louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02569684: Effects of Prebiotics on GLP-1 in Type 2 Diabetes
Official title: Effects of Prebiotics on GLP-1 in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Diabetes Association
name: Norwegian Extra Foundation for Health and Rehabilitation
First posted: 2015-10-07
Enrollment: 37
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: The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.

Detailed description: We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.

Eligibility criteria: Inclusion Criteria:

* diabetes type 2
* BMI 18,5 - 40
* Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors
* Moderate intake of alcohol
* Not excessive exercise
* Less than 3 kg weight change the last two months
* Intake of less than 30 g dietary fiber per day

Exclusion Criteria:

* IBD
* IBS
* Coeliac disease
* Have used antibiotics within the last two months
* Have used supplements with prebiotics or probiotics the last two months
* Pregnancy

Primary outcomes:
measure: Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anne-Marie Aas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birkeland E, Gharagozlian S, Gulseth HL, Birkeland KI, Hartmann B, Holst JJ, Holst R, Aas AM. Effects of prebiotics on postprandial GLP-1, GLP-2 and glucose regulation in patients with type 2 diabetes: A randomised, double-blind, placebo-controlled crossover trial. Diabet Med. 2021 Oct;38(10):e14657. doi: 10.1111/dme.14657. Epub 2021 Aug 7.
citation: Birkeland E, Gharagozlian S, Birkeland KI, Valeur J, Mage I, Rud I, Aas AM. Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial. Eur J Nutr. 2020 Oct;59(7):3325-3338. doi: 10.1007/s00394-020-02282-5. Epub 2020 May 21.
Clinical trial NCT06708884: Telerehabilitation as an Alternative to Face-to-Face Rehabilitation After Total Hip Arthroplasty
Official title: Is Telerehabilitation a Good Alternative to Face-to-Face Rehabilitation Beyond Clinical Walls in Recovery After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty (THA)
Keywords: total hip arthroplasty
telerehabilitation
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2024-11-27
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if telerehabilitation in patients who had undergone total hip arthroplasty. The main questions it aims to answer are:

* Does telerehabilitation improve the functional level of the participants?
* Does telerehabilitation improve the locomotor performance of the participants? Researchers will compare telerehabilitation to face to face rehabilitation (traditional rehabilitation programme) to see if telerehabilitation works in total hip arthroplasty recovery.

Participants will:

* Attend physiotherapy and rehabilitation sessions supervised by a physiotherapist 2 days a week for 8 weeks.
* Participate in assessments (before surgery and at 6 weeks and 12 weeks after surgery).


Eligibility criteria: Inclusion Criteria:

* Having hip arthroplasty surgery
* To be able to understand verbal and written information
* No cognitive impairment
* To be able to speak and understand Turkish

Exclusion Criteria:

* Having a neurological disease
* Having a psychiatric disorder
* Visual or hearing loss that cannot be corrected with any assistive device

Primary outcomes:
measure: Functional level
timeFrame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Secondary outcomes:
measure: Pain intensity
timeFrame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
measure: Quality of life
timeFrame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
measure: Locomotor performance
timeFrame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
measure: Lower extremity muscle strength
timeFrame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
measure: Hip Joint Range of Motion (ROM)
timeFrame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
References:
Clinical trial NCT04992884: Non-invasive Measurement of Gastric Motility
Official title: Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adults,Gastric Symptoms,Suspected Gastric Motility Disorders
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 adult patients with upper gastrointestinal symptoms suspected to have gastric motility disorders.

Brief summary: Clinical evaluation to compare performance of the physiological recordings from the Gastric Alimetry System vs a predicate reference device (Medtronic Polygram NET / Polygraf ID EGG System

Detailed description: A prospective, non-randomised, single centre investigation on patients with suspected motility disorders comprising a simultaneous head-to-head comparison of device performance between the Gastric Alimetry System and the Medtronic Polygram NET / Polygraf ID EGG System.

Eligibility criteria: Inclusion Criteria:

* Age 22 years old or older
* Able to provide written informed consent
* Patients with a suspected motility disorder, meetingRome IVCriteria for functional dyspepsia or chronic nausea and vomiting syndromes or having a diagnosis of gastroparesis as confirmed by a standardized gastric scintigraphy study, including having \>10% gastric meal retention at 4-hours.

Exclusion Criteria:

* BMI \>35 kg m(2)
* Known metabolic, neurogenic or endocrine disorders known to cause gastrointestinal dysmotility e.g. multiple sclerosis, Parkinson's disease, hypothyroidism
* Known current gastrointestinal infection (includes H.pylori when being actively treated)
* Known current inflammatory bowel disease
* Known current gastrointestinal malignancy
* Previous gastroduodenal surgery
* Open abdominal wounds or abdominal skin not intact (e.g.rash, abrasions, weeping tissues)
* Fragile skin evidenced by high susceptibility to skin tears or skin that bruises easily
* Regular cannabis use
* Allergy to adhesives
* Pregnancy

Primary outcomes:
measure: Performance comparison (frequency) between Gastric Alimetry and predicate device
timeFrame: 90 minutes
Secondary outcomes:
measure: Performance comparison (amplitude) between Gastric Alimetry and predicate device
timeFrame: 90 minutes
measure: Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes).
timeFrame: 90 minutes
measure: Safety Endpoint
timeFrame: Five hours
measure: User Needs Endpoint
timeFrame: Five hours
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Research Centre, Building 507, The University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: John A Windsor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04093284: Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
Official title: Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Needle-free jet injection
Insulin glargine
Flash Glucose Monitoring
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen

Detailed description: Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile of CGMS and safety in type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes, aged 18-65 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (12-18 units) combined with oral medicationis, stable for more than 2 months.
* No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Patients with insulin allergy.
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
* Drug abuse and alcohol dependence in the past 5 years.
* Systemic hormone therapy was used in the last three months.
* Patients with poor compliance and irregular diet and exercise.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Primary outcomes:
measure: Blood glucose profile
timeFrame: 9 days
Secondary outcomes:
measure: Sensitivity Questionnaire of Patients
timeFrame: 9 days
Other outcomes:
Locations:
Study officials:
References:
citation: Kong X, Luo M, Cai L, Zhang P, Yan R, Hu Y, Li H, Ma J. Needle-free jet injection of insulin glargine improves glycemic control in patients with type 2 diabetes mellitus: a study based on the flash glucose monitoring system. Expert Opin Drug Deliv. 2021 May;18(5):635-641. doi: 10.1080/17425247.2021.1863945. Epub 2021 Feb 19.
Clinical trial NCT05378984: Cocoa Intake and Muscle Pain Sensation
Official title: Cocoa Intake and Muscle Pain Sensation: an Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Pain
Keywords: Myalgia
Experimental pain
Human
Temporomandibular disorders
Cocoa
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This experimental randomized, double-blind, and controlled study included fifteen young, healthy, and pain-free men and 15 age-matched women.

It lasted for three visits with at least one-week washout. Pain was experimentally induced, twice at each visit, with intramuscular injections of 0.2 mL hypertonic saline (5%), before and after intake of one of the different chocolate-types; white (30% cocoa-content), milk (34% cocoa-content), dark (70% cocoa-content). Pain duration, pain area, peak pain, and pressure pain threshold were assessed every fifth minute after each injection, between the time-points 5 to 30 min.

Prior to inclusion, all participants underwent an examination in a dental chair. This included a clinical examination of the orofacial region according to the Diagnostic Criteria for temporomandibular disorders (DC/TMD) by a blinded examiner. Participants were also examined regarding their psychosocial status prior to inclusion, this included depression, somatization, anxiety, pain catastrophizing and stress.


Eligibility criteria: Inclusion Criteria:

1. good general health
2. age between 18-40 years

Exclusion Criteria:

1. any pain-related diagnosis of TMD or of the orofacial region
2. any headaches
3. a diagnosis of systemic muscular or joint diseases (fibromyalgia or rheumatoid arthritis)
4. whiplash-associated disorders
5. neurological disorders
6. psychiatric disorders
7. any allergy to the substances used

Primary outcomes:
measure: Change in pain intensity by intake of chocolate
timeFrame: 5 min after injection of hypertonic saline
measure: Change in peak pain intensity before and after intake of chocolate
timeFrame: 5 min after injection of hypertonic saline
measure: Change in pain duration by intake of chocolate
timeFrame: Pain duration up to 300 seconds after injection of hypertonic saline
measure: Change in pain area by intake of chocolate
timeFrame: Pain area is marked 5 min after injection of hypertonic saline
Secondary outcomes:
measure: Change in pressure pain threshold by intake of chocolate
timeFrame: Pressure pain thresholds are assessed 5 min after injection of hypertonic saline
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet, Department of Dental Medicine
Study officials:
References:
Clinical trial NCT05571384: High Intensity Body-weight Circuit Training Feasibility and Efficacy for in Middle Aged Persons With Type 2 Diabetes
Official title: High Intensity Body-weight Circuit Training Feasibility and Efficacy for Improving Metabolic Profile, Body Composition, and Health-Related Fitness in Middle Aged Persons With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Keywords: Exercise
Lead sponsor: Kennesaw State University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study proposes to quantify the efficacy of the novel high intensity body-weight circuit (HIBC) training intervention on metabolic profile, body composition, and health related fitness exercise in middle aged persons with type-2 diabetes (T2DM). This research project is extremely relevant to public health, in that prevalence of T2DM continues to rise on a national and global scale, placing a heavy economic cost on both the healthcare industry and the individual patient in an age-dependent fashion. Results of this study may provide an effective and appealing alternative exercise intervention for cardiometabolic disease management in adults with T2DM, and have significant clinical and public health applications.


Eligibility criteria: Inclusion Criteria:

* Recent diagnosed of type 2 diabetes (T2DM) (within a year) \* HbA1c of 6% or higher

  * Non-insulin dependent
  * No medicinal treatment
  * Not currently undergoing a physical activity program in the last six months
  * Received written medical clearance from overseeing physician

Exclusion Criteria:

* Those who have undergone any revascularization procedure

  * Diagnosed with or symptomatic of any renal, pulmonary, or cardiovascular disease (CVD)
  * Diagnosed cognitive dysfunction
  * Current smoker

Primary outcomes:
measure: HbA1c change within participant
timeFrame: Pre and post 16-week intervention
measure: Oral Glucose Tolerance Test change within participant
timeFrame: Pre and post 16-week intervention
measure: Body Composition change within participant
timeFrame: Pre and post 16-week intervention
measure: Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant
timeFrame: Pre and post 16-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kennesaw
country: United States
facility: Kennesaw State Univeristy
state: Georgia
Study officials:
References:
Clinical trial NCT04805684: Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia
Official title: Comparison of Two Different Lung Ultrasound Imaging Protocols in COVID -19 Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Ultrasound
Pneumonia
Covid19
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-18
Enrollment: 59
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: DIAGNOSTIC

Brief summary: Lung ultrasonography (LUS) is also used in COVID 19 pneumonia for diagnostic and follow-up purposes.It has been demonstrated in different studies that it can be used for pathologies in pleural and lung tissue. LUS was applied by different researchers by dividing the lungs into 12 and 14 regions and the results were shared.

Detailed description: In our study, we aimed to determine the correlation between lung findings of COVID 19 pneumonia and thoracic tomography with the results of LUS applied to different numbers (12 versus 14) of areas.

Eligibility criteria: Inclusion Criteria:

* 18 and 85 years old
* Hospitalized in intensive care unit
* PCR (polymerase chain reaction) tested
* Thoracic CT applied

Exclusion Criteria:

* Previous lung operation
* Thoracic wall disorder
* Interstitial lung disease
* Patients who did not consent to participate in the study

Primary outcomes:
measure: Correlation between Thoracic CT imaging results and LUS results
timeFrame: 6 hours
Secondary outcomes:
measure: Characteristics of lesions
timeFrame: 6 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
References:
Clinical trial NCT05766384: Hyperpolarized 129Xe MRI Lung Health Cohort
Official title: Hyperpolarized 129Xe MRI to Identify Structural Determinants of Low Lung Function and Respiratory Symptoms in Young Adults From the Lung Health Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Iowa
name: Duke University
name: University of Illinois at Chicago
name: Baylor College of Medicine
name: Temple University
name: University of Pennsylvania
First posted: 2023-03-13
Enrollment: 260
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants enrolled in the Lung Health Cohort at participating Airways Clinical Research Centers. The investigators target to enroll approximately 50% females and enroll approximately 1/3 low socioeconomic status (SES) participants, 1/3 middle SES, and 1/3 high SES. The target for the population demographics is to match those of the larger, LHC parent study.

Brief summary: A subset of young adults participating in the American Lung Association (ALA) Lung Health Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and function. Images will be used to improve the understanding of lung health and early lung abnormalities that may lead to chronic lung disease.


Eligibility criteria: Inclusion Criteria:

* Is enrolled in the American Lung Association Lung Health Cohort Study.
* Has completed CT imaging for the LHC study within 2 years of the scheduled Xe-MRI date.

Exclusion Criteria:

* Pacemaker, internal defibrillator or other implanted electronic devices or any standard MRI contraindications (e.g., claustrophobia, \> 140 cm shoulder circumference, dependent on weight distribution).
* Is pregnant or breastfeeding
* Oxygen saturation (SpO2) \<88% on room air or with supplemental oxygen.

Primary outcomes:
measure: Xe-MRI Apparent Diffusion Coefficient
timeFrame: At baseline imaging timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois-Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: