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NCT ID: NCT03978611 Completed - Melanoma Clinical Trials

A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment

Start date: December 9, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.

NCT ID: NCT03978507 Completed - Parkinson Disease Clinical Trials

Digital Wearable Walking Aid for Freezing of Gait in Parkinson´s Disease

Start date: June 13, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the effects of relatively long-term use of a wearable device that provides personalized and intelligent cues (e.g. only when FOG is detected) on FOG.

NCT ID: NCT03978247 Completed - Obesity Clinical Trials

Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy

SIGNALS
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

Evaluation of the diagnostic performance of an algorithm developed to detect metabolic profiles specific of non-alcoholic steatohepatitis NASH and based on the reading of a blood sample's infrared spectra

NCT ID: NCT03973905 Completed - Whooping Cough Clinical Trials

Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States

Start date: February 15, 2019
Phase:
Study type: Observational

The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.

NCT ID: NCT03971968 Completed - Cicatrix Clinical Trials

Observational Study for the Long-Term Effects of a Dermal Substitute on Patients With Facial Burns.

Start date: January 31, 2019
Phase:
Study type: Observational

The aim of this observational study is to investigate the long-term (between 10-20 years) results for the surgical treatment of third degree burn injury in the face and/or the neck by means of Integra® Dermal Regeneration Template. This study is an observational case-control study. The healthy skin of a comparable and/or contralateral skin-site of the face/neck serves as a comparator. The population consists of human volunteers between 18 and 75 years old with third degree full thickness burn injuries in the face and/or neck, who underwent surgical treatment with IDRT between 1998 and 2008.

NCT ID: NCT03971422 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

NCT ID: NCT03970902 Completed - Clinical trials for Postmenopausal Osteoporosis

Quality of Life in Postmenopausal Women With Osteoporosis

Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

The researchers will evaluate the effectiveness of a complex intervention composed of multiple actions targeting primary care healthcare workers and postmenopausal women with osteoporosis by means of a quasi-experimental design in the form of a cluster-controlled trial with clustering at family physician level. The study has 2 study arms. In one arm, osteoporosis stakeholders receive a complex intervention (Integrated Osteoporosis Care(IOC)). The second study arm serves as control and receives care as usual. The complex intervention is composed of - education and provision of educational material for all stakeholders in primary osteoporosis care (patients, family physicians, nurse-educators, physiotherapists, dietitians, pharmacists and if present patient's informal caregivers) - patient self-management support by primary care osteoporosis stakeholders - the construction of a primary care osteoporosis treatment guideline and care pathway Effectiveness will be measured by questionnaires and data from the (Electronic Medical Record)EMR and IMA-database, in patients and family physicians. Effects measured in family physicians are: - Identification failure rate - Percentage of family physicians correctly implementing the osteoporosis treatment guideline - Proportion of patients treated correctly as stated in the osteoporosis treatment guideline - Proportion of family physicians correctly registering osteoporosis related information in the EMR - Intensity of collaborative practices - Knowledge of osteoporosis management and treatment Effects measured in patients are: - Medication Possession Ratio(MPR) (Primary outcome) - Health literacy - Self-management efficacy - Self-reported treatment adherence - Self-reported nutritional intake - Intensity of integrated osteoporosis care - Patient satisfaction with integrated osteoporosis care - HRQoL - Functional independence (Activities of Daily Living - ADL) - Patient resource use The study elapse time is 18 months. Participating family physicians will receive postgraduate education and start to include patients during consultations in their doctor's office. The inclusion period is 6 months, patients eligible for participation are non-institutionalized postmenopausal women with a diagnosis of osteoporosis who are able to give informed consent. The follow-up period for patients is 12 months. Follow-up period for family physicians is 18 months.

NCT ID: NCT03969888 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

Start date: December 11, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

NCT ID: NCT03969849 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants

Start date: June 3, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants. The secondary objectives of the study are: In Part A and Part B: - To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults - To assess the immunogenicity of single dose of REGN5713-5714-5715. In Part B: - To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715 - To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.

NCT ID: NCT03969433 Completed - Foetal Wellbeing Clinical Trials

Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing. Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages. The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing. Clinical information related to subjects' pregnancy and foetal health is also collected.