cyrilzakka/clinical-trials huggingface dataset:
Ig PRx in AECOPD: Pilot Study

This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive lung disease (COPD) patients with frequent exacerbations.

This is a Phase II, pilot randomized double blind control study, meaning this study will help assess if this research can be expanded to evaluate Ig treatment in patients with COPD. Ig treatment is a sterile solution of human immunoglobulin proteins given intravenously (in the vein). Immunoglobulins are part of the immune system and help the body fight infections. Participants will be assigned to either receiving the Ig treatment or normal saline as a control product every 4 weeks for 12 months.

Participants will continue on current standard therapy as determined by their treating physician.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patient with AECOPD (clinically dominant AECOPD in the case of multiple co-morbidities eg. absence of overt lobar pneumonia or acute congestive heart failure or alternate diagnosis such as acute coronary syndrome or pulmonary embolism)
* Diagnosis of severe COPD (post bronchodilator FEV1 \<50%, FEV1/FVC ratio \<0.7) made by standard spirometry within previous 12 months or within three days of admission if previous PFT data is not available
* Age \>40 years
* \>10 pack year smoking history
* At least one COPD exacerbation in the previous 12 months before enrollment, defined by having had documented inpatient or outpatient treatment by physician with antibiotics and/or prednisone for physician diagnosed COPD exacerbation
* Expected to live \> 12 months

Exclusion Criteria:

* Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis)
* Underlying malignancy (including chronic lymphocytic leukemia)
* History of hematopoietic stem cell transplant or solid organ transplant
* Current treatment with a biological therapy for other conditions
* Concomitant significant immunodeficiency or on immunosuppressive treatment other than for COPD
* Alpha-1 antitrypsin deficiency
* Significant proteinuria (dipstick proteinuria ≥ 3+ or known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis)
* IgA deficiency (IgA \<0.1 g/L)
* Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html)
* Obesity (BMI ≥35 kg/m²)
* Pregnancy
Effect of a Mixture of Probiotics on the Antigen Specific Antibody Response in a Influenza Vaccination Model of Healthy Adults

the aim of the study is to get evidence for an enhancement of immune status in subjects after probiotics mixture consumption ( lactobacillus gasseri PA 16/8, Bifidobacterrium longum SP 07/3, Bifidobacterium bifidum MF 20/5) based on influenza vaccination model - compared to placebo.

probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host" . many health effects are associated with probiotics , but various degrees of evidence support the benefits associated to probiotics consumption . Impact on defences and the immune system has been shown with several strains and this may result in improved protection against some infections or improvment of vaccine efficacy .

In its scientific requirments for health claims related to immune function, EFSA indicates that it is generally accepted that higher vaccination responses are beneficial.

Eligibility Criteria:
Inclusion Criteria:

* healthy male and female adult
* between 18 and 60 years old non menopausal female( with effective contraception)
* female non pregnant- not wishing to be pregnat during the study capable to respect the protocol
* affialted to the social security system aggreeing to be registered in the national fileof volunteers

Exclusion Criteria:

* food allergy( component of the experimental product- vaccines)
* manifestation of allergy
* vaccinated against flu during the 2 previous winters
* Food allergy, allergy to one of the component of the experimental products or allergy to one of the component of the flu vaccine;
* Subject displaying manifestation of allergy or being treated for these;
* Subject vaccinated against flu during the 2 previous winter (winter 2009-2010 and winter 2010-2011);
* Subject who had symptoms evocating flu during the previous winter (winter 2010-2011);
* Subject immunodepressed;
* Subject with immunomodulatory treatment;
* Subject who received a treatment resulting in systemic immunossuppression or local immunosuppression at pulmonary level, for at least 1 week during the last 3 months before inclusion (V1);
* Subject with auto-immune disease;
* Subject with inflammatory and chronic diseases;
* Subject with on-going antibiotics treatment at the time of the inclusion;
* Subject not agree to stop his/her usual probiotics supplementation during the study;
* Use of medication which could interfere with the study in the investigator's opinion (antibiotics, etc...);
* Any health condition for which the influenza vaccine is not recommended;
* Subject having received any other vaccine within one month prior to enrolment or intent to receive any other vaccination during the study period.
Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer

This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. Following screening to confirm eligibility patients will commence a six week treatment period. After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). End of study is defined as 24 months after treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix
2. FIGO stage IIB-IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement
3. Measurable disease on MRI
4. Age \> 18 years (no upper limit)
5. WHO performance status 0,1
6. Adequate renal function with EDTA clearance\> 55ml/min
7. Adequate liver function, as defined by ALT or AST less than 2.5 x ULN, and bilirubin less than 1.25 x ULN
8. Adequate bone marrow function, defined by WCC \>3.0 x 109/litre, neutrophils \> 1.5 x 109/litre and platelets \> 100 x 109 /litre
9. Able to understand and give written informed consent

Exclusion Criteria:

1. Evidence of common iliac or para-aortic nodal involvement, or distant metastases
2. Previous history of cancer except skin tumour
3. Previous pelvic radiotherapy or surgery other than toparoscopic node disection
4. Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus
5. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy if required. Acceptable contraception should be used such as barrier or hormonal methods.
6. Females must not be pregnant or breastfeeding
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).

Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).

This study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications.

Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients.

Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed.

Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion.

Data analysis will be stratified by lesion location.

Eligibility Criteria:
Inclusion Criteria:

* Subject age is ≥ 18 years
* Subject is able and willing to provide informed consent
* Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.

Exclusion Criteria:

* In the opinion of the treating investigator the subject has a life expectancy of less than 12 months
* In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes

The human ovary is the target of an autoimmune attack, usually in organ or non-specific autoimmune disorders. Serum anti-Müllerian hormone (AMH) levels decrease early in menopause and menopause is seen in women with type 1 diabetes mellitus (DM1) at a young age. DM1 is aimed to show DM1 relationship with ovarian reserve based on the assumption that it will have lower AMH levels than controls, secondary to bad glycemic control and autoimmune attack in women.

The study was designed prospectively. Ovarian functions in healthy volunteer women and patients who use DM1 diagnosed between 18-40 years old will be examined. Gonadotropin and AMH levels will be measured in follicular phase. To calculate the number of antral follicles (AFC) and ovarian volume, ultrasound will be looked at. Fasting and satiety blood glucose, HbA1c and C-peptide levels will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* female patients between 18 and 40 years of age who had consent and had gynecological examination in our polyclinic;
* study group for patients with type 1 diabetes mellitus healthy volunteers control group

Exclusion Criteria:

* Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and
* previous surgery, which may reduce ovarian reserves;
* medical and / or radiotherapy
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML, a certain type of ALL, NHL and MM
* certain types of cancer of the lymph nodes
* certain types of leukemias (blood cancers)
* disease has or will fail with other treatments
* relatively good overall health other than your cancer

Exclusion Criteria:

* poor bone marrow function (not producing enough blood cells)
* serious heart conditions
* poor liver or kidney function
A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II)

The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.

Abciximab is a drug that prevents platelets from sticking together and forming a clot. There are limited studies using abciximab in the treatment of strokes. This phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study is designed to assess the effectiveness and safety of abciximab for treatment of acute ischemic stroke, in helping dissolve clots in brain arteries so that blood and oxygen can flow better and there may be less brain damage.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either Abciximab: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 µg/kg/min infusion (to a maximum of 10 µg/min) for 12 hours or a bolus of placebo followed by infusion for 12 hours

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of acute ischemic stroke with onset within 5 hours and 30 minutes before randomization and planned treatment initiation within 6 hours of onset
* After 600 patients are enrolled in previous criteria, the new criteria for enrollment will be, patients with diagnosis of acute ischemic stroke with onset within 4 hours and 30 minutes before randomization and planned treatment initiation within 5 hours of onset

Exclusion Criteria:

* Patients who had participation in another study with an investigational drug or device within the last 30 days, prior participation in the present study, or planned participation in another trial
* Patients with symptoms suggestive of subarachnoid hemorrhage
* Female patients known to be pregnant, lactating, or having a positive or indeterminate pregnancy test
* Patients with neurological deficit that has led to stupor or coma
* Patients with minor stroke
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Vertical intrabony defect from radiographs at baseline
* Age of 20 years or older

Exclusion Criteria:

* Using an investigational drug within the past 24 months
* Coexisting malignant tumour or history of the same
* Coexisting diabetes (HbA1C 6.5% or more)
* Taking bisphosphonates
* Coexisting gingival overgrowth or history of the same
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.

This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* A male or female child of between 5 months and 17 months of age at the time of first vaccination.
* Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child..
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

Exclusion Criteria:

* Acute disease at the time of enrolment.
* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
* Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
* Planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.
* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
* Previous participation in any other malaria vaccine trial.
* Simultaneous participation in any other clinical trial.
* Same sex twin.
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
ORWH:SCOR on Sex and Gender Factors Affecting Women's Incontinence

This study consists of two studies with overlapping cohorts. One is a follow up epidemiological study of urinary incontinence, the other is a case control study of lower urinary tract dysfunction in women with diabetes.

Study One:

Subjects for the study will be a retrospective cohort of 2100 middle-aged and older women from a large health maintenance organization who have participated in the Reproductive Risk Factor for Incontinence Study at Kaiser (RRISK). The RRISK I study assembled a retrospective cohort of long-term female Kaiser Permanente members to determine the association between specific childbirth events, hysterectomy, hormone use and urinary incontinence later in life. The study also provides descriptive information on urinary incontinence by type, age, ethnicity, severity and age of onset.

Study Two:

Women with diabetes have a 30-70% increased risk of lower urinary tract dysfunction, including lower urinary tract symptoms, urinary incontinence, and ultimately bladder cystopathy. This sudy investigates the natural history, risk factors, and possible mechanisms of lower urinary tract dysfunction and infection among women with type 2 diabetes as compared to women without diabetes.


Eligibility Criteria:
Previous participation in the Reproductive Risk Factors for Incontinence Study at Kaiser.
Children and Parents With ADHD and Related Disorders

Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not validated in France. This clearly hampers the development of the diagnosis and the monitoring of patients but also research in this domain. This study is conceived to collect data in the general population of children aged from 4 to 18 years in public schools in the city of Nice.

Children are pseudo-randomly selected from classes of randomly selected schools in the city of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask parents to fill out a similar set of questionnaires regarding their child's behaviour at home. Since ADHD has a strong genetic components, parents are also asked to fill out questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.

Additionally, known factors related to ADHD and other disorders as well as other putative factors are tested in the epidemiologic study.


Eligibility Criteria:
Inclusion Criteria:

* Child known for the teacher for at least three months so that his evaluation Reflect most faithfully possible the usual behavior of the child,
* Child having the Frenchman for mother tongue to avoid the consequences on him Behavior of a linguistic obstacle,
* Authorization to use the data signed by at least one of the parents of the child and by the very child when he is old at least of six years.
* Parents speaking and reading the Frenchman.

Exclusion Criteria:

* Child known to follow a specific treatment of a disorder(confusion)attentional with / without Hyperactivity-impulsiveness (eg. Ritaline Ò, Ritaline Ò LP, Arranged Ò LP, Strattera Ò) Whatever is its duration. Indeed, a selection on this criterion would introduce a way Major which(who) would return the less reliable results(profits) of the study.
* Child presenting a known neurological or psychiatric disorder, or a deficit Intellectual because the attentional disorders(confusions), the psychomotor excitement and The impulsiveness can be symptoms inherent to the other pathologies Neurological and\\or psychiatric.
Delirium at the Intensive Care Unit - a Retrospective Cohort Study

This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and to identify risk and preventive factors associated with development of delirium.

Especially, the investigators want to investigate if an imitated natural light/dark cycle influences frequency of delirium.

A common problem for patients in the ICU is episodes of delirium. Recent trials have described incidences ranging from 60-87% of patients in a number of different countries. Delirium is a condition with fluctuating conscience, disorganized thinking and disturbance of the sleep/wake cycle. Many patients with delirium experience hallucinations and agitation which can be very unpleasant for both patients and their families.

Some risk factors for the development of delirium well known, e.g. dementia, hypertension, illness severity (SAPS II score), delirium on the previous day, mechanical ventilation, emergency surgery and metabolic acidosis. The effect of sedative drug administration is not clear, as studies has been inconclusive.

Even though studies regarding the impact of sleep deprivation on development of delirium have been inconclusive, there is no doubt that delirious patients have a disturbed sleep-wake cycle, sleep architecture and circadian rhythm.

At the intensive care unit at the Department of Anesthesiology at Køge Hospital, three out of nine rooms have a simulated circadian light installed. The idea is that this light rhythm may help to keep a natural circadian rhythm, minimizing the risk of delirium.

With this descriptive and retrospective cohort study, the investigators therefore want to describe the incidence and possible risk- and preventive factors of delirium for the participants (ICU patients at Køge Hospital), and with a special focus on the possible effect of imitated circadian light..

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age admitted to the ICU at Køge Hospital in the study period

Exclusion Criteria:

* Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period
* No CAM-ICU scores during the ICU stay
* Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage)
* Severe dementia documented in electronic patient charts (OPUS)
* Patients not receiving active treatment (moribund patients)
The Trial of SHR6508 in Secondary Hyperparathyroidism

The study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving maintenance hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Stably use of concomitant medication of other therapies of SHPT
6. Meet the standard of iPTH level, cCa

Exclusion Criteria:

1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
8. Subjects with a treatment history of similar drugs
9. Allergic to a drug ingredient or component
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Subject with a history of alcohol abuse and drug abuse
13. Participated in clinical trials of other drugs
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial