cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine for Marginal Zone Lymphoma

Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.

We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.

Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed marginal zone B-cell lymphoma
* Performance status (ECOG) ≤3
* Age ≥ 18
* At least one or more bidimensionally measurable lesion(s):

  * 2 cm by conventional CT
  * 1 cm by spiral CT

    * skin lesion (photographs should be taken)
    * measurable lesion by physical examination
* Laboratory values:

  * Cr \< 2.0 mg% or Ccr \> 60 ml/min
  * Transaminase \< 3 X upper normal value
  * Bilirubin \< 2 mg%
  * ANC \> 1500/ul, platelet \> 75,000/ul
* Informed consent
* Ann Arbor stage III or IV

Exclusion Criteria:

* Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
* Serious comorbid diseases
* Pregnancy or breast feeding
Using Travelan to Boost Immune Response in Vitro to COVID-19

The gut immune system was shown as an effective target for inducing systemic immune signals against viruses. Oral administration of Travelan, an over the counter product which contains hyperimmune bovine colostrum was shown in preclinical studies to augment the anti-viral immune towards several strains of influenza viruses (RNA viruses).

This study will evaluate the option that Trevalan may help improve the immune system reaction when introduced to COVID-19 proteins in-vitro. 5 healthy volunteers will receive a treatment regimen of 5 days with Trevalan. Before and after treatment, blood samples will be taken in order to test immune response towards viral proteins of the COVID-19 virus in vitro by measuring the number of T cell clone secreting IFNγ against viral antigens.


Eligibility Criteria:
Inclusion Criteria:

1. Adult healthy volunteers aged 18 years old and above.
2. No history of drug or alcohol abuse.
3. Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
4. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
5. Patients must satisfy a medical examiner about their fitness to participate in the study.
6. Patients must provide written informed consent to participate in the study

Exclusion Criteria:

1. Acute illness resulting in emergency department (ED) evaluation or hospitalization in the last 6 month or any acute illness in the last month before enrollment
2. Patients with evidence of other serious infectious, malignant, autoimmune, kidney, hepatic, or other non-cardiac systemic disease.
3. Chronic drug therapy of any sort
4. Known allergy to milk
5. Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 4 weeks prior to and throughout the duration of the study
6. Participation in another clinical trial within 30 days prior to intervention.
7. Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
8. Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
9. Known substance abuse, including inhaled or injected drugs in the year prior to Screening
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus

Exclusion Criteria:

* Patients with type 1 diabetes mellitus
Diet and Vascular Health Study

The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular disease risk using biochemical indicators such as blood lipid profiles, most notably cholesterol; markers of inflammation as well as established physiological measurements such as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure Measurements (ABPM). Broccoli contains compounds known as glucosinolates which are metabolised to isothiocyanates when consumed. The major glucosinolate in broccoli is known as glucoraphanin which produces the isothiocyanate sulforaphane. The glucosinolates are thought to be the principal component in broccoli that may reduce CVD risk. The investigators will use a standard cultivar of broccoli and a cultivar that has enhanced levels of glucosinolates ('HG broccoli'). This broccoli has been used in previous intervention studies (e.g. ClinicalTrials.gov NCT00535977). Volunteers will be asked to consume 400g of standard broccoli, HG broccoli or peas each week over a 12 week period in a double blinded (for the broccoli) parallel study. The volunteers recruited will, according to the Joint British Societies (JBS 2) Guidelines on the prevention of cardiovascular disease (CVD) in clinical practise, have a 10-20% (mild to moderate) risk of developing cardiovascular disease or having a cardiovascular (CV) event in the next 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 50 years will be recruited onto the study using the JBS 2 cardiac risk assessor calculator (Copyright University of Manchester 1998): Scores of 10-20% will be acceptable for participation in the study.
* Total cholesterol ≥ 5.0mmol/L
* Blood pressure measurements

  * Systolic≥ 120mmHg
  * Diastolic ≥ 80mmHg
  * BMI ≥20
  * Smokers and Non Smokers

Exclusion Criteria:

* Diagnosed diabetics;
* Fasting glucose \>6mmol/L;
* Blood pressure \<90/50 or 95/55 if symptomatic; \>160/100
* Chronic kidney disease;
* Those on any lipid lowering therapies like statins, bile acid sequestrants, cholesterol absorption inhibitors and nicotinic acid;
* Those who have suffered a cardiovascular event like stroke, myocardial infarction or trans ischemic attacks;
* Peripheral vascular disease including Claudication
* Consumption of fish oil supplements (unless volunteer is willing to discontinue their use 4 weeks prior to the start of the)
* Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/materials
* Any person related or living with any member of the study team
* Participation in another research project which involves blood sampling within the last four months; Blood from both studies should not exceed 470mL
* BMI \<20
* BMI \>40
* Fasting total cholesterol \> 8.0mmol/L
* Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated
* Going on holiday for more than 7 days in any single period or within 2 weeks of their clinical appointment at the CRTU
* Currently suffering from or have suffered from any neck and throat injuries and surgery
Slow Versus Rapid Rehydration of Severely Malnourished Children

The recommendation for correction of dehydration of severely malnourished children with diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example, in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart failure. There is not enough evidence to convince some of the physicians dealing with severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid rehydration per se is associated with increased incidence of over hydration and heart failure. And whether this approach is applicable in the management of severely malnourished children with severe cholera, which usually require rapid correction of water and electrolyte deficits for prevention of deaths due to hypovolaemic shock and other complications, has not been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help in improving the renal function, acidosis and thus improve appetite and reduce ORS failure subsequently. Since our study was uncontrolled, so we have planned a randomised controlled study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12 hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for length \<-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery of \<24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked to participate in this study. After the parents'/Legal guardian's consent, the children will be transferred to the study ward and will be treated according to the protocol. All children will receive similar treatment except the mode of rehydration, different for the two groups. The children will be closely monitored throughout the study period. The primary outcomes incidence of over hydration and ORS failure and secondary outcomes improvement of renal function and improvement of appetite measured by the food intake will be compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

1. History of acute watery diarrhoea of \<24 hours.
2. Either sex.
3. Severe dehydration according to WHO guidelines
4. Wt for length/wt for age \< -3 SD of WHO growth standard with or without oedema.(malnutrition)
5. Consent given by the parents or legal guardian

Exclusion Criteria:

1. Bloody diarrhoea.
2. Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
3. Those who received antibiotics/antimicrobial for the current illness
The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children

Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.

The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus


Eligibility Criteria:
Inclusion Criteria:

* Minor patient aged 3 months to 17 years
* 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
* Supported in one of the participating centers during the period from November 1, 2019 to May 31, 2023
* Subject or parents who have not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Patient or parents having expressed their opposition to participating in the study.
Transcranial Magnetic Stimulation for Methadone Maintenance Therapy Combined With Methamphetamine Abuse

Repetitive transcranial magnetic stimulation (rTMS) has been used to treat opioid and methamphetamine addiction in previous studies, while no evidence was proved for patients methadone maintenance therapy with methamphetamine abuse. The aim of this study is to evaluating the effectiveness and safety of rTMS treatment for methamphetamine abuse in patients with methadone maintenance therapy.

First, a multicenter, double-blind, randomized control study is going to be carried out. 60 recruited patients will be randomized assigned to the intervention group (40) and the control group (20), receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 16-week urine drug test (1 time per week, 4 weeks before rTMS, 4 weeks during rTMS and 8 weeks after rTMS). Self-report methamphetamine use or urine test is set as primary outcome. Cognitive function and craving are also evaluated before and after the intervention. Functional magnetic resonance imaging (fMRI) is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for methadone maintenance therapy with methamphetamine abuse and decrease risk of relapse for both the patients and their families.

Eligibility Criteria:
Inclusion Criteria:

* Currently in methadone maintenance therapy
* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
* Junior high school degree or above
* Normal vision and hearing

Exclusion Criteria:

* Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
* Have cognitive-promoting drugs in the last 6 months
* Other substance abuse or dependence in recent five years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders according to DSM-5 criteria
* Physical diseases
Conservation of Praxis in the Food and Alzheimer Disease

The insanities, priority of public health in 2008, have significant prevalency in Limousin, region in the ageing demography (1/3 of the population is more than 60 years old against 1/5th of average in France). To prevent the lack of therapeutic solutions, for these evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.

The insanities deprive gradually the individual of their autonomy, their personality and their identity. The help of an institution is sometimes inevitable. In the middle of this stressful environment, the patient affected by severe insanity, need marks.

The aspect of their old objects, significant for them, has to be prioritized because the institutional universe, often depersonalized doesn't mean anything for them. In front of repeated failures, they're hurt in their self respect.

The prevention of the undernutrition, comes by a preservation of praxis and pleasure at table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular, divided) and can be destabilizing for the mentally ill person.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of more than 75 years
* Patients suffering from insanities of type Alzheimer
* Severe stage of the disease
* Residents in a Hospital for dependent old persons, with its own dining room
* Persons accommodated in the clinical service for more than 30 days
* EBS score \<16
* Information in the participation of the resident, their legal representative and their family
* Patients affiliated to the Social Security.
* Filled and signed form of participation
* Patient having a appointed reliable person or one helping known whose references are indicated in the patient file.

Exclusion Criteria:

* Patients presenting pathologies being able to interfere with the evaluation
* Participating patients in another research for type clinical trial.
* Undernutrition patients
* Patients presenting oral hurts
* Protected patient or having nobody helping.
Neutrolin Versus Heparin for Locking Hemodialysis Catheters

Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.

Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.

This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* New hemodialysis catheter
* Subject who will need chronic hemodialysis at least twice/week
* Subject likely to require for at least 120 days
* Subject or relative is likely to understand the nature of the study and sign the consent
* Age 18 years and older

Exclusion Criteria:

* Subject with unstable malignancy
* Subject with liver cirrhosis with encephalopathy
* Subject know to have allergy to heparin, citrate or traoulidine
* Documented history of arterial thrombosis or known to have hypercoagulable state
* Subjects with active skin infections and ulcers
Caudal Block With Tramadol and Levobupivacaine or Bupivacaine

Caudal block is the regional anesthetic technique that is used most frequently in pediatric surgery. Opioid drugs have been added to local anesthetic solutions to prolong duration of analgesia but ideal combination were not found that has minimal adverse effect. The aim of this study was to compare the postoperative analgesic efficacy of equal concentrations of bupivacaine plus tramadol or levobupivacaine plus tramadol in pediatric patients undergoing minor urological surgery.

Sixty-eight children aged 2 to 7 years who were undergoing inguinal herniorrhaphy or orchidopexy received bupivacaine 0.25% plus tramadol 2 mg/kg (BT group) or levobupivacaine 0.25% plus tramadol 2 mg/kg (LT group) by the caudal route after laryngeal mask anesthesia. The primary outcome of the study was to compare the duration and quality of postoperative analgesia. The postoperative pain relief was evaluated by the Children and Infants Postoperative Pain Scale (CHIPPS) at 2, 4, 6, 12, and 24 h postoperatively. In addition, the time of first analgesic requirement was noted.

Eligibility Criteria:
Inclusion Criteria:

* ASA I,
* 2 to 7 years old children
* Elective inguinal herniorrhaphy or orchidopexy operation

Exclusion Criteria:

* Infection at the site of block, bleeding diathesis, pre-existing neurological or spinal disease, or abnormalities of the sacrum) or with a known allergy to local anesthetics were excluded.
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.

This surveillance will specifically focus on the occurrence of the following:

1. Local reactions at the injection site
2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.

Eligibility Criteria:
Inclusion Criteria:

* Infants at the age of more than 2 and less than 7 months
* Infants who have been vaccinated with Prevenar for the first time
* Infants expected to complete four vaccinations with Prevenar

Exclusion Criteria:

Vaccination with Prevenar must not be given to any of the following;

* History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
* Evident pyrexia
* Evident serious acute disease
* Any other infants or children ineligible for vaccination
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged more than 18 years
* Strongly suspected of having renal arterial disease
* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)

* Prospective, randomized, controlled, multi-center study
* A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
* Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
* All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
* Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
* Patients will be followed clinically for 1 year after the procedure.
* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Symptomatic peripheral artery disease:

  * Moderate or severe claudication (Rutherford category 2 or 3)
  * Critical limb ischemia (Rutherford category 4 or 5)
* Femoropopliteal artery disease (stenosis \> 50%)
* ABI \<0.9
* Patients with signed informed consent

Exclusion Criteria:

* Acute critical limb ischemia
* Severe critical limb ischemia (Rutherford category 6)
* Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
* Patients requiring oral anticoagulation using warfarin or NOAC
* Age \> 85 years
* Severe hepatic dysfunction (\> 3 times normal reference values)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* LVEF \< 40% or clinically overt congestive heart failure
* Pregnant women or women with potential childbearing
* Life expectancy \<1 year due to comorbidity
* Previous bypass surgery or stenting in the target femoropopliteal artery
* Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)