cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors

This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.

The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over 21-day cycles.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age at the time of signing the informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective
* Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Adequate baseline organ function and hematologic function
* Life expectancy \>3 months

Exclusion Criteria:

* Systemic anti cancer therapy within 4 weeks of first dose of study drug
* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
* Uncontrolled intercurrent illnesses
* Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.
Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection

The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.


Eligibility Criteria:
Inclusion Criteria:

* patients with CHD receive long-term statin treatment

Exclusion Criteria:

* ALT is over ULN at baseline
* infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus
* triglyceride is over 4.5 mmol/L
* decompensated liver cirrhosis (Child B or C)
* active stage of HBV
* infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease
* congestive heart failure
* malignant tumor
* autoimmune disease
* receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.
A Cohort of Patients With Phenotyped Diffuse Interstitial Lung Disease With Longitudinal Follow-up

The purpose of the study is to conduct a descriptive analysis of the population of patients with an interstitial lung disease received in the pulmonary department of University hospital of Nice (France). Analysis and documentation of clinical forms of the disease, therapeutics used and evolutions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosis of interstitial lung disease according to the multidisciplinary monthly meeting for interstitial lung disease occuring at University hospital of Nice, France

Exclusion Criteria:

* Patient-led opposition to data collection
CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and CardioVAscuLar Disease

The principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary carnitine and choline in humans.

The principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary trimethylamine nutrients in humans. We have recently shown that dietary intake of two trimethylamines abundant in animal products, carnitine and the choline group of phosphatidylcholine (PC), are mechanistically linked to cardiovascular disease risk. We wish to further explore the metabolism of these nutrients in humans, and to test the hypothesis that the intestinal micro flora (gut flora) plays a critical role in generation of metabolites from dietary carnitine and choline/PC linked to cardiometabolic disease. We further hypothesize that the production of specific metabolites of carnitine and choline/PC are influenced by the composition of gut flora, and these may be altered by the preceding dietary patterns of the subjects. We therefore wish to test whether dietary supplementation with carnitine and/or choline alters the metabolism of carnitine and choline/PC in subjects. We also hypothesize that transient suppression or modulation of gut flora via short-term broad spectrum antibiotic therapy, or by reconstitution of micro flora composition via probiotic therapy, in healthy subjects, can alter the metabolism of carnitine and choline/PC. We will also examine the impact of low dose aspirin on these pathways by examining subjects before versus after taking aspirin.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 years or above.
* Able to provide informed consent and comply with study protocol

Exclusion Criteria:

* Significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, hematologic diseases or pregnancy.
* Active infection or received antibiotics within 2 months of study enrollment
* Use of Over-The-Counter (OTC) probiotic within past 2 months, or ingestion of yogurt within past 7 days
* Chronic gastrointestinal disorders, or intolerance to probiotic therapy
* Having undergone Bariatric procedures or surgeries such as gastric banding or bypass
Besponsa Post Marketing Surveillance Study

Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.

Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.

Eligibility Criteria:
Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
2. Patients to whom BESPONSA® is contraindicated as per the local labeling.

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Anesthesia Geriatric Evaluation and Quality of Life After Peripheral Vascular Surgery

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in peripheral vascular surgery patients.

Introduction:

The percentage of elderly in the general population is increasing rapidly. Currently, the Dutch population comprises for one fifth of persons aged 65 years or older and recent estimates show this will increase to roughly a quarter in the next 20 years. Since th incidence of peripheral arterial disease increases with age, this rise in elderly will also reflect on the population of patients being referred for vascular surgery. Elderly patients are at higher risk for postoperative complications, mortality or functional decline than younger patients. In frail elderly this effect might be more pronounced. Frailty is an umbrella term that encompasses patient related factors such as weight loss, muscle wasting, inactivity, comorbidities and polypharmacy. Current scoring systems that are used to predict postoperative mortality and complications following vascular surgery perform poorly in the elderly population and do not take into account frailty. Moreover they are designed to predict mortality and complications and are not validated to predict patient reported outcome measures such as quality of life or functional status. The aim of the AGE VASC study is assess the value of frailty factors in predicting an improvement in quality of life one year after peripheral vascular surgery.

Methods:

The AGE VASC study is a prospective observational cohort study. All patients aged 70 years or older, scheduled for peripheral vascular surgery of the lower limb, mentally competent and have signed informed consent are eligible for the study. Before surgery patients will be screened for frailty using different questionnaires and physical tests. The battery of tests exists of Short Form 36 (SF36), Walking Impairment Questionnaire (WIQ), Multi Nutritional Assessment (MNA), Montreal Cognitive Assessment (MoCA), Nagi's scale for disability, Geriatric Depression Scale -8 (GDS8), three physical tests: five meter walking speed, timed get up and go test and hand grip strength. And a non-invasive measurement of Advanced Glycation Endproducts (AGEs). A blood sample will be taken to determine vitamin status, immune status and iron deficiency. After surgery, electronic patients charts will be studied to score postoperative complications or mortality. Three and twelve months after surgery patients will receive SF-36, WIQ, and World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaires to determine quality of life and functional status.

Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or older
* Mentally competent
* Planned peripheral vascular surgery of the lower limb (femoral artery desobstruction, bypass surgery, amputation), possibly combined with endovascular procedure
* Signed informed consent
Remote Monitoring of Chronic Heart Failure in Veneto Region

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

The study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years.
* Discharge from hospital after acute heart failure in the previous 3 months and EF \< 40% or EF \> 40% plus BNP \> 400 (or plus NT-proBNP\>1500) during hospitalization

Exclusion Criteria:

* Comorbidities prevalent on CHF with life expectation \< 12 months.
* Impossibility or inability to use the equipment and help at home not available.
* Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.
* Coronary artery bypass, valve substitution or correction in the last 6 months.
* Being on waiting list for heart transplantation.
* Being enrolled in other trial
Parkin Mutations and Their Functional Consequences

Parkinson's disease (PD) is the most frequent neurodegenerative disease with a prevalence of 2% over 65 years and because of this high prevalence as the population ages, it is a major problem of public health.

An exhaustive repertory of not only parkin mutations in autosomal recessive forms of PD but also in other known genes such as DJ-1, PINK1 and LRRK2, is of major importance for both genetic counseling in families affected with PD and physiopathological approaches to this disease.

Through a French network for the study of Parkinson's disease genetics and extended collaborations with European, Mediterranean and other various countries, a total of 2934 subjects including 1683 patients and 1251 unaffected individuals has been collected since 2002. These samples consisted of 122 families with autosomal recessive PD, 285 cases of isolated early onset PD, 110 autosomal recessive and 129 autosomal dominant families with late onset PD, 201 isolated late onset PD cases and 250 matched controls.

DNAs from all subjects are now available, lymphocytes and lymphoblastoid cell lines have been stored for most patients from France and recently, fresh fibroblasts have been obtained for some individuals.

The genetic approach to autosomal recessive PD is focused on the identification of mutations in the parkin gene but also on the screening of DJ-1, PINK1 and LRRK2 genes.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with Parkinson's disease, with a family history or not,
* Minors presenting clinical signs of the disease,
* Controls (without signs of the disease, matched by sex and age with the patients, relatives for the familial cases)

Exclusion Criteria:

* Persons refusing to sign the informed consent,
* Lack of clinical information
Acute Control of Chronic Hypertension

The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's history of preexisting hypertension, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

The investigators seek to asses the effect of preexisting hypertension on the patient's response to treatment for severe hypertension in preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Gestational age ≥ 24 weeks
* Singleton gestation
* Chronic hypertension as defined as two elevated blood pressures (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg) at least 4 hours apart before 20 weeks gestation

Exclusion Criteria:

* Known allergic reaction to labetalol
* Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
* Obstructive airway disease
* Bradycardia \< 70 beats/min
* Heart block \> 1st degree or history of heart failure
Evaluation of Demonstrations to End Childhood Hunger - NV

The 2010 Child Nutrition Reauthorization provided funding to test innovative strategies to end childhood hunger and food insecurity. Demonstration projects were funded in Chickasaw Nation, Kentucky, Navajo Nation, Nevada, and Virginia. This study focuses on Nevada.

SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (\<5 years) per month; (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education; or (3) only regular monthly SNAP benefit. The first two groups were the treatment arms and the third was the control group.

Objectives: To (1) reduce food insecurity among children; (2) increase enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and other nutrition assistance programs; and (3) improve nutrition and healthy shopping habits through nutrition education.

Target Population: Supplemental Nutrition Assistance Program (SNAP) households with children under age 5 and incomes below 75 percent of the Federal Poverty Level living in Clark County, Las Vegas, Nevada.

Intervention: SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (\<5 years) per month; (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education; or (3) only regular monthly SNAP benefit. The first two groups were the treatment arms and the third was the control group.

The two treatment groups were ultimately combined because of the low uptake of case management and nutrition education.

Eligibility Criteria:
Inclusion Criteria:

* Supplemental Nutrition Assistance Program (SNAP) households with children under age 5 and incomes below 75 percent of the Federal Poverty Level living in Clark County, Las Vegas, Nevada.
TENS Trial to Prevent Neuropathic Pain in SCI

The purpose of this research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to learn more about this kind of pain and who is at risk for suffering from this type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in about 50% of people with spinal cord injury. This type of pain is usually described as "burning" or "tingling," and is present around the level of injury and/or in areas below the level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help prevent this pain from occurring. Pain symptoms will be compared between the study participants who receive active TENS and the study participants who receive a sham TENS treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18;
* Traumatic spinal cord injury;
* Date of injury occurring within four months of study enrollment.

Exclusion Criteria:

* More than four months since date of injury;
* Contraindications for the study intervention, transcutaneous electrical nerve stimulation (TENS),88 including:
* Implanted electronic device such as a pacemaker;
* Cardiovascular problems;
* Pregnancy;
* Epilepsy;
* Cancer;
* Persons with a spinal cord injury at the C2 level, as placement of TENS electrodes on the neck is not recommended;
* Cognitive dysfunction which limits the ability of the participant to adequately understand procedures and risks.
* Prisoners
* Pregnant Women

Special populations:

* Adults unable to consent: excluded from study
* Individuals -who are not yet adults: individuals who are less than 18 years old will be excluded from the study
* Pregnant women: Women who are known to be pregnant will not be recruited into the study. A pregnancy test will be administered to females prior to enrollment in TENS (or sham) treatment. Women who become pregnant before or during the 8-week TENS treatment period will be discontinued from the study. Women who become pregnant after the 8-week TENS treatment portion of the study will continue to be enrolled, and followed according to protocol guidelines (no information will be collected specifically on the pregnancy or fetus).
* Prisoners: excluded from study
* Neonates: not applicable
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation

The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal.
* Lower eyelid skin is free of any irritation, scarring or dermatologic conditions which might interfere with the study.
* Willing and able to participate in the study and follow all study directions.
* Able to read, understand and sign the consent form prior to any study related procedures.

Exclusion Criteria:

* Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
* Presence of irritation or dermatologic skin conditions in the lower eyelid area.
* Known allergies to materials within the test formulations (i.e., yeast and/or yeast products).
* Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation.
* A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change.
* An unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications.
* Use of any investigational medication or device for any indication within 30 days of screening.
Try Walking a Mile in These Shoes: Activity Level of Lower Extremity Amputees

The purpose of this study is to compare the accuracies of the Patient Activity Monitor to that of a standard pedometer during a walking task and some day-to-day activities in a simulated apartment setting.

The ability to accurately measure daily activity levels in lower extremity amputee patients is important for a better understanding of their use of prosthetic limbs. Most studies have shown that patients often report their activity level inaccurately. More objective data on activity levels will not only provide information helpful for determining the appropriate prosthetic components for an individual, it will also be helpful when assessing the effects that medical illness have on activity levels and in objectively determining the benefits of rehabilitation. In addition, being able to measure activity accurately will allow further verification of currently developed clinical surveys designed to determine amputee activity in a practical form.

Until more recently a practical, accurate and affordable means of monitoring lower extremity amputee activity has not been available for use. Currently a monitoring device designed specifically for this task is available for research use. It is called the Patient Activity Monitor (PAM). Many different models of more generic activity monitoring devices, called pedometers, also exist and need to be further tested in the amputee population.

The objective of our study was to measure and compare the step count and ambulation distance accuracies of a Yamax Digi-Walker pedometer and the PAM in transtibial amputees at the K3 Level within a simulated apartment setting and during relatively continuous gymnasium walking.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transtibial amputees who were identified as community level ambulators (K-Level 3)

Exclusion Criteria:

* Malfunction of prosthesis; or
* New medical co-morbidities that impacted on ambulation.