louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05011617: Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass
Official title: Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monitored Anesthesia Care
Cardiac Surgery
Postoperative Recovery
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Though Cardiac surgery under cardiopulmonary bypass (CPB) under epidural anesthesia in conscious patients is associated with increased risk of epidural hematoma. The investigators developed a monitored anesthesia care (MAC) platform for cardiac surgery under CPB. In the current prospective study, the investigators investigated the safety and effectiveness of the MAC platform versus intubated general anesthesia (IGA) in patients receiving elective open-heart surgery.

The study included adult patients who were scheduled to undergo open-heart surgery under CPB at Shuguang Hospital between April 2012 and December 2021. MAC consisted of local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil and electroacupuncture. MAC versus IGA was chosen by the patients. The investigators will investigate the safety and effectiveness of the MAC platform versus IGA in patients receiving elective open-heart surgery.

Detailed description: The detailed description of clinical trial will be published by protocol later.

Eligibility criteria: Inclusion Criteria:

* 1) NYHA class II or less;
* 2) expected aortic block time at ≤ 120 min;
* 3) body mass index (BMI) between 18 and 30 kg/cm2.

Exclusion Criteria:

* 1) systolic pulmonary blood pressure \> 70 mmHg;
* 2) chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, or simplified airway risk index \> 3;
* 3) Child-Pugh grade B or C liver insufficiency or renal insufficiency (24-h creatinine clearance \< 80 mL/min and blood urea nitrogen \> 7.5 mmol/L);
* 4) coagulopathy (aPTT prolongation \> 10 seconds versus normal controls, PT prolongation \> 3 seconds versus normal controls, and INR \> 3.0).

Primary outcomes:
measure: intraoperative consumption of opioids
timeFrame: end of the surgery, up to 48 hours after surgery
Secondary outcomes:
measure: time to drinking
timeFrame: through study completion, an average of 24 hours
Other outcomes:
measure: length of ICU stay
timeFrame: through study completion, an average of 12 days
measure: The Vasoactive-inotropic Score
timeFrame: end of the surgery, up to 48 hours after surgery
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Acupuncture and Anesthesia Research Institute, Shanghai, China
name: Jianggang Song, MD
role: STUDY_CHAIR
References:
Clinical trial NCT07004517: The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors
Official title: The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peri-Implantitis
Diagnosis
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: For this study, the calculation was estimated considering the peri-implantitis prevalence at implant level, thealternative the area under the receiver operating characteristic curve 0.90 , a 5% alpha error and 90% power. Thus, the minimum required sample size was 83 subjects.

Brief summary: The aim of the diagnostic accuracy study was to compare the diagnostic accuracy of probing depth before (PPD-1) and following (PPD-2) the removal of prothesis in identifying the presence of peri-implantitis and assess the factors influencing peri-implant probing.

Detailed description: This study aims to design a diagnostic accuracy study to compare the peri-implant probing depth and bleeding on probing before and after crown removal. It will explore the impact of prosthetic design on the accuracy of peri-implant probing and its diagnostic accuracy, and provide clinical recommendations on whether the prosthesis should be removed prior to peri-implant probing.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years.
2. The implant has completed osseointegration and has undergone final restoration for at least one month.
3. The final restoration needs to be removed or retrieved for various reasons.

Exclusion Criteria:

* Patients with serious systemic diseases, severe intraoral infections, severe mental disorders, pregnancy/lactation in women, or other conditions that make oral treatment operations unsuitable.
* History of crown removal or re-restoration within the past month prior to the visit.
* The prosthesis has fallen off or is severely damaged and has lost its original form before the visit.
* The prosthesis cannot be completely removed.
* Refusal to participate in this study.

Primary outcomes:
measure: probing depth
timeFrame: On the day of enrollment
Secondary outcomes:
measure: bleeding on probing
timeFrame: On the day of enrollment
measure: Emergency angel
timeFrame: The X-ray examination will be completed on the day of enrollment
measure: Emergency profile
timeFrame: The X-ray examination will be completed on the day of enrollment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05985317: Effect of Collagen Versus PRF on BMA Osteogenic Potential
Official title: Evaluation of Collagen Versus Platelet Rich Fibrin Membrane on the Osteogenic Potential of Bone Marrow Aspirate Concentrate (BMAC) for Lateral Sinus Floor Augmentation : A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Loss, Alveolar
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing

Detailed description: Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine graft mixture in sinus lift procedure

Eligibility criteria: Inclusion Criteria:

* Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
* Highly motivated patients
* Age more than 18 years

Exclusion Criteria:

* Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
* Patients suffering from any sinus pathosis.
* Patients with conditions that could potentially compromise Bone Marrow ( BM)quality, including history of hematologic malignancy, current chemotherapy, BM suppressive and anti-platelet medications, previous BM Aspiration, or acute illness.
* Heavy smoker (\> 20 cigarettes daily)

Primary outcomes:
measure: Radiographic Bone density assessment
timeFrame: 4 months ( immediate - 4 months postoperative)
Secondary outcomes:
measure: Radiographic Bone height assessment
timeFrame: 4 months ( immediate - 4 months postoperative)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Lecturer at Faculty of Dentistry, Cairo University
name: Eman Said
role: STUDY_DIRECTOR
References:
Clinical trial NCT00173017: The Physiological Impact of N95 Masks on Medical Staff
Official title: The Physiological Impact of N95 Masks on Medical Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Hypercapnia
Keywords: N95 mask
medical staff
hypoxemia
hypercapnia
neurological study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Wearing N95 masks may have adverse physical effect on medical staff

Detailed description: Wearing N95 masks results in hypooxygenemia and hypercapnia which reduce working efficiency and the ability to make correct decision.

Medical staff are at increased risk of getting 'Severe acute respiratory syndrome'(SARS), and wearing N95 masks is highly recommended by experts worldwide. However, dizziness, headache, and short of breath are commonly experienced by the medical staff wearing N95 masks. The ability to make correct decision may be hampered, too. The purpose of the study was therefore to evaluate the physiological impact of N95 mask on medical staff.

Eligibility criteria: Inclusion Criteria:

* medical staff

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: EEG change, ABG change, change in scores of attention test, etc
Secondary outcomes:
measure: symptoms wearing N95 masks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Tze-Wah Kao, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521024: Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics
Official title: Evaluation of Esthetic and Biomechanical Outcome of Maxillary Anterior Single-Tooth Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on PEKK Abutments: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Keywords: Zirconia implants
PEKK crowns
high performance polymer crowns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will receive a restoration with superior function, esthetics, and quality.
Primary purpose: TREATMENT

Brief summary: aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments .

Detailed description: High performance polymers may be a valid alternative to other conventional materials for abutments and crowns over zirconia implants because of their cushioning effect and elastic modulus (5.1GPa), which absorb occlusal forces and avoid overload of the underlying bone from the direct transmission of biting impacts ; which could optimize and preserve osseointegration with time. Zirconia implants with high performance polymers restorations can be considered a good alternative for replacing natural teeth.

For many years lithium disilicate has been the esthetics standard used in Veneers ,Inlays , onlays, occlusal veneers, partial crowns,minimally invasive crowns and Implant superstructures due to its natural-looking tooth colouring and excellent light-optical properties.

Due to the promising esthetics of high performance polymers as it can be veneered with different veneering materials it would successfully restore esthetics.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* No active intraoral or systemic disease
* No pregnancy or lactation
* controlled periodontal conditions
* Adequate bone volume to place an implant
* Occlusal function with a natural tooth

Exclusion Criteria:

1. Current pregnancy.
2. Psychiatric disorders.
3. Smokers
4. Poor motivation.
5. Several occlusal parafunction.
6. Persistent intraoral infections.
7. Severe mucosal disease.
8. Active periodontitis.
9. Poor oral hygiene.
10. Lack of occluding dentition at implant rehabilitation level

Primary outcomes:
measure: Esthetic outcome
timeFrame: 9 month
Secondary outcomes:
measure: bone resorption
timeFrame: 9 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Lamiaa Abdelsalam, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725824: Investigations of Ear Tip Performance, Perceptions, and Experiences
Official title: Novel Technology Adoption in the Audiology Clinic: Investigations of Ear Tip Performance, Perceptions, and Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Aids
Keywords: earmold
hearing aid
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Normal hearing participants will be fit with a hearing aid and different types of customized earmolds. Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. Objective acoustic real ear measures and subjective ratings of sound quality and physical comfort will be evaluated and compared between earmolds. Findings will help researchers to better understand the impacts of different earmolds and how each might affect overall point-of-care.


Eligibility criteria: Inclusion Criteria:

* Normal hearing thresholds (\<25 dB HL) at octave frequencies from 250-8000Hz.
* Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
* English as primary spoken language.

Exclusion Criteria:

* history of extensive or current outer or middle ear pathology.
* history of extensive outer or middle ear surgery.
* history of neurological or cognitive disorder.

Primary outcomes:
measure: Real Ear Measures
timeFrame: 15 minutes
measure: Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire
timeFrame: 2nd listening session appointment (15 minutes)
measure: Physical Dimensions
timeFrame: Prior to 2nd listening session appointment (15 minutes)
measure: Production Variable
timeFrame: Prior to 2nd listening session appointment (15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References:
Clinical trial NCT04154124: Applying PET/MR in Rectal Cancer.
Official title: Applying PET/MR in Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment.

Objectives

1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT.
2. To preliminary assess the potential value of PET/MR in predicting pMR to nT.
3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.


Eligibility criteria: Inclusion Criteria:

1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin.

Exclusion Criteria:

1. Patients younger than 18 years;
2. pregnancy;
3. other known active malignancy;
4. previous chemotherapy or radiotherapy;
5. previous pelvic operation;
6. patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.

Primary outcomes:
measure: Number of patient that shown the different between diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04366024: A Novel Nomogram to Predict Severity of COVID-19
Official title: A Novel Nomogram to Predict Severity of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Disease
Nomogram Model
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 disease patients

Brief summary: Investigators use clinical data from a large sample of COVID-19 disease patients to screen out biomarkers associated with disease severity. Then, a novel nomogram model will be established to predict covid-19 disease severity, which could provide important assistance and supplement for clinical work. In the case of extremely shortage of front-line medical resources, patients with potential severe diseases will be timely treated with the help of the novel nomogram model.


Eligibility criteria: Inclusion Criteria:

* COVID-19 disease patients confirmed by virus nucleic acid RT-PCR and CT

Exclusion Criteria:

* unconfirmed suspected cases
* Patients during pregnancy and lactation
* incomplete clinical data
* investigators considered patients ineligible for the trial
* Child patients

Primary outcomes:
measure: the consistency of predicted severe rate and observed severe rate of COVID-19 patients
timeFrame: up to 3 months
measure: Duration of severe illness
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
state: Chongqing
Study officials:
References:
Clinical trial NCT05000424: Clary Sage Essential Oil & Pregnancy
Official title: Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Pregnancy Related
Keywords: clary sage
essential oil
aromatherapy
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.

Detailed description: Women will be informed of the opportunity to participate through their care providers, childbirth educators, or doulas. If they meet inclusion criteria, they will be given a brochure describing the risks and benefits of the study and the informed consent paperwork.

If they provide consent, they will be randomized to one of two groups: active essential oil and inert placebo. Both groups will receive a 4-ounce bottle of oil to apply daily during the third trimester of pregnancy. Those in the placebo group will be given an inert plant oil. Those in the intervention group will be given the same oil with the addition of clary sage essential oil.

Eligibility criteria: Inclusion Criteria:

* Age 20-39
* Lives in the United States
* Pregnant, singleton
* Low risk
* Less than 27 weeks gestation

Exclusion Criteria:

* PCOS diagnosis
* Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure \> 140/90)
* Gestational Diabetes
* History of Preeclampsia
* Preterm labor
* Incompetent cervix
* Allergy to salvia sclarea or related plants
* Known Birth Defects
* Thyroid Disease diagnosis

Primary outcomes:
measure: Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36.
timeFrame: Pregnancy week 27 and 36
measure: Change in quality of life from week 27 to 36 of the pregnancy using the World Health Organization's Quality of Life, Brief-Form Scale (WHOQOL-BREF).
timeFrame: Pregnancy week 27 and 36
Secondary outcomes:
measure: Duration of Pregnancy
timeFrame: from enrollment to birth, up to 16 weeks
measure: Duration of phase 2 of labor
timeFrame: from the onset of labor to birth, up to 24 hours
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
References: