nils-herrmann/clean_scirepeval huggingface dataset:
Unerwünschte Therapiewirkungen bei verhaltenstherapeutischer Gruppentherapie

Psychotherapie hat nicht nur positive, sondern auch negative Wirkungen. Dies gilt insbesondere für Gruppenpsychotherapie, wegen der zusätzlichen gruppendynamischen und interaktionellen Prozesse. Anhand des UE-G-Fragebogens haben 71 Patienten berichtet, welche Negativerfahrungen sie während einer verhaltenstherapeutischen Gruppentherapie gemacht haben. Die Fragebogenantworten wurden zusätzlich durch ein qualitatives Interview während der Gruppensitzung validiert. Über mindestens eine Negativerfahrung berichteten 98,6 % der Patienten und 43,7 % über mindestens ein stark bzw. extrem belastendes Negativereignis. Am häufigsten sind die Induktion von Hoffnungslosigkeit und Demoralisierung durch das, was sie bei anderen Patienten während der Gruppentherapie sehen oder hören. Belastende und damit unerwünschte Erfahrungen sind bei Gruppentherapie regelhaft zu erwarten. Negativerleben kann therapie- sowie patientenbedingt sein. In jedem Fall sind unerwünschte Begleitwirkungen bei der Gruppentherapiedurchführung, bei der Schulung von Gruppentherapeuten und in der Qualitätssicherung zu beachten. Psychotherapy not only has positive but also negative effects, which is especially true for group psychotherapy due to psychodynamic and interactional processes. Using the UE-G questionnaire 71 patients who participated in cognitive behavioral group psychotherapy reported on negative experiences in the context of the group therapy. The answers were then validated in a qualitative interview. Of the patients 98.6 % reported about at least one negative experience and 43.7 % about severe or extremely severe negative experiences. Most prominent was the induction of hopelessness and demoralization by what patients saw and heard from other patients in the group. Burdensome and therefore undesired treatment effects are regularly seen in group psychotherapy, because of treatment or patient related factors. In any case they must be taken into account during treatment, in the training of group psychotherapists and in quality control.
Phase I clinical, pharmacokinetic and pharmacodynamic study of SB939, an oral histone deacetylase (HDAC) inhibitor, in patients with advanced solid tumours

SB939 is an orally available, competitive histone deacetylase (HDAC) inhibitor selective for class I, II and IV histone deacetylases. Preclinical evaluation of SB939 revealed a profile suggesting improved efficacy compared to other HDAC inhibitors. This phase I study was carried out to determine the safety, dose-limiting toxicity, recommended phase II dose (RPTD), as well as pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SB939 in a daily × 5 schedule in advanced solid tumours.Sequential dose-escalating cohorts of patients were enrolled into 8 dose levels. At dose level 1, SB939 was taken on days 1–3 and 15–17 every 4 weeks, then on days 1–5 and 15–19 for other dose levels. Detailed PK sampling was performed in cycle 1, days 1 and 5. Peripheral blood mononuclear cells (PBMCs) were collected on cycle 1 at various time points for determination of acetylated histone H3 (AcH3) levels.In total, 38 patients received a total of 96 cycles of treatment. The maximal administered dose was 90 mg and the RPTD was 60 mg given 5 consecutive days every 2 weeks. The most frequent non-hematologic adverse events (AEs) of at least possible attribution to SB939 were fatigue, nausea, vomiting, anorexia and diarrhoea. Pharmacokinetic analysis showed dose-proportional increases in AUC across the doses evaluated. Elimination half-life was 5.6–8.9 h. There was no clear relationship between AcH3 changes and dose level or anti-tumour response.SB939 is well tolerated in patients with advanced solid tumours. The RPTD of this drug is 60 mg on a schedule of 5 consecutive days every 2 weeks. The toxicities of SB939 are consistent with other HDAC inhibitors.
Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors lower glycemia by enhancing urinary glucose excretion. The physiologic response to pharmacologically induced acute or chronic glycosuria has not been investigated in human diabetes.



We evaluated 66 patients with type 2 diabetes (62 ± 7 years, BMI = 31.6 ± 4.6 kg/m(2), HbA1c = 55 ± 8 mmol/mol, mean ± SD) at baseline, after a single dose, and following 4-week treatment with empagliflozin (25 mg). At each time point, patients received a mixed meal coupled with dual-tracer glucose administration and indirect calorimetry.



Both single-dose and chronic empagliflozin treatment caused glycosuria during fasting (median, 7.8 [interquartile range {IQR}, 4.4] g/3 hours and 9.2 [IQR, 5.2] g/3 hours) and after meal ingestion (median, 29.0 [IQR, 12.5] g/5 hours and 28.2 [IQR, 15.4] g/5 hours). After 3 hours of fasting, endogenous glucose production (EGP) was increased 25%, while glycemia was 0.9 ± 0.7 mmol/l lower (P < 0.0001 vs. baseline). After meal ingestion, glucose and insulin AUC decreased, whereas the glucagon response increased (all P < 0.001). While oral glucose appearance was unchanged, EGP was increased (median, 40 [IQR, 14] g and 37 [IQR, 11] g vs. 34 [IQR, 11] g, both P < 0.01). Tissue glucose disposal was reduced (median, 75 [IQR, 16] g and 70 [IQR, 21] g vs. 93 [IQR, 18] g, P < 0.0001), due to a decrease in both glucose oxidation and nonoxidative glucose disposal, with a concomitant rise in lipid oxidation after chronic administration (all P < 0.01). β Cell glucose sensitivity increased (median, 55 [IQR, 35] pmol • min(-1) • m(-2) • mM(-1) and 55 [IQR, 39] pmol • min(-1) • m(-2) • mM(-1) vs. 44 [IQR, 32] pmol • min(-1) • m(-2) • mM(-1), P < 0.0001), and insulin sensitivity was improved. Resting energy expenditure rates and those after meal ingestion were unchanged.



In patients with type 2 diabetes, empagliflozin-induced glycosuria improved β cell function and insulin sensitivity, despite the fall in insulin secretion and tissue glucose disposal and the rise in EGP after one dose, thereby lowering fasting and postprandial glycemia. Chronic dosing shifted substrate utilization from carbohydrate to lipid.
A randomized clinical trial with two doses of a omega 3 fatty acids oral and arginine enhanced formula in clinical and biochemical parameters of head and neck cancer ambulatory patients.

Postsurgical patients with head and neck cancer could have a high rate of ambulatory complications. The aim was to investigate whether oral ambulatory nutrition of head and neck cancer patients with recent weight loss, using two different doses of an omega 3 fatty acids and arginine enhanced diets could improve nutritional parameters.



At Hospital discharge post surgical head and neck cancer patients (n=37) were asked to consume two or three cans per day of a designed omega 3 fatty acid and arginine enhanced supplement for a twelve week period.



Albumin, prealbumin, transferrin and lymphocytes levels improved in both groups. Weight, fat mass and fat free mass improved during supplementation in group II (3 bricks per day). No differences were detected in anthropometric parameters in group I. Gastrointestinal tolerance with both formulas was good, no episodes were reported. There are no differences between both formulas on postsurgical complications rates.



Omega 3 and arginine enhanced formulas improved blood protein concentrations and lymphocyte levels in ambulatory postoperative head and neck cancer patients. A high dose of arginine and omega 3 fatty acids formula improved weight, too.
PREFERE – die Deutsche Prostatakrebsstudie

Bei der PREFERE-Studie handelt es sich um eine multizentrische randomisierte Studie für Patienten mit einem Prostatakarzinom niedrigen oder frühen intermediären Risikos. Dabei werden die vier nach der deutschen S3-Leitlinie und den internationalen Leitlinien empfohlenen Behandlungsoptionen „radikale Prostatektomie, perkutane Strahlentherapie, permanente Seedimplantation und aktive Überwachung“ auf ihre Effektivität, aber auch ihre potentiellen Nebenwirkungen geprüft und verglichen. In 4 Jahren sollen 7600 Patienten rekrutiert werden. Ihnen wird nach ihrer persönlichen Präferenz (d. h. Ausschluss von einer oder zwei Therapieoptionen) in einem 2- bis 4-armigen Studiendesign per Randomisation eine der oben genannten Therapieformen zugeteilt. The PREFERE study is a multicenter randomized study of patients with low or early intermediate risk for prostatic cancer. The four treatment options, radical prostatectomy, percutaneous irradiation therapy, permanent seed implantation and active surveillance recommended by the German S3 guidelines and international guidelines will be tested and compared with respect to effectiveness and potential side effects. Over a period of 4 years a total of 7,600 patients are to be recruited and assigned to 1 of these 4 therapy forms according to personal preference (by possible exclusion of 1 or 2 therapy options) in a 2-4 arm study design by randomization.
Safety and efficacy of 4-aminopyridine in humans with spinal cord injury: a long-term, controlled trial.

To determine the effects of the long-term administration of 4-aminopyridine (4-AP) on sensorimotor function in humans with long-standing spinal cord injury (SCI).



Randomized, open-label, active-treatment control, dosage-blinded study.



University-affiliated, tertiary-level care, Department of Veterans Affairs Medical Center.



Twenty-one healthy men and women outpatients suffering from traumatic SCI (14 tetraplegic, 7 paraplegic) for 2 years or more.



Dosages of an immediate-release formulation of 4-AP were titrated. At 3 months, 16 subjects were receiving 4-AP 30 mg/day (high dose); 5 subjects were receiving 4-AP 6 mg/day (low dose) and served as an active-treatment control group.



Composite motor and sensory scores had statistically significant increases at 3 months. Maximal expiratory pressure, maximal inspiratory pressure, forced vital capacity, and forced expiratory volume in 1 second showed clinically meaningful and/or statistically significant increases among patients receiving 4-AP 30 mg/day. These subjects also had significant decreases in spasticity (modified Ashworth Scale). Serial biochemical profiles and electroencephalographs were unchanged from baseline, and no clinically significant drug toxicity was encountered.



Long-term oral administration of immediate-release 4-AP was associated with improvement in and recovery of sensory and motor function, enhanced pulmonary function, and diminished spasticity in patients with long-standing SCI. 4-Aminopyridine appears to be safe and relatively free from toxicity when administered orally over 3 months. Each patient who received immediate-release 4-AP 30 mg/day showed a response in one or more of the outcome measures.
Resting leukocyte telomerase activity is elevated in major depression and predicts treatment response

Telomeres are DNA-protein complexes that cap linear DNA strands, protecting DNA from damage. When telomeres critically shorten, cells become susceptible to senescence and apoptosis. Telomerase, a cellular ribonucleoprotein enzyme, rebuilds the length of telomeres and promotes cellular viability. Leukocyte telomeres are reportedly shortened in major depression, but telomerase activity in depression has not been previously reported. Further, there are no published reports of the effects of antidepressants on telomerase activity or on the relationship between telomerase activity and antidepressant response. Peripheral blood mononuclear cell (PBMC) telomerase activity was assessed in 20 medication-free depressed individuals and 18 controls. In total, 16 of the depressed individuals were then treated with sertraline in an open-label manner for 8 weeks, and PBMC telomerase activity was reassessed in 15 of these individuals after treatment. Pre- and post-treatment symptom severity was rated with the Hamilton Depression Rating Scale. All analyses were corrected for age and sex. Pre-treatment telomerase activity was significantly elevated in the depressed individuals compared with the controls (P=0.007) and was directly correlated with depression ratings (P<0.05) across all subjects. In the depressed group, individuals with relatively lower pre-treatment telomerase activity and with relatively greater increase in telomerase activity during treatment, showed superior antidepressant responses (P<0.05 and P<0.005, respectively). This is the first report characterizing telomerase activity in depressed individuals. PBMC telomerase activity might reflect a novel aspect of depressive pathophysiology and might represent a novel biomarker of antidepressant responsiveness.
Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial

Endovascular infrapopliteal treatment of patients with critical limb ischemia using percutaneous transluminal angioplasty (PTA) and bail-out bare metal stenting (BMS) is hampered by restenosis. In interventional cardiology, drug-eluting stents (DES) have shown better patency rates and are standard practice nowadays. An investigator-initiated, multicenter, randomized trial was conducted to assess whether DES also improve patency and clinical outcome of infrapopliteal lesions.



Adults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA±BMS or DES with paclitaxel. Primary end point was 6-month primary binary patency of treated lesions, defined as ≤50% stenosis on computed tomographic angiography. Stenosis >50%, retreatment, major amputation, and critical limb ischemia-related death were regarded as treatment failure. Severity of failure was assessed with an ordinal score, ranging from vessel stenosis through occlusion to the clinical failures. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) received PTA±BMS. Six-month patency rates were 48.0% for DES and 35.1% for PTA±BMS (P=0.096) in the modified-intention-to-treat and 51.9% and 35.1% (P=0.037) in the per-protocol analysis. The ordinal score showed significantly worse treatment failure for PTA±BMS versus DES (P=0.041). The observed major amputation rate remained lower in the DES group until 2 years post-treatment, with a trend toward significance (P=0.066). Less minor amputations occurred after DES until 6 months post-treatment (P=0.03).



In patients with critical limb ischemia caused by infrapopliteal lesions, DES provide better 6-month patency rates and less amputations after 6 and 12 months compared with PTA±BMS.
Photodynamic therapy outcome for T1/T2 N0 oral squamous cell carcinoma.

This new prospective clinical study assessed the oncological outcomes following surface illumination mTHPC-photodynamic therapy of T1/T2 N0 oral squamous cell carcinoma (OSCC) patients.



Thirty-eight patients participated in this study. Their mean age at the first diagnosis of OSCC was 58.0 years. Common clinical presentation was an ulcer mainly identified in the tongue, floor of mouth (FOM), or buccal mucosa. Current and ex-smokers represented 89.5% of the cohort; while current and ex-drinkers were 86.8%. Clinically nine patients had T1 disease while 29 had T2 disease.



Pathological analysis revealed that 12 patients had well differentiated SCC, 16 moderately differentiated and 10 had poorly-differentiated cancer. All patients were discussed in a multidisciplinary meeting and, subsequently, underwent mTHPC-PDT. PDT was repeated in 6- to 7-month period following the first round when residual tumor was identified in the treated site. At last clinic review post-PDT, 26/38 patients showed complete normal clinical appearance of their oral mucosa in the primary tumor site. Recent surgical biopsies from the study cohort showed that 17 had normal mucosa, five with hyperkeratinization, 10 with dysplastic changes and six showed recurrent SCC. The overall recurrence was 15.8% and the 5-year survival was 84.2%. Death from loco-regional and distant disease spread was identified in three patients. The recurrence group comprised six patients. Most common presentation was an ulcer involving the buccal mucosa or retromolar area, identified in current or ex-smokers and current drinkers. The surgical margins in this group were also evaluated following laser or surgical excision and reconstruction.



mTHPC-photodynamic therapy (up to three rounds) is a comparable modality to other traditional interventions in the management of low-risk tumors of the oral cavity. Although, sometimes, multiple rounds of the treatment is required, morbidity following PDT is far less when compared to the three conventional modalities: surgery, radiotherapy, and chemotherapy.
Substance or style? An investigation of the NEO-PI-R validity scales.

The Revised NEO Personality Inventory (NEO-PI-R; Costa & McCrae, 1992b) has been criticized for the absence of validity scales designed to detect response distortion. Recently, validity scales were developed from the items of the NEO-PI-R (Schinka, Kinder, & Kremer, 1997) and several studies have used a variety of methods to test their use. However, it is controversial whether these scales are measuring something that is substantive (such as psychopathology or its absence) or stylistic (which might be effortful distortion or less conscious processes such as lack of insight). In this study, we used a multimethod-multitrait approach to examine the validity of these scales in a clinical sample of 668 participants diagnosed with personality disorders or major depression. Using various indicators of both stylistic and substantive variance, confirmatory factor analyses (CFA) suggested that these validity scales measure something that may be conceptually distinct from, yet highly related to, substantive variance in responding.
CA-125 can be part of the tumour evaluation criteria in ovarian cancer trials: experience of the GCIG CALYPSO trial

CA-125 as a tumour progression criterion in relapsing ovarian cancer (ROC) trials remains controversial. CALYPSO is a large randomised trial incorporating CA-125 (GCIG criteria) and symptomatic deterioration in addition to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (radiological) to determine progression.In all, 976 patients with platinum-sensitive ROC were randomised to carboplatin–paclitaxel (C-P) or carboplatin-pegylated liposomal doxorubicin (C-PLD). CT-scan and CA-125 were performed every 3 months until progression.In all, 832 patients (85%) progressed, with 60% experiencing a first radiological progression, 10% symptomatic progression, and 28% CA-125 progression without evidence of radiological or symptomatic progression. The benefit of C-PLD vs C-P in progression-free survival was not influenced by type of first progression (hazard ratio 0.85 (95% confidence interval (CI): 0.66–1.10) and 0.84 (95% CI: 0.72–0.98) for CA-125 and RECIST, respectively). In patients with CA-125 first progression who subsequently progressed radiologically, a delay of 2.3 months was observed between the two progression types. After CA-125 first progression, median time to new treatment was 2.0 months. In all, 81%of the patients with CA-125 or radiological first progression and 60% with symptomatic first progression received subsequent treatment.CA-125 and radiological tests performed similarly in determining progression with C-PLD or C-P. Additional follow-up with CA-125 measurements was not associated with overtreatment.
The influence of BASIC on performance in introductory computer science courses using Pascal

Results are presented testing the hypothesis that knowledge of BASIC has a positive effect on performance in introductory Pascal courses. During the Fall 1985 term, two computer science courses were surveyed at the University of Illinois, and students' final course grades were analyzed based on their programming background. In CS 121 surveys were given out in both lecture sections, with students being expected to mail surveys back on their own. The largest lecture section of five was surveyed for CS 105. The surveys were distributed to students and collected at the end of class. The data for the course for computer science majors (CS 121, which is a requirement) show no grade differences based on prior background. The data for the course for non-majors (CS 105, which is only required for finance majors and is an alternate choice for a few others) show significantly higher grades for students with background in BASIC in comparison to students with no programming background.
The Emotional Reactions to Challenging Behavior Scale-Korean (ERCBS-K): modification and validation.

The purpose of this study was to explore the original version of Mitchell and Hastings's (1998) Emotional Reaction to Challenging Behavior Scale (ERCBS) and estimate validity and reliability of a revised version containing 29 items. The Emotional Reaction to Challenging Behavior Scale-Korean (ERCBS-K) was studied using 445 in-service physical educators (228 females; 217 males). Data were collected using onsite administration as well as mail survey administration procedures. Confirmatory and exploratory factor analyses results supported a five-factor, 28-item scale ERCBS-K. Acceptable internal consistency coefficients were found for each of the subscales of the ERCBS-K (Cronbach's alpha ranged from 0.71 to 0.87).
Results of a phase II placebo-controlled randomized trial of minocycline in acute spinal cord injury.

Preclinical studies have attributed neuroprotective properties to the antibiotic minocycline. Animal studies and early clinical trials support its use in several neurological diseases. In animal spinal cord injury models, minocycline improved neurological and histological outcomes, reduced neuronal and oligodendroglial apoptosis, decreased microglial activation and reduced inflammation. A single-centre, human, double-blind, randomized, placebo-controlled study of minocycline administration after spinal cord injury was undertaken for the purposes of dose optimization, safety assessment and to estimate outcome changes and variance. Neurological, functional, pharmacological and adverse event outcomes were compared between subjects administered 7 days of intravenous minocycline (n = 27) or placebo (n = 25) after acute traumatic spinal cord injury. The secondary outcome used to assess neurological differences between groups that may warrant further investigation was motor recovery over 1 year using the American Spinal Cord Injury Association examination. Recruitment and analyses were stratified by injury severity and injury location a priori given the expected influence of these on the sensitivity of the motor exam. Minocycline administered at higher than previously reported human doses produced steady-state concentrations of 12.7 µg/ml (95% confidence interval 11.6-13.8) in serum and 2.3 µg/ml (95% confidence interval 2.1-2.5) in cerebrospinal fluid, mimicking efficacious serum levels measured in animal studies. Transient elevation of serum liver enzymes in one patient was the only adverse event likely related to the study drug. Overall, patients treated with minocycline experienced six points greater motor recovery than those receiving placebo (95% confidence interval -3 to 14; P = 0.20, n = 44). No difference in recovery was observed for thoracic spinal cord injury (n = 16). A difference of 14 motor points that approached significance was observed in patients with cervical injury (95% confidence interval 0-28; P = 0.05, n = 25). Patients with cervical motor-incomplete injury may have experienced a larger difference (results not statistically significant, n = 9). Functional outcomes exhibited differences that lacked statistical significance but that may be suggestive of improvement in patients receiving the study drug. The minocycline regimen established in this study proved feasible, safe and was associated with a tendency towards improvement across several outcome measures. Although this study does not establish the efficacy of minocycline in spinal cord injury the findings are encouraging and warrant further investigation in a multi-centre phase III trial. ClinicalTrials.gov number NCT00559494.