combined use of vortexing and Maki techniques provides profitability versus the Maki technique for the diagnosis of catheter tip colonization (CTC) and CRBSI.

METHODS Observational and prospective study carried out in an Intensive Care Unit. Patients with suspected catheter-related infection (CRI) and with one central venous catheter for at least 7 days were included. The area under the curve (AUC) of the Maki technique, the vortexing technique and the combination of both techniques for the diagnosis of CTC and CRBSI were compared.

Eligibility criteria: Inclusion Criteria:

* Patients with suspicion of catheter-related infection (CRI) and with long term CVC (at least 7 days)

Exclusion Criteria:

* none

Primary outcomes:
measure: diagnosis of catheter related bloodstream infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Leonardo Lorente
state: Tenerife
Study officials:
References:
Clinical trial NCT04475484: Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children
Official title: Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Investigating Psychological Impact
Confinement Measures
Coronavirus Outbreak
School-age Children
Keywords: coronavirus epidemic
Children
Schooling
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 30000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon

Brief summary: The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement.

In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children.

In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.


Eligibility criteria: Inclusion Criteria:

* school-age children in the Academy of Lyon
* parental consent

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of children presenting signs of psychological suffering during confinement.
timeFrame: We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT04084184: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HGP1602 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Cmax of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
measure: AUClast of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Secondary outcomes:
measure: AUCinf of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
measure: Tmax of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
measure: t1/2 of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
measure: CL/F of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
measure: Vd/F of Dapagliflozin
timeFrame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT00246584: A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
Official title: Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Hypertension
angiotensin
renin
aliskiren
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)


Eligibility criteria: Inclusion Criteria:

* Diagnosed as essential hypertension -

Exclusion Criteria:

* Patients with secondary hypertension or suspected of having secondary hypertension.
* Patients suspected of having malignant hypertension
* Patients with any serious diseases or symptoms

Primary outcomes:
measure: Incidence of adverse events, vital signs, abnormal laboratory changes,etc.
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure after 52 weeks
measure: Change from baseline in systolic blood pressure after 52 weeks
measure: Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00979784: Better Weight-Better Sleep (BWBS) Trial
Official title: The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: obesity
primary care
Lead sponsor: Summa Health System
Sponsor class: OTHER
Collaborators: name: Northeastern Ohio Universities College of Medicine
name: Ross Products
First posted: 2009-09-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hypothesis of this study is that overweight and obese patients exposed to sleep focused counseling and standard dietary and exercise counseling will have better outcomes than similar patients exposed to standard dietary and exercise counseling only.

Detailed description: Objective: To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial. Methods: We randomized 49 overweight or obese adult patients either to a better weight (BW) cognitive behavioral intervention, or to a combination of the BW intervention and a better sleep intervention, better weight-better sleep (BWBS). Results: The BWBS group lost weight faster (P=.04), and coping self-efficacy accelerated (P=.01). Conclusions: These preliminary results merit replication in a larger primary care-based trial with a longer continuous intervention and followup period. Key words: obesity, sleep, weight loss, primary care, health behavior E Logue et al. Am J Health Behav. 2012;36(3):319-334 DOI: http://dx.doi.org/10.5993/AJHB.36.3.4

Eligibility criteria: Inclusion Criteria:

* BMI 25 to 39.9
* ages 18 to 84
* PCP permission
* patient in Family Medicine Center with an encounter in the last six months

Exclusion Criteria:

* various obesity and sleep related disorders

Primary outcomes:
measure: percent baseline weight lost
timeFrame: 16 weeks
Secondary outcomes:
measure: feasibility, variance-covariance estimates
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Akron
country: United States
facility: Family Medicine Center, Summa Health System
state: Ohio
Study officials:
References:
Clinical trial NCT05775484: Exercise to Slow Cardiovascular Ageing Progression
Official title: Exercise to Slow Cardiovascular Ageing Progression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Ageing
Exercise
Cardiovascular
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruited through research studies and community studies.

Brief summary: In ageing, deleterious alterations in cardiovascular (CV) structure and function increase risks of ageing-related cardiovascular disease (CVD). Investigators found that these CV alterations were associated with circulating serum metabolites, suggesting a metabolic basis to CV ageing. Investigators hypothesize that modification of these metabolites by intervention, such as exercise, may retard CV alterations and reduce CVD in ageing.

Detailed description: Participants from each stratum will be randomized to receive either an exercise program intervention or no exercise. At the start and end of study, participants will undergo cardiovascular imaging and metabolic profiling. Investigators will determine if exercise can reverse high-risk metabolic profiles and improve cardiovascular structure and function.

Without clear mechanisms to explain cardiovascular ageing nor interventions known to retard cardiovascular ageing, our approach will provide much needed translational evidence to incorporate targeted interventions aimed at reducing cardiovascular disease risk in older populations.

Eligibility criteria: Inclusion Criteria:

* Age \>=21 years old
* Outdoor ambulant

Exclusion Criteria:

* Wheelchair or bed-bound
* Dementia
* Residing in sheltered or nursing home
* Cancer
* Participation in ongoing clinical trials that involve interventional drugs or devices
* Aneurysms
* Acute infections (in the last six months)
* Uncontrolled thyrotoxicosis
* Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
* Uncontrolled asthma or chronic lung disease
* Restrictive lung disease

Primary outcomes:
measure: Metabolite profiles
timeFrame: 12 Months
measure: Cardiovascular structure and function
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
References:
Clinical trial NCT05087784: AlloLife - Life After Transplantation
Official title: AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Survivorship
Stem Cell Transplant Complications
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: Universität des Saarlandes
name: Institut Paoli-Calmettes
name: Medical University of Warsaw
name: University Of Perugia
name: Centre for Research and Technology Hellas
First posted: 2021-10-21
Enrollment: 192
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: Survivors of allo HCT can experience long-term survival, which is however limited by a number of late effects. These will be addressed in AlloLife to improve quality of life (QoL) and survival.

Detailed description: The complex intervention in AlloLife will consist of a set of technically-supported tools that will enable active care management through the patient and treating physician to improve QoL.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Patients with performed allogeneic stem cell transplantation any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen and at least at day +20 after HCT.
* Hematologic Remission after HCT at study entrance, MRD positive patients are allowed to enter the study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship to participate in the study
* Access to an internet connected device (smartphone/tablet/computer)
* Able to understand and communicate in the respective language
* Consent to use a wearable device through the time of the study
* Consent to use a chatbot application for both healthcare data exchange and psychologic intervention

Exclusion Criteria:

* Missing consent to use a wearable device and contribute personal data collected at the point of life to the study
* ECOG performance status of 4
* Relapse of the disease at study inclusion
* Uncontrolled systemic infection
* Diagnosis of a secondary malignancy requiring systemic therapy
* Reported ongoing severe depression or potential suicidal ideation
* Vulnerable patients such as: minor, persons deprived of liberty, persons in Intensive Care Unit unable to provided informed consent prior to the intervention
* Other ongoing interventional protocol that might interfere with the current study primary endpoint

Primary outcomes:
measure: Quality of Life as measured by the FACT-BMT score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: