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An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.
Case-Control Studies ; Cohort Studies ; Research Design

OBJECTIVES: Previous studies have shown the relationship between recognition of facial expressions and psychiatric symptoms. This study investigated how healthy young adults recognize neutral faces and which psychological distresses and symptoms relate to their recognition of neutral faces. METHODS: One hundred forty-three healthy volunteers participated in this study. We used neutral facial pictures, selected from the Japanese and Caucasian Facial Expressions of Emotion (JACFEE) photo set, to evaluate participants' facial expression recognition and the State-Trait Anxiety Inventory, Beck Depression Inventory, Toronto Alexithymia Scale, Conner-Davidson Resilience Scale, and Temperament and Character Inventory (TCI) to measure and examine their psychological characteristics. RESULTS: There were significant positive correlations between the recognition rate of neutral expressions as contempt and trait-anxiety level (r=0.21 ; p=0.01) and depression (r=0.20 ; p=0.02). This contempt-recognition was significantly negatively correlated with resilience score (r=-0.22 ; p=0.01) and the TCI self-directedness subscale (r=-0.29 ; p=0.00). Also, the TCI's harm avoidance subscale score was significantly positively correlated with the contempt recognition rate (r=0.21 ; p=0.01). CONCLUSION: These finding suggests recognition of neutral faces as contempt may be related to psychological distress, including trait and temperament characteristics. This negative bias toward neutral emotion (expressions) may affect interpersonal relations and social functioning in a healthy population.
Affective Symptoms ; Anxiety ; Asian Continental Ancestry Group ; Bias (Epidemiology) ; Depression ; Facial Expression ; Humans ; Interpersonal Relations ; Polymethacrylic Acids ; Temperament ; Young Adult

OBJECTIVE: Bipolar disorder patients often show excessive goal-directed and pleasure-seeking behavior during manic episodes and reduced hedonic capacity during depressive episodes, indicating that bipolar disorder might involve altered reward processing. As such, bipolar disorder subjects have been reported to show impaired reward learning in situations requiring integration of reinforcements over time. In this study, we examined characteristics of reward learning in euthymic patients with bipolar disorder using a probabilistic reward task. METHODS: We recruited 23 euthymic patients with bipolar disorder and 47 healthy subjects for the probabilistic reward task. This task is a reward-based paradigm to produce a response bias, in which correct identifications of two ambiguous stimuli are differently rewarded. The other dependent measures were the discriminability, hit rate and reaction time. RESULTS: Relative to comparison subjects, bipolar patients showed a reduced acquisition of response bias toward the more frequently rewarded stimulus (p<0.01). The overall reward learning was positively correlated with state and trait anxiety levels in bipolar patients (p<0.01). No significant differences of discriminability, hit rates, and reaction time were found between bipolar patients and controls. CONCLUSION: These findings suggest that euthymic patients with bipolar disorder may have deficits in reward learning related to anxiety.
Anxiety ; Bias (Epidemiology) ; Bipolar Disorder ; Humans ; Learning ; Reaction Time ; Reinforcement (Psychology) ; Reward

OBJECTIVES: Autobiographical memory (ABM) is a special type of episodic memory, containing events that have occurred in a personal life. Overgeneral tendency of ABM refers to the retrieval of memory with only general and categorical descriptions rather than specific events. ABM specificity in depression and posttraumatic stress disorder is a robust finding with relation to cognitive vulnerability, affect regulation, problem-solving ability. It is also implicated in bipolar disorder with frequent relapses. In this study, we investigated whether ABM specificity was related to manic or euthymic mood states in patients with bipolar disorder. METHODS: Forty bipolar patients with manic and euthymic episodes and 25 healthy controls participated in this study. Prompted by 5 positively and 5 negatively valenced emotional cue words, each participant was instructed to recall positive or negative memories and describe them in detail. The one-way ANOVA was used to compare ABM scores and post-hoc analyses were done. RESULTS: Comapred to the healthy persons, the bipolar patients reported significantly more general than specific negative memories in both manic and euthymic episodes (p = 0.003). However, there was no significant difference between manic and euthymic patients (p = 0.074). CONCLUSIONS: These results suggest that overgeneral tendency of negative ABM may be a trait abnormality in bipolar disorder. Moreover, this phenomenon might be related to underlying cognitive deficits or affect regulation irrespective of the mood state.
Bipolar Disorder ; Cues ; Depression ; Humans ; Memory ; Memory, Episodic ; Recurrence ; Sensitivity and Specificity ; Stress Disorders, Post-Traumatic

OBJECTIVE: The transplantation of bone marrow cells into the injured spinal cord improves neurologic functions in experimental animals. However, it is unclear whether bone marrow cells can similarly improve the neurologic functions of complete spinal cord injury patients. To study their therapeutic effects in human spinal cord injury (SCI), we transplante autologous bone marrow cells into the SCI sites and administer granulocyte macrophage-colony stimulating factor (GM-CSF) in three complete SCI patients. METHODS: Bone marrow cell transplantation with GM-CSF administration was performed on two patients (patients1 and 2), wherein concentrated bone marrow cell pastes were injected into the injury area using a sterile 21 gauge fine needle. The total volume of bone marrow cells injected was 1.8ml (cell concentration 1.1X106/ul). Patient 3 was administered GM-CSF only. The follow up periods were 5 months (patient 1), 4 months (patient 2) and 6 months (patient 3). RESULTS: Sensory improvements were followed immediately after the operations. Sensory recovery in the sacral segment was noticed at 3 weeks (patient 1), 13 days (patient 2) and at 2 months (patient 3) postoperatively. Significant motor improvements were noticed at 3 months in patients 1 and 2, and at 4 months in patient 3. All three patients showed neurologic improvements at the last follow up 5, 4 and 6months respectively (Frankel grade C, AIS grade C). CONCLUSION: Treatment of SCI patients with autologous bone marrow cell transplantation and GM-CSF administration shows some beneficial effects during the early postoperative periods. However, long-term and more comprehensive clinical studies are required.
Animals ; Bone Marrow Cells* ; Bone Marrow Transplantation* ; Bone Marrow* ; Follow-Up Studies ; Granulocyte-Macrophage Colony-Stimulating Factor ; Granulocytes* ; Humans ; Needles ; Ointments ; Postoperative Period ; Spinal Cord Injuries* ; Spinal Cord* ; Stem Cells ; Transplantation

OBJECTIVE: The aim of this study was to evaluate whether the Bishop score, length, volume and gray-scale histogram of the cervix has a predictive value of assessing the rate of success in trial of induction. METHODS: Forty-one nulliparous patients with its Bishop score six or less were enrolled for this prospective study. All were on prostaglandin E2 (PGE2, Propess(R); Controlled Therapeutics Ltd) pessary. Three-dimensional transvaginal ultrasound scans of the cervix were performed on the ACCUVIX XQ (Medison) to measure length, volume, and gray-scale histogram. Bishop score was determined by digital examination. The successful induction was defined as the ability to achieve the active phase of labor corresponding to a cervical dilatation of > or =4 cm within 12 hours of removing the PGE2 pessary. The receiver operating characteristics (ROC) curves were also used to estimate an optimal cutoff point for the Bishop score, length, volume, and gray-scale histogram of the cervix. Logistic regression analysis was used for statistical analyses. RESULTS: The overall successful rate of labor induction was 73.2% (30/41). Multiple logistic regression analyses demonstrated that the value of anterior lip histogram was significantly associated with the successful labor induction. ROC curve for anterior lip histogram value in predicting success of induction indicated a significant relationship with successful induction. The best cutoff value was 69.4. CONCLUSION: The value of anterior lip histogram associates significantly with the prediction of successful induction in nulliparous women. But, Bishop score and other sonographic measurement of cervical length, volume, and posterior lip histogram have no predictive values for successful induction.
Cervix Uteri ; Dinoprostone ; Female ; Humans ; Labor Stage, First ; Lip ; Lipids ; Logistic Models ; Pessaries ; Pregnancy ; Prospective Studies ; Quaternary Ammonium Compounds ; ROC Curve

PURPOSE: The purpose of this study was to identify the risk factors for intrauterine fetal death (IUFD). METHODS: We carried out a case control retrospective study, at the Chonnam National University Hospital, Korea. We included all pregnant women diagnosed as singleton IUFD in pregnancies of 28 weeks of gestation or more, admitted to the hospital from Jan 2003 to Dec 2007. There were 53 cases of singleton IUFD and 3,298 cases of singleton live birth during that period. The incidence, age distribution, and prevalent gestational weeks were analysed. The risk factors were analyzed by using odds ratio, student's t test, and Chisquare test. Logistic regression analysis was applied to determine independent risk factors. RESULTS: The overall incidence of IUFD was 1.6%. The age distribution of mother with IUFD was highest in the age group of 20 year old or less (5.3%). IUFD was the most prevalent at 28-32 weeks of gestation (41.5%). Significant risk factors were maternal body weight just before delivery, weight gain during pregnancy, and abruptio placentae. The independent risk factors were weight gain during pregnancy (beta=0.002, P=0.000) and abruptio placentae (beta=-0.067, P=0.000). CONCLUSION: Lower maternal body weight just before delivery, lower weight gain during pregnancy, and abruptio placentae are factors significantly associated with IUFD. Further investigations are needed to understand the complex etiology of stillbirth.
Abruptio Placentae ; Age Distribution ; Body Weight ; Case-Control Studies ; Female ; Fetal Death ; Humans ; Incidence ; Korea ; Live Birth ; Logistic Models ; Mothers ; Odds Ratio ; Pregnancy ; Pregnant Women ; Retrospective Studies ; Risk Factors ; Stillbirth ; Weight Gain

BACKGROUND: To develop a rabbit epidural steroid injection (ESI) model for analyzing steroid retention in the tissue, and to assess the difference in steroid retention in the model according to the location and time elapsed after ESI. METHODS: Fluoroscopy-guided ESI was performed using the interlaminar approach between the lowest two lumbar segments in 13 female New Zealand white rabbits. Four rabbits were allocated to each of three different groups according to the time of sacrifice: 3, 7, and 15 days post-ESI; the remaining rabbit was sacrificed immediately post-ESI to obtain baseline data. After sacrifice, two segments were harvested: the lowest two lumbar vertebrae and another two lumbar vertebrae immediately above these. The residual steroid amount (RSA) and residual steroid concentration (RSC) in the collected spinal columns were analyzed. A linear mixed model was used to compare RSAs and RSCs between the injected and adjacent segments, and among the number of days until sacrifice; P < 0.05 was considered statistically significant. RESULTS: Both RSA and RSC of the injected segment were significantly higher than those of the adjacent segment (P < 0.001, both). The RSA and RSC significantly decreased over time (P = 0.009 and P = 0.016, respectively). CONCLUSIONS: The developed rabbit ESI model verified that significantly more steroid was retained at the injected segment than at the adjacent segment and the residual steroid decreased over time. This model could be useful not only for comparing current steroid medications, but also for developing new, better steroid formulations.
Female ; Fluoroscopy ; Humans ; Injections, Epidural ; Lumbar Vertebrae ; Models, Animal ; Rabbits ; Spine ; Steroids

OBJECTIVE: To evaluate obstetric variables in the placental abruption that affect on perinatal mortality. METHODS: We reviewed clinical data of all singleton deliveries complicated with placental abruption between January 2000 and December 2007, in Department of Ob. & Gyn., Sanggye Paik Hospital. RESULTS: Placental abruption complicated 54 cases (0.55%) of all deliveries (n=9,903) from January 2000 to December 2007. The peak age was 26-30 years (42.1%). The most common symptom was vaginal bleeding (57.4%) and intrauterine fetal death had already occurred in 9.3%. Perinatal mortality rate was 13.0% and there was no maternal death. 38.9% of placental abruption occurred between 33 to 36weeks of gestational age. 38.9% of placental abruption was diagnosed before delivery with ultrasonography and 9.3% was chronic placental abruption. 33.3% of placental abruption was associated with preeclampsia, and then associated with PPROM (24.1%), uterine myoma (3.7%), chronic hypertension (1.9%) and smoking (1.9%). When the hypertensive disorders were associated, fetal distress rate was higher than normotensive pregnancy (63.2% vs 20.0%, P-value: 0.005). Mean gestational age (days) (194+/-32.8 vs 248.12+/-28.0, P-value<0.001) and the severity of placental abruption (P-value: 0.005) affect perinatal mortality in placental abruption. The most common complication of placental abruption was DIC (16 cases, 29.6%), followed by Couvelaire uterus (4 cases, 7.4%) and uterine rupture (1 case, 1.9%). CONCLUSION: Obstetric variables that affect perinatal mortality were gestational age at the diagnosis and the severity of placental abruption.
Abruptio Placentae ; Dacarbazine ; Female ; Fetal Death ; Fetal Distress ; Gestational Age ; Hypertension ; Maternal Death ; Myoma ; Perinatal Mortality ; Pre-Eclampsia ; Pregnancy ; Smoke ; Smoking ; Uterine Hemorrhage ; Uterine Rupture ; Uterus