cyrilzakka/clinical-trials huggingface dataset:
Sevoflurane Concentrations in Children

The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.

Protocol definition:

This study will not deviate from standard anesthetic management of children with the exception of recording the child's vital signs and anesthetic gas concentrations during the anesthetic induction.

Healthy children, 2-6 years of age, fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Children's Hospital in Buffalo, NY will be consented for this protocol by the principal investigator. Parents who speak English will be approached for consent; the formal hospital translator service will be used for those parents who do not speak English. The medical translator will translate the consent form for the parents.

Children will be selected for inclusion in this study from the elective surgery list. A total of 28 children of both sexes will be enrolled, 14 with each of the two workstations. We will strive to include the workstation in each operating room at least once in the study. The choice of anesthesia workstations, Drager Apollo or GE Ohmeda, is predetermined by the floor on which the surgery is planned. Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei.

Once the standard anesthesia monitors are applied, the children will undergo a routine inhalational induction that begins with a mixture of 5 liters/minute nitrous oxide and 2 liters/minute oxygen. Once the end-tidal nitrous oxide concentration reaches 0.45, the sevoflurane vaporizer will be dialed to 8%. The inspired and expired concentrations of sevoflurane will be recorded at the designated times (see data collection sheet) for the first 10 minutes of anesthesia. All vital signs (oxygen saturation, end-tidal carbon dioxide tension, blood pressure and heart rate) will also be recorded.All unusual movements and airway responses will also be recorded and when they occurred (under Notes on the data collection form). At the conclusion of the 10 minutes of the induction, the airway will be secured with an airway device, the surgery will proceed as planned and the recording will cease. The study will be terminated.

The inspired and expired concentrations of Sevoflurane with the Drager Apollo and GE Ohmeda workstations over time will be summarized and displayed graphically. The maximum inspired concentrations of Sevoflurane during each induction with the two types of workstations will be compared using Student's t-test at a significance level of P\&lt;0.05.

Jerrold Lerman MD, FRCPC, FANZCA July 11, 2024

Eligibility Criteria:
Inclusion

* scheduled for elective surgery under general anesthesia,
* ASA physical status 1 or 2

Exclusion Criteria:

* parents refuse consent
* presence of moderate or severe cardiorespiratory disease
* difficult airway
* malignant hyperthermia
* neuromuscular disorders
* obesity
* obstructive sleep apnea
Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Patiens.

Currently, cervical pain is the second most frequent musculoskeletal disorder, which generates an important impact on the function and quality of life. It is estimated that its anual prevalence for the general population can reach 50%.

Non-specific cervical pain attends without signs or symptoms of structural or neurological pathology, its etiology is unknown. However, it is related with joint and muscular structures. It has been observed a decrease in the strength and endurace of the deep cervical flexor muscles in 70% of patients with cervical pain; as well as motor control déficit and coordination alterations in the sinergy between the activity of the superficial and deep musculature.

Also, phycosocial factors, as for example: behaviors of fear-avoidance, catastrophism, hypervigilancy, psychosocial stress and negative adaptative neuroplastic changes, may have an importante role in chronic musculoskeletal pain.

In the last years, RV has been used in clinical rehabilitation, being a reliable and valid tool, which allows the patient distration to virtual world and they have offered results like: decreased pain and fear of movement and also improvements in motor performance and neuroplasticity processes.

The aim of this single-blinded randomized novel pilot study is to observe the effects generated in motor variables, when a protocol of manual therapy combined with augmented reality as a method of exercise in subjects with non-specific cervical pain is applied; in comparaison with a protocol of manual therapy combined with conventional cervical exercises.

Different variables will be measured at the beginning and at the end of intervention. Also, they will be measured one month after the intervention to observe the changes produced in short term. These variables are: pain, function, satisfaction, propioception, endurance, as well as phychological and somatosensory variables.


Eligibility Criteria:
Inclusion Criteria:

* - Men and women.
* Age: 18-65 years old.
* Persistent neck pain for at least 3 month or intermittent neck pain for 6 month or more.
* 5 points or 10% at the Neck Disability Index questionnaire.

Exclusion Criteria:

* Cervical whiplash (10 years before)
* Cervical fractures.
* Vestibular pathology.
* Epilepsy or other neurological condition.
* Systemic diseases.
* Cardiovascular or respiratory disorders that affect physical performance.
* Lasik eye surgery.
* Fibromyalgia
* Pregnancy
Dengue Vaccine Hesitancy and Acceptance in Endemic Regions of Argentina: Impact of Communication Strategies

Among all arboviruses, Dengue (DEN) is the vector borne disease with the highest burden worldwide. Around 390 million infections per year are estimated, of which around 96 million are clinically apparent.

Since its re-emergence in 1998 in Argentina, DEN has shown an epidemic behavior affecting mainly the northern and central regions in which the circulation of serotypes has been heterogeneous. The last significant outbreak was registered between the end of 2019 and the beginning of 2020..

Vaccine development for DEN prevention has been a long and challenging journey. The only vaccine that has reached registration to date is a recombinant attenuated tetravalent vaccine (Dengvaxia, Sanofi Pasteur) showing an efficacy against virological confirmed DEN infection of 36.6% (4.2-61.4) in seronegative subjects at baseline and 77.9% (65.1-86.0) in seropositive. However, this vaccine has not been pre qualified by the World Health Organization. New dengue vaccines are in advanced stages of development worldwide. At least three vaccines are in advanced stages of development including one produced by Takeda, the Butantan Institute and the Merck, Sharp \& Dohme development.

The implementation of a vaccination strategy in Argentina could be a health-relevant approach. However, the best way to implement this requires prior information describing and investigating numerous aspects of vaccination including acceptability.

A systematic review of two acceptability surveys showed an acceptability of 77% to 86% but in countries with endemic DEN at time of the surveys.

It is possible that in Argentina, the introduction to the regular calendar, for use in specific regions with a high and periodic burden of disease, of highly effective and safe DEN vaccines will be considered. However, to our knowledge, we do not have available evidence of the potential acceptability of these vaccines.

The main objectives of this research will be:

To evaluate the acceptability of a DEN vaccine in potential target populations in regions of high burden of disease in Argentina.

Describe main determinants of and barriers to DEN vaccine acceptability in regions of high burden of disease in Argentina.

Identify information and intervention needs to design and implement communication strategies that have a positive impact on the acceptability of a DEN vaccine.


Eligibility Criteria:
Inclusion Criteria:

* People who express willingness to participate and who are residents of communes with a high burden of Dengue disease.

Exclusion Criteria:

* Persons who do not give informed consent.
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.

Patients will be randomized to one of two study arms:

dexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1).

Prednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).

Eligibility Criteria:
Inclusion Criteria :

* a true thrombocytopenia on blood smear
* adequate megakaryopoiesis on bone marrow examination
* the absence of clinically apparent associated conditions or cause of thrombocytopenia
* Age over 16 years
* A platelet count of less than 30x109/L

Exclusion criteria :

* previous treatment for ITP.
* other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.
* Patients with life threatening bleeding and pregnant women should be excluded.
The Impact Of A Catheter Coating On Clinical Bacteriuria

A prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter.

Each participant will take part in the trial from the time the participant signs the informed consent form (ICF).

After the screening visit, the participants will be randomized to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed as per standard hospital guidelines, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.

During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
2. Patients aged 18+ years will be eligible for the study.
3. Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

Exclusion Criteria:

1. Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
2. Pregnant or Breastfeeding.
3. Patients with a potentially immunocompromised conditions (HIV)
4. Has a known silicone allergy or sensitivity
5. Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
6. Any medication deemed by the Investigator to potentially interfere with the study treatment
7. Participation in any other clinical study.
8. Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis

Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy. However, discontinuation of denosumab produces a rapid increase in bone turnover, bone loss and potentially increased risk of multiple vertebral fractures.

76 postmenopausal women from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE) were firstly considered, of which 23 presented elimination criteria and only 55 who had received denosumab therapy for an average of 2.5 years without a significant improvement in hip and lumbar spine T-scores were enrolled. First, a general medical evaluation was performed. Serum levels of vitamin D were analysed to find the prevalence of hypovitaminosis D. A bone mineral density test was done to calculate hip and lumbar spine T-scores. Then, vitamin D was administrated daily for one year at a dose of 4,000 IU and the studies were repeated after one year. Statistical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. The assigned α value for this study was \<0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of postmenopausal osteoporosis or osteopenia in treatment with denosumab 60mg every six months plus calcium carbonate 1.2g/day + vitamin D 800IU/day.
* Diagnosis of hypovitaminosis D, with serum cholecalciferol values \<30ng/dL.

Exclusion Criteria:

* Incomplete clinical records or clinical records.
* Age over 90 years.
* Diagnosis of secondary (hereditary) osteoporosis.
* History of prolonged use of steroids.
* Lack of adherence to medical treatment.
* Diagnosis of cancer.
* Diagnosis of depression.
* Diagnosis of Celiac disease or with the presence of alterations in intestinal absorption.
* Allergies to any of the medications administered.
An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.

Human immunodeficiency virus (HIV)-1-infected, clinically stable, treatment-naïve adult participants who have completed 96 weeks of elvucitabine therapy and whose HIV ribonucleic acid (RNA) levels remain below 50 copies/milliliter (mL) at the 92-week assessment in Protocol ACH443-015 or participants who have completed 48 weeks of elvucitabine therapy and continue to maintain an HIV-1 RNA viral load below their baseline level upon entry into Protocol ACH443-018.

Eligibility Criteria:
Inclusion Criteria:

• Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 .

Exclusion Criteria:

* Participant has experienced virologic rebound as defined in Section 5.6.1.3 of Protocol ACH443-015.
* Participant has exceeded their Baseline HIV-1 RNA level by Week 44 as measured in Protocol ACH443-014A-018
* Participant is experiencing a drug-related Grade 3 or 4 rash or a drug-related Grade 3 or 4 laboratory toxicity other than Grade 3 or 4 cholesterol, triglyceride, creatinine kinase, or lactate dehydrogenase (LDH).
Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D

In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive)
* No contraindications for combined oral contraceptive (COC) use
* Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle Exclusion Criteria:
* Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) \> 30,
* Known hypersensitivity to any of the study drug ingredients
* Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results
Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations

Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints.

About 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.

Numerous studies pointed out the close relationship between sleep apnea and cognitive impairment. To the investigators' knowledge, no trials have assessed the existence of a relationship between the IAH index and the cerebral arterial blood flow rate (macrocirculation). Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood flow through phase contrast MRI also called "flow MRI". The main hypothesis tested in this study is the existence of a relationship between OSAS and total cerebral arterial vascular inflow measured by PC-MRI (in mL/min) in the elderly population.

* Primary outcome: The apnea/hypopnea index (measured by nocturnal respiratory polygraphy) and total arterial flow rate (measured by PC-MRI)
* Secondary outcomes:

  1. Measurement of arrhythmia
  2. Measurement of arterial blood pressure

Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients about or over 75 years
2. Any gender
3. Dementia Group:

   3.1. MMSE (Mini Mental State Examination)\> 15

   3.2. Diagnosis of dementia established according to DSM-IV

   3.3. Dementia of the Alzheimer type from NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
4. Control Group:

   Preserved cognitive function corresponding to a normal MMSE score by the standards of Poitrenaud
5. Ability to understand and give consent freely (for demented subjects, a legal representative will be delegate)

Exclusion Criteria:

1. Elderly patients under 75 years
2. Anyone with a classic contraindication to MRI

   2.1 Major behavioral disorders that do not allow the realization of MRI in optimal conditions

   2.2 Claustrophobia

   2.3 Presence of foreign non-compliant material

   2.4 Presence of intraocular metal body
3. Having a history of chest surgery or neurosurgical
4. Chronic respiratory failure
5. Suffering from dementia other than that associated with Alzheimer's disease
6. Patients with a handicap
7. Patients under legal protection
Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors

The study will follow the MRC Framework to develop an evidence-based BE intervention protocol to help breast cancer survivors with better management of cancer-related chronic pain.

Cancer-related chronic pain remains as a big challenge for cancer survivors, which significantly affects the quality of life of cancer survivors. Evidence suggests that pain is well managed through combination of pharmacological and non-pharmacological interventions. Among all non-pharmacological interventions, breathing exercise (BE) might have potential effect for chronic pain management in cancer survivors, but the evidence is sparse in current literature. Therefore, this study will follow the Medical Research Council Framework for Developing and Evaluating Complex intervention (the MRC Framework) to develop an evidence-based BE protocol to help with cancer-related chronic pain management in breast cancer survivors. The first two phases of the MRC Framework will be included in this study. In the first phase, an evidence-based method will be utilized to develop the BE intervention protocol. In the second phase, a pilot randomised controlled trial (RCT) will be conducted to examine the feasibility of study and the acceptability of the BE intervention by the participants as well as to preliminarily assess the effect of the BE on chronic pain management in breast cancer survivors. Semi-structured interviews will be conducted after the RCT to explore participants' experiences of participating in the study and practicing the BE.

Eligibility Criteria:
Inclusion Criteria:

1. female breast cancer survivors ≥18 years age;
2. has a confirmed diagnosis of breast cancer at stage I, II or IIIa;
3. has been experiencing pain since cancer diagnosis constantly or intermittently for ≥3 months, with the average pain intensity in the last seven days on a numerical scale ≥4/10 ("0" indicates no pain and "10" indicates the worst pain);
4. has completed active anticancer treatment (such as chemotherapy, radiotherapy, surgery) for at least three months;
5. agrees to participate in the research and is willing to give informed consent;
6. can read and understand Mandarin Chinese.

Exclusion Criteria:

1. extremely weak and unable to perform the breathing exercises;
2. mentally incapable (i.e., unable to follow the study instructions);
3. has scheduled pain management interventions, such as having a procedure or operation;
4. receiving other pain relief treatments, such as acupuncture, yoga, qigong, exercise program, etc.;
5. has any pre-existing chronic pain conditions before cancer diagnosis, such as arthritis, rheumatoid arthritis, chronic low back pain, migraines, trigeminal neuralgia, fibromyalgia, joint dysfunction, Complex Regional Pain Syndrome, endometriosis, etc.