cyrilzakka/clinical-trials huggingface dataset:
Brief Alcohol Intervention for School-to-Work Transitions

This is a 2-year research project to test the efficacy of brief motivational intervention for reducing heavy alcohol use in young adults transitioning out of high school. Participation occurs within 3 months prior to graduation or within 1 year following graduation or dropout from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session of BMI or one session of relaxation training. All participants complete identical assessments at baseline and immediately post-intervention (during session 1). Participants also complete in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators (person-level predictors) of intervention response; and c) identifying mediators (mechanisms) of intervention effects, that is, how BMI exerts its effect on outcomes.

This study tested the efficacy of a single session of BMI for reducing heavy drinking and related adverse consequences among underage young adult drinkers not attending a 4-year college or university. We designed the intervention to be delivered proximal to the transition out of high school (with or without graduation), because such periods of transition and discontinuity in the life course present opportunities to positively alter developmental paths (Masten et al., 2009). Thus, interventions timed to co-occur with naturalistic transition points may have great potential for decreasing drinking trajectories or preventing harmful escalations in trajectories going forward. To increase the applicability of our findings to the heterogeneous population of community-dwelling young adults, our recruitment targeted a purposefully inclusive "non-4-year-college" population. We hypothesized that, compared to a time and attention-matched control condition (i.e., relaxation training \[REL\]), BMI would result in significantly reduced heavy drinking and reduced adverse consequences of alcohol use at 6-week and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* high school students anticipating graduation within 3 months, drop outs or graduates
* males must report at least one day drinking 5 or more standard drinks in past month
* females must report at least one day drinking 4 or more standard drinks in past month

Exclusion Criteria:

* plans to enroll at traditional 4-year college within 12 months
* plans to enter military within next 12 months
* plans to move more than 1 hour from current location in within 12 months
To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug

SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment of respiratory infections.

The purpose of this study is to estimate the bioavailability of four different formulations and to evaluate the safety of each of the four formulations


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible physician, based on medical evaluations performed at screening.
* Healthy adults between 18 and 60 years of age, inclusive.
* Body weight proportional to height.
* Capable of giving written informed consent.
* Female subjects must be of non-childbearing potential.
* QTc less than 450 msec at screening

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening history and physical or on the 12-lead surface electrocardiogram at screening or pre-dose.
* The subject has a positive pre-study alcohol/urine drug screen.
* History of regular use of tobacco, or nicotine-containing products.
* A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result within 3 months of screening.
* Use of certain prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
* An unwillingness to comply with lifestyle and/or dietary restrictions.
DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions

The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C \& D) Is is the first time that the use of 200 mm long stents will be evaluated in these lesions. It is expected that the outcome of the treatment with this type of long stents will be better as the treatment of identical lesions lengths with multiple shorter stents.


Eligibility Criteria:
Inclusion Criteria:

GENERAL

* De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for stenting
* Patient presenting a score from 2 to 5 following Rutherford classification
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Prior to enrollment, the guidewire has crossed target lesion
* Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent

ANGIOGRAPHIC

* The target lesion is located within the native femoropopliteal artery until maximally 3 cm proximally of the knee joint.
* The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
* The target lesion, visually estimated, has a minimal length of 15 cm and can be categorized as either a type C or D lesions according the TASC II guidelines
* Target vessel diameter visually estimated is \>4mm and \<6.5 mm
* There is angiographic evidence of at least one-vessel-runoff to the foot

Exclusion Criteria:

* Presence of another stent in the target vessel that was placed during a previous procedure
* Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
* Previous by-pass surgery in the same limb
* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
* Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
* Perforation at the angioplasty site evidenced by extravasation of contrast medium
* Patients with known hypersensitivity to nickel-titanium
* Patients with uncorrected bleeding disorders
* Aneurysm located at the level of the SFA
* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Life expectancy of less than twelve months
* Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure
* Use of thrombectomy, artherectomy or laser devices during procedure
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness

The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients (minimum age 18) meeting specific criteria for dry eye.

Exclusion Criteria:

* Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
* History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.
The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion

Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p\<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p\<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.

The purpose of this study is to determine if postoperative cryotherapy with a cold-therapy system reduces postoperative pain and narcotic consumption following single and multi-level spinal fusion.

The investigators hypothesize that patients undergoing lumbar spinal fusion who receive postoperative cryotherapy treatment with a cold-therapy system will have reduced inpatient pain scores and require less narcotics as compared to patients that receive standard care (ice pack).

Eligibility Criteria:
Inclusion Criteria:

1. Single or multi-level lumbar spinal fusion for degenerative pathology, including: radiculopathy, central spinal stenosis, foraminal stenosis, herniated nucleus pulposus, degenerative disc disease, and isthmic or degenerative spondylolisthesis.
2. Patient able to provide informed consent

Exclusion Criteria:

1. Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery
2. Workers' compensation insurance claim
3. Active or history of malignancy
4. Unable to speak, read, or comprehend English language
Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis

The purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Adults between 18 and 85 years of age with palmar plantar psoriasis with well defined psoriatic plaques on the palms and/or soles with a Physician Global Assessment (PGA) of 3 or higher who are unresponsive to topical management. Pustules, fissures and psoriatic arthritis may be present but are not required.
2. Adults in general good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination.
3. Females of reproductive potential are eligible to participate in the study if they have a negative urine pregnancy test at screening and baseline and who are using 2 forms of effective birth control.
4. Palmar/Plantar PGA of 3 or more

Exclusion Criteria:

1. Psoriasis patients without palm and/or sole psoriasis or a palmar/plantar PGA score of less than 3
2. Patients younger than 18 and older than 85 years old.
3. Evidence of skin conditions at the time of the screening visit (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
4. Receipt of any investigational drugs within 4 weeks of study drug initiation
5. Psoralens + UltraViolet A (PUVA) or oral systemic treatments within 4 weeks of study drug initiation.
6. Biologics within 3 months of study initiation
7. Ultraviolet B (UVB) therapy or topical steroids within 2 weeks of study drug initiation
8. A prior history of tuberculosis, and/or a positive Purified Protein Derivative (PPD) skin test/Chest X-Ray (CXR) at screening without appropriate treatment. Treatment of latent Tuberculosis (TB) infections (for those with positive PPD tests) must be initiated prior to therapy.
9. Receipt of live vaccines 1 month prior to or while in study
10. Chronic hepatitis B or hepatitis C infection
11. History of alcohol or drug abuse one year before and during the study.
12. Known Human Immunodeficiency Virus (HIV)-positive status or any other immune-suppressing disease.
13. Any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study
14. Presence of a grade 3 or 4 infection \<30 days prior to the screening visit, between the screening visit and the first day of treatment on study, or any time during the study that in the opinion of the Investigator would preclude participation in the study.
15. Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)
The Dynamics of Human Atrial Fibrillation

Atrial fibrillation (AF) is an enormous public health problem in the United States, affecting 2-5 million Americans and causing rapid heart beats, stroke, heart failure or death. In this project, the applicant will develop a novel framework to better understand human AF that builds on agreement between several concepts for the disease. The applicant will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.

The specific aim of this clinical study is to identify patients who will or will not respond to PVI, PVI plus other ablation or Maze surgery based on locations of organized-to-disorganized areas and clinical profile. We will develop non-invasive ECGI and intracardiac recordings in our registry, then test them prospectively in an observational study.

Premise: Identifying responders or non-responders to PVI alone, or PVI plus other ablation or Maze surgery may enable patient-tailored therapy. This may raise overall success, reduce risks from unsuccessful procedures and improve resource utilization(58,128-130). This proposal will prospectively test in single-arm observations studies if patients who exhibit large organized AF areas at planned ablation regions have higher procedural success than patients with smaller areas. We will use non-invasive ECGI indices of organized AF, based on Preliminary data(9, 84, 85).

This project is significant because it will establish a deeper understanding of AF and will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.

Eligibility Criteria:
Inclusion Criteria:

* referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts \>7 days)
* Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of \>or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.

Exclusion Criteria:

* active coronary ischemia or decompensated heart failure
* atrial or ventricular clot on trans-esophageal echocardiography
* pregnancy (to minimize fluoroscopic exposure)
* inability or unwillingness to provide informed consent
* rheumatic valve disease (results in a unique AF phenotype)
* thrombotic disease or venous filters
* prior chest surgery is a relative contraindication for Maze surgery
A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus

Primary objective:

* To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.

Secondary objectives:

* To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
* To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
* To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
* To obtain safety data on the use of insulin glargine in each treatment algorithm.
* To measure change in subject weight and insulin dose between baseline and end of treatment.
* To determine subject quality of life and treatment satisfaction (sub-study)


Eligibility Criteria:
Inclusion criteria:

* Subjects with Type 2 Diabetes Mellitus,
* Subjects on antidiabetic treatment (oral and/or insulin therapy) for \> 6 months,
* Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
* HbA1c values \> 7.0% and \< 12 %,
* BMI \< 40 kg/m².

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Dynamic Area Telethermometry (DAT) as an Imaging Modality in Patients With Cancer

The purpose of this study is to evaluate whether this new method of taking pictures called Dynamic Area Telethermometry (DAT) might be a good way of looking at patients with cancer that is relatively close to the surface of the body.

* The DAT system resembles a video camera which picks up changes in body temperature which may reflect disease-related changes in blood flow to some areas, particularly those involved with tumors.
* Patients with known tumor sites amendable to DAT evaluation will be imaged at the time of staging and at later time points. Thermal profiles will be compared to those of normal adjacent tissues and correlated with the images of the tumors on conventional images.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy
* Primary or secondary tumor location amendable to DAT scanning: subcutaneous tissues
* Older than 15 years of age
* Able to withhold movement for 20 seconds, hold breath for 20 seconds for chest wall lesions and clinically stable acutely

Exclusion Criteria:

* Uncontrolled motion
* Tumors not verified or measurable by standard imaging
Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR

Post Market TKR study

A post-market study to evaluate the safety and effectiveness of the GAP-FLEX device in combination with standard of care physical therapy compared to the standard of care CPM device in combination with standard of care physical therapy in Subjects who have undergone TKR

Eligibility Criteria:
Inclusion Criteria:

* Minimum age 50 years
* Subject is undergoing total knee replacement
* Subject agrees to comply with the physical therapy regime

Exclusion Criteria:

* With a flexure contracture \> 10 degrees
* Degree of flexion \< 60 degrees pre-procedure or immediately post-procedure
* Severe motion restriction as determined by the investigator
* Severe deformity determined by the investigator
* Taking chronic pain medication for use other than knee pain
* Post surgery hospital stay is \> 4 days
* Knee disorders other than osteoarthritis
* With fibromyalgia
* Chronic narcotic use as determined by the investigator.
* Have a medical or psychological history that in the opinion of the investigator would make the subject a poor candidate for the study.
* Who need a revision implant
* Who have participated in clinical study within the past 30 days (prior to enrollment) that may affect the outcome of this study
* Amputations below or above knee of non-operated leg
* Weight is \>250 pounds and/or morbidly obese (BMI \> 40)
* History of blood clots
* Deep vein thrombosis
* Females who are pregnant
* Females who wish to become pregnant during the length of study participation
* Subjects with any of the following post-surgery conditions;
* Screws needed
* Intraoperative identification of a fracture or soft bone
* Admitted to ICU
* Additional procedures (other than TKR) needed for other identified or pre-existing conditions
Healthy Homes Study

This study is about home air radon testing and has two phases.

The goal of the first phase is to learn about renters' and homeowners' views and plans related to radon testing. The main question this phase aims to answer is:

1. Does taking part in a focus group with information about radon testing change people's plans to test for radon?

Participants in the first study phase will:

* Take a survey about their views on and plans for radon testing.
* Take part in a focus group discussion about radon testing, during which they will receive information about radon testing.
* Right after the focus group, take a survey about their plans for radon testing.

The second phase is a pilot interventional study. The goal is to test interventions about radon testing with renters and homeowners who smoke and do not smoke. The main questions this phase aims to answer are:

1. Does the recruitment strategy result in enough participants enrolling within 3 months?
2. Will at least 80% of participants complete data collection activities?
3. Will more participants who view an online intervention developed by the researchers request free radon test kits, set them up in their homes, and complete radon testing, compared to participants who view a standard public health infographic? And will even more participants who receive reminder messages, in addition to the online intervention, request free radon test kits, set them up in their homes, and complete radon testing?

Participants in this second phase will:

* Take a survey about their views on and plans for radon testing.
* View an intervention about radon testing.
* Right after viewing the intervention, take a survey about their views on and plans for radon testing.
* 2 months later, take a survey about what, if any, steps they've taken to test their homes for radon.
* Provide the researchers permission to collect data from their State Radon Program on: a) whether they requested a free radon test kit and b) whether testing was completed.

Some participants will receive reminder messages for 2 months after viewing the intervention.

Researchers will compare an online intervention they developed about radon testing to: a) a standard public health infographic and b) their online intervention combined with reminder messages about radon testing. They will compare the interventions by proportion of participants who: a) request a free radon test kit from their State Radon Programs, b) set-up the radon test kit in their homes, and c) complete radon testing.

This study is a pilot research study.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Have a valid mailing address in New Hampshire or Vermont,
* Have not tested their current homes for radon,
* Rent or own their home, and
* Live at their home year-round

Exclusion Criteria:

* N/A