cyrilzakka/clinical-trials huggingface dataset:
Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.

Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Histologically confirmed colorectal cancer
* Age 18-70 years old
* Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
* Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* ECOG 0-1
* Life expectancy of more than 3 months.
* Normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, serum creatinine \< 1.5×upper limit of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN, AKP \< 4×ULN

Exclusion Criteria:

* Pregnant or lactating patients
* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
* Active or uncontrolled infection
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
* Patients could not swallow the tablets
* Concomitant with brain metastases
Sorbent Treatment Prescriptions Pilot Study

This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.

The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.

This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.

How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.

Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.

Eligibility Criteria:
Inclusion Criteria:

* age \</=18 years
* end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for \</= 6 months at time of enrollment
* well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of \>/= 300 mL/min
* ability to understand the English language

Exclusion Criteria:

* Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
* Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
* Active Infections
* Hepatitis B
* Any other active infection that has required antibiotic treatment in the preceding eight weeks
* Pre-study lab values of any of the following (in the most recent routine lab work)
* Sodium - Na+ \> 150 mmol/L, Na+ \< 132 mmol/L
* Potassium - K+ \> 6.5 mmol/L, K+ \< 3.5 mmol/L
* Total Calcium - Ca \> 12 mg/dL (3 mmol/L), total Ca \< 7.2 mg/dL (1.8 mmol/L)
Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients

The study aims to evaluate the performance of the prediction algorithm NAVOY® AKI in a Swedish adult ICU patient population versus fulfilment of KDIGO diagnostic criteria.


Eligibility Criteria:
Inclusion Criteria:

* The study will only include the subjects from the SEP-SE-02 study population. (NCT04570618)

Exclusion Criteria:

* None
Pilot Study for Cell Based Therapies in Patients With Asthma

The aim of this study is to investigate the immunomodulatory potential of Isolated Plasmacytoide Dendritic Cells (pDCs) and Regulatory T-cells (TREGs) isolated with clinical grade magnetic bead isolations techniques (MACS®) on the antigen presenting cell-induced proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.

pDCs as well as TREGs will be co-incubated with generated allergen presenting cells, lymphocytes, and allergen. For in vitro experimentation immune cells will be collected from blood of grass mix or house dust mite sensitized atopic/asthmatic patients.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects suffering from allergic rhinitis and/or allergic asthma against timothy grass pollen (phleum pratense) and/or house dust mite.
* age 18-60 years,
* Nonsmokers or smokers with a history of less than 1 pack years who have not smoked within the last 12 months.
* Positive skin prick test for timothy grass pollen (phleum pratense) and/or house dust mile within 12 months
* Able and willing to give written informed consent
* Hemoglobin ≥135 g/l
* Hematocrit ≥ 0,40
* Body weight ≥ 50 kg and Body Mass Index (BMI) within the range 19-32 kg/m²

Exclusion Criteria:

* History of lower respiratory tract infection and /or exacerbation of asthma within four weeks prior to the informed consent visit
* Febrile illness within four week before the trial examination
* Administration of oral, injectable, or dermal corticosteroids within the last 8 weeks or intranasal and/or inhaled corticosteroids within the last 4 weeks.
* Intake of methylxanthines, antihistamines, antileukotrienes, oral cromolyn sodium, or oral nedocromil sodium
* Past or present disease, which as judged by the investigator, may affect the outcome of this trial. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
* Specific immunotherapy (SIT) within the last two years prior to screening
* Participation in another clinical trial 30 days prior to enrollment
* Donation of more than 500 ml of blood in the preceding 9 weeks before the trial-examination
* Hemoglobin below the normal lower limit
* History of drug and/or alcohol abuse or dependence within 12 months of the trial
* Risk of non-compliance with trial procedures
* Suspected inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
* Patient is tested human immunodeficiency virus (HIV)-1/2Ab, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab) positive
Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment

To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.


Eligibility Criteria:
Inclusion Criteria:Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images

AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥22
2. Male or female
3. Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
4. Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

1. Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
3. Previously diagnosed with Diabetic Retinopathy.
4. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
5. Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
6. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
7. Participant is contraindicated for imaging by fundus imaging systems used in the study:

   1. Participant is hypersensitive to light
   2. Participant recently underwent photodynamic therapy (PDT)
   3. Participant is taking medication that causes photosensitivity
   4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
8. Subject is pregnant.
Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia

The prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and respiratory functions.


Eligibility Criteria:
Inclusion Criteria:

1. Prone spine surgery after general anesthesia is planned.
2. Age 18\~85 years old.
3. ASA grade I or II.
4. BMI18.3-30kg/m2

Exclusion Criteria:

1. Unstable angina or myocardial infarction, coronary heart disease, congestive heart failure, structural heart disease, arrhythmia within 6 months;
2. Increased intracranial pressure and central nervous system injury or disease;
3. Severe hypertension
4. Patients with other diseases affecting their own circulatory system.
5. Have or have a history of severe mental disorders;
6. Bleeding volume \>600ml or intraoperative blood transfusion treatment.
7. Severe liver and kidney insufficiency
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy

This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and provide written informed consent.
* Male and female adults aged ≥18 years.
* History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
* A PHES of ≤ -4 during Screening.
* MELD score of ≤ 22 at Screening.
* Support of a primary caregiver who is able and willing to give written informed consent.

Exclusion Criteria:

* Hospitalization or serious medical condition.
* Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
* History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
* Expectation of a liver transplant during the study.
* Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.
Investigation of Validity and Reliability of the Minnesota Manual Dexterity Test in Parkinson's Disease

Parkinson's Disease (PD) is a disease that affects upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia, and causes limitations in patients' daily life activities. The impairment of upper extremity functional skills is related to the deficiency in planning both voluntary and complex movements, as well as the deficiency in multiple motor planning. In particular; fine manual dexterity, reaching, and grasping movements are affected, greatly affecting patients' daily activities. Therefore, upper extremity evaluations are an important issue to consider for training upper extremity motor skills in PD. There are minimal assessment tools for evaluating the upper extremity functions of individuals with PD. The Nine-Hole Peg Test and the Jebsen Hand Function Evaluation Test are the most commonly used scales in the evaluation of the upper extremity in PD, and their validity and reliability have been demonstrated. These scales roughly evaluate both extremities separately. However, these scales are not suitable assessment tools for testing activities in which both extremities are frequently used in daily life. Therefore, there is a need for valid and reliable scales that can evaluate upper extremity activities both in isolation and bilaterally. The Minnesota manual dexterity test (MMDT) allows both hands to be evaluated together. It also evaluates hand-eye coordination and gross motor skills in addition to manual dexterity. MMDT is used in individuals with PD, but there is no study in the literature examining the validity and reliability of the scale. Therefore, this study aims to evaluate the reliability and validity of MMDT in individuals with PD.

At baseline, the MMDT, 9-hole peg test, and Jebsen-Taylor Hand Function Test (JTHFT) will be applied to the MS group. The MMDT will be repeated seven days after the first application in MS. Healthy controls are going to perform only the MMDT.

Eligibility Criteria:
Inclusion Criteria:

* Between 40-80 years old
* Diagnosed with only "Parkinson's Disease" by a neurologist
* Between 1-3 values of your thoughts according to Hoehn and Yahr manufacturers

Exclusion Criteria:

* Having any vision, hearing or perception problems that may affect the research results,
* Having an orthopedic problem that may affect manual skills in the upper extremity,
* Having a cardiovascular, pulmonary disorder
Trial to Improve Access to PMTCT Services and Reduce HIV Transmission From Mother to Child

The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility and acceptability of an enhanced community health worker (CHW) intervention and outreach system to improve antenatal care and PMTCT uptake and retention, and to decrease mother-to-child HIV transmission.

Mother-to-child transmission of HIV/AIDS (MTCT) is still a major contributor to the burden of HIV infections among infants and children in Sub-Saharan Africa. Among the major challenges of each approach to achieving maximum benefits is late and incomplete antenatal care (ANC) attendance. While attendance to one ANC visit is almost universal, only about half of pregnant women attend the four WHO-recommended visits. Moreover, those that attend often book late in pregnancy. This nationwide challenge can lead to delays or interferences with the appropriate PMTCT medications for mothers -thus substantially diminishing the potential of PMTCT care to reduce mother-to child-transmission of HIV in Tanzania.

The investigators will examine the effectiveness, cost-effectiveness, feasibility, and acceptability of an enhanced community health worker intervention and outreach system for pregnant women to facilitate early and consistent ANC attendance, early and effective PMTCT uptake, with the aim to further reduce mother-to-child transmission of HIV. We will test the effectiveness hypothesis in a cluster-randomized controlled trial; the unit of randomization is the administrative unit of a ward, which is the geographical unit below a district in the Tanzanian government system. We randomly allocate all 60 wards in two of the three districts in Dar es Salaam, Tanzania -- Kinondoni and Ilala districts -- to receiving the enhanced community health worker intervention and outreach system vs. receiving the standard of care in the Tanzanian public-sector health system.

The results of this study will inform implementers and policy makers on whether and how a community outreach system and PMTCT algorithm may maximize benefits of antenatal care and PMTCT services in Tanzania and inform decisions surrounding future maternal and newborn health programs moving forward.

This study was initially designed to test both the effectiveness of the enhanced CHW intervention and outreach system and the effectiveness of WHO PMTCT option B (vs. A) in ensuring successful PMTCT in the Tanzanian public-sector health system. However, in reaction to a report of non-compliance by the investigator team (incomplete records of written informed consent among PMTCT patients in the public-sector PMTCT clinics) the IRB at the Harvard School of Public Health decided to stop involvement in the option A vs. B component of this study. The IRB approved continuation of the enhanced CHW intervention and outreach system in the study.

Eligibility Criteria:
Inclusion Criteria:

• All pregnant women who are identified by the CHW during the routine household visits
Improving Treatment Adherence in HIV-Infected Individuals

This study will develop and evaluate the efficacy of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals.

When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized.

Participants in this \~18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* English-speaking
* Currently receiving treatment at one of the participating sites
* Currently receiving antiretroviral therapy

Exclusion Criteria:

* Marked cognitive impairment
Celebrex With Preoperative Chemoradiation - Rectal Cancer

Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a significant impact on our society.C linical trials have shown that this type of cancer is less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination of all three types of therapy is now standard.

Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2 (COX-2) also known as a "COX-2 inhibitor". It is an anti-inflammatory capsule (drug that reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug. Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy, without increasing radiation side effects. This has not yet been confirmed in humans.The main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We shall also be looking at how effective the combination of radiotherapy, chemotherapy and celecoxib is in shrinking rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* patients with resectable or potentially resectable adenocarcinoma of the rectum
* clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)
* age greater than 18 years, ECOG performance status \< 2 (appendix, section 13.1)
* biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy

Exclusion Criteria:

* Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy
* History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)
* Pregnancy
* Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU
* Significant comorbid illness
* History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
* Use of aspirin, other NSAID or coxib in the two weeks prior to study entry
* Neutrophil count \<1.5x109/L, platelet count \<100x109/L, serum bilirubin \>1.25xULN (upper limit of normal), AST/ALT \>3xULN, serum creatinine \>1.25xULN
Statin Therapy In Patients With Vasospastic Angina

The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Vasospastic angina
* LDL less than 160mg/dl
* Written consent

Exclusion Criteria:

* Coronary artery stenosis more than 50% or ischemic coronary disease
* History of percutaneous coronary intervention
* Cerebrovascular diseases or peripheral
* Dyslipidemia required statin therapy
* Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery
* NYHA III and IV
* Arrhythmia
* Primary cardiac electrical diseases
* Cardiac pacemaker or implantable defibrillator
* Pregnancy or breast feeding
* Life expectancy less than 2 years