louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05012553: The Effect of Self and Peer Assesment Education Given to Nursing Students: Stoma Care Skill Example
Official title: The Effect of Self and Peer Assesment Education Given to Nursing Students: Stoma Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assessment, Self
Stoma Colostomy
Achievement
Keywords: stoma care
peer assesment
self assesment
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Self- and peer-assessment is one of the important methods among student-centered assessment methods. The ability of the student to evaluate himself and his peers provides many contributions to him in his education and professional life.Nursing education aims to gain many psychomotor skills.Aim is to examine the effects of self and peer assessment training on the success of stoma care skills.

Detailed description: There are different results regarding the effects of self-assessment and peer assessment on psychomotor skill achievement. It is thought that the reason for this difference in results may be student-related reasons or may be related to the effectiveness of the education.

The aim is to measure the stoma care skill success of the students who are given self and peer assessment training through the rating scale.

Eligibility criteria: Inclusion Criteria:

* Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing 1st year AGNO score not to be below 1.8
* To be registered in the HMSR 2016 Surgical Diseases Nursing course in the spring semester of the 2019-2020 academic year
* Not having received peer and self-assessment training before
* Having no previous stoma care training
* Not working as a part-time or full-time nurse

Exclusion Criteria:

* To have training in stoma care
* Having received self- and peer-assessment training
* Working as a part-time or full-time nurse
* Having an AGNO score below 1.8

Primary outcomes:
measure: The self and peer assessment scale
timeFrame: Baseline,:6 months Change from self and peer assessment scale score at 6 months
measure: self and peer assessment impressions scale
timeFrame: 6 months
measure: The stoma care rating scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Florence Nightingale Faculty of Nursing
Study officials:
affiliation: Istanbul University-Cerrakpasa
name: Sevim Ulupınar, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01802853: A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
Official title: Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.


Eligibility criteria: Inclusion Criteria:

* Male healthy volunteers, 18-45 years of age inclusive
* Healthy as determined by screening assessments
* Body mass index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
* History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
* Any history of alcohol and/or drug of abuse addiction during the past 5 years
* Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
* Any clinically relevant abnormal test results prior to first dosing
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1

Primary outcomes:
measure: Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)
timeFrame: 48 hours
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 5 weeks
measure: Pharmacodynamics: Fasting serum glucose/serum insulin
timeFrame: 48 hours
measure: Nausea scale: Visual analogue scale
timeFrame: 48 hours
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06163053: A Study to Evaluate Satisfaction With Care in Patients With Cancer Receiving Immunotherapy Treatment at Home
Official title: A French Non-interventional Prospective Multicenter Study Evaluating Quality of Care Perception of Cancer Patients Treated by Immunotherapy at Home - SATISFACT-HOME
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 150
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: Participants in France with solid tumors transitioning from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home

Brief summary: The purpose of this observational study in France is to evaluate changes in satisfaction with care in participants with solid tumors who transitioned from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years old
* Participants whose oncology specialist has already initiated treatment with immune checkpoint inhibitors (ICIs) in the outpatient hospital setting for an advanced solid tumor (as monotherapy or in combination) or as adjuvant therapy, in an indication approved and reimbursed in France
* Participants whose oncology specialist has independently of the study defined their eligibility for hospital at home (HAH) before contacting the HAH unit for final admission
* Participants who provide oral informed consent to participate in the study

Exclusion Criteria:

* Participants who have expressed an opposition to their data collection
* Participants under guardianship
* Participants taking part in an interventional study for cancer treatment with at least one ICI as an investigational drug

Primary outcomes:
measure: Change in patient satisfaction on the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) when transitioning from Outpatient Hospital to Hospital at Home to receive immunotherapy
timeFrame: Participants follow up approximately 24 weeks after transition to treatment at home
Secondary outcomes:
Other outcomes:
Locations:
city: Chambéry
country: France
facility: CH Metropole Savoie
city: Mantes-La-Jolie
country: France
facility: CH Francois Quesnay
city: Pau
country: France
facility: CH de Pau
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05675553: The Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With AUD
Official title: A Randomized Controlled Trial Protocol Testing the Efficacy of Robot-Assisted Intelligent Rehabilitation Treatment in Patients With Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to test the efficacy of robot-assisted intelligent rehabilitation treatment in patients with alcohol use disorders with a randomized controlled trial. Specifically, the objective of this trial is to determine whether the robot-assisted intelligent rehabilitation treatment plus treatment as usual has greater efficacy than traditional therapy in the treatment of alcohol use disorders.

Detailed description: Based on artificial intelligence technology, face recognition technology, and virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for patients with alcohol use disorders, and compare with traditional treatment to verify the efficacy and safety of the Robot-assisted rehabilitation intelligent system in Chinese patients with alcohol use disorders.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18-55;
2. Meeting DSM-5 criteria for alcohol use disorders;
3. Withdrawing alcohol for less than 12 months;
4. Ability to use computers;
5. Signing informed consent;

Exclusion Criteria:

1. Having comorbidities of other neuropsychiatric diseases;
2. Diseases that affect cognitive function, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
3. With a family history of mental illness
4. Not familiar with computer operation, unable to complete assessment and treatment.

Primary outcomes:
measure: Desire for alcohol
timeFrame: 3 months
Secondary outcomes:
measure: Change Readiness and Treatment Eagerness
timeFrame: 3 months
measure: Impulsiveness
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Perception of stress
timeFrame: 3 months
measure: Sleep Quality
timeFrame: 3 months
measure: coping style
timeFrame: 3 months
measure: use of alcohol
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT05830253: Free-living Monitoring of Parkinson's Disease Using Smart Objects
Official title: Free-living Monitoring of Parkinson's Disease Using Smart Objects: Towards Digital Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
First posted: 2023-04-26
Enrollment: 30
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 with Parkinson's disease

Brief summary: Parkinson's disease, one of the most common neurodegenerative diseases of the central nervous system, presents motor symptoms, including tremor, rigidity, bradykinesia, and postural instability. Assessments of patients with Parkinson's disease are typically performed using clinical scales, compiled by the healthcare staff or by the patient. Although commonly used in clinical practice, they have some limitations, including the low temporal resolution of the scales, the low granularity of the scores and the possible low inter- and intra-operator reliability. The recent development of digital technologies has led to the creation of IoT (Internet of Things) devices capable of providing quantitative indicators, potentially useful for an accurate differential diagnosis, as well as for monitoring the effects of therapeutic interventions. The peculiarity of these systems is the ability to provide indicators not only during periodic visits to the clinic, but also the ability to remotely monitor the patient's daily life activities. In this scenario, this study wants to test the hypothesis that the IoT devices like smart-ink pens and insoles are usable options for monitoring patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Adult individuls
* Cognitive impairments
* Ability to independently sign the written informed consent

Exclusion Criteria:

* Unstable pharmacological treatment for Parkinson's Disease during the study
* Previous history of major neurological, vascular, musculoskeletal disorders

Primary outcomes:
measure: System Usability Scale
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Movement Disordered Society - Unified Parkinson's Disease Rating Scale
timeFrame: Baseline
measure: Execution handwriting time
timeFrame: Baseline
measure: Execution handwriting time
timeFrame: 1-2 weeks
measure: Average handwriting force
timeFrame: Baseline
measure: Average handwriting force
timeFrame: 1-2 weeks
measure: Gait speed
timeFrame: Baseline
measure: Gait speed
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
References:
Clinical trial NCT06424353: Postoperative Pain After Pulpectomy of Primary Molars
Official title: Postoperative Pain After Pulpectomy of Primary Molars Using Two Different Root Canal Obturation Techniques: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Testing postopertive pain after pulpectomy of primary molars with endoflas using modified Wong-Baker scale of pain.

Detailed description: Testing postopertive pain after pulpectomy of primary molars with endoflas using lentilospiral files and pressure seringe by using modified Wong-Baker scale of pain.

Eligibility criteria: Inclusion Criteria:

* The current study will include children who meet the following clinical and radiographic criteria:

3.1a.Clinical:

1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
3. Presence of at least one primary molar with deep carious lesion.
4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

3.1b. Radiographic:

1. Extensive caries approaching to the pulp.
2. Presence of at least two-thirds of root length.

Exclusion Criteria:

* A child's tooth with any of the following criteria:

3.2a. Clinical findings:

1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
4. History of administering analgesics 12 hours before tooth obturation.

3.2b. Radiographic findings:

1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
2. Presence of pathological internal/external root resorption.
3. Absence of underlying permanent successor.

Primary outcomes:
measure: postoperative pain
timeFrame: after one day and after one week
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Shimaa Mohamed Abd Elhafeez
Study officials:
affiliation: Pediatric Dentistry Department, Faculty of Dentistry, Minia University
name: osama s gad elhak, phD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06928753: Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion
Official title: Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chikungunya Virus Infection
Keywords: Prophylaxis, Safety, Efficacy, Vaccine effectiveness, Chikungunya
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: ANRS, Emerging Infectious Diseases
name: Région La Réunion
name: ARS La Réunion
name: Direction Générale de l'offre de Soins (DGOS)
First posted: 2025-04-15
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Against the backdrop of a growing chikungunya epidemic in La Réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of IXCHIQ® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the French Health Autority (HAS) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). This study will also provide input for the preparation of a cluster randomized trial on a population scale.


Eligibility criteria: Inclusion Criteria:

* Eligible for anti-chikungunya vaccination according to french Health Authority (HAS)
* Beneficiary of social security coverage
* Signature of informed consent form

Exclusion Criteria:

* Pregnant women
* Vaccine contraindication for patients undergoing medical treatment
* Persons under guardianship, curatorship or safeguard of justice
* Anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration

Primary outcomes:
measure: To measure the vaccine effectiveness at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St Denis
country: France
facility: CHU La Réunion
Study officials:
affiliation: CHU La Réunion
name: Patrick GEARADIN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01211951: A Study of KCT-0809 in Patients With Dry Eye Syndromes
Official title: A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry eye syndromes
Corneal diseases
Conjunctival diseases
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 160
Sex: ALL
Minimum age (years): 20
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 efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.


Eligibility criteria: Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion or tear film instability
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta

Primary outcomes:
measure: Corneal-conjunctival staining scores
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tohoku, Kanto, Chubu, Kansai, Kyushu region
country: Japan
facility: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Katsumi Hontani
role: STUDY_DIRECTOR
References:
Clinical trial NCT03041051: Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients
Official title: Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infection
Lead sponsor: Aghia Sophia Children's Hospital of Athens
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.


Eligibility criteria: Inclusion Criteria:

* CD4 T cell count \>200cells/μl
* on ART

Exclusion Criteria:

* no previously recorded allergy to PCV, PPV23
* no intravenous immunoglobulin (IVIG) given within the previous 6 months
* no other vaccine given within the previous 6 months

Primary outcomes:
measure: immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
timeFrame: One month post-PCV13, PPV23
measure: immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
timeFrame: One month post-PCV13, PPV23
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
name: Vana Spoulou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farmaki PF, Chini MC, Mangafas NM, Tzanoudaki MT, Piperi CP, Lazanas MZ, Spoulou VS. Immunogenicity and Immunological Memory Induced by the 13-Valent Pneumococcal Conjugate Followed by the 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. J Infect Dis. 2018 Jun 5;218(1):26-34. doi: 10.1093/infdis/jiy135.