cyrilzakka/clinical-trials huggingface dataset:
ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study

The primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.

This is a 12-month, 3-arm randomized controlled trial of 315 Childhood Cancer Survivor Study (CCSS) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. Participants will be randomly assigned to one of three groups: control, patient activation (PA) using a text message/video intervention, or patient activation + primary care provider activation (PA + PCP) which will include providing primary care providers with resources about colorectal cancer risk in this population. All participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations.

The primary outcome is the proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if the Cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. The study will test the hypothesis that, compared to controls, survivors randomized to the PA and PA + PCP activation groups will have significantly higher rates of completion of colorectal cancer screening.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants will include people who:

* Enrolled on the Childhood Cancer Survivor Study
* Were treated with radiation to the abdomen, pelvis, spine, or total body irradiation
* Have no history of colorectal cancer
* Have not had a colonoscopy in the last 5 years or Cologuard in the last 3 years
* Have a smartphone

Exclusion Criteria:

* Do not reside in the United States
* Do not speak English
Interleukin-1 Blockade With Canakinumab to Improve Exercise Capacity in Patients With Chronic Systolic Heart Failure and Elevated High Sensitivity C-reactive Protein (Hs-CRP)

The proposed study is a sub-study of the CANTOS trial (A randomized, double-blind, placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated high sensitivity C-reaction protein (hsCRP) \[CACZ885M2301\]).

The study proposes to perform serial Cardiopulmonary Exercise Tests (CPX) to prospectively measure changes in aerobic exercise capacity in patients with prior myocardial infarction (MI), elevated C reactive protein plasma levels, and symptomatic heart failure with reduced systolic function, who are enrolled in the main CANTOS trial and are randomly assigned to Canakinumab (3 different doses) or Placebo.

The subjects enrolled in this substudy will undergo repeated CPX and echocardiograms over the first 12 months of the CANTOS trial. The subjects will received the experimental treatment as randomized in the main CANTOS trial and they will not receive any additional experimental treatment as part of the sub-study.

This study is a an Investigator-initiated (Dr. Abbate) single-center (Virginia Commonwealth University) sub-study of the CANTOS trial, supported by Novartis pharmaceuticals.

Patients enrolled in the CANTOS trial (with prior acute myocardial infarction \[\>30 days\] and elevated C reactive protein levels \[CRP\>2mg/l\]) who also have reduced left ventricular ejection fraction (LVEF\<50%) and are symptomatic for heart failure (New York Heart Association symptoms class II-III) will be offered to take part in this sub-study at the Virginia Commonwealth University site.

As part of the sub-study, patients will undergo a cardiopulmonary exercise test (CPX) at baseline prior to initiation of treatment, then repeated at 3 and 12 months, and a transthoracic echocardiogram at baseline and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* all criteria listed in the CANTOS trial (CACZ885M2301)
* left ventricular ejection fraction \<50%
* symptoms of heart failure (NYHA class II-III)

Exclusion Criteria:

* all criteria listed in the CANTOS trial (CACZ885M2301)
* inability to complete a treadmill exercise test
* conditions preventing interpretation of the cardiopulmonary test (arrhythmias, ischemia, hypertension, pulmonary disease)
Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery

This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. The investigators wish to test whether a narcotic free anesthetic will result in an overall safer surgery, better patient recovery, and satisfaction. The investigators think also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover faster after surgery , and consume less pain medicines in the postoperative period.


Eligibility Criteria:
Inclusion Criteria

* Men and women 18- to 80-years old
* ASA 1, 2, 3
* 1 or 2 levels ACDF

Exclusion Criteria

* ASA 4
* Seizure disorders
* Chronic narcotic use
* Opiate abuse
* Major cardiac comorbidity, or significantly elevated blood pressure
* Known hypersensitivity to fentanyl analogs, ketamine, or propofol injectable emulsions.
* Known allergy to eggs, egg products, soybeans, or soy products
Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy

Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment with exclusive radiotherapy or exclusive surgery.
* patients treated for these cancers at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
* Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors.

Exclusion Criteria:

-
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies

This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.


Eligibility Criteria:
Inclusion criteria:

Patients may be included in the study if they meet all of the following criteria:

* Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification
* Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy)
* Patients must be ≥ 18 years
* Patients must have life expectancy \> 3 months
* Patient must have adequate laboratory results
* Patients must have WHO Performance Status grade 0, 1, or 2
* Patients must have at least one site of measurable disease
* Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
* Patients must be willing and able to sign the informed consent form and comply with the study protocol

Exclusion criteria:

Patients will be excluded from the study if they meet any of the following criteria:

* Patients who have been treated with any anti-CD40 antibody
* Patients who have received prior allogeneic stem cell transplant
* Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
* Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
* Women of child-bearing potential (WCBP) who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply
A Longitudinal Study of Function and Participation in Life Activities of Patients With Developmental Disabilities

A Longitudinal Study of Function and Participation in Life Activities of Patients with Developmental Disabilities

Developmental Disabilities (DD) is defined as a group of neurodevelopmental issues, leading to significant lag in one or more areas (e.g. cognition, speech, motor, self-care and psychosocial function) for various reasons. On the basis of International Classification of Functioning, Disability and Health -Children and Youth Version (ICF-CY) framework, problems related to Developmental Disabilities further limit activities of daily living (ADL) and participation of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Developmental Disabilities
2. Age 0-25 y/o
3. Agree to sign informed consent

Exclusion Criteria:

1. Active medical condition (e.g. infection)
2. Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
3. Concurrent illness or disease not typically associated with DD (e.g. pneumonia)
Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects

Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic patients (all types)
* Skin phototype 1-4

Exclusion Criteria:

* For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
* For female participants: Breastfeeding
* Subjects not able to understand and read Danish
* In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
* Diagnosed with reduced circulation
* Extensive skin changes, tattoos or diseases on probe application site
* Known allergy to medical grade alcohol
* Known allergy to adhesives, applicable to subjects in RSP-16-01
* Systemic or topical administration of glucocorticoids for the past 7 days and under investigation
* Participants undergoing dialysis treatment
* Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Participants currently enrolled in another study
Air Optix Night and Day Aqua (AONDA) Retrospective Study 1

The purpose of this study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations.

In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.

Eligibility Criteria:
Key Inclusion Criteria:

* Normal eyes, as determined or known by the investigator;
* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
* Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
* Baseline and 1-year visit chart available;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline;
* The use of systemic or ocular medications contraindicating regular contact lens wear at baseline;
* History of refractive surgery or irregular cornea;
* Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline;
* Other protocol-specified exclusion criteria may apply.
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial

Haloperidol is known to be a safe alternative medication to control difficult pain, and has been shown effective when compared to placebo for controlling headaches. Investigators hypothesized that the combination of haloperidol and diphenhydramine would be a useful medication choice for migraine headache patients in the emergency department in comparison to a common migraine treatment regimen of metoclopramide and diphenhydramine.

Investigators conducted a prospective, double-blind, randomized controlled trial in migraine patients who presented to an academic emergency department between June 2013 and November 2013. Research data was derived from an IRB approved protocol. All subjects met IHS migraine criteria and received a one liter bolus of normal saline plus 25 milligrams (mg) of diphenhydramine. Subjects were subsequently randomized to receive 10 mg metoclopramide or 5 mg haloperidol IV. Pain was self-reported at onset and at 20 minute intervals using a 100mm visual analog scale (VAS). Adequate pain control was considered to be patient satisfaction with symptomatic relief. If adequate pain relief was not obtained after 80 minutes, rescue medication was given at the treating physician's discretion. Adverse reactions were recorded and electrocardiograms (ECGs) were obtained before and after study medication administration. Follow up phone surveys were performed 72 hours after discharge to assess headache recurrence, adverse effects, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Migraine Headache must contain the following:

* At least two: Unilateral, Throbbing, Worsening with activity, Moderate to severe pain
* At least one: Nausea or Vomiting, Photophobia or phonophobia
* Ages 18-50

Exclusion Criteria:

* Hypersensitivity to haloperidol, metoclopramide, and/or diphenydramine
* History of ischemic heart disease or signs or symptoms of ischemic heart disease
* History of stroke or transient ischemic attack (TIA)
* History of peripheral vascular disease
* History of uncontrolled hypertension with presenting diastolic blood pressure \> 100
* Use of an ergotamine derivatives, triptan, or dopamine-blocking anti-emetic within the past 24 hrs
* Concurrent administration or within 2 weeks of discontinuing an MAO inhibitor
* Concurrent management of hemiplegic or basilar migraine or known neurologic disorder
* Severe hepatic impairment
* Pregnancy or breastfeeding
* History of cancer (except non-melanoma skin cancer)
* Previous involvement in the study
* Febrile to 100.5 or greater
* Any indication for further diagnostic evaluation of this headache such as a lumbar puncture or CT scan.
* Headache differs from their normal headache
Tiotropium and Salmeterol PK Study in COPD Patients

The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

COPD patients of \>= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years

Exclusion Criteria:

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Pregnant or nusing women
7. Known hypersensitivity to components of the study medication
GPC3/Mesothelin-CAR-γδT Cells Against Cancers

The third generation of GPC3/mesothelin targeted CAR-γδT cells have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.

1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to determine the expression of GPC3 or Mesothelin of the tumors by western blotting or IHC;
3. Collect blood from the patients and isolate mononuclear cells, select and grow γδT cells and transfect the γδT cells with GPC3 or Mesothelin targeting CAR, amplify the transfected γδT cells as needed, test the quality and killing activity of the CAR-γδT cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced cancer that expresses GPC3 or Mesothelin protein; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

-

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate. -
Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT

The purpose of this project is to examine the effect of expectancy on mood and alertness after consumption of caffeine "treatment" or placebo "control" pill, given that participants know their probability for receiving the caffeine versus placebo pill. Participants will be randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and this probability will be revealed to them before consumption of the assigned pill and subsequent cognitive testing. At the time of consumption, neither study staff administering the intervention nor participants will know for certain which pill is given to each participant. Pill assignment will depend on pre-determined randomization probabilities, which will be provided and assigned by the study statistician. By revealing participants' individual probability of receiving the caffeine pill, we will induce positive or negative expectancies regarding likelihood for receipt of the caffeine pill. These experimental manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes, and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world conditions than would a conventional randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years-old or older
* available to participate on the dates specified
* willing to take a caffeine or placebo pills at study session
* willingness to abstain from caffeine for 12 hours prior to study visit (8:30pm-8:30am)
* UAB employees or students with some college education (including current enrollment)

Exclusion Criteria:

* self-reported use of ADHD medication
* self-reported use of anxiety medication
* self-reported use of sleep medication
* self-reported use of nicotine products
* self-reported lactose intolerance
* self-reported uncorrected vision
* self-reported pregnancy or trying to become pregnant
Pre-analytical Sample Handling Conditions and Their Effects on the Human Serum Metabolome

This study evaluates how blood serum handling conditions can affect the concentrations of \~1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 65 years at beginning of study.
* BMI between 18.5 and 35.0 kg/m2.

Exclusion Criteria:

* Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
* Unable or unwilling to give informed consent or communicate with study staff.
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.