Clinical Trials Logo

Filter by:
NCT ID: NCT04647604 Completed - COVID-19 Clinical Trials

Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -

Start date: June 23, 2020
Phase: Phase 2
Study type: Interventional

A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.

NCT ID: NCT04647526 Active, not recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

SPLASH
Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

NCT ID: NCT04647331 Recruiting - Clinical trials for Infective Endocarditis

Betalactam Pharmacokinetics in Endocarditis Patients

Start date: June 1, 2021
Phase:
Study type: Observational

Infectious endocarditis (IE) is associated with mortality rates of 10-12%. Adequate antibiotic therapy is crucial for survival and is administered in high doses due to the severity of the disease. In most cases, beta-lactam antibiotics (e.g. ampicillin, penicillin G, cefotaxime or cloxacillin) are employed. A number of patient characteristics, such as age, body weight, and renal function) influence the pharmacokinetics of these drugs. Yet, the interindividual variability is poorly understood meaning that a large proportion of patients are at risk of subtherapeutic or excessive drug concentrations that might result in treatment failure or side effects, respectively. In the present study, data will be collected on antibiotic concentrations in patients treated with beta-lactams for infectious endocarditis as well as patient characteristics and treatment outcomes. A mathematical model will be developed to determine which patient factors determine drug pharmacokinetics. Based on this model, predictions will be made by mathematical simulations on which dosing regimens are optimal for individual patients to ensure therapeutic and non-toxic drug concentrations. In total, 150 patients will be included at four University Hospitals in Sweden; Uppsala University Hospital, Sahlgrenska University Hospital in Gothenburg, Skåne University Hospital in Lund and Karolinska University Hospital in Stockholm. Following informed consent to participate blood samples will be collected at 6 time-points during a dose interval and then at 3 time-points weekly during the full treatment episode (maximum 6 weeks).

NCT ID: NCT04647110 Completed - ALK-positive NSCLC Clinical Trials

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Start date: December 14, 2020
Phase:
Study type: Observational

This study aims to explore for the first time how the different ALK TKIs have been sequenced in real-world clinical practice and with which outcomes for Swedish lung cancer patients

NCT ID: NCT04646421 Recruiting - Gambling Disorder Clinical Trials

Responsible Gambling Telephone Intervention to High-risk Gamblers by a State-owned Gambling Operator in Sweden.

Start date: March 12, 2021
Phase:
Study type: Observational

The present overall project evaluates an intervention carried out by the Swedish state-owned gambling operator AB Svenska Spel, in order to help high-risk gamblers reduce or quit their gambling. The intervention is a motivational telephone intervention, called by responsible gambling officers trained in motivational interviewing, and who call gamblers who are screened for suspected high-risk gambling practices either through the operator's own records, or because they have voluntarily taken a self-test indicating a hazardous gambling pattern. The present projects evaluates the effectiveness, user satisfaction and acceptability of the intervention, in two parts: 1) A retrospective, register-based follow-up of gamblers reached by the telephone intervention, in comparison to control individuals for whom attempts were made to carry out the same intervention, but who were never successfully reached on telephone. The effectiveness measures include potential changes in gambling level (frequency, level of wagering) post-intervention compared to pre-intervention, as well as occurrence of deposit limits, or voluntary self-exclusion. 2) A prospective web survey study involving individuals reached with the intervention from November, 2020, who - after receiving electronic written information and after providing informed consent - will answer a web survey around 10 days after the intervention, about their attitudes to the telephone intervention, and their self-reported gambling (on the same operator and on other gambling operators), self-limiting interventions and treatment seeking after the intervention. The study will provide important data on the effectiveness of this intervention aiming to reduce high-risk gambling practices, and will be able to study also the risk of gamblers transferring their gambling practices to other operators after a motivational intervention as the present one. Also, as acceptability and user satisfaction of the intervention are crucial for its success over time, these measures are also included in order to improve the understanding or how effective responsible gambling interventions can be implemented by gambling operators with a harm-reducing mission.

NCT ID: NCT04644575 Active, not recruiting - Hemophilia A Clinical Trials

Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A

XTEND-ed
Start date: February 23, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B). - To evaluate the efficacy of BIVV001 for perioperative management

NCT ID: NCT04643951 Recruiting - Pain Clinical Trials

Pain in Pediatric Dentistry - a Grounded Theory Study on the Experiences of Dental Professionals and Students

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

This is a qualitative interview study, using Grounded Theory. The aim is to deepen our knowledge about how the dental team (dentists, dental hygienists, and dental assistants) and dental students perceive child patients' pain and how they perceive they are equipped to prevent and deal with child patients' pain and the child's response to pain during and after dental treatment.

NCT ID: NCT04642196 Completed - Covid19 Clinical Trials

COVID-19 in Home Healthcare

Start date: May 2, 2020
Phase:
Study type: Observational

Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020. Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.

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: NCT04640922 Completed - Bacterial Vaginosis Clinical Trials

Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis

Nefertiti
Start date: January 27, 2020
Phase: N/A
Study type: Interventional

This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV. The study population will consist of post-menarchal, pre-menopausal females 18 years or older seeking for BV symptoms (fishy smell, irritation and burning). Patients will be recruited at study sites' gynaecological and sexual health clinics and a total of 150 patients are planned to be randomised in the study. On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or a vehicle control (placebo) to be self-administered daily (Days 0 to 5). Patients will be re examined at Day 7 (+2 days) for clinical cure rate. Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self administered once a week for a duration of 126 days. Patients not clinically cured at Day 7 will be offered rescue treatment (metronidazole) for 7 days. They will return at Day 14 for clinical assessment and sampling for microbiome and mycobiome analysis, and if cured they will be assessed for recurrence up to Day 128. Patients that are not cured at Day 14 will be discontinued from the study. Patients that are clinically cured at Day 7 and continuing in Part 2 will be followed up until confirmed recurrence or Day 128 if no recurrence. Vaginal samples will be taken by self-swab on Days 35, 63 and 91, a visit to the clinic will be performed at Day 63 and telephone follow up will be done at Days 35 and 91. Vaginal samples will also be taken at the visit on the Day of potential recurrence and/or at Day 128 if no recurrence. Vaginal samples will be used for confirming the diagnosis (Nugent score on Day 0 and Day 7) and sequencing analysis of the vaginal microbiome and mycobiome (Days 0, 7, 35, 63, 91 and Day of confirmed recurrence or Day 128 if no recurrence). Patient follow-up as regards to patient questionnaire/usability, AEs and BV recurrence notification will be handled with a mobile phone application. In case of a suspected BV recurrence, the patient should return to the clinic for confirmation of BV diagnosis.