louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00847535: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Official title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Cell Therapy
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Patient has SUI with normal detrusor activity confirmed with urodynamics
* Patient has bladder capacity \>200 mL
* Patient's incontinence has not shown any improvement for at least -6 months
* Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion Criteria:

* Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
* Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
* Patient has uncontrolled diabetes
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study
* Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
* Patient has current or acute conditions involving cystitis or urethritis
* Patient is scheduled to receive radiation treatment to the vicinity
* Patients with a history of radiation treatment to the urethra or adjacent structures

Primary outcomes:
measure: Number of Participants That Experienced Biopsy Procedure-related Adverse Events
timeFrame: at biopsy or between biopsy and treatment
measure: Biopsy Procedure-related Adverse Events
timeFrame: at biopsy or between biopsy and treatment
measure: Number of Participants That Experienced Injection Procedure-related Adverse Events
timeFrame: 30 days
measure: Injection Procedure-related Adverse Events
timeFrame: 30 days
measure: Number of Participants That Experienced AMDC Product-related Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Wm Beaumont Hospital
state: Michigan
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516435: Efficacy of Different Electrical Stimulation Placement in Patients With Overactive Bladder Syndrome
Official title: Randomized,Single-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: Intravaginal electrical stimulation
Parasacral transcutaneous electrical stimulation
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.

Detailed description: This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.

Eligibility criteria: Inclusion Criteria:

* Urinary incontinence due to detrusor overactivity
* No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.

Exclusion Criteria:

* stress incontinence
* urinary tract infection
* neurological disease
* genital prolapse higher than stage II on POP-Q system
* pregnancy
* diabetes mellitus
* a history of anti-incontinence surgery and/or prolapse repair
* pelvic tumors and previously treated with radiation therapy or antimuscarinic agents
* patients who were not cooperative
* electrical stimulation contraindications

Primary outcomes:
measure: 3 Days Voiding diary
timeFrame: 3 days
Secondary outcomes:
measure: Overactive Bladder Symptom Score( OABSS）
timeFrame: 20 min
measure: minVisual analogue scale (VAS) for urgency
timeFrame: 10 min
measure: Pad test
timeFrame: 20min-1hr
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Chen Gin-Den, PhD
role: STUDY_CHAIR
affiliation: Chung Shan Medical University
name: Chen Yi-Ching, MS
role: STUDY_DIRECTOR
affiliation: Chung Shan Medical University
name: Chang Chia-Yun, MS student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06563635: Frequency of Tuberculosis in Psoriasis Patients
Official title: Frequency of Tuberculosis in Psoriasis Patients Using Anti-TNF Therapy During 15 Years of Follow-up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Tuberculosis
Keywords: psoriasis
tnf inhibitor
tuberculosis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: psoriasis patients receiving TNF inhibitor therapy in a single center in 15 years

Brief summary: Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center.

Detailed description: Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center. TNF inhibitor therapy may increase the risk for tuberculosis infection. According to medical data in our hospital in last 15 years, tuberculosis rate of psoriasis patients receiving etanercept, adalimumab and infliximab will be compared.

Eligibility criteria: Inclusion Criteria:

* psoriasis patients receiving TNF inhibitor therapy

Exclusion Criteria:

* patients without TNF inhibitor therapy

Primary outcomes:
measure: tuberculosis rate
timeFrame: patients from June 2007 to January 2023, up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
References:
Clinical trial NCT02982135: Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease
Official title: Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moyamoya Disease
Keywords: hemorrhagic moyamoya disease
bypass
indirect bypass
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2016-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.


Eligibility criteria: Inclusion Criteria:

1. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate "moyamoya collaterals"
2. patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture.
3. Patients requiring surgery

Exclusion Criteria:

1. Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage
2. patients refused to participate in the study

Primary outcomes:
measure: rebleeding events
timeFrame: 5-10 years
Secondary outcomes:
measure: ischemic events
timeFrame: 5-10 years
measure: postoperative compilications
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03288935: Trauma Informed Care for Newly Resettled Refugees
Official title: Trauma Informed Care for Refugee Newcomers in Virginia: A Factorial Design of Effectiveness-Implementation Hybrid Research
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Stress
Emotional Stress
Keywords: refugee
trauma-informed case management (TICM)
trauma-informed cultural orientation (TICO)
PTSD
depression
refugee resettlement
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The main purpose of this study is to evaluate early-phase interventions for refugee wellness promotion and build evidence for dissemination of the intervention model and curricula through refugee resettlement programs, local and national.

Detailed description: This study will examine the main effects of trauma-informed case management (TICM) and trauma-informed cultural orientation (TICO) interventions, respectively, in reducing resettlement distress and increasing coping capacity, which will improve emotional wellness and social adaptation and thus resettlement outcomes. This project will also test the interaction effects of two-tiered intervention model, discerning effective and ineffective components of the intervention model. Differences in effects across intervention conditions may inform how improvement in what outcomes or which phase can affect refugees' wellness and adjustment over time.

Eligibility criteria: Inclusion Criteria:

* Refugee adults who arrive in Richmond or Charlottesville between January and February 2018

Exclusion Criteria:

-

Primary outcomes:
measure: Change in resettlement distress
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in emotional well-being
timeFrame: Baseline to 6 months
measure: Resettlement Outcomes
timeFrame: Baseline to 6 months
measure: Change in Social Adaptation
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth Univeristy
name: Hyojin Im, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04743635: CONtrolled Focal Fibrous Band Release Method Study
Official title: CONtrolled Focal Fibrous Band Release Method Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Lead sponsor: Revelle Aesthetics, Inc
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 74
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants were treated with the Avéli device.
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.

Detailed description: Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe cellulite

Exclusion Criteria:

* Body Mass Index ≥30.0

Primary outcomes:
measure: The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
timeFrame: 3 months
measure: Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
timeFrame: 12 Months
measure: The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
timeFrame: 12 months
measure: The Percentage of Patients Satisfied With Their Results at 3 Months
timeFrame: 3 month
measure: The Number of Patients Satisfied With Their Results at 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Site #3
state: California
city: San Diego
country: United States
facility: Clinical Site #5
state: California
city: San Francisco
country: United States
facility: Clinical Site #4
state: California
city: Coral Gables
country: United States
facility: Clinical Site #2
state: Florida
city: Shreveport
country: United States
facility: Clinical Site #6
state: Louisiana
city: Chestnut Hill
country: United States
facility: Clinical Site #8
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Site #1
state: Minnesota
city: Southport
country: Australia
facility: Clinical Site #7
state: Queensland
city: Toowoomba
country: Australia
facility: Clinical Site #9
state: Queensland
Study officials:
affiliation: Marina Plastic Surgery
name: Dr. G. William Stevens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00880035: Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients
Official title: M.U.S.I.C (MUSicotherapy in the Intensive Care) Interventional, Pilot, Cross-Over, in Mechanically-Ventilated Patients on ICU Ward
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sedative Drug Consumption
Mechanically Ventilated ICU Patients
Keywords: sedative drug
stress
music
mechanical ventilation
IL-6
cortisol
prolactin
CRP
copeptin
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de Recherche Clinique CHUS
First posted: 2009-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Major objective: a three-days interventional cross-over trial \[one day music on, one day wash-out, one day music off\]\[two periods of listening/day\], to evaluate:

1. Impact on sedative drug consumption.
2. Alteration of stress neuropeptide blood concentrations.

Population: mechanically-ventilated ICU patients

The investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.

Detailed description: The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.

There will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.

Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.

We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.

Eligibility criteria: Inclusion Criteria:

* adults older than 18 years old
* expected time of mechanical ventilation of more than 72 hours
* sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1

Exclusion Criteria:

* hearing impairment
* pregnancy
* needs of vasopressin
* needs of curarisation

Primary outcomes:
measure: sedative drug consumption in mechanically ventilated ICU patients
timeFrame: 3 days
Secondary outcomes:
measure: stress neuropeptide blood content evolution with MUSIC listening
timeFrame: 3 days
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS
state: Quebec
Study officials:
affiliation: CHUS and Université de Sherbrooke
name: Olivier Lesur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184535: Recording Methods of Muscle Activity "Onset".
Official title: Muscle Activity "Onset" in the Transversus Abdominis - Simultaneous Recordings by Intramuscular Electromyography and High Frame Rate Ultrasound Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Low back pain
Neuromuscular control
Anticipatory motor control
Musculoskeletal Physiologic Processes
Muscle, Skeletal
Ultrasonography
Electromyography
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women between 30-65 yrs with no recent low back pain

Brief summary: Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been observed in patients with low back pain, indicative of a pathological condition. Muscle activity onset is traditionally recorded by intramuscular electromyography, but there is a need for a less cumbersome recording method in large clinical studies. The purpose of this experimental study is to explore whether high-frame rate m-mode ultrasound and tissue velocity imaging could measure anticipatory muscle responses ("onset") in the abdominal muscles reliably and comparably accurate to intramuscular EMG.


Eligibility criteria: Inclusion Criteria:

* Healthy
* 30-65 yrs

Exclusion Criteria:

* recent low back pain
* low back, neck or shoulder pain inflicting work absence or bed rest
* cardiac, rheumatic or other serious illness
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology (NTNU), Nasjonal senter for spinale lidelser
Study officials:
affiliation: Norw. Univ of Sci and Technol
name: Ottar Vasseljen, PhD
role: STUDY_CHAIR
References:
citation: Vasseljen O, Dahl HH, Mork PJ, Torp HG. Muscle activity onset in the lumbar multifidus muscle recorded simultaneously by ultrasound imaging and intramuscular electromyography. Clin Biomech (Bristol). 2006 Nov;21(9):905-13. doi: 10.1016/j.clinbiomech.2006.05.003. Epub 2006 Jul 5.
Clinical trial NCT02913235: Salivary Bacterial Associations to Short Term Discontinuation of Self-performed Oral Hygiene
Official title: Does Short Term Discontinuation of Self-performed Oral Hygiene Procedures Influence the Composition of the Salivary Microbiota?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Diseases
Keywords: biofilm
saliva
bacteria
oral hygiene
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Forsyth Institute
name: Rigshospitalet, Denmark
First posted: 2016-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the present investigation is to record and compare bacterial compositions in supragingival plaque samples and saliva samples in subjects discontinuing regular oral hygiene for 10 days. The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to discontinuation of oral hygiene.

Detailed description: 35 orally healthy individuals will be enrolled in this study, in which they will discontinue regular oral hygiene procedures for a period of 10 days. Clinical registrations and collection of microbiological samples (supragingival and saliva) will be performed at baseline and 4, 7 and 10 days after discontinuation of regular oral hygiene, and will be repeated 14 days after regular oral hygiene has been resumed.

Eligibility criteria: Inclusion Criteria:

* Oral and systemically healthy individuals

Exclusion Criteria:

* Periodontitis
* Dental caries
* Systemic diseases or medications with known associations to oral health
* Antibiotics within the latest 6 month

Primary outcomes:
measure: Comparison of changes in α-diversity in saliva samples before and after discontinuation of regular oral care
timeFrame: 10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
Secondary outcomes:
measure: Comparison of species specific changes in saliva samples before and after discontinuation of regular oral care
timeFrame: 10 days of discontinuation of regular oral care and 14 days after resuming regular oral care
Other outcomes:
Locations:
Study officials:
affiliation: University of Copenhagen
name: Daniel Belstrøm, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belstrom D, Sembler-Moller ML, Grande MA, Kirkby N, Cotton SL, Paster BJ, Twetman S, Holmstrup P. Impact of Oral Hygiene Discontinuation on Supragingival and Salivary Microbiomes. JDR Clin Trans Res. 2018 Jan;3(1):57-64. doi: 10.1177/2380084417723625. Epub 2017 Jul 31.