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NCT ID: NCT03847805 Recruiting - Clinical trials for Sports Physical Therapy

Scapulothoracic and Glenohumeral Stabilization Exercises in Boulderers

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Introduction. In the block climbing, the fluidity with which the athlete climbs a certain route is fundamental. The speed with which the movements are executed and the number of grippers of upper limbs is related to sports performance. Shoulder injuries are very prevalent in this sport. The inhibition of the stabilizing musculature can alter joint positioning and its normal biomechanics. Objective. To evaluate the efficacy of a program of stability exercises, scapulothoracic and glenohumeral, in the improvement of shoulder stability and sports performance, in boulder climbers. Material and method. Forty randomized subjects will be recruit into two groups: experimental (scapulothoracic and glenohumeral stability exercises) and control (glenohumeral stabilization). The stability of the shoulder (Closed Kinetic Chain Upper Extremity Stability Test) and the sports performance (Climbing Test) will be evaluated. The intervention last 6 weeks, with two weekly sessions of 30 minutes each. Differences between evaluations will be analyzed with the t-sudent for related samples and the intra- and intersubject effect with the repeated measures ANOVA test.

NCT ID: NCT03843970 Recruiting - Hip Fractures Clinical Trials

Hemodynamic Safety of Levobupivacaine vs Bupivacaine in Patients Over 65 Years Undergoing Hip Surgery

Start date: June 14, 2018
Phase: Phase 4
Study type: Interventional

The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.

NCT ID: NCT03841981 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Body Fat as Determinant of Female Gonadal Dysfunction

Start date: January 31, 2020
Phase:
Study type: Observational

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be: Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle. Secondary objectives: 1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution. 2. To study body composition and body fat distribution in these women and their relationships with: 2.1, Sex steroid profiles. 2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure. 2.3 Markers of low-grade chronic inflammation. 2.4. Oxidative stress markers. 2.5. Cardiovascular autonomic function. 2.6. Surrogate markers of subclinical atherosclerosis. 2.7. Circulating concentrations of endocrine disruptors. 2.8. Oral and gut microbiome. The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

NCT ID: NCT03839771 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

HOVON150AML
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

NCT ID: NCT03838718 Recruiting - Clinical trials for Retroperitoneal Sarcoma

REtroperitoneal SArcoma Registry: an International Prospective Initiative

RESAR
Start date: September 1, 2016
Phase:
Study type: Observational [Patient Registry]

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: - to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. - patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: - to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; - to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; - to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; - to utilize collected pathological material for research collaborations.

NCT ID: NCT03836040 Recruiting - Migraine Clinical Trials

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

OASIS(EM)
Start date: July 19, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

NCT ID: NCT03834207 Recruiting - Depression Clinical Trials

A Study of the Usefulness & Usability of a Healthcare IT System for Managing Multi-morbidity and Poly-pharmacy

C3-Cloud
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

To assess the acceptability of a personalised ICT tool that facilitates coordinated care planning, treatment optimisation and patient self-management for patients with multiple long term conditions and their team of health professionals.

NCT ID: NCT03833336 Recruiting - Clinical trials for Heart Failure With Normal Ejection Fraction

Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)

PREFER-HF
Start date: August 23, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether the administration of iron to patients with heart failure and preserved ejection fraction results in an improvement of symptoms and functional class, in addition to evaluating whether oral iron is equivalent to intravenous iron to achieve this improvement.

NCT ID: NCT03833154 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

PACIFIC-4
Start date: March 6, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

NCT ID: NCT03832959 Recruiting - Atrial Fibrillation Clinical Trials

Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study evaluates the benefit of using the EnsoETM, a device device for esophageal temperature adjustments, during catheter ablation of atrial fibrillation. Half of participants will undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the other half will undergo catheter ablation with no esophageal temperature adjustment.