louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02810925: Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6
Official title: Weight Loss and Appetite Reduction and Their Correlation With Plasmatic Ghrelin Levels After Percutaneous Electrical Stimulation Dermatome T6 Associated With a Hypocaloric Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.

Detailed description: The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).

Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.

Eligibility criteria: Inclusion Criteria:

* Patients with obesity (BMI\>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)

Exclusion Criteria:

* Untreated endocrine disease causing obesity
* Serious psychiatric illness.

Primary outcomes:
measure: Weight loss
timeFrame: After 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinica Garcilaso
name: Dolores Castro
role: STUDY_CHAIR
References:
Clinical trial NCT03025425: Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD
Official title: Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD Exacerbation
Dyspnea
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.


Eligibility criteria: Inclusion Criteria:

* a previous diagnosis of COPD
* hospitalized due to acute exacerbation of COPD
* at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
* no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa)
* able to understand the study and to give informed consent

Exclusion Criteria:

* unable to participate and use MPV due to e.g. delirium or lack of co-operation
* acute hypoventilation (pH \< 7.35 or PCO2 \> 6.0 kPa)
* acute need for ventilatory support
* the cause of the dyspnea can be successfully treated
* unable to give informed consent
* a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home

Primary outcomes:
measure: Change in dyspnea after initial period of using MPV
timeFrame: 5-60 min
Secondary outcomes:
measure: Change in dyspnea after 24 hours of using MPV
timeFrame: 24 hours
measure: Proportion of subjects having side-effects or not being compliant with MPV
timeFrame: 24 hours
measure: Proportion of subjects gaining from MPV
timeFrame: 24 hours
measure: Proportion of subjects willing to continue on MPV after the intervention
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Dpt of Respiratory Medicine, Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital, Allergy centre
name: Lauri Lehtimäki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06458725: Assessment of DW-MRI Measures : Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers
Official title: Comprehensive Assessment of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) Measures: Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers. (PILLAR)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectum Cancer
Pelvic Cancer
Keywords: Repeatability
Reproducibility
MR-Linac
Radiotherapy
Functional MRI
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the reliability of functional MRI measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. The aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional MRI in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.

Detailed description: Volunteers will be required to complete a questionnaire to ensure their eligibility and safety for undergoing an MRI. This questionnaire, along with safety information, will be reviewed before each MR session.

Subsequently, volunteers will undergo three MRI sessions, ideally two on the same day, with the last session scheduled 10 to 17 days apart from the previous ones. Each session is expected to last approximately 60 minutes (several sequences), and no contrast agent will be injected at any point.

On the first day, volunteers will have an MRI on the 1.5 Tesla MR-Linac Unity (Elekta device) and an MRI on a standard 1.5 Tesla MRI (Siemens). Between days 10 to 17, they will exclusively undergo an MR-Linac session.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 yo
* Healthy
* Volunteer
* Ability to undergo an MRI

Exclusion Criteria:

* \< 18yo
* Contraindication to undergoing an MRI (see safety questionnaire)
* Previous pelvic irradiation
* Pelvic pathology

Primary outcomes:
measure: Assess the repeatability coefficient (RC) (percentage)
timeFrame: Day 1 and Day 10-17
measure: Assess the reproducibility coefficient (RDC) (percentage)
timeFrame: Day 1 and Day 10-17
Secondary outcomes:
measure: Percentage of variation between the different calculation Methods for Repeatability Coefficient.
timeFrame: Day 1 and Day 10-17
measure: Percentage of variation across various pelvic organs for Repeatability Coefficient.
timeFrame: Day 1 and Day 10-17
Other outcomes:
measure: Percentage of variation based on sequence types for the Repeatability Coefficients.
timeFrame: Day 1 and Day 10-17
Locations:
Study officials:
affiliation: Jules Bordet Institute
name: Madeline A Michel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05569525: Type I Diabetes and Non-surgical Periodontal Treatment
Official title: Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Periodontitis
Periodontal Diseases
Diabetes
Diabetes Mellitus
Diabetes Mellitus, Type 1
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 100
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: Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed.

The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 1 diabetes
* Patients under treatment in the department of Diabetology of AOU Careggi having a microinfusor for continuous subcutaneous insulin infusion (CSII) and a Flash Glucose Monitoring (FGM) device
* Diagnosis of periodontitis (all stages and grades)

Exclusion Criteria:

* Contraindications for non-surgical periodontal therapy
* Pregnancy
* History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: 6 months after the non-surgical periodontal treatment
Secondary outcomes:
measure: Standard Deviation (SD) of glycaemia
timeFrame: 6 months after the non-surgical periodontal treatment
measure: Glucose coefficient of variability (CV)
timeFrame: 6 months after the non-surgical periodontal treatment
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Università degli Studi di Firenze
state: FI
Study officials:
References:
Clinical trial NCT01507025: The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis
Official title: The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: hinge position
dry eye
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Wenzhou Medical University
First posted: 2012-01-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients were scheduled to undergo LASIK and randomized to different hinge locations

Brief summary: The purpose of this study is to investigate the possible effect of hinge location on corneal sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).

Detailed description: Dry eye symptoms are a frequent postoperative complication of laser in situ keratomileusis (LASIK). Although estimates of the incidence of dry eye syndrome vary widely, from 3% to 59%, almost all patients will have transient dry eye during the immediate postoperative period.Because of the variability in corneal innervation patterns, altering flap characteristics in LASIK may affect postoperative corneal sensation and dry-eye disease. Some studies have reported that postoperative corneal sensation may be higher and recovery faster in eyes with horizontal flaps (nasal- or temporal-hinge) than in eyes with vertical flaps (superior- hinge). However, some other studies have not established an association between corneal sensation and hinge position. This study reviewed the published literature and performed a meta-analysis aimed to investigate the effects of hinge location on corneal sensation and dry-eye symptoms after LASIK.

Eligibility criteria: Inclusion Criteria:

1. each trial should be a prospective randomized controlled clinical trial (RCT),
2. the age of patient population should be over 18 years

Exclusion Criteria:

1. non-randomized controlled trials
2. patients who had had a previous ophthalmic surgery or ocular surface disorders
3. the raw data was not completed

Primary outcomes:
measure: Corneal sensitivity
timeFrame: 6 months
measure: Tear break-up time
timeFrame: 6 months
measure: Schirmer's I test
timeFrame: 6 months
Secondary outcomes:
measure: Corneal fluorescein staining
timeFrame: 6 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Yifan Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng YF, Yu JG, Wang DD, Li JH, Huang JH, Shi JL, Ye T, Wang QM, Zhao YE. The effect of hinge location on corneal sensation and dry eye after LASIK: a systematic review and meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2013 Jan;251(1):357-66. doi: 10.1007/s00417-012-2078-5. Epub 2012 Jun 15.
Clinical trial NCT05555225: Methylome Study in Sporadic Limb Malformations
Official title: Methylome Study in Patients Affected With Sporadic Limb Malformations
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amelia
Femur Fibula Ulna Syndrome
Keywords: Amelia
Femur-Fibula-Ulna Syndrome
Methylation
Limb development
Gene regulation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2022-09-26
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DNA samples were obtained from the molecular biology laboratory of Lille university hospital. All patients exhibiting amelia or Femur-Fibula-Ulna Syndrome and with enough DNA available in the lab could be included.

Brief summary: Some limb malformations are known to be sporadic (non hereditary). For these malformations, no molecular cause was identified, even after whole genome sequencing. Methylation of CpG islands is an epigenetic process which is usually not transmitted to the descents. We hypothesize that sporadic limb malformations may be due to a methylation anomaly. This study will include patients with Amelia or Femur Fibula Ulna Syndrome. With patients consent, we will study the methylome on DNA samples already available in our laboratory. Each patient sample will be paired to a control of same tissue, age and sex. By bioinformatics comparison, we will identify differentially methylated candidate regions.


Eligibility criteria: Inclusion Criteria:

* Specific consent for this study
* DNA available in the laboratory
* For amelia : agenesia of 2 or 4 limbs
* For Femur-Fibula-Ulna Syndrome : hypoplasia or agenesia of the femur uni or bilateral with hypoplasia or agenesia or bowing of the fibula and/or of the ulna

Exclusion Criteria:

* No consent
* No available DNA or poor quality of the DNA sample
* Patient under tutorship
* Pregnancy or nursing mother
* Patient non covered by the French social security

Primary outcomes:
measure: Differentially Methylated Regions
timeFrame: through study completion an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Perrine BRUNELLE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409525: Rate of Microbial Colonization Over Native Calcified Cardiac Valves
Official title: Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Cardiac Valve Disease
Coronary Artery Bypass Surgery Patients
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 200 eligible adult subjects, scheduled to undergo elective cardiac surgery in RAMBAM medical center.

Brief summary: The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed
* Male or Female subject, 50 years or older
* Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease

Exclusion Criteria:

* Subjects have an established or indicated history of IE.
* Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur)
* Subjects are current users or have a close history of drug abuse

Primary outcomes:
measure: To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.
timeFrame: Patients will be followed for the duration of their hospitalization, average of 5 days.
Secondary outcomes:
measure: Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease
timeFrame: Patients will be followed for the duration of their hospitalization, average of 5 days.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Liran Shani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222425: Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3
Official title: Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sars-cov-2
Keywords: sars-cov-2
Lead sponsor: Biomad AS
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 3000
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: This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.

Detailed description: An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events will be registered.

Eligibility criteria: Inclusion Criteria:

* Age 18 or higher
* Newly diagnosed (no longer than 10 days)
* PCR or clinically confirmed Covid-19

Exclusion Criteria:

* Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Duration of Disease From Beginning of Treatment
timeFrame: 30 days
measure: Hospitalization
timeFrame: 30 days
measure: Duration of Hospitalization When Occurred
timeFrame: 30 days
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Directorate of health of Sulaimani, Iraq -KRG
Study officials:
References:
Clinical trial NCT05365425: Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Official title: Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dyslipidemia
Atherosclerosis
Diabetes Mellitus, Type 2
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Daewon Pharmaceutical Co., Ltd.
First posted: 2022-05-09
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

Detailed description: In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
* Male or female of 20 years or over
* Mixed dyslipidemia: triglyceride 200\~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL
* Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
* Creatinine ≤1.8 mg/dL

Exclusion Criteria:

* Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
* Uncontrolled hypertension
* Severe renal dysfunction
* GOT/GPT \>120/120 or chronic liver disease
* Pregnant or childbearing woman who does not have enough contraception
* Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
* Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)

Primary outcomes:
measure: Carotid intima media thickness
timeFrame: 24 week
Secondary outcomes:
measure: Area of carotid artery plaque
timeFrame: 24 week
measure: Plaque characteristics
timeFrame: 24 week
measure: Glucose homeostasis
timeFrame: 24 week
measure: Lipid metabolism
timeFrame: 24 week
measure: Bioelectrical Impedance Analysis
timeFrame: 24 week
measure: Proteinuria
timeFrame: 24 week
measure: changes of gut microbiota
timeFrame: 24 week
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: SNUBH
state: Gyeonggi
Study officials:
References: