louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03375632: Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Official title: Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperuricemia With or Without Gout
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fuji Yakuhin Co., Ltd.
First posted: 2017-12-18
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.


Eligibility criteria: Inclusion Criteria:

* Serum urate level:

  * \>= 7.0mg/dL in patients with gouty nodule or with history of gout, or \>=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL
* Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
* Outpatients

Exclusion Criteria:

* Gouty arthritis within 14 days before randomized allocation

Primary outcomes:
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
timeFrame: 2-week
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
timeFrame: 6-week
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
timeFrame: 10-week
measure: Pharmacodynamics (Amount of uric acid excreted in urine)
timeFrame: 14-week
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational sites
Study officials:
affiliation: Clinical Research Department
name: Kazuki Furuno
role: STUDY_DIRECTOR
References:
Clinical trial NCT06067932: Foot Disorders in X-linked Hypophosphatemia
Official title: Mid- and Forefoot Disorders in Adolescents and Adults With X-linked Hypophosphatemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: X-linked Hypophosphatemia
Keywords: foot and ankle
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rare bone disease (XLH) with and without foot problems

Brief summary: This study aimed to characterize foot pathologies using X-rays and clinical examination and assess related outcome scores in adolescents and adults with X-linked Hypophophatemia

Detailed description: A single center, cross-sectional analysis of adolescent and adult patients with XLH with and without previous surgical intervention was performed at the Orthopaedic Hospital Speising, Vienna, Austria. Clinical examination, quality of life questionnaires and radiographic data of foot x-rays in standing position were collected. Radiographic evaluation was performed to analyze foot deformity as well as signs of osteoarthritis at the foot.

Eligibility criteria: Inclusion Criteria: - Patients with confirmed XLH, ≥ 16 years were invited to participate in this study

Exclusion Criteria:

* Exclusion criteria were other forms of hypophosphatemia, pregnancy and recent lower limb surgery within 3 months.

Primary outcomes:
measure: Number of feet with signs of osteoarthritis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orthopedic Hospital Speising Vienna
Study officials:
affiliation: Orthopedic Hospital Speising Vienna
name: Gabriel Mindler, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT06937632: Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease
Official title: Effect of a Nurse-Led Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease: A Quasi-experimental Research Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Keywords: Sleep
Sleep Hygiene
Sleep Quality
Aged
Parkinson's disease
Quasi-Experimental Design
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 136
Sex: ALL
Minimum age (years): 58
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep disorders (SDs) are one of the most frequent non-motor symptoms of Parkinson's disease (PD), usually increasing in frequency over the course of the disease and disability progression. SDs include nocturnal and diurnal manifestations such as insomnia, REM sleep behavior disorder, and excessive daytime sleepiness. The causes of SDs in PD are numerous, including the neurodegeneration process itself, which can disrupt the networks regulating the sleep-wake cycle and deplete a large number of cerebral amines possibly playing a role in the initiation and maintenance of sleep.

Detailed description: Sleep disorders (SDs) constitute the second most frequent complaint, affecting 64% of PD patients, ranging from 41.1% in naïve patients to 78.3% in complicated patients. SDs in PD are multifactorial and include nocturnal and diurnal manifestations. Reduced sleep efficiency and an increased number of awakenings characterize sleep in PD. These disturbances are linked, on one side, to PD motor (akinesia, rigidity, and dystonia) and autonomic symptoms (nocturia) and, on the other side, to the presence of concomitant SDs such as REM sleep behavior disorder (RBD), restless legs syndrome (RLS), or breathing disorders such as obstructive sleep apnea (OSA). Diurnal manifestations include excessive daytime sleepiness (EDS) and sudden sleep attacks, which could be a consequence of nocturnal sleep impairment or dopaminergic treatment or, more interestingly, to the neurodegenerative process of PD itself dysregulating the circadian sleep-wake rhythm.

Eligibility criteria: Inclusion Criteria:

* Elderly individuals aged 60 years or older, with a confirmed diagnosis of Parkinson's Disease.
* Cognitively and physically able to engage in the study.

Exclusion Criteria:

* Participants using sedative medications .

Primary outcomes:
measure: The Parkinson's Disease Sleep Scale (PDSS).
timeFrame: 3 month
Secondary outcomes:
measure: Sleep Hygiene Index (SHI)
timeFrame: 3 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
Clinical trial NCT05124132: Resilience and Brain Health of Older Adults (MEDEX-2)
Official title: Resilience and Brain Health of Older Adults (MEDEX-2)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: Exercise
Mindfulness
Education
Elderly
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2021-11-17
Enrollment: 468
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This project capitalizes on a natural experiment imposed by the COVID-19 pandemic in conjunction with an extensive set of cognitive, emotional, biological, and neuroimaging variables already collected at multiple time points in older adults participating in a clinical trial of exercise and mindfulness. This project will elucidate the effects of stress on cognitive function and emotional health in later life, including biological measures of Alzheimer Disease risk, stress, and aging, with the ultimate goal of discovering how to mitigate these effects, among older adults who have made and maintained a lifestyle change.


Eligibility criteria: Inclusion Criteria:

* Participated in the parent study, Protocol ID #201410093

Exclusion Criteria:

* Inability to safely continue classes or complete assessments, as per PI discretion

Primary outcomes:
measure: Effects of the interventions on changes in cognitive performance
timeFrame: Approximately three years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric J Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03235232: BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
Official title: Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Primary Open-angle Glaucoma
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the treatment of primary open-angle glaucoma or intraocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Signed Consent;
* Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;
* Participants who have 20/80 visual acuity or more, in both eyes;

Exclusion Criteria:

* Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;
* Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;
* Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;
* Participants who had significant visual loss in the last year;
* Treatment-naive participants for open-angle glaucoma or ocular hypertension;
* Participants nonresponders to previous triple combination drug therapy, used in concomitance;
* Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;
* Participants with history of hypersensitivity to any formula compounds;
* Participants presenting contraindications to use of beta-adrenergic antagonists;
* Participants diagnosed with uncontrolled cardiovascular disease;
* Participants with severe renal insufficiency or hyperchloremic acidosis;
* Participants in therapy with monoamine oxidase inhibitors (MAOIs);
* Participants who were in use of drugs that can interfere in the evaluation;
* Pregnancy or risk of pregnancy and lactating patients;
* Alcoholism or illicit drug abuse in the last two years;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
timeFrame: 8 weeks
Secondary outcomes:
measure: Safety will be evaluated through the adverse events occurrences
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allegisa
state: São Paulo
Study officials:
References:
Clinical trial NCT05287932: Brief Physical Activity Intervention for Older People With Multimorbidity
Official title: A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Conditions, Multiple
Old Age; Debility
Physical Inactivity
Keywords: Multimorbidity
Older people
Physical activity
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Physical activity is an important determinant of health and well-being in older people. However, many older people do not achieve recommended physical activity levels and increasing older people's physical activity is challenging. This preliminary study will explore the effects of a brief physical activity intervention on physical activity and physical function in older people with multimorbidity. The findings will be used to inform the design of a subsequent adequately-powered randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* aged ≥60 years
* 2 or more chronic conditions
* able to walk outside the home
* able to attend the study visits

Exclusion Criteria:

* living in a residential or nursing home
* housebound
* ≥3 falls in previous year
* dementia or significant cognitive impairment (unable to follow simple instructions)
* contraindication to increasing physical activity
* unable to read or speak English
* unable to provide consent
* no more than one person per household

Primary outcomes:
measure: Average daily acceleration
timeFrame: 4 weeks
Secondary outcomes:
measure: Intensity gradient
timeFrame: 4 weeks
measure: Time in MVPA
timeFrame: 4 weeks
measure: Steps
timeFrame: 4 weeks
measure: Muscle strengthening exercise
timeFrame: 4 weeks
measure: 30-second chair rise performance
timeFrame: 4 weeks
measure: Handgrip strength
timeFrame: 4 weeks
measure: Timed 8ft up and go performance
timeFrame: 4 weeks
measure: Timed single-leg balance performance
timeFrame: 4 weeks
measure: 6-minute walk test performance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: Garry A Tew, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04059432: CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?
Official title: CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tooth Wear
Musculoskeletal Disorder
Keywords: Tooth Wear
Musculoskeletal Disorders
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in the Fixed Prosthesis Department (Dentistry Department) at the Polyclinic Lucien Brull from Liège University Hospital between March 2019 and October 2019

Brief summary: This study aims to explore the relationships between tooth wear (TW) and musculoskeletal disorders (MSDs). The null hypothesis is that TW is not associated to MSDs. It also explores the influence of bruxism signs, life habits and stress on TW and MSDs.

Detailed description: This study is based on questionnaires and clinical examination performed by a dentist.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 80 years old
* Have the mental abilities to participate in study
* Understand the language of the survey (French)
* Sign free and informed consent

Exclusion Criteria:

* Consult for a painful dental emergency
* Do not have at least 8 teeth per maxilla, with natural dental tissues in contact with the antagonistic teeth
* Being in the process of an orthodontic treatment
* Wear of a bimaxillary orthognathic nightguard

Primary outcomes:
measure: Presence of musculoskeletal disorders (MSDs)
timeFrame: through study completion, an average of 1 year
measure: Tooth wear following BEWE index
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Life habits and stress
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Institute of Dentistry University of Liege
state: Choose A State
Study officials:
affiliation: CHU-ULg
name: Amélie Mainjot
role: STUDY_DIRECTOR
References:
Clinical trial NCT06742632: Comparative Psychiatric Problems Between First and Second Trimester Miscarriage
Official title: Comparative Study in Psychiatric Problems Among Mothers With Miscarriage in First and Second Trimester
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abortion
Keywords: abortion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all miscarrying women aged from 28 to 45 years less than or equal to 26 weeks gestation

Brief summary: Description of the psychiatric impact of miscarriage on women.

Detailed description: miscarriage, a significant reproductive health issue, often has profound psychological implications for women. The emotional and psychiatric effects of abortion can vary widely based on individual, cultural, and situational factors, as well as the timing of the procedure (1). First-trimester abortions are typically more common and are generally less complex medically, while second-trimester abortions often involve more intricate decision-making processes and greater societal and personal stigma (2).

Emerging evidence suggests that women undergoing abortions in different trimesters may experience distinct psychiatric challenges, including anxiety, depression, and post-traumatic stress disorder. However, the comparative psychological burden between first- and second-trimester abortions remains underexplored (3-6). Understanding these differences is crucial for tailoring mental health interventions and providing comprehensive care to affected women.

This study aims to compare the prevalence and types of psychiatric problems in mothers undergoing abortion in the first versus the second trimester, thereby contributing to the body of knowledge on maternal mental health and informing evidence-based support strategies.

Eligibility criteria: Inclusion Criteria:

* all miscarrying women less than or equal to 26 weeks gestation

Exclusion Criteria:

* ectopic pregnancy and vesicular mole

Primary outcomes:
measure: measure psychiatric problems among the stuided groups
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Medicine
Study officials:
References:
citation: Ayaulym N. Blushinova, Gulnara M. Shalgumbayeva, Duman Berikuly, Zaituna G. Khamidullina, Gaukhar A. Korganbayeva, Inabat N. Ordabayeva, Nazerke K. Sailauova ABB. Epidemiological aspects of pregnant losses. literature review. Sci Healthc J. 2023;25(2):236-43.
citation: Herbert D, Young K, Pietrusinska M, MacBeth A. The mental health impact of perinatal loss: A systematic review and meta-analysis. J Affect Disord. 2022 Jan 15;297:118-129. doi: 10.1016/j.jad.2021.10.026. Epub 2021 Oct 20.
Clinical trial NCT05546632: Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry
Official title: Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Keywords: Intensive care unit
HLA-DR
blood sample
Cyto-chex tube
EDTA tube
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will focus on patients hospitalized in the intensive care unit of the Edouard Herriot hospital in Lyon

Brief summary: The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.

The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.


Eligibility criteria: Inclusion Criteria:

* Adult patient hospitalized in intensive care unit
* Patient able to consent and having expressed his non-objection (in the case where the patient is aware) OR Patient whose trusted person has given his non-objection (in the case where the patient is not able to consent, example intubated patient)

Exclusion Criteria:

* Pregnant women
* Minors
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)
* Patient who doesn't understand French language

Primary outcomes:
measure: Quantity of anti-HLA-DR antibodies per cell
timeFrame: The day of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de reanimation chirurgicale
Study officials:
affiliation: Hospices Civils de Lyon
name: Anne-Claire LUKASZEWICZ, Professor
role: PRINCIPAL_INVESTIGATOR
References: