louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05433337: Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study
Official title: "PROSPER-FM-EXT": Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management: An Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Swing Therapeutics, Inc.
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a virtual, single-arm, pragmatic, non-significant risk device study. Study participants will continue to have access to Digital Acceptance and Commitment Therapy (ACT) after the original 12-week study (PROSPER-FM, NCT05243511), in addition to their standard care for fibromyalgia
Primary purpose: TREATMENT

Brief summary: This study is designed as a 9-month extension of the original study (PROSPER-FM). The purpose of the extension study is to assess the long-term (up to 1 year) response to a digital therapy in the treatment of fibromyalgia.


Eligibility criteria: Key Inclusion Criteria:

* Participant has completed participation in the PROSPER-FM study and was assigned to the Digital ACT Arm
* Participant is willing and able to comply with all protocol-specified requirements

Key Exclusion Criteria:

* Based on the investigator's judgment, any new diagnosis of acute or chronic disease/condition since participant's enrollment in PROSPER-FM study that may impact the outcome of this study
* Severe depression at the final visit of the PROSPER-FM study (measured by BDI-II)
* Increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS") at the final visit of the PROSPER-FM study

Primary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: Month 9
Secondary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
timeFrame: Original Study Baseline to Month 9
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Swing Therapeutics
state: California
Study officials:
affiliation: Swing Therapeutics
name: Brian Keefe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03823937: Evaluation of Smell and Taste in Fibromyalgia
Official title: Evaluation of Smell and Taste in Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: fibromyalgia
smell
taste
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 18-70 years old fibromyalgia diagnosed with 2016 ACR criteria and age, sex-matched healthy controls will be included in the study.

Brief summary: Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.


Eligibility criteria: Inclusion Criteria:

* 18-70 years of fibromyalgia patients
* Giving informed consent
* Knowing how to write and read in Turkish

Exclusion Criteria:

* Mentally retarded patients
* Psychiatric disorders (bipolar disorder, schizophrenia etc.)
* Severe organ failure (kidney, liver, heart failure)
* History of head trauma
* Any disorder associated with smell and taste functions

Primary outcomes:
measure: Sniffin' Sticks Test Score
timeFrame: Baseline
measure: Taste Strips Test Score
timeFrame: Baseline
Secondary outcomes:
measure: Quality of Life Score
timeFrame: Baseline
measure: Anxiety Score
timeFrame: Baseline
measure: Alexithymia Score
timeFrame: Baseline
measure: Depression Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdulhamid Han Training and Research Hospital
Study officials:
References:
citation: Hur K, Choi JS, Zheng M, Shen J, Wrobel B. Association of alterations in smell and taste with depression in older adults. Laryngoscope Investig Otolaryngol. 2018 Feb 21;3(2):94-99. doi: 10.1002/lio2.142. eCollection 2018 Apr.
citation: Lotsch J, Kraetsch HG, Wendler J, Hummel T. Self-ratings of higher olfactory acuity contrast with reduced olfactory test results of fibromyalgia patients. Int J Psychophysiol. 2012 Nov;86(2):182-6. doi: 10.1016/j.ijpsycho.2012.09.003. Epub 2012 Sep 15.
Clinical trial NCT05675137: Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia
Official title: Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Cognitive Impairment, Mild
Aging
Dementia
Lead sponsor: Silvia Health
Sponsor class: INDUSTRY
Collaborators: name: Chosun University Hospital
First posted: 2023-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigated the efficacy of the Silvia program, a mobile-based multidomain intervention, to improve cognitive function and health-related outcomes of older adults with a high risk of dementia. We compare its effects to a conventional paper-based multidomain program on various health indicators related to risk factors of dementia.


Eligibility criteria: Inclusion Criteria:

1. experiencing subjective cognitive decline,
2. had a smart phone and could use it, and
3. understood the purpose and process of this study.

Exclusion Criteria:

1. major psychiatric disorders
2. dementia,
3. degenerative brain diseases
4. severe or unstable heart diseases
5. neurological or psychological diseases that affected cognitive functioning
6. severe vision or hearing impairment,
7. current participation in a cognitive training program
8. does not know how to use mobile devices.

Primary outcomes:
measure: Change from baseline Korean version of the Repeatable Battery for the Assessment of Neuropsychological status at 12 weeks
timeFrame: baseline and after the 12-week intervention
Secondary outcomes:
measure: Change from baseline Korean version of the mini-mental state examination, 2nd edition(K-MMSE-2) at 12 weeks
timeFrame: baseline and after the 12-week intervention
measure: Change form baseline Korean version of the prospective and retrospective memory questionnaire(K-PRMQ) at 12 weeks
timeFrame: baseline and after the 12-week intervention
measure: Change from baseline Center for Epidemiological Studies Depression (CES-D) questionnaire at 12 weeks
timeFrame: baseline and after the 12-week intervention
measure: Change from baseline State-Trait Anxiety Inventory-X-1(STAI-X-1) at 12 weeks
timeFrame: baseline and after the 12-week intervention
measure: Change from baseline Perceived Stress Scale (PSS) at 12 weeks
timeFrame: baseline and after the 12-week intervention
measure: Change from baseline EuroQoL 5-Dimension 5-Level(EQ-5D-5L) at 12 weeks
timeFrame: baseline and after the 12-week intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Silviahealth
Study officials:
References:
Clinical trial NCT01725737: Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Placebo-Controlled Trial With GlyTI-M Among Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ADHD
Keywords: ADHD
GlyTI-M
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 116
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant. We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This study will also help us to understand the mechanism of ADHD and give a way to develop new drug and also a more possible way to treat ADHD children under 6 years old.

Detailed description: The accumulated neuro-image, hereditary and animal studies showed the correlation between glutamate transport dysfunction and ADHD psychopathology. However, there is limited clinical trial to testify the effect of modulating the NMDA receptor function of glutamate to treat ADHD.

GlyTI-M is an endogenous Glycine transporter I inhibitor, and it acts on the glutamatergic synapse to modulate the neurotransmission of N-Methyl-D-Aspertate (NMDA) receptor. This study aims to explore the effect of GlyTI-M among children with ADHD.

Eligibility criteria: Inclusion Criteria:

* Fulfill the criteria of ADHD according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
* Subjects and parents agree to participate in the study and provide informed consent.

Exclusion Criteria:

* Autism, Mental retardation.
* inability to follow protocol.

Primary outcomes:
measure: Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)
timeFrame: 1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week
Secondary outcomes:
measure: Barkley's side effect rating scale
timeFrame: 1. Change from Baseline adverse effect at 2, 4, 6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Ruu-Fen Tzang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957437: Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305
Official title: A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
healthy volunteer
male
pharmacokinetics
AZD1305
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures.
* Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Primary outcomes:
measure: Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma
timeFrame: From predose until 48 hours post last dose
Secondary outcomes:
measure: Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight
timeFrame: Frequent safety measurements during the study, from screening period to follow-up
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde
role: STUDY_DIRECTOR
affiliation: PAREXEL Early Phase Clinical Unit, London UK.
name: Klaus Francke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03654937: Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
Official title: Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza Virus Vaccine Adverse Reaction
Influenza Vaccine Allergy
Keywords: Influenza vaccination
elite athletes
Immune response
Side effects
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Federal Institute of Sport Science
First posted: 2018-08-31
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Seasonal influenza vaccination was used to assess whether induction of immunity as well as the rate of side effects is influenced by the timing of the last training session before vaccination. Healthy athletes were vaccinated with the tetravalent influenza vaccine and blood samples were collected before, 1, 2 and 26 weeks after vaccination. The athletes were randomly assigned to vaccination within 2 hours after the last training session ("2h") vs. vaccination after a resting period of at least 26 hours ("26h"). All participants documented side effects and training restrictions. Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.


Eligibility criteria: Inclusion Criteria:

* performance-oriented training on at least five days a week, healthy athletes

Exclusion Criteria:

* current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases

Primary outcomes:
measure: Immune response
timeFrame: 26 weeks
measure: Rate of side effects
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01452737: Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient Colonic Preparation
Official title: 2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
bowel preparation
Golytely
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.


Eligibility criteria: Inclusion Criteria:

* Inpatients undergoing colonoscopy
* Age 19 or over

Exclusion Criteria:

* Unable to provide informed consent
* Patients with constipation
* Patients with suspected bowel obstruction or severe inflammatory bowel disease
* Same-day colonoscopy
* Intensive/critical care patient
* History of colorectal resection

Primary outcomes:
measure: Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups
timeFrame: 30min
Secondary outcomes:
measure: Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
timeFrame: 20hours
measure: Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
timeFrame: 20hours
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Robert A. Enns, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259037: A Study of Ultrasonography With Elastography in Skin Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign and Malignant Skin Neoplasms
Keywords: Elastography
Cutaneous
Imaging
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General dermatologic population from suburban referral clinic.

Brief summary: This study will look at high frequency ultrasound as a medical imaging modality and apply it to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area. We will use this to try and differentiate between benign and cancerous skin lesions.


Eligibility criteria: Inclusion Criteria:

* Patients with skin lesions undergoing biopsy for diagnosis.

Exclusion Criteria:

* Patients with skin lesions which do not require biopsy for diagnosis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References:
Clinical trial NCT05040737: PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients
Official title: Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2 Infection
Keywords: Haemodialysis
SARS-CoV-2 Infection
cytokines
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.

Detailed description: Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.

Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years .
* Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-19.
* Signature of informed consent or legal representative.
* Estimated duration of admission greater than 8 days (4 haemodialysis sessions).
* Patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmHg.

Exclusion Criteria:

* Refusal to sign the consent form.
* Patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week.
* Allergy (documented or suspected) to either of the two membranes involved in the study.
* Patient with haemodynamic instability (Mean arterial pressure \< 100 mmHg).

Primary outcomes:
measure: Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
timeFrame: Day 8
Secondary outcomes:
measure: Percentage of Inflammatory interleukins reduction
timeFrame: Days 5 and 8
measure: Inflammatory interleukins reduction (30 minutes)
timeFrame: Days 1,3,5,8
measure: Populational characteristics
timeFrame: Day 8
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
state: Valencian Community
Study officials:
References:
Clinical trial NCT05681637: SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation
Official title: SpO2 Difference Between Fingers of the Hand During Sequential Desaturation and Step Resaturation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Pulse Oximetry
SpO2
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective study
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the project is to experimentally compare the fingers of the hand in terms of measured concentrations of peripheral blood oxygen saturation (SpO2) in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

Detailed description: The finger sensors of pulse oximeters are most often placed on the middle two fingers of the hand. Although there have been many studies looking at the accuracy of different pulse oximeters or comparing fingers in terms of SpO2. There is no study comparing fingers in terms of SpO2 under hypoxic condition with simultaneous randomization of finger probe placement. At the same time, there is no study that compares SpO2 changes between fingers during a step change in blood oxygen saturation. The data obtained could help to improve the reliability of monitoring physiological parameters with pulse oximeters.

Eligibility criteria: Inclusion Criteria:

* Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation

Exclusion Criteria:

* post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers.
* pneumothorax or a condition after cardiovascular surgery.
* anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.

Primary outcomes:
measure: Non-invasive SpO2 measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other.
timeFrame: 1 hour
Secondary outcomes:
measure: Non-invasive Perfusion Index measurements will be performed continuously on all individual fingers of left hand of volunteers and then the measured values will be compared between each other.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University
name: Karel Roubik, Professor
role: STUDY_DIRECTOR
References:
citation: Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070.