cyrilzakka/clinical-trials huggingface dataset:
TAURINE and HCC PATIENTS

Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients candidate for LDLT.

Taurine has been demonstrated to have a direct and indirect antioxidant effect and to display antineoplastic activity by preventing angiogenesis and enhancing tumor cell apoptosis. Also it was suggested that measurement of serum taurine level in hepatic patients beside fibroscan is of great value in the early diagnosis of any fibrotic and cancerous liver changes.Aim of the work was to correlate serum taurine level with the levels of the specific tumor markers (α- fetoprotein and α-L-fucosidase ) for early diagnosis of different stages of HCC in Egyptian patients.

This observational case-control study was conducted in the Tropical Medicine Department, Ahmed Maher Teaching Hospital. Eighty hepatic patients were assigned to three groups (Chronic hepatitis, Cirrhosis and HCC). Twenty healthy subjects were enrolled as a control group. Serum levels of AFP, AFU, and taurine beside complete biochemical analysis and liver biopsies from all selected patients were done. Patients who accepted to be a candidate for living donor liver transplant (LDLT) were referred to Ain Shams University Specialized Hospital (ASUSH) liver transplant unit.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis
* Cirrhosis
* HCC patients

Exclusion Criteria:

* Patient refusal
* Bleeding tendency
* Tense ascites
* Inability to obtain a liver biopsy
Correlation of Biomarkers With the Presence and Severity of Coronary Artery Disease

The development of coronary artery disease is multifactorial. Peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. However, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. The present study aims to identify the differentially expressed biomarkers from peripheral blood between normal population and patients with different disease burden confirmed by coronary angiography, and to analyze the correlation of those biomarkers with the severity of coronary artery disease. Finally, the prediction of biomarkers for clinical events.

This study includes three parts:

1. Part 1 (Pilot analysis): 30 normal people and 30 patients with at least one epicardial coronary artery disease confirmed by angiography will be included. 10 ml peripheral blood from arterial sheath (just before angiography) will be collected in each subject. Proteomics analyses are performed in order to obtain the differentially expressed proteins (coded by Proteins 1-x.
2. Part 2 (Training group): Differentially expressed Proteins 1-x are measured and compared between patients with diameter stenosis \<70% (n=100) vs. with diameter stenosis ≥ 70%(n=100), respectively. Finally, Proteins 1-y from Proteins 1-x will be identified. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.
3. Part 3 (Validation group): The difference in blood concentration of Proteins 1-y between patients with different disease burden will be further analyzed: patients with diameter stenosis \<70% (n=200) vs. diameter stenosis ≥70% (n=200), respectively. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.

Eligibility Criteria:
Inclusion Criteria:

* For Pilot study, both health and patients with at least one epicardial coronary artery disease are included
* For both Training group and Validation group, patients must have at least one epicardial coronary artery disease
* Left ventricular ejection fraction \> 30%
* Stable or unstable angina
* Myocardial infarction older than 1 month
* No active inflammation
* No scheduled non-cardiac surgery within 12 months
* eGFR \> 30 ml/min/m2
* Patients agree to participate in this study

Exclusion Criteria:

* Severe liver dysfunction
* Blood platelet count \<100 x 109/L
* Cancer
* On dialysis
* Pulmonary hypertension (defined as mean pulmonary arterial pressure \> 25 mmHg and pulmonary vessel resistance \> 3.0 Woods Unit)
Hepatocellular Carcinoma Surveillance in Cirrhotics

This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

There is a substantial burden of HCC-related morbidity and mortality: The age-adjusted incidence rates of HCC have tripled in the US since the 1980s due to the burden of hepatitis C virus (HCV) and the epidemic of non-alcoholic fatty liver disease (NAFLD). The overwhelming majority of HCC in the US occurs in the setting of cirrhosis. Early diagnosis of HCC dictates survival: The American Association for the Study of Liver Diseases (AASLD) recommends biannual HCC surveillance for all patients with cirrhosis using an abdominal ultrasound. These guidelines seek to maximize early diagnosis of HCC which leads to earlier detection and improved survival because early-stage HCC is curable, with 70% 5-year survival compared to 5% in advanced disease.

HCC surveillance rates are suboptimal: Despite longstanding published guidelines for HCC surveillance, adherence is low, with surveillance rates ranging from 15-30% in the US. Two RCTs have tested interventions to increase HCC surveillance, including electronic reminders for primary care providers and mailed reminders (with or without navigators), but neither has been scalable, produced durable responses, or increased surveillance rates above 50%.

This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18+ years old
* Current diagnosis of cirrhosis or advanced fibrosis
* 1 or more visits to a Penn Gastroenterology/Hepatology practice in the preceding two years
* Currently followed by Penn Gastroenterology/Hepatology
* Must live in the Philadelphia Metropolitan Statistical Area

Exclusion Criteria:

* History of HCC or other liver carcinoma diagnosis
* History of liver transplant
* Completed HCC screening within the past 7 months
* Have a future screening scheduled
* Have a different screening modality recommended by their physician (MRI, CT, etc.)
* Patients with metastatic cancer
* Patients receiving hospice care
Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age

The metabolic syndrome (MetS) is a cluster of clinical indices that signals increased risk for cardiovascular disease and Type 2 diabetes. Women with polycystic ovary syndrome (PCOS) were associated with MetS and insulin resistance. Cluster analysis was a useful tool for identifying groups of women sharing similar metabolic risk factor patterns. Oligomenorrhea, hyperandrogenism and polycystic ovary morphology were the three major components of PCOS. Obesity is a main risk factor in metabolic syndrome. the investigators are interesting to evaluate the relationship between risk of metabolic syndrome and their clinical and/or biochemical characteristics in women with reproductive age.

Design: Retrospective study; medical records reviewed. Participants and setting: The investigators retrospectively reviewed the medical records of female patients who visited our Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.

Definitions of the metabolic syndrome based on arbitrary cutoff points for several quantitative variables, where each variable is related linearly to cardiovascular risk. Even consensual definitions differ between international authorities and continue to change. Moreover, such cutoff s should be gender and ethic difference. Cluster analysis is a statistical method base on algorithms, which seek to minimize within-group variation and maximize between-group variation for the clustering variables. This technique is suitable for defining groups, reflecting the natural structure of data without relying on inappropriate arbitrary cutoffs. We conduct this retrospective study to review the medical records of female patients who visited our Reproductive Endocrinology Clinic from Jan. 1, 2009 to Dec. 31, 2012. Cluster analysis was performed in our studied cases to evaluate the correlation between clinical/biochemical characteristic and risk of metabolic risk in women with reproductive age.

Eligibility Criteria:
Inclusion Criteria:

Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.

Exclusion Criteria:

1. women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, and chromosomal anomalies;
2. women who had had menarche less than 1 years before evaluation or who were older than 49;
3. women who received hormones or drugs for major medical diseases within three months of blood sampling.
Milk Supplementation and Energy Balance.

The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.

Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of weight by elevating the calcium consumption to reach the recommended level. Milk supplementation could be a good alternative to reach this objective, but its impact on weight loss and on appetite sensations has not been verified. Furthermore, losing weight leads to some negative consequences like a decrease of bone mineral content. Considering the benefits of milk on bone health, a higher intake of this food product during weight loss could represent a healthy strategy.

Eligibility Criteria:
Inclusion Criteria:

* Low-calcium consumer (less than 800 mg daily)
* BMI between 27 to 42 kg/m2
* Sedentary
* Healthy

Exclusion Criteria:

* In menopause
* Medications that alter the project's objectives
* Smoker
* Dietary supplement consumer
* High alcohol or caffeine consumer
Behavioral Interventions to Increase Parent Adherence With Behavior Plans

Many children with autism demonstrate severe problem behavior (SPB) in the form of self-injury, aggression, and disruptive behavior. Conducting a functional analysis and implementing derived treatments can produce effective behavior plans. Nonetheless, skills training and an effective plan may not be sufficient to produce parent adherence. This applied research proposal describes an approach to target the negative maintaining contingencies supporting parent reinforcement of problem behavior (accommodation) and nonadherence. The intervention, borrowed from Acceptance and Commitment Therapy and Behavioral Activation strategies, is matched specifically to the hypothesized function of the problematic caregiver responses (negative reinforcement). Parents who participate in the proposed investigation will be assigned to either the Defuse Experience Accept Live intervention (DEAL) protocol group or treatment as usual. Five 45-min DEAL sessions will 1) introduce caregivers to behavior change strategies that maximize contact with positive-maintaining contingencies related to adherence, while undermining the contingencies that maintain accommodation, and 2) provide caregivers with new treatment-related committed actions that are sensitive to positive changes in parent-child interactions. Within and between participant analyses will be conducted to determine the effectiveness of the DEAL protocol.


Eligibility Criteria:
Inclusion Criteria:

* Child under the age of 18 years,
* Child is diagnosed with ASD, as confirmed by the Gilliam Autism Rating Scale-3,
* Child problem behavior is socially-maintained as identified via functional analysis,
* Parent is English-speaking, and
* Parent attendance of at least 80% of appointments at entry into the study.

Exclusion Criteria:

* Child is older than 18 years of age,
* Child does not have ASD,
* Child's problem behavior is not socially-maintained,
* Parent does not speak English, and
* Parent attendance at time of study entry is less than 80%.
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18.5 to 40 kg/m2
* On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
* Lipids meet the following criteria twice during screening period:
* Fasting LDL C = or \> 80 mg/dL;
* Fasting TG \< 400 mg/dL.

Exclusion Criteria:

* History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
* Poorly controlled type 1 or type 2 diabetes mellitus.
* Poorly controlled hypertension.
* Fasting triglycerides \> 400 mg/dL
* 12 lead ECG demonstrating QTcFF \>455 msec at screening.
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma

This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.

Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.

Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign an informed consent form.
* Must be ≥ 18 years of age at the time of signing the informed consent form.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:

  * Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or
  * Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
* Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.
* Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.

Exclusion Criteria:

* Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects with Endometriosis-Associated Pain

This study is designed to evaluate the safety and efficacy of HMI-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.

This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women with moderate to severe Endometriosis associated pain.

Part 1 of the study will determine the safety and efficacy of HMI 115 at 3 dose levels. Part 2 will detect a higher dose and might be conducted after Part 1.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent.
2. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.
3. Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening.
4. Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

1. Subject is pregnant or breastfeeding or is planning a pregnancy during the study period.
2. Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain
3. Subject has clinically significant gynecologic condition other than endometriosis
4. Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding
5. Subject has history of hysterectomy and/or bilateral oophorectomy
6. Subjects with past or present pituitary tumor growth
7. Subjects has a history of osteoporosis or other metabolic bone disease
FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening

To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.

The project will have a total duration of 24 months and will mainly consist of a data collection phase (months 1-24) and a data analysis and results publication phase (months 15-24). Preoperative clinical and socio-demographic data will be collected from patients' medical records. Psychological variables will be administered to the patient before elective neurosurgical surgery.

BIS-guided general anesthesia will be induced by administering sedative and analgesic drugs to the effector site Ce (Effect Site) by target-controlled infusion (TCI). Propofol and remifentanil will be titrated to maintain blood pressure, body temperature, pCO2 and SaO2 in a normal range and BIS values between 40 and 60. Pharmacological data will be relevant at the end of the intervention from the drug infusion pumps. The Recovery Room multidisciplinary team will assess the quality of awakening following the Awakening Chart (Figure 1). This assessment involves dichotomous scoring (yes/no; correct/incorrect) of specific items. To assess the recovery of consciousness, during the pre-extubation phase, simple requests/questions will be asked of the patient: show tongue; show two fingers; give phone number; state place; identify what day is today; report date of birth; notify residence; perform simple multiplication (e.g., 4x5). The following variables will be collected during the periestubation phase: cough, blood pressure ± 20% of baseline, chills, NRS \> 3, RASS \< -1 or \> 0. An abbreviated version of the STAI questionnaire will also be administered to the patient to assess anxiety on awakening. Awakening is considered good and optimal only if a score of 13 is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled:
* Age greater than or equal to 18 years

Exclusion Criteria:

* Psychiatric illness in history and/or taking psychotropic drugs
* Glasgow Coma Score (GCS) \< 15
* Presence of overt cognitive decline or speech disorders
* Patients younger than 18 years of age
* Intraoperative hypothermia (\< 36°)
* Intraoperative hypotension (MAP \< 20% of baseline)
Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer

The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody in patients with pancreatic cancer


Eligibility Criteria:
Inclusion Criteria:

1. age:18-75 years, male or female.
2. Histologically or cytologically confirmed pancreatic cancer.
3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
4. Can provide either a newly obtained or archival tumor tissue sample.
5. ECOG 0-1.
6. Life expectancy of greater than 12 weeks.
7. Adequate organ function.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
3. Known central nervous system (CNS) metastases.
4. Subjects with any active autoimmune disease or history of autoimmune disease.
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. History of Interstitial Pneumonia or active non-infectious pneumonitis.
8. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
9. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
10. Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy.
11. Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
12. Received a live vaccine within 4 weeks of the first dose of study medication.
13. Pregnancy or breast feeding. Decision of unsuitableness by principal investigator or physician-in-charge.