cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia

Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.

Laryngeal microsurgery (LMS) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. Endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal CO2.

Nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (HFNO) is another option for LMS. LMS with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. Furthermore, LMS with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. Current practice in LMS with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. However, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. Therefore, the investigators investigated the use of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during LMS with nonintubated anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* The patient who needed to undergo LMS.

Exclusion Criteria:

* Severe airway obstruction.
* Severe airway disease.
* American Society of anesthesiologists (ASA) physical state \> III.
* Pregnancy or body mass index (BMI) ≥ 40 kg/m2.
Safety and Efficacy of MT-4666

The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA) criteria
* MMSE score of 10 to 24 inclusive at screening and at Day 1, and CDR-SB score of ≥ 2 at screening
* Modified Hachinski Ischemic Score (mHIS) ≤ 4 at screening
* Caregiver available; caregiver sees subject at least four days (at least 12 hours) each week
* Subject living at home; if living at senior residential setting, or an institutional setting, subject with caregiver indicated above is available

Exclusion Criteria:

* Inability to perform cognitive tests (ADAS-cog-13 and MMSE) at screening and at Day 1
* Diagnosis of any other disease which may cause dementia
* MRI or CT scan within 6 months before screening, with findings inconsistent with the diagnosis of Probable AD
* Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years
* History of or current diagnosis of any psychosis
* History of myocardial infarction or unstable angina within six months before screening
* History of cerebrovascular disorder within 18 months before screening
Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.

Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.

Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18-65 years.
* in good health (ASA classification II or higher).
* able to provide informed consent.

Exclusion Criteria:

* allergy to articaine.
* history of significant medical problems (ASA classification of III or worse).
* diagnosed depression (taking tri-cyclic antidepressant medications to control).
* have taken central nervous system (CNS) depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing.
* lactating or pregnant.
* inability to give informed consent.
the Hypoalgesic Effect of Spinal Manual Therapy

To study the immediate effect of spinal manual therapy on pain perception in normal subjects

Is this effect only local or is it also noticed away from the stimulated area? How long does it last? Is there a dose/response phenomenon?

Eligibility Criteria:
Inclusion Criteria:

Healthy Students who volunteer from Murdoch University

-

Exclusion Criteria:

* contraindication to spinal manual therapy
Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery

Pre-treatment of patients with erythropoietin subcutaneously and iron supplement intravenously, in order to create a clinical pathway to minimize transfusion of red blood cells in a selected group of cardiac patients with an increased risk for blood transfusions in our cardiac surgery program.

Blood transfusion is identified as an independent predictor of early mortality after Coronary artery bypass grafting operations In addition, female gender, lower body surface area (BSA), low preoperative Hemoglobin (Hb), previous cardiac surgery, emergency operation and low preoperative creatinin clearance were found to be independent risk factors for receiving Red Blood Cells (RBC) units.

We create a clinical pathway to reduce transfusion of red blood cells by pretreating patients with erythropoietin and iron to determine the reduction of number of patients who receive blood transfusion perioperatively. Also we want to investigate the decrease in the mean number of RBC units received per patient in the perioperative period.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing isolated Coronary Artery Bypass Grafting operation or Aortic Valve Repair (AVR).
2. Preoperative Hb \< 7 mmol/l.

Exclusion Criteria:

1. Off pump surgery.
2. Combination surgery.
3. Re-operation.
4. Emergency operation.
5. Patients with bleeding disturbances; e.g, hemophilia and patients with chronic liver disease.
6. Concomitant use of cyclosporine prior to, during or following surgery.
7. Female patients who are pregnant or planning to become pregnant.
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period
* Participants of child-bearing potential must use a medically accepted method of

contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.

Exclusion Criteria:

* Proven invasive fungal infection (IFI) before study entry
* Severe nausea and/or vomiting at screening
* Received posaconazole within 10 days before screening
* Unable to receive study drug by mouth or via an intestinal (enteral) tube
* Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
* History of anaphylaxis attributed to the azole class of antifungal agents
Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma

The aim of this study is to learn about how mesothelioma affects patients' emotional and physical well-being. Also, the investigators would like to learn more about what patients need and how they deal with this illness. This information can help us find ways to lessen physical and emotional strains. Part of the study tests an alternate way of giving emotional support through the Internet. By providing support online, patients can participate in the comfort of their home.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pleural mesothelioma and receiving care at MSKCC
* At least 18 years of age or older
* Able to read and speak English
* Patients who choose to participate in the Internet-based discussion groups, need a telephone, a computer, Internet access, and an e-mail account.

Exclusion Criteria:

* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment).
Pilates Pelvic Floor Strengthening Program to Improve Urinary Incontinence

Does a twice weekly, 12-week Pilates pelvic floor strengthening program improve short- and long-term measures of stress urinary incontinence symptoms in women ages 45-70 years of age?


Eligibility Criteria:
Inclusion Criteria:

1. Age 45-70 years of age.
2. Able to provide informed consent.
3. Able to lower and rise from the floor safely and independently.
4. Anticipated to be able to attend at least 9 of the first 12 classes (75%) in weeks 1-6.
5. Anticipated to be able to attend at least 9 of the final 12 classes (75%) in weeks 7-12.
6. Score of 6+ on ICIQ-UI Short Form.

Exclusion Criteria:

1. Pregnancy
2. Unable to speak and comprehend English
3. Chronic neurologic condition (e.g., Parkinson's or Multiple Sclerosis) that impacts bladder function.
Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass

The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata: neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.

Few data are available in current literature about pharmacokinetics (PK) of antibiotics administered as surgical prophylaxis to children scheduled for cardiac surgery with CPB. In particular, vancomycin PK during CPB has been studied only in small case series, whereas no specific study has been conducted, so far, in the specific setting of children receiving cefoxitin during CPB.

CPB affects patients' volemia and drugs PK is eventually altered. On the other side during and after surgery for heart defects, many risk factors may decrease renal and hepatic clearance, including altered renal perfusion, use of vasoactive agents, and use of concomitant nephrotoxic medications.

Primary Objective of the study will be:

• To study the pharmacokinetic profile of vancomycin and cefoxitin administered, as antibiotic prophylaxis to children undergoing elective CPB.

Secondary Objectives will be:

* To evaluate if a significant difference in blood levels will occur in the four predetermined patients' categories.
* To evaluate the role of hemodilution during CPB on studied antibiotics' serum concentration
* To verify the incidence of post-operative infections in the studied population with particular attention to sensitive bacteria
* To evaluate the impact of ultrafiltration in studied antibiotics' clearance
* To evaluate safety of the administered antibiotics This is a prospective monocentric, open label, not controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Elective cardiac surgery schedule with the planned application of CPB
2. Parents of neonates, or their legal representative, able to consent and comply with protocol requirements.

Exclusion Criteria:

1. Urgent or emergent surgery
2. Antibiotic therapy (any) administered before surgery
3. Patients receiving, before surgery, any other ofr of extracorporeal treatment (i.e extracorporeal membrane oxygenation, continuous renal replacement therapy)
4. Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.
5. Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)
6. extremely low birth weight neonates.
Green Tea Extract in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers and may prevent the development of new cancers.

PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Determine the effectiveness and toxicity of green tea extract in patients with androgen-independent metastatic prostate cancer. II. Determine the response rate and response duration in patients treated with this regimen. III. Determine whether a decline in prostate-specific antigen (PSA) coincides with evidence of disease regression in these patients.

OUTLINE: Patients receive oral green tea extract six times daily for 4 months. Patients with a 50% decline in PSA, complete or partial response, or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 4 months receive no further treatment. Patients are followed every 3 months for 5 years or until disease progression. If disease progression, patients are followed every 6 months for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Clinically proven androgen-independent metastatic prostate cancer Radiological, physically palpable, and/or biochemical evidence of progression Increase in PSA after orchiectomy or hormonal treatment No symptoms directly attributable to metastatic disease No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Cardiovascular: No uncontrolled high blood pressure No unstable angina No symptomatic congestive heart failure No uncontrolled cardiac arrhythmias No myocardial infarction in past 6 months Other: No other malignancy within the past 5 years except basal cell skin cancer No uncontrolled diabetes mellitus or inability to tolerate high sugar content of green tea at discretion of oncologist No other medical or psychiatric conditions that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior flutamide or megestrol At least 6 weeks since prior longer-acting hormonal agents such as bicalutamide At least 4 weeks since prior hormonal therapy, except luteinizing hormone- releasing hormone agonist No concurrent hormonal therapy, including corticosteroids for cancer treatment Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents
Virtual Weight Management Shared Medical Visit

Culinary medicine has emerged which provides the practical application of nutrition education through experiential learning. Studies have shown that patients with metabolic syndrome who underwent a series of classes that featured nutrition recommendations and cooking classes had weight loss, and improved cardiac health and blood sugar management.

Given the increasing focus on providing remote experiences to minimize contact and risk of infection with Sars-COV2, this pilot study at Boston Medical Center (BMC) will integrate a physician consultation, interactive didactic presentations, nutritious cooking and mind- body exercises. Patients with obesity and metabolic syndrome can attend a virtual shared medical visit series co-taught by a registered dietician and chef and an endocrinologist and weight management specialist. Data will be collected in the form of surveys, phone interviews, chart review, and home monitoring to test both the feasibility of running such an intervention virtually and to explore whether attending this one month program with weekly remote classes/visits improves vitals including weight and blood blood pressure and other small habit changes in patients.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* BMI =\> 30
* Must have documented measured blood pressure, weight, height in the 12 months prior to the intervention
* Enrolled in Boston Medical Center's (BMC's) Food Pantry Program

Exclusion Criteria:

* Patients with advanced dementia or uncontrolled psychiatric disease
* Uncontrolled medical illness including severe hypertension, recent acute coronary syndrome, active malignancy or other condition that would make the subject unable to complete the study procedures
Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar

The main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars

The main objective of the study is to compare the effects of piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars. Post-operative swelling is analyzed using a photogrammetry facial scanner (Marathon MT-4000).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 14 and 24 years, with both lower third molars in the developmental stage (with incompletely formed roots) and requiring extraction of both for prophylactic, therapeutic or strategic reasons
* Good quality of radiographic investigations (CBCT)
* Good health status
Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients after mitral repair.

The main questions it aims to answer are:

* Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients after mitral repair?
* Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.


Eligibility Criteria:
Inclusion Criteria:

* under 14 years old
* after mitral valve repair

Exclusion Criteria:

* Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
* Patients with severe pulmonary hypertension (pulmonary arterial pressure \>6 Wood·U)
* Patients with severe liver and kidney failure
* Patients who are allergic to related medications
* Patients with symptomatic hypotension who cannot tolerate related drugs
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction.

Methods: We enrolled 270 patients at Beijing Tongren Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.

OSDI score, TBUT, OPAS, NPSI-eye, and Schirmer I expressibility and secretion score to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 and Age \<=65.
2. Clinical diagnosis of dry eye disease with meibomian gland dysfunction.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.