cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the LMA Position Using Ultrasound in Pediatric Patients

Introduction: Although the LMA insertion is not difficult and majority of the cases with LMA fare well in ventilation, the FOB assessment demonstrates a high incidence of LMA malpositioning. The LMA must be seated at the laryngeal inlet with the occlusion of esophageal inlet by the inflated tip. When we meet the signs of LMA malposition, we then reinsert the LMA. The laryngoscopic grading of Rowbottom et al. is commonly used for LMA position, but the rotated degree of LMA was not considered in that grading. We hypothesized that the LMA can affect the position of the arytenoids/thyroid cartilages and it may be detected on ultrasound. This study was designed to assess the predictability of the rotated LMA according to the position change of arytenoids/thyroid cartilages using ultrasound.

Methods: Children, aged 1 ms - 6 years, undergoing infraumbilical surgery were enrolled to this study. Ultrasound was performed on supraglottic and vocal cords area before and after LMA insertion. Transverse images were obtained on end-expiratory phase. LMA-position was evaluated with Bonfils fiberscopy. Position grading was made as usual. If grade \>3 was showed, LMA was repositioned while fiberscopic watching. If the face of LMA was rotated to one-side, the LMA was rotated to the opposite side a little. The ultrasound findings of pre- and post-LMA were compared. On fiberscopic images, conventional LMA grade and the degree of rotation were measured.


Eligibility Criteria:
Inclusion Criteria:

* Aged 1 ms - 6 years,
* undergoing infraumbilical surgery

Exclusion Criteria:

* coagulopathy
* pathologic lesions on neck or upper airway
* mallampati class III or IV
* difficult airway past history
* high risk group of aspiration pneumonitis
Surgical Conditions During Laparoscopic Bariatric Surgery

Obesity affects more than 78 million adults in the United States and it is estimated that 35% of the US population is obese. Currently, more than 179,000 bariatric procedures are performed in the US each year with the majority of these surgeries using laparoscopic techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but there is no evidence that a deep NMB improves surgical conditions and that the surgeons can discriminate between a moderate and deep NMB. There is also evidence that maintaining low insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize lower insufflation pressure and decreases postoperative pain requirements after laparoscopic bariatric surgery.

Subjects will be randomized to one of four groups:

1. moderate neuromuscular block (NMB) + 10 mm insufflation pressure (IP);
2. moderate NMB + 15 mm IP;
3. deep NMB + 10 mm IP; or
4. deep NMB + 15 mm IP.

A moderate NMB block will be defined as 2-3 twitches in the train of four (TOF) and a deep NMB will be defined as 0-1 posttetanic count. The surgeons will be asked to rate their satisfaction with the surgical conditions using a five-point ordinal scale ranging from 1 (extremely poor) to 5 (optimal conditions). The first rating will occur at the beginning of the procedure when the NMB level is stable at either a deep or moderate block and the intra-abdominal pressure is either 10 or 15 mm Hg (per randomization). The surgeon will be blinded to the insufflation pressure at this point. If the surgical conditions are rated as extremely poor or poor, the level of the neuromuscular block can be increased and/or the insufflation pressure can be increased to 15 mm Hg.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ASA I-III
* BMI ≥ 35

Exclusion Criteria:

* Inability to obtain written informed consent
* Pregnancy or breastfeeding
* Allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol
* Known or suspected neuromuscular disorders
* Significant renal disease with a serum creatinine ≥ 2 mg/dl f. Significant liver disease g. A family history of malignant hyperthermia
A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.


Eligibility Criteria:
Inclusion Criteria:

* FEV1 \> 35% predicted
* COPD
* Exacerbation
* Inpatient

Exclusion Criteria:

* Pneumonia
* CO2 retention
Serious Gaming for Chemotherapy-induced Nausea and Vomiting

The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or control group. Outcomes such as symptom severity, quality of life, and resource use will be examined.

The goal of this study is to increase the use of preventative self-management behaviors for nausea and vomiting in older adults receiving chemotherapy to reduce negative outcomes and emergency or hospital admissions. Early reinforcement of standard education and re-framing any preconceived beliefs about the ability of nausea and vomiting to be managed will increase preventative self-management behaviors and improve patient outcomes. Participants will be in the study for 6 chemotherapy treatment cycles. This could be 12 to 24 weeks depending on if they receive treatment every 2, 3 or 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age 60 or older
* newly diagnosed with cancer
* treatment with any chemotherapeutic agent of moderate or high emetic potential
* on a 2, 3 or 4 week treatment cycle
* proficient in English
* has a telephone

Exclusion Criteria:

* previous diagnosis and/or treatment for cancer
* end stage disease with less than 6 months to live
* visually or hearing impaired without corrective device
Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas

This study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters:

* Time to erythema margin cessation to progress
* Time to defervescence
* Time to hospital discharge following relief of the presenting cellulitis or erysipelas
* Degree of improvement of the following signs and symptom of cellulitis or erysipelas including
* Degree of improvement of cellulitis-related pain and swelling as reported by subjects

Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin will be described.

same as above

Eligibility Criteria:
Inclusion Criteria:

1. Read and sign the informed consent form after the nature of the study has been fully explained;
2. Male or female \> or = 18 years of age;
3. If female of childbearing potential, a negative pregnancy test is required;
4. Primary diagnosis of cellulitis/ erysipelas

   1. with onset of signs or symptoms within 3 days of 1st dose of study medication
   2. requiring hospitalization, and severe enough to warrant IV antibiotics
   3. temperature \>37.5°C (99.5° F) oral or \>38° C (100.2° F) rectal, documented within 48 hours prior to enrollment, and
   4. anticipated treatment to be limited to medical (NOT surgical) interventions
   5. at an anatomical location that allows of a clear assessment of the erythema margin

Exclusion Criteria:

1. Pregnant or lactating female;
2. Conditions where required surgery (in and of itself) constitutes curative treatment of the infection or removal of infected site (e.g., amputation);
3. Conditions requiring emergent surgical intervention at the site of infection (e.g., progressive necrotizing infections);
4. Previous systemic antimicrobial therapy exceeding 24 hours duration, administered anytime during the 72 hours prior to the first dose of study drug unless on previous antibiotics for at least 72 hours and without any clinical improvement;
5. Cellulitis associated with a wound infection or ulcer requiring incision and drainage or debridement
6. Perirectal abscess or hidradenitis suppurativa or third degree burn infections
7. Buccal cellulitis, facial cellulitis, perianal cellulitis, or periorbital cellulitis;
8. Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection;
9. Known to be allergic or intolerant to study medications;
10. Subjects with a Creatinine Clearance (CLCR) \<30 mL/min;
11. Requirement for non-study systemic antibiotics;
12. Requirement for systemic steroids from enrollment through stabilization of cellulitis;
13. Rhabdomyolysis;
14. Neutropenic subjects with absolute neutrophil count ≤ 500 cells/mm3
Boiled Peanut Oral Immunotherapy

Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.

Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-16 years
* History of immediate hypersensitivity reaction to peanut
* Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
* SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE \>0.35 kU/L

Exclusion Criteria:

* History of life threatening peanut anaphylaxis
* Asthma requiring more than medium dose ICS
* Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
* Oat allergy
* Cardiovascular Disease
* Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers
* Use of steroid medications in the following manners:
* Daily oral steroid dosing for greater than 1 month during the past year
* Burst or steroid course in the past 3 month before inclusion
* Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration
* Pregnancy or lactation
* Eosinophilic Gastrointestinal Disease
* History of food protein-induced enterocolitis
* History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator
5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results

The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of medical records from clinical visits with physician.

The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
* Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
* 16 Years and older

Exclusion Criteria:

* Less than 16 Years of age
Concurrent School Attendance And Cancer Therapy: The Experiences of 6-12 Year Old Pediatric Oncology Patients

Many children with cancer cannot participate regularly in school due to frequent hospitalizations for treatment or treatment related effects such as pain, nausea, and fatigue. Prior studies have shown that children with cancer desire to attend school while receiving therapy despite these challenges, and that they report psychological and psychosocial difficulties if unable to attend. While school attendance has been found to correlate with Health-Related Quality of Life (HRQoL), self-efficacy beliefs, and self-esteem, little is known about how children with cancer experience school attendance while receiving active cancer therapy. The purpose of this study will be to explore how 6-12 year old children with cancer perceive school attendance pre and post diagnosis during active therapy as measured at one-time point, 6 months (± 2months) into active therapy.

The primary objective of this study is to explore 6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis.

This study will utilize qualitative interview methods. Potential participants who meet inclusion criteria will be approached by the principal investigator to obtain consent and assent in accordance with institutional guidelines. Upon giving consent, the child will participate in a one-hour audio-taped interview session with the principal investigator. The interview session will begin with some general rapport building questions to help the child grow comfortable with the interviewer, the interview room, and the interview format. The rest of the interview will consist of questions pertaining to the child's school experiences both before and during diagnosis and treatment for malignancy. The interview will conclude with the child being asked to draw a picture of themselves at school before diagnosis, and of themselves at school since being diagnosed. Demographic data will be collected from each participant's medical chart pertaining to age, gender, ethnicity, diagnosis, and the type of school attended before and after diagnosis and the principal investigator and study staff involved in data coding will complete field note entries directly following the conclusion of each interview or data coding session (see Appendix V). The participant's involvement in the study will end at the conclusion of the interview session.

Eligibility Criteria:
Inclusion Criteria:

* Participant is 6-12 years of age at the time of diagnosis.
* Participant has a primary diagnosis of leukemia/lymphoma or solid tumor.
* Participant has been on therapy for six months (plus or minus 2 months) at the time of enrollment on this protocol.
* Participant is able to read and speak English.

Exclusion Criteria:

* Participant has not received any type of schooling services either in the home, community, or hospital setting since diagnosis.
* Participant did not receive any type of schooling services prior to diagnosis.
Inflammatory Consequences of Crystalloids in Severely Burned Patients

This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. On the long term, the investigators will identify the crystalloid that prevents hyperactivation of macrophages and death of severely burned patients.

The investigators have 4 specific objectives. First, the investigators will compare the activation profiles of macrophages and neutrophils in patients admitted to the severely burned unit with regards to the crystalloids used. Secondly, the investigators will assess the differences in the SOFA scores according to the crystalloids used. Thirdly, the investigators will evaluate the impact of crystalloids in the quality of skin grafts performed on severely burned patients. Lastly, with the help of a patient partner, the investigators will determine the right immunological terminology of the study for a non-scientific population.

Eligibility Criteria:
Inclusion Criteria:

* admission to the CHUM
* more than 20% of burned area
* first blood withdrawal in the first 24 hours following burn

Exclusion Criteria:

* immunosuppression
* chemotherapy 6 months before admission
* radiotherapy 6 months before admission
* autoimmune diseases
* neoplasia
* pregnancy
* severe infections
* cardiac dysfunctions
* renal dysfunction
* hepatic dysfunctions
* Hepatitis C
* HIV
Meditation Based Lifestyle Modification in Depression

To evaluate effectiveness of a 8-week behavioral Mind-Body-Intervention based on Yoga and Meditation in depressive outpatients.

As a contribution to the field of Integral Medicine, Meditation Based Lifestyle Modification (MBLM) is a holistic therapy for patients with mental disorders. Influenced by Ayurveda and Yoga, it uses mantra meditation, ethical conduct and healthy life style to promote physical, mental and spiritual health. MBLM explains processes within the body and the mind and their relation to diet, exercise, biorhythms, social and personal conduct in an easy but profound way and on an experiential level. Besides providing tools for physical, mental and emotional self-regulation, MBLM lays ground for personal growth and transcendence of the mind. It is intended to be implemented in groups of patients as well as individual daily training, and because of its modular structure can be adjusted in intensity, duration and weighting of the components according to the specific needs and disorders to be addressed. This makes it also eligible for its potential use in prevention of mental disease and treatment of psychic comorbidities in patients with chronic somatic illness.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following criteria to be enrolled:

1. Outpatients
2. Written informed consent by patients who are competent to consent to study participation
3. Diagnosis of current mild or moderate episode of depression diagnosed by a consultant psychiatrist
4. Male or female ≥18 years of age
5. BDI-II \>= 10
6. Patients must be physically able to perform simple Yoga postures and to sit silently for 20 minutes

Exclusion Criteria:

Patients will be excluded for ANY ONE of the following reasons:

1. Psychotic Symptoms
2. Acute suicidal tendencies
3. Compulsive disorders
4. Cerebro-organic diseases with clinically relevant symptoms
5. Severe multimorbidity
6. Clinically relevant addictions (tobacco abuse or addiction is allowed)
7. Current participation in another trial
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma

The purpose of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).

Omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. Patients must also present the total serum IgE levels between 30 and 700UI/mL. Children until 12 years the IgE level is between 30 and 300 IU/ml.

Eligibility Criteria:
Inclusion Criteria:

Patients on optimal asthma treatment, good compliance and no response to treatment according to asthma consensus (GINA/NAEEP and the Latinamerican Consensus for Difficult to treat Asthma)
Periodontal Disease and Preterm Birth

To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

Patients will be enrolled in the study at their first prenatal visit after the details of the study have been discussed. Potential subjects will be presented with a questionnaire to determine eligibility for the study. The patient will be scheduled for an exam between 18-24 weeks at which time they will undergo a periodontal assessment, to determine the presence or absence of periodontal disease, a sampling of gingival crevicular fluid (GCF) and a vaginal swab collection. Periodontal disease will be determined by measuring the depth of gingival sulci, amount of periodontal attachment loss, and prevalence of gingival bleeding at six sites for each tooth present.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 15-35
* Singleton gestation

Exclusion Criteria:

* Diabetes prior to pregnancy
* Require antibiotic prophylaxis prior to dental treatment
* Require steroids during pregnancy
A Phase I Study of LFA102 in Japanese Patients

This study will evaluate safety and tolerability to determine the MTD/RD.

This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.

This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of prostate cancer
* Histologically or cytologically confirmed locally advanced or metastatic breast cancer

Exclusion Criteria:

* Patients with untreated and/or symptomatic metastatic CNS disease
* Prior anaphylactic or other severe infusion reaction
* Treatment with agent which affect prolactin levels
* Active autoimmune disease

Other protcol-defined Inclusion/Exclusion criteria may apply.