cyrilzakka/clinical-trials huggingface dataset:
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer

Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer.

II. Determine the toxicity of this regimen in these patients. III. Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy

  * Limited stage or extensive stage SCLC
* Measurable disease

  * At least 20 mm by conventional techniques OR
  * At least 10 mm with spiral CT scan
* No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease
* No symptomatic or uncontrolled brain or leptomeningeal disease

  * Previously treated brain metastases allowed if neurologically stable

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-2

Hematopoietic:

* WBC at least 2,500/mm\^3
* Platelet count at least 70,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No symptomatic heart disease
* No myocardial infarction within the past 6 months

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study
* No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders)
* No other serious concurrent illness
* No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

Chemotherapy:

* At least 3 weeks since prior chemotherapy
* No more than 2 prior chemotherapy regimens

Endocrine therapy:

* Concurrent steroids allowed at stable dose

Radiotherapy:

* No prior radiotherapy to study lesions

Other:

* At least 3 weeks since prior systemic retinoid or carotenoid therapy
* No concurrent anticonvulsants
Assessing Choice in the Employer Setting (ACES) Study

The purpose of this study is to determine, among adults and in the total population, the effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the employer setting when compared to a control group.

The primary objective is to determine, among adults in the 18-49 year old population and in the total population, the effects of offering a choice of FluMist or TIV with and without enhanced advertisement/added incentive on the overall influenza vaccination rates in the employer setting when compared to a control group.

Eligibility Criteria:
Inclusion Criteria for employer sites:

* Located in the United States
* Has not previously offered FluMist in an employee vaccination program in the past or FluMist represented less than 5% of all vaccine received at past programs
* Data are available that will allow for a reliable estimate of the employee (total and 18-49 year old populations) vaccination rate for the 2007-2008 influenza season
Healthy Youth Places: A Program to Promote Nutrition and Physical Activity in Adolescents

To reduce the risk for chronic disease, adolescents should eat at least five servings of fruit and vegetables and be physically active daily. This study will implement and evaluate a school-based program to encourage adolescents to achieve and maintain a healthy diet and exercise regimen.

The Healthy Youth Places project will test if an intervention strategy that implements school environmental change, with both adult leader and youth participation, will influence and maintain adolescent fruit and vegetable consumption and physical activity.

The study will assess the effects of school environment and curriculum interventions promoting fruit and vegetable (F\&V) consumption, physical activity (PA), and their environmental determinants. The project will involve goal-setting and efficacy-building interventions designed to develop the skills and group efficacy of both adult school personnel and students. The adult-based interventions are designed to change the school environments through a school coalition assisted by a local coordinator. The youth interventions involve the participation of students in the processes of building the local health behavior environments and target both school lunch and after-school activity environments.

The project encourages adult and youth participation in the process of planning and implementing environmental change in targeted adolescent physical and social environments (school lunch place, after-school program place). Environmental change is defined as implemented practices, programs, and policies that promote critical elements (connection, autonomy, skill-building, healthy fruit and vegetable and physical activity norms). These critical elements are social environmental processes of behavior change.

Sixteen schools will be randomly assigned to either the experimental or the control (no treatment) condition. The health behavior of adolescents will be assessed during the sixth, seventh, eighth, and ninth grades. Measurement of F\&V and PA behaviors are the primary outcomes and will be assessed by self-report and verified by objective measures of school lunch purchases and physical activity monitoring. The impact of the program on personal, environmental, and behavioral determinants of F\&V and PA will also be measured.

Eligibility Criteria:
Inclusion Criteria

* Student attending sixth through eighth grades
* Participating middle school
Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement

The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.

The present study will prospectively recruit 100 patients scheduled for elective total hip replacement with Corin's TriFIT Hip System at the Ottawa Hospital - General Campus. As part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. Using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. Femoral stem migration will be assessed using computer-assisted software. The study will also assess the rate of implant failure during the first two post-operative years. Clinical assessments and questionnaires will also be completed during each of the follow-up intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery.
* Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis.
* Patients who do not meet any of the exclusion criteria.

Exclusion Criteria:

* Patients with previous fusions, acute femoral neck fractures, above knee amputations, or previous total knee replacement.
* Patients who had previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device.
* Patients with neuropathic joints.
* Patients who required structural bone grafts.
* Patients with an ipsilateral girdlestone.
* Patients who otherwise met the study criteria, but for which appropriate clinical follow-up data is not available (i.e. patients deceased prior to 2-year follow-up, patients refused to return for follow-up).
A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.


Eligibility Criteria:
Inclusion Criteria: - Age \>= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 \>=30% and \<80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF \>450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.
A Multicenter Breast Cancer Biospecimen Registry

This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.


Eligibility Criteria:
Inclusion Criteria:

1. Females of all racial and ethnic groups who are 40 years or older.
2. Women must:

   1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
   2. be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.

Exclusion Criteria:

1. Inability to sign informed consent.
2. More than one radiological finding.
3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
4. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
5. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
6. Received any experimental therapeutic treatment during the previous 3 months.
7. Received any blood product transfusion within the previous 3 months.
8. Use of illegal drugs during the previous 3 months.
9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.
The Role of Mid-Life Adiposity in Functional Brain Connectivity

The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease.

Participants will have one visit for:

* Blood draw
* Body composition scan
* Cognitive screen
* Neurological exam
* MRI scan

The visit will take approximately 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* 45-65 years of age
* Normal memory
* Right-handed
* General good physical health

Exclusion Criteria:

* History of stroke or neurological disease
* Seizures or head injury with loss of consciousness within the last five years
* Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
* Claustrophobia

More detailed inclusion/exclusion criteria must be met in order to qualify for the study. The study coordinator will determine eligibility.
A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models.

Phase I study, Fimasartan (BR-A-657-K) 20 mg \~ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

34 male healthy volunteers were enrolled during 2 months.

In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.

In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.

Eligibility Criteria:
Inclusion Criteria:

* age: 20 - 45 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and hydrochlorothiazide
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism
* history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study
Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

The purpose of this study is to evaluate safety issues pertaining to dihydrexidine (DHX), to cocaine, and to its interaction, and to determine how pretreatment with DHX modifies the subjective as well as physiological effects of cocaine infusion.


Eligibility Criteria:
Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.

Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant nulliparous or multiparous woman in labour
* Age ≥18 years
* Obtained consent for epidural analgesia
* ASA classification I-II-III
* Early labour (cervical dilation ≤6cm)

Exclusion Criteria:

* Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
* Prematurity (\<36 weeks of gestation)
* Multiple gestation
* Fentanyl allergy or hypersensitivity
* Patient unable to understand the PCEA
* Fetal breech position
* Maternal cardiac pathology and contraindication to Valsalva manoeuvre
* Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus
* Intrathecal catheter or intravascular catheter
* Accidental dural puncture
* Patient refusal
* Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia

The purpose of the study is to assess the effects of regular Viniyoga in patients suffering from primary insomnia.

Insomnia is very prevalent in Europe (14-27%). Cognitive behavioral therapy is the treatment of choice in patients suffering from primary insomnia, allowing to obtain a long term (2 years) sleep quality improvements in 62% of patients. Yoga is another behavioral therapy that have shown benefits in patients suffering from anxiety disorders. Few studies have been focused on yoga benefits in sleep disorders. The purpose of the study is to assess the effects of regular Viniyoga on sleep quality (subjective and objective) in patients suffering from primary insomnia.

Eligibility Criteria:
Inclusion Criteria:

-primary insomnia

Exclusion Criteria:

* shift work,
* associated sleep disorder (sleep apnea, narcolepsy,..)
Project Impact: A Culturally-Tailored Adherence Intervention for Latino Smokers

The goal of this research study is to collect information from Latino and Hispanic smokers and recent quitters about factors that are important to them when they are trying to quit. Researchers want to better understand some of the challenges and problems that Latinos and Hispanics face when they try to quit smoking, and then use that information to design a treatment for future smokers.

If participant decides to take part in this study, they will complete a questionnaire about themselves (such as their age, preferred language, and education level) and their smoking habits. This questionnaire should take about 10-15 minutes to complete.

After participant completes this questionnaire, they will be interviewed by a researcher. During this interview participant will be asked to discuss a variety of topics related to smoking and quitting, such as their experience with attempts to quit smoking and problems they may have had. This interview will last about 1 hour.

The interview will be audio-recorded. Participant's interview answers will later be transcribed (written down) without their name or any other identifying information.

Study participation will be complete after the interview.

This is an investigational study.

Up to 48 people will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age
2. Current smoker (\>10 cigarettes per day for the past 3 months) or recently quit Smoking (within the past year) but has not smoked for the past 2 months)
3. Read, understand and speak Spanish
4. Identify as being of Latino (or Hispanic) heritage, ethnicity, or ancestry.

Exclusion Criteria:

1. The self-report of a diagnosis of Schizophrenia, Delusional Disorder, Schizoaffective Disorder or Bipolar Disorder in the past year.
2. The self-report of a diagnosis of a Substance Dependence Disorder other than Nicotine in the past year (i.e., Alcohol Dependence, Amphetamine Dependence, Cannabis Dependence, Cocaine Dependence, Hallucinogen Dependence, Inhalant Dependence, Opioid Dependence, Phencyclidine Dependence, Sedatives, Hypnotics, or Anxiolytic Dependence, or Polysubstance Dependence)
3. Unavailable for a 1.5 hour visit to MD Anderson Cancer Center.
Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis

Objective: The objective of this study is to evaluate a steroid-embedded Terpolymers polymer implant of L-lactide and trimethynele carbonate (TCM) at the level of disease control in patients with eosinophilic and central compartment chronic rhinosinusitis (CRS) after placement of the endonasal device, compared to a control group (placebo). The secondary objectives of this study are to assess comfort, perception of improvement and satisfaction, as well as adverse events.

Methods: A randomized controlled trial will be carried out, with a blinded participant, therapist and evaluator. Patients over 18 years of age, with chronic rhinosinusitis (CRS) who have already undergone endoscopic sinus surgery (CENS), but who do not have the disease under control and, therefore, with an indication for a new CENS, will be selected. Participants will come from the otorhinolaryngology outpatient clinic of the academic and public service of the University of São Paulo - USP. Eligible patients will receive either the Terpolymers L-lactide and trimethynele carbonate (TCM) polymer implant placement or the placebo polymer. The primary outcome will be the control of the symptoms of chronic uncontrolled rhinosinusitis that will be evaluated through the NOSE Questionnaire, a nasal endoscopic evaluation based on the Lund-Kennedy criteria and the SNOT-22 Questionnaire. The sample size calculation was performed based on a difference between the intervention and placebo groups of 30% for cases that achieved disease control, resulting in a sample of 36 participants (18 in each group). Data will be analyzed using mixed linear models.


Eligibility Criteria:
Inclusion Criteria:

- Patients with chronic rhinosinusitis undergoing endoscopic sinus surgery, but who do not have the disease under control. The uncontrolled disease and its respective classification regarding the degree of the disease will be carried out through 3 assessments: 1) Nose Obstruction Symptom Evaluation Questionnaire (NOSE) validated version in Portuguese; 2) nasal endoscopic evaluation; and, 3) Sino Nasal Outcome Test Questionnaire (SNOT-22). Through the NOSE questionnaire, the patient's disease will be classified as "Controlled", "Partially Controlled" or "Uncontrolled (Uncontrolled)". Any variation in the endoscopic evaluation score based on the Lund-Kennedy Criteria will be considered an alteration. And for the SNOT-22 Questionnaire, changes will be considered when the total score varies by at least 11 points. Patients who present these 3 alterations will be considered to have the 'uncontrolled disease' and, therefore, will be eligible for the study.

Exclusion Criteria:

* Patients with malformations, trauma and/or tumors in the nasal and paranasal sinuses will be excluded;
* Patients with a history of recent nasal surgery up to 6 months previously, with glaucoma and cataracts.
Gene Expression in Hyperparathyroidism

Objectives:

1. To better define the differences in molecular genetics of parathyroid tumors in patients with MEN1, single gland parathyroid disease in patients less than 50 years old and single gland disease in patients greater than 50 years old.
2. To better define the incidence of HRPT2 mutation in young patients with primary hyperparathyroidism and determine whether routine testing in these patients is indicated.

Patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports. Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients will be stained for parafibromin to evaluate for HRPT2 mutations.

Eligibility Criteria:
Inclusion Criteria:

1. All patients previously enrolled in parathyroid tissue banking under protocol Lab08-0034.
2. For the subgroup designated for HRPT2 mutation testing:

Patients with primary hyperparathyroidism who are younger than 50 years of age and have tested negative for MEN1, between January 1, 1980 and the present.

Exclusion Criteria:

N/A