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NCT ID: NCT03805204 Recruiting - Forearm Fracture Clinical Trials

Vascularity of the Ulna and Its Association With Forearm Nonunion

Nonunion
Start date: December 18, 2018
Phase:
Study type: Observational

Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely disabling and challenging to treat. Multiple factors have been associated with the establishment of this non-union. Many non-unions are associated with soft tissue damage, fracture site vascularity, persistent instability, infection, and the surgical treatment technique. This study analysed the systemic conditions and local factors associated with the failure of bone fracture healing The aim of our study was to identify the risk factors for ulnar nonunion

NCT ID: NCT03805100 Not yet recruiting - Clinical trials for Macular Degeneration

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

XPLORE
Start date: March 2019
Phase: Phase 3
Study type: Interventional

The objectives of this study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

NCT ID: NCT03803891 Recruiting - Colorectal Cancer Clinical Trials

Endoscopic Full-Thickness Resection In Colon

EFTRICOM
Start date: May 1, 2018
Phase:
Study type: Observational [Patient Registry]

Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) as a closure mechanism is a recent technique that allows the endoscopic resection of colonic lesions that are poor candidates for conventional endoscopic resection techniques. The aim is to study the safety and efficacy of EFTR in colon.

NCT ID: NCT03803540 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

FECAL MICROBIOTA TRANSPLANTATION FOR THE TREATMENT OF NON-ALCOHOLIC STEATOHEPATITIS

FMT-NASH
Start date: February 1, 2019
Phase: Phase 1
Study type: Interventional

Human microbiota is the set of microorganisms that, in a symbiotic way, coexist and develop in the different surfaces (skin and mucous membranes) of the human body. It is estimated that it is composed of approximately 10^14 bacteria and other unicellular life forms . The gastrointestinal (GI) tract is the organ in which the microbiota reaches its greatest complexity, influencing its metabolic activities in different organs and human systems. Human microbiota plays a role in multiple homeostatic and physiological functions including energy and intermediary metabolism, normal immune responses, and even appropriate bowel development and nervous system functioning. Given its vascular supply, the liver plays important roles in metabolism and immunological functions. It receives 70% of blood supply through the portal vein which carries all metabolic products derived from GI microbiota. Non alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries (with an estimated prevalence around 25 - 40% of adults) and it is expected that the burden of disease will increase in the near future. This condition can progress through a spectrum of progressive liver damage to non alcoholic steatohepatitis (NASH), liver fibrosis, cirrhosis and liver cancer. Around 20-30% of NAFLD patients develop NASH, with a lower rate progressing further to fibrosis and cirrhosis. Currently, there is no approved pharmacological or interventional treatment for the management of this so prevalent disease, apart from changes in lifestyle aiming weight loss. The aim of the present pilot study is to assess the efficacy and safety of microbiota manipulation by means of Fecal Microbiota Transplantation in the treatment of patients with NASH.

NCT ID: NCT03803462 Recruiting - Behçet Disease Clinical Trials

Behçet's Disease Overall Damage Index

BODI
Start date: August 1, 2017
Phase:
Study type: Observational

Damage in vasculitis, as well as in other chronic inflammatory disorders, accrues over time resulting in impairment of quality of life, development of disability and increased mortality. For these reasons, damage represents an important outcome to be assessed and measured both in trials and clinical practice. Currently, the most widely used assessment tool for damage in vasculitis is the Vasculitis Damage Index (VDI). However, VDI was developed for a no specific type of vasculitis and it appears to be more suitable for damage assessment in ANCA-associated vasculitis than in Behçet' disease (BD). BD is a chronic and multisystem inflammatory disorder classified among vasculitides. As well as in other vasculitides, disease activity and treatment in BD can result in the development and accumulation of irreversible organ damage, such as blindness, tissue loss and a wide range of neurologic disorders. Recently the OMERACT has defined the Core Set domain of Outcome Measures for BD. Despite damage is included in the OMERACT outcome core set for rheumatic disease, a specific assessment tool for BD is currently not available. The aim of this study is to develop and validate the first tool for describing and measuring organ damage in patients with Behçet Disease (Behçet's disease Overall Damage index - BODI).

NCT ID: NCT03803280 Recruiting - Major Surgery Clinical Trials

Implementation of Enhaced Recovery Protocol in Spain (IMPRICA)

IMPRICA
Start date: July 15, 2016
Phase:
Study type: Observational [Patient Registry]

The main objective is the multicenter and uniform implementation of a consensued perioperative evidence based program emanated from the Enhanced Recovery for abdominal surgery pathway (RICA) published by the Spanish MSSSI and the IACS, in hospitals of the National Health Network. The evaluation and outcomes of such implementation is proposed as a secondary objective. Different established indicator will compared traditional care results with those from the new program in the short and medium term. 10 interested hospital centers are selected. In each of them a retrospective study will be conducted to analyze the clinical results obtained in abdominal surgery in the past six months. After making the necessary training to clinical teams and assure the project development and implementation in each center, a prospective study in which all patients in the program are being recruited will be held. Hospital stay as well as perioperative mortality and morbidity will be collected. We will analize data from: days of hospital stay (potential and actual), efficiency (cost/procedure), quality of care, time to complete reintegration into family, social and labor environment and quality of life.

NCT ID: NCT03803241 Recruiting - Colorectal Cancer Clinical Trials

Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.

cellcol
Start date: May 2015
Phase: Phase 2
Study type: Interventional

Treatment of patients with metastatic colorectal carcinoma is surgical resection. Only 10-15% of the patients will be candidates for curative resection. After response to chemotherapy this figure rises 10-13% more. To perform the surgery it is necessary to have a sufficient remnant liver volume (RLV), which allows maintaining optimal liver function after resection. If the estimated RLV is insufficient preoperatively, portal venous embolization site (PVE) is performed for compensatory hypertrophy, thus increasing the number of resections 19%. Still, in 20% of these patients surgery can not be performed because RLV is not achieved or because the disease progresses while waiting for growth. Therefore, it is necessary to improve liver regeneration without promoting tumor growth. Studies on liver regeneration, have determined that cells (CD133 +) are involved in the liver hypertrophy that occurs after hepatectomy. CD133 + have been used to induce liver hypertrophy with encouraging results. This population of CD133 +, can be selected from peripheral blood after stimulation with Granulocyte colony-stimulating factor (G-CSF), being able to obtain a large number of them. The investigators propose to treat patients who do not meet criteria for surgery because of insufficient volume <40%, with CD133 + and portal embolization in order to carry out a surgical resection in a second place.

NCT ID: NCT03802604 Recruiting - Breast Cancer Clinical Trials

Combination of Talimogene Laherparepvec With Atezolizumab

PROMETEO
Start date: December 10, 2018
Phase: Early Phase 1
Study type: Interventional

PROMETEO is a window opportunity, single arm, exploratory study to evaluate the effect of T- VEC combined with Atezolizumab in women with operable early breast cancer who present residual disease after Neoadjuvant Chemotherapy (NAC). Other eligibility criteria include TNBC or LumB like primary tumor sized at least 1.5 cm, ECOG PS 0-1 and evaluable diagnostic tumor sample.

NCT ID: NCT03801109 Recruiting - Fibromyalgia Clinical Trials

Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia

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

Fibromyalgia syndrome (FMS) is a multisystem disease, characterized by generalized chronic musculoskeletal pain. In addition, there is a lot of care for fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function in general. Patients with fibromyalgia (FM) often show pain at specific points that are known as "tender spots or tender spots, with an increased sensitivity to painful stimuli" (hyperalgesia) and a decreased pain threshold (allodynia). which can be evidenced in the physical examination and in the absence of anomalies that justify in the biological or image tests. These pain points to pressure, based on the most specific and specific criteria for the diagnosis of the disease, traditionally based on the criteria of the American College of Rheumatology (ACR), according to which, should be presented so minus 11 out of 18 painful points to confirm it. Although the etiology remains unknown and unclear, its appearance is attributed to a problem of central sensitization, that is, changes in central processing, which causes an alteration of the mechanisms that regulate the sensation of pain, with amplification of nociceptive input . and perpetuation of painful stimuli. Fibromyalgia is becoming a common syndrome in the countries of Western Europe, with a prevalence in the general population that ranges between 1-3%, and specifically in Spain, around 2.4%. In addition, it has a higher incidence in women than men (73-95%), predominantly affecting women between the ages of 40-50 years. About 3% of women with fibromyalgia are at an age when menopause occurs, so not only do they experience the symptoms of both states but they even exacerbate the syndrome with each other. On the other hand, and in relation to its chronicity, the care of this type of patients involves large costs for society with a significant consumption of health resources in the field of primary care, as well as the costs of work absenteeism. For these reasons, it is considered an important problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease. The therapeutic approach includes low cost and easy access measures, such as physical exercise (EF) programs to improve the symptoms of FM. Physical exercise has positive effects directly on pain, joint and muscle stiffness, generalized sensitivity and fatigue, among others, and secondarily on cognitive disorders. Thus, the vast majority of studies focus on low-impact aerobic exercise, performed between 60% and 70% of the maximum heart rate two to three times a week. However, to date, there is no study that compares the effectiveness of physical exercise with other innovative therapeutic actions, such as transcranial magnetic stimulation (TMS), the hyperbaric chamber (HBOT), in parameters related to pain and quality of life. the life of patients with fibromyalgia. The general objective is the effectiveness of transcranial magnetic stimulation and the hyperbaric chamber in women with fibromyalgia. As specific objectives we propose: To assess the effect of HBOT, TMS and EF on quality of life in women with fibromyalgia. - Object the effect of HBOT, TMS and EF in cortical functioning. - Evaluate the effect of HBOT, TMS and EF on fatigue. - Evaluate the effect of HBOT, TMS and EF on psychological aspects, such as depression and anxiety. - Evaluate the effect of HBOT, TMS and EF on the perception of pain and the number of painful points. - Evaluate the effect of HBOT, TMS and EF on the quality of sleep. - Evaluate the effect of HBOT, TMS and EF on the quality of life. - Evaluate the effect of HBOT, TMS and EF on the pain constructs. - Determine the effect of HBOT, TMS and EF on plasma endorphin levels.

NCT ID: NCT03800836 Recruiting - Breast Cancer Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Start date: February 13, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, open-label, multicenter study evaluating the safety and efficacy of ipatasertib in combination with atezolizumab and paclitaxel or nab-paclitaxel for patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) who have not previously received chemotherapy in the advanced setting. Two triplets; ipatasertib in combination with atezolizumab and paclitaxel (Paclitaxel arm) and ipatasertib in combination with atezolizumab and nab-paclitaxel (Nab-Paclitaxel arm) are being evaluated for first-line chemotherapy treatment for advanced TNBC. Cohort 1 will evaluate first-line chemotherapy treatment in advanced TNBC patients and Cohort 2 will contain biopsy assessments of TNBC patients who have progressed after at least one line of chemotherapy in the advanced setting.