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NCT ID: NCT04992663 Recruiting - Labor Pain Clinical Trials

Investigating the Effect of Virtual Reality on Labour Analgesia Use

DELIVR
Start date: June 17, 2021
Phase: N/A
Study type: Interventional

Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of pain. The implementation of alternative methods like VR to reduce labour pain can contribute to reduce the use of pharmacological pain management methods and associated side effects. The objective of this study is to asses the effect of VR on the request for labour analgesia compared with standard care. Secondary objectives are the effect of VR on; the referral rate from midwifery led first line care to second line obstetrical care, patient satisfaction of VR use, delivery expectancy and experience (WIDEQ-A and WIDEQ-B), patient reported outcome measures (PROMs) and patient reported experience measure (PREMs) as defined by international consortium for health outcome measures (ICHOM) and evaluate the social, economic, organizational and ethical issues of VR by using the health-technology assessment analysis (HTA). Study design: The study concerns a non-blinded, single centre, randomised controlled trial Study population: Nulliparous and multiparous women with a singleton in cephalic presentation beyond 36+0 weeks' gestation and an intention for vaginal delivery. The study population will be randomly assigned to the intervention group (VR-group) or the care as usual group. The intervention group will be exposed to an immersive guided relaxation VR experience (BirthVR) during labour. If a woman in the intervention group requires additional pharmacological pain relief, this will be offered according to the local protocol. The participants who are randomised to the standard care group receive labour pain analgesia on maternal request according to the local usual standard care.

NCT ID: NCT04992065 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe). Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks. The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart. Women can only take part in the study if they are not able to become pregnant.

NCT ID: NCT04991181 Completed - Clinical trials for Pulmonary Arterial Hypertension

Absorption, Distribution, Metabolism and Excretion of BIA 5-1058

ADME
Start date: March 31, 2017
Phase: Phase 1
Study type: Interventional

the purpose of this study is: - to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 3.7 Megabecquerel (MBq) of radiocarbon; - to determine the pharmacokinetics (PK) of total radioactivity (TRA) in plasma and whole blood and to assess the blood-to-plasma ratio; - to determine the PK of BIA 5-1058 and its metabolites in plasma.

NCT ID: NCT04990947 Recruiting - Obesity Clinical Trials

Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

CIBuS
Start date: April 7, 2021
Phase:
Study type: Observational

To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.

NCT ID: NCT04990232 Active, not recruiting - Sepsis Clinical Trials

Personalized Immunotherapy in Sepsis

ImmunoSep
Start date: July 29, 2021
Phase: Phase 2
Study type: Interventional

Αim of ImmunoSep is to assess whether personalized adjunctive immunotherapy directed against a state of either fulminant hyper-inflammation or immunoparalysis is able to change sepsis outcomes. Patients will be selected by a panel of biomarkers and laboratory findings and will be allocated to placebo or immunotherapy treatment according to their needs.

NCT ID: NCT04989803 Recruiting - Clinical trials for Relapsed and/or Refractory B-cell Lymphoma

Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

Start date: October 27, 2021
Phase: Phase 1
Study type: Interventional

The goal of this clinical study is to learn more about the safety and dosing of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

NCT ID: NCT04989387 Active, not recruiting - Clinical trials for Advanced Solid Tumors

Study of INCA 0186 in Subjects With Advanced Solid Tumors

Start date: October 4, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

NCT ID: NCT04988386 Active, not recruiting - Clinical trials for Amyloid Cardiomyopathy, Transthyretin-Related

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Start date: October 27, 2021
Phase: Phase 3
Study type: Interventional

Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)

NCT ID: NCT04988308 Terminated - Clinical trials for Hidradenitis Suppurativa

A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

LYRA
Start date: October 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

NCT ID: NCT04988295 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

MARIPOSA-2
Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.