louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00280046: Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
Official title: Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 307
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
* HbA1c: At least 8.0%

Exclusion Criteria:

* Impaired hepatic, renal or cardiac function

Primary outcomes:
measure: HbA1c
timeFrame: after 16 weeks of treatment
Secondary outcomes:
measure: Self-measured 7-point capillary plasma glucose profile
measure: Change in body weight
measure: Incidence of hypoglycaemic episodes and adverse events
measure: Quality of Life
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belgorod
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Khabarovsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Omsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Vladivostok
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Voronezh
country: Russian Federation
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ushakova O, Sokolovskaya V, Morozova A, Valeeva F, Zanozina O, Sazonova O, Zhadanova E, Starceva M, Kazakova E, Saifullina M, Shapiro I, Tarasov A, Al-Tayar B, Starkova N. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia. Clin Ther. 2007 Nov;29(11):2374-84. doi: 10.1016/j.clinthera.2007.11.017.
Clinical trial NCT04930146: Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
Official title: To Evaluate the Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury (TBI)
Keywords: Traumatic brain injury, TBI
Bloodletting
acupuncture
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.


Eligibility criteria: Inclusion Criteria:

1. Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included.
2. Patient with normal consciousness and no cognitive or motor function disease before brain injury.
3. Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient).

Exclusion Criteria:

1. Patients who are vital sign unstable and with severe complication.
2. Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
3. Pregnant patients.
4. Any other conditions deemed unsuitable by the physician in charge.
5. Patients (agent of the patient) who did not sign the consent.

Primary outcomes:
measure: GCS(Glasgow Coma Scale)
timeFrame: 4 weeks
measure: Barthel index
timeFrame: 4 weeks
measure: Muscle power
timeFrame: 4 weeks
measure: mGOS(Modified Glasgow Outcome Score)
timeFrame: 4 weeks
measure: RTS (Revised Trauma Score)
timeFrame: 4 weeks
Secondary outcomes:
measure: Meridian energy assessment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Medical Foundation
name: wei Ling Chou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04900246: Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions
Official title: Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions: Study Protocol for a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Caries Class II
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: According to the World Health Organization (WHO), dental caries is considered one of the major pediatric health problems worldwide, due to its high prevalence and incidence. Therefore, the early diagnosis of caries lesions is a fundamental procedure for building the treatment plan, aiming at prevention, minimal intervention and the promotion of oral health. The present study aims to evaluate, through a randomized and controlled clinical study, which is the best strategy for diagnosing primary caries lesions located in the interproximal region in individuals aged from 4 to 10 years. Diagnostic methods will be analyzed and compared: visual clinical examination using the International Caries Detection and Assessment System (ICDAS), iTero Element 5D System (intraoral scanner with NIRI technology) and bitewing radiography (BWX). All evaluations will be carried out by 02 examiners. The examiners will be trained and calibrated to use the visual and radiographic criteria, and also to use the iTero 5D intraoral scanner, following the manufacturer's guidance.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes who seek dental treatment at the Dentistry Clinic of Universidade Metropolitana de Santos.
* Be between 04 and 10 years old;
* Good general health;
* Present at least two tooth surfaces that can be included in the study.

Exclusion Criteria:

* Dental surfaces with proximal restorations;
* Surfaces with evident proximal cavities (marginal crest break);
* Absence of adjacent tooth (absence of proximal contact).

Primary outcomes:
measure: Diagnosis of primary caries lesions through visual inspection (ICDAS)
timeFrame: Baseline.
measure: Diagnosis of primary caries lesions through the iTero Element 5D scan
timeFrame: Baseline.
measure: Diagnosis of primary caries lesions BWX Radiographic Assessment
timeFrame: Baseline.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sobral APT, Goncalves MLL, D Annibale AS, Santos EM, Guedes CC, Gallo JMAS, Ferri EP, Moretti LAC, Motta LJ, Deana AM, Horliana ACRT, Kalil Bussadori S. Evaluation of different methods for the diagnosis of primary caries lesions: Study protocol for a randomized controlled clinical trial. PLoS One. 2022 Aug 24;17(8):e0273104. doi: 10.1371/journal.pone.0273104. eCollection 2022.
Clinical trial NCT05751746: The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression
Official title: The Effect of Peripartum Magnesium Sulfate Use on the Occurrence of Postpartum Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Depression
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is aimed adult singleton pregnant women with gestation age more than 30 weeks who are scheduled to give birth. Participants who get peripartum administration of magnesium sulfate are classified as magnesium group, and participants who do not get magnesium sulfate administration are classified as control group.

Brief summary: This is an observational study that will be conducted on pregnant women under vaginal delivery or cesarean section. The magnesium sulfate will be given to appropriate participants with a protocol that obstetrician are already using in our hospital. After delivery, participants are asked to answer sequential questionnaires to assess postpartum depression.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who will do delivery.
* Gestational week \>= 30 week
* Singleton

Exclusion Criteria:

* History of depression

Primary outcomes:
measure: postpartum depression
timeFrame: 6 week after discharge
measure: postpartum depression severity
timeFrame: 6 week after discharge
Secondary outcomes:
measure: postpartum depression
timeFrame: 2week after discharge
measure: postpartum depression severity
timeFrame: 2 week after discharge
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonguido
Study officials:
References:
Clinical trial NCT06612346: Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
Official title: Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Keywords: MINT
Trabeculostomy
Minimally Invasive Glaucoma Surgery
MIGS
Intraocular Pressure
Lead sponsor: Sanoculis Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of subjects of Armenian descent that underwent the MINT procedure.

Brief summary: This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be explored.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years to ≤ 85 years old
2. Subject who underwent MINT, and surgery was performed not earlier than 18 months from enrollment

Primary outcomes:
measure: Intraocular Pressure Measurement
timeFrame: 18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).
Secondary outcomes:
Other outcomes:
measure: Adverse Events Outcomes
timeFrame: 0-24 +/-2 months post MINT surgery from previous study (MMS-EEU-4).
Locations:
city: Yerevan
country: Armenia
facility: S. Malayan Eye Center
Study officials:
References:
Clinical trial NCT03296046: Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL)
Official title: Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Polyclonal B-Cell Lymphocytosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 100
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: PPBL patients in France

Brief summary: The main purpose of this study is the description of all French cases of PPBL and the establishment of minimal criteria for the pathology diagnosis and its follow-up.

The secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.


Eligibility criteria: Inclusion Criteria:

* PPBL diagnosis established during a previous medical visit

Exclusion Criteria:

* None

Primary outcomes:
measure: Relevant medical history
timeFrame: Baseline
measure: Complete blood count
timeFrame: Baseline
measure: Administration of first-line treatment or not
timeFrame: Baseline
Secondary outcomes:
measure: Lymphocyte phenotype
timeFrame: Baseline
Other outcomes:
Locations:
city: Marseille
country: France
facility: group GFHC and intergroup LLC (GCFLL-MW / GOELAMS)
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy - Hopitaux de Brabois
Study officials:
References:
Clinical trial NCT03557346: Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions
Official title: Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accommodation
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who visited the department of ophthalmology in Chung-Ang university hospital for ocular examination

Brief summary: The investigators believe that this simple, clear, and objective study may be a great help in understanding the accommodative response during various accommodative stimulation conditions.

Detailed description: The purpose in this study was to investigate physiological changes in accommodative power, pupil diameter, astigmatic value, and axis when visual stimuli were applied under binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions using the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan).

Eligibility criteria: Inclusion Criteria:

1. age between 20 and 40 years
2. spherical equivalent (SE) within ± 4.0 diopters (D)
3. correctable distant and near visual acuity by glasses to 20/20
4. normal ocular alignment.

Exclusion Criteria:

1. disturbance of accommodation (e.g., Adie's pupil, Parkinson's disease, accommodative esotropia, accommodative spasm, presbyopia)
2. disorders that can affect accommodation (e.g., history of ocular trauma, previous ocular surgery)
3. disorders that might limit testing accuracy (e.g., corneal pathological features, cataract, glaucoma, vitreous opacity, and retinal abnormalities).

Primary outcomes:
measure: Accommodative power
timeFrame: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
measure: Pupil diameter
timeFrame: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
measure: Astigmatic value and axis change
timeFrame: Subjects performed this examination while being under binocular, monocular, and pinhole conditions with one week apart in random order after baseline study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Park H, Park IK, Shin JH, Chun YS. Objective Verification of Physiologic Changes during Accommodation under Binocular, Monocular, and Pinhole Conditions. J Korean Med Sci. 2019 Jan 21;34(4):e32. doi: 10.3346/jkms.2019.34.e32. eCollection 2019 Jan 28.
Clinical trial NCT04911946: Training of Orthopedic Residents in OP Treatment
Official title: Evaluation of the Management of Patients With Osteoporotic Fractures by Orthopedics Residents: an Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporotic Fractures
Keywords: Osteoporotic fractures
Secondary prevention
Brazil
Orthopedics
Medical professionals
Knowledge Gap
Osteoporosis treatment
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.

Brief summary: Objective: To assess whether residents (R1, R2 or R3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (OP) and whether this learning is improved over the years of residence.

Methods: Residents answered diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture (OF) in 4 scenarios, which were the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. Answers were compared between years of residence.


Eligibility criteria: Inclusion Criteria:

* Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.

Exclusion Criteria:

* Abandonment of the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
* Withdrawal from the medical residency program in orthopedics and traumatology at the IOT-HC-FMUSP for a period of more than 120 days.
* Expulsion from the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
* Transfer of the medical residency program in orthopedics and traumatology from IOT-HC-FMUSP to another institution.

Primary outcomes:
measure: Secondary prevention of osteoporotic fracture
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Patient referral to secondary prevention of osteoporotic fracture
timeFrame: through study completion, an average of 1 month
measure: Change the proficiency of secondary prevention with increasing graduation in the residency program
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
name: Marcia U Rezende, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03191669: Vaccine Exposure in Patients With MS
Official title: Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 335
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 MS attending an outpatient MS clinic or hospitalization

Brief summary: Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet.

Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS.

Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France).

Data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period.

Statistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.


Eligibility criteria: Inclusion Criteria:

* Multiple sclerosis according to MacDonald 2010 criteria
* Age 18 and more

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of patients exposed to seasonal flu vaccine in 2016-2017
timeFrame: Two-weeks period in July 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Pierre Wertheimer
city: Clermont-Ferrand
country: France
facility: Service de Neurologie - Hôpital G. Montpied
city: Grenoble
country: France
facility: Service de Neurologie - CHU de Grenoble
city: Lyon
country: France
facility: Service de Neurologie - Hôpital Saint Joseph Saint Luc
city: Lyon
country: France
facility: Cabinet de Neurologie - Clinique de la Sauvegarde
city: Saint-Étienne
country: France
facility: Service de Neurologie - Hôpital Nord - CHU St Etienne
Study officials:
affiliation: Hôpital Neurologique Pierre Wertheimer - GHE
name: Sandra VUKUSIC
role: PRINCIPAL_INVESTIGATOR
References: