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NCT ID: NCT04068597 Recruiting - Multiple Myeloma Clinical Trials

Study to Evaluate CCS1477 in Haematological Malignancies

Start date: August 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

NCT ID: NCT04067531 Recruiting - Clinical trials for Infection, Bacterial

Treatment of BV With First Deqularum and Then Direkt After Clindamycin

BV
Start date: August 1, 2020
Phase: Phase 3
Study type: Interventional

Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.

NCT ID: NCT04066244 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study of Safety and of the Mechanism of BLZ945 in ALS Patients

Start date: December 30, 2019
Phase: Phase 2
Study type: Interventional

It is an open label study to evaluate safety, tolerability and brain microglia response in participants with ALS following multiple doses of BLZ945.

NCT ID: NCT04064060 Recruiting - Beta-thalassemia Clinical Trials

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Start date: August 12, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: - Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept - Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met - The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase - Transition Phase is defined as one Enrollment visit - Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol - Follow-up Phase includes: - 42 Day Safety Follow-up Visit - During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting - Long-term Post-treatment Follow-up (LTPTFU) Phase - Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.

NCT ID: NCT04061967 Recruiting - Cervical Cancer Clinical Trials

SMS-based Summons in Cervical Screening

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken). Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

NCT ID: NCT04060433 Recruiting - Anorexia Nervosa Clinical Trials

Implementation of Evidence-Based Treatment of Restrictive Eating Disorder With Pronounced Starvation

ROCKETLAUNCH
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

In the Region Skåne in Sweden, the investigators have developed guidelines for providing intensive and evidence-based treatment during the first month in case of severe restrictive eating disorder with pronounced starvation. The project is aiming at implementing this treatment program in the general Child Psychiatric clinic, with its main focus on the implementation of evidence based family therapy. The study aims to evaluate the implementation of a standardized treatment model during the first month. The outcome will be compared with the patients and families who have been in treatment before the ROCKETLAUNCH project started.

NCT ID: NCT04059835 Recruiting - Complication Clinical Trials

OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery

Start date: May 20, 2019
Phase: Phase 3
Study type: Interventional

This study evaluates how two different types of postoperative bra 1) standard bra, soft VS 2) compression bra compression after breast cancer surgery affect pain, seroma, other symptoms and complications, and the womans experience of comfort

NCT ID: NCT04057378 Recruiting - Clinical trials for Depressive Disorder, Major

Optimal Electrical Stimulus During Electroconvulsive Therapy

Start date: October 30, 2019
Phase: Phase 4
Study type: Interventional

Synopsis Aim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli. Design: National, register-based randomized trial, unmasked with two treatment arms. Primary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (< 11 on the MADRS-S) than a 0.5ms pulse width stimulus. Secondary objectives include testing for differences in: self-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm. Inclusion criteria: At least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10. An indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent. Exclusion criteria: If the investigator judges a certain pulse width to be inappropriate for the patient. Inclusion time 2019-05-01-2022-11-15. Abbreviations 1. CGI: Clinical Global Impression Scale 2. CPRS: The Comprehensive Psychopathological Rating Scale 3. ECT: Electroconvulsive therapy 4. EQ5D: EuroQual-group 5 Dimensions Scale 5. ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision, 6. MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version. 7. Q-ECT: Swedish national quality register for ECT 8. VAS: Visual analogue scale

NCT ID: NCT04045015 Recruiting - Cushing Syndrome Clinical Trials

Liquorice and Salivary Cortisol

Start date: October 16, 2018
Phase: N/A
Study type: Interventional

Salivary cortisol is used as a diagnostic analysis in the investigation of suspected Cushings' syndrome. This study evaluates if liqourice intake increases salivary cortisol in healthy individuals. Late night salivary cortisol and cortisone is analysed before, during and after 7 days of liqourice intake in three different doses.

NCT ID: NCT04043494 Recruiting - Clinical trials for Lymphoblastic Lymphoma, Childhood

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

LBL 2018
Start date: August 23, 2019
Phase: Phase 3
Study type: Interventional

Primary objectives: - Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) - Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)