louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00322075: LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous
Official title: Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.


Eligibility criteria: Inclusion Criteria:

* Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

Exclusion Criteria:

* Diabetic ketoacidosis
* Any other severe disease
* Pregnancy or fertile female without contraception
* Alcohol/drug abuse, selected prohibited concomitant medication
* Nightshift work

Primary outcomes:
measure: 3 days continual glycaemic profile fluctuation
measure: occurrence of adverse events
measure: HbA1c
measure: FBG
measure: BMI
measure: total daily dose of insulin and ratio of doses of basal/prandial insulines
measure: patients´satisfaction
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Zuzana Priborska
role: STUDY_DIRECTOR
References:
Clinical trial NCT04250675: Intermittent Pneumatic Compression to Improve Revascularization Outcome
Official title: Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Roseguini, Bruno, PhD
First posted: 2020-01-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.

Detailed description: Restenosis following revascularization procedures occur frequently and as early as 3 months after the intervention. There is an urgent need for adjunctive therapies that aid in the improvement of tissue blood flow and consequently relieve pain and improve functional capacity in these patients. It has been previously shown that exposure to IPC enhances leg blood flow to collateral-dependent tissues. In this study, subjects who have undergone nonsurgical revascularization will be randomly assigned to two groups: IPC or placebo pump. Subjects will receive a commercially available IPC device (Art Assist, ACI Medical, San Marcos, CA) and will apply the treatment at home for 2 hours daily over 3 consecutive months. At 3 time points (pre, 1 and 3 months post procedure) assessments will be performed (hemodynamics, rest pain, calf muscle oxygenation during exercise, walking endurance and quality of life).

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Scheduled for endovascular revascularization of one or both lower extremities.

Exclusion Criteria:

* Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
* Open and/or non-healing wounds in the areas covered by IPC cuff
* Walking limited by a symptom other than PAD
* Presence of any clinical condition that makes the patient unsuitable to participate in the trial
* Concern for inability of the patient to comply with study procedures and/or follow-up

Primary outcomes:
measure: Walking Endurance
timeFrame: Baseline and after 1 and 3 months of treatment
Secondary outcomes:
measure: Ankle-brachial Index (ABI)
timeFrame: Baseline and after 3 months of treatment
measure: Vascular Quality of Life Score (VascuQol)
timeFrame: Baseline and after 1 and 3 months treatment
measure: Toe-brachial Index
timeFrame: Baseline and after 1 and 3 months of treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist
state: Indiana
Study officials:
References:
Clinical trial NCT03646175: Choline Supplementation and Cardiovascular Health
Official title: Acute Choline Supplementation and Cardiovascular Health in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Choline
Trimethylamine N-Oxide
Vascular health
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if acute supplementation of dietary choline, which increases TMAO, impairs vascular function.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Healthy
* Non-smoking
* Weight stable for previous 6 months (±2.0 kg)
* BMI \<35 kg/m\^2
* Verbal and written informed consent
* Approved for participation by study medical director (Jose Rivero, M.D.)

Exclusion Criteria:

* Smoking
* Pregnancy
* Obese (BMI\>35 kg/m2)
* Altered dietary patterns within the last month of recruitment
* Unstable heart disease or diabetes
* Untreated high blood pressure or high cholesterol
* Allergies to choline
* Unvaccinated against COVID-19

Primary outcomes:
measure: Change in brachial artery function after supplementation
timeFrame: 30-minute measurement in laboratory
Secondary outcomes:
measure: Change in arterial stiffness after supplementation
timeFrame: 45-minute measurement in laboratory
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Polytechnic and State University
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Kevin Davy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00167375: Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Official title: Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Insomnia
Sleep Initiation and Maintenance Disorders
Keywords: Insomnia
polysomnography
sleep onset
time series analysis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
name: Sumitomo Pharma America, Inc.
First posted: 2005-09-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This study tests a new kind of sleep study in which subjects are awakened 2 times after initially going to sleep. The study focuses on the EEG signal process as a person goes to sleep. The general hypothesis is that the signal properties are stable from night to night during baseline studies, and are different between controls and patients with primary insomnia. The primary insomnia patients then go on to have about 2 weeks of an insomnia intervention. Then the new kind of study is repeated in the patients. The controls only are examined in baseline studies.

Detailed description: Patients are carefully screened to have DSM primary insomnia, and do not have another disorder than may cause a sleep disturbance. After a 2-week baseline period, the subjects undergo a screening sleep study to rule out sleep apnea and periodic limb movement disorder. Then they undergo the NSLP procedure. In that procedure, there pre-bedtime EEG recordings and questionnaire responses taken. Then at a planned time, the subjects go to bed and try to sleep while there EEG signals are recorded. After the first and second sleep cycles, they are awakened for one minute, then asked to return to sleep. In the morning additional recordings and questionnaire responses are obtained. Two nights later they repeat a baseline NSLP procedure. The controls then end their participation. The Patients then receive an open treatment with eszopiclone and behavioral treatments so that their insomnia may improve. After 2 weeks intervention, the patients complete one NLSP night. The goal of the study is to see if there can be data to support the idea that the sleep onset process might harbor a sign of primary insomnia that could be used for the development of a better medical model of primary insomnia.

Eligibility criteria: Inclusion Criteria:

* Primary Insomnia (N = 12) Age \& Gender matched Healthy controls (N = 12)

Exclusion Criteria:

* Unstable Medical illness No other Sleep disorder BMI \> 35, AHI \> 10, PLM Index \> 10, Ferritin \< 50. Unable to communicate in English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas E Moul, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01948375: A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle
Official title: Effect of Blinding With a New Pragmatic Placebo Needle: a Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Ineffective
Keywords: subject blinding
placebo needle
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have applied a new kind of placebo needle in large scale acupuncture clinical trials, which named as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials, this pragmatic placebo needle shows several advantages: the outlook closer to traditional acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and more economical. However, its blinding effect is not yet validated. The primary objective of this trial is to validate the blinding effect of the new pragmatic placebo needle; the secondary objective is to explore factors influencing the blinding effect of the placebo needles.

Detailed description: blinding refers to subject blinding

Eligibility criteria: Inclusion Criteria:

* 18-74 years old;
* with a basic capacity of listening, speaking, reading and writing in Chinese;
* volunteer to join this research and sign the informed consent.

Exclusion Criteria:

* with acute or chronic pain;
* taking analgesics or drugs inducing abnormal sensation;
* with diseases of sensory disturbance or sensory loss;
* with alcohol or drug abuse history;
* serious cardiovascular, cerebral, hepatic, renal, hematopoietic, hemorrhagic or psychiatric diseases;
* diabetes mellitus or dermatological disease;
* women in pregnancy or lactation period;
* cardiac pacemaker carrier, metal allergy or severe needle phobia.

Primary outcomes:
measure: Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
timeFrame: in the third acupuncture session in each period
Secondary outcomes:
measure: Southampton Needle Sensation Questionnaire-Type of Needle Sensation
timeFrame: in the third acupuncture session in each period
measure: Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
timeFrame: in the third acupuncture session in each period
measure: Degree of Acupuncture Pain
timeFrame: in the third acupuncture session in each period
measure: Acceptability of the Acupuncture Needle
timeFrame: in the third acupuncture session in each period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02537275: Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinted Contact Lense
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.


Eligibility criteria: Inclusion Criteria:

* normal subject
* aged above 20 years old

Exclusion Criteria:

* subject who had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease,
* patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.

Primary outcomes:
measure: score of best-corrected visual acuity (BCVA)
timeFrame: 1 day
Secondary outcomes:
measure: Total score of ocular higher-order aberrations
timeFrame: 1 day
measure: contrast sensitivity with tinted lense
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
citation: Jung JW, Kim SM, Han SH, Kim EK, Seo KY, Kim TI. Effect of the pigment-free optical zone diameter of decorative tinted soft contact lenses on visual function. Br J Ophthalmol. 2016 May;100(5):633-7. doi: 10.1136/bjophthalmol-2015-306731. Epub 2015 Sep 16.
Clinical trial NCT04812275: Absorbable or Non Absorbable Sutures in Hand Surgery
Official title: Absorbable or Non Absorbable Sutures in Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Complication Hand Surgery
Lead sponsor: Department of Hand surgery Södersjukhuset
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After all surgical procedures, the skin must be closed with some form of stitch, in healthcare called suture. According to the tradition of hand surgery, sutures that must be removed by caregivers, ie non-resorbable thread, have been used extensively, and the frequency of complications in the form of wound rupture and infection is low. For many procedures, however, it can be an advantage to avoid removing the stitches, as it is both painful for the patient and time-consuming and resource-consuming for both the patient and the healthcare system. You can then use a thread that the body itself breaks down and absorbs, ie resorbable suture. In the project, we will compare resorbable and non-resorbable suture with the primary outcome of superficial infection in the surgical area sometime day 1-20 after surgery. Secondary outcomes are the occurrence of wound rupture, pain VAS (Visual Analog Scale) when changing 2 weeks postoperatively, patient satisfaction VAS at 2 weeks and time spent in minutes for changing at 2 weeks postoperatively. The project will include all consecutive patients\> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet the exclusion criteria. The project will include 270 patients.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients\> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet any of the exclusion criteria.

Exclusion Criteria:

* -The researcher has an age \<18 years.
* Patients with known healing problems in the past, for example patients with burns or during cortisone treatment.
* Patients undergoing surgery where skin grafting occurs.
* Patients with acute injuries that include a traumatic wound-ie what is usually referred to as "open injuries" -where the risk of infection is higher from the beginning.

Primary outcomes:
measure: Infection
timeFrame: 2 weeks
Secondary outcomes:
measure: Rupture
timeFrame: 2 weeks
measure: VAS
timeFrame: 2 weeks
measure: Time
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset Hospital
Study officials:
References:
Clinical trial NCT06689475: The Effect of Simulation on Cardiac Auscultation Competence
Official title: The Effect of Simulation on Cardiac Auscultation Competence of Nursing Students: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auscultation of Heart
Simulation Based Learning
Psychoacoustics
Keywords: auscultation of cardiac sounds
Simulation
psychoacoustic
nursing students
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This randomized controlled study aims to determine the effect of simulation on the cardiac auscultation competence of nursing students. The main questions it aims to answer are:

* Simulation is effective in developing the cardiac auscultation competence of nursing students.
* The psychoacoustic approach is effective in developing the cardiac auscultation competence of nursing students.

One week after the 2-hour theoretical lecture, all three groups will be taken simultaneously to a 3-hour laboratory practice for cardiac auscultation. An instructor will lead each group to ensure coordination. The psychoacoustic approach group will listen to normal heart sounds (S1, S2), abnormal heart sounds (S3, S4) and murmur sounds from the audio file uploaded to their mobile phones in the laboratory environment through headphones for 500 repetitions each. The simulation group will practice auscultation of heart sounds in a one-to-one and repetitive manner, working with a high reality simulator. Trainers will act as facilitators during the cardiac auscultation practice of the students in the intervention groups. The control group will continue with the standard education.


Eligibility criteria: Inclusion Criteria:

- First-time registration in the course.

Exclusion Criteria:

* Non-native speakers of the country's native language.
* Previous graduation from any health-related university.

Primary outcomes:
measure: achievement test
timeFrame: From enrollment to the end of education at 4 weeks.
Secondary outcomes:
measure: Student Satisfaction and Confidence in Learning
timeFrame: At the end of education at 4 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Nursing
state: Yenimahalle
Study officials:
References:
Clinical trial NCT05618275: Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS
Official title: Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the University Hospital of Strasbourg (HUS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: BK Virus Infection
Keywords: BK virus infection
Neutralizing antibodies
Hematopoietic stem cell
Polyomaviridae
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019

Brief summary: The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally asymptomatic, occurs during childhood. The virus then persists in latent form in the body, mainly in the epithelial cells of the kidney and urinary tract. Cellular immunosuppression favors BKV replication. It is responsible for pathologies of the renal-urinary tract such as BKV-associated nephropathy (BKVAN) in kidney transplant recipients, hemorrhagic cystitis (HC) in hematopoietic stem cell (HSC) recipients or ureteral stenosis.

To date, there is no specific antiviral treatment against BKV. The management of patients is essentially symptomatic and requires a multidisciplinary approach. It is therefore necessary to identify early prognostic markers for the occurrence of CH and to develop new therapeutic strategies.


Eligibility criteria: Inclusion criteria:

* Adult patient aged 18 to 19 years
* Minor patient (from birth to 17 years old)
* HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019

Exclusion Criteria:

* Opposition of the patient (or parental authority holders) to participate in the study
* Biological resources from a patient who does not meet all inclusion criteria
* Patient deprived of liberty or under court protection
* Patient under guardianship or curatorship

Primary outcomes:
measure: Retrospective study of the role of anti-BKV neutralizing antibodies in HSCT patients in the pediatric oncology-hematology department of the HUS
timeFrame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
Study officials:
References: