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NCT ID: NCT04941781 Completed - Multiple Sclerosis Clinical Trials

PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-center, open-label, adaptive-design PET study to investigate the occupancy of brain muscarinic Type 1 receptors (M1AChR) by PIPE-307 in healthy volunteers.

NCT ID: NCT04941534 Completed - Pregnancy Clinical Trials

This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.

Start date: June 4, 2021
Phase:
Study type: Observational

This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.

NCT ID: NCT04941001 Completed - Asthma Clinical Trials

Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)

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

A digital tool, called ReferID has been developed to facilitate the review of asthma patients. It aims to assist in the identification of patients with uncontrolled and/or severe asthma and to ensure a timely referral to secondary care where appropriate. To validate the tool, patients will be randomised to have a review with a healthcare professional using tool to facilitate the review or to continue receiving usual care. Outcome measures including exacerbation frequency and level of asthma control will be assessed at 12 months.

NCT ID: NCT04940897 Completed - Clinical trials for Diabetic Ketoacidosis

Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

KARMA2
Start date: October 25, 2021
Phase: N/A
Study type: Interventional

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of diabetic ketoacidosis using blood ketone meters and start fluid (saline) therapy before arriving at hospital. The investigators aim to include 800 patients in this stepped wedge control study and the results will help decide if a larger study is warranted.

NCT ID: NCT04940364 Completed - Healthy Clinical Trials

A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers

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

The primary objective of the study is to assess the concentration-time profiles of total pozelimab, total C5, cemdisiran, and cemdisiran metabolite(s) in Japanese adult participants following single doses of intravenous (IV) and subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart. The secondary objectives of the study are: - To evaluate the safety and tolerability of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants - To assess the pharmacodynamic (PD) profile of pozelimab alone and in combination with cemdisiran in healthy Japanese adult participants - To assess the immunogenicity of pozelimab and cemdisiran in healthy Japanese adult participants

NCT ID: NCT04940026 Completed - Breast Cancer Clinical Trials

Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women

Start date: June 15, 2021
Phase: Phase 1
Study type: Interventional

Primary Objectives: - To assess the excretion balance after oral and IV administration of [14C]-SAR439859 - To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and, PK of radioactivity, SAR439859 and M7 after oral administration of SAR439859 alone or with [14C]-SAR439859 - To assess IV clearance and absolute bioavailability of SAR439859 using microdose of [14C]-SAR439859 tracer on top of a single tablet oral dose. - To assess relative bioavailability of SAR439859 given as tablet or solution Secondary objectives: - To collect samples in order to assess metabolic profile in plasma and excreta of SAR439859 after oral administration of [14C]-SAR439859 as solution, contribution in plasma of SAR439859 and metabolite relative to total radioactivity and identify metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report). - To assess safety and tolerance of SAR439859

NCT ID: NCT04939818 Completed - Parkinson Disease Clinical Trials

Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders

RHAPSODY
Start date: June 14, 2021
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of self-assessment. Secondary objectives include (1) evaluating the reliability of speech tasks in the remote self-administered setting, as measured by the intra- and inter-subject variance; (2) accessing the adherence of speech tasks in this setting, as measured by the subject average fraction of days during the first week, where at least one task response is submitted; (3) evaluating the feasibility of using speech tasks in the setting of a telemedicine videoconference, as measured by the average length of speech elicited in each group; (4) evaluate whether a set of acoustic and linguistic patterns can detect each indication, compare to either a control group or all other indications, as measured by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5) evaluating how the performance of such algorithms can be impacted by speaker and environment covariates, as measured by the Kendall rank correlation coefficient of the AUC of each classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.

NCT ID: NCT04939558 Completed - Healthy Clinical Trials

Cardiorespiratory Diagnostic Study

CARES
Start date: June 2, 2021
Phase:
Study type: Observational [Patient Registry]

This study uses a new breathing device called 'N-Tidal C' handset which measures breathing patterns. Investigators have found that people with cardiac and respiratory illnesses breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathed out CO2 (the waveform) varies according to the underlying health of the user's lungs. Monitoring these changes may help doctors to more accurately diagnose and monitor the most common and serious respiratory conditions.

NCT ID: NCT04938557 Completed - Diabetes Clinical Trials

Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

AiDAPT
Start date: September 26, 2019
Phase: N/A
Study type: Interventional

Evaluation of the biomedical and psychosocial impact of automated Closed-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy

NCT ID: NCT04937777 Completed - AL Amyloidosis Clinical Trials

A Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe

Start date: April 23, 2019
Phase:
Study type: Observational

This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations.