cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese.

Macintosh laryngoscope is still considered a standard for tracheal intubation, however, visualization of the glottis may be inadequate mainly in morbidly obese patients. The Vie Scope is a novel type of laryngoscope consisting of a straight, shielded, illuminated tube that offers intubation via a bougie using the paraglossal technique. In this prospective, non-randomized study, we tested the research hypothesis that the use of Vie Scope may improve visualization of the larynx in comparison with the Macintosh blade.

Prior to tracheal intubation, all patients were placed in the head-elevated laryngoscopy position (HELP). All study subjects were anesthetized with the concordance to European Society for Peri-Operative Care of Obese Patient (www.espcop.eu) protocols: proper positioning, pre-oxygenation with CPAP, induction of anesthesia with propofol 2.0 mg kg-1 of corrected body weight; for muscle relaxation rocuronium 0.6 mg kg-1 of ideal body weight (IBW); ketamine 50 mg ; lidocaine 100 mg, and fentanyl 0.1 mg. After achieving 100% neuromuscular block confirmed by TOF-Watch monitoring, laryngoscopy was performed by the anesthesiologist familiar with the use of both Vie Scope and Macintosh blade laryngoscope, and also experienced in bariatric anesthesia. All anesthesiologists participating in the study underwent training with Vie Scope on the manikin model.

The evaluation of glottis visualization in direct laryngoscopy using Cormack-Lehane scale (CL) in all patients was performed in sequence using two laryngoscopes: first Macintosh blade laryngoscope (MCL) and then Vie Scope laryngoscope (VS). Tracheal intubation was performed with the VS. The study subjects all received oxygen using nasal CPAP in order to maintain sufficient oxygenation

Eligibility Criteria:
Inclusion Criteria:

* morbid obesity BMI\>40 kg/m2
* scheduled for elective bariatric procedure
* no anatomy abnormalities of upper airway

Exclusion Criteria:

* lack of conscent
* predicted difficult intubation
Incidence of Emergence Delirium in the PACU

Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period.

The potential risk factors for ED development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. The incidence of ED is higher in postoperative period, for example in the Post-anaesthesia Care Unit - PACU. Patients with ED are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. For the therapy of ED propofol, midazolam and eventually ketamine in a reduced dosage are used.

After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ED) using PAED, WATCHA and Richmond agitation and sedation scale (RASS) score in patients hospitalized in the post-anaesthesia care unit (PACU) after general anaesthesia, in the Departement of paediatric anaesthesia and intensive care unit, University Hospital Brno in the term from 1.9.2020 until 30.6.2021 will be measured.

Paediatric Emergence Delirium (PAED) score, WATCHA score and Richmond agitation and sedation scale (RASS) will be measured in 0., 5., 10., 15., and 20. minute after PACU admission and after obtaining RASS ≥ - 2 . Emergence delirium is defined as PAED score above 10 points. In the case of ED development, the duration of ED will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. The average PAED, WATCHA, RASS scale will be reported, the incidence of postoperative nausea and vomiting (PONV) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (TIVA, combined, inhalational), length of the surgery, type of the surgery will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021.

Exclusion Criteria:

* Patients in the age from 0 to 1 month.
Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy

Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)

Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (Rankin Scale) and instrumental imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they will have a break of 10-15 days during which also performs the instrumental survey (Magnetic Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of HBO

Eligibility Criteria:
Inclusion Criteria:

* between 10 and 75 years
* understanding of the Italian language
* ability to understand the procedures and carrying out of the study
* signing informed consent for adults and minors in use
* underwent radiosurgery with clinical and instrumental signs of radiation necrosis

Exclusion Criteria:

* younger than 10yrs old and older than 75yrs old
* not capable to understand Italian language or to understand the protocol procedures and visits' scheme
* informed consent not given
* enrolled in another clinical trial
* concomitant pathologies contraindicate HBO as: emphysema, asthma, epilepsy, claustrophobia; Paul Bert Syndrome, Lorrain Smith Syndrome
* under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment
* life expectancy less than 6 months
* Rankin Scale \>5
Craving and Lifestyle Management Through Mindfulness Study

The purpose of this study is to determine whether a mindfulness-based stress reduction and mindful eating program will lead to reductions in abdominal fat and total weight and improve cell aging in overweight and obese women compared to a waitlist control group.

Obesity is the largest growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). Obesity, in particular, abdominal obesity, confers increased risk for a host of diseases, including hypertension, Type 2 diabetes, and coronary heart disease, resulting in shortened life span (Fontaine, Redden et al. 2003). Psychological stress is widely cited anecdotally as a factor that causes people to engage in overeating, and studies provide strong evidence that stress can promote obesity. Stress induces selective preference of sweet, high-fat food and increases visceral fat depots. The telomere maintenance system (telomerase activity and telomere length)are markers of cellular aging and predict mortality (Cawthon et al, 2003)and have been linked to both psychological stress and components of the metabolic syndrome. The proposed study adapts a program called Mindfulness-Based Stress Reduction (MBSR) that has been shown to be effective in a variety of other stress-related conditions. Fifty overweight, pre-menopausal women at risk for the Metabolic Syndrome will be randomized in a 1:1 distribution to either a 3-month intervention to reduce stress and overeating \[Craving and Lifestyle Management with Mindfulness (CALMM)\] or wait list control group. The primary outcome measures include amounts of abdominal fat, weight, and telomerase activity. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will investigate the effects of the CALMM intervention on the metabolic and psychological processes assessed in this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal
* BMI (25 - 40)
* Weight \< 300 lbs.
* Negative urine glucose test

Exclusion Criteria:

* Inability to provide informed consent
* Age \< 21 or menopausal as determined by self-report
* DSM-IV diagnosis of an eating disorder
* Any substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention
* Factors that confound relations between stress and eating, including, drug abuse and use of medications containing corticosteroids.
* Diabetes
* Polycystic Ovary Syndrome
* CHD
* Breastfeeding (due to interference with stress hormone measurement)
* Non English speaker
* Pregnant as determined by pregnancy test at screening visit or planning to get pregnant in the next 6 months
* Previous MBSR training and/or current meditation, yoga, or other mind-body practice
* Initiation of new class of psychiatric medications in past 2 months.
* Currently on a weight loss diet
"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction

Acceleration of orthodontic tooth movement persuades tremendous rise in the interest of adolescents and aduts, as it not only shortens the treatment duration but also lessens the incidence of white spot lesions, root resorption, periodontal and other soft tissue problems. Minimal invasive techniques i.e.both piezocision and micro-osteoperforations had promising results in accelerating tooth movement. Therefore current study will provide evidence for better minimal invasive technique in terms of reducing treatment time and patient comfort.

Patients with Angle's Class II division 1 malocclusion meeting selection criteria and are indicated for maxillary first premolar extraction, patients will be referred for extraction of the maxillary first premolars , treatment will be initiated by bonding preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, leveling and alignment will be done in all subjects, after insertion of 0.019"× 0.025" stainless steel arch wire, alginate impression and periapical radiograph of canine and first molar region will be taken(Before the initiation of canine retraction), randomisation and allocation of two sides of maxillary arch i.e. right and left will be done and active interventions(piezocision and micro-osteoperforations) for each side will be done, immediately maxillary canine retraction will be started with mini-implant and closed NiTi coil spring, patient will be asked to fill pain and discomfort assessment card immediately after initiation of canine retraction., subsequent impressions records will be taken at 4th, 8th, 12th and 16th weeks for measuring rate of maxillary canine retraction, data collection and interpretation of results, further pain assessment cards will be filled after 24 hours, on 7th day and 28th day

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age between 16-25 years
2. Patients with Angle's class II division 1 malocclusion requiring bilateral extraction of maxillary first premolars.
3. Overjet of ≤ 10mm
4. No debilitating systemic disease.
5. No radiographic evidence of bone loss.
6. No history of periodontal disease/ therapy.
7. No smoking habit.
8. Probing depth of not more than 3mm in all teeth.

Exclusion Criteria:

1. Presence of any signs and symptoms of gingival and periodontal diseases.
2. Overjet more than 10mm.
3. Long-term drug history.
4. Systemic diseases.
5. Evidence of bone loss.
6. Smoking habit.
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.

Eligibility Criteria:
Inclusion Criteria:

* A child whose parents or representative provided written consent
* A Korean child aged 12-23 months on the day of the first vaccination
* No history of hepatitis A or a having hepatitis A vaccination
* A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results

Exclusion Criteria:

* Tympanic temperature of 38℃ or above within 48 hours prior to the vaccination or on the day of vaccination
* Moderate to severe acute or chronic infectious disease on the day of vaccination
* History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
* Disorders in the immune system, or congenital or acquired immunodeficient diseases
* Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
* A child with uncontrolled epilepsy or neurological disorders
* Planned with other vaccine within 4 weeks after the vaccination date
* Administered with other vaccine within 4 weeks prior to the vaccination date
* Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the vaccination date
* A child who has participated or is participating in another clinical trial within 12 weeks prior to the vaccination date(systemic corticosteroids administered at doses corresponding to ≤0.5 mg/kg/day of prednisolone for 14 consecutive days or less is exceptionally allowed)
* Other reasons not specified above that, in the opinion of the investigator, may make the subject ineligible to participate in the study
Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment

To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours

A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 or older Early stage breast cancer and planned surgery
* Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
* World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.

Exclusion Criteria:

* Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
* Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
* Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6
Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM

Objectives

1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV voluntary counseling and testing (VCT)
2. To determine the impact of MSM-targeted multidisciplinary services on the enrollment into care and retention of HIV-positive MSM

Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the Thai Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo Hospital in Jakarta, and the Sanglah Hospital in Bali, Indonesia

Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants

This is a prospective cohort study which will recruit 350 MSM clients within 3 months, and follow them for 12 months. MSM to be recruited will be first-time clients who come to the clinics for services other than VCT. These services may include but would not be limited to sexually transmitted infection (STI) diagnosis and treatment, anal dysplasia screening, nutritional counseling and non-occupational post-exposure prophylaxis (nPEP).

Approximately 250 MSM clients with unknown or previously negative HIV status will be offered HIV testing every 3 months (HIV-negative MSM cohort). MSM from the HIV-negative cohort who tested HIV-positive during the study (estimated 20%, 50 MSM) will be referred to the HIV-positive MSM cohort and will be followed up every 6 months. Additional clients who visit the clinic during the 3-month recruitment period with previously known HIV-positive status but have not been linked to HIV care (up to 100) will also be enrolled into HIV-positive MSM cohort. Therefore, there will be up to 150 HIV-positive subjects enrolled in this study. Each enrolled participant will have 12 months in the study.

This study will allow us to assess VCT and linkage into care, as well as HIV risk behavior and need for nPEP, and the incidence or prevalence of important morbidities in MSM such as STIs, anal dysplasia/cancer, hyperlipidemia, and diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Male with history of anal sex with men
2. Age 18 years old or older
3. Thai or Indonesian citizen as identified by the Thai or Indonesian National Identification card
4. Willing to provide location or contact information and allow contact
5. Live in or near Bangkok, Jakarta, or Bali and is available for follow-up for the planned study duration
6. Understand the study and sign informed consent form.

Exclusion Criteria:

1. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with ability to give informed consent.
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer

There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. No study drug will be provided as part of this study protocol.

This retrospective, non-interventional study is designed to assess the following primary objectives:

1. To identify predictors of event-free survival (EFS) in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and
2. To stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as EFS, overall survival and pathological complete response across patient groups of different risk level.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed HR+ and HER2-low/negative breast cancer diagnosed between January 1, 2010 and December 31, 2022 (Aged ≥18 years at the time of diagnosis)
* Stage I-IIIB at the time of diagnosis
* Received neoadjuvant chemotherapy and/or endocrine therapy and/or IO therapy
* Received curative intent surgery (mastectomy after neoadjuvant chemotherapy, endocrine, or IO therapy)

Exclusion Criteria:

* Patients who received HER2-targeted therapies including

  * Trastuzumab
  * Pertuzumab
  * Ado-trastuzumab emtansine
  * Neratinib
  * Tucatinib
  * Lapatinib
  * Fam-trastuzumab deruxtecan-nxki
  * Margetuximab
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy

This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.

This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.

140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.

Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age \>/= 18
* Singleton gestation
* \>/=20 weeks gestation, \<37 weeks gestation
* Hemoglobin \<11g/dL and/or hematocrit \<33%
* Able to read/speak English or Spanish

Exclusion Criteria:

* Maternal age \<18
* Multiple gestation
* \<20 weeks gestation, \</= 37 weeks gestation
* Hemoglobin \>/=11g/dL and/or hematocrit \>/=33%
* Unable to read or speak English or Spanish
* Incarcerated patients
Exercise Performance in Patients With Atrial Fibrillation

Heart failure and stroke are the two major complication of atrial fibrillation. Current treatment for atrial fibrillation is so focused to stroke prevention, but the risk assessment for heart failure is less highlighted. The most of patients with atrial fibrillation have cardiac functional limitation of variable degree. We hypothesize that the exercise test would reveal the subclinical cardiac dysfunction, and might be helpful to classify the patients with atrial fibrillation according to their exercise capacity real cardiac function.


Eligibility Criteria:
Inclusion Criteria:

* Nonvalvular chronic atrial fibrillation
* Left ventricular ejection fraction \>40%

Exclusion Criteria:

* Acute decompensated heart failure within 30 days
* unstable hemodynamic status
* Significant coronary artery disease
* Any condition interfering sufficient exercise
* Valvular stenosis or regurgitation of moderate or severe degree
* Obstructive or restrictive lung disease of moderate or severe degree
* Active malignancy