cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults

To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for participation in the study; ages between 50 and 80 years at recruitment

Exclusion Criteria:

* Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
* Current participation in any other clinical trial
* Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
* Prior pneumococcal conjugate vaccine (PNC)
* 23 valent pneumococcal vaccine(PPV) in last 5 years
* Severe general or local reaction to a previous dose of PNC or PPV
* Patients currently immunocompromised as listed in UK Handbook "Immunisation Against Infectious Disease" ed 1996
* Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study
* Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook "Immunisation Against Infectious Disease"
* Deferral of vaccination if acute systemic illness or temperature \>38C on day of vaccination
Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy

Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia,
* with ASA physical status classification I, II, III,
* and with (1) or (2)

  1. documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle \> 10 degree)
  2. previous history of lumbar spinal surgery

Exclusion Criteria:

* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
* Patients with morbid cardiac diseases
* Pregnancy
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers

This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.


Eligibility Criteria:
Inclusion criteria:

* Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.

Exclusion criteria:

* Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation. SAE, clinically significant laboratory abnormality or significant cardiovascular event during prior study.
Effect of an EAA/Whey Composition on Protein Metabolism

Sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable natural process of aging. While it may be impossible to completely reverse the progress of sarcopenia, it is well established that intake of dietary protein through essential amino acids (EAAs) and whey protein increases anabolic response. The current study will test if a specially formulated mixture of EAAs and whey protein can maximally stimulate anabolic responses at the levels of whole body and muscle compared to whey protein alone.

The product composition is protected by intellectual property. It contains a combination of ingredients designed to stimulate anabolic responses at whole body and muscle and to ultimately induce long-term improvements in muscle function and size. EAAs are the only dietary macronutrients that are required for survival. They are "essential" because the body cannot produce them. There are 9 dietary EAAs while there are 11 dietary non-essential amino acids that are not required in the diet because they can be produced in the body. The composition is based on a blend of 8 of the 9 EAAs. In addition to being the "active" components of dietary protein, EAAs also have the advantage over intact protein including whey protein because free EAAs are absorbed from the intestine more quickly and more completely than amino acids contained in protein, which requires digestion before absorption indicating that intact protein is relatively slowly absorbed. Therefore, the combination of free EAAs and intact protein give not only an immediate response (from the free EAAs) but also a prolonged response (from the intact protein) over time by the slower digestion. The idea of combining a specific formulation of EAAs with an intact protein to obtain both an immediate as well as a more sustained response in protein anabolism is novel. Investigators propose that consumption of the EAA/protein composition will stimulate the net protein balance at the whole body level in a dose-dependent manner. The investigators further propose that the magnitude of increase in the net protein balance will be greater than induced by the consumption of the same amount of whey protein isolate.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 30 kg/m\^2

Exclusion Criteria:

* Current diagnosis of diabetes
* History of malignancy in the 6 months prior to enrollment
* Weight reduction surgery
* Chronic inflammatory (Lupus, HIV/AIDS)
* Currently pregnant females
* Unable to eat dairy protein
* Unable to stop eating protein or Amino Acid (AA) supplements during the participation
* Regular resistance training (\> once per week)
* Concomitant use of corticosteroids (ingestion, injection or transdermal)
* Subjects who cannot safely stop using aspirin for 7 days prior to muscle biopsies
* Hemoglobin less than 9.5 g/dL, and platelets less than 150,000 at the screening visit
* Any other disease or condition placing the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Use of Botulinum Toxin to Treat Psoriasis

Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation.

Recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions.

This pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects. Psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. In addition, the subject should have at least a score of 2 for keratoderma and erythema. Signed informed consent. Willing to adhere to protocol.

Exclusion Criteria:

* Immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.
Physical Activity and Gestational Complications

The association between physical activity and several complication of pregnancy will be evaluated .

The association between physical activity and several complication of pregnancy will be evaluated. Patients with complications of pregnancy will be recruited. Physical activity will be evaluated using questioner or smart bracelet.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* Non pregnant women
Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis

The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.


Eligibility Criteria:
Inclusion criteria:

* Patients starting Spesolimab IV for the first time in accordance with the approved label in Korea (complete enumeration for the first 2 years after product launch)
* Patients with generalized pustular psoriasis (GPP) flare
* Age \>/=19 years at enrolment
* Patients who have signed the data release consent form

Exclusion criteria:

* Patients with Severe or life-threatening hypersensitivity to Spesolimab or to any of the excipients
* Patients with clinically important active infections (e.g. active tuberculosis)
Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block

This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.

52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups) Thoracic paravertebral block was administered from two consecutive levels for TPVB group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, visual analog scale values during at rest and coughing, time of the first analgesic request, and additional analgesic consumption were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo VATS
* ASA I-II-III patients

Exclusion Criteria:

* Patients with ASA IV
* Clinically diagnosis of spinal or chest wall deformity or pathology
* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\>40 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy
The Effect of Synaquell™ in Contact Sport Athletes

This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.

This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood \& saliva biomarkers, impact monitoring mouthguard, and a rapid number naming test (King Devick).

Eligibility Criteria:
Inclusion Criteria:

* Fluent English Speakers
* Medically cleared to play contact sport

Exclusion Criteria:

* An allergy to the ingredients of Synaquell™ or the placebo (ingredients listed on page
* Clinically documented hearing issues,
* In-ear hearing aid or cochlear implant
* Implanted pacemaker or defibrillator
* Metal or plastic implants in skull
* Lack of verbal fluency in the English language
* History of seizures
* Allergy to rubbing alcohol or EEG gel
* Pregnancy
Comparative Clinical Evaluation of Soft Toric Lens Designs

This study is evaluating the initial fit of toric contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Be greater than or equal to 18 years old.
* Read, understand, and sign written Statement of Informed Consent.
* Appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
* Require a visual correction in both eyes (monovision allowed but no monofit).
* Have a spherical contact lens requirement in the range -0.50D to -6.00D.
* Have astigmatism of between -0.50 and -2.00DC in both eyes.
* Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
* Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery

Exclusion Criteria:

* Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
* Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
* Extended lens wear in last 3 months.
* Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
* Any systemic disease affecting ocular health.
* Abnormal lacrimal secretions.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial.
* Any previous anterior ocular surgery.
* Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
* Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
* Subjects who are known to have diabetes.
* Employees or family members of the Research site, Principal Investigator or study team.
Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole

A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.


Eligibility Criteria:
Inclusion Criteria:

* Body weight of at least 65.0 kg and no greater than 85.0 kg.
* Body Mass Index (BMI) of at least 18.5 and no greater than 30.0 kg/m2.

Exclusion Criteria:

* Known or suspected hypersensitivity to MDV3100, itraconazole, gemfibrozil, any components of the formulations used, or any history of liver toxicity with other drugs.
* Confirmed CYP2C8 PM status based on genotyping analysis.
* Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
* History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
* Abnormal pulse and/or blood pressure (BP) measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic BP \>140 mmHg ; mean diastolic BP \>90 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
* A QTc interval of \>430 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
* Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical and ophthalmic nucleoside analogues.

Patients must have:

* HIV positive.
* No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
* Currently stable retinitis.

Prior Medication:

Allowed:

* Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Persistent or clinically significant diarrhea, nausea, or abdominal pain.
* Severe odynophagia.
* Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
* Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
* Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
* Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

* Acyclovir sodium (Zovirax) by any route other than topical.
* Valacyclovir.
* Brovavir.
* Vidarabine.
* Amantadine hydrochloride.
* Cytarabine.
* Idoxuridine.
* Ribavirin.
* Interferon.
* Foscarnet (non-nucleoside pyrophosphate analogue).
* CMV hyperimmune globulin.
* Soluble CD4.
* Trichosanthin (Compound Q).
* Imipenem-cilastatin.
* Isoprinosine.
* Levamisole.
* Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

* More than three induction regimens with intravenous anti-CMV therapy.
* Any prior oral ganciclovir.
Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen(DPANDA) Study

The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic aneurysm/aortic dissection.

The study aims to investigate the role of candidate biomarkers in the diagnosis and prognosis of AA and AD. In the diagnosis part, we begin with a discovery phase where individually matched case-control study. Patients within each disease outcomes (i.e. AD, AMI, PE, AA without AD and healthy controls) are age and sex matched and retrospectively included.In the prognosis part of the study, patients with confirmed AA and AD are enrolled. The primary outcome is the all-cause mortality based on the death certificates. The secondary outcome is the in-hospital mortality according to the patients'medical records.

Eligibility Criteria:
Inclusion Criteria:

Retrospective

* All patients who were referred to the surgical service for evaluation and management of aortic dissection were included.

Perspective

* Patients with initial suspicion of having AAD were perspectively enrolled.

Exclusion Criteria:

Retrospective

* Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;
* Patients with aortic trauma, pseudo aneurysm, history of heart failure, renal dysfunction, severe pulmonary diseases, or active cancer;
* Patients who entered the hospital for checkups after surgery.

Perspective

* Patients in whom there is little or no suspicion of a life-threatening disease;
* Patients with confirmed acute myocardial infarction,angina or pulmonary embolism
* The symptoms were clearly not related to AD (e.g. pleurisy, pneumonia, acute abdominal diseases).
B0151005 Open-Label Extension Study

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.


Eligibility Criteria:
Inclusion Criteria:

* Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

Exclusion Criteria:

* Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
* Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.