cyrilzakka/clinical-trials huggingface dataset:
Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy

It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases.

For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.

Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. While previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of liver metastases can be drawn from present data.

As disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for curative (R0) resection
* No evidence of extrahepatic disease
* No history of previous hepatic lymphadenectomy
* Age equal or greater than 18 years
* Written Informed consent

Exclusion Criteria:

* Expected lack of compliance
* Impaired mental state or language problems
* History of another primary cancer, except:

  * Curatively treated in situ cervical cancer or curatively resected non-melanoma skin cancer
  * Other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomisation
Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients

The link between post-stroke pathways and patient sequelae have not yet been clearly defined. The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode.

Stroke is a serious health event, involving the entire health care system and generating considerable socioeconomic weight for society. Knowledge of the components, the diversity and the scalability of post-stroke life pathways is currently not sufficient. Moreover the link between post-stroke pathways and patient sequelae have not yet been clearly defined.

The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode. The secondary objectives are: 1) To define a typology of the life pathways of stroke patients, , 2) To analyze the social and geographical inequalities in the management of stroke, 4) To estimate the cost of the pathway elements of stroke management; 5) Measure the sequelae of stroke patients at three months and one year after the acute episode.

The design is a prospective multicenter cohort study with a follow up to 1 year after the acute episode, managed in several hospitals in the Aquitaine region (France).

Eligibility Criteria:
Inclusion Criteria:

* Patient being over 18 years of age living in metropolitan France;
* Patient with recent stroke (not before 2019) whose diagnosis confirmed by a neuro-vascular physician;
* Patient managed for stroke in one of the 13 participating hospitals of the Aquitaine region;
* Patient giving consent to participate to PAPASéPA;
* Patient to be alive at the end of the acute management hospital stay

Exclusion Criteria:

* Patient refuse to participate to PAPASéPA
* Patient died during the initial stay
Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases with Dietary Treatment

The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months.

Inherited Metabolic Diseases (IMDs) are rare conditions, which are the consequence of a genetic defect affecting an enzyme or a transporter involved in metabolism. This enzymatic defect leads to the accumulation of a potentially toxic compound located upstream of the deficiency and/or the absence of a compound located downstream of the defect. Treatment is possible and it consists of dietary and/or drug treatment.

Pediatric Eating Disorders (PED) cover "all the difficulties of oral feeding. These may be disorders due to absence of spontaneous feeding behavior, or refusal to eat, and disorders which affect the child's entire psychomotor, language and emotional development.

To date, the investigators note the absence of data on the prevalence of PED in IMDs and more generally on the quality of life and psychomotor development of these patients.

The causes and mechanisms of PED are numerous and heterogeneous. Their origins can be endogenous and/or exogenous.

Our main hypothesis is that the presence of PEDs varies depending on the different categories of IMDs with dietary treatment. Estimating their prevalence would enable awareness and early, better quality care.

This study aims to obtain clear and consistent results from a validated scale. It is a single-site study prospectively including patients from the Necker-Enfants Malades hospital reference center.

Parents will be informed of the study by an investigator (psychomotor therapist or dietician) during a phone call, by email or in hospital prior to the inclusion visit.

On the day of inclusion, the parent's and the child's (depending on their age) non-opposition will be collected before carrying out any procedure and recorded in the patient's medical file.

The MCH (Montreal children's hospital) scale and the parental questionnaire will be proposed by the study investigators at the same time, in a physical interview.

The collection of medical data in the patient's file and the rating of the MCH scale will be done in parallel by the study investigators.

Eligibility Criteria:
Inclusion Criteria:

* Patient from 12 months to 6 years and 11 months old
* Patient with an Inherited Metabolic Diseases with dietary treatment
* Patient having experimented a dietary diversification at least 6 month prior
* Patient whose parents do not object to their participation in the study

Exclusion Criteria:

* Patient with an associated chronic disease
* Patient with diagnosed Autistic Spectrum Disorder (ASD) or Pervasive Developmental Disorders (PDD)
* Patient born before 36 weeks of amenorrhea
* Patient with multiple disabilities
* Patient with dystonia
* Patient with absent or unstable head posture
* Patient whose parents do not fully understand or speak French
Effects of Thai Dance With Twenty-five Squares in Elderly With Mild Cognitive Impairment

The objective of this study was to determine the effects of Thai dance with twenty-five squares on cerebrovascular and cognitive function in elderly with mild cognitive impairment

Twenty elderly with mild cognitive impairment aged 60 years and over were randomized into 2 groups: control group (CON; n=20) and Thai dance with twenty-five squares training group (TDT; n=20). Participants in CON group do their daily routine without receiving any training program, while those in TDT group completed receiving Thai dance with twenty-five squares training program three time a week for twelve week-long (60 minutes/time). The physiological data, cerebrovascular function, cognitive, respiratory function, health-related physical fitness, and Blood biochemistry variables were analyzed during the pre-test and post-tests. The dependent variables between pre-test and post-tests were analyzed by paired t-test. The variables between pre-test and post-test were analyzed by paired t-test. In addition, an independent t-test was used to compare the variables between groups. Statistical significance was defined as p \< .05.

Eligibility Criteria:
Inclusion Criteria:

* Elderly males and females aged 60-79 years who can lead normal daily lives. Individuals with mild cognitive impairment identified through the Montreal Cognitive Assessment (MoCA) with a score in the range of 17 - 25.
* Must be able to listen, speak, read, write, and understand the Thai language.
* Should not have diseases or abnormalities such as heart disease, eye complications caused by diabetes, uncontrolled high blood pressure, kidney complications caused by diabetes, and stroke.
* Must not have other respiratory diseases such as tuberculosis (Tuberculosis), asthma (Asthma), lung cancer (Lung cancer), emphysema (Emphysema), chronic obstructive pulmonary disease (COPD), etc.
* Must be a person not at risk of falling, determined through a test of the ability to walk and turn 3 meters within a time period of 7 - 15 seconds.
* Must not have received medication to treat dementia.
* Should not have received exercise training for more than 20 minutes at a time, 3 days/week, or more in the past 6 months before participating in the research.
* Should not have symptoms of mental disorders such as schizophrenia, bipolar disorder, or depression.
* Should have passed the pre-exercise readiness assessment (PAR-Q).
* Must be willing to participate in the research and sign the consent form to take part in the study.

Exclusion Criteria:

* A force majeure event, such as illness, that prevents participation in the research.
* Participation in less than 80% of the research sessions (must participate 29 times out of 36 times).
* Unwillingness to continue participating in the research.
A Survey on the Rate of Glucose Intolerance in Hong Kong Chinese

Hypothesis: There is a high rate of glucose intolerance among Hong Kong Chinese.

The investigators plan to screen Hong Kong Chinese from the community with oral glucose tolerance test (OGTT). The subjects will be referred from GP centers in the community and self-referred with public advertisement on this survey.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese without history of diabetes

Exclusion Criteria:

* known diabetic patients
Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)

The objectives of this study are to evaluate efficacy and safety of longan extract spray (P80 spray) in volunteers with coronavirus disease 2019 (COVID19).Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) are enrolled in the study. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). After that, they will be nasal swabbed for detecting COVID 19 infection. Adverse event will also be evaluated by physician or nurse.

Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) and pass inclusion criteria are enrolled in the study. The patients will be checked the clinical symptoms and chest x-ray by physician. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). Physician or nurse will ask for adverse events every day. After 3 days, the patients will be nasal swabbed for detecting COVID 19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Positive nasal swab test of coronavirus disease 2019 (COVID-19) (reverse transcriptase-polymerase chain reaction (RT-PCR) เป็นบวก (cycle threshold \<40))
* Mild symptom with normal chest radiograph
* No history of Chronic Obstructive Pulmonary Disease (COPD) and other chronic lung diseases, Chronic kidney disease (CKD), Cardiovascular diseases and congenital heart diseases, Cerebrovascular diseases, Poorly controlled diabetes,BMI \> 35 kg/m2, Cirrhosis, Immunocompromised condition
* Can read and write
* Vulnerable to participate

Exclusion Criteria:

* Allergic history to longan
* Uncontrollable disease status
* Pregnancy or lactation
* Participated in other studies
Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT

The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).

In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC

Eligibility Criteria:
Inclusion Criteria:

* Recurrence of macular edema defined as any kind of fluid accumulation in the macula (microcystic changes with or without increase of central retinal thickness) detected by OCT in the month 1 to 6 after the last Lucentis injection without any decrease of BCVA measured with ETDRS charts 2. Diagnosis of BRVO with macular edema treated with at least three intravitreally applied injections of ranibizumab after the up-load phase of treatment 3. Age ≥ 18 years 4. Ability and willingness to attend all scheduled visits and assessments 5. For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study

Exclusion Criteria:

1. Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
2. Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
3. Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry
4. History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months
5. Pregnancy (positive pregnancy test) or lactation
6. History of allergy to humanized antibodies or any component of the ranibizumab formulation
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US).

The primary objectives of this study are to characterize the pharmacokinetics (PK) of LEN and to evaluate the safety of LEN and F/TDF for PrEP in US PWID.


Eligibility Criteria:
Key Inclusion Criteria:

* Urine drug screen positive for any drug of misuse including, but not limited to, opioids (eg, fentanyl, heroin), stimulants (eg, cocaine, amphetamines), psychoactive drugs (eg, benzodiazepines), or a combination of these drugs.
* Evidence of recent injection (eg, track marks).
* Self-report of injection paraphernalia sharing in the prior 30 days.
* Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
* Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
* Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

Key Exclusion Criteria:

* Self-reported history of previous positive results on an HIV test.
* Any reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
* Coenrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation) without prior approval from the Medical Monitor/Joint Clinical Management Committee while participating in this study.
* Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).
* Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).
* Acute viral hepatitis A or acute or chronic hepatitis B or C infection.
* Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
* Evidence of moderate or severe liver fibrosis or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding). In individuals with active hepatitis C, Fibrosis-4 (FIB-4) score \> 3.25 (formula provided below).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Aromatherapy Versus Diet

Eligible children were randomly divided into 2 groups assigned to receive dietary recommendations (group A) or to receive herbal compounds (group B). Children were treated for a period of one week , then cross over the two groups is done


Eligibility Criteria:
Inclusion Criteria:

* The participants age will be ranged from 5to 10 years.
* primary Nocturnal enuresis(NE) number of wet nights/week is more than 4\\7

Exclusion Criteria:

* secondary nocturnal enuresis to any neurological disorders , musculoskeletal problems, or congenital abnormalities
* the child receives any Pharmacological treatment to NE
Protective Effect of Coronary Collaterals on Infarct Size in Patients With Acute Myocardial Infarction

The hypothesis of the current proposal is that collateral flow is an important determinant of myocardial protection during an ischemic event. Increased collateral flow for any given area at risk will decrease the myocardial damage caused by the occlusion of the infarct related epicardial artery.

It is further hypothesized that myocardial salvage provided by collateral flow will decrease infarct size and this in turn will decrease LV dilatation post-myocardial infarction.

The hypothesis of the current proposal is that collateral flow is an important determinant of myocardial protection during an ischemic event. Increased collateral flow for any given area at risk will decrease the myocardial damage caused by the occlusion of the infarct related epicardial artery.

It is further hypothesized that myocardial salvage provided by collateral flow will decrease infarct size and this in turn will decrease LV dilatation post-myocardial infarction.

The two primary endpoints are infarct size as assessed by increase of biochemical cardiac markers and coronary collateral perfusion index (CPI) as obtained by transthoracic MCE.

Extent of LV remodelling, i.e., LV dilatation as assessed by serial assessment of LV dimension by LV angiogram and/or echocardiography, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myocardial infarction with electrocardiographic criterion and/or typical history of angina pectoris and planned revascularisation according to the acute myocardial infarction disease management guidelines of the University Hospital Bern. Including both, patients undergoing primary PCI and patients referred for rescue PCI after failed thrombolytic therapy
* Patients \> 18 years old of either sex
* Patients who have given informed consent to the study

Exclusion Criteria:

* Patients unable to give informed consent e.g. because of mechanical ventilation
* Patients with cardiogenic shock
* Patients with myocardial infarction secondary to occlusion of a recently revascularized vessel (subacute stent thrombosis)
* Patients with severe arrhythmias
* Patients whose door-to-balloon time exceeds 120 minutes
* Pregnancy
Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity

Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC.

Plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at CCMC and Nationwide Children's Hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy regimen.

The duration of study participation will be approximately a year.

Patients will have a total of four study visits:

Baseline

1 week after patient's anthracycline cumulative dose hits between 60 and 100 mg/m2 After the patient has completed maximal therapy One year after completion of anthracycline treatments

Study tasks for all four visits will be:

Collection of clinical data Blood draw for micro RNA and Biomarkers Cardiac MRI Echocardiogram One time blood draw for genetics

Eligibility Criteria:
Inclusion Criteria:

* Age (≥ 9years old)
* Newly diagnosed with a malignancy that will receive ACs as part of their chemotherapy.
* Parental/caregiver consent and subject assent to enrollment.

Exclusion Criteria:

* Subject has contraindications to CMR.\*
* Subject requiring sedation for CMR
* Subject too large to be safely accommodated by CMR
* Pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded
* Subject's serum creatinine above guidelines for adequate renal function. See table below:

Age (years) Male Female 6-10 1.0 mg/dL 1.0 mg/dL 10-13 1.2 mg/dL 1.2 mg/dL 13-16 1.5 mg/dL 1.4 mg/dL \>16 1.7 mg/dL 1.4 mg/dL
Urinary Aquaporin 2 and Expression of the NPHS2 Gene in Adults Suffering From Nephrotic Syndrome

We want to test the hypothesises that patients with nephrotic syndrome have a higher excretion of AQP2 in the urine,that they have a higher concentration of AVP,and a lower C-H2O.Everything will normalize, when the syndrome is in remission.Furthermore we want to test the hypothesis that the expression of mutations in the NPHS2-gene,that codes for podocin,will cause a lack off or a poorer response in the treatment of nephrotic syndrome


Eligibility Criteria:
Inclusion Criteria:

adult patients with nephrotic syndrome in the years 1995 until now; both male and female; the kidney disease must be based upon a kidney biopsy ; age \> 18 years -

Exclusion Criteria:

severe diseases in the heart, lungs or liver; diabetes mellitus; other not well-treated diseases in endocrine organs; cancer unwillingness to participate

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