- Urinary leakage measured by pad test in grams; time frame: within the day 2 or day 5 after the surgery for 24 hours<br/>
- toxic death or relevant grade 4 toxicity; time frame: up to 7 months; Relevant grade 4 toxicities are defined as ascites, adult respiratory distress syndrome, capillary leak syndrome, cytokine release syndrome, dyspnea, hypotension, motor neuropathy, sensory neuropathy.<br/>
- Ongoing Pregnancy Rate at the End of the Study; time frame: 10 weeks after treatment start<br/>
Induction of ventricular fibbrilation or ventricular tachycardia during treatment
- Change in Number of Urinary Urge Incontinence Episodes; time frame: Baseline, Week 2, Week 6, Week 12; Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.<br/>
- Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.; time frame: up to 54 months<br/>- Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).; time frame: up to 54 months<br/>
- Pregnancy rate; time frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)<br/>
- Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose; Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.<br/>
- Change in proportion of patients with Complete Response (CR) defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 during first cycle; time frame: 0 to 24 hours after T0; Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy<br/>
- Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.; time frame: any toxicities occurring within 90 days post radiation start<br/>
- Major Molecular response (MMR) rate; time frame: 12 months after first dose; To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)<br/>
- Ocular phenotype; time frame: patients will be followed longitudinally with an expected 1-year average interval between visits; Patients are investigated using a multimodal imaging approach and visual function testing.<br/>
- Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture; time frame: 12 months; Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.<br/>
- Overall survival; time frame: 36 months<br/>
- Overall Survival; time frame: Up to 60 months; Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.<br/>
- Change from Baseline in mean number of incontinence episodes per 24 hours; time frame: Baseline to end of treatment (12 weeks)<br/>
- Bone turnover assessed by bone turnover parameters; time frame: every 30 days<br/>
- Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival.; time frame: 3 years<br/>
- Ocular phenotype; time frame: patients will be followed longitudinally with an expected 1-year average interval between visits; Patients are investigated using a multimodal imaging approach and visual function testing.<br/>
- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period; time frame: Baseline and week 12 to 16<br/>
- 24-h Area under the Curve at steady state (AUCt,ss); time frame: Approximately 67 Days<br/>
- Overall survival at 3 years after inclusion; time frame: From inclusion until death from any cause or after 36 months, whichever comes first<br/>
- late toxicity; time frame: 24 months after therapy; measured from the first day of treatment<br/>
To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
survival free of amputation (after 4 weeks)
- Overall survival; time frame: up to 6 years<br/>
- To measure the plasma concentrations of POL7080; time frame: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion<br/>
- Median progression-free survival in routine clinical practice; time frame: approximately 7.5 years<br/>
- number of cumulus-oocyte-complexes; time frame: at the time of oocyte retrieval; the number of 'oocytes' obtained by transvaginal retrieval after ovarian stimulation<br/>
Difference in the T cell response of patients with sepsis, chronic tonsillitis and tonsil hyperplasia regarding activation, proliferation and apoptosis and thereby investigate the existence of T cell specific parameters to systemic and local inflammation
Progression-free survival within 2 years.
Non-inferiority of the annulus diameter measurement in the 3D TEE ultrasound vs MSCT (Multidetector computed tomography). The measurement of the diameter using 3D TEE and CT is performed before intervention.
Safety effectivity endpoint: Proportion of MACE (all- cause death or survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III)) within 30 days Copeptin vs. Control arm (non-inferiority).
Number and indication of pre-hospital TXA applications during the investigation period
1. Quality of life <br/>a) external assessment by the nursing staff at all four assessment points: mood, sleep quality, social participation (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), depressive symptoms (assessed with the Cornell Scale for Depression in Dementia, CSDD)<br/>b) Observation of behavior will be conducted three times during the intervention period using an adapted rating scale: emotional and motor changes (facial expression, body movement, other (positive) reactions), activation regarding social participation<br/>	<br/>2. Problem behavior: <br/>a) external assessment by the nursing staff at all four assessment points: resistance to care (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), problem behavior/behavioral syndromes (assessed with the Cohen-Mansfield Agitation Inventory (CMAI) and the Nurses Observation Scale for Geriatric Patients (NOSGER II)<br/>b) Observation of behavior (see above): appearance of problem behavior or other negative reactions<br/><br/>Assessment points: <br/>6 weeks before start of the intervention (T0) <br/>beginning of the intervention (T1)<br/>directly after the intervention (T2)<br/>follow-up  6 weeks after the end of the intervention (T3)<br/> <br/>
The primary outcome is the successful measurement of regional aortic stiffness in healthy volunteers and patients with the help of ultrasound elastograpyh. This is a feasibility study with the purpose of introducing a new diagnostic parameter.
Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month
Evaluation of the prevalence of a conincident outletimpingement in patients with calcifying tendinitis: - classification of the x-rays according to Bigliani, acromial index, acromial slope (Bigliani/Kitay) and lateral acromion angle -> definition of an outletimpingement as follows: Type II or III of the Bigliani classification; acromial slope >= 25,7%; acromial index >= 0,73; lateral acromial angle <= 83°. As we have to expect also suboptimal radiographs, e.g. for projection errors in limited recording condition (the patients participating in the study are not supposed to have extra x-rays done if an x-ray comes out as suboptimal), one fulfilled criteria of those mentioned above is sufficient for the definition of a radiological outletimpingement.<br/>- qualitative Rating of the intraoperative arthroscopic views of the subacromial space (view from lateral; evaluation of alignment of the acromial caudal surface compared with a shaver which is inserted from dorsally after cut of the coracoacromial Ligament): a parallel alignment means no impingement; a non-parallel alignment or nudging of the shaver to the caudal surface of the acromion is defined asl intraoperativ outletimpingement.
Effectiveness of bexarotene monotherapy in various defined CTCL subtypes
Comparison of the number of failures of the temporary restoration being made of Protemp  4 with the number of failures of temporary restorations being made of Luxatemp® Automix Plus (Reference data)
Leads the Matrixstimulation to a significant pain reduction compared to Baseline? Rating carried out in accordance of the Numeric Rating Scale (NRS)
Early performance success, defined as the rate of a successful placement of the device and successful closure of the defect without major complication until the day of discharge.
Concordance between current resistance analysis (evaluated by ultra deep sequencing from proviral DNA) and prior resistance pattern (historical test results)
Do the participants of the test group achieve better results (which means grades) than the control group or are there no differences?
Pulmonary embolism post operative during hospitalisation; diagnosis through clinic or ct-scan
standardized mortality ratio (i.e. ratio of actual to expected mortality) of patients with sepsis, severe sepsis and septic shock for each participating hospital, analysed every 3 months by §21-dataset
Number of injections of study drug during the first year of treatment<br/><br/>Mean change from baseline in BCVA at month 12 (visit 13)<br/>Visual acuity measured by ETDRS-charts
Incidence of drug-related hospital admissions
Knowledge about changes in well-being during an alcohol detoxification therapy by taking dietary-supportive supplement (Eusano formulation).<br/>The results will be obtained by using a questionnaire (Bf-SR '), which will be filled out by the patient only 5 times during the detoxification therapy.<br/>
incident daytime napping; incident sleep disturbances; trigger of acute myocardial infarction / of stroke
- Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review; time frame: Up to approximately 2 years<br/>- Overall Survival (OS); time frame: Up to approximately 39 months<br/>
The use of Klacid® will be documented in a high number of patients under conditions simulating practical use. Rare adverse effects shall be traced or previously known good tolerability of the drug shall be confirmed. An additional goal is to collect further data on efficacy and also the rapid onset of action.
Accuracy of analysis:  a comparison between manually analysed data and automotically generated data is being made. Apart from lung density, lung aereation, amount of overdistended lung tissue, amount of atelectatic lung areas and others are being compared.
Isoflavon plasma concentrations (LC-MS/MS), weekly
4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:<br/>Size of patellofemoral cartialge contact area will be determined using MRI at 0,10,20,30° of flexion.
- progression-free survival rate at 6 months; time frame: 6 months after study entry<br/>
Teamwork, measured by a questionnaire before and after the training (i.e. questionnaire on teamwork by Kauffeld)
To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by<br/>inspecting the bladder under white light first, followed by blue light. Diagnostic performance is confirmed by biopsy.
Maxima of flow and pressure: Comparison between manual and machine ventilation<br/>
Analysis of innate immune cells and inflammatory mediators after Alemtuzumab therapy <br/>(primary endpoint: macrophage populations, macrophage polarizations with immunohistochemistry and flow cytomerty,<br/>
10m Walking Test six months after end of the training period <br/><br/>
To assess the effect of 3% Polidocanol on pruritus induced by Mucuna pruriens (cowhage) by itch intensity (VAS) within 30 minutes after Mucuna application
Examination of differences in speech comprehension after 2-3 weeks adaptation(speech understanding in quiet by Freiburger words; speech understanding in noise by Oldenburger sentences)
Degree of disability after stroke assessed by modified Rankin Scale (mRS)  outcome at 90 days poststroke
Tolerable expiratory flow limitation, rated by the volunteer directly after the experiment.
Overall survival (OS) from the date of the first histological diagnosis until death or November 30, 2014 or lost to follow-up, whatever is earlier.
The study will cover various types of stress across lifespan, including occupational stress (Fragebogen zu Intensität und Tätigkeitsspielraum, FIT), stress-associated personality traits (EPQR-K, neuroticism), incriminating life events (Life Events Checklist (LEC), as well as neglect and abuse experiences childhood (Childhood Trauma Questionnaire; CTQ). Cognition at the time of completing the questionnaires is recorded using the Clinical Dementia Rating Scale (CDR), Shulman´s clock drawing test and Consortium to Establish a Registry for Alzheimer's Disease (CERAD). In addition, routine clinical data such as CSF-derived dementia markers are also used in the study.
Sensitivity and specificity of quantitative flow Ratio (QFR) according to instantaneous wave-free Ratio (iFR): Proportion of patients with positive/negative QFR and positive/negative iFR resp. (true positives/negatives) <br/><br/>Diagnostic performance of QFR in comparison to iFR reported as positive and negative likelihood ratio <br/><br/>Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to iFR<br/>
Skin transplant take rate 1 week after grafting, as well as after 6-12 months. Scar evaluation with POSAS scar scale and high resolution skin ultrasound examination
time till achiving walking ability (FAC 3): <br/>daily measurement before start of study therapy until discharge<br/><br/>mobility (FSS-ICU):<br/>before start of study therapy, directly after last study therapy unit and 3 weeks after the last examination
- Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters; time frame: up to 3 years<br/>
Primary endpoint is muscle power assessed by the Nottingham Power Rig at 15°C and 25°C and the correlation between the change of power, related to different environmental temperature, and muscle mass assessed by MRI.
- progression free survival  assessed as rate of patients without progression   Second malignancy or clinical progression - patients with unknown or missing PFS  will be treated as non-responder; time frame: 6 months<br/>
Primary outcome are the circadian variation measures of heart rate variability i.e. the rhythm adjusted mean (MESOR), Amplitude (Day-Night Difference) and Acrophase (Phase-Shift of amplitude) of RMSSD (root mean sum of squares of successive differences)
- The difference in event-free survival time will be compared between both arms; time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up<br/>
Reduction in the Liebowitz Social Anxiety Scale (LSAS; German version: Stangier & Heidenreich, 2005) between baseline and post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.
The incidence of adenoma and of CRC in study participants who undergo one of the proposed screening options will be measured in the context of this screening option. <br/>The incidence of adenoma and of CRC in study participants who do not participate in any screening measures and in those who do not participate in the program will be estimated based on administrative health records during the project period. The statistical analysis will take the difference in detection probabilities of adenoma and of CRC in the different groups in account. <br/>
- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period; time frame: Baseline and week 12 to 16<br/>
- Progression free survival; time frame: 3 years<br/>
To evaluate the efficacy of lenabasum compared to placebo in the treatment of diffuse cutaneous <br/>systemic sclerosis (SSc) by assessing change from baseline in the modified Rodnan skin score<br/>(mRSS) at Week 52.