louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06238206: What User-requirements Need to be Considered When Developing a Lower-limb Exoskeleton? A Qualitative Study.
Official title: What User-requirements Need to be Considered When Developing a Lower-limb Exoskeleton? A Qualitative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Sarcopenia
Keywords: Assistive technology
Exoskeleton
User perspective
Stroke
Sarcopenia
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to identify the needs and requirements of end-users regarding the implementation of a lower-limb exoskeleton in a remote home setting. The end-users include older adults with sarcopenia, post-stroke individuals and physiotherapists. The main question it aims to answer is:

• What are the needs and requirements of the end-user population when developing a lower-limb exoskeleton that can be implemented in a remote home setting?

Participants will engage in three separate focus group sessions, in which they will discuss the predetermined topics. Interactions between the participants will be guided by open questions.


Eligibility criteria: People post-stroke:

Inclusion Criteria:

* \> 18 years old
* ≥ 3 months ago stroke diagnosis
* Current difficulties during gait

Exclusion Criteria:

* Serious speech disorder
* Lowered cognitive competence

Older adults with sarcopenia:

Inclusion Criteria:

* \> 65 years old
* Difficulties during chair sit to stand
* Current difficulties during gait

Exclusion Criteria:

* Lowered cognitive competence

Physiotherapist:

Inclusion Criteria:

* Currently active as a physiotherapist
* Experience in treating people with sarcopenia and/or post-stroke conditions

Exclusion criteria:

* Can't verbally answer

Primary outcomes:
measure: User Personas
timeFrame: 8 weeks
measure: Identification of Activities for Exoskeleton Use
timeFrame: 8 weeks
measure: Interface and Design Concept Formulation
timeFrame: 8 weeks
measure: Digital Rehabilitation Outcomes
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Brubotics Rehabilitation Research Center
state: Brussels
Study officials:
affiliation: Vrije Universiteit Brussel
name: Eva Swinnen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01166906: Pain Blocking During Drug Administration or Blood Collection With Needles
Official title: Pain Blocking During Drug Administration or Blood Collection With Needles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Intractable
Keywords: pain blocking
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2010-07-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample,

Brief summary: There is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or inhibit transmission of pain signals to the brain. The gate can be closed by mechanical stimuli such as touch and vibration.

Detailed description: The researcher develope a device that can use to reduce pain during drug administration or blood collection with needles.

Eligibility criteria: Inclusion Criteria:

* Receiving an injection with a needle
* Able to score the pain on a scale of 0-10 using the universal pain assessment tool, preferably 7 years of age or older

Exclusion Criteria:

* Current pregnancy
* Inability to understand and carry out instruction

Primary outcomes:
measure: Pain Blocking During Drug Administration or Blood Collection With Needles
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Wangcun Jia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515606: Noninvasive Positive Pressure Ventilation Using Helium:Oxygen Versus Air:Oxygen in Acute Respiratory Failure in Chronic Obstructive Pulmonary Disease Patients Exposed to Sulfur Mustard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Bronchiolitis
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2007-08-14
Sex: MALE
Minimum age (years): 38
Maximum age (years): 59
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: to assess the effectiveness of helium:oxygen mixture adjunct with non-invasive ventilation in sulfur mustard exposed patients with acute decompensation


Eligibility criteria: Inclusion Criteria:

* a history of previous exposure to sulfur mustard
* worsening dyspnea during the last 10 days
* respiratory rate \>25/min
* arterial pH\<7.35
* PaCO2 of \>50 mmHg
* PaO2 of \<50 mmHg

Exclusion Criteria:

* recent pneumothorax (\<1 month)
* severe respiratory failure or hemodynamic instability with forthcoming intubation
* FIO2 of \<0.4
* impaired consciousness or absence of patient cooperation
* facial lesions precluding NIV

Primary outcomes:
measure: assess spirometry and hemodynamic measures after heliox or air:oxygen use
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University
name: Mostafa Ghanei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06071806: Recurrence of Odontogenic Keratocyst
Official title: The Application of Topical 5-Fluorouracil to Reduce the Recurrence of Odontogenic Keratocyst
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Odontogenic Cyst
Keywords: Odontogenic Keratocyst
5- Fluorouracil
Recurrence
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of current cross over clinical trial is to evaluate the effect of topical 5-FU as adjunct therapy in reducing risk of the recurrence of OKCs

Detailed description: The main inclusion criteria in this study will be 48 patients with biopsy proved odontogenic keratocyst with no relevant systemic diseases which might affect healing process. patients will be treated with 5-FU cream (Efudex; Valeant Inc, Laval, Quebec, Canada) after enucleation and peripheral ostectomy of the odontogenic keratocyst.

* A detailed preoperative assessment for all patients will be carried out including history taking, clinical and radiographical examination.
* All surgical procedures will be carried out under general anesthesia with nasal endotracheal intubation.
* Through an intraoral incision, the full thickness mucoperiosteal flap will be raised. The entire cyst lining radically enucleated in conjunction with any overlying mucosa, followed by extensive cavity thorough curettage with meticulous evaluation of any residual daughter cyst lining with reduction of the lingual and buccal undercut bony walls to remove residual macroscopic cystic epithelium.
* After enucleation and peripheral ostectomy of the OKC lesion, a sterile radiopaque quarter-inch ribbon gauze is coated with 5-FU cream and packed into the surgical wound. The wound is closed in the usual manner using 3/0 vicryl leaving a small distal end (approximately1 cm) of gauze exposed to allow for gauze removal at 24 hours postoperatively.

All patients will be regularly followed up for 12 months postoperatively clinically and radiographically

Eligibility criteria: Inclusion Criteria:

* patients with biopsy proved odontogenic keratocyst

Exclusion Criteria:

* relevant systemic diseases which might affect healing process.

Primary outcomes:
measure: degree of pain
timeFrame: 6 month
measure: swelling
timeFrame: 6 month
Secondary outcomes:
measure: Quantitative computed tomography (CT)
timeFrame: 12 month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
affiliation: Tanta University
name: Mohamed K Allam, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02859506: Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
Official title: Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behaviour
Liver Transplant
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis.

The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.


Eligibility criteria: Inclusion Criteria:

* persons who have provided written informed consent
* persons aged between 18 and 70 years
* persons waiting for a liver transplantation (group LT)
* persons with stable liver damage
* persons waiting for a kidney transplantation (KT)
* healthy subjects (control group) no known disease

Exclusion Criteria:

* persons without national health insurance cover
* persons with chronic infection,
* persons with acute infection,
* persons with progressive cancer,
* persons with an antibiotic treatment,
* persons who drink alcohol,
* pregnant or breast-feeding women,
* persons with an aversion to the foods proposed in the study,
* persons taking treatments known to interfere with gustatory and olfactory performance,
* adults under guardianship

Primary outcomes:
measure: Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
timeFrame: At month 0, month 3, month 9 and month 15
measure: Change in olfactory liking compared with baseline values by questionnaire
timeFrame: At month 0, month 3, month 9 and month 15
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT06486506: Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results
Official title: Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Tumor
Bone Cancer
Keywords: Proximal Femur Reconstruction
primary bone tumors
imaging
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023

Brief summary: From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023.

A review will be made from the medical records, radiological imaging, and histological data of these patients


Eligibility criteria: Inclusion Criteria:

* Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
* Age: 18-90 years old (at the time of primary surgery)
* Diagnosis of bone sarcoma
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criterion not met

Primary outcomes:
measure: longevity of the reconstruction
timeFrame: At baseline (Day 0)
Secondary outcomes:
measure: Musculoskeletal tumour society (MSTS) functional evaluation
timeFrame: at baseline (day 0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Tobey D, Wing C, Calkins T, Heck RK. The Use of Proximal Femur Replacement for the Management of Oncologic Lesions in the Proximal Femur: A Review. Orthop Clin North Am. 2023 Jan;54(1):23-35. doi: 10.1016/j.ocl.2022.08.006. Epub 2022 Oct 23.
citation: Menendez LR, Ahlmann ER, Kermani C, Gotha H. Endoprosthetic reconstruction for neoplasms of the proximal femur. Clin Orthop Relat Res. 2006 Sep;450:46-51. doi: 10.1097/01.blo.0000229332.91158.05.
Clinical trial NCT04957706: Diagnostic Study of ACL Rupture With Anterior Drawer Test at 90° of Hip Flexion
Official title: Diagnostic Study of Anterior Cruciate Ligament Rupture With Anterior Drawer Test at 90° of Hip Flexion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient are from Peking University Third Hospital

Brief summary: For patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. The researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. Good diagnostic effect, but no research statistics. The purpose of this study is to explore the effectiveness of the 90° of hip flextion anterior drawer test in the diagnosis of anterior cruciate ligament rupture.

Detailed description: A total of 300 hospitalized patients who were diagnosed with anterior cruciate ligament rupture by MR and prepared for anterior cruciate ligament reconstruction were included, of which 150 cases were injured in the acute phase (within 2 months after the injury) and the chronic phase (more than 2 months after the injury). After the patient was admitted to the hospital, the patients were sequentially subjected to the 90° anterior drawer test, Lachman test, pivot-shift test, and anterior drawer test. The examination results were recorded. Compare the effectiveness of different physical examinations in diagnosing the anterior cruciate ligament. The patient's age, gender, injury time, BMI, the type of ACL rupture in the surgical records, and whether meniscus or cartilage damage were combined were counted. Regression analysis was used to evaluate the influencing factors of the modified anterior drawer test to correctly diagnose the rupture of the ACL.

Eligibility criteria: Inclusion Criteria:

* （1）ages between 18 and 60 years old. (2) Inpatients diagnosed with unique anterior cruciate ligament rupture and ready for anterior cruciate ligament reconstruction. (3) no combined injuries.

Exclusion Criteria:

* (1) The patient is younger than 18 years old or older than 60 years old, (2) multiple ligament injuries of the knee joint are suspected, and (3) combined fractures are suspected.

Primary outcomes:
measure: anterior drawer test at 90° of hip flexion
timeFrame: 1 week after injury
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: yingfang ao, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01169506: Sublingual Tonometry to Assess Tissue Perfusion in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A New Method of Sublingual Tonometry to Assess Tissue Perfusion in Patients With COPD and Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Healthy Subjects
Keywords: blood gas analysis
ventilatory insufficiency
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Sublingual positioning of a silicon capillary system is applied. After 15 min, while the individual is in resting position with closed mouth and normal tidal breathing through the nose is performed, the silicon capillary system is connected to a capnometer and CO2 tension is measured.

The investigators hypothesis is that this setup offers a non-invasive assessment of ventilatory efficiency with similar accuracy as arterial PCO2.

Detailed description: We have developed a new silicon capillary system for sublingual monitoring of CO2 tension in order to assess tissue perfusion. This set up is non-invasive, cheaper than previous tonometry devices and easier to apply in clinical routine. We have recruited patients with stable COPD and healthy individuals.

Sublingual tonometry results were evaluated after 15 min of tidal breathing with a capnometer for CO2 tension. Corresponding end tidal CO2 (PETCO2)and arterial blood gas values (pH, PaCO2, PaCO2) were also investigated.

Eligibility criteria: Inclusion Criteria:

* COPD patients with stable disease

Exclusion Criteria:

* acute exacerbation of COPD

Primary outcomes:
measure: sublingual tonometric PCO2 - arterial PCO2
timeFrame: one year
Secondary outcomes:
measure: sublingual tonometric PCO2 - PETCO2
timeFrame: one year
Other outcomes:
Locations:
city: Deszk
country: Hungary
facility: Department of Pulmonology, Albert Szent-Györgyi Clinical Center, University of Szeged
Study officials:
affiliation: Department of Pulmonology, University of Szeged, Hungary
name: Attila Somfay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boda D, Kaszaki J, Talosi G. A new simple tool for tonometric determination of the PCO2 in the gastrointestinal tract: in vitro and in vivo validation studies. Eur J Anaesthesiol. 2006 Aug;23(8):680-5. doi: 10.1017/S026502150600055X.
Clinical trial NCT01885806: Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease
Official title: Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Apathy
Keywords: Apathy; Alzheimer's disease; Cognition; Burden of Care
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.

Detailed description: This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.

Eligibility criteria:

* Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
* Diagnosis of apathy;
* age between 60 and 85 years-old;
* On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;

The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.

Eligibility criteria: Inclusion Criteria:

* Age between 60 to 85 years-old
* Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
* Apathy diagnosis
* On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment

Exclusion Criteria:

* history of epilepsy or convulsions
* History of migraine or headaches episodes twice per week or more
* History of neurodegenerative diseases other than Alzheimer's disease
* Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
* History of cerebral ischemic episode

Primary outcomes:
measure: Change in apathy symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in ADAS-Cog scores
timeFrame: 12 weeks
measure: Change in the Zarit Burden Scale
timeFrame: 12 weeks
Other outcomes:
measure: Safety assessment
timeFrame: 4th week, 8th week, 12th week
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Outside of U.S.
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Outside of U.S.
Study officials:
affiliation: Federal University of Minas Gerais
name: Breno S Diniz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: