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NCT ID: NCT04511494 Active, not recruiting - Peanut Allergy Clinical Trials

Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT

SmaChO
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to: 1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or 2. Control group with peanut allergic children who do not undergo OIT. 3. In addition, a group of healthy children without allergic diseases will be included in the study. The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4 weeks of avoidance. Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.

NCT ID: NCT04508530 Active, not recruiting - Clinical trials for Pediatric Acute-Onset Neuropsychiatric Syndrome

Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS)

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

A Superiority Study To Compare The Effect of Panzyga Versus Placebo in Patients with Pediatric Acute-onset Neuropsychiatric Syndrome

NCT ID: NCT04508322 Active, not recruiting - Quality of Life Clinical Trials

Treatment of Class II Malocclusion With Excessive Overjet

Start date: December 5, 2013
Phase: N/A
Study type: Interventional

Class II malocclusion with excessive overjet is one of the most common malocclusions among children and adolescents. The overall goal of the project is to analyze orthodontic treatment of Class II malocclusion with excessive overjet when the treatment is started in different ages and treated with removable and/or fixed appliance. Treatment initiated before the age of eleven is performed with a removable functional appliance, Headgear Activator (HGA). Treatment starting in early adolescence is performed with fixed orthodontic appliance (FA). The hypotheses are: - Treatment with HGA at the age of nine or eleven is effective. No spontaneous correction of the malocclusion is expected in the untreated control group. - Patient experience, treatment effect and cost-effectiveness are equivalent whether the treatment with HGA is initiated at the age of nine or eleven. - Treatment results, patient experience and treatment- and cost-effectiveness are equivalent whether treatment is initiated early with HGA or initiated in early adolescence with FA. - The treatment of Class II malocclusion with excessive overjet renders long-term treatment stability and patient satisfaction.

NCT ID: NCT04497844 Active, not recruiting - Clinical trials for Metastatic Castration-sensitive Prostate Cancer

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

AMPLITUDE
Start date: September 23, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

NCT ID: NCT04494425 Active, not recruiting - Clinical trials for Advanced or Metastatic Breast Cancer

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

DB-06
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

NCT ID: NCT04490915 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

CAHtalyst
Start date: November 16, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

NCT ID: NCT04489290 Active, not recruiting - Clinical trials for Bacterial Vaginosis | Vaginal | Microbiology

Efficacy and Safety of D005 Vaginal Mousse on Bacterial Vaginosis

Start date: February 12, 2021
Phase: N/A
Study type: Interventional

This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis. The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.

NCT ID: NCT04488536 Active, not recruiting - Clinical trials for Myocardial Infarction

Management and Outcomes of Patients Admitted to Coronary Care Units, Depending on Degree of Frailty and Comorbidities

Start date: July 29, 2020
Phase:
Study type: Observational [Patient Registry]

Background Patients less than 80 years of age, who suffer a myocardial infarction (MI) are usually (>90%) offered an early invasive strategy including coronary angiography possibly followed by intervention, preferably percutaneous coronary intervention (PCI). Among non ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only approximately 40% receive an invasive approach in Sweden, since the majority are handled in a conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological treatment, there is a large variation between Swedish counties regarding the choice of strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger variation between acute hospitals ranging from 20% to 90 %. The Swedish national guidelines for heart disease have emphasized that the patient's biological age, i.e. the patient's biological status and expected length of life, is crucial for decision-making. The Clinical Frailty Scale (CFS) is a global clinical measure of biological age, mixing co-morbidity, disability and cognitive impairment. The investigators have previously reported the potential importance of frailty for short-term (1 month) and medium-term outcome (1 year) in a NSTEMI population. However, published data on the role of frailty´s prognostic value, its capacity to predict adverse effects including complications, and the potential to guide clinical decision-making for elderly patients with myocardial infarction are scarce. Similarly, there is a lack of knowledge of how different patterns of comorbidity burden might influence rational decision-making. Aims To explore the association between frailty and treatment patterns in cardiac care To study the association between outcomes and degree of frailty, with and without comprehensive adjustment for differences in baseline characteristics. To study how treatment benefits for patients admitted to coronary care units differ in patients depending on comorbidities and frailty. Hypothesis The investigators hypothesize that frailty is independently associated with worse outcomes, including mortality, readmissions and complications. Methods and material An observational, register based, multicentre study. Inclusion criteria: Patients consecutively included in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. Exclusion criteria: None. SWEDEHEART is a national quality registry collecting information on all patients hospitalized with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with data. Briefly, information is collected prospectively about individual patients' medical history, treatment before admission, management during hospital stay, treatment at discharge, and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry. However, as a pilot project to ensure feasibility, five hospitals began to register frailty November 1st, 2017. For the investigators initial analyses data will be used from the pilot study to assess the association between CFS level and outcomes. The data extraction will be done by one of the monitors of the SWEDEHEART registry. After about two years the investigators will extract data prospectively entered into the registry. The frailty instrument The crucial study instrument CFS is a 9-point scale. It has good predictive validity and prognostic power, is relying on clinical judgment, and is relatively easily used in clinical practice. Since the scale includes several degrees it can be considered to be particularly appropriate for risk stratification, and accordingly it has been used for this purpose. The investigators have got the instrument owner´s permission to use this scale. The case record form (CRF) focus on demographic and clinical patient characteristics registered in the SWEDEHEART, particularly those which are supposed to be potential confounders when testing the hypothesis: chronological age, gender, cardiovascular risk, diabetes, heart failure, renal insufficiency, other co-morbidities, including the Charlson Comorbidity Index (CCI), previous MI, medications, ejection fraction, and the classification of MI. Cardiovascular risk will be assessed according to the Global Registry of Acute Coronary Events (GRACE) risk score (GRS). Results from echocardiography, ECGs, laboratory testing and registration of anthropometric data will be included according to routine practice within the frame of SWEDEHEART. Follow-up of cohorts of invasively or conservatively treated patients with different stages of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point respectively.

NCT ID: NCT04488289 Active, not recruiting - Clinical trials for Hypertension,Essential

The Föllinge Hypertension and Lifestyle Study

FIHST
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Ambulatory blood pressure measurement is more demanding in terms of technical equipment and specially trained staff. If blood pressure measurement in a self-care room is on average equivalent to the ambulatory blood pressure daytime monitoring of hypertension in primary care could be simplified. We therefore want to examine patients monitored for hypertension (ICD 10) with three different methods: conventional blood pressure measurement in office, self-directed automated measurement and ambulatory blood pressure, starting in December 2020. We will also offer an interview covering cardiovascular risk factors, at time for enrollment and after 6 months. The study was approved to include 150 adult study patients (The swedish ethical review authority 2020-01375), men and women, where diagnosis and treatment of hypertension is relevant after a clinical evaluation.

NCT ID: NCT04475939 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

ZEAL-1L
Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).