cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis

The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.

G-colony stimulating factor(5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis. On the day 4th, plasmapheresis will be done to collect peripheral blood mononucleated cells

. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.

Eligibility Criteria:
Inclusion Criteria:

1. 20 =\< Age \< 80
2. Advanced liver cirrhosis with Child-Pugh score 8 or 9 (including patients who have no radiologic evidence of remnant HCC for more than 2 years after treatment)

Exclusion Criteria:

1. HBsAg-positive
2. Active status of hepatocellular carcinoma (HCC) (except patients who have no radiologic evidence of remnant HCC for more than 2 years after treatment)
3. History of hemochromatosis and/or autoimmune hepatitis
4. Pregnant women or lactating women
5. Hemoglobin \< 8g/dL (male), 7.5g/dL (female) or white blood cell (WBC) \<1,500 mm3 or Neutrophils \<500/mm3 or platelet count \<50,000/mm3
6. Serum creatinine\> 1.5 x normal upper limit or creatinine clearance \<60 ml/min
7. Presence of signs of malignant tumors or tumor suspected symptoms, or history of malignant tumors with recurrence rate greater than 20% within two years
8. Gastrointestinal bleeding within the last 3 months or if there is a history of spontaneous bacterial peritonitis
9. Presence of portal vein thrombosis
10. Presence of acute infections
Metabolism Characteristics in the Children With Narcolepsy

A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children. There is no specific study on the population and the consequences of overweight in the lives of these long-term patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is also known that weight gain is not related to the treatment of narcolepsy. The etiology of obesity in narcoleptic patients is not established. Several assumptions were made (physical activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and obesity in this population therefore remain unclear.

In this study, potential change in the total metabolism (24h) for narcoleptic children that could explain their tendency to obesity will be assessed ?


Eligibility Criteria:
Inclusion Criteria:

NARCOLEPTIC PATIENTS

* Girl or boy age\> 6 years \<18 years;
* Narcoleptic: defined by the ICSD diagnostic criteria 2 (International Classification of Sleep Disorders)
* Beginning of the troubles there more than 6 months
* Parental consent and agreement of the child.

HYPERSOMNIC PATIENTS

* Girl or boy age\> 6 years \<18 years;
* Hypersomnic : defined by the ICSD diagnostic criteria 2 (International Classification of Sleep Disorders)
* Beginning of the troubles there more than 6 months
* Parental consent and agreement of the child.

Exclusion Criteria:

NARCOLEPTIC PATIENTS

* Secondary Narcolepsy;
* Narcolepsy already treated with psychostimulant or anticataplectic;
* Restless legs;
* Sleep apnea syndrome;
* Obesity known outside narcolepsy cause;
* Absence of parental consent.

HYPERSOMNIC PATIENTS

* symptomatic or secondary hypersomnia;
* Hypersomnia already treated psychostimulant or anticataplectic; Restless legs;
* Sleep apnea syndrome;
* Pathology neurological, psychiatric, endocrine or concurrent;
* Lack of parental consent
Formal Pre-Operative Education

The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy they might need. All participants will receive a pre and post operative questionnaire to determine level of understanding of anticipated needs and barriers due to surgery. Group one will receive formal education from an occupational therapist or physical therapist while Group two will receive only standard education in the MD clinic.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* English as Primary language,
* scheduled to have orthopedic upper extremity surgery.

Exclusion Criteria:

* less than 18 years
* Conservative management or non operative management of orthopedic upper extremity surgery
Natural History Study for Pediatric Patients With Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidoses, or Gaucher Disease Type 2

This study is being conducted to better understand the natural course of GM1 gangliosidosis, GM2 gangliosidoses and Gaucher disease Type 2 (GD2). Information is planned to be gathered on at least 180 patients with GM1 gangliosidosis, GM2 gangliosidoses, and Gaucher Disease type 2. Retrospective data collection is planned for at least 150 deceased patients (Group A). Group B is for patients alive at the time of enrollment. In Group B it is planned to prospectively collect more comprehensive data from at least 30 patients. The purpose of this study is to collect relevant information for a adequate design of a potential subsequent research program in these diseases.

In this study no therapy is being offered.


Eligibility Criteria:
Inclusion Criteria:

* Patient with either GM1 gangliosidosis, GM2 gangliosidoses (Tay-Sachs, Sandhoff, or AB Variant), or Gaucher Disease Type 2.
* Diagnosis confirmed by either biochemical (enzyme activity) or genetic testing, or both.
* Date of birth on or after 1 January 2000.
* Onset of first neurological symptom within 24 months of age.
* Informed consent of parent or legal guardian as required by local law.
Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study

Idiopathic pulmonary fibrosis (IPF) is a progressive scarring condition of the lungs the cause of which is unknown.There are currently no effective treatments for IPF and the condition tends to cause progressive disability and death with an average survival of 3.5 years from diagnosis. The condition is responsible for the deaths of 4000 people per year in the UK. At present the definite diagnosis of IPF rests on the identification of a specific pattern of fibrosis when a section of fibrotic lung tissue is examined under a microscope. Unfortunately, the process of obtaining a lung biopsy requires an operation and is not with out risk. The investigators hope to identify specific markers in the blood and lungs of patients with IPF that will enable the condition to be diagnosed without biopsy. Furthermore, the investigators hope to identify indicators(biomarkers) that will predict which patients have more aggressive and progressive disease and also to identify biomarkers that might be useful in identifying a response to treatment and might therefore be used in future clinical trials in IPF. As well as looking at markers in the blood and lungs the investigators also plan to assess the use of daily home lung function measurement and a computerised technique for analyzing lung sounds to see if these are investigations that are able to predict the development of worsening lung fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18 with a diagnosis of definite or probable IPF or definite or probable fibrotic NSIP as defined by the ATS/ERS consensus classification

Exclusion Criteria:

* Patients with co-existent conditions known to be associated with the development of fibrotic lung disease will be excluded.
* This includes

  * connective tissue disease
  * suspected drug-induced lung disease
  * asbestosis or other asbestos related disease (pleural plaques, mesothelioma, asbestos pleural effusions)
  * granulomatous disease including sarcoidosis.
* Patients with an auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms.
* Non-specific rises in auto antibodies e.g. rheumatoid factor, anti-nuclear antibody etc. will not be used to exclude individuals from the study.
* Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
* Patients involved in clinical trials assessing novel IPF therapies will be excluded from enrolment in this study.
Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children

This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* A male or female 7 to 8 years of age at the time of enrolment.
* Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
* Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment.
* In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care
* Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
* History of or intercurrent hepatitis B disease.
* Hepatitis B vaccination at birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis B vaccine challenge dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Acute disease and/or fever at the time of enrolment.
Increasing Contingency Management Success in Smoking Cessation

Incentives can be used to facilitate the acquisition of many healthy behaviors, such as smoking cessation. However, there is much room for improvement in the use of incentives. This study investigates how two aspects of providing incentives influence the effectiveness of using incentives to promote smoking cessation. One aspect is the criterion for providing incentives, e.g., whether to require smoking cessation before providing an incentive or to provide incentives following smoking reductions. The other aspect being investigated is whether it is best to use a fixed incentive amount or an amount that increases with continued cessation success.


Eligibility Criteria:
Inclusion Criteria: Daily Smokers smoking a pack or more of cigarettes a day who are able to report to the study site each work day for about 5 minutes for around 3 months. Subjects must also have a breath CO level indicative of smoking at this level, and most report smoking for at least two years. Subjects must intend on quitting smoking.

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Exclusion Criteria: Participation in another study by this group within the past year. Inability to give informed consent. Incapable of attendance each workday during the morning hours.

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Cardio-Oncology Rehabilitation Exercise

Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* History of early-stage breast cancer (I-III)
* Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
* Able to communicate in English

Exclusion Criteria:

* Pregnancy
* Metastatic disease (Stage IV)
* Unable or unwilling to complete cardiopulmonary exercise test
Mass Spectrometry in Single Bladder Cancer Cells

The study is a pilot study in the feasibility of a diagnostic technique. There is no current data on detection of cisplatin in cancer cells derived from human urine. This study will generate preliminary data so that future studies may be done with more definitive end points in mind.

The aim of this study is to determine the feasibility of using a novel mass spectrometry instrument to measure the intracellular concentration of chemotherapeutic drug within an active tumor cell. If successful, this technique could be applied to dosage streamlining in patients and customization of dosage based on individual tumor characteristics. It also opens the door to research on novel chemotherapy agents or agents not typically used in a specific malignancy to determine if therapeutic levels can be obtained in tumor cells.

Personalized chemotherapy is an evolving field with the underlying goal being minimization of side effects of treatment while maximizing net patient benefit for therapy. A key difficulty in personalized chemotherapy is that the determination of therapeutic benefit comes well after the administration of treatment has been completed. For most forms of chemotherapy there does not exist a laboratory study that can determine the concentration of therapeutic agent within the tumor itself and as such, real time dose adjustments are based only on toxicity, not on tumor penetrance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of bladder cancer
2. Patients must be undergoing their first cycle of cisplatin based chemotherapy due to metastatic disease or as pre-operative treatment before cystectomy
3. Patients with a diagnosis of bladder cancer who will not be undergoing chemotherapy
4. Patients must have demonstrated positive urinary cytology prior to inclusion in the study

Exclusion Criteria:

1. Patients who do not have bladder cancer.
Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

Exclusion Criteria:

* Current Therapy With Any DMARD Or Biologic
PGL4001 Versus GnRH-agonist in Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.


Eligibility Criteria:
Inclusion Criteria:

* Be a pre-menopausal woman between 18 and 50 years inclusive.
* Have excessive uterine bleeding due to myoma
* Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
* Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
* If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
* Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

* Has a history of or current uterine, cervical, ovarian or breast cancer.
* Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
* Has a known severe coagulation disorder.
* Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
* Has a history of or known current osteoporosis.
* Has abnormal hepatic function at study entry.
* Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
* Has a current (within twelve months) problem with alcohol or drug abuse.
* Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Pregabalin Versus Levetiracetam In Partial Seizures

This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (male or female) must be \> 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
* Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
* Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Exclusion Criteria:

* Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
* Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
Effects of Ischemic Preconditioning After Aortic Clamping

Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.


Eligibility Criteria:
Inclusion criteria:

* Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
* Patients who received clear information, with signed consent
* Patients 18 to 85 years

Exclusion criteria:

* Patients under guardianship
* No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
* Pregnancy, lactation
* Hemodialysis
The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan

The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will be associated with less inflammation including less atherosclerotic plaque inflammation (inflammation of the vessel walls).


Eligibility Criteria:
Inclusion Criteria:

* A signed consent form;
* Male or Female, 50 years or older;
* Diagnosed with end stage renal disease (ESRD), on maintenance hemodialysis for at least three (3) months;
* On calcium-based phosphate binders;
* Subject must be able to understand and provide informed consent;
* No known contraindications to therapy with sevelamer carbonate.

Exclusion Criteria:

* Any patient with a medical condition or taking any medications that would be contraindicated with the use of sevelamer carbonate, such as history of bowel obstruction;
* History of severe allergic reactions to the study medication;
* History of active infection (other than a simple respiratory tract infection) or acute gouty attack within 2 weeks prior to enrollment;
* Known serological positivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCV Ab) except dose with normal liver function tests (AST, ALT, Bilirubin, and Alkaline Phophatase) and no history of cirrhosis;
* Elevation of liver function tests at time of entry (Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) \> 2 times the upper limit of normal);
* History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;
* History of malignancy except those adequately treated, has completed treatment and clinically in remission for more than 6 month; adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
* History of an inflammatory disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis or ulcerative colitis except those in remission for more than 6 months;
* Patients currently on sevelamer carbonate or sevelamer chloride or history of taking them for more than a week in the past three months;
* Patients receiving chronic anti-inflammatory therapy;
* Patients in whom FDG-PET/CT dual scans are contraindicated.