cyrilzakka/clinical-trials huggingface dataset:
Replacement of Lamivudine by Telbivudine to Improve Renal Function

Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. This study is to see whether renal function is improved when Lamivudine is replaced by telbivudine in liver transplantation patients.

Liver transplantation is the only effective treatment for the patients with liver failure. Hepatitis B-related liver cirrhosis is the major indication to have liver transplantation in Taiwan. After liver transplantation, prophylaxis of hepatitis B recurrence will be performed by anti-hepatitis B immunoglobulin and anti-viral agents. Currently, lamivudine is the drug the investigators choose to prevent HBV recurrence for many years because it is safe for long-term use. However, nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Recently, the studies on chronic hepatitis B patients showed improvement of glomerular filtration rate for those receiving telbivudine treatment. In this study, the investigators will include our post-transplant HBV patients who have stable liver function, receive lamivudine for prophylaxis of recurrent hepatitis B, and have renal dysfunction in stage II-IV. The patients will be randomized to receive telbivudine or lamivudine continuously at 1:1 ratio. Renal function will be examined at 6 months interval to determine whether renal function is improved. The achievement will determine whether telbivudine is better than lamivudine for the HBV patients with renal dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Sign inform consent
2. Age is not less than 16 years old.
3. Post liver transplantation patient for HBV-related indication.
4. Chronic hepatitis B transplant patients who are treated by lamivudine for not less than 6 months.
5. eGRF stage 2-4 patients (15\<eGFR\<90ml)
6. Stable liver function, ALT not more than 2 folds of upper limit.

Exclusion Criteria:

1. Acute rejection with increase CNI dose within a month.
2. Pregnant or nursing.
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study

This study collects mammogram images, blood samples, and clinical information from women undergoing routine screening mammograms. Creating a bank of blood samples and a database of clinical and risk information may be used in future research related to breast cancer, other cancers, and women's health.

PRIMARY OBJECTIVES:

I. To establish a longitudinal cohort (n=10,000) of women who undergo routine annual mammography screening with follow-up for at least five years for each study participant or until breast cancer diagnosis.

II. To create a repository of blood specimens from the cohort to use for biomarker discovery and validation.

III. To create a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data on the study participants.

OUTLINE:

Participants complete questionnaires over 15-25 minutes about personal and family history of cancer, health status, breast cancer risk factors, diet, weight gain, and physical activity, and undergo collection of blood samples at baseline and then annually for 5 years. Participants also undergo standard of care mammography at baseline and then annually for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the study and ability to provide informed consent
* Willingness to complete a questionnaire and to provide a blood sample at the initial visit and at follow up annual visits
* Undergoing a screening mammogram at participating sites. Subjects undergoing routine annual diagnostic mammograms or CEM as part of a screening study are also eligible.

Exclusion Criteria:

* Current or recent (within the prior 6 months) history of breast feeding
* Personal history of breast cancer (ductal breast carcinoma in situ \[DCIS\] or invasive breast cancer)
* Personal history of any other cancer (excluding in-situ, stage 0, and non-melanoma skin cancers and other pre-cancerous conditions) treated within the last 5 years.
Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring

Previous studies found that the incidence of acute kidney injury afer partial nephrectomy is higher than 30%. In addition to nephron loss induced by renal parenchyma resection, ischemia/reperfusion injury produced by clamping/unclamping of renal arteries is also an important reason. However, studies investigating the effect of circulatory management on the incidence of acute kidney injury after partial nephrectomy are limited.

It has been shown that perioperative hemodynamic optimization protected renal function in surgical patients. And in patients undergoing renal transplantation, adequate hydration and optimal perfusion enhances early graft function. The investigators hypothesize that hydration and circulatory management to guarantee optimal renal perfusion may decrease the occurrence of acute kidney injury after partial nephrectomy. The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years;
2. Planning to undergo partial nephrectomy;

Exclusion Criteria:

1. Patients with renal function damage (chronic kidney disease stage 3-5) before surgery;
2. Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation);
3. Patients who has participated in other trials.
The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise

The primary purpose of this study is to to compare immediate changes in pressure pain threshold at the exercising muscle (quadriceps) and a non-exercising muscle (upper trapezius) during low and high weight knee extension exercise. Participants will attend one session that consists of pain sensitivity testing, completion of pain-related psychological questionnaires, and random assignment to one of three interventions: 1) knee extension exercise with a high weight, 2) knee extension exercise with a low weight, or 3) quiet rest.


Eligibility Criteria:
Inclusion Criteria:

* Pain-free
* 18-60 years old
* Participant can appropriately perform the knee extension exercise (assessed during screening)

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* Known presence of cardiovascular, pulmonary, or metabolic disease
* Current use of tobacco products
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Surgery, injury, or fracture to the lower back or lower extremity within the past 6 months
Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis

Quadriceps femoris (QF) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (OA) patients. Exercise therapy is mile stone in knee OA patients also it can help thicken QF muscle of RA patients. We primarily aimed to demonstrate the influence of 4 weeks of knee isometric home-based training on QF muscle parts thickness and pennation angle measurements of RA patients with ultrasonography (USG). This study included 12 patients with RA, 12 patients with knee OA as positive control group and 13 volunteers as healthy control group. All participants were given 4 weeks of quadriceps-hamstring isometric home-based training. At baseline and at the end of the program, WOMAC and Lequesne algofunctional index scores of knee OA patients and DAS28-CRP scores of RA patients were recorded. Dominant knee thickness and pennation angle measurements of QF muscle parts were evaluated by ultrasonography.


Eligibility Criteria:
The inclusion criteria for all participants were being between 18-65 yy.

The inclusion criteria for RA patients were: confirmed diagnosis of RA according to 2010 ACR/EULAR classification criteria and lack of any other inflammatory articular diseases.

The inclusion criteria for knee OA patients were: diagnosis according to ACR classification criteria of knee OA with grade 2-3 according to the Kellgren-Lawrence grading system and lack of any other inflammatory articular diseases.

Volunteers who did not have any knee pain, no clinical degenerative or inflammatory signs were included in the healthy control group.

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Exclusion criteria for all participants were: being out of age range, history of knee joint trauma, surgery or knee joint injection in the previous 6 months, presence of any other disease that can affect thigh muscles (radiculopathy, myopathy, hip problems). Patients with secondary knee OA were not included.

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SCALE: Small Changes and Lasting Effects

The goal of this study is to translate basic behavioral and social science discoveries into effective behavioral interventions that reduce obesity and obesity related morbidity in Black and Latino communities. This intervention will focus on promoting small changes in eating behavior and increasing physical activity among Black and Latino participants in Harlem and the South Bronx. The desired result from these activities is individual weight loss that will be sustained years after participation in the study.

SCALE is a five year study (October 1, 2009 through June 30, 2014) funded by NHLBI. The study will examine the possibility and acceptance of a mindful eating intervention in African American and Latino participants. We will test whether positive thinking can protect participants against the negative impact that stress and depression can have on making positive behavior changes such as mindful eating and physical activity.

Currently, the SCALE study is in the trial phase. Among overweight or obese Black or Latino adults who live in Harlem or the South Bronx, the primary goal of this project is to achieve weight loss of 7% or more over 12 months by making small sustained changes in eating behavior coupled with sustained increases in physical activity. Participants are enrolled for 12 months and are randomized to one of two study groups.

Group 1: Will choose one of ten small change eating strategies, a physical activity goal and will receive the positive affect/self affirmation component.

Group 2: Will choose one of ten small change eating strategies and a physical activity goal

For inquiries regarding potential enrollment in this study, please contact Rosio Ramos at 646-962-5070 or email ror2023@med.cornell.edu

Eligibility Criteria:
Inclusion Criteria:

Eligibility Criteria:

Black or Latino community-dwelling subjects who are 21 years or older and have a body mass index of \>25 but \<50 or considered to be obese or overweight are be eligible for study participation. All participants must be able to participate in physical activity and Must be fluent in English or Spanish.

Exclusion Criteria:

Subjects will be excluded if:

1. Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol addiction
2. Pregnant or are planning to become pregnant within the year
3. Participating in another weight loss program or trial
4. On medications for obesity
5. Have a history of bulimia;
6. history of surgery for obesity;
7. Have severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, congestive heart failure.
8. They live in an institutional setting (nursing home, prison or group home).
9. Have severe disease or are terminally ill, including stroke, myocardial infarction, coronary artery disease requiring angioplasty.

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Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study

This study will investigate the impact of motivational interviewing in achieving low-density lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.

To determine whether a strategy of enhanced information about the risks of high plasma low-density lipoprotein cholesterol (LDL-C) and the importance of lipid-lowering medication together with close follow-up and motivational interviewing is superior than usual care in achieving LDL-C therapeutic targets, as set by current practice guidelines (LDL-C \<70 mg/dL or \>50% reduction from baseline LDL-C) in patients with acute coronary syndromes.

Eligibility Criteria:
Inclusion Criteria:

* Subject hospitalized for acute coronary syndrome (STEMI, NTEMI or unstable angina)
* Subject currently on lipid-lowering therapy or prescribed lipid-lowering therapy at hospital discharge (statins and/or other agents)
* Subject who is 18 years or older
* Subject or legally authorized representative who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria:

* Subject unable to communicate via telephone for study interviewing
* Subject with contraindication to statin therapy
* Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy

There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy. The aim of the present study is to compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps, LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative complications, return of gastrointestinal activity and hospitalization time.


Eligibility Criteria:
Inclusion Criteria:

* any women with the indication of hysterectomy

Exclusion Criteria:

* malignancy
* having 3 or more previous abdominal surgeries
* uterus being larger than 12 weeks of gestation
* patients who must undergo additional surgical procedures during the same operation
Efficacy of Acceptance and Commitment Therapy on Impulsivity and Suicidality Among Clients With Bipolar Disorders

Psychiatric nurses face a huge challenge in predicting and preventing suicide behaviour in their patients with bipolar disorders, but it may also be one of the most accurate measures of how well their clinical care is working. In addition to, high impulsivity scores are associated with increased overall functional impairment, a higher number of episodes with early onset, and a higher number of past suicide attempts, as well as increased substance intake. Thus, this study aimed at evaluating the efficacy acceptance and commitment therapy on impulsivity and suicidality among bipolar clients.

research hypnosis

* Clients who engaged in acceptance and commitment therapy had less impulsivity than the control group.
* Clients who engaged in acceptance and commitment therapy had less suicidality than the control group.


Eligibility Criteria:
Inclusion Criteria:

* Clients had to be at least 18 years old
* able to converse intelligibly and meaningfully
* read and write
* have an illness that hadn't lasted more than 10 years to assure the client's functionality
* ready to take part in the study.

Exclusion Criteria:

* Clients who demonstrated psychotic symptoms
* attended another group sessions
* were intoxicated or under the influence of alcohol
* had any comorbidity were excluded from this study
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

HMG co-A reductase inhibitors, commonly called statins, are an effective treatment for dyslipidemia and atherosclerotic heart disease with proven mortality benefit. While the lipid-lowering effects of statins are well-known, other metabolic effects, including effects on glucose tolerance and ectopic fat distribution, are less completely understood. Recent studies have shown that some statins may increase the risk of diabetes. Further, research has suggested that statins may have some benefit in nonalcoholic fatty liver disease (NAFLD), a condition associated with obesity that includes increased fat in the liver (steatosis) and, in some cases, inflammation and hepatocellular damage (steatohepatitis). Pitavastatin, approved by the United States Food and Drug Administration (FDA) in 2009, is the most recent statin to enter the market. Unlike most statins, pitavastatin is not primarily metabolized through cytochrome P450 (CYP450), and thus has reduced potential for interactions with other medications that are metabolized by CYP450. Previous studies have suggested that pitavastatin may be neutral to glucose homeostasis and may improve hepatic lipid. Neither of these effects has been proven definitively, however, and the current proposal aims to characterize in detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and steatohepatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Men age 40-65yo
2. BMI ≥ 27kg/m2 and waist circumference ≥102cm, high probability risk factors for NAFLD
3. At least one of the following indicating insulin resistance: Fasting glucose ≥100mg/dL and \<126mg/dL, HOMA-IR \>2.0, and/or 2 hour glucose ≥140mg/dL and \<200mg/dL following standard glucose tolerance test.
4. 10-year cardiovascular disease risk ≥5% by American Heart Association(AHA)/American College of Cardiology (ACC) Pooled Cohort Equations CV Risk Calculator or LDL ≥ 100mg/dL
5. No use of any statin within 1 year of study entry and not being actively considered for statin therapy by a treating provider.

Exclusion Criteria:

1. Diagnosis of diabetes or use of anti-diabetic medications.
2. Use of erythromycin, rifampin, cyclosporin, colchicine, or gemfibrozil.
3. Use of statin therapy within 1 year prior to study entry as above. Use of any other lipid-modifying therapy (including fish oil, fibrates, niacin, gemfibrozil) within 6 months of study entry.
4. Contraindication to statin therapy.
5. Creatinine \> upper limit of normal or known renal disease
6. AST or ALT \> 3 times the upper limit of normal
7. hemoglobin \< 10g/dL
8. Contraindication to undergoing a magnetic resonance scan.
9. Atherosclerotic cardiovascular disease or low-density lipoprotein cholesterol (LDL-C) ≥ 190mg/dL.
10. Triglyceride ≥500mg/dL
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age
* ECOG performance status of 0 or 1
* Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
* Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy

Exclusion Criteria:

* Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction
* Breastfeeding or pregnant
The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction

Sacubitril/Valsartan (SAC/VAL) is a new treatment of congestive heart failure (CHF) recently indicated as class I, level of evidence B in the recent European Society of Cardiology (ESC) guidelines 2016 of CHF. PARADIGM-HF trial demonstrated a significant improvement of morbidity and mortality with SAC/VAL in comparison to enalapril. So far, no data available about the effect of usage of SAC/VAL post-acute myocardial infarction (AMI) except in animal experimental models.

The purpose of the research is evaluation of the effects of SAC/VAL in post-AMI in comparison to the traditional Angiotensin Converting Enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in a real-life clinical trial in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.

Background and study rationale:

Sacubitril/Valsartan (SAC/VAL) is now approved by the U.S. Food and Drug Administration (FDA) for heart failure with reduced ejection fraction (HFrEF) and also, recently indicated as class I indication, level of evidence B in the European Society of Cardiology (ESC) guidelines 2016 on congestive heart failure (CHF).(1) PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SAC/VAL In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalization for CHF by 20% with a 16% reduction in all-cause mortality.(2) So far, no available data about the effect of usage of SAC/VAL in post-AMI except in animal experimental models that proved efficacy of SAC/VAL in preventing AMI-induced LV dysfunction compared with SAC/VAL, also significantly attenuated LV scar size following AMI compared with placebo .(3)

Aim of the work:

* This study aims to investigate the effects of SAC/VAL in post-AMI through using it instead of conventional Angiotensin Converting enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.
* Design: Randomized open label interventional clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Post-AMI patients who underwent successful PPCI and LVEF ≤40%.

Exclusion Criteria:

* Post-AMI patients who underwent successful PPCI and LVEF \>40%.
* History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
* Symptomatic hypotension and/or an SBP \< 100 mmHg.
* Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula or serum potassium \> 5.2 mmol/L.