cyrilzakka/clinical-trials huggingface dataset:
Ultra-early STatin in Patients With Aneurysmal subaRachnoid Hemorrhage (Ue-STAR)

A researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage (aSAH).

To further explore the efficacy and safety of ultra-early statin administration in aSAH, the investigators propose a Phase III randomized controlled trial-The Ultra-early Statin in patients with Aneurysmal subArachnoid hemorrhage (Ue-STAR) trial. This study aims to determine whether ultra-early (within 6 hours), short-term treatment (2 weeks) with a high intensive long-acting statin (atorvastatin 40 mg/day) improves clinical outcomes at 6 months in aSAH patients. Through this research, the investigators hope to provide more robust evidence for the clinical management of aSAH, ultimately improving treatment outcomes for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female; Aged ≥18 years
2. Signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence
3. Treatment within 6 h after symptom onset

Exclusion Criteria:

1. Treatment with statin prior SAH
2. Non-aSAH (e.g. traumatic subarachnoid hemorrhage, arteriovenous malformation)
3. Treatment \&gt; 6 h after symptom onset
4. Allergy to statin medications or presence of severe adverse reactions such as abnormal liver function or rhabdomyolysis
5. Evidence of irreversible brain damage or expected death within 7 days
6. Known severe liver or kidney disease
7. Non-compliance with follow-up
8. Pregnant or breastfeeding
9. History of severe cranial or psychiatric illness
10. Concomitant serious systemic disease
11. Patients with malignant tumors
12. Currently participating in another clinical trial
13. Considered unsuitable for the clinical trial by clinical physicians or researchers
Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery

The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also with complications on long term, such as development of chronic kidney disease. A better understanding of the mechanism of this hypthesis will lead to better management of this complication.

A randomized blinded prospective study included 206patients who the candidate for major surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt. From April 2018 till April 2019, a detailed history and careful examination, routine laboratory investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours postoperative at ICU.

Eligibility Criteria:
Inclusion Criteria:

* patients who were candidates for major non cardiac surgery

Exclusion Criteria:

* chronic cardiac diseases (myocardial ischemia, heart failure), Active severe infection, pregnancy, chronic kidney disease
Helmet NIV in Acute Respiratory Failure

Non-invasive ventilation (NIV) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. This study will investigate the feasibility of performing a larger study examining whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* 1) patients who are admitted to the adult ICU
* 2) deemed to require NIV, as per the clinical team, for acute respiratory failure.

Exclusion Criteria:

* 1) with impending cardiac arrest or need for intubation
* 2) Glasgow coma scale \<9
* 3) tracheostomy or upper airway obstruction
* 4) elevated intracranial pressure
* 5) untreated pneumothorax
* 6) who refuse endotracheal intubation (do not intubate order documented)
* 7) facial trauma
* 8) are unable to wear the helmet or facemask
* 9) who use NIV chronically
MGPOCUS Assisted Bronchoscopy in Difficult Endotracheal Intubation

Introduction Endoracheal intubation (ETI) is a crucial but risky procedure, especially among patients with suspected difficult endotracheal intubation (DTI). Bronchoscopy, as an improved technique commonly used in DTI, might encounters the difficulties of visualization. The magnetic point-of-care ultrasound (MGPOCUS) not only provide an novel visualization from outside, but also enable the estimation of relative position and trajectory of bronchoscopy. The study aims to evaluate the efficiency of MGPOCUS assisted bronchoscopy in time taken to the first-attempt success, the first-attempt and overall success of ETI, complications and satisfaction of visualization among patients suspected with DTI.

Methods and analysis The current study is a randomized, parallel-group, single-blinded, single-center study. Participants (n=350) will be recruited by primary anesthesiologist and randomized to groups of ETI with bronchoscopy or MGPOCUS assisted bronchoscopy. The primary outcome is time taken to the first-attempt success ETI. Secondary outcomes include procedure time, the first-attempt and overall success, complications and satisfaction of visualization. Cox regression with the Bonferroni correction and the linear mixed regression will be used to analysis the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 85 years old.
* Requiring ETI.
* Anticipated DTI meets one or more positive findings in the airway evaluation, including history, examination, and appropriate investigations of anatomy .
* Signed written informed consent.
* Willingness for the primary anesthesia team to participate.

Exclusion Criteria:

* Anterior neck lesions (masses, lacerations, or subcutaneous emphysema).
* A history of neck operation or tracheotomy.
* Allergies to ultrasound coupling gel.
* At risk of pulmonary or cardiovascular complications during intubation with flexible bronchoscope, including severe hypoxemia, severe pulmonary hypertension, unstable or severe obstructive airway disease.
* At risk of bleeding during bronchoscope, including anticoagulants or coagulopathy, renal insufficiency, and superior vena cava syndrome.
* High risk of aspiration.
* Current pregnancy.
* Patient unable to cooperate (for awake intubation).
Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain

A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational intervention with individual feedback or a treatment-as-usual control condition. The intervention was delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students. Primary outcomes for testing efficacy were alcohol use and alcohol-related consequences.

Aims: To assess the potential efficacy and the feasibility of a peer-led brief alcohol intervention aimed to reduce the alcohol consumption in Spanish heavy nursing student drinkers.

Methods: A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational enhancement intervention with individual feedback (n=23) or a treatment-as-usual control condition (n=27). Both motivational interviewing and personalized feedback were delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students (BASICS). Participants were assessed during their pledge year of university with a one-month follow-up. Primary outcomes for testing efficacy were alcohol use (quantity, heavy-drinking episodes, and peak blood alcohol concentration), and alcohol-related consequences. Quantitative data were analyzed using the U-Mann-Whitney and Wilcoxon test. Content analysis was used for measuring the feasibility of the program.

Eligibility Criteria:
Inclusion Criteria:

* First year university students of Nursing Degree, between 18 and 20 years old.
* Students of first access to the University.
* Having had at least one episode of heavy drinking or binge drinking in the past month.

Exclusion Criteria:

* Students who have started or previously studied other university degrees or a higher degree.
* University students who do not consume alcohol or, if they do consume alcohol, have not had binge drinking in the last month.
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis

The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must first be established.

This is a pilot, open-label, study on 10 female patients with AMA-positive PBC to determine the effects of two infusions of rituximab on response of memory B cells to bacterial motifs, on biochemical function, and histological features. We will enroll 10 consecutive AMA-positive patients with the diagnosis of PBC based on internationally accepted criteria and histological staging determined at liver biopsy and being currently treated with UDCA. Importantly, patients with advanced histological stages, decompensated liver disease, or waiting for OLT will not be included in the study (see exclusion criteria).

Patients eligible and willing to enter the study will be evaluated at baseline by isolation and study of frequency and absolute numbers of B cells and their function, biochemical and AMA tests. Histology and quality of life will be also evaluated in all patients. The methodology to be used for B cell study is already well-established in our laboratory as can be seen in the attached paper (Kikuchi et al. 2005b). Patients will be administered 1,000 mg rituximab intravenously by slow infusion on Day 1 and Day 15 (+/- 1 day). Rituximab's pharmacokinetics indicate that complete B cell depletion is obtained 2-3 days after administration and that such effect may be lost after 9 months (Vieira et al. 2004). In addition to our B cell work, serum samples will undergo AMA testing, including titers, using recombinant mitochondrial antigens (Miyakawa et al. 2001). Patients will also undergo serum chemistry panel, which includes liver function tests. Patients will continue on a steady dose of UDCA therapy throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy showing histological PBC stages I, II, or III
* Presence of all criteria for the diagnosis of PBC
* serum AMA at titer \>1:40
* alkaline phosphatase \>2X normal value for \>6 months
* compatible liver histology
* Incomplete response to UDCA after 6 months of treatment.
* Negative pregnancy test (female patients in fertile age)
* Adequate renal function (serum creatinine \< 1.2)

Exclusion Criteria:

* End-stage/decompensated liver disease
* ascites
* jaundice with serum bilirubin \> 2mg/dl
* history of digestive bleeding secondary to portal hypertension or endoscopic evidence of varices at stage F2
* history of hepatic encephalopathy
* INR\>1.2
* Other coexisting causes of liver disease
* Use of other immunosuppressive medications 4 weeks prior to enrollment
* Diuretics use
Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
* Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
* Patient willing to comply with follow up.

Exclusion Criteria:

* Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
* Patient had active infection
* Medial MCK onlay implants were implanted without bone cement
* Patients did not have sufficient bone stock to allow for insertion and fixation of components
* Patient did not have sufficient soft tissue integrity to allow for stability
* Patient had a neurological or muscular deformity that did not allow for control of the knee.
Study of an Emergency Department-based Intervention to Reduce Alcohol Misuse in Older Adults

This is a randomized trial to assess the value of an emergency department-based intervention to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will result in a 25% reduction in the prevalence of hazardous alcohol use while the control group will only have a 5% reduction.

The goal of this project is to perform a pilot, randomized, controlled trial of a brief intervention and referral for treatment among older adults in the emergency department (ED) with alcohol misuse. The pilot data would then be used to design a larger study. The intervention for this trial will consist of a Brief Negotiation Interview (BNI) with a stratified referral for further treatment, compared with usual care. The BNI is a standardized, well-described intervention that has been implemented in a broad range of clinical settings but has not been specifically tested in older adults in the ED. Following the BNI, we will provide a referral for further care for the patient that is stratified by severity of alcohol misuse. Patients with hazardous or harmful alcohol use will follow-up with a primary care physician; patients with alcohol abuse or dependence will follow-up with an outpatient alcohol and substance abuse program; those at risk for complicated withdrawal will be recommended for inpatient treatment. In all cases we will contact the referral physician to help transition the patient's care, and ensure the patient receives a consistent message regarding their alcohol use across the different care settings.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and older
* Receiving care in the emergency department
* Hazardous alcohol use, defined as reporting drinking more than 7 drinks per week on an average week during the three months prior to the visit, and whether they have consumed more than three drinks on any given occasion.

Exclusion Criteria:

* Prisoner
* psychosis or psychiatric hold
* nursing home
* life-threatening condition
* current hospice care
Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

OBJECTIVES:

Primary

* To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx.

Secondary

* To determine response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of laser light therapy.

Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment.

After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-confirmed diagnosis of 1 of the following:

  * Mild to severe dysplasia of the larynx

    * Dysplastic lesions \> 3 mm in thickness
  * Squamous cell carcinoma in situ of the larynx
  * T1 squamous cell carcinoma of the larynx

    * Tumor \> 3 mm in thickness
    * No T2-T4 squamous cell carcinoma of the larynx
* Newly diagnosed or recurrent disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Total bilirubin \> 2.0 mg/dL
* Creatinine \> 2.0 mg/dL
* SGOT \> 3 times upper limit of normal (ULN)
* Alkaline phosphatase \> 3 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
* No porphyria
* No hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

* Any prior therapy allowed
* At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
The Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture on Sedentary Individuals

There are very few studies on the effect of core stabilization exercises on balance, posture and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the study is to investigate the effects of core stabilization exercises on balance, trunk muscle endurance and posture in healthy sedentary individuals. According to the results of International Physical Activity Questionnaire, the researcher includes sedentary individuals over the age of 18 in the study. The participants are divided into two groups as control (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle endurance tests. Intervention includes core stabilization exercises 3 times a week and walking twice a week for 6 weeks. There is no treatment or intervention for the control group. The researcher evaluates both groups at the beginning and 6 weeks after the intervention.

Core stabilization exercises are performed under the supervision of a physiotherapist as face-to-face exercises, guided online exercises, and as an individual home exercise each once a week, totaling 3 times a week. Each exercise will be performed with 10 repetitions for 8 seconds. Each of the exercises is varied from easy to difficult. Progress in the exercises will be achieved by increasing the difficulty level of the exercises according to the condition of the participant once every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Be voluntary to participate in the study
* Being between the ages of 18-40
* Being sedentary

Exclusion Criteria:

* Not volunteering to participate in the study
* Having a complaint of low back pain in the last two months
* Being pregnant
* Having chronic lower extremity pain
* Having an orthopedic disease and undergoing a surgical operation
* Having had abdominal surgery
* Being a neurological disease pathology
Fibromyalgia and Psychiatric Symptoms Among PMS and PMDD Patients

Assessing FM and psychiatric disorder in patients suffering from PMS or PMDD


Eligibility Criteria:
Inclusion Criteria:

* PMDD
* PMS
* Referral to gynecologist clinic without symptoms of PMS or PMDD
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* healthy 6-8 months old infants

Exclusion Criteria:

* previous receipt of any meningococcal B vaccine;
* previous ascertained or suspected disease caused by N meningitidis;
* history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
* any present or suspected serious acute or chronic disease
* known or suspected autoimmune disease or impairment /alteration of immune function
ROX Index Versus MROX Index to Predict Treatment Outcome for High Flow Nasal Cannula And/or Noninvasive Ventilation in Patients with Respiratory Failure

One of managing steps in respiratory failure is high flow nasal cannula (HFNC), but the exact time to turn to invasive machine ventilation (IMV) is necessarily being determined. Respiratory rate and oxygenation (ROX) index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SO2)/ FiO2 to respiratory rate (RR), is used to determine when to intubate the patients who are on HFNC and prevent the delayed intubation. Modified Respiratory rate and oxygenation (mROX), defined as (PaO2/ FiO2) / respiratory rate, is also used to point the time of intubation in case HFNC of patients with respiratory failure . The diagnostic and prognostic accuracy of both parameters are reported in previous papers, but the preference of them is under research. In this study, we aim to observe and compare the diagnostic accuracy between ROX and mROX in determine the time of invasive mechanical ventilation.

Respiratory Failure (RF) is a condition where there's insufficient oxygenation in the body tissue, whether acute, chronic or acute on chronic; occurring due to decreased oxygen or excessive carbon-dioxide in the blood . There are four types of respiratory failure; Hypoxemic respiratory failure (Type1), hypercapnic respiratory failure (Type2), ) . Causes of RF are varied and accounted for any abnormality related upper respiratory tract, lower respiratory tract, central and peripheral nervous system or muscles of respiration . However, in the last three decades, the most common causes of RF is acute myocardial infarction (AMI), acute respiratory distress syndrome (ARDS), RF related to corona virus (Covid-19) and acute exacerbation of chronic obstructive lung disease (COPD).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sex aged between 18 to 80 years
* Patient diagnosed with acute type 1or 2 or chronic type 1or 2 respiratory failure.
* Patient for chest ICU admission
* Patient for HFNC and/ or Noninvasive mechanical ventilation.

Exclusion Criteria:

* Pediatric patients
* Pregnant females
* Patients who are for intubation on ICU admissionc.