louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06837363: Effect of Untact Upper Extremity Rehabilitation Using a Smart Board for Late Subacute and Chronic Patients with Brain Disorder
Official title: A Multicenter Confirmation Clinical Trial of Untact Upper Extremity Rehabilitation Using Smart Board 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
Home Based Rehabilitation
Brain Disorder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
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 Board by comparing the effects between a group using the home-based Neofect Smart Board 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 neurological diseases 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 shoulder flexor and adductor muscle strength of MRC grade 2 or higher
* Patients with shoulder extensor and abductor spasticity of MAS grade 1+ or lower
* Participants with sufficient cognitive function to understand the instructions from the researcher and the smart board, 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, which is required for using the smart board
* Significant visual impairment to the extent that the screen cannot be recognized when using the smart board

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 NCT03424863: Blood Pressure Changes During Moderate Intensity Strength Training in Aortic Stent-graft Patients
Official title: Peak Systolic Blood Pressure in Heart Patients With Aortic Stent-graft During Moderate Intensity Strength Training: A Descriptive Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stent Graft
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with an aortic stent graft are recommended to do muscle strengthening exercise as part of their rehabilitation. But, as excess blood pressure pose a risk to the integrity of the stent graft, high intensity muscle strengthening exercise may potentially be detrimental, and hence moderate intensity muscle strengthening is recommended. However, the blood pressure changes during moderate intensity strengthening exercises are unknown, and this study aims to quantify these among patients and compare them to those of healthy volunteers.

Purpose:

The purpose of this study is to investigate the increase in blood pressure during quadriceps muscle strength training in patients with aortic stent graft.

Methods:

Patients with aortic stent graft will be included. The participants are investigated once. During the investigation, the blood pressure increase during a single strength training exercise (leg press) is measured. The strength training exercise is done at 60% of maximal strength (moderate intensity) corresponding to 15 Repitition Maximum (RM) (a load that can be lifted exactly 15 times).


Eligibility criteria: Inclusion Criteria patients:

* Adults (+18y) with aortic stent graft following aortic dissection or aneurism
* Minimum 8 weeks post surgery
* Strengthening exercise approved by treating cardiologist
* Able to perform the exercise

Exclusion Criteria patients:

* Lack of ability to read, speak or understand instructions in Danish or English
* Other unspecified heart disease

Inclusion Criteria healthy volunteers:

* Adults (+18y)
* In good health (self report)

Exclusion Criteria healthy volunteers:

• Lack of ability to read, speak or understand instructions in Danish or English

Primary outcomes:
measure: Peak systolic pressure during a single lower extremity muscle strengthening exercise
timeFrame: 5 minutes: 15 repetitions of leg press muscle strength exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical and Occupational Therapy
Study officials:
affiliation: Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
name: Christian Dall, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00694863: Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Official title: Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Membranous Nephropathy
Keywords: high risk for ESRD
immunosuppressive treatment
membranous nephropathy
ACTH
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
First posted: 2008-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven idiopathic membranous nephropathy.
* Nephrotic syndrome: proteinuria \> 3.5 g/day and serum albumine \< 30 g/l
* Normal or mildly impaired renal function (eGFR \> 60 ml/min, MDRD formula)
* High risk for renal failure: beta-2-microglobulin excretion \> 500 ng/min
* Relative contra-indication for cyclophosphamide treatment:

  * fertility and wish for (future) family expanding
  * high age ( \> 60 years)
  * former cyclophosphamide treatment
  * intolerance to cyclophosphamide

Exclusion Criteria:

* Clinical,biochemical or histological signs of any underlying systemic disease
* Any infectious disease (including latent tuberculosis and/or latent amoebiasis)
* Active gastric or duodenal ulcers
* Pregnancy, lactation, inadequate contraceptives
* Clinical signs of renal vein thrombosis
* Asthma and /or any allergic conditions or hypersensitivity reactions
* Allergic reaction to synthetic ACTH in the past

Primary outcomes:
measure: Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.
timeFrame: 9 months
Secondary outcomes:
measure: Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment
timeFrame: 9 and 24 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University
Study officials:
affiliation: Department of Nephrology, Radboud University
name: Jack FM Wetzels, M.D.Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Nephrology, Radboud University
name: Julia M Hofstra, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van de Logt AE, Beerenhout CH, Brink HS, van de Kerkhof JJ, Wetzels JF, Hofstra JM. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study. PLoS One. 2015 Nov 12;10(11):e0142033. doi: 10.1371/journal.pone.0142033. eCollection 2015.
Clinical trial NCT04636463: Music in Wide Awake Hand Surgery
Official title: Music in Wide Awake Local Anesthesia no Tourniquet (WALANT) Hand Surgery: Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Wide awake local anesthesia no tourniquet (WALANT) surgery has emerged as a popular technique in hand surgery over the last decade. It is possible that the unfamiliar sounds of the operating room could contribute to intraoperative patient anxiety during WALANT surgery. This study intends to investigate whether utilizing noise cancelling headphones and listening to music intraoperatively during WALANT hand surgery has an effect on patient anxiety, pain, and satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Already chose to undergo WALANT hand surgery with the participating surgeon

Exclusion Criteria:

- Age \<18 years old

Primary outcomes:
measure: Patient anxiety levels will be recorded on a 10 point VAS scale
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03313063: Post-Pregnancy Cardio Trial
Official title: Myocardial Characterization With Magnetic Resonance Imaging in Patients After Preeclampsia (Pilot Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: magnetic resonance imaging
myocard
preeclampsia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 50 years of age, 0.5 - 20 years postpartum either with preeclampsia diagnosis during index pregnancy or without pathological findings. Controls are matched to cases based on age and BMI.

Brief summary: Preeclampsia is a systemic pregnancy disorder and is associated with an increased cardiovascular risk later in life. This study will characterize myocardial tissue in patients after preeclampsia compared to controls and investigate potential functional and structural changes in the heart of preeclamptic women primarily with two methods: cardiovascular magnetic resonance imaging and echocardiography. A comparison between these two methods, where appropriate, is also envisaged.


Eligibility criteria: Inclusion Criteria:

* postpartal window: 0.5 - 20 years
* cases: diagnosis of preeclampsia during the index pregnancy
* controls: age and BMI matched

Exclusion Criteria:

* metal implants
* kidney insufficiency (GFR \< 30 ml/min/)
* claustrophobia
* contrast medium allergy
* current pregnancy/ lactation
* chronic hypertension (\> 140/90)
* diagnosis of previous cardiovascular disease
* body weight over 120 kg
* big tattoos in thorax area

Primary outcomes:
measure: any structural or functional change of the heart (combined outcome)
timeFrame: 0.5 - 20 years after delivery
Secondary outcomes:
measure: myocardial fibrosis
timeFrame: 0.5 - 20 years after delivery
measure: myocardial edema
timeFrame: 0.5 - 20 years after delivery
measure: myocardial fat infiltrates
timeFrame: 0.5 - 20 years after delivery
measure: myocardial inflammation
timeFrame: 0.5 - 20 years after delivery
measure: myocardial hypertrophy
timeFrame: 0.5 - 20 years after delivery
measure: reduced ejection fraction
timeFrame: 0.5 - 20 years after delivery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center (ECRC)
Study officials:
References:
Clinical trial NCT00733863: Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Official title: A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Active immunization
Alzheimer disease
Antibody
Central Nervous System Diseases
Neurodegenerative diseases
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Mild Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

* Previously participated in an AD vaccine study and received active treatment
* History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
* History or presence of seizures and/or cerebrovascular disease.
* Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

Primary outcomes:
measure: Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
timeFrame: 52 weeks
Secondary outcomes:
measure: Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire Pellegrin
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Basel
country: Switzerland
facility: NeuroPsychologieZentrum
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.
Clinical trial NCT06274463: A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients
Official title: Effects of Customized Trunk Stabilization Exercise Program to Patients With Brain Disease on Trunk Stability and Satisfaction With the Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Diseases
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease.


Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years old
2. Brain disease patients hospitalized in the rehabilitation medicine department of our hospital and receiving exercise therapy 5 times a week
3. Patients with a functional ambulatory category (FAC) score of 0-4
4. After receiving a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to follow the precautions.

Exclusion Criteria:

1. Those who have suffered prior to participating in the study
2. Those in good physical condition, such as unstable conditions in the state system, coordination system, problem system, and endocrine system, and those with cerebrovascular disease
3. Other cases of investigation without participation in this study

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: baseline, 5 weeks after intervention
measure: Berg Balance Scale
timeFrame: baseline, 5 weeks after intervention
Secondary outcomes:
measure: Joint angle
timeFrame: baseline, 5 weeks after intervention
measure: Joint moment
timeFrame: baseline, 5 weeks after intervention
measure: Joint power
timeFrame: baseline, 5 weeks after intervention
Other outcomes:
Locations:
Study officials:
affiliation: CHA Bundang Medical Center
name: MinYoung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05339763: Long Term Bowel Function Following Rectal Cancer Surgery
Official title: Long Term Bowel Functional Outcomes Following Anal Sphincter Preserving Surgery for Rectal Cancer: A Single Center Longitudinal Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel; Functional Syndrome
Rectal Cancer
Keywords: Rectal cancer
Sphincter preserving surgery
Neoadjuvant therapy
ow anterior resection syndrome
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * In this longitudinal study, 171 patients were evaluated and compared based on the radiation therapy they received.
* Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.

Detailed description: Background Despite advances in the neoadjuvant chemoradiation therapy and anal sphincter-preserving surgeries for rectal cancer, bowel dysfunction is still unavoidable which negatively affect the patients' quality of life. In this longitudinal study, The aim of this study was to investigate the changes in bowel function with follow up time and the effect of the neoadjuvant chemo radiotherapy on bowel function following low anterior resection for rectal cancer.

Materials and methods In this study, 171 patients with rectal cancer who underwent low anterior resection between 2012 and 2018 were included. Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes,
* Aged between 18 and 75 years,
* Patients with mid and upper rectal cancer (6-15) cm from the anal verge(AV) with or without preoperative chemo radiotherapy.
* Patients who underwent low anterior resection(LAR).
* Patients who were followed up with at least two outpatient visits for bowel function assessment.

Exclusion Criteria:

* Patients with recurrent rectal tumors,
* Surgically unfit patients,
* Patients with tumors infiltrating the puborectalis muscle or external sphincter.
* Patients with preoperative fecal incontinence.
* Patients who were followed up only once in the outpatient clinic.
* Patients with lower rectal cancer less than 6cm from AV,
* Patients who underwent abdominoperineal resection(APR) or intersphincteric resection(ISR).

Primary outcomes:
measure: bowel function
timeFrame: 6 months-24 months
Secondary outcomes:
measure: fecal incontinence
timeFrame: 6 months-24 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ahmad
Study officials:
References:
Clinical trial NCT05633563: The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis
Official title: The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transthyretin Amyloid Cardiopathy
Mitochondrial Pathology
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Wild-type transthyretin cardiac amyloidosis (ATTRwt) is a deposition disorder in which one of the proteins of the body misfolds and accumulates at various places in the body, including the heart, leading to both mechanical and cellular damage. The gradual development of the disease will ultimately lead to heart failure and death

The protein which deposits in the heart of patients, damages both the heart mechanically as the myocardium becomes rigid and hypertrophic over time but also at the cellular level. Cell damage can be observed by elevated blood tests for cell damage (Troponin) and during exercise tests that show patients' hearts burning oxygen inefficiently when exposed to physical stress compared with the hearts of healthy individuals . No one has, however, intimately studied this cellular damage.

Vastarel® (Trimetazidine, TMZ) is an already known drug for the treatment of chest pain. The mechanism of action indicates that it may have an effect on patients with cardiac amyloidosis.

The study aims to investigate the effects of TMZ on the mitochondrial function, myocardial performance, and invasive hemodynamics in patients with ATTRwt with a randomized, double-blinded, crossover-trial.


Eligibility criteria: Inclusion Criteria:

* Wild-type transthyretin cardiac amyloidosis
* NAC stage I
* NYHA class of I or II
* Informed consent

Exclusion Criteria:

* Other, similar diagnoses
* Hereditary transthyretin cardiac amyloidosis
* Light chain amyloidosis
* Morbus Waldenstrøm
* Myelomatosis
* Medical treatment with loop diuretics in standard doses (40 mgx1 daily)
* Contraindications to trimetazidine
* Significant comorbidity assessed by the investigators
* Unable to provide informed consent

Primary outcomes:
measure: Change: pulmonary capillary wedge pressure (PCWP)
timeFrame: Four weeks of treatment
Secondary outcomes:
measure: Change: cardiac index (CI)
timeFrame: Four weeks of treatment
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Department of Cardiology
state: Danmark
Study officials:
References: