louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06130800: Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia
Official title: Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia: Prevalence and Associated Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Respiratory Function Impaired
Keywords: sarcopenia
respiratory force
institutionalized elderly
Lead sponsor: Catholic University of Murcia
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Institutionalized elderly diagnosed with respiratory sarcopenia

Brief summary: Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. A prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory force variables (MIP and PEF) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and KaplanMeier curves will be used to analyze the data from the longitudinal study.


Eligibility criteria: Inclusion Criteria:

* To have functional ambulation and/or wheelchair.
* preserved cognitive status.
* have sufficient ability to Oral occlusion for carrying out respiratory tests.

Exclusion Criteria:

* presence of respiratory diseases or in treatment of respiratory diseases.
* serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia.
* those who present any contraindication for carrying out the procedure will be excluded.
* of the respiratory pressure measurement tests, as established in the SEPAR guidelines.

Primary outcomes:
measure: Sociodemographic
timeFrame: 8 MONTHS
measure: Clinical variables
timeFrame: 8 MONTHS
measure: Palm grip strength
timeFrame: 8 MONTHS
measure: 5 SIT TO STAND
timeFrame: 8 MONTHS
measure: 4 METRES
timeFrame: 8 MONTS
measure: Body composition
timeFrame: 8 MONTHS
measure: Respiratoy muscle force
timeFrame: 8 MONTHS
measure: Diaphragmatic ultrasound variables
timeFrame: 8 MONTHS
Secondary outcomes:
measure: Health results
timeFrame: 8 MONTHS
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Residence of the elderly
Study officials:
References:
Clinical trial NCT06984900: How Short-Term Aerobic Exercise Affects Stress and Mood in Students
Official title: Investigating The Effect of Short-Term Aerobic Exercise on Stress and Mood Among Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Mental Health
Well-Being
Exercise
Stress
Mood
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to understand how short-term aerobic exercise affects mood and stress in university students. The research focused on healthy male and female students between the ages of 18 and 25. Participants were asked to complete two questionnaires: one to measure their mood and another to assess their stress levels. These questionnaires were filled out before, immediately after, and at several intervals up to 24 hours after a single session of aerobic exercise.The goal was to see whether exercise could quickly improve mood and reduce stress, and how long these effects might last. The study was carefully designed, and ethically approved. By focusing on immediate and short-term changes, the research highlights the potential benefits of exercise for mental well-being in young adults.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female students aged between 18 and 25 years.
* Ability to speak and understand written English.

Exclusion Criteria:

* Students who are pregnant or planning to become pregnant.
* Students who currently smoke.
* Students who respond "yes" to any of the seven questions on the Physical Activity Readiness Questionnaire (PAR-Q).
* Students taking medications for chronic diseases such as high blood pressure or diabetes.
* Students with a current or past diagnosis of a psychotic disorder.

Primary outcomes:
measure: Improvement in Total Mood Disturbance Following Short-Term Aerobic Exercise in University Students
timeFrame: TMD is assessed at eight time points: Before exercise (T0) Immediately after exercise (T1) At intervals: 1 hour (T2), 2 hours (T3), 4 hours (T4), 8 hours (T5), 12 hours (T6), and 24 hours post-exercise (T7).
measure: Perceived Stress Levels Following Short-Term Aerobic Exercise in University Students
timeFrame: Assessed at two time points: Before exercise (T0) 24 hours after exercise (T7).
Secondary outcomes:
Other outcomes:
Locations:
city: Buraydah
country: Saudi Arabia
facility: Qassim University, in Qassim University Medical City, the Kingdom of Saudi Arabia (KSA).
Study officials:
References:
Clinical trial NCT04556500: Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
Official title: Psychometric Properties of the Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Genetic Disease
Metabolic Disease
Delays Developmental
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Parent who have 18-42 months child
* Volunteers

Brief summary: This study aimed to translate the Affordance in the Home Environment for Motor Development -Toddler (AHEMD-T) into Turkish and examine its psychometric properties.

Detailed description: Child motor development is a complex process which results from the interaction between genetics and the environment. The role of the home as the first environment for child experiences is very important for motor development, especially during infancy. Thus, a more supportive and stimulating environment is associated with more affordances and challenges for infant motor development that may lead to improvement in social and cognitive development.

There is no Turkish questionnaire to evaluate home environment so we aimed to translate the AHEMD-T for using with Turkish children and to investigate psychometric properties.

Eligibility criteria: Inclusion Criteria:

* Parent who have 18-42 months child
* Volunteers

Exclusion Criteria:

* Parents who are not willing to participate in the study

Primary outcomes:
measure: Affordance in the Home Environment for Motor Development-Toddler (AHMED-T)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University
Study officials:
affiliation: Hacettepe University
name: Ayşe Numanoğlu Akbaş, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang AW, Liao HF, Granlund M, Simeonsson RJ, Kang LJ, Pan YL. Linkage of ICF-CY codes with environmental factors in studies of developmental outcomes of infants and toddlers with or at risk for motor delays. Disabil Rehabil. 2014;36(2):89-104. doi: 10.3109/09638288.2013.777805. Epub 2013 Apr 17.
citation: Carl G, Priscila M, Cacola. A New Inventory For Assessing Affordance in the Home environment For Motor Development. Early Childhood Edu J 2008;36(1):5-9.
Clinical trial NCT04143100: Anxiety and Symptom Burden in Hemodialysis Patients
Official title: Anxiety, Symptom Burden, and Dialysis Adherence in In-center Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
ESRD
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment at The Rogosin Institute (Rogosin) hemodialysis treatment facilities.

Brief summary: Anxiety has been identified as a prevalent and significant co-morbid condition in patients with End Stage Renal Disease (ESRD) being treated with hemodialysis. In particular, anxious sensitivity to symptoms commonly experienced by dialysis patients may lead patients to prematurely terminate their dialysis sessions and may have consequences on their dialysis adequacy and overall quality of life.

The proposed study will examine the relationships between anxiety, depression, quality of life, symptom burden and dialysis prescription adherence. The primary regression analyses will be used to predict the influence of anxiety and depression (independently and together) on measures of adherence behaviors.

Detailed description: Additional analyses will examine the relationship of elevated anxiety and depression scores on symptom burden, QOL, and other measures of dialysis adherence. Retrospective data of the preceding three months will be used to calculate measures of dialysis adherence (shortening and skipping) and clinical parameters.

Eligibility criteria: Inclusion Criteria:

* Receiving In-center hemodialysis

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: This is a cross-sectional study, with anxiety scores being correlated with previous 6 months of adherence data
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Daniel Cukor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01634100: Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid
Official title: A Randomised, Open-label, Three-way Crossover Trial to Investigate the Effect of Rifampicin and Probenecid on Empagliflozin Pharmacokinetics in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.


Eligibility criteria: Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

Primary outcomes:
measure: Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose
measure: Total Empa: Maximum Measured Concentration (Cmax)
timeFrame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose
Secondary outcomes:
measure: Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
timeFrame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1245.83.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1.
Clinical trial NCT02372500: Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Official title: Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Surgery
Lead sponsor: Countess of Chester NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.

Detailed description: Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.

The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).

The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

Eligibility criteria: Inclusion Criteria:

* Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent

Exclusion Criteria:

* Emergency colorectal surgery, unable to consent

Primary outcomes:
measure: Bowel function (as assessed by questionnaire)
timeFrame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)
Secondary outcomes:
measure: Diet (as assessed by questionnaire)
timeFrame: Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)
measure: Length of stay
timeFrame: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days)
measure: Post op nausea and vomiting score (as recorded by visual analogue scale)
timeFrame: Recorded daily for first 5 days
measure: Morbidity
timeFrame: Days (recorded up to 30 days and defined by Clavien-Dindo scale)
Other outcomes:
Locations:
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
state: Cheshire
Study officials:
affiliation: Countess of Chester
name: Dale Vimalachandran, MD FRCS
role: STUDY_DIRECTOR
affiliation: Countess of Chester
name: Rachel Clifford, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03695900: Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
Official title: Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Prematurity
Desaturation of Blood
Central Apnea
Periodic Breathing
Obstructive Apnea of Newborn
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2018-10-04
Enrollment: 19
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2, 93-95% vs 90-92%) on ventilatory stability in premature infants.
Primary purpose: OTHER

Brief summary: This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).


Eligibility criteria: Inclusion Criteria:

* 23 0/7- 29 6/7 weeks gestational age
* Postnatal age ≥ 14 days
* Requiring FiO2 ≥ 0.25 to keep SpO2 90-95%
* Parental informed consent

Exclusion Criteria:

* Severe congenital anomalies that may affect pulmonary or neurosensory development
* Severe CNS pathology that may alter respiratory control function

Primary outcomes:
measure: ventilatory stability by frequency of central apnea
timeFrame: 2 hours
measure: ventilatory stability by frequency of obstructive apnea
timeFrame: 2 hours
measure: ventilatory stability by density of periodic breathing
timeFrame: 2 hours
measure: ventilatory stability by time series of inter-breath intervals
timeFrame: 2 hours
Secondary outcomes:
measure: oxygenation stability by frequency of intermittent hypoxemia episodes
timeFrame: 2 hours
measure: frequency of bradycardia episodes
timeFrame: 2 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Holtz Children's Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Nelson Claure, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Eduardo Bancalari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Deepak Jain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jackson Health System
name: Waleed Kurtom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurtom W, Dormishian A, Jain D, Schott A, Aguilar AC, Grieb G, Bancalari E, Claure N. Effect of the Target Range on Arterial Oxygen Saturation Stability in Extremely Premature Infants. Neonatology. 2022;119(5):638-643. doi: 10.1159/000525271. Epub 2022 Aug 26.
Clinical trial NCT04127500: The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery
Official title: The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dexmedetomidine
Delirium
Cardiac Surgery
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate the roles of α7nAchR in the mechanisms of dexmedetomidine in improving delirium after cardiac surgery. The results of this study would lay the foundation for revealing the mechanisms of dexmedetomidine improving delirium after cardiac surgery and provide a new idea to the early treatment of delirium.


Eligibility criteria: Inclusion Criteria:

* ICU patients underwent cardiac surgery
* age ≥ 60 years

Exclusion Criteria:

* Preoperative cognitive decline, mental illness,
* preoperative long-term use of hormone patients,
* preoperative alcohol dependence,
* patients with alcohol withdrawal symptoms

Primary outcomes:
measure: delirium incidence
timeFrame: 1 month
measure: α7nAChR level
timeFrame: 7 days
Secondary outcomes:
measure: mechanical ventilation time
timeFrame: 7 days
measure: ICU stay time
timeFrame: 1 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03686800: The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
Official title: The Comfort and Adherence of Rivelin® Plain Patches in Vulva Lichen Sclerosus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Lichen Sclerosus
Keywords: VLS
Lead sponsor: Dermtreat
Sponsor class: INDUSTRY
Collaborators: name: Larix A/S
First posted: 2018-09-27
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This explorative investigation will assess the adhesion and tolerability of the Rivelin® plain patch when applied directly on lesions in subjects with Vulvar Lichen Sclerosus (VLS).

Detailed description: The Rivelin® plain patch works by forming a protective barrier over a lesion, protecting it from further irritation and thus providing pain relief in much the same way as the adhesive pastes and films that are available to treat VLS. However, the adhesion/protection time of the Rivelin® plain patch is expected to be longer compared to current treatment with bioadhesive agents, thereby potentially increasing the pain free period for the subject.

This study is undertaken to gather information covering adhesion time and tolerability of the Rivelin® plain patch on areas affected by VLS. Since protecting a lesion with a physical barrier could reduce the sensation of pain caused by normal function, this investigation will also explore subject experienced pain and/or symptom relief during use of the patch for further development.

Eligibility criteria: Inclusion Criteria:

1. Women (≥ 18 years) diagnosed with VLS
2. Has received written and oral study information
3. Has given her written consent to study participation

Exclusion Criteria:

1. Pregnant
2. Menstruating at the time of patch application
3. Unable to communicate clearly with the examining doctors
4. Under the guardianship of another person or institution

Primary outcomes:
measure: Adhesion time for Rivelin® plain patches
timeFrame: 2 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 2 days
measure: Ability to apply patches correctly
timeFrame: 2 days
measure: Understanding of the Instructions for use leaflet
timeFrame: 2 days
measure: Visual analogue scale (VAS) scores
timeFrame: 2 days
measure: Optimising the design of the patch
timeFrame: 2 days
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Dermatology dpt.
Study officials:
affiliation: Zealand University Hospital, Dermatology dpt.
name: Gregor B.E. Jemec, MD
role: PRINCIPAL_INVESTIGATOR
References: