cyrilzakka/clinical-trials huggingface dataset:
Probiotics for the Prevention of Major Complications of Cirrhosis

The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.

Colonic bacteria clearly play a major role in the pathogenesis of major complications in patients with liver cirrhosis. By producing ammonia and endotoxins they can cause hepatic encephalopathy , and their translocation from the gut to the peritoneal cavity is the major mechanism for spontaneous bacterial peritonitis. There are also new studies suggesting a possible connection between bacterial translocation and bleeding from esophageal varices. Some of the therapeutic measures for the treatment and prevention of complications in cirrhotic patients, such as antibiotics and lactulose, are partially directed against gut bacteria.

In recent years there is a growing interest in the effect of probiotic bacteria on gut flora and prevention of infection. They were found to prevent pediatric infectious diarrhea and antibiotic-associated diarrhea- especially those caused by Clostridium difficile.

The probiotic bacteria, among which the most common are the lactose fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the gut mucosa and by that are thought to prevent bacterial translocation from the gut. These effects of probiotics raised the idea that they may have a role in the treatment and prevention of cirrhosis complications. A recent study examined the effect of probiotics on patients with minimal chronic hepatic encephalopathy. Hepatic encephalopathy was reversed in 50% of the patients receiving probiotics. These patients also demonstrated a significant reduction of blood levels of ammonia, bilirubin and ALT, and of pathologic bacteria in stool cultures. This study showed promising results but was carried out on a relatively small population. Furthermore, the effect of probiotics on the prevention of hepatic encephalopathy and other major complications of cirrhosis has not been studied yet. Therefore, more studies are needed to establish the role of probiotics in patients with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

Patients with liver cirrhosis with at least one of the followings

1)Major complication of cirrhosis in the past (including variceal bleeding, encephalopathy and SBP) 2)Evidence for portal hypertension 3)Reduced hepatic synthetic function

-

Exclusion Criteria:

1. Patients with alcoholic cirrhosis who still consume alcohol
2. Patients that are chronically treated with antibiotics or lactulose -
Osimertinib as 1st Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer

The present study will evaluate the use of osimertinib as 1st line therapy for patients with advanced EGFR positive non-small cell lung cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.

This will be an observational, multicentric, retrospective/ prospective analysis of patients with advanced EGFR positive non-small cell lung cancer that receive osimertinib as 1st line therapy. The patient data will be collected at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology during scheduled patient clinical visits, from February 2020 for a total period of three years. The biological material obtained from the patients of this analysis will be possibly used in a future translational study as an exploratory analysis.

Eligibility Criteria:
Inclusion Criteria:

* men or women of 18 years or older that live in Greece
* histologically or cytologically confirmed, advanced EGFR positive non-small cell lung cancer
* untreated patients for advanced NSCLC
* patients who are expected to receive osimertinib regardless of their enrollment in the study
* signed written informed consent

Exclusion Criteria:

* patients with cancer other than NSCLC that require treatment
* pretreated patients for NSCLC
* patients that receive or are expected to receive or have received an investigational drug/product/intervention
Lower Extremity Proprioception Sensory and Functionality in Hemiparetic

The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-65 and discharged from the hospital,
* Diagnosed with hemiparesis at least 4 weeks ago,
* First time and unilateral hemiparesis,
* Modified Rankin Score ≤ 3,
* Hodkinson Mental Test ≥ 6,
* Individuals who agree to receive treatment will be included in the study.

Exclusion Criteria:

* Having vision and hearing problems,
* Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis,
* Medically unstable,
* Diseases that will affect the lower extremity sense,
* Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants

The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.

This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.

Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.

Both parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.

For each neonates, neonatal parameters were collected.

5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.

In two investigation centers, at the end of the 6th month, immuno-allergic test was realised.

Stools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Term health newborn infant with gestational age ranging from 37 to 42 weeks
* Eutrophic
* Non breastfed children
* Apgar score \> 5 to 7 minutes

Exclusion Criteria:

* Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
* Evidence of protein cow milk allergy
* Infant presenting lactose intolerance
* Newborn whose parents did not provide informed consent
* Newborn currently participating in another trial
Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment

To determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health in improving global cognitive function and dual-task ability in older adults with mild cognitive impairment.

The primary aim of the study is to determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health, relative to a standard Tai Ji Quan intervention and an exercise stretching control, in improving global cognitive function and dual-task ability among community-dwelling older adults with amnestic mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* complaint of memory loss
* clinical dementia rating (CDR) scale score ≤0.5
* having normal general cognitive function screened, with MMSE ≥24
* capable of exercising safely, as determined by a healthcare provider
* willingness to be randomly assigned to an intervention condition and complete the 24-week intervention and 6-month follow-up

Exclusion Criteria:

* having medical conditions likely to compromise survival, such as metastatic cancer, or render a participant unable to engage in physical activity, such as severe cardiac failure
* participating in any type of Tai Ji Quan or daily and/or structured vigorous physical activity (i.e., brisk walking for exercise 30 minutes or longer at a time, or engaging in muscle-strengthening activities, e.g., weight lifting on 3 or more days per week 3 months prior to the study)
Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome

The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PCOS duration \> 3 months
* 12-17 years old
* BMI \> 75th percentile
* CESD \> 16

Exclusion Criteria:

* Weekly or bi-weekly therapy with licensed behavioral health provider
* Inability to speak, read, or write in English (teen)
* Major medical conditions
* HbA1c \> 7.0%
* Hormonal contraception \< 3 months
* Metformin \< 3 months
* Antidepressants/psychotropic medications \< 4 weeks
CT Coronary Angiography for Type 2 Myocardial Infarction

This study is to explore whether a computed tomography (CT) scan of the heart arteries might improve the care of patients that have presented with a suspected Type 2 myocardial infarction (MI). The Investigators hope to demonstrate that these patients may be the ideal group of patients to benefit from cardiac CT scan imaging by; 1. confirming whether they have any disease in their heart arteries 2. demonstrating the severity of the heart artery disease 3. revealing an alternative cause for their presentation 4. avoiding the need for an invasive heart artery angiogram.

An increasing number of patients present to hospital with a heart attack (myocardial infarction, MI). Heart attacks can be caused by instability and narrowing in heart arteries (Type 1 MI) or strain on the heart (Type 2 MI). Type 2 MIs can be the result of other problems with the heart including inflammation and rhythm problems or other conditions such as infection or low blood count. Both Type 1 and Type 2 MI patients have increased risk of further problems following this presentation. Deciding whether a patient has suffered a Type 1 MI or a Type 2 MI can be very difficult leaving uncertainty for patients and health care staff. Often patients with Type 2 myocardial infarction are either referred for an invasive coronary angiogram (a procedure where dye is injected into the heart arteries directly) or have no further investigations. Invasive angiograms carry a small risk of complications including heart attack, stroke and, rarely, death.

Cardiac CT scanning has emerged in the last 20 years as the first test usually performed to investigate patients that present with stable chest pain symptoms to the outpatient department. The role of cardiac CT in patients that present as an emergency with a suspected heart attack is not yet established.

To date, there are no substantive data on the role of computed tomography coronary angiography (CTCA) in patients with known or suspected Type 2 MI. A pilot study is proposed to address the information gaps. The specific areas of uncertainty include feasibility of enrolling into an imaging trial during acute medical care, feasibility of randomisation (including compliance and cross-overs), incremental diagnostic value, safety (procedure and post-procedure) and healthcare resource utilisation. The study aims to address the gap in evidence highlighted by the recent European Society of Cardiology Guidelines for the management of acute coronary syndromes, 'evaluating diagnostic strategies to better classify patients according to their type of MI (Type 1 vs Type 2)'.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected Type 2 MI

Exclusion Criteria:

1. Unable to provide written informed consent
2. Known severe coronary artery disease
3. Previous PCI
4. Previous CABG
5. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
6. Tachycardia (\>75bpm) refractory to heart rate control
7. Pregnancy
Comparison of ACL Reconstruction With Stump Preservation and Stump Resection

To assess the clinical outcome in patients who had ACL reconstruction with preservation of the remnant and compare it with patients in whom the stump was resected

100 patients are subjected to ACL reconstruction. Half of them had ACL reconstruction with Stump preservation and the other half had ACL reconstruction with stump resection.

The clinical outcome in both groups is assessed and compared

Eligibility Criteria:
Inclusion Criteria:

* patients with torn ACL within 6 months

Exclusion Criteria:

* Old ACL injury Multi-ligamentous knee injuries Mal-alignments
Ultrasound Guided ESP Block Versus Intrathecal Morphine for Postoperative Analgesia in Major HPB Surgery.

To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
* patients with the American Society of Anesthesiologists (ASA) physical status I - II,
* Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.

Exclusion Criteria:

* Patient's refusal
* Allergy or contraindications to the study drugs,
* Infection at the site of injection,
* Coagulopathy,
* Psychiatric disorders
* Severely co-morbid patients,
* Chronic pain syndromes,
* Prolonged opioid medication,
Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD

Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.

The study is a randomized trial with crossover of consecutively recruited patients with symptomatic COPD. Each patient will participate in seven visits over a 3-4 week period. At the first visit patients will provide informed consent and then be familiarized with equipment and testing protocols. At visits 2 and 3 patients will inhale 2 puffs of albuterol HFA MDI, and then perform symptom limited incremental exercise on the treadmill or cycle ergometer (randomized order); after a one hour rest, the patient will perform constant work exercise at 80-85% of peak VO2 on the same exercise mode.

At visits 4 - 7, patients will perform PFTs at baseline and at 30 and 120 minutes after inhaling arformoterol or normal saline (randomized order) and then constant work exercise on the treadmill or cycle ergometer (randomized order). Metabolic measurements will be made throughout exercise, and patients will provide continuous ratings of breathlessness and leg discomfort using a system consisting of a computer, monitor, and a mouse.

Eligibility Criteria:
Inclusion Criteria:

* male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of \< 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 \< 80% predicted; a post-bronchodilator FEV1/FVC ratio \< 70%; and clinically stable condition.

Exclusion Criteria:

* any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing
EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS

The aim of the study is to compare, in patients with patellofemoral joint disorders, the values related to the bone indexes of this joint, obtained from CT performed both in orthostatism and clinostatism

The aim of the study is to compare, in patients with patellofemoral joint disorders, the values related to the bone indexes of this joint, obtained from CT performed both in orthostatism and clinostatism.

Young patients with patellofemoral joint pathology, for which a diagnostic examination is necessary in order to determine a possible surgical indication, will be included in this pilot study, and will be evaluated using the "Cone Beam Computed Tomography "(CBCT), a machine that use a low dose of radiation compared to traditional CT systems, and allows the examination in supine and standing position knee . In this way, for the same patient it will be possible to calculate the bone indexes both in weight-bearing condition and in non-weight-bearing, comparing the values between them, to identify possible differences due to the influence of orthostatism.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, between 18 and 50;
2. Pathology or suspected patellofemoral joint pathology in which a CT examination is required for a diagnostic examination;
3. Signature of informed consent.

Exclusion Criteria:

1. Patients incapable of understanding and will;
2. Pregnant women;
3. Patients with history of previous fractures of the knee.
4. BMI\> 40.
Weekly Sirolimus Therapy

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.


Eligibility Criteria:
Inclusion Criteria:

* Patient 2 years of age and older
* Venous, lymphatic, or venolymphatic malformations

Exclusion Criteria:

* Children with contraindication to use of sirolimus
* Children with history of transplant
* Children with a history of natural immunodeficiency
* Children with a history of artificially induced immunodeficiency
* Children with a history of a serious or life-threatening infection
* Children taking CYP3A4 inhibiting medications
* Children taking strong CYP3A4 inducers to avoid subtherapeutic dosing/exposure.
* Inability or unwillingness of subject or legal guardian/representative to give informed consent
* Women that are or may become pregnant o Sirolimus is a Pregnancy Category C drug. No randomized controlled studies have been done on pregnant women. Women of childbearing potential must be on effective contraception prior to, during, and for 12 weeks following sirolimus therapy.
A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants

Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment to control the symptoms.

For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options.

In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Post-menarcheal age through menopause.
* Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
* Decision for the treatment with Visanne was made as per physician's routine treatment practice.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Any contraindication according to Visanne Chinese label
Mid-term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery

The purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (\> 75 years) undergoing open heart surgery at Hadassah medical center between 2008-2011. All alive patients will be phone interviewed using the 36-item short form health survey. Results will be compared to similar health survey results (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled group). The investigators hypothesize that elderly patients achieve improvement in quality of life after open heart surgery with acceptable operative morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* all patients age \> 75 years who discharged alive after surgery

Exclusion Criteria:

* death