cyrilzakka/clinical-trials huggingface dataset:
Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)

This proposed pilot study will examine the tolerability, feasibility, acceptability, and preliminary effects of a gentle yoga intervention "Kids 2 Be \& Breathe" (K2B2; a manualized 30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11 with severe asthma.

Pre-Intervention Assessment: permission/assent from the child and consent of the parent/guardian will be obtained and initial data and measurements will be collected to ensure continued eligibility; baseline measures will be assessed.

Intervention: participants will engage in a one-time manualized, age appropriate, 1:1, 30-minute intervention involving gentle yoga and mindfulness techniques in a private room in the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be taught by certified and experienced child yoga instructors who have been trained in the study protocol by the applicant. These yoga instructors collaborated with the interdisciplinary research team in the development of manualized age-appropriate yoga sequences. Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be maintained through the use of a manualized intervention and the PI observing all sessions for manual consistency. The intervention will cease if the participant suffers from any asthma symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle use, chest tightness or shortness of breath, or experiences any other adverse events which precludes the his or her ability to actively participate in the intervention.

Post-Intervention Assessment: upon completion of the intervention, brief semi-structured interviews will be conducted with the child and parent/guardian separately in order to explore the acceptability of the intervention and the PI will again assess the child for any asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign measurements will then be collected.

Eligibility Criteria:
Inclusion Criteria:

* on medium to high doses of steroids and/or leukotriene inhibitors
* a Child-Asthma Control Test Score \<21

Exclusion Criteria:

* inability to speak English (child); inability to read/write English (parent/guardian)
* child hospitalized in past two weeks for their asthma
* current illness associated with oral temperature \>100.4
* pulse ox \<95% and/or any wheezing, retractions or accessory muscle use
Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success.

This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of sevoflurane anaesthesia in difficult to intubate (DTI; Mallampati Score III or IV) Egyptian patients who had been prescribed sevoflurane for anaesthesia by their treating physician.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV

2. Patients with at least one of the below criteria:

1. Anatomic

   * micrognathia - small mandible
   * macroglossia - large tongue
   * short or fixed neck
   * anterior vocal cords
2. Trauma - neck or face
3. Burns - airway edema
4. Infections - edema

   * Retropharyngeal abscess
   * Submandibular abscess
   * epiglottitis
   * laryngotracheobronchitis (croup)
5. Neoplasms; e.g., laryngeal tumors
6. Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
7. Diabetes mellitus
8. Waxy skin - palm test
9. Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
10. airway closure in supine position
11. Morbid obesity (body mass index \[BMI\] \>35)
12. Airway edema
13. Laryngospasm
14. Edentulous patients - indent cheeks.

3. Patients willing to sign informed consent

Exclusion Criteria:

1. Patients with present use of opioids and/or narcotic dependent.
2. Patients with known sensitivity to sevoflurane or to other halogenated agents.
3. Patients with known or suspected genetic susceptibility to malignant hyperthermia.
4. Alcohol addictive patients.
5. Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
6. Patient is a pregnant or breastfeeding female
Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia

Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure.


Eligibility Criteria:
Inclusion Criteria:

* 1. Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Exclusion Criteria:

* 1. Patients under 20 years old
* 2. Patients who should undergo tracheostomy
* 3. Patients who need to use an endotracheal tube without a cuff
* 4. Pregnant women
* 5. Patients who can not read the consent form or are not fluent in Korean
* 6. Patients who refused the clinical trial
Adrenaline for the Treatment of No-Reflow in Normotensive Patients

No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* All patients with acute coronary syndrome who developed No-reflow during PCI.
* Patients with systolic blood pressure of \> 100 mmHg.

Exclusion Criteria:

* Hypotensive patients
* Patients with Valvular or congenital heart disease.
* Patients with Atypical chest pain
* Patients with Cardiomyopathy
* Patients with Pericarditis
* Patients with Myocarditis
* Patients refused to give consent
Effect of Vitamin D in Burn Patients

The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.

Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications.

The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* vitamin D \<30 ng/ml
* patients undergoing burn surgery

Exclusion Criteria:

* age \< 18 years old
* hypercalcemia
* renal disease
* cardiac disease ( EF\<40%, MI, angina)
* respiratory disease (ARDS, pneumonia)
* intubated patients
* electrical burn
PERFECT Project - Part 2 - Study 2

The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of cereals containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. The investigators also hypothesize that consumption of cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.


Eligibility Criteria:
Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
* Body Mass Index of 18.5-29.9 kg/m2

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
* Those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity)
* Those unable to walk for an hour continuously
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)

The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.

The investigators are seeking to study the combination of decitabine and bexarotene. These two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal hematopoiesis via different mechanisms of action and with non-overlapping side-effect profiles. By combining these agents, the investigators hope to improve overall response rates. The investigators further hope to improve platelet and neutrophil counts in an even greater number of patients, thus treating two of the most important sources of morbidity and mortality in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* AML with bone marrow blasts ≥ 20%.
* Relapsed disease after 1 or more lines of prior salvage chemotherapy and any FAB-AML, or
* Diagnosis of AML and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any FAB-AML except FAB-M3.
* Performance status ≤ 2.
* Age ≥ 18 years.

Exclusion Criteria:

* Peripheral white blood cell count (WBC) \> 10,000/microliter.
* Total bilirubin \> 1.5 x normal.
* AST/ALT \> 2.5 x normal.
* Serum creatinine \> 2 x normal.
* Fasting serum triglyceride \> 1,000 mg/dL.
* Active or poorly controlled graft vs host disease (GVHD).
* Pregnant or nursing.
* Known CNS leukemia.
* History of positive HIV serology.
* History of positive Hepatitis C serology.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of NYHA class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
* Chemotherapy within 21 days of enrollment.
* Radiation therapy within 14 days of enrollment.
IH Convidecia as Second Booster Dose Against Breakthrough Infections

This will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of IH Convidecia (CanSino), as a second booster vaccination against Omicron and other emerging VOCs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose.

These subjects will be randomized in a ratio of 1:1 to receive a second booster dose of IH Convidecia vaccine (treatment arm), or a second booster dose of mRNA vaccine BNT162b2 (Pfizer).


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give written informed consent for participation in the study.
* Male or Female, aged 18 years or above and in good health as determined by study clinician. Participants may have well controlled or mild-moderate comorbidity.
* Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation.
* In the Investigator's opinion, participant is able and willing to comply with all trial requirements.
* At least 16 weeks after first booster dose of vaccination.

Exclusion Criteria:

* Confirmed cases, suspected cases or asymptomatic cases of COVID-19.
* Self-reported history of SARS and MERS infection.
* Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination.
* Receipt of any SARS-COV-2 vaccine after first dose of booster vaccination.
* Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
* Any history of anaphylaxis.
* Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture.
* Suspected or known current alcohol or drug dependency.
* Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
* Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
* Participant with life expectancy of less than 6 months.
Study to Evaluate the Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With ALS

The FLX-787-106 study will determine how well FLX-787-ODT works to reduce fasciculations in patients with Amyotrophic Lateral Sclerosis (ALS). The study will measure how often fasciculations occur, and monitor any side effects that might develop while taking the investigational product. Participants will be assessed before and after taking a single dose of FLX-787-ODT. Approximately 15 people will take part in this study at one center in the United States. Participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ALS diagnosis of less than 3 years.
* Expected survival \> 6 months
* Frequent fasciculations noted during clinical examination of any single muscle (\>6 visible fasciculations per minute) observed in Part I
* Normal oral cavity exam at screening
* Proficient in English
* Male subjects will either be surgically sterile or agree to use a medically acceptable method of contraception during sexual contact with females of childbearing potential, and will refrain from sperm donation for 45 days following the study
* Male subjects will either be surgically sterile or agree to use a medically acceptable method of contraception during sexual contact with females of childbearing potential, and will refrain from sperm donation for 45 days following the study

Exclusion Criteria:

* Presence of clinically significant or unstable condition that would result in an increased risk of study participation or difficulty in interpretation of the study results
* Tremor or other movement disorder that would interfere with recording
* Inability to lie flat
* Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers
* Presence of laryngospasm or significant swallowing problems
* Presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or G-tube
* Inability to tolerate a spicy sensation in the mouth or stomach
* Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol
* Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening
* Pregnant, breastfeeding, or planning to become pregnant
* Blood pressure of ≥160 mmHg systolic and/or ≥100 mmHg diastolic
* Clinically significant abnormalities in laboratory findings (including screening complete electrolyte panel, complete blood count, liver function tests).
Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.


Eligibility Criteria:
Inclusion Criteria:

* Born at less than 32 weeks newborns

Exclusion Criteria:

* Congenital heart disease
* Syndromic and/or major congenital anomaly
CRUZ Tunisia-Multivessel Registry

The primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).

This is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the Supraflex Cruz SES in an unselected, all-comer patient population with multivessel disease. The multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the Supraflex Cruz SES. The registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (CAD) as well as acute coronary syndrome (STEMI and NSTEMI).

All patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure.

Subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of Target Lesion Failure (TLF) at 12 months. The following subgroups are pre-defined according to their presentation at enrolment:

1. Treatment in relation to clinical presentation \[Acute Coronary Syndrome (ACS)\]
2. Treatment in relation to specific lesion subsets \[Left Main, Chronic Total Occlusion\]
3. Patients undergoing atherectomy

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be at least 18 years of age
2. Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure
3. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
4. The patient is willing and able to co-operate with study procedures and required follow up visits

Exclusion Criteria:

1. Women with known pregnancy or who are lactating
2. High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
4. Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media
Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation

In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. Measures include: a) patients' knowledge of essential facts \[options, benefits, harms, and outcome probabilities\]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks.

In the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a good experience for many patients, improving their quality of life and their survival. However there are potential risks of lung transplantation including infection, organ rejection and early death. Cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. Our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. The decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.

Patients randomized to either arm of the study will be required to undergo a lung transplantation education and counselling session with their CF physician prior to randomization. Subsequent to this session patients will be randomly allocated to receive: 1) usual care plus the patient decision aid or 2) usual care. For purposes of this study, usual care will include a booklet entitled, "Cystic fibrosis and lung transplantation" written by the Canadian Cystic Fibrosis Foundation plus any other written or educational material that the local CF centre normally provides.

Eligibility Criteria:
Inclusion Criteria:

* FEV less than or equal to 40% predicted

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients on a lung transplant waiting list
* Patients who are lung transplant recipients
* Patients deemed too sick for transplant
* Only one sibling per family to minimize contamination