Gerstungen, Germany

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Effect on the HIV Diagnosis Rates of Integration of AIDS Indicator Conditions Into the Hospital Information Systems

Scientific Basis/Rationale The HIV infection was first diagnosed in our country in 1985, and the number of the patients diagnosed with this infection has been gradually increasing since then. The number of these patients was found 21.520 in December 2018. Having CD4 cell count <350 cell/mm3 at the time of diagnosis or having an AIDS defining illness regardless of CD4 count has been defined as late diagnosis. 48-52% of HIV-positive cases have been shown to receive late diagnosis in the studies conducted in our country. It is being reported that there are no strategies of HIV screening for risky individuals and a significant part of the patients receive HIV diagnosis accidentally or during differential diagnosis of certain diseases. In the patients having late diagnosis, the treatment response is low and slow whereas progression to AIDS and death rates are high. The patients who could not be diagnosed also contribute to spread of the infection in the society. Therefore, it is significant that these patients should have early diagnosis and thus they could start treatment at the early phases of the infection in order to keep the disease under control. Hypothesis In the studies, it was reported that most of the patients with late diagnosis were the patients who were not defined to have a risk of HIV infection, although these patients had a number of applications to the healthcare centers before the diagnosis of the disease, HIV infection was not considered because they were not in the risky patient group and no tests were requested; therefore, the opportunities of the diagnosis could be missed. Diseases and the indicator conditions for which HIV test should be requested other than AIDS descriptive diseases are also identified in the studies conducted. The objectives of this study include studying the indicator conditions and diseases for which HIV test should be requested, determining the ratio of HIV test requests related to these conditions and diseases, integrating these diseases into the automation systems used in the hospitals and increasing the rate of HIV diagnosis by this means, prevention of missing diagnosis opportunities and raising awareness on this issue. Primary Objective Change in the number of HIV diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system Secondary Objectives Change in the number of HIV test requests before and after the integration of the indicator conditions and diseases to hospital automation system Assessment of CD4 levels at the time of diagnosis before and after the integration of the indicator conditions and diseases to hospital automation system Study Design and Research Methods This study has been designed as a multi-center retrospective cohort study. The indicator conditions and diseases for which HIV test should be requested will be recorded from the automation systems of the hospitals, and the rate of HIV test requests and rate of HIV positivity when the test was requested will be recorded for the all patients applied to hospital retrospectively for the past 6 months. For this period, due to retrospective design, physicians working at the hospitals do not have any information about the study. After the necessary approvals the indicator conditions and diseases for which HIV test should be requested shall be integrated into the hospitals automation systems and a warning stating that HIV test should be requested at the moment when these diseases and conditions are diagnosed shall pop-up. All the physicians working at the hospitals shall be notified of this activation by means of a letter. After this activation, 6 months later second retrospective step (phase) will start that, we will record the indicator conditions and diseases for which HIV test should be requested, and the rate of HIV test requests and the rate of HIV positivity when the test is requested will be recorded. During the study, the information obtained from the hospital automation system including age, gender, date of diagnoses, CD4 cell counts at the time of diagnoses, the HIV RNA levels, immigration status, concomitant diseases, and the residential area of all patients diagnosed with HIV infection shall be recorded on the appropriate forms. The characteristics of the patients that are diagnosed due to the indicator conditions and diseases for which HIV test should be requested shall be compared with the patients that are diagnosed due to other reasons. The HIV infection diagnoses rates during the two phases of the study shall also be compared. Furthermore, the patients shall be evaluated according to their CD4 counts at the time of the diagnosis, and shall be divided into two groups of patients as late diagnoses or not. We shall evaluate whether or not there is a difference regarding the rate of the patients with late diagnoses during the two phases of the study, and both groups shall be compared with respect to receiving late diagnosis factors. The ethical approval of the study shall be obtained from the Ethical Committee of Ankara Training and Research Hospital. The centers participating in the study will obtain their approval to participate to the study from the centers where they work, using the ethical approval obtained form Ankara Training and Research Hospital. Each hospital will be responsible for the arrangements that must be made regarding the hospital automation system.

Wheelchair Use in Patients With Amputation

There are no specific criteria for chair use in patients with lower extremity amputations. The main purpose of this study is to determine the characteristics of wheelchair use in lower extremity amputee patients. In addition, it is aimed to determine the reasons for using and not using a wheelchair, and what type of wheelchair is needed. Thus, it is thought that the main points to be considered while prescribing a wheelchair in patients with amputation can be determined. Patients with traumatic unilateral or bilateral lower extremity amputation who are hospitalized or applied to outpatient clinics will be included in the study. Demographic and clinical characteristics of the patients will be recorded. Current age, time since the injury (in months), occupation, etiology (mine,rocket launcher, rifle, shrapnel, etc.), amputation level, amputation side, accompanying upper extremity problem, last operation reason, and activity level, knee joint type (hydraulic, simple microprocessor, other microprocessor), foot type (carbon, hydraulic, microprocessor controlled), socket-suspension type, daily use of prosthesis (hour/day), use of assistive device or AFO, how long he/she has been using a wheelchair, the type of wheelchair (light manual, active, battery powered), the reason for using a wheelchair, the reason for not using, the frequency of using a wheelchair, the upper extremity problem/pain while using the chair will be recorded.

The Effect of Premedication on Postoperative Pain and Anxiety in Breast Cancer Surgery

In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. The STAI-1(State Trait Anxiety İnventory ) form and APAIS (Amsterdam Preoperative Anxiety and İnformation Scale) scale were filled in for all preoperative patients. Afterwards, the patients were treated with either midazolam or dexmedetothymidine, depending on the anesthesiologist's preference. After administration, he was taken to surgery. As intraoperative analgesics, 2 mg/kg tramadol and 15 mg/kg paracetamol were administered to all patients. postoperative recovery time (aldrete 10), 1., 2.,6.,12.,24. VAS score, postoperative nausea-vomiting scale, STAI-1(State Trait Anxiety İnventory ) form, first need time if postoperative analgesic was needed, and 24-hour total analgesic consumption were recorded. It was aimed to examine the effects of different premedications on postoperative pain and anxiety

Low Back Activity Confidence Scale: Cross-cultural Adaptation, Reliability, and Validity of the Turkish Version

Because self-efficacy represents a situation-specific construct and not a general or personality construct, confidence in performing one type of activity can differ significantly from confidence in performing other actions, all of which can contribute to a common outcome. Optimally, self-efficacy measures are tailored to assess individuals' confidence in exhibiting key behaviors related to recovery or alleviation from their own health condition or condition. Therefore, self-efficacy scales involve measuring an individual's confidence in each unique behavior or set of behaviors. Self-efficacy also explained more discomfort than pain intensity in patients with chronic pain. In addition, with appropriate insight and assessment, self-efficacy can perhaps be developed more effectively or appropriately than other non-modifiable (e.g. demographics) or less easily modifiable factors, such as fear beliefs and catastrophic thinking. Although several instruments have been developed to assess self-efficacy in low back pain, they do not address relevant functional and self-regulatory behaviors in the post-intervention clinical population. Therefore, the Low Back Activity Confidence Scale (LoBACS) was created to assess various forms of self-efficacy potentially related to low back pain. LoBACS is general, non-work-specific, but self-efficacy for backward functional activities such as standing, carrying, and pushing, self-regulation or self-control to manage one's thoughts, emotions, and behaviors to perform or avoid activities that may contribute to back health. and self-efficacy to do regular exercise, a core activity in a range of therapeutic interventions for low back pain. There is no Turkish version and validity study of LoBACS. This study is aimed to evaluate the validity and reliability of the Turkish version of LoBACS. The study of validity and reliability is planned with 104 individuals with low back pain. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with LoBACS, International Physical Activity Questionnaire (IPAQ), Back Pain Functional Scale (BPFS), Waddell Disability Index (WDI), Modified Oswestry Disability Index (MODI), Roland-Morris Disability Questionnaire (RMDQ), Short Form-36 (SF-36), Fear Avoidance Beliefs Questionnaire (FABQ) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Study of Novel Treatment Combinations in Patients With Lung Cancer

Effect of Different Focused Techniques on Thigh Muscle Activation After Anterior Cruciate Ligament Reconstruction

Exercises are given for the symptoms of knee edema, knee range of motion, and quadriceps reflex inhibition in the acute period after anterior cruciate ligament surgery. In recent years it has been shown that the different focuses when explaining exercises to patients affect exercise performance and rehabilitation outcomes. It has been shown that the increase in performance of some exercises that require strength and power, such as long jump and sprint, especially with the applied external focus (the method of focusing on the result of the movement). However, it has been shown that there is an increase in muscle activation with internal focus (focusing on the muscles that reveal the movement). There is no study examining the effects of focusing differences on the exercise program given after anterior cruciate ligament reconstruction, especially on muscle activation after knee reflex inhibition. 30 individuals between the ages of 18-and 30 who had undergone anterior cruciate ligament reconstruction for the first time will be included in the study. The first evaluation will be performed and rehabilitation will begin in the first week after surgery. Patients who were taken into rehabilitation after anterior cruciate ligament surgery will be distributed into two different groups by the block randomization method. The same structured exercise program will be applied to the patients in both groups. Only the commands given during the exercise will be different. Group 1: Internal Focused Exercise: E.g; While describing the knee pressing exercise (quadriceps isometric) in the long sitting position, the command "press your knee towards the bed by squeezing your thigh muscle" will be given by showing the muscle. Group 2: External Focused Exercise: E.g; While describing the knee pressing (quadriceps isometric) exercise in the long sitting position, the command "press the towel/cloth that we put under your knee and compress your knee" will be given by showing the towel. Patients will be followed under the supervision of a physiotherapist in the clinic 2 days a week and exercise progression will be provided. On the other days, the exercises will be continued as a home program. In order for the patients to comply with the exercises more easily and to be reminded easily, an exercise brochure will be given to the patients with the commands written and the exercises explained with pictures. The last measurements will be performed at the end of one month after surgery.

Observational Registry of Patients With Rheumatoid Arthritis /Spondyloarthritis Using Biological or Targeted Synthetic DMARDs

In this study, investigators aimed to observe the examination findings, laboratory findings and drugs used in routine polyclinic controls of the participants using biological and targeted synthetic disease-modifying antirheumatic drug (DMARD) and the doses and side effects of these drugs. The aim of this registry is to evaluate the real-life data of participants receiving these medications. Analysis of treatment follow-up, drug changes, causes of change, treatment-related paradoxic / immune reactions, compliance with adult vaccination programs, nutritional profiles, presence of metabolic syndrome, fertility status, pregnancy outcomes, and vitamin D levels will be recorded in the outpatient clinic. Rheumatoid Arthritis Impact of Disease, Psoriatic Arthritis Impact of Disease (RAID and PSAID indexes), Work Productivity and Activity Impairment Questionnaire (WPAI), drug compliance, central sensitization and fall risk will be evaluated with verbal evaluation forms performed at policlinic controls in patients with spondyloarthritis and rheumatoid arthritis. It is planned to conduct scientific analyzes and publish on various subjects from the recorded information on this registration system. Patients using biological and targeted synthetic DMARD treatments are closely monitored and evaluated in many ways due to the risk profiles and various characteristics of the drugs. With this registry system, it is aimed to evaluate the real-life data of the participants using these drugs. Real-life data are very valuable in monitoring the disease and the drugs. Planned studies are: ROMATOID ARTHRITIS CLINICAL DEMOGRAPHIC ASSESSMENT / DISEASE EFFECT / DRUGS - SPONDYLOARTHRITIS CLINICAL DEMOGRAPHIC EVALUATION / DISEASE EFFECT / DRUGS - COMORBIDITY IN ROMATOID ARTHRITIS - COMORBIDITY IN SPONDYLOARTHRITIS - RE ACTIVITATION AND SAFETY MONITORING IN VIRAL HEPATITIS - TREATMENT PARADOXIC / IMMUNE REACTIONS (SYSTEMIC AUTOIMMUNE, ARTHRITIS, HEMATOLOGIC, NEUROLOGIC, PULMONARY, OPHTHALMOLOGICAL, INFLAMMATORY BOWEL DISEASE, LIVER, CUTANEOUS, OTHER) - WORK FORCE LOSS IN AXIAL SPONDYLOARTHRITIS - WORK FORCE LOSS IN PSORIATIC ARTHRITIS - WORK FORCE LOSS IN ROMATOID ARTHRITIS - PREGNANCY / FERTILITY OUTCOMES - TUBERCULOSIS MONITORING - DRUG SWITCH ANALYSIS - THROID DISEASE IN EARLY AND ESTABLISHED ROMATOID ARTHRITIS (AUTOIMMUNE THROIDITIS, MALIGNITY etc) - TREATMENT COMPLIANCE IN RHEUMATIC DISEASES - ADULT IMMUNIZATION PROGRAM IN RHEUMATIC DISEASES - METABOLIC SYNDROME ASSESSMENT - CARDIOVASCULAR RISK ASSESSMENT - FALL / FRACTURE AND RELATED VARIABLES IN RHEUMATIC DISEASES - VITAMIN D STATUS IN RHEUMATIC DISEASES - CENTRAL SENSITIZATION AND PAIN IN ROMATOID ARTHRITIS AND SPONDYLOARTROPATHIES AND RELATED VARIABLES The study is observational and there is no expected risk since no intervention is planned.

Investigation of the Effects of Exercise Program in Patients With Chiari Type 1 Malformation

This study will be conducted in Hacettepe University Faculty of Medicine Neurosurgery Department and Hacettepe University Faculty of Physical Therapy and Rehabilitation. The study was designed as a randomized controlled trial. At the beginning of the study, demographic data and characteristics of the cases will be recorded. Patients will be evaluated in three different periods throughout the study. The first assessments will be performed on the first day after the patient's condition is appropriate after the surgical procedure for Type 1 CM. Following this evaluation, all patients will be divided into two groups using. a simple randomization method. The first group will be exercised for 6 weeks while the second group will not be intervened during this period and will be followed as a control group. Immediately after the exercise program administered to the first group after 6 weeks, both groups will undergo second assessments. After these assessment measures, the same exercise program in the first group will be applied to the second group only this time for 6 weeks. In the meantime, the first group will stop their exercise programs. After the 6-week exercise program of the second group has ended, both groups will be given the third assessment, the final assessment. "The study will be conducted in individuals aged 18-65 years who have been diagnosed with Type 1 CM by the physician and have been decided to undergo surgery for this diagnosis. In our study whose primary outcome parameters were determined as "Neck Disability Index" and "Visual Analogue Scale minimum, the minimum sample width required to reach 95% -99% power was six individuals in total. For various reasons (patient withdrawal, etc.), the rate of withdrawal from the study was predicted to be 25%. Accordingly, the study was decided to be conducted with a total of eight individuals. Patients with a history of primary neurological disease other than Chiari Type 1 Malformation, severe cognitive impairment (> 24 from Mini-Mental State Assessment), peripheral vestibular problem, and history of orthopedic surgery will not be included in the study. The data will be evaluated using SPSS for Windows 22.00. Descriptive statistics will be presented as a minimum, average, median, standard deviation, maximum and categorical variables for numerical variables and as percentages. The suitability of the variables to normal distribution will be examined by the Shapiro-Wilk normality test. Whether the groups (Group 1, Group 2) are similar in terms of gender will be examined by the Pearson Chi-Square Test when the prerequisites are met, and Fisher's exact test if not. By the cross-pass research design, the block, period, trial and sequence effects will be analyzed with a mixed effect model. At the beginning of the study, demographic data, characteristics and disease information will be recorded. The evaluations to be made are summarized below: - Visual Analogue Scale, pain threshold and pain tolerance tests, Neck Disability Index, for the determination of pain level in the neck region and throughout the body - Cervical range of motion (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3) device for the evaluation of the cervical region. - Berg Balance Scale for evaluation of performance-based balance, - Timed Rise Walk Test, Sharpened Romberg test and "8" shaped walk test (F8WT) for evaluation of fall risk, static and dynamic balance, - The International Ataxia Assessment Scale (ICARS) for coordination, - Grip Ability Test (GAT) for the assessment of fine motor skill in the upper extremity, - Posture evaluation, - Eating Assessment Tool (EAT-10) for evaluation of swallowing function - For daily living activities, Barthel Daily Living Activities Index, - For the quality of life, the Short Form 36 questionnaire will be used.

Leukemic Stem Cell Detection for Chronic Myeloid Leukemia Patients With Major Molecular Response

In the present study, its aimed to compare the amount of CD45+/CD34+/CD38−/CD26+ levels of CML stem cells in CML patients with and without BCR-ABL hematopoiesis. Therefore, the amount of CD45+/CD34+/CD38−/CD26+ levels of CML stem cells in CML patients will be analyzed using bone marrow and peripheral blood samples and whether leukemic stem cells are present in the bone marrow and at what amount, if present, although these cells are cleared from the peripheral blood, will be investigated. Additionally this study would pave the way for further cellular treatment strategies against CML stem cells, being the pioneer of development of curative treatments in CML. Until now, TKI discontinuation studies have failed in patients with long-term BCR-ABL negativity. There is a chance for cure in patients in whom the BCR-ABL status becomes negative with chimeric antigen receptor (CAR) T-cell treatment modalities which target leukemic stem cells. Also, monoclonal antibodies and/or cellular treatments targeting leukemic stem cells are the main treatment strategy is to reduce the CML treatment-related cost. In the international platform, the accurate definition of leukemic stem cell in CML and development of targeted cellular treatments have been also paid a great attention with a given priority for patent application. The primary objective of the present study is to accurately detect leukemic stem cells in CML and to estimate the threshold value for the prediction of recurrence or cure. To the best of investigators knowledge, there is a very limited number of studies in the literature and there is no study available comparing leukemic stem cells (CD45+/CD34+/CD38-/CD26+) in patients with BCR-ABL-positive hematopoiesis and CML patients with BCR-ABL activity inhibition under TKI therapy in Turkey. Therefore,for the first time, it is planned to evaluate the prognostic value of the amount of leukemic stem cells in CML and to tailor individual treatment options. Newly diagnosed CML patients or patients with a previous diagnosis under follow-up with or without TKIs will be included in this study. The patients will be divided into two groups as follows: Group 1: Patients with BCR-ABL-positive hematopoiesis (newly diagnosed CML patients, CML patients with leukocytosis, CML patients without a hematological and/or cytogenetic and/or molecular response, CML patients whose BCR-ABL status becomes negative and then positive) will be included. Group 2: Patients with CML with BCR-ABL activity inhibition under TKI therapy (patients with major molecular response (MMR) and/or deeper response) will be included. Peripheral blood samples from 30 patients and bone marrow aspiration samples from 20 patients will be collected for each group. A total of 100 patients will be included in the study. The number of bone marrow aspiration samples is limited to 20 patients for each group, as this method is more invasive with a higher rate of complications. Peripheral blood samples will be collected simultaneously in patients in whom bone marrow samples are collected. For an accurate examination, the bone marrow samples and the peripheral blood samples will be concomitantly analyzed for each individual patient. The presence and amount of CD45+/CD34+/CD38-/CD26+ leukemic stem cells will be analyzed using multicolor flow cytometry at Ankara University, Faculty of Medicine, Ibni Sina Hospital, Hematology Lab. The peripheral blood and bone marrow samples obtained at Hacettepe University and Ege University will be transferred to Ankara University, Faculty of Medicine, Ibni Sina Hospital, Hematology Lab in accordance with the codes of the Biological Material Transfer Agreement. As bone marrow aspiration and BCR-ABL molecular testing are routinely used in the diagnosis and follow-up of CML patients, these interventions pose no additional burden for the patients.