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NCT ID: NCT06161324 Enrolling by invitation - Clinical trials for Urinary Incontinence

Tele-rehabilitation for Women With Urinary Incontinence: A Randomized Controlled Trial

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

We are conducting a study in Greece, where the prevalence of urinary incontinence (UI) in the female Greek population is 1 to 3 women (27%) . PFM training is effective for UI treatment, when occurs intensively (daily), with physiotherapy supervision for at least 3 months. However, adhearance to such intense treatment is very often compromised. We therefore believe that a telerehabilitation programme, such as a mobile application (app) in collaboration with a pelvic floor muscle sensor and with the simultaneous supervision of the physiotherapist (via the mobile app), will provide sufficient motivation for the patient to adhere with daily exercises. The development of tele-rehabilitation programs through mobile applications (mobile apps) has been a breakthrough for UI treatment. The pelvic floor muscle (PFM) exercise programs through mobile apps, provide optimal health care services by offering to the patients a therapy program in the convenient environment of their homes, with safety and less expense. Moreover, the majority of the existence mobile apps, work as simple verbal instructions, do not being tailored in patients' individual needs, and they are not able to assess the right direction of PFM contraction (inwardly and towards the navel), which is necessary for the successful implementation of the PFM exercises. Therefore the main purpose of the study is to investigate the effectiveness of a tele-rehabilitation program, through a novel, innovative mobile app in cooperation with a pelvic floor muscle sensor, indicating the direction of the PFM contraction in real time, which might be effective in UI treatment. The mobile app as well as the pelvic floor sensor will be created for the needs of the present study. A secondary objective of the study will be to investigate the degree of adherence to PFM exercises and the degree of supervision, which needs in the tele-rehabilitation program. The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms. We believe that the contribution of the current research has a social and economic impact on the life of the Greek woman with incontinence and this lies in the fact that, it is a fast, easy-to-use, modern approach opening new horizons in the field of rehabilitation. In addition, the patient maintains her interest in the exercises, performs them safely, more economically in her own time and in a familiar environment of her choice. Finally, rehabilitation through the mobile app in cooperation with the pelvic floor transperineal sensor is an extremely useful clinical "tool" for Physiotherapists and patients, giving the opportunity to patients with mobility problems or with lack of transport or to them who live in remote areas, to treat their incontinence.

NCT ID: NCT06114368 Enrolling by invitation - Clinical trials for Achilles Tendon Rupture

Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture

Start date: March 5, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare the outcomes of two different surgical techniques (Endoscopic Flexor Hallucis Longus transfer - Group 1 vs Minimally Invasive primary repair - Group 2) for patients with acute Achilles tendon rupture. The main questions to be answered are: 1. Which group's patients are more satisfied? 2. Which group's patients appear to have a greater complication rate? 3. Which group's patients have greater calf and ankle circumference compared to the unaffected limb? 4. Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb? 5. Are group 1 patients characterized by strength deficit in hallux flexion power?

NCT ID: NCT06049693 Enrolling by invitation - Endometrial Cancer Clinical Trials

Iron Prehabilitation in Endometrial Cancer

IROGYN
Start date: January 1, 2023
Phase: Phase 4
Study type: Interventional

Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT06032988 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 2

Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes Mellitus in Greece

Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a matching placebo capsule that does not contain active ingredients). The main questions to answer are: 1. Will glycemic indices, i.e., glycated hemoglobin (HbA1c) and fasting blood glucose, be different in people taking the probiotic treatment, compared to those not taking it, after 6 months? 2. Will other metabolic indices, mostly blood lipid levels (total cholesterol, triglycerides, HDL- and LDL-cholesterol) and liver function tests, be different in people taking the probiotic treatment compared to those not taking it after 6 months? 3. Will adiposity measures (weight, waist circumference) be affected by probiotic treatment in the two groups? Studies in animals and humans, mostly of shorter duration (<12 weeks) so far, have shown a possible trend towards improvement with probiotic treatment in all these parameters, but longer-term studies are scarce, and in Greece, there is none. Since diabetes treatment is complex (usually involving many medications) and expensive, developing cost-effective functional healthcare products for regulating blood glucose more efficiently has been recognized as a beneficial alternative. Participants will be adult individuals (>18 years old) with T2D, followed at the outpatient Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece, who will be randomized to receive either a probiotic dietary supplement or a matching placebo capsule, once a day. They will be followed every 3 months (as is customary for diabetic patients). They will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric changes (weight, waist circumference, and blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).

NCT ID: NCT05919914 Enrolling by invitation - Clinical trials for Lateral Epicondylitis

The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.

BFR
Start date: April 29, 2023
Phase: N/A
Study type: Interventional

A randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (BFR) on pain perception in patients with lateral elbow tendinopathy (LET).

NCT ID: NCT05861544 Enrolling by invitation - Psychiatry Clinical Trials

NUTRItion-driven Detoxification of OPioid Addicted patiEnts

NUTRIDOPE
Start date: March 23, 2023
Phase: N/A
Study type: Interventional

The NUTRIDOPE (NUTRItion-driven Detoxification of OPioid addicted patiEnts) study is a clinical trial that aims to investigate the role of pomegranate juice consumption by opioid-addicted patients under buprenorphine and methadone on craving, which is the primary outcome, and other parameters. In detail, fresh pomegranate juice will be administered for 120 days (250 ml, 7 days/week) to the patients and craving as well as other psychosocial (e.g., depression, mood state, quality of life) and biochemical (i.e., blood redox status and inflammation) parameters will be evaluated. It is hypothesized that pomegranate juice will reduce craving probably through the improvement of blood redox and inflammation status. Pomegranate juice, which is the examined nutritional intervention, will be administered to the participants of the experimental group, whereas their counterparts in the control group will not consume any similar beverage as a placebo due to the objective difficulties of making one that will be identical and not separable with the fresh pomegranate juice.

NCT ID: NCT05685303 Enrolling by invitation - Heart Failure Clinical Trials

Alleviant ALLAY-HF Study

Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

NCT ID: NCT05626751 Enrolling by invitation - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

NCT ID: NCT05612243 Enrolling by invitation - Healthy Clinical Trials

Effect of Consumption of a Novel Functional Yogurt on Blood Biomarkers of Healthy Participants

FB-CL1
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the effect of a dietary intervention that includes the consumption of a novel functional yogurt (enriched with probiotics and polyphenols) on the blood biomarkers of healthy participants.