cyrilzakka/clinical-trials huggingface dataset:
Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis

The purpose of this study is to assess the efficacy and safety of multi-target therapy in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.

1. To assess the efficacy of FK506 combined with MMF vs intravenous cyclophosphamide (CTX) pulses in treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis (LN).
2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ LN.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent by subject or guardian
2. 18 to 65 years of age (inclusive 18 and 65), male or female
3. Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
4. Diagnosis of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+ⅤLN according to the ISN/RPS 2003 classification by light, immunofluorescence, and electron microscopy within 6 months before enrollment
5. Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
6. SLE Disease Activity Index (DAI) \>10'
7. Proteinuria ≥1.5g/d，with or without active urinary sediment
8. Serum creatinine (Scr)≤3.0mg/dl (265.2 mol/L)

Exclusion Criteria:

1. Previous treatment with MMF, CTX, tacrolimus, Cyclosporin A (CsA), large doses of immunoglobulin and methylprednisolone (MP), plasmapheresis or renal replacement therapy within the past 12 weeks. Oral glucocorticoids, azathioprine, intravenous MP (≤80mg/d)， short-time CsA (\<2 weeks) or leflunomide (\<4 weeks) are allowed
2. ALT or AST increase twice above the upper limit of the normal range
3. Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level\>11.1 mmol/L
4. Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
5. History of present illness:

   1. active HBV infection (HBsAg, HBeAg and anti-HBc positive or HBsAg, anti- HBe and anti-HBc positive), HCV infection, pulmonary tuberculosis, cytomegalovirus(CMV) infection (defined as CMV-IgM positive or CMV-DNA positive), fungal infection or HIV infection, within 3 months before the enrollment
   2. non-healed active peptic ulcer within 3 months before the enrollment
   3. drug or drinking abuse
   4. malnutrition (BMI \<18.5kg/m2) or body weight \<50Kg
6. Other active diseases, such as:

   1. severe cardiovascular diseases
   2. chronic obstructive pulmonary disease(COPD)or asthma requiring oral glucocorticoids
   3. marrow depression not due to SLE activation: white blood cell count \<3000/mm3 or neutrophil count \<1300/mm3 or platelet count \<50000/mm3
7. Severe infection or need of antibiotic therapy
8. Female patients who are pregnant/breastfeeding or those patients (both gender) who refused contraception
9. Life-threatening complications such as large hydropericardium, pneumohemorrhagia, lupus encephalopathy and severe pulmonary hypertension or patients in need of MP pulse (\>0.5g/d ) treatment because of aggravation of SLE
10. Known to be non-compliance or violation of the protocol base on investigator's judgement
11. Patient who participate of any other investigational drug study.
Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients

The purpose of this study is to investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome.

Patients with pathologically proven NPC, stage II-IVB and finishing curative RT ≧70 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. Before entry, 8 CC venous blood will be obtained for EBV DNA and antibody screen tests after patient's consent. Those who have undetectable plasma EBV DNA (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered.

Routine re-staging work-ups after RT should show no active lesion in nasopharynx, neck and distant organs. Re-staging survey should include nasopharyngoscope, pEBV DNA assay, CBC, platelet count, renal and liver function tests, CXR, abdominal sonography or CT scan, whole body bone scan, MRI or CT scan of the head and neck region.

Within one week after finishing registration, EGCG or placebo should be started. A blood sample before taking EGCG/placebo will be collected for antibodies test and pEBV DNA assay.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven NPC.
* 2010 AJCC stage II-IVB.
* Age ≧ 20 years old.
* Performance status of ECOG ≦ 2.
* Finished RT ≧66 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy).
* Clinical complete remission by re-staging work-ups within 3 months before entry.
* Plasma EBV DNA = 0 copy/ml within 4 weeks before entry.
* Adequate liver, renal, and bone marrow function:Serum total bilirubin level ≦ 2.5 mg/dl. Serum creatinine ≦ 1.6 mg/dl. WBC ≧ 3,000/ul. Platelet count ≧ 100,000/ul.
* No intake of EGCG or similar dietary supplements.
* Signed informed consent.
* No further anti-cancer treatment.

Exclusion Criteria:

* Occurrence of locoregional recurrence or distant metastasis.
* Inadequate RT or finishing RT \> 6 months.
* Not complete remission by re-staging work-ups within 3 months before entry.
* Plasma EBV DNA \> 0 copy/ml within 4 weeks before entry.
* Intake of EGCG or similar dietary supplements during recent 3 months.
* Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
Adherence Improvement in Glaucoma Patients

The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis glaucoma or ocular hypertension
* Treatment with travoprost or travoprost/timolol

Exclusion Criteria:

* High risk of side effects expected from travoprost or travoprost/timolol
* Absolute inability to administer eye drops
* Difficulty in reading or speaking Dutch
A Validity and Reliability Study for Urdu Version of Rivermead Mobility Index in Stroke Patients

The aim of the study is to translate and cross-culturally adapt the Rivermead mobility index questionnaire into traditional Urdu language to investigate its psychometric properties (reliability \& validity) for those patients who are confronting stroke.

As per preceding commendation, Rivermead Mobility Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among Stroke population, Rivermead Mobility Index will be conducted in 50 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Rivermead Mobility Index, Barthel Index and Functional Independence Measure will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 has been used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Rivermead Mobility Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Male and female both genders
* Adults between the ages of 18 and above
* Stroke patients ( chronic)
* Ability to provide informed consent

Exclusion Criteria:

* Any musculoskeletal pathologies
* Suffering from any cardiovascular pathologies
* Any history of fracture
* Any histories of infections
* Any history of neurological disorders
* Having any spinal deformity
MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)

The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator. Cardiac innervation will be assessed using an imaging agent administered intravenously.

The survival benefit provided by implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death in heart failure compared to medical treatment alone is well established. First limited to the most severe patients, the indications have gradually been extended in accordance with the results of more recent studies. This beneficial effect in terms of public health is accompanied by an increase in health spending which threatens to grow strongly at short and medium term. However, the majority of ICDs implanted will not be solicited because of the overall low incidence of severe ventricular arrhythmias in the population meeting the implantation criteria. To optimize our resources, it is therefore important to better assess the risk of sudden death in those patients candidates for ICD implantation.

The overactivation of NEURO-humoral systems plays an important role in the progression of heart failure, and in the occurrence of ventricular arrhythmias. The iodine-123 meta-iodobenzylguanidine scintigraphy (MIBG), is a functional imaging method that can noninvasively evaluate cardiac sympathetic innervation. It has been shown that cardiac adrenergic hyperactivation estimated by MIBG scintigraphy was associated with a poor outcome, and that its value was independent and superior to other prognostic factors in heart failure. More importantly, the risk of occurrence of major cardiac events is minimal when the cardiac uptake of MIBG is high. Furthermore, plasma natriuretic peptides (particularly BNP and NT-proBNP), which are other indicators of the NEURO-hormonal activation used in the diagnosis and assessment of prognosis in heart failure, are predictive of the risk of occurrence of sudden death in the same population. In summary, the MIBG scintigraphy and NT-proBNP are two prognostic markers in heart failure related to the degree of NEURO-hormonal dysfunction, and have a good negative predictive value of mortality. Their combined use could therefore help identify patients at low risk of severe arrhythmias.These tests are not currently part of heart failure diagnosis in patients who are candidates for ICD implantation.

Eligibility Criteria:
Inclusion Criteria:

* Indication for ICD in primary prevention according to European Society of Cardiology guidelines

Exclusion Criteria:

* Secondary prevention indication of ICD
* Acute coronary syndrome within the last 40 days
* Revascularization procedure (bypass or percutaneous coronary angioplasty) performed within the last 3 months of planned
* Pregnancy or lactating female
Improving Quality of Life for African American Female Adolescents With Lupus

This study will evaluate a program designed to help African American adolescents with lupus (systemic lupus erythematosus or SLE) cope with the disease.

SLE is the most common autoimmune connective tissue disease of childhood, affecting 5,000 to 10,000 children; the prevalence is higher among African American children and approximately 80% of sufferers are female. SLE is multisystemic in onset and has no known cure. Children with chronic illness have at least a two-fold increased risk for adjustment problems relative to their healthy peers. This risk is heightened among adolescents, who are at greater risk for psychopathology than are younger children. The diagnosis of a chronic medical condition during adolescence presents unique stressors, particularly for adolescents with lupus, who must endure bodily changes, including dermatological problems, hair loss, and changes in appearance due to medical therapies. Psychosocial processes, including methods of coping, expectations, and family functioning, are believed to mediate the influence of disease severity. This study will evaluate the effectiveness of a cognitive-based intervention to improve the quality of life of adolescents with SLE.

Participants in this study will be randomly assigned to either the cognitive-based intervention, a lupus education program, or a control group. Participants in the intervention group will have five study visits over 5 months. The first three visits are biweekly, 45-minute sessions during which the adolescent will be taught coping skills and cognitive restructuring techniques. The coping skills training will include training in relaxation, distraction, and problem-solving skills. The cognitive restructuring techniques will assist adolescents in using more accurate and adaptive cognitive responses. Caregivers will join the adolescent at the end of each training session to gain familiarity with the content reviewed in each session. The remaining two study visits are booster sessions during which the intervention material will be reviewed.

Participants in the education program will also have five study visits. Study visits will include disease-appropriate education materials. Caregivers will not be included in the education program. Participants will be assessed at study entry and Months 6, 9, and 12. Assessments will include questionnaires designed to measure disease severity, pain intensity, methods of coping, expectations of efficacy, social support, and adjustment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus (SLE)

Exclusion Criteria:

* Severe depression with suicidal thoughts
* Delirium, dementia, or cognitive impairment (e.g., Mini Mental Status Examination 24 or less)
* Severe intellectual impairment
* Terminal illness with a life expectancy of less than 1 year
Behavioural Study in Chronic Pain : Creativity and Motivation, and Circuits Involved in Functional MRI

Being creative means having the ability to produce ideas, actions or works that are original and different from what we have already done. This process involves mental flexibility, in particular the association of distant ideas or divergent thinking. This creative potential is complex and depends on a number of factors, both internal (personality, motivation, emotional state, stress) and external to the individual (socio-cultural context). The generation of creative ideas involves the fronto-striatal circuit, with a balance between flexibility and perseverance. The striatum is central to the reward system and mental flexibility, while the prefrontal cortex is involved in executive control, underpinning perseverance functions. Dopamine plays a key role in this balance, and changes in dopamine levels, depending on the type of receptor activated, will have a direct impact on the transition between mental flexibility and perseverance. Furthermore, in the context of chronic pain, changes in connectivity and activity can be observed in neuroimaging in these same regions of the reward circuit. This suggests that the dopaminergic system is also involved in the chronicisation of pain. The creative process would therefore be correlated with the dopaminergic reward system, involving several dimensions, both cognitive in terms of mental flexibility, coping strategies and perseverance, and motivational. In this context, art therapy treatments are beginning to be studied, particularly in patients suffering from Alzheimer's or Parkinson's disease, showing improvements in anxiety and depression.

Art therapy has not yet been widely proposed or studied for patients suffering from chronic pain. A more detailed behavioural study would confirm and clarify the clinical benefits for patients, by exploring the neuronal circuits involved, particularly the dopaminergic reward system.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over
* Consent to participate in the study
* Available for protocol visits
* Treated for chronic pain

Exclusion Criteria:

* Progressive neurodegenerative neurological pathology impairing cognitive function
* Untreated clinical depressive syndrome
* Fibromyalgia in the foreground
* High doses of opioid treatment (greater than 100 mg/d of morphine equivalent)
* Impaired judgement or inability to receive information that prevents performance of behavioural tasks
* Absolute contraindication to MRI (e.g. pacemaker and implantable stimulator not MRI compatible, intra-orbital metallic foreign body);
* Persons benefiting from a legal protection measure
* Pregnant or breast-feeding women
* Patient deprived of liberty
* Patient suffering from mental disorders
Remote Monitoring of Cancer Patients with Outpatient Treatment

This project focuses on studying the use of digital platforms for monitoring, between medical visits, parameters such as toxicities and therapeutic adherence.

The goal of this observational study is to know the degree of usability of the Caaring® digital platform in cancer patients undergoing outpatient oral treatment. This will allow in the future to design comparative studies that demonstrate the advantages of using this application in the management of these patients.

Participants will fill out various questionnaires in the Caaring app related to their symptoms, adherence to treatment, quality of life and physical activity, among others.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with adjuvant or metastatic oncological treatment
* Cancer patients with oral oncological treatment
* Patients who are able to complete the study questionnaires
* Patients who are able to handle the application on a smart mobile phone.
* Informed consent is obtained from the patient.

Exclusion Criteria:

* Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills.
* Patients with inability to give adequately the informed consent.
Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain

Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).

Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.

Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).

Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic LBP
* BMI \< 30

Exclusion Criteria:

* Hernia
* Lower limb pathologies
* Previous experience with unstable shoes
An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study

This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled and receiving either control treatment or onartuzumab-based study treatment in an eligible P-trial
* Has not met the treatment discontinuation criteria specified in their P-trial protocol at the time of enrollment into the extension trial (E-trial)
* Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
* For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 180 days after the last dose of study drug
* For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 180 days after the last dose of study drug and agreement to refrain from donating sperm during this same period

Exclusion Criteria:

* Pregnancy or lactation or intention to become pregnant during the study (serum pregnancy test required before enrollment)
* Any non-protocol anti-cancer therapy started between discontinuation from treatment in P-trial and start of enrollment in E-trial.
Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy

The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.

Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.

The investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.

The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.

Eligibility Criteria:
Inclusion Criteria:

* Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
* Age greater than or equal to 18 years old
* Able to give consent

Exclusion Criteria:

* Current implantable cardioverter-defibrillators or pacemaker in place
* Suspected intestinal obstruction
* Esophageal swallowing disorder
* Esophageal stenosis
* Age less than 18 years old
* Pregnancy
* Known Zenker's diverticulum
* Patients with previous endoscopic or surgical esophageal treatment