louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05031715: Berberine and Altered Fasting Glucose
Official title: Effectiveness of the Assumption of a Berberine Phytosoma-based Supplement on the Hematic Values of Glucose in a Group of Patients With Altered Fasting Glucose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Fasting blood glucose range:100-125 mg/dl

Exclusion Criteria:

* Diabetes mellitus

Primary outcomes:
measure: Changes on insulin resistance
timeFrame: Changes from baseline insulin resistance at 4 weeks and at 8 weeks
measure: Changes on carbohydrate profile
timeFrame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
measure: Changes on carbohydrate profile
timeFrame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Secondary outcomes:
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
measure: Changes on body composition
timeFrame: Changes from baseline body composition at 4 weeks and at 8 weeks
measure: Changes on lipid profile
timeFrame: Changes from baseline lipid profile at 4 weeks and at 8 weeks
measure: Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
measure: Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
measure: Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
measure: Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Mariangela Rondanelli
Study officials:
affiliation: Fondazione Casemiro Mondino
name: Mariangela Rondanelli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02106715: Overuse Injuries in Road Cyclists, Prevalence and Prevention
Official title: Overuse Injuries in Road Cyclists, Prevalence and Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overuse Injuries
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2014-04-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the prevalence of overload injuries to road cyclists in Sweden, and if it 's possible to prevent low back pain by a simple exercise program for two months of training .


Eligibility criteria: Inclusion Criteria:

* Planning to ride "Vätternrundan 2014" in a subgroup .
* Cycled "Vätternrundan" at least twice in the past or bicycled for exercise at least 800 mil ( the equivalent of two seasons) .
* Age 18-55 years .
* Training cycle at least three hours a week or three days a week .

Exclusion Criteria:

* Do not have access to a computer.

Primary outcomes:
measure: Number and type of overuse injuries
timeFrame: Four months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Div Physiotherapy, Linkoping University
Study officials:
References:
Clinical trial NCT05650515: A Technology-based Exercise Program for Older Adults
Official title: The Development of a Technology-based Exercise Program for Older Adults Based on the Opinions of Older Adults and Geriatric Experts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Older Adults
Exercise
Mobile Application
Lead sponsor: PXL University College
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults (65 years or older) who have interesting/creative opinions/ideas regarding exercise (specifically for older adults), technology, health.

Experts (no age limits) from the field of geriatric rehabilitation/research/medicine who have interesting opinions regarding exercise, technology, health specifically targeted at older adults.

Brief summary: This intervention aimed to collect relevant information for the development of a technology-based exercise application. This information-collection is based on the opinions of older adults (65+ years) as well as experts from the field of geriatric rehabilitation/medicine/research.

Detailed description: This intervention aimed to collect relevant information for the development of a technology-based exercise application. This information-collection is based on the opinions of older adults (65+ years) as well as experts from the field of geriatric rehabilitation/medicine/research.

The exercise application will be specifically designed for older adults:

* exercises targeted at endurance, strength, balance, coordination and flexibility
* importance of motivational aspects to motivate older adults to continue the program on the long term

Information that is aimed to be collected is related to a variety of aspects of the exercise application such as 1) information/education regarding the importance (health benefits) of exercise 2) design of the exercise application 3) technological aspect of the exercise application 4) motivational aspect of the exercise application

Eligibility criteria: Inclusion Criteria:

* Interested to contribute to the development of a technolgy-based exercise program specifically developed for older adults
* Interested to think about aspects such as "How to motivate older adults to exercise?" "Which information regarding exercise/health is relevant for older adults to motivate them to continue an exercise program?"

Exclusion Criteria:

* No interest in exercise for older adults

Primary outcomes:
measure: Educational aspects of the exercise application
timeFrame: 2 days
measure: Exercise aspect of the exercise application
timeFrame: 2 days
measure: Technological aspect of the exercise application
timeFrame: 2 days
measure: Motivational aspect of the exercise application
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: PXL University College
state: Limburg
Study officials:
affiliation: PXL University College
name: Kim Daniëls, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05022615: Comparing 3 Imaging Systems
Official title: Comparison of Standard and Ultrawide Field Imaging Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (18 or older) with either Type 1 or Type 2 diabetes presenting at a single center of an ophthalmic retina practice for examination of diabetic retinopathy including color photography for standard medical care.

Brief summary: The purpose of this study is to evaluate the quality of ocular images captured on 3 different cameras of patients with diabetic retinopathy. The study will determine whether diabetic retinopathy assessment is comparable between the cameras. The research is being done to see if a camera takes higher quality pictures over the other cameras.

60 participants will be enrolled into this study. Participants need to have diabetic eye disease. This is a one-time study visit that lasts approximately 1 hour.


Eligibility criteria: Inclusion Criteria:

* any race
* Established diagnosis of diabetes.
* Willing to participate as evidenced by signing the written informed consent.

Exclusion Criteria:

* Unable to tolerate ophthalmic imaging.
* Ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images.
* History of panretinal laser photocoagulation or vitrectomy (history of anti-vascular endothelial growth factor treatment is not an exclusion criteria).
* Presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.

Primary outcomes:
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging and statistical comparison
timeFrame: 1 day
measure: Number of Ungradable ETDRS Images within the 7 standard fields of Clarus, Optos, and Standard 7 Field imaging
timeFrame: 1 day
Secondary outcomes:
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Level assessment of Clarus global, Optos global, and Standard 7 Field grading and statistical comparison
timeFrame: 1 day
measure: Number of Ungradable ETDRS Images within the Clarus global, Optos global, and Standard 7 Field grading
timeFrame: 1 day
measure: Image quality assessment per image grader
timeFrame: 1 day
measure: Reason Image Quality is compromised per image grader
timeFrame: 1 day
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health - University Station Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Barbara Blodi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03387215: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Official title: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure, Systolic
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.


Eligibility criteria: Inclusion Criteria:

* NYHA class II-III heart failure
* Ejection fraction equal to or below 35%
* On stable heart failure drug treatment

Exclusion Criteria:

* Considered medically inappropriate for study participation

Primary outcomes:
measure: Echocardiogram with Doppler imaging and hemodynamic monitoring
timeFrame: 2 hours
Secondary outcomes:
measure: 12-lead electrocardiogram (ECG)
timeFrame: 2 hours
measure: Hemodynamic monitoring
timeFrame: 5-6 hours
measure: Number of patients with treatment-emergent adverse events
timeFrame: 5 days
Other outcomes:
measure: Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers
timeFrame: 2 hours
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
References:
citation: Gilotra NA, DeVore AD, Povsic TJ, Hays AG, Hahn VS, Agunbiade TA, DeLong A, Satlin A, Chen R, Davis R, Kass DA. Acute Hemodynamic Effects and Tolerability of Phosphodiesterase-1 Inhibition With ITI-214 in Human Systolic Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008236. doi: 10.1161/CIRCHEARTFAILURE.120.008236. Epub 2021 Aug 31.
Clinical trial NCT04580615: Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate
Official title: Anonymized Data Collection From the CardiacSense1 and Other Modalities for the Purpose of Developing a System for Monitoring of Respiratory Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Disease
Keywords: Respiratory rate
Lead sponsor: CardiacSense Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Collect data from the CardiacSense1's sensors and Capnograph, for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) in patients while at hospital

Detailed description: Hospitalized subjects, diagnosed with a Respiratory disease or subjects with no known Respiratory disease will be will be connected simultaneously to CardiacSense watch and Capnograph for a duration of at least 30 minutes and up to 24 hours in order to collect data for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) by the CardiacSense watch.

The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation. CardiacSense1 senses the radial artery inflation and deflation and together with a PPG sensors give an ultimate performance that is superior to PPG only.

Eligibility criteria: Inclusion Criteria:

* Age of eighteen (18) year and above
* Diagnosed with Respiratory disease/impairment or without any known Respiratory disease/impairment
* Ability and willingness to sign an informed consent form

Exclusion Criteria:

* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
* Patients with significant co morbidities (assessed by the clinician at screening only
* BMI\>40
* Presence of an acute disease process that might interfere with test performance
* Subjects with PPG SNR \<100 indicated by the CardiacSense1 device
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Respiratory rate
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Giris Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02392715: Inspiratory Muscle Training Combined With General Exercise Training in COPD
Official title: Inspiratory Muscle Training Combined With General Exercise Training, Compared to General Exercise Training Alone in Patients With COPD: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Inspiratory muscle training
General exercise training
pulmonary rehabilitation
chronic obstructive pulmonary disease
Lead sponsor: Hôpital Riviera-Chablais, Vaud-Valais
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.

Detailed description: Prospective, parallel-group, randomized controlled trial

80 COPD patients will be randomized into two groups. One group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. The other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions.

We will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. We will also assess the difference of improvement in quality of life with St-George's respiratory questionnaire. Finally the difference of improvement in maximal inspiratory pressure will be determined.

Patients and investigators assessing the outcomes will be blinded to group allocation.

Written informed consent will be obtained from each subject. The data will be treated anonymously.

Eligibility criteria: Inclusion Criteria:

* COPD demonstrated by spirometry using Gold Criteria
* Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey
* Patient with maximal inspiratory pressure \< 60 cmH20
* Patient older than 40 years

Exclusion Criteria:

* Orthopaedic or neurological troubles that could slant the 6 minute walking test

Primary outcomes:
measure: Exercise capacity (six minute walking test)
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of Life (St-George's Respiratory questionnaire)
timeFrame: 12 weeks
measure: Maximal inspiratory pressure (MicroRPM by MicroMedical)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: stephanie.vaudan@hopitalrivierachablais.ch
name: Stéphanie Vaudan, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05781815: Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate
Official title: Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trochanteric Fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare the results in treatment of unstable trochanteric fracture by using DHS and DHS with Trochanteric Stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration


Eligibility criteria: Inclusion Criteria:

* pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter

Exclusion Criteria:

* stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture

Primary outcomes:
measure: neck shaft angle measurment .Harris hip score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Babhulkar S. Unstable trochanteric fractures: Issues and avoiding pitfalls. Injury. 2017 Apr;48(4):803-818. doi: 10.1016/j.injury.2017.02.022. Epub 2017 Feb 27.
citation: Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
citation: SCHUMPELICK W, JANTZEN PM. A new principle in the operative treatment of trochanteric fractures of the femur. J Bone Joint Surg Am. 1955 Jul;37-A(4):693-8. No abstract available.
citation: Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
Clinical trial NCT00317915: Irbesartan in Type 2 Diabetes
Official title: The Irbesartan in Patients With Type 2 Diabetes and Microalbuminuria (IRMA 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Microalbuminuria
Hypertension
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Sanofi-Synthelabo
First posted: 2006-04-25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this multicenter, doubleblind, randomized study was to investigate the renoprotective effect of irbesartan treatment in patients with type 2 diabetes and microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was the primary outcome measure.


Eligibility criteria: Inclusion Criteria:

Type 2 diabetes. Hypertension. Persistent microalbuminuria. Serum creatinine concentration of no more than 1.5 mg per deciliter (133 µmol per liter) for men and no more than 1.1 mg per deciliter (97 µmol per liter) for women. -

Exclusion Criteria:

Nondiabetic kidney disease. Cancer. Life-threatening disease with death expected to occur within two years. Indication for angiotensin-converting- enzyme (ACE) inhibitors or angiotensin-II-receptor antagonists. -

Primary outcomes:
measure: Development of overt nephropathy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Hans-Henrik Parving, Prof. DMsc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piazza M, Hanssen NMJ, Persson F, Scheijen JL, van de Waarenburg MPH, van Greevenbroek MMJ, Rossing P, Hovind P, Stehouwer CDA, Parving HH, Schalkwijk CG. Irbesartan treatment does not influence plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone in participants with type 2 diabetes and microalbuminuria: An IRMA2 sub-study. Diabet Med. 2021 Sep;38(9):e14405. doi: 10.1111/dme.14405. Epub 2020 Oct 16.
citation: Persson F, Rossing P, Hovind P, Stehouwer CD, Schalkwijk CG, Tarnow L, Parving HH. Endothelial dysfunction and inflammation predict development of diabetic nephropathy in the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria (IRMA 2) study. Scand J Clin Lab Invest. 2008;68(8):731-8. doi: 10.1080/00365510802187226.