cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
* A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
* Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
* Child in care.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Acute disease and/or fever at the time of enrollment.

  * Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
  * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash

Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a "runny" nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to improve these symptoms without side effects common to over the counter and prescription medication. It is hypothesized that Calcium Glycerophosphate will have a perceived improvement in breathing comfort.

Subjects will be screened for inclusion and exclusion criteria and consented if they fit the same criteria. They will be instructed on keeping a nasal diary of symptoms "runny, itchy, congestion, sneezing, voice changes and throat clearing". They will have blood drawn for allergy testing. After a 1 week run-in, subjects will return their diary. If they still qualify based on the diary they will have baseline labs drawn and baseline breathing test (Spirometry) performed. They will also have a nasal wash and specimen collection performed. They will be instructed on use of the nasal wash. There will be three more weekly visits before study conclusion which will include diary submission, Spirometry and nasal wash and specimen collection. On the final visit blood will again be collected as well.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18-80 years of age
* Twelve months or more of allergic rhinitis symptoms
* Allergic antibodies to perennial aeroallergens to be confirmed by blood draw

Exclusion Criteria:

* Intranasal or systemic glucocorticosteroids within one month of study entry
* Intranasal cromolyn for 2 weeks prior to study
* Intranasal or systemic antihistamine for 3 days prior to the study
* Loratadine for ten days prior to study
* History of rhinitis medicamentosa
* Planned travel outside the study area that will inhibit study follow-up visits

  _Persons with Asthma with more than 2 episodes per week or month of nighttime awakenings
* Persons with Known sensitivity to Calcium or phosphorus supplements
* Persons taking antihistamine treatment intermittently. (Chronic steady use throughout study is acceptable)
* Immunomodulatory or cytotoxic drugs
* Clinically significant uncontrolled disease that in the opinion of the investigator would put the subject at risk or may confound the study interpretation
* Persons with hypercalcemia
* Persons whose nasal obstruction(s) would be significant to obstruct air flow
* Persons who are employees of Investigator or AkPharma or whose spouse, parent, child or sibling is employee of investigator
* Pregnant persons or persons planning to conceive/inseminate partner during study or for one month after
Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in serum creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in general population and up to 50% in high risk population. High risk patients include those with chronic kidney disease (GFR\<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart failure, anemia and advanced age. Amount and kind of contrast medium and decreased circulating blood volume are other important predictors of CIN. 50% of cases of CIN happen within 24 hours of contrast injection. Maximum creatinin levels are reached between 48-72 hours. It usually returns to previous levels in 7-10 days. Suggested mechanisms are renal vasoconstriction and tubular injury. N-acetylcysteine and hydration are proved to be protective against CIN and theophylline may have a role. In this study, it is hypothesized that pentoxifylline, a dimethylxanthine, can also protect renal cells from CIN. It has been observed that pentoxifylline improves oxygen delivery to ischemic tissues, diminishes oxidative damage to renal tissue and may also scavenge free radicals. Percutaneous coronary intervention is assumed a high risk procedure for developing CIN as the amount of contrast used in PCI is remarkable. Therefore, the patients undergoing PCI were selected for the trial. A prospective randomized trial will be conducted on patients undergoing PCI.


Eligibility Criteria:
Inclusion Criteria:

* All eligible consecutive patients who are admitted to the angiography center of university hospitals for PCI since April 2011 will be enrolled to enter the study.

Exclusion Criteria:

* Serum creatinine above 1.5 mg/dl
* Frank bleeding tendency
* Those previously on pentoxifylline
SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease

With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect motor, emotional, and cognitive fluctuations in Parkinson's disease patients.

Parkinson's disease (PD) affects mobility (motor function), thought processes (cognition) and mood (emotion). The language is one of the most complex programs in humans. It contains information about mobility, thinking and mood at the same time. These three levels of agility, thinking and mood are subject to spontaneous fluctuations and can be influenced by external stimuli such as pictures that induce emotions. In addition, these three levels are influenced on the one hand by Parkinson's disease itself, and on the other hand by its treatment with medication or with deep brain stimulation (DBS). For this reason, the investigators would like to investigate language in Parkinson's disease patients in a very detailed computerized way for motor, cognitive and emotional elements for better management of therapies.

With this study, the investigators want to investigate whether computerized speech analysis can be used to reliably and objectively detect fluctuations in motor, mood, and thinking in Parkinson's disease patients.

Even in healthy subjects, speech changes in a situational manner, due to which the investigators will also include healthy subjects as a control group.

Eligibility Criteria:
Patients with Parkinson's Disease

Inclusion Criteria:

* Written informed consent
* Idiopathic PD according to the Movement Disorders Society Criteria;
* Age of participants \> 30 and ≤ 75 years;
* Treatment with or without bilateral deep brain stimulation in the subthalamic nucleus;
* Fluent in German or French

Exclusion Criteria:

* Dysarthria caused in addition by a condition other than PD (e.g. stroke, myasthenia);
* Clinical diagnosis of aphasia;
* Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
* Cognitive impairment (Montreal Cognitive Assessment (MoCa) \< 24/30 points);
* Depression with acute suicidal ideation

Healthy Controls

Inclusion Criteria:

* Written informed consent
* Adults from 50-70 years old;
* Fluent in German or French

Exclusion Criteria:

* Diagnosis of Parkinson's disease;
* Cognitive impairment (Montreal Cognitive Assessment (MoCa) \< 24/30 points);
* Suffering from brain disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.);
* Clinical diagnosis of aphasia, dysarthria, and stuttering;
* Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria
Prostate Biomarker Study

Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. Typically, a serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. However, these assessments are imperfect. There is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.

The Inter-SPORE Prostate Biomarkers Study (IPBS) was established to prospectively collect and analyze biological specimens to predict and validate outcomes after treatment for prostate cancer. The study population will consist of patients scheduled to receive standard of care therapy for localized prostate cancer, either radical prostatectomy (RP) or radiation therapy (XRT; includes external beam radiation, brachytherapy, or both). Seven hundred (700) patients (350 RP, 350 XRT) will be recruited from 11 SPORE sites over a two-year interval. We will collect serum, plasma, lymphocytes, and prostate tissue samples for distribution to collaborating biomarker validation sites at other prostate SPOREs, along with clinical and epidemiologic data.

Eligibility Criteria:
Inclusion Criteria:

* Males, 35 years of age or older, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland.
* Biopsy performed at the SPORE institution.
* No prior therapy for prostate cancer (patients who receive neoadjuvant therapy after collection of blood and biopsy samples are eligible).
* The patient should have 2 or more cores involved with carcinoma. The minimum amount of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor. (This amount can be made up from 2 positive cores if 1 core is insufficient).
* Patients with clinical stage T1-T2a NXM0 prostate cancer who elect to be treated with RP or XRT (includes external beam radiation, brachytherapy, or both) at the SPORE institution.
* Patients with a nomogram predicted 5-year probability of freedom from biochemical recurrence (Kattan 1998) of less than or equal to 85% (patients with intermediate risk of recurrence).
* Ability and willingness to sign informed consent

Exclusion Criteria:

* Participation in a therapeutic clinical trial with an experimental agent.
* Previous cancer of any kind except non-melanoma skin cancer
* Previous surgical or minimally invasive treatment for enlarged prostate (e.g. TURP, TUNA, TUIP, laser, microwave)
* Use of anti-androgen drugs during the 6 months prior to diagnosis
* Use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis
Cognitive Function in Adults With Cardiac Disease

The purpose of this study is to identify cardiac patients' degree of unappreciated mild impairment in cognitive function patterns of cognitive function, and influencing factors related to cognitive functioning during hospitalization. The results from the study will contribute to tailoring the delivery of patient education to optimize patient understanding of information in future clinical practice.

It is hypothesized that the study will demonstrate the following:

1. The degree of cognitive function for patients hospitalized in a CICU will be below the scores for normal functioning adults.
2. Patients with acute cardiovascular conditions will score differently in cognitive functioning at various times throughout their hospitalization.
3. Relationships between cognitive function and following variables:

   * Patients with greater sleep deprivation or fatigue will exhibit lower cognitive functioning.
   * Patients with greater hunger will exhibit lower cognitive functioning.
   * Patients who are experiencing greater anxiety will exhibit lower cognitive functioning.
   * Patients who are experiencing depression will exhibit lower cognitive functioning.
   * Patients who have undergone or will undergo shortly treatment or procedures will exhibit lower cognitive functioning.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the Cardiac Intensive Care Unite for acute cardiological issues during time of enrollment.
* Patients with NYHA class I, II, III, and IV.
* 18 years or older and must be awake and conversant at time of enrollment.

Exclusion Criteria:

* History of neurological disorder or injury (e.g., Alzheimer's Disease, dementia, stroke, seizures).
* Moderate or severe head injury (defined as \> 24 hours loss of consciousness)
* Past or current history of severe psychiatric illness. Specifically, psychotic disorders (e.g., schizophrenia) and bipolar disorder. Potential participants will not be excluded on the basis of managed depression or anxiety disorder. These conditions are common in cardiac patients and their exclusion may limit the generalizability of findings.
* 5 years past or current history of alcohol or drug abuse (defined by DSM-IV criteria).
* History of learning disorder or developmental disability (defined by DSM-IV criteria).
* Renal failure requiring dialysis.
* History of sleep apnea (defined through previous sleep studies).
* Severely ill individuals, including those who are sedated, on a ventilator, exhibiting acute hemodynamic changes, and/or those deemed inappropriate by patient's physician to participate in study.
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD

A variety of medications have been used to treat the anxiety, discomfort, and fear associated with continuous and sudden episodic breathlessness in patients with advanced respiratory disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed for this distressing symptom. Clinicians are concerned about the adverse effects of opioids, especially respiratory depression, so they frequently prescribe benzodiazepines. Recent studies have shown that benzodiazepine use is associated with increased adverse respiratory outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).

Dexmedetomidine may be an alternative to current drug therapies for breathlessness. Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without respiratory depression or cognitive dysfunction. The drug can be administered intranasally to induce light to moderate sedation of several hours duration.

The objective of the proposed research, a pilot study, is to assess the dose dependent safety and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD. This will be accomplished in a staffed acute care setting with routine vital signs monitoring and pulse oximetry. Patients will be assessed objectively and subjectively for their level of sedation by validated sedation scales.

This pilot study is an initial investigation of a drug with favorable pharmacologic properties in this patient population with distressing and difficult to treat symptoms. The pilot study may provide evidence that a larger trial is needed to confirm the study results, or evidence that additional study in symptomatic patients and treatment comparison trials should be pursued.


Eligibility Criteria:
Inclusion Criteria:

* Severe COPD (FEV1 30-50% predicted)
* Age 45-70
* American Society of Anesthesiologists (ASA) Class 3
* Body Mass Index \<35 kg/meter squared
* No prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine)
* Women of non-child bearing age

Exclusion Criteria:

* known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists
* not nothing by mouth (NPO)
* ASA class \>3
* Home oxygen therapy \>2LPM by nasal cannula continuous use
* Any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration
* Pregnancy, or possibility of pregnancy
* Coronary heart disease with stable or unstable angina
* Baseline heart rate \<55 beats per minute
* Bradyarrhythmia, heart block, presence of pacemaker
* Congestive Heart Failure or known Cardiomyopathy (Ejection Fraction \<40% by ECHO, MUGA, or myocardial perfusion imaging)
* Cor pulmonale
* Liver disease (hepatic transaminases above the upper limit of normal, cirrhosis, end stage liver disease)
* diagnosis of moderate to severe Obstructive Sleep Apnea
* currently enrolled in any other research study involving drugs or devices
Tracheostomy Change

The purpose of this study is to compare outcomes of first tracheostomy change on postoperative day 4 to our current standard of care of first tracheostomy change on postoperative day 7.

A "fresh tracheostomy" is a tracheostomy whose tract is not yet well formed and that has not yet been changed since the operative procedure. It is considered a "critical airway" since replacement following dislodgement may be difficult and at risk of forming a false tract. Thus, an infant or a child with a fresh tracheostomy is cared for in the intensive care unit and kept sedated to prevent accidental dislodgement. During this time wound care is often suboptimal due to fear of manipulating the neck. Patients are at increased risk of complications such as pressure ulcers and pneumonia related to being sedated for an extended length of time. Furthermore, prolonged sedation can lead to difficulties with withdrawal and delay recovery. Progression of the patient's care and the teaching of tracheostomy care to caregivers is also delayed. Thus, timing of the first tracheostomy change has great implications for prevention of complications as well as length of hospital stay. While in adults is it accepted that the first trach change can be done as early as post-operative day 3. In pediatrics no good evidence or clear guidelines is available as to when the first tracheostomy change should occur. It is common to wait until days 5-7 which allows establishment of a mature tract however, there is no biologic reason to think that a pediatric tracheostomy tract should take any longer to epithelize than in an adult. Several studies have reported safe tracheostomy change in pediatric patients as early as postoperative day 3 (Deutsch 1998, Lippert 2014, Van Buran 2014). Currently at CHOP our standard of care is to perform the first tracheostomy change on post-operative day 7. The investigators aim to compare tracheostomy tube change at post-operative day 4 by randomizing patients undergoing tracheostomy at CHOP to day 4 (treatment) or day 7 (control) groups.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 0 to 2 years of age at the time of tracheostomy.
2. Scheduled to undergo tracheostomy, or underwent tracheostomy and is currently postoperative day 4 or less
3. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Anatomical or physiological states identified preoperatively or intraoperatively that, in the investigator's judgment, raise concern over the viability of the tracheostomy tract to form within the first several days, or would otherwise increase the difficulty of performing an early tracheostomy change.
2. Previous or concomitant surgery at tracheostomy site
3. Subjects who cannot be physically intubated orally or for whom intubation would be difficult for the experienced ears nose and throat physician
4. Subjects who cannot be mask ventilated

Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with Institutional Review Board Policies and Procedures.
Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients

The purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

Cirrhosis is associated with qualitative and quantitative changes in the gut microbiota that can potentiate disease progression and complications such as hepatic encephalopathy (HE) and infections. Dysbiosis or altered gut microbiota, due to decreased autochthonous or commensal taxa, has been found in stool and colonic mucosa in cirrhotic patients, which is in turn linked with disease severity and systemic inflammation.

TIPS can decompress the hypertensive portal vein,so that the intestinal congestion can be decrease too. Hence we summarize that TIPS may have effect on gut microbiota and associated inflammatory factors in cirrhotic patients.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients who received TIPS;
* Treatment-naive to TIPS and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation)

Exclusion Criteria:

* Uncontrolled infection or sepsis;
* Hepatobiliary or pancreatic malignancy or biliary obstruction;
* Vital organ dysfunction;
* Administration of antibiotics (after TIPS and 2 weeks before TIPS);
* Cachexia;
* Pregnant or breeding women