cyrilzakka/clinical-trials huggingface dataset:
The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy

To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.

The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female \> 18 years of age
2. Indicated for nasal endoscope for indeterminate NPC
3. Willing and able to comply with study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

1. Subjects for whom pCLE procedures are contraindicated
2. Known allergy to fluorescein dye
3. If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

Studies suggest that dietary omega-3 fatty acids influence the extent to which the time interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated with increased risk of sudden cardiac death (SCD). The purpose of this research is to investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid levels in patients who have recently commenced haemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 5 commencing haemodialysis,
* male or female,
* aged 40-80 y,
* written informed consent

Exclusion Criteria:

* history of chronic liver disease or neuropathy, infection or antibiotics within the last month.
MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)

This study evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation


Eligibility Criteria:
Inclusion Criteria:

* Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests
* Patient Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug
* Patient Has At Least 1 Year Of Mild-To-Moderate Asthma
* Patient Has Been A Nonsmoker For At Least 6 Months
* Patients Of Childbearing Potential Must Agree To Use A Medically Acceptable Method Of Contraception During The Study
* Patients Must Be Able To Swallow Tablets

Exclusion Criteria:

* Patient Has A History Of Clinically Significant Endocrine, Gastrointestinal, Cardiovascular, Hematological, Hepatic, Immunological, Renal, Respiratory, Other Than Asthma, Or Genitourinary Abnormalities Or Diseases
* Patient Has Required A Visit To A Hospital Or Emergency Room Due To An Asthma Exacerbation Within 3 Months Of The Prestudy Visit
* Patient Has Unresolved Signs And Symptoms Of An Upper Respiratory Tract Infection (Uri) Or Has Had Had An Upper Respiratory Tract Infection Within 3 Weeks Prior To The Prestudy Visit
* Patient Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder
* Patient Has A History Of Neoplastic Disease
* Use Of Theophylline, Anti-Allergic Compounds (Except For Nasal Drop And Eye-Drop Omalizumab, Zileuton, Oral Corticosteroid, And Oral Beta Agonists (Including Patch) Are Excluded \~ 2 Weeks Prior To Administration Of Study Drug And Throughout The Study 7)Patient Consumes Alcoholic Beverages
Aspirin-Myocardial Infarction Study (AMIS)

To determine whether the daily administration of 1 gm of aspirin to individuals with a documented myocardial infarction would result in a significant reduction in mortality over a three year period.

BACKGROUND:

It had been postulated that thrombosis plays a major role in the late stages of coronary artery occlusion. Platelet aggregation is a large component in the formation of arterial thrombi. Theoretically, an agent which prevents the aggregation of platelets would be of value in people with coronary artery disease. Aspirin, in small doses, inhibits platelet aggregation for prolonged periods of time, and therefore might be expected to prevent or retard the occlusion of coronary arteries. This would be reflected in a decrease in the incidence of myocardial infarction and a decrease in mortality due to coronary artery disease.

Several studies had given preliminary evidence that regular administration of aspirin may be of benefit to patients with known coronary artery disease. A National Heart and Lung Institute-sponsored study, the Coronary Drug Project, ran a pilot trial of aspirin and placebo in men with previous myocardial infarctions. Preliminary results from this trial demonstrated its feasibility and led NHLBI to sponsor a more definitive controlled study of the benefit of aspirin in the secondary prevention of coronary heart disease.

An Institute Planning Committee met four times between October 1974 and April 1975 and developed a protocol, manual of operations, and data collection forms. Recruitment of patients began in June 1975, with the first patient randomized on July 2, 1975. Patients who were randomized had been seen at the AMIS Clinical Center for two initial visits and one baseline visit and were free of any reasons for exclusion, such as the current use of anticoagulants and a history of adverse reactions to aspirin. Patients took acetaminophen at times when they would normally take aspirin.

Follow-up was for a minimum of 3 years, with each patient seen at 4-month intervals and monitored for side effects and various nonfatal events, including cardiovascular problems. The primary endpoint was mortality. Annually, a detailed history was obtained and a complete physical examination performed. The study involved 30 clinical centers, a coordinating center, and a central laboratory.

The study completed patient recruitment in the scheduled one year period. A total of 4,524 post-MI patients were enrolled by the 30 clinical centers. Three-year minimum patient follow-up ended in August 1979.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Eligible patients were assigned to a treatment group receiving 1 gm of aspirin daily (the equivalent of three standard aspirin tablets) or to a control group receiving a placebo.

Eligibility Criteria:
Men and women, ages 30 to 69. Had a documented myocardial infarction.
PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)

This study is aimed at investigating the effect of PPIs on gastroesophageal varices in liver cirrhosis. Half of participants will receive PPI, while the other half will receive a placebo.

PPIs can inhibit parietal cell H+/K+-ATPase and reduce secretion of gastric acid. PPIs can promote platelet aggregation and stabilize the formation of fibrin thrombosis by maintaining the high pH environment in the stomach and inactivating pepsin. The effect of PPIs on ulcerative upper gastrointestinal bleeding was confirmed but it is not clear whether PPIs is applicable in esophagogastric variceal bleeding whose etiology and bleeding position are different from ulcerative upper gastrointestinal bleeding. There is lack of consensus and sufficient evidences to support to use PPIs in esophagogastric variceal bleeding in cirrhotic patients universally. Nevertheless, the use of PPIs in liver cirrhotic patients with gastroesophageal varices is common.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cirrhosis
* GEVs was diagnosed by endoscopy

Exclusion Criteria:

* Acute gastrointestinal bleeding need emergency surgery
* Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases (GERD)
* Hepatocellular carcinoma (HCC) or other malignant tumor
* History of esophagus, stomach or liver surgery
* Child-Pugh C and can't be improved to Child-Pugh A or B
* Preparing to be pregnant, pregnant or breast feeding
* Allergic to PPIs(proton pump inhibitors) or intolerable
* Cannot provide informed consent
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers

To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. Age of 18 to 50 years
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented histologically confirmed primary grade 4 advanced malignant glioma.
* No more than 3 prior relapses or prior systemic treatments.
* Recurrent disease documented by MRI after prior therapy.
* Must have at least one site of bidimensionally measurable disease:

archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment.

* Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.
* Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.
* At least 18 years old.
* Both men and women must practice adequate contraception.
* Informed consent.

Exclusion Criteria:

* Progressed while on temozolomide.
* Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1.
* Not recovered from the toxic effects of prior therapy.
* Pregnant or breast feeding.
* History of diabetes mellitus.
* Uncontrolled intercurrent illness.
* Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
* HIV positive.
* Diagnosis of another malignancy may exclude subject from study.
Ai Youmian (Love Better Sleep) for People Living With HIV

People living with HIV (PLWH) frequently report sleep disturbances. The social rhythm theory, which proposes that stressful life events can interfere with sleep by disrupting the stability of daily routines, provides new insights into identifying predictors of sleep disturbances and improving sleep in PLWH. This study is a randomized controlled trial. PLWH with poor self-reported sleep quality (Pittsburgh sleep quality index\>7) was randomly divided into a control group or an intervention group. The control group receives the usual care, that is, daily disease management and routine drug guidance (set as waitlist). The intervention group received a sleep promotion intervention program based on social rhythm theory, along with daily disease management and routine drug guidance. The intervention period was 8 weeks, once a week, and the duration of each intervention was about 40-60 minutes. The sleep-related outcome indicators were measured before the intervention (T0), immediately after the intervention (T1), and 3 months after the intervention (T2), and the participants' social rhythm, daytime sleepiness, sleep belief and attitude, depression, etc. were evaluated to verify the effects of the intervention. At the same time, participants who insisted on completing all intervention modules were selected from the intervention group after the end of the whole study. Self-designed satisfaction questionnaires and semi-structured interviews were used to understand the participants' experience and feedback on the intervention program. In addition, the investigator asked the reasons for the withdrawal of participants who withdrew from the study through an interview during the outcome period.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection,
2. Aged 18 years or above,
3. Total score of Pittsburgh sleep quality index \> 7,
4. Possess basic literacy,
5. Voluntary participation in the study.

Exclusion Criteria:

1. Self reported previous diagnoses of severe sleep disorder disorders such as obstructive sleep apnea, restless legs syndrome, periodic limb movement of sleep, nocturnal urinary frequency or diurnal phase shift disorder,
2. Initiation of antiretroviral therapy within the past 30 days or change in antiretroviral therapy regimen within the past 30 days,
3. Current treatment with psychotropic medication, or use of any medication with sedative or excitatory effects,
4. Working in jobs that require night shifts that may affect the circadian rhythm and no consideration of changing jobs in the recent month,
5. Currently participating in other research projects.
Evaluation of the Change in the DA Ratio, IR and SSI as Parameters of Corneal Biomechanics Post Different LVC Procedures

In the study, The Investigators will compare the participates' corneal biomechanical properties including:

Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI)

All measurements will be taken before and after 3 months of LVC.

Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3 months post operative.

The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto LASIK.

Collected data will before and after surgery will be compared in each arm and then the 3 arms will be compared together.

Eligibility Criteria:
Inclusion Criteria:

* • Age range 18 - 40 years.

  * Normal eyes with normal tomographic indices.
  * Patients with maximum mean refractive spherical equivalent (MRSE) of -7.00 diopters and with maximum astigmatism of -3.00 diopters.

Exclusion Criteria:

* • Patients with any other coexisting corneal diseases.

  * Keratoconus eyes.
  * Eyes with previous refractive corneal surgery.
  * Patients with increased intraocular pressure.
A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts \<= 200 cells/mm3 or \<= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides.

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication: Strongly recommended:

* Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count \< 100 cells/mm3 and are toxoplasmosis seropositive.

Patients must have:

* Working diagnosis of HIV infection.
* CD4 count \<= 200 cells/mm3 or \<= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
* History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.

NOTE:

* Pregnant patients are eligible at the clinician's discretion.

Prior Medication:

Allowed:

* Prior PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active pneumocystosis.

Concurrent Medication:

Excluded:

* PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.

Patients with the following prior conditions are excluded:

* Known treatment-limiting reaction to dapsone or atovaquone.
Measurement of Cancer-Related Risk Perception in Smokers

The purpose of this study is to develop an accurate way of measuring people's thoughts about cancer risk. The researchers at the Queens Hospital Center, Memorial Sloan-Kettering Cancer Center and Adelphi University are working together to design a new measure. Findings from this study will help us find new ways to help people avoid cancer.

The goal of the study is to develop and provide initial evidence for the reliability and validity of a measure of cancer-related risk perception. As such, the primary outcomes of the study will be initial construct validity (convergent validity and discriminant validity) of the proposed scale as evidenced by correlations of this test with other tests that vary in the degree of association to the proposed construct of cancer-related risk perception. It is anticipated that the cancer-related risk perception scale will correlate most highly (.50-.60) with measures of tobacco and environmental risk exposures, readiness to quit smoking, and family cancer history.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be \>= to 18 years of age
* For recruitment at Adelphi University: Speak English
* For recruitment at Queens Hospital Center: Speak English
* For recruitment at Queens Hospital Center: Must be a Queens Hospital Center Patient

Exclusion Criteria:

* Patients who have a history of colorectal cancer at the Queens Hospital Center
* Patients who cannot give informed consent
Educational Intervention to Improve Vaccine Acceptance

This research project will develop an educational intervention to improve immunization acceptance by vaccine hesitant parents. This is prospective interventional case-control trial, where the investigators will provide the intervention in the clinical setting. Enrollees will be screened and selected if they meet criteria for "vaccine hesitancy". The investigators will conduct follow up surveys following the intervention to assess change in attitude and follow immunization rates through 18 month well visit.

The intervention is a 8 minute video addressing common concerns that have been reported by vaccine hesitant parents. The video includes an expert in pediatric infectious diseases answering these common questions as well as 3 parental accounts of children who contracted vaccine preventable diseases. Also, the interventional group will be provided with two handouts: one listed information on how parents can find accurate vaccine information on the internet, and another that addresses more common concerns of vaccine hesitant parents and available for our use from the Children's Hospital of Philadelphia Vaccine Center website.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old for parent
* \< 30 days old for infant
* full term (\>37 weeks gestational age) infant

Exclusion Criteria:

* none
Hypotensive Effect of Anaesthesia With TCI

Hypotension will often complicate induction of anaesthesia. The investigators want to test the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion, leads to less degree of hypotension.

Severe hypotension may be a serious complication to induction of anaesthesia. The patients preoperative clinical circulatory status will help define the risks of such a side-effect. A patient with a preexisting heart condition will be at increased risk for morbidity/mortality in relation to anaesthesia induction.

Total intravenous anaesthesia may be delivered by two different approaches. The old way where the drug (Propofol and/or Remifentanil) is delivered in a velocity (mg/kg x hour or microg/ kg x min) specified by the anaesthetist. Hereafter called Velocity Controlled Infusion (VCI). At induction, to get effect of the drug, a high infusion rate is desired. A high infusion rate is associated with increased risks of hypotension if it is not adjusted in accordance with the current circulatory status of the patient. A failure to adjust may be futile for the patient. Therefore, induction takes some time because infusion rate is set within a relatively safe range. After a few minutes, once airway control is achieved, the infusion rate must be adjusted down to avoid hypotension.

There is a more modern way of adjusting the infusion rate, the so called Target Controlled Infusion. With this approach, the pump delivering the drug will help the anaesthetist to select the appropriate infusion rate for any given situation. The anaesthetist selects a preferred concentration of the drug at the target, that is in the circulation. The pump then administrates the drug, first at high rate and then at lower rate, taking into account the patients age, weight and sex and the preferred target concentration.

It is possible that this help from the machine is associated with less risk for hypotension at anaesthesia induction. If this is so it would have an impact on which of TCI and VCI that would be the best choice of anaesthesia. This would have special impact when giving anaesthesia to patients with a heart condition.

Eligibility Criteria:
Inclusion Criteria:

\* All patients scheduled for anaesthesia at Östersunds Hospital

* ASA class I-II

Exclusion Criteria:

* On beforehand decision to start continous delivery of blood pressure increasing drug at induction.
* Any contraindication to Total Intravenous Anaesthesia