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NCT ID: NCT04163250 Completed - Clinical trials for Contrast-induced Nephropathy

Use of Urinary Cell-Cycle Arrest Biomarkers in Contrast-Associated Nephropathy After Coronary Angiography

Start date: June 1, 2019
Phase:
Study type: Observational

Radiological examinations that require the administration of iodinated contrasts (IC) for diagnostic and therapeutic purposes are essential in current clinical practice, and their use in interventional procedures has been progressively increasing. IC can cause kidney damage, so there is caution in their use in at-risk populations. This fact may limit its diagnostic use, with data on underutilization of interventional techniques in patients with renal insufficiency, which worsen their prognosis. In addition, once the use of IC contrasts is decided, preventive measures, such as hyperhydration,are used and can have potential side effects, especially in patients at risk of heart failure (acute coronary syndrome, low left ventricular ejection fraction). New biomarkers of kidney damage have recently been developed, based on the detection of molecules expressed by the kidney in situations of early damage. The quantitative determination of cell cycle arrest proteins (Tissue Inhibitor of metalloproteinase 2 (TIMP2) and Insulin-Like Growth Factor Binding Protein -7 (IGFBP7)) can be predictive of the development of moderate to severe contrast-associated acute kidney injury. Urinary determination of [TIMP-2] x [IGFBP7] in patients with ACS (acute coronary syndromes) before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures.

NCT ID: NCT04163016 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

CHERISH
Start date: June 19, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.

NCT ID: NCT04162249 Completed - Atrial Fibrillation Clinical Trials

High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.

POWER_FAST
Start date: September 15, 2017
Phase:
Study type: Observational

The POWER FAST I pilot study is a unicentric, observational, non-randomized controlled clinical study. In the control group pulmonary veins isolation was performded in consecutive patients with irrigated radiofrequency cateters without contact force-sensing capabilities and using conventional low-power and long-duration radiofrequency parameters (20-30 W, 30-60 s) under continuous intracardiac-echo image and esophageal temperature monitoring. The study group consist of consecutive patients distributed in three succesive subgroups. In the study group radiofrequency ablation was performed using a point-by-point technique with contact-force catheters with different high-power and short-duration parameters: - Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall). - Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g. - Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. The safety endpoint was evaluated with systematic esophageal endoscopy performed <72 h after the index procedure. The efficacy endpoint was evaluated: - during the ablation procedure: acute procedural efficacy, firts-pass isolation of ipsilateral pulmonary veins, total radiofrequency and procedural time, acute reconnections and dormant conduction, - during the follow-up: any atrial tachycardias documented and longer than 30 s were considered recurrences.

NCT ID: NCT04162080 Completed - Athletes Clinical Trials

Kayak Polo Athletes

KYAth
Start date: December 1, 2019
Phase:
Study type: Observational

Kayak polo (KP) is a sport that, as a breviary, can be defined as the union between water polo and canoeing. The objective of this study is to compare anthropometric parameters, joint assessment, strength and functional capacity between two groups of KP players from the Valencian Community. The sample will be divided into a Sub21 group and a Senior group. Anthropometric variables (body mass index [BMI], percentage of fat mass, waist - hip index [CHF], body perimeters ...), shoulder assessment (Range of movement in rotations, Scapular Dyskinesis Test [SDT]) will be assessed. glenohumeral instability ...), hip assessment (modified Thomas test), strength (Hand Grip Strength test and upper limb thrust), lower limb power (Counter Movement Jump [CMJ]) and functional capacity (1 'push-ups for limbs upper and 1 'Sit-to-Stand test for lower limbs).

NCT ID: NCT04161495 Completed - Clinical trials for Factor VIII Deficiency

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

XTEND-1
Start date: November 19, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for the prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life outcomes. - To evaluate the efficacy of BIVV001 for perioperative management. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.

NCT ID: NCT04161300 Completed - Athletic Injuries Clinical Trials

Foam Rolling and Orthopaedic Manual Physical Therapy in Athletes

FRvsMTAth
Start date: November 15, 2019
Phase: N/A
Study type: Interventional

The main objective of the present study was to evaluate whether FR massage is effective in improving dynamic balance, flexibility and dynamic strength after intense exercise recovery compared to OMPT protocol or a control group. The present study was a randomized controlled trial. Amateur athletes will be recruited from two athletic clubs. Participants will be randomizing and allocating into three non-balanced groups through a computer software by an external assistant who will be blinding to the study objectives: FR group (n = 18), OMPT group (n = 15) and control group (CG) (n = 14). The intervention period will be lasting one day (1 session). Participant assessment will be perform twice: prior to the study (pre-intervention) and immediately after finishing the intervention (post-intervention). Interventions: FR group. FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes; OMPT group. Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; The total duration will be approximately 10-15 minutes.; CG. The CG did not receive any intervention. Outcomes will be Lumbar flexibility, Hip flexion, Dynamic balance, Standing Jump and Impression of Change.

NCT ID: NCT04161274 Completed - Skin Tags Clinical Trials

Randomized Clinical Trial on Skin Tags Approachment.

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

Skin tags are a benign dermal disease very frequent in the general population. Their exeresis is indicated in case of discomfort of the affected person (usually because of friction or increase in size). In the minor surgery guidelines, their extraction is recommended with cryotherapy, electrocoagulation or shaving with cauterization of silver nitrate (traditional healing techniques). This randomized clinical trial proposes its extraction with a non before referenced technique in the manuals of minor surgery and that is nowadays applied with very good outcomes in the domain of pressure ulcers, chronic wounds and, in recent years, in acute wounds; the moist healing environment. Therefore, the investigators propose the surgical exeresis of the fibroid in the most proximal part of the pendulum with the subsequent placement of a thin hydrocolloid dressing. The objective of this trial is to compare the traditional healing with the moist healing environment in minor surgery, analyzing costs, time invested by the professional, healing time and their respective complications. Expected results: faster healing and lower cost are expected with the new technique. By contrast, more complications are expected in the techniques of cryotherapy and silver nitrate. Applicability / Relevance: it is a common pathology usually treated in the minor surgery office or routine visit. Therefore, it can show us which treatment leads to fewer complications for the patient and which is more cost-efficient for the health system.

NCT ID: NCT04161222 Completed - Clinical trials for Injuries:Knee Injuries

Effectiveness of a Protocol of Specific Activation.

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

In football, knee is the joint that suffers the most severe injuries. Sometimes, this is produced by poor pre-activation of the musculature that is responsible for knee stability and central stability. OBJETIVE: Study the efficacy of specific gluteus medius and core activation protocol in knee stability in youth football players.

NCT ID: NCT04159805 Completed - Myasthenia Gravis Clinical Trials

A Study of TAK-079 in People With Generalized Myasthenia Gravis

Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

Myasthenia gravis is an autoimmune condition that causes muscle weakness. Autoimmune means the body makes antibodies that attack its own cells and tissues. These types of antibodies are also known as autoantibodies. People with generalized myasthenia gravis have a weakness in many muscles. TAK-079 is a medicine to help people with generalized myasthenia gravis. The main aim of this study is to check if people with generalized myasthenia gravis have side effects from 2 doses of TAK-079. Other aims are to learn if TAK-079 improves their clinical condition and lowers their autoantibody levels. At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will continue with their standard medicines for this condition during the study. Each participant will have a check-up by the study doctor. Then, the participants will have 1 of 3 treatments: - A low dose of TAK-079. - A high dose of TAK-079. - A placebo. In this study, a placebo looks like TAK-079 but does not have any medicine in it. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. For each treatment, participants will receive injections just under the skin, once a week for 8 weeks. The study doctors will check for side effects from the study treatments. The study doctors can stop or delay the injections in each participant if needed. Then, the study doctors will continue to check for side effects for up to 24 weeks after treatment. They will also check the clinical condition of the participants, including their autoantibody levels.

NCT ID: NCT04159623 Completed - Clinical trials for Application Site Atrophy

Clinical Applicability of the Device Belk in the Rehabilitation Process

Start date: November 10, 2020
Phase: N/A
Study type: Interventional

Pilot, interventional, randomized of parallel groups and multicenter clinical trial.