louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06837324: Effect of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients with Brain Disorder
Official title: A Multicenter Confirmation Clinical Trial of Untact Upper Extremity Rehabilitation Using Smart Glove for Late Subacute and Chronic Patients with Brain Disorder - a Randomized Single-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Untact Upper Extremity Rehabilitation
Brain Disorder
Home Based Rehabilitation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2025-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to clinically validate the clinical efficacy, usability, and safety of home-based upper limb rehabilitation training using the Neofect Smart Glove by comparing the effects between a group using the home-based Neofect Smart Glove and a group performing conventional home-based occupational therapy in patients with upper limb dysfunction in the late subacute and chronic stages of neurological diseases.


Eligibility criteria: Inclusion Criteria:

* Patients with brain disorder aged 19 to 85 years old
* patients with hemiparesis lasting for more than 3 months due to neurological diseases (stroke, traumatic brain injury, brain tumor) and impaired upper limb function
* Patients with spasticity of the wrist and finger flexors and extensors on the affected side, with a Modified Ashworth Scale (MAS) score of 1+ or lower
* Participants with sufficient cognitive function to understand the instructions from the researcher and the smart glove, and to perform the tasks (K-MMSE ≥21)

Exclusion Criteria:

* pre-existing significant neurogenic disorders
* major psychiatric disorders such as schizophrenia, bipolar disorder, or dementia
* History of diseases that caused pain or muscle atrophy in the affected upper limb before the onset of the neurological disease, which interfered with rehabilitation
* Severe spasticity of the affected upper limb (Modified Ashworth Scale score ≥3)
* skin disorders or open wounds on the affected upper limb
* Amputation, fractures, or soft tissue-related diseases or injuries on the affected upper limb
* severe pain that interferes with rehabilitation of the affected upper limb (Numeric Rating Scale \> 6)
* Inability to maintain a seated posture for more than 10 minutes
* Significant visual impairment to the extent that the screen cannot be recognized when using the smart glove

Primary outcomes:
measure: Improvement of uper limb score in Fugl-Meyer assessment
timeFrame: Within 14 days before the intervention, within 2 days after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06886724: Investigating the Efficacy of Probiotics in Enhancing Gastrointestinal and Immunological Health
Official title: A Study on the Role of Ligilactobacillus Salivarius LS97 in Modulating Gut Microbiota and Immune System Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intestinal and Lmmune Function Lmproved
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness and safety of Ligilactobacillus salivarius LS97 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Willing to undergo 3 follow-up visits during the intervention period
2. Be willing to provide blood, urine and stool samples 2 times during the intervention period
3. Good eyesight, can read and write, can wear glasses
4. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria:

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia psychosis, bipolar disorder
4. Take medication for depression or low mood
5. Internal organ failure (heart, liver or kidney failure, etc.)
6. Have received radiation or chemotherapy in the past
7. have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past

Primary outcomes:
measure: Change in the composition of fecal microbiota before and after intervention.
timeFrame: Week 0 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Xu fei
state: Henan
Study officials:
References:
Clinical trial NCT04050124: Impact of Prisma on Donor Site Pain
Official title: Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Graft Disorder
Donor Site Complication
Keywords: Donor site pain after skin graft harvesting
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled to undergo STSG for any reason
* Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.

Exclusion Criteria:

* Active infection or history of radiation to the donor site
* Patient has a known sensitivity to Promogran Prisma™ or silver
* Elevated INR \>3.0
* Insensate at the donor site
* Chronic narcotic use (\>6 months of daily use)

Primary outcomes:
measure: Pain Score on Visual Analogue Scale (VAS)
timeFrame: Postoperative Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Scott Gorenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00755924: Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholesterol, HDL
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a double-blinded randomized placebo controlled prospective clinical trial evaluating the impact of apple cider vinegar on serum HDL. 112 participants will be randomized to consume either 2 tablespoons of vinegar daily or a placebo containing a 2% balsamic vinegar solution in water. Baseline, two month and 4 month blood samples will be obtained for fasting lipids. The primary endpoint is met if HDL levels increase in the treatment arm versus baseline after 2 month intervention.


Eligibility criteria: Inclusion Criteria:

* Those older than 18 years of age
* Park Nicollet Health Services patient

Exclusion Criteria:

* Because of a potential positive effect of vinegar on improving diabetes mellitus8 and the subsequent change in medication regime for diabetes diabetic patients will be excluded from this study. If this study finds that vinegar does increase HDL levels, a subsequent study of diabetic patients will be conducted.
* History of allergy to apple cider vinegar
* Those with a terminal illness
* Diagnosis of Inflammatory bowel disease
* Those with Immunosuppression diseases
* Patients on dialysis
* Severe psychiatric illness who are unable to consent or reliably participate
* No evidence of end stage renal disease
* Those who use alcohol greater than or equal to 2 drinks per day
* Those who take in \>3 tsp vinegar/day supplement
* Plans to increase exercise or begin diet during the protocol period
* Any use of niacin or niacin-like compounds
* Initiation of niacin, fibrates (eg gemfibrozil); statin or ezetimibe medication within the last 6 weeks or during the trial
* Inability to read English
* Age less than 18 years given clinical events would be unlikely in this population
* LDL greater than 160mg/dL and requires adjustment or addition of statin therapy (which could reduce HDL)
* History of liver failure in medical history review
* Current smoking (as this can reduce HDL levels and it would be unethical to require people to continue smoking during the study)

Primary outcomes:
measure: Change in HDL-Cholesterol level
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Park Nicollet Health Services
state: Minnesota
Study officials:
References:
Clinical trial NCT01749124: My Coach Connect: An Automated Telephone-based Reporting System for Patients With Mental Illness
Official title: "My Coach Connect": Pilot Under the Partnered Research Center for Quality Care, RHINO 2008-0132
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Mental Illness
Major Depression
Schizophrenia
Bipolar Disorder
Keywords: mental illness
depression
schizophrenia
bipolar disorder
IVR
automated
telephone
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, Los Angeles
First posted: 2012-12-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study for a novel, automated telephone system called "My Coach Connect". The purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare.

Detailed description: Clients will use this tool (My Coach Connect) to leave voice messages and survey answers which their providers will have access to by logging in to a secure website. Providers will also be able to indicate using the website whether they found a particular narrative helpful or not. Providers will have access to audio recordings of the voice responses, transcribed text of the responses, as well as "word clouds" generated from the text. Word clouds are a method of displaying the content of text such that words that are used more frequently are displayed in a larger size than words used less frequently. Clients will call in to the system approximately twice a week for a period of four months.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the ROADS program
* English speaking
* Have a working telephone

Exclusion Criteria:

* Must speak english

Primary outcomes:
measure: Client and provider telephone intervention
timeFrame: four months
Secondary outcomes:
measure: Client and provider survey
timeFrame: 4 months
Other outcomes:
measure: Discussion groups
timeFrame: 4 months
Locations:
city: Long Beach
country: United States
facility: ROADS (Recovery, Opportunity, And Developing Skills)
state: California
Study officials:
affiliation: RAND
name: Ken Wells, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Armen Arevian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03310424: Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
Official title: Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Syphilis
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Brief summary: Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab.

In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.


Eligibility criteria: Inclusion Criteria:

* Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Exclusion Criteria:

* Age \<18 years
* Unable to provide consent
* Patients with other stages of syphilis apart from Primary or Secondary OR patients without a lesion from which swabs can be obtained

Primary outcomes:
measure: Whole Genome Sequencing
timeFrame: From samples collected at baseline
measure: Host Transcriptomic Response
timeFrame: From samples collected at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Mortimer Market Centre
Study officials:
References:
Clinical trial NCT00457834: Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)
Official title: Study on the Efficacy of bi-Ventricular Pacing of Patients With Severe Heart Failure and Chronic Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Keywords: Heart failure
Dyssynchrony
Cardiac resynchronization therapy
Atrial fibrillation
RVOT
RVapex
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2007-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cardiac resynchronization therapy (CRT) is used to treat dilated heart failure with discoordinate contraction. Dyssynchrony typically stems from electrical delay leading to mechanical delay between the septal and lateral walls. Right ventricular apical pacing might be associated with long-term adverse effects on left ventricular function, and alternative pacing sites such as high septal or RVOT has been suggested. Previous studies have however been conflicting. The aim of this study is to determine if bi-ventricular pacing from RVOT + LV is better than RVapex+LV. To avoid influence from possible atrial delay only patients with chronic atrial fibrillation are included. All patients will receive a bi-ventricular pacemaker with 3 leads placed in RVapex, RVOT and via coronary sinus to pace the left ventricle. After a run in period (to determine if AV-junction ablation is necessary) the patients are randomised to one of the following pacing configurations: RVOT+LV or RVapex+LV with cross-over after 3 month.


Eligibility criteria: Inclusion Criteria:

* Heart failure NYHA III-IV
* LVEF\<35%
* QRS duration\>150 ms
* Chronic atrial fibrillation.

Exclusion Criteria:

* Heart failure not related to systolic function
* Unstable angina pectoris, AMI, PCI or CABG within 2 month
* Inclusion in other studies

Primary outcomes:
measure: quality of life
Secondary outcomes:
measure: NYHA class
measure: 6-MWT
measure: bi-cycle test
measure: pro-BNP
measure: echocardiographic measures
measure: apnea-hypopnea index
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Heart Centre, Umeå University Hospital
Study officials:
affiliation: Heart Centre, Umeå University Hospital
name: Steen M Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Centre, Umeå University Hospital
name: Folke Rönn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ronn F, Kesek M, Karp K, Henein M, Jensen SM. Right ventricular lead positioning does not influence the benefits of cardiac resynchronization therapy in patients with heart failure and atrial fibrillation. Europace. 2011 Dec;13(12):1747-52. doi: 10.1093/europace/eur193. Epub 2011 Jun 28.
Clinical trial NCT02119234: Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
Official title: Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.


Eligibility criteria: Inclusion Criteria:

* COPD patients
* smokers or ex-smokers
* post-bronchodilator FEV1 between 30 and 60% of predicted value

Exclusion Criteria:

* Positive serology to HIV and hepatitis
* Known respiratory disorder other than COPD
* Recent COPD exacerbations or hospitalization for COPD
* Treatment with non-permitted concomitant medication
* clinically relevant concomitant disease
* clinically relevant abnormal laboratory or ECG parameters

Primary outcomes:
measure: Area under the curve of B17MP, formoterol and glycopyrrolate
timeFrame: Over 24 and 48h after single administration
Secondary outcomes:
measure: Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma
timeFrame: over 24 or 48h after single administration
measure: Adverse events
timeFrame: over a period of 6 to 11 weeks
measure: Lung function
timeFrame: 30 min after single administration
measure: plasma cortisol
timeFrame: over 24 h after single administration
measure: cortisol urinary excretion
timeFrame: over 24 h after single administration
measure: potassium plasma profile
timeFrame: over 24 h after single administration
measure: Vital signs
timeFrame: over 24 h after single administration
measure: ECG parameters
timeFrame: over 24 h after single administration
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University in Lodz
state: Ul. Kopcińskiego 22
Study officials:
affiliation: Medical University Lodz
name: Piotr Kuna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00327834: Atomoxetine in the Treatment of Binge Eating Disorder
Official title: Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Binge-eating Disorder
Lead sponsor: Lindner Center of HOPE
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2006-05-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The specific aim of this study is to assess the efficacy and safety of atomoxetine compared with placebo in outpatients with binge eating disorder.


Eligibility criteria: Inclusion Criteria:

* Subjects will meet the DSM-IV criteria for a diagnosis of binge-eating disorder for at least the last 6 months
* In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization

Exclusion Criteria:

* Have concurrent symptoms of bulimia nervosa or anorexia nervosa
* Women who are pregnant, lactating, or of child bearing potential who are not using adequate contraceptive measures
* Patients who are displaying clinically significant suicidality or homicidality

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Susan L: McElroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McElroy SL, Guerdjikova A, Kotwal R, Welge JA, Nelson EB, Lake KA, Keck PE Jr, Hudson JI. Atomoxetine in the treatment of binge-eating disorder: a randomized placebo-controlled trial. J Clin Psychiatry. 2007 Mar;68(3):390-8. doi: 10.4088/jcp.v68n0306.