cyrilzakka/clinical-trials huggingface dataset:
Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma

To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male and female patients, 18 years of age or older
* Patients who have leukemia (acute lymphocytic leukemia \[ALL\], acute myelogenous leukemia \[AML\], chronic lymphocytic leukemia \[CLL\], chronic myelogenous leukemia \[CML\]), that is newly diagnosed, who have had initial induction, re-induction, or intensification chemotherapy or who have had a bone marrow (allogenic, syngeneic, or autologous) or peripheral blood stem-cell transplant OR Patients with lymphoma, Hodgkin's disease, multiple myeloma, myelodysplastic syndrome or myelodysplasia (refractory anemia \[RA\], refractory anemia with ringed sideroblasts \[RARS\], refractory anemia with excess blasts \[RAEB\], refractory anemia with excess blasts in transformation to leukemia \[RAEB-T\], or chronic myelomonocytic leukemia \[CMML\].
* Fever, defined as an oral temperature of ≥ 37.9°C /100.2°F, a rectal temperature ≥ 38.4°C /101.4°F, or a tympanic temperature ≥ 38°C /100.4°F

Exclusion Criteria:

* The presence of any clinically acute or chronic disease or condition that, in the opinion of the investigator, may interfere with the patient's ability to safely comply with the conditions of the protocol, or could preclude the evaluation of the patient's response or could make the completion of the therapy unlikely
* Neutropenia associated with syndromes that are not associated with a high risk of bacterial infection (eg. chronic benign neutropenia or Kostmann's syndrome)
* Neutropenia due to primary bone marrow failure
Evaluation of the Protective Role of the L-DOPA Against Age Related Macular Degeneration in Parkinson's Patients

Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to validate the hypothesis stating that he L-DOPA would play a protective role against age related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged of 70 years old and more
* Parkinson's disease

Exclusion Criteria:

* Opposition to participate in this trial
* Patient under a measure of legal protection
* Absence of affiliation to social security or universal health coverage (CMU)
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).


Eligibility Criteria:
Inclusion Criteria:

* Patients being treated with erythropoiesis stimulating agent.

Exclusion Criteria:

* Patients having complication or history of a cardiovascular / lung / brain infarction.
* Patients having a pronounced hemorrhagic lesion.
Immune Response to Toll-Like Receptor 9-Agonist Adjuvanted Pneumococcal Vaccination in HIV Infected Adults

The purpose of this study is to determine whether TLR-9 adjuvanted pneumococcal is more immunogenic than pneumococcal vaccination alone in HIV-infected adults.

Pneumococcal disease is a major source of morbidity and mortality in HIV-patients. HIV-patients are vaccine hyporesponders. A good immune response to pneumococcal vaccination enhances vaccine effectiveness, thereby preventing the morbidity and mortality caused by pneumococcal disease. Even when an optimized regimen containing both conjugated and polysaccharide pneumococcal vaccine is used, only 13% of the immunized HIV patients are high responders at week 96. Recent data indicate that TLR9-agonists have excellent vaccine adjuvant potential and are safe to use in immunocompetent as well as immunocompromised individuals. The aim of this study is to evaluate the qualitative and quantitive immune response to pneumococcal vaccination with or without TLR9-agonist in HIV-infected adults

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and authority statement provided according to local regulatory and ethical practice using a participant information sheet and informed consent form approved by the responsible Ethics Committee.
* HIV-seropositive individuals.

Exclusion Criteria:

* Pregnancy as determined by a positive urine beta-hCG (if female)
* Participant unwilling to use reliable contraception methods for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female)
* Currently breast-feeding (if female)
* Latest CD4 count \< 200 x106 cells/µL
* Viral load (HIV RNA) \> 50 copies/mL if on HAART (defined as at least three antiretrovirals including either a protease inhibitor or a NNRTI, i.e. combivir 300/150 mg x2 + stocrin 600 mg x1 for a minimum of 6 months)
* Previous enrollment in this study
* Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia)
* Unable to follow protocol regimen
* Pneumococcal vaccination 5 years or less prior to inclusion
* Planned participation in other vaccination trials during the time of the study
Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention

To explore the status quo and influencing factors of hyperpain in patients after thoracoscopic surgery, and to explore the effect of earphone sound isolation during combined operation of flurbiprofen axidate and binaural beat music played by earphone during combined operation on the intervention of hyperpain after thoracoscopic surgery.

In this study, patients undergoing thoracoscopy radical lung cancer surgery in Union Hospital Affiliated to Fujian Medical University were selected for A randomized controlled trial. Patients were selected according to the inclusion and exclusion criteria, and the patients were randomly divided into group A of flurbiprofen axidate combined with noise-canceling headset music test, group B of flurbiprofen axidate combined with noise-canceling headset test, and the control group for intraoperative intervention study.

Eligibility Criteria:
Inclusion Criteria:

* Patients selected by the same group of surgeons to perform thoracoscopic three-hole radical resection of lung cancer
* Patients ≥18 years old, able to communicate effectively and cooperate with the completion of clinical trials
* ASA grade I-III
* Normal hearing; Patients who have not participated in other trials in the last two months

Exclusion Criteria:

* Previous history of thoracic surgery
* History of chronic pain and any intake of analgesics 48 hours before surgery; ● Have a history of mental illness, or have taken psychiatric drugs or received psychological treatment in the past six months
* Deformity of the auricle, inability to wear headphones, and failure to cooperate with this study for any reason
* suffering from concurrent severe organ system diseases and hearing impairment
* Incomplete data collection
Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

The primary purpose of this study is to investigate the effects of carbohydrate-rich drink on postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty. The secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of recovery and inflammation in diabetic patients after total knee arthroplasty.

Carbohydrate-rich drink has been proved to neither delay gastric emptying nor affect gastric acidity and is therefore considered safe to use in elective surgical patients without risk factors for pulmonary aspiration. It reduced postoperative nausea and vomiting and improved sense of well-being after surgery. Moreover, carbohydrate-rich drink was not found to be affected by delayed gastric emptying in patients with uncomplicated type 2 diabetes. Therefore, carbohydrate drink may be safely administered 3 h before anesthesia without risk of hyperglycemia or aspiration.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM patients undergoing elective total knee arthroplasty

Exclusion Criteria:

* Contraindication to regional anesthesia
* Patients whose operation is scheduled to start after 9:00 am
* Dementia or cognitive dysfunction
* HbA1c \> 8%
* Gastroesophageal reflux disease
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery

The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

1. Multi-vessel CAD with an indication for revascularization,
2. Presence of at least 1 risk factor for increased risk of post-operative death or major complication,

   * Any patient Age \> 80, OR
   * Any patient with eGFR (Glomerular Filtration Rate) \< 50, OR
   * Any patient with LVEF \< 40%, OR
   * Any patient deemed to be "frail" by consulting surgeon. OR
   * Patients \> 75 years of age with at least one of the following:

     * Ejection fraction \< 50%
     * History of prior CVA (Cerebral Vascular Accident)
3. Coronary artery anatomy appropriate for a robotically-assisted MIDCAB or regular CABG, vessels other than the left anterior descending with lesions amenable to either CABG or PCI.

Exclusion criteria

1. Significant left main coronary artery disease,
2. Ejection fraction \< 30%,
3. Patients with GFR \< 30,
4. Patients unable to take dual anti-platelet agents due to high bleeding risk,
5. Patients requiring emergent surgery, including patients with hemodynamic instability,
6. Patients with anatomy not suitable for a robotically-assisted approach (by CT chest).
Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study

The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per night for 4 weeks) on nighttime blood pressure in African Americans with a history of elevated nighttime blood pressure.

The main outcome of interest is the mean nighttime blood pressure. The investigator is also trying to see the mechanism of action of melatonin on blood pressure by analyzing data from sleep studies to see if melatonin lowers blood pressure by providing a better quality of sleep or is that independent of the quality of sleep.

The investigator is also looking into the effect of melatonin on sympathetic nervous system by measuring urinary catecholamines.

Finally, the investigator is looking into changes in vascular biology markers P-selectin and e-selectin) on Melatonin.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 18 to 64
* Prior history of elevated nighttime blood pressure (BP) ((systolic blood pressure (SBP) \> 115mmHg))
* Taking no more than 2 antihypertensive medications
* African American (self-defined by the participant)

Exclusion Criteria:

* Secondary forms of hypertension
* Presence of other diseases requiring treatment with BP lowering medication
* Known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or history of cerebrovascular disease, including stroke and transient ischemic attacks)
* Diabetes mellitus (Type 1 or 2)
* Cancer/malignancy other than nonmelanoma skin cancer
* Primary renal disease
* Serum creatinine \> 1.5 mg/dL in men or \> 1.4 mg/dL in women
* Severe anemia
* Liver enzymes \> 2.5 times upper limits of normal
* Hepatitis B, Hepatitis C, or HIV positive as assessed by questionnaire
* Current treatment with or regular use of calcium channel blocking agents, cyclooxygenase-2 inhibitors (COX2-I), oral contraceptives, estrogen, sildenafil, vardenafil, tadalafil, antidepressants, corticosteroids, or warfarin
* Current use of melatonin or any sleep aids containing melatonin
* Regular consumption (1 or more times per week) of: Vitamin methyl B12, St. Johns Wort, feverfew, black and white mustard seeds, wolf berry seed
* Severe Sleep apnea
* Night work
* Women who are pregnant, breast feeding, attempting conception, or planning to attempt conception over the next 6 months.
Arterial Waveform Analysis for Predicting Post-induction Hypotension

The goal of this observational study is to develop a computation model for accurately predicting post-induction hypotension in patients receiving laparoscopic surgery under general anesthesia. The main question\[s\] it aims to answer are:

• whether the corresponding characteristics on pressure wave forms could be use to predict post-induction hypotension.

Participants will be observed before and after induction of general anesthesia for non-invasive arterial pressure wave forms and blood pressure changes.

In this project, an equivalent circuit model will firstly be established to simulate patient's hemodynamics. This model will be applied into analyzing blood pressure wave forms in the MIMIC II database. It will facilitate deep understanding of the effects of induction drugs on pressure waveforms. As a result, the corresponding characteristics on pressure wave forms will be identified. The extracted characteristics from the MIMIC II database will then be applied for developing a computation model via machining learning approaches. The developed model will be validated with another available dataset of 100 patients. This project will then conduct a non-invasive and observational clinical study of 50 patients to prove the clinical value of this project. In this trial, a novel pressure sensor will be employed on patient's fingertip to continuously collect pressure waveform before and after anesthesia induction. Medical records and vital signs will also be collected for exploring the potential of the developed model for predicting other events. Endoscopic surgery patients will be recruited in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 20 years
* Ease of access to the hand used for the ArteVu device during the one-hour it is being used during the operation.
* Able to provide written informed consent for participation in the study.

Exclusion Criteria:

* Pregnant patients.
* Medical or surgical condition that prevents the ability to apply the ArteVu device on an upper extremity finger for a period of one-hour during anesthesia and operation.
* Impaired skin integrity of the fingers (e.g. injuries to the finger, burn injuries, or skin graft surgery on the finger).
* Operations involving the upper extremities or the blood vessels of the upper extremities.
* Arthritis or severe deformities of the hand and fingers
* Prosthetic devices or jewelry (such as a wedding band) that cannot be removed from the finger to be used for the ArteVu device.
* History of malignant hyperthermia
* Raynaud's disease affecting the fingers or hands.
* Topical allergy to ABS or silicone
* Swelling, edema or lymphedema of the upper extremity
* Participants with upper extremity occlusive peripheral vascular diseases
* Inability of the patient to provide written informed consent.
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Jianpi Qushi Huatan Decoction) in women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of PCOS is based on the Rotterdam criteria.
2. Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness in TCM theory.
3. women aged 18-40 years without fertility requirements.
4. A willingness to undergo this treatment plan.

Exclusion Criteria:

1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
4. Suspected Cushing's syndrome.
5. Adrenal or ovarian tumors secreting androgen.
6. Poorly controlled type II diabetes.
7. Pregnancy or lactation.
8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
9. Those who had taken hormones or other drugs during the previous 3 months.
10. Acute heart, liver, kidney or blood diseases.
Cervical Multifidus Muscle Function

The purpose of this study is to determine the relationship between cervical multifidi thickness, cervical spine proprioception and possible reflex activation of cervical multifidi through stimulation of joint mechanoreceptors. Cervical mechanoreceptors will be activated with an innocuous, nonspecific stimulation. Participants will have cervical spine proprioception assessed through joint position sense testing. The multifidus muscle thickness and activation state is to be assessed by sonography. These measures are done pre \& post to the innocuous stimulation. There is no specific hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Logan student, staff, or faculty, ages 18 - 30 years

Exclusion Criteria:

* Fractures
* Tumors
* Dislocations
* Myopathies
* Signs and/or symptoms of neuromotor disorders
* Consumption of prescription drugs that affect the nervous system
* Recent cervical spine injuries or surgeries
* Pain
* Manipulative therapy within the preceding 7 days
* Neck pain
Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects

This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.


Eligibility Criteria:
* Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years.
* Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.
Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D

The goal of this study is compare the effect of hybrid closed loop system (HCL) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (T1D) in patient with different initial glycated hemoglobin.

Rationale for the Study:

According to our hypothesis, even T1D patients with an initially optimal glucose level should benefit from this treatment method in the form of a reduction in glycemic variability.

There are very few clinical studies from real practice in a larger group of patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with T1D
* Type 1 diabetes for \> 1 years
* ≥ 18 years old
* CSII (without HCL) or MDI

Exclusion Criteria:

* Severe noncompliance
* Known severe diabetic retinopathy and/or macular edema,
* Lactation, pregnancy, or intending to become pregnant during the study;
* A condition likely to require MRI. Use of acetaminophen-containing medication;
* Unwillingness to use the study device for \>70% of time.
* Conditions that affect red blood cell turnover (hemolytic and other anemias, glucose-6-phosphate dehydrogenase deficiency, recent blood transfusion, use of drugs that stimulate erythropoesis, end-stage kidney disease).
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
* Evidence of measurable disease
* Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
* Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug