cyrilzakka/clinical-trials huggingface dataset:
to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers

This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 55 years old
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
* Clinically significant vital sign

  * SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg
  * DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg
* History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
* History of clinically significant allergies, including imatinib
* Clinical laboratory test values are outside the accepted normal range

  * AST(ASpartate Transaminase), ALT(ALanine Transaminase)( \> 1.5 times to normal range
  * Estimated GFR(Glomerular Filtration Rate) \< 80 mL/min
* History of caffeine, alcohol, smoking abuse

  * caffeine \> 4 cups/day
  * grapefruit juice \> 4 cups/day
  * smoking \> 20 cigarettes/day
  * alcohol \> 140g/week
* Participated in a previous clinical trial within 3 months prior to dosing
* Donated blood within 60 days prior to dosing
* Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
* Subjects considered as unsuitable based on medical judgement by investigators
Validation of a Universal Cataract Intelligence Platform

This study established and validated a universal artificial intelligence (AI) platform for collaborative management of cataracts involving multi-level clinical scenarios and explored an AI-based medical referral pattern to improve collaborative efficiency and resource coverage.The datasets were labeled using a three-step strategy: (1) categorize slit lamp photographs into four separate capture modes; (2) diagnose each photograph as a normal lens, cataract or a postoperative eye; and (3) based on etiology and severity, further classify each diagnosed photograph for a management strategy of referral or follow-up. A deep residual convolutional neural network (CS-ResCNN) was used for the image classification task. Moreover, we integrated the cataract AI agent with a real-world multi-level referral pattern involving self-monitoring at home, primary healthcare, and specialized hospital services.


Eligibility Criteria:
Inclusion Criteria:

Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the primary healthcare center.

Exclusion Criteria:

The patients who cannot cooperate with the examinations.
A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine

Investigators in the Division of Infectious Diseases and the Division of Hospital Medicine of The George Washington University Medical Center are carrying out a study to determine if hospitalized patients receiving the polyvalent pneumococcal vaccine during an acute illness develop an adequate antibody response. The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol, which assigns appropriate patients for vaccination based on the current guidelines from the Advisory Committee on Immunization Practices (ACIP).


Eligibility Criteria:
Inclusion Criteria:

* Males or female patients ages 18 or older
* Diagnosis of pneumonia requiring hospitalization
* Admission to the Medicine Ward under the Pneumonia Core Measure protocol
* Eligible to receive standard of care pneumococcal vaccine by the treating physician
* Able to receive an injection
* Able to provide informed consent

Exclusion Criteria:

* Preexisting history of immunosuppression, to include any of the following: HIV/AIDS, Chronic corticosteroid use, Malignancy requiring myeloablative chemotherapy, Hematologic malignancy, History of solid organ or stem cell transplant
* Pregnancy
* Receipt of pneumococcal vaccine within the last 5 years
* Prior history of hypersensitivity reaction to the vaccine
* Unable to return for follow-up testing
Fully Disposable Patient-Specific Instrumentation

To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.

The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 85 years
* able to understand information
* affiliated to social security

Exclusion Criteria:

* active or suspected sepsis
* tumor around the knee
* previous partial or total knee replacement
* extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
* social situation that could impair follow-up
Rasburicase (Fasturtec) Registration Trial

Primary:

To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.

Secondary:

To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).


Eligibility Criteria:
Inclusion Criteria:

* At high risk of malignancy and/or chemotherapy-induced hyperuricemia
* Performance status less than 3 on ECOG scale or more than 30% KPS scale
* Uric acid concentrations ≥ 8.0mg/dL
* Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia

Exclusion Criteria:

* Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
* Pregnancy or lactation
* Prior treatment with Uricozyme or Rasburicase
* Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
* Treatment with Allopurinol within the seven days preceding study Day 1
* History of significant atopic allergy problems or documented history of asthma
* History of severe reaction to allopurinol
* Known history of glucose-6-phosphate dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery

The purpose of this study is to determine if there is a difference on the penetration of betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract surgery. This will be assessed comparing bacterial colony count and species by taking swabs from the eye surface before and after the topical anesthesia has been administered.

The purpose of this research study is to show that using Lidocaine2% jelly before surgery as an anesthetic (keep you from feeling touch or pain) for cataract surgery does not block the antiseptic (cleans and kills germs) effect of Betadine5%.

Eligibility Criteria:
Inclusion Criteria:

* greater or equal to 18 years old
* uni- or bi-lateral visually significant cataracts

Exclusion Criteria:

* hypersensitivity to betadine5%, topical tetracaine0.5%, or lidocaine2% jelly
* pregnancy
Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense

Introduction. The prevalence of the use of drugs that act on the gastric system has increased in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use, mainly as a prophylactic to prevent reflux esophagitis, gastric pathological hypersecretory conditions, prevention of recurrence of gastric or duodenal ulcers, gastric mucosal protection against damage caused by nonsteroidal anti-inflammatory drugs and during Zollinger-Ellison syndrome. However, omeprazole is associated with several adverse events due to abusive use or irrational prescribing, in disagreement with the indication, which may cause the ineffectiveness of the drug and decreased patient safety. Objectives. To assess the risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic use of omeprazole in hospitalized patients and to know the reasons for the prophylactic use (indicated use or not approved). Patients and Methods. A observational and cross pharmacoepidemiological study will be performed from June to November 2014, in the General State tertiary referral Américo Brasiliense Hospital. Hospitalized patients will be separated into three groups: those who make indicated and approved prophylactic use of omeprazole (exposed group 1), those who make not indicated and not approved prophylactic use (exposed group 2), and those who do not use the omeprazole (non-exposed group). Patients who do not make prophylactic use of omeprazole will be excluded. Patients will have their pharmacotherapy monitored and data will be collected daily using an investigation guide of the first day of admission and will be included in group 1 or 2, from the first use of omeprazole to discontinuation (washout period of seven half-lives or higher). National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) algorithm will be used for causality analysis is used. Data will be tabulated according to the presence or absence of effectiveness and the presence or absence adverse events in the three groups. The odds ratio of adverse events and effectiveness of indicated and approve or not indicated and not approved prophylactic use of omeprazole will be calculated. Expected results. It is intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with or without indication or use approval, and the potential indications, dosage and unapproved methods of prophylactic use in omeprazole label.


Eligibility Criteria:
Inclusion Criteria: patients in use of omeprazole prophylactic (off label or indicated use) who will be admitted at the hospital under study,

Exclusion Criteria: Patients transferred from another hospital or ward; those with prescheduled surgery; those unable to communicate (intubated, in isolation, or mentally disoriented); and those with a hospital stay ≤24 hours.
Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118

Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of NKTR-118.

An Open-label, fixed-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Rifampin on Pharmacokinetics of NKTR-118 in Healthy Subjects.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female volunteers must have a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential.
* Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
* Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.

Exclusion Criteria:

* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, or major physical impairment), as judged by the Investigator.
* Any clinically significant illness, medical/surgical procedure or trauma, in the opinion of the Investigator, within 4 weeks of the first administration of IP.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
* Significant orthostatic reaction at enrollment as judged by the Investigator.
* Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in geriatric and younger adult subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-35 years (both inclusive) (younger adult group) or below or equal to 65 years (geriatric group) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
* Body Mass Index (BMI) between 20 and 30 kg/m\^2
* Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted
Co-trimoxazole as Maintenance Therapy for Melioidosis

This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.

Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 15 years
2. Culture-confirmed melioidosis
3. Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
4. High likelihood of completing at least 6 months follow up
5. Willingness to participate in the study and written, informed consent obtained from the patient

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
3. Relapse melioidosis with at least 2 year symptom free period from last episode
Effect of Wheat Dextrin on Calcium and Magnesium Absorption

To compare calcium and magnesium absorption within subjects with and without chronic consumption of wheat dextrin.


Eligibility Criteria:
Inclusion Criteria:

- Subjects will be generally healthy Caucasian females aged 19 and older with no known abnormalities of gastrointestinal function, and taking no medications that might alter absorptive performance. BMI will be between 19 and 31 kg/m2

-
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \<100 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>/=18 years of age
* histologically confirmed metastatic melanoma (Stage IV, AJCC)
* patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
* BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
* measurable disease by RECIST criteria
* negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

* active CNS metastases on CT/MRI within 28 days prior to enrollment
* history of or known carcinomatous meningitis
* previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
* cardiac dysrhythmias \>2 NCI CTCAE or treatment with drugs with dysrhythmic potential
* uncontrolled hypertension(\>150/100mmHg) despite optimal medical therapy
* infectious disease including HIV, HBV and HCV
Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM

Diabetes affects almost 21 million people in the United States. In this study we will test a drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels after a meal. Lowering high sugar levels and fat levels after a meal is very important in the prevention of the problems that persons with type 2 diabetes often encounter. Hypothesis is that Pramlintide will lower blood sugar and fat levels after a meal.

A well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal. To date the mechanisms driving this increased post prandial glycemia are unclear. Pramlintide is believed to affect intermediary metabolism as well as nutrient absorption. The relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and TG concentrations remain uncertain, however. Combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions.

Aims:

1. To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein (VLDL)-triglycerides(TG) following a high fat breakfast, lunch and dinner in patients with type 2 diabetes mellitus (T2DM). A triple isotope approach will be used to determine rate of appearance of (VLDL)-triglycerides following breakfast, lunch and dinner.
2. To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production (glucagonstatic mechanism) in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM study participants will be C-Peptide positive (levels \> 0.3 nmol/L)
* Receiving insulin, metformin and/or sulfonylurea/glitinide.
* Maintained on stable anti-hypertensive medication.
* BMI \< 52 kg/m2.
* T2DM for at least 3 months with HBA1C under 10%.

Exclusion Criteria:

* Receiving TZDs, exenatide, sitagliptin or pramlintide therapy.
* Receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids.
* Triglyceride levels \> 400 mg/dl.
* BMI \> 52 kg/m2.
Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma

This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
* Age ≧16 years, ≦75 years
* ECOG (Eastern Cooperative Oncology Group) =0,1,2
* No previous history of malignancy
* Radiologically measurable disease
* Life expectancy\>6 months
* Informed consented

Exclusion Criteria:

* Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
* Lab at enrollment(unless caused by lymphoma)

  * Neutrophile\<1.5\*10\^9/L
  * Platelet\<75\*10\^9/L
  * Hemoglobulin\<90g/L
  * ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) \>2\*ULN,AKP(alkaline phosphatase) or bilirubin \>1.5\*ULN (upper limit of normal )
  * Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study

  * Not able to comply to the protocol for mental or other unknown reasons
* Pregnant or lactation
* HIV infection