louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02037308: Glu298Asp Polymorphism and Blood Pressure
Official title: The Effects of Beetroot Bread on Postprandial Blood Pressure According to Glu298Asp Polymorphism in the eNOS Gene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Glu298Asp polymorphism
Blood pressure
Plasma NOx
Beetroot
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events, proposed to be due to reduced nitric oxide production by eNOS reported in some but not all studies. We hypothesise that beetroot-enriched bread interacts with the Glu298Asp polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite, particularly in carriers of the T allele, which have been associated with lower eNOS activity and increased risk of hypertension.


Eligibility criteria: Inclusion Criteria:

* Male
* A signed consent form
* Age 18-64 years
* Body mass index - 18.5-30 kg/m2
* Non-smoking, healthy individuals
* Normal blood pressure at screening (\< 150/90)

Exclusion Criteria:

* Subjects with anaemia
* Sufferers of chronic illnesses
* Individuals with food allergies
* People with diabetes
* People with coeliac disease
* Women
* Vegetarians

Primary outcomes:
measure: Postprandial blood pressure
timeFrame: 30 minute intervals for a period of 6 hours
Secondary outcomes:
measure: Postprandial plasma NOx
timeFrame: 30 minute intervals for a total period of 6 hours
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Julie Lovegrove, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hobbs DA, Goulding MG, Nguyen A, Malaver T, Walker CF, George TW, Methven L, Lovegrove JA. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial. J Nutr. 2013 Sep;143(9):1399-405. doi: 10.3945/jn.113.175778. Epub 2013 Jul 24.
citation: Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
Clinical trial NCT03471208: Dynamic Navigation-Assisted Dental Implant Placement
Official title: Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants, Surgery, Computers
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dental implant surgery assisted by a stereotaxic surgical instrument
Primary purpose: TREATMENT

Brief summary: Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach.

All patients received implants in the right and left the side of their upper jaws via the random use of the navigation or the freehand approach. Positional deviations between the planned and placed implants were measured on a final tomographic image matched to the baseline.


Eligibility criteria: Inclusion Criteria:

* men and women aged \>18 years.
* Patients approving to participate in the trial and giving written consent
* must be able to open his/her mouth

Exclusion Criteria:

* Hemodynamically significant mitral valve stenosis
* Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
* Planned cardioversion (electrical or pharmacological)
* Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery, myocardial infacrtion)
* Known presence of atrial myxoma or left ventricular thrombus
* Active endocarditis

Primary outcomes:
measure: Change between the planned and placed implant positions
timeFrame: 12 weeks
Secondary outcomes:
measure: Damage to the surrounding critical anatomy
timeFrame: 1 day (On the day of surgery).
Other outcomes:
Locations:
Study officials:
References:
citation: Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
Clinical trial NCT04311008: Turkish Life Balance Inventory
Official title: Turkish Version of Life Balance Inventory: Validity, Reliability and Cultural Adaptation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Version
Adaptation
Reliability
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 371
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: student at the Faculty of Health Sciences

Brief summary: The Turkish Version of Life Balance Inventory: Validity, Reliability and Cultural Adaptation.

Detailed description: The Life Balance Inventory (Kathleen Matuska; 2012) is a measure for life balance. This study was planned for the purpose of carrying out Turkish Version of the Life Balance Inventory.

Eligibility criteria: Inclusion Criteria:

19-25 years old student at the Faculty of Health Sciences

-

Exclusion Criteria:

* not between age 19-25

Primary outcomes:
measure: Turkish Life Balance Inventory is Valid and Reliable
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Özgü İnal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06272708: Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients
Official title: Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thromboelastography
Hemodialysis
Anticoagulation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 200
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: stable patients undergoing maintanence hemodialysis

Brief summary: Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.

Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.

Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer.


Eligibility criteria: Inclusion Criteria:

1. male or female patients aged over 18 years
2. stable patients undergoing maintenance hemodialysis treatment for at least 3 months
3. signed informed consent form

Exclusion Criteria:

1. concomitant with severe diseases such as active malignancy, severe liver diseases, systemic infection, etc.
2. planned or ongoing pregnancy or lactation
3. unsuitable for inclusion in this study after assessment

Primary outcomes:
measure: thromboelastography parameter R value
timeFrame: 2 hours after hemodialysis began
Secondary outcomes:
measure: thromboelastography parameter K value
timeFrame: 2 hours after hemodialysis began
measure: thromboelastography parameter Angle
timeFrame: 2 hours after hemodialysis began
measure: thromboelastography parameter MA
timeFrame: 2 hours after hemodialysis began
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Yiwei Shen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RenJi Hospital
name: Renhua Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00994708: The Effect of Esomeprazole and Fundoplication on Airways
Official title: The Effect of Esomeprazole and Nissen Fundoplication on Bronchial Responsiveness, Quality of Life, Exhaled Nitric Oxide and Pulmonary Function in Patients With Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Airway Responsiveness
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2009-10-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Evaluate the prevalence of bronchial responsiveness (BHR) among patients with gastroesophageal reflux disease (GERD).

Investigate correlation between bronchial reactivity and the severity of GERD, and similarly investigate the correlation between exhaled nitric oxide (NO) and the severity of GERD.

Compare the effects of esomeprazole 40 mg twice daily and Nissen fundoplication on bronchial reactivity, exhaled NO, pulmonary function and quality of life.


Eligibility criteria: Inclusion Criteria:

1. Over 18 of age
2. Diagnosis of gastroesophageal reflux disease
3. Compliance to perform methacholine inhalation challenge (judged by the investigator)

Exclusion Criteria:

1. Known allergy to esomeprazole or any other PPI
2. Use of systemic corticosteroids within 3 weeks before any study visit
3. Pregnancy (in a written informed consent patients are asked to assure that they are not pregnant and they are also told to immediately stop the study medication if they become pregnant during the study)
4. Incapability to keep a 3-week washout with usual antireflux medication prior to the first visit
5. Regular use of PPI or H2-RA medication 3 months after fundoplication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
citation: Kiljander T, Rantanen T, Kellokumpu I, Koobi T, Lammi L, Nieminen M, Poussa T, Ranta A, Saarelainen S, Salminen P. Comparison of the effects of esomeprazole and fundoplication on airway responsiveness in patients with gastro-oesophageal reflux disease. Clin Respir J. 2013 Jul;7(3):281-7. doi: 10.1111/crj.12005. Epub 2012 Oct 24.
Clinical trial NCT03488823: Flavonols and Endothelial Injury
Official title: Evaluation of Effects of Flavonols on Endothelial Function and Hyperplasia of Intima After Endothelium Injury During Transradial Catheter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: Endothelial Function
Flavonols
Intima Injury
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.


Eligibility criteria: Inclusion Criteria:

* planed catheterization, that has be done via Arteria radialis

Exclusion Criteria:

* acute infection (CRP\>0.5 mg/dl)
* malignant diseases
* heart failure (NYHA III-IV)
* renal failure (GFR\<60 ml/min)
* profoundly atrial fibrilation
* hypotension (≤100/60 mmHg)
* intolerance of nitroglycerin

Primary outcomes:
measure: Increase of Endothelial Function of Arteria radialis
timeFrame: week 2
Secondary outcomes:
measure: Degree of intimal Injury after Catheterization
timeFrame: 1 month
Other outcomes:
measure: Microvascular Function
timeFrame: 1 month
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
state: NRW
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf
name: Roberto Sansone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02740023: Quality Control of CE-Certified Phonak Hearing Aids - 2015_03
Official title: Quality Control of CE-Certified Phonak Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.


Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Speech intelligibility in percent in a quiet listening situation
timeFrame: One week
Secondary outcomes:
measure: Speech intelligibility in percent in a noisy listening situation
timeFrame: One week
Other outcomes:
measure: Initial first fit acceptance (pre-calulation) in lab
timeFrame: One week
measure: Sound quality and listening effort ratings in lab
timeFrame: Four weeks
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT05889923: Training and Evaluation of Ultrasound-Guided Procedures
Official title: Training and Evaluation of Ultrasound-Guided Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning Anesthesia Procedures
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: University of Miami
First posted: 2023-06-05
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 38 certified registered nurse anesthetist (CRNA) students will learn 5 different ultrasound-guided regional anesthesia blocks both with and without a novel device, the EDU which gives the student help finding the right needle path.

Detailed description: 38 students enrolled in a course for ultrasound-guided nerve blocks will be participants in a study to evaluate the benefit of learning with ultrasound guidance. The EDU, a computer assisted guide for ultrasound interventions will be used for half the students for each of 5 nerve blocks/interventional procedures. Then the students will switch (crossover study) and perform the same interventions. Data will be recorded by dint of the tiny video cameras on the EDU and anonymized and evaluated.

Eligibility criteria: Inclusion Criteria: All CRNA students in Dr. Hauglum's class on ultrasound-guided nerve blocks -

Exclusion Criteria: Any CRNA students who drop Dr. Hauglum's class on ultrasound-guided nerve blocks

-

Primary outcomes:
measure: Distance to target
timeFrame: Day 1
measure: number of redirects
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References:
Clinical trial NCT04414423: Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting
Official title: Combination of Bone Marrow Concentrate and Iliac Cancellous Bone Graft in Alveolar Cleft Grafting: a Clinical & Radiographic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Cleft Grafting
Keywords: bone marrow concentrate
alveolar cleft
CBCT
Bone density
bone volume
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eighteen patients will be divided into two equal groups. Each group comprises nine patients.
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to analyze the newly formed bone volume and density, 6 months after alveolar cleft grafting using iliac cancellous bone graft, with and without bone marrow concentrate.

Detailed description: Twelve patients with unilateral alveolar cleft will be enrolled in this randomized comparative study.

The patients will be divided into two groups, the control (group A) who received illiac cancellous bone graft and study group who received a combination of bone marrow concentrate and illiac cancellous bone graft (group B).

Cone Beam CT (CBCT) images will be done prior to surgery to asses preoperative alveolar defect volume. Six months postoperative CBCT images will be done and postoperative newly bone formed volume and density will be evaluated and bone formation ratio (BF%) will be calculated as follows: BF% = (formed volume/alveolar defect) × 100%.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from maxillary alveolar cleft
* Patient with Primary, complete cleft lip

Exclusion Criteria:

* Syndromic cases will be excluded
* Previous operated cases

Primary outcomes:
measure: bone volume
timeFrame: six months postoperative
Secondary outcomes:
measure: bone density
timeFrame: six months postoperative
measure: bone formation ratio
timeFrame: six months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
city: Fayoum
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
citation: Pinheiro FHSL, Drummond RJ, Frota CM, Bartzela TN, Dos Santos PB. Comparison of early and conventional autogenous secondary alveolar bone graft in children with cleft lip and palate: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):385-397. doi: 10.1111/ocr.12394. Epub 2020 Jun 28.
citation: Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.
Clinical trial NCT01232023: Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
Official title: Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Indobufen
healthy volunteers
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 19 to 50 years at screening.
* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 24 Hours
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyeong-Seok Lim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: