Sominex

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

James B. Odone, MD

• Department of Diagnostic Imaging
• David Grant USAF Medical Center
• Travis AFB, California

Evaluation of ultrasonographic diagnostic criteria for autosomal dominant polycystic kidney disease 1 sleep aid usa discount 25mg sominex free shipping. The disorder classically presents in the neonatal period insomnia before period order sominex online now, but may occur in adolescents or adulthood insomnia znaczenie buy sominex now. In older children kidneys may be normal or show changes similar to sleep aid in tylenol pm discount 25 mg sominex free shipping, but milder than, the neonatal form. Hereditary polycystic kidney diseases in children: changing sonographic patterns through childhood. Short stature, round face, thickset features, mental retardation and hypocalcaemia. Pencil-in-cup and cup-and-saucer appearances are a consequence of severe erosive changes. Surgical procedures, especially major abdominal and gynaecological surgery and hip operations. Duration of embolism in the pulmonary arteries may be acute (<48 hours), subacute (several days or weeks) or chronic (months or years). The characteristic abnormality is a segmental perfusion defect at the periphery of the lung with no corresponding ventilation defect, i. Arthritis (radiological changes in 80% of cases) (a) Involvement of synovial and cartilaginous joints and entheses. It consists of osteomalacia or rickets + secondary hyperparathyroidism + osteosclerosis. Changes most marked in the skull, pelvis, scapulae, vertebrae and metaphyses of tubular bones. The synovial articulations of the axial skeleton may also be affected, especially the apophyseal and atlantoaxial joints of the cervical spine. The sequence of pathological/radiological changes at synovial joints is (a) Synovial infammation and effusion > soft-tissue swelling and widened joint space. Para-articular, extra-articular and systemic features in rheumatoid arthritis Musculoskeletal 1. Especially extensor carpi ulnaris, fexor carpi ulnaris and extensor carpi radialis. Rheumatoid arthritis: a practical guide to state-of-the-art imaging, image interpretation and clinical implications. Results from diminished calcium phosphate product causing failure of hyperptrophied chondrocytes in the growth plate to undergo apoptosis. Thin bony spur extending from the metaphysis to surround the uncalcifed growth plate (c). Risk of fractures probably low in the absence of severe rachitic changes and clear demineralization. Equal sex incidence in white population but female preponderance in black population. Intrathoracic sarcoidosis Thoracic disease at some stage in majority (>90%) of patients. Nodal enlargement on chest radiography is most common manifestation and almost always before lung infltration. Anterior mediastinal lymph nodes also involved in 16% but isolated anterior node disease very rare (think lymphoma, metastatic malignancy). Most commonly manifests as acute uveitis + bilateral hilar lymphadenopathy + erythema nodosum. Cerebral sarcoidosis is evident in 25% of autopsies of patients dying of sarcoidosis, but in less than 10% clinically. Joint sarcoidosis A transient, symmetrical arthropathy involving knees, ankles and, less commonly, the wrists and interphalangeal joints. Hands and feet are most commonly affected (a) Enlarged nutrient foramina in phalanges and, occasionally, metacarpals and metatarsals. In the remainder of the skeleton (a) Well-defned lucencies with a sclerotic margin. The most obvious clinical manifestation of the disease is induration and thickening of the skin. Erosions at the distal interphalangeal, frst carpometacarpal, metacarpophalangeal and metatarsophalangeal joints. Ribs Symmetrical erosions on the superior surfaces which predominate along the posterior aspects of the third to sixth ribs. Lung disease most common cause of death (due to pulmonary hypertension and/or interstitial fbrosis). Non-specifc interstitial pneumonia more prevalent than usual interstitial pneumonia pattern of fbrosis. Other patterns of lung disease in systemic sclerosis include organizing pneumonia and diffuse alveolar damage.

A cavernous henangioma is raised and red or hematoma insomnia late pregnancy discount 25mg sominex with mastercard, intracerebral A hematoma within purplish insomnia 2015 buy discount sominex 25mg line. The normal hematoma insomnia facts 25mg sominex otc, subdural A hematoma between the ranges for Hct depend on the age and insomnia severity index 25 mg sominex overnight delivery, after adoles- brain and its covering, the dura. The values returned impaired gait, and dizziness may result and on Hct tests may vary slightly between laboratories. Subdural An abnormally low level of Hct is referred to as ane- hematomas can be caused by minor accidents to the mia and can come from bleeding, iron deficiency, head, major trauma, or the spontaneous bursting of breakage of red blood cells (hemolysis), and many a blood vessel in the brain (aneurysm). An abnormally high level of Hct is dural hematomas are usually due to severe head. Chronic subdural hematomas may be very to 50 years of age in males and after menopause in insidious. The excess iron gives the skin a bronze 2 to 4 weeks: When they do cause problems, the color and damages the liver, causing liver scarring incident that caused the bleeding is often long past. Symptoms include increasing daily headache, fluc- Diabetes also occurs due to damage to the pan- tuating drowsiness or confusion, and mild weakness creas. Early diagnosis and treatment before symp- drilling through the skull to drain the excess blood. Hemochromatosis is inherited in an auto- hematopoiesis the production of all types of somal recessive manner. Also known as bronze dia- blood cells including formation, development, and betes and hereditary hemochromatosis. Prenatally, hematopoiesis occurs in the yolk sack, then in the hemodialysis See dialysis. In the normal situation, hematopoiesis in adults occurs in the hemoglobin the oxygen-carrying protein pig- bone marrow and lymphatic tissues. All types of ment in the blood, specifically in the red blood blood cells are derived from primitive cells (stem cells. Hb is usually measured as cells) that are pluripotent (they have the potential to total Hb expressed as the amount of Hb in grams develop into all types of blood cells). The normal ranges are approximately 14 to 17 gm/dl for adult hematuria See blood in the urine. Values returned on Hb tests may vary slightly between lab- hematuria, gross Blood in the urine that can be oratories. Hematuria may or may not be accompanied by pain, but it is always abnormal hemoglobin A Normal adult hemoglobin, the and should be further investigated. The left concentration: the higher the glucose concentra- hemidiaphragm is more often subject to rupture tion in blood, the higher the level of HbA1c. See also diaphragm; of HbA1c are not influenced by daily fluctuations in diaphragmatic hernia. Measurement of HbA1c is a useful indicator of how well the blood glucose level has been controlled in hemiplegia Paralysis on one side of the body. Also known as glycosy- hemizygous Having only a single copy of a gene lated or glucosylated hemoglobin. All the genes on the single X chromosome in the male are hemoglobin E Normal embryonic hemoglobin, hemizygous. The E stands for embryonic and also for hemochromatosis An inherited disorder char- epsilon, a chain that is unique to embryonic hemo- acterized by abnormally high absorption of iron by globin. Common early symptoms include main type of hemoglobin found in the fetus and abdominal pain, weakness, lethargy, and weight newborn baby. It differs Salmonella, or it may be related to other conditions from hemoglobin A only by a single amino acid sub- and infections. Hemophagocytic conditions, such as bleeding and paroxysmal noc- lymphohistiocytosis can be an inherited condition, turnal hemoglobinuria. Treatment involves occurs to a minor degree normally as red blood chemotherapy and in some cases bone-marrow cells age. There hemolytic anemia Anemia due to the destruc- are two types of hemophilia: hemophilia A and tion, rather than underproduction, of red blood hemophilia B. The disease is inher- hemolytic disease of the newborn Abnormal ited as an X-linked trait, so males are affected and breakup of red blood cells in a fetus or newborn. Hemophilia A has affected the Russian royal house Symptoms can be mild or severe and may include and the descendants of Queen Victoria. There is renewed hemolytic jaundice, congenital See spherocy- bleeding after the initial bleeding has stopped. Also called Christmas disease young children, but the condition can also occur in (named for the first patient with the disease to be adults. Hemoptysis the blood vessels of the kidneys, which can lead to occurs when tiny blood vessels that line the lung air- kidney failure. Low- can be internal, and therefore invisible, or external, weight heparin may be superior to regular (unfrac- and therefore visible on the body. For example, tionated) heparin in cases of unstable angina and bleeding into the spleen or liver is internal hemor- other cardiac diseases. There are three hepatic ducts: the right caused by viruses and characterized by the abrupt hepatic duct (which drains bile from the right half onset of high fever and chills, headache, cold and of the liver); the left hepatic duct (which drains bile cough, and pain in the muscles, joints, and from the left half of the liver); and the common abdomen, with nausea and vomiting. Hepatitis is caused by a number of known to cause hemorrhagic fever include the conditions, including drug toxicity, immune dis- arboviruses, the Marburg virus, and the Ebola virus. Specific hepatitis viruses have been labeled A, Symptoms start with bleeding after defecation. Some other viruses, such as the untreated, hemorrhoids can worsen, protruding Epstein-Barr virus and cytomegalovirus, can also from the anus. Treatment involves changing the diet cause hepatitis, but the liver is not their primary to prevent constipation and avoid further irritation, target. When may also be purified or synthesized for use as a immediate protection against hepatitis A infection is medication. As a drug, heparin is useful in prevent- needed, immunoglobulin (gamma globulin) is used. See also glycosaminoglycan; heparin, poor sanitation and high hepatitis A rates before vac- low-weight. Patients can receive immunoglobulin and hepatitis A vaccine simultane- heparin, low-weight A relatively new form of ously. Also called infectious hepatitis and epidemic the drug heparin (brand names: Lovenox and jaundice. Fewer blood tests are needed for hepatitis A immunization A vaccine that may monitoring when low-weight heparin is given, as be considered for individuals in high-risk settings for contracting the hepatitis A virus. Two can be prevented with the hepatitis B vaccine and doses are recommended for adults, and three doses through avoidance of activities that could lead to are recommended for children under 18 years of getting the virus. Symptoms include fatigue, There is no vaccine or treatment for hepatitis E, jaundice, nausea, vomiting, dark urine, and light although antiviral drugs may be tried. Chronic hep- some patients with posttransfusion hepatitis that is atitis B may be treated with interferon. Cirrhosis may be caused by hepatitis B immunization A vaccine that pro- viral hepatitis, primarily hepatitis B and C, alcohol tects against both hepatitis B and hepatitis D. It gives abuse, hemochromatosis, certain autoimmune dis- prolonged protection, but three shots over 6 eases of the liver, and other diseases that result in months are usually required. Symptoms include tion is one of the recommended childhood vaccina- abdominal pain or tenderness, jaundice, enlarged tions. Adults in high-risk situations, including health abdomen, and easy bruising or bleeding. Diagnosis is that is found in abnormally high levels on, and pro- made by blood test. There is no tend to be more aggressive than other types of vaccine for hepatitis C. Previously known as non-A, breast cancer and are less responsive to treatment non-B hepatitis.

One goal of treatment is to with agalsidase beta (brand name: Fabrazyme) insomnia third trimester discount 25mg sominex fast delivery, protect the eye on the affected side from dryness insomniax download purchase sominex 25mg on line. Episodes of pain in the hands and reduce inflammation during the first weeks of ill- feet may benefit from medications such as diphenyl- ness sleep aid machine generic 25 mg sominex otc. Surgical decompression to reduce swelling hydantoin (brand name: Dilantin) or carbamazap- and pressure on the affcted nerve may also be ine (brand name: Tegretol) insomnia pokemon discount 25mg sominex overnight delivery. These tubal cilia are essential to the movement of the egg through the tube and factor, rheumatoid An antibody that is measur- into the uterus. Rheumatoid factor is commonly infection, an egg may not be pushed along normally used as a blood test for the diagnosis of rheumatoid but may stay in the tube. Rheumatoid factor is present in about 80 partial or complete blockage of the tube with scar percent of adults (and a much lower proportion of tissue, physically preventing eggs from getting to the children) with rheumatoid arthritis. An example of a false negative Fahr syndrome A rare, inherited, progressive would be if a particular test designed to detect can- brain disorder that is characterized clinically by cer returns a negative result but the person actually involuntary movements, prolonged muscle contrac- does have cancer. It is characterized by abnormal deposits of calcium in the basal ganglia and cere- false positive A result that indicates that a given bral cortex of the brain. An example of a ble for Fahr syndrome has been mapped to false positive would be if a particular test designed chromosome 14. There is no cure for Fahr syn- to detect cancer returns a positive result but the drome. A rib is said to be false if it does not attach to the sternum failure, heart See congestive heart failure. The upper three false ribs con- nect to the costal cartilages of the ribs just above failure to thrive the inability of a child to phys- them. The last two false ribs usually have no ventral ically grow as quickly and as much as his or her attachment to anchor them in front and so are peers. It usually refers to a child whose growth is below the 3rd or 5th per- familial A condition that tends to occur more centiles for his or her age or whose growth has often in family members than is expected by chance fallen off precipitously and crossed two major alone. A familial disease may be genetic (such as growth quartiles (for example, from above the 75th cystic fibrosis) or environmental (such as chicken percentile to below the 25th percentile). The chronic kidney disease, gastrointestinal disorders, polyps usually begin to form at puberty, and colon undiagnosed metabolic disorders, emotional depri- cancer almost always develops later in life. Fanconi anemia predisposes a person to familial polyposis, familial polyposis coli. Mutations in multiple different familial hypercholesterolemia the most com- genes can cause the disease, which is inherited as mon inherited type of hyperlipidemia (high lipid an autosomal recessive trait. There are also a number of other genetic disease that is characterized by the onset, in less frequent forms of this disorder. Familial hyper- the first few weeks of life, of swollen, painful joints; cholesterolemia predisposes a person to premature nodules under the skin; profound motor and devel- arteriosclerosis, including coronary artery disease, opmental delay; cherry-red spots in the retina; and and can lead to heart attacks at an unusually young cardiorespiratory problems. Treatment involves dietary modifications and ited as an autosomal recessive trait and is due to a the use of cholesterol-lowering medications. Farber lipogranulomatosis is one of the sphingolipidoses, a familial Mediterranean fever A rare genetic group of genetic diseases that involve overproduc- disorder that is characterized by recurrent attacks tion or accumulation of fatty substances called of inflammation, with fever and pain in the sphingolipids in the brain and nervous system. The symptoms may differ from patient to patient, even in farsightedness An error of refraction in the the same family. In some cases, protein deposits, human eye that causes light rays to focus behind the called amyloid, can accumulate in tissues (amyloi- retina instead of on it. When this injures the kidneys it can lead to has normal vision at a distance but has trouble kidney failure. Molecular genetic test- ing can also detect carriers and the prenatal pres- fart See flatulence. Fasciculations can occur in normal individuals without an associated family planning See birth control. They are popular in Mediterranean and fasciitis, plantar Inflammation of the plantar Middle Eastern cuisines, are eaten raw when very fascia, the bowstring-like tissue that stretches from young, can be cooked in soups and many other the heel bone to the base of the toes. Fava itis can be due to calcaneal spurs, which typically beans are the main commercial source of the drug cause localized tenderness and pain that is made L-dopa. Icing occurs exclusively in people with a deficiency of reduces pain and inflammation. A donut-shaped shoe ism; this indicates that an additional genetic factor insert can take pressure off a calcaneal spur and is needed in order to create susceptibility to favism. Diabetes is typically diagnosed fecal occult blood test A test to check for hid- when fasting blood glucose levels are 126 mg/dl or den blood in the stool. Fecaliths can also obstruct fat 1 Along with proteins and carbohydrates, one diverticuli. The energy produced by fats is 9 calories per feces the excrement discharged from the gram. These fats are greasy, solid materials found in animal tissues and in some plants. This principle is the basis for the practice of biofeed- fatty acid, trans See trans fatty acid. The pelvic basin of the female is presence of an enlarged spleen (splenomegaly) and more spacious and less funnel-shaped than the an abnormally low white blood cell count. From a purely anatomic viewpoint, the may have an increased susceptibility to infection. The a particular physical appearance, chromosome urethra in a female is shorter than the urethra in the constitution, or gender identification. A minority of females have other iliac artery after it passes under the inguinal liga- chromosome complements, such as 45, X (45 chro- ment. The femoral vein is a continuation of the popliteal vein, and it carries female genital mutilation See circumcision, blood back to the heart from the lower extremities. The blood ferritin level serves as an indica- female organs of reproduction the ovaries, tor of the amount of iron stored in the body, and it which produce eggs (ova) and female hormones; can become elevated due to the presence of condi- the Fallopian tubes, which transport the egg from tions featuring significant inflammation. The term fetal and there is a history of alcohol exposure before distress is commonly used to describe fetal hypoxia birth. No amount of alcohol has been proven safe of fetoscopes: A fiberoptic scope for looking directly during pregnancy. At least two of the following groups fetus An unborn offspring, from the embryo stage of signs must be present: small head size (micro- (the end of the eighth week after conception, when cephaly); small eyes (microphthalmia) and/or the major structures have formed) until birth. For that fever, remittent A type of fever that gradually reason, low fevers should normally go untreated, decreases in intensity over time. Home treatment possibilities include the use of aspirin or, fever, spotted See Rocky Mountain spotted in children, nonaspirin pain killers such as aceta- fever. Fever therapy was done in the past but is rarely, if fever, Lassa An acute viral infection found in the ever, used today. Person-to-person transmission also tion; it helps the body move food through the occurs via direct contact, contamination of skin digestive tract, reduces serum cholesterol, and con- breaks with infected blood, and aerosol spreads tributes to disease protection. The antiviral drug ribavirin is used for fiber, cholesterol and Cholesterol blood levels treatment along with supportive care. Soluble fiber substances are effective in helping reduce the level fever, Mediterranean See familial of blood cholesterol. Insoluble fiber retains water in the colon, resulting in softer and larger. Fiber is used effectively in treating constipa- normal rhythm, and prevention of blood clots. Soluble fibers found in oat bran, fibrillation, ventricular An abnormal and apples, citrus fruits, pears, peas and beans, psyl- irregular heart rhythm in which there are rapid lium, and other foods slow down the digestion of uncoordinated fluttering contractions of the lower carbohydrates (sugars), which results in improved chambers (ventricles) of the heart. A diet high in cereal fiber has rillation disrupts the synchrony between the heart- been linked to a decreased risk for developing type beat and the pulse beat.

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Syndromes

• Sensitivity to light (photophobia)
• Methyldopa
• Infection
• Muscle tightness (tight hamstring muscle)
• Death of intestinal tissue (necrotizing enterocolitis)
• Hydrocortisone sodium phosphate (Solu-Cortef)
• Dose
• Vascular ultrasound, such as carotid ultrasound

However insomnia help purchase sominex no prescription, sometimes it is important to explore differences between active treatments sleep aid belsomra buy sominex 25mg visa. A reliable investigation of the differences between active treatments can only be undertaken for specific adverse effects within well-defined populations insomnia 90s song generic 25mg sominex free shipping. An analysis of three systematic reviews indicated that two included a broad range of events insomnia questionnaire order sominex with a mastercard, but generated a large volume of work and yielded little useful information for decision making. Primary studies that report on adverse events may differ, for example in the definitions of a specific adverse event, severity (or intensity); the reporting (or not) of events of differing degrees of severity; the terminology used to describe similar events. The review team will need to decide whether outcomes from different studies are similar enough to group together in the review. However, primary studies may define serious adverse events differently, for example those that the investigator (or the patient) considers serious. An adverse event may be severe in intensity (as opposed to mild or moderate) without necessarily being serious. Rare events almost never occur in controlled trials, with their limited participant numbers and follow-up duration. However, even published observational studies are seldom large enough to provide definitive estimates of incidence. The lack of evidence of a rare adverse effect is therefore not proof that such an adverse effect is not associated with the intervention of interest. Taking a broad approach in specifying the review question, for example by including all adverse effects, could be considered hypothesis generating, whereas hypothesis testing should seek to clarify the statistical nature of the risk, and/or better define the characteristics of the adverse effect by having a more focussed question. They may not be generalisable having excluded patients at high or even medium risk of experiencing certain adverse effects, or may have only short-term follow-up and relatively small sample sizes. Post-marketing surveillance studies may be useful sources of7 adverse events/effects data for pharmaceuticals. Published case reports have significant limitations,24 for example they frequently fail to provide important information, including an assessment of likely causal relationship to the intervention being evaluated, and some investigations have concluded that stricter criteria and guidelines for reporting are required. Although any indication that a treatment might have a significant harmful effect should not be ignored, a balance has to be struck between responding to each report of an adverse effect and trying to eliminate uncertainty before acting. However, it should be noted that analysis of this type of8 information is more akin to primary research than systematic review; using such sources will require a properly designed study to yield information, see for example the study on the role of paroxitine in suicide. If adverse effects are a secondary outcome, then the way that searches are conducted will depend largely on how the effectiveness searches were carried out. For example, if a search for effectiveness studies included only terms for the population and intervention with no search filters for study design, no terms for the outcomes, and the definition of the population has not changed, then it may be sufficient to scan the results of the effectiveness searches for information on adverse effects. These searches would be carried out in the sources already searched, as well as in additional sources specific to adverse effects. It should be noted, however, that due to the poor reporting and poor indexing of adverse effect data this method will not necessarily retrieve all the relevant papers. Consideration should be given to whether the adverse effect(s) of interest are common or rare, short or long-term, known or unknown as this will have implications for the choice of study design and therefore the most relevant sources of information and search filters. Problems in Pharmacovigilance the Australian Adverse Drug Reactions Bulletin, or Reactions Weekly (via PharmaNewsFeed) are also useful sources. Potential sources of unpublished information on adverse effects are listed in Table 4. Very few evaluations have been carried out of the comparative usefulness of these sources in terms of yield of relevant information. The way in which adverse events were monitored or recorded may affect the reported frequency and so should also, if possible, be extracted. For example, noting whether the data were collected at follow-up (and if so how frequently), and whether collected by patient diary or checklist, or relied on spontaneous reporting. In studies using patient diaries, adverse effects were found to be significantly more common in the active treatment than control groups. Withdrawals and drop-outs should be extracted where possible, together with the reason if known. However, withdrawals and drop-outs are not reliable surrogates for safety or tolerability; withdrawals may be for other reasons than adverse events, for example unpleasant or inconvenient study procedures, lack of improvement or earlier than expected recovery. For example, some studies only report the number of adverse events, not the number of patients with adverse events. It is possible to derive the number of patients from the number of adverse events or use the number of adverse events. Such differences are commonly related to the sample size and study duration, which may be adequate for the primary efficacy/effectiveness variable but not for adverse effects. However, different criteria should be used for different study designs, and the criteria should have been validated by empirical evidence wherever possible. Examples include active or passive surveillance, questionnaire derived data, clinical laboratory and pharmacokinetic and pharmacodynamic data. The choice of instrument can significantly affect the identification, measurement and reporting of adverse effects. For example, were the adverse effects assessed independently by someone other than the surgeon performing the procedurefi Similarly, the Brighton Collaboration has developed guidelines for reporting adverse effects following immunisation. Studies should make clear how they identified that the harm was related to the intervention, who made the attribution. A variety of terms are used to identify adverse effects, with some of the terms remaining ill-defined and the boundaries between them not clearly described. In particular the severity of adverse effects should be adequately defined by either detailed description of severity or reference to a known scale of severity. Ideally, study results should be reported according to the methods section of the study protocol. The timing of events should also be reported, particularly when the follow- up period is prolonged. The report should specify the number of patients withdrawn from the study because of adverse effects by study arm and by type of adverse effects and detail who decided to withdraw (participant or physician) and whether attribution was blinded to the assigned treatment. Sometimes more than one adverse effect may occur in a patient but this is not always reported clearly. It is most helpful when both the number of affected participants and the total number of adverse effects are reported, with the denominators and incidence or prevalence rates. It may however, underestimate adverse effects particularly when there is a high rate of nonadherence with allocated treatment. There are a number of factors associated with bias in the reporting of adverse effects data. It is important to be clear about whether a paper includes all adverse effects that occurred or just a selected sample. It should also be clear whether the selection was made on the basis of frequency. Where critical or otherwise significant adverse effects have been reported they should ideally have been investigated and the findings included in the report. For example if the study is of healthy individuals and the main focus is prevention, even minor harms might be important in the balance of harms and benefits. Alternatively, if the main study outcome is survival, only major or life- threatening harms might be relevant. Likely effects of confounding factors should be considered, particularly when using data from case series and observational studies. There are difficulties in synthesising disparate data sets and differences between studies have to be considered as a source of heterogeneity (whether narrative or quantitative). For example, in cohort studies many patients might have received an incomplete course of medication which may lead to the underestimation of the true rate or severity of adverse effects. Patients in the control group may have procured the medication during a generally prolonged follow-up period and this may lead to overestimation of the rate of adverse effects in the control group. Attempts should be made to explore possible relationships between characteristics of included studies and their reported findings and also between the findings of different studies. Researchers should clearly indicate the populations addressed by the included studies and carefully assess the applicability to other populations. Researchers should provide a detailed description of cases of unusual or not previously recorded adverse effects.