cyrilzakka/clinical-trials huggingface dataset:
Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis

Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)

Primary Objective The investigation seeks primarily to determine the performance of abdominal US examinations realized with TUP and CUS based on defined imaging criteria Secondary Objectives Evaluate satisfaction and comfort and reproducibility of use of the ultraportable US

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* All adult patients with viral hepatitis for which an ultrasound is planned

Exclusion Criteria:

* Known or suspected non-compliance
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrollment into the current study
Role Functioning Changes NOS

During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. This will happen in the context of providing treatment-as-usual to individuals who arrive seeking help with the early phases of mental illness.

The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan.

While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 26 years
2. Individuals seeking treatment for psychiatric symptoms in a clinical care setting
3. Able to provide informed consent (age 18-26)
4. Subjects must consent to a review of the medical records in order to track changes in clinical symptoms
5. Fluent in English

Exclusion Criteria:

1. Adults unable to consent
2. Individuals who have not reached the age of 18
3. Pregnant women
4. Prisoners.
Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)


Eligibility Criteria:
Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

* Written informed consent/assent is obtained.
* The patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are English-speaking.
* The patient has a previous diagnosis of ADHD and is currently receiving medication for the treatment of ADHD.
* The patient, or the patient's parent/legal guardian, is dissatified (VAS score \<50) with current ADHD medication (medication and reason for dissatisfaction documented).
* The patient is in good health as determined by a medical or psychiatric history, screening physical examination, and clinical laboratory evaluations.
* Girls who are postmenarche or sexually active, must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implant, or injected) in conjunction with a barrier method; intrauterine device (IUD); and abstinence.
* The patient's parent/legal guardian must be willing and able to comply with study procedures and restrictions.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

* The patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder, or pervasive mental disorder, that requires pharmacotherapy.
* The patient is satisfied with current ADHD medication and has no side effects.
* The patient is using other prescription medications for ADHD with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the baseline visit.
* The patient has used monoamine oxidase (MAO) inhibitors within 1 week before the baseline visit.
* The patient has used an investigational drug within 1 month before the screening visit.
* The patient has a known clinically significant drug sensitivity to modafinil or any of its inactive ingredients.
* The patient is pregnant or lactating. (Any patients becoming pregnant during the study will be withdrawn from study).
The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal

The purpose of this study is to investigate the effect of 4 days of sitting and moderate exercise on plasma triglyceride elevation after a meal.

Subjects will undergo three weeks (two intervention, one washout) of testing during which they will participate in two conditions: 1) prolonged sitting (\~14-hours/day) with a 1-hour bout of acute exercise at 65% of pre-intervention VO2max and 2) prolonged sitting (\~14-hours/day) without an acute bout of exercise. During each intervention week, subjects will have 2 days of dietary and activity control, followed by 4 days during which prolonged sitting will occur. On the evening of the 4th day, subjects in the exercise group will perform the acute bout of exercise. On day 5, all subjects will undergo a lipid tolerance test to determine the body's ability to clear triglycerides from the blood as well as insulin/glucose response and substrate oxidation. Blood samples will be assayed for the previously mentioned substances and postprandial gas collection will be analyzed via indirect calorimetry.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
* respiratory problems
* musculoskeletal problems that prevent prolonged sitting or exercise
* obesity
* susceptibility to fainting
Analysis of Surgical and Oncologic Outcomes After Complete Mesocolic Excision or Non-complete Mesocolic Excision for Right-Sided Colon Cancer

The goal of this observational study is to investigate the efficacy and safety of a modified D3 lymphadenectomy approach compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. The main question it aims to answer is:

Does a modified D3 approach improve disease-free survival (DFS) in patients with Stage I-III right-sided colon cancer who undergo right-sided colectomy, without increasing surgical complications compared to CME?

Patients with right-sided colon cancer, Stage I-III, who undergo either modified D3 lymphadenectomy or CME as part of their standard treatment, will have their DFS, complications, bleeding volume, number of lymph nodes harvested, and stage distribution compared over a follow-up period. This study ultimately aims to determine the optimal surgical approach for maximizing oncologic outcomes in right-sided colon cancer.

This observational, population-based, cohort study was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Approval was obtained from the institutional review board (IRB) of the primary institution and the ethics committees of each participating institution in the Republic of Korea. Given that the study utilized anonymized data retrospectively, the need for informed consent was waived.

The study aimed to evaluate the efficacy and safety of modified D3 lymphadenectomy compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020 were included. Patients were classified into those who received modified D3 lymphadenectomy or CME, and the study assessed disease-free survival (DFS), surgical complications, bleeding volume, lymph node yield, and stage distribution.

Data collection was carried out at multiple tertiary medical centers across the Republic of Korea, ensuring a broad representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, and Kyungpook National University Chilgok Hospital. These centers vary in location and size, enhancing the study's generalizability within the context of right-sided colon cancer management in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020
* Patients who received curative right hemicolectomy with lymphadenectomy

Exclusion Criteria:

* Familial adenomatous polyposis (FAP)
* Hereditary non-polyposis colon cancer (HNPCC)
* Patients with inflammatory bowel disease
* Patients with synchronous malignancies in other organs
* Patients with non-adenocarcinoma histology of colon cancer
Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.

OBJECTIVES:

Primary

* To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.

Secondary

* To determine the tolerability and safety of this regimen.
* To determine the duration of response.
* To determine the duration of survival.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2 courses in the absence of disease progression or unacceptable toxicity.
* Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8 of each month. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:

  * At least 20% of blasts in the bone marrow
  * AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
* No acute promyelocytic leukemia
* No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
* No active CNS leukemia

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy ≥ 4 weeks
* Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
* AST and ALT ≤ 2.5 times ULN\*
* Serum creatinine ≤ 1.0 mg/dL\* OR estimated glomerular filtration rate \> 60 mL/min
* No active uncontrolled systemic infection
* No concurrent active malignancy
* No HIV positivity
* No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: \*Unless due to organ leukemic involvement

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 2 weeks since prior myelosuppressive chemotherapy
* At least 48 hours since prior hydroxyurea
* No prior clofarabine or temsirolimus
* No prior allogeneic stem cell transplantation
* No investigational drug within the past 30 days
Selenium in the Treatment of Complicated Lymphatic Malformations

The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials.

Hypotheses:

* Selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations
* Disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have clinical and radiographic features consistent with a lymphatic malformation (LM). Patients with combined venous lymphatic malformations (CVLM) will be included if the predominant componet is lymphatic based on MRI. Both macrocystic and microcystic LM will be eligible. Tissue biopsy is required to confirm the presence of an abnormal lymphatic malformation.
* All patients diagnosed with lymphatic malformations between 14 and 30 years of age will be eligible.
* Patients must have lymphatic malformations with potential to cause morbidity including one or more of the following: Lymphedema, Coagulopathy, Chronic Pain, Recurrent Cellulitis (\> 1 episodes/year), Ulceration and/or bleeding, Impairment of organ function, Visceral and/or bone involvement, or Disfigurement.
* Patients receiving previous systemic therapy, surgical, debulking, or sclerotherapy will be eligible eight weeks following completion of therapy if they meet all inclusion criteria.
* All patients and/or their parents or legal guardians must sign a written informed consent. All institutional FDA requirements for human studies must be met.

Exclusion Criteria:

* Younger than 14 years of age or older than 30 years of age
* Life-threatening complications related to LM
* Patients with preexisting renal, hepatic, or thyroid disorders
* Patients receiving a daily multivitamin supplement or other natural products that include selenium
* Patients that have received previous selenium therapy will not be eligible
* Women who are pregnant or breastfeeding
Transversus Abdominis Plane Block Versus Erector Spina Plane Block

Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II,
* undergo elective lower abdominal surgery
* 2-6 years

Exclusion Criteria:

* Psychiatric patients,
* weight\> 40 kg,
* those with cardiac-pulmonary-neurological disease,
* those with bleeding disorders,
* infection or wound scarring at the injection site,
* known allergy to local anesthetics
VSL#3® vs Placebo in the Treatment of Fatigue and Other Symptoms in Long Covid (DELong#3)

This study aims to evaluate the effectiveness of VSL#3® in reducing Fatigue and other symptoms in Long Covid Syndrome compared to placebo.

Long Covid syndrome is a chronic condition characterized by persistent symptoms experienced by individuals who have recovered from acute coronavirus disease (COVID-19). Among the various symptoms reported, fatigue stands out as a particularly burdensome and pervasive issue, significantly impacting the quality of life and daily functioning of Long Covid patients. Recent studies report that gut microbiota is altered during acute illness and not restored even after several months from recovery. Based on this evidence, modulation of intestinal microbiota can be considered as a possible therapeutic approach for Long Covid Syndrome. On this basis, the aim of this study is to evaluate efficacy of VSL#3® compared to placebo in reducing Fatigue in Long Covid Symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18; \<65 yo
* Previous diagnosis of SARS-CoV-2 infection, documented by nasopharyngeal or antigenic molecular swab;
* Not currently be in quarantine or isolation;
* No antibiotics treatment in the 30 days prior to the trial;
* Chalder Fatigue Scale (in dichotomous form)\>=4 possibly associated with signs and symptoms of Long COVID-19 syndrome: signs and symptoms that develop during or after SARS-CoV-2 infection, which persist for more than 4 weeks and are not reasonably explained otherwise; signs and symptoms include: fatigue, sleep disturbances, cognitive deficits (i.e. brain fogging, loss of concentration and memory, anxiety, depression), strength deficits, arthralgias and myalgias, gastroenterological alterations (reduced appetite, nausea, changes in bowel habits, abdominal pain

Exclusion Criteria:

* Cardiovascular and pulmonary disease with moderately severe organ dysfunction (NYHA\>2, Borg scale\>=2);
* Decompensated endocrine and metabolic diseases (child cirrhosis \>= B, decompensated hypo/hyperthyroidism, decompensated hypoadrenalism)
* Diagnosis of FM, CFS/ME, and/or IBS prior to SARS-CoV-2 infection;
* Confirmed diagnoses of neurological pathologies, psychiatric diseases and cognitive disorders prior to SARS-CoV-2 infection;
* Previous confirmed diagnosis of chronic musculoskeletal pathologies prior to prior to SARS-CoV-2 infection;
* Refusal to participate in the study / refusal to process personal data;
* Pregnancy or breastfeeding;
* Addiction to alcohol or drugs in previous years;
* Use of other probiotics during the trial;
* Use of antibiotics during the trial and in the previous 30 days;
* Substantial change of diet during the trial;
* Participation in another clinical study in the previous 30 days or previous participation in this same trial;
* Known intolerance/hypersensitivity to the investigational drug or to the excipients of the placebo formulation
Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea

Clostridium difficile associated diarrhoea is an important cause of morbidity in patients treated with antibiotics, especially in hospital. Clinical relapse occurs after up to 30% of initially successful treatments for colitis. Preliminary reports suggest that Rifaximin, a poorly absorbed antibiotic used to treat travellers diarrhoea can prevent relapse. We plan to carry out a randomised placebo controlled trial to test the hypothesis that Rifaximin given in a reducing dose over 4 weeks after successful treatment will reduce the relapse rate.

Aims i) To examine efficacy of a follow-on course of Rifaximin given after a successful initial course of standard treatment, in the prevention of relapse in C. difficile associated diarrhoea (CDAD).

ii) To examine changes in faecal microbiota in patients given Rifaximin vs. Placebo.

Treatment 4 weeks treatment with Rifaximin or Placebo tablets. Tapering dose starting with 2 x 200mg tablets three times a day (total = 1.2g per day) for the 1st 2 weeks, reduced to 1 x 200mg tablet three times a day (total = 0.6g per day) for the 2nd 2 weeks.

Primary endpoint: The difference in % relapse between Rifaximin and placebo at 12 weeks

Eligibility Criteria:
Inclusion criteria:

1. Men / Women aged 18 and over (We will also include those adults who lack mental capacity for whom we have a legal representative)
2. Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines).

Exclusion criteria:

1. Woman of child bearing potential and not willing to use at least one highly effective contraceptive method throughout the study
2. Male with spouse/partner of child bearing potential and not willing to use condoms
3. Pregnant or breast feeding
4. Unable to swallow tablets
5. Life expectancy of \<4 weeks
6. Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of its excipients (Tablet core: Sodium starch glycolate type A, glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose. Tablet coating: hypromellose, titanium dioxide (E171), disodium edentate, propylene glycol and red iron oxide E172)
7. \>5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD
8. Taking ciclosporin
Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss

Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has been widely used in obese patients to reduce their weight but also to decrease morbidity conditions related to obesity. It could be involved in an improvement in liver lesions observed in obese patients. To evaluate the severity of liver lesions, the gold standard is pathological examination of the liver using percutaneous or surgical biopsies, with a scoring called Fibrosis score stage. Alternative less invasive techniques have been developed to evaluate liver lesions. These tests are commonly used in clinical hepatology and consisted of serum levels determination of fibrosis markers (Fibrotest, Transthyretin).

The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a population of patients operated on for morbid obesity ( BMI \> 40kg/m2 or BMI\> 35kg/m2 with comorbidity). The primary end point is to evaluate the concordance between Fibrotest and transthyretin serum levels. The number of patients has been calculated on the basis of a concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in this study. According to the number of patients operated on in the 3 centres (\>150/year), the time for recruitment is 12 months. Secondary end points will evaluate in these patients the excess weight loss, the improvement in fibrosis liver tests and the correlation with improvement in other obesity- related conditions, according to surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* patients operated on for morbid obesity (BMI \>40kg/m2 or \>35kg/m2 associated with comorbidity)

Exclusion Criteria:

* contraindications to morbid obesity surgery