louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03796715: Red Cell Distribution Width Versus Presepsin (Soluble CD14) as a Prognostic Marker in Critically-ill Sepsis Patients
Official title: Comparison of Red Cell Distribution Width Versus Presepsin (Soluble CD14) for Prognosis Assessment in Sepsis Patients Admitted to the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
presepsin
red cell distribution width
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the general ICU with sepsis or septic shock of both sexes between 18 and 65 years of age.

Brief summary: Presepsin (soluble CD14 subtype) is a novel marker with growing body of evidence supporting its accuracy and value for the diagnosis of sepsis. Patients with sepsis showed higher Prsepsin levels compared to those with SIRS. In addition the increase in Prsepsin levels correlates well with sepsis severity. Red cell distribution width variations are increased in a variety of medical conditions such as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia, critical illness, and cardiac arrest , and is a predictor of mortality in the general population. we aim to compare between Presepsin (soluble CD14) and RDW as prognostic markers in critically-ill patients with sepsis.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 65 years.
* Appropriate clinical data to enable classification into sepsis or SIRS according to Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
* Written informed consent by the patient or guardian

Exclusion Criteria:

* No informed consent
* Renal failure
* Liver failure
* Hematologic diseases
* Neutropenia
* Malignancy
* Chemotherapy during the previous 90 days.
* Patients using antibiotics at presentation

Primary outcomes:
measure: Mortality during intensive care unit stay
timeFrame: 28 days
Secondary outcomes:
measure: Length of ICU stay
timeFrame: assessed up to 3 months
measure: Need for readmission to ICU
timeFrame: assessed up to 3 months
measure: Ventilatory support duration
timeFrame: assessed up to 3 months
measure: Number of participants who need renal replacement therapy
timeFrame: assessed up to 3 months
measure: Number of participants who need inotropic or vasopressor support
timeFrame: assessed up to 3 months
measure: Transfusion requirements (blood and blood products)
timeFrame: assessed up to 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Ain Shams University
name: Ahmed Elsayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04806815: Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
Official title: Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Problem
Covid19
Fatigue
Keywords: Menstrual Problem
Covid19
Fatigue
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.

Brief summary: The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. The aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.

Detailed description: The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. It has been examined that menstruation volume decreased or cycle lengthened in one-fifth of women who had COVID-19, and this condition was more intense in those who had severe COVID-19. Studies have shown that the possible effects of COVID-19 on the female genital system often remain theoretical hypotheses. In the literature, there was no study in which menstrual dysfunctions and secondary problems caused by the state of inactivity entering our lives during pandemic were discussed in a wide spectrum of women who had COVID-19. Therefore the aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18 and 45,
* PCR test result positive confirmed having COVID-19 infection,
* Women had at least one period of Menstrual cycle after COVID-19
* Being an Internet connection,
* To be able to speak and write in Turkish.

Exclusion Criteria:

* To be in the premenaposual/postmenopausal period (to be in the transition period to menopause or in the period after menopause.)
* Having insufficient co-operation.

Primary outcomes:
measure: Menstrual Symptom Questionnaire
timeFrame: 1 day
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: 1 day
measure: Short Form Of Coronavirus Anxiety Scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Buket Akinci
role: STUDY_DIRECTOR
References:
Clinical trial NCT05403515: Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Official title: Effects of Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Foot massage
Aromatherapy massage
Happiness
Sleep quality
Fatigue
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world.

Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke.

Material and method: The present study is a randomized clinical study with a control group. Participants were randomly divided into three groups (foot massage + aromatherapy, aromatherapy, and control). The study was carried out with 91 patients diagnosed with stroke. The data were collected using Sociodemographic Status Survey, Oxford Happiness Questionnaire, Piper Fatigue Scale, Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were performed using SPSS (IBM SPSS Statistics 24) package program. The results were interpreted using frequency tables and descriptive statistics. Foot massage group was given 30min foot massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was given lavender oil inhaler during the foot massage.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were diagnosis of stroke at least 3 months, stroke levels of mild or moderate, no use of sleeping pill, volunteering in participation, not being allergic to aromatic oils, no problem with sense of smell, and no lung problem

Exclusion Criteria:

* Exclusion criteria were ulceration or lesion problem in foot, bone deformation in foot, history of allergy, cognitive or mental or language problems, difficulty in verbal communication, psychotic disorders, and not knowing the Turkish language.

Primary outcomes:
measure: foot massage changes improves happiness and sleep quality.
timeFrame: 1 month
Secondary outcomes:
measure: Lavender oil inhalation changes happiness and sleep quality
timeFrame: 1 month
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Sercan Altın
Study officials:
affiliation: OSMANİYE KORKUT ATA UNİVERSİTY
name: Kevser Sevgi Ü ASLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06677515: Improving Social Functioning in People with Substance Use and Mental Health Disorders Using VR
Official title: Improving Social Functioning in People with Substance Use and Mental Health Disorders Using Virtual Reality (ROPVR): Study Protocol for a Multi-centre, Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Mental Disorder
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ROPVR, a multi-centre, pragmatic randomized controlled trial (RCT) aims to evaluate a VR-technology which has been developed within an exploratory study and a development study, which facilitates social functioning among persons with a substance use and mental health disorder. Investigators will test a VR-program versus treatment as usual among patients enrolled into a long-term addiction-treatment facility. The RCT aims to evaluate the effectiveness of VR training compared to treatment as usual in improving resilience, quality of life, practical and social functioning and social participation (from baseline to 6 months), and to evaluate the cost-effectiveness of VR training versus treatment as usual.


Eligibility criteria: Inclusion Criteria:

* adults aged 18 years or older receiving in-patient SUD treatment in specialized addiction treatment units in South-East Norway. This may include persons serving prison sentences during in-patient treatment according to the Execution of Sentences Act in Norway
* having the capability to read, understand and sign the Norwegian informed consent form
* willing and able to attend VR training two times a week for 5 weeks

Exclusion Criteria:

* significant visual, auditory, or balance impairment or other diseases affecting safety during VR sessions (e.g., epilepsy)
* current clinically significant severe mental health disorder (e.g., acute episode of psychosis or current active suicidal plans). Persons with psychotic disorders or other severe mental illness are not excluded if their condition is stable.
* severe travel sickness as a proxy for simulation sickness

Primary outcomes:
measure: Health and disability
timeFrame: From enrolement into the study until ca. 6 month
Secondary outcomes:
measure: Practical and social functioning
timeFrame: From enrolement into the study until ca. 6 month
measure: Social participation
timeFrame: From enrolement into the study until ca. 6 month
measure: Resilience
timeFrame: From enrolement into the study until ca. 6 month
measure: Cost-effectiveness
timeFrame: From enrolement into the study until ca. 12 month
Other outcomes:
Locations:
city: Brumunddal
country: Norway
facility: Innlandet Hospital Trust
Study officials:
affiliation: Sykehuset Innlandet HF
name: Marja Leonhardt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03889015: Antibacterial Effect of Probiotic Yogurt Compared to Xylitol
Official title: Comparison of Antibacterial Effect of Probiotic Yogurt Against Xylitol-containing Chewing Gum on Salivary Streptococcus Mutans Count, Bacterial Adherence and Salivary pH in Geriatric Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Geriatric Patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate the antibacterial effect of probiotic bacteria in yogurt in decreasing streptococcus mutans count in saliva and plaque, decreasing bacterial adherence and increasing salivary pH compared to xylitol-containing chewing gum after three months.

Detailed description: The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months. The probiotic yogurt is (Activia; Danone, Egypt) containing Bifidobacterium (7x107 CFU/g). The subjects assigned to probiotic yogurt group will be instructed to eat 100 g of the provided yogurt 10 minutes after dinner and not to brush their teeth until one hour later. The subjects assigned to the xylitol-chewing gum group will be instructed to chew the provided gum three times daily for five minutes after each meal.

Eligibility criteria: Inclusion Criteria:

* Above 50 years old.
* Have sufficient cognitive ability to understand consent procedures.
* Males or Females.
* Co-operative patients.
* High caries risk patients (≥105 CFU for streptococcus mutans count)

Exclusion Criteria:

* Under antibiotic treatment
* Milk intolerant
* Consuming any other probiotic product
* Habitual consumers of xylitol products
* Use antibacterial mouthwash
* Lack of compliance
* Any systemic condition affecting salivary secretion

Primary outcomes:
measure: streptococcus mutans count in saliva
timeFrame: 3 months
Secondary outcomes:
measure: streptococcus mutans count in plaque
timeFrame: 3 months
measure: salivary pH
timeFrame: 3 months
measure: bacterial adherence
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05898815: A Multicenter Study of Retrospective Rehabilitation Medical Data for the Development for Medical Twins
Official title: A Multicenter Study of Retrospective Rehabilitation Medical Data for the Development for Medical Twins
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health-Related Behavior
Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and stroke patients

Brief summary: Based on previous studies, when medical digital twin-based convergence medical contents are applied to degenerative musculoskeletal and central nervous system diseases, it is possible to more accurately evaluate the subject's motor function and neurological function to predict the subject's disease. In order to create an effective ICT application protocol and clinically apply a treatment program that can improve the subject's kinematic function and neurological function, etc.


Eligibility criteria: 1. Inclusion Criteria:

   * Healthy subjects : who underwent imaging examination at Bundang CHA hospital from January 1, 2010 to December 31, 2021
   * Stroke patients : who underwent imaging examination at Bundang CHA hospital from January 1, 2010 to December 31, 2021
2. Exclusion criteria - Who cannot meet the inclusion criteria

Primary outcomes:
measure: Imaging examination
timeFrame: A time point at which imaging was performed between January 1, 2010 and December 31, 2021
Secondary outcomes:
measure: Basic characteristics
timeFrame: A time point at which imaging was performed between January 1, 2010 and December 31, 2021
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
Study officials:
References:
Clinical trial NCT05034315: Effects of Whole Egg Consumption on Inflammation, Mood, and Recovery in Collegiate Female Gymnasts
Official title: Effects of Whole Egg Consumption on Inflammation, Mood, and Recovery in Collegiate Female Gymnasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objectives were to investigate the effects of whole egg consumption by collegiate female gymnasts on inflammatory markers, mood, and recovery.


Eligibility criteria: Inclusion Criteria:

* Membership on the university gymnastics team

Exclusion Criteria:

* egg allergies, asthma, coronary artery disease, depression, diabetes, hypertension, migraines, cancer or cancer-related complications, or auto-immune disorder

Primary outcomes:
measure: Serum C-reactive protein (CRP)
timeFrame: 8 months
measure: Serum interleukin-6 (IL-6)
timeFrame: 8 months
measure: Serum soluble interleukin-6 receptor (sIL-6R)
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
References:
Clinical trial NCT06884215: Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
Official title: A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of Test Articles Following Repeated Cutaneous Patch Applications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritation/Irritant
Sensitisation
Keywords: HRIPT
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: Princeton Research Corporation
First posted: 2025-03-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method


Eligibility criteria: Inclusion Criteria:

* Healthy males or females,18 years of age or older (50% with sensitive skin).
* Completed written informed consent.
* Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).

Exclusion Criteria:

* Pregnancy or lactation.
* Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
* Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.

Primary outcomes:
measure: Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: PCR Corp
Study officials:
affiliation: Amazentis SA
name: Anurag Singh, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01199315: A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 in Young and Elderly Healthy Japanese Volunteers After Oral Single and Repeated Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
AZD1446
AD
ADHD
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers.
* BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion Criteria:

* History of severe allergy/hypersensitivity reactions including drug-allergy or drug hypersensitivity reactions, or ongoing allergy/hypersensitivity.
* History or present symptoms or signs of Quincke oedema, angiooedema, or urticaria pigmentosa, or history of repeated episodes of urticaria.

Primary outcomes:
measure: To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG.
timeFrame: During the whole study period, ca. 50 days
Secondary outcomes:
measure: To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers.
timeFrame: PK samplings are taken at defined timepoints during residential period, 10 days.
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Björn Paulsson
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic
name: Shunji Matsuki, PhD
role: PRINCIPAL_INVESTIGATOR
References: