louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06913673: Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth
Official title: Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Endodontic Disease
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth.

The main question it aims to answer is:

Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material lead to post-operative pain and paste extrusion to periapical tissues or not?


Eligibility criteria: Inclusion Criteria:

* Patients with failed endodontic treatment in single root teeth
* Systemic free

Exclusion Criteria:

* Muktirooted teeth

Primary outcomes:
measure: Clinical assessment of the post retreatment pain.
timeFrame: One week after re-treatment procdure
measure: Radiographic assessment of the extrusion of the paste into periapical tissues using Digital radiograph
timeFrame: Immediate after retreatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03807973: Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
Official title: Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Multiple Sclerosis
Healthy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called \[Zr-89\]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.


Eligibility criteria: Inclusion Criteria:

1.18 to 65 years of age 2.Healthy volunteer OR

* Clinical diagnosis of Multiple Sclerosis (MS) OR
* Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR
* Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
7. Diagnosis of cancer, including leukemia
8. Blood or blood clotting disorder
9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
10. Positive urine pregnancy test day of procedure or a serum pregnancy test within 48 hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes
11. Currently enrolled in a clinical trial utilizing experimental therapies
12. Contraindication to gadolinium based contrast agents

Primary outcomes:
measure: Regional brain distribution of radiolabeled white blood cells
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jonathan McConathy, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03303573: Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy
Official title: Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Erythropoeitin
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 164
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with cerebral palsy who had received recombinant human erythropoietin more than once.

Brief summary: This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy

Detailed description: Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.

Eligibility criteria: Inclusion Criteria:

* confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,
* less than 18 years of age,
* received recombinant human erythropoietin (rhEPO) more than once.

Exclusion Criteria:

* not responding to phone interview or
* no functional assessments available.

Primary outcomes:
measure: Adverse events
timeFrame: interview was performed at an average of 1 year after the completion of rhEPO injections
Secondary outcomes:
measure: Change of Gross Motor Function Measure
timeFrame: The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03475173: New Non-invasive Modalities for Assessing Retinal Structure and Function
Official title: New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Optic Neuropathy
Branch Retinal Artery Occlusion
Hemianopia
Leber Hereditary Optic Neuropathy
Acute Zonal Occult Outer Retinopathy
Keywords: Optic Neuropathy
, Retinopathy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.


Eligibility criteria: Controls:

Inclusion:

Normal eye exam in last 2 years

Exclusion:

Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal.

Subjects with Inner Retina Defect:

Inclusion:

Defined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies.

Exclusion:

Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.

Subjects with Outer Retinal Defect:

Inclusion:

AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function

Exclusion:

Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.

The 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)

Primary outcomes:
measure: Ocular Blood Flow
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Department of Ophthalmology
state: Iowa
Study officials:
affiliation: University of Iowa Department of Ophthalmology
name: Randy H Kardon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381273: Oral Health and Psychosocial Factors During the Covid-19 Pandemic
Official title: Oral Health and Psychosocial Factors During the Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Periodontal Diseases
COVID
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 1178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The largest possible number of people should be given the opportunity to participate in this questionnaire considered the eligibility criteria.

Brief summary: This prospective observational study examines the effects of the Covid-19 pandemic on oral health, taking psychosocial factors into account, and the possible impact of a high periodontitis risk on the severity of the need for treatment in Covid-19 patients.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Residence in Germany
* Understanding of study participation and consent

Exclusion Criteria:

* \<18 years old
* Residence outside of Germany

Primary outcomes:
measure: How do people assess their oral health-related quality of life in times of the Covid-19 pandemic?
timeFrame: 08.05.2020-31.07.2020
measure: Does the periodontitis risk have an influence on the severety of the Covid-19 disease and its' treatment?
timeFrame: 08.05.2020-31.07.2020
Secondary outcomes:
measure: Do psychosocial stress factors in times of the Covid-19 pandemic have an impact on their oral health related quality of life?
timeFrame: 08.05.2020-31.07.2020
measure: Have people changed their oral hygiene practices in times of the Covid-19 pandemic?
timeFrame: 08.05.2020-31.07.2020
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Antonio Ciardo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03089073: Study of Minirin Melt® in Adult Patients With Nocturia
Official title: Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 835
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients to whom Minirin melt is prescribed as regular treatment is included in accordance with their usual practice and consistent with Korean prescribing information for Minirin melt.

Brief summary: Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia


Eligibility criteria: Inclusion Criteria:

* Adult aged between 19 and 65 years
* Patients having nocturia
* Decision made to prescribe Minirin Melt according to prescription information
* Willingness and ability to provide written informed consent

Exclusion Criteria:

* When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)
* When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis
* When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)
* When patients have known hyponatremia
* When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
* When patients have hypersensitivity to the active substances or to any of the excipients

Primary outcomes:
measure: Change from baseline in mean number of nocturnal voids
timeFrame: Baseline and treatment-related visits up to 3 months
Secondary outcomes:
measure: Reduction from baseline in the mean number of nocturnal voids
timeFrame: Baseline and treatment-related visits up to 3 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT03204773: Studying Non-motor Symptoms in HSP
Official title: Studying Non-motor Symptoms in Patients With Hereditary Spastic Paraplegia (HSP) Compared to Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SPG4
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We recruit known patients to our department or via patient interest groups.

Brief summary: Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires

Detailed description: https://lamapoll.de/NMS_in_HSP

Eligibility criteria: Inclusion Criteria:

* Group 1: Patients with HSP (hereditary spastic paraplegia)
* Group 2: Healthy controls
* Age 18 to 70 years
* Written, informed consent

Exclusion Criteria:

* Lack of ability for a written, informed consent
* Presence of spastic gait disorder or other neurological condition (Group 2)

Primary outcomes:
measure: Identification of relevant non-motor symptoms in SPG4
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Center for Neurology
Study officials:
affiliation: Researcher
name: Tim W. Rattay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rattay TW, Boldt A, Volker M, Wiethoff S, Hengel H, Schule R, Schols L. Non-motor symptoms are relevant and possibly treatable in hereditary spastic paraplegia type 4 (SPG4). J Neurol. 2020 Feb;267(2):369-379. doi: 10.1007/s00415-019-09573-w. Epub 2019 Oct 23.
Clinical trial NCT01838473: In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
Official title: In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Harm Reduction
Keywords: smokeless tobacco
Nicotine
Cadmium
lead
Tobacco Specific Nitrosamines
Lead sponsor: Contract Research Organization el AB
Sponsor class: INDUSTRY
Collaborators: name: Swedish Match AB
First posted: 2013-04-24
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Detailed description: Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.

Eligibility criteria: Inclusion Criteria:

* non-smokers, 18 to 50 years of age.
* Habitual use of \> 7 portions snus daily since minimum 1 year.
* Healthy according to the health declaration and interview.
* Written informed consent given.

Exclusion Criteria:

* Concurrent participation in another clinical trial.
* History of allergy.
* History of allergy.

Primary outcomes:
measure: In-vivo extraction of cadmium
timeFrame: 30 minutes' use
Secondary outcomes:
measure: in-vivo extraction of tobacco specific nitrosamines (TSNAs)
timeFrame: 30 minutes' use
measure: In-vivo extraction of lead
timeFrame: 30 minutes' use
measure: In-vivo extraction of nicotine
timeFrame: 30 minutes' use
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: CROel AB
Study officials:
affiliation: Croel AB
name: Erik Lunell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152373: Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS
Official title: A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 192
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.


Eligibility criteria: Inclusion Criteria:

1. subject suffering from partial onset seizures, whether or not secondarily generalized,
2. presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type IA, IB or IC) with or without secondary generalization.
3. subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).
4. subject who has been exposed to at least one classical AEDs,
5. CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.

Exclusion Criteria:

1. history of status epilepticus within three months prior to the Selection visit,
2. subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),
3. use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed.,
4. history or presence of pseudoseizures,

Primary outcomes:
measure: The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance)
Secondary outcomes:
measure: Seizure freedom ;
measure: The partial onset (type I) seizure reduction response rate ;
measure: Safety and tolerability
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06307873: Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations
Official title: Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations on Anatomical Recovery, Effectiveness and Quality of Life.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genital Prolapse, Unspecified
Keywords: sacrospinous fixation
v-notes lateral suspension
genital prolapse
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic.


Eligibility criteria: Inclusion Criteria:

* patient aged 35-75 patients without pelvic mess, servical or endometrial lesion

Exclusion Criteria:

* patients with pelvic mess, servical or endometrial lesion patient with diagnosed endometrial cancer

Primary outcomes:
measure: Pre and post operative assessment of POP-Q measurements
timeFrame: 1 year
measure: Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
References: