louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05107102: Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI
Official title: Value of Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-Segment Elevated Myocardial Infarction
Keywords: ST-segment elevated myocardial infarction
myocardial work
left ventricular remodeling
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with anterior STEMI who underwent primary PCI \<12 hours after symptom onset were consecutive enrolled in our center.

Brief summary: The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
* Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

Exclusion Criteria:

* significant valvular disease;
* cardiomyopathy; l
* left bundle branch block;
* atrial fibrillation;
* previous myocardial infarction (MI);
* history of cardiac surgery;
* pacemaker implantation.

Primary outcomes:
measure: Delta-work efficiency by echocardiography
timeFrame: 24-72 hours after PCI
Secondary outcomes:
measure: Global work index by echocardiography
timeFrame: 24-72 hours, 3-month after PCI
measure: Global constructive work by echocardiography
timeFrame: 24-72 hours, 3-month after PCI
measure: Global work efficiency by echocardiography
timeFrame: 24-72 hours, 3-month after PCI
measure: Work index-LAD
timeFrame: 24-72 hours, 3-month after PCI
measure: Constructive work-LAD
timeFrame: 24-72 hours, 3-month after PCI
measure: Work efficiency-LAD
timeFrame: 24-72 hours, 3-month after PCI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Song Ding, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang W, Zhao H, Wan F, Shen XD, Ding S, Pu J. Inhomogeneous Distribution of Regional Myocardial Work Efficiency Predicts Early Left Ventricular Remodeling After Acute Anterior Myocardial Infarction Treated With Primary Percutaneous Intervention. Front Cardiovasc Med. 2022 Jul 27;9:922567. doi: 10.3389/fcvm.2022.922567. eCollection 2022.
Clinical trial NCT02392702: Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects
Official title: A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Safety/Efficacy Study
Randomized
Open Label
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This two-part study will assess, in healthy volunteers, under both fasted and fed conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of single doses of C-10355 and C-10358 and single ascending doses of the selected compound compared to a single dose of Kalydeco®.


Eligibility criteria: Inclusion Criteria:

* Healthy adults between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal.
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
* Urinalysis positive for greater than trace blood, protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use.
* Inability to comply with food and beverage restrictions during study participation.
* Donation or blood collection or acute loss of blood prior to screening.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 hours
measure: Pharmacokinetic Profile
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Lana Pilja
role: STUDY_DIRECTOR
References:
Clinical trial NCT00323102: A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain
Official title: Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Pathology
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication


Eligibility criteria: Inclusion Criteria:

* 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days

Exclusion Criteria:

* Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams

Primary outcomes:
measure: Superiority of Multihance in terms of by-patient global diagnostic performance
timeFrame: immediately post dose
Secondary outcomes:
measure: To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions
timeFrame: immediately post dose
measure: To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity
timeFrame: immediately post dose
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Barry Hogstrom, M. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06151002: PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's
Official title: PD Frontline, Part of RAPSODI GD (Remote Assessment of Parkinsonism Supporting Ongoing Development of Interventions in Gaucher's Disease) to Build an Online Trial-ready Cohort of GBA Genotyped People With Parkinson's
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: Cure Parkinson's
First posted: 2023-11-30
Enrollment: 4800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Randomly selected population, recruited via established NHS sites and self-referral to the website.

Brief summary: PD Frontline (part of RAPSODI GD) is an online study observational study with the goal of bringing People with Parkinson's to the frontline of research by getting them trial ready. To do this, participants are offered genetic sequencing for the GBA and LRRK2 gene with an at-home saliva collection kit.

Detailed description: PD Frontline is an online one-time questionnaire based study with the purpose of identifying potential candidates for gene targeted trials and observational studies.

Once the questionnaire is completed, the participant is sent a saliva collection kit in the post to provide a sample for genetic testing. The genes tested for are GBA1, the most common risk factor gene for Parkinson's, and LRRK2.

Once tested, the participant is informed of their results and kept up-to-date with any studies or trials for which they may be eligible.

Eligibility criteria: Inclusion Criteria:

* Formal diagnosis of Parkinson Disease

Exclusion Criteria:

* Confirmation that the individual carries a GBA variant (GBA positive). These individuals will be referred to sister-study, RAPSODI.
* History of Parkinsonism (progressive supranuclear palsy, multiple system atrophy, traumatic, manganese toxicity, postencephalitic, vascular PD; drug induced PD; corticobasal degeneration)
* Individuals with another neurological disorder including: dementia, movement disorders, and motor neurone disease.
* Individuals on drugs known to be associated with parkinsonism, including neuroleptic agents (Amisulpride, Chlorpromazine Hydrochloride, Flupenthixol, Fluphenazine Hydrochloride, Haloperidol, Methotrimeprazine, Levomepromazine, Olanzapine, Oxypertine, Pericyazine, Perphenazine, Pimozide, Pipotiazine, Prochlorperazine, Promazine Hydrochloride, Reserpine, Risperidone, Sulpiride, Thioridazine, Trifluoperazine, Zuclopenthixol acetate, Zotepine), plus Bupropion, , Lithium, Methyldopa, Metoclopramide and Sodium Valproate).

Primary outcomes:
measure: Genotype of participants
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London (UCL)
Study officials:
References:
Clinical trial NCT03578302: The Heidelberg Engineering BI US Evaluation Study
Official title: The Heidelberg Engineering BI US Evaluation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes
Eye Abnormalities
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with:

1. Eyes with Normal Anterior Segment or
2. Eyes with Abnormal Anterior Segment, including Eyes with Cataract Eyes without a Crystalline Lens Eyes with Corneal Abnormality Eyes with Anterior Segment Pathology

Brief summary: Evaluation of defined parameters measured in pathological and non-pathological eyes with the Heidelberg BI

Detailed description: The primary objectives of this study are to assess the feasibility to acquire acceptable images and to assess repeatability

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions

   At least one of the following:
3. Eyes with Normal Anterior Segment
4. Eyes with Cataract
5. Eyes without a Crystalline Lens
6. Eyes with Corneal Abnormality
7. Eyes with Anterior Segment Pathology

Exclusion Criteria:

1. Subjects unable to read or write
2. Active infection or inflammation in one or both eyes
3. Insufficient tear film or corneal reflex
4. Physical inability to be properly positioned at the study devices or eye exam equipment
5. Inability to fixate
6. Rigid contact lens wear during past 2 weeks
7. Soft lenses, in the study eye, if worn, should be removed at least one hour prior to the measurements \*Note: Eyes with risk for acute angle closure glaucoma are excluded from the dilated portion of the study

Primary outcomes:
measure: Percentage of successfully scanned biometry images of the eye
timeFrame: 1 day
measure: Repeatabiltiy of specific parameters of the biometry images of the eye
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York College of Optometry
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Mitchell Dul, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530802: Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy
Official title: Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leiomyoma
Laparoscopic Myomectomy
Keywords: laparoscopic myomectomy, leiomyoma, blood loss, uterine artery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible for the study when between 18 and 50 years of age,
* diagnosed with either symptomatic or asymptomatic leiomyomata, and with desire to keep the uterus, and whose leiomyomata had a minimal combined diameter of ≥ 4 cm.

Exclusion Criteria:

* patients with severe accompanying medical problems, or
* with psychiatric illnesses, which jeopardize the participation, or
* undergoing treatment affecting coagulation and/or hematopoiesis, and
* patients with suspected malignancy.

Primary outcomes:
measure: Blood loss during laparoscopic myomectomy
timeFrame: perioperative (preop and postoperative day3)
Secondary outcomes:
measure: Patency of uterine artery after laparoscopic clipping
timeFrame: perioperative
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Hospital
city: Damme
country: Germany
facility: Bernd Holthaus
Study officials:
References:
Clinical trial NCT02455102: Electronic Warning System for Atrial Fibrillation
Official title: Electronic Warning System to Improve Stroke Prevention in Atrial Fibrillation - A Quality Improvement Initiative at the University Hospital Bern
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Prevention
Anticoagulation
Electronic warning system
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 1707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized controlled study is to evaluate whether a newly designed electronic warning system will increase the initiation rate of adequate stroke preventive measures in patients with atrial fibrillation.

Detailed description: A large proportion of patients with atrial fibrillation do not receive stroke prevention therapy in line with the guidelines, in spite of the presence of an increased risk of stroke. It will be investigated whether an electronic alert to physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will increase the rate of adequate stroke preventive measures as compared to a control group of patients without an electronic alert. The electronic alerts will be sent if patients with atrial fibrillation but without adequate stroke preventive measures receive in-patient treatment at the University Hospital Bern. The electronic alert system includes a feature that helps the physicians in charge to evaluate the CHA2DS2VASC Score. At the end of the hospital stay medical discharge letters will be reviewed for initiation of adequate stroke preventive measures.

Eligibility criteria: Inclusion Criteria:

* All in-patients with atrial fibrillation

Exclusion Criteria:

* Ongoing anticoagulant therapy

Primary outcomes:
measure: Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge
timeFrame: End of hospital stay (expected average duration of 1 week)
Secondary outcomes:
measure: Use of the CHA2DS2VASc score calculation tool by the physician in charge
timeFrame: During hospital stay (expected average duration of 1 week)
measure: Rate of correct evaluation of the CHA2DS2VASC Score through the calculation tool by physician in charge
timeFrame: End of hospital stay (expected average duration of 1 week)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Swiss Cardiovascular Center, Inselspital, University of Bern
Study officials:
affiliation: Department of Angiology, Swiss Cardiovascular Center, University of Berne
name: Nils Kucher, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silbernagel G, Spirk D, Hager A, Baumgartner I, Kucher N. Electronic Alert System for Improving Stroke Prevention Among Hospitalized Oral-Anticoagulation-Naive Patients With Atrial Fibrillation: A Randomized Trial. J Am Heart Assoc. 2016 Jul 22;5(7):e003776. doi: 10.1161/JAHA.116.003776.
Clinical trial NCT03707002: Effect of scFOS on Increase in Stool Frequency in Constipated People
Official title: Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Healthy
Lead sponsor: Syral
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Mérieux NutriSciences
name: CreaBio Rhone-Alpes
First posted: 2018-10-16
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

Detailed description: This randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

Eligibility criteria: Inclusion Criteria:

* functional constipation according to ROME III criteria with 3 or less than 3 stools per week
* BMI between 18 and 32kg/m², limits included
* Subjects who do not usually eat high-fibre foods
* Subjects who do not usually consume foods siad "reduced in sugars" or "light"
* Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements

Exclusion Criteria:

* subjects presenting Irritable bowel syndrome
* history of chronic GI disorders: crohn disease, ulcerative colitis,....
* treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...)
* Antibiotic therapy in progress or in the past 8 weeks
* medical history with impact on the study objectives as defined by investigator
* known food allergy to one of the compounds of the study product

Primary outcomes:
measure: Stool frequency
timeFrame: 6 weeks
Secondary outcomes:
measure: Stool consistency
timeFrame: 6 weeks
measure: Frequency and severity of Gastrointestinal symptoms
timeFrame: 6 weeks
measure: Anxiety and depression
timeFrame: 6 weeks
Other outcomes:
measure: Heart rate
timeFrame: at baseline and at the last visit (after 6 weeks)
measure: systolic blood pressure
timeFrame: at baseline and at the last visit (after 6 weeks)
measure: diastolic blood pressure
timeFrame: at baseline and at the last visit (after 6 weeks)
measure: Adverse event
timeFrame: 6 weeks
Locations:
city: Saint-Herblain
country: France
facility: Biofortis SAS
Study officials:
affiliation: BioFortis
name: David Gendre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02465021: Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia
Official title: Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: Satiety
Food intake
Breakfast cereals/snacks
Postprandial glycemia
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2015-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2

Exclusion Criteria:

* Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives
* Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy
* Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet

Primary outcomes:
measure: Food intake
timeFrame: 120 minutes
Secondary outcomes:
measure: Perceived satiety
timeFrame: 120 minutes
measure: Blood glucose
timeFrame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
measure: Blood insulin
timeFrame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
Other outcomes:
measure: Food Recall
timeFrame: 24 hours
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: