cyrilzakka/clinical-trials huggingface dataset:
Hepatitis C Treatment in Underserved Populations

The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.

This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Used heroin, cocaine, or injected other drugs for at least 1 year
* Have used heroin, cocaine and/or methamphetamine within the last 30 days
* Test positive for HCV antibody
* Are interested in being evaluated for HCV treatment

Exclusion Criteria:

* Persons who are obviously intoxicated, incoherent or otherwise unable to give informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.
Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)

The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of RRMS per McDonald criteria
* Initiated treatment with DMF, GA, teriflunomide, or fingolimod (defined as index therapy) no earlier than January 2011 and no later than 12 months prior to the date of medical record abstraction (i.e., patient has at least 12 months of data available in the medical record following initiation of index treatment). Note: Patients who have initiated the index therapy but subsequently discontinued or switched to other therapies are allowed in this study as long as there is at least 12 months of follow-up following the initiation of the index therapy.
* Have sufficient available medical records for data abstraction to meet the objectives of the study, i.e., the patient was either under the medical care of the investigating site during the entire period of the index treatment or the patient's complete MS disease and treatment history is otherwise available at the investigating site

Key Exclusion Criteria:

* Diagnosis of a progressive form of MS (progressive relapsing, primary progressive, secondary progressive) at any time before or during the period for which data will be collected
* Have received disease-modifying therapies other than one platform therapy (IFN or GA) prior to initiation of index therapy. In patients for whom GA is index therapy, only one prior IFN therapy is allowed.
* Have received any formulations of DMF, Fumaderm®, or compounded fumarates (e.g., Psorinovo) at any time prior to initiation of treatment with Tecfidera®
* Concurrent enrollment in any interventional clinical trial of an investigational product during time evaluated for medical record abstraction

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Acute Right Ventricular Infarction Registry

This Study aims to provide an assessment of clinical presentation, management, hospital course, and prognosis of acute right ventricular infarction presenting with or without Inferior or infero-posterior wall Myocardial Infarction and the assessment of composite adverse clinical outcome after reperfusion in-hospital and post-discharge (in 30 Days Prognosis).

After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity.Data will be collected for various patient, system, and procedure related characteristics with the help of a predefined structured proforma consisted of demographic data, clinical presentation, history and co-morbid conditions, and angiographic and procedural characteristics. All the recruited patients will be kept under observiton during the hospital stay and a telephonic follow-up will be carried out after 30-days of discharge and occurrence of the MACE will be recorded.

Univariate and multivariable binary logistic regression analysis will be performed to determine the clinical predictors of RVI. Odds ratio (OR) along with 95% confidence interval (CI) will be reported. The statistical significance criteria will be set as p-value\<0.05.

For data verification, 10% of the data will be cross-checked with the source document (Patient file).

Eligibility Criteria:
Inclusion Criteria:

* Patients of Inferior, infero-lateral and infero-posterior wall MI with and without RV infarction undergoing PPCI.
* Both male and female patients.
* Patients of age ≥ 18 years.

Exclusion Criteria:

• Patients who will not give consent for participation.
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).
* Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase).
* Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).

Exclusion Criteria:

* Patients with known hypersensitivity to fluvastatin or any of the excipients.
* Dyslipidemia secondary to other causes.
* Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN).
* A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks.
* Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN.
* Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks continuous monotherapy with a recommended dose and administration in the label) within the previous 3 months prior to visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.
Non-Invasive Cooling of Fat Cells

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back.
3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
4. Subject has used diet pills within the past 6 months.
5. Subject is unable or unwilling to comply with the study requirements.
6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
8. Patient is pregnant or intending to become pregnant in the next 9 months.
9. Patient is lactating or has been lactating in the past 9 months.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans

Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation.

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval).

Dose-constraints: MLD \> 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.

Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):

* carboplatin AUC 5 day 1
* etoposide 120 mg/m2 days 1-3

Q 3 weeks; 5 cycles

In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proven SCLC
* UICC stage I-III, "limited disease"
* Performance status 0-2
* FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria:

* Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung carcinoma)
* UICC stage IV
* Performance status 3 or more
* FeV 1 and DLCO \< 30% of the age-predicted value
Cardiac Dysfunction in Patients with Fatty Liver Disease

Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.

Nonalcoholic fatty liver disease (NAFLD) and heart failure (HF) are obesity-related conditions with high cardiovascular mortality. Many new studies have linked NAFLD to changes in myocardial energy metabolism, and to echocardiographic measurements of cardiac dysfunction especially heart failure with preserved ejection fraction. Cardiac dysfunction in NAFLD is related to the release of inflammatory cytokines among those with steatohepatitis (NASH). However composite models looking at coronary artery disease, systolic and diastolic heart failure and outcomes in patients with NAFLD are limited, and the few preliminary analyses of this relationship using histologically-defined NASH or lean NAFLD remain unclear.

In this project the investigators will screen patients with a diagnosis of 'non-alcoholic fatty liver disease' for presence of coronary artery disease, arrhythmias, cirrhotic cardiomyopathy and develop a model for cardiac dysfunction in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Age range of 18-65 years
* metabolic dysfunction associated steatotic liver disease as diagnosed either by histology or clinical, laboratory, non invasive tests, USG findings and vibration controlled transient elastography (VCTE).

Exclusion Criteria:

* Age \>65 years
* Chronic renal disease
* Pregnancy and peripartum cardiomyopathy
* Hypertension
* Valvular heart disease
* Sick sinus syndrome/ Pacemaker
* Cardiac rhythm disorder
* Hypothyroidism
* Hyperthyroidism
* Portal vein thrombosis
* Transjugular intrahepatic porto systemic shunt (TIPS) insertion
* Hepatocellular carcinoma
* Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males at the time of assessment
Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries

Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries

Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of EVUSHELD in GCC.

This will be a multi-country, multi-centre, single-arm, observational, prospective study using primary data collection to describe the demographic and clinical characteristics of patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers that are authorized to administer AZD7442, agree to participate in the study, and wherein investigators have access to all medical records (electronic/paper) for individual patients. The physicians at the hospital/centers will make a decision to administer AZD7442 to patients according to the local regulations (including the prescribing information) and such a decision to use AZD7442 is independent of the study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2 infection within the 30 days prior to study enrolment.
* The ability or willingness to sign informed consent/assent forms

Exclusion Criteria:

* Patients currently participating in interventional clinical trials of SARS-CoV-2 vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments.
* Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as judged by the study physician.
Apatinib in Combination With S-1 as First-Line Treatment in Patients With Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, aged ≥18 years;
2. Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease;
3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3;
5. No previous chemotherapy for advanced/metastatic disease 1) Prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study); 2) No previous targeted therapy; 3) For patients who can't tolerate first-line chemotherapy or refuse to accept chemotherapy, if they request to participate in this study, may receive apatinib monotherapy after consultation with the principal investigator in consideration of ethics.
6. Hematological, Biochemical and Organ Functions: HB ≥ 80 g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L, BIL \< 1.5×ULN, ALT or AST \< 2.5×ULN (or \< 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min;
7. Life expectancy of more than 3 months;
8. Duration from operation is more than 4 weeks;
9. For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
10. Signed informed consent.

Exclusion Criteria:

1. Patients with poor-controlled arterial hypertension (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mm Hg) despite standard medical management; Coronary heart disease, arrhythmia (including QT interval prolongation, for man \> 450 ms, for woman \> 470 ms), and cardiac dysfunction greater than Class II;
2. Factors affecting the oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction;
3. Patients with a clear tendency of gastrointestinal bleeding;
4. Abnormal coagulation function (INR \> 1.5×ULN, APTT \> 1.5×ULN), with tendency of bleed;
5. Pregnant or lactating women;
6. Other conditions regimented at investigators' discretion.
Non-nutritive Sucking and Breastfeeding in Preterm Infants

The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.

Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants.

The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* born less than or equal to 34 weeks gestational age (GA);
* appropriate size for their GA;
* receiving nasal continuous positive airway pressure;
* receiving only enteral feedings (orogastric or nasogastric);
* mothers are pumping their milk.

Exclusion Criteria:

* congenital anomalies
* mother not expressing milk
* transferred in hospital
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer

The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT). Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory cytokines and adipokines, participating in the formation of local inflammation, promoting the formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients with lung cancer have increased inflammatory response and are more prone to suffer thrombosis. However, in lung cancer patients, the clinical correlation between EAT and pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density, as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer patients, half with pulmonary embolism and half without. The incidence of adverse prognosis and related factors were followed up by telephone.


Eligibility Criteria:
Inclusion Criteria:

* The pathological diagnosis was lung cancer
* Pulmonary artery was evaluated by CTA during hospitalization.

Exclusion Criteria:

* Patients with incomplete clinical data
* Patients with no follow-up data
* Patients with a history of PE before diagnosis of lung cancer