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NCT ID: NCT05770492 Recruiting - Clinical trials for Map Dot Fingerprint Dystrophy

Deep Learning Assisted Epithelial Basement Membrane Dystrophy Detection

Start date: February 27, 2023
Phase:
Study type: Observational

Epithelial basement membrane dystrophy, also known as Map-Dot fingerprint dystrophy or Cogan microcystic dystrophy, is a common bilateral dystrophy of the anterior human cornea. According to one study, it affects approximately 2% of the human population. A more recent study even reported basement membrane changes in 25% of the general population. However, due to its clinical and morphological appearance, the disease is probably often overlooked. Although epithelial basement membrane dystrophy is asymptomatic in many affected patients, there are some important clinical consequences of the disease to consider: Dystrophy is estimated to be the second most common cause of recurrent corneal erosion syndrome and is also an important differential diagnosis of dry eye disease. Therefore, it can cause severe pain in affected patients. In addition, epithelial basement membrane dystrophy plays an important role in the context of cataract surgery, one of the most commonly performed surgeries worldwide: besides the importance of appropriate disease management before surgery to prevent postoperative exacerbation of ocular surface symptoms, epithelial basement membrane dystrophy is also a risk factor for inaccurate preoperative biometry. In recent years, specific features of epithelial basement membrane dystrophy have been introduced in examination methods other than slit-lamp biomicroscopy, such as epithelial thickness mapping or optical coherence tomography. Due to the recent introduction of a variety of deep learning systems, the application of machine learning could significantly increase the detection rate for epithelial basement membrane dystrophy. Furthermore, to the best of our knowledge, the change in disease characteristics over time is currently unknown. Therefore, the first part of this study will investigate the ability of an automated deep learning system using optical coherence tomography scans to distinguish between normal human corneas and corneas affected by epithelial basement membrane dystrophy. For this purpose, 100 eyes of 50 patients will be included in both study groups. In an optional 2nd part of the study, a second visit will be planned in patients with epithelial basement membrane dystrophy to investigate the reproducibility of disease characteristics as a secondary outcome.

NCT ID: NCT05769543 Recruiting - Body Image Clinical Trials

WATSU and Body Awareness

IWOBA
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Body awareness (BA) is an essential factor for health and well-being. In 2021, the IOBA (Impact on Body Awareness) study was conducted at the Institute of Physical Medicine & Rehabilitation at Kepler University Hospital. Thereby, the impact of massage and of gymnastics on BA in healthy individuals was surveyed. The protocol provides a solid basis for further research projects on BA. In the present study, the direct effect of a WATSU® (Shiatsu in Water) application on BA as well as on the state of health of healthy persons will be determined and BA will be further investigated. In a randomized controlled study with 60 healthy adults in two groups (WATSU and control group), the use of the Awareness Body Chart (ABC) questionnaire and further German questionnaires (Short questionnaire on self-perception of the body, self-rating mood scale - revised) concerning body awareness and well-being should analyse the following hypothesis: There is a difference in the change of BA between the WATSU group and the control group. Before interventions demographic data and further questionnaires concerning health conditions of the participants (Simple Physical Activity Questionnaire, Short Form Health Survey, Brief Symptom Inventory, Like/Dislike Body Chart and additional questions) are administered. Correlations between BA and the results of these tests will be investigated too. All these analyses can provide innovative information about BA and be indicative in the use of physiotherapeutic measures.

NCT ID: NCT05764161 Recruiting - Prurigo Nodularis Clinical Trials

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

TRuE-PN2
Start date: June 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

NCT ID: NCT05754957 Recruiting - Clinical trials for Acute Coronary Syndrome

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

LIBREXIA-ACS
Start date: April 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

NCT ID: NCT05753995 Recruiting - Glioblastoma Clinical Trials

Immuno-Positron Emission Tomography (PET)-Glioma Study, a Proof-of-principle Imaging Study

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Imaging of proinflammatory activated microglia by Purine 2X7 (P2X7) receptor scintigraphy in Positron Emission Tomography (PET) scanner in Glioblastoma patients.

NCT ID: NCT05752812 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer

Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to validate a pretreatment prognostic score (Heidelberg Prognostic Pancreatic Cancer Score - HELPP) in patients with pancreatic ductal adenocarcinoma. The main questions it aims to answer are: - Is the HELPP score able to predict median overall survival in a prospective multi-institutional cohort of patients with pretherapeutic localized non-metastatic pancreatic cancer? - Is the HELPP score able to predict median recurrence-free survival and patterns of recurrence after resection of pancreatic cancer?

NCT ID: NCT05750173 Recruiting - Clinical trials for Transcatheter Aortic Valve Implantation (TAVI)

The EASE-IT CT Registry

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

NCT ID: NCT05750030 Recruiting - Clinical trials for Hepatocellular Carcinoma

FMT in IT-refractory HCC - FAB-HCC Pilot Study

Start date: May 16, 2023
Phase: Phase 2
Study type: Interventional

This single-center, pilot study (phase IIa) will evaluate the safety, feasibility, and efficacy of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to respond to atezolizumab/bevacizumab.

NCT ID: NCT05748483 Recruiting - Migraine Clinical Trials

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

TEMPLE
Start date: October 7, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

NCT ID: NCT05748171 Recruiting - Clinical trials for ACUTE LYMPHOBLASTIC LEUKEMIA

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

Start date: May 17, 2023
Phase: Phase 2
Study type: Interventional

This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.