cyrilzakka/clinical-trials huggingface dataset:
Comparison of 19g FNA and 19g FNB Needles for EUS-LB

Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing EUS-LB
2. Platelet count \> 50,000
3. International normalized ratio (INR) \< 1.5
4. Age \> 18 years
5. Non-pregnant patients

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant patients
3. Inability to obtain consent
4. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
5. Platelet count \< 50,000
6. INR \> 1.5
7. Presence of ascites
8. Known liver cirrhosis
9. Hemophilia
Timing and Intensity of the Exposures and Attributable Burden of Acute Lung Injury

The purpose of the study is to identify the patients at high risk of developing Acute Lung Injury (ALI) at the time of hospital admission, and before intensive care unit admission.

Aim 1- To validate the prediction model (Lung Injury Prediction Score) in a population based sample of hospitalized patients.

Aim 2- To determine the significance of health-care related ALI risk modifiers in a population based sample.

Aim 3- To compare the short and long term outcomes between patients at high risk who do, and do not develop ALI.

Acute lung injury (ALI) is an example of a critical care syndrome with limited treatment options once the condition is fully established.Not surprisingly, many treatments targeting the mechanisms identified in preclinical studies have failed to improve patient outcomes.The most likely reason could be due to inadequate and delayed recognition of patients at risk and the subsequent development of the full blown syndrome.ALI/ARDS usually develops during the first hours of ICU admission, and often is the very reason for ICU admission.

Clinical prediction models have been extensively used in the clinical practice to identify patients at high risks who may benefit from specific interventions. However, no such tool exists to predict the development of ALI in patients at risk. We have recently developed an ALI prediction model (Lung Injury Prediction Score:LIPS)which incorporates demographic, environmental and clinical characteristics at the time of, and before, hospital admission. If validated, this model will serve to find the population of patients at high risk of ALI in whom future prevention trials will be conducted. By determining not only patients at high risk but also the attributable burden of ALI/ARDS in contemporary cohorts of patients at risk, our findings will facilitate the prioritization of preventive strategies and future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* All Olmsted County residents more than 18 years of age who were admitted to the two Mayo Clinic Rochester hospitals

Exclusion Criteria:

* Denied the use of medical records for research
* Acute lung injury or pulmonary edema already present at the time of hospital admission
* Admitted for comfort or hospice care only
* Children
* Hospital readmission
* Patients admitted for cardiac telemetry, coronary care unit, low risk elective surgeries, labor and delivery
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up

Context: Obesity, defined as excessive body fat, can lead to disability and loss of autonomy. If there is concomitant quantitative and qualitative muscle loss, sarcopenic obesity (SO) is suspected in this context. Although this clinical entity was defined several years ago, it is only very recently that precise assessment criteria have been established for screening and diagnosing this pathology (Donini et al. 2022).

Defined by the ESPEN/EASO consensus, SO has various consequences for health, particularly in terms of mobility and worsening of co-morbidities. It is therefore necessary to screen for SO, to determine its prevalence in the general population and to identify the determining factors in the loss of muscle mass during obesity. Most studies on the prevalence of sarcopenic obesity focus on the elderly population, bearing in mind that the prevalence of this syndrome in the elderly will increase rapidly as a result of the shift in the incidence of obesity from adults to this population in the coming decades.

The aim of this project is to determine the prevalence and determining or predisposing factors for sarcopenic obesity in a population of obese people in a broad age range (18-70 years).

Longitudinal follow-up of this cohort is planned in order to assess multifactorial changes (body composition, muscle function and physical performance) at 5 and 10 years after their inclusion in the OBESAR-2 study. In addition, patients who have undergone bariatric surgery will also be followed in the shorter term to analyse the phenotypic changes induced by rapid weight loss on muscle loss.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70
* Sex: men and women
* Clinical nutrition patient receiving a metabolic assessment to optimise clinical and paraclinical management
* Patient meeting obesity criteria defined by BMI \> 30 kg/m².
* Patient of legal age who has given free, informed and signed consent
* Patient covered by social security

Non-inclusion criteria :

* Patients with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
* Patients with neuromuscular disease
* Patient with total walking disability
* Patients who are minors
* Patient refusing to take part in the study
* Pregnant or breast-feeding women
* Under guardianship, curatorship, deprived of liberty or under court protection
* Patient who has taken part in the OBESAR study
Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic and Hypertensive Patients With Microalbuminuria

Numerous clinical and experimental data show that the elective treatment of diabetic nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS). Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists II have proven effective in reducing proteinuria in power even if different therapeutic drug to drug. ACE inhibitors are one of the most known and used treatment options for blocking the renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril, lisinopril and ramipril are standard therapy in diabetic patients with micro or macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of view, the same or varies from drug to drug. This is particularly true in the diabetic microalbuminuria, a condition in which there is sufficient documentation to prove that ramipril is effective. The main objective of this study was to assess the magnitude and trend of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and microalbuminuria.


Eligibility Criteria:
Inclusion Criteria:

* Blood pressure\> 130/80 ≤ 170/100 mmHg at the end of the period of wash-out
* Type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c \<7%)
* Microalbuminuria in the upper range of normal (\> 150 \<300 mg/24 h)

Exclusion Criteria:

* Pregnancy, lactation or women of childbearing age.
* Inability to stop treatment in place for a few days during the wash-out.
* Sitting diastolic blood pressure\> 100 mmHg or systolic pressure\> 170 at the end of the wash-out.
* History of hypertensive encephalopathy or cerebrovascular accident within 12 months prior.
* Secondary hypertension.
* Heart failure
* Acute myocardial infarction; angina pectoris
* Liver and kidney dysfunction
* Known hypersensitivity to ACE inhibitors
* All other physiological or pathological condition that the physician may affect the evaluation of the parameters under study or interfere with the proper conduct of the study.
Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization

Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with with atrophied posterior mandibular ridge
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence pathological lesions
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Eligibility Criteria:
Inclusion Criteria:

Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.

Exclusion Criteria:

Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control.

Unstable cardiac status. History of coronary artery bypass graft. History of percutaneous coronary intervention within the past six months. See protocol for additional details.
Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients

This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study.

We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study.

We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

Eligibility Criteria:
Inclusion Criteria: Children aged 0-18 years with a cardiac defect resulting in a left-to-right shunt (i.e. ventricular septal defect) who develop congestive heart failure. Patient must have been treated with one of the study medications: carvedilol, digoxin, or furosemide.

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Exclusion Criteria: Patients who are not between 0-18, who do not have a defect resulting in left-to-right shunt, who do not have congestive heart failure and who have not been treated with one of the study medications: carvedilol, digoxin, or furosemide.

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Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

Prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a 25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as decrease of Systolic blood pressure\>20% from the baseline value, was managed using Ephedrine increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients of GN group. Intraoperative hemodynamic data of the 2 groups were compared.

Prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. All patients were ASA status I/II and patients with arrhythmia were excluded. Spinal anesthesia was performed in sitting position at L3-4 or L4-5. A 25 G spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. All patients received 15 ml/kg of crystalloids intravenously during the spinal block. Patients were positioned in left lateral tilt position. Baseline hemodynamics; HR, systolic (SBP) and diastolic blood pressure (DPB) were recorded before spinal anesthesia and intraoperatively (every 2 min). Post anesthesia hypotension was defined as decrease of SBP\>20% from the baseline value. If hypotension occurred, patients were randomized into 2 groups:

* GE group in which hypotension were managed using ephedrine increments of 6 mg Ephedrine every 3 min until correction of SBP
* GN group: patients of this group received 5mcg of Norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* Fully term parturients
* Caesarean section under spinal anesthesia
* ASA status I or II

Exclusion Criteria:

* Severe cardiac disease
* Cardiac arrhythmia
Naltrexone in the Treatment of Pyromania

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. Ten subjects with DSM-IV pyromania will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to set fires patients with pyromania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 16-75;
2. current DSM-IV pyromania

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 3 months) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.


Eligibility Criteria:
General Inclusion Criteria

Prospective subjects must meet all of the following criteria to be eligible for participation:

* 18 years of age or older
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits
* Contact lens removal prior to evaluation and treatment

Inclusion criteria for progressive keratoconus

Prospective subjects must meet two of the following criteria:

* Having a diagnosis of progressive keratoconus:
* An increase of ≥ 1.00 D in the steepest keratometry value
* An increase of ≥ 1.00 D in astigmatism manifest refraction
* A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
* Presence of central or inferior steepening on the Pentacam map.
* Axial topography consistent with keratoconus
* Steepest keratometry (Kmax) value ≥ 47.00 D

Inclusion criteria for ectasia

Prospective subjects must meet the following criteria:

* History of having undergone a keratorefractive procedure
* Meeting two of the following criteria
* Steepening by topography, either Pentacam or Humphrey
* Thinning of cornea
* Shift in the position of thinnest portion of cornea
* Change in refraction with increasing myopia
* Development of myopic astigmatism
* Development of irregular astigmatism
* Loss of best spectacle corrected acuity. 6.2 Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from this protocol:

* Eyes classified as either normal, atypical normal,
* Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye to be treated
* A history of chemical injury or delayed epithelial healing in the eye to be treated.
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment
* Inability to cooperate with diagnostic tests.
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
* Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
* Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults

This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.


Eligibility Criteria:
Inclusion criteria:

* HIV-1 infected subjects.
* Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
* Plasma HIV-1 RNA (viral load) \>/=1,000 copies/mL at Screening.
* CD4+ cell count \>/= 200 cells/mm3 at Screening.
* Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen.
* Willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

* Active CDC Class C disease.
* Pregnant or breastfeeding women.
* Protocol-specified laboratory abnormalities at Screening.
* Personal or family history of autoimmune disease.
* History or current indication of thyroid dysfunction or current thyroid gland abnormalities.
Dual Implant Versus Single Implant Distal End of Femur

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.


Eligibility Criteria:
Inclusion Criteria:

* Femur fracture distal to the femoral diaphysis.
* Operative treatment within 72 hours of presenting to the treating hospital.
* Patient was previously ambulatory.
* Fracture amendable to either single or dual implant fixation.
* Informed consent can be obtained from the patient, family member, or power of attorney.

Exclusion Criteria:

* Associated major lower extremity fracture.
* Ongoing infection.
* History of metabolic bone disease (Paget's, etc).
* Pathologic fracture.
* Open fracture.
* Severe cognitive impairment (Six Item Screener with 3 or more errors).
* Stage 5 Parkinson's disease.
* Significant femoral bone loss requiring planned staged bone grafting.
* Vascular injury.
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.

Investigators can choose any patient who is within the scope of I/E criteria

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as advanced RCC after failure of one prior systemic therapy.

Exclusion Criteria:

* Any patient who does not agree that Pfizer or companies working on behalf of Pfizer can use his/her information.
* Patients with hypersensitivity to axitinib or to any other component of INLYTA® .
* Patients under 18.
* Pregnant women.