cyrilzakka/clinical-trials huggingface dataset:
Role of Lung Ultrasound in Screening for Interstitial Lung Disease in Patients With Rheumatoid Arthritis

The aim of this observational cross-sectional study is to assess accuracy of Lung Ultrasound to early diagnose ILD among Rheumatoid arthritis patients. Rheumatoid arthritis patients with suggestive history of chest troubles will be evaluated using chest ultrasound and high resolution CT chest to evaluate ability of chest ultrasound to early diagnose ILD among rheumatoid arthritis patients.

Interstitial lung disease (ILD) is a common complication of connective tissue disease (CTD) and a leading cause of morbidity and mortality. Thus, early diagnosis and treatment may improve the prognosis of patients with ILD.

High-resolution computed tomography (HRCT) is the gold standard for ILD diagnosis. It can detect the location and type of lesions through its high resolution. Unfortunately, it is hampered by high cost and potential risks associated with radiation exposure, especially for pregnant women.

Accordingly, finding a low-cost, non-invasive, and non-ionizing diagnostic method is necessary for ILD. Lung ultrasound (LUS) has all of these advantages and is an accessible bedside procedure. As a result, it is easily accepted by patients. Over the last 20 years, LUS has mainly been applied in CTD-ILD diagnosis, where it has shown high sensitivity and specificity. The assessment of ILD by LUS is determined by the number of B-lines, which appear as a comet tail signal and originate from the pleural line without fading to the edge of the screen.

The total number of B-lines was found to correlate well with the HRCT score. To assess the number of B-lines, previous studies used various scoring systems by designing different intercostal spaces (LIS), such as 72 LIS, 50 LIS, and 14 LIS. This study aims to assess Lung ultrasound as a screening tool for early interstitial lung disease in connective tissue disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age \> 18 years

Exclusion Criteria:

* Patients who refuse to participate in the study,
* Patients with a history of pulmonary neoplasia or
* Patients with causes of interstitial fluid, such as, heart failure, diastolic dysfunction, asthma or pulmonary edema.
Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood

Background

Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).

Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern.

Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect.

Purpose

The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.

Abstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.

After infusions of Rituximab or placebo, patients will be examined by their nephrologist on a monthly basis during five months. Follow up will be focused on proteinuria, albuminemia, lymphocyte phenotyping and Rituximab pharmacokinetics

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients over 2 and under 18 years, with an idiopathic nephrotic syndrome (NS)
* Steroid Sensitive Nephrotic Syndrome (according to the French pediatric protocol).

NEPHRUTIX

* Calcineurin inhibitor Dependent NS or NS for which anticalcineurin treatment has not been effective. Others immunosuppressive treatments (MMF) must have failed to control the disease activity.
* Effective contraception for girls of childbearing age.
* The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtained prior to the initiation of any study procedure

Exclusion Criteria:

* Terminal renal failure requiring dialysis/transplantation
* Transcutaneous oxygen stauration \< 97%
* Clinical or Radiological brochopulmonar or pleural abnormality
* Asymptomatic carrier of Hepatitis B virus our history of Hepatitis B
* Contraindication to Rituximab (RTX)
* Parents/patient refusing to participate in the study
Physical Telerehabilitation in Veterans With Multiple Sclerosis

The primary objective of this study will be to assess the feasibility and patient acceptance of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients.

Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation of multiple sclerosis patients. Specifically, the investigators hypothesize that home telemanagement using a daily exercise diary, monitoring of compliance with a tailored exercise program and regular assessment of strength and motor functions will: 1. Be feasible and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality of life


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65
* Clinical Diagnosis of MS based on McDonald criteria
* Functional disability defined by the PDDS in the range of 2 to 6
* Have a working telephone line in their home or a cell phone
* Willingness and ability to use MS HAT platform with individual modifications based on preferred user interface
* Patient demonstrates ability to successfully perform physical therapy exercises and procedures independently or with assistance of a caregiver.
* Ability to complete 25-foot walk test in at least 3 minutes

Exclusion Criteria:

* Age less than 18 years old
* No diagnosis of MS
* Other musculoskeletal diagnoses, unstable cardiovascular, respiratory, metabolic or other conditions that would interfere with this study
* One or more exacerbations in the preceding 3 months
* Received a course of steroids (IV or oral) within 60 days of screening
Encouraging Social Inclusiveness as a Means to Improving Academic Performance

Children's peer relationships in elementary school are important to promote their academic learning and their social-emotional development. Many children with or at risk for Attention-Deficit/Hyperactivity Disorder (ADHD) have difficulty being accepted and getting along with their classroom peers. This study tested a classroom intervention that aimed to help improve the peer relationships of elementary school age children, with a particular focus on children with or at risk for ADHD.


Eligibility Criteria:
Inclusion Criteria:

-General education teachers of grades K-5 or children in these teachers' classrooms

Exclusion Criteria:

-None
Oral Glucose Tolerance Testing After Gestational Diabetes

This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational diabetes

Exclusion Criteria:

* Multiple gestations
* pre-pregnancy diabetes
Infection Rates of Myeloablative Allo SCT Recipients Receiving Neutropenic Diets Versus Non-Neutropenic Diets

In the transplant community, there is debate regarding the most appropriate food services for stem cell transplant patients. Recommendations regarding the use of low bacterial diets have been based on theoretical concepts of reducing the risk of contracting infections from pathogens found in food sources rather than clinical trials. The evidence for the use of a neutropenic diet is weak. To date, there have been little to no randomized controlled studies addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is necessary as infection prevention in myeloablative stem cell transplant patients. For this reason, our research is aimed at providing data to substantiate the use of neutropenic diets in preventing infections in recipients of myeloablative stem cell transplants.

In the proposed pilot study, a randomized design will be used to address the primary and secondary aims. Subjects will be randomized to either the experimental group receiving a non-neutropenic diet without restriction, or to the control group receiving the standard neutropenic diet. While randomization will occur prior to, or on the day of their inpatient admission and the subjects will begin study procedures upon admission to the Adult Stem Cell Transplant Inpatient Unit at Duke University Medical Center.

The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize the opportunity for deviation from the assigned diet. Absence of neutropenia will be defined as an absolute neutrophil count of greater than 500/uL (manual differential) and a total white blood cell count of 1000/uL for three consecutive days.

All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other supportive care will also be consistent in the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo a myeloablative allogeneic stem cell transplant for any cancer or non-cancer illness from any related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood
2. Age 20-70 years of age
3. Karnofsky Performance Scale KPS\> 80
4. Ability to read and write English

Exclusion Criteria:

1. Autologous stem cell transplant recipients
2. Non-myeloablative or reduced intensity stem cell transplant recipients
3. Pregnant women
4. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable.

However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* Age ≥ 18 years old
* Pathological confirmation of esophageal squamous cell carcinoma
* Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
* No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
* Tumor longitudinal diameter ≤ 10cm
* The tumor did not involve the dentate line
* ECOG score 0 or 1
* No hematological diseases, no liver or kidney dysfunction
* Absolute neutrophil count ≥ 1.5 × 109/L
* Platelets ≥ 100 × 109/L
* Hemoglobin ≥ 11g/L
* ALT ≤ 2 times the upper limit of normal value
* TBil ≤ 1.5 times the upper limit of normal value
* Creatinine clearance rate (Cockroft) ≥ 50ml/min
* Obtain informed consent

Exclusion Criteria:

* T staging evaluation is T1/T2
* PET/CT and other evaluations show distant metastasis (M1)
* Planned pregnancy or patients during pregnancy or lactation
* History of previous chemotherapy, radiation therapy, or immunotherapy
* Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
* Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
* Previous autoimmune disease requiring systemic treatment within 2 years
* Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
* Previous motor or sensory neurotoxic diseases
* Previous mental illness
* Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
* Acute infectious diseases requiring systemic treatment
* Previous HIV, HBV, or HCV infections
* Previously received stem cell or solid organ transplantation
Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly

The purpose of this study is to evaluate whether low dose complex B-vitamins (folic acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an apparently healthy population with low folate/B12 and high Hcy status.

Hyperhomocysteinemia has been well known as an independent risk factor for CVD. Numerous studies have demonstrated that certain kinds of vitamin B(folic acid,vitamin B6 and vitamin B12)can reduce Hcy level and may prevent CVD. However, the majority of those studies has been conducted always used high dose vitamin in patient or high risk population. There is thus absence of data that the effectiveness of low dose complex B-vitamins on the apparently Chinese elderly population with relative sub-nutritional status. Our study is just focus on the aforementioned aspect.

Eligibility Criteria:
Inclusion Criteria:

* Male and female residents living in the field site for at least 12 months
* Aged 60-74 years

Exclusion Criteria:

* History of chronic disease and taking medications for treatment such as CVD, COPD, cancer, severe renal and liver disease, diabetes.
* Use of multivitamins, and individual vitamins such as folic acid, B12, or B6 in the last 6 months.
* Taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, L-DOPA, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), Metformin, Sulfasalazine.
* Conditions that prevent participation or compliance such as Downs syndrome, mental problems, or severe cognitive impairment
Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease

A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.

An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (\> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
* Participates in a qualified pulmonary rehabilitation program
* Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
* Able and willing to sign the informed consent
* Ability to be fitted with the test nasal mask and to use the test ventilator system

Exclusion Criteria:

* Requires \> 5LPM of constant flow to maintain SpO2\> 90% during exercise
* Reports having serious epistaxis within the last 14 days prior to enrollment
* Currently enrolled in another clinical study or has participated within 30 days of enrollment
* Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.

Dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. Scientists at the Naval Medical Research Center have been working on vaccines to prevent dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.

Eligibility Criteria:
Inclusion Criteria:

* Available to participate for the duration of the study (approximately 12 months)
* Completion and review of knowledge assement quiz

Exclusion Criteria:

* Pregnant (by history or as ascertained by pregnancy test) or lactating female
* Female who intends to become pregnant during the study
* Plan to have elective surgery during the study period
* HIV infection
* Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed)
* History of splenectomy
* Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination
* Evidence of active (acute or chronic) hepatitis B or C infection
* Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease
* Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening
* Clinical or laboratory evidence of significant anemia
* History of flavivirus infection or previous receipt of flavivirus vaccine
* Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment
* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous history of allergic or anaphylactic reaction to any vaccine
* Planned travel to areas with endemic dengue during the study period
* Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol
A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence

The purpose of this study is to test whether a violence prevention curriculum delivered by Big Brothers and Big Sisters staff and mentors can reduce violence involvement for assault-injured youth.

Violent injury is a major cause of morbidity and mortality among adolescents. The presence of a positive adult role model is a well-established protective factor against violence and other maladaptive outcomes among youth. Big Brothers Big Sisters (BBBS) is the largest U.S. mentoring organization with proven effectiveness in improving youth outcomes. However, these programs may be less effective with youth who already are exhibiting involvement in problem behavior at the time of program referral. Take Charge!, a mentor- and professional-implemented intervention with 10-15 year old assault-injured youth, showed promise for improving perceived self efficacy for avoiding violence and for decreasing aggression and problem behavior.

The overall goal of the proposed project is to develop, implement, and evaluate a research-informed youth development program that adapts the BBBS model to work for assault-injured youth. The aims are:

* To expand and refine Take Charge! and integrate it with BBBS practices;
* To conduct a randomized, controlled trial in which assault-injured 10-15 year old youth recruited from emergency departments in Baltimore and D.C. receive either standard emergency department follow-up care or the Take Charge! 2 intervention with assessment of violence-related, mental health, and educational outcomes;
* To conduct a comprehensive process evaluation of Take Charge! 2;
* And to accurately measure the costs of the intervention and assess cost-effectiveness.

Youth violence is a major cause of morbidity and mortality with marked disparities by race/ethnicity and socioeconomic status. This study is a critical next step in translating evidence-based research to real-world settings and practice.

Eligibility Criteria:
Inclusion Criteria:

* Treatment for an assault injury in the emergency room
* English speaking (parent and youth)

Exclusion Criteria:

* Treatment for child abuse, sexual abuse, sibling fights, or police fights
* Severe psychopathology
A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets DSM-IV-TR criteria for schizophrenia.
* Patient is aged 18 through 74 years at informed consent.
* Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion Criteria:

* Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
* Patient has Parkinson's disease.
* Patient has a history or complication of malignancy.