Nuevos Temas del Consenso Argentino de Hepatitis C

El Consenso Argentino de Hepatitis C acaba de finalizar y éste año fue el más extenso por la cantidad de temas que se agregaron .
Lo nuevo:

• Conducta en parejas discordantes.
• Dificultades actuales para el acceso a los medios diagnósticos.
• Rol de la hepatitis C en trasplante hepático.
• Implicancia de la respuesta virológica rápida en el manejo terapeútico.
• Relación costo-eficacia del tratamiento con PEG -IFN + Ribavirina en pacientes con hepatitis crónicas leves y severas.
• Dificultades en la obtención de drogas en la Nación y en las provincias .
• Recursos legales del paciente y del médico ante la no provisión de drogas.

En los próximos diás desarrolaremos los temas más relevantes.

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New NASH (Fatty Liver) Clinical Trials

The Effect of a Probiotic on Hepatic Steatosis

Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.

Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome.

Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.
Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.
Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.
Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.

Metformin in Non-Alcoholic Fatty Liver Disease

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.

A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis (FLIRT)

This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis.

This study will evaluate the effectiveness of pioglitazone, a new diabetes medicine, on decreasing insulin resistance and improving liver disease in patients with nonalcoholic steatohepatitis (NASH). NASH is a chronic liver disease with unknown cause that involves fat accumulation and inflammation in the liver, leading to liver cirrhosis in 10 to 15 percent of patients and significant liver scarring in another 30 percent. Although similar to a condition that affects people who drink excessive amounts of alcohol, NASH occurs in people who drink only minimal or no alcohol. It is most often seen in patients with insulin resistance. Pioglitazone decreases insulin resistance and improves blood lipid (fat) levels, so that it may improve liver disease in NASH.

Treating Nonalcoholic Steatohepatitis With Pioglitazone

Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is unclear, but it is commonly associated with diabetes, obesity, and insulin resistance. Several pilot studies, including a study of pioglitazone at the NIH Clinical Center (01-DK-0130), have shown that the insulin-sensitizing thiazolidinediones lead to decreases in serum alanine aminotransferase (ALT) levels and improved liver histology. Once therapy is stopped, however, ALT levels rapidly return to pre-treatment values. Inaddition we are currently enrolling patients with NASH in a pilot study of metformin therapy for 48-weeks, however our results in 3 patients thus far have not been very encouraging.
In the current study, patients who have completed the pilot study of pioglitazone and have been off therapy for 48 weeks will be offered re-treatment for 3 years. We also propose to treat patients who have not had a satisfactory response to metformin with pioglitazone for the same duration. After a repeat medical and metabolic evaluation and liver biopsy, patients with moderate-to-severe NASH (activity score greater than or equal to 4) will restart pioglitazone at a dose of 15 mg daily. If after 48 weeks, ALT levels are not normal or improved to the degree identified during the pilot study, the dose will be increased to 30 mg daily at the end of 3 years, all patients will undergo repeat medical and metabolic evaluation and liver biopsy. The primary end point will be improvement in liver histology. Secondary end points will be improvements in insulin sensitivity, reduction in visceral fat, liver volume, and liver biochemistry. The aim of this study is to evaluate whether long-term pioglitazone therapy can safely achieve and maintain biochemical and histological improvements in NASH.

New Hepatitis B Clinical Trials

Adding Adefovir Dipivoxil Versus Switching to Entecavir in Patients With Lamivudine-Resistant Chronic Hepatitis B

Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At year 2, resistance to adefovir may occur as high as 25% in patients with history of lamivudine resistance. Resistance to entecavir is reported to be 10% in lamivudine refractory patients during the same period. However, combination of lamivudine and adefovir decreased the adefovir resistance rate as low as 0% in the recent studies. By overcoming the antiviral resistance, the efficacy of therapy will be maximized. This study is intended to compare the efficacy of two strategies, combination of lamivudine and adefovir vs. entecavir monotherapy in patients with lamivudine resistance.

Hepatitis B Vaccination in HIV-Infected Persons

In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.

It is known that HIV-infected persons are more prone to develop chronic hepatitis B infection when they get infected with this virus. After developing chronic hepatitis B these patients are more likely to get livercirrosis and hepatocellular carcinoma (Bodsworth et al.).

Hepatitis B vaccination is available and the vaccine is about 95% protective in preventing immunocompetent persons from developing chronic hepatitis B infection (Lemon). The response on this vaccin is less effective in HIV-infected persons (Carne et al.). Furthermore there is a compliance problem in the standard scheme.

In this study we compare the efficacy of two different HBV vaccination schedules in HIV-infected persons concerning immune response and compliance. A short schedule: t=0,1,3 weeks, in which there are good results concerning immune response and compliance in immunocompetent persons (Saltog et al.) and the standard schedule: t=0,1,6 months. Patients not immune at week 28 will be offered boostervaccination. This consists of double doses at t=0,1,2 months.

800 persons are needed to show non-inferiority with lower margin of 10% of the short schedule in comparison with the control group. Powercalculation is 80%. Randomization is stratified according to CD4 count(CD4 500).

The hypothesis of the study is a better compliance and a comparable immune response in the short schedule, through which persons will be protected against hepatitis B in an early stage.

Evaluation of a New Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD’s Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Lost Antibody After Previous Hepatitis B Vaccination.

The immune response of uraemic patients to hepatitis B vaccination is impaired compared to healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this population.

Study Comparing the Safety of Switching From Lamivudine to Adefovir Dipivoxil Versus Overlapping Lamivudine and Adefovir Before Adefovir Dipivoxil Monotherapy in Patients With Chronic Hepatitis B

In earlier clinical studies, when patients who have been on lamivudine (LAM) were switched to adefovir dipivoxil (ADV), some patients developed ALT flares with an elevation of ALT > 10 x the upper limits of normal (ULN).

There were no cases of hepatic decompensation with the flares, however. The transition methods were varied among physicians from no overlapping to overlapping for 1 to 3 months with LAM and ADV. There is still some uncertainty about the optimal approach to switching from LAM to ADV.

This study will compare the safety of directly switching to ADV to a protocolled switch after a period of overlap of 12 weeks. This will facilitate pro-active switching in patients on LAM and will also highlight genotypic resistance ahead of phenotypic resistance as a reason to switch patients. Data to date have only been presented as part of a controlled study in patients with clinically evident LAM-resistance. This study will enroll patients who still have serum hepatitis B virus (HBV) DNA suppression whilst receiving LAM.

New Hepatitis C Clinical Trials

Nowaday hepatitis C response to the treatment is between 50 and 80 % . Here I choose a list of new trials to inprove the response and the qol of patients with HEP C.

Vaccine :

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech’s HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.

Paroxetine :

Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

Telaprevir :

The purpose of the study is to explore the safety and effectiveness of each treatment combination and to study the amount of telaprevir in the blood. Two different doses of telaprevir (750 mg every 8 hours, and 1125 mg every 12 hours) will be studied in combination with the two standard therapies commercially available for chronic Hepatitis C Virus infection. Telaprevir will be administered for 12 weeks in combination with 24 weeks of standard therapy. In case of sub-optimal response, standard therapy will be extended to 48 weeks

Irbesartan :

The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adults patients with chronic hepatitis C. The expected total enrollment is 200 patients during two years.
Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of hepatic fibrosis and blood markers of hepatic fibrosis .

Rituximab:

This study will examine the safety and effectiveness of the drug Rituximab in treating hepatitis C-associated cryoglobulinemic vasculitis. About 5 percent of patients with hepatitis C develop cryoglobulinemic vasculitis. This syndrome, characterized by inflammation of blood vessels (vasculitis), may involve the skin, joints, kidneys, nerves and other sites, and cause skin rashes, joint pain, weakness, fatigue, and numbness. About 10 to 30 percent of patients develop kidney disease, which, in some cases, can lead to kidney failure.
Although the cause of cryoglobulinemic vasculitis is not known, a critical component is the presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes produce in response to the chronic hepatitis C infection. Rituximab decreases the number of B cells. The Food and Drug Administration approved Rituximab in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma.
Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of cryoglobulinemic vasculitis may be eligible for this study. They must have failed, or been unable to tolerate, treatment with IFN-a and ribavirin. Candidates will be screened with a history and physical examination, electrocardiogram (ECG), blood and urine tests, 24-hour urine collection and chest X-ray, if clinically indicated.
Participants will be randomly assigned to receive Rituximab upon entering the study or 6 months after entering the study. Those whose treatment is delayed 6 months will be followed once a month at NIH for disease evaluation and blood tests during that time.
Patients will be given Rituximab intravenously (through a vein) once a week for 4 weeks. For the first dose, patients will be admitted to the hospital for at least 24 hours after the infusion for monitoring. Subsequent infusions will be given on an inpatient or outpatient basis, depending on how the infusion is tolerated. The day before each infusion they will have a history and physical examination, blood work, and other tests, such as X-rays, as clinically indicated.
After the four infusions, patients will be followed for drug side effects and response to treatment. They will have blood tests every week for 4 weeks and will then return to NIH for 1 day every month for 12 months for a physical examination, blood tests, and X-rays, if medically indicated. Visits may be more frequent, if necessary, and patients may be asked to stay longer than a day if test findings require further investigation.
Patients whose cryoglobulinemic vasculitis improves and remains inactive for 12 months after completing Rituximab therapy will have completed the study. Those who benefit from treatment but have a later worsening of disease may receive a second course of four infusions, with follow-up for 12 months after the last infusion. Patients who do not respond to treatment and whose disease worsens will be advised of other treatment options, but will be asked to return to NIH monthly for 12 months for follow-up.

Dr Hirose

Lasker Awards Winners Announced

NEW YORK (AP) — Two researchers who opened up the field of heart-valve replacement and a scientist who discovered a type of cell that plays a key role in the immune system have won prestigious medical prizes.

The $150,000 Albert Lasker Medical Research Awards will be presented Sept. 28 in New York by the Albert & Mary Lasker Foundation.

Dr. Albert Starr of the Providence Health System in Portland, Ore., and Dr. Alain Carpentier of the Georges Pompidou European Hospital in Paris will share the clinical research prize for developing replacement heart valves. More than 300,000 people a year worldwide get heart valves replaced, and it’s the second most common heart surgery in the United States, the foundation said.

In the 1950s, Starr and the late engineer Lowell Edwards defied conventional wisdom by developing an artificial heart valve that looked nothing like a natural one. Their design, a free-floating ball inside a cage, had been used in bottle stoppers for a century.

In September 1960, Starr performed the first successful valve replacement in a human, a man who survived for a decade before dying in an accident.

But people who get artificial heart valves must take blood thinners for the rest of their lives to cut their risk of blood clots. To get around that, Carpentier adapted valves from pigs. In 1965, he and a colleague did the first successful replacement of a human valve with an animal valve. In 1968, he implanted an improved version in a patient who survived for 18 years.

Carpentier also developed a valve repair surgery that “ushered in the modern era of valve reconstruction,” the foundation said.

The prize for basic research goes to Dr. Ralph Steinman of The Rockefeller University in New York for discovering dendritic cells, which trigger defenses against germs.

“He revolutionized our understanding of the events that instigate an immune response,” the foundation said.

Steinman began his work in 1970, trying to discover what made immune system cells react to invaders. Working with material recovered from mouse spleens, he spotted the irregularly shaped dendritic cells under a microscope. He went on to show that dendritic cells goaded other cells called T cells into action against invaders.

Dendritic cells are now being studied for turning the immune system against cancers and germs such as HIV.

In addition to the research prizes, the $150,000 Lasker award for public service will be presented to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, for spearheading government efforts against AIDS and bioterrorism.

La mejor enseñanza acerca de lo que es la Anorexia y la Bulimia (Video)

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Sexo y Salud en Edad Avanzada

Nuestros resultados, basados en datos nacionalmente representativos del NSHAP, indican que el predominio de la actividad sexual declina con la edad, a pesar de esto un número sustancial de hombres y mujeres tienen relaciones vaginales , sexo oral, y masturbación incluso en las octavas y novenas décadas de la vida.

En nuestro estudio, la frecuencia de la actividad sexual divulgada por los respondedores que eran sexualmente activos eran similares a las de los adultos 18 a 59 años.
Los problemas sexuales específicos no fueron determinados entre adultos sexualmente inactivos; por lo tanto, este estudio subestima probablemente su predominio total. Casi uno en siete hombres dijo tomar medicación para mejorar la función sexual. terapéuticas.

Encontramos varias disparidades con respecto a la sexualidad de hombres y de mujeres en edadades avanzadas . Un total de el 78% de hombres 75 a 85 años de edad, con respecto al 40% de mujeres en esta categoría de edad, dijeron tener relaciones sexuales . Esta diferencia se puede explicar por varios factores, incluyendo la estructura de edad de relaciones maritales entre adultos de mayores ( los hombres, en promedio, se casan con mujeres más jóvenes.

Una estudio multinacional reciente entre personas 40 a 80 años de edad (tasa de respuesta, el 19%) también demostró que las mujeres eran más probables que los hombres a clasificar el sexo como parte poco importante de sus vidas además de tener carencia de placer con el sexo. A pesar de un predominio semejantemente alto de problemas sexuales entre mujeres y hombres, encontramos que en las mujeres eran menos probables que los hombres a discutir temas sexuales con un médico

Los estudios anteriores, incluyendo el NHSLS, 11 el estudio global de actitudes y de comportamientos sexuales, 3 y un estudio grande de adultos más jóvenes (16 a 44 años de la edad) en el Reino Unido, 37 demostraron que la disfunción sexual está asociada a salud pobre. Las personas en buena salud física son más probables tener relaciones sexuales.

Nuestro estudio indica que la diabetes está asociada positivamente a dificultades con la erección así como con un predominio más bajo de la actividad sexual y/ o masturbación.

Como se ha divulgado previamente, el predominio de dificultades eréctiles es más altos en personas mas viejas que en jóvenes.

En cambio, el predominio de algunos problemas sexuales, tales como dolor o, entre los hombres, eyaculación precoz , es más bajo entre personas de edad avanzada.

Artículo completo en ingles

Fuente:From the Department of Obstetrics and Gynecology, the Department of Medicine, and the MacLean Center for Clinical Medical Ethics, University of Chicago Pritzker School of Medicine (S.T.L.); the Department of Health Studies (L.P.S.), the Department of Sociology (E.O.L., L.J.W.), and the Harris School for Public Policy Studies and NORC, University of Chicago (C.A.O.) — all in Chicago; and the Department of Medicine, University of Toronto, Toronto (W.L.).

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HIV Vaccine Trials Produce Encouraging Results

Vical Incorporated (Nasdaq: VICL) announced today that results from a series of HIV vaccine Phase 2a clinical trials, using a plasmid DNA (pDNA) vaccine developed by the NIH Vaccine Research Center and manufactured by Vical, reinforced previously reported Phase 1 conclusions that a “DNA prime-adenoviral vector boost” vaccine regimen was safe and well-tolerated, and was effective in inducing T-cell immune responses in up to 70% of the vaccine recipients.”These recent vaccine trials contribute to the growing body of knowledge demonstrating plasmid DNA priming as a key factor in achieving significant immune responses against HIV, a particularly difficult target pathogen, bringing us one step closer to evaluating the effectiveness of a prime-boost HIV vaccine regimen in a prophylactic setting,” said Vijay B. Samant, Vical’s President and Chief Executive Officer. “The latest International AIDS Vaccine Initiative (IAVI) listing of ongoing preventive HIV vaccine clinical trials shows that more than half use pDNA either alone or in combination with other vaccine modalities. We are very pleased that DNA technology is an integral part of the effort to address this high priority global health problem.”The trials involved priming an immune response with three doses of a pDNA vaccine over a two month period, based on Vical’s proprietary DNA technology, and boosting the response with a single dose of adenoviral vector vaccine at six months. The three trials, collectively known as TRIAD, were conducted by the National Institute of Allergy and Infectious Diseases (NIAID) HIV Trials Vaccine Network (HVTN), the IAVI, and the U.S. Military HIV Research Program (USMHRP). Richard Koup, M.D., Chief of Immunology at the Dale and Betty Bumpers Vaccine Research Center (VRC), NIAID, National Institutes of Health (NIH), highlighted TRIAD summary results and conclusions in an oral presentation, “Update on safety and immunogenicity of VRC products,” at the AIDS Vaccine 2007 conference (Seattle – August 20-23).About the VaccineThe “prime-boost” strategy uses two vaccine components given at different times. Both contain synthetic versions of genes encoding three HIV proteins: gag, pol and env. The DNA component also includes a gene encoding a fourth protein, nef. The gag, pol and nef genes come from HIV subtype B, the primary virus found in Europe and North America. The env gene encodes an HIV coat protein that allows the virus to recognize and attach to human cells. The vaccine incorporates modified env genes from subtypes A and C, most common in Africa and parts of Asia, as well as subtype B. These three subtypes collectively represent about 85 percent of HIV infections worldwide.The two vaccine components differ in how the genes are packaged. The pDNA component contains only the specific gene sequences in a pDNA ring, and cannot reconstitute into an infectious virus. The adenoviral vector component uses a replication-defective adenoviral vector to shuttle the same non-infectious gene sequences into the body. The pDNA vaccine used in the trials was developed by VRC scientists and was manufactured by Vical. The adenoviral vector vaccine was developed by VRC in collaboration with GenVec Inc., of Gaithersburg, Md., which also manufactured the adenoviral vector vaccine.About VicalVical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at http://www.vical.com/.This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether VRC will continue development of prime-boost or other HIV vaccines and initiate additional trials as planned; whether immunogenicity results will be predictive of protection; whether the HIV vaccine or any other product candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market the HIV vaccine or any other product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

Chapter 2.3. Type of study and general design

From the point of view of the knowledge that the doctor and the patient they have about the medication that is receiving the patient distinguish the open studies and the blind studies. In the open studies as much the investigator as the patient knows the treatment that receives the patient. Usually they are opened to the studies of prolonged acceptability and tolerance, the studies made in rare or incurables diseases, the studies badly designed and the farmacocinéticas studies. Blind person means ignorance of the identity of the treatment that is received. The blindness is used to eliminate all those subjective factors, as much on the part of the investigator as of the patient, that can bring confusion at the time of interpreting the results of a treatment in study. The blind studies are classified as well in: , 1) Simple blind person, the doctor knows the treatment that receives the patient but the patient does not know it 2) Double blind person neither the investigator nor the patient know the treatment that receives the patient , 3) Triple blind person neither the patient, nor the investigator nor the patrocinante know the assigned treatment the patients In order to establish causality, that is to say, to be able to affirm that a drug produces a certain effect or is superior to another drug, it is necessary to carry out controlled, randomized and blind studies. This type of design as much provides protection against the slant in the allocation on the part of the investigator and the slant in the evaluation of results by the investigator as by the patient. According to the number of measurements that are made of the variable in study the design can be cross-sectional or longitudinal. In the cross-sectional studies the variables in study are moderate a single time, that is to say, that register diverse characteristics of the population in study in a while determined, as if it was a photography of that population. Soon it is examined if some association between the observed characteristics exists. For example, in a certain population data can be gathered on weight, height, numbers of cholesterol and habit to smoke. Through this design it is possible to be determined if there is association between the different variables, but as the temporary sequence is not known the events, cause cannot be established/effect that is causality. In general, the cross-sectional designs are used for studies of biological processes that are carried out within the laboratories, for diagnosis and stratification (normal ranks), for description of diseases and studies of dose (phase I and 11). In the longitudinal design the evolution in the time of the variables in study is evaluated. Most of the studies in which there is an external intervention and are wanted to establish causality are longitudinal. Although frequently a cross-sectional design is more expeditious, the longitudinal design offers better information generally.

Thank you for contributing your translation suggestion to Google Translate.

We’ll use your suggestion to improve translation quality in future updates to our system.		From the point of view of the knowledge that the doctor and the patient they have about the medication that is receiving the patient distinguish the open studies and the blind studies. In the open studies as much the investigator as the patient knows the treatment that receives the patient. Usually they are opened to the studies of prolonged acceptability and tolerance, the studies made in rare or incurables diseases, the studies badly designed and the farmacocinéticas studies. Blind person means ignorance of the identity of the treatment that is received. The blindness is used to eliminate all those subjective factors, as much on the part of the investigator as of the patient, that can bring confusion at the time of interpreting the results of a treatment in study. The blind studies are classified as well in: , 1) Simple blind person, the doctor knows the treatment that receives the patient but the patient does not know it 2) Double blind person neither the investigator nor the patient know the treatment that receives the patient , 3) Triple blind person neither the patient, nor the investigator nor the patrocinante know the assigned treatment the patients In order to establish causality, that is to say, to be able to affirm that a drug produces a certain effect or is superior to another drug, it is necessary to carry out controlled, randomized and blind studies. This type of design as much provides protection against the slant in the allocation on the part of the investigator and the slant in the evaluation of results by the investigator as by the patient. According to the number of measurements that are made of the variable in study the design can be cross-sectional or longitudinal. In the cross-sectional studies the variables in study are moderate a single time, that is to say, that register diverse characteristics of the population in study in a while determined, as if it was a photography of that population. Soon it is examined if some association between the observed characteristics exists. For example, in a certain population data can be gathered on weight, height, numbers of cholesterol and habit to smoke. Through this design it is possible to be determined if there is association between the different variables, but as the temporary sequence is not known the events, cause cannot be established/effect that is causality. In general, the cross-sectional designs are used for studies of biological processes that are carried out within the laboratories, for diagnosis and stratification (normal ranks), for description of diseases and studies of dose (phase I and 11). In the longitudinal design the evolution in the time of the variables in study is evaluated. Most of the studies in which there is an external intervention and are wanted to establish causality are longitudinal. Although frequently a cross-sectional design is more expeditious, the longitudinal design offers better information generally.

No es un buen lugar para tener un DIU (Foto)

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