Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity in dose-ranging and formulation-finding meningococcal b (menb) vaccine study in 2-month-old infants

Conditions: Meningococcal Meningitis; Meningococcal Infections

Summary: this study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new novartis meningococcal b recombinant vaccine.


Eligibility criteria:
inclusion criteria: * healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg * available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements exclusion criteria: * any meningococcal b or c vaccine administration * prior vaccination with any diphtheria, tetanus, pertussis (acellular or whole cell), polio (either inactivated or oral), haemophilus influenzae type b (hib), and pneumococcal antigens; * any ascertained or suspected disease caused by n. meningitidis * household contact with and/or intimate exposure to an individual with laboratory confirmed n. meningitidis * history of severe allergic reaction after previous vaccinations * recent significant acute or chronic infection * oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw; * any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus type i, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, hiv infection or aids, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition) * any impairment/alteration of the immune system resulting from (for example): * receipt of any immunosuppressive therapy at any time since birth * receipt of immunostimulants at any time since birth * use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth * receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation * participation in another clinical trial * family members and household members of research staff * history of seizure * any contraindication to paracetamol

Keywords: immunogenicity meningitis antibody infants
association between anaemia and handgrip strength in female planned for major surgery and the effect of intravenous iron on handgrip strength

Conditions: Anemia; Iron-deficiency; Patient Blood Management; Iron Deficiency Anemia

Summary: this is a sub-study parallel to propbm : a randomised control trial comparing a modified patient blood management protocol against standard care for patients undergoing major surgery (nct03888768). only female participants of propbm will be included in this sub-study. association between anaemia and handgrip strength and the effect of intravenous iron therapy as part of propbm protocol within female participants is elucidated in this study.

background: maximal physical efforts and aerobic exercise depend highly on adequate oxygen supply provided by haemoglobin and level of iron bound to haemoglobin. handgrip strength has been shown to have a strong validity and high reliability in testing the upper body and lower body muscle strength, however its use as a potential tool to identify early anaemic patients planned for surgery is not fully explored. to our knowledge, this study is the first to investigate the diagnostic power of functional performance test within preoperative anaemic population and the change of handgrip strength after administration of intravenous iron. methods: at recruitment of propbm study, all eligible patients for this sub-study will be invited to this sub-study and have their full blood count, ferritin and transferrin saturation recorded and handgrip strength assessed. after randomization, those within the propbm protocol will receive iv iron therapy as indicated. participants who are randomized to standard care will follow usual medical management. participants will be admitted 1 day prior to surgery. on admission, preoperative bloods and handgrip strength will be repeated for patients who were randomized into the propbm arm.

Eligibility criteria:
inclusion criteria: * female patients participating in the propbm study * undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics surgery * the patient must be willing and able to provide informed consent for the study exclusion criteria: * patients with known muscle weakness eg myasthenia gravis * patients with cerebrovascular or orthopaedic disease that could influence muscle mass and/or upper body function * patients in which iv iron is contraindicated eg 1st trimester of pregnancy or known allergy or hypersensitivity to parenteral iron * patients with iron overload

Keywords: handgrip strength intravenous iron
gamma-delta tocotrienol as potential maintenance treatment in women with metastatic breast cancer

Conditions: Healthy Subjects

Summary: twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated gamma-delta formulation with trf.

twelve healthy subjects will be admitted to a clinical study ward on the day 0. physical check up and the health status will be confirmed during check in. after fasting for a minimum of 10 hours overnight, each subject will be administered a single dose of trf or gamma-delta after taking a standardized high-fat meal breakfast on day 1. thereafter, standard meals will be provided at 4 and 12 hours after dosing. blood samples (5ml will be taken using an in-dwelling canula placed in the antecubital vein immediately before and at 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, and 24 hours after dosing. subjects will be admitted for 24 hours and discharged after the last blood sampling. during the study, blood pressure and the heart rate will be monitored regularly for safety profile. after a one week wash out period, subject will return to the ward and be given the other formulation (trf or gdt) and the same procedures will be repeated. any adverse events that arise during the treatment will be recorded and followed up till resolution.

Eligibility criteria:
inclusion criteria: * male and female aged 21-55 years old * good health * no allergy to vitamin e/ palm oil * no past (within 3 months) / current use of dietary supplements containing vitamin e exclusion criteria: * history of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers * candidate for surgery or had undergone surgery in the past 6 months * current or past use (last 3 months) of antithrombotic drugs such as antiplatelets (aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents (streptokinase), etc * current or past history of cancer * pregnant/ breastfeeding women * smokers * drug or alcohol abuse * hypercholesterolemia * chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, hiv infection, or other psychiatric illness/ social situations that might limit adherence to study protocol. * unable or unwilling to stop taking vitamins, herbal preparations or nonprescription medications
screening for uterine cavity abnormalities in women scheduled for ivf

Conditions: Infertility

Summary: evaluation of the endometrial cavity is an important step in the infertility work-up, particularly if assisted reproductive therapy is planned. the aim is to identify possible endometrial abnormalities that may impair implantation.undiagnosed endometrial abnormalities are present in 11 to 45% of women scheduled for in vitro fertilization (ivf).traditionally, two dimensional transvaginal ultrasound (2d tvus) and hysterosalpingography (hsg) are the basic methods for assessment of the endometrial cavity. however, these imaging modalities have shown high false negative rates among infertile women, a finding that could confine their rule to initial screening rather than definite diagnosis. office hysteroscopy (oh) is the gold standard for evaluation of the endometrial cavity. although the endoscopic approach has been proven to increase pregnancy rate in women who experienced prior implantation failure, evidence on treatment of unsuspected hysteroscopically-diagnosed endometrial lesions, to improve ivf outcome, is still lacking. nevertheless,clinicians tend to use oh routinely prior to ivf because the psychological and financial burden that infertile couples may experience as a consequence of failed ivf cycle is unjustifiable.yet, costs and invasiveness of oh counteract its global implementation to all women prior to ivf.


Eligibility criteria:
inclusion criteria: * history of primary infertility * normal uterine cavity on hsg * women were selected for ivf therapy. exclusion criteria: * women with known diagnosis of uterine abnormality by office hysteroscopy

Keywords: assisted reproductive technology
memory changes in patients with major depression disorder treated with ect

Conditions: Depressive Disorder

Summary: the basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ect.

current literature provides insufficient information on the degree of cognitive impairment during and after electroconvulsive therapy (ect), mostly due to the fact that applied tests lacked sensitivity and flexibility. our goal was to evaluate cognitive functioning in adult depressed patients treated with bi \& uni lateral \& ect, using tests sensitive for detection of possible acute and medium-term memory changes.(9) major depressive disorder (mdd) is estimated to affect around 16 million americans (substance abuse and mental health services administration \[samhsa\], 2013) and, according to the world health organization, is the leading cause of disability worldwide (world health organization 2012). among in the u.s. workforce, the prevalence of mdd has been estimated at 7.6% .(2) electroconvulsive therapy (ect) is an effective treatment for severe depression but entails cognitive adverse effects, particularly the effects on memory. ect may cause a temporary deficit in the cognitive processes of information encoding, consolidation, and retrieval. transient memory disturbances are regarded as an inevitable adverse effect of therapeutic convulsions. various strategies have been tried to decrease the cognitive adverse effects while retaining the antidepressant effect, including the use of unilateral instead of bilateral electrode placement, changes in waveform, and reducing the electrical stimulus intensity, (4).

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as having major depression according to dsm v. 2. patients aged (18-50 years) of both sexes. exclusion criteria: 1. history or current evidence of systemic medical illness, e.g.: hepatic, renal, cardiovascular, endocrinal, metabolic disorders or others. 2. history or current evidence of any neurological disease. 3. pregnant females. 4. co-morbid psychiatric disorders other than depression. 5. patients with mental subnormality.
measuring subjective quality of vision and metamorphopsia before and after epiretinal membrane and macular hole surgery

Conditions: Ophthalmologic Complication; Epiretinal Membrane; Metamorphopsia; Macular Holes

Summary: assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery

metamorphopsia is a visual symptom in which straight lines appear distorted, for example a vertical window blind may appear wavy which can affect quality of vision. metamorphopsia is a common symptom in retinal conditions such as epiretinal membranes (erm) and macular holes. there is a lack of studies analysing the prevalence of erm in the uk and europe. both of the conditions have shown to be a higher risk factor with age. with an aging population it is likely these numbers will increase. currently the only treatment option is surgery (vitrectomy) or conservative management to monitor the condition. it would therefore be beneficial to find a tool that would inform the surgeon of a patient's quality of vision and how this impacts their life. a patient's severity of metamorphopsia reveals more precise information on the progression of the disease than visual acuity alone (nomoto et al. 2013) therefore gaining a better understanding can help aid clinical decisions. current clinical practice is to monitor metamorphopsia with an amsler chart, a grid with lines; the patient is then asked to draw where they can see distortion. they are used to detect metamorphopsia but are unable to quantify and provide an accurate measurement of the severity of metamorphopsia and quality of vision the quality of vision questionnaire (qov) (mcalinden et al. 2010) is a modern tool developed to specifically measure subjective quality of vision. the metamorphopsia questionnaire (arimura et al. 2011) has been developed to provide a measurement of subjective metamorphopsia in macular disease. both have been psychometrically validated and are in use in a number of clinical trials worldwide. it would be valuable to investigate the role of each questionnaire in identifying quality of vison and metamorphopsia pre- and post-surgery for erm and macular holes to establish if there are changes to patient responses. we would compare this to visual acuity and optical coherence tomography (oct) images pre- and post-surgery to see if changes correspond to the questionnaire responses. if a questionnaire can measure metamorphopsia and its impact on quality of vision in erm and macular holes, this would assist in clinical decision making.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent * \>18 years old * patients listed for epi retinal and macular hole surgery * patient is able to perform study procedures exclusion criteria: * patients who are diagnosed with a condition other than epiretinal membrane or macular hole * patients not undergoing epiretinal or macular hole surgery * patients will be excluded if there are any complications within surgery, or undergo any procedures that is not an epiretinal or macular hole surgery (i.e vitrectomy, phacoemulsification (lens extraction) as this can affect visual outcomes.
a study of long-term safety and efficacy of vx-670 in participants with myotonic dystrophy type i

Conditions: Myotonic Dystrophy Type 1 (DM1)

Summary: the purpose of the study is to evaluate the long-term safety and tolerability, efficacy and pharmacokinetics of vx-670 in participants with myotonic dystrophy type i (dm1).


Eligibility criteria:
key inclusion criteria: • completed study drug treatment in parent study vx23-670-001 (nct06185764) key exclusion criteria: • history of any illness or any clinical condition as pre-specified in the protocol other protocol defined inclusion/exclusion criteria may apply.

Keywords: dm 1 myotonic dystrophy 1 myotonic dystrophy type 1 (dm1) vx-670 myotonic dystrophy dm myotonia dystrophy myotonic myotonic disorders steinert disease vertex entrada pmo aso myotonic muscular dystrophy muscular disorders, atrophic muscular diseases musculoskeletal diseases neuromuscular diseases nervous system diseases genetic diseases, inborn heredodegenerative disorders, nervous system neurodegenerative diseases muscular dystrophies
ipack block after total knee arthroplasty

Conditions: Knee Arthropathy; Postoperative Pain

Summary: adductor canal block (acb) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (tka) which however does not relieve posterior knee pain. the recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (ipack) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. the hypothesis was that the combination of acb + ipack will provide better pain relief and improve knee function in the immediate postoperative period compared to acb alone.

this is a prospective, randomized and double blinded study all patients received : * pregabalin 150 mg preoperatively 12 h before the surgery. * single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive: * group 1: ipack + acb single shoot * group 2: contineous acb for group 1: ipack was realized after spinal anesthesia with 40 ml ropivacaine 0.2% all patients received acb in the immediate postoperative period with 20 ml ropivacaine 0.2% post operative analgesia included: * paracetamol 1g iv every 6 hours * diclofenac sodium (50mg) 1 tablet x 2 per day * pregabalin 150 mg given orally once daily for a period of 4 weeks. * pca morphine (patient controlled analgesia), as a rescue analgesia, * continuous acb catheter for 48h with : 4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1

Eligibility criteria:
inclusion criteria: * primary total knee arthroplasty under spinal anesthesia exclusion criteria: * contraindication or refusal to regional anesthesia * contraindication to non steroidal anti inflammatory (nsaid's) * allergy to opioids * allergy to paracetamol * creatinine clearance \< 30ml/min * weight\ 100kg

Keywords: knee arthoplasty nerve block analgesia
virtual reality simulation for intrauterine device insertion: a randomized clinical trial

Conditions: IUD

Summary: aim of this study is to evaluate the effect of vr on the patients overall experience during the iud insertion procedure.

a single center, investigator initiated randomized controlled clinical trial. 200 women to be recruited, 100 in the intervention group and 100 in the control group. the control group will receive the usual treatment (without specific pain management) and the intervention group will receive the usual treatment with vr support. endpoints are: * objective: successful procedure, need for general anesthesia, presence of syncope and/or vomitus * subjective: pain, procedural cooperation, the degree of difficulty encountered by the physician in performing the treatment, ability to complete vr procedure.

Eligibility criteria:
inclusion criteria: * healthy women who are seeking hormonal intrauterine contraception will be offered participation in the trial if they are 18 years of age or older (minors can be included if a guardians permission has been obtained), are not pregnant, and are willing to follow-up after 6 weeks for a sonographic iud check. exclusion criteria: * epilepsy * auditive or visual disabilities * invalidating claustrophobia

Keywords: virtual reality iud discomfort
hepatocellular carcinoma registry for turkey (3k trial)

Conditions: Hepatocellular Carcinoma

Summary: this registry study is national, multi-center, prospective study without any interventions to the treatment strategies and/or decisions of the investigators. it is designed in order to determine the general profile of hcc patients in turkey. socio-demographic characteristics, family history, medical history and treatment pattern of hcc patients will be evaluated.


Eligibility criteria:
inclusion criteria: * to be diagnosed with hepatocellular carcinoma in last 3 months * to be older than 18 years old * to sign informed consent form (icf) exclusion criteria: * patients that does not sign or withdraw informed consent form. * according to investigator's opinion; existence of any situation/condition that will significantly complicate patient follow up. * currently or previously taking part in 3k observational study

Keywords: hepatocellular carcinoma registry turkey
prevalence of amyloidosis in trauma patients

Conditions: Amyloidosis

Summary: this study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.


Eligibility criteria:
inclusion criteria: * men and women included in the waiting list for scheduled trauma surgery with at least one of the following criteria defined as red flags: over 65 years old; possible family history of amyloidosis, cardiac pathology: aortic stenosis, presence of left ventricular hypertrophy defined as interventricular septal thickness \> 12mm measured by echocardiography, history of previous brady- or tachyarrhythmias including cardiac conduction blocks, history of syncope or presyncope, pro bnp \> 300 in previous blood tests; history of sensory peripheral neuropathy; history of nephropathy without etiological diagnosis; history of liver disease without a clear cause. * ability to cooperate in the necessary evaluations. * signed informed consent for inclusion in the study, either by the participant or their legal representative. exclusion criteria: - participants previously diagnosed with amyloidosis cannot be included in the study.

Keywords: amyloidosis red flags tool traumatology
prospective i-factortm analysis fusion rate and quality of life

Conditions: Spinal Deformity; Bone Graft; Fusion Rate; Quality of Life

Summary: adult spinal deformity surgery is a complex procedure that involves many risks and complications. bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery. autologous bone has been considered the "gold-standard" for obtaining a spinal fusion. however, the source from which to obtain it is limited. furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options. i-factor ™ bone graft (cerapedics, inc., westminster, co) is a compound formed by peptide p-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (abm) particles. in the literature there are no articles which identify bone formation with the i-factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending


Eligibility criteria:
inclusion criteria: * patients of legal age. * patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. in which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs. * patients who provide their informed consent in writing. (in the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative). * present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery. * the implants used in the surgery are cobalt chrome bars and titanium screws and interbody cages. exclusion criteria: * patients who are expected to be unavailable for follow-up. * patients with mental disabilities that make it difficult for them to fill in the questionnaires. * patients who have had other types of implants placed, other than cobalt chrome bars and titanium screws and interbody cages. * patients who are going to have cemented and / or expansive screws, peek boxes or another type of material other than titanium. * underlying neurological or neuromuscular disease. * underlying inflammatory or tumor disease.

Keywords: adult spinal deformity bone graft fusion rate quality of life spinal surgery functional limitations