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NCT ID: NCT04958044 Completed - Esophageal Cancer Clinical Trials

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer

Start date: May 25, 2021
Phase: Phase 1
Study type: Interventional

In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to tumor necrosis. It is hypothesized that: - Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer - CaEP debulks the tumor, facilitating the patient's ability to eat and drink In this single-arm pilot study, eight patients will be treated.

NCT ID: NCT04957667 Completed - Clinical trials for Hirschsprung Disease

Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population

Start date: February 1, 2020
Phase:
Study type: Observational

This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire.

NCT ID: NCT04956705 Completed - Aging Clinical Trials

Vitamin D and Calcium Supplementation at Danish Nursing Homes

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Nursing home residents are in high risk of vitamin D deficiency, which negatively affects bone health. Vitamin D and calcium supplements have shown to increase bone density and reduce fracture risk and may affect daily physical functioning. Therefore, The Danish Health Authority recommends all nursing home residents a daily supplement of 20 µg vitamin D and 800-1000 mg calcium. However, adherence to the recommendation is low. The present project hypothesizes that this low adherence results in a high number of residents with a deficient or insufficient vitamin D status, and that daily physical functioning can be improved or maintained by an improved adherence to the recommendation.

NCT ID: NCT04949867 Completed - Type 1 Diabetes Clinical Trials

Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes

DHCL2021
Start date: May 20, 2021
Phase: Phase 4
Study type: Interventional

Objective: To assess the efficacy and safety of an insulin-glucagon dual-hormone (DH) closed-loop system compared with an insulin-only single-hormone (SH) closed-loop system in adolescent with type 1 diabetes. Methods: In a 26-h, randomized, crossover, inpatient study, 20 children and adolescents with type 1 diabetes used two modes of the DiaCon Artificial Pancreas system: DH and SH closed-loop control. During each study period, participants will have one overnight stay, received three meals and performed exercise for 45 min (bicycle with estimated 50% V02max). Endpoint: The primary endpoint is sensor-derived percentage of time in hypoglycemia (<3.9 mmol/L).

NCT ID: NCT04949841 Completed - Chronic Hand Eczema Clinical Trials

Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

DELTA3
Start date: August 23, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib. Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

NCT ID: NCT04949048 Completed - Pulmonary Embolism Clinical Trials

Evaluation of the Safety and Performance of Magneto PE Kit

Start date: August 26, 2021
Phase: N/A
Study type: Interventional

This study is designed as a prospective, multi-center, multinational open labeled, single armed study to evaluate the safety and performance of the Magneto PE Kit.

NCT ID: NCT04948892 Completed - Cesarean Section Clinical Trials

Presence of the Father During Hyperacute Cesarean Section in General Anesthesia

Start date: January 1, 2022
Phase:
Study type: Observational

This study concerns cesarean sections, category 1, meaning those cases where the life of mother and/or fetus is in immedeate danger and the child must be delivered within 15 minutes from activating the cesarean section team. In most hospitals in Denmark, these cesarean sections are most often performed in general anesthesia and the mother is endotracheally intubated. Previously in these situations, as the mother was rushed from the Labour Ward to the operation room (OR), her spouse/partner, would be placed outside the operating room (OR), and would stay there until the child had been delivered. In Lillebaelt Hospital, Kolding, Denmark, the newborn-resuscitation table is placed inside the OR. The father would most often be allowed to enter the OR when the child was delivered and placed on the resuscitation table (no matter the status of the child). However, during spring 2021, Lillebaelt Hospital Kolding updated the policy regarding the handling of the father/partner during cesarean section category 1. Now the father/partner is present in the OR during the whole procedure, including induction of general aesthesia, endotracheal intubation, performance of the cesarean section (drapings are positioned so that the father cannot see the operation field) and potential resuscitation efforts of the newborn. In another hospital in the same region (Region of Southern Denmark), Aabenraa Hospital, the father is not present in the OR during the cesarean section. He waits in the labour ward. The investigators therefore wish to investigate how the cesarean section category 1 is experienced by: the father/partner; the mother; the obstetrician; the anestesiologist; the midwife; the OR nurse; the anesthetic nurse, both in Kolding where the father/partner is present in the OR, and in Aabenraa, where the father/partner is not present in the OR during the cesarean sectio.

NCT ID: NCT04946838 Completed - Labor Pain Clinical Trials

Transcutaneous Electrical Nerve Stimulation for Labor Pain Control in Combination With Cardiotocography

Start date: July 9, 2021
Phase: N/A
Study type: Interventional

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. It is aimed to investigate TENS1 alternating between 4 to 100 Hz compared to sham-TENS. The present study aims to evaluate TENS in combination with cardiotocography (CTG). The combination of TENS with CTG in a feedback-loop has not been reported in any studies before.

NCT ID: NCT04945486 Completed - Clinical trials for Ischemic Heart Disease

The Effect of Peer-mentor Support for Older Vulnerable Patients With Ischemic Heart Disease

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older Ischemic Heart Disease (IHD) population in need of cardiac rehabilitation (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established; CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life among patients with IHD. These positive effects of CR has also been established among older patients. The inherent problem lies in the low attendance rate, often below 50%. Several studies, including studies from Denmark, have shown that low participation in CR is most prevalent among older, vulnerable and female patients. The notion vulnerable covers patients with low socioeconomic position (SEP), patients with non-western background and patients living alone, as these groups have particularly low CR attendance. Effective interventions aiming at increasing CR attendance among these low attending groups are thus warranted and the current study will seek to address this. AIM: To test the effect of a peer-mentor intervention among older vulnerable IHD patients. DESIGN AND METHODS: The study is designed as a two arm RCT-study applying mixed methods. Power calculations were based upon primary outcome 'Cardiac rehabilitation (CR) attendance'. Proportion attending CR in control group was set at 25% and intervention group at 50% based upon previous research. With a 5% significance level and 80% power. 110 patients were required (55 in each group) to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 25% in the control group to 50% in the experimental group. Expected dropout was 6%. I.e., in total 117 patients are enrolled. Patients (n=117) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital and randomized (with 1:1 individual randomisation) to peer-mentor intervention or usual care. Data is collected through both qualitative and quantitative data (mixed methods). Data is collected at three timepoints, baseline, 12 weeks and 24 weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring by a person with a similar life situation or health problem as one self) is a low-cost intervention that holds the potential to improve CR attendance and improve physical and psychological outcomes among older patients. Peer-mentors are role models who can guide and support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR setting among older, female and vulnerable IHD patients; establishing the novelty of the current study.

NCT ID: NCT04940377 Completed - Clinical trials for Venous Thromboembolism

Effect of the Genotype on Postoperative DVT

Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

Postoperative Venous Thromboembolism Events (VTE) constitute a major source of morbidity and mortality after surgery. The aim of this study was to investigate whether commonly occurring Single Nucleotide Polymorphisms (SNPs) are associated with VTE in the surgical setting.