cyrilzakka/clinical-trials huggingface dataset:
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
* An IVIG treatment during the last 8 weeks prior to enrollment.
* Age ≥18 years.
* Written informed consent for study participation obtained before undergoing any study-specific procedures.

Exclusion Criteria:

* Any polyneuropathy of other causes
* Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
* Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
* History of thrombotic episodes within the 2 years prior to enrolment
* Known allergic or other severe reactions to blood products including intolerability to previous IVIG
Volumetric Magnetic Resonance Imaging in Dementia

Dementia is a term for the impaired ability to remember, think, or make decisions that interferes with doing everyday activities. Alzheimer's disease is the most common type of dementia. Though dementia mostly affects older adults, it is not a part of normal aging. This study aims to assess the role of volumetric MRI in evaluation of different types of dementia.

Neurocognitive disorders (dementia) are prevalent clinical problems. With the increase in average life expectancy, its prevalence is rising at an alarming rate. In 2005, an estimated 24 million people around the world suffered from dementia, and that number is expected to double every 20 years. By 2040, it is predicted that over 81 million people worldwide will suffer from dementia. Most experts agree that treatment will be most beneficial if applied early, before significant, potentially irreversible neurodegeneration and functional impairment has occurred.

Clinical symptoms of most subtypes of dementia arise from progressive neuron and synapse loss, with the resulting tissue atrophy. Brain magnetic resonance imaging (MRI) is regularly used in diagnosing dementia as it visualises the structural changes caused by neurodegeneration. It is key in defining subtle differences between healthy and pathological cerebral volume loss and between dementia subtypes.

Visual assessment of brain atrophy patterns is commonly supported through the use of visual rating scales. However, these scales have a subjective element and their application relies heavily on the prior experience of the radiologist using them. And they have poor sensitivity to subtle or prodromal changes and have ceiling and/or floor effects.

Application of quantitative volumetric reporting tools, which automatically quantify an individual patient's regional brain volumes and compare them to healthy populations, can potentially help in interpretation of the severity and distribution of brain atrophy and contextualize their findings by referencing normative brain volumes in healthy populations. This will improve the accuracy of radiological diagnosis of different subtypes of dementia

Eligibility Criteria:
Inclusion Criteria:

* Patients with any type of dementia.
* Patients with mini mental state examination equal or more than 18.

Exclusion Criteria:

* Patients with contra-indications to MRI.
Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy

The purpose of this study is to analysis changes in anterior segment morphology after laser peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment effectiveness

In the study ,primary angle closure(PAC) and primary angle closure glaucoma (PACG) will be recruited. Anterior segment optical coherence tomography images captured before and after laser peripheral iridotomy will be analysed to provide objective and reproducible quantification of anterior segment biometric parameters.The outcomes can provide useful information for clinical strategies in the treatment and management of pathology related to angle closure.

Eligibility Criteria:
Inclusion Criteria:

1 .The gonioscopy or UBM examination has confirmed the diagnosis of PACS or PAC 2. Intraocular pressure within 10 to 21 mmHg ，C/D≤0.6 3. Visual field is normal or only show paracentral scotoma 4. Vision or corrected visual acuity ≥0.8 5. Refractive degree no more than 200D 6. Exclude other ocular and systemic diseases

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Exclusion Criteria:

1. Corneal macula and other corneal diseases, ocular surface disease or corneal edema
2. Iridocyclitis
3. Ocular trauma and intraocular operation history
4. No fixationFundus lesions such as diabetic retinopathy or retinal detachment
5. No fixation
6. Ocular or systemic application of cortical steroids -
A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia

This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

Eligibility Criteria:
Inclusion Criteria:

* Women above 18 years old after giving birth
* Women who suffer from iron deficiency anemia, defined as hemoglobin\< 9.5 g/dl without one of the conditions that are described in the exclusion criteria

Exclusion Criteria:

* Women who suffer from known allergy for iron supplements
* Women who suffer from anemia not due to iron deficiency
* Women who suffer from acute infection
* Women who suffer from liver failure or viral hepatitis
* Women who suffer from thalassemia or hemoglobinopathies
* Women who suffer from renal failure
* Women who suffer from unbalanced thyroid disorder
Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

Patients often experience moderate to severe postoperative pain, especially during the first hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al. 2005), but the analgesic effect can be limited and undesirable side effects may occur.

A case report described that right thoracic paravertebral block reduced pain and analgesic requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural analgesia, thoracic paravertebral block probably carries a much lower risk of spinal haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist 1998; Karmakar 2001).

We therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with sufentanil.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo right lobe hepatectomy
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
An Integrative-"Omics" Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China

This is a multi-omics research of Chinese cardiomyopathies patients, aiming to determine genetic risk factor and serial biomarkers of cardiomyopathies in diagnosis and prognosis.

Identification of novel biomarkers is needed to improve the diagnosis and prognosis of cardiomyopathy. Also,the marked variation of genes which is still unclear, may influence clinical outcomes is determined in part by genetic heterogeneity of the systemic response to pathological process.

Specific aim:

1. Proteomics, microRNA-seq and metabolomics will be to determine the correlation of echocardiographic parameters of systolic and diastolic functional entry with circulating molecules
2. Genomics will be to determine the association of clinical outcome

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
2. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.

Exclusion Criteria:

1. Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
2. History of rheumatic fever
3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
4. HIV infection or born to an HIV positive mother
5. Kawasaki disease
6. Immunologic disease
7. Uremia, active or chronic
8. Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia

10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy
Supporting Cognitive Control Training With tDCS

Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex. This can be ameliorated by non-invasive brain stimulation. In this randomised single-blind study we compare effects of transcranial direct current stimulation (tDCS) on CC in healthy subjects. The study includes 162 subjects who undergo a two-week (six sessions) training of cognitive control (adaptive paced auditory serial addition task, PASAT) supported by tDCS. Subjects are randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1 mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups. Stimulation effects on performance changes are compared to a sham control group.Changes in Affective state are measured by the positive and negative affect schedule (PANAS), possible transfer effects are assessed by the Eriksen Flanker task. Stability of effects is measured up to three months after the last intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Right-handed (assessed by Edinburgh Handedness Inventory)
* No other concurrent brain stimulation during participation
* Proficient in German (min. CEFR level B)
* Ability to strictly adhere to study timeline

Exclusion Criteria:

* Diagnosed neurological illnesses
* Diagnosed psychiatric disorders
* Achromatopsia
* Metallic implants / tattoos on or near electrode sites
* Consumption of tobacco to an equivalent of ten or more cigarettes per day
* Prior participation in experiments involving the PASAT
Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure

Exposure to air pollution is associated with increase in cardiovascular morbidity and mortality. Controlled human exposure studies have demonstrated impaired vascular function and heart rate variability on healthy volunteers. The aim of this study is to investigate the effects of reducting diesel exhaust inhalation on endothelial function, heart rate variability and cardiopulmonary stress testing in healthy volunteers and patients with chronic heart failure, by using a filter mask.

Design and setting: Double-blind randomised crossover studies in a university teaching hospital

Patients: 30 patients with stable Heart Failure (NYHA I-III) and 15 healthy volunteers

Interventions: All 45 subjects will be exposed to dilute diesel exhaust (PM2.5 of 300 mg/m3), filtered diesel exhaust (filter mask), or filtered air

Main outcome measures: Endothelial function, heart rate variability, six-minute walking test and blood samples for inflammatory factors

Eligibility Criteria:
Inclusion Criteria:

* NYHA I-III;
* Left Ventricle Ejection Fraction \< 50%;
* Clinical condition stable for more than three months prior to the randomization;

Exclusion Criteria:

* Severe arterial hypertension;
* Severe Pulmonary disease;
* Patients with pace-markers;
* Patients with constrictive pericarditis;
* Severe chronic kidney disease;
* Patients with pulmonary hypertension;
* Stroke within the last six months;
* Severe hepatic disease;
* Patients with musculoskeletal limitations to exercise;
* Patients with cardiac cachexia.
Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Primary objective:

* To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.

Secondary objectives:

* To determine how well irbesartan 300mg is tolerated versus 150mg
* To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
* Blood pressure of \< 180/110mmHg at baseline
* Normal serum creatinine

Exclusion Criteria:

* Type 1 diabetes
* Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
* Pregnant or lactating women
* Severe hypertension
* Overt nephropathy
* Allergy to study drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
* Has measurable or evaluable-only disease
* Is female, ≥18 yrs of age, post menopausal or surgically sterile
* HER2 negative, HR+, ER+ and/or PgR+ breast cancer
* 0-1 prior chemotherapy regimen for metastatic disease.
* Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
* Prior tamoxifen therapy is allowed
* No AI therapy for \>1 year without recurrence

Exclusion Criteria:

* Pregnant or breast feeding
* Prior hormonal therapy for metastatic or locally recurrent disease
* \>1 chemotherapy regimen for metastatic disease
* Pleural or pericardial effusion
* Serious cardiac condition
Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

1. Our hypotheses on the relationship between periodontitis and AS are as follows;

   * The prevalence of periodontitis is higher in AS patients group than that of non-AS control group
   * Anti-TNF-α therapy would favorably affect the disease course of periodontitis.
2. Based on our hypotheses, the specific objectives of the present proposal are as follows;

   * The primary objective is to compare the prevalence rate of periodontitis between AS patient group and non-AS group.
   * The secondary objectives will be:

     * To observe the carriage rate of P. gingivalis in AS and non-AS groups
     * To identify clinical parameters associated with the severity of periodontitis in AS group.
     * To compare the progression of periodontitis at weeks 12 and 24 between AS and non-AS groups or between AS patients with and without anti-TNF-α treatment


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Subjects giving informed written consent
* In case of AS patients, subjects to meet the 1984 modified New York criteria for AS.
* In case of controls, subjects without a history of inflammatory arthropathy

Exclusion Criteria:

* Subjects having received periodontitis treatment including scaling within 6 months before study participation.
* Subjects with a history of taking antibiotics including prophylactic anti-tuberculosis agents within 3 months before study participation.
* Subjects with a hitory of taking immuno-suppresives (methotrexate, leflunomide, tacrolimus, cyclosporin, or azathioprine) or any dose of glucocorticoids (oral or pareneral) within 3 months before study participation.
* Subjects with a history of diabetes mellitus.
* Subjects with aggressive periodontitis requiring open flap debriment at enrollment immediately.
* Subjects with a hitory of clinical inflammatory bowel disease.
* Subjects with active infection, which can make an influence on the levels of acute phase reactants.
* Subjects with any other condition to render the patient unable to understand the scope of the study or preclude the patient from following the protocol in the physician's opinion.
Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?

The purpose of the research is to evaluate whether routine screening for woman abuse in health care settings, as compared to no screening, does more good than harm. Recent reviews have identified the need for high quality research to understand 1) the actual impact on all women of instituting mass screening procedures to identify woman abuse and 2) the extent to which early identification through screening is effective in preventing or ameliorating important outcomes. The main outcomes for the study are reduction in violence, improvement in life quality, and potential harms of screening. A number of secondary outcomes to help understand the process by which screening and usual care might lead to changes in the primary outcomes will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-64 years
* Patients at the health care site
* Able to participate in English
* Able to separate from accompanying person(s)

Exclusion Criteria:

* Too ill to participate
* Unable to separate from accompanying person(s)
* Unable to speak, read, or write English
Students With Involved Families and Teachers

PURPOSE: In the proposed project, the investigators seek to examine whether the SWIFT Program might be efficacious to improve students' prosocial skills and emotion and behavior regulation and improve home-school communication and the use of positive parenting practices for families. The investigators will also test whether the SWIFT program might be efficacious to improve students' longer-term school adjustment and parents' involvement in school.

SETTING: Study activities will take place in ten school districts in Lane County, OR. The districts have approximately 10,000 middle school students (Grades 6-8), and approximately 60% of students are eligible for free and reduced price lunch. Some participating districts participated in the IES-funded Goal 2 study to develop the SWIFT Program.

POPULATION: 320 students in Grades 6-8 who are receiving special education services for emotional or behavioral disorders, and transitioning or at risk of transitioning between school settings and placements will be recruited. Parents and content area teachers of all participating students will be recruited to complete assessment measures. It is expected that up to 15% of the children in the study will be of Latino ethnicity and approximately 60% will be European-American and 10-20% will be of other or multiple ethnicities.

INTERVENTION: The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) case management of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students.

SERVICES AS USUAL (SAU) CONTROL CONDITION: The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study (as will the SWIFT students and families). These may include school-based interventions and supports and related services as required in the student's IEP.


Eligibility Criteria:
Inclusion Criteria:

* Students in grades 5 through 8
* In school districts in the the Lane Education Service District
* Eligible for or at risk of eligibility for special education services for emotional or behavior disorders
* Transitioning or at risk of transitioning between school settings or placements
* English or Spanish speaking

Exclusion Criteria:

* Students receiving intensive family and school support services from local community mental health agencies
* Students with a hearing or vision impairment that would limit participation in the program components or the assessment protocol.