cyrilzakka/clinical-trials huggingface dataset:
SMF to Improve Performance of Microscopy for the Diagnosis of PTB in a High HIV Prevalence Setting

This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now.

TB is a disease caused by a bacterium called Mycobacterium tuberculosis that can affect the lungs or other parts of the body. In most of the world and in Mbarara, Uganda, the method of diagnosis that is used is AFB smear microscopy. This method is widely available, inexpensive and rapid. However, this method's ability to truly detect people having TB is poor. That is, if someone has TB, the test results may say that they are negative, leading to delays in diagnosis, disease progression, and an ongoing transmission of the bacteria.

The new test for TB diagnosis we are studying is called the Small Membrane Filtration (SMF) method. This test that is being compared to the method currently being used and is very similar to the one that is currently used (standard smear microscopy) but has the advantage of concentrating the sputum (mucus) so that we can more easily see if bacteria are present in the sputum. It is hoped that a better way of knowing if someone has TB will help doctors decide when people need to be treated for TB and when not, which will improve the health of patients and help avoid passing the infection to others.

This study will enroll 740 HIV-infected and 310 HIV-uninfected adults with culture confirmed pulmonary TB. These individuals will be identified prospectively at two TB clinics in Mbarara, Uganda.

Study hypothesis: The investigators will assume that one sputum sample will be equivalent to two (null hypothesis) with respect to sensitivity unless we have evidence that the use of two has higher sensitivity (alternative hypothesis). The investigators will assume that SMF is equivalent to AFB smear with respect to sensitivity and specificity unless the investigators find evidence it is superior. The investigators will assume that SMF is equivalent to Xpert unless the investigators find evidence that Xpert is superior.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years)
* Pulmonary TB suspect defined as any person who presents with a productive cough for more than 2 weeks AND accompanied by at least one other respiratory symptom (shortness of breath, chest pains, hemoptysis) and/or constitutional symptom (loss of appetite, weight loss, fever, night sweats, and fatigue) (6).
* Willing to undergo TB evaluation and spontaneously expectorate ≥2 mL of sputum
* Willing to be tested for HIV, if no results available within past 6 months

Exclusion Criteria:

* Too ill or unable to provide written consent
* Treated with TB drugs for more than 3 days
* Extra-pulmonary or disseminated TB without pulmonary involvement (i.e. no cough)
Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 2-17 years old at the time of consent.
* Clinical diagnosis of active atopic dermatitis
* vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of "mild" (2) or "moderate" (3) at Baseline
* EASI (Eczema Area and Severity Index) score of \>/= 5 at Baseline

Exclusion Criteria:

* Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil
* Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body.
* Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period.
* Subjects with an ongoing secondary infection of the skin.
* Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period.
* Subjects with a diagnosis of Scabies.
* Pregnant women
* Prisoners
Endothelin Concentrations in a Population With Cardiovascular Disease and Periodonitis

Recently, a key role played in the ethiology of periodontitis has been highlighted by a Endothelin (ET-1). ET1 possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. ET originate from bone marrow

The aim of the present study was to investigate the association between ET-1 in patients with periodontitis. Furthermore, the objective was to determine if the periodontal status influenced ET-1 levels.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Inflammatory Biomarkers in Seizure

1. Evaluation of the role of TRAIL and MCP-2 in differentiation between epileptic seizure and psychogenic non-epileptic seizure.
2. Possible role to predict the prognosis of patients with epileptic seizure

Epilepsy is one of the most prevalent neurological disorders characterized by frequent somatic and psychiatric co-morbidities(1). Accurate diagnosis of epilepsy is challenging because clinicians rarely observe the actual clinical seizure outside of the hospital. Furthermore, psychogenic nonepileptic seizures (PNES) can mimic epileptic seizures (ES), leading to erroneous diagnosis and inappropriate treatments. A critical gap in the diagnostic assessment of seizures is a blood test that can distinguish ES from PNES (2). Both diagnoses were confirmed by the gold standard diagnostic method video/electroencephalogram (EEG) monitoring (3). Taking all in to account, the notion that neuro-inflammation is the key pathology behind focal epileptic seizure initiation and maintenance and the dynamic and adaptative process of neuro -inflammation is associated with blood-brain-barrier disruption and glial activation is no longer a surprise (4).

Tumor necrosis factor related apoptosis inducing ligand (TRAIL) regulates immune responses via apoptosis, with lower levels associated with severe infection, including sepsis (5). Monocyte chemoattractant protein-2 (MCP-2) has been well recognized to participate in immune regulation via binding to chemokine receptors and activation chemotaxis in lymphocytes T, natural killer (NK) cells, and monocytes therefore contributing to the pathogenesis of monocyte-dependent tissue injury (6). Hence, MCP-2 overexpression could result in an increased immune response. Further, since increased levels of MCP-2 have been observed in patients with Alzheimer's disease, this may further support the existence of the biodirections relationship between neurodegeneration and seizures/epilepsy (7).

Eligibility Criteria:
Inclusion Criteria:

patients diagnosed as epileptic seizure are aged \>12 years patients diagnosed as psychogenic non-epileptic seizure are aged \>12 years Normal healthy control for comparison. Heathy control are aged \>12 years with no history of lifetime seizures or suspected seizures or febrile seizure and no treatment with an antiepileptic drug (AED) prior to blood draw

Exclusion Criteria:

* Neurological criteria: Other CNS disorders including Parkinson's disease, amyotrophic lateral sclerosis ,cerebrovascular stroke, Psychiatric disorders {major depression disorder , generalized anxiety, mania and other psychiatric diseases).

Others: Tumors and cardiovascular
Role of Nitric Oxide in the Impact of Aging on Myocardial Remodeling

The purpose of this study is to determine, with Positron Emission Tomography (PET), the role of nitric oxide in the age-associated effect on fatty acid and glucose delivery on myocardial substrate metabolism.

Aging is associated with an increased incidence and severity of various cardiovascular disorders. Previously, our laboratory has demonstrated an age-related shift in the substrates used by the heart for metabolism from primarily fatty acids to primarily glucose. Furthermore, other institutions have demonstrated that a similar shift can be induced, in animal models, with specific nitric oxide synthase inhibitors, such as L-NAME (N-Nitro-L-Arginine Methyl Ester). Our hypothesis is that a reduction in nitric oxide (NO) synthesis is responsible for the age-related shift in heart function. Accordingly, we aim to demonstrate, in young patients, an acute, transient shift in substrate use from fatty acids to glucose with L-NMMA (citrate) in association with depressed heart function. Also, we aim to demonstrate in the elderly an acute, transient shift in substrate use from glucose to fatty acids with L-arginine, in association with improved cardiac function. These results will demonstrate a portion of the mechanism for the age-related shift in substrate utilization.

Each participant will undergo a screening visit which will include a Glucose Tolerance Test, an echocardiogram in conjunction with a treadmill stress test to exclude cardiac disease, and baseline blood work. Then each patient will have 3 PET study days, each lasting about 5-6 hours. During this time, the patient will have two IVs (one in each arm). They will have 4 injections of different radioactive isotopes (015 Water, C11 Acetate, C11 Glucose, and C11 Palmitate). After each injection, about 8-10 blood samples will be drawn over the course of about ½ to 1 hour of time. In between each injection, there will be about an hour break for the patient to rest and move around. During one of the breaks, the patient will have another echocardiogram. On the day 2 and 3 PET, the patient will have a 30-60 minute infusion of L-NAME. Then the PET study will commence. After the study is over the participant will have a 10-minute infusion of L-arginine to reverse the effects of L-NAME.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-35 or 60-75
* Normal glucose tolerance test
* Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
* Normal rest/stress echocardiogram
* BMI (Body Mass Index) less than 30 kg/m2

Exclusion Criteria:

* Coronary artery disease
* High blood pressure
* Current smoker
* Diabetes mellitus
* Cardiovascular disease (signs and symptoms of any kind)
* History of stroke, peripheral vascular disease, or arrhythmia
* Pregnant or breastfeeding
"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

This trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Usage of nanopore sequencing for detection of bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

PRIMARY OBJECTIVE:

I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting.

SECONDARY OBJECTIVE:

I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

ARM II: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

After completion of study, patients' medical records are reviewed for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 year (yr) male (M) or female (F)
* Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent

Exclusion Criteria:

* Women who are pregnant
* Patients who are institutionalized or incarcerated
* Patients without the cognitive capacity to consent
* Patients undergoing emergency pancreaticoduodenectomy or total pancreatectomy
* Patients enrolled in similar clinical trials involving use of perioperative antibiotics
Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial

According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Male ≥18y
* Histologically proven PC
* Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy) or PSMA PET-CT
* ECOG 0-1 (2 if related to local PC symptoms)
* Eligible for local treatment
* Written informed consent and able and willing to comply with protocol requirements

Exclusion Criteria:

* Previous systemic treatment for PC except ADT started within 3 months before randomization
* Previous radiotherapy to the pelvis interfering with prostate irradiation
* Previous surgery in the pelvis interfering with radical prostatectomy
* Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
* Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
* Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
* Psychological disorder intervening with understanding the information or the informed consent
HCV/HIV Coinfection: Antiviral Therapy and Fibrosis

The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART.

Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.

Eligibility Criteria:
Inclusion Criteria:

Co-Infected Arm

1. Subject must be an HIV/HCV co-infected adult with HIV infection diagnosed by antibody testing and chronic HCV infection diagnosed by reactive HCV antibody and detectable plasma HCV RNA.
2. Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.
3. Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.
4. Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
5. Subject must be able to provide informed written consent.

Control Arm

1. Subject must have or be at risk of having medical conditions that increase the risk of liver disease. These include, but are not limited to, HIV mono-infection, HCV mono-infection, Hepatitis B infection, alcohol addiction, and/or non-alcoholic steatohepatitis.
2. Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
3. Subject must be able to provide informed written consent.

Exclusion Criteria:

1. To avoid risks associated with ionizing radiation, female subjects may not be pregnant or breast feeding at the time of DEXA scanning. To avoid unknown risks to the fetus, female subjects may not be pregnant at the time of liver biopsy or FibroScan.
2. To avoid interference with the DEXA scan, the subject may not have undergone a nuclear medicine exam with the past week and/or may not have undergone an x-ray procedure with contrast solution within the past 72 hours.
3. To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.
Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure

This paper will mainly present the renal results from a clinical study aimed to observe the effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart failure.All patients will receive LCZ696.The results will be compared before and after treatment.

On trial entry, patients will first receive LCZ696 50mg twice daily.According to the condition of disease and tolerance,the dose will be doubled every 2 weeks until the target maintenance dose 200mg twice daily is reached unless potassium or change in kidney function preclude a dose increase(reduction in dose will be permitted if the larger dose will not be tolerated, and temporary interruption will be permitted at any time if required for clinical reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at 2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor participant safety).

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed with Chronic kidney disease (eGFR\<60 ml/ min/1.73m²) and heart failure
2. documented history of heart failure with associated signs or symptoms
3. New York Heart Association (NYHA) classes II-IV
4. mean sitting systolic blood pressure (msSBP) ⩾140mmHg
5. good compliance

Exclusion Criteria:

1. isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac causes, primary valvular or myocardial diseases, or coronary or cerebrovascular diseases needing revascularization within 3months of screening or during the trial
2. acute renal failure
3. systolic blood pressure lower than 100 mm Hg at screening (\<95 mm Hg at the randomisation visit)
4. significant laboratory abnormalities at screening interfering with assessment of study drug safety or efficacy(such as serum potassium\>5.5 or \<3.5mmol/L, serum sodium\<130mmol/L or alanine aminotransferase or aspartate aminotransferase\>2 times the upper limit of the normal range)
5. history of angioedema（drug-related or otherwise)
6. any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study 7)pregnant female
Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes

The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2 diabetes (T2D) is heavily debated but evidence from large populations in China is scant. The investigators aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term association between fish, PUFA intake and T2D risk.

The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of T2D is heavily debated but evidence from large populations in China is still lacking. The investigators aim to utilize data from China Health and Nutrition Survey (CHNS, 1997-2011). The investigators will calculate cumulative means of fish and PUFA intake based on 3-day food records in each wave. Sex-specific Cox regression models will be used to estimate relative risk of T2D. Results from this work will provide epidemiological evidence for improving recommendations on fish and PUFA intake for Chinese in dietary guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥20 with complete data on diet and follow-up time

Exclusion Criteria:

* Missing information for Type 2 diabetes
* Type 2 diabetes
* Cardiovascular disease
A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
* Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion Criteria:

* An active, known or suspected autoimmune disease
* Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
* Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
* Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

Other protocol-defined inclusion/exclusion criteria apply