cyrilzakka/clinical-trials huggingface dataset:
A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

In this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of advanced or metastatic KIT mutant GIST.
* Documented disease progression on imatinib therapy as current or prior treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
* At least 1 measurable lesion per mRECIST.
* Negative pregnancy test for female patients of childbearing potential.
* Adequate organ function per protocol requirements.
* Resolution of all clinically significant toxicities from prior therapy to ≤Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.

Key Exclusion Criteria:

* Diagnosis of non-KIT mutation or a T670X KIT mutation-driven GIST.
* History of prior or currently has cancer which has potential to interfere with obtaining study results.
* Received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives prior to the first dose of study intervention.
* Active central nervous system metastases.
* Uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* Mean corrected QT interval (QTcF) greater than 470ms.
* Left ventricular ejection fraction (LVEF) \<50%.
* Major surgery within 2 weeks prior to the first dose of study intervention.
* Is pregnant or lactating.
* Gastrointestinal abnormalities that may impact taking study intervention by mouth.
* Actively bleeding, excluding hemorrhoidal or gum bleeding.
Biomarker Study of Chemotherapy Resistance and Outcomes in Samples From Older Patients With Acute Myeloid Leukemia

RATIONALE: Studying blood samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and outcomes in samples from older patients with acute myeloid leukemia.

OBJECTIVES:

* Delineate the spectrum of genetic and epigenetic lesions occurring in elderly patients with acute myeloid leukemia (AML).
* Determine the biological functions perturbed by these lesions.
* Identify and validate lesions or pathways that are most highly associated with chemo-sensitive and chemo-refractory disease, and with adverse outcome in elderly AML.
* Identify potential classifiers and biomarker lesions that we can then evaluate prospectively in the E2906 trial which is about to begin enrollment.

OUTLINE: DNA and RNA extracted from cell samples are analyzed for genetic and epigenetic expression by Agilent SureSelect sequencing, Illumina HiSeq2000 platform coding and sequencing, DNA methylation, and microarray assays. Results are then associated with patients' overall survival, progression-free survival, and complete response rate. Results are also analyzed assessing the prognostic relevance of known mutations and epigenetic alterations that have shown to have an impact on overall survival and response to therapy in younger patients with acute myeloid leukemia (AML) in E1900 including, but not limited to, FLT3, DNMT3A, IDH1, IDH2, TET2, ASXL1, WT1, and MLL, and 15-gene DNA methylation classifier, and with novel recurrent mutations identified by other AML-profiling efforts.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Subset of patients diagnosed with acute myeloid leukemia (AML) enrolled on E3999
* AML resistant or sensitive to chemotherapy
* Mononuclear cell samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Safety and Efficiency Study of Loading Dose Atorvastatin in Cardiac Surgery

Statins were reported to have pleiotropic effects including antiinflammatory, anti-oxidative stress effects and stabilise plaque in some conditions. Some researches indicate loading dose statin can reduce contrast induced nephropathy, and the levels of inflammatory markers were significantly decreased. The investigators hypothesis loading dose atorvastatin may attenuate inflammatory response during cardiopulmonary bypass (CPB) and therefore reduce postoperative acute kidney injury in cardiac surgery.

Acute kidney injury occurs up to 30% in cardiac surgery which influenced patients' mid-term and long-term outcomes. Furthermore, evidence shows patients who initiate renal placement therapy in hospital have higher mortality and morbility. The pathologies of Cardiac surgery-associated acute kidney injury (CSA-AKI) is not clear yet ,many researches find cardiopulmonary bypass is an independent risk factor in developing AKI, and inflammatory bursts during cardiopulmonary bypass (CPB) may play an important role in CSA-AKI.

Statins are reported to have anti-inflammatory reaction in many researches. In Some multicenter RCTS, Statins are reported to reduce myocardial infarction,atrial fibrillation and have renoprotective effects due to pleiotropic effects in percutaneous coronary intervention. While in the cardiac surgery settings, the renoprotective effect of statin is still controversial. The investigators believe the differences between surgery and PCI may contribute to the discrepancy. The investigators plan to test the renoprotective effect of atorvastatin in a randomized,double-blind control manner and try to explore the mechanism of this protective effect.

The investigators hypothesise loading dose atorvastatin pretreatment in elective coronary artery bypass grafting surgery may attenuate inflammatory response in CPB and therefore reduce postoperative AKI or help recovery from AKI.

The investigators randomize patients into two arms, the Atorvastatin group takes Atorvastatin 80mg 12h before surgery with another 40mg 2h before operation, the control arm takes placebo in the same regime. The investigators plan to compare the inflammatory cytokines at different time points and the incidence of AKI between the two groups. The investigators hope Atorvastatin group can decrease AKI incidence and has a lower level of inflammatory cytokines, what's more, the two have a good correlation in the time frame.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* elective coronary artery bypass surgery in CPB

Exclusion Criteria:

* emergent surgery
* re-operation
* acute kidney dysfunction
* chronic kidney disease
* GFR \< 60ml/min
* liver dysfunction
* existing myopathy
* LEVF \< 40%
* statin allergic or contradictive
* pregnancy
* breast feed period
Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.

Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.

Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Exclusion Criteria:

* Severe hear failure (NYHA IV)
* Left ventricular ejection fraction \<0.30
* Left atrial diameter \>65 mm
* Age \> 70 years
* Contraindication to anticoagulation with warfarin
* Presence of a mechanical prosthetic valve
* Presence of left atrial thrombus on TEE or CT
* Woman currently pregnant
* Renal failure (GFR \< 30 ml/min)
* Hepatic failure
* Untreated hypothyroidism or hyperthyroidism
* LVOT gradient \> 50 mmHg
Adding Vortexing to the Maki Technique Provides no Benefit for the Diagnosis of Catheter-related Bacteremia

The investigators wanted to determine whether the combined use of vortexing and Maki techniques provides profitability versus the Maki technique for the diagnosis of catheter tip colonization and catheter-related bloodstream infection

BACKGROUND A previous study compared vortexing and Maki techniques for the diagnosis of catheter-related bloodstream infection (CRBSI), and concluded that vortexing was not superior to Maki method.

AIM To determine whether the combined use of vortexing and Maki techniques provides profitability versus the Maki technique for the diagnosis of catheter tip colonization (CTC) and CRBSI.

METHODS Observational and prospective study carried out in an Intensive Care Unit. Patients with suspected catheter-related infection (CRI) and with one central venous catheter for at least 7 days were included. The area under the curve (AUC) of the Maki technique, the vortexing technique and the combination of both techniques for the diagnosis of CTC and CRBSI were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicion of catheter-related infection (CRI) and with long term CVC (at least 7 days)

Exclusion Criteria:

* none
Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
2. Confirmed metastatic or locally advanced, unresectable disease.
3. Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
4. Willing to provide tumor tissue for PD-L1 biomarker analysis.
5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
6. ECOG performance status of 0 to 1.
7. Life expectancy of more than 12 weeks.
8. Signing the informed consent forms.
9. Adequate bone marrow, liver and renal function.

Exclusion Criteria:

1. Squamous cell or undifferentiated gastric cancer.
2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
4. Clinically significant cardiovascular and cerebrovascular diseases.
5. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
6. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
7. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
8. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
9. Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC

This retrospective, external comparator study for Lazertinib aims to assess the real-world effectiveness of Lazertinib as the second-line treatment versus platinum-based chemotherapy in patients with epidermal growth receptor sensitizing mutation-positive, locally advanced or metastatic Non-small Lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Target and Period: Patients aged 18 or older
* Target Conditions:

  1. Lazertinib:

     * Patients diagnosed with locally progressive or metastatic non-small cell lung cancer, who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period
     * Patients with T790M mutation positive
     * Patients with an ECOG PS score of 0 to 1 at the time of initial drug administration
  2. Platinum-based Chemotherapy

     * Patients who were diagnosed with locally advanced or metastatic non-small cell lung cancer, and previously received first or second-generation EGFR-TKI treatment during the baseline period
     * Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period
     * Patients who were confirmed positive for active EGFR mutations (L858R, Exon19Del, G719X, L861Q) during the baseline period
     * Patients with an ECOG PS score of 0 to 1 at the time of initial drug administration

Exclusion Criteria:

* Patients with carcinoma besides NSCLC requiring treatment
* Any unstable brain metastasis with symptomatic and/or requiring emergency treatment
Pentoxifylline Treatment in Acute Pancreatitis (AP)

The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.

Participants were randomized to either the treatment group (Pentoxifylline medication) or the control group (Placebo).

Participant took a pill orally, starting from the time of admission. Participants received a total of 9 doses over the three days of hospitalization (72 hours).

Research blood draws were done at baseline and on 5 successive days or until the time of discharge, whichever occured earlier. The study gathered clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.

Eligibility Criteria:
Inclusion criteria

* Enrollment within 72 hours of diagnosis of acute pancreatitis (AP)
* Ability to give informed consent or a Legal Adult Representative (LAR) able to give informed consent for subject when needed as defined buy LAR use guidelines.
* Adult subjects of age ≥18 years.

Exclusion Criteria:

* Moderate or severe congestive heart failure
* History of seizure disorders or demyelinating disease
* Nursing mothers
* Pregnancy
* History of prior tuberculosis or risk factors for tuberculosis
* Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV)
* Evidence of active hemorrhage
* Paralytic ileus with severe nausea and vomiting
Clinical Evaluation of Two Daily Disposable Contact Lenses

The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
4. The subject must be a current successful spherical soft contact lens wearer in both eyes.
5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
6. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.
7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
3. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
10. Amblyopia
11. Evidence of lid abnormality or infection (including blepharitis/meibomitis)
12. Conjunctival abnormality or infection.
13. Any active ocular disease.
14. Employee or family member of the staff of the investigational site.
The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters

Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults.

One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active ingredients. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin condition and signs of skin aging.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
* Signed Informed consent form (ICF),
* Fitzpatrick skin phototypes II and III,
* Signs of skin aging,
* In good health condition,
* Willingness to avoid a consumption of any food supplements containing CoQ10 and other antioxidants, collagen or vitamins during the study,
* Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Known or suspected allergy to any ingredient of the tested products,
* Changes in dietary habits and dietary supplementation in last three months prior to inclusion,
* Regular use of food supplements containing CoQ10 or other antioxidants, collagen or other protein-based food supplements, vitamin A, vitamin E or biotin in last three months prior to inclusion,
* Veganism,
* Changes in cosmetic facial and body care routine in last month prior to inclusion,
* Diagnosed and uncontrolled/untreated/unregulated disease,
* Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease,
* Acute skin diseases,
* Skin pigmentation disorders,
* Increased cholesterol and use of cholesterol lowering drugs (statins),
* Anticipated sunbathing or solarium visits before or during the study,
* Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
* Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
* Mental incapacity that precludes adequate understanding or cooperation.
Comparison of Objective and Subjective Changes Induced by Multiple Pinhole Glasses and Single Pinhole Glasses

Purpose of this study is to compare the ocular functional changes including pupil size, visual acuity, depth of focus, accommodative amplitude, visual field, contrast sensitivity, and stereopsis induced by multiple and single pinhole glasses, in addition, to check reading speed and survey for ocular discomfort after using both pinhole glasses.


Eligibility Criteria:
Inclusion Criteria:

1. age between 20 and 45 years;
2. spherical equivalents (SE) within ± 6.0 diopters (D);
3. correctable distant and near visual acuity by glasses up to 20/20;
4. normal intraocular pressure with normal optic disc appearance;
5. normal ocular alignment.

Exclusion Criteria:

1. disturbance of accommodation due to any reasons such as an Adie's pupil, Parkinson's disease, a history of previous ocular surgery or trauma, and a history of systemic or topical medication that might affect accommodation;
2. corneal pathologic features;
3. glaucoma;
4. cataracts of grade II or greater by the Lens Opacities Classification System III (LOCS III);
5. vitreous and retinal abnormalities that might limit the accuracy of testing.