louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03016117: Anesthetic Efficacy of PECS II Block and Parasternal Block
Official title: Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery

Detailed description: All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II block, performed at the 4th rib level, and parasternal block performed at the level of the 2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be recorded

Eligibility criteria: Inclusion Criteria:

* patients who need of quadrantectomy with or without axillary dissection
* ASA I-III patients
* age between 18 and 75 years
* filled informed consent

Exclusion Criteria:

* pregnant women
* obesity (BMI \> 39,99)
* radical mastectomy
* ASA IV patients
* chest wall abnormalities
* neurological disorders
* septic status
* chest skin infections
* coagulopathies

Primary outcomes:
measure: Anesthetic efficacy
timeFrame: The anesthetic efficacy was assessed in the first 72 hours, after block
Secondary outcomes:
measure: Painkillers request
timeFrame: The painkillers request was assessed in the first 72 hours, after surgery
measure: Side effects
timeFrame: The side effects recorded in the first 72 hours, after surgery
Other outcomes:
Locations:
city: Coppito
country: Italy
facility: San Salvatore Academic Hospital
state: L'Aquila
Study officials:
affiliation: San Salvatore Academic Hospital
name: Pierfrancesco Fusco, MDD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03075917: Validation of an Allergic Rhinitis Control Test in Children
Official title: Validation of an Allergic Rhinitis Control Test in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 135
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.


Eligibility criteria: Inclusion Criteria:

* Patients aged 5 to 11 years old, consulting a practitioner for an allergic rhinitis
* Parents formulated their study participation agreement by signing the consent form.

Exclusion Criteria:

* Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatment.

Primary outcomes:
measure: Score of the allergic rhinitis control self questionnaire
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bagnols-sur-Cèze
country: France
facility: CH Louis Pasteur
city: Lasalle
country: France
facility: Maison de santé de Lasalle
city: Millau
country: France
facility: CH de MILLAU
city: Montpellier
country: France
facility: Centre (Ctre) Medical Ravas - Malbosc
city: Montpellier
country: France
facility: University hospital of Montpellier
city: Paris
country: France
facility: Hôpital Trousseau,
Study officials:
References:
Clinical trial NCT06293417: To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
Official title: To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: T2DM (Type 2 Diabetes Mellitus)
Dyslipidemias
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 3958
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: The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:

* major adverse cardiovascular events within 48 months of the trial duration
* microvascular events within 48 months of the trial duration

Detailed description: A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial to assess the long-term efficacy and safety of Combined Therapy with Ezefeno Tab. in patients with dyslipidemia who do not achieve adequate control of Non-HDL-C levels even with Moderate-intensity monotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
* Age ≥ 19 years
* Non-HDL-C ≥100 mg/dL, TG ≥200, \<500 mg/dL on moderate-intensity statins
* with cardiovascular risk factor

Exclusion Criteria:

* Pregnant or breastfeeding women
* Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
* Patient with myopathy and rhabdomyolysis
* AST/ALT more than 3 ULN
* Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption

Primary outcomes:
measure: major adverse cardiovascular events and diabetic microvascular events for 48 months
timeFrame: 48month from baseline
Secondary outcomes:
measure: proportion of patients achieving Non-HDL-C less than 100mg/dL
timeFrame: 48month from baseline
measure: proportion of patients achieving LDL less than 70mg/dL
timeFrame: 48month from baseline
measure: change in Non-HDL-C at 48month from baseline
timeFrame: 48month from baseline
measure: change in LDL at 48month from baseline
timeFrame: 48month from baseline
measure: change in HDL-C at 48month from baseline
timeFrame: 48month from baseline
measure: change in TG at 48month from baseline
timeFrame: 48month from baseline
measure: change in LDL-C/HDL-C ratio at 48month from baseline
timeFrame: 48month from baseline
measure: change in TC/HDL-C ratio at 48month from baseline
timeFrame: 48month from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: SIN-GON KIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339517: Postoperative Identification of Tumor Cells At the Lumpectomy Site of Patients with Early Breast Cancer
Official title: Postoperative Identification of Tumor Cells At the Lumpectomy Site of Patients with Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 20
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: For early breast cancer, local surgery followed by breast radiation is a standard local treatment. It has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. The researchers think that such relapse occurs because of persistent tumor cells (PTCs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. The researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. Results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.


Eligibility criteria: Inclusion Criteria:

1. Women with pathologic stage I to IIB invasive mammary breast cancer.
2. Tumor size over 1 cm.
3. Patient age 50 years or younger.
4. Primary tumor non-lobular.
5. Primary tumor non-low grade or Oncotype DX score \> 18.
6. Patient is six weeks or earlier post-lumpectomy.
7. Seroma is clinically palpable and symptomatic causing discomfort and/or swelling of the lumpectomy site OR re-excision of the lumpectomy site is planned.

Primary outcomes:
measure: Identification of Persistent Tumor Cells (PTCs)
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Program; Lawson Research Institute
state: Ontario
Study officials:
affiliation: Lawson Research Institute
name: Francisco Perera, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05460117: Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population
Official title: Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascia; Contracture
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

Detailed description: Plantar Fasciopathy pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. Many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing foot injuries by using a radiofrequency stimulus.

The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Eligibility criteria: Inclusion Criteria:

* Age between 18-50 years --Sporty people with at least 3 days of training per week and presenting an upper limb dominance

Exclusion Criteria:

* Suffer from any painful shoulder condition.
* History of significant shoulder trauma, such as fracture or ultrasonography
* Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.
* Recent shoulder dislocation in the past two years

Primary outcomes:
measure: Change from Baseline in plantar fasciopathy measured by quantified elastography.imaging at 3 months [ Time Frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)]. Changes in tendinous thickness
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Clinica Ana Gonzalez
state: Málaga
city: Malaga
country: Spain
facility: Clinica Ana Gonzalez
state: Málaga
Study officials:
References:
Clinical trial NCT01413217: Which is a Better Breakfast? Egg or Cereal?
Official title: "Which is a Better Breakfast? Egg or Cereal?"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hunger
Satiety
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2011-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the community area of Baton Rouge, LA area exclusively random process to guarantee that each participant or population has specified chance of selection.

Brief summary: Which is a better breakfast? Egg or cereal?

Detailed description: Which breakfast has the most beneficial effect on blood glucose and insulin, blood hormones and blood pressure, egg or cereal breakfast? Over a seven week period the participant will take part in eating breakfast of either egg breakfast or cereal breakfast which will be monitored. Blood samples will be taken before participants eat and different times throughout until after Lunch on day 1 and day 7. Questionnaires will be given to determine satiety (feeling of fullness) and hunger before and after breakfast and lunch. After a two week period participants will return for another week of the same procedure and tests that was followed from Day 1 though day 7 listed. However, this time participants will be eating the second of the two breakfasts whichever one they did not have for the first test period.

Eligibility criteria: Inclusion Criteria:

* 18-60 years of age
* not lost more than 5% of body wight in the past 3 months, or not trying to actively lose weight at the moment.
* are not suffering from disease such as major heart conditions, cancer, type 1 diabetes, eating disorders, very high cholesterol or triglycerides levels, or any serious illness that requires intensive and long term medical treatment.

are not allergic to or sensitive to eggs, soy or wheat, and do not dislike these foods.

* have a BMI of equal to or \>30 to equal to or \<60

Primary outcomes:
measure: Caloric intake for Lunch after you have received an Egg or Cereal Breakfast and Levels of glucose, insulin, and lipids are measured.
timeFrame: 7 weeks
Secondary outcomes:
measure: Satiety or hunger
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: Bayham BE, Greenway FL, Johnson WD, Dhurandhar NV. A randomized trial to manipulate the quality instead of quantity of dietary proteins to influence the markers of satiety. J Diabetes Complications. 2014 Jul-Aug;28(4):547-52. doi: 10.1016/j.jdiacomp.2014.02.002. Epub 2014 Feb 13.
Clinical trial NCT06283017: Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
Official title: Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea
Sleep Apnea, Obstructive
Sleep Disorder
Sleep Apnea Syndromes
Lead sponsor: Invicta Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Adelaide Institute for Sleep Health, Flinders University
First posted: 2024-02-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.


Eligibility criteria: Inclusion Criteria:

Subject must be eligible for a diagnostic or surgical procedure and

* Suffers from OSA (apnea/hypopnea index \>10 event/h sleep) based on history and a physical exam.
* Is a surgical candidate.
* Is willing and capable of providing informed consent.
* Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
* Is willing to participate in the designated follow-up visits.
* Must be in good general health.
* Is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
* Must be minimum of 18 years and maximum 80 years of age.

Exclusion Criteria:

* Has Body Mass Index above 35 kg/m2.
* Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
* Has significant co-morbidities making them unable or inappropriate to participate in this POC study.

Primary outcomes:
measure: Target identification and access outcomes
timeFrame: Day 0
measure: Tongue protrusion outcomes
timeFrame: Day 0
measure: Characterization of lead placement outcomes
timeFrame: Day 0
measure: Lead placement and removal outcomes
timeFrame: Day 0
measure: Safety outcomes
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Adelaide Institute for Sleep Health, Flinders University
state: South Australia
Study officials:
References:
Clinical trial NCT01176617: Assessing Arrhythmias After Ablation Using Implantable Recorders
Official title: Assessment of Arrhythmia Burden in Patients Undergoing Atrial Fibrillation Using an Implantable Loop Recorder (ILR) Versus Conventional Monitoring Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
A-Fib
AF
Persistent
Permanent
Pulmonary Vein isolation
Ablation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2010-08-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. The device being used for this study is the Reveal XT, which, is currently FDA approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years
* Undergoing ablation for atrial fibrillation at the University of Pennsylvania

Exclusion Criteria:

* Patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices

Primary outcomes:
measure: Arrhythmia Burden
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Detection of Actionable Events Resulting in Change of Clinical Care
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sanjay Dixit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kapa S, Epstein AE, Callans DJ, Garcia FC, Lin D, Bala R, Riley MP, Hutchinson MD, Gerstenfeld EP, Tzou W, Marchlinski FE, Frankel DS, Cooper JM, Supple G, Deo R, Verdino RJ, Patel VV, Dixit S. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. 2013 Aug;24(8):875-81. doi: 10.1111/jce.12141. Epub 2013 Apr 11.
Clinical trial NCT02659917: Performance of Glass-ionomer Cements: 2-year Follow-up
Official title: Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Keywords: glass-ionomer cement
atraumatic restorative treatment
pit and fissure sealants
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 147
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.

Detailed description: Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.

Eligibility criteria: Inclusion Criteria:

* Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
* Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.

Exclusion Criteria:

* Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
* No history of spontaneous pulpal pain.

Primary outcomes:
measure: Number of the teeth with glass-ionomer cement retention and prevention of caries.
timeFrame: 6-month
measure: Number of the teeth with good restoration and caries absence.
timeFrame: 6-month
Secondary outcomes:
measure: Frequency of loss of the sealing material and prevention of caries.
timeFrame: 6-month
Other outcomes:
Locations:
Study officials:
affiliation: Piracicaba Dental School - University of Campinas
name: Raquel V Rodrigues, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School - University of Campinas
name: Ana Carolina G Luciano, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental School - University of Campinas
name: Kelly MS Moreira, MS Student
role: PRINCIPAL_INVESTIGATOR
References: