louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00530153: School Intervention Study of Nutrition, Wellbeing and Dental Health
Official title: School Intervention Study of Nutrition, Wellbeing and Dental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating
Oral Health
Keywords: Eating
Food Habits
Adolescent
Dental Research
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: University of Oulu, Department of dental health
name: Sitra, the Finnish Innovation Fund
First posted: 2007-09-17
Enrollment: 769
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of an intervention programme on dietary intake and dental health of 8th grade students.


Eligibility criteria: Inclusion Criteria:

* 7th grade students from the participating schools, written informed consent both from the student and the parent

Primary outcomes:
measure: Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.
Secondary outcomes:
measure: Nutritional quality of school meals and snacks. Laser fluorescence values of the occlusal surfaces of permanent molar and premolar teeth.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Public Health Institute
Study officials:
affiliation: National Public Health Institute
name: Pirjo Pietinen, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196453: Fit Child - Clinical Study on Weight Control
Official title: Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Nutrition Disorder, Child
Weight Change, Body
Keywords: overweight
probiotic
weight management
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2017-06-22
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, placebo controlled,
Primary purpose: TREATMENT

Brief summary: Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted

Detailed description: In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG.

The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers.

Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.

Eligibility criteria: Inclusion Criteria: 2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development

-

Exclusion Criteria:Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics

Primary outcomes:
measure: weight gain
timeFrame: 3 months
Secondary outcomes:
measure: Blood biomarkers
timeFrame: 3 months
measure: Weight change
timeFrame: 3 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku and University Hospital Turku
state: Varsinaissuomi
Study officials:
affiliation: University of Turku, Department of Pediatrics
name: Erika Isolauri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06527053: Digital Obturators in Maxillectomy Cases
Official title: Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Malfunction
Keywords: digital obturators-roofless design-maxillectomy-mucorycosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with maxillary defects had received two types of obturators
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Using Digital approach to treat patients with maxillofacial defects without surgical intervention

Detailed description: Evaluating digital dental and maxillofacial obturators to artifitially close maxillofacial defects in paients with oral cancer and patients with mucormycosis fungal post covid infection.

Craeting Digitized database for all patients included in the study.

Recording casses with post covid infection in specific period.

Eligibility criteria: Inclusion Criteria:

-

All participants in this study will be selected according to the following criteria:

* Patients with maxillary defects Class I and class II Aramany Classification with completely healed tissues.
* Patients' age ranging from 20 to 70 years old.
* Nearly intact mandibular arch.

Exclusion Criteria:

-

Participants with the following criteria will be excluded from the study:

* Physical or mental instability.
* Completely edentulous patients.
* Patients presenting allergy to materials being used.
* Patients lacking compliance to maintain acceptable oral hygiene.
* Patients taking radiotherapy

Primary outcomes:
measure: Evaluation of hypernasality in speech
timeFrame: one month
measure: Evaluation of masseter muscle muscle
timeFrame: three months
measure: Evaluation of Patient Quality of Life
timeFrame: six months
measure: Evaluation of retention
timeFrame: 1 day (at time of device insertion)
measure: Obturator misfit
timeFrame: 1 day (at time of device delivery)
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Eman Nasr
state: Gharbeya
Study officials:
affiliation: Tanta University
name: ali al shaikh, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302051: Assessment of Fatty Liver with Thermo-acoustic Device
Official title: Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NASH
NAFLD
Non-alcoholic Fatty Liver
Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Fatty Liver
Fatty Liver Disease
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: ENDRA Life Sciences, Inc.
First posted: 2020-03-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.

Brief summary: The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.

Detailed description: Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed or suspected to have non-alcoholic fatty liver disease
* Patients 18-70 years of age
* be able to understand and sign on written informed consent
* able to undergo ultrasound and MRI examinations

Exclusion Criteria:

* any metal or electronic implants including but not limited to pacemakers, clips, hips
* known history of pregnancy or becoming pregnant during study period
* unable to understand and sign on written informed consent
* intolerant to ultrasound and/or MRI examinations

Primary outcomes:
measure: Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique
timeFrame: one year
Secondary outcomes:
measure: Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver
timeFrame: One year
measure: Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.
timeFrame: One year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: ACHUTHAN SOURIANARAYANANE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00707551: An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
Official title: A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1305
Verapamil
Ketoconazole
pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 27
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.


Eligibility criteria: Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range

Primary outcomes:
measure: Pharmacokinetic variables
timeFrame: During all dosing visits
Secondary outcomes:
measure: Adverse events, vital signs, ECG, laboratory variables and physical examination
timeFrame: During the study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: PAREXEL International GmbH, Berlin, Germany
name: Dago Mazur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05960851: A Study of LY3871801 in Healthy Asian and Non-Asian Participants
Official title: A Phase I, Participant- and Investigator-Blind, Single-center Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of LY3871801 in Healthy Asian and Non-Asian Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 32
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: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A \& B). The study will last up to approximately 24 days excluding the screening period.


Eligibility criteria: Inclusion Criteria:

* Are Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
* Have body weight of \>/= 45 kilograms (kg) \& a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²

Exclusion Criteria:

* Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
* Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Are females who are lactating or have a positive pregnancy test at screening or Day 1
* Positive for drug or alcohol screen at screening or Day -1
* Smoke more than 10 cigarettes per day

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Predose up to 24 days post dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801
timeFrame: Predose on Day 1 up to postdose on Day 17
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801
timeFrame: Predose on Day 1 up to postdose on Day 17
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03865251: Effects of Kinesiology Tape Tensions on Gastrocnemius and Soleus H-reflex Modulations
Official title: Effects of Kinesiology Tape Tensions on Gastrocnemius and Soleus H-reflex Modulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kinesiology Taping
Keywords: H-reflex modulation
motoneuronal excitability
Ia afferent inputs
posture
Kinesiology tape
Lead sponsor: University of Taipei
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Kinesio tape (KT) has been widely used in the areas of sports and physical therapy (Kase, 2003). The effect of KT tensions on H-reflex modulation has not been discussed in the literature. This study investigated the effect of different KT tensions on the H-reflex modulation in the gastrocnemius and the soleus muscles.


Eligibility criteria: Inclusion Criteria:

* Undertake regular exercise at least 3 times a week with accumulation of 150 min per week
* Age between 20 and 30 years old

Exclusion Criteria:

* History of severe neuromuscular injury
* Current lower extremity injury
* Current neurological diseases

Primary outcomes:
measure: H-reflex and M-wave ratio
timeFrame: 30 min before kinesiology taping application
measure: H-reflex and M-wave ratio
timeFrame: During kinesiology taping application
measure: H-reflex and M-wave ratio
timeFrame: Immediately following kinesiology taping application
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Exercise and Health Sciences, University of Taipei
Study officials:
References:
Clinical trial NCT03260751: Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.

Detailed description: This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.

Eligibility criteria: Inclusion Criteria:

* age between 19 and 65 years,
* BMI 25\~29.9 kg/m2
* subjects giving written informed consent

Exclusion Criteria:

* Significant variation in weight(more 10%) in the past 3 months
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding etc,.

Primary outcomes:
measure: Changes of body fat mass
timeFrame: Baseline and 12 week
Secondary outcomes:
measure: Changes of percent body fat
timeFrame: Baseline and 12 week
measure: Changes of fat free mass
timeFrame: Baseline and 12 week
measure: Changes of weight
timeFrame: Baseline and 12 week
measure: Changes of body mass index
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT05213351: Two Different Exercise Training in Frozen Shoulder Treatment
Official title: Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: frozen shoulder
exercise
graded motor imagery
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.

Detailed description: After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double-blind manner in a 1:1 (participant and investigator) to graded motor imagery or exercise group.

Eligibility criteria: Inclusion Criteria:

* Patients aged \>60 years
* Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;
* Patients with ability to follow simple orders; iii)
* Patients with ability to sign to provide informed consent

Exclusion Criteria:

* Normal passive ROM
* External ROM \< 30
* To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint
* Pain \< 3 according to the numbered pain assessment scale

Primary outcomes:
measure: Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
Secondary outcomes:
measure: Change from baseline NPRS at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
measure: Change from baseline range of motion at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
measure: Change from baseline QuickDASH at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
measure: Change from baseline two-point discrimination at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
measure: Change from Pain Catastrophizing Scale at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
measure: Change from SF-12 at 6th and 8th week
timeFrame: Baseline,6th week and 8th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University
name: Derya Çelik
role: STUDY_DIRECTOR
References:
Clinical trial NCT02107651: Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants
Official title: Serious Adverse Events in Patients Treated With New Oral Anticoagulants Are Underreported
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding as Complication to Anticoagulation Therapy
Keywords: Bleeding
Anticoagulation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for GI bleeding while in treatment with NOAC

Brief summary: Serious adverse events in patients treated with new oral anticoagulants are underreported.

Detailed description: The study investigates if serious adverse events in patients treated with NOAC are reported to the Health and Medicines Authority.

Eligibility criteria: Inclusion Criteria:

* patients admitted for GI bleeding while in treatment with NOAC

Exclusion Criteria:

* none

Primary outcomes:
measure: Proportion of patients admitted with adverse event reported to authorities
timeFrame: Within one year of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital University of Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Bisgaard Thue, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bay-Nielsen M, Kampmann JP, Bisgaard T. Gastrointestinal bleedings during therapy with new oral anticoagulants are rarely reported. Dan Med J. 2014 Nov;61(11):A4952.