cyrilzakka/clinical-trials huggingface dataset:
Comparison of Effect-site Concentration of Remifentanil for Preventing Cough Against Endotracheal Tube During Anesthetic Emergence According to Anesthetics (Sevoflurane, Desflurane, and Propofol)

It has been reported that target-controlled infusion of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. We hypothesized that effective concentration of remifentanil for preventing cough during anesthetic emergence varies depending on the type of main anesthetic agents which is administered with remifentanil during general anesthesia. The purpose of this study is to evaluate the effective concentrations of remifentanil to prevent coughing during emergence from general anesthesia according to main anesthetic agent (sevoflurane, desflurane, and propofol).


Eligibility Criteria:
Inclusion Criteria:

* aged 20-60
* ASA classification I\~II
* female patients
* patients who undergoing thyroidectomy

Exclusion Criteria:

* Patients with acute or chronic respiratory disease
* patient who has smoking history
* patient who has hypertension
* patient who has esophageal reflux
* patient who having an expectorant or cough remedy
Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

The objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity.

The high level of anemia persists in Negev children despite the existence of a policy of the Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12 months of age. In addition, other micronutrient deficiencies in this population have been described in several studies. These may be related to; low adherence with existing recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D; the need for a different delivery system more acceptable to mothers and infants.

We will compare in Bedouin and Jewish children separately the efficacy of daily use of Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in Maternal and Child Health clinics.

The comparison will be children recruited in clinics of comparable socioeconomic status, where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are the treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Infant aged 5-7 months
* Infant whose parents give their written informed consent
* Infants whose parents intend to reside within the area for at least 12 months
* Infants receiving any additional food besides breast feeding

Exclusion Criteria:

* Known or suspected haemotological disorders
* Known or suspected anemia (Hb \<11 gr/dl)
* Known or suspected immunological disorders
* Known or suspected malabsorption disorders
* Enrolled or scheduled to be enrolled in another clinical trial
Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of fosamprenavir with posaconazole in healthy volunteers.

Infections with fungi and yeast frequently occur in patients infected with the human immunodeficiency virus type 1 (HIV-1).

Fosamprenavir is a PI that is used to treat HIV-infection in combination with ritonavir. Once hydrolyzed to amprenavir, this substance is a substrate for CYP3A4. Ritonavir is an extremely potent inhibitor of CYP3A4 and serves as a booster of the pharmacokinetics of amprenavir. Posaconazole is a very potent CYP3A4 inhibitor and therefore might enhance amprenavir pharmacokinetics in a similar way as ritonavir.

The current study is designed to test this hypothesis. When there is an indication for antifungal therapy in an HIV-infected patient, temporal replacement of ritonavir by posaconazole would be an attractive option for combined treatment of HIV and fungal infection.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 and not older than 55 years of age on the day of the first dosing.
* Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing.
* Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose.
* Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.

Exclusion Criteria:

* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Positive HIV test.
* Positive hepatitis B or C test.
* Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female.
* Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
* Subjects with an ECG with QTc interval greater than 450 ms for men, and greater than 470 ms for women at screening.
* Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose.
* Donation of blood within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose
The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.

After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary.

This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient.

The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices.

Eligibility Criteria:
Inclusion Criteria:

* General anesthesia
* Age 18-70 years
* American Society of Anesthesiology (ASA)physical status 1-3
* Elective case

Exclusion Criteria:

* ASA physical status class 4 or more
* Unstable pulmonary diseases
* BMI \> 35 kg/m2
* oxygen saturation \< 94% when breathing in room air
* Respiratory muscle weakness eg.myasthenia gravis
* Central nervous system abnormalities eg.drowsiness, hypoventilation
* Patients who have been intubated or needed ventilatory support before operation
* Plan to remain intubated after the operation
* Intracranial, intrathoracic and upper abdomen surgery
* Patients who nasogastric tube is inserted
* Airway problems eg. sinusitis
* Nasal cavity related surgery or nasal packing eg. endoscopic sinus surgery
* Patient refusal
Renin-angiotensin-aldosterone System Polymorphisms in Resistant Hypertension and Adverse Cardiovascular Events

Renin-angiotensin-aldosterone system (RAAS) polymorphisms influence 24h arterial pressure fluctuation. Resistant systemic arterial hypertension (RSAH) has an increased risk of end organ damage and unfavourable prognosis, whereas pseudo-RSAH usually respond favourably to drug therapy.

To prospectively investigate, in subjects with RSAH in a tropical South American city: 1) Adverse cardiovascular events defined as fatal and non-fatal stroke or acute myocardial infarction (AMI); and 2) the association of RAAS polymorphisms and adverse cardiovascular events in this population.

Study population: 212 hypertensives recruited from primary care assistance (time since first diagnosis of hypertension: 16.5±8.1 years) and without appropriate pressure control, between 2001 and 2006, corresponding to 0.48% of all hypertensives under care (18 new cases/year), 57±10 years old, 66% females. Under drug treatment schedule: three or more drugs including a diuretic. Ninety two randomly selected hypertensives basis had renin-angiotensin-aldosterone system genetic profile determined. Genetic assessment was carried out using a polymerase chain reaction assay amplification technique. The following single nucleotide polymorphisms were analyzed: renin (G1051A), angiotensinogen (M235T), angiotensin converting enzyme-ACE (I/D), angiotensin II type 1 receptor (A1166C), aldosterone synthase (C344T) and mineralocorticoid receptor (G3514C).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with uncontrolled systemic arterial hypertension despite use of three anti-hypertensive drugs, including one diuretic

Exclusion Criteria:

* Secondary causes of systemic arterial hypertension
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays

The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.

The main questions to be answered are:

* Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays?
* Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays?
* Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study?

This is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).


Eligibility Criteria:
Inclusion criteria:

* Patients, on gluten-containing diet, with TGt-IgA antibodies \> Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD).
* Patients with TCRγδ+ \>10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium.
* Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies \>10xULN) without duodenal biopsy performed.

Exclusion criteria:

* Patients already diagnosed with CD.
* Patients who refused duodenal biopsy.
* Patients with primary or secondary immunodeficiencies.
* Patients with malignancy.
* Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.
Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points

Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. The pressure release is one of the most recommended manual therapy techniques.

Objective: To determine the time effect of the pressure release technique application in the latent MTrPs of the levator scapulae muscle.

Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.

The manual technique than us apply, be sustained digital pressure with thumbs or with the 2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling of tissue resistance (barrier), as decreases, adds more pressure. different times of sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a control), 60 (group 2) and 90 seconds (group 3) shall apply.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with aged between 18 and 60 years.
* Subjects with presence of latent PGM levator scapulae muscle.

Exclusion Criteria:

* Pregnant.
* Subjects with spontaneous pain.
* Subjects with neck or shoulder pain.
* Subjects with musculoskeletal injuries.
* Subjects with neurological problems.
* Fibromyalgia
Test-retest Reliability of Myocene

The test retest reliability of Myocene will be tested.


Eligibility Criteria:
Inclusion Criteria:

* active individuals

Exclusion Criteria:

* injured participants
* unhealthy volunteers
Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin

A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings

The main obstacle for organ procurement in brain dead patients in France is organ donation refusal by the next of kin. When refusal is reflecting the patient's position, ending the organ donation procedure respects the bioethic French laws. Nevertheless, the actual position of the deceased patient often remains unknown. In these cases, organ donation refusal does not necessarily respect the deceased wishes. Many factors have been associated to next of kin organ donation refusal in such situations. Among those factors, some concerning the meeting with the next of kin have been isolated. French data on this subject are lacking.

A dedicated guide for the conduct of meetings with the next of kin has been elaborated by a working group of our network. Its diffusion will take place last quarter of 2016. The purpose of our study is to evaluate its usefulness through an observational multicenter before-after study, concerning every situation of brain dead patient where the next of kin are met by the medical staff. The refusal rate will be assessed over the first period (before the diffusion of the guide), from july 2012 to june 2014, and compared to that assessed over the second period (after the diffusion of the guide) from january 2017 to december 2018, using the national database of Biomedicine Agency. A comparison of this change in refusal rate will be made between centers of our network and the remaining centers in France nationwide. Anxiety of professionals will be assessed prospectively after each meeting conducted in one of our network centers, over 2 periods, before (from July to October 2016) and after (starting in january 2017) the diffusion of the dedicated guide for the conduct of the meeting with the next of kin. Compliance to the guide by the physicians and organ procurement nurses will be assessed after its diffusion in the centers of our network.

Eligibility Criteria:
Inclusion Criteria:

* situation of confirmed brain dead patient, or dead patient with pending confirmation of brain death

Exclusion Criteria:

* situations where the next of kins are met before brain death
The Hemodynamic Effects of Hypertonic Saline Preload Versus Coload Measured by Non-invasive Cardiometry in Patients Undergoing TURP Surgery

This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.

Benign prostatic hyperplasia is common in elderly males, and this group of patients is commonly associated with different comorbidities especially of the cardiovascular system , this make them at risk of many intraoperative complications. The associated adverse effects arising in both the cardiovascular and nervous systems are known as transurethral resection (TUR) syndrome.Therefore TURP patients need meticulous monitoring of hemodynamics and fluid therapy.

This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.

100 ASA physical status I-III male patients scheduled to electively undergo transurethral resection of the prostate under spinal subarachnoid block were included in this study

Preload group (Group P):

50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula over 15-20 min before the induction of spinal anaesthesia.

Co-load group (Group C):

50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula at the maximal possible rate at the time of identification of C.S.F .

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I - III.

Exclusion Criteria:

* Patient refusal.
* Patient in whom spinal anesthesia is absolutely contraindicated.
* Known sensitivity to local anesthetics.
* Preoperative electrolyte imbalance.
A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants

The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants


Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy males and females (INOCBP)
* Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.
* Participant must have Body weight ≥ 50 kg

Exclusion Criteria:

* Participant must not have current or recent GI disease
* Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.
* Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life

Patients will be randomly assigned to two separate groups. Both patient groups will be evaluated using the WHOQOL-BREF questionaire. Evaluations will be carried out just before the study begins and at intervals of six months during a period of one year for a total of three evaluations. Group one will be made up of patients who will begin homeopathy or acupuncture or anthroposophic medicine treatment and patients from group two will start homeopathy or acupuncture or anthroposophic medicine six months after the beginning of the study. Each one of these three research branches will be done independently (Homeopathy versus control; Acupuncture versus control; Anthroposophic Medicine versus control). Conventional medical treatment will be available for all patients in both groups. A data sheet will be filled out on each patient with data as to age, education level, marital status and the patient's own perception of their health status. During the interviews the interviewer will have no influence whatsoever over the respondents' answers. Integrative/complementary or traditional medicine doctors do not participate in the research and will not be informed about which patients are participating in this project, and as such the research will be blinded for these doctors. Minitab software, version 16, was used for sample calculation through the module Power and Sample Size. Sample calculation option for paired t-tests before and after intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy branch (225 patients in the homeopathy group and 225 patients in the control group), 228 patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in the control group), and 228 patients for anthroposophic medicine branch (114 patients in the anthroposophic medicine group and 114 patients in the control group).


Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age
* Patients with chronic diseases

Exclusion Criteria:

* Women below 18 years of age
* Previous treatment with homeopathy (for homeopathy versus control branch)
* Previous treatment with acupuncture (for acupuncture versus control branch)
* Previous treatment with anthroposophic medicine (for anthroposophic medicine versus control branch)
Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug.

Exclusion Criteria:

* Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means; using a highly effective method of birth control; or agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance.
* With clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study.
* Patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site.