cyrilzakka/clinical-trials huggingface dataset:
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
* Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
* Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to \[≤\] 28 days prior to randomization)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
* Participants whose tumors harbor an EGFR-activating mutation
* Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
* Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
* Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
* Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
* Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
* Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
* Any inflammatory changes of the surface of the eye
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Prostate Cancer

Men with a history of prostate cancer may be in this study. Subjects recommended for a prostatectomy or oligometastectomy will undergo PET/CT imaging using a novel radiotracer \[18F\]FTT to evaluate PARP-1 activity in known or suspected sites of primary or metastatic disease. Imaging will be compared with pathology results, including additional research assays when possible.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be ≥ 18 years of age
* Biopsy proven prostate cancer
* Must meet one of the following criteria:

  1. At least two tissue cores containing at least 50% tumor (per pathology report) OR
  2. At least one lesion that is 1 cm or greater in size by standard imaging (e.g. ultrasound, MRI, CT). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study.
* Recommended for clinically indicated radical prostatectomy or oligometastectomy
* Willing to allow use or collection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available)
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
* Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Women, children, fetuses, neonates, or prisoners are not included in this research study.
The Effect of Synbiotics on the Upper Respiratory Tract Infection

Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. However, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few. Therefore, this study aims to examine the effect of synbiotics on the incidence and severity of upper respiratory tract infection, gut microbiota composition and function, as well as biomarkers of immune function.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years；
* good general health as determined by medical questionnaires;
* BMI \<35 kg/m2;

Exclusion Criteria:

* known congenital or acquired immune defects；
* allergies and other chronic or acute diseases requiring treatment；
* subjects with chronic gastrointestinal diseases;
* alcohol or drug misuse or both；
* pregnancy or lactation；
* vaccination against influenza within the last 12 months；
* use of oral antibiotics, probiotics, prebiotics, synbiotics, drugs active on gastrointestinal motility, or a laxative of any class within the last month.
Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas

RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about the risk factors for developing blood clots may help doctors plan better treatment for gliomas.

PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients who are undergoing cancer treatment for newly diagnosed gliomas.

OBJECTIVES:

Primary

* Determine the overall hazard rate of first venous thromboembolism per person-year of follow-up in patients undergoing antineoplastic therapy for newly diagnosed high-grade gliomas.
* Correlate ABO blood type with incidence of venous thromboembolism in these patients.
* Correlate factor VIII level with incidence of venous thromboembolism in these patients.

Secondary

* Determine the overall and individual incidence rate of thromboembolism in these patients.
* Correlate clinical variables, such as type of antineoplastic treatments, Karnofsky performance status, and type of tumor, with incidence of venous thromboembolism in these patients.
* Correlate demographic factors, such as age, with incidence of venous thromboembolism in these patients.

OUTLINE: This is a pilot, multicenter study.

Patients undergo blood collection for blood typing (if not already obtained) and factor VIII and C-reactive protein levels at baseline. Patients are followed to obtain information on their Karnofsky performance status, treatment they receive for their brain tumor, and occurrence of any thrombotic events (e.g., pulmonary embolism or deep-vein thrombosis). Patients are followed every 28 days until the development of thrombotic events, after which they are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 107 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed malignant brain tumor

  * Supratentorial grade III or IV astrocytoma of 1 of the following types:

    * Anaplastic astrocytoma
    * Anaplastic oligodendroglioma
    * Glioblastoma multiforme
* No prior thrombotic event

PATIENT CHARACTERISTICS:

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior immunotherapy or biologic agents, including immunotoxins, immunoconjugates, antisense therapy, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphocyte-activated killer cells, or gene therapy, for the brain tumor

Chemotherapy

* No prior chemotherapy for the brain tumor except polifeprosan 20 with carmustine implant (Gliadel wafer)

Endocrine therapy

* No prior hormonal therapy for the brain tumor except glucocorticoids

Radiotherapy

* No prior radiotherapy for the brain tumor
* No prior cranial irradiation

Other

* No concurrent chronic anticoagulation therapy
The Effect of Mobilising Patients Using Nature Sounds on Anxiety, Pain and Stress Levels

The Effect of Mobilization Using Nature Sounds on Patients' Anxiety, Pain and Stress Levels


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are willing to participate in the study,
* Patients undergoing their first laparoscopic surgery due to gallbladder stones,
* Patients scheduled for elective surgical procedures,
* Patients with no hearing impairment,
* Patients with no vision impairment,
* Mentally stable individuals,
* Individuals who are open to communication and cooperation,
* Patients aged 18 years and older will be included in the study.

Exclusion Criteria:

* Individuals with mental health issues,
* Individuals who are unwilling to participate,
* Patients with hearing impairment,
* Patients undergoing their second surgery (recurrent) due to gallbladder stones,
* Patients using hearing aids,
* Individuals who are uncooperative or unwilling to communicate,
* Patients who require emergency surgery will not be included in the study.
BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes

The landmark study Diabetes Control and Complication Trial (DCCT) clearly showed that intensive insulin management delays the onset and progression of longterm complications in adolescents with type 1 diabetes mellitus (T1DM). The same clinic trial also showed increased rate of severe hypoglycemia which required assistance. The risks of severe hypoglycemia, defined as loss of consciousness or seizure associated with hypoglycemia, include lower HbA1C, younger age, higher insulin dose, male sex, lower parental socioeconomic status, non-Hispanic white ethnicity, longer duration of disease, the presence of psychiatric disorders, and underinsurance.

The purpose of this protocol is to explore the relationship between hypoglycemic seizures and BMI.

This is a retrospective study using questionnaire/survey/interview. We will give subjects a letter stating the purpose and describing the study. We will answer all questions they have about the study. Once the parents and patient verbally agree to participate in the study, we will proceed with the survey.

Eligibility Criteria:
Inclusion Criteria:

* T1DM
* 2-17 years old

Exclusion Criteria:

* T2DM
* Known seizure disorder
Assessment of Overall Functioning in Patients With Complex Health Issues

The overall aim of the study is to assess whether each outcome measures the same aspect of overall functioning or contributes with different aspects. More specifically, the aim of this study is to investigate the correlation between each single instrument.

During study period all patients presenting at our clinic will be offered to participate in the study. Patients will be included in the study when referred to the department of Social Medicine and providing written informed consent to participate in the study. Inclusion will continue until 100 patients have completed an AMPS test. All participants will, apart from standard procedure, be asked to complete:

* An AMPS-test
* ADL-Q (Questionnaire concerning Activities of Daily Living)
* ADL-I (Interview based questionnaire concerning Activites of Daily Living)

As standard procedure all participants will also perform/complete:

* 30 seconds chair stand test (30sCST)
* Hand grip strength (HGS)
* Evaluation of ambulation (Cumulated Ambulation Score /CAS)
* WORQ (Work Rehabilitation Questionnaire)

To obtain the aim of the study correlation-analysis will be performed to investigate the relationship between each included instruments.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred by a municipality to the Department of Social Medicine at Bispebjerg and Frederiksberg Hospital for a clinical assessment (Klinisk Funktion) who provide written consent to participate.

Exclusion Criteria:

* Insufficient ability to communicate either in written or oral Danish
Giving Immunizations Through Vaccine Education

This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.

* Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
* Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* All clinicians practicing at participating sites
* Parents with an eligible adolescent girl
* Adolescent girls
* Ages 11-17
* Has a visit at one of the primary care centers within the last 15 months.
* Has not completed the teen vaccine series

Exclusion Criteria:

* None
Cardiopulmonary and Metabolic Responses to Early Exercise in Patients After Coronary Arterial Bypass Grafting

Coronary arterial bypass graft surgery (CABG) is proven safe with improved survival and greater quality of life in patients with coronary arterial disease. Evidences on the cardiovascular and gas-exchanges responses during and right after early exercise-based rehabilitation of this patients are limited. Objective: The investigators aim to analyse breath-by-breath cardiopulmonary and metabolic responses during six-minute walk test (6MWT) and shuttle walk test (SWT) in patients with or without left ventricular dysfunction (LVD) after CABG. In addition, the investigators will investigate oxygen consumption and cardiopulmonary responses during the early exercise-based rehabilitation in the first days after surgery. Methods: According to the left ventricular ejection fraction (LVEF), subjects will be allocated into two groups: with LVD (LVEF \< 45%) and without LVD (LVEF \> 45%). Patients will be submitted to the 6MWT and SWT linked to portable spirometric-telemetric device before and 6 days after CABG. During the first days after surgery, patients will be evaluated about pulmonary function and respiratory strenght at rest and oxygen consumption during the portable cycle ergometer protocol. Clinical outcomes as time to hospital discharge, pulmonary complications and occurence of arrythmias will be assessed during inpatient time until hospital discharge. Incidence of mortality, hospital readmission and angina recurrence will be evaluated in a one-year follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age between 35 to 75 years old;
* Coronary arterial disease proved by coronary angiography
* Elective Coronary arterial bypass grafting

Exclusion Criteria:

* Pulmonary chronic disease
* Disabling neurological or orthopedic disease
* Morbidity obesity
* Urgency surgery
* Bilateral pleural opening
* Arrhythmias during exercise protocol
* Prolonged mechanical ventilation (\>12 hours)
* Inability to comprehend or perform the tests
Evaluation of Computerized Template Entry for Compensation and Pension (C&P) Examinations

The purpose of this study is to compare C\&P examination reports performed using a Compensation and Pension Examination Program (CPEP) computerized, templated documentation tool to a customary examination performed and then report dictated in quality, completeness, timeliness and veteran satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Subjects for the current study included veterans scheduled for C\&P examination of two or fewer joints at VA TVHS.
* No ethnic or racial group or gender was excluded.

Exclusion Criteria:

* Veterans were excluded if they were scheduled:

  1. for examination of more than two joints,
  2. with other requested exam protocols in addition to joints
Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages

In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. The government of Senegal has implemented a flour fortification program including iron and folate. Iron is a difficult mineral to add to foods efficiently due to its organoleptic properties and typical low bioavailability in man. The aim of this study is to determine iron absorption from fortified wheat flour consumed with a phenolic containing beverage in women and child pairs. The fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly investigated.

The bioavailability of the different iron compounds will be determined using stable iron isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women between 18-45y) will be selected for participation in the study. After a screening, each women and child will receive 4 test meals consisting of a bread roll fortified stable isotopes with and without the tisane beverage. The first two test meals will be consumed on consecutive days. Two weeks after the second test meal a blood sample will be taken from each women and child before the third meal administration. After the forth test meal administration, and again two weeks later, the last blood sampling will take place and the study will be conducted for the subjects (duration 30 days). The samples will be sent to Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as well as inflammation status (CRP) will be determined.

In this study each subject will act as his own control and receive all interventions. Iron absorption data from the different test meals will be therefore compared assessing within and subject effects (main outcomes). Secondary outcomes will also investigate between subject effects and co variates of iron absorption.

Eligibility Criteria:
Inclusion Criteria

* Mother and child are willing to participate in the study jointly

Specific inclusions criteria for mothers

* Body weight \< 65 kg
* 17 ≤ BMI ≤ 25 (kg/m2)
* Non anemic (Hb ≥ 11,0 g/dl)
* Generally healthy and no chronic illnesses
* Non pregnant
* Non lactating
* No blood donation in the last 4 months
* No consumption of vitamin and nutritional supplements during and 2 weeks prior the study start.

Inclusion criteria for children:

* Age 3-6 years
* Generally healthy and no chronic illnesses
* no consumption of vitamin and mineral supplements during and 2 weeks prior the study start
Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis

The purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic extra- and intracranial artery stenosis and to determine its role in secondary prevention of ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between above 40 year-old and 75 year-old.
2. Ischemic stroke related to extra- and intracranial atherosclerosis stenosis, transient ischemic attack (TIA ), onset time within 90 days
3. Implantation of stent should be at least 1 week after stroke onset, and patient's medical condition stable, no time limit for TIA,
4. Stenosed ICA or MCA or BA or VA is the candidate arteries for stent implantation.
5. Degree of stenosis of target artery ranges between 51%-99%
6. Modified Rankin score≤3 or NIHSS Score ≤4
7. Informed consent is obtained.

Exclusion Criteria:

Patients will be excluded from entry if any of the criteria listed below are met:

1. Target stenosis artery is not suitable for stent implantation after evaluation.
2. Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation.
3. Ischemic stroke is caused by conditions other than atherosclerosis .
4. Documented non-atherosclerosis angiopathy.
5. Clinically unstable at the time of enrollment,
6. Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
7. Severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
8. Severe co-morbid or unstable medical condition, ie，severe heart failure, pulmonary failure or renal failure, liver dysfunction (serum liver enzyme twice or more than normal level),malignancy with likelihood of death within the next 2 years
9. Significant memory or behavioral disorder, ie, Alzheimer disease, etc.daily care needed.
10. Concurrent participation in another clinical trial
11. Unable to return follow up
12. History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
13. Intracranial arteriovenous malformation or aneurysm.
Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer

A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed high risk prostate cancer with a risk of lymphatic spread \>15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
* Written informed consent
* \> 18 years
* Fiducial gold markers implanted in the prostate (min 3)

Exclusion Criteria:

* • Non MR-safe implants or other contraindication to MRI

  * WHO PS\>1
  * Previous pelvic irradiation
  * TURP within 6 months
  * IPSS \>19
  * Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
  * Creatinin clearance \< 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp