louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03449615: Validation of Ferromagnetic Tracer in Melanoma Sentinel Node
Official title: Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma Stage
Sentinel Lymph Node
Keywords: Cutaneous melanoma
Sentinel node biopsy
Lead sponsor: Sociedad Española de Oncología Quirúrgica
Sponsor class: OTHER
Collaborators: name: Sysmex España
First posted: 2018-02-28
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cutaneous malignant melanoma with indication for sentinel lymph node biopsy in staging.

Brief summary: This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.

Detailed description: * Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day).
* Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes.
* Optional: colorant injection in standard form. Local massage of 5-10 minutes.
* After 20 minutes: transcutaneous measurement with SentiMag®
* Valuing territories (lymphoscintigraphy information?)
* Surgical identification measures:

  1. st with SentiMag®
  2. nd with gamma detection probe
* Ex vivo check and HRD record

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years of age),
* with diagnosis of cutaneous melanoma and
* in which SLNB is indicated as a staging method, and
* with cN0 result after clinical-echographic-cytohistological evaluation.

Exclusion Criteria:

* Previous treatment with systemic therapy.
* Recent previous surgery (\<3 months) in the area susceptible of lymphatic drainage from the melanoma.
* Intolerance or hypersensitivity to iron or dextran compounds.
* Impossibility of use of radioisotope.
* Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin).
* Implantation of pacemakers or partially or totally metallic thoracic implants.
* Treatment with iron chelators (deferasirox, deferoxamine, ...).

Primary outcomes:
measure: SN detection
timeFrame: During surgery
Secondary outcomes:
measure: SN agreement
timeFrame: During surgery
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario "Virgen de la Arrixaca"
Study officials:
References:
Clinical trial NCT03993015: Accuracy of eDiagEPU, a Medical Computerized Tool for EPU
Official title: eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women Less Than 14 Weeks of Gestation
Keywords: Viable pregnancy
miscarriage
ectopic pregnancy
early pregnancy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women less than 14 weeks of gestation

Brief summary: In a recently published study, a poor knowledge of guidelines in the field of early pregnancy was observed in France, Belgium and Switzerland. To improve the respect of the most recent criteria of diagnoses, a computerized tool was developped.

Detailed description: In December 2018, the investigators published an prospective multinational survey, with 17 questions that assessed the participants' knowledge, interest, and management of early pregnancy in France, Belgium and Switzerland1. Knowledge about early management of pregnancy was limited among the practitioners surveyed ; 211/306 (69.0%) participants reported incorrect management when they visualized a gestational sac without embryo and 265/306 (86.6%) misinterpreted changes in serum levels of chorionic gonadotropin during early pregnancy.

To fill this gap, the investigators developped a computerized tool who is following strictly the most recent criteria of diagnoses in the field of early pregnancy. This tool should be evaluated in an observational study, using data of real patients without modification of their management.

Eligibility criteria: Inclusion criteria:

* Pregnancy of unknown location (hCG + without gestational sac found in ultrasound)
* Viable pregnancy with embryo less than 14 weeks of gestation
* Non-viable pregnancy ; ectopic pregnancy, complete, incomplete or missed miscarriage

Exclusion criteria:

- Incomplete follow up and no diagnosis and lack of data to establish a diagnosis

Primary outcomes:
measure: tyde of Medical diagnosis (senior physician)
timeFrame: 1 week
measure: tyde of Medical diagnosis (diagnosis tool)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Frederic BLAVIER, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blavier F, Cosyns S, Dony N, Faron G, Parra J, Gucciardo L. Perception and knowledge of early pregnancy assessment units among perinatal practitioners in Europe. Int J Gynaecol Obstet. 2018 Dec;143(3):289-299. doi: 10.1002/ijgo.12661. Epub 2018 Sep 21.
Clinical trial NCT04009785: Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home
Official title: Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti Infective
Pediatric Population
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 75
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in the study are patients under 16 years of age (\< 16 years of age) admitted to full hospitalization in the paediatric units

Brief summary: Nowadays, resistance to anti-infectives has become a global public health problem and its increased prevalence threatens human health.

To date, few studies have focused on drug compliance in the paediatric population and it varies according to the pathology This drug adherence in the paediatric population is directly linked to outpatient care by the parents or the child's immediate family. In addition, there are no studies on adherence to antibiotics prescribed at the end of hospitalization in the paediatric population.

In this context, it seems urgent to seek an intervention capable of leading to responsible and appropriate use of antibiotics in order to improve efficiency in the drug management of acute paediatric infections.

This pilot study would characterize pediatric patients and determine the compliance rate in this population.


Eligibility criteria: Inclusion Criteria:

* The patient is under 16 years of age (\< 16 years of age).
* The patient is admitted to a full hospitalization in one of the 2 paediatric units of the University Hospital of Nîmes.
* The patient is discharged with a prescription for anti-infectives to be taken at home, for a maximum of 30 days.
* The patient and the holder of parental authority are available for a follow-up of 1 month after discharge from hospital.

Exclusion Criteria:

-

Primary outcomes:
measure: Rate of patients observing anti-infectives
timeFrame: 2018
Secondary outcomes:
measure: Rehospitalization rates / emergency visits related to worsening infection
timeFrame: 2018
Other outcomes:
measure: Rate of observing patients who have recovered their anti-infective treatment
timeFrame: 2018
measure: Rate of observing patients who have taken anti-infective treatment as prescribed
timeFrame: 2018
measure: Sociodemographic and clinical characteristics
timeFrame: 2018
measure: Overall success rate in the quiz on understanding anti-infectives
timeFrame: 2018
Locations:
city: Nîmes
country: France
facility: Chu Nimes
Study officials:
References:
Clinical trial NCT00971685: The Treatment of Lenalidomide in Patients With POEMS Syndrome
Official title: Evaluation of Efficacy and Safety of Lenalidomide (Revlimid®) in Patients With POEMS Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: POEMS Syndrome
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate.

More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of POEMS syndrome based on published diagnostic criteria

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Primary outcomes:
measure: Evaluation of clinical efficacy of Lenalidomide for 21 days every month for 6 cycles, with once-weekly dexamethasone (40 mg)) in patients with POEMS syndrome after 6 cycles.
timeFrame: one year
Secondary outcomes:
measure: Evaluation of the safety and the activity.
timeFrame: one year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinco Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06378385: Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition
Official title: Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aging
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dental surgeons with experience in the subject of Childhood Early Oral Aging Syndrome

Brief summary: Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population.


Eligibility criteria: Inclusion Criteria:

-Dental surgeons

Exclusion Criteria:

-Other healthcare professionals

Primary outcomes:
measure: Development of CEOAS index
timeFrame: Immediately
Secondary outcomes:
measure: Validation of CEOAS index
timeFrame: Immediately
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Universidade Metropolitana de Santos - UNIMES
state: São Paulo
Study officials:
References:
Clinical trial NCT03972085: Neural Gliding Exercise for Low Back Pain
Official title: Comparison of Conservative Treatment With and Without Neural Gliding Exercise for Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Neurodynamics
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a very common problem that causes pain, disability, gait and balance problems. Neurodynamic techniques is used for treatment of low back pain. The aim of the study is comparing the effects of electrotherapy and neural mobilization techniques on pain, functionality, gait and balance.

Detailed description: There are many physiotherapy modalities in the treatment of low back pain (LBP). Electrotherapy procedures, manual therapy techniques, kinesiotherapy and specific exercises are among those that are frequently used. In neural mobilization techniques, which began to gain popularity in 1990s, neural tissue and the surrounding structures are glided or tensioned to mobilize them. Neural mobilization is thought to have a positive effect on symptoms by inducing intraneural circulation, axoplasmic flow, and neural visco-elasticity and sensitivity associated with the connective tissue. There are studies in which this modality has yielded therapeutic success in terms of both pain and functionality, particularly in lumbar region and lower limb disorders where neural mechanosensitivity is increased.

Eligibility criteria: Inclusion Criteria:

* Subjects scoring below 70 degrees in the straight leg raise test
* received no physiotherapy until at least 6 months before initial evaluation

Exclusion Criteria:

* subjects who were unable to walk independently,
* who had systemic diseases besides LBP,
* who underwent spinal and lower limb surgery,
* who scored above 70 degrees in the straight leg raise test,
* used analgesics within 48 hours before initial evaluation were excluded.

Primary outcomes:
measure: Visual Analog Scale (VAS) for pain levels
timeFrame: 3 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
state: Center
Study officials:
References:
Clinical trial NCT01151085: Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Mycosis
Keywords: Systemic Mycosis
Aspergillus infection
Candidiasis
Cryptococcal infections
Japanese
voriconazole
VFEND
Regulatory Post Marketing Commitment Plan.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 1002
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).

Brief summary: To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.

Detailed description: All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.

Exclusion Criteria:

* Subject who heve been prescribed voriconazole (VFEND) before.

Primary outcomes:
measure: Number of Participants With the Frequency of Treatment Related Adverse Events.
timeFrame: 16 weeks
measure: Number of Participants That Responded to Voriconazole Treatment.
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
timeFrame: 16 weeks
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.
timeFrame: 16 weeks
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.
timeFrame: 16 weeks
measure: Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.
timeFrame: 16 weeks
measure: Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05439785: Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss
Official title: A Comparison of Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss in Patients With Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Dental Plaque
Lead sponsor: Fatima Jinnah Dental College
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare between plaque control efficacy of interdental brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and to determine the most convenient routine interdental plaque control method amongst the two


Eligibility criteria: Inclusion Criteria:

* All patients above 18 years of age with gingivitis
* patients of both gender

Exclusion Criteria:

* patients who refuse participate in the study
* patients with systemic medical problems
* patients using medications that may affect gingival tissue (overgrowth/bleeding)
* patients habitual of betel nut/tobacco smoking/substance abuse
* patients with fluorosis or any other enamel and dentinal deformity
* pregnant women
* patients undergoing orthodontic treatment

Primary outcomes:
measure: Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6
timeFrame: baseline and week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Fatima Jinnah Dental College and Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT03613285: A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets
Official title: A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Resorption
Lead sponsor: Institute of Dental Science and Technologies
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of the study was to evaluate and compare the extent of root resorption in the maxillary and mandibular anterior teeth during orthodontic treatment with the use of different types of brackets. Materials and methods: The study consisted of 21 patients (11 males and 10 females) within the age group of 16-25 years, having bimaxillary protrusion. They were divided into three groups. In Group 1- Conventional brackets, Group 2- Self-ligation brackets:Smart Clip (Passive), and in Group 3 Self-ligation brackets: Empower (Active) were bonded. Computed Tomography scans and Orthopantomograms were taken before start of treatment and after six months of retraction. Root resorption is computed as the difference between the pre treatment total tooth length and the post treatment total tooth length.


Eligibility criteria: Inclusion Criteria:

- Patients having complete root formation at start of treatment,

Exclusion Criteria:

* Patients with skeletal or dental anomalies .
* Patients having history of root resorption
* Patients having any systemic or metabolic anomalies,
* Patients with trauma of anterior teeth
* Patients with periapical inflammation of the anterior teeth
* Patients with impacted teeth
* Patients with tumors and cysts in the examined area
* Patients having undergone orthodontic treatment previously.

Primary outcomes:
measure: root resorption
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghāziābād
country: India
facility: Institute of Dental Studies & Technologies
state: Uttar Pradesh
Study officials:
affiliation: IDST
name: Puneet Batra, MDS
role: STUDY_CHAIR
References:
Clinical trial NCT00068185: A Study of the Pharmacokinetics of Black Cohosh
Official title: Interactions Between SERMs, Soy and Black Cohosh
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hot Flashes
Keywords: Black cohosh
Pharmacokinetics
Alternative therapies
Natural product
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-09-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. Remifemin is a standardized form of black cohosh. The purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking Remifemin.

Detailed description: As per Brief Summary

Eligibility criteria: Inclusion Criteria:

* No prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix
* No current prescription medication use
* Negative urine pregnancy test OR greater than age 50 with no menses for at least one year OR documented status post hysterectomy
* Competent to understand and sign informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Heather S Shaw, MD
role: PRINCIPAL_INVESTIGATOR
References: