louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06554756: Annexin Levels of Periodontal Inflammatory Regulation
Official title: Annexin Levels in GCF Determine the Imbalance of Periodontal Inflammatory Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Inflammation
Keywords: periodontal disease
annexin
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Saliva, serum and gingival crevicular fluid of periodontitis patients collected for analyzing anxa1, anxa2 and IL-1beta
Primary purpose: PREVENTION

Brief summary: ANXA1, a member of the annexin family, plays a role in the resolution of inflammation and the regulation of anti-inflammatory responses, while ANXA2 is involved in the initiation of the inflammatory responses. The aim of this study was to determine the effects of annexin family (ANXA1 and ANXA2) in periodontal disease.

Detailed description: Healthy participants (n:25) and stage III, grade B periodontitis (n:25) patients enrolled for this study. Clinical periodontal parameters and PISA levels were noted. Serum, saliva, and GCF samples were collected to measure the ANXA1, ANXA2 and IL-1β levels.

Eligibility criteria: Inclusion Criteria:

systemically healthy

* clinical diagnosis of periodontitis
* clinical diagnosis of periodontal health

Exclusion Criteria:

* • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)

  * nonsurgical periodontal treatment (previous 6 months)
  * surgical periodontal treatment (previous 12 months)
  * presence of\<10 teeth
  * current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
  * diabetes
  * diagnosis of rheumatoid arthritis
  * pregnancy
  * lactating
  * smoking
  * excessive alcohol consumption.

Primary outcomes:
measure: Pocket probing depth
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Bleeding on probing
timeFrame: 6 months
Secondary outcomes:
measure: Saliva, serum and GCF samples processing and analyses
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, School of Dentistry
state: Fatih
Study officials:
References:
Clinical trial NCT04377256: Hyaluronic Acid Effect on Xenogenic Bone Healing
Official title: Hyaluronic Acid Effect on Xenogenic Bone Substitutes Healing During Ridge Preservations: A Radiological and Histomorphometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Tooth Loss
Keywords: tooth extraction
ridge preservation
hyaluronic acid
dental implant
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation.

Following tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. at the implant placement phase, a cone beam computer assisted tomography file is recorded in order to compare it with the baseline and a biopsy to evaluate the histological consequences.


Eligibility criteria: Inclusion Criteria:

* Patients in need of tooth extraction and willing to receive dental implants in the extraction site
* Presence of two mono radicular teeth in need of extraction

Exclusion Criteria:

* Patients with systemic diseases
* Patients under 8 years and above 60 years.
* Presence of endodontic or periodontal lesion in the extraction sites

Primary outcomes:
measure: Radiological assessement of the boe resorption
timeFrame: 4 months
measure: Histomorphometric analysis
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph university
city: Beirut
country: Lebanon
facility: Universte Saint Joseph-Beyrouth
Study officials:
affiliation: Head of oral surgery department, facuty of dentistry ,Universite SainT Joseph-Beyrouth
name: Ronald J Younes, Phd
role: STUDY_DIRECTOR
affiliation: Department of oral surgery, facuty of dentistry ,Universite SainT Joseph-Beyrouth
name: Bachar A Husseini, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03671356: Risk Management in Interventional Cardiology - a Quality Management Single-center Registry
Official title: Risk Management in Interventional Cardiology - a Quality Management Single-center Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: risk score
risk management
NCDR
interventional cardiology
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 2067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consenting adult patients undergoing cardiac catheterization at University Hospital Düsseldorf, Germany

Brief summary: The validity and applicability of different clinical risk scoring models in a variety of settings of interventional cardiology is evaluated in a retrospective and continuing prospective single-center registry at University Hospital Düsseldorf. Risk-adapted safety interventions are additionally tested.

Detailed description: Beginning with a retrospective assessment of 2014-2017 and continuing with a prospective registry, clinical outcomes of interventional cardiac catheterization procedures at University Hospital Düsseldorf in a variety of settings (elective and emergency coronary procedures, structural and rhythmologic cardiac interventions etc.), will be evaluated. Different risk scoring models are recommended for risk stratification by cardiovascular societies (e.g. GRACE, CRUSADE, NCDR, ACEF, EUROScore scores) and will be evaluated for their applicability to contemporary and local clinical practice in interventional cardiology. Risk-adapted safety interventions (e.g. intensified monitoring, vascular access closure, renal protective measures) will be applied to all patients and will be evaluated for their impact on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* \>18 yeas of age, written informed consent, cardiac catheterization at university hospital Düsseldorf, Germany

Exclusion Criteria:

* no written informed consent

Primary outcomes:
measure: mortality
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding (according to BARC bleeding definition)
timeFrame: 30 days and up to 5 years post procedure
measure: Acute and chronic kidney injury (according to KDIGO definitions)
timeFrame: 30 days and up to 5 years post procedure
measure: TIA and Stroke
timeFrame: 30 days and up to 5 years post procedure
measure: Quality of life (assessed by standardized QoL surveys)
timeFrame: 30 days and up to 5 years post procedure
measure: Long-term mortality
timeFrame: up to 5 years post procedure
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06372756: Deep Learning Reconstruction Algorithms in Dual Low-dose CTA
Official title: Evaluation of Deep Learning Reconstruction Algorithms in Dual Low-dose CT Vascular Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Learning
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy or diseased adults undergoing CT vascular imaging

Brief summary: The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA.

Detailed description: 1. The raw data from patients who underwent head and neck CTA, coronary CTA, and abdominal CTA in both standard dose and double low-dose groups were included.
2. Techniques such as filtered back projection, iterative reconstruction, and deep learning reconstruction were performed.
3. The feasibility of deep learning reconstruction in double low-dose CTA was evaluated based on image quality and diagnostic performance.

Eligibility criteria: Inclusion Criteria:

* Patients with head and neck CTA, coronary artery CTA, and abdominal CTA due to stroke, coronary heart disease and abdominal inflammatory disease, and abdominal tumors.

Exclusion Criteria:

* Age \<18 years, pregnancy, allergic reaction to iodine contrast agent, renal insufficiency, and severe hyperthyroidism.

Primary outcomes:
measure: The specificity and sensitivity calculated through the optimal cutoff value of the receiver operating characteristic curve.
timeFrame: 2026.1
Secondary outcomes:
measure: The signal-to-noise ratio calculated from image CT values and noise
timeFrame: 2026.1
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Hao Tang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05608356: Effect of Injectable Platelet-rich Fibrin on the En Masse Retraction of Maxillary Anterior Teeth
Official title: Effect of Injectable Platelet-rich Fibrin (i-PRF) on the Rate of Orthodontic En Masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Platelet-rich Fibrin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 26
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional group will receive injectable platelet rich fibrin intraligamentally distal to the right and left canines, and palatal to the upper 4 incisors, in three time points with 21 days interval, control group will receive sham injection instead.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of local injection of injectable platelet rich fibrin (i-PRF) on the rate of orthodontic en masse retraction of anterior teeth clinically and to report any associated pain as well.

Detailed description: Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants.

1. Subject examination to ensure he/she meets the eligibility criteria of the research.
2. Leveling and alignment using fixed orthodontic appliance.
3. Upper first premolars extraction as a part of the orthodontic treatment planning.
4. With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.

Eligibility criteria: Inclusion Criteria:

1. Orthodontic patients with and age range (16 - 30) years.
2. Protruded upper anterior teeth requiring extraction of first premolars and anterior teeth retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
3. Patients with full permanent dentition (with the exception of third molars).
4. Healthy dental and periodontal condition with good oral hygiene

Exclusion Criteria:

1. Patients with extensive restorations on the anterior teeth.
2. Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.
3. History of previous orthodontic treatment or trauma to the anterior teeth.
4. Syndromic patients and patients with systemic diseases.
5. Poor oral hygiene or periodontal diseases.

Primary outcomes:
measure: Rate of En masse retraction
timeFrame: 4 months
Secondary outcomes:
measure: Associated Pain
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
References:
Clinical trial NCT02033356: ED95 of Lidocaine 1.0% for Filling the Adductor Canal
Official title: An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: adductor canal block
volunteers
US-guided peripheral nerve block
lower limb
MRI
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.


Eligibility criteria: Inclusion Criteria:

* 18-30 years
* Men
* American Society of Anesthesiologists' class 1
* Body Mass Index 18-25

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to the lower limb
* Diabetes Mellitus - Contraindications to MRI

Primary outcomes:
measure: To estimate the ED 95 for the volume needed to fill the adductor canal distally.
timeFrame: MRI performed 15 minutes post block
Secondary outcomes:
measure: To investigate the effect of volume on proximal spread to the femoral triangle
timeFrame: MRI performed 15 minutes post block
measure: Quadriceps muscle strength
timeFrame: 1 hour post block
measure: Pin prick test
timeFrame: 1 hour post block
measure: Temperature discrimination test
timeFrame: 1 hour post block
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Aleris-Hamlet Hospitals Copenhagen
Study officials:
affiliation: Department of Anaesthesia, HOC, Rigshospitalet, Denmark
name: Pia Jaeger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.
Clinical trial NCT05669456: Zeit Alert for Stroke at Home (ZASH) Protocol
Official title: Zeit Alert for Stroke at Home (ZASH) Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Ischemic Stroke
Stroke
Keywords: reoccurring
detection
Lead sponsor: Zeit Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects who are 18 years of age or older with a new acute ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the primary reason for hospital or clinic presentation during which screening took place.

Brief summary: This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight.

Detailed description: This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. Approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. The EEG tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. The labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use.

Eligibility criteria: Inclusion Criteria:

1. New ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the reason for current hospital admission or stroke clinics visit. Time from ictus to enrollment should be ≤ 2 weeks;
2. RRE-90 \> 2;
3. Age ≥ 18 years old;
4. Patient is discharged to home;
5. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Subject is a member of a vulnerable population, such as prisoners, individuals without legal papers, or otherwise exploitable population;
2. Treatment with another investigational drug or intervention within the last two (2) weeks prior to start of this study, if said drug/intervention is expected to interfere with the normal function of the Halo Alert System;
3. Does not have WIFI internet access in their home;
4. Does not have access to a smartphone;
5. Open traumatic injury on the head;
6. Allergy to any of the components of the headband, such as the fabric of the band (88% Rayon, 9% Nylon, 3% Spandex), the electrode surfaces (conductive silver ink.)

Primary outcomes:
measure: Feasibility of Halo Alert System to collect EEG data for algorithm development
timeFrame: 12 months enrollment period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06307756: The Effect of Music on Maternal Stress and Milk Amount
Official title: The Effect of Music Played to Mothers of Premature Babies Inpatient Neonatal Intensive Care Unit on Their Stress Levels and Milk Amount
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amount of Breast Milk
Maternal Anxiety Level
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk.


Eligibility criteria: Inclusion Criteria:

* Mothers whose babies are born prematurely (gestational age between 32-37 weeks), -whose babies do not have any congenital anomalies,
* whose babies are not connected to mechanical ventilation,
* who are over 18 years of age, who are not diagnosed with any psychological disease and
* who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Greater than 32-37 weeks of gestation

Primary outcomes:
measure: amount of breast milk measured at the same time every day
timeFrame: 4 months
Secondary outcomes:
measure: State Anxiety Inventory
timeFrame: 4 months
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi
Study officials:
References:
Clinical trial NCT05036356: Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE)
Official title: Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to develop a mobile app-based intervention to reduce burnout and improve well-being using human-centered design principles and stakeholder feedback.

Detailed description: Recent studies of professional burnout among physicians have highlighted urology as a worrisome outlier: 39% of practicing urologists and 64% of urology residents reported high levels of depersonalization and emotional exhaustion. Despite the known association of burnout with adverse clinical outcomes, psychological distress, and career dissatisfaction, rigorous studies of physician-focused interventions remain limited.

Pilot studies of well-being mobile applications (e.g. headspace ®) have demonstrated better outcomes compared to traditionally delivered mindfulness interventions (e.g. in-person guided meditation). Nevertheless, a rigorous assessment of the impact of an app-based intervention on burnout is needed.

Therefore, the present study will assess the effectivity of a mobile app-based intervention to reduce burnout among healthcare professionals.

Eligibility criteria: Inclusion Criteria:

* Being a health-professional at the Urology Department of Mayo Clinic, RST
* Sign the informed consent and agreed to share data from the app to the research team.

Exclusion Criteria:

* Using an alternate app designed with the same purpose at the beginning, part and/or entire duration of the study.
* Not provide any data despite being included in the study

Primary outcomes:
measure: Change in burnout syndrome
timeFrame: Baseline, Week 12, Week 24
measure: Change in professional fulfillment
timeFrame: Baseline, Week 12, Week 24
Secondary outcomes:
measure: User engagement metrics
timeFrame: Through study completion, approx. 24 weeks
measure: Qualitative knowledge and experience with app-based mindfulness practices
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Candace Granberg, MD
role: PRINCIPAL_INVESTIGATOR
References: