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NCT ID: NCT04838600 Terminated - Chronic Leg Ulcer Clinical Trials

A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®

ChloraSolv02
Start date: June 7, 2021
Phase:
Study type: Observational

This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users. Approximately 65 subjects will be enrolled (calculated dropout range 20%) from at least 6-12 sites in Sweden. Subjects presented with chronic leg ulcers and chronic diabetic foot ulcers in need of debridement will be enrolled and receive application of ChloraSolv per clinical routine at treating site and in accordance with the ChloraSolv Instruction for Use for up to 24 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. There will be two follow up visits in the investigation. The first follow up visit will take place at End of Treatment, as based on investigator judgement and clinical routine at the treating site, maximum 24 weeks post baseline per the IFU. After End of Treatment, subjects will continue in the investigation with wound management per clinical routine at the treating sites for 6 weeks. At 6 weeks post End of Treatment, subjects will attend a Follow-up visit to assess safety, wound status and relative change in wound size. Besides confirmation of the clinical performance and safety when used in a larger population the investigation also includes analysis of treatment period duration. Additionally, health economy parameters will be analyzed. The investigation will be monitored to confirm the already known precautions as well as identify new precautions and possible contraindications for the use of the device. Photography of the wound pre and post debridement will be performed to confirm wound size and amount of devitalized tissue in the wound.

NCT ID: NCT04826874 Terminated - Clinical trials for Emotional Dysregulation

Affect Labeling - Experimental Evaluation and Behavioral Intervention

AL_ER
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The overall aim of this project is to better understand the emotion regulating effect of labeling emotions (affecting labeling, AL) for individuals with self-perceived emotional regulation difficulties from both a clinical population and a non-clinical population, by using both self-assessment and psychophysiological testing of emotional activation. The main part of the project includes a brief intervention aiming to test the emotion-regulating effect of a short behavioral intervention to learn and practice AL. This two-week intervention, aims to improve the ability to regulate emotions, and to assess the benefits of emotion regulation strategies for individuals with and without a clinical diagnosis, but with self-perceived difficulties in emotion regulation. The second part of this study aims to conceptually replicate a previous basic research study on AL and its emotion-regulating effect in a experimental laboratory setting and to extend that replication to include a clinical group. The replication contributes to an indepth understanding of AL as an implicit emotion regulation strategy in the short term, i.e. as a strategy used directly in the emotionally charged situation, and expands that knowledge to also include the effect in individuals with a clinical diagnosis. Also, it provides the opportunity to evaluate the effect of the two week AL behavioral intervention using psychophysiological testing.

NCT ID: NCT04810208 Terminated - Solid Tumor Clinical Trials

Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours

Start date: February 28, 2019
Phase: Phase 1
Study type: Interventional

This is a multicentre, open-label, first in man, study of a novel NanoZolid®-docetaxel depot formulation (NZ-DTX Depot) given as an intra-tumoural injection in patients with advanced solid tumours. The study includes a dose escalation part and a dose expansion part.

NCT ID: NCT04778397 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

ENHANCE-2
Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

NCT ID: NCT04753658 Terminated - Neuroblastoma Clinical Trials

Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Start date: March 19, 2021
Phase:
Study type: Observational

The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.

NCT ID: NCT04641273 Terminated - Clinical trials for Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain

Start date: January 22, 2021
Phase: Phase 2
Study type: Interventional

People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). There are treatments for DNP but in many patients they do not reach a good pain reduction and have unwanted side effects. In this trial, the researchers will look at how BAY1817080 works and how safe it is. They will compare it to a placebo or another treatment for DNP called pregabalin. A placebo looks like a treatment but does not have any medicine in it. The researchers will use a placebo to learn if the participants' results are due to BAY1817080 or if the results could be due to chance. The researchers will also learn more about the right dose of BAY1817080 for these participants. The trial will include participants who have DNP and either type 1 or type 2 diabetes. It will include about 440 men and women who are at least 18 years old. This trial will have 2 parts. In Part 1, the participants will take either BAY1817080 or the placebo. These treatments will be taken as a tablet by mouth twice a day for 8 weeks. In Part 2, participants will take BAY 1817080, pregabalin, or a matching placebo of either treatment. BAY1817080 and a placebo will be taken as a tablet by mouth twice a day for 12 weeks. Pregabalin and a placebo will be taken as a capsule by mouth twice a day for 12 weeks. The participants in Part 1 will visit their trial site 6 times. The participants in Part 2 will visit their trial site 7 times. At these visits, the doctors will ask the participants if they have any health problems, take blood samples, and do a physical exam. They will also ask the participants to complete questionnaires about their pain and other symptoms.

NCT ID: NCT04631601 Terminated - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)

Start date: January 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).

NCT ID: NCT04613154 Terminated - Clinical trials for Thumb Osteoarthritis

Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

A randomised controlled trial of addition to the standard pain treatment of 1000 mg oral magnesium citrate or placebo for 7 Days during surgery for thumb base arthrosis. Intraoperative nociception will be measured with the NoL-index with a PM-200 machine.

NCT ID: NCT04611074 Terminated - Chronic Disease Clinical Trials

Health-related Quality of Life in Patients at Nordic Clinic

Start date: August 22, 2019
Phase:
Study type: Observational

Nordic Clinic is a private clinic for personalised treatment based on the Functional Medicine concept. In summary, functional medicine is aimed at addressing the lifestyle and behavioral factors that are believed to contribute to the symptoms the patient suffers from. In short, the treatment is based on a timeline of health-related life events, current lifestyle factors and behaviors and physiological examinations to develop a personalised lifestyle program. The main component of the treatment provided at Nordic Clinic is in-depth lifestyle coaching to achieve the desired behavioral and lifestyle changes. Working at the clinic is a clinical physiologist, nutritionist, physician specialist in general medicine and researchers work. The vast majority of people who apply for the clinic have long-standing symptoms that have been investigated by the healthcare system without any organic explanation for the symptoms having been identified. Common causes are gastrointestinal problems, persistent fatigue and insomnia. The aim of the study is to investigate symptom-borne and health-related quality of life during and after treatment and to identify predictors of improvement of health-related quality of life. The main purpose is to investigate whether the health-related quality of life is improved during treatment. This is an observational study and all adult patients who are able to complete the web form in Swedish at the clinic are asked to participate. Participants who give consent will receive a link to the questionnaire via email once a month for one year and once after two years. Participants are recruited for two years, and will be completed after the last questionnaire is completed by the last included participant, ie autumn 2022. In addition to the self-assessments, the number of visits to the clinic, sampling and results, who finances the treatment and treatment plan are recorded. The first aim is to investigate improvement in symptom burden and health related quality of life during and after treatment (does symptom burden and health related quality of improve during treatment and are improvements stable at the 2 year follow-up?) The second aim is to investigate factors that predict recovery (Do persons with a high level of motivation for behavioural change experience a better improvement in symptom burden and health related quality of life than persons with a low level of motivation for behavioural change?).

NCT ID: NCT04583423 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)

Start date: November 11, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.