cyrilzakka/clinical-trials huggingface dataset:
A Dose-Escalation Study for Patients With Advanced Cancer

This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).

This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in patients with advanced and/or metastatic cancer (including non-Hodgkin's lymphoma) for whom no treatment of higher priority exists.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering the dose confirmation phase (Part B) of the study must also have a tumor that is safely amenable to serial biopsies
* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or Revised International Working Group Lymphoma Response Criteria
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
* Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
* Females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
* Have an estimated life expectancy of greater than or equal to 12 weeks.

Exclusion Criteria:

* Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
* Have current acute or chronic leukemia
* Have had an autologous or allogenic bone marrow transplant
* Females who are pregnant or lactating
Study on the Value of Three-dimensional Speckle Tracking Technique

For a long time, it has been hoped that doctors could screen and diagnosis of coronary heart disease through non-invasive imaging techniques, so as to maximize the benefit/risk ratio of patients. This trial is to explore the screening and diagnostic value of three-dimensional speckle tracking technology for coronary heart disease, and the evaluation value of 3D speckle track image(3D-STI) technology for cardiac function improvement after coronary intervention, and to seek reliable, accurate and quantifiable non-invasive imaging examination for the diagnosis, follow-up and prognosis of coronary heart disease.

In this study, coronary angiography is taken as the "gold standard", and 3d-STI echocardiography technology is proposed to combine with clinical characteristics of subjects for joint diagnosis, so as to evaluate the value of 3d-sti technology in the diagnosis of coronary heart disease.

Patients were followed up with echocardiography after interventional treatment to explore the feasibility of 3D-STI technology in evaluating cardiac function improvement.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with coronary heart disease
* patients underwent coronary angiography with or without PCI

Exclusion Criteria:

* patients with non-sinus rhythm
* patients with severe heart valvular disease
* patients with severe cardiomyopathy
* patients with congenital heart disease
* patients with severe heart failure stage
* patients with acute myocardial infarction occurred during follow-up
* patients with other extremely severe illness
* patients whose images are not clear enough to mark the endocardium
Using Virtual Reality (VR) Models for Preoperative Planning

A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic partial nephrectomy) and improved patient care.


Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
* Subject is willing to be randomized between intervention and control arms

Exclusion Criteria:

* Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
* Cases in which the subject has a solitary or horseshoe kidney
* Cases in which the subject has more than two masses in the applicable kidney
* Cases involving a bilateral operation
A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer

This study is an open-label, single-arm, pilot, perioperative study of EZH2 inhibition in patients undergoing Radical Prostatectomy (RP). The EZH2 inhibition is intended to increase the sensitivity of the underlying tumor to the patient's immune system.

Given the absence of data in this setting, we propose to pilot this experience with 4 weeks of tazemetostat at doses known to be clinically safe and effective at inducing clinical effects via inhibition of EZH2 as established for follicular lymphoma and epithelioid sarcoma: 800 mg twice daily with or without food.

Prior to tazemetostat, blood will be collected (4 tubes) for immune cells, Circulating Tumor Cells, and plasma. This will be repeated at the time of RP. RP tissues will be collected.

Additionally, patients will have a week lead-in to wear a FitBit Charge 5TM device (or similar model) to continuously monitor physical activity from baseline up until end of study. The start of the week lead-in will be considered the baseline visit. Subjects will also be asked to continue wearing the device until end of study and option to continue for up to 2 years after end of study in follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Men electing to undergo radical prostatectomy with preoperative tissue available
* Able to take oral medications
* Age ≥18 years
* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Adequate organ function
* Men with partners of childbearing potential, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception
* Inclusion criteria for remote monitoring component of study with Fitbit only (failure to meet inclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Access to a device (e.g., smart phone, tablet) that has the capability to sync to the Fitbit. Note: access can be via family member, friend, caregiver, or study-designated device provided by study member

Exclusion Criteria:

* Active intercurrent illness or malignancy requiring therapy outside of prostate cancer
* History of bleeding disorders
* Concurrent use of anti-platelet agents or therapeutic anticoagulants with the exception of low-dose aspirin (81 mg daily) or NSAIDs for pain/inflammation.

Concurrent use of strong and moderate CYP3A inhibitors and inducers

* Subjects who have previously received tazemetostat
* Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of tazemetostat
* Exclusion criteria for remote monitoring component of study with Fitbit only (failure to meet exclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, per PI's discretion.
A 6 microRNA Tool for Stratifying Stage II Colon Cancer of Receiving Adjuvant Chemotherapy

Whether patients with stage II colon cancer should receive adjuvant chemotherapy or not is still on debate.MicroRNA(miRNA) is a promising tool. Investigators invented a tool consisting of 6 miRNA(miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215) that was effective to identify one should accept adjuvant chemotherapy or not. Here investigators randomly assign patients to be assessed by classical pathological features or the miRNA tool of determining who should accept chemotherapy. Disease free survival and overall survival are the end points of observation.

Investigators randomly assign patients to be assessed by classical pathological features(control group) or the miRNA tool(experimental group). Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and \<12 lymph nodes examined.MicroRNA tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215. Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miR-21-5p)+(0.086×status of miR-20a-5p)+(0.240×status of miR-103a-3p)+(0.095×status of miR-106b-5p)-(0.238×status of miR-143-5p)-(0.237×status of miR-215),low expression status equals 0 and high expression status equals 1). Investigators defined high risk patient if had any pathological features in control group or the score larger than 1 in the experimental group ,the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation. Primary endpoint is the disease free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of stage II colon cancer.
* With moderate/good ECOG health rating (PS): 0-1 score.
* The patient receive no anti-cancer treatment before primary surgery.
* The patient receive radical operation for colon cancer with negative margin.

Exclusion Criteria:

* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive adjuvant chemotherapy.
The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
2. Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
3. Presence of abnormal dilated choroidal vasculature in ICGA
4. Patients with symptomatic CSC of at least 3 months duration

Exclusion Criteria:

1. Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA
2. Patients receiving exogenous corticosteroid treatment
3. Patients with systemic diseases such as Cushing's disease or renal diseases
4. Pregnant patients
Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

Capillary or venous lactate level evaluation in prehospital care could be simple and beneficial tool for optimising prehospital care in patients with severe trauma.

Evaluation of blood lactate level and its trend are important morbidity and mortality predictive factors. In prehospital care, lactate level is more sensitive marker and have better prognostic value in severe trauma than basic vital signs. Worse outcome is associated with levels between 2 - 4 mmol/l. Measurement of lactate level in venous or capillary blood is quick and simple method with minimal risks and with no special needs for medical staff training. In spite of good availability of this method in the Czech Republic the method feasibility has never been analysed in patients with severe trauma.

Eligibility Criteria:
Inclusion Criteria:

* patient having / suspected to have severe trauma treated by cooperating Emergency Medical System organization

Exclusion Criteria:

* possible alterations of plasma lactate level in the time of trauma (seizure, malignity, use of beta-2 agonists, severe liver and/or kidney failure, ketoacidosis, intoxication)
The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer

1. Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
2. Indication Diabetic kidney disease
3. Efficacy

   1. Primary

      * AUClast, AUCinf, AUClast/D, AUCinf/D
      * Cmax, Cmax/D
   2. Secondary

      * Tmax, t1/2, CL/F, Vz/F
4. Safety

   1. Adverse Event Monitoring
   2. V/S, EKG, Laboratory Test, P/E

Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d \~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.

Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .

The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .

One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .

The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .

Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .

Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.

After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .

Eligibility Criteria:
Inclusion Criteria:

* More than 20 years of age at the time of screening and less than 55 years old healthy male
* (17.5 \~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more

  ☞ body mass index (BMI) = weight (kg) / height (m) 2
* No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings

Exclusion Criteria:

* Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
* Drugs that may affect the absorption of all the states (eg, gastrectomy)
* Investigational drugs within two months before the first dose participated in other clinical trials
Dispensing Study for the Phenacite Project

Dispensing Study for the Phenacite Project.

The investigational test lens was not the final optical design and the study was not used for design validation.

Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

Eligibility Criteria:
Inclusion Criteria:

* Oculo-visual examination in the last two years
* Between 18 and 35 years of age and has full legal capacity to volunteer
* Has read and understood the informed consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
* Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
* Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
* Has not worn lenses for at least 12 hours before the initial visit
* Has a subjective response at baseline, which indicates suitability for this study
* Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
* Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

Exclusion Criteria:

* Has never worn contact lenses before
* Any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
* Has any ocular pathology or anomaly that would affect the wearing of the lenses
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
* Is aphakic
* Has anisometropia of \>1.00
* Has undergone corneal refractive surgery
* Has strabismus
* Has any ocular amblyopia \>= 1line of HC Visual Acuity
* Is participating in any other type of eye related clinical or research study
* Has participated in study CV-14-32.
CHS 828 in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

OBJECTIVES:

* Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Determine a safe dose of this regimen for phase II evaluation.
* Determine the pharmacokinetic profile of this regimen in these patients.
* Determine any antitumor activity in these patients.

OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed for up to 4 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor not amenable to standard therapy
* No symptomatic brain or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.5 mg/dL
* Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)

Renal:

* Creatinine no greater than 1.4 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active bacterial infection
* No other nonmalignant disease
* No alcoholism, drug addiction, or psychiatric disorders
* Able to take oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
* No other concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
* No concurrent radiotherapy (except palliative radiotherapy)

Surgery:

* Not specified

Other:

* No other concurrent investigational drugs
* No other concurrent antitumor drugs
Families and Schools for Health

The purpose of the study is to test the effectiveness of a child obesity intervention with multiple components targeting nutrition and/or psycho-social factors in children, their parents, and their classmates. The specific aims of the study are to (1) Determine the effectiveness of two family-level interventions for improving child outcomes (unhealthy eating, low activity, and overweight); (2) Determine the extent to which adding a family dynamics component enhances the effectiveness of a family lifestyle intervention and improves the child outcomes listed above; and (3) Determine the extent to which a peer-level intervention improves the effectiveness of two family-level interventions among overweight children.

The Families and Schools for Health (FiSH) Project evaluates a psychosocial intervention that targets the family and peer contexts of overweight children. 23 rural schools were identified for participation (schools within a 90-mile radius of the PI's campus were targeted) and each was assigned to one of five intervention conditions using stratified random sampling, with stratification based on proximity to each other (to avoid spill-over effects) and proportion of Native American Indian students. A community sample of 1186 1st grade children, their families, and their teachers were successfully recruited. Anthropometric assessments were conducted with the 1186 children. Those who were not at Control schools were invited to participate in the intervention. 541 children qualified for the intervention (i.e., had BMI% \> 75%), including 459 at Intervention schools and 82 at Control schools. Intervention conditions were (1) a 12-week Family Food \& Lifestyle intervention (FL), aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating; (2) a 12-week Family Food \& Lifestyle and Family Dynamics intervention (FL+FD) that additionally targets dysfunctional family patterns such as high conflict, poor parent-child communication, and parental over-control or permissiveness; and (3) a Peer Group (PG) intervention conducted throughout one semester of the school year that includes a guidance-type curriculum sensitizing children to the importance of social inclusion of all children. Thus, 5 treatment groups were evaluated in the intervention year and followed through 4th grade: FL, FL+FD, FL+PG, FL+FD+PG, and Control. Child psychosocial variables such as emotional eating, self-esteem, loneliness, and social withdrawal will be analyzed as mediators between family/peer contexts and child overweight.

Eligibility Criteria:
Inclusion Criteria:

* Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.

Exclusion Criteria:

* Children with BMI% \< 75%.
Plasma Gabapentin Concentration During and Following Cardiac Bypass

This open label investigation is to determine whether cardiopulmonary bypass affects plasma gabapentin concentration after preoperative administration in the setting of cardiac bypass surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before separation from bypass, 30 minutes following bypass and then before and 2 hours following each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and morphine equivalents will be documented for one day following surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for cardiac bypass surgery involving median sternotomy and CPB
* signed informed consent

Exclusion Criteria:

* history of chronic pain
* regular opioid consumption
* regular anticonvulsant consumption
* regular gabapentin or pregabalin use
* recent congestive heart failure
* ejection fraction \<35%
* chronic pulmonary disease
* liver disease
* renal insufficiency (preoperative creatinine \> 140umol/L
* history of adverse reaction to acetaminophen