cyrilzakka/clinical-trials huggingface dataset:
Pemetrexed in Advanced Non-small Cell Lung Cancer

Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution
* Patients treated with single agent pemetrexed for metastatic disease
* Availability of full clinical data

Exclusion Criteria:

* Cytological diagnosis of advanced Non-small cell lung cancer
* Lack of tumor tissue at our institution
* Lack of full clinical data
Hydralazine Valproate for Cervical Cancer

The current standard for recurrent, persistent or metastatic cervical cancer is palliative chemotherapy with cisplatin topotecan, however, the results need to be improved. Epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity of chemotherapy.

Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate plus standard cisplatin topotecan against placebo plus cisplatin topotecan upon progression-free survival.

Hypothesis. Hydralazine and magnesium valproate associated to cisplatin topotecan will increase progression-free survival from 4.6 to 7.6 months as compared with the same regimen of chemotherapy plus placebo.

Randomized, double-blind phase III trial. A total of 143 patients (alpha 0.5, power 0.8)with metastatic, persistent or recurrent cervical cancer without previous systemic treatment will be randomized to cisplatin topotecan + placebo or cisplatin topotecan hydralazine valproate for 6 courses every 3 weeks. Patients will receive an oral dose of hydralazine of 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d. Both drugs in a slow-release formulation. Experimental drugs or placebo will start from seven days before day 1 of chemotherapy until the end of the sixth course.

Eligibility Criteria:
Inclusion Criteria:

* informed consent, histological diagnosis of persistent, recurrent or metastatic cervical carcinoma; measurable disease by physical examination, CT Scan, MRI or PET-CT. Biopsy is required for confirmation only if the lesion is unique, has less than 2cm in the longest diameter or has no clearly defined borders.
* Patients should have no previous systemic treatment (could have received chemotherapy as radiosensitization to the pelvis and or para-aortic field.
* Aged \>18 years, performance status 0-2 according to ECOG classification, and adequate liver, hematological and renal function, as defined by: hemoglobin \>10 g/L, leukocytes \>4000/mm3, platelets \>100 000mm3; normal creatinine value and creatinine clearance \>60 mL/min; total bilirubin \< 1.5 upper normal limit value.

Exclusion Criteria:

* History of allergy to hydralazine or valproate; past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; newly diagnosed hypertension patients with or without pharmacological treatment are allowed as long as their treatment do not include hydralazine.
* Previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. Other exclusion criteria are uncontrolled systemic disease or infection.
Effect of Type 2 Diabetes Genetic Risk Information on Health Behaviors and Outcomes

The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized risk assessment alone, and to measure whether changes in perceived risk following genetic testing for Type 2 diabetes risk are correlated with behavior change and increased concern about risk for Type 2 diabetes.

One thousand outpatients will be enrolled over two years at two university-affiliated primary care clinics. Patients will be assigned to one of three study arms: those who want genetic testing for diabetes risk will be randomly assigned to either receive the testing in addition to the SRA (SRA+G) or to receive the SRA only (SRA-only). Those who do not wish to have genetic testing will receive the SRA only. All patients will be surveyed at baseline, immediately after going through the SRA (risk-counseling visit; 2-4 weeks after initial visit), at 3 months post risk counseling visit and at 12 months post risk counseling visit. BMI, waist circumference, fasting plasma glucose and insulin will be measured at baseline and 12 months. Surveys will allow us to track patients' emotional responses to diabetes risk information and changing perceptions of personal risk for Type 2 diabetes over time, and to see if these correlate with subsequent diet and exercise behaviors.

We will use a linear model to assess the effects of genetic testing among the three study groups, using HOmeostasis Model Assessment of Insulin Resistance (HOMA-IR) and weight loss as the primary outcomes. We will use generalized linear ordinal regression models to fit the ordinal survey outcomes of risk perceptions to the continuous HOMA-IR and weight outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Are male or female outpatients
* No self-reported history of diabetes
* No self-reported history of prior genetic testing for diabetes
* Not pregnant (self report)
* Are ≥18 and \<81 years of age
* Scheduled to receive serum glucose test in participating clinic
* Fasting at time of blood draw (no food or drink - except water - previous 8 hours: self report)
* Able and willing to give legally effective consent
* Able and willing to participate in patient questionnaires
* Ambulatory

Exclusion Criteria:

* Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening
* Self-report of current or prior diabetes diagnosis
* Self-reported prior history of genetic testing for diabetes
* Baseline serum glucose test result \>125
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

To identify the proportion of patients remaining medically castrated (testosterone level \< 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.


Eligibility Criteria:
Inclusion Criteria:

* Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient
* Patient must be 18 years old or over
* Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy
* Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment

Exclusion Criteria:

* Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy)
* Patient who underwent a previous surgical castration
* Prostate cancer therapy within 2 months of baseline visit
* Patient with testosterone level below 150 ng/dL at screening
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes

Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.


Eligibility Criteria:
Inclusion Criteria

* Age 18-65
* fasting C-peptide \<0.3 ng/ml.
* HbA1c \<10%
* history of onset of type 1 DM at or before 20 years of age.
* Otherwise healthy
A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants

The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2), inclusive.
* Total body weight between 60.0 and 90.0 kg, inclusive.
* Systolic blood pressure \<135 millimeters of mercury (mmHg) or \>85 mmHg at Screening, after being supine for at least 5 minutes.
* No clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, no cardiac pacemaker.

Key Exclusion Criteria:

* History or positive test result at Screening for human immunodeficiency virus (HIV).
* History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody.
* Current hepatitis B infection (defined as positive for hepatitis B surface antigen \[HBsAg\] and total hepatitis B core antibody \[anti-HBc\]).
* Serious infection (as determined by the Investigator) within the 6 months prior to Screening.
* History of systemic hypersensitivity reaction to the active drug substance, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
* History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders.
* History of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma, urticaria, eczematous dermatitis, allergic rhinitis), hypersensitivity, or allergic reactions.
* History of angioedema.
* A positive diagnostic tuberculosis test result within 35 days prior to Day -1, defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results.
* Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products (e.g., siltuximab, sarilumab etc.).
* Administration of immunoglobulins for anti-tetanus and anti-rabies post-exposure prophylaxis within 3 weeks prior to administration of study drug.
* Any live or attenuated immunization or vaccination given within 30 days prior to Day -1 or planned to be given during the study period.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Dialysis Catheter Comparative Clinical Trial

The purpose of this clinical trial is to compare the longevity of two dialysis catheters.

This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older.
* Subject must meet labeled indication for hemodialysis.
* Subject must have End Stage Renal Disease (ESRD).
* Subject must have a patent right or left internal jugular vein.
* Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
* Subject must give written informed consent.

Exclusion Criteria:

* Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
* Subjects with active infection at the time of study enrollment.
* Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
* Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
* Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
* Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
* Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
* Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.
Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy

The aim of this study was to compare the Antibacterial Efficacy of Diode Laser 810nm and Photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.

Conventional techniques of root canal treatments such as mechanical instrumentation and chemical debridement with antimicrobial irrigants, such as Sodium hypochlorite (NaOCl) and chlorhexidine and use of calcium hydroxide do not always suffice to predictably render root canals free of bacteria Using the high-power diode laser is a new approach of disinfection allowing access to the previously unavailable areas, such as the tubular network. This study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.

Eligibility Criteria:
Inclusion Criteria:

- endodontic retreatment of teeth with periradicular lesion.

Exclusion Criteria:

-
ctDNA Assay in Patients With Resectable Pancreatic Cancer

The purpose of this study is to determine the proportion of positive ctDNA -freely circulating tumor DNA fragments found in the blood plasma- in patients with pancreatic cancer and to better understand the relationship between possible ctDNA biomarkers and patient survival. A successful study may provide preliminary evidence that helps improve future patient care through targeted diagnostics, prognosis, and/or treatment.

The objective of this study is to assess the role of serial ctDNA analysis as integrative biomarker in patients with resectable or borderline resectable pancreatic cancer undergoing treatment with curative intent. This is a single arm prospective tissue/blood collection from patients undergoing neoadjuvant treatment and Surgery as well as surveillance, plan to accrue up to 50 patients. Primary objective is to determine the proportion of ctDNA positive in patients with resectable pancreatic cancer and to evaluate the progression free survival (PFS) in subjects with ctDNA positive versus ctDNA negative.

Patients who consent to the study will participate in pre-study exams and tests to find out if they can take part in the study. This includes, but is not limited to, a doctor's visit with medical history and physical evaluation, blood work, pregnancy test for those capable of becoming pregnant, and imaging tests.

The study itself will include the patient's regular treatment for pancreatic cancer which may include 4 to 6 months of chemotherapy, chemo-radiation, surgery to remove pancreatic cancer, 24 weeks of post operative ctDNA surveillance and follow up for 2 years. Blood will be drawn at regular time points during this study for ctDNA detection. The tumor tissue at diagnosis will be collected to develop a personalized and tumor informed PCR test.

Eligibility Criteria:
Inclusion Criteria

1. Newly diagnosed exocrine pancreatic cancer with either pathology or radiology imaging suggestive of adenocarcinoma
2. Resectable/Borderline Resectable Pancreatic cancer as defined by the NCCN guidelines
3. ≥ 18 years old at the time of informed consent
4. ECOG Performance Status 0 or 1
5. Patients who are candidates for neoadjuvant chemo/chemoradiotherapy or upfront surgery are eligible for the study.
6. Ability to provide written informed consent and HIPAA authorization
7. Patients must have a life expectancy of at least 6 months

Exclusion Criteria

1. Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies
2. Positive pregnancy test, pregnant, or breastfeeding
3. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
4. Locally advanced or metastatic disease
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)

Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F\&P Toffee nasal pillows mask for use in-home.

The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult (22+ years of age)
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing nasal pillows mask user

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.
Clinical Significance of Occult Central Nervous System Localization

In acute lymphoblastic leukemia (ALL), the occult central nervous system (CNS) involvement appears to be associated with poor prognosis. Flow cytometry (FCM) allows detection of occult CNS localization. The current international guidelines do not recommend the use of FCM in the assessment of CNS at onset in adult ALL patients. Large-scale prospective studies will help to clarify whether or not patients with occult CNS localization should undergo CNS-directed therapy. Understanding this seems particularly important nowadays considering that with the introduction of new drugs (monoclonal antibodies, next-generation tyrosine kinase inhibitors, CAR-T) the therapeutic approach of patients with ALS is increasingly "chemo-free"

The investigators propose a multicenter prospective study to evaluate the incidence of occult CNS localization and the impact of such localization on clinical outcome.Adult ALL patients routinely undergo diagnostic lumbar puncture (PL); cerebrospinal fluids (CSF )samples will be studied by investigation of conventional cytology (CC) and FCM at the time of the first and subsequent diagnostic PLs.

Eligibility Criteria:
Inclusion criteria.

* Patients aged more than18 years with diagnosis of ALL at onset undergoing diagnostic-therapeutic PL.
* Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

Exclusion criteria.

* Patients \<18 years of age
* Diagnosis other than ALL
* Inability to perform PL
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

The study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein.

Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.


Eligibility Criteria:
Inclusion Criteria:

* All patients going for laparoscopic cholecystectomy

Exclusion Criteria:

* Age below 18,
* Use of NSAID, morphine, steroids
* Disability
* Previous surgery in the past month
* Pregnancy
The Characteristics of Blood Glucose Profile and the Changes of Hormones in PPDM-C Population

The purpose of this study was to explore the characteristics of blood glucose spectrum, changes of endocrine/exocrine pancreatic function and the correlation between them in patients with PPDM-C.

The benefits of this study to participants include:

1. It will help to make early diagnosis or risk screening for the potential related risks and concomitant diseases of the disease;
2. Provide necessary suggestions for the treatment and intervention of the disease, or provide useful information for the related research of the disease.
3. We will provide Abbott version h dynamic glucose meter and assessment of internal and external secretion function. The researcher will provide professional endocrine related lifestyle and drug guidance for the subjects according to their CGMS data.

The risks that this study may bring to participants are:

There may be some very small risks in specimen collection, including transient pain, local cyanosis, etc. a few people will have mild dizziness or extremely rare needle infection.

Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese subjects;

  * Was ≥ 18 years old when signing the informed consent;

    * Patients with complete diagnosis of chronic pancreatitis; ④ Those who voluntarily signed informed consent; ⑤ Those who complete serum samples in multiple centers and put them into storage.

Exclusion Criteria:

* Patients with impaired glucose tolerance but undiagnosed diabetes;

  * Patients with T1DM related autoimmune markers or other types of DM;

    * Patients with autoimmune pancreatitis, recurrent acute pancreatitis or acute onset of chronic pancreatitis;

      * Patients who underwent pancreatic surgery or related invasive procedures during treatment;

        * Previous or current malignant tumor; ⑥ Pregnancy or lactation; ⑦ Suffering from severe heart, liver or kidney dysfunction or malignant disease; ⑧ Failure to sign informed consent for cognitive impairment or other reasons.