cyrilzakka/clinical-trials huggingface dataset:
Endotracheal Intubation Without Muscle Relaxants

Prospective study conducted between March 2013 and November 2014 at Hospital Universitario Puerta de Hierro-Majadahonda, in Madrid, Spain to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.

This is a prospective study conducted between March 2013 and November 2014 at Hospital Universitario Puerta de Hierro-Majadahonda, in Madrid, Spain, with the previous approval by the institutional clinical research ethics committee. A total of 91 subjects who underwent general, gastrointestinal, orthopedic, urology and neurological surgery were randomly selected and provided written informed consent before any study-related procedures were performed.

The aim of this study was to identify complications and evaluate the efficacy of pure inhalational anesthesia induction to achieve endotracheal intubation without the use of muscle relaxant and analgesic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients
* Age ≥ 18 years
* ASA ≤ 3
* Able to provide informed consent

Exclusion Criteria:

* Subjects with left ventricle ejection fraction (LEVF) ≤ 35%
* History of ischemic heart disease in the last year
* History of malignant hyperthermia
* Presence of thoracic drain tubes
* Increased intracranial pressure (ICP) or brain tumors, undergoing neurophysiological monitoring
* Hemodynamic instability or likely to become unstable during induction of anesthesia
A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection

The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
* Participants who were never treated for hepatitis C virus infection
* Participants without any significant lab abnormalities
* Participants who agree to the use of two effective methods of contraception
* Participant who were judged to be in good health

Exclusion Criteria:

* Participants who had contraindications for starting anti-HCV therapy
* Participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
* Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
* Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
* Participants who have hypersensitivity to tartrazine
The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

Long term steroid exposure, as in Cushing's disease, causes myocardial dysfunction, hypertrophy and fibrosis in addition to causing obesity, hypertension and glucose intolerance. The aim of our study was to verify if short-term high-dose exogenous steroid therapy adversely effects the heart.

Patients eligible for high dose steroid therapy due to inflammatory diseases were offered to participate in this study. The minimal total intravenous dose was 375 mg prednisone, and the daily steroids were divided into 2-3 doses. To determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain. Each patient had a baseline echocardiographic study performed before high-dose steroid therapy was initiated and again immediately after it. A follow-up echo study was performed after completion of a 3-month low-dose steroid therapy period. The paired 2-tailed t-test was used to compare group means

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Patient with rheumatic disease that need high dose steroids due to exacerbation
* Patient whom echocardiographic study can be performed with a good quality

Exclusion Criteria:

* age below 18
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo


Eligibility Criteria:
Inclusion Criteria:

* Male/Females at least 20 years of age.
* Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
* Females have a negative pregnancy test at screening.
* Diagnosis of RA and met ACR criteria.
* Must discontinue any TNF at least 2 months prior to baseline.
* In condition of general good health.

Exclusion Criteria:

* History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
* History of current acute inflammatory joint disease.
* Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
* Recent (3 month) history of influenza or pneumococcal bacterial infection.
* Known positive human immunodeficiency virus (HIV) status.
* Positive hepatitis B or hepatitis C virus.
* Positive PPD \>5 mm.
* Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation

The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin. The investigators also hypothesize that Apixaban reduces cognitive decline by reducing the rate of new cerebral infarction and cerebral microbleeds detected by cerebral MRI compared to warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Non-valvular Atrial Fibrillation
* CHA2DS2-VASc Score \> or = to 2
* Never been treated with Apixaban (Eliquis) or prior treatment of \< 1 month
* Candidate for oral anticoagulation as assessed by a treating physician

Exclusion Criteria:

* Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
* Active Bleeding
* Prior treatment with Apixaban \>1 month
* Recent stroke within 7 days
* Dementia
* Implanted devices not compatible with MRI/any cardiac implanted device
* Claustrophobia
* Active alcohol/drug abuse
* Life expectancy \< 1 year
* Taking asprin with \>100mg doses
* Known hypersensitivity to warfarin or Apixaban
* Severe renal insufficiency
* Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring transfusion)
* Psychosocial reasons that make study participation impractical
* Currently enrolled in another IND or IDE trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
* Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the study.
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
* Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole, itraconazole, ritonavir, clarithromycin)
* Need for dual anti-platelet therapy with aspirin and another agent such as thienopyridine
Patient Preference in Blood Pressure Therapy

Written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension.

The alternative treatment option is renal sympathetic denervation using catheter ablation. This new treatment method is not yet used in the standard care. Currently, studies are being conducted in specific centers to demonstrate the efficacy of this treatment.

Questionnaires are used to determine the preference of patients for one or the other option of hypertension treatment. So far, there are no findings.


Eligibility Criteria:
Inclusion Criteria:

* untreated Hypertension
* treated Hypertension with one or more medications

Exclusion Criteria:

* illiteracy
Long Term Follow-up Grafted Huntington's Disease Patients

Long-term follow-up of Huntington's disease patients treated with intrastriatal allografts is essential to assess the benefit/risk ratio of grafts as well as their effectiveness. Indeed, some patients are likely to develop adverse effects and the impact of alloimmunisation phenomena remains to be explored.

The aim is to create a specific cohort of transplant patients, to homogenise their follow-up methods, to collect all the patient data (medical, paramedical, imaging, biological) acquired from the end of their participation in MIG-HD'study (Foetal Striatal allografting in Huntington's disease: a multicentre, randomised, delayed start, phase 2 open-label cell therapy trial) until the last possible follow-up of the last patient in the study

Eligibility Criteria:
Inclusion Criteria:

* Adult patients transplanted under the MIG-HD protocol
* Information and informed consent from patients or their representative
* Affiliation with a social security scheme or beneficiary

Exclusion Criteria:

* Patient under AME
* Patient unable to express consent and not subject to legal protection
* Knowned pregnancy or breastfeeding woman
PCO2 Gab Marker of Tissue Adequacy of Cardiac Output in Shock State

1. To assess validity of of central and pulmonary veno - arterial CO2 gradient to predict fluid responsiveness and to guide fluid management and determine the cut off point to continue or stop resuscitation.
2. comparison between PCO2 gab and left ventricular outflow tract velocity time integral to determine whether to continue or stop resuscitation and whether PCO2 gab is a surrogate of cardiac output or not.

Assessing the adequacy of oxygen delivery with oxygen requirements is one of the key-goal of hemodynamic resuscitation. Clinical examination, lactate and central or mixed venous oxygen saturation (SvO2 an ScvO2 respectively) all have their limitations (Gavelli et al., 2019). The veno- arterial difference in CO2 tension (delta CO2 or PCO2 gap) is not indicator of anaerobic metabolism since it is influenced by the oxygen consumption. By contrast, it reliably indicates whether blood flow to remove is sufficient to carry CO2 from prepheral tissues to the lung in view of its clearance: it, thus, reflects the adequacy of cardiac output with the metabolic condition (valley et al., 2013). The gap is a marker of adequacy of venous blood flow to remove CO2 produced rather than a marker of tissue hypoxia (Vallet et al., 2013).

The gab can be calculated from simultaneous sampling of central venous blood from a central vein catheter and arterial blood.

Determining the delta PCO2 during resuscitation of septic shock Patients might be useful when deciding when to continue resuscitation despite a central venous oxygen saturation\>70% associated with elevated blood lactate levels. because a high blood lactate level is not a discriminatory factor in determining the source of that stress, an increased delta PCO2 (\>6 mmHg) could be used to identify Patients who still remain inadequately resuscitated.

Fluid responsiveness in shocked patients is conventionally defined as an increase of at least 10% to 15% in stroke volume in response to a fluid challenge. Assessment of response to a fluid challenge can be guided with echocardiography. It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VI) immediately before and after fluid challenge (miller et al; 2016).

Eligibility Criteria:
Inclusion Criteria:

* all critical ill-patients with acute physiological assessment and chronic health evaluation II score (APACHE II score)≥25 with central line insertion, in the critical care uint of internal medicine department of Assuit university hospital in the period between January 2023 to January 2024.

Exclusion Criteria:

1. Pateints with poor echocardiographic window.
2. Pateints with APACHE II score \< 25.
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms

Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.


Eligibility Criteria:
Inclusion Criteria:

* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Signs of severe sunburn (vesicles, bullae or ulceration)
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy to any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility
Efficacy of an App for Monitoring Physical Activity and Weight of Obese Pregnant Women (Pas&Pes)

This study evaluate the efficacy of an App for monitoring the physical activity and weight with a smart watch and the provision of virtual advice through messages with a mobile phone in obese pregnant women in the second trimester.

Half of the women will be randomized at the intervention group (App + smart watch) and the other half, to the control group who will receive the usual prenatal care.

Randomized controlled trial among obese women. These women will be randomized in two groups in order to evaluate an improvement in several outcomes thanks to different strategies:

Intervention group (IG). An App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care.

Control group. Pregnant women will receive the usual prenatal care. Main hypothesis: In the intervention group pregnant women will improve the weight gain adjusted to the preconception BMI, during pregnanacy, with respect to the pregnant women of the control group.

Secondary hypothesis. In the intervention group pregnant women will improve the physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with BMI ≥ 30 Kg / m2 preconceptional
* Speak Spanish fluently
* Viable singleton non-malformed fetus
* 12-18 weeks of gestation
* Users of Android or Iphone smart mobile phone with internet connection

Exclusion Criteria:

* Pregnant women users of a physical activity and weight monitoring App
* Pregnant women with Type I or II Diabetes Mellitus
* Pregnant Women with psychiatric disorders
* Pregnant women with thyroid disorders
* Women with chronic hypertension
* Pregnant women who for some reason have contraindicated the performance of exercise or mobility problems that make it impossible to walk in a moderate way.
* Pregnant women who do not accept to participate in the study.
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections

Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.

Present study aims to identify in which degree multifocal IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. Specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)

Eligibility Criteria:
Inclusion Criteria:

* age between 45 to 70 years

Exclusion Criteria:

* astigmatism \>1.00 diopters
* glaucoma
* former incisional eye surgery
* corneal or fundus disease
* diabetes mellitus
* autoimmune diseases
* neurological or psychiatric diseases
* posterior capsule rupture or lens misalignment
* postoperative uncorrected bilateral distant visual acuity \< 8/10.
Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults

This will be a study looking at trying to change community-dwelling older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.

Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.

Eligibility Criteria:
Inclusion Criteria:

* Any adult between the ages of 50 and 80 will be recruited for the study

Exclusion Criteria:

* Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking device on their wrist.
A NEW SCORING SYSTEM FOR PREDICTION OF PDA

Patent ductus arteriosus (PDA) is an important morbidity of that the diagnosis and treatment is controversy in premature infants. A number of scoring systems have been developed, including the findings of echocardiography on the diagnosis and treatment of PDA. This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* informed consent obtained from parents
* extremely preterm infants
* infants born before 28 gestational week

Exclusion Criteria:

* lack of informed consent
* chromosomal abnormality
* cardiovascular abnormality