louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03564964: Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease
Official title: An Intermediate-Size, Expanded Access to SUVN-502 for the Treatment of Subjects With Alzheimer's Disease Who Have Completed the CTP2S1502HT6 Study
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Alzheimer Disease
Dementia
Cognition Disorders
Keywords: SUVN-502
Expanded Access
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2018-06-21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.

Subjects will not be evaluated for efficacy and safety during the expanded access.


Eligibility criteria: Inclusion Criteria:

* Subjects who have completed the 30 week treatment period of study CTP2S1502HT6 as planned and wish to continue treatment with SUVN-502.
* Subject (or subject's legally acceptable representative) and caregiver must sign the Informed Consent Form (ICF) to participate in the study.

Exclusion Criteria:

* Has participated or is participating in any other clinical (investigational) study after completion of CTP2S1502HT6 study.
* Is treated or likely to require treatment during the study with any medication prohibited by this expanded access program.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01055964: a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
Official title: a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharmacokinetics
Tacrolimus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.


Eligibility criteria: Inclusion Criteria:

* ABO-compatible renal transplant recipients

Exclusion Criteria:

* multi-organ transplant
* HIV(+) donor or recipients
* history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca)
* more than three-fold increase in AST or ALT level for 28 days
* pregnancy
* lactation

Primary outcomes:
measure: pharmacokinetics
timeFrame: at postoperative 10~14 days and at postoperative 6 months for crossover study
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Jongwon Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02193464: Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk
Official title: Observational Study Using Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk, Southeastern Area of Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Chronic Inflammatory Bowel Disease
Keywords: inflammatory bowel disease, registry, incidence, Korea
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Yeungnam University Hospital
name: Daegu Catholic University Medical Center
name: DongGuk University
First posted: 2014-07-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with inflammatory bowel disease from primary, secondary, and tertiary hospital in Daegu-Gyeongbuk province of Korea.

Brief summary: The purpose of this study is to investigate the incidence and natural course of inflammatory bowel disease in the southeastern area of Korea.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of inflammatory bowel disease including Crohn's disease and ulcerative colitis
* Followed up for at least 6 months for the correct diagnosis

Exclusion Criteria:

* Patients who do not live in Daegu-Gyeongbuk province

Primary outcomes:
measure: All newly diagnosed cases
timeFrame: one year
Secondary outcomes:
measure: All operation cases
timeFrame: one year
Other outcomes:
measure: All cases of disease relapse
timeFrame: one year
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University School of Medicine
name: Eun Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06164964: Study of Social Cognition Processes With Multimodal MRI on Healthy Adult Patients.
Official title: Study of Social Cognition Processes With Multimodal MRI on Healthy Adult Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Cognition
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Behavioral study with neuro-anatomical functional correlates consisting of cognitive activation experiments during functional magnetic resonance imaging, with observation of images of a social nature and decision making in an individual or social context.

Brief summary: The study of higher cognitive functions (learning, memory, language, reasoning, decision making) in humans constitutes an interdisciplinary field, which combines neurobiological and neurological, neuropsychological, as well as linguistic and artificial intelligence skills. Historically, the study of patients with cerebrovascular lesions or brain pathologies associated with primary and/or cognitive deficits has produced fundamental knowledge in this area. The development of modern non-invasive investigation techniques of the human brain - such as Structural Magnetic Resonance Imaging (MRI), Diffusion Tensor Imaging, Functional Magnetic Resonance Imaging (fMRI), Positron emission (PET), the study of event-related electrophysiological potentials (ERP) or magneto-encephalography (MEG) - has made it possible to carry out similar studies on healthy subjects, as well as the in-vivo analysis of adaptive and plastic mechanisms of the human brain. Recently, the interest of cognitive neuroscience - this is the name taken by this vast interdisciplinary sector which aims to understand the neural mechanisms underlying human cognitive processes - has been oriented towards the study of decision making in social contexts. Knowledge of the mechanisms underlying these processes is fundamental for the most complete description of the biological bases of human behavior and above all for the optimal development of treatments for brain pathologies, whether surgical, pharmacological or rehabilitation in general.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 35 years old; Monolingual native speakers of Italian; Absence of neurological or psychiatric pathologies that could interfere with carrying out the exam.

Exclusion Criteria:

* Clinical and/or anamnestic evidence of significant neuropsychiatric or systemic pathologies; Previous head trauma with loss of consciousness

Primary outcomes:
measure: behavioral study with neuroanatomical functional correlates consisting of cognitive activation experiments during functional magnetic resonance imaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05872464: Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Official title: Efficacy and Safety of Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Xerostomia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 52
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 objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

Detailed description: There are 52 patients in this study. They are divided into 2 groups which are artificial saliva containing cumin and ginger extract group (test group) 26 patients and placebo group 26 patients. The patients spray the sample into the mouth 3 times/day for 14 day. Amount of saliva, pH of saliva, xerostomia questionnaires, WHO Oral Mucositis Grading Scale, quality of life, adverse events, and satisfaction were assessed.

Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Head and neck cancer with xerostomia
* 6 months post radiation
* Willing to participate in this study

Exclusion Criteria:

* Sialolith or Sjogren's syndrome
* Uncontrolled cancer
* Using artificial saliva more than 2 weeks
* Taking Pilocarpine or cevimeline more than 2 weeks
* Allergic to cumin, ginger, xylitol, and glycerin
* History of other oral mucosal diseases
* Pregnancy and lactation

Primary outcomes:
measure: Amount of saliva
timeFrame: 14 days
Secondary outcomes:
measure: Acid and base characteristic of saliva
timeFrame: 14 days
measure: Xerostomia questionnaires
timeFrame: 14 days
measure: Oral Mucositis Grading Scale
timeFrame: 14 days
measure: Adverse reaction: Skin reaction
timeFrame: 14 days
measure: Adverse reaction: Respiratory reaction
timeFrame: 14 days
measure: Adverse reaction: Gastrointestinal trat reaction
timeFrame: 14 days
measure: Quality of life of the patient
timeFrame: 14 days
measure: Satisfaction of the patient
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538690: The Effect of Exercise Therapy in Painful Shoulder Disorders
Official title: The Effect of Exercise Therapy on Balance and Pain in Painful Shoulder Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Shoulder Disease
Balance; Distorted
Exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.

Detailed description: 20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Exercises will be applied 3 days a week for 4 weeks, 45-55 minutes by a physiotherapist within the framework of shoulder rehabilitation. In addition, balance exercises will not be given. Balance measurements will be made by the Biodex Balance System, which provides objective data.

Eligibility criteria: Inclusion Criteria:

* Having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon,
* Pain severity felt by the patient above-8 according to the Visual Analogue Scale divided into 10 equal intervals,
* Patients who were recommended conservative treatment

Exclusion Criteria:

* Any previous surgical operation,
* Skeletal system fractures or dislocations,
* Other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy

Primary outcomes:
measure: Objective Balance Measurement
timeFrame: 4 week
measure: Pain Intensity
timeFrame: 4 week
Secondary outcomes:
measure: Range of Motion
timeFrame: 4 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Gizem Ergezen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145690: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD)
Official title: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Anxiety Disorder
Keywords: cognitive behaviour therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample is constituted by all 80 participants who received Internet-based CBT in 2005 within the context of a RCT in Sweden.

Brief summary: Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder.

In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.


Eligibility criteria: Inclusion Criteria:

* Must have a primary diagnosis of social phobia

Exclusion Criteria:

* Substance abuse during the last 6 months
* Other dominating diagnosis (not phobic personality disorder)
* A history of bipolar disorder or psychosis
* Major depression according to DSM-IV and \>20 on madrs-s
* Risk of suicide
* Start of medication or change of dosis during the last 2 months
* Other parallel psychological treatment
* Previous CBT (last 3 years) for social phobia

Primary outcomes:
measure: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 5-year follow-up
Secondary outcomes:
measure: Measures of social anxiety in interaction and performance situations - SIAS & SPS
timeFrame: 5-year follow-up
measure: Measure of depressive symptoms - MADRS-S
timeFrame: 5-year follow-up
measure: Measure of general anxiety - BAI
timeFrame: 5-year follow-up
measure: Measure of quality of life - QOLI
timeFrame: 5-year follow-up
measure: Measure of social anxiety disorder diagnosis - SPSQ
timeFrame: 5-year follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri Sydväst, Stockholm County Council
Study officials:
References:
citation: Hedman E, Furmark T, Carlbring P, Ljotsson B, Ruck C, Lindefors N, Andersson G. A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. J Med Internet Res. 2011 Jun 15;13(2):e39. doi: 10.2196/jmir.1776.
Clinical trial NCT05898490: The Effect of Animation Therapy on Time Perception in Primary School Children
Official title: The Effect of Animation Therapy on Time Perception in Primary School Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Time Perception Altered
Keywords: time perception
animation therapy
occupational therapy
children
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effects of animation therapy on time perception and daily activity routine performances of primary school children.

Detailed description: Time is a process that forms the basis of executive functions used to reveal adaptive behavior and motor performance. However, the way we perceive time can be changed by different factors. This may reveal changes in executive functions such as decision making, behavioral inhibition, planning, and accordingly, in the performance levels and daily routines of daily living activities. Animation therapy is the therapeutic use of the process of shooting a stop-motion animation film. It creates a "flow" effect by nature. The concept of flow includes the loss of the sense of time. In this study, it is aimed to examine whether animation therapy has an effect on the perception of time and daily activity routines in primary school children.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 7-10
* Absence of any orthopedic, neurodevelopmental, and psychiatric problems/diagnosis
* Continuing formal education
* Voluntarily agreeing to participate in the research

Exclusion Criteria:

* Receiving orthopedic, neurodevelopmental and psychiatric diagnosis during the study period
* To be absent from the study process or to quit the process
* Not participating in the first and last evaluations
* Voluntary refusal to participate or continue with the research

Primary outcomes:
measure: Time Discrimination Task
timeFrame: Baseline, preintervention
measure: Time Discrimination Task
timeFrame: Immediately after the intervention
measure: Time Reproduction Task
timeFrame: Baseline, preintervention
measure: Time Reproduction Task
timeFrame: Immediately after the intervention
measure: Executive Functions and Occupational Routines Score
timeFrame: Baseline, preintervention
measure: Executive Functions and Occupational Routines Score
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Özel Yaşam Köyü İlkokulu
Study officials:
affiliation: Hacettepe University
name: Gonca Bumin, Prof.
role: STUDY_DIRECTOR
affiliation: Kütahya Health Sciences University
name: Özgün Belen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05686590: Prehospital Provider Training With Augmented Reality (AR)
Official title: Prehospital Provider Training Using Augmented Reality Simulation: A Mixed-Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Pediatric ALL
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.


Eligibility criteria: Inclusion Criteria:

* Trainees/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
* 18 years and older

Exclusion Criteria:

* Participants who do not consent
* Have a history of severe motion sickness
* Currently have nausea
* History of seizures
* Are clinically unstable
* Currently using corrective glasses (not compatible with AR headset)
* Currently pregnant

Primary outcomes:
measure: Thematic Analysis of Post-Simulation Discussions
timeFrame: Duration of post-simulation debrief (15-20 minutes)
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Duration of Intervention (less than one hour)
measure: Headset Ergonomics
timeFrame: Duration of Intervention (less than one hour)
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Mountain View Fire Department
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
References: