cyrilzakka/clinical-trials huggingface dataset:
Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. For primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (CT, MRI or histology). For secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment.

All work up, treatment and follow up are applied in standard of care fashion.

Eligibility Criteria:
Inclusion Criteria:

* all patients with focal liver lesions and liver cirrhosis

Exclusion Criteria:

* no consent
* under 18 years
Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.

A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. A prolonged hospital stay increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and total hospital costs.

The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel function in patients undergoing abdominal complete staging surgery for gynecological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Female patients preparing for complete surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancerwere assessed for eligibility. Exclusion Criteria: Exclusion criteria for the study
* included thyroid diseases,
* inflammatory bowel disease,
* complaints of chronic constipation (defined as two or fewer bowel movements per week),
* a history of prior abdominal bowel surgery, abdominal radiation, neoadjuvant chemotherapy,
* need for intensive care more that 24 hpostoperatively,
* nasogastric tube drainage beyond the first postoperative morning,
* bowel anastomosis and upper abdominalmultivisceral surgical approaches in relation to the debulking surgery.
Pilot Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection

Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and 80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause for liver transplantation in Chile. Even though treatments are evolving with new direct antiviral agents (DAAs) that are increasing response rates, there are several issues with these new approaches, including increased toxicity, need for using interferon and ribavirin, complex algorithms of treatment, high cost, limited effectivity in certain groups (liver transplant patients) and drug interactions. Treatments targeted at host factors required for the viral cycle are becoming increasingly explored as an alternative or complement to DAAs. It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter in the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an approved and generally safe drug used for the management of hypercholesterolemia. Our hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20 mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV RNA and core antigen in plasma, bile and feces.


Eligibility Criteria:
Inclusion criteria:

* Chronic hepatitis C defined as detectable HCV RNA for more than 6 months.
* Age \> 18 years old.
* Compensated liver disease (bilirubin \< 3mg/dL, unless having Gilbert´s syndrome, albumin \> 3 g/dL, INR \< 2, no hepatic encephalopathy, no ascites or recent -1 month- history of variceal bleeding).
* HCV RNA level \> 10.000 IU/mL.
* Signed informed consent document.

Exclusion criteria:

* History of cholecystectomy or known gallstones.
* Current HCV antiviral treatment.
* Medications for dyslipidemia in the preceding 2 months.
* Abdominal surgery that could alter biliary or intestinal anatomy.
* Evidence of sitosterolemia.
* Negative pregnancy test in urine (for females).
Foster With or Without Charcoal Block or Aerochamber Plus

The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator


Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* 18≤age≤45 years old
* BMI: 18≤BMI≤28 kg/m2
* Non-smokers
* Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm, measured after 5 min of rest in the sitting position
* Full comprehension: ability to use correctly the pMDI preparations; ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
* Informed Consent: signed written informed consent prior to inclusion in the study.

Exclusion Criteria:

* ECG (12 leads): clinically relevant abnormalities and/or QTc \>450 msec;
* Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study; in particular any abnormality in the lung functionality: FEV1 \<80% predicted values according to European Respiratory Society basing upon Quanjer et al. (25)
* Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness; in particular positive HIV1 and HIV2 serology and/or positive hepatitis serology indicating acute or chronic hepatitis B or C
* Allergy: ascertained or presumptive hypersensitivity to the active principles and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
* Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
* Medications: medication, including OTC, during 2 weeks before the start of the study. Any known enzyme inducing drug or enzyme inhibitor must be stopped at least 2 months before study start
* Investigative drug trials: participation in the evaluation of any drug within 3 months prior to the screening
* Blood donation: blood donations during the 3 months prior to this study
* Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>2 drinks/day, defined according to USDA Dietary Guidelines 2005 (26)\], caffeine (\>5 cups coffee/tea/day) abuse or smoking
* Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.
A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
* Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
* Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin
* Eligibility for treatment with an oral anticoagulant
* Further inclusion criteria apply

Exclusion criteria:

* Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma
* Planned surgical treatment for CVT
* Conditions associated with increased risk of bleeding
* History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
* Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
* Severe renal impairment
* Active liver disease
* Pregnancy, nursing or planning to become pregnant while in the trial
* Further exclusion criteria apply
Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum

This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary.

The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sperm). However, early data demonstrated that some individuals have persistent sperm in their semen despite treatment. We hope to be able to determine whether differences in intratesticular hormone levels account for persistent sperm production in men who do not reach counts of zero as compared to those who do in the male contraceptive study. This study will measure testosterone levels in the testes of men who are participating in male contraceptive studies. Testosterone will be measured in a small amount of testicular fluid at the end of the study treatment phase after sperm counts have been reduced to zero or very low levels.

Eligibility Criteria:
Inclusion Criteria:

* Male between 18-55
* In good health
* With normal sperm counts and willing to use an acceptable form of contraception during the study

Exclusion Criteria:

* Male in poor health
* Significant chronic or acute medical illness
* Skin conditions that might interfere with or be exacerbated by testosterone gel
* No history of alcohol, illicit drug or anabolic steroid abuse
* Abnormal reproductive function
* Participation in a long-term male contraceptive study within three months of screening
Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD

The objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. To this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (IBD) with and without associated primary sclerosing cholangitis (PSC-IBD).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of UC, CD or PSC-IBD
* Willingness, to follow a gluten-free diet for 78 weeks
* Stable therapeutic treatment for more 8 weeks
* For CD: Harvey Bradshaw index (HBI) of more 5 points, corresponding to a minimum of mild intestinal inflammation in CD
* For UC: Mayo Score of more 2 points, corresponding to a minimum of mild intestinal inflammation in UC
* Patient signed informed consent

Exclusion Criteria:

* Antibiotics during last 4 weeks
* Intake of probiotics
* Gluten-free diet is already practiced
* Concomitant diagnosis of celiac disease
* Positive serology for transglutaminase IgA / IgG antibody or deamidated gliadin IgA / IgG
* Breast feeding
* Pregnancy
PREhospital Prediction of the Risk of Intracranial Hemorrhagic Injury in the Elderly Patient with a Fall

Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software.

A callback at D7 for patients not transferred and/or not scanned will be carried out by a clinical research associate to gather information on the neurological evolution. If, during this telephone interview, the neurological evolution is not good (GOS-E score \< 7), an investigating physician will call back the patient or his trusted person/family/legal representative in order to carry out a medical assessment and propose appropriate management if necessary.

Patients who have undergone brain imaging will not be recontacted, as it has now been established that normal brain imaging performed on an emergency basis eliminates the risk of delayed cerebral hemorrhagic lesions, even in patients on anticoagulants.

Monocentric study at Toulouse University Hospital. A questionnaire collecting the elements of the study is made available to regulating physicians. All callers (≥ 65 years of age) contacting center 15 for head trauma following a fall from a height are eligible. The regulating doctor will take charge of the call according to the service's protocol, filling in the regulation form on the Appli-SAMU software. He will complete the questionnaire at a later stage, once the patient has been taken into care.

A callback at D7 for patients not transferred and/or not scanned will be carried out by a clinical research associate to gather information on the neurological evolution. If, during this telephone interview, the neurological evolution is not good (GOS-E score \< 7), an investigating physician will call back the patient or his trusted person/family/legal representative in order to carry out a medical assessment and propose appropriate management if necessary.

Patients who have undergone brain imaging will not be recontacted, as it has now been established that normal brain imaging performed on an emergency basis eliminates the risk of delayed cerebral hemorrhagic lesions, even in patients on anticoagulants. The medical records of these patients will be consulted by the clinical research team to collect the information required for the study.

Eligibility Criteria:
Inclusion Criteria:

* patient ≥ 65 years old
* call to the SAMU/centre 15 following a fall from a height (bed, chair, standing)
* proven or suspected head trauma

Exclusion Criteria:

* high fall kinetics (greater than 1 m or 5 steps, pedestrian knocked down)
The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse

The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.

The study is a multi-center, randomized trial of women with symptomatic utero-vaginal or post-hysterectomy vaginal vault prolapse desiring non-surgical treatment with a pessary. This study will compare outcomes in women randomized to vaginal estrogen cream or vaginal placebo cream.

Women who meet the inclusion/exclusion criteria will be evaluated. A pessary (ring with support) will be fit by an experienced physician. After successful pessary fitting, they will be randomly divided into experimental active medication and control groups. The experimental group will start intravaginal estrogen cream, and the control group will start intravaginal estrogen-free cream. Then patients will be followed every 3months until 1year.

The purpose of this trial is to evaluate the effect of intravaginal estrogen use on pessary treatment for pelvic organ prolapse, including short-term and long-term use rate, patient impression of improvement, improvement in symptom-specific quality of life and complication incidence.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic POP, stage II, stage III or stage IV
2. Postmenopausal women (patients with serum FSH\>40lu/L; or amenorrhea for 12 months)
3. Successfully fit with ring with support pessary
4. Ability to attend the clinical trial and follow-up
5. Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent
6. Willing and able to place vaginal cream

Exclusion Criteria:

1. Acute infection of internal genital tract
2. Hormone replacement therapy in recent 3 months
3. Suspected or untreated lower genital tract tumor
4. Genital fistula
5. Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc)
6. Life expectancy less than 1 year
7. Vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium≥5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer
8. The volume of post-voiding residual is more than 250ml. -
A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142)

This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily within two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment
* American Rheumatism Association (ARA) functional Class I, II or III
* Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID), a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing to maintain treatment during baseline phase
* Moderate to severe daily pain intensity on his or her current pain regimen
* Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
* Negative serum pregnancy test

Exclusion Criteria:

* Has not experienced at least 3 consecutive days of daily pain intensity \>4 on 10-point scale
* Severe hepatic insufficiency
* Advanced renal insufficiency
* Presence of gastro-intestinal ulcer disease with active bleeding or history of the same within the past 6 months or a presence or history of inflammatory bowel disease
* History of gastric, biliary (including gastric bypass surgery), or small intestinal surgery that results in clinical malabsorption
* Receiving or will likely require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
* Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease including a history of stroke, myocardial infarction or transient ischemic attack, and recent revascularization procedures
* Any other contraindications mentioned in the approved study drug European Union (EU) Summary of Product Characteristics (SmPC)
* Therapy with glucosamine and/or chondroitin sulfate for \<6 months prior to study start.
Education Against Tobacco Randomized Trial in Bosnia and Herzegovina

A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in Bosnia and Herzegovina. The primary endpoint is the change in smoking prevalence between the two groups.


Eligibility Criteria:
Inclusion Criteria:

Visiting grades 7-9 of regular secondary schools in Bosnia and Herzegovina.

Exclusion Criteria:

Not fulfilling inclusion criteria.
Daptomycin Vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia

This is an open label randomized controlled trial for patients with methicillin resistant S. aureus (MRSA) bloodstream infection which will directly compare the two most commonly used therapies, vancomycin and daptomycin.

This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)


Eligibility Criteria:
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:

Inclusion Criteria:

* Methicillin-resistant S. aureus bacteremia

Exclusion Criteria:

* Severe allergy or non-severe rash to vancomycin or daptomycin
* Suspected or confirmed MRSA pneumonia
* Known vancomycin minimum inhibitory concentration (MIC) greater than or equal to 2mg/L or daptomycin MIC greater than or equal to 1mg/L
High Volume Caudal Study

The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.


Eligibility Criteria:
Inclusion Criteria:

* 3 years old or less
* Weight \<= 13.3kg
* American Society of Anesthesiology Physical Status (ASA) 1 or 2
* Undergoing circumcision surgery
* Patients whose plan of care includes caudal block

Exclusion Criteria:

* Known allergy to clonidine, epinephrine, or amide local anesthetics
* Inability or unwillingness of parent or legal guardian to give informed consent