cyrilzakka/clinical-trials huggingface dataset:
Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity

The finding that the combination of the inactivated probiotic Bifidobacterium Lactis (BPL1), inulin as a source of soluble fiber and omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in a surimi matrix has positive effects on visceral adiposity , insulin resistance and plasma tryclycerides in a preclinical model of rats that present obesity induced by diet is the basis of the present hypothesis. This finding is based on the fact that these three bioactive compounds exert these effects through sensibly different and complementary mechanisms, which suggests that their combined use may have synergistic effects.

On this basis the present hypothesis is posed: the consumption of surimi enriched with inactivated probiotic BPL1, inulin and omega-3 fatty acids, in the same doses that have been effective in obese rats (SIAP), can induce a reduction of more than 5% of visceral adipose tissue, being clinically relevant in people with abdominal obesity.

If the effect on abdominal obesity is associated or not with a lower glycemia and / or absorption of fats induced by the consumption of surimi can be evaluated by monitoring these parameters for 4 hours after the ingestion of a breakfast high in fat.

The main objective of this study was to evaluate the effects of the consumption of surimi enriched with the probiotic BPL1, inulin and omega-3 fatty acids, on visceral abdominal adiposity in people with abdominal obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 years of age with a waist circumference ≥102 cm in men and ≥88 cm in women.
2. Sign the informed consent.

Exclusion Criteria:

1. Having any condition incompatible with nuclear magnetic resonance (RNM) tests, such as metallic implants or sensitive to magnetic fields, pacemakers or suffering from claustrophobia.
2. Having diabetes (glucose ≥ 126 mg / dL).
3. BMI values ≥ 40 kg / m2
4. Waist circumference\> 150 cm.
5. Present dyslipidemia (LDL cholesterol ≥ 189 mg / dL and / or triglycerides ≥ 350 mg / dL).
6. Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
7. Present chronic alcoholism.
8. Present some chronic gastrointestinal disease.
9. Present intolerances and / or food allergies related to the study product.
10. Presenting anemia (hemoglobin ≤13 g / dL in men and ≤12 g / dL in women)
11. Present some chronic disease in clinical manifestation.
12. Being pregnant or intending to become pregnant.
13. Be in breastfeeding period.
14. Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
15. Follow a hypocaloric diet and / or pharmacological treatment for weight loss.
16. Suffer eating disorders.
17. Being unable to follow the study guidelines.
Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.

This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18\~75 years old;
* T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,\<1500mg) constantly for at least 8 consecutive weeks;
* 7.5% ≤ HbA1c ≤ 10.0% at screening;
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2 at screening;

Exclusion Criteria:

* Any anti-diabetic therapy other than Metformin within 8 weeks before screening；
* T1DM;
* Received insulin therapy more than 14 days within 1 year before screening;
* Female who is pregnant, breast-feeding;
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;
* History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；
* History or presence of pancreatitis (acute or chronic);
* Presence or history of malignant neoplasms within the past 5 years prior to the day of screening
Phase I/II Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.

This is a phase I, dose-escalation study of bortezomib followed by a phase II study.

Phase I:

- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22, rituximab IV on days 8 and 15, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 15.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

- Consolidation therapy: Beginning 6-7 weeks after completing induction therapy, patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Phase II: Patients receive induction therapy and consolidation therapy as in phase I, with bortezomib administered at the MTD determined in phase I.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

A total of 24 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed follicular lymphoma
* CD20+ at time of diagnosis or subsequently
* More than 4 weeks since prior rituximab
* More than 3 weeks since prior anticancer therapy (6 weeks for nitrosourea or mitomycin C)
* More than 4 weeks since prior major surgery
* More than 2 weeks since prior investigational drugs

Exclusion Criteria:

* AIDS-related lymphoma
* History or evidence of CNS involvement
* Pregnant or nursing
* known HIV positivity
* serious medical or psychiatric illness that would preclude study participation
* myocardial infarction within the past 6 months
* congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities
* known hypersensitivity to rituximab, bortezomib, boron, or mannitol
* prior autologous or allogeneic stem cell transplantation
* prior radioimmunoconjugate therapy or prior exposure to murine antibodies
* prior external-beam irradiation to \> 25% of active bone marrow
Effectiveness of a Proprioceptive Neuromuscular Proprioceptive Neuromuscular Facilitation

Introduction: Paddle tennis is a popular sport which can cause lower limb injuries due to impaired flexibility, such as ankle dorsiflexion. To improve this, methods such as proprioceptive neuromuscular facilitation (PNF), eccentric exercises and electrical stimulation (NMES) can be used. Objective: To compare the effectiveness of a PNF program with one of eccentric exercise plus NMES in the weight bearing lunge, lateral step down and drop jump test in amateur paddle tennis players. Methods: Pilot randomized clinical trial involving 20 male amateur paddle tennis players.

Participants were randomly divided into two groups of ten. One group received a PNF protocol, while the another group was given an Eccentric+ NMES exercise protocol. During the study, range of dorsal ankle flexion (ROMDf) was measured, as well as the vertical jump and lateral step down capacity of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Be a professional padel player.
* Be over 18 years of age.
* Sign the informed consent to participate in the study.
* Completion of the IPAQ physical activity questionnaire (Annex 1) to assess the level of physical activity of the participants and to ensure that they meet the physical activity level of the participants and to ensure that they meet the requirements for requirements for participation in the study.

Exclusion Criteria:

* Traumatic or musculoskeletal history that may affect the performance of the study exercises, as determined in the exercises of the study.
* A neurological history that may cause impairment in the performance of the exercises.
* Use of orthoses that may generate alterations in the result.
* Difficulty in performing exercises as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
Compartmental Overpressures Associated to Reamed Intramedullary Nails

The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.

Compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. When reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. Diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. In fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-P value, which is the result of the mean arterial pressure minus compartmental pressure. If this one is less than 30 mm Hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.

Eligibility Criteria:
Inclusion Criteria:

* Tibial shaft fractures treated with intramedullary reamed nails

Exclusion Criteria:

* Tibial fractures treated with other types of fixation or nails not reamed.
Interval Training in Cardiac Rehabilitation

The purpose of this study is to determine whether high intensity interval training (INT) is more effective in suppressing platelet reactivity than continuous, moderate intensity training (CONT) in patients undergoing cardiac rehabilitation after percutaneous coronary intervention.

Background: Platelets play an important role in cardiovascular disease: First, they promote the development of atherosclerotic lesions, and second, platelets form vessel occluding thrombi on top of (ruptured) lesions, ultimately leading to thrombotic events like myocardial infarctions (MCI). Whereas acute, strenuous exercise causes platelet activation and transiently increases the risk for MCIs, long-term chronic exercise training results in a clear reduction of both platelet activation and MCI incidence.

Exercise training plays a key role in cardiac rehabilitation, since improvements in cardiorespiratory fitness (CRF) are associated with decreased mortality in these patients. With respect to CRF improvements, high-intensity interval training has been demonstrated to be more effective than moderate-intensity continuous exercise. However, the beneficial effect of high-intensity interval training on platelet function in patients with cardiovascular disease has never been investigated.

Scientific question: The aim of this study is to determine the effect of interval training in cardiac rehabilitation on platelet function.

Hypotheses: Cardiac rehabilitation with interval training components (INT) reduces

1. platelet activation and platelet reactivity at physical rest
2. changes of platelet activation and -reactivity induced by acute, strenuous exercise to a greater extent than cardiac rehabilitation consisting exclusively of moderate-intensity continuous exercise training (CONT).

Work program: 80 patients at the beginning of phase II cardiac rehabilitation will be randomly assigned to an interval group or to a control group. In both groups, patients will exercise 4x / week for 12 weeks. At the beginning, after 6 weeks and at the end an exercise test will be carried out. Blood will be taken before (platelet function at rest) and immediately after each exercise test (platelet function after acute, strenuous exercise). Basal platelet activation as well as platelet responsiveness towards a platelet agonist (platelet reactivity) will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* No regular exercise training within the last 6 months
* Dual anti-platelet therapy (low-dose aspirin plus ADP(adenosine diphosphate)-receptor antagonist)
* Status post percutaneous coronary intervention after recent acute coronary syndrome as underlying reason for current rehabilitation
* Eligibility for outpatient cardiac rehabilitation according to Table I in Niebauer et al. 2013 (PMID: 22508693)

Exclusion Criteria:

* Type II diabetes mellitus
* Aortic aneurysm / dissection
* Uncontrolled hypertension (\>180/110 mmHg)
* Pulmonary hypertension (\>55 mmHg)
* Previously known hereditary platelet disorders
* Disorders of plasmatic coagulation
* Anemia (Hb \< 13g/dl)
* History of end-stage liver or kidney disease
Pulmonary Rehabilitation of Patients With a History of COVID-19

This study will determine the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.

In December 2019, a novel coronavirus, SARS-CoV-2, appeared, causing a wide range of symptoms, mainly respiratory infection. In March 2020, the World Health Organization (WHO) declared Coronavirus Disease 2019 (COVID-19) a pandemic. COVID-19 has spread rapidly over several months, affecting patients across all age groups and geographic areas. The disease has a diverse course; patients may range from asymptomatic to those with respiratory failure, complicated by acute respiratory distress syndrome.

The main objective of this study is to assess the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.

The patients after COVID-19 will be included in the pulmonary rehabilitation protocol. The duration of rehabilitation will depend on the patient's condition: from 7 to 14 days.

Measurements:

* quality of life (WHOQoL-BREF)
* body composition (bioelectrical impedance analysis, BC-420 MA, Tanita)
* weight, height and BMI
* spirometry (Spirometr PNEUMO, abcMED)
* diffusion lung capacity for carbon monoxide (LUNGTEST 1000)
* morphology (CRP, D-Dimer, WBC) and gasometry (pCO2, pO2)
* chest computed tomography (CT).

These parameters will be recorded before the first day of rehabilitation (baseline), after completion of rehabilitation protocol, and three months after completion the rehabilitation protocol. A change in evaluated parameters will be assessed.

This will be a prospective, interventional, non-randomized study. All patients will be enrolled by Podkarpackie Center for Lung Diseases in Rzeszów.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients treated in Provincial Clinical Hospital No. 1 in Rzeszów/ Podkarpackie Center for Lung Diseases in Rzeszów,
* Patients with a history of COVID-19,
* Having obtained written informed consent (signed and dated) to participate in the study,
* Age at enrollment ≥ 18 years of age,
* No contraindications to pulmonary rehabilitation,
* No contraindications for body composition testing (bioelectrical impedance analysis).

Exclusion Criteria:

* Refusal to participate in the study,
* Patients with any acute disease in the last 3 months before baseline,
* Patients currently enrolled in any clinical trial,
* Currently infected patients with COVID-19.
Tx for Child Sexual Behavior Problems

A significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. Unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. This project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* A caregiver is willing to participate in treatment
* A clinically significant T-score on the Child Sexual Behavior Inventory
* Child is between the ages of 5 and 12, inclusive

Exclusion Criteria:

* Child and/or caregiver IQ below 70
* Active child and/or caregiver psychosis or suicidal/homicidal ideation
* Active substance use problems of the caregiver
Smoking: a Risk Factor for Pulmonary Arterial Hypertension?

Environmental factors may play a role in the genesis of pulmonary hypertension, especially in endothelial dysfunction. One widespread environmental factor associated with systemic endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact with other risk factors such as a genetic background and associated conditions. The existing studies which deal with this subject are only small single center case control studies providing less data. Therefore a large European multicenter study is necessary.

The investigators hypothesis are:

* a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to the unaffected general population.
* a history of tobacco smoke exposure is more prevalent in patients with PAH compared to CTEPH.


Eligibility Criteria:
Inclusion Criteria:

* pulmonary artery pressure \>25mmHg
* pulmonary capillary occlusion pressure ≤15mmHg

Exclusion Criteria:

* pulmonary artery pressure \<25mmHg
* pulmonary capillary occlusion pressure \>15mmHg
Covid-19 Pandemic and Pancreatic Surgery in Italy

Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.


Eligibility Criteria:
Inclusion Criteria:

all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods

Exclusion Criteria:

* patients under the age of 18
* inability to give informed consent
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as informed consent
* Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section

Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.

Hospital anxiety is commonly encountered, and it is reported to be seen in 60%-80% of patients who undergo surgery. There are many causes of preoperative anxiety including fear of death due to anesthesia or surgical procedure and fear of preoperative or postoperative pain.

Preoperative anxiety varies according to the patient's age, gender, educational status, history of previous operations, and medical status as well as the type of surgery and type of anesthesia. Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.

The anxious patients tend to prefer general anesthesia (GA) for cesarean section (CS). The patient refusal is the main contraindication for applying spinal anesthesia (SA) during CS. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods including preoperative visit, information, and music, listening to Holy Quran recitation, hypnosis, nitrous oxide, and benzodiazepines. Intravenous sedation can control the anxiety in 90% of patients subjected to spinal procedures. While the evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •

Exclusion criteria:

High risk pregnancy eg: pre eclampsia Absolute contra indiction for SA eg: severe anaemia Emergent CS. Patients with previous exposure to anaesthesia ( spinal or general ). Patients with educational level more than high school.