louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02650947: Sucralose Effects on Glucose Metabolism and Gut Microbiota
Official title: Effects of Sucralose Consumption on Glucose Metabolism, Incretin and Gut Microbiota in Healthy Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Sucralose
Insulin Secretion
Insulin Sensitivity
Incretin
Gut Microbiota
Food and Eating Behaviour
Healthy Volunteers
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: The Endocrine Society of Thailand
First posted: 2016-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothesis:

1. Long-term consumption of sucralose may effect glucose metabolism, incretin hormone secretion and gut microbiota in healthy adults.
2. Long-term consumption of sucralose may alter food behaviour in healthy adults.

Detailed description: Artificial sweeteners such as sucralose, are among the most widely used food additives worldwide. Artificial sweetener consumption is considered safe and beneficial owing to their low caloric content. However, many emerging evidences showed artificial sweeteners may induce glucose intolerance. The objectives of this study were to determine the effect of sucralose on glycemic response, insulin secretion, insulin sensitivity, incretin response, gut microbiota and food behavior in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers without underlying disease
* Normal oral glucose tolerance test
* Agree to participate by written informed consent

Exclusion Criteria:

* Shift workers
* History of diabetes mellitus or prediabetes (impaired fasting glucose and/or glucose tolerance test)
* Malabsorption problem
* Regular consumption of nonnutritive sweeteners
* Liver impairment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3-folds upper normal limit)
* Renal impairment (serum creatinine \>1.5 mg/dL)
* Use of medications affecting glucose level such as glucocorticoid, estrogen, androgen
* Pregnant and lactating woman
* Smoking within 6 months

Primary outcomes:
measure: The effect of sucralose on insulin secretion
timeFrame: 2 hours
Secondary outcomes:
measure: Glucagon-like peptide-1 secretion
timeFrame: 2 hours
measure: Gut microbiota
timeFrame: 4 weeks
measure: Food record
timeFrame: 4 weeks
measure: The effect of sucralose on insulin sensitivity
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Ramathibodi Hospital
name: Chutintorn Sriphrapradang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04730947: Dapagliflozin (DAPA) Effects in HFpEF
Official title: Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 38
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 determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to any study specific procedures.
* Male or female.
* Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.
* EF ≥ 50% + BMI ≥ 30 kg/m\^2
* Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized .

Exclusion Criteria:

* Type I diabetes.
* Type II diabetes with poor control (HgbA1C ≥ 10%).
* Recent hospitalization (\< 30 days) or revascularization (\< 90 days).
* Primary cardiomyopathy (such as amyloid).
* Constrictive pericarditis.
* Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator.
* Severe anemia (hemoglobin \< 9gm/dl.
* Significant left-sided valvular heart disease (\> mild stenosis, \> moderate regurgitation),
* Severe kidney disease (estimated glomerular filtration rate (GFR) \< 30) or liver disease,

Primary outcomes:
measure: Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
timeFrame: Baseline, 24 weeks
measure: Pulmonary Capillary Wedge Pressure (PCWP) at Rest
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 24 weeks
measure: Change in Total Blood Volume
timeFrame: Baseline, 24 weeks
measure: Change in Plasma Volume
timeFrame: Baseline, 24 weeks
measure: Change in Right Atrial (RA) Pressure at Maximal Exercise
timeFrame: Baseline, 24 weeks
measure: Change in Right Atrial (RA) Pressure at Rest
timeFrame: Baseline, 24 weeks
measure: Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise
timeFrame: Baseline, 24 weeks
measure: Change in Mean Pulmonary Arterial Pressure (PA) at Rest
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry A Borlaug
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06410547: Using Large Language Models Such As GPT-4 to Assess Guideline Adherence in Patients with Chronic Obstructive Pulmonary Disease
Official title: Using Large Language Models Such As GPT-4 to Assess Guideline Adherence in Patients with Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 70
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: According to studies in the US and the Netherlands, 33-40% of patients with chronic conditions receive care that does not follow guideline recommendations. These findings have also been demonstrated in the management of COPD. This leads to under- or over-treatment of patients and, in the case of COPD, to exacerbations and hospitalisations. These exacerbations are a significant clinical problem, affecting patient's lung function, quality of life and mortality. They are also a burden on the healthcare system. Technological advances in artificial intelligence offer the opportunity to address these issues in COPD management. In the past year, there have been remarkable innovations in the field of natural language processing, especially through large language models such as GPT-4 from OpenAI and Bard or Gemini from Google. These models offer an opportunity to improve the implementation of evidence-based care in clinical practice.

This study is a prospective, randomised trial that will compare therapy on discharge for patients with COPD. One arm will receive no intervention, while the other arm will receive a treatment recommendation from an LLM. The study will compare the percentage of patients treated according to the guideline.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Consent
* Discharge after hospitalization

Exclusion Criteria:

* Lack of Consent

Primary outcomes:
measure: Adherence to treatment guidelines at the time of hospital discharge
timeFrame: From date of admission (which is enrollment) to the date of discharge, assessed up to one month
measure: Percentage of patients treated in concordance with treatment guidelines at the time of hospital discharge
timeFrame: From date of admission (which is enrollment) to the date of discharge, assessed up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University
Study officials:
affiliation: Charité
name: Matthias Gröschel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01207947: LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
Official title: LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: Vardenafil
Erectile dysfunction
Phosphodiesterase Inhibitors
Combination use with alpha-blockers
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 491
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Erectile dysfunction patients of 18 years-old or older and also the patients with combination use of alpha-blockers.

Brief summary: Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.

In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.


Eligibility criteria: Inclusion Criteria:

* Patients \>/= 18 years
* Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers

Exclusion Criteria:

Primary outcomes:
measure: Efficacy of Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
timeFrame: 2 months
measure: Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated
timeFrame: 2 months
Secondary outcomes:
measure: Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied
timeFrame: 2 months
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01640847: MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
Official title: Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Painful Bone Metastases
Breast Carcinoma
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Adenocarcinoma
Keywords: Painful bone metastases
Bone Cancer
Bone Cancer Pain
Patients with
Lead sponsor: Imunon
Sponsor class: INDUSTRY
Collaborators: name: Philips Healthcare
First posted: 2012-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate
* Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S5.
* Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT)

Exclusion Criteria:

* Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin
* LVEF \< 50%
* Significant Cardiac History
* Brain Metastases
* Contraindication for MR imaging (as incompatible implanted metallic device, weight \>250 lbs etc) or known intolerance or allergy to MRI contrast agents.

Primary outcomes:
measure: Rate of complete pain response
timeFrame: 12 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Imunon
name: Nicholas Borys, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01194947: Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Common Melanocytic Nevi
Keywords: banal-appearing nevi
NEVUS
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients visiting the pigmented lesion clinic for skin cancer surveillance

Brief summary: Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.


Eligibility criteria: Inclusion Criteria:

* Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination
* Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination.

Exclusion Criteria:

* Patients who are unwilling or medically unable to lie down for 30 minutes.
* Pregnant women

Primary outcomes:
measure: Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).
timeFrame: 3 YEARS
Secondary outcomes:
measure: Description of rates of retention and change in RCM pattern of nevi during follow-up
timeFrame: 3 YEARS
Other outcomes:
Locations:
city: Rmat-gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: ALON SCOPE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02602847: Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients With B Virus Markers
Official title: Study of cccDNA in Liver Transplant Patients With B Virus Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: Liver transplantation
HBV
cccDNA
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver transplantation planned

Brief summary: The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation.


Eligibility criteria: Inclusion Criteria:

* Patient registered on the national Organ Transplant Waiting List for liver transplantation
* Indication of transplantation :
* Alcoholic related disease without serum anti-hepatitis B core antibody (HBc) (less than 4 weeks) OR - HCV related disease without serum anti-HBc antibody (less than 4 weeks) OR - Patients who sign consent for liver transplantation from hepatitis B core antibody positive donors OR - HBV related disease with positive serum HBs antigen (with or without HBV replication measured by polymerase chain reaction (PCR) within 6 months prior transplantation)
* Signed consent form
* Patient with a social cover
* Patient not covered by any measure of legal protection

Exclusion Criteria:

* Co-infection with HIV, hepatitis delta virus (HDV), HBV (for control arm), HCV (for Test arm) - Positive serology within the4 weeks before inclusion
* Patient covered by any measure of legal protection
* informed consent not signed

Primary outcomes:
measure: cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy
timeFrame: 1 year after transplantation
Secondary outcomes:
measure: Correlation between cccDNA rate and serologic status
timeFrame: 1 year after transplantation
measure: Correlation between cccDNA rate and virologic status
timeFrame: 1 year after transplantation
measure: Correlation between cccDNA rate and patient's treatment
timeFrame: 1 year after transplantation
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Service d'Hépatologie, Hôpital de la Croix-Rousse
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Nice
country: France
facility: CHU de Nice
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon
name: Fabien ZOULIM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538147: Restless Leg Syndrome and Severe Preeclampsia
Official title: Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Leg Syndrome
Severe Preeclampsia
Keywords: Restless Leg Syndrome
Severe Preeclampsia
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients with severe preeclampsia (cases) and normal pregnancies at term (control).

Brief summary: Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has been done trying to link both disorders.


Eligibility criteria: Inclusion Criteria:

* Gestational age between 24-34 weeks
* Severe preeclampsia

Exclusion Criteria:

* Neurological disorders (central nervous system)

Primary outcomes:
measure: Restless Leg Syndrome
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo A Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03194347: Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas
Official title: Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a gynecological malignancy, in whom a genetic testing of tumor tissue (somatic mutation) and blood cells (germ line mutation) has already taken place.

Brief summary: The aim of the planned research project is to find out the clinical significance of molecular genetic analyzes in gynecological malignomas. In particular, it will be investigated how the knowledge of a molecular-genetic finding affects the therapeutic decision of the physician. Furthermore, genetic changes in the tumor tissue will be compared with the changes in CTCs, DTCs and cfDNA.


Eligibility criteria: Inclusion Criteria:

* Patients with a solid tumor disease
* The presence of a molecular genetic diagnosis of the tumor tissue from practice for human genetics
* Age \> 18 years
* informed consent

Exclusion Criteria:

* life expectancy \<12 months or worse general condition (Karnofsky \<70)

Primary outcomes:
measure: Influence of molecular genetic findings to the therapy decision
timeFrame: 3years
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Women's Hospital
Study officials:
affiliation: Department of Women's Health
name: Andreas D Hartkopf, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202747: Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
Official title: Pilot Study for Evaluation of LipiFlow Screening Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chalazion
Dry Eye Syndromes
Lead sponsor: TearScience, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 50
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: The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.


Eligibility criteria: Inclusion Criteria:

* Meibomian gland dysfunction
* Dry Eye symptoms

Exclusion Criteria:

* Ocular surgery, ocular injury or ocular Herpes infection within past 3 months
* Active ocular infection
* Active ocular inflammation or recurrent inflammation within past 3 months
* Moderate to severe allergic conjunctivitis
* Severe eyelid inflammation
* Eyelid abnormalities that affect lid function
* Ocular surface abnormalities that may compromise corneal integrity
* Systemic disease conditions or medications that cause dry eye
* Use of other treatments for meibomian gland dysfunction or dry eye
* Pregnant or nursing women
* Participation in another ophthalmic clinical trial within past 30 days

Primary outcomes:
measure: Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
timeFrame: Baseline and 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hoffman Estates
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Winchester
country: United States
state: Massachusetts
Study officials:
affiliation: TearScience
name: Christy Stevens, OD
role: STUDY_DIRECTOR
References: