louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06359704: Intervention for Emotions in Caregivers of Dementia
Official title: Integrative Therapeutic Program to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial: a Study Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: BPSD
Expressed Emotion
Depressive Symptoms
Keywords: Dementia care
Caregiver burden
Integrative intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled arm with waitlist treatment
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes).

Detailed description: A dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program can be developed to address EE in caregivers, such as (1) reduce caregivers' EE, (2) reduce caregivers' depressive symptoms, (3) reduce the behaviorally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and (4) improve caregivers' perceived stress from PLwD's BPSD.

Eligibility criteria: Inclusion Criteria:

* with a high level of expressed emotion as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C);(Kavanagh et al., 1997; Van Humbeeck et al., 2002; Yu et al., 2016)
* provides care at least 4 hours per day;(Moon \& Adams, 2013)
* consent to participate, and
* no acute psychiatric illness.

Exclusion Criteria:

* with a low level (scored lower than 35 on FAS-C) of expressed emotion
* do not provide consistent or sufficient care (fewer than 4 hours per day) to PLwD
* do not consent to participate;
* with comorbid acute psychiatric illness.

Primary outcomes:
measure: Expressed emotions
timeFrame: From baseline to 3rd month followup
Secondary outcomes:
measure: depressive symptoms
timeFrame: From baseline to 3rd month followup
measure: social dynamics
timeFrame: From baseline to 3rd month followup
measure: BPSD
timeFrame: From baseline to 3rd month followup
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Shuangzhou Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830904: Efficacy of Lycra Garments in Ataxic Subjects
Official title: Efficacy of Lycra Garments in Ataxic Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ataxia, Cerebellar
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study iss to analyze the effect of Lycra garments in the axial stabilization in subjects affected by ataxia, both in acquired cerebellar injuries and malformative etiology.

Improvement are expected for what concerns:

* greater stability during stance
* smoother walking pattern
* reduction of risk of fall.

The two groups (acquired and malformative) will be compared.


Eligibility criteria: Inclusion Criteria:

* subjects recruited must show a framework of ataxia consequent to acquired brain injury or malformative etiology.
* subjects must be able to walk autonomously without any device

Exclusion Criteria:

* presence of spasticity or muscular contractures
* subjects who already used lycra garments

Primary outcomes:
measure: Movement of the center of mass over GRAIL/no device
timeFrame: immediately before wearing the lycra garment
measure: Movement of the center of mass over GRAIL/ with lycra garments
timeFrame: immediately after wearing the lycra garment
measure: Berg Balance Scale/no device
timeFrame: immediately before wearing the lycra garment
measure: Berg Balance Scale/ with lycra garments
timeFrame: immediately after wearing the lycra garment
measure: 6 Minute Walking Test/no device
timeFrame: immediately before wearing the lycra garment
measure: 6 Minute Walking Test/ with lycra garments
timeFrame: immediately after wearing the lycra garment
measure: Goal Attainment Scaling/no device
timeFrame: immediately before wearing the device
measure: Goal Attainment Scaling/ with lycra garments
timeFrame: immediately after wearing the lycra garment
Secondary outcomes:
measure: Likert tolerability questionaire
timeFrame: 14 days after wearing the lycra garment
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT03875404: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Official title: Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: Deep Brain Stimulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
* Age ≥ 18 years

Exclusion Criteria:

* Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor
* Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)
* Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)
* Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)
* Pregnant

Primary outcomes:
measure: Change in tremor rating score
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Erik H Middlebrooks
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147804: Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations
Official title: Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Bladder Trauma
Keywords: Urinary bladder trauma after gynaecological and obstetric operations
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We aimed to evaluate the management and outcome of bladder trauma after gynecological and obstetric operations at Assiut university hospital and to evaluate the methods of treatment of these complications.

We aimed to find out risk factors for vesico uterine fistula after bladder trauma

Detailed description: The female genital and urinary systems are closely related embryologically and anatomically. The surgeon should know the anatomy of this area to avoid urinary tract (UT) injuries during obstetric (Obst) and gynecologic (Gyn) surgeries (Solyman et al., 2022)

UT injuries during Obst/Gyn surgeries are rare but have a significant psychological impact on both patient and surgeon, and their medico legal aspects are very bothering (Safrai et al., 2022)

UT injuries during Obst/Gyn operations range from 0.3 to 1% (Blackwell et al., 2018) Most cases are bladder injury, approximately three times more than ureteral injury (Wong et al., 2018)

The primary goal of the Obst/Gyn surgeon is to avoid UT injuries during his procedure. Still, in some situations, this will be difficult as in patients with abnormal anatomy, difficult operations as in the presence of severe bleeding or pelvic adhesions, and with surgeons with low experience. Immediate intraoperative repair of these injuries is optimal. In some cases, diagnosis and management are delayed postoperatively(Patel and Heisler, 2021)

UT injuries during Obst/Gyn operations are either acute injuries such as bladder and ureteral laceration, and ureteral ligation identified immediately intra operatively or chronic injuries as fistula formation and stricture ureter, which are discovered later on (Lee et al., 2012) Iatrogenic urological complications from gynecological surgery can be prevented and reduced by complying with standard surgical

Eligibility criteria: Inclusion Criteria:

-

All patients with Urinary bladder injuries related to Obst/Gyn operations

Exclusion Criteria:

* no exclusion criteria in all patients with bladder trauma after gyn \&obs operations

Primary outcomes:
measure: To measure the surgical managment of the bladder tear
timeFrame: Follow up after 3 weeks and 3 months and 6 months
Secondary outcomes:
measure: To evaluate the quality of life, satisfaction of patients, UTI manifestations
timeFrame: After 3 weeks and 3 months and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01450904: The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length
Official title: The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty: The Effect of Quadriceps Incision Length
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 60
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: Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the less postoperative pain and shorter recovery time compared to the conventional technique. With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more quadriceps strength and improve functional performance after TKA. However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.


Eligibility criteria: Inclusion Criteria:

* The patients who diagnosed primary osteoarthritis of knee with

  1. varus or valgus deformity \< 20 degrees
  2. preoperative range of motion \> 90 degrees
  3. extension lag \< 10 degrees
  4. Flexion contracture \< 30 degrees

Exclusion Criteria:

* Bilateral simultaneous total knee arthroplasty
* Previous knee surgery
* Inadequate exposure during the surgery

Primary outcomes:
measure: The recovery time of Quadriceps strength
timeFrame: Upto 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Keerati Charoencholvanich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03073304: A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.
Official title: A Randomized Controlled Study With the Aim to Compare Crystalloid Prime Solution With a Prime Solution Containing Packed Red Blood Cells in Relation to the Patient's Regional Metabolic Needs and Immunological Influence During Isolated Limb Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Sarcoma
Keywords: isolated limb perfusion
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2017-03-08
Enrollment: 18
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 primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.


Eligibility criteria: Inclusion Criteria:

1. The patient scheduled for treatment with isolated hyperthermic perfusion
2. Age over 18 years.
3. Signed informed consent

Primary outcomes:
measure: Lactate level during and after perfusion.
timeFrame: 1 hour
Secondary outcomes:
measure: Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
timeFrame: 1 hour
measure: Hematocrit during and after completion of perfusion.
timeFrame: 1 hour
measure: Oxygen extraction during, and after perfusion.
timeFrame: 1 hour
measure: Complications
timeFrame: 30 days
measure: Immunological effects
timeFrame: 30 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
citation: Corderfeldt Keiller A, Holmen A, Hansson C, Ricksten SE, Bragadottir G, Olofsson Bagge R. Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion. Perfusion. 2023 Jul;38(5):1019-1028. doi: 10.1177/02676591221093201. Epub 2022 May 16.
Clinical trial NCT01518504: Effects of Thoracic Mobilization on Shoulder Range of Motion
Official title: Effects of Thoracic Mobilization on Shoulder Range of Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Range of Motion in Healthy Individuals
Keywords: Thoracic
Manipulation
Manual Therapy
Mobilization
Shoulder
Range of Motion
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion.

Detailed description: Many individuals who have a primary complaint of shoulder pain often demonstrate deficits in glenohumeral and scapulothoracic mobility. Typically individuals will have limitations in shoulder range of motion, specifically, flexion (elevation) as well as external and internal rotation. Although the glenohumeral joint is the primary joint for shoulder motion adjacent joints such as the sternoclavicular, acromioclavicular, scapulothoracic, and thoracic spine also contribute to maximal shoulder motion. Limited shoulder motion may be a result of joint hypomobility, muscle inhibition, or pain. Typically interventions such as stretching and joint mobilization/manipulation are directed at the glenohumeral joint to improve shoulder motion, but little is known about interventions targeting adjacent sites which may also improve shoulder range of motion. This study will evaluate the effect of thoracic spine joint manipulation on active and passive shoulder range of motion.

Eligibility criteria: Inclusion Criteria:

* Adults 19-45 years

Exclusion Criteria:

* Individuals who are pregnant
* History of cervical or thoracic surgery
* Bone or joint disease
* Current infection or tumor
* Osteopenia/osteoporosis
* Spinal fracture
* Rheumatologic pathologies

Primary outcomes:
measure: Changes in Shoulder Range of motion
timeFrame: Single Study Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Terry L Grindstaff, PHD,PT,ATC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206504: Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure
Official title: Expanded Access to MGAWN1 in Subjects With: Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection and a Compromised Immune System; or Substantial Accidental Exposure to West Nile Virus
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: West Nile Virus Infection
Keywords: West Nile virus
WNV
Encephalitis
Meningitis
Acute Flaccid Paralysis
Monoclonal Antibody
WNND
West Nile Neuroinvasive Disease
Accidental Exposure to West Nile Virus
Lead sponsor: MacroGenics
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-09-22
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.

Detailed description: The objective of this study is to provide expanded access to MGAWN1; the study is not intended for subjects who are eligible for and have access to non-expanded access protocols.

Eligibility criteria: Inclusion Criteria:

1. For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis
2. For immunocompromised subjects with suspected West Nile virus infection:

   * Receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or
   * Have received organs or tissues or cells from donors likely infected with West Nile virus (as shown by serology or PCR/NAT from the donor, organs, or tissues) or
   * Have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency
3. For subjects with substantial exposure to West Nile virus: Exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident)
4. Develop signs and/or symptoms within 14 days before study enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04857801: Teduglutide in Short Bowel Syndrome Patients
Official title: Teduglutide in Short Bowel Syndrome Patients - A Way Back to Normal Life?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 17
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: SBS-IF patients receiving teduglutide for at least 6 months

Brief summary: A retrospective analysis was performed using data of patients suffering from non-malignant SBS-IF. They were treated with teduglutide in a multidisciplinary SBS-IF program at a single university medical center between June 2016 and June 2020.


Eligibility criteria: Inclusion Criteria:

* SBS-IF

Exclusion Criteria:

* \< 18 years
* Incompliance
* \< 6 months of treatment

Primary outcomes:
measure: enteral autonomy
timeFrame: at least 6 months of teduglutide treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01485601: Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
Official title: A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®


Eligibility criteria: Inclusion Criteria:

* Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
* Women of childbearing potential must have a negative serum pregnancy test at screening

Exclusion Criteria:

* Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
* Patients with an anaphylactic response history to botulinum toxin type A.
* Patients who have been administered botulinum toxin type A within the previous 6 months.
* Pregnant or lactating women.
* Participation in any research study involving drug administration within 90 days preceding enrollment.

Primary outcomes:
measure: Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
timeFrame: at Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
Study officials:
affiliation: Austrailia
name: Peter Foley, Doctor
role: PRINCIPAL_INVESTIGATOR
References: