louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03536403: Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
Official title: Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain, radicular pain, neurologic complications, or spinal deformities. However, radiography does not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait remain largely unexplored. This prospective and controlled study try to assess the Vicon system for detecting sagittal spinopelvic imbalance and to determine the modification induced by ant induced anterior sagittal imbalance on the kinetics walking parameters


Eligibility criteria: Inclusion Criteria:

* Male subjects
* Aged between 20 to 40 years
* Height between 165 to 190 centimeters
* Asymptomatic subjects from spinal point of view
* BMI \< 30 kg/m²
* Affiliated to French Social Security
* Subjects having read the information note and signed informed consent

Exclusion Criteria:

* Subjects with neurological, vestibular, rheumatological or orthopedic pathology which can influence walking and balance
* Subjects with known spinal pathology
* Subjects with visible morphologic spinal deformity
* Subjects with significant visual impairment (visual acuity \< 6/10) despite an optical correction port
* Subjects unable to walk without help
* Person placed under the safeguard of justice, guardianship or curatorship
* Subjects involved in other biomedical research during this study
* Subjects presenting an asymptomatic spinal pathology discovered at the inclusion on the spinal EOS images.

Primary outcomes:
measure: Variations in spino-pelvic sagittal balance measured by EOS X-ray
timeFrame: 1 hour
Secondary outcomes:
measure: Position of the ground point projection of the center of mass
timeFrame: 1 hour
measure: vertical deceleration of the center of mass during the second part of the oscillating phase
timeFrame: 1 hour
measure: Velocity of the center of mass during the second part of the oscillating phase
timeFrame: 1 hour
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Mourad OULD SLIMANE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672303: Pain During Vaccine Administration
Official title: The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Newborn, Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc Elif Simay KOÇ
First posted: 2023-01-05
Enrollment: 59
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.

In the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.

This study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.


Eligibility criteria: Inclusion Criteria:

* 28-36 gestational week
* No congenital malformation
* follow up with a diagnosis of respiratory distress syndrome,
* receive oxygen support with a nasal cannula or tube,
* not receive mechanical ventilation support,
* no contraindications for hepatitis B vaccine administration,
* stable vital signs before vaccination,
* not receive analgesic sedation treatment
* whose parents give verbal and written consent to participate in the study.

Exclusion Criteria:

* Infants of parents who did not give informed voluntary consent will not be included in the study.
* Decreased oxygen saturation levels
* Tachycardia just before the vaccine administration
* Invasive intervention in the right hand.

Primary outcomes:
measure: pain level will be measured in the premature baby
timeFrame: 15 minutes
Secondary outcomes:
measure: Crying time
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Türkan Kadiroğlu
state: Erzurum
Study officials:
References:
Clinical trial NCT04800003: The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth
Official title: The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth on Panoramic Radiographs: A Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implants
Submandibular Fossa Depth
Gonial Angle
Cone-beam Computed Tomography
Panoramic Radiography
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the present diagnostic accuracy study, 75 dry human mandibles were used. 24 dry human mandibles with insufficient bone integrity to make the necessary measurements or which were dentate in the posterior region were not included in the study and the study was carried out with 51 dry mandibles.

Brief summary: The aim of the study is to evaluate the relationship between submandibular fossa depth and gonial angle measurements in cone beam computed tomography examinations in terms of dental implant applications. Cone-beam computed tomography images of 51 dry human mandibles were included in the study.

Detailed description: Gonial angle and fossa depths were determined and evaluated separately for left and right sides. Gonial angle was measured on Cone-beam computed tomography images as the angle between the tangent line drawn posterior to the border of the ramus of the mandible and the tangent line drawn to the lower border of the mandible. Determination of the submandibular fossa depth was made with a line was drawn to connect the most dislocated upper and lower points on the inner surface of the mandible in the coronal plane sections, and the length of the line drawn at a right angle from the deepest point of the fossa to this line. Measurements were made separately for left and right sides.

Eligibility criteria: Inclusion Criteria:

* Dry mandibles with sufficient bone integrity to make the necessary measurements

Exclusion Criteria:

* Dry mandibles which were dentate in the posterior region

Primary outcomes:
measure: Gonial angle
timeFrame: 2 months
measure: Submandibular fossa depth
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
Clinical trial NCT06816303: Patients With Diabetes Mellitus on Drug Treatment on the List or Already Undergoing Orthotopic Liver Transplantation
Official title: Adult Patients With Diabetes Mellitus, on Drug Treatment, on the List or Already Undergoing Orthotopic Liver Transplantation: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus Type 2
Liver Transplant
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 100
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 followed for hepatological problems on the list for OLT or post-transplant with type 2 diabetes

Brief summary: observational study through which we aim to collect information on metabolic compensation, the degree of satisfaction with hypoglycemic therapy, the onset of complications of diabetes or liver disease, evaluation of survival, in patients on the list for at least three months or already undergoing liver transplantation for at least three months


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* presence on the list for OLT for at least 3 months or have already been submitted to OLT for at least 3 months
* age ≥ 18 years
* signature of written informed consent to participate in the observational study, either by the participant or legal guardian

Exclusion Criteria:

- Pregnancy or breastfeeding

Primary outcomes:
measure: glycosilated hemoglobin (%)
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: degree of satisfaction with therapy
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Lucia Brodosi
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Lucia Brodosi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03050203: Custom Pack in Spine Surgery
Official title: Surgical Field Custom Pack's Efficacy on Soft Tissue Dissecting Time Reduction, on Relative Risks and Materials Wasted, in Patients Undergoing Spine Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Diseases
Spine Cancer
Spine Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs. Nevertheless ,the studies available are sponsored by the industry and their results are very few. The aim of this study is to evaluate the correlation and reliability of spine surgery "custom pack" efficacy in adult patients obtained in the reduction of surgery time, relative risks, and materials wasted compared with the standard surgical field procedure practice .


Eligibility criteria: Inclusion Criteria:

* Degenerative spinal disease from 2 to 4 levels,
* Oncologic spine disease with only decompression and stabilization.

Exclusion Criteria:

* Revision surgeries,
* Minimally invasive interventions,
* Interventions that provide a dual access, and
* Patients who refuse consent to experimentation.

Primary outcomes:
measure: Soft Tissue Dissecting Time
timeFrame: up to the first day post intervention
Secondary outcomes:
measure: Surgery Time
timeFrame: up to the first day post intervention
measure: Postoperative Complications
timeFrame: up to 2 weeks
measure: Numbers of Materials Wasted
timeFrame: up to the first day post intervention
measure: Blood Loss
timeFrame: up to 2 weeks
measure: Pain (Score on the "Numeric Rating Scale")
timeFrame: up to the first 3 days post intervention
measure: Length of Stay
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Annamaria Nicolini, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03035903: Energy Cost for Holding a MedGem® Indirect Calorimeter
Official title: Energy Cost for Holding a MedGem® Indirect Calorimeter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resting Metabolic Rate
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2017-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.

Detailed description: Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:

1. RMR with MedGem® Indirect Calorimeter
2. RMR without MedGem® Indirect Calorimeter

Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).

Eligibility criteria: Inclusion Criteria:

* Age between 18-65 y
* BMI 25-40 kg/m2

Exclusion Criteria:

* Diabetes mellitus
* Current smoker
* Presently on a weight loss regimen
* Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs
* Claustrophobia
* Pregnant or breastfeeding
* Congestive heart failure
* Chronic kidney disease
* Pacemaker or other metal implants

Primary outcomes:
measure: Resting Metabolic Rate (RMR)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Eric Ravussin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885103: Combination of NHF and Nebulizer on Lung Function in COPD
Official title: Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: NHF
nasal highflow
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.

Detailed description: Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.

Eligibility criteria: Inclusion Criteria:

* stable disease
* COPD

Exclusion Criteria:

* exacerbation
* right heart decompensation
* acute respiratory insufficiency
* acute disease

Primary outcomes:
measure: changes in forced expiratory volume in 1s (FEV1)
timeFrame: 45 minutes
measure: changes in breath way resistance (Rtot)
timeFrame: 45 min
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Respiratory Medicine
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Hubert Wirtz, MD
role: STUDY_DIRECTOR
References:
citation: Braunlich J, Wirtz H. Oral Versus Nasal High-Flow Bronchodilator Inhalation in Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2018 Aug;31(4):248-254. doi: 10.1089/jamp.2017.1432. Epub 2017 Dec 20.
Clinical trial NCT01332903: Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069
Official title: A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\] AZD5069.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
* Healthy Male volunteers aged 50 and over

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within last 5 years
* History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Primary outcomes:
measure: To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood
timeFrame: From pre-dose until 168 hours post last dose
measure: To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax).
timeFrame: From pre-dose until 168hours post last dose
measure: To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance.
timeFrame: From pre-dose until 168hours post last dose
Secondary outcomes:
measure: To investigate the safety and tolerability of AZD5069 given orally
timeFrame: From screening visit, Day 12, up to follow up visit
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Prof. Tim Mant, FRCP, FFPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.
Clinical trial NCT06644703: Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth
Official title: Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Cryotherapy
Vital pulp therapy
Irreversibl pulpitis
Postoperative pain
Total pulpotomy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 62
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.


Eligibility criteria: Inclusion Criteria:

Teeth with

* moderate or severe pain
* diagnosed with symptomatic irreversible pulpitis
* no tenderness to percussion and palpation
* positive response to cold test and electric pulp test
* no signs of periapical pathology

Exclusion Criteria:

Teeth which

* could not be restored or required post-core
* had periapical lesions,
* had poor periodontal status (pocket depth\> 4 mm),
* had negative responses to pulp sensitivity tests,
* had no pulp exposure after caries removing Patients who
* had no preoperative pain or had mild preoperative pain
* had bleeding disorders
* had systemic diseases such as immunosuppressive disease or diabetes

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye
Study officials:
affiliation: Cukurova University
name: Hamdi Oğuz Yoldaş, DDS PHD
role: STUDY_DIRECTOR
References:
citation: Akhil VS, Kumar V, Aravind A, Sharma R, Sharma S, Chawla A, Upadhyay AD, Logani A. Novel cryotherapy technique for pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis- a randomized controlled trial. Clin Oral Investig. 2024 Apr 26;28(5):275. doi: 10.1007/s00784-024-05661-y.
citation: Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.
Clinical trial NCT00498303: Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008
Official title: A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Vaccine
Keywords: influenza vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
* available for all the visits scheduled in the study and able to comply with all study requirements
* in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion Criteria:

* n/a

Primary outcomes:
measure: evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
measure: evaluate safety of trivalent split influenza vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Herborn
country: Germany
facility: Werksarztzentrum Herborn
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: