louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06375330: Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy.
Official title: Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. A 3-months Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disease
TMJ Pain
Keywords: polynucleotides
TMJ
VAS
Physiotherapy
Hyaluronic acid
Laterality
Lead sponsor: Sidoti & Tartaglia Srl
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy.


Eligibility criteria: Inclusion Criteria:

* patients who signed the informed consent
* age \>18;
* male and female sex;
* affected by temporomandibular arthrosis

Exclusion Criteria:

* Patients treated with painkillers and anti-inflammatories;
* patients suffering from rheumatoid arthritis with TMJ involvement;
* patients with a positive history of allergies to products of fish origin;
* patients suffering from alteration of the internal TMJ;
* patients suffering from mandibular condylar hyperplasia;
* patients suffering from myofascial pain syndrome;
* patients unable to express their consent for participation in the study;
* patients suffering from psychiatric and behavioral disorders;
* patients suffering from oncological and onco-haematological pathologies with compromised general clinical status.

Primary outcomes:
measure: Maximum mouth opening
timeFrame: 3 months
Secondary outcomes:
measure: Lateral movements improvements
timeFrame: 3 months
measure: Pain assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: MI
Study officials:
affiliation: ORDINARY PROFESSOR Department of Biomedical, Surgical and Dental Sciences
name: Gianluca Tartaglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05432830: Sex Differences in E-cig Perception: Study 1
Official title: Sex Differences in E-Cigarette Flavor Sensory Perception As It Relates to Appeal and Reinforcing Efficacy Among Adult Smokers: Study 1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Addiction
E-Cig Use
Cigarette Smoking
Sex Differences
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subject design, all participants will receive all flavors
Primary purpose: OTHER

Brief summary: The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.

Detailed description: This study looks at the effect of sex on the sensory effects of flavor components in e-cigarettes. Regular combustible tobacco users will sample 3 different flavored e-cigarettes containing nicotine in a human lab paradigm.

Eligibility criteria: Inclusion Criteria:

* 21-44 years old
* Able to read/write
* Current cigarette smoking
* Recent E-cig Exposure (\>/= 10 uses in past 6 mo.)
* Urine cot \>200ng/ml
* Willing to abstain from nicotine/tobacco 6-8hrs prior to lab session
* Not looking to quit

Exclusion Criteria:

* Untreated chronic medical conditions
* Non-stable Rx medication
* Illicit drug use
* Pregnant, trying to become pregnant, breastfeeding
* Not fully vaccinated for Coronavirus (e.g. COVID-19)

Primary outcomes:
measure: Appeal
timeFrame: immediately after intervention, up to 15 minutes
measure: Sensory Effects
timeFrame: immediately after intervention, up to 15 minutes
measure: Reinforcing Efficacy
timeFrame: immediately after intervention, up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Danielle Davis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05972330: Efficacy of VRx MyBiotics Oral Lozenges
Official title: Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Microbiome Health
Keywords: oral health
oral lozenge
oral microbiome
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be assigned an oral lozenge formulation based on the baseline analysis of their oral microbiome.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome.

Detailed description: This is a single arm, interventional trial on adults residing in the United States. The study will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at improving oral microbiome health according to Viome's Oral Health Score.

Eligibility criteria: Inclusion Criteria:

* Any person with a US address that is 18 years old or older
* Able to speak and read English
* Willing and able to follow the trial instructions, as described in the recruitment letter
* Signed and dated informed consent prior to any trial-specific procedures.

Exclusion Criteria:

* Systemic antibiotic treatment 30 days prior to enrollment or during the trial
* Not willing to stop sporadic use (less frequently than daily) of any mouthwash.
* Significant diet, supplements, or lifestyle change in the previous 1 month or next 2 months once enrolled
* Allergy to tapioca, peppermint, or sweet potato
* Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent caries, oral cancer, etc)
* No dental procedures 30 days prior to enrollment or during the trial (regular cleanings, bone grafts, dental implants, etc)
* Pregnancy or planned pregnancy
* Currently have cancer or undergoing cancer therapy
* Dentures
* Fewer than 20 teeth
* Use of at home teeth whitening products 30 days prior to enrollment or during the trial
* Start new medications or supplements during the trial

Primary outcomes:
measure: Viome Oral Health Score
timeFrame: ~ 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03675230: Study of Tomotherapy HD in Medulloblastoma
Official title: Study of Tomotherapy HD in Medulloblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medulloblastoma
Keywords: TOMO irradiation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 220
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.

Detailed description: The technical advantages of Tomotherapy HD in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.

Eligibility criteria: Inclusion Criteria:

* The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery.

Exclusion Criteria:

* Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.

Primary outcomes:
measure: QoL(quality of life)
timeFrame: 2 years
Secondary outcomes:
measure: PFS (progression free survival)
timeFrame: 2 years
measure: OS (overall survival)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: mawei jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06257030: The AMARA (As Much As Reasonably Achievable) Study
Official title: The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals presenting with either primary or metastatic hepatic malignancies are the study population.

Brief summary: Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose \>200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.


Eligibility criteria: Inclusion Criteria:

* Age \>18 yr
* Both sexes eligible for study
* Patients with primary or secondary liver tumors
* Liver dominant disease
* At least one lesion greater than 5.0 cm in maximum diameter
* Life-expectancy \> 3 months
* FLR \>40% or greater than 500mls
* Must be able to tolerate pre-treatment CT scan , DSA and 99mTc-MAA infusion and imaging with SPECT/CT scan
* Able to schedule and tolerate post-treatment Y90 PET/CT imaging
* Able to tolerate follow-up imaging with dynamic contrast CT liver phase or MRI with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.

Exclusion Criteria:

* Child Pugh \> B
* Bilirubin \>2 mg/dl
* Albumin\<3.0
* Central portal invasion
* Multi-focal bilobar disease
* Disseminated extrahepatic disease
* Lung shunt \>20% or a estimated Lung dose \> 20 Gy
* Focuses of extra-hepatic liver uptake.
* Patients that cannot tolerate addition follow-up imaging.

Primary outcomes:
measure: Complications
timeFrame: 6 months
measure: LPFS
timeFrame: 2 years
measure: Tumor Response
timeFrame: 2 years
Secondary outcomes:
measure: Post-treatment dosimetry analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Patra
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Platon Dimopoulos, Resident
role: STUDY_DIRECTOR
References:
Clinical trial NCT01965730: Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery
Official title: The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Aortic Disease
Keywords: dilated ascending aorta
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events


Eligibility criteria: Inclusion Criteria:

* Ability to sign informed consent
* Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest

Exclusion Criteria:

* Inability to sign informed consent
* Baseline hypercoagulable condition as defined in medical record
* Coronary disease with untreated lesions or recent coronary stent placement
* Severe renal dysfunction (ESRD) as documented in medical record

Primary outcomes:
measure: degree of fibrinolysis as measured by thromboelastography
timeFrame: Length of cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Prakash A Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01782430: PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Official title: PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Adult Patients
Requiring Intubation
Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)
Patient Covered by French Health Care System
Keywords: Preoxygenation
Intubation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Hopital Gabriel Montpied
First posted: 2013-02-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Detailed description: Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Eligibility criteria: Inclusion Criteria:

* adults patients
* requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
* patient covered by french health care system

Exclusion Criteria:

* patient refusal
* intubation for other causes (excluding hypoxemia)
* impossibility to measure pulse oxymetry value
* contraindication for NIV : vomiting
* NIV intolerance
* cardiac arrest during intubation

Primary outcomes:
measure: least pulse oxymetry value
timeFrame: at day 1
Secondary outcomes:
measure: pulse oxymetry value (at the end of preoxygenation)
timeFrame: at 5 minutes and at 30 minutes after intubation
measure: Partial pressure of arterial oxygen (PaO2)
timeFrame: at day 1
measure: Regurgitation rate
timeFrame: at day 1
measure: oxyhemoglobin desaturation below 80 %
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04855630: Combating Alzheimer's Through Sleep and Exercise
Official title: Combating Alzheimer's Through Sleep and Exercise (CASE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Shipley Foundation
name: Dreem
First posted: 2021-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to see how sleep and exercise affects dementia risk over time.


Eligibility criteria: Inclusion Criteria:

1. Able to perform mild exercise
2. Able to wear DREEM 2 Headband
3. Able to wear a Fitbit wrist watch
4. Able to perform the Everlywell biomarker procedure
5. Able to Understand and Speak English
6. Able to operate a digital device like mobile phone, iPad, or computer
7. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
8. Only participants cognitively able and willing to provide consent will be included.

Exclusion Criteria:

1. Prohibited from or unable to perform mild exercise
2. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
3. Unable to speak or understand English
4. Unable to use mobile device/smartphone technology
5. Unable or unwilling to consent for any reason.

Primary outcomes:
measure: Total Cholesterol Levels
timeFrame: Up to Week 12
measure: High-Density Lipoprotein (HDL) Levels
timeFrame: Up to Week 12
measure: Low-Density Lipoprotein (LDL) Levels
timeFrame: Up to Week 12
measure: Triglycerides Levels
timeFrame: Up to Week 12
measure: High-sensitivity C-reactive protein (hs-CRP) Levels
timeFrame: Up to Week 12
measure: HbA1c Levels
timeFrame: Up to Week 12
measure: Heart Rate
timeFrame: Up to Week 12
measure: Blood Pressure
timeFrame: Up to Week 12
measure: Total Sleep Duration
timeFrame: Up to Week 12
measure: Slow Wave Sleep Duration
timeFrame: Up to Week 12
measure: Cortisol Levels
timeFrame: Up to Week 12
measure: Cortisone Levels
timeFrame: Up to Week 12
measure: Melatonin Levels
timeFrame: Up to Week 12
measure: Creatinine Levels
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospitals
state: Florida
Study officials:
affiliation: University of Miami
name: Azizi A Seixas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06752330: Evaluation of the Effect of a Probiotic in Patients Undergoing Orthodontic Therapy
Official title: Evaluation of the Effect of a Probiotic in Subjects Undergoing Fixed Orthodontic Appliances With Multibrackets or Clear Aligners: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontics
Dental Hygiene
Gingivitis and Periodontal Diseases
Keywords: probiotics
Fixed orthodontic
oral hygiene
clear aligners
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Orthodontic patients need supplementary oral hygiene tools in addition to professional oral hygiene. The aim of this study is to evaluate the effects of Bifidobacterium animalis subs. Lactis HN019 on plaque accumulation and gingival bleeding in orthodontic patients.


Eligibility criteria: Inclusion Criteria:

* age range of 10 to 30 years old;
* good general health;
* patients undergoing fixed multibracket orthodontic treatment;
* patients undergoing invisible aligner orthodontic treatment.

Exclusion Criteria:

* physical, mental or motor disabilities;
* systemic conditions that influence the progression of gingivitis;
* presence of non-plaque-induced gingivitis;
* known allergies;
* smokers (if more than 5 cigarettes per day);
* use of antibiotics, anti-inflammatories, or probiotics in the 6 months prior to recruitment.

Primary outcomes:
measure: Full Mouth Bleeding Score (FMBS)
timeFrame: 4 months
Secondary outcomes:
measure: Full Mouth Plaque Score (FMPS)
timeFrame: 4 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
References:
Clinical trial NCT06107530: Living a Pregnancy After a Peri-natal Grief: How Well Does Pregnancy Follow-up Meet Women's Needs and Expectations?
Official title: Living a Pregnancy After a Peri-natal Grief: How Well Does Pregnancy Follow-up Meet Women's Needs and Expectations?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: peri-natal loss
pregnancy follow up
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Every year in France, around 7,000 children are born without life, following a medical termination of pregnancy (IMG), fetal death in utero (FDIU) or premature delivery ("late miscarriage"). For families affected by perinatal bereavement, the pregnancy that follows this silent birth is a moment apart, between anguish and guilt, joy and apprehension. The aim of this research project is to improve the understanding of what women go through during the pregnancy that follows, with a view to proposing a practical tool for the professionals who take care of them, in order to improve and personalize their follow-up.


Eligibility criteria: Inclusion Criteria:

* Women who have given birth to a stillborn child (singleton or twin pregnancies):

  * delivery following fetal death in utero or medical termination of pregnancy at 15 weeks gestational age and later
  * extreme preterm birth ("late miscarriage") from 15 weeks gestational age Patient who subsequently carried a pregnancy to term and gave birth to a live, viable child between 2020 and 2023.
* French-speaking patient
* Patient who does not object to her participation in this research study

Exclusion Criteria:

* Women who have experienced a natural termination of pregnancy ("early miscarriage") before 15 weeks of amenorrhea.
* Women who have given birth by suction in the operating theatre.
* Women who are pregnant with twins in the pregnancy following bereavement. Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection

Primary outcomes:
measure: Identify women's specific needs and expectations for the follow-up of this particular pregnancy
timeFrame: 4months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation hôpital Saint Joseph
Study officials:
References: