louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02179905: Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome
Official title: Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: MRI
Heart rate variability
Fatty acid
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Irritable bowel syndrome patients, Control

Brief summary: This study is to analyze the relationship between brain structure, the heart rate variability and the serum fatty acid component of the irritable bowel syndrome patients.

Detailed description: Several studies showed that the gray matter and white matter of the brain related to the symptoms of irritable bowel syndrome patients.

The investigators study is to analyse the relationship between thickness of cortex of irritable patients, the sympathetic tone and the serum fatty acid component of the irritable bowel syndrome patients. It is to clarify the mechanism of irritable bowel syndrome, whether the symptoms of irritable bowel syndrome are related to the thickness of cortex or inflammation status of the body.

Eligibility criteria: Inclusion Criteria:

* female
* between 20 and 50 years old
* meet Rome III criteria

Exclusion Criteria:

* colon and small intestinal disease
* psychiatric disease patients
* patients received major surgery in the past 5 years
* diabetic patients
* patients with metal implant

Primary outcomes:
measure: The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients.
timeFrame: Patients who suffered from IBS for more than 5 years.
Secondary outcomes:
measure: The relationship between thickness of brain cortex and the symptoms of irritable bowel syndrome
timeFrame: Patients who suffered from IBS for more than 5 years.
Other outcomes:
measure: The relationship between heart rate variability and symptoms of irritable bowel syndrome patients.
timeFrame: Patients who suffered from IBS for more than 5 years.
measure: The relationship between component of fatty acid and symptoms of irritable bowel syndrome patients.
timeFrame: Patients who suffered from IBS for more than 5 years.
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
References:
Clinical trial NCT06329505: Impact of Extracorporeal Membrane Oxygenation Care Strategy Application Development
Official title: National Taipei University of Nursing and Health Science
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Learning Problem
Keywords: Learning
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There was a total of 97 participants in this study, with an average of 9 years of nursing experience; the shortest experience was 1 year, and the longest was 29 years, of which 35 (36%) participants were nurses with less than 5 years of experience, and 36 (37%) were nurses with more than 10 years of experience.

Brief summary: The objective of this study was to develop an educational training App for ECMO care, and to apply a blended learning approach to improve the knowledge and skills of nurses.

Detailed description: In recent years, for patients with acute cardiac infarction, severe cardiac shock, and refractory acute respiratory distress syndrome, the intervention of Extracorporeal Membrane Oxygenation (ECMO) has become an adjunctive treatment for severe cardiopulmonary diseases, which can temporarily replace cardiopulmonary function, slow the deterioration of cardiopulmonary function, and buy time to assist in clinical treatment. However, the education and training of ECMO is mainly based on traditional classroom teaching, which has also been affected by COVID-2019, resulting in training process difficulties as nurses are easily restricted by time and environment.

Eligibility criteria: Inclusion Criteria:

* licensed nurse practitioners working in the intensive care center of the teaching hospital and willing to participate in the study.

Exclusion Criteria:

* those who did not use smart phones.

Primary outcomes:
measure: Comparison of knowledge and skills of nurses between groups after the intervention For 6 months.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei university of nursing and health science
Study officials:
affiliation: National Taipei university of nursing and health science
name: Pei-Hung Liao, PH.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04722705: Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
Official title: Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intense Pulsed Light
Erbium-yttrium Aluminum Garnet Laser
Scar Prevention
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 30
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 scar site was divided into 3 sites; combined IPL/fractional Er:YAG laser treatment site, fractional Er:YAG laser treatment site and untreated control site. At baseline, three lesions were randomized to IPL / fractional Er:YAG laser combination therapy site, fractional Er:YAG laser treatment alone site, and untreated control site. The laser treatment was conducted total three sessions, immediately at suture removal (baseline), 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment (20 weeks after suture removal).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of postoperative scars on the abdomen
* scars were symmetrical shaped in a line of 3cm or more

Exclusion Criteria:

* uncontrolled systemic or chronic disease
* hypersensitive to the ingredients
* a history of other laser treatments within the past 6 months
* pregnancy
* lactation
* Recent sun exposure

Primary outcomes:
measure: Patient Observer Scar Assessment Scale
timeFrame: 4 weeks
measure: Patient Observer Scar Assessment Scale
timeFrame: 8 weeks
measure: Patient Observer Scar Assessment Scale
timeFrame: 20 weeks
Secondary outcomes:
measure: Total Vancouver Scar scale
timeFrame: 4 weeks
measure: Total Vancouver Scar scale
timeFrame: 8 weeks
measure: Total Vancouver Scar scale
timeFrame: 20 weeks
measure: Erythema index
timeFrame: 4 weeks
measure: Erythema index
timeFrame: 8 weeks
measure: Erythema index
timeFrame: 20 weeks
measure: Melanin index
timeFrame: 4 weeks
measure: Melanin index
timeFrame: 8 weeks
measure: Melanin index
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
Study officials:
affiliation: Department of Dermatology, Kangnam Sacred Heart Hospital
name: Bo Young Chung, M.D., PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04919005: Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Official title: Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. The specific objective of this research was to develop and validate a virtual environment of games (called SorrisoTur) that allows the intervention of cognitive training.

Detailed description: SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which were coded in the form of 2D mini-games that are run on a computer connected to the Web, and designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual skills, language (expression, comprehension, reading, and writing) and personality/behavior. For the comparison of results, three groups were created; one group of elderly people with Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence Scale for Adults (WAIS-III) before and after of interventions with the games.

Eligibility criteria: Inclusion Criteria:

* People with physical or psychological conditions allow interacting with digital games;
* Elderly over 60 years with mild Alzheimer;
* Seniors over 60 Healthy;
* Healthy Youth;

Exclusion Criteria:

* People without physical or psychological conditions allow interacting with digital games;
* Elderly people over 60 years old who have any type of dementia other than Alzheimer, or moderate or severe Alzheimer;

Primary outcomes:
measure: Change on Wechsler Intelligence Scale for Adults (WAIS-III)
timeFrame: Baseline and after 4 weeks
measure: Change on Mini Mental State Examination (MMSE)
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Terigi Augusto Scardovelli
state: São Paulo
Study officials:
affiliation: University of Mogi das Cruzes
name: Marcia A Bissaco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05561205: rTMS for Apathy Clinical Trial
Official title: Repetitive Transcranial Magnetic Stimulation for Apathy Clinical Trial (REACT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Apathy in Dementia
Keywords: Apathy
Alzheimer's disease
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Apathy is a common, early, and disabling symptom in dementias such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in AD in individuals receiving methylphenidate and individuals not receiving medication for apathy.


Eligibility criteria: Inclusion Criteria:

* Major neurocognitive disorder
* Apathy for at least 4 weeks
* Stable dose of medication (\>4 weeks) that may affect cognition or behaviour
* Care partner who spends at least 10 hours a week with the subject

Exclusion Criteria:

* Current major depressive episode
* Agitation, delusions, hallucination
* Medical contraindications to rTMS
* Currently taking an amphetamine product
* Central nervous system abnormalities, Tourette's syndrome, or motor tics
* Current participation in another clinical trial

Primary outcomes:
measure: Neuropsychiatric Inventory-apathy
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT03634605: Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
Official title: Assessment of Tetracycline Pleurodesis in Prevention of Primary Spontaneous Pneumothorax Recurrence in Patients With Normal CT-scan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Spontaneous Pneumothorax
Keywords: Tetracycline
Pleurodesis
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary spontaneous pneumothorax (PSP) defines as presence of air in chest cavity occurs most commonly in young, tall, and smoker men without underlying lung disease.

Trends for PSP treatment tend toward more invasive procedures. Thoracotomy with pleurectomy and bullectomy is definitive treatment of PSP which significantly reduces recurrence probability. This procedure has been reported to cause high rate of morbidity and mortality. Thus video-assisted thoracoscopic surgery (VATS) has become the preferred method for treatment of PSP with recurrence rate of 5-10%. For persistent or recurrent cases, mechanical or chemical pleurodesis have been suggested.

Based on guidelines patients with large size of lesions in CT or with unstable condition should undergo surgical procedure for recurrence prevention but Patients with small lesion size and stable condition can be only observed. Conservative management of PSP is safe and effective, but as mentioned this method has high recurrence rate. On the other hand fear of recurrence can negatively affect patients' quality of life, so that some patients prefer surgical intervention to observation management. Also some studies recommend invasive treatments because of cost effectiveness of this methods.

As mentioned above, chemical pleurodesis is a usual method for treatment in patients with persistent or recurrent spontaneous pneumothorax. This method has been done using variety of chemical agents including tetracycline, minocycline, blood, and talc to irritate pleura. According to different studies tetracycline has the highest efficacy between irritant agents.

In current study, the investigators have aimed to assess tetracycline chemical pleurodesis through tube thoracostomy in prevention of spontaneous pneumothorax in symptom free patients with normal CT-scan following first episode of PSP.


Eligibility criteria: Inclusion Criteria:

* First episode of primary spontaneous pneumothorax
* Do not have bullae in CT-scan
* No history of chest trauma or thoracic surgery

Exclusion Criteria:

* History of chest trauma or thoracic surgery and start/quiting of smoking during past year.
* Not willing to participate in the study

Primary outcomes:
measure: Recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan Unviersity of medical Sciences
Study officials:
References:
Clinical trial NCT03320005: EFFECTS OF RESISTANCE TRAINING IN ELDERLY
Official title: EFFECTS OF RESISTANCE TRAINING ON THE PHYSICAL AND FUNCTIONAL RESPIRATORY PERFORMANCE OF ELDERLY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging Disorder
Keywords: respiratory performance
quality of life
physical performance
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.

Detailed description: Will be measured the strength of the respiratory muscles (Mip and Mep), peak expiratory flow (Peak-Flow), thoracic movements and abdominal movements, distance traveled in Incremental Shuttle Walk Test, grip strength manual, pulmonary leukocytes, biochemical parameters and indicators of quality of life and physical activity through the WHOQOL-old and IPAQ-short. The data will be tested against the distribution of the Gauss curve, by the shapiro-wilk test and, if they have a normal distribution (parametric) are expressed as mean and standard deviation, if not submit normal (non parametric) distribution will be expressed as median or range interquartílico. The first chance to compare the evolution of the group studied, will be applied to two-way ANOVA. If the distribution is abnormal, it will apply Mann-Whitney test. The multiple regression test will be used to compare the Mip and Mep with variables with the Peak-Flow, Thoracoabdominal mobility, distance traveled, immune competence, physical fitness and quality of life in the groups studied.

Eligibility criteria: Inclusion Criteria:

* 60 year old or more
* Do not have cardiac or respiratory diseases
* neurological, Musculoskeletal and other diseases preventing the practice of exercises
* not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.

Exclusion Criteria:

* Difficult to complete the tasks
* Acute diseases
* Refuse to continue the program

Primary outcomes:
measure: Physical performance
timeFrame: Change from Baseline at 24 weeks
Secondary outcomes:
measure: quality of life
timeFrame: Change from Baseline at 24 weeks
measure: respiratory muscle strength
timeFrame: Change from Baseline at 24 weeks
measure: Hand grip
timeFrame: Change from Baseline at 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nove de Julho University
name: Dirceu Costa, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00330005: A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder
Official title: A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: psychotherapy
bipolar disorder
psychodynamic
psychoeducation
illness management
controlled trial
pilot study
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2006-05-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare a group psychotherapy intervention, the Integrative Outpatient Model, to a convenience control, in adults with bipolar disorder.

Detailed description: The psychotherapy literature suggests that psychological treatments can have a significant impact on the clinical course and outcome for bipolar disorder (Swartz \& Frank, 2001). Very few outcome studies have been conducted in group psychotherapy for bipolar disorder, and there are no preliminary studies conducted using the Integrative Outpatient Model, developed specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a matched-control design is indicated to obtain preliminary data regarding this treatment modality and approach. The IOM is a weekly, long term psychotherapy.

Comparison: Individuals who participate in group psychotherapy will be compared to a control group on mood and symptom ratings, up to 1 year post intervention.

Eligibility criteria: Inclusion Criteria:bipolar disorder; functioning level appropriate for outpatient group psychotherapy; willingness to engage in a psychotherapeutic intervention -

Exclusion Criteria: cognitive impairment; prominent psychosis; under 18 years old

-

Primary outcomes:
measure: depression symptoms
measure: manic symptoms
measure: number of days without a bipolar mood episode
measure: global assessment of functioning
measure: clinical global impression for bipolar disorder
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center - Department of Psychiatry
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Jodi M Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05713305: Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
Official title: Effect of an Online Self-help Psychological Intervention on the Physical and Mental Health of Non-professional Staff Who Supported the ICU During the Omicron Outbreak: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2 Infection
Staff Attitude
Anxiety
Mental Health Issue
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 110
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: Timely interventions may reduce the occurrence of post-traumatic stress disorder (PTSD) in ICU medical staff. Existing research suggests that either self-learning psychological relief methods or seeking online counseling or therapy from professional psychotherapists during the SARS-CoV-2 Omicron outbreak has the potential to alleviate the emotional distress and promote the physical and mental health of health care workers. Web-based online mental health interventions complemented by joint effective mental health advice can further reduce harmful negative effects.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Non-ICU professional staff providing direct health care services to critically ill SARS-CoV-2 Omicron patients in the ICU
3. Signing the informed consent form

Exclusion Criteria:

1. No reported acute suicidal tendencies
2. No history of psychotic or dissociative symptoms
3. Pregnancy or lactation
4. Major family changes within the last 12 weeks( For e.g. death of immediate family member)
5. Participated in other clinical trials

Primary outcomes:
measure: Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention
timeFrame: 28 days after intervention
Secondary outcomes:
measure: Proportion of depression and anxiety problems among different types of staff
timeFrame: 28 days after intervention
measure: The degrees to which depression and anxiety problems occur in different types of staff
timeFrame: 28 days after intervention
measure: Incidence of posttraumatic stress disorder
timeFrame: 28 days after intervention
measure: Well-being was measured with the WHO-5 well-being index
timeFrame: 28 days after intervention
measure: Improvement in sleep quality
timeFrame: 28 days after intervention
measure: Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention
timeFrame: Three months after intervention
measure: Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
References: