cyrilzakka/clinical-trials huggingface dataset:
Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.

Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients with a planned rapid sequence induction of anaesthesia.
* Informed consent.
* Legally competent.
* Be able to understand Danish and be able to read the given information in Danish.
* Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.

Exclusion Criteria:

* Presence of kidney disease, defined as S-creatinine \>0,200 mmol/L.
* Known lung or heart disease, defined as NYHA-class \>2 or CCS-class \>2.
* Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.
* Contraindications to Suxamethon. Including raised P-potassium (\>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.
* Body mass index of \>35 kg/m2.
* Pregnant.
* Breastfeeding.
Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice

This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. We hypothesize that combination of dietary polyphenolics and non-digestible carbohydrates (NDC) will increase the production of phenolic acids by bacteria in the human colon and these will be detected in urine. Participants will attend for three arms in a randomised order: Strawberry juice (a high polyphenol food), Inulin (NDC) or Mixture of strawberry juice and inulin.

Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols. The colonic microbiota are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as dietary fibre to short chain fatty acids. It is likely that there are key interactions in the colonic bacteria metabolism of fibre and phenolics. We hypothesize that combination of polyphenolics and non-digestible carbohydrates (NDC) will increase the urinary output of bioactive phenolic acids.

This study will enable a better understanding of how to deliver combinations of ingredients and nutrients to achieve maximum nutritional value and health benefits.

Eligibility Criteria:
Inclusion Criteria:

Self-reported healthy adults

Exclusion Criteria:

Antibiotic use within the last 3 months, identified gastro-intestinal diseases, on prescribed medication other than the contraceptive pill, individuals who are pregnant or breastfeeding. Individuals who have been diagnosed as anaemic, as well as those who are allergic to any food, or paracetamol.
Pharmacokinetics of Advantage Arrest in Children

The purpose of this study is to characterize basic PK parameters (Cmax, t1/2, AUC) in healthy children to contribute to evidence for the safety of Advantage Arrest, consistent with Guidance for Industry--Exposure--Response Relationships (April 2003).

This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest. This is an open label exposure-response study with up to 50 healthy children ages 3-13 years of age. Subjects will be treated with Advantage Arrest and have one blood sample withdrawn at a randomly assigned time point. A minimum of 3 subjects per time point at 2,4,6,24,48,96 and 168 hours. Serum samples will be analyzed for F and Ag.

Eligibility Criteria:
Inclusion Criteria:

* Healthy.
* At least one carious lesion.

Exclusion Criteria:

* Oral mucositis
* Any ulcerative lesions
* Hypersensitivity to silver
* Hypersensitivity to fluoride.
* SDF treatment within 3 months.
Squalamine for the Treatment in Proliferative Diabetic Retinopathy

The purpose of this study is to determine the efficacy in the use of topical Squalamine Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting from proliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Individuals \<18 years old are not being included because PDR is so rare in this age group that the diagnosis of PDR may be questionable.
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Any one of the following will be considered to be sufficient evidence that diabetes is present:
* Current regular use of insulin for the treatment of diabetes
* Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
* Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions)
* At least one eye meets the study eye criteria
* Able and willing provide informed consent

Exclusion Criteria:

* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
* Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
* Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
* Note: study participants cannot receive another investigational drug while participating in the study.
* Known allergy to any component of the study drug.
* Blood pressure \> 180/110 (systolic above 180 or diastolic above 110).
* If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
* Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
* These drugs should not be used during the study.
* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
* Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
* Individual is expecting to move out of the area of the clinical center during the study.
* History of allergy to Squalamine
Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers

The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in moderate smokers. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged between 18 and 60 years and a current smoking rate ≥ 5 points.

Exclusion Criteria:

* Were excluded participants who presented diagnosis of cardiorespiratory disease, systemic or metabolic disease such as rheumatoid arthritis or cancer, history of thoracic surgery, vertebral fracture, spinal structured musculoskeletal disorders and thoracic region and contraindication to the treatment techniques used (osteoporosis).
Clinical Comparison of Silicone Hydrogel Monthly Lenses

The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent;
* Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
* Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
* Screening lenses worn 10 hours exhibiting high lipid uptake.

Exclusion Criteria:

* Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
* Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
* History of herpetic keratitis, corneal surgery, or irregular cornea;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Abnormal ocular conditions or findings, as specified in the protocol;
* Known pregnancy and lactation.
Palatability of a Novel Oral Formulation of Prednsione

Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 32 years, male and female who are healthy at the time of study
* can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
* demonstrate ability to complete study questionnaire

Exclusion Criteria:

* history of smoking or using any tobacco products
* previous history of taste disturbance
* any condition or dietary habit known to interfere with the sense of smell and taste
* any structural or functional abnormality of the upper gastrointestinal tract
* ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
* history of any significant illness within the two weeks prior to study
* history of autonomic dysfunction, bronchospastic disease or atopic allergy
* known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
* any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
* brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
* inability to speak and/or read English at a grade 10 level
Conventional Clipping Versus Punching Closure

Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients undergoing gastrointestinal ESD wound closure in the First Affiliated Hospital of Ningbo University from April 20, 2024 to December 31, 2025; 2. Age 18-75 years old; 3. Patients who voluntarily agreed to participate in this study and signed informed consent.

Exclusion Criteria:

* 1. Persons under the age of 18 2. Unwilling or unable to provide informed consent 3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.. Severe abdominal pain, bloating, nausea and other abdominal symptoms 5.. Patients with lifelong anticoagulant therapy or severe bleeding disorders, and patients who have recently taken anticoagulant or antiplatelet drugs 6. Pregnant or lactating 7. Patients with aggressive lesions and recurrent or residual tumors
Early EMDR Following Covid-19 Critical Illness: A Feasibility Trial

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT).

This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

A significant number of patients worldwide, have been admitted to intensive care suffering from Covid-19 related organ failure. Patients who survive a period of critical illness have a disproportionately high chance of suffering from significant and persistant poor psychological outcomes.

Eye-Movement Desensitisation and Reprocessing (EMDR) has reduced incidence of psychological morbidity in war veterans and victims of man-made and natural disasters. Small studies have also shown it to be effective in healthcare settings, within the Emergency department, following cancer diagnosis and implantation of cardioverter defibrillators. EMDR is validated by UK National Institute of Clinical Excellence guidance for use in treating adult onset PTSD.

Because of ongoing social distancing guidance our study programme aims to investigate whether it is feasible to treat patients with an early online Eye Movement Desensitisation Reprocessing (EMDR) intervention, delivered soon after hospital discharge and whether this intervention will improve psychological outcome for survivors of critical illness.

Eligibility Criteria:
Inclusion Criteria:

* Acute admission to Critical Care who have required mechanical ventilation for at least 24 hours
* PCR confirmed Covid-19 positive
* \>18 years of age
* Capacity to provide informed consent

Exclusion Criteria:

* Acute brain injury
* Cognitive impairment
* Pre-existing psychotic diagnosis
* Not expected to survive post-hospital discharge
* Refusal to grant consent
Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.

Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe Malawi with sigmoid volvulus will be eligible for inclusion.

Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous sigmoid volvulus).

Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty

Exclusion Criteria:

* pregnancy,
* age under 18 years,
* prisoners
Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy

The iliac crest is one of the most commonly used bone graft sources, especially in pediatric pelvic osteotomy operations for developmental dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. In this study, we aimed to identify the effects of inner side and two-sided approaches for iliac crest bone harvesting on post-surgery ilium growth in children.

Autogenous bone grafting is still the gold standard and most effective method for treatment of non-union and bone defects due to congenital disease and infection. Despite the development of bone engineering, none of the allogeneic bone products can match the osteoinductive, osteoconductive, and immunogenic properties of autogenous bone. The iliac crest is one of the most harvested sites other than the fibula, ribs, and ulna. An iliac crest bone graft (ICBG) can supply a larger amount of cortical and cancellous bone than grafts from other donor sites. Pelvic osteotomy is widely used for treating developmental dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. Tricortical structural bone such as that in the ilium is needed to stabilize the pelvis after osteotomy, and the anterior and posterior iliac crest are the two most used graft donor sites. When surgery is planned in the prone position, such as that for posterior spinal fusion, surgeons generally prefer to adopt the posterior approach for ICBG procedures. In supine position surgeries such as pelvic osteotomy for DDH or Legg-Calve-Perthes disease, surgeons prefer the anterior approach for ICBG procedures. There are many studies on iliac bone growth and complications after ICBG procedures. Most of the studies demonstrated good outcomes and few complications. However, according to our literature review, none of the previous studies used the iliac bone for transplantation in pelvic osteotomy. In this study, we compared the results between an inner table harvest site and an inner-outer table harvest site for ICBG used to maintain stability in pelvic osteotomy.

Eligibility Criteria:
Inclusion Criteria:

* the patients who performed iliac crest bone graft and pelvic osteotomy at the same time

Exclusion Criteria:

* they had a history of pelvic osteotomy or iliac crest bone graft surgery, bilateral hip disease or congenital bone dysplasia, or were lost to follow-up.
Collection of Outcomes Data for Pregnant Patients With Cancer

This study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care.

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment and outcome for pregnant patients with malignancies seen at M. D. Anderson Cancer Center.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and pregnancy outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository, kept on a secure platform, that will integrate clinical information and research findings and serve as a secure archive for future research.

OUTLINE:

Patients' medical records are reviewed prospectively and retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer are eligible, regardless of their diagnosis or treatment plan
* Patients may receive prenatal care from any obstetrician, but a consult with Maternal Fetal Medicine is encouraged
Retrospective WGS Study

This retrospective case series reviews clinical notes to assess whether NHS whole genome sequencing provides tangible benefits for paediatric tumours.

The NHSE-commissioned whole genome sequencing programme went live at the end of 2020. It remains as yet unproven, whether this whole genome sequencing programme for children with cancer can deliver tangible benefits in real-time. There is an urgent need, therefore, to assess whether children with tumours who are receiving NHS whole genome sequencing are actually benefiting from this additional assay. This is a retrospective case series. The principal methodology is that of reviewing clinical notes to assess whether children with tumours have benefited from NHSE whole genome sequencing. Apart from the contribution of our work to the scientific literature, this research will inform government on the potential benefits, or lack thereof, of the live NHSE whole genome programme and has the potential to influence policy on whether this programme should be continued.

Eligibility Criteria:
Inclusion Criteria:

* All children and young people (up to the age of 21 years) diagnosed with a neoplastic disorder who have been offered NHSE whole genome sequencing.

Exclusion Criteria:

* Anyone not offered NHSE whole genome sequencing
* Individuals beyond the age of 21
* Individuals without a neoplastic disorder.
A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient

Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel

Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study

Eligibility Criteria:
Inclusion Criteria:

* Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged \>18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
* Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Women must have a negative urine pregnancy test at Visit 1

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
* Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
* Patients who had acute coronary syndrome or stent placed within 12 months of screening
* Planned arterial revascularization
* Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol