louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04040556: Enhancing Student Learning by Simulation
Official title: Enhancing Student Learning by Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre and Post Simulation Session Self-directed Learning Time
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 22
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: - Anesthesia residences who are currently studying in the department of Anesthesia

Brief summary: As the standard of best practice, care of complicated or difficult patient needs not only knowledge but also including skills and clinical thinking in many aspects.

Simulation is now accepted as the way of teaching for adult learners. This learning method can help students to apply their knowledge, practical skills and non-technical skills. A systematic review study showed that self-directed learning (SDL) in health professions education is associated with moderate improvement in the knowledge domain. SDL also help the learners to improve self-efficacy and the learning outcomes in complicated tasks.In this study, the investigators wanted to evaluate that simulation can enhance student to do SDL in the both pre and post session period.

Detailed description: After approval from the instution's Ethics Committee, a prospective cohort study was conducted between November 2017 to March 2018. Twenty-five anesthesia residents were participated in this study. Students were noticed about the simulation classes which are emergencies in pediatric anesthesia and complications at one-month prior the day of practice. The list of standard references was given. On the day of study, at the institute's simulation center, students were voluntarily separated into two groups, directed- learner and observer. Post class debriefing sessions were done as routine activities. After the class, the investigator invited the students to be enrolled in this study by using the flyers. Following the consent process, three consecutive questionnaires (day 0 ,30, 90) were sent to the subjects. The data analysis will be done by using R program. The statistically significance in this study was classified at p \<0.05.

Eligibility criteria: Inclusion Criteria:

* Anesthesia residences who are currently studying in the department of Anesthesia

Exclusion Criteria:

* Refuse to participate

Primary outcomes:
measure: Pre-class Self-directed learning time
timeFrame: 1 month before class
measure: Post-class Self-directed learning time
timeFrame: upto 3 months after class
Secondary outcomes:
measure: Knowledge retention
timeFrame: upto 3 months after class
measure: Level of self-confidence to treat the real patient
timeFrame: upto 3 months after class
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Ngamjit Pattaravit
Study officials:
References:
Clinical trial NCT01279356: Volatile Organic Compounds (VOCs) and Liver Diseases
Official title: Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Keywords: Liver diseases
Volatile organic compounds
Inflammation
Oxidative stress
non-invasive tests
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients with various liver diseases visiting the outpatient clinic.

Brief summary: Liver diseases such as non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease (ALD) and viral hepatitis have the potential to progress to cirrhosis and finally hepatocellular carcinoma (HCC). Early diagnosis and treatment of liver diseases is important since progression is likely and is associated with significant morbidity and mortality. However, in daily clinical practice no specific and non-invasive biomarkers are used for the diagnosis and follow-up of patients with liver diseases. It is known that patients with liver diseases produce compounds that can be excreted in breath as a consequence of metabolic processes, inflammation and/or oxidative stress. These are called volatile organic compounds (VOCs). Analysis of VOCs in exhaled air has been reported to provide valuable information in patients with chronic obstructive lung disease (COPD) and inflammatory bowel disease (IBD). Also, in patients with liver disease, exhaled VOCs have been detected.

The investigators hypothesize that analysis of VOCs in exhaled air of patients with liver diseases can be used for diagnosis and follow-up.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of liver diseases based on laboratory, radiological and histological characteristics
* Age between 18 and 85 years

Exclusion Criteria:

* Inflammatory bowel disease
* Chronic obstructive lung disease, lung cancer, asthma
* Rheumatoid arthritis

Primary outcomes:
measure: To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls
timeFrame: 12 months
Secondary outcomes:
measure: To compare the VOC profiles in exhaled air between various liver diseases
timeFrame: 12 months
measure: To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases
timeFrame: 12 months
measure: To compare VOC profiles with systemic inflammatory and oxidative stress markers
timeFrame: 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center, Division of Gastroenterology/Hepatology
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: A Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383356: Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Official title: A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
measure: Area Under the Curve 0 to Last Measurable Value (AUC0-t)
timeFrame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
Secondary outcomes:
measure: Area Under the Curve 0 to Inf (AUC0-inf)
timeFrame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 1288.19.1 Boehringer Ingelheim Investigational Site
state: Ontario
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02895256: Long-term Prognosis of Cluster Headache: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cluster Headache
Disease Course
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cluster headache

Brief summary: Cluster headache is a syndrome characterized by disabling headache and accompanying autonomic symptoms. Despite cluster headache is called "suicide headache", its natural history has not been well investigated. The investigators aimed to investigate its disease course, overall prognosis, and treatment pattern in retrospective cohort.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as cluster headache
* More than 5 years after the first visit

Exclusion Criteria:

* Subjects who refused the telephone visit

Primary outcomes:
measure: overall prognosis
timeFrame: at least 5 years after the first visit
measure: Changes in the length of active/inactive periods
timeFrame: at least 5 years after the first visit
measure: Changes in seasonal and diurnal predilections
timeFrame: at least 5 years after the first visit
measure: Changes in autonomic symptoms
timeFrame: at least 5 years after the first visit
measure: Changes in treatment responses
timeFrame: at least 5 years after the first visit
Secondary outcomes:
measure: Any depression
timeFrame: at least 5 years after the first visit
measure: Any suicidal thoughts (active/passive), plans, and attempts
timeFrame: at least 5 years after the first vis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03491956: Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism
Official title: Double Filtration Plasmapheresis (DFPP) Improves Lipid Profile and Platelet Function in Hyperlipidemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: DFPP and Platelet Function
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients.


Eligibility criteria: Inclusion Criteria:

1. hyperlipidemia

Exclusion Criteria:

1. Severe liver and kidney dysfunction
2. Severe cardiopulmonary insufficiency
3. tumor
4. pregnancy

Primary outcomes:
measure: lipid levels
timeFrame: 1 year
Secondary outcomes:
measure: Platelet RNA sequencing
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pudong Hospital
name: Bo Yu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang XM, Gu YH, Deng H, Xu ZQ, Zhong ZY, Lyu XJ, Jin HM, Yang XH. Plasma Purification Treatment Relieves the Damage of Hyperlipidemia to PBMCs. Front Cardiovasc Med. 2021 Jul 7;8:691336. doi: 10.3389/fcvm.2021.691336. eCollection 2021.
Clinical trial NCT02554656: Vfend Special Investigation For Pediatric - Observational
Official title: VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Safety and Effectiveness
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 89
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who have been treated with voriconazole for severe mycosis

Brief summary: Examine the safety and effectiveness of Vfend \[voriconazole\] for pediatric under general clinical practices.


Eligibility criteria: Inclusion Criteria:

* Patients who is under 15 years old and deep mycosis infection.

Exclusion Criteria:

* Patients who have been previously enrolled in this study. -

Primary outcomes:
measure: Number of Participants With Adverse Reactions
timeFrame: 16 weeks at maximum
Secondary outcomes:
measure: Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction)
timeFrame: 16 weeks at maximum
measure: Incidence of Aadverse Reactions by Diagnosis (Infection)
timeFrame: 16 weeks at maximum
measure: Overall Clinical Response
timeFrame: 16 weeks at maximum
measure: Clinical Response Rate by Diagnostic Name (Name of Infection)
timeFrame: 16 weeks at maximum
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: XXXXXXX
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04663256: Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment
Official title: Effectiveness of a Cognitive Stimulation Program on Anxiety, Depression and Quality of Life in People Older Than 70 Years With Mild Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Older People
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 85
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Mild cognitive impairment is becoming one of the most common cynical manifestations that affect older people. That is why there is a need to investigate non-pharmacological interventions that help to improve or maintain this problem.

Detailed description: Each week for 12 weeks, GE participants will attend three 60-minute sessions of cognitive exercises. Each session is divided into 10 minutes of memory practice, which includes short-term and long-term memory; 10 minutes of language skills, including vocabulary, comprehension, reading and writing exercises; 10 minutes of calculation, in which arithmetic, similar and different operations are carried out; 10 minutes of praxis and gnosis where drawing and recognition and auditory, tactile, spatial, visual attention were promoted; 10 minutes of orientation where knowledge of space, person and place is developed; and 10 minutes of executive functions in which exercises of organization, planning and problem solving are worked.

Eligibility criteria: Inclusion Criteria:

* With or without dependency to move.
* People who show mild cognitive impairment.
* That they were able to carry out the different selected questionnaires.

Exclusion Criteria:

* People with visual deficit.
* People already enrolled in a cognitive program.
* Score between 24 and 10 in the Mini Cognitive Exam (MEC).

Primary outcomes:
measure: MMSE (mini-mental state examination)
timeFrame: Baseline-8 weeks
measure: Yesavage Geriatric Depression Scale Adjetivo 1 relating to old people, especially with regard to their healthcare. a geriatric hospital Sustantivo 1 an old person, especially one receiving special care. a rest home for geriatrics.
timeFrame: Baseline-8 weeks
measure: Hamilton Scale for Anxiety.
timeFrame: Baseline-8 weeks
measure: SF-36 (The Short Form-36 Health Survey)
timeFrame: Baseline-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: U.E.D. Virgen de la Capilla
Study officials:
References:
Clinical trial NCT01956656: Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
Official title: Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingivitis
Keywords: lotus leaf, mouthwash, gingivitis
Lead sponsor: Sri Hasanamba Dental College and Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Traditionally, in Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.

Detailed description: The objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis.

Study design: 30 systemically healthy volunteers will be randomly allocated into two arms

Arm A: Lotus leaf mouth wash (aqueous) group \[Test group\] Arm B: Placebo mouth wash group \[Control group\]

All the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. Clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. All the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. All volunteers were recalled on 5th day for clinical and microbiological analysis. Statistical analysis and results are awaited

Eligibility criteria: Inclusion Criteria:

1. Subjects willing to comply with the study protocol \& instruction.
2. Clinically diagnosed with chronic gingivitis.
3. No history of allergies to herbal formulations.
4. No history of periodontal therapy within the previous 6 months.
5. No history of antibiotic therapy within the previous 6 months.

Exclusion Criteria:

1. Any systemic diseases
2. Use of tobacco or tobacco related products
3. Pregnant woman and lactating mothers
4. Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.

Primary outcomes:
measure: Plaque induced gingivitis
timeFrame: 4 days
Secondary outcomes:
measure: Grams Staining of the plaque collected from the subjects
timeFrame: 4 days
Other outcomes:
Locations:
city: Hassan
country: India
facility: Sri Hasanamba Dental College and Hospital
state: Karnataka
Study officials:
affiliation: Sri Hasanamba Dental College and Hospital
name: Dr Ravindra Shivamurthy, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00895856: Functional Capacity in Institutionalized Elders
Official title: Evaluation of the Functional Capacity in Institutionalized Elders Who Do Not Receive Physiotherapic Assistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Keywords: Physiotherapy
Aged
Functionality
Physiotherapic assistance
Functional capacity
Lead sponsor: Centro de Estudos Superiores de Maceio
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 3
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, eder people.

Brief summary: Getting old is a process of transformation of the body that occurs along the vital cycle in a universal and progressive way causing functional restrictions in the human being. The aim of this work was to identify, analyze and quantify the limitations of the functional capacity of the institutionalized elderly who are not provided with physiotherapic assistance.

Detailed description: A descriptive, qualitative, quantitative and transverse field research was made, based on an evaluation of the activities of daily living (ADL) using the Katz Index, with 62 institutionalized elderly people from Casa do Pobre de Maceió, Alagoas, both genders, average age of 77.03 years old and different levels of functions. Activities related to the self care were emphasized. At first, people were classified as independent, partially dependent and totally dependent. According to the Katz Index score, they were classified regarding their functional dependency, which varies from level 0 (a totally independent person) to level 6 (a totally dependent person in the six evaluated functions).

Eligibility criteria: Inclusion Criteria:

* To be elderly and a resident of Casa do Pobre de Maceió

Exclusion Criteria:

* Individuals under the age of 60 years and over 90, or received private care or physical therapy who refused to participate in the evaluation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maceió
country: Brazil
facility: CESMAC - Centro de Estudos Superiores de Maceió
state: Alagoas
Study officials:
affiliation: Centro de Estudos Superiores de Maceio
name: Juliana F Pontes
role: PRINCIPAL_INVESTIGATOR
References: