louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01103557: Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma
Official title: The Effectiveness of Prophylactic Selective Lateral Neck Dissection in Papillary Thyroid Carcinoma Patients With Central Neck Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasm
Lymphatic Metastasis
Keywords: Papillary thyroid carcinoma with neck metastasis
neck dissection
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).

Detailed description: The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.

Eligibility criteria: Inclusion Criteria:

* Papillary thyroid carcinoma with central neck metastasis
* No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography

Exclusion Criteria:

* History of previous thyroid operation
* Isthmic thyroid lesion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02481557: Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be in good general health as determined by the Investigator/designee
* agree to delay any elective dentistry, and to report any dentistry received during the course of the study
* agree to not participate in any other oral care study for the duration of this study
* agree to return for scheduled visits and follow all study procedures
* have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge.

Exclusion Criteria:

* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* active treatment for periodontitis
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
* fixed orthodontic appliances

Primary outcomes:
measure: Change From Baseline Air Challenge
timeFrame: 10 Minutes
Secondary outcomes:
measure: Change From Baseline for Yeaple Probe
timeFrame: 10 Minutes
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research Group
state: Nevada
Study officials:
References:
Clinical trial NCT04335357: TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Official title: A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Functional Pituitary Adenoma
Pituitary Tumor, Nonfunctioning
Lead sponsor: Tiburio Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.

Detailed description: This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks. Approximately 150 patients will be enrolled.

Eligibility criteria: Key Inclusion Criteria:

* Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS with a NFPA remnant of ≥ 10mm (maximum diameter)
* Study subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained by the Investigator or Investigator designee
* Study subject must be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff.

Key Exclusion Criteria:

* Has undergone more than one TSS, or had TSS \<6 months prior to screening, or is anticipated to require TSS within 6 months of Screening
* Has undergone radiation therapy to the head for any reason, or is already planned to have or anticipated to require radiation therapy during the study period;
* Has any contraindications to magnetic resonance imaging including allergy or intolerance to gadolinium or gadolinium-based contrast;
* In the opinion of the Investigator, the patient is unable to meet the requirements of the study.

Primary outcomes:
measure: tumor volume reduction
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06625957: Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition
Official title: A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 Versus NTCB-C in Patients Who Require Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 versus NTCB-C in patients who require parenteral nutrition


Eligibility criteria: Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Patients are expected to require PN for more than 3 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 3 days
* Patients BMI is over 30 kg/m2
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients with difficult central venous line
* Patients judged to be unsuitable for this trial by investigators

Primary outcomes:
measure: Occurance rate of adverse drug reaction
timeFrame: Day 1 to day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
state: Goyang-si
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Hwasun-gun
city: Jeollabuk-do
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeonju-si
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang
state: Seongnam-si
Study officials:
References:
Clinical trial NCT05311657: Oral Health and Severe COPD
Official title: Oral Health in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Periodontitis
Caries
Quality of Life
Tooth Loss
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing routine pulmonary or dental care.

Brief summary: This case-control study aims to investigate the association of severe COPD with oral health.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 40 years and ≤ 85 years;
* Test group: patients with COPD GOLD 3 and 4 with available pulmonary function test values (FEV1, FVC) within the last two weeks;
* Control group: patients without diagnosed or self-suspected pulmonary disease matched for age, sex, smoking and number of systemic diseases to the test group;
* Understanding of measures performed in the study;
* Written informed consent.

Exclusion Criteria:

- Pregnancy.

Primary outcomes:
measure: Tooth loss
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT06112457: Anxiety and Depression Among Gendarmes Posted to French Guiana
Official title: Anxiety and Depression Among Gendarmes Posted to French Guiana (TAD-GENDGF)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anxiety Depression Disorder
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteer

Brief summary: This is a mixed-method, single-center study involving two concurrent phases: a quantitative phase with an anonymous self-administered questionnaires, and a qualitative phase with individual contextual interviews and a focus group. The hypothesis underlying this study is that isolated postings are a risk factor for anxiety-depressive disorders. The aim of this study is to provide new information to help propose targeted prevention and health promotion measures.


Eligibility criteria: Inclusion Criteria:

* Gendarme in active position
* Age over 18
* Assignment in French Guiana for more than 6 months at the time of the study
* Not opting for study participation

Exclusion Criteria:

* Previously diagnosed psychiatric condition
* People with a reading/writing disability in the French language
* Major incapacity

Primary outcomes:
measure: Prevalence of anxiety-depressive disorders according to posting site.
timeFrame: Through study completion (6 months)
Secondary outcomes:
measure: Factors associated with the presence of an anxiety-depressive disorder
timeFrame: Through study completion (6 months)
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: DIASS Guyane
state: Guyane
Study officials:
References:
Clinical trial NCT05601557: Research on the Clinical Characteristics and Key Diagnosis and Treatment Technology of Genetic and Metabolic Liver Disease
Official title: Research on the Clinical Characteristics and Key Diagnosis and Treatment Technology of Genetic and Metabolic Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diagnosis ， Treatment， Genetic and Metabolic Liver Disease
Lead sponsor: Beijing YouAn Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 480
Sex: ALL
Minimum age (years): 0
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inherited metabolic liver disease

Brief summary: 1. Establish a follow-up cohort of genetic and metabolic liver disease in The Chinese population, and carry out research on disease spectrum, clinical characteristics and personalized diagnosis and treatment to improve the level of diagnosis and treatment.
2. Establish a multidisciplinary collaborative diagnosis and treatment model of genetic metabolic liver disease, develop and promote diagnosis and treatment paths, and improve the diagnosis and treatment ability of genetic metabolic liver disease in Beijing and even the whole country.
3. Establish a new CRISPR gene diagnosis technology to realize fast and low-cost genetic testing.
4. Elucidating the genetic mutation spectrum of common genetic and metabolic liver disease in China is helpful to accurate gene diagnosis and functional research.
5. Study the genotype-phenotype, mutation and clinical outcome relationship and influencing factors of the common genetic and metabolic liver disease population in China, to guide the early diagnosis, early treatment and improve the prognosis.


Eligibility criteria: Inclusion Criteria:

Meet the diagnostic criteria of each disease.

Exclusion Criteria:

1. Co-infected with hepatitis B virus, hepatitis C virus and HIV;
2. Patients with liver fibrosis and cirrhosis caused by other causes;
3. Patients with alcoholic liver disease and autoimmune liver disease;
4. Liver malignancy has been suggested or confirmed by evidence;
5. Combined with other serious systemic diseases.

Primary outcomes:
measure: death
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02982057: Non Culprit Lesion Study
Official title: A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: STEMI
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 50
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: The aim of the present study is to compare the evolution of non culprit lesions after treatment by BVS versus optimal medical therapy at 2-years follow- up

Detailed description: Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modifications of plaque morphology, especially the lipid content which is considered as one of the main factor leading to recurrent MACE after an ACS.

The interaction between the polymer Platform and the vessel wall, the effect of the everolimus on neointima growth and cellular response into the media could reduce the inflammatory process into the vulnerable plaque could be different Under OMT and BVS implantation.

Eligibility criteria: Inclusion Criteria:

* STEMI and multivessel ASCL
* Successful and uneventful primary PCI
* Non culprit lesion \> /= 2.5mm RVD suitable for investigation by FFR
* At least one segment of minimum 10 mm length containing a non culprit lesion

Exclusion Criteria:

* non compliant profile
* patient not able to sign an IC
* cardiogenic shock
* left main disease
* GFR\<30ml/min/m2
* previous CABG
* LVEF\<35%

Primary outcomes:
measure: measure size of the vulnerable plaque
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: StLuc
Study officials:
References:
Clinical trial NCT00835757: Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy
Official title: Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2009-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two groups of 25 subjects each will be studied: subjects with confirmed diabetic peripheral neuropathy (DPN) and age- and sex-matched healthy controls.

Brief summary: This study aims to validate magnetic resonance imaging and diffusion tensor imaging (MRI/ DTI) analysis as a non-invasive method for the assessment of myelinated nerve fibers loss in diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

1. Presence of diabetes mellitus diagnosed for more than 6 months as defined by the World Health Organization Classification.
2. Presence of confirmed DPN as defined below.
3. Age between 18-70 years.
4. Have no risk factors for other non-diabetic neuropathies (as determined by medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations).
5. Willingness to provide informed consent and cooperate with the medical procedures for the study.

Inclusion Criteria for Healthy Controls:

1. Age-matched non-obese (BMI \< 30) control subjects
2. Normal glucose tolerance
3. Normal blood pressure
4. Normal lipid profile
5. Free of any causes of neuropathy as described above.

Exclusion Criteria:

1. Nursing mothers or pregnant women (excluded by a positive pregnancy test).
2. Patients with a history of previous kidney, pancreas or cardiac transplantation.
3. Patients with a past history of neuropathy (independent of diabetes), or with a disease known to be associated with neuropathy (e.g. end stage renal disease, hepatitis C, systemic lupus erythematosus).
4. Participation in an experimental medication trial within 3 months of starting the study.
5. Subjects with implantable cardioverter defibrillators and other devices that would preclude MRI scanning.
6. Subjects who are unable or unwilling to comply with the experimental protocol.

Primary outcomes:
measure: The difference in means between DTI parameters (FA and MD) measured in the sural nerve between subjects with DPN and healthy control subjects.
timeFrame: 12-18 months
Secondary outcomes:
measure: The association between DTI parameters and clinical and electrophysiological measures of DPN
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rodica Pop-Busui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02389257: Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods (ECG and MEG)
Official title: Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods : Electrocardiography (ECG) and Magnetoencephalography (MEG)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.

Detailed description: Optically Pumped 4He Magnetometers vs reference sensors electrocardiogram (ECG) or SQUIDs data acquisitions

Eligibility criteria: Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* informed consent form signed
* without cardiac, neurologic, psychiatric or metabolic medical history.

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person with any implant

Primary outcomes:
measure: Number of Participants with Adverse EventsMagnetic brain or cardiac activity
timeFrame: 1 year
Secondary outcomes:
measure: Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
References:
Clinical trial NCT03183557: Efficacy of Zoledronic Acid in Osteoporosis
Official title: Examination of Bone Metabolism and Bone Mineral Density by Zoledronic Acid in Primary and Secondary Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Osteoporotic patients who want to take zoledronic acid

Exclusion Criteria:

* Patients who are allergic to zoledronic acid or vitamin D
* Patients who are pregnant or breast-feeding
* Patients who have not taken zoledronic acid for the last 2 years

Primary outcomes:
measure: Bone mineral density
timeFrame: Change from Baseline Values at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References: