cyrilzakka/clinical-trials huggingface dataset:
Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique?

To study the patients' and dentists' perception of receiving/ administering maxillary buccal infiltration anesthesia using an open or closed mouth techniques

Background: Local anesthesia is an essential part of dentistry. The most commonly used technique to anesthetise maxillary posterior teeth is buccal infiltration with a local anesthetic agent. The technique described in the literature focuses on the location of injection, the direction of the needle insertion in relation to the root apex, the direction of needle bevel in relation to the cortical bone plate, the size of needle and the type and amount of the local anesthetic agent used. However, there is no mention to whether the patient should open their mouth or maintain their teeth in intercuspation during the injection procedure.

Aims: This research aims to a) compare two techniques of injection (open and closed-mouth techniques) in terms of the discomfort experienced by patients during the injection procedure and b) evaluate the dentists' preference in performing either of the two techniques.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (16 years old and older)
* Healthy (American Society of Anaesthesiologists (ASA) category I or II)
* A maxillary posterior tooth (excluding third molars) referred for root canal treatment and diagnosed with irreversible pulpitis and normal apical tissues

Exclusion Criteria:

* Psychological disorders
* Intraoral soft tissue abnormalities
* necrotic pulp with/ without apical pathology
* tenderness to palpation and/or percussion
* The use of analgesics in the preceding 12 hours before the appointment.
Re-evaluation of the Effect Site Model of the PKPD Propofol Eleveld Model

in healthy patients undergoing elective surgery, after a very slow induction, using Eleveld's kinetics as a reference, after loss of consciousness (LOC) and intubation, proceed to infuse propofol until 1% burst suppression ratio is obtained. Then return to the LOC concentration. The BISindex predicted by the model and the real one will be evaluated. The evolution of spectral density frequencies over time will also be evaluated.

Eleveld is a recently developed PKPD model of propofol, which includes multiple covariates in its pharmacokinetics.

This model, called Universal, includes data from all studies conducted with plasma levels in the world, where the principal investigator (PSV) has been directly involved.

For pharmacodynamics (PD), Eleveld, includes processed electroencephalogram (EEG) readings, but only by nominal BIS index.

The use of BIS as a unique marker of propofol hypnosis shows multiple limitations as it results from a computer algorithmic application, which can be influenced by drugs, inter-individual variability, among others.

Therefore, to determine the effect there are nowadays more accurate tools such as spectrogram processing and determination of alpha power by spectral density (PDS).

This project aims to re-evaluate the modelling of the temporal behaviour of the effect in the BIS index, using the reference of the Eleveld kinetic model, associated to a spectrogram that allows the evaluation of the alpha and delta band dynamics as a predictor of the propofol effect.

In our study we intend to replace the BIS value by the alpha and delta power progress in decibels (dB) and eventually build a pharmacodynamic (PD) model with a marker more associated to the specific cortical electrical phenomenon.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients between 18 and 60 years of age, who undergo elective surgery in the central ward of the Hospital Base San José Osorno, Chile. Consecutive patients from the beginning of the study up to 12 months from the admission of the first patient.

Exclusion Criteria:

* Emergency surgery patient.
* Patients with dementia, delirium or altered state of consciousness.
* Full stomach or risk of aspiration.
* Allergic to propofol.
Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension

The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
* IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
* Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent \~20/100) or better in either eye.

Exclusion Criteria:

* Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
* Subjects with known contraindications to nitric oxide (NO) treatment.
* Subjects whose central corneal thickness was greater than 600um in either eye.
* Subjects with any condition that prevented reliable applanation tonometry in either eye.
* Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
* Subjects with previous or active corneal disease.
* Subjects with a history of severe dry eye.
* Subjects with monophthalmia.
* Subjects with optic disc hemorrhage.
* Subjects with a history of central retinal vein and artery occlusion.
* Subjects with a history of macular edema.
* Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
* Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
* Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
* Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
* Subjects who were expected to require treatment with ocular or systemic corticosteroids.
* Subjects who were in need of any other topical or systemic treatment of OAG or OHT.
* Subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect IOP during the study period.
Midsagittal Tongue Measurement to Predict Difficult Airways

An unanticipated difﬁcult airway is a potentially life-threatening event during elective surgery or management of critical conditions. However, the common clinical screening tests, show low sensitivity and specificity with a limited predictive value. Recently, ultrasound has been used to identify difficult airway. Tongue volume is one of the parameters evaluated by ultrasound. In this study, we aim to evaluate the capacity of mid-sagittal tongue CSA and tongue width to predict difficult laryngoscopy and difficult intubation.

Anatomical changes that adversely affect airway accessibility due to increased adipose tissue in obese patients make it difficult to establish an advanced airway by orotracheal intubation. Difficulty with airway management for anesthesia has potentially serious implications, as failure to secure a patent airway can result in hypoxic brain injury or death in a matter of minutes. There have been no effective methods to predict difficult airways accurately. Ultrasonography is a non-invasive, safe, and painless modality for evaluating soft tissues. In recent years, studies have been carried out on the parameters that can be used in determining the difficult airway with ultrasound. These include the distance from the skin to the epiglottis, the tongue thickness, the tongue volume, the mandibular condylar mobility, and the visibility of the hyoid. Few studies have whether midsagittal tongue cross section area and tongue width can also be used to predict difficult airways similarly to tongue volume. Therefore, this study was designed to evaluate the predictive value of accurately measured tongue thickness and cross-sectional tongue area using ultrasonography for predicting difficult tracheal intubation and difficult laryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical condition I-II-III
* Patients are required general anesthesia with tracheal intubation for bariatric surgery.

Exclusion Criteria:

* Patients with maxillofacial deformity, trauma, or tumor
* Patients with identified difficult airway or difficult airway history
* Patients with cancellation of tracheal intubation for a non-difficult airway reason
The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain

Ongoing fear and catastrophization in people with chronic low back pain (CLBP) causes increased pain, disability and kinesiophobia, and decreased endurance of trunk muscles. Nowadays, recurrent low back pain complaints are increasing day by day. Besides the use of electrophysical agents and exercise in the treatment of chronic low back pain, education methods used to reduce the negative effects of psychosocial factors are important for healing.

Although there were studies about the combination of Therapeutic Neuroscience Education (TNE) with exercise in CLBP, there are no studies that combine electrophysical agents, exercise and TNE methods in the literature. Therefore, in this study, we aimed to investigate whether TNE combined with physiotherapy consisting of electrophysical modalities and home program exercise is superior to only physiotherapy in patients with CLBP.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were:

* aged between 18-60 years
* to have CLBP ˃ 3 months duration
* to have independent walking ability
* to be literate in Turkish.

Exclusion Criteria:

* to have vertebral compression fractures
* to have transitional vertebrae
* to have an underlying tumoral, rheumatologic or inflammatory disease
* to have trauma, surgical history
* to be pregnant or less than six months postpartum period
Repetitive Transcranial Magnetic Stimulation in Cancer Pain Management

Over half of cancer patients experience cancer-related pain. Despite advances in pain management with opioids, many patients continue to suffer from chronic cancer pain. The underlying mechanisms of cancer-related pain remain poorly understood, but they may be linked to brain neuroplasticity. As a result, some researchers suggest that targeting the motor cortex in cancer patients could improve pain management. However, few studies have investigated the effectiveness of remodeling neuroplasticity with repetitive transcranial magnetic stimulation (rTMS) to reduce cancer-related pain. To validate the use of rTMS in cancer-related pain, we plan to conduct a randomized controlled trial involving 30 cancer pain patients. Participants will be randomly assigned to receive either rTMS or sham rTMS treatment. Functional magnetic resonance imaging (fMRI) and pain index assessments will be conducted before and after the treatment to evaluate the outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients have cancer pain symptoms, confirmed by a physician as cancer pain or neuropathic cancer pain
2. Experienced the worst pain NRS score ≥ 4
3. The patient demonstrate good cognition and is able to cooperate with the assessment of pain severity.
4. The estimated survival time exceeds 3 months.
5. Pre-existing bisphosphonate, chemotherapy, and hormonal therapy regimens remained unchanged throughout the study.

Exclusion Criteria:

1. Individuals who have undergone head surgery or have metal implants in the head.
2. Individuals with implanted cardiac pacemakers or cochlear prostheses.
3. Have a history of epilepsy.
4. Patients diagnosed with primary brain tumors or metastatic brain lesions.
5. Present with additional neurological, psychiatric, or severe medical disorders.
6. Individuals with metallic implants located in the cranial or cervical regions.
7. Women who are pregnant.
8. Presence of acute pain in any body region attributable to other medical conditions. -
A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults

The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Plan to undergo elective surgery under general anesthesia；
3. ≥18 years old
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification
6. Expected postoperative hospital stay ≥72 hours
7. PONV risk factors ≥3

Exclusion Criteria:

1. Subjects with vomiting and/or retching and nausea occurred before surgery
2. Subjects with a history of vestibular disease, central nervous system and other system diseases
3. Subjects with a previous history of chronic nausea or vomiting/retching
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Abnormal electrocardiogram
9. Abnormal values in the laboratory
10. Allergic to a drug ingredient or component
11. Received treatment with potential antiemetic effects before starting the investigational product
12. Subjects who received chemotherapy prior to surgery
13. Use of drugs that affect the antiemetic effect, and the time between the last use of the test drug and the start of the time is less than 5 half-lives
14. Plan to receive local anesthesia only or total intravenous anesthesia only
15. Subjects who are expected to require an in-situ nasogastric tube or orogastric tube after completion of surgery
16. Subjects expected to be transferred to the ICU at the end of surgery
17. Pregnant or nursing women
18. No birth control during the specified period of time
19. Participated in clinical trials of other drugs (received experimental drugs)
20. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Ertugliflozin in Chronic Heart Failure

The purpose of this study is to determine the effects on heart failure signs and symptoms of the use of either ertugliflozin, metolazone or placebo, in conjunction with intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy.

There are two general purposes for this study. The proposed study is both larger and more rigorous than essentially all PK/PD studies that form the basis of current practice with loop diuretics as well as all studies looking at add-on thiazide therapy (current guideline-recommended adjuvant). The second is to generate a mechanistic understanding of the pleotropic cardio-renal factors with chronic therapy that differentiate ertugliflozin from traditional diuretics particularly in how they maintain reduced blood volume without the complication of over-diuresis and volume depletion.

This is a randomized placebo controlled mechanistic study to understand the utility of ertugliflozin in acute and post-acute hospitalized heart failure patients with or without diabetes, compared to both placebo and the active control metolazone. The broad study design will be designed around evaluation of change in gold standard determined body fluid spaces (blood volume, extracellular fluid, total body water), administering a sodium chloride challenge, and collecting the necessary biospecimens to test our hypotheses. The general study design will randomize to ertugliflozin vs. placebo early during IV diuretic therapy with continuation post discharge for a total therapy of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of ADHF with at least one objective sign of volume overload (rales, edema, elevated JVP, or preadmission weight gain)
2. As judged by the treating physician, a projected need and ability to tolerate treatment with an extended need for IV diuretics with the goal of significant fluid removal (i.e., goal \>1L/day net fluid loss)
3. Chronic daily oral loop diuretic dose \> or equal to 20mg furosemide equivalents for at least one month prior to admission
4. eGFR 30 mL/min/1.73 m2
5. Signed informed consent

Exclusion Criteria:

1. Current use or plan to initiate renal replacement therapy or ultrafiltration this hospital admission
2. Significant bladder dysfunction or urinary incontinence
3. Inability to comply with the serial urine collection procedures
4. Current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone
5. Prior heart transplant, critical stenotic valvular disease or complex congenital heart
6. History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 3 months
7. History of or current urosepsis or frequent urinary tract infections
8. Anemia with hemoglobin \<8g/dL (due to required phlebotomy for the study)
9. Pregnancy or breastfeeding
Corticosteroid Injection in Carpal Tunnel Syndrome

To compare the effectiveness of different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation

This is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with CTS. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (Shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. The follow up at 6 and 12 weeks includes Boston Carpal Tunnel Questionnaire, nerve conductive study and VAS pain score.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CTS
* The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

* presence of thenar atrophy
* existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
* prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery
* history of distal radius fracture
* pregnancy or lactation
* regular use of systemic NSAIDs ,corticosteroids or diuretics
* known allergy to corticosteroids and local anesthetics.
* impaired cognitive function
Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting

Self-monitoring of blood glucose using capillary glucose testing has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood as a reference. Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions.

Self-monitoring of blood glucose using capillary glucose testing (C) has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood (IV) as a reference. Postprandial blood glucose levels were measured after 50 g oral glucose load and after the consumption of a portion of different foods containing 50 g of carbohydrates. We also evaluated the associations between postprandial glucose responses and the clinical characteristics of the participants at the beginning of the study. Incremental area under the curve (AUCi) of postprandial blood glucose was calculated for 1 h (AUCi 0-60) and 2 h (AUCi 0-120). Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old

Exclusion Criteria:

* acute diseases, severe illness with in-patient treatment during the last 3 months, weight change \>2 kg/week during the last month, smoking secession during the last 3 months, drugs for active weight reduction, chronic medication
Study to Evaluate the Effects of the Cooling Bolero in Women With Menopause Symptoms

The Cooling Bolero is a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbed heat. The vest is manufactured by Nanohealth. It intended to provide moderate cooling (\~15C/59F) through indirect contact with the skin. The material in the device is safe, non-toxic, and eco-friendly.

Recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep disturbances) have shown a reduction in both the frequency and intensity of those symptoms after using the Cooling Bolero. Specific (moderate) temperature cooling of the neck and upper torso appears to target and mitigate these common menopausal symptoms. This pilot study attempts to collect additional data on the effects of the Cooling Bolero.

Participants who have consented for this study will first be asked to complete a Baseline Assessment of their menopausal symptoms, including documentation of their baseline weight. If the assessment indicates that the participant has at least 'moderate' menopausal symptoms, then she will then enter the Run-In Period.

During the two-week Run-In Period, participants will use a Symptom Diary for to document the frequency and severity of their menopausal symptoms. At the start of Week 3, participants will return their completed Run-In Period Symptom Diary and receive their Cooling Bolero with instructions on how to use the product during the Treatment Period.

During the Treatment Period, participants should use the Cooling Bolero at least two times per day (morning and evening) for one hour. As feasible, the participant should start to wear the product 30 minutes prior to meal time for these two applications. The participant may also wear the product at additional times, as desired. All applications of the Cooling Bolero during the four-week Treatment Period are to be documented in the Product/Symptom Diary. During the Treatment Period, the participant will also continue to document the frequency and severity of their menopausal symptoms in the Product/Symptom Diary.

At the end of Week 6, the participant will stop using the Cooling Bolero. She will be asked to complete a Product Assessment and have her weight documented.

Participants will be contacted at Week 10 to ask about the status of menopausal symptoms after four weeks of not using the Cooling Bolero

Eligibility Criteria:
Inclusion Criteria:

* Female who is at least 18 years old
* Self-reports having at least two (2) daily hot flashes associated with menopause

Exclusion Criteria:

* Taking hormonal therapy (currently or within the last 3 months).
* Has another existing medical condition that would prevent study compliance.