cyrilzakka/clinical-trials huggingface dataset:
Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls

The purpose of this research study is to understand if platelets in the blood become more active during cancer and specially advanced stages of cancer, in the future the investigators want to see if reducing platelet activity can improve survival in advanced cancer.

Hypotheses for proposed study

Platelet reactivity as measured by percentage aggregation in response to agonists such as ADP is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls.

Platelet activation as measured by release of cytokines and vasoactive substances such as VEGF, TGF-beta, and PDGF is increased in patients with metastatic cancer compared to age sex and ethnicity matched controls.

Study Design:

Single center matched case control design; matching variables are age, sex and ethnicity

Inclusion Criteria

Cases:

25 adult patients (\>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy.

Controls:

25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic.

Exclusion Criteria:

Thrombocytopenia, defined as a platelet count of \<100,000 at the time of recruitment of in the last available laboratory data

History of known bleeding disorder or known platelet dysfunction

Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing

CKD stage IV or greater

Eligibility Criteria:
Inclusion Criteria:

Cases:

25 adult patients (\>18 years old) with any form of metastatic or advanced stage (TNM stage III or equivalent) solid adenocarcinoma including breast, colon, and lung cancer will be eligible for inclusion in this study with no restrictions related to previous chemotherapy, radiotherapy, biological therapy or surgical management at the time of enrollment or in the past., although we will prefer to recruit them prior to initiating chemotherapy.

Controls:

25 patients will be selected based on age (+/- 5 years), sex and ethnicity matches from the outpatient medicine Clinic at Sinai hospital, as well as the Sinai community care clinic.

Exclusion Criteria:

* Thrombocytopenia, defined as a platelet count of \<100,000 at the time of
* recruitment of in the last available laboratory data
* History of known bleeding disorder or known platelet dysfunction
* Patients on antiplatelet treatment or anticoagulant therapies at the time of enrollment or 10 days prior to testing
* CKD stage IV or greater
A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.


Eligibility Criteria:
Inclusion Criteria:

* Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
* Eighteen years of age or above
* Able to understand and sign an informed consent (or have a legal representative who is able to do so)
* Measurable disease according to RECIST v1.1
* ECOG Performance Score of 0 or 1
* Adequate bone marrow, hepatic, renal and cardiac function
* Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141

Exclusion Criteria:

* Active infection or fever \> 38.5°C during screening visits or on the first scheduled day of dosing
* Symptomatic CNS disease
* Received other recent antitumor therapy
* Pregnant or breast feeding
Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis

The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.

A prospective multi-center study to establish the clinical utility of the measurement of monocyte volume width distribution, a cell population parameter of the CBC-Differential, on the Beckman Coulter Unicel DxH analyzers. The study will validate the cut-off for the early detection of sepsis in an adult emergency room population where the standard of care included a CBC with Differential and will evaluate the diagnostic performance of the parameter.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-89 years) presenting to ED
* All races \& ethnicities
* CBC with Differential performed upon presentation
* Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted)

Exclusion Criteria:

* Previously enrolled
* Subjects discharged \<12 hours form ED presentation
One Year Glargine Treatment in CFRD Children and Adolescents

Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. They were classified on the basis of a "gluco-score" ranging 0-5. Patients with gluco-score \> 1 were treated with glargine. We report on the results of the first 20 patients who completed 12 months of treatment. BMI z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections in the previous year and HbA1c were the study outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Cystic Fibrosis who had shown glucose derangements.

Exclusion Criteria:

* Patients with/without Cystic Fibrosis without glucose derangements.
Efficacy of Diuretics in Kidney Disease

This study will determine the efficacy of diuretics in patients with chronic kidney disease.

Participants with chronic kidney disease will undergo two 1-week study periods (diuretic versus placebo) separated by 1-2 weeks of washout in a cross-over design. Blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. Participants will weigh themselves daily and complete quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic kidney disease patients able to provide consent
* stable dialysis patients who produce urine and able to provide consent

Exclusion Criteria:

* use of antibiotics for last two months or expected antibiotic use
* recent hospitalization or other event resulting in instability of food intake
Non Alcoholic Fatty Liver Disease (NAFLD) in Hong Kong

The true incidence and prevalence of NAFLD in Hong Kong has not been determined. The natural history of NAFLD is not well defined partly because of differences in the exclusion limit of alcohol and the required histological criteria between studies. NAFLD is previously believed to be a benign non-progressive condition, but it has since been determined that a subset of patients can progress to cirrhosis and even hepatocellular carcinoma.

In fact in a recent histological review of NAFLD, fibrosis or liver cirrhosis was present in 15-50% of patients at index liver biopsy. The presence of obesity or type 2 diabetes mellitus are the strongest predictors of fibrosis. These same risk factors are also more common in patients with cryptogenic cirrhosis. Further evidence of the link between diabetes, obesity and NAFLD are mainly from the field of liver transplantation. In patients who underwent liver transplantation for cryptogenic liver cirrhosis, NAFLD recuured in a quarter of the hepatic allografts. The patients with recurrent NAFLD were more likely to be diabetic and had a higher body mass index (BMI) at the time of recurrent NAFLD. This suggests that NAFLD may have a significant role in the pathogenesis of crytogenic cirrhosis.

Although NAFLD was initially described as a slowly progressive disease, there are emerging data which shows that it can progress rapidly. Liver failure has even been described in patients with NAFLD after bariatric surgery, and a recent report described 5 cases of subacute liver failure in obese middle aged females with NAFLD related cirrhosis. NAFLD can also affect the progression of other diseases as well. Hepatic steatosis related to visceral obesity is a major independent risk factor for fibrogenesis related to chronic HCV hepatitis.

However, the prevalence of NAFLD and its interaction with chronic HBV, if any, is uncertain. This study aims to determine the prevalence of NAFLD in patients with unknown cause of hepatitis and to determine the histological fibrosis and inflammation in chronic HBV patients with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Gender: male and female

Exclusion Criteria:

* HBV patients and fatty liver HCV HIV
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation

This study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus strict volume control (by strict dietary salt restriction and persistent ultrafiltration) without using antihypertensive drugs on cardiac structure and inflammation.

This randomised, controlled and prospective study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus persistent strict volume control without using antihypertensive drugs on cardiac structure (mainly left ventricular hypertrophy)and inflammation.

We hypothesize that better blood pressure control and regression of left ventricular mass may be reached by a policy of strict volume control consisting of strict dietary salt restriction and persistent ultrafiltration.

258 Hypertensive hemodialysis patients (BP\>130/80 mmHg and/or being on antihypertensive medication) will be randomized to two arms:

Group 1: Antihypertensive medicine will be stopped and strict volume control policy will be applied.

Group 2: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.

The patients will be evaluated at 12 months for primary outcomes. Primary end-points are significant changes in left ventricular hypertrophy and left ventricular mass and significant change in left ventricular end-diastolic volume.

Secondary end-points are changes in post-dialysis weight, changes in hematocrit, albumin, BNP and hsCRP levels.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18-70 years old
* on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
* willingness to participate in the study with a written informed consent.

Exclusion Criteria:

* to be scheduled for living donor renal transplantation
* to have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating
Toripalimab With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

This is a single-institution, single arm trial of Toripalimab with neoadjuvant carboplatin and paclitaxel for locally advanced esophageal squamous cell carcinoma (ESCC).The primary study hypothesis is that the patients who received Toripalimab combined with carboplatin and paclitaxel will increase complete pathologic response rate.

Enrolled patinets will receive two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks. Giving the drugs on the first day of each cycle.

Eligibility Criteria:
Inclusion Criteria:

* 1.Histologically confirmed ESCC;
* 2.Clinical stage T1-2N2-3M0 or T3N1-3M0 or T4N0-3M0(AJCC 8 TNM classification);
* 3.Have a performance status of 0 or 1 on the ECOG Performance Scale;
* 4.The important organs functions meet the following requirements:the absolute neutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L; bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5 times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal;
* 5.Expected survival time is greater than or equal to 3 months;
* 6.Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
* 7.Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 90 days after the last dose of study medication;
* 8.Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

* 1.Has any active autoimmune disease or a history of autoimmune disease;
* 2.The patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
* 3.The patient had active infection, fever of unknown cause ≥38.5℃ within 7 days before the medication, or white blood cell count at baseline \>15×109/L;
* 4.The patient had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-L1,or received chemoradiotherapy;
* 5.Have a history of mental illness or psychiatric substance abuse;
* 6.Patients who had participated in clinical trials of other drugs within 4 weeks;
* 7.Patients with a serious risk to treating patients' safety or a concomitant disease that affects the completion of the study according to the researchers judgment;
* 8.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
* 9.Other patients whom the medical practitioner considers inappropriate for inclusion.
Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer

By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.

Eligibility Criteria:
* Inclusion criteria
* Pathologically confirmed to be rectal adenocarcinoma.
* Distance \< 10cm from the end of the tumor to the anal verge found on colonoscopy
* Tumor in stage T3-4N0-2 (pelvic MRI evaluation)
* Patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes)
* Patients with Karnofsky score greater ≥ 70
* WBC \> 3.5 x 109/ml , PLT \> 10 x 109/ml , TBIL\<22.2 umol/l , BUN \<7.14mmol/l , Cr\<132umol/l or Ccr \> 50ml/min (Evaluated using the Cockcroft-Gault formula: Creatinine clearance (male) = {(140 - age) x LBM (kg)} / {plasma creatinine (mg/dl) x 72} ; Creatinine clearance (female) = 0.85 x {(140 - age) x LBM(kg)}/ { plasma creatinine (mg/dl) x 72})
* Patients must sign the informed consent form
* Female subjects must be contraceptive during the trial
* Patients who did not receive any form of chemotherapy and radiotherapy
* No other important related diseases (such as other tumors, severe heart disease and central nervous system diseases, etc.)
* Age must be equal or more than 20 and must be equal or less than 70
* Exclusion criteria
* Previously received radiation therapy, chemotherapy or anti-tumor biological therapy
* Previously received immuno-suppressive therapy
* Participation in interventional clinical trial over the past time
* Suffering from malignant colonic neoplasms simultaneously
* With peripheral neuropathy(above WHO I level)
* Affected cognitive abilities because of neurological or psychiatric abnormalities Including central nervous system metastasis
* Medical history of severe allergies or allergic constitution
* Severe pulmonary or heart disease history
* Female patients who are in pregnancy or lactation and refuse contraception
* Previously with other malignant tumors
* Exit criteria
* Occurrence of bleeding, obstruction, perforation and other complications
* Occurrence of distant metastasis during the period of neoadjuvant therapy
* Adverse reactions, not be tolerated and do not want to continue to receive treatment
* Patients voluntarily quit
* Capecitabine-related Grade 4 Hand-Foot Syndrome
Storage of Bile From Routine Procedures to Study Risk Factors

The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.

The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18

Exclusion Criteria:

* Problems other than biliary tract disease
Influence of Corneal Biomechanical Properties on Myopia Control

to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control

High myopia is accompanied by excessive growth of eyeball, which leads to many complications. Myopia control is a great concern of the government and ophthalmologists worldwide.

Atropine eye drops is used clinically to control the progression of myopia. In recent years, low dose Atropine eye drops (0.01%, 0.05% and 0.1%) have been proven to be effective in slowing growth of eyeball. With less negative effects, these eye drops have been widely used for school children in Taiwan. Orthokeratology is another effective tool to control myopia, and long-term wearing of Ortho-k lens can inhibit the speed of eyeball growth, it is the most useful optical treatment for myopia control.

The Corvis® ST is a combination of an air pulse tonometer with an ultra-high-speed Scheimpflug camera. The movement of the cornea is mainly influenced by three factors which can be measured by the instrument:

Intraocular pressure (IOP)，biomechanical properties of the cornea and corneal thickness. The relationship between adult corneal biomechanics and refractive error has been noted in recent years. Previous studies pointed out that corneal biomechanics analyzer (Corvis ST) can measure the deformation process of the cornea and the biomechanics parameters. These literature found that the corneas of myopic patients， esp. high myopic, have larger corneal deformation in biomechanics analysis and revealed that the corneal stiffness of myopia patients was lower. There are still few discussions about the effect of orthokeratology on corneal biomechanics and there is no research focused on the change of corneal biomechanics of low-concentration atropine user which is worthy of our further exploration.

In this study, the investigators hope to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control.

Eligibility Criteria:
Inclusion Criteria:

* myopia (\<-1D)
* received Orthokeratology or 0.01% atropine for myopia control
* regular follow-up

Exclusion Criteria:

* ocular surface disease( dry eye, keratoconus..)
* allergy to orthokeratology or atropine
* received eye surgery

  * strabismus
  * premature birth
A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.


Eligibility Criteria:
Inclusion criteria:

* Weight between 40 kg and 125 kg
* Documented CHC genotype 1 infection
* Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response
* Documented diagnosis of cirrhosis
* No evidence of hepatocellular carcinoma (HCC) by ultrasound
* Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)

Exclusion criteria:

* Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus
* Use of any investigational drugs within 30 days prior to study enrollment
* Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
* Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded.
* Clinically significant ocular examination findings
* Pre-existing significant psychiatric condition(s)
* Clinical diagnosis of active or recent substance abuse
* Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)