louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01131494: Swallowing Training in Parkinson's Disease
Official title: Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Deglutition Disorders
Voice Disorders
Keywords: Parkinson's disease
Dysphagia
Treatment
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and sensory abnormalities, and incoordination between swallowing and breathing. Despite harming as respiratory infections and increased risk of death, treatment of this condition remains uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal exercises for five weeks and will be evaluated before and after intervention by swallowing videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson disease
* Complaint of dysphagia

Exclusion Criteria:

* Hoehn and Yahr stage 5
* Other neurological conditions
* Therapy for swallowing in the last 3 months
* Cognitive disorders
* Psychiatric disorders

Primary outcomes:
measure: Oropharyngeal Swallowing Score
timeFrame: five weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: five weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Federal University of Bahia
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Ana Caline Nóbrega, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04629794: The OsteoStrand Plus Deformity Study
Official title: The OsteoStrand Plus Deformity Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Fusion
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study evaluating outcomes for patients with spinal deformity.

Detailed description: A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.

Eligibility criteria: Inclusion Criteria:

-≥18 years of age

* Indicated for deformity correction surgery
* Require spinal fusion at four or more levels
* Are willing to return for follow-up visits
* Willing to sign the Informed Consent Forms

Exclusion Criteria:

* Uncontrolled diabetes
* Morbid obesity
* history of alcohol or drug abuse
* Corticosteroid use
* Fever or leukocytosis
* Systemic infection
* Active malignancy
* Elevation of white blood cell count
* Osteoporosis
* Disease of bone metabolism
* Unsuitable or insufficient bone support
* Skeletal immaturity
* Prior fusion
* Use of steroids, immune suppressants, osteoporosis medications
* Use of internal bone stimulators
* Institutionalized or a prisoner
* Undergoing (Undergone) a worker's compensation case
* Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
* Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study
* Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study

Primary outcomes:
measure: Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
timeFrame: 12 Months
Secondary outcomes:
measure: Clinical outcomes
timeFrame: 24 Months
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Sonoran Spine
state: Arizona
Study officials:
affiliation: Sonoran Spine
name: Michael Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487694: Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women
Official title: Cimicifuga Racemosa Rhizome and Root Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hot Flashes
Keywords: back cohosh
cimicifuga racemosa
menopausal symptoms
hot flashes
Kupperman index
MENQOL
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 54
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.


Eligibility criteria: Inclusion Criteria:

* Thai women, aged ≥ 40 years
* Peri- or postmenopause
* Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20

Exclusion Criteria:

* Using any drugs or hormonal treatment within 1 month before enrollment
* BMI ≥ 30 kg/m2
* Allergic to drugs or any ingredient
* Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
* Psychiatric disease
* Alcohol consumption or any elicit drug use
* Vegetarian (may consume more phytoestrogen)

Primary outcomes:
measure: Mean differences of Kupperman index
timeFrame: 12 weeks
Secondary outcomes:
measure: Frequencies of menopausal symptoms
timeFrame: 12 weeks
measure: Compliance
timeFrame: 12 weeks
measure: adverse events
timeFrame: 12 weeks
measure: Mean differences of liver function test
timeFrame: 12 weeks
measure: quality of life
timeFrame: 12 weeks
measure: Overall satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Patsama Vichinsartvichai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200094: Micardis®. Observational Study in Patients With Essential Hypertension
Official title: Micardis®. Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 4532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients over 18 years of age suffering essential hypertension, treated by general practitioners and/or specialists

Brief summary: This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician

Exclusion Criteria:

* Hypersensitivity to the active component or to any of the excipients
* Pregnancy and lactation
* Biliary obstructive disorders
* Severe hepatic impairment
* Severe renal impairment

Primary outcomes:
measure: Changes in systolic and diastolic blood pressure
timeFrame: Baseline, 4 weeks and 3 months after start of treatment
measure: Percentage of patients with dose titration to 80 mg
timeFrame: 4 weeks and 3 months after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 3 months after start of treatment
measure: Global evaluation of treatment compliance by investigator, a 6-point rating scale
timeFrame: 4 weeks and 3 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01323894: Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling
Official title: Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling/Hydroxyapatite Nanoparticles--Comparisons Between Non-viral and Viral Administration in Tissue Engineered Bone Regeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Disease
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-03-28
Enrollment: 3
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients require surgery ner iliac or abdomen areas

Brief summary: The first year purpose:

The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Detailed description: Our previous work is investigating the viral (Adv-BMP-2) administration for the development of a model to generate bones for possible use in clinical settings; the non-viral and viral administrations will be compared for best osteogenesis effects.

The first year purpose:

The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Eligibility criteria: Inclusion Criteria:

* age above 10 years old
* The patients require surgery ner iliac or abdomen areas

Exclusion Criteria:

* age below 10 years old

Primary outcomes:
measure: Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling/Hydroxyapatite Nanoparticles--Comparisons between Non-viral and Viral administration in Tissue Engineered Bone Regeneration
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical Universty Hospital
Study officials:
affiliation: China Medical University Hospital
name: Sopha Chia-Ning Chang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022294: Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Official title: Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pain
Muscle Sensitivity to Pressure
Skin Sensitivity to Electric Stimulation
Keywords: children
analgesia
dental treatment
inhalation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 56
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip

Detailed description: The present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles.

It is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark

Eligibility criteria: Inclusion Criteria:

* ASA-groups I or II
* 12-15 year of age
* sound upper central incisors

Exclusion Criteria:

* difficulties breathing through the nose
* pregnancy
* trauma to test teeth

Primary outcomes:
measure: Dental pain (pulp) threshold
timeFrame: During and after inhalation
Secondary outcomes:
measure: Muscle sensitivity to pressure
timeFrame: During and after inhalation
measure: Skin sensitivity ot electric stimulation
timeFrame: During and after inhalation
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University
Study officials:
affiliation: Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark
name: Sven Poulsen, dr.odont.
role: STUDY_CHAIR
References:
Clinical trial NCT00839280: Moisturizing Effect of Two Dexpanthenol Formulations
Official title: Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Abnormalities
Keywords: Dry skin
Dexpanthenol
Moisturizing effect
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Phototype: I to IV according to Fitzpatrick scale
* Subjects with dry skin on their forearms

Exclusion Criteria:

* Pregnant or nursing women
* Subjects registered as being in exclusion period in the French Health Minister file of subjects
* Subjects with hypersensitivity to one of the test products

Primary outcomes:
measure: Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
timeFrame: 0 min, 15 min, 30 min, 1h, 2h, 3h, 5h
Secondary outcomes:
measure: Cutaneous hydration rate
timeFrame: 15 min, 30 min, 1h, 2h, 3h, 5h
measure: Incidence of Adverse Events
timeFrame: FPFV - LPLV
Other outcomes:
Locations:
city: Villeurbanne
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05634980: Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function
Official title: The Application of Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function in Dysphagia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a swallowing disorder

Brief summary: Diet modification has been a vital component in the management of dysphagia. The lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. However, there is a limited literature and consensus regarding how to apply different food consistency in the swallowing function evaluation of dysphagic patients. Recently, International Dysphagia Diet Standardization Initiative (IDDSI) has provided a universal standard of food consistency. The present study aims to evaluate the accuracy of clinical swallowing evaluation using IDDSI standardized food in dysphagic patients, in an attempt to establish protocols of clinical evaluation and diet selection in dysphagic patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20 years or older with a swallowing disorder on the Functional Oral Intake Scale (FOIS) of 1-6.

Exclusion Criteria:

* Unconscious, unable to communicate via gestures or words and cooperate with commands.
* Acutely infected or requiring respirator use.
* The oropharyngeal structure is abnormal and cannot be examined by endoscopy.
* Presence of tracheostomy tube

Primary outcomes:
measure: Penetration aspiration scale (PAS)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT06166680: Tongue Muscular Assessment in Healthy Children
Official title: Assessment of Tongue Motor Functions in Healthy Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Tongue
Motor functions
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children between the ages of 4 to 17

Brief summary: This study aims to obtain normative values for tongue motor functions in healthy children.

Detailed description: Since the tongue is a complex structure consisting of a continuous array of muscle fibers with varying orientation, tongue motor functions (strength, endurance) are likely to differ according to a protrusion (pulling out the tongue), elevation (lifting the tongue to the roof of the mouth) or swallowing movement.

There are currently no normative data for the motor functions of the tongue in children. After their parents fulfilled the Pediatric Sleep Questionnaire, each included children will undergo an anthropometric and a tongue motor functions assessment.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 4 and 17

Exclusion Criteria:

* Eating disorder
* Dysphagia
* Cardiorespiratory disorder
* Neurological disorder (including neuromuscular disorders)
* Previous or ongoing obstructive sleep apnea-hypopnea syndrome
* Previous or ongoing cancer of the head or neck
* Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)
* Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)
* Previous or ongoing orthodontic treatment (e.g. braces)
* More than 33% of positive answers to the Pediatric Sleep Questionnaire (8/22)

Primary outcomes:
measure: Tongue peak pressure during elevation and protrusion movements
timeFrame: At baseline
Secondary outcomes:
measure: Tongue mobility restriction
timeFrame: At baseline
measure: Orofacial praxis
timeFrame: At baseline
measure: Tongue endurance during elevation and protrusion movements
timeFrame: At baseline
measure: Tongue pressure during swallowing
timeFrame: At baseline
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Université Catholique de Louvain
name: William Poncin, PT, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04490980: The Analgesic Effect of Butorphanol After Cesarean Section
Official title: The Analgesic Effect of Butorphanol After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the vital signs of patients, general condition of newborns and pain assessment.


Eligibility criteria: Inclusion Criteria:

Healthy women at term (37 to 42 weeks of gestation), who desired cesarean section were eligible to participate. undergoing ；No drug sensitive history

Exclusion Criteria:

Patients with a history of anesthetics allergy and patients with preterm labor, multiple pregnancies and severe obstetric complications

Primary outcomes:
measure: change from Visual Analogue Score for pain
timeFrame: assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section
Secondary outcomes:
measure: heart rates
timeFrame: at 24 hours, 30 hours, 36 hours after the cesarean section
measure: jaundice index of the newborn,1 minute and 5 minutes Apgar score
timeFrame: jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section
measure: blood pressure
timeFrame: at 24 hours, 30 hours, 36 hours after the cesarean section
measure: breath
timeFrame: at 24 hours, 30 hours, 36 hours after the cesarean section
measure: pulse
timeFrame: at 24 hours, 30 hours, 36 hours after the cesarean section
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Xun Gong
role: STUDY_CHAIR
References:
Clinical trial NCT04957680: Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents
Official title: Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effectiveness of a computer-based Cognitive Behavioral Therapy (CCBT) and online stress management program for adolescents, and identify the characteristics of depressed adolescents that participate in the programs.


Eligibility criteria: Inclusion Criteria:

* adolescents that scored above the threshold for mild depression (PHQ, CES-D)

Exclusion Criteria:

* adolescents with severe depression/neuropsychiatric conditions

Primary outcomes:
measure: CES-D
timeFrame: 5 week
measure: PHQ
timeFrame: 5 week
Secondary outcomes:
measure: DSM-5 Severity measure for Depression, Child-Adolescent version
timeFrame: 5 week
measure: Perceived Stress Scale
timeFrame: 5 week
measure: Study Stress Scale
timeFrame: 5 week
measure: BAI
timeFrame: 5 week
measure: EPQ
timeFrame: 5 week
measure: Self-esteem Scale
timeFrame: 5 week
measure: PedsQL 4.0
timeFrame: 5 week
measure: Homework compliance
timeFrame: 5 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: