cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome

This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

This clinical study is designed as a multicenter, randomized, placebo-controlled, double-blind, phase 4 study to evaluate the efficacy and safety of the combination therapy of Uro-Vaxom® Capsule and alfuzosin in patients with recurrent chronic prostatitis.

Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.

In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26.

The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male adults aged ≥19 to ≤55 at the time of obtaining the written consent
* Those who have t pain or discomfort in the pelvic or genital area
* NIH-CPSI (the National Institutes of Health Chronic Prostatitis Symptom Index) ≥ 15 in total score
* voluntarily signed the informed consent form to participate in this study

Exclusion Criteria:

* Prostate specific antigen (PSA) ≥ 4.0 ng/ml at Visit 1 (screening)
* Received a prostate biopsy, surgery, or treatment within 12 weeks before Visit 1 (screening)
* Past or current medical history as Herpes infection treatment within 1 year before the Screening,Treatment for genital infections or sexually transmitted diseases and History of urogenital tumors.
* Those who have a medication history of the drugs(Drugs or health functional food, Health functional foods that affect prostate function etc)or have a plan to receive them during the study at Visit 1
Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing

Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can decrease the catheters colonization, closely related to infection thereof.

Objective: To determine the efficacy of the dressing "Tegaderm CHG" dressings versus "Tegaderm IV" dressings in reducing the risk of colonization of central intravascular catheters in the intensive care unit (ICU).

Methods: Randomized controlled trial with blinding professional who reviews the main outcome. The study included patients over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent. Excluding subjects with positive blood culture at the time of catheter implantation.

The estimated sample size is 398 patients, with a confidence level of 95% and a statistical power of 80%. The study protocol was approved by the ethics committee of the hospital.

Be made prospectively followed subjects from study entry until catheter removal collecting information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site and removal, reason for withdrawal and microbiological information.

For statistical analysis, a model is adjusted multivariate logistic regression, determining the interaction of variables with the likelihood ratio test and confusion by switching between the crude and adjusted effect greater than 10%.

Results and conclusions: The recruitment has started in November 2012 and is scheduled for completion in March 2013. This study will determine whether these new dressings are effective in our environment.


Eligibility Criteria:
Inclusion Criteria: over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent -

Exclusion Criteria:positive blood culture at the time of catheter implantation.

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Reducing Frailty for Older Cancer Survivors Using Supplements II

This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Be age 65 or over.
2. Be diagnosed with stage I-III Cancer
3. Have completed curative intent treatment ≤10 years prior to screening Patients on the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
4. Have a Fried's Frailty Score (FFS) of ≥ 1
5. Able to provide informed consent

Exclusion Criteria:

1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)

   * 3 times institutional upper limit of normal for ALT and AST
   * 1.5 times institutional upper limit of normal for bilirubin
3. Have uncontrolled or unmanaged liver disease.
4. Consume more than 6 cups of green tea per day.
5. Have known allergies to caffeine.
6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
7. Be diagnosed with dementia.
8. Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units

Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).

Secondary objectives will be:

1. to assess efficacy and safety of ECCO2R,
2. to compare the data issue from the registry to others studies assessing the same population and to other centers and
3. to compare the different ECCOR devices in terms of efficacy and adverse events.

The registry will be conducted prospectively during 2 years in 10 ICUs of l'APHP on behalf on the CEDIT. The 10 centers are : (1) ICU of l'hôpital europeén Georges Pompidou, (2) ICU of l'Hôpital Louis Mourier, (3) ICU of l'Hôpital de Bicêtre, (4) ICU of GHPS, (5) Respiratory ICU of GHPS, (6) ICU of l'Hôpital Lariboisière (7) ICU of l'Hôpital Cochin (8) ICU of l'Hôpital Saint-Antoine (9)ICU of l'Hôpital Henri Mondor and (10) ICU of l'Hôpital Tenon.

The primary outcome will be the number of patients implanted by ECCO2R monthly in each center during the 2 years period study.

Secondary outcomes will be ICU-mortality, invasive ventilation duration, non invasive ventilation duration, ICU duration, modalities of ventilation at the ICU discharge, hemorragic complications due to the ECCOR device, thrombotic complications due to ECCO2R device, intravascular hemolysis due to ECCO2R device, duration of ECCO2R, adjunct therapy to ECCO2R and reasons of ECCO2R discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with ECCCO2R

Exclusion Criteria:

* Contra-indication to ECCO2R
Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy

In this prospective study, patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy were included. The aim of this study is to assess the prevalence of tubal histopathological abnormalities such as Serous Tubal Intraepithelial Carcinoma (STIC) and tumor protein 53 (p53) signatures) as well as the prevalence of perioperative and postoperative complications related to opportunistic laparoscopic salpingectomy in a low risk population. The hypothesis is that prophylactic salpingectomy during benign laparoscopic hysterectomy is both feasible and innocuous. Peri- and postoperative complications, duration of salpingectomy and post-salpingectomy blood loss, histopathological and immunohistochemical analysis with anti-p53 antibody were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy

Exclusion Criteria:

* Hysterectomy in a context of gynecologic cancer
* Hysterectomy not carried out using laparoscopy
* Fimbriated end missing or damaged or impossible for pathologist to analyze
Brain Imaging Study of Brain Plasticity in Chronic Stroke Patients

In chronic stroke patients, brain network reorganization and recovery mechanism are investigated after stroke onset using functional MRI and diffusion tensor imaging analyses.


Eligibility Criteria:
Inclusion Criteria:

* more than 3 months post-stroke
* ischemic or hemorrhagic stroke
* a person who understands the experiment and has a willingness to participate and signs the agreement

Exclusion Criteria:

* User of artificial heartbeat
* Patients with claustrophobia
* Patients with metal implants
* Patients who are contraindicated for other common MRI
Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package

The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions.

This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package.

The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.


Eligibility Criteria:
Inclusion Criteria:

* Subject undergoing a percutaneous coronary intervention.
* Subject 18 years of age or older, or of legal age to give informed consent per state or national law.

Exclusion Criteria:

* Subject undergoing an emergency treatment
* Primary angioplasty for acute ST segment elevation myocardial infarction.
* Subject with contrast allergies
* Subject with severe kidney disease (e-GFR \< 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
* Subject participates in a potentially confounding drug or device trial during the course of the study.
* Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.
Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Previous studies of vitamin D supplementation have suggested there may be differences in response between individuals. This study is an open label study of vitamin D supplementation in patients with active or latent tuberculosis in which active disease patients take 100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex vivo markers of vitamin D response. Latent patients will only be studied for vitamin D response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells will be related to polymorphisms in the DBP gene, and that this may relate to clinical response in terms of post supplementation vitamin D level.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 or above
* Microbiologically or histologically confirmed active tuberculosis
* Clinically confirmed latent tuberculosis

Exclusion Criteria:

1. Patients being managed with regimes outside standard NICE guidance
2. Drug resistant MTb
3. HIV positive
4. Known intolerance of vitamin D
5. Sarcoidosis
6. Hyperparathyroidism or nephrolithiasis
7. Taking vitamin D supplementation in the two months preceding enrolment
8. Baseline serum corrected calcium \>2.65 mmol/L
9. Current haemodialysis
10. Children, pregnant or breastfeeding individuals
11. Concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC

The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* accordance with primary hepatocellular carcinoma diagnosis standard：cytohistology standard or non-invasive standard.1）+2）a or 1）+2）b+3）of the following are the non-invasive diagnosis criteria:(1)patients with HBV or HCV related liver cirrhosis.(2)radiological lesion(s) in liver with arterial hypervascularity and venous or delayed phase washout: a.one kind of imaging technology diagnosis for those with lesions\>2cm;b.two kinds of imaging technology obtains the consistent conclusion for lesions with diameter of 1-2 cm.(3)serum AFP level ≥400 ug/L lasting for more than 1 month or ≥200 ug/L lasting for more than 2 months, other diseases that may cause the AFP level increase can be excluded,such as pregnancy, genital or embryonic tumors and active hepatitis.
* age of 18 to 75 year,male or female
* life expectancy of 12 weeks
* Barcelona Clinic Liver Cancer (BCLC)stage B
* laboratory tests:(1)leukocyte\>3\*19\^9/L;(2)hemoglobin≥8.5g/dl;(3)platelet count ≥50\*10\^9/L,(4)ALT and AST were less than three times the normal limit;(5)albumin ≥ 3.0 g/dl;(6)total bilirubin acuities 3 mg/dl;(7)prothrombin time international standardization ratio (PT - INR) \< = 2.3 or prothrombin time (PT)more than normal compared 3 seconds;(8)serum creatinine is less than 1.5 times the normal of the upper limit
* patients with signed informed consent

Exclusion Criteria:

* concomitant malignancies distinct from HCC currently or previously
* allergic to subject agent(such as arsenic) or other agent related to the trial
* BCLC stage 0,A,C or D
* HCC accounting for the 70% of the liver size or more
* liver function Child-Pugh score of C
* ECOG score of 1 or higher
* severe heart diseases,such as congestive heart failure with cardiac function of New York Heart Association(NYHA)functional class II or severe, active coronary disease(except for who with myocardial infarction for more than 6 months) and cardiac arrhythmia needing medical management(except for that controllable by β-blockers、calcium channel blockers and digoxin )
* uncontrollable hypertension(diastolic blood pressure cannot be controlled below 90 mmHg even after antihypertension treatment by antihypertensive drugs).
* active severe infection(grade 2 or higher according to NCI-CTCAE version 4.0)
* active tuberculosis or pulmonary tuberculosis cannot be excluded
* CNS malignancies, including intracranial metastases
* gastrointestinal bleeding with clinical findings in the previous 30 days
* chronic renal failure
* pregnancy or breastfeeding
* any other unstable conditions or circumstances possibly to jeopardise the safety or compliance of the subjects.
Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia

Primary Objective:

Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving executive functions in patients with refractory schizophrenia as measured by the BADS.

Secondary Objectives: improvement of functional aspects,basic and instrumental activities of daily living,negative symptoms and cognitive functions improvement

Hypothesis: OT is more effective than control group to improve executive functions in patients with refractory schizophrenia.

A single-center, randomized, single blind, controlled study, lasting one year, including the follow-up.

The study is conducted in two groups:the experimental group is based on the OGI method (N=30 patients) and the control group receives craft activities (N = 30 patients).

Psychiatric, neuropsychological and functional aspects are assessed at the beginning, after 30 sessions and 6 months after the intervention. The scale PANSS (Positive and Negative Syndrome Scale) is used for monitoring psychopathological symptoms during the study.

Scales BADS, DAFS-R, ILSS-BR respectively assess executive functions, functionality and basic and instrumental activities of daily living. The neuropsychological evaluation includes a battery to measure attention, executive functions, memory and estimated intellectual efficiency.

Statistical analysis to be used: ANOVA (Analysis of Variance)for repeated measures; data are also calculated to messure clinical efficacy, effect size and needed number to treat.

Eligibility Criteria:
Inclusion Criteria:

* Pacients with diagnosis of schizophrenia for DMS IV-R.
* Pacients that signed the consent in writing and receive explanations about the nature of the study.
* Patients who carefully counted another responsible person to provide reliable support to the patient and ensure adherence to the same study treatment.
* Patients with minimum education: five years (elementary school).

  * Patients who present rates below those expected for their age group in at least 3 of the executive functions assessed on neuropsychological tests, and evaluation of executive functions.
* Patients with stable clozapine and which have not been recently admitted (3 months).

Exclusion Criteria:

* Comorbid diagnosis of substance dependence or other psychiatric Axis I;
* History of head trauma and / or other neurological problems;
* Medical problems that compromise somehow the central nervous system;
* History of mental retardation;
* Patients treated with medication other than clozapine;
* Patients who are suffering other psychosocial treatments.
ECC5004 RBA FE Study in Healthy Participants

This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants

Eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods. In the first two treatment periods under fasted conditions, participants will fast for a minimum of 10 hours, then they will receive a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2. In the subsequent third and fourth treatment periods under fed conditions, participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants of non-childbearing potential
* Age of 18 to 65 years
* BMI of 18.0 to 32.0 kg/m2
* Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence
* Male participants agree to use contraception, or agree to practice true abstinence
* No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history
* Able to understand and sign and date informed consent

Exclusion Criteria:

* Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study.
* Concomitant participation in any investigational study of any nature
* Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing
* Serum calcitonin \> 20 ng/L
* Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
* Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC
* History of pancreatitis
* Significant allergic reaction to active ingredients or excipients of the study drug
* Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.
Rapid Flu Tests in Travelers With Fever

Influenza is a frequent cause of fever in returning travelers. Usually diagnosis rests on the clinical picture. Rapid flu tests are becoming increasingly popular, although their sensitivity and specificity are suboptimal. The objective of this study is to evaluate if rapid flu tests influence the medical management of returning travelers with fever, a population at intermediate risk for influenza infections.

Travelers are at risk of acquiring infectious diseases. Previous studies have estimated that about 11% of travelers develop fever during or shortly after their trip abroad. Influenza has been shown to be one of the most important cause of fever amongst travelers. A sero-epidemiological survey showed that 27 of 211 patients (12.8%) with fever during or after a trip abroad developed antibodies against the influenza virus. Another study showed that 13% of travellers, who consulted after return with flu-like symptoms, had PCR or culture-proven influenza. The incidence of influenza in travellers varies according to the seasons, but cases can be seen year round. In tropical countries transmission is year-long and in the southern hemisphere the flu epidemics occur during the summer of the northern hemisphere.

In most hospitals no confirmatory test for influenza is routinely done. For special cases a PCR or viral culture can be requested, but the results are only available after 48 hours for the PCR and after several days for the culture. It is suspected that the inability to confirm the diagnosis of flu contributes to the request of a greater number of useless investigations and inappropriate use of anti-infective treatments.

Rapid diagnostic tests are easy to use, relatively cheap and they yield a result within a clinically relevant time frame (30 minutes). For the detection of influenza there are a variety of rapid diagnostic tests on the market. The reported sensitivities and specificities are quite variable, but the new generations report median sensitivities of 70 - 75% and median specificities between 90 and 95%. The rapid tests are considered most useful in patient populations with a significant proportion of influenza cases. The WHO encourages to use rapid diagnostic tests for influenza in returning travelers with fever, considering that this patient population is at significant risk of acquiring influenza during their trip.

The aim of this study is to evaluate if rapid flu tests influence the medical management of returning travelers with fever

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* Returning from abroad within the last 14 days
* Documented fever of 38oC or above or anamnestic fever + cough or sore throat within the last 4 days before the consultation.

Exclusion Criteria:

* Unwillingness to participate