louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04257318: Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study
Official title: Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman, whatever the term, primiparous or multiparous
* Age ≥ 18 years old
* Patient having read and understood the information letter and signed the consent form
* Patient affiliated to Social Security

Exclusion Criteria:

* Inability to understand French or information,
* Person deprived of their liberty by an administrative or judicial decision
* Person placed under the protection of justice
* Person under guardianship or curatorship

Primary outcomes:
measure: Acceptability
timeFrame: through study completion, an average of 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Eric VERSPYCK, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Manon BESTAUX, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292018: Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India
Official title: A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Type 2 Diabetes Mellitus
Keywords: Management of dyslipidemia in Type 2 Diabetes Mellitus adult patients in India
Dyslipidemia control rates in Type 2 diabetic Mellitus patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-09
Enrollment: 5400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).

Brief summary: The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.


Eligibility criteria: Inclusion Criteria:

* Adult who is a known Type 2 diabetic as per the ADA 2010 criteria OR controlled diabetic (taking any antidiabetic medication)
* Patients in the study will have been on lipid lowering drugs at a stable dose for the last three months before the designated study visit.

Exclusion Criteria:

* Type 1 diabetic patients
* Patients with a history of hepatic or renal diseases
* Hypertension due to organic diseases

Primary outcomes:
measure: Proportion of type 2 diabetic dyslipidemia patients achieving the target LDL goal according to ADA 2010. These patients should be on stable dose of Lipid Lowering Drugs(LDL) for at least 3 months
Secondary outcomes:
measure: Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender
measure: Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination
measure: Control of dyslipidemia by all commercial available brands hypolipidemics drugs
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01440218: Idiopathic Diseases of Man
Official title: Idiopathic Diseases of Man (IDIOM)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Rare Disease
Idiopathic Disease
Keywords: Idiopathic diseases
family member of the affected individual
unknown etiology
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic diseases, referred by their physician.

Brief summary: This research is being done to learn more about possible genetic causes of currently undiagnosed conditions, and to find out how the development of new technologies, such as DNA sequencing, can increase knowledge of the role genetic variants play in disorders and possibly how genetic variants may help de-termine the best treatment options.

The recent development of new technologies has increased our ability to understand how genetic mutations are associated with disease. Using these technologies to find the genetic variants responsible for rare diseases is a rapidly growing field and has already begun to transform the way conditions with unknown causes are diagnosed and treated.

Hypothesis: Identification of new genomic variants associated with idiopathic diseases and/or diseases of unknown etiology will advance medical knowledge about rare and common diseases.


Eligibility criteria: Inclusion Criteria:

1. Individual with rare disorder with previous unknown etiology.
2. Individual with known disorder that does not respond to conventional treatment.
3. Individual experienced a rare adverse event that was a result of the administration of a pharmacologic or biologic agent, immunization or device.
4. Individual is a family member of the affected individual. -

Exclusion Criteria:

1. Unwilling or unable to grant informed consent if they do not have a legal guardian who has authority to sign a consent form on their behalf.
2. Have a significant medical, affective, or psychiatric condition that in the Investigator's opinion may interfere with subject's study participation.

Primary outcomes:
measure: Genomic sequencing of tissue
timeFrame: Day 1
Secondary outcomes:
measure: Identification of modifying genomic alterations
timeFrame: Day 1
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
References:
Clinical trial NCT02291718: Thoracoabdominal Arortic CTA Study
Official title: Comparison of High Iodine Concentration Contrast Material (Isovue 370) vs Standard Protocol (Isovue 300) in Thoracoabdominal Aortic Computed Tomographic Angiography (CTA) for Radiation Dose Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracic Aortic Aneurysm
Keywords: Suspected or confirmed
TAA
Computed tomography angiography
CTA
Contrast agent
Radiation dose
Thoracoabdominal aortic aneurysm
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracoabdominal aortic (TAA) CTA
* Able to provide informed consent
* Body Mass Index (BMI) equal to or less than 30

Exclusion Criteria:

* Creatinine greater than 2.0
* Allergy to contrast media
* Pregnant women

Primary outcomes:
measure: Radiation Dose
timeFrame: 30 minutes
Secondary outcomes:
measure: Signal to Noise Ratio
timeFrame: 30 minutes
measure: Hounsfield Unit Attenuation Values
timeFrame: 30 minutes
measure: Variation in Contrast for the Entire Vascular System (coV)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT06216418: Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds
Official title: A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Hugel
Sponsor class: INDUSTRY
Collaborators: name: Jworld
First posted: 2024-01-22
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.

Detailed description: This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.

Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years of age
2. Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)
3. Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing

Exclusion Criteria:

1. A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.
2. Those who are pregnant or lactating

Primary outcomes:
measure: Improvement rate (%) at 12 weeks after the procedure compared to baseline.
timeFrame: Baseline to week 12
Secondary outcomes:
measure: WSRS evaluation by an independent evaluator
timeFrame: Baseline to week 4, 8, 24
measure: WSRS evaluation by tester
timeFrame: Baseline to week 4, 8, 24
measure: Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.
timeFrame: Baseline to week 4, 8, 12, 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hugel Inc.
Study officials:
References:
Clinical trial NCT06892418: Impact of Ketoflex 12/3 Diet on Parkinson's Disease Symptoms: A Clinical Study
Official title: A Clinical Study on the Effects of Ketoflex 12/3 Diet on Motor and Non-Motor Symptoms in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson&#39;s Disease
Parkinson
Keywords: Parkinson's Disease
Ketogenic Diet
Intermittent Fasting
Ketoflex 12/3
Neurodegenerative Disorders
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effects of the Ketoflex 12/3 diet on motor and non-motor symptoms in patients with Parkinson's disease. Participants will follow the Ketoflex 12/3 dietary regimen, and their cognitive function, motor symptoms, sleep patterns, gastrointestinal health, and overall well-being will be assessed through standardized clinical scales. The study will help determine whether a plant-based ketogenic diet combined with intermittent fasting can have a beneficial impact on Parkinson's disease progression.

Detailed description: Parkinson's disease is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms. Emerging evidence suggests that dietary interventions, particularly ketogenic diets and intermittent fasting, may play a role in neuroprotection and symptom management. This study investigates the effects of the Ketoflex 12/3 diet, a plant-based ketogenic dietary approach combined with intermittent fasting, on Parkinson's disease progression. Clinical assessments will include Unified Parkinson's Disease Rating Scale (UPDRS), Mini-Mental State Examination (MMSE), depression and anxiety scales, sleep quality assessments, and gastrointestinal health evaluations. The study aims to provide new insights into the potential benefits of metabolic-based nutritional interventions in Parkinson's disease patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Age between 40-85 years
* Native Turkish speakers
* Able to comply with the study protocol

Exclusion Criteria:

* History of alcohol or substance dependence
* Diagnosis of chronic renal failure
* Presence of neuromuscular disorders
* Having amalgam dental fillings and/or failure to remove them according to the SMART protocol
* Severe vitamin deficiencies that have not been corrected prior to the study

Primary outcomes:
measure: Change in Motor Symptoms as Measured by the Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medipol Üniversitesi
Study officials:
References:
Clinical trial NCT06714318: SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening
Official title: SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All citizens referred to a colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program.

Brief summary: The project aims to investigate whether colorectal cancer screening can be improved using blood tests, thereby reducing the number of unnecessary colonoscopies. The Danish colorectal cancer screening program was implemented in 2014, and currently, all individuals aged 50-74 are invited every two years to participate. Those who test positive for hidden blood in their stool are referred for a colonoscopy. More than a third of the approximately 25,000 colonoscopies performed annually in the screening program can be classified as unnecessary, as they reveal a normal colon. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources.

The project seeks to reduce the number of these unnecessary colonoscopies by investigating whether blood biomarkers can identify individuals at very low risk of colorectal cancer after a positive stool test for hidden blood. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.


Eligibility criteria: Inclusion Criteria:

* Participation in the colorectal cancer screening program.

Exclusion Criteria:

* Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.

Primary outcomes:
measure: Correlation between result of blood test and colonoscopy result in patients screened positive for blood in the stool
timeFrame: From enrollment in study till 120 days after colonoscopy. The blood sample will be drawn before the colonoscopy and the final diagnosis from the colonoscopy will be registered 120 days after the colonoscopy.
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Hospital Sønderjylland
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Biochemistry and Immunology, Lillebaelt Hospital
name: Jonna Skov Madsen, Prof., MD
role: STUDY_CHAIR
References:
Clinical trial NCT01782118: LGG for Prevention of Infectious Complications During PPI Treatment in Children
Official title: Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Gastrointestinal Infections
Respiratory Tract Infections
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.

Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.

Study design: Randomized, double-blind, placebo controlled trial.

Detailed description: Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* age \<5,
* clinical symptoms of GERD
* treatment with proton pump inhibitors
* signed informed consent

Exclusion Criteria:

* treatment with PPI within the last 4 weeks for at least 2 weeks
* administration of probiotics within 7 days prior to the study
* acute or chronic respiratory tract infections
* acute or chronic gastrointestinal tract infections
* neurological disorders
* immunodeficiency

Primary outcomes:
measure: Respiratory tract infections
timeFrame: up to 3 months after termination of intervention
measure: Gastrointestinal tract infections
timeFrame: up to 3 months after termination of intervention
Secondary outcomes:
measure: Number of pneumonias
timeFrame: up to 3 months after termination of intervention
measure: Adverse events
timeFrame: up to 3 months after termination of intervention
Other outcomes:
measure: serum level of 25OHD
timeFrame: at 6 weeks
measure: serum level of ferritin
timeFrame: at 6 weeks
measure: Total iron binding capacity
timeFrame: at 6 weeks
measure: serum level of ferrum
timeFrame: at 6 weeks
measure: fecal calprotectin
timeFrame: at 6 weeks
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
References:
Clinical trial NCT00877318: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine
Official title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.


Eligibility criteria: Inclusion Criteria:

* Patient with a dysfunction of left ventricle with ejection fraction of left ventricle \< 40 % appreciated by echocardiogram at hospital discharge for cardiac rehabilitation.

Exclusion Criteria:

* Patient non authorized to follow an effort training
* Therapeutic education impossible
* Pregnant woman or breast-feeding
* No assent
* Incapacity to use the terminal
* Minor patient or under supervision

Primary outcomes:
measure: Variation of VO2 peak at 3 months in comparison to VO2 peak at hospital discharge
timeFrame: 3 months
Secondary outcomes:
measure: VO2 peak at 3 months compared with VO2 peak at the beginning of the hospitalization
timeFrame: 3 months
measure: BNP
timeFrame: 3 months
measure: % patient with a BNP < 300 pg/ml
timeFrame: 3 months
measure: Medical treatment by ACE inhibitor (in % of target dose)
timeFrame: 3 months
measure: Ejection fraction of left ventricle
timeFrame: 3 months
measure: Disease knowledge questionnaire
timeFrame: 3 months
measure: Life quality questionnaire (Minnesota)
timeFrame: 3 months
measure: Beck questionnaire
timeFrame: 3 months
measure: Day number at hospital
timeFrame: 3 months
measure: Number of medical consultation
timeFrame: 3 months
measure: Pharmaco-economic analysis
timeFrame: 3 months
measure: Total mortality
timeFrame: 3 months
measure: Cardiovascular mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Cricqueboeuf
country: France
facility: Centre Hospitalier de la Côte Fleurie
city: Saint Martin d'Aubigny
country: France
facility: William Harvey Center
Study officials:
affiliation: University Hospital, Caen
name: Annette Belin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Rémi Sabatier, MD
role: PRINCIPAL_INVESTIGATOR
References: