louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00823537: Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities
Official title: Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities in Acute Stroke Patients. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Fujita Health University
Sponsor class: OTHER
First posted: 2009-01-15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Power-assisted therapeutic electrical stimulation (TES) or conventional TES to upper extremities in acute stroke patients were performed in a randomized controlled trial. The changes in finger and hand function will be evaluated. The hypothesis is that a power-assisted TES is more effective than a conventional TES.


Eligibility criteria: Inclusion Criteria:

* acute or subacute phase of stroke

Exclusion Criteria:

* chronic phase of stroke

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06228937: Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis
Official title: Typing of Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Microbiota
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective observational cohort study will be conducted on patients with limb lymphedema, clinical stage I, II and III according to the International Society of Lymphology (ISL), followed by the Plastic Surgery Unit of the University Polyclinic A. Gemelli IRCCS. According to the positive or negative history for recurrent soft tissue infectious episodes, patients will be divided into two homogeneous groups for demographic and clinical characteristics (Groups A and B).

Brief summary: Lymphedema is a chronic and progressive disease of the lymphatic vessels which affects about 300 million people worldwide. Patients may experience recurrent soft tissue infection of the limb affected by lymphedema, in terms of erysipelas, lymphangitis or cellulitis. No previous study has ever investigated the possible role of the gut microbiota in the genesis of acute infectious/inflammatory episodes in these patients. Our hypothesis is that lymphedema patients with recurrent soft tissue infections are characterized by pro-inflammatory changes in the microbiota.


Eligibility criteria: Inclusion Criteria (Group A):

* 18-85 years
* primary or secondary, upper or lower limb lymphedema, I-II-III stage ISL
* at least 3 episodes of soft tissue infection in an year, in the last 2 years
* consent to participate in the study

Inclusion Criteria (Group B):

* 18-85 years
* primary or secondary, upper or lower limb lymphedema, stage I-II-III (ISL)
* no episodes of soft tissue infection in the last 2 years
* consent to participate in the study

Exclusion Criteria:

* No compliance to perform limb compression and skin hygiene
* Antibiotic therapy in the last 15 days
* Diabetes mellitus
* Immunodeficiency
* Ongoing neoplastic pathology
* Taking immunosuppressive drugs
* Unavailability to follow-up for at least 24 months post-enrollment.

Primary outcomes:
measure: comparison alpha diversity
timeFrame: 60 months
Secondary outcomes:
measure: comparison beta diversity
timeFrame: 60 months
measure: evaluation of the microbiome differential abundance
timeFrame: 60 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT01686737: Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Official title: Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Neoplasms
Fatigue
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.

It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.


Eligibility criteria: Inclusion Criteria:

* non-metastatic invasive breast cancer
* currently receiving adjuvant chemotherapy
* moderate to severe chemotherapy-induced fatigue
* physical and cognitive capacity to participate in yoga or walking

Exclusion Criteria:

* diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
* ECOG status \> 1
* prior malignancy with a disease-free survival \< 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
* prior ductal carcinoma in situ (DCIS) ot the breast
* pregnancy or breastfeeding
* regular practice of yoga or walking during the past 12 months

Primary outcomes:
measure: Fatigue
timeFrame: Week 12
Secondary outcomes:
measure: Fatigue
timeFrame: Week 36
measure: Health-related quality of life
timeFrame: Week 12, week 36
measure: Depression and anxiety
timeFrame: Week 12, week 36
measure: Sleep quality
timeFrame: Week 12, week 36
measure: Perceived Stress
timeFrame: Week 12, week 36
measure: Salivary Cortisol
timeFrame: Week 12, week 36
measure: Safety
timeFrame: Week 0-36
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
city: Köln
country: Germany
facility: Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind
Study officials:
affiliation: University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
name: Holger Cramer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
name: Gustav J. Dobos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04598737: Assessment of Anterior Teeth Restored With Ultra-translucent Multilayer Zirconia vs Lithium Disilicate Laminate Veneers
Official title: Clinical Assessment of Anterior Teeth Restored With Ultra-translucent Multilayer Zirconia Versus Lithium Disilicate Laminate Veneers (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retention, Color Match, Marginal Adaptation and Restoration Integrity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to assess the clinical performance of multilayered translucent zirconia laminate veneers versus lithium disilicate laminate veneers in terms of modified USPHS criteria for assessment of dental restorations (retention, restoration integrity, color match and marginal adaptation)

Detailed description: inferior mechanical properties of glass ceramics necessities the continuous development and modification for materials suitable for all clinical situations

multilayered translucent zirconia provides the advantages of high mechanical properties than all glass ceramic in addition to the improved translucency in the new generations.

Therefore, the purpose of the present study is to evaluate the clinical performance of newly introduced multilayered translucent zirconia as a monolithic laminate veneer in comparison with lithium disilicate laminate veneer to determine the clinical functional and structural integrity of the restoration

Eligibility criteria: Inclusion Criteria:

* sufficient sound enamel thickness
* Presence of one adjacent natural teeth that doesn't need laminate to compare shade
* age range 20 to 40 years old
* non smokers
* diastema less than 2mm
* tooth fracture not exceeding incisal one third
* normal occlusion
* vital teeth
* healthy periodontal tissues

Exclusion Criteria:

* -insufficient enamel thickness
* restoration more than 40 % of tooth surface
* parafunctional habits
* deep discoloration
* sever teeth rotation
* edge to edge or deep bite
* abnormal occlusion
* bad oral hygiene

Primary outcomes:
measure: Retention
timeFrame: 12 months follow up period
Secondary outcomes:
measure: Restoration integrity
timeFrame: 12 months follow up period
Other outcomes:
measure: Color match
timeFrame: 12 months follow up period
measure: Marginal adaptation
timeFrame: 12 months follow up period
Locations:
Study officials:
References:
Clinical trial NCT03930537: Change of Intramedullar Pressure After Implantation of Hip Prothesis
Official title: DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty Complications
Lead sponsor: University Clinical Centre of Kosova
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this issue.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing hip replacement with cemented and non-cemented femoral component

Exclusion Criteria:

* ASA IV
* Patient with periprosthetic fractures
* Patient with hip replacement revision

Primary outcomes:
measure: Change of pressure in femoral intramedullary canal after implantation of femoral component
timeFrame: The femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral component
Secondary outcomes:
measure: Difference of arterial pressure after implantation of femoral component
timeFrame: The changes will be measured before implantation and during first 10 minutes after implantation
measure: Difference of changes of Leukocyte formula after implantation of femoral component
timeFrame: The blood will be taken from patience 1 hour before and POD1
measure: Difference of SpO2 after implantation of femoral component
timeFrame: The changes will be measured before implantation and during first 10 minutes after implantation
measure: Difference of SpCO after implantation of femoral component
timeFrame: The changes will be measured before implantation and during first 10 minutes after implantation
measure: Difference of changes of CRP after implantation of femoral component
timeFrame: The blood will be taken from patience 1 hour before and POD1
measure: Difference of changes of Histamine after implantation of femoral component
timeFrame: The blood will be taken from patience 1 hour before and POD1
Other outcomes:
Locations:
city: Prishtina
country: Kosovo
facility: University Clinical Center of Kosovo
Study officials:
References:
citation: Ukaj S, Veslko M, Krasniqi S, Podvorica V, Ukaj F, Ahmeti A, Hernigou P, Cimerman M. Cemented stems in healthy elderly patients result in higher hypoxia despite a paradoxical lower femoral increase of intramedullary pressure. Int Orthop. 2021 Apr;45(4):915-922. doi: 10.1007/s00264-021-04955-0. Epub 2021 Feb 2.
Clinical trial NCT05749237: The Impact of Breath Exercises by Telemedicine in Patients Aged 8-18 Years With a Diagnosis of Asthma
Official title: The Impact of Breath Exercises by Telemedicine in Patients Aged 8-18 Years With a Diagnosis of Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Asthma
Keywords: allergy, asthma, respiratory exercises, children
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo controlled
Primary purpose: TREATMENT

Brief summary: The goal of this randomized, placebo controlled study is to evaluate the effect of respiratory exercises on asthma attack frequency, symptom and medication scores and quality of life of children with a diagnosis of asthma.

Participants will be asked to perform respiratory exercises described at once in hospital at home regularly. Control group will comprised children with asthma without respiratory exercises.

Detailed description: At the beginning of the study anthropometric measurements, basal respiratory function assessment, drugs, demographic information, allergen sensitivity, asthma control levels and quality of life scales will be documented. Patients will be randomly divided into two groups; one group following respiratory exercises and relaxation exercises and the other following only relaxation exercises. Both groups will be called regularly to remind the exercises.

The spirometric tests and asthma control forms will be reevaluated at the 3rd and 6th month at hospital.

Peak flow meters will be given to patients to document PEF values during study.

Eligibility criteria: Inclusion Criteria:

clinical diagnosis of allergic asthma allergic asthma severity step 1 or step 2 -

Exclusion Criteria:

asthmatic children more severe than step 2 other comorbid disorders involving respiratory system or neuromusculatory disorders

-

Primary outcomes:
measure: Change in asthma attack frequency
timeFrame: at third and sixth months
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: at third and sixth months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayca Kiykim
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlas University
name: Hilal Denizoglu
role: STUDY_CHAIR
affiliation: Atlas University
name: Hikmet Uçgun
role: STUDY_CHAIR
References:
Clinical trial NCT02612337: Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meniere's Disease
Keywords: Meniere's Disease
Vertigo
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has experienced an adverse reaction to IT injection of steroids.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a trial of OTO-104.

Primary outcomes:
measure: The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).
timeFrame: Week 12 (3 months)
Secondary outcomes:
measure: Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3)
timeFrame: 3 months
measure: Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
timeFrame: 3 months
measure: Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)
timeFrame: 3 months
measure: Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
timeFrame: Week 12 (Month 3)
measure: Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
timeFrame: Week 12 (Month 3)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Many sites in US. Refer to the contact info listed below.
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Kathie Bishop, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06967337: Microsteps Study-Short, Animated Storytelling Video
Official title: Short, Animated Storytelling Video and Written Messages to Promote Adoption of Health "Microsteps": an Online Randomized Experiment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavior, Health
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effect of single exposure to written Microsteps messages and short video booster content, on behavioral expectation to adopt behavioral nudges, in the immediate and medium term. Beyond that, the study will examine the effect of exposure to written Microsteps messages and short video booster content, on hope and happiness. This study will be conducted entirely online. Adult participants, in the US and the UK, will be recruited through the platform Prolific Academic (ProA).


Eligibility criteria: Inclusion Criteria:

* Registered with the Prolific Academic platform
* Using a GLP-1RA medication or having used a GLP-1RA medication in the past.

Exclusion Criteria:

* None

Primary outcomes:
measure: Effects of the written Microsteps, with instructional booster video or storytelling booster video, on behavioral expectation to adopt behavioral nudges, in the immediate and medium-term.
timeFrame: Baseline, immediately post-intervention exposure (up to 24 hours) and 2 weeks post exposure.
Secondary outcomes:
measure: Medium-term effects of the written Microsteps, with instructional booster video or storytelling booster video, on self-reported consumption of sweetened beverages.
timeFrame: Baseline, 2 weeks post intervention exposure
measure: Medium-term effects of the written Microsteps, with instructional booster video or storytelling booster video, on self-reported consumption of dietary protein.
timeFrame: Baseline, 2 weeks post intervention exposure
measure: Medium-term effects of the written Microsteps, with instructional booster video or storytelling booster video, on self-reported physical activity.
timeFrame: Baseline, 2 weeks post intervention exposure
measure: Effects of the written Microsteps, with instructional booster video or storytelling booster video, on Hope
timeFrame: Baseline, immediately post intervention exposure (up to 24 hours) and 2 weeks post intervention exposure
measure: Effects of the written Microsteps, with instructional booster video or storytelling booster video, on Happiness
timeFrame: Baseline, immediately post intervention exposure (up to 24 hours) and 2 weeks post intervention exposure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Maya Adam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733837: Cervical Multifidus Muscle Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Proprioception
Muscle Activation
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the relationship between cervical multifidi thickness, cervical spine proprioception and possible reflex activation of cervical multifidi through stimulation of joint mechanoreceptors. Cervical mechanoreceptors will be activated with an innocuous, nonspecific stimulation. Participants will have cervical spine proprioception assessed through joint position sense testing. The multifidus muscle thickness and activation state is to be assessed by sonography. These measures are done pre \& post to the innocuous stimulation. There is no specific hypothesis.


Eligibility criteria: Inclusion Criteria:

* Logan student, staff, or faculty, ages 18 - 30 years

Exclusion Criteria:

* Fractures
* Tumors
* Dislocations
* Myopathies
* Signs and/or symptoms of neuromotor disorders
* Consumption of prescription drugs that affect the nervous system
* Recent cervical spine injuries or surgeries
* Pain
* Manipulative therapy within the preceding 7 days
* Neck pain

Primary outcomes:
measure: sonographic measurement of multifitus thickness
timeFrame: pre - post
Secondary outcomes:
measure: cervical spine repositioning error
timeFrame: pre - post
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College
state: Missouri
Study officials:
References: