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NCT ID: NCT03739385 Recruiting - Physical Activity Clinical Trials

Generations on the Move (GIB-Study): Intergenerational Exercise and Health Promotion

GIB
Start date: November 10, 2018
Phase: N/A
Study type: Interventional

During the past century, major demographic changes have occurred in Europe which primarily affect the older age groups. According to the Swiss federal office of statistics, the number of senior citizens has tripled (from 5.8% to 18.0%) while the number of young adults (younger than 20 years old) has decreased from 40.7% to 20.1%. There is evidence that with increasing age, physical activity and fitness level decreases. Additionally to lower physical activity, natural aging results in a decrease of muscle strength and a modulation of afferent and efferent reflex pathways due to a slowing down of neuromuscular performance. As a consequence, there are multiple consequences on general health, disease and injury rates in the older population such as a higher risk of sustaining fall injuries. An intergenerational approach combining balance and strength promotion appears to possess great potential for fall-prevention, for satisfying physical, social and behavioral need of children and seniors as well as reducing health care costs due to increased inactivity in both age groups. No studies have examined the effects of intergenerational exercise and health programs.

NCT ID: NCT03738722 Not yet recruiting - Apnoeic Oxygenation Clinical Trials

Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy

PAPUA-Flow
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The main objective of this explorative observational study is to investigate the pressures in infraglottic airway and the pharynx provided by THRIVE , using flows ranging from 1l/min to 80 l/min, in patients hospitalized for elective surgical procedure; to investigate the correlation between airway pressure and nasal oxygen flow.

NCT ID: NCT03735901 Not yet recruiting - Clinical trials for Acute Ischemic Stroke

Enhancement of Stroke Rehabilitation With Levodopa

ESTREL
Start date: February 1, 2019
Phase: Phase 3
Study type: Interventional

Trial investigates the benefits and harms of Levodopa /Carbidopa 100/25mg compared to placebo (given in addition to standardized rehabilitation based on the principles of motor learning) and whether there is an association with a patient-relevant enhancement of functional recovery in acute ischemic stroke patients. Study participants will be randomized 1:1.

NCT ID: NCT03735030 Not yet recruiting - Infertility Clinical Trials

Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation

Start date: December 2018
Phase: Phase 1
Study type: Interventional

In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years.

NCT ID: NCT03731455 Not yet recruiting - Epilepsy Clinical Trials

Wise Cortical Strip for Intraoperative Neurophysiological Monitoring

WIN
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the Wise Cortical Strip (WCS) for CE certification purposes. Participants with documented diagnosis of epilepsy or brain tumor requiring intracranial surgery, who meet all eligibility criteria, will undergo IntraOperative Neurophysiological Monitoring (IONM) during a neurosurgical intervention with the WCS and a comparator device (Subdural Strip Electrode, Ad-Tech Medical Instruments Corporation, Racine, Wisconsin, USA). The WCS is a single use medical device intended for intraoperative use on the surface of the brain for stimulating the brain or recording the brain's electrical activity. This supports brain monitoring during resection of brain tumors or epileptogenic lesions. In the WIN Study 28 adult participants will be enrolled in up to 5 investigational sites in Europe. The enrollment is expected to take 6 months per site. Subject participation will last from the date of signing of the informed consent to 24 hours following the conclusion of the surgical procedure or, if applicable, until completion of the follow-up assessments. However, a participant is considered enrolled in the WIN Study after having signed the informed consent form and when the WCS comes in contact with the participant. The WIN Study will consist of the following treatments/follow-up visit: - Screening will be performed within 28 days prior to the neurosurgical intervention. - Neurosurgical intervention (by using the WCS and Comparator Device) will be divided in two phases: 1) "baseline phase" is foreseen at the beginning of the surgical procedure, before the surgical resection; 2) "IONM phase" is foreseen after baseline phase when the lesion resection surgery will take place. During both phases, WCS safety and performance data will be collected, while the usability data will be collected after intervention. - Neurological assessment within 24 hours following the neurosurgical intervention will be performed to determine the neurological status of each participant. - Follow-up will be performed according to the standard of care. However, due to the intraoperative intended use of the WCS, follow-up will be considered part of the WIN Study only in cases of SADEs and ADEs associated with WCS occurring during the surgical procedure phase in which the WCS is used or occurring within 24 hours following the surgical intervention.

NCT ID: NCT03731312 Recruiting - Iodine Deficiency Clinical Trials

Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies

VIOLET
Start date: October 1, 2018
Phase:
Study type: Observational

Iodine status in populations is assessed using urinary iodine concentration (UIC) measured in spot urine samples. The iodine intake is classified as deficient, sufficient, or excessive iodine based on the median UIC (mUIC). However, this approach has limitations, as it does not quantify the prevalence of individuals with habitually deficient or excess iodine intakes. The EAR cut-point method has the potential to quantify prevalence of iodine deficiency and excess. However, little is known about the effects of the inter- and intra-individual variance of UIC. The aim of the study is to quantify the intra-individual variability in dietary iodine intake. The overall goal is to estimate the prevalence of iodine deficiency and excess in the study population and propose sample size recommendations for future iodine nutrition population studies. The results will provide evidence guiding international recommendations for iodine nutrition studies.

NCT ID: NCT03730935 Recruiting - Healthy Clinical Trials

Respiratory Muscle Endurance Training in Healthy Elderly

RETE
Start date: November 2018
Phase: N/A
Study type: Interventional

Prevalence of hypertension in the elderly is high. Given that hypertension is the leading cause of cardiovascular disease worldwide, safe and efficacious treatment options for this condition are highly desired. Apart from medication, changes in lifestyle are recommended to lower blood pressure, such as an increase in physical exercise. However, whole-body exercise is not feasible for all. Mobility disabilities, for example, increase sharply with age and are already common in middle age. For this population, it is necessary to have alternative, non-invasive interventions with similar effects on blood pressure. One such intervention might be respiratory muscle endurance training (RMET), but the effects on blood pressure are currently unknown. The primary aim of this project is therefore to investigate the effects of RMET over the course of several weeks on resting blood pressure in healthy elderly. The secondary aim of the project is to evaluate the effects of RMET on uphill exercise performance in healthy active elderly given that elderly experience structural and functional changes of the lungs potentially affecting exercise performance. Finally, since prevalence of subjective sleep complaints is also high in the elderly, the present study will also investigate the effects of RMET on sleep quality.

NCT ID: NCT03729908 Recruiting - Clinical trials for Acquired Brain Injury

Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury

AAMI
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of an animal assisted mindfulness intervention (AAMI) on patients with acquired brain injuries on their global severity of psychological distress. In addition, the effects on the patients' symptoms of depression, anxiety, perceived stress, mood, coping and mindfulness/self-compassion will be assessed. The study experimental condition consists of 6 weeks of intervention, containing 6 different modules. In every session, an animal will be present. In the control condition, the same program and same exercises will be used without the presence of or reference to animals. Sessions take place two times a week for 6 weeks (leading up to a total of 12 experimental/control sessions), each lasting for about 60 minutes. 24 participants will be included, 12 patients in each group.

NCT ID: NCT03728179 Not yet recruiting - Solid Tumor, Adult Clinical Trials

RACIN in Patients With Advanced TIL-negative Solid Tumors

RACIN
Start date: November 15, 2018
Phase: Phase 1
Study type: Interventional

Subjects with locally advanced or metastatic incurable Tumor Infiltrating Lymphocytes (TIL)-negative solid tumors who are not eligible for, declined or failed standard therapy will be treated with a combination of checkpoint inhibitors (nivolumab and ipilimumab), low dose cyclophosphamide (Cy), low-dose ionizing radiation (RT) (0.5-3 Gy) and aspirin (ASA). The study comprises 2 phases: The aim of Phase Ia, is to determine safety and tolerability of this combination therapy, as well as the maximum tolerated dose (MTD) or recommended phase Ib dose (RP1bD) of radiotherapy. Phase Ib aims to further explore safety and tolerability of this treatment in an expansion cohort. In Phase Ia, 4 distinct cohorts will receive combination therapy for 5 cycles (C0-C4) which includes: RT (0.5-3 Gy) every 2 weeks (Q2W), Cy (200 mg/m2) Q2W (cycles C0 to C4); ASA (300 mg) daily, with nivolumab 240 mg flat dose Q2W and ipilimumab 1 mg/kg every 6 weeks (Q6W) will be administered (cycles C1 to C4). RT will be given at an escalation design (0.5, 1, 2, 3 Gy) for 5 cycles (cycle C0 without Ipi/Nivo and ASA, and then C1-C4). In Phase Ia, MTD or RP1bD will be defined. RP1bD will be the MTD or, in the absence of dose limiting toxicities (DLTs), the biologically best RT dose based on pharmacodynamics parameters. In Phase Ib, patients will be treated with the MTD or RP1bD dose of RT and will follow the same schema of treatment used in the Phase Ia cohort (5 cycles). At the end of the 5th cycle, patients eligible for nivolumab maintenance, will be treated with nivolumab at 240 mg Q2W until progression or excessive toxicity; ASA will be maintained according to tolerability.

NCT ID: NCT03727399 Enrolling by invitation - Pollen Allergy Clinical Trials

Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients

Start date: October 1, 2018
Phase:
Study type: Observational

The project examines the hypothesis that monoclonal allergen-neutralizing antibodies can be recombinantly produced from B lymphocytes isolated from pollen allergic patients. Patient samples suitable for antibody cloning are selected based on seroprofiling for the respective allergens. The study aims at isolating lymphocytes from patients with potential allergen-neutralizing IgG in serum and to clone antibodies from antibody gene sequences obtained from B cells of those patients.