louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02804269: Molecular and Imaging Studies of Cardiovascular Health and Disease
Official title: Molecular and Imaging Studies of Cardiovascular Health and Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Ischemic Heart Disease
Keywords: Healthy Volunteer
Dilated cardiomyopathy
Hypertrophic cardiomyopathy
ischemic heart disease
Cardiovascular Magnetic Resonance Imaging
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore. For healthy volunteer, they will be recruited through poster and advertisement.

Brief summary: Biobank is a program which collects biological samples, health information and imaging data from consented patients and stored them at the core facility. These information would be used to study the molecular, imaging and outcome studies of cardiovascular health and disease.

Detailed description: This program recruits patient from National Heart Centre Singapore and collects their biological sample, health information and imaging data.The donated biospecimens will be stored indefinitely and used for any future research on molecular, imaging and outcome studies of cardiovascular health and disease.The same biological samples and imaging data will be obtained from consented healthy volunteers for comparison.

Eligibility criteria: There is no inclusion/exclusion criteria except for the age limit as this is a repository program.

Inclusion Criteria:

•Subject aged ≥ 16 years and ≤ 90 years.

Exclusion Criteria:

•No

Primary outcomes:
measure: Numbers of genetic variation in genes known to cause inherited cardiac condition and circulating biomarkers which are linked with DNA changes using advanced sequencing and informatics approaches
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: National Heart Centre Singapore
name: Stuart Cook, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03398369: Mechanistic Clinical Trial of Advanced Imaging for CRT
Official title: Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Systolic
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.

Detailed description: At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.

Eligibility criteria: Inclusion Criteria:

1. Chronic systolic HF
2. LVEF 35% or less
3. Guideline-based class I or II indication for CRT

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy
3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
4. Cerebral aneurysm clips
5. Cochlear implants
6. Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
7. Severe claustrophobia
8. Acute kidney injury
9. Acute renal failure or chronic kidney disease with GFR \< 45 cc/min/1.73m2
10. Liver transplant
11. Gadolinium allergy
12. \>10% premature ventricular contraction (PVC) burden; and 13) estimated \>10% atrial fibrillation (AF) burden based on available clinical data.

Primary outcomes:
measure: Left ventricular end-systolic volume (LVESV) improvement
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Kenneth C Bilchick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00508469: Adherence Assessment With Travalert Dosing Aid
Official title: Adherence of Patients Using Travalert® for Instillation of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Compared to a Concomitant Regimen of Travoprost 0.004% and Timolol 0.5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Intraocular pressure
Open-angle glaucoma
Ocular hypertension
Adherence
Compliance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 102
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 the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension;
* Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
* Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
* Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
* Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
* History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
* History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
* History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;
* Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
* Any abnormality preventing reliable applanation tonometry of either eye;
* Best-corrected visual acuity worse than 20/30 Snellen in either eye;
* Use of any additional topical or systemic ocular hyposensitive medication during the study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Zaragoza
Study officials:
affiliation: Independent
name: Dr Francisco M. Honrubia
role: STUDY_DIRECTOR
References:
Clinical trial NCT04767269: Efficacy of Cuminum Cyminum Herbal =Preparation in Inhibition of Plaque and Gingivitis.
Official title: Efficacy of Cuminum Cyminum Herbal Preparation in Inhibition of Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Gingivitis
Keywords: Mouthwash
chlorhexidine
stain
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1. Group phase A
2. Group phase B
3. Group phase C
Primary purpose: TREATMENT

Brief summary: Present work was to investigate the possible efficacy of 0.2% cuminum cyminum herbal preparation as an antiplaque and antigingivitis agent when compared with chlorhexidine.

Detailed description: To evaluate and compare the efficacy of 0.2% cuminum cyminum herbal preparation against 0.2% chlorhexidine by various clinical parameters i.e. plaque index, gingival index and sulcus bleeding index.

Eligibility criteria: Inclusion Criteria:

* volunteers with minimum 20 natural teeth without restoration.
* cooperative
* motivated and committed to participate in the trial period.

Exclusion Criteria:

* Antibiotic or anti-inflammatory therapy in previous month.
* Any known allergy/ hypersensitivity to any product used in trial.

Primary outcomes:
measure: PLAQUE INDEX
timeFrame: changes from baseline to 8 days
measure: Gingival Index
timeFrame: changes from baseline to 8 days
measure: Bleeding on probing
timeFrame: changes from baseline to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ambāla
country: India
facility: Department of Periodontology, M.M. College of Dental Sciences and Research.
state: Haryana
Study officials:
affiliation: PROFESSOR
name: surinder sachdeva, M.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Southern EN, McCombs GB, Tolle SL, Marinak K. The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis. J Dent Hyg. 2006 Winter;80(1):12. Epub 2006 Jan 1.
citation: Salgado AD, Maia JL, Pereira SL, de Lemos TL, Mota OM. Antiplaque and antigingivitis effects of a gel containing Punica granatum Linn extract: a double-blind clinical study in humans. J Appl Oral Sci. 2006 Jun;14(3):162-6. doi: 10.1590/s1678-77572006000300003.
citation: Bettaieb I, Bourgou S, Wannes WA, Hamrouni I, Limam F, Marzouk B. Essential oils, phenolics, and antioxidant activities of different parts of cumin (Cuminum cyminum L.). J Agric Food Chem. 2010 Oct 13;58(19):10410-8. doi: 10.1021/jf102248j.
Clinical trial NCT01307969: Formulations of Liposomal Local Anesthetics
Official title: Formulations of Liposomal Local Anesthetics for Dental Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Underdosing of Local Anesthetics, Initial Encounter
Keywords: liposomes
ropivacaine
dental anesthesia
dentistry
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Detailed description: This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Primary outcomes:
measure: After anesthetic injection the pulpal response was assessed by an electrical pulp tester.
timeFrame: 100 minutes
Secondary outcomes:
measure: Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School
state: São Paulo
Study officials:
affiliation: Researcher at Unicamp
name: Michelle Franz-Montan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franz-Montan M, de Paula E, Groppo FC, Ranali J, Volpato MC. Efficacy of liposome-encapsulated 0.5% ropivacaine in maxillary dental anaesthesia. Br J Oral Maxillofac Surg. 2012 Jul;50(5):454-8. doi: 10.1016/j.bjoms.2011.07.010. Epub 2011 Aug 9.
Clinical trial NCT05361369: Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
Official title: A Single Center, Single Arm, Single Dose, Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule (a Fixed Dose Combination of 600 mg Fenticonazole Nitrate + 1000 mg Tinidazole + 100 mg Lidocaine) in 18 Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Keywords: fenticonazole nitrate
tinidazole
lidocaine
fixed-dose combination
Lead sponsor: Exeltis Turkey
Sponsor class: INDUSTRY
Collaborators: name: Monitor CRO
First posted: 2022-05-04
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A single dose of the study drug will be administered to healthy female subjects in a single period to obtain pharmacokinetic parameters for each active ingredient.

Detailed description: The study drug, EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine. It is manufactured by Exeltis İlaç San. ve Tic. A.Ş., Turkey. It is an antibacterial and antifungal medication that will be used in the treatment of common vaginitis (e.g. bacterial vaginosis, candidal vulvovaginitis). Its efficacy and safety were previously evaluated in a Phase III clinical trial. In this single-center, single-arm, single-dose, bioavailability study, pharmacokinetic parameters for each active ingredient will be evaluated in 18 healthy female subjects following intravaginal administration of this fixed-dose combination.

Eligibility criteria: Inclusion Criteria:

* Healthy female adult subject with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year),
* Subject with a body weight ≥ 50 kg and body mass index between 16 and 30 kg/m2
* Informed consent signed by the subject.

Exclusion Criteria:

* Positive rapid antigen or polymerase chain reaction test result for COVID-19
* Pregnancy and/or breastfeeding, or subject who doesn't accept not to get pregnant during the study
* Known hypersensitivity to active ingredients (including their derivatives) of the study medication
* Postmenopausal women

Primary outcomes:
measure: AUC0-72
timeFrame: 0-72 hours
measure: Cmax
timeFrame: 0-72 hours
Secondary outcomes:
measure: Tmax
timeFrame: 0-72 hours
measure: AUC0-inf
timeFrame: 0-72 hours
measure: T1/2
timeFrame: 0-72 hours
measure: Lambda-z
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
Study officials:
References:
Clinical trial NCT03486769: Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients
Official title: Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: transcranial direct current stimulation
dual stimulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.


Eligibility criteria: Inclusion Criteria:

* unilateral hemiplegic stroke patient
* Fugl Meyer Assessment score between 9 to 84

Exclusion Criteria:

* difficult to understand experimental tasks because of extremely severe cognitive impairment
* history of psychiatric disease

Primary outcomes:
measure: Changes in motor evoked potentia
timeFrame: Baseline and after intervention (approximately 2 weeks)
Secondary outcomes:
measure: changes in nine hole peg test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: changes in grip and tip pinch strength test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: changes in box and block test
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Changes in brain activation of resting-state functional MRI
timeFrame: Baseline and after intervention (approximately 2 weeks)
measure: Changes of Cortical activation
timeFrame: Baseline and after intervention (approximately 2 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02463669: The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
Official title: The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infectious Mononucleosis
Splenomegaly
Keywords: Point-of-care ultrasound
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample of patients between July 2016 and October 2017. Inclusion criteria are patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis.

Brief summary: The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).

Detailed description: The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis

Exclusion Criteria:

* Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)
* Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)
* Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)
* Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)
* Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)
* Storage diseases (eg. Gaucher, Niemann-Pick)
* Splenectomy
* Inability to give informed consent

Primary outcomes:
measure: Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT02706769: Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Pain
Official title: A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2016-03-11
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: National guidelines advocate the use of paracetamol in conjunction with strong opioids for cancer pain, despite a lack of evidence for its efficacy. Work is needed to examine the analgesic benefit of paracetamol in this large patient group. The investigators aim to establish if paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.


Eligibility criteria: Inclusion Criteria:

1. Age 16 years and over
2. Under palliative care/oncology service review
3. Diagnosis of incurable cancer
4. Clinician-predicted life expectancy \>2 months
5. Anticipated to be clinically stable for duration of study involvement
6. Receiving daily regular strong opioids
7. Able to take study drug/placebo in its current form
8. Prescribed and taking paracetamol 1g four times a day
9. Average pain \>3 and \<9 in past 24 hours
10. Able to provide written informed consent
11. Able to complete necessary assessments required as part of the trial
12. Average NRS pain score stable (ie. maximum range of 1 point) for the three consecutive days prior to randomisation

Exclusion Criteria:

1. Pain which the clinician deems to be unstable
2. Clinically significant renal or liver disease
3. Weight less than 50kg
4. Those whose pain is expected to change during the course of the study as a result of oncological or other treatments
5. Co-enrolment in other drug trials
6. Known to be pregnant or breast-feeding at the time of recruitment
7. Previously enrolled in this study

Primary outcomes:
measure: Proportion of participants with a 30% increase in total Brief Pain Inventory between day 0 and day 14 in the active drug group versus the placebo group.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
References: