cyrilzakka/clinical-trials huggingface dataset:
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.

OBJECTIVES:

* Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2.
* Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen.
* Determine the incidence of adverse events in these patients.

OUTLINE: This is a multicenter study.

Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven metastatic renal cell carcinoma

  * Clear cell
  * Papillary
  * Sarcomatoid
  * Mixed
* Measurable or evaluable disease
* Evidence of disease following surgical resection of metastases
* No CNS disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin at least 10 g/dL
* WBC at least 4,000/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Not specified

Renal:

* Creatinine no greater than 1.8 mg/dL

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception (barrier plus 1 other method)
* Thyroid-stimulating hormone normal
* No known hypersensitivity or allergy to components of recombinant human interleukin-2
* No known autoimmune disease (e.g., Crohn's disease)
* No other concurrent medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior recombinant human interleukin-2
* No concurrent interferon alfa

Chemotherapy:

* No concurrent cytoxic chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy
* No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed)
* No concurrent systemic corticosteroids

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to index lesion
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* Prior surgery for renal cell carcinoma allowed

Other:

* No prior systemic therapy for renal cell carcinoma
* At least 4 weeks since prior investigational drugs
* No other concurrent investigational drugs or participation in another clinical study
* No concurrent iodinated radiocontrast dye
* No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)
Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases

The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .


Eligibility Criteria:
Inclusion Criteria:

* incident and prevalent cases of patients with type I or type II diabetes. arthritis:
* incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010).

Renal failure :

• incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not.

Prostate cancer :

• Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy).

Breast cancer :

• Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast).

Colorectal cancer :

• Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive).

Exclusion Criteria:

- The subject participates in an experimental study of research affecting the therapeutic management of the patient.

* The subject is exclusion period determined by a previous study.
* The subject is under judicial protection, guardianship or curatorship.
* It is not possible to give informed about information
* The subject does not read French and is not autonomous filling a questionnaire.
* The patient has psychiatric disorders.
* The subject is an emergency.
* Monitoring between patient visits than 6 months.
Alterations in the Brain's Connectome After Severe Traumatic Brain Injury

This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.

Severe Traumatic Brain Injury (TBI) can result in a long-lasting altered state of consciousness. At present, the underlying neurological determinants of recovery in patients with disorders of consciousness (DOC) after a severe TBI are not well understood, and individual prognosis is very limited. Moreover, the rate of misdiagnosis between different states of altered consciousness by standard clinical scales is high, which further impacts on the clinical prognosis. In this project, multimodal neuroimaging measures will be applied and whole-brain data will be obtained from patients recovering from severe TBI in a longitudinal fashion. Patients will be examined at four time points during the sub-acute stage: immediately after admission to the neurorehabilitation unit, after ten weeks of admission, at discharge, and after one year of the TBI episode. Brain connectivity will be assessed with functional Magnetic Resonance Imaging (fMRI) combined with electroencephalography (EEG), structural MRI, diffusion MRI, high-density EEG (hdEEG) alone, and hdEEG combined with Transcranial Magnetic Stimulation (EEG-TMS), and \[18F\]-fluorodeoxyglucose positron emission tomography (FDG-PET).

The overall aim of the study is to find reliable biomarkers for the recovery of consciousness based on changes in cortico-cortical and cortico-subcortical brain connectivity. In order to explore this, patients that suffered a severe TBI as well a matched healthy participants group will be included in the study.

Eligibility Criteria:
Patient's inclusion criteria:

- closed-head injury

Patient's exclusion criteria:

* high level of consciousness after coma
* ventricular shunt for hydrocephalus
* large intracerebral hemorrhages or infarctions
* structural lesions in the brain stem
* locked-in syndrome due to motor pathway lesions
* contraindications for MR
* contraindications for TMS

Healthy participant's inclusion criteria:

- no prior history of neurological disorders and / or head injury

Healthy participant's exclusion criteria:

* contraindications for MR
* contraindications for TMS
A Comparison of Techniques for Treating Skin Abscesses

Management of abscesses traditionally involves incision and drainage (I\&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.

Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.

We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.

Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I\&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.

The study investigators will then compare outcomes between the two study groups.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient over 18 years of age
* Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
* English speaking
* Able to provide written informed consent
* Willing to return in 14 days for follow-up visit
* Able to give a telephone number for follow-up contact

Exclusion Criteria:

* Previously treated for this abscess
* Altered mental status
* Patients with active psychiatric issues that preclude their ability to provide informed consent
* Previously enrolled in the study
* Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
* Abscess is post-operative or post-procedure
* Clinician determines abscess is not amenable to drainage by particular method
* Abscess is too small for packing or loop
* Need for hospital admission
Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction

To investigate bile culture and susceptibility test in patients with malignant biliary obstruction (MBO) or relation between bile, portal vein or vein culture and biliary infection. Also to get the information of bile metabonomics to find potential tumor marker .Culture of the organism is recognized as the "gold standard" for diagnosis of infection. Our research may be one of the first research on culture and susceptibility test in patients with MBO. The results of the trial research will be benefit to experiential therapy of MBO with biliary infection and diagnosis of MBO.

We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Exclusion Criteria:

* Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)
FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.

The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of \> 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. child BMI \>= 85th percentile for age/sex,
2. participating parent and child English speaking,
3. parent has access to a telephone and is available to participate in telephone counseling sessions, and
4. referred by the child's primary care provider.

Exclusion Criteria:

1. planning to move out of the area during the period of study participation,
2. medical condition that precludes adherence to AAP dietary and physical activity recommendations,
3. genetic or endocrine causes of obesity,
4. prescribed medications associated with weight gain,
5. child on psychiatric medications, and/or
6. morbidly obese (\> 300 pounds). -
National Longitudinal Cohort of Hematological Diseases (NICHE) - CART

This is a multicenter, ambispective, longitudinal, observational cohort study investigating CAR-T cell therapy in Chinese patients with hematological malignancies. A consortium of Phase IV clinical trials and real-world studies of Chimeric antigen receptors (CAR) T cell therapy will be established in China. Patient-level data from these studies will be collected to create a large real-world cohort. In addition, patients receiving CAR-T cell therapy for hematological malignancies identified from an existing hematology longitudinal cohort study, the National Longitudinal Cohort of Hematological Diseases (NICHE), will also be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically diagnosed hematologic malignancies
* Patients treated with CAR-T cell therapy
* Signed the informed consent form
Oral Postbiotics in Patients With Macular Atrophy

A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy secondary to age-related macular degeneration, myopia, or angioid streaks.

A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy (GA) secondary to age-related macular degeneration, myopia or angioid streaks.

The study's main objective is to evaluate if oral postbiotic therapy will induce epigenetic factors that would impact the progression of the GA, and it will compare the rate of growth of GA from the Baseline to 12 months, to the rate shown during the 12 months before Baseline.

Eligibility Criteria:
Inclusion Criteria:

* patients with GA secondary to AMD, myopia or angioid streaks
* with 12 months of previous follow-up,
* and a known progression of \>0,20mm/year as per SQRT

Exclusion Criteria:

- history of choroidal neovascularization in the study eye
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.

The objective of the study is to determine whether treatment of the low IGF-1 syndrome in patients with CHF is able to modify some functional parameters, recognized as valid surrogate end-points of CHF progression.


Eligibility Criteria:
Inclusion Criteria:

* patients of either sex affected by CHF NYHA class II-III, secondary to ischemic or idiopathic dilated cardiomyopathy
* age range 30-80 years
* stable medications for at least two months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated).
* LV ejection fraction 40% or less
* Peak VO2 consumption during a CPET ≤ 16 ml/kg/min.
* LV end-diastolic dimension 55 mm or more
* low IGF-1 levels and a satisfactory response to an IGF-1 generation test
* informed consent

Exclusion Criteria:

* haemodynamic clinically significant primary valvular disease or significant congenital heart disease
* acute pericarditis/myocarditis
* inability to perform a bicycle exercise test
* Poorly controlled diabetes mellitus (HbA1c \>8.5)
* active proliferative or severe non-proliferative diabetic retinopathy
* active and/or history of malignancy
* evidence of progression or recurrence of an underlying intracranial tumor
* unstable angina or recent myocardial infarction (less than 5 months)
* severe liver disease
* serum creatinine levels \>2.5 mg/dl
* Inability to cooperate or administer the study drug
* Patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period
Heated Humidified High Flow Nasal Cannula for Children With Obstructive Sleep Apnea

The purpose of this study is to determine whether heated humidified high flow nasal cannula (HHHFNC) is effective as a treatment of obstructive sleep apnea syndrome (OSAS) compared to continues positive airway pressure (CPAP) treatments in children and to compare their adherence and compliance.


Eligibility Criteria:
Inclusion criterias:

* Age: 0-16 years old.
* Refered for treatment with non invasive ventilation.
* Diagnosed with OSAS and AHI\>=5

There are no exclusion criteria
Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia

Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized prospective study.

We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular vision at baseline. The angle of strabismus was measured pre- and postoperatively in a standardized fashion. The primary parameter to assess difference between BR and RR was the variation of the latent angle of strabismus at distance at three months postoperatively, secondary outcomes were reduction of convergence excess and binocular vision.

Eligibility Criteria:
Inclusion Criteria:

* Eligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age one who visited one of the clinics during the study period.

Exclusion Criteria:

* previous strabismus surgery, an angle of strabismus larger than 24° or smaller than 10°, any normal binocular vision, convergence excess with angle of strabismus at near fixation 1.5 times larger than the angle at distance, more than 1 line Logmar acuity difference between the two eyes, hypermetropia over 6 diopters or myopia over 3 diopters, up- or downshoot in (25°) adduction more than 8°, V-pattern (25° up and down gaze) over 8°, A-pattern (25° up and down gaze) over 5° and manifest vertical strabismus over 4°
The Effect of Moxibustion on the Meridian

The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.

Moxibustion is a traditional Chinese medicine, which use the burned moxa to generate warmth on the human's local skin and then exerts a therapeutic effect. Research found that moxibustion has effect on analgesic and anti-inflammation, which can be applied on myofascial pain, insomnia, osteoarthritis, osteoporosis, cancer related fatigue, irritable bowel disease etc.. Although research reveal that moxibustion can treat these diseases probably by effect on analgesic and anti-inflammation, the mechanism of moxibustion is still not clear.

In modern study, the meridian has electric characteristic and the therapeutic effect of acupuncture may be related to the electricity resulting by acupuncture manipulation. However, there is no study to investigate the electric effect of moxibustion on the meridian. In our study, the investigators applied the semiconductor analyzer Agilent B1500A to investigate the electric characteristic of meridians and visual analogue scale (VAS) before and after moxibustion, which may provide another vision on moxibustion in the future.

The investigators intend to recruit 30 healthy participants with age more than 20 years old to participate this study. The participants receive acupuncture and then measure the VAS and electric characteristic by the semiconductor analyzer Agilent B1500A immediately(baseline data). The investigators add the burned moxa on the acupuncture as a method for moxibustion. After the moxa burned out, the investigators measure the VAS and electric characteristic immediately again(post moxibustion data). The investigators will use paired t test and repeated measure two ways ANOVA to compare the VAS and electricity of baseline data and post moxibustion data in each participant.

The purpose of this study is to combine the Chinese medicine and physics, using acupuncture to conduct electrical measurement, and to understand the effects of moxibustion on meridian.

Eligibility Criteria:
Inclusion Criteria:

* at least 20 years old
* agree to the informed consent

Exclusion Criteria:

* under 20 years old
* pregnant or breast-feeding women
* those with an empty stomach before the study
* a tendency toward bleeding with thrombocytopenia or history of platelets \< 20000 or a user of an anti-platelet drug.
Development of a Blood Test for Marfan Syndrome

The objective of this study is to determine whether a simple blood test can be a useful clinical tool for monitoring aortic disease in Marfan syndrome and Marfan-related disorders.

The primary objective of this study is to determine whether increased quantitites of circulating microfibril fragments, measured with a simple blood test, are associated with aortic root size and increased growth of the aortic root in Marfan syndrome and related disorders. The secondary objectives of this study are to: (1) Determine a Marfan "signature" profile of circulating microfibril fragments. (2) Determine if high concentrations of fibrillin-1 fragments are associated with large aortic root diameters. (3) Determine which fibrillin-1 fragments are good biomarkers for aortic root growth and size in Marfan syndrome. (4) Determine the relation between fibrillin-1, aortic root diameter, and medical and lifestyle factors reported on questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-26 years of age for all participants
* Diagnosis of Marfan syndrome, Loeys-Dietz syndrome, vascular Ehlers-Danlos syndrome, or Familial Thoracic Aortic Aneurysm and Dissection for inclusion in Marfan and Marfan-related disorders groups
* Diagnosis of unaffected by Marfan syndrome and Marfan-related disorders for inclusion in control group
* Able and willing to sign informed consent/assent
* Signed HIPPA compliant research authorization

Exclusion Criteria:

* Other known cardiovascular disorder for unaffected controls
Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens

The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older at initiation of prior DCV-based therapy
* Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks
* Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies

Exclusion Criteria:

- N/A