louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04386408: Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections
Official title: Preliminary Study on the Effect of Consuming a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Living in a Nursing Home.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune Response
Respiratory Diseases
Keywords: Immunostimulation
Respiratory diseases
Plant extracts
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2020-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to evaluate the effectiveness of daily consumption of a Combination of Plant Extracts (BSL_EP027) on the incidence of respiratory infection symptoms and their duration in older healthy volunteers living in a nursing home.

Detailed description: A prevalence of deficient immune state is estimated at 44% of the world's population, a figure that rises in the senior population group.

Traditionally, protection against infection and improvement of the immune response has been addressed through the use of plant extracts. An effective immune response involves the action of both innate and specific responses and the perfect coordination between both. Natural strategies that can activate both types of immune response can lead to more effective treatments.

Our hypothesis is that the different effects of the combination of several plant extracts can lead to a synergy that generates a more effective product in the prevention of respiratory infections, especially in susceptible populations such as the elderly.

Eligibility criteria: Inclusion Criteria:

* Living in a nursing home with medical service.
* Freely accept to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Having a disease that affects the development and results of the study.
* Suffer alterations of the state of health incompatible with the continuity in the study.
* Suffer any adverse event not tolerated by the subject.

Primary outcomes:
measure: Respiratory infection symptoms
timeFrame: 16 weeks
Secondary outcomes:
measure: Duration of the respiratory infection symptoms
timeFrame: 16 weeks
Other outcomes:
measure: Type of Medication for the respiratory infection symptoms
timeFrame: 16 weeks
measure: Dose of the Medication for the respiratory infection symptoms
timeFrame: 16 weeks
measure: Duration of the medical treatment for the respiratory infection symptoms
timeFrame: 16 weeks
Locations:
city: Granada
country: Spain
facility: Claret Nursing home
Study officials:
affiliation: Doctor of the Claret Nursing Home (Granada, Spain)
name: Carlos Gracián, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03206008: The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery
Official title: The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery After Outpatient Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 11
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: SUPPORTIVE_CARE

Brief summary: Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case


Eligibility criteria: Inclusion Criteria:

* aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery

Exclusion Criteria:

* ASA class ≥ III
* suspected imbalance of electrolyte
* myocardial damage or conduction delay
* myasthenia gravis or other neuromuscular disease
* impaired renal function
* already using any type of analgesia
* denial of participating in the study or not giving the informed consent

Primary outcomes:
measure: severity of postoperative pain
timeFrame: 1 hour interval
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, department of Anesthesia and pain
state: Gyenggo-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: SangHwan Do
role: STUDY_CHAIR
References:
Clinical trial NCT06172023: Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm
Official title: Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm (An in Vitro - in Vivo Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Given these characteristics, it would be valuable to evaluate and compare a new irrigation solution containing nanosilver and nanozinc-oxide particles with sodium hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate and disrupt microbial cell membranes. Consequently, the current study aims to assess and compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as well as their impact on post-operative pain.


Eligibility criteria: Inclusion Criteria:

* Medically stable healthy patients (category: American society of anesthesiologists class I).
* The patient ranges in age from 20 to 40.
* No sexual orientation
* Necrotic pulp evaluated by thermal or electrical pulp testing.
* Enough crown structure to provide adequate isolation.
* One root and one canal.
* Patients' desire to engage in this research.
* Patients' comprehension of the visual analogue scale (VAS).
* Patients' ability to sign informed consent.

Exclusion Criteria:

* Endodontic treatment for the tooth previously.
* Teeth with poor conditions for using rubber dams.
* Vital pulp tissue was observed throughout the treatment.
* Patients who have a medical condition.
* Teeth with open apices that are immature
* Women who are pregnant or breastfeeding.
* Psychologically disturbed patients.
* Patients having a history of allergy to any of the research drugs were barred from participation.
* A periodontally affected tooth with grade 2 or 3 mobility.

Primary outcomes:
measure: Postoperative Pain Assessment
timeFrame: 6, 12, 24, 48, and 72 hours
Secondary outcomes:
measure: Antimicrobial Activity Assessment
timeFrame: 1 hour, 24 hours, 7 days, and 30 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
References:
Clinical trial NCT02164123: Autonomic Effects of T4 Mobilization in Asymptomatic Subjects
Official title: Autonomic Effects of T4 Mobilization in Asymptomatic Subjects: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Disorders of the Autonomic Nervous System
Vertebra; Degeneration
Keywords: Autonomic effects
spinal mobilization
clinical trial
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether passive accessory intervertebral mobilization applied to the fourth thoracic vertebra produces autonomic effects.

Detailed description: Asymptomatic subjects will be recruited to this study. Pressure pain threshold, heart rate, heart rate variability and skin conductance will be measured before, immediately after and fifteen minutes after the intervention.

Subjects will be randomized into three groups: Passive accessory intervertebral mobilization one, passive accessory intervertebral mobilization two and placebo group.

The researcher that will do the intervention will be blinded to the outcomes measures, and the researcher that will do the measurements will be blind to the intervention.

Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects
* Aged between 18 - 40 years old
* Portuguese readers and writers

Exclusion Criteria:

* History of lesion or surgery to the spine

Primary outcomes:
measure: Skin conductance
timeFrame: Change from Baseline imediately after, and 15 minutes after the intervention
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Change from Baseline imediately after, and 15 minutes after the intervention
Other outcomes:
measure: Heart rate variability
timeFrame: Change from Baseline imediately after the intervention
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Francisco De Araujo, Pt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394823: VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients
Official title: A Randomized, Open-label, Multicentric Parallel Group Study to Assess the Impact of Supportive Measures on the Drug Adherence of Patients With Essential Hypertension Treated With Valsartan or Valsartan Plus HCTZ for 34 Weeks With or Without Respective Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, valsartan, compliance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-01
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension


Eligibility criteria: Inclusion Criteria:

* Male or female patients \>= 18 years
* Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
* Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and \< 170 and/or diastolic blood pressure ≥ 90 mmHg and \< 105 mmHg"

Exclusion Criteria:

* Moderate and severe hypertension
* Pregnant or nursing women
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Drug adherence in patients (daily proportion of patients taking one tablet of the prescribed hypertensive therapy as prescribed)
Secondary outcomes:
measure: Compliance and persistence between randomized groups over time.
measure: To assess discrepancies between pill counts, Morisky questionnaire and electronic monitoring to estimate patient adherence to prescribed therapy
measure: To assess the relation between drug exposure and BP reduction.
measure: To assess the relation between drug exposure and the likelihood to switch to valsartan 160 mg plus HCTZ 12.5 mg
measure: To assess the safety and tolerability of valsartan 160 mg and valsartan 160 mg plus
measure: HCTZ 12.5 mg.
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: +41 61 324 1111
name: Novartis Basel
role: STUDY_CHAIR
References:
citation: Dusing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894-901. doi: 10.1097/HJH.0b013e328323f9be.
Clinical trial NCT05685823: The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
Official title: The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Chronic Kidney Diseases
Fibrosis
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced chronic kidney disease, pre-dialysis or pre-transplant, in the records of the Clinical Hospital "Dr. C. I. Parhon" Iasi

Brief summary: The objective of this study is to evaluate a group of patients with chronic kidney disease in stages 3-5 by conventional 2D echocardiography, tissue Doppler techniques and speckle tracking - LV GLS and determine the correlation of ultrasound parameters with mortality. Additionally, fibrosis-related biomarkers will be studied in this population.


Eligibility criteria: Inclusion Criteria:

* eGFR \< 15 ml/min/1.73m2 (CKD - EPI)
* NYHA class I-II
* Hemodynamic stability

Exclusion Criteria:

* age \< 18 years old
* poor acoustic window
* atrial fibrillation
* recent Acute Myocardial Infarction
* pacemaker

Primary outcomes:
measure: Variation of GLS
timeFrame: 3 years
measure: All-cause mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Gr T Popa University of Medicine and Pharmacy
Study officials:
References:
Clinical trial NCT02968823: Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery
Official title: Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat (ENT) and Maxilla-Facial Surgery - A Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Surgery, Oral
Keywords: Postoperative Pain
Anesthesia
Oral Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2016-11-21
Enrollment: 127
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our primary aim is to determine whether licorice gargling provides meaningful analgesia after oral surgery. Specifically, we propose to test the primary hypothesis that gargling with licorice solution reduces pain after oral surgery more than gargling with sugar water. Because effective analgesia can reduce pain and/or opioid consumption, we will jointly evaluate verbal response pain scores and overall morphine consumption considering licorice to be beneficial only if it proves non-inferior on both measures and superior on at least one.


Eligibility criteria: Inclusion Criteria:

1. Oropharyngeal surgeries including:Panendoscopic surgery; elective tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma
2. Anticipated extubation in the operating room
3. American Society of Anesthesia physical status 1-3

Exclusion Criteria:

1. Rapid Sequence Induction
2. Known or suspected allergy to licorice or its ingredients
3. Liver failure with bleeding disorders
4. Insulin-dependent diabetes mellitus
5. Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery
6. Chronic opioid use
7. Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump
8. superinfected oropharyngeal tumors
9. Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)

Primary outcomes:
measure: joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)
timeFrame: first 2 postoperative hours
Secondary outcomes:
measure: joint - pain scores and opiate consumption on day of surgery
timeFrame: from end of surgery until the morning of Post-Operative Day (POD) 1
measure: joint - pain scores and analgesic consumption
timeFrame: from surgery conclusion to Post-Operative Day (POD) 3
measure: postoperative coughing
timeFrame: first 2 postoperative hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: MUVienna
Study officials:
affiliation: Medical University of Vienna
name: Olga Plattner, M.D.
role: STUDY_CHAIR
affiliation: Medical University Vienna
name: Marita Windpassinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784223: Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Official title: Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Gland
Keywords: F18-choline
Surgery
Indeterminate
Thyroid node
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Canceropôle Nord Ouest
First posted: 2016-05-27
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient with thyroid nodule ≥15 mm with an indeterminate cytology according to the Bethesda Classification 2008 (vesicular lesion of undetermined significance (Bethesda 3); follicular neoplasm or Hürthle cells (Bethesda 4); lesion suspicious for malignancy (Bethesda 5)), and to be operated on
* Patient affiliated to a social security scheme
* Informed consent and signed

Exclusion Criteria:

* Thyroid nodules \<15 mm
* Coalescing nodules preventing proper individualization of targeted nodule;
* Thyroid nodule with non-diagnostic cytology (Bethesda 1), benign cytology (Bethesda 2) or malignant cytology (Bethesda 6)
* Hot thyroid nodule on the thyroid scan
* Major subject to a measure of legal protection or unable to consent
* Pregnant women / nursing
* Refusal to participate

Primary outcomes:
measure: Sensitivity
timeFrame: Up to 4 months
measure: Specificity
timeFrame: Up to 4 months
Secondary outcomes:
measure: Predictive diagnostic capabilities
timeFrame: Up to 4 months
measure: Duration for acquisition
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
citation: Ciappuccini R, Licaj I, Lasne-Cardon A, Babin E, de Raucourt D, Blanchard D, Bastit V, Saguet-Rysanek V, Lequesne J, Peyronnet D, Grellard JM, Clarisse B, Bardet S. 18F-Fluorocholine Positron Emission Tomography/Computed Tomography is a Highly Sensitive but Poorly Specific Tool for Identifying Malignancy in Thyroid Nodules with Indeterminate Cytology: The Chocolate Study. Thyroid. 2021 May;31(5):800-809. doi: 10.1089/thy.2020.0555. Epub 2020 Dec 23.
Clinical trial NCT00901823: Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline
Official title: A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hypertriglyceridemia
Lead sponsor: Essentialis, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Healthy adults
* Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5
* Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion Criteria:

* Known CAD, DM, uncontrolled HTN
* Pregnancy or unable to complaint with the birth control method required

Primary outcomes:
measure: Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR
timeFrame: 35 days
Secondary outcomes:
measure: Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions
timeFrame: 35 days
Other outcomes:
Locations:
Study officials:
References: