cyrilzakka/clinical-trials huggingface dataset:
Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

Indonesia is one of country that contributes the most cases of tuberculosis worldwide. Tuberculosis is the most commonly etiology of exudative pleural effusion. There have been many studies about undiagnosed exudative pleural effusion, but there are not many studies about the use of medical thoracoscopy for diagnosing transudative and exudative pleural effusion, especially on biomarkers of C-Reactive Protein (CRP), D-dimer, Adenosine Deaminase (ADA), Antinuclear Antibody (ANA), C3 C4 complements, Cancer Antigen 125 (CA-125), Xpert Mycobacterium Tuberculosis (Xpert MTB), Lupus Erythematosus cell (LE cell), cytology (effusion and smear) and histopathology. Information gained from those biomarkers via thoracenthesis and medical troracoscopy, etiology of exudative and transudative pleural effusion can be detected earlier and clearly, especially etiology of infection, autoimmune, and malignancy that further can be used to reduce patients' hospitalization period, mortality, and to develop the new therapeutic agents.

Medical thoracoscopy is a minimally invasive procedure to access pleura with combination of visual and medical instrument. The procedure is performed under local anesthesia and conscious sedation. Medical thoracoscopy plays role in basic diagnotic and therapeutic. The most common indication on basic diagnostic is on pleural effusion case that has primary target to get specific diagnosis when the etiology of pleural effusion is unknown. Pleural effusion is fluid accumulation inside the pleura for about 15-20 ml. Primary aim of pleural effusion diagnosis is to differentiate exudative and transudative effusions based on Light Criteria. Most of time thoracentesis cannot give etiology of exudative and transudative pleural effusion.

Researchers will evaluate subjects based on inclusion and exclusion criteria in Cipto Mangunkusumo Hospital. Furtehrmore, research subjects will be asked for informed consent. Data will be collected based on research form. Researcher will perform medical thoracoscopy to take specimen for analysing CRP, D-dimer, ADA, ANA, C3 C4 complements, Xpert MTB, LE cell, cytology (effusion and smear) and histopathology to detect the etiology of tuberculosis, malignancy or autoimmune.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult age 18 - 75 years old
* Willing to be involved in the research
* Undiagnosed transudative and exudative pleural effusion post-thoracentesis twice on right and left lung
* Patients can undergo medical thoracoscopy under local anesthesia, based on ATS and BTS guideline

Exclusion Criteria:

* Pregnant and breastfeeding women
* Patients in non-invasive ventilation and mechanical ventilator
* Transudative and exudative pleural effusion with etiology of chronic heart failure, chronic kidney disease, hepatocirrhosis with or without hepatic hydrothorax and hypoalbuminemia.
Vitamin E in Aging Persons With Down Syndrome

The goal of this study is to determine the safety and efficacy of the administration of vitamin E, which has been shown to delay the progression of Alzheimer's disease, in slowing the rate of cognitive/functional decline in older persons with Down syndrome.

The growing success of therapeutic interventions (including the antioxidant Vitamin E) for Alzheimer's disease in the general population requires a solution to the methodological problems so that therapeutic trials can be conducted in the aging population with Down syndrome which will ultimately improve their quality of life as well as that of their families and caregivers. The experience gained in this trial will be useful to the design of appropriate cognitive measures of Alzheimer's disease in persons with Down syndrome in subsequent trials.

The goal of this international three-year study is to determine whether the administration of vitamin E, which has been shown to delay the progression of Alzheimer's disease, will slow the rate of cognitive/functional decline in persons age 50 or older with Down syndrome. Persons with Down syndrome functioning at all levels of intellectual disability will be eligible. Men and women of approximately equal numbers and people from minorities and ethnic groups other than Caucasian will be included. A total of 350 individuals with Down syndrome, 50 years of age and older, have been recruited at approximately 21 trial sites. The study is a randomized, double-blind, placebo-controlled, parallel group design with stratification by geographic site and presence of Alzheimer disease according to DSM-IV (American Psychiatric Association) criteria for diagnosing this disease.

Apolipoprotein E (Apo E) genotype will be determined at the screening visit to allow secondary analyses of the impact of Apo E genotype (that may influence Alzheimer's disease risk) on outcome measures and the response to treatment. DNA specimens will also be stored for possible future genetic analyses, with trial sites allowing for non-participation in this procedure. Visits will occur at baseline and then at 6 monthly intervals, with each visit including interval medical history, current and interval medications, side effects checklist, adverse events, pill count, institutionalization status, cognitive, functional, and behavioral measures, and DSM-IV diagnostic assessment for Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Presence of clinically determined Down syndrome (karyotypes optional).
* Medically stable.
* Medications stable over 3 months.
* Appropriately signed and witnessed consent form.
* Involvement/cooperation of informant/caregiver.

Exclusion Criteria:

* Medical/neurological condition (other than Alzheimer's disease) associated with dementia.
* Brief Praxis Test score \<20.
* Modified Hachinski score \>4.
* Major depression within 3 months.
* History of any disorder of blood coagulation (inherited or acquired).
* Current use of anti-coagulants.
* Use of experimental medications within 3 months.
* Regular use of vitamin E greater than 50 units per day during the previous 6 months.
MRI of Myocardial Infarction

Heart failure (HF) is an enormous health burden affecting approximately 5.1 million people in the US and is the cause of 250,000 deaths each year. Approximately 50% of HF is caused by myocardial ischemia and requires immediate restoration of coronary blood flow to the affected myocardium. However, the success of reperfusion is partly limited by intramyocardial hemorrhage, which is the deposition of intravascular material into the myocardium. Hemorrhagic reperfusion injury has high prevalence and patients have a much greater risk of adverse left ventricular remodeling, risk of fatal arrhythmia, impaired systolic function and are hospitalized at a greater rate. Recent magnetic resonance imaging techniques have improved assessment of reperfusion injury, however, the association between MRI contrasts and reperfusion injury is highly unclear, and lacks specificity to IMH. Improved imaging of IMH and accurate knowledge about its spatial and temporal evolution may be essential for delivery of optimal medical therapy in patients and critical to identify patients most at risk for adverse ventricular remodeling. The overall goal is to investigate the magnetic properties of hemorrhage and develop MRI techniques with improved specificity to hemorrhage. New MRI techniques permit noninvasive assessment of the magnetic susceptibility of tissues and can target tissue iron. Therefore, the investigators hypothesize that MRI imaging of myocardial magnetic susceptibility can map hemorrhagic myocardium. The investigators will perform a longitudinal observational study in patients after reperfusion injury to validate these methods, compare the methods with conventional MR contrasts and develop MR methods for imaging humans.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 80
* Patients must be able to read and understand English
* Participants must sign the informed consent form
* Elevated and delayed peak creatine kinase-MB and troponin I (cTnI) and troponin T (cTnT) in blood serum,
* ST elevation detected on ECG

Exclusion Criteria:

* contraindications to cardiac MRI, including claustrophobia
* advanced renal disease (estimated glomerular filtration rate 30 mL/min) or hypersensitivity to gadolinium
* presence of a cardiac pacemaker or implanted cardiac cardioverter defibrillator
* pregnancy
* personal or family history of hypertrophic cardiomyopathy
* inability to provide informed consent
* history of seizure disorder
HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder

The purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet each one of the following inclusion criteria in order to be eligible for participation in the study:

1. Be at least 21 years of age.
2. Have a current (past 12 months) DSM-5 diagnosis of AUD.
3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
4. Be seeking treatment for problems with alcohol.

Additional will be evaluated in clinic.

Exclusion Criteria:

Evaluations will be conducted in clinic.
Evaluation of Stereotactic Radiosurgery For Liver Malignancies

This study is intended to establish the practicality of treating cancer in the liver with precisely administered single fractions of high-energy radiation using a radiosurgical (cross-firing) technique. A second purpose is to establish a safe dose for such therapy. Finally, the efficacy of radiosurgical ablation of liver tumors, in terms of radiographic response, will be measured.


Eligibility Criteria:
Inclusion Criteria:All the following criteria must be met:

* Liver tumors not to exceed 5 cm in diameter. If this size can be increased at all, that would be beneficial as many liver lesions present at a larger size given the lack of symptoms until they are larger and adequate hepatic function with albumin \>3.0, total bilirubin \<3, INR 1.8. In the case of patients with known or 7 Dose Escalation Study Evaluating Stereotactic Radiosurgery for Liver Malignancies suspected cirrhosis, patients must have creatinine \<1.5 and cannot have uncontrolled ascites, encephalopathy, active or recent gastrointestinal bleed (GIB).
* Age \> 18 years old
* Histologically confirmed hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (IHCC), or metastatic adenocarcinoma of the breast/colon. Metastatic tumors of other histologic types or sites of origin may be included if the patients have a life expectancy of 6 months or greater. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases may be used. Hypervascular lesions \> 2cm with alpha-fetoprotein (AFP) \> 400ng/mL or hypervascular lesions \>2cm on at least 2 imaging studies.
* Unresectable disease as determined by a surgeon
* Eastern Clinical Oncology Group performance status 0,1 or 2
* No chemotherapy within 1 month of registration
* No prior radiotherapy to the liver or upper abdominal area
* Life expectancy \> 6 months
* Patients with IHCC or HCC with distant metastasis are not eligible for this study.
* For colon cancer patients with metastatic tumor of the liver who are not amenable to surgical resection due to the efficacy of removal of simultaneous lung and liver metastasis. Exclusion Criteria:- Children are excluded because HCC, IHCC, and hepatic metastases rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
* No laboratory personnel will be included.
Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer

The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy, in relation to the time of treatment interruption and acute effects. This study evaluates whether there is an increase in treatment time with the addition of the bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous tissue. The patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.

Rational:

* The use of high-energy photons (6 MeV) creates a characteristic skin-sparing effect, which can generate a region of low-dose subcutaneous tissue.
* The subcutaneous tissue is a possible area of clinical failure in the chest wall after mastectomy for breast cancer.
* To optimize treatment, it is used a bio-equivalent material to increase the surface dose.
* This dose increase may be accompanied by greater skin reaction, making it necessary to temporarily discontinue treatment to recover radiodermatitis.
* The total treatment time is a determinant of tumor control in the treatment of cancer with radiation.

Description:

* This study aims to evaluate whether different intensities of application of the bolus correlate with greater likelihood of treatment discontinuation.
* This will be a single blind randomised controlled trial. The target population comprises patients with indication of post mastectomy radiation (PMRT).
* The patients will be divided into two groups: one with higher risk of recurrence in subcutaneous, which will be randomized to use 0.5cm bolus every other day or on consecutive days, and one lower risk group, which will be randomized to use bolus 0.5cm on alternate days or do not use bolus. The group with high risk is defined as patients with clinical or pathological tumor invasion of skin. The others will be considered standard risk.
* Randomization will be made so that each group has the same proportion of patients with high body mass index (\> / = 30 kg/m2), as this may be a factor in worsening radiodermatitis.
* The patients will be followed during treatment and will be evaluated weekly for the radiodermatitis, interruption time of treatment for recovery from the acute effects and expenditures for local care. The evaluation will be done blindly (without knowledge of the utilization of bolus) by trained nurses in the management of radiodermatitis. After treatment, patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing mastectomy with or without reconstruction of early breast
* breast malignancy histologically proven
* protocol addended to allow inclusion of men that meet all inclusion criteria

Exclusion Criteria:

* Karnofsky Performance Scale (KPS) \<70%
* Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted)
* Prior ipsilateral thoracic / cervical irradiation
* Proven metastatic disease (excluded from oncologic outcomes analyses)
Observatory on Elderly Patients "Les S.AGES"

Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients :

* DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics
* CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months)
* AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before enrollment

Secondary objectives shared by the 3 observatories:

* Describe the occurrence of clinical events, hospitalizations and death, according to the different medical care conditions, and analyze their predicting factors
* Estimate the resources consumption according to the medical and non medical management of these patients,
* Analyze the impact of some factors (patient's cognitive status, autonomy, renal function ...) on the current practice

Secondary objectives specific shared by DB and AF registries :

- Analyze the geriatric pharmaco-genetic aspects

Specific secondary objectives for each observatory :

* DB : Describe HbA1c level, percentage of responders and body weight evolution according to the different medical care conditions
* CP : Evaluate pain consequences on Daily Living Activities and patient autonomy


Eligibility Criteria:
Inclusion Criteria specific for each observatory :

* DB : Established type 2 diabetes treated with oral and / or injectable antidiabetics
* CP : Pain lasting for over 3 months, requiring therapeutic care
* FA : Ongoing Atrial fibrillation or AF diagnosed within the 12 months before enrollment and documented by ECG or Holter ECG, whatever the rhythm at inclusion

Exclusion Criteria shared by the 3 observatories:

* Living in accommodation facility for dependent patients
* Patient with non cardiovascular progressively unstable disease
* Patient already enrolled in a clinical trial
* Patient unlikely to complete the study

Exclusion Criteria specific for just AF observatory :

- Transitional AF due to thyrotoxicosis, alcohol, myocarditis, pericarditis, acute myocardial infarction, pulmonary embolism, metabolic disorders or electrocution, Post cardiac surgery AF (\<3 months).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Use of Determine Learning-based Cardiodynamicsgram (CDG) for Rapid and Precise Stratification of Chest Pain in Emergency Department

Chest pain accounts for 10-20 percent of all emergency department visits. The stratification of chest pain is always a challenge. Electrocardiograms (ECG) have been used in clinical practice for 100 years, which is too important to be replaced due to its advantages of non-invasive, simple, rapid and inexpensive. ECG contains numerous signals derived from depolarization and repolarization of cardiomyocytes. However, the interpretation of ECG hasn't improved much in a hundred years. Based on determine-learning, Cong W's team developed an technique called "cardiodynamicsgram (CDG)", which is an outstanding method to identify myocardial ischemia. This study will further investigate the accuracy of CDG in stratification of patients with chest pain in Emergency department.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* Those with suspected ACS who have symptoms of acute chest pain, visiting in the emergency department

Exclusion Criteria:

* Those who diagnosed with ST-segment elevation myocardial infarction (STEMI)
* Those with hemodynamic instability (cardiogenic shock, cardiac arrest)
* Those with malignant arrhythmias(ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block)
* Those with aortic coarctation, or acute pulmonary embolism
* Those who has an unanalysable ECG report due to loosened leads, unstable baseline, or signal interference, etc.
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System

The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.

The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy
* Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

* Use of acetaminophen
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification of the study-assigned blood glucose meter
Pedal Cycle Related Trauma at the Royal London Hospital

Bespoke is an observational, prospective, cohort study. The aim of this study is to explore injury patterns of patients who require admission to the Royal London Hospital (RLH) Emergency Department (ED)or outpatient clinics as a result of any collision involving a bicycle. Secondary objectives are to determine the circumstances around cycling injury and to explore the effect of cycling collisions on the return to work, activities of daily living and cycling. All patients that attend the Emergency Department of the Royal London Hospital following an injury sustained while cycling, will be invited to take part in the study. Participants will be asked to answer a questionnaire about their cycling routines as well as provide information about the location, conditions and events surrounding their collision. Patients' recovery will be followed by the study team using the electronic health record and by reviewing the patients' notes. Morbidity and mortality data will be completed at death, discharge or 28 days from admission (whichever comes first). The patients will be followed up in person, email, or via telephone at 6 weeks following their initial admission. The research team hosted a Patient and Public Involvement (PPI) event, to determine which outcome measures were important for the public to investigate. It was found that the majority of the group felt it was important to follow up return to work, return to cycling and return to activities of daily living in any patients who have had a cycling collision. These outcomes will be measured at the 6 week follow up.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are 16 years and older attending the Royal London Hospital Emergency department who have been injured while riding a bicycle (pedal cycle)
* All patients who are 16 years and older who are transferred to the Royal London Hospital, either for inpatient or outpatient care, who were injured whilst riding a bicycle

Exclusion Criteria:

* Patients who have been injured while involved in activities other than cycling
* Patients that decline to take part in the study
* Patients who are 15 years or younger
* Off road cyclists
* motorbike riders
Physical Training in Transposition of the Great Arteries

In transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.

This is a randomized, controlled, prospective trial on the safety of physical training in TGA patients after atrial switch operation.

In transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.

Primary endpoints are Systemic Ventricle Ejection Fraction and Volumes, Exercise Capacity.

Secondary endpoints are Echo Diastolic Function, as well as laboratory markers of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years

Exclusion Criteria:

* tricuspid regurgitation grade 2 or more
* sign. LVOTO or RVOTO
* pacemaker or defibrillator
* recent hospitalisation for heart failure (90 days)