cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection

The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT).

The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT)
2. Subject is clinically diagnosed with RSV infection with new onset or acute worsening
3. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
4. Documented RSV infection in the upper respiratory tract (URT)
5. Subject has:

   * Diagnosis of RSV lower respiratory tract (LRT) disease or
   * Diagnosis of RSV URT disease with high risk of progression to lower respiratory tract infection (LRTI)

Others as defined in the protocol

Exclusion Criteria:

1. Subject has clinically significant bacteremia or fungemia within 7 days of screening
2. Subject has clinically significant bacterial, fungal or viral pneumonia
3. Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
4. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration.

Others as defined in the protocol
The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter

The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.

BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after cardiac surgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective cardiac surgery, a randomized trial will be performed in current study.

DESIGNING 150 patients will be randomize assigned to cardiac surgery with RIPC or without RIPC (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points.

EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury in cardiac surgery.

CONCLUSIONS:

In patients undergoing elective cardiac surgery, RIPC reduces the incidence of postoperative cerebral injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acquired heart valve diseases scheduled for valve replacement or CABG

Exclusion Criteria:

* Were unable to give informed consent
* Patients who presented with other systemic diseases such as hepatic,renal, and pulmonary diseases, or have had a heart operation before, were excluded.
* Additionally, patients taking antidiabetic sulfonylurea or glibenclamide were excluded because these agents have been shown to abrogate the cardioprotection elicited by ischemic preconditioning.
Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone

Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma with at least one previous therapy.
* 18 years or older
* Signed, written informed consent

Exclusion Criteria:

* Pregnancy or nursing
* All other exclusion criteria listed in SmPC (summary of product characteristics)
SEx-specific Differences in Cardiac Surgery Patients (SECS).

The aim of this study is to evaluate the differences between females and males undergoing cardiac surgery. The investigators will look at perioperative factors such as adaption of body weight, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at sort-term (within 30 days) and long-term (90 days and 1 year).

There are now an increasing number of studies on preoperative cardiovascular differences in females and males, but no study to date has focused on a female-specific approach to perioperative anaesthesia and critical care in cardiac surgery patients.

Given the higher mortality and morbidity in females after cardiac surgery, as well as the abovementioned sex differences, it is likely that females require different perioperative care than males, for better and faster recovery.

The investigators hypothesise that females require different perioperative care (pathways) compared to males when undergoing cardiac surgery. The investigators would therefore like to investigate which factors are different in female and male patients, by setting up a database of perioperative parameters. By identifying the factors that adversely affect morbidity and mortality in females and linking these parameters, the investigators would like to improve outcome in fmales after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.

Exclusion Criteria:

* None
Stereotactic Aspiration for Primary Brainstem Hemorrhage Based on 'Zhe-er Classification'

The purpose of this study is to determine the benefit of stereotaxic aspiration for patients with primary brainstem hemorrhage with the guidance of 'Zhe-er Classification'

This is a retrospective study aiming to analyze the clinical record of patients from March 2014 to October 2020. This study is indicated for primary brainstem hemorrhage.

Eligibility Criteria:
no new patients will be enrolled within this project

Inclusion Criteria:

* Patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Exclusion Criteria:

* patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies
Effect of Beta Blockade on Left Ventricular Remodeling and Function in Moderate to Severe Asymptomatic Aortic Regurgitation

The primary objective of this study is to evaluate the effect of beta-blocker on left ventricular (LV) remodeling in asymptomatic patients with moderate to severe aortic regurgitation.

The left ventricle responds to the volume load of chronic aortic regurgitation (AR) with a series of compensatory mechanisms, including an increase in end-diastolic volume, an increase in chamber compliance that accommodates the increased volume without an increase in filling pressures, and a combination of eccentric and concentric hypertrophy. The greater diastolic volume permits the ventricle to eject a large total stroke volume to maintain forward stroke volume in the normal range. This is accomplished through rearrangement of myocardial fibers with the addition of new sarcomeres and development of eccentric LV hypertrophy. As a consequence left ventricular ejection fraction will remain in the normal range.

The clinical course of chronic aortic regurgitation is characterized by a prolonged phase of stability during which the left ventricle adapts to the volume overload. Eventually myocardial failure ensues through a series of complex events that include changes in myocyte phenotype due to re-expression of fetal genes, cellular apoptosis alteration in the expression and function of contractile proteins and changes in the extracellular matrix.

The role of long-term vasodilator therapy in the care of asymptomatic patients with severe aortic regurgitation is controversial. Vasodilator therapy has been used to reduce the regurgitant volume, afterload, left ventricular volumes, and wall stress in an effort to preserve left ventricular function and reduce left ventricular mass. Thus time to surgical intervention has been found to be delayed by calcium antagonists, ACE-inhibitors and hydralazine, while a more recent study did not find any effect of nifedipine or enalapril on time to surgery or left ventricular volume and function.

The decision to recommend operative intervention to the asymptomatic patient with chronic, severe aortic regurgitation (AR) is very difficult because aortic valve replacement (AVR) continues to entail immediate risk, and biologic and mechanical valves still have problems resulting in significant morbidity and mortality. On the other hand, the mortality rate in asymptomatic patients with AR is very low, and surgery does not improve the quality of life. Thus, the indication in asymptomatic patients must be delayed until changes occur that will predict an increased risk of operative or long-term death after AVR. At present indication for aortic valve replacement is development of symptoms, an increase in left ventricular volume or a decline in left ventricular function.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe aortic valve insufficiency
* Asymptomatic

Exclusion Criteria:

* Arrhythmia
* Other severe valve disease
Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service

This feasibility study evaluates whether it is possible to run a larger scale study to investigate the use of a self-management programme with adults who have recently had a stroke. Half of the participants will receive support with self-management from stroke therapists, while the other half will receive it from rehabilitation assistants.

Supporting self-management post-stroke is a key priority in healthcare policy, but not yet embedded into the provision of stroke rehabilitation. Barriers to implementation include time and resource. The feasibility of using the Bridges Stroke Self-Management Programme within an Early Supported Discharge Service and delivery by Rehabilitation Assistants is unknown.

The aim of this study was to evaluate key trial parameters to inform the protocol of a future definitive trial into the effectiveness of Bridges delivered by rehabilitation assistants within an Early Supported Discharge Service.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of new stroke
* Being referred to the ESD service
* Medically stable
* Able to give informed consent
* Can follow a two-stage command

Exclusion Criteria:

* Being discharged to a care home
Difficult Intubation and Tongue Protrusion

Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.

Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.

To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing abdominal surgery with general anesthesia
* Able to sit

Exclusion Criteria:

* Enable to sit,
* Patients had head or neck surgery,
* Patients with unstable cardiological and respiratory hemodynamic symptoms,
* Dental prosthesis
Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.

Rationale: Fatigue is a common symptom in patients with sarcoidosis and has great impact on quality of life. Several aspects in the pathogenesis of sarcoidosis and co-morbidities accompanying sarcoidosis could contribute to fatigue. However, until now the etiology of fatigue in sarcoidosis is unknown. Measurements of steroid hormones in scalp hair could possibly be directional in elucidating the underlying mechanism and could also be used as a screening and follow up tool in interventional studies.

Objective: A pilot to investigate whether cortisol and testosterone levels measured in hair differ between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue and healthy subjects.

Study design: A prospective observational study, using hair samples of sarcoidosis patients with and without fatigue, compared to an already existing age matched healthy control group.

Study population: Adult sarcoidosis patients at the outpatient clinic of the pulmonary department of the Erasmus MC, Rotterdam Main study parameters/endpoints: Cortisol and testosterone levels in scalp hair, correlation with Fatigue Assessment Scale.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
* Able to speak, read and write in Dutch
* Presence of sarcoidosis related fatigue, defined as a ≥ 22 score on the Fatigue Assessment Scale
* Other causes of fatigue are excluded or contributing comorbidities are optimally treated (e.g. OSAS, hypothyroidism or anemia)

Exclusion Criteria:

* Unable to understand questionnaires (intellectual impaired or language barrier)
* Hair length \< 1 cm
* Use of systemic and/ or inhalation steroids in the last year
* Use of methylphenidate (Ritalin) \< 1 month before the study
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients

The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients undergoing primary resection of esophageal cancer and resultant esophagectomy.

Exclusion Criteria:

* Patients \< 55kg or \> 140 kg, based on literature regarding accuracy of FloTrac.
* Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation).
* Patients with diagnosed NYHA class III-IV failure or documented EF \< 30%
* Patients who are unable/unwilling to consent for study procedures
Swiss Transplant Cohort Study

The Swiss Transplant Cohort Study is an observational prospective cohort study enrolling all patients after solid organ and stem cell transplantation since 5/2008 in Switzerland. Predefined variables are collected at defined time points. Individual samples (PBMC, plasma, DNA) will be stored for future projects. Data relevant to transplantation outcome with emphasis on immunological and infectious complications as well as psychosocial variables will be gathered.


Eligibility Criteria:
Inclusion criteria:

* All patients after organ and stem cell (planned 2009) transplantation.

Exclusion criteria:

* No informed consent given
Game-Based Digital Intervention for Depression in Adolescents

The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.

Participants will be asked to engage with the digital intervention platform for a period of two months.


Eligibility Criteria:
Inclusion Criteria:

* The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
* no prior use of antidepressants or antipsychotic medications.
* having a HAMD (Hamilton Depression scale) score \>= 8 upon enrollment
* demonstrate normal cognitive function.
* voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.
* being able to read and typeset Chinese.

Exclusion Criteria:

* with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning
* with concurrent psychiatric disorders (as determined by clinical assessment)
* at high risk of suicide
Aromatherapy Massage for Itching Management in Liver Diseases

The aim of this study is to determine the effect of aromatherapy massage on itching, comfort, skin pH level and skin moisture in individuals with liver disease.

Research Hypotheses:

H1: Aromatherapy massage has an effect on the level of itching in individuals with itchy liver disease.

H2: Aromatherapy massage has an effect on the general comfort level in individuals with itchy liver disease, H3: Aromatherapy massage has an effect on skin pH level in individuals with itchy liver disease.

H4: Aromatherapy massage has an effect on skin moisture in individuals with itchy liver disease.

This randomised controlled trial was conducted in order to examine study effect of aromatherapy massage on itching, comfort, skin pH level, and skin moisture among individuals with liver diseases

Eligibility Criteria:
Inclusion Criteria:

* patients who volunteered to participate in the study,
* with a diagnosis of chronic liver disease (liver cirrhosis (primary biliary cirrhosis, alcoholic, cardiac, post-necrotic, cryptogenic cirrhosis, Wilson's Cirrhosis, hemochromatosis), chronic viral hepatitis),
* had no cognitive impairment,
* were not included in the pre-application,
* could answer questions,
* itch score of above 3 (with Visual Analogue Scale).

Exclusion Criteria:

* patients are taking antipruritic treatment,
* have itchy skin disease before, ulcer, eczema, etc. in the area to be applied
* patients with dermatological problems, any swelling or signs of inflammation in the area ---to be treated, neuropathy or loss of sensation in the area to be treated
* patients with allergic to tea tree oil, perfume, or cosmetics,
* diagnosed with cancer
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.

The hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD (FEV1/FVC \<0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)
* accepting of walking in water
* BMI \>/= 21 kg/m2

Exclusion Criteria:

* long-term oxygen therapy
* contraindications to entering a hydrotherapy pool
Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.

The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* Signed agreement

Exclusion Criteria:

* Delirium at admittance or MMSE score \<24 points
* High risk for postoperative ICU treatment
* Haloperidol or Ketamine intolerance
* Risk of lack of cooperation
* Drug an alcohol abuse
* Dementia
* QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
* Parkinson's disease
* Intake of dopaminergic drugs (Levodopa, dopamine agonists)
* Parkinsonism
* Epilepsy
* Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
* Delay of operation of more than 72 hours past hospital admittance
* Body weight \>100kg
Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach

The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery

The investigator will compare the maxillary stability in class III orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery
2. Patients free from any systemic disease
3. Patients who approved to be included in the trial and signed the informed consent
4. Patients with no signs or symptoms of temporomandibular disorders.

Exclusion Criteria:

1. Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)"
2. Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) "
3. Patients who refused to be included in the trial