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  • Stepcare Extended Follow-up Substudy

    This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management. Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study. Participants will be followed up at 6 and 12 months. The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    Region Skane

    Tubingen

    Recruiting

  • The NEU-STIM Trial

    Rationale: A randomised study demonstrated that preterm infants who received repetitive stimulation at birth (10 second episodes of stroking of the soles of the feet and/or back, followed by 10 seconds rest) showed an increase in respiratory effort. This may in turn improve clinical outcomes as improved breathing effort may reduce the need for invasive respiratory support. Tactile stimulation can be immediately and easily performed at birth at no extra cost. It therefore has great potential to be implemented in delivery rooms (DRs) worldwide. Objective: To determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Study design: This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation. Study population: Infants born before 32 weeks of gestation will be included in this trial. Intervention: At the start of the study, each participating centre will perform selective tactile stimulation in accordance with international guidelines, as is their usual practice. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. In the second stage of the study, centres will be randomised to switch their stimulation approach to repetitive stimulation. Clinicians will then gently rub the back, chest, extremities or soles of the feet for 10 seconds. To avoid extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds of rest (no stimulation). Repetitive stimulation will be performed for the first 5 minutes of life, or longer if the breathing is still considered insufficient or absent. Main study parameter: The proportion of infants with pre-ductal oxygen saturation (SpO2) ≥ 80%.

    Phase

    N/A

    Span

    95 weeks

    Sponsor

    Leiden University Medical Center

    Tubingen

    Recruiting

  • A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

    Phase

    N/A

    Span

    337 weeks

    Sponsor

    Janssen Pharmaceutica N.V., Belgium

    Tubingen

    Recruiting

  • Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies

    This is a multi-center study to identify biomarkers or marker combinations for early prediction of pregnancy complications in twin pregnancies in the first, second or third trimester. In the future, the identified patients' risk will enable patients' referrals for proper prevention when such will become available Specifically the investigators aim for - Predicting the risk to develop preeclampsia, IUGR, preterm delivery, gestational Diabetes Melitus - Assessment of major and minor markers for chromosomal and structural anomalies - Identification of placenta accrete spectrum disorders and vasa previa - Diagnosis of specific MC twin complications such as TTTS The investigators will stratify and assess all the above according to chorionicity and delivery with complications at <32 weeks, <34 weeks, <37 weeks, and at any gestation. Screening methods will be conducted in the first, second or third trimester or at any gestation Also the investigators aim to Identify the risk to lose one or both twins at <32 weeks, <34 weeks, <37 weeks and at any gestation, the ability to predict fetal birth weight at <32 weeks, <34 weeks, <37 weeks and at any gestation The investigators also aim for monitoring any of the following maternal complications including placental abruption (clinically or on placental examination), postpartum hemorrhage (defined as blood loss ≥1 L within the first 24 hours after birth) at <32 weeks, <34 weeks, <37 weeks and at any gestation. The investigators will monitor 1. Neonatal morbidity due to intraventricular hemorrhage (IVH) grade II or above - Defined as bleeding into the ventricles, Grade II (moderate) - IVH occupies <50% of the lateral ventricle volume, Grade III (severe) - IVH occupies ≥50% of the lateral ventricle volume or Grade IV (severe) - Hemorrhagic infarction in periventricular white matter ipsilateral to a large IVH 2. Neonatal sepsis confirmed bacteremia in cultures, anemia defined as low Hemoglobin and / or hematocrit requiring blood transfusion, respiratory distress syndrome defined as need for treatment by surfactant and ventilation, necrotizing enterocolitis requiring surgical intervention, and composite of any of the above 3. Newborn admission to neonatal intensive care units (NICU), length of stay and therapies during the admission. 4. Ventilation defined as a need for a positive pressure (continuous positive airway pressure (CPAP), nasal continuous positive airway pressure (NCPAP)) or intubation and a composite of any of the above 5. Any maternal complications within the first 6-10 weeks post delivery. The investigators will recruit patients in the different sites aiming for 1200 twin pregnancy and will collect the patients' entire pregnancy data for developing an algorithm to calculate the risk to develop the complications 6. Evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.

    Phase

    N/A

    Span

    158 weeks

    Sponsor

    Assaf-Harofeh Medical Center

    Tubingen

    Recruiting

    Healthy Volunteers

  • Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons

    The hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. With an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. With an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. As randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. Stratification criteria will include: Age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. Comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.

    Phase

    N/A

    Span

    496 weeks

    Sponsor

    Technische Universität Dresden

    Tubingen

    Recruiting

  • Effects of tDCS-enhanced Cognitive Control Training on Depression

    Phase

    N/A

    Span

    94 weeks

    Sponsor

    University Hospital Tuebingen

    Tubingen, Baden-Württemberg

    Recruiting

  • Next Generation Sequencing Diagnostics - On the Road to Rapid Diagnostics for Rare Diseases

    In the study NextGen SE (single-center, prospective, open diagnostic study) are on-hand a cohort comprising each 50 pediatric and 50 adult patients, and in which there are an unclear movement disorder or an unclear cognitive disorder, examines the following questions: Primary: - Number of diagnoses made by next-generation sequencing (NGS) Secondary: 1. Restriction of the quality of life by unclear disease 2. Cost of not purposeful preliminary diagnostics (beyond the minimal diagnostic data of the diagnosis to therapy and follow-up examinations 3. Time to diagnosis

    Phase

    N/A

    Span

    409 weeks

    Sponsor

    University Hospital Tuebingen

    Tubingen, Baden-Württemberg

    Recruiting

  • Product Surveillance Registry

    Phase

    N/A

    Span

    1466 weeks

    Sponsor

    Medtronic

    Tubingen

    Recruiting

  • Post-Market Clinical Follow-Up onTVT EXACT® Continence System

    Phase

    N/A

    Span

    764 weeks

    Sponsor

    Ethicon, Inc.

    Tubingen

    Recruiting

  • Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

    Phase

    N/A

    Span

    751 weeks

    Sponsor

    Ethicon, Inc.

    Tubingen

    Recruiting

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