louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02150226: Y-TZP and In-mouth Low Thermal Degradation: A Prospective Clinical Study
Official title: Low Thermal Degradation of Monolithic Zirconia Prostheses: an up to 5-year Original Prospective Clinical Study Using ex Vivo Analyses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Zirconia Monolithic Dental Restorations: In-mouth Behaviour, LTD and Wear
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: DMG Paris Descartes
First posted: 2014-05-29
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this work is to study in-mouth aging and LTD of monolithic zirconia restorations. Microstructural changes characteristic of LTD processes, wear, and clinical behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D laser surface analysis will be used, directly on the restorations, which will be removed at regular intervals.The working hypothesis is that LTD process is very slow at the scale at the lifespan of dental prostheses.


Eligibility criteria: Inclusion Criteria:

* Full zirconia crowns in the posterior region (molar/premolar)
* On teeth or implants
* Single unit restorations cemented on natural teeth and implants (including screw-retained restorations if possible, but no internal connections)
* Multi-unit restorations on implants
* If nightguard: to be performed on the antagonist

Exclusion Criteria:

* Patients with removable prosthesis as an antagonist

Primary outcomes:
measure: in-mouth LTD of monolithic zirconia restorations on natural teeth and implants
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Institute of Dentistry University of Liege
Study officials:
References:
citation: Koenig V, Wulfman CP, Derbanne MA, Dupont NM, Le Goff SO, Tang ML, Seidel L, Dewael TY, Vanheusden AJ, Mainjot AK. Aging of monolithic zirconia dental prostheses: Protocol for a 5-year prospective clinical study using ex vivo analyses. Contemp Clin Trials Commun. 2016 Jun 17;4:25-32. doi: 10.1016/j.conctc.2016.06.001. eCollection 2016 Dec 15.
Clinical trial NCT03035526: Sex Hormones and Pericardial Adipose Tissue
Official title: Do Endogenous Sex Hormones Affect Pericardial Adipose Tissue Volume of Males in The Multi-Ethnic Study of Atherosclerosis (MESA)?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pericardial Adipose Tissue and Sex Hormones
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 3213
Sex: MALE
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 3161 men (45-84 years old; white, black, Hispanic, or Chinese) at 6 centers in the United States

Brief summary: In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males.


Eligibility criteria: Inclusion Criteria:

* 3213 males
* African American
* Caucasian
* Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002)

Exclusion Criteria:

* Patients with known coronary artery disease

Primary outcomes:
measure: Relation ship between pericardial adipose tissue and sex hormones in males
timeFrame: years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03317626: Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
Official title: Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Anesthesia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures.

The gravity flow technique is not well known, and is therefore used in only a few hospitals. The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women.

Detailed description: The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women. This gravity flow technique was first described 26 years ago in 1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been formally studied and this study is designed to enable assessment of the success rate of the gravity flow technique.

Eligibility criteria: Inclusion Criteria:

* Patients requesting epidural analgesia for labor
* ASA physical status I to II
* Ability to speak and read English to fully comprehend the consent process

Exclusion Criteria:

* Combined spinal-epidural anesthesia
* Coagulopathy
* History of lumbar spine surgery
* Allergy or contraindication to any of the study medications
* Contraindication to epidural analgesia
* ASA physical status \>III

Primary outcomes:
measure: Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.
timeFrame: 30 Minutes post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gilbert Grant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179426: Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy
Official title: Antiseizure Medication-Induced Elevation of Serum Estradiol and Reproductive Dysfunction in Men With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizure Disorder
Epilepsy
Keywords: Seizure Disorder
Hypogonadism
Sexual Function
Epilepsy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-16
Enrollment: 175
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.

Detailed description: This study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. You will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.

Eligibility criteria: Inclusion Criteria:

* Must be a male between 18-50 years of age
* Must have seizures
* Must be on antiseizure medication for at least six months duration

Exclusion Criteria:

* Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Andrew G. Herzog, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herzog AG, Drislane FW, Schomer DL, Pennell PB, Bromfield EB, Kelly KM, Farina EL, Frye CA. Differential effects of antiepileptic drugs on sexual function and reproductive hormones in men with epilepsy: interim analysis of a comparison between lamotrigine and enzyme-inducing antiepileptic drugs. Epilepsia. 2004 Jul;45(7):764-8. doi: 10.1111/j.0013-9580.2004.60703.x.
Clinical trial NCT00418626: Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Official title: A Phase I, Single Center, Open-label, Single Oral Dose, Study to Assess the Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: nilotinib
hepatic impairment
Child-Pugh scale
PK
healthy, subject(s)
Subjects with impaired hepatic function and healthy subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male (18 -70 yrs)
2. Body weight must be ≥ 50 kg and \< 120 kg, with a body mass index (BMI) \>18 but \< 35.
3. Laboratory parameters values within the normal range

Exclusion Criteria:

1. Contraindication or hypersensitivity to receiving nilotinib
2. Smokers or those who use of tobacco products or products containing nicotine
3. A past medical history of clinically significant Electrocardiogram abnormalities or a history/family history of long QT-interval syndrome.
4. History of fainting spells.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetics of nilotinib
Secondary outcomes:
measure: impact on hepatic function assessed by laboratory values and an electrocardiogram
Other outcomes:
Locations:
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Yin OQ, Gallagher N, Tanaka C, Fisher D, Sethuraman V, Zhou W, Lin TH, Heuman D, Schran H. Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study. Clin Ther. 2009;31 Pt 2:2459-69. doi: 10.1016/j.clinthera.2009.11.015.
Clinical trial NCT04622826: plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients
Official title: Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid-19 Pneumonia
Keywords: covid-19 pneumonia
convalescent plasma
hyperimmune plasma
Lead sponsor: Azienda USL Toscana Nord Ovest
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms.

Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area.
* informed consent for plasma infusion
* informed consent to blood samples storing for future studies.

Exclusion Criteria:

* pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study

  * immunoglobulin infusion in the last month

contraindication to transfusion or previous adverse reaction

Primary outcomes:
measure: ITU admission
timeFrame: up to 30 days
measure: administration of O2
timeFrame: up to 30 days
measure: hospital mortality
timeFrame: up to 90 days
measure: immune plasma infusion adverse reaction
timeFrame: in the first 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Massa
country: Italy
facility: Ospedale delle Apuane
state: Toscana
Study officials:
affiliation: ospedale delle Apuane
name: antonella vincenti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06910826: Visual Education for Spinal Anesthesia Acceptance
Official title: Explaining Spinal Anesthesia to Pregnant Women: A Visual Approach to Overcoming Fears
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Incidence of Spinal Anesthesia Preference
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 318 pregnant women aged 18-45 who are undergoing elective cesarean sections and classified as ASA I-II according to the American Society of Anesthesiologists (ASA) scale.

Brief summary: Primary outcome: To determine the incidence of spinal anesthesia preference after exposure to the visual information catalog.

Secondary outcomes: To analyze independent (age, education, profession, previous experiences) and dependent (fear, anxiety) factors influencing patient choices.


Eligibility criteria: Inclusion Criteria:

* Aged 18-45
* who are undergoing elective cesarean sections
* and classified as ASA I-II according to the American Society of Anesthesiologists (ASA) scale

Exclusion Criteria:

* patients under 18 or over 45 years old,
* emergency cesareans,
* preeclampsia,
* cardiovascular disorders,
* fetal abnormalities,
* those not receiving spinal anesthesia or converted to general anesthesia during surgery,
* those who refuse to participate in the study,
* hospital clinical or administrative staff,
* patients with psychiatric disorders

Primary outcomes:
measure: incidence of spinal anesthesia preference
timeFrame: 4 MONTH
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Emadi SA, Gholipour Baradari A, Khademloo M, Abotorabi M, Hassanzadeh Kiabi F. Evaluating patients' choice of general and spinal anesthesia for elective cesarean section and associated factors: a descriptive study. Ann Med Surg (Lond). 2023 Jan 12;85(1):6-12. doi: 10.1097/MS9.0000000000000010. eCollection 2023 Jan.
citation: Shahid N, Rashid AM. Knowledge, fear and acceptance rate of spinal anesthesia among pregnant women scheduled for cesarean section: a cross-sectional study from a tertiary care hospital in Karachi. BMC Anesthesiol. 2024 Nov 12;24(1):408. doi: 10.1186/s12871-024-02736-x.
Clinical trial NCT01518426: Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population
Official title: Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Attitude to Computers
Keywords: Brain computer interface
EEG recording
Electrodes
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2012-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).

Detailed description: Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.

The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers male or female aging over 18
* Signed informed consent
* Passed the preliminary exam
* Registered in the national database for persons willing to participate in Biomedical research

Exclusion Criteria:

* Visual or hearing problems
* Cognitive problems
* Illiterate persons
* Persons under Guardianship or Trusteeship
* Having Epilepsy
* Pregnant women Not covered by the social security system

Primary outcomes:
measure: Wilcoxon statistic (Area Under the Curve)
timeFrame: T0+2h (end of each technique)
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital
state: Paris Area
Study officials:
affiliation: Centre d'Investigation Clinique et Technologique 805
name: Louis Mayaud, ENGINEER
role: STUDY_DIRECTOR
References:
Clinical trial NCT03359226: Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
Official title: Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson&Apos;s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.

Detailed description: Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in living patients with probable Parkinsons disease (PD) would be extremely valuable as a diagnostic test, as a marker of molecular therapeutic target engagement and as a progression marker. Based on recent data from our group with both early and advanced PD patients, we propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12 patients who have previously been biopsied and had LTS present in their SMG tissue.

Eligibility criteria: Inclusion criteria

1. PD patients ages up to age 85.
2. Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported

Exclusion criteria

1. Evidence for dementia that would preclude the patient from signing informed consent
2. History of bleeding diathesis or hematologic disorders
3. Medically unable to undergo a core needle biopsy of the submandibular gland
4. Prior treatment of the submandibular gland with botulinum toxin injections.
5. History of past or current acute infection or abscess of the submandibular gland.
6. History of past or current neoplastic process within the submandibular gland.
7. History of peripheral neuropathy.

Primary outcomes:
measure: Presence of alpha-synuclein in the submandibular gland
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Charles H Adler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577226: Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine
Official title: Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Scoliosis
Keywords: scoliosis, immature spine
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whose data is observed are those who have undergone the shilla surgical technique.

Brief summary: The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth.

The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.

Detailed description: Traditional "growing rod" constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.

Eligibility criteria: Inclusion Criteria:

* between the ages of 1 yr and 10 yrs
* have severe, progressive scoliosis unresponsive to bracing
* have severe, progressive scoliosis who cannot tolerate bracing

Exclusion Criteria:

* none

Primary outcomes:
measure: Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.
timeFrame: 5 yrs
Secondary outcomes:
measure: Patients will have continued spinal growth
timeFrame: 5 yrs
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Childrens Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
name: Richard E. McCarthy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: